UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
(Mark
One)
x
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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For
the fiscal year ended December 31, 2007
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or
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¨
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the transition period from ___________ to ___________
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Commission
File No. 000-23143
PROGENICS
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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13-3379479
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(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer Identification Number)
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____________
777
Old Saw Mill River Road
Tarrytown,
NY 10591
(Address
of principal executive offices, including zip code)
Registrant’s
telephone number, including area code: (914) 789-2800
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each
class Name of each exchange on
which registered
Common
Stock, par value $0.0013 per
share The
NASDAQ Stock Market LLC
Securities
registered pursuant to Section 12(g) of the Act:
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None
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____________
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities
Act. Yes o No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes o No
x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports) and (2) has been subject to such filing requirements for
the past 90 days. Yes
x
No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company. See
definition of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (Check one):
Large
Accelerated Filer ¨ Accelerated
Filer x
Non-accelerated Filer ¨ Smaller
Reporting Company ¨
(Do
not check if a smaller reporting
company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No x
The
aggregate market value of the voting and non-voting stock held by non-affiliates
of the registrant on June 30, 2007, based upon the closing price of the Common
Stock on The NASDAQ Stock Market LLC of $21.57 per share, was approximately
$380,080,000
(1). .
(1)
|
Calculated
by excluding all shares that may be deemed to be beneficially owned by
executive officers, directors and five percent stockholders of the
Registrant, without conceding that any such person is an “affiliate” of
the Registrant for purposes of the Federal securities
laws.
|
As of
March 13, 2008, 29,846,762 shares of Common Stock, par value $.0013 per
share, were outstanding
DOCUMENTS
INCORPORATED BY REFERENCE
Specified
portions of the Registrant’s definitive proxy statement to be filed in
connection with solicitation of proxies for its 2008 Annual Meeting of
Shareholders are hereby incorporated by reference into Part III of this
Form 10-K where such portions are referenced.
PART
I
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Item
1.
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1
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Item
1A.
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18
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Item
1B.
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28
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Item
2.
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28
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Item
3.
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29
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Item
4.
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29
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PART
II
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Item
5.
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30
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Item
6.
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31
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Item
7.
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32
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Item
7A.
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51
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Item
8.
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51
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Item
9.
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51
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Item
9A.
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52
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Item
9B.
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52
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PART
III
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Item
10.
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53
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Item
11.
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53
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Item
12.
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53
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Item
13.
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53
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Item
14.
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53
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PART
IV
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Item
15.
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54
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F-1
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S-1
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E-1
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PART
I
Certain
statements in this Annual Report on Form 10-K constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995. Any statements contained herein that are not statements of historical
fact may be forward-looking statements. When we use the words ‘anticipates,’
‘plans,’ ‘expects’ and similar expressions, it is identifying forward-looking
statements. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause our actual results, performance
or achievements, or industry results, to be materially different from any
expected future results, performance or achievements expressed or implied by
such forward-looking statements. Such factors include, among others, the risks
associated with our dependence on Wyeth to fund and to conduct clinical testing,
to make certain regulatory filings and to manufacture and market products
containing methylnaltrexone, the uncertainties associated with product
development, the risk that clinical trials will not commence, proceed or be
completed as planned, the risk that our product candidates will not receive
marketing approval from regulators, the risks and uncertainties associated with
the dependence upon the actions of our corporate, academic and other
collaborators and of government regulatory agencies, the risk that our licenses
to intellectual property may be terminated because of our failure to have
satisfied performance milestones, the risk that product candidates that appear
promising in early clinical trials are later found not to work effectively or
are not safe, the risk that we may not be able to manufacture commercial
quantities of our products, the risk that our products, if approved for
marketing, do not gain sufficient market acceptance to justify development and
commercialization costs, the risk that we will not be able to obtain funding
necessary to conduct our operations, the uncertainty of future profitability and
other factors set forth more fully in this Form 10-K, including those described
under the caption Item 1A. –
Risk Factors, and other periodic filings with the U.S. Securities and
Exchange Commission, or SEC, to which investors are referred for further
information.
We do not
have a policy of updating or revising forward-looking statements, and we assume
no obligation to update any forward-looking statements contained in this Form
10-K as a result of new information or future events or developments. Thus, you
should not assume that our silence over time means that actual events are
bearing out as expressed or implied in such forward-looking
statements.
Available
Information
We file
annual, quarterly and current reports, proxy statements and other documents with
the SEC under the Securities Exchange Act of 1934, or the Exchange Act. The SEC
maintains an Internet website that contains reports, proxy and information
statements and other information regarding issuers, including Progenics, that
file electronically with the SEC. The public can obtain any documents that we
file with the SEC at http://www.sec.gov.
The public may also read and copy any materials that we file with the SEC at the
SEC’s Public Reference Room at 100 F Street NE, Washington, DC 20549. The public
may obtain information on the operation of the Public Reference Room by calling
the SEC at 1-800-SEC-0330.
We also
make available, free of charge, on or through our Internet website
(http://www.progenics.com) our Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K, proxy materials and, if applicable,
amendments to those reports filed or furnished pursuant to Section 13(a) of the
Exchange Act as soon as reasonably practicable after we electronically file such
material with, or furnish it to, the SEC.
Overview
Progenics
Pharmaceuticals, Inc. is a biopharmaceutical company focusing on the development
and commercialization of innovative therapeutic products to treat the unmet
medical needs of patients with debilitating conditions and life-threatening
diseases. Our principal programs are directed toward gastroenterology, virology
and oncology. We commenced principal operations in late 1988, and since that
time we have been engaged primarily in research and development efforts,
development of our manufacturing capabilities, establishment of corporate
collaborations and raising capital. We do not currently have any commercial
products.
Gastroenterology
In the area of gastroenterology, our
work is focused on methylnaltrexone, which is our most advanced product
candidate. In December 2005, we entered into a license and co-development
agreement (the “Collaboration Agreement”) with Wyeth Pharmaceuticals (“Wyeth”)
to develop and commercialize subcutaneous, intravenous and oral formulations of
methylnaltrexone. Both the U.S. Food and Drug Administration (“FDA”) and the
European Medicines Agency (“EMEA”) have provisionally accepted the name
RELISTOR™ as the
proprietary name for methylnaltrexone. The Collaboration Agreement involves the
development and commercialization of three formulations: (i) a subcutaneous
formulation of RELISTOR, to be used in patients with opioid-induced constipation
("OIC"); (ii) an intravenous formulation of RELISTOR, to be used in patients
with post-operative ileus; and (iii) an oral formulation of RELISTOR, to be used
in patients with opioid-induced constipation. We have submitted a New Drug
Application (“NDA”) to the FDA for marketing of the subcutaneous formulation of
RELISTOR for treatment of OIC in patients receiving palliative care. See Gastroenterology and Licenses – Progenics Licenses –
Wyeth, below.
Virology
In the area of virology, we are
developing viral-entry inhibitors for Human Immunodeficiency Virus (“HIV”), the
virus that causes Acquired Immunodeficiency Syndrome (“AIDS”), and Hepatitis C
virus infection (“HCV”). These inhibitors are molecules designed to inhibit
a virus’ ability to enter certain types of immune cells and liver cells. In
May 2007, we announced positive results from a phase 1b trial of an intravenous
formulation of our monoclonal antibody, PRO 140, in HIV-infected
individuals. We are also investigating a subcutaneous formulation of PRO 140
with the goal of developing a long-acting, self-administered therapy for HIV
infection. In January 2008, we initiated the phase 2 clinical program for PRO
140, which will involve both the intravenous and subcutaneous
formulations.
Hepatitis
C is a major cause of chronic liver disease, affecting an estimated 4.1 million
Americans of whom 3.2 million are chronically infected. We are exploring
both monoclonal antibody and small molecule approaches in our HCV research and
have identified lead molecules that potently inhibit viral entry in in vitro models.
We are
also engaged in research regarding a vaccine against HIV infection.
See Virology, below.
Oncology
In the
area of prostate cancer, we are developing a human monoclonal antibody-drug
conjugate, consisting of a selectively targeted cytotoxic antibody directed
against prostate specific membrane antigen (“PSMA”), a protein found on the
surface of prostate cancer cells. We are also developing vaccines designed to
stimulate an immune response to PSMA. Our PSMA programs are conducted through
our wholly owned subsidiary, PSMA Development Company LLC (“PSMA LLC”), which
prior to April 2006 was a joint venture with Cytogen Corporation (“Cytogen”).
See Prostate Cancer,
below.
In the
second quarter of 2007, we discontinued our GMK melanoma vaccine program. An
independent data monitoring committee recommended that treatment in the
European-based phase 3 trial, which began in 2001, be stopped because lack of
efficacy was observed after an interim analysis. We have subsequently terminated
our license agreement with Memorial Sloan-Kettering Cancer Center relating to
this program.
Product
In-Licensing
We seek
out promising new products and technologies around which to build new
development programs or enhance existing programs. We own the worldwide
commercialization rights to each of our product candidates except RELISTOR, the
commercialization of which is the responsibility of Wyeth under the
Collaboration Agreement.
The following table summarizes the current status of our principal
development programs and product candidates:
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Program/product
candidates (note 1)
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Proposed
Indication
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Status
(note 2)
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Gastroenterology
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RELISTOR-Subcutaneous
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Treatment
of opioid-induced constipation in patients receiving palliative
care
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Applications
for marketing submitted in the U.S., E.U., Australia and Canada; FDA
action date of April 30, 2008
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RELISTOR-Subcutaneous
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Treatment
of opioid-induced constipation in patients receiving opioids for chronic
pain not related to cancer, such as severe back pain
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Phase
3
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RELISTOR-Subcutaneous
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Treatment
of opioid-induced constipation in patients receiving opioids for pain
during rehabilitation from an orthopedic surgical procedure
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Phase
2
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RELISTOR-Intravenous
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Management
of post-operative ileus
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Phase
3 (note 3)
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RELISTOR-Oral
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Treatment
of opioid-induced constipation
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Phase
2
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Virology
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HIV
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PRO
140
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Treatment
of HIV infection
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Phase
2
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ProVax
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Treatment
and prevention of HIV infection
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Research
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Hepatitis
C (HCV)
Viral
entry inhibitors
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Treatment
of HCV infection
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Research
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Oncology
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Prostate
Cancer
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PSMA:
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Monoclonal
antibody drug conjugate
Recombinant
protein vaccine
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Treatment
of prostate cancer
Immunotherapy
for prostate cancer
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Pre-clinical
Pre-clinical
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Viral-vector
vaccine
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Immunotherapy
for prostate cancer
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Pre-clinical
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(1)
(2)
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RELISTOR
is a trademark of Wyeth Pharmaceuticals, a division of Wyeth.
“Research”
means initial research related to specific molecular targets, synthesis of
new chemical entities, assay development or screening for the
identification of lead compounds.
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“Pre-clinical”
means that a lead compound is undergoing toxicology, formulation and other
testing in preparation for clinical trials.
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Phase
1-3 clinical trials are safety and efficacy tests in humans as
follows:
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“Phase
1”: Evaluation of safety.
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“Phase
2”: Evaluation of safety, dosing and activity or
efficacy.
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“Phase
3”: Larger scale evaluation of safety and efficacy.
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(3)
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For
recent developments concerning this program, see Gastroenterology –
RELISTOR – Intravenous RELISTOR, below.
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None of
our product candidates has received marketing approval from the FDA or any other
regulatory authority, and we have not yet received any revenue from the sale of
any of them. We must receive marketing approval before we can commercialize any
of our product candidates.
Gastroenterology
About
Opioids. Opioid-based medications such as morphine and codeine,
which are often referred to as narcotics, are the mainstay used by healthcare
practitioners to control moderate-to-severe pain. We estimate that approximately
240 million prescriptions for opioids are written annually in the U.S.
Physicians prescribe opioids for patients receiving palliative care, undergoing
surgery or experiencing chronic pain, as well as for other medical
conditions.
Opioids
relieve pain by interacting with receptors that are located in the brain and
spinal cord, which comprise the central nervous system. At the same time,
opioids also activate receptors outside the central nervous system, resulting,
in many cases, in undesirable side effects, including constipation, delayed
gastric emptying, nausea and vomiting, itching and urinary retention. Current
treatment options for opioid-induced constipation include laxatives and stool
softeners, which are often therapeutically insufficient, are not recommended for
chronic use and do not address the other associated side effects. As a result,
many patients may have to stop or reduce their opioid therapy and many opt to
endure pain in order to obtain relief from opioid-induced constipation and its
associated side effects.
RELISTOR
RELISTOR
is a selective, peripherally acting, mu-opioid-receptor antagonist that reverses
certain side effects induced by opioid use. RELISTOR competes with opioid
analgesics for binding sites on opioid receptors, and its chemical composition
restricts its ability to cross the blood-brain barrier. As a result, RELISTOR
“turns off” the effects of opioid analgesics outside the central nervous system,
including the gastrointestinal tract, but does not interfere with opioid
activity within the central nervous system, namely analgesia. RELISTOR is
designed to treat OIC without interfering with the pain relief that the opioids
provide, an important need not currently met by any approved drugs. To date,
individuals treated with RELISTOR, in addition to opioid pain medications, have
experienced a reversal of many of the side effects induced by opioids and have
reported no diminution in pain relief. Methylnaltrexone has been studied in
numerous clinical trials. To date, RELISTOR has been generally well tolerated
and certain formulations have been active in inducing laxation in individuals
suffering from OIC without interfering with pain relief.
Under the
Collaboration Agreement, we share with Wyeth the responsibilities for developing
and obtaining marketing approval of RELISTOR. Wyeth is responsible for
commercializing all three formulations of RELISTOR worldwide. We have an option,
under certain circumstances, to co-promote the sale of any or all of the three
formulations of RELISTOR in the United States. See Progenics Licenses – Wyeth,
below. Some of our rights to RELISTOR arise under a license from the University
of Chicago. See Progenics’
Licenses – UR Labs/University of Chicago, below.
Subcutaneous
RELISTOR. Our most advanced clinical experience with RELISTOR is as a
treatment for opioid-induced constipation. Constipation is a serious medical
problem for patients who are being treated with opioid medications. We estimate
that each year in the U.S., approximately 1.5 million patients receiving
palliative care experience opioid-induced constipation.
We have completed two
pivotal phase 3 clinical trials of the subcutaneous formulation of
methylnaltrexone in individuals receiving palliative care, including cancer,
AIDS and heart disease. We achieved positive results from these trials (studies
301 and 302), including extensions. All primary and secondary endpoints of both
studies were met with statistical significance, and the investigational
drug was generally well tolerated in both.
In March
2007, we submitted an NDA to the FDA for marketing in the United States of a
subcutaneous formulation of RELISTOR for the treatment of opioid-induced
constipation in patients receiving palliative care. In May 2007, Wyeth submitted
a regulatory marketing application to the EMEA for the subcutaneous formulation
in the same patient population. Both applications were accepted for review in
May 2007, which resulted in our earning $9.0 million in milestone payments from
Wyeth under the Collaboration Agreement. The FDA review is expected to be
completed by its Prescription Drug User Fee Act (“PDUFA”) date of April 30,
2008. In August 2007, Wyeth submitted a marketing application to the
Therapeutic Goods Administration division of the Australian government, and in
October 2007, it submitted a New Drug Submission marketing application for
subcutaneous RELISTOR to Health Canada, the Health Products and Food branch of
the Canadian regulatory agency.
In
October 2007, we and Wyeth commenced two additional clinical trials of the
subcutaneous formulation of RELISTOR in individuals outside of the palliative
care population: a phase 3 trial, conducted by Wyeth, in individuals with
chronic pain not related to cancer, such as chronic severe back pain that
requires treatment with opioids; and a phase 2 trial, conducted by us, in
individuals rehabilitating from an orthopedic surgical procedure in whom opioids
are used to control post-operative pain.
Intravenous
RELISTOR. We are also developing, in collaboration with
Wyeth, an intravenous formulation of RELISTOR for the management of
post-operative ileus (“POI”), a temporary impairment of the gastrointestinal
tract function. Of the patients who undergo surgery in the U.S. each year,
approximately 2.4 million patients are at high risk for developing POI.
Post-operative ileus is believed to be caused in part by the release by the body
of endogenous opioids in response to the trauma of surgery and may be
exacerbated by the use of opioids, such as morphine, in surgery and in the
post-operative period. Post-operative ileus is a major factor in increasing
hospital stay, as patients are typically not discharged until bowel function is
restored. Development of the intravenous formulation of RELISTOR for POI
has been granted “Fast Track” status from the FDA, which facilitates development
and expedites regulatory review of drugs intended to address an unmet medical
need for serious or life-threatening conditions.
We and Wyeth have conducted two global
pivotal phase 3 clinical trials to evaluate the safety and efficacy of
intravenous RELISTOR for the treatment of POI in patients recovering from
segmental colectomy surgical procedures. In October 2006, we earned a $5.0
million milestone payment under the Collaboration Agreement in connection with
the initiation of the first phase 3 clinical trial. In October 2007, a third
phase 3 intravenous RELISTOR study, being conducted by Wyeth, was initiated
in individuals with POI following a ventral hernia repair via laparotomy or
laparoscopy.
In March
2008, we reported that preliminary results from the phase 3 segmental colectomy
clinical trial conducted by Wyeth showed that treatment did not achieve the
primary end point of the study: a reduction in time to recovery of
gastrointestinal function (i.e., time to first bowel
movement) as compared to placebo. The study also did not show that secondary
measures of surgical recovery, including time to discharge eligibility, were
superior to placebo. We and Wyeth are conducting the necessary analyses to
determine greater clarity regarding the outcome of this clinical study, whose
preliminary findings are inconsistent with results demonstrated in our previous
phase 2 study of intravenous methylnaltrexone for the management of
postoperative ileus. We are leading the second phase 3 trial of intravenous
methylnaltrexone for management of POI, which is similar in design to the Wyeth
study, and expect results of that trial to be reported by midyear
2008.
Oral RELISTOR.
We and Wyeth are also developing an oral formulation of RELISTOR for the
treatment of opioid-induced constipation in patients with chronic pain. More
than 215 million prescriptions are written annually for opioids and
approximately 12 million patients in the U.S. use opioids chronically (i.e., six months or more),
many of whom experience opioid-induced constipation.
In March
2007, Wyeth began clinical testing of a new oral formulation of methylnaltrexone
for the treatment of opioid-induced constipation, and in July 2007 we and Wyeth
announced positive preliminary results from this phase 1 clinical trial. In
October 2007, we and Wyeth announced the initiation of two four-week phase 2
clinical trials to evaluate daily dosing of this formulation and a different
oral formulation in individuals with chronic, non-malignant pain who are being
treated with opioids and are experiencing opioid-induced constipation. These
studies are designed to evaluate these oral formulations separately. We and
Wyeth plan to assess the safety and dose-response of oral methylnaltrexone as
measured by the occurrence of spontaneous bowel movements during the treatment
period. We expect the studies to assist in determining the formulation and
doses to be advanced into phase 3 studies.
Virology
HIV
Infection
by HIV causes a slowly progressing deterioration of the immune system resulting
in AIDS. HIV specifically infects cells that have the CD4 receptor on their
surface, including T-lymphocytes, monocytes, macrophages and dendritic cells,
all of which are critical components of the immune system. Receptors and
co-receptors are structures on the surface of a cell to which a virus must bind
in order to infect the cell. The devastating effects of HIV are largely due to
the multiplication of the virus within these cells, resulting in their
dysfunction and destruction.
Viral
infection occurs when the virus binds to a host cell, enters the cell, and by
commandeering the cell’s own reproductive machinery, creates thousands of copies
of itself within the host cell. This process is called viral replication. Our
scientists and their collaborators have made important discoveries in
understanding how HIV enters human cells and initiates viral
replication.
The Joint
United Nations Program on HIV/AIDS and the World Health Organization estimate
that the number of individuals living with HIV in 2007 reached 33.2 million,
including over 2.5 million new infections. In North America and Western and
Central Europe, the number of people living with HIV continues to increase due
to the life-prolonging effects of antiretroviral therapy, a steady number of new
HIV infections in North America and an increased number of new HIV diagnoses in
Western Europe. During 2007, there were over two million people living with HIV
in those regions, including 78,000 who acquired HIV in the past year. Although
the number of people living with HIV in those regions has continued to increase
over recent years, the number of annual patient deaths has decreased to
approximately 32,000 in 2007.
Five
classes of products have received marketing approval from the FDA for the
treatment of HIV infection and AIDS: nucleoside reverse transcriptase
inhibitors, non-nucleoside reverse transcriptase inhibitors (these are
considered as different classes by researchers and prescribers alike and have
non-overlapping resistance profiles), protease inhibitors, entry inhibitors and
integrase inhibitors. Reverse transcriptase and protease inhibitors inhibit two
different viral enzymes required for HIV to replicate once it has entered the
cell. Entry inhibitors interrupt the viral life cycle at an earlier point,
namely before HIV can bind to and transfer its genetic material into certain
immune system cells in order to initiate the viral replication
process.
Since the
late 1990s, many HIV patients have benefited from using a combined regimen of
protease and reverse transcriptase inhibitor therapies, known as “combination
therapy.” While combination therapy slows the progression of disease, it is not
a cure. HIV’s rapid mutation rate results in the development of viral strains
that are resistant to these inhibitors. Increasingly, after years of combination
therapy, patients begin to develop resistance to them. The potential for
resistance is increased by inconsistent dosing which leads to lower drug levels
and permits ongoing viral replication. Inconsistent adherence with dosing
requirements for HIV drugs is common in patients on combination therapies
because these drug regimens often require multiple tablets to be taken at
specific times each day. In addition, many of these currently approved drugs
often produce toxic side effects in patients, affecting a variety of organs and
tissues, including the peripheral nervous system and gastrointestinal tract.
These side effects may result in patients interrupting or discontinuing therapy.
Furthermore, as most HIV medications work inside the CD4 cell and are
metabolized, they have the potential to interact with other medications and may
exaggerate side effects or result in sub-therapeutic blood levels.
Viral
entry inhibitors such as our drug candidate PRO 140 represent a new class of
drugs for HIV patients that may avoid many of the issues associated with current
HIV medications. Our scientists, in collaboration with researchers at the Aaron
Diamond AIDS Research Center, or ADARC, described in an article in Nature in 1996 the discovery of a
co-receptor for HIV on the surface of human immune system cells used for HIV
entry. This co-receptor, CCR5, enables fusion of HIV with the cell membrane
after binding of the virus to the CD4 receptor. This fusion step results in
entry of the viral genetic information into the cell and subsequent viral
replication. Our PRO 140 program is based on blocking binding of HIV to the CCR5
co-receptor. Further work by other scientists has established the existence of a
second co-receptor, CXCR4, which is considered to be less ubiquitous for HIV-1
viral entry. Based on our pioneering research, we believe we are a leader in the
discovery of viral entry inhibitors, a promising new class of HIV therapeutics.
We believe viral entry inhibitors could become the next generation of HIV
therapy.
PRO 140 is a humanized
monoclonal antibody designed to block HIV infection by inhibiting the virus’
ability to bind to and enter immune system cells and initiate the viral
replication process. We have designed PRO 140 to target a distinct site on the
co-receptor CCR5 without interfering with CCR5’s role, which includes, in part,
directing the migration of immune cells to sites of inflammation in the body.
PRO 140 has shown promising activity in pre-clinical studies. In in vitro studies, PRO 140
demonstrated potent, broad-spectrum antiviral activity against more than 40
genetically diverse “primary” HIV viruses isolated directly from infected
individuals. Single doses of a murine-based PRO 140 reduced viral burdens to
undetectable levels in an animal model of HIV infection. In mice treated with
murine PRO 140, initially high HIV concentrations became undetectable for up to
nine days after a single dose. Additionally, multiple doses of murine PRO 140
reduced and then maintained viral loads at undetectable levels for the duration
of therapy in an animal model of HIV infection. Sustaining undetectably low
levels of virus in the blood is a primary goal of HIV therapy.
In
mid-2005, we completed a phase 1 study of humanized PRO 140 designed to evaluate
the tolerability, safety, pharmacology and immunogenicity of PRO 140 in healthy
volunteers. PRO 140 was generally well tolerated at all dose levels in this
study. In February 2006, we received “Fast Track” designation from the FDA
for PRO 140.
In
December 2006, we completed enrollment and dosing in a phase 1b clinical trial
of PRO 140. This clinical trial was designed to assess the tolerability,
pharmacokinetics and preliminary antiviral activity of PRO 140 in 39
HIV-positive individuals. This multi-center, double-blind, placebo-controlled,
dose-escalation study was conducted in individuals who had not taken any
anti-retroviral therapy within the previous three months and who had HIV plasma
concentrations greater than or equal to 5,000 copies/mL. Subjects received a
single intravenous dose of study medication ¾ either placebo or one of
three increasingly higher doses of PRO 140. PRO 140 blood levels and CCR5
coating were determined and compared with antiviral effects measured as changes
in plasma HIV viral load following treatment. In May 2007, we announced
positive results from this trial. Subjects receiving a single 5.0 mg/kg dose of
PRO 140, which was the highest dose tested, achieved an average maximum decrease
of viral concentrations in the blood of 98.5% (1.83 log10). In
these infected individuals, reductions in viral load of greater than 90% (1.0
log10)
on average persisted for two to three weeks after dosing. In addition, PRO 140
was generally well tolerated in this phase 1b proof-of-concept
study.
We are
also developing a subcutaneous formulation of PRO 140 with the goal of
developing a long-acting, self-administered therapy for HIV infection. In
January 2008, we initiated the phase 2 clinical program for PRO 140, which will
investigate multiple dose levels of PRO 140 via intravenous and subcutaneous
routes of administration. The intravenous dose will be evaluated up to 10 mg/kg,
which is double the dose previously tested in the phase 1b study.
The
objective of these phase 2 studies is to identify an optimal dosing regimen of
PRO 140 for evaluation in pivotal clinical trials as well as to further assess
the investigational drug's safety and tolerability. We currently believe
that intravenous PRO 140 has the potential for infrequent (e.g., monthly) dosing,
whereas subcutaneous PRO 140 may enable self-administration as infrequently as
every two weeks.
The “humanized” version of PRO 140 was
developed for us by PDL BioPharma, Inc. (formerly, Protein Design Labs, Inc.)
See Progenics’ Licenses—PDL
Biopharma, Inc., below.
During
2005, we were awarded a $9.7 million grant from the National Institutes of
Health (the “NIH”) to partially fund our PRO 140 program over a 42-month
period.
ProVax is our vaccine
product candidate under development for the prevention of HIV infection or as a
therapeutic treatment for HIV-positive individuals. We are currently performing
government-funded research and development of the ProVax vaccine in
collaboration with the Weill Medical College of Cornell University.
ProVax
contains critical surface proteins whose form closely mimics the structures
found on HIV. In a pre-clinical model, ProVax stimulated the production of
specific HIV neutralizing antibodies. When tested in the laboratory, these
antibodies inactivated certain strains of HIV isolated from infected
individuals. The vaccine-stimulated neutralizing antibodies were observed to
bind to the surface of the virus, rendering it non-infectious. Such neutralizing
antibodies against HIV have been difficult to induce with vaccines currently in
development.
In
September 2003, we were awarded a contract by the NIH to develop a prophylactic
vaccine designed to prevent HIV from becoming established in uninfected
individuals exposed to the virus. Funding under the NIH Contract provided for
pre-clinical research, development and early clinical testing. These funds are
being used principally in connection with our ProVax HIV vaccine program. The
NIH Contract originally provided for up to $28.6 million in funding to us,
subject to annual funding approvals and compliance with its terms, over
five years. The total of our approved award under the NIH Contract through
September 2008 is $15.5 million. Funding under this contract includes the
payment of an aggregate of $1.6 million in fees, subject to achievement of
specified milestones. Through December 31, 2007, we had recognized revenue of
$13.3 million from this contract, including $180,000 for the achievement of two
milestones. We have recently been informed by the NIH that it has decided not to
fund this Contract beyond September 2008. To continue to develop the HIV vaccine
after that time, therefore, we will need to provide funding on our own or obtain
new governmental or other funding. If we choose not to provide our own or cannot
secure governmental or other funding, we will discontinue this
project.
Hepatitis
C Viral Entry Inhibitor
We are
conducting research into therapeutics for Hepatitis C virus infection that block
viral entry into cells. We are exploring both monoclonal antibody and small
molecule approaches in our HCV research and have identified lead molecules that
potently inhibit viral entry in in vitro
models. Hepatitis C is a major cause of chronic liver disease.
According to the U.S. Centers for Disease Control and Prevention, an estimated
4.1 million Americans (1.6%) have been infected with HCV, of whom 3.2 million
are chronically infected, most as a result of illegal injection drug
use. Its estimated number of new HCV infections in 2006 was approximately
19,000.
Oncology
Prostate cancer is the most
common cancer affecting men in the U.S. and is the leading cause of cancer
deaths in men each year. The National Cancer Institute estimates that, based on
rates from 2002-2004, one in six men will be diagnosed with cancer of the
prostate during their lifetime. The American Cancer Society estimated that
186,320 new cases of prostate cancer would be diagnosed and that 28,660 men
would die from the disease in 2008 in the U.S.
Conventional
therapies for prostate cancer include radical prostatectomy, in which the
prostate gland is surgically removed, radiation and hormone therapies and
chemotherapy. Surgery and radiation therapy may result in urinary incontinence
and impotence. Hormone therapy and chemotherapy are generally not intended to be
curative and are not actively used to treat localized, early-stage prostate
cancer.
PSMA. We have been engaged in research and
development programs relating to vaccine and antibody therapies directed against
prostate specific membrane antigen, or PSMA, a protein that is abundantly
expressed on the surface of prostate cancer cells as well as cells in the newly
formed blood vessels of most other solid tumors. We believe that PSMA has
applications in therapies for prostate cancer and potentially for other types of
cancer.
In June
1999, we and Cytogen formed a joint venture with equal membership interests for
the purposes of conducting research, development, manufacturing and marketing of
products related to PSMA. With certain limited exceptions, all patents and
know-how owned by us or Cytogen and used or useful in the development of
PSMA-based antibody or vaccine immunotherapies were licensed to the joint
venture. The principal intellectual property licensed initially were several
patents and patent applications relating to PSMA owned by Memorial
Sloan-Kettering Cancer Center.
In April 2006, we acquired
Cytogen’s entire membership interest in PSMA LLC for $13.2 million cash,
together with $0.3 million of transaction costs. In connection with the
acquisition, the license agreement entered into by Cytogen and us upon the
formation of PSMA LLC, under which Cytogen had granted a license to PSMA LLC for
certain PSMA-related intellectual property, was amended to provide that Cytogen
granted an exclusive, even as to Cytogen, worldwide license to PSMA LLC to use
certain PSMA-related intellectual property in a defined field. Under the terms
of this amended license agreement, PSMA LLC will pay to Cytogen, upon the
achievement of certain defined regulatory and sales milestones, if ever, up to
$52 million, and will also pay royalties on net sales, as defined. Since our
acquisition of Cytogen’s interest, we are continuing to conduct the PSMA-related
programs on our own through PSMA LLC, now our wholly-owned
subsidiary.
In
December 2002, PSMA LLC initiated a phase 1 clinical trial, conducted pursuant
to a physician IND by Sloan-Kettering, with its therapeutic recombinant protein
vaccine. The vaccine, which is designed to stimulate a patient’s immune
system to recognize and destroy prostate cancer cells, combines the PSMA cancer
antigen (recombinant soluble PSMA, or “rsPSMA”) with an immune stimulant to
induce an immune response against prostate cancer cells. The genetically
engineered PSMA vaccine generated potent immune responses in pre-clinical animal
testing. This clinical trial was designed to evaluate the safety, immunogenicity
and immune-stimulating properties of the vaccine in individuals with either
newly diagnosed or recurrent prostate cancer. Preliminary findings from the
trial showed that certain prostate cancer patients produced anti-PSMA antibodies
in response to the vaccine. We have conducted additional research to optimize
the production, immune response and anti-tumor activity of the vaccine prior to
conducting additional testing. We plan to initiate additional phase 1
clinical studies with an optimized version of the vaccine in 2008.
We are
also pursuing a vaccine program that utilizes viral vectors designed to deliver
the PSMA gene to immune system cells in order to generate potent and specific
immune responses to prostate cancer cells. In pre-clinical studies, this vaccine
generated a potent dual response against PSMA, yielding a response by both
antibodies and killer T-cells, the two principal mechanisms used by the immune
system to eliminate abnormal cells. We are completing pre-clinical development
activities on the PSMA viral-vector vaccine.
We have
also developed human monoclonal antibodies which bind to PSMA. These antibodies,
which were developed under license from Amgen Fremont, Inc. (formerly Abgenix,
Inc.), are designed to recognize the three-dimensional physical structure of the
protein and possess a high affinity and specificity for PSMA.
We are
investigating a PSMA monoclonal antibody-drug conjugate (“PSMA ADC”) using one
of these human monoclonal antibodies. See PSMA Licenses – Seattle Genetics,
below. In September 2005, PSMA LLC reported that in a mouse model of
human prostate cancer, mice given the experimental drug PSMA ADC had survival
times of up to nine-fold longer than mice not treated with the
drug.
In 2004,
the NIH awarded us three grants totaling $8 million to be paid over up to four
years in support of our PSMA efforts. In November 2007, we were awarded
additional grants totaling $1.9 million by the NIH, the proceeds of which are to
be disbursed over two years to partially fund work on the PSMA projects
described above. Funding under these grants is being used for that work,
including the development and initiation of clinical testing of the novel
antibody-drug conjugate and vaccine therapies that target PSMA.
Licenses
We are a
party to license agreements under which we have obtained rights to use certain
technologies in our product development programs. PSMA LLC, our wholly owned
subsidiary, has also entered into license agreements with third parties. Set
forth below is a summary of the more significant of these licenses.
Progenics’ Licenses
Wyeth. At
inception of the Collaboration Agreement, Wyeth paid to us a $60 million
non-refundable upfront payment. Wyeth has made $14.0 million in milestone
payments since that time and is obligated to make up to $342.5 million in
additional payments to us upon the achievement of milestones and contingent
events in the development and commercialization of RELISTOR. Costs for the
development of RELISTOR incurred by Wyeth or us starting January 1, 2006 are
paid by Wyeth. We are being reimbursed for our out-of-pocket development costs
by Wyeth and receive reimbursement for our efforts based on the number of our
full time equivalent employees (“FTE”s) devoted to the development project.
Wyeth has the right once annually to engage an independent public accounting
firm to audit expenses for which we have been reimbursed during the prior three
years. If the accounting firm concludes that any such expenses have been
understated or overstated, a reconciliation will be made. Wyeth is obligated to
pay to us royalties on the sale of RELISTOR by Wyeth throughout the world during
the applicable royalty periods.
In January 2006, we began recognizing
revenue from Wyeth for reimbursement of our development expenses for RELISTOR as
incurred during each quarter under the development plan agreed to by us and
Wyeth. We also began recognizing revenue for a portion of the $60 million
upfront payment we received from Wyeth, based on the proportion of the expected
total effort for us to complete our development obligations, as reflected in the
most recent development plan and budget approved by us and Wyeth, that was
actually performed during that quarter. During the year ended December 31, 2007,
we recognized $16.4 million of revenue from the $60 million upfront payment
received in December 2005 and $40.1 million as reimbursement for our
out-of-pocket development costs, including our labor costs. In March
2007, we earned $9.0 million in milestone payments in connection with
submission and approval for review of a New Drug Application with the FDA in the
U.S. and a comparable filing in the European Union for the subcutaneous
formulation of RELISTOR in patients receiving palliative care, which were
recognized as revenue under the Substantive Milestone method (see Management's Discussion and Analysis of Financial Condition
and Results of Operations - Critical Accounting Policies – Revenue Recognition, below).
From inception of the Collaboration Agreement to December 31, 2007, we
recognized $35.2 million of revenue from the $60 million upfront payment, $74.7
million as reimbursement for our out-of-pocket development costs, including our
labor costs and $14.0 million in milestone payments.
The Collaboration Agreement establishes
a Joint Steering Committee and a Joint Development Committee, each with an equal
number of representatives from both Wyeth and us. The Joint Steering Committee
is responsible for coordinating the key activities of Wyeth and us under the
Collaboration Agreement. The Joint Development Committee is responsible for
overseeing, coordinating and expediting the development of RELISTOR by Wyeth and
us. In addition, a Joint Commercialization Committee was established, composed
of representatives of both Wyeth and us in number and function according to each
of our responsibilities, with responsibility for facilitating open communication
between Wyeth and us on matters relating to the commercialization of
products.
Under the
Collaboration Agreement, we granted to Wyeth an exclusive, worldwide license to
develop and commercialize RELISTOR. We are responsible for developing the
subcutaneous and intravenous formulations of RELISTOR in the United States,
until the drug formulations receive regulatory approval. Wyeth is responsible
for the development of the subcutaneous and intravenous formulations of RELISTOR
outside of the United States. Wyeth is responsible for the development of the
oral formulation of RELISTOR, both within the United States and in the rest of
the world. In the event the Joint Steering Committee approves for development
any formulation of methylnaltrexone other than the subcutaneous, intravenous or
oral formulations, or any other indication for a product using any formulation
of methylnaltrexone, Wyeth will be responsible for development of such products,
including conducting clinical trials and obtaining and maintaining regulatory
approval and we will receive royalties on all sales. We will remain the owner of
all U.S. regulatory filings and approvals relating to the subcutaneous and
intravenous formulations of RELISTOR; Wyeth will be the owner of all U.S.
regulatory filings and approvals related to the oral formulation. Wyeth will be
the owner of all regulatory filings and approvals outside the United States
relating to all formulations of RELISTOR.
Wyeth is responsible for the
commercialization of the subcutaneous, intravenous and oral formulations, should
they be approved as products, throughout the world, will pay all costs of
commercialization of all products, including all manufacturing costs, and will
retain all proceeds from the sale of the products, subject to the royalties
payable by Wyeth to us. Decisions with respect to commercialization of any
products developed under the Collaboration Agreement will be made solely by
Wyeth.
We have transferred to Wyeth all
existing supply agreements with third parties for RELISTOR and have sublicensed
any intellectual property rights to permit Wyeth to manufacture or have
manufactured RELISTOR, during the development and commercialization phases of
the Collaboration Agreement, in both bulk and finished form for all products
worldwide. Progenics has no further manufacturing obligations under the
Collaboration Agreement.
We have an option to co-promote any of
the products developed under the Collaboration Agreement, subject to certain
conditions. The extent of our co-promotion activities and the fee that we will
be paid by Wyeth for our activities will be established if, as and when we
exercise our option. Wyeth will record all
sales of products worldwide (including those sold by us, if any, under a
co-promotion agreement). Wyeth may terminate any co-promotion agreement if a
top-15 pharmaceutical company acquires control of us, and has agreed to certain
limitations regarding its ability to purchase our equity securities and to
solicit proxies.
The
Collaboration Agreement extends, unless terminated earlier, on a
country-by-country and product-by-product basis, until the last-to-expire
royalty period for any product. Progenics may terminate the Collaboration
Agreement at any time upon 90 days written notice to Wyeth upon Wyeth’s material
uncured breach (30 days in the case of breach of a payment obligation). Wyeth
may, with or without cause, following the second anniversary of the first
commercial sale, as defined, of the first commercial product in the U.S.,
terminate the Collaboration Agreement by providing Progenics with at least 360
days prior written notice. Wyeth may also terminate the agreement (i) upon 30
days written notice following one or more specified serious safety or efficacy
issues that arise and (ii) upon 90 days written notice of a material uncured
breach by Progenics. Upon termination of the Collaboration Agreement, the
ownership of the license we granted to Wyeth will depend on which party
initiates the termination and the reason for the termination.
UR Labs/University of Chicago.
In 2001, we entered into an exclusive sublicense agreement with UR
Labs, Inc. (“URL” or “UR Labs”) to develop and commercialize methylnaltrexone in
exchange for rights to future payments (the “Methylnaltrexone Sublicense”). The
rights URL granted us under this Sublicense were derived from a 1985 agreement
that it had made with the University of Chicago (the “URL-Chicago License”). At
the time we entered into the Methylnaltrexone Sublicense with URL, URL also
entered into an agreement (the “URL-Goldberg Agreement”) with certain heirs of
Dr. Leon Goldberg (the “Goldberg Distributees”), which provided them with the
right to receive payments based upon revenues received by URL from the
development of the Methylnaltrexone Sublicense and for URL’s obligation to make
royalty payments to the University of Chicago. As of December 22, 2005, we had
paid $550,000 to UR Labs and $500,000 to the University of Chicago under the
Methylnaltrexone Sublicense. As described below, subsequent to that date we are
not obligated to make any additional payments under the Methylnaltrexone
Sublicense.
In
December 2005, we acquired substantially all of the assets of URL, comprised of
its rights under the URL-Chicago License, the Methylnaltrexone Sublicense and
the URL-Goldberg Agreement, thus assuming URL’s rights and responsibilities
under those agreements and extinguishing our obligation to make royalty and
other payments to URL. At the same time, we entered into an agreement with the
Goldberg Distributees, under which we assumed all their rights and obligations
under the URL-Goldberg Agreement, thereby extinguishing URL’s (and,
consequentially, our) obligations to make payments to them.
In
consideration for the assignment of the Goldberg Distributees’ rights and of the
acquisition of the assets of URL described above, we issued a total of 686,000
shares of our common stock, with a fair value at the time of $15.8 million, and
paid a total of $2,604,900 in cash to URL’s shareholders and the Goldberg
Distributees, together with $310,000 in transaction fees, the total amount of
which was expensed in the period of the transaction.
During
2006 and 2007, we entered into two agreements with the University of Chicago
which give us the option to license certain of its intellectual property over
defined option periods. As of December 31, 2007, we have paid the University of
Chicago $310,000 and may make payments aggregating $890,000 over the option
periods.
Although
we no longer have any obligation to make royalty payments to URL or the Goldberg
Distributees, we continue to have an obligation to make those payments
(including royalties) to the University of Chicago that would have been made by
URL under the URL-Goldberg Agreement.
PDL BioPharma,
Inc. (formerly Protein Design Labs). Under a license agreement, PDL
Biopharma, Inc. (“PDL”) developed for us a humanized PRO 140 monoclonal antibody
and granted to us related exclusive and nonexclusive worldwide licenses under
patents, patent applications and know-how. In general, the license agreement
terminates on the later of ten years from the first commercial sale of a product
developed under the agreement or the last date on which there is an unexpired
patent or a patent application that has been pending for less than ten years,
unless sooner terminated. Thereafter, the license is fully paid. The last of the
currently issued relevant patents expires in 2014; pending U.S. and
international patent applications and patent term extensions may however, extend
the period of our license rights when and if such applications are allowed and
issued or extensions are granted. We may terminate the license agreement on 60
days prior written notice. In addition, either party may terminate the license
agreement, upon ten days written notice, for payment default or upon 30 days
prior written notice for uncured breach of other material terms. As of December
31, 2007, we have paid to PDL $4.05 million under this agreement. If all
milestones specified under the agreement are achieved, we will be obligated to
pay PDL an additional approximately $3.0 million. We are also required to pay
annual maintenance fees of $150,000 from April 30, 2007 and royalties based on
the sale of products we develop under the license.
Columbia
University. We are party to a license agreement with Columbia University
under which we obtained exclusive, worldwide rights to specified technology and
materials relating to CD4. In general, the license agreement terminates (unless
sooner terminated) upon the expiration of the last to expire of the licensed
patents, which is currently 2021; patent applications that we have also licensed
and patent term extensions may however, extend the period of our license rights,
when and if the patent applications are allowed and issued or patent term
extensions are granted.
This
license agreement requires us to achieve development milestones, including
filing for marketing approval of a drug by June 2001 and manufacturing a drug
for commercial distribution by June 2004. We have not achieved either of these
milestones due to delays that we believe could not have been reasonably avoided
and are reasonably beyond our control. As of December 31, 2006, we were
obligated to pay Columbia a milestone fee of $225,000 and four annual
maintenance fees of $50,000 each, which had been accrued but not paid, in
accordance with an oral understanding that suspended our obligation to make such
payments until a time in the future to be agreed upon by the parties. In
addition, we were required to pay royalties based on the sale of products we
develop under the license, if any.
We have
had discussions with Columbia regarding the terms of an agreement under which we
would relinquish all rights related to the license agreement with Columbia in
exchange for making a one-time payment of $300,000, which was accrued at
December 31, 2007, and previously due milestone and maintenance fees as well as
future royalty payments would be cancelled. These discussions have not yet
resulted in a formal agreement.
As of
December 31, 2007, we have paid Columbia a total of $865,000 under this
license agreement.
Aquila
Biopharmaceuticals. We have entered into a license and supply agreement
with Aquila Biopharmaceuticals, Inc. (“Aquila”), a wholly owned subsidiary of
Antigenics Inc. (“Antigenics”), pursuant to which Aquila agreed to supply us
with all of our requirements for the QS-21™ adjuvant used in
GMK, a program that we terminated in development in the second quarter of 2007.
QS-21 is the lead compound in the Stimulon® family of
adjuvants developed and owned by Aquila. In general, the license agreement
terminates upon the expiration of the last to expire of the licensed patents,
unless sooner terminated. In the U.S., the licensed patent will expire in
2008.
Our
license agreement requires us to achieve development milestones. The agreement
states that we are required to have filed for marketing approval of a drug by
2001 and to commence the manufacture and distribution of a drug by 2003. We have
not achieved these milestones due to delays that we believe could not have been
reasonably avoided. We believe that these delays satisfy the criteria for a
revision, contemplated by the agreement, of the milestone dates. Aquila has not
consented to a revision of the milestone dates as of the date of this document.
In the event of a default by one party, the agreement may be terminated, after
an opportunity to cure, by the non-defaulting party upon prior written
notice.
We have
received a written communication from Antigenics alleging that Progenics is in
default of certain of its obligations under the license agreement and asserting
that Antigenics has an interest in certain intellectual property of Progenics.
Progenics has responded in writing denying Antigenics’ allegations. We do not
believe that this dispute will have any material effect on us.
As of
December 31, 2007, we have paid to Aquila $769,000 under this agreement. We
have no future cash payment obligations relating to milestones under the
agreement.
KMT Hepatech,
Inc. In October 2006, we and KMT Hepatech, Inc. (“KMT”) entered into a
Research Services Agreement, under which KMT will test certain compounds
(“Compounds”) related to our HCV research program. In consideration for KMT’s
services, we made an upfront payment for certain services, will reimburse KMT
for direct costs incurred by it in rendering the services and will make
additional payments upon our request for additional services. As of December 31,
2007, we have paid KMT a total of $175,000 in connection with this agreement. We
will also make one-time development milestone payments, aggregating up to $6.0
million, upon the occurrence of defined events in respect of any Compound. In
the event that we terminate development of a Compound, certain of those
development milestone payments will be credited to the development milestones
achieved by the next Compound. The KMT agreement will terminate upon its second
anniversary unless terminated sooner. The parties may extend the term of the KMT
agreement by mutual written consent. Either party may terminate the KMT
agreement upon 60 days written notice to the other party. In the event of an
uncured default by either party, including non-performance, bankruptcy or
liquidation or dissolution, the non-defaulting party may terminate the KMT
agreement upon 30 days written notice.
PSMA LLC Licenses
Amgen Fremont,
Inc. (formerly Abgenix). In February 2001, PSMA LLC entered into a
worldwide exclusive licensing agreement with Abgenix to use its XenoMouse™
technology for generating fully human antibodies to PSMA LLC’s PSMA antigen. In
consideration for the license, PSMA LLC paid a nonrefundable, non-creditable
license fee and is obligated to pay additional payments upon the occurrence of
defined milestones associated with the development and commercialization program
for products incorporating an antibody generated utilizing the XenoMouse
technology. As of December 31, 2007, PSMA LLC has paid to Abgenix $850,000 under
this agreement. If PSMA LLC achieves certain milestones specified under the
agreement, it will be obligated to pay Abgenix up to an additional $6.25
million. In addition, PSMA LLC is required to pay royalties based upon net sales
of antibody products, if any. This agreement may be terminated, after an
opportunity to cure, by Abgenix for cause upon 30 days prior written notice.
PSMA LLC has the right to terminate this agreement upon 30 days prior written
notice. If not terminated early, this agreement continues until the later of the
expiration of the XenoMouse technology patents that may result from pending
patent applications or seven years from the first commercial sale of the
products.
AlphaVax Human
Vaccines. In September 2001, PSMA LLC entered into a worldwide exclusive
license agreement with AlphaVax Human Vaccines to use the AlphaVax Replicon
Vector system to create a therapeutic prostate cancer vaccine incorporating PSMA
LLC’s proprietary PSMA antigen. In consideration for the license, PSMA LLC paid
a nonrefundable, noncreditable license fee and is obligated to make additional
payments upon the occurrence of certain defined milestones associated with the
development and commercialization program for products incorporating AlphaVax’s
system. As of December 31, 2007, PSMA LLC has paid to AlphaVax $1.4 million
under this agreement. If PSMA LLC achieves certain milestones specified under
the agreement, it will be obligated to pay AlphaVax up to an additional $5.4
million. In addition, PSMA LLC is required to pay annual maintenance fees of
$100,000 until the first commercial sale and royalties based upon net sales of
any products developed using AlphaVax’ system. This agreement may be terminated,
after an opportunity to cure, by AlphaVax under specified circumstances,
including PSMA LLC’s failure to achieve milestones; the consent of AlphaVax to
revisions to the milestones due dates may not, however, be unreasonably
withheld. PSMA LLC has the right to terminate the agreement upon 30 days prior
written notice. If not terminated early, this agreement continues until the
later of the expiration of the patents relating to AlphaVax’s system or seven
years from the first commercial sale of the products developed using that
system. The last of the currently issued patents expires in 2015; pending U.S.
and international patent applications and patent term extensions may, however,
extend the period of our license rights when and if such applications are
allowed and issued or extensions are granted.
Seattle Genetics.
In June 2005, PSMA LLC entered into a collaboration agreement with
Seattle Genetics, Inc. (“SGI”). Under this agreement, SGI provided to PSMA LLC
an exclusive worldwide license to its proprietary antibody-drug conjugate
technology (the “ADC Technology”). Under the license, PSMA LLC has the right to
use the ADC Technology to link cell-killing drugs to PSMA LLC’s monoclonal
antibodies that target prostate-specific membrane antigen. During the initial
research term of the agreement, SGI also is required to provide technical
information to PSMA LLC related to implementation of the licensed technology,
which period may be extended for an additional period upon payment of an
additional fee. PSMA LLC may replace prostate-specific membrane antigen with
another antigen, subject to certain restrictions, upon payment of an antigen
replacement fee. The ADC Technology is based, in part, on technology licensed by
SGI from third parties . PSMA LLC is responsible for research, product
development, manufacturing and commercialization of all products under the SGI
agreement. PSMA LLC may sub-license the ADC Technology to a third party to
manufacture the ADC’s for both research and commercial use. PSMA LLC made a
technology access payment to SGI upon execution of the SGI agreement and will
make additional maintenance payments during its term. In addition, PSMA LLC will
make payments aggregating up to $15.0 million, upon the achievement of certain
defined milestones and will pay royalties to SGI and its licensors, as
applicable, on a percentage of net sales, as defined. In the event that SGI
provides materials or services to PSMA LLC under the SGI agreement, SGI will
receive supply and/or labor cost payments from PSMA LLC at agreed-upon rates.
PSMA LLC’s monoclonal antibody project is currently in the pre-clinical phase of
research and development. All costs incurred by PSMA LLC under the SGI agreement
during the research and development phase of the project will be expensed in the
period incurred. The SGI agreement terminates at the latest of (i) the tenth
anniversary of the first commercial sale of each licensed product in each
country or (ii) the latest date of expiration of patents underlying the licensed
products. PSMA LLC may terminate the SGI agreement upon advance written notice
to SGI. SGI may terminate the agreement if PSMA LLC fails to cure a breach of an
SGI in-license within a specified time period after written notice. In addition,
either party may terminate the SGI agreement after written notice upon an
uncured breach or in the event of bankruptcy of the other party. As of December
31, 2007, PSMA LLC has paid to SGI approximately $3.0 million under this
agreement, including $0.5 million in milestone payments.
ADARC. We
have a letter agreement with The Aaron Diamond AIDS Research Center pursuant to
which we have the exclusive right to pursue the commercial development, directly
or with a partner, of products related to HIV based on patents jointly owned by
ADARC and us.
Rights and
Obligations. We have the right generally to defend and enforce patents
licensed by us, either in the first instance or if the licensor chooses not to
do so. We bear the cost of doing so with respect to our license agreement with
the University of Chicago for methylnaltrexone. Under the Collaboration
Agreement, Wyeth has the right, at its expense, to defend and enforce the
RELISTOR patents licensed to Wyeth by us. With most of our other license
agreements, the licensor bears the cost of engaging in all of these activities,
although we may share in those costs under certain circumstances. Historically,
our costs of defending patent rights, both our own and those we license, have
not been material.
The
licenses to which we are a party impose various milestone, commercialization,
sublicensing, royalty and other payment, insurance, indemnification and other
obligations on us and are subject to certain reservations of rights. Failure to
comply with these requirements could result in the termination of the applicable
agreement, which would likely cause us to terminate the related development
program and cause a complete loss of our investment in that
program.
Patents
and Proprietary Technology
Our
policy is to protect our proprietary technology, and we consider the protection
of our rights to be important to our business. In addition to seeking U.S.
patent protection for many of our inventions, we generally file patent
applications in Canada, Japan, European countries that are party to the European
Patent Convention and additional foreign countries on a selective basis in order
to protect the inventions that we consider to be important to the development of
our foreign business. Generally, patents issued in the U.S. are
effective:
·
|
if
the patent application was filed prior to June 8, 1995, for the longer of
17 years from the date of issue or 20 years from the earliest asserted
filing date; or
|
·
|
if
the application was filed on or after June 8, 1995, for 20 years from
the earliest asserted filing date.
|
In
addition, in certain instances, the patent term can be extended up to a maximum
of five years to recapture a portion of the term during which the FDA regulatory
review was being conducted. The duration of foreign patents varies in accordance
with the provisions of applicable local law, although most countries provide for
patent terms of 20 years from the earliest asserted filing date and allow patent
extensions similar to those permitted in the U.S.
We also
rely on trade secrets, proprietary know-how and continuing technological
innovation to develop and maintain a competitive position in our product areas.
We generally require our employees, consultants and corporate partners who have
access to our proprietary information to sign confidentiality
agreements.
Our
patent portfolio relating to our proprietary technologies in the
gastroenterology, virology and cancer areas is currently comprised, on a
worldwide basis, of 171 patents that have been issued and 281 pending patent
applications, which we either own directly or of which we are the exclusive
licensee. Our issued patents expire on dates ranging from 2009 through 2025.
Patent term extensions and pending patent applications may extend the period of
patent protection afforded our products in development.
We are
aware of intellectual property rights held by third parties that relate to
products or technologies we are developing. For example, we are aware of other
groups investigating methylnaltrexone and other peripheral opioid antagonists,
PSMA or related compounds, CCR5 monoclonal antibodies and HCV therapeutics and
of patents held, and patent applications filed, by these groups in those areas.
While the validity of issued patents, patentability of pending patent
applications and applicability of any of them to our programs are uncertain, if
asserted against us, any related patent rights could adversely affect our
ability to commercialize our products.
The
research, development and commercialization of a biopharmaceutical often involve
alternative development and optimization routes, which are presented at various
stages in the development process. The preferred routes cannot be predicted at
the outset of a research and development program because they will depend upon
subsequent discoveries and test results. There are numerous third-party patents
in our field, and it is possible that to pursue the preferred development route
of one or more of our product candidates we will need to obtain a license to a
patent, which would decrease the ultimate profitability of the applicable
product. If we cannot negotiate a license, we might have to pursue a less
desirable development route or terminate the program
altogether.
Government
Regulation
Progenics
and our product candidates are subject to comprehensive regulation by the FDA
and by comparable authorities in other countries. These national agencies and
other federal, state and local entities regulate, among other things, the
pre-clinical and clinical testing, safety, effectiveness, approval, manufacture,
labeling, marketing, export, storage, recordkeeping, advertising and promotion
of our products. None of our product candidates has received marketing or other
approval from the FDA or any other similar regulatory authority.
FDA Regulation.
FDA approval of our products, including a review of the manufacturing
processes and facilities used to produce such products, will be required before
they may be marketed in the U.S. The process of obtaining approvals from the FDA
can be costly, time consuming and subject to unanticipated delays. We cannot
assure you that approvals of our proposed products, processes, or facilities
will be granted on a timely basis, or at all. If we experience delays in
obtaining, or do not obtain, approvals for our products, commercialization of
our products would be slowed or stopped. Even if we obtain regulatory approval,
the approval may include significant limitations on indicated uses for which the
product could be marketed or other significant marketing
restrictions.
The
process required by the FDA before our product candidates may be approved for
marketing in the U.S. generally involves:
·
|
pre-clinical
laboratory and animal tests;
|
·
|
submission
to the FDA and effectiveness of an investigational new drug application,
or IND, before clinical trials may
begin;
|
·
|
adequate
and well-controlled human clinical trials to establish the safety and
efficacy of the product for its intended
indication;
|
·
|
submission
to the FDA of a marketing application;
and
|
·
|
FDA
review of the marketing application in order to determine, among other
things, whether the product is safe and effective for its intended
uses.
|
Pre-clinical tests include
laboratory evaluation of product chemistry and animal studies to gain
preliminary information about a product’s pharmacology and toxicology and to
identify safety problems that would preclude testing in humans. Products must
generally be manufactured according to current Good Manufacturing Practices, and
pre-clinical safety tests must be conducted by laboratories that comply with FDA
good laboratory practices regulations.
The
results of the pre-clinical tests are submitted to the FDA as part of an IND (Investigational New Drug)
application, which must become effective before clinical trials may commence.
The IND submission must include, among other things, a description of the
sponsor’s investigational plan; protocols for each planned study; chemistry,
manufacturing and control information; pharmacology and toxicology information
and a summary of previous human experience with the investigational
drug.
Unless
the FDA objects to, makes comments or raises questions concerning an IND, it
will become effective 30 days following submission, and initial clinical studies
may begin. Companies often obtain affirmative FDA approval, however, before
beginning such studies. We cannot assure you that an IND submission by us will
result in FDA authorization to commence clinical trials.
Clinical trials involve the
administration of the investigational new drug to healthy volunteers or to
individuals under the supervision of a qualified principal investigator.
Clinical trials must be conducted in accordance with the FDA’s Good Clinical
Practice requirements under protocols submitted to the FDA that detail, among
other things, the objectives of the study; the parameters to be used to monitor
safety; and the effectiveness criteria to be evaluated. Each clinical study must
be conducted under the auspices of an Institutional Review Board, which
considers, among other things, ethical factors, the safety of human subjects,
the possible liability of the institution and the informed consent disclosure
which must be made to participants in the trial.
Clinical
trials are typically conducted in three sequential phases, which may overlap.
During phase 1, when the drug is initially administered to human subjects, the
product is tested for safety, dosage tolerance, absorption, metabolism,
distribution and excretion. Phase 2 involves studies in a limited population to
evaluate preliminarily the efficacy of the product for specific, targeted
indications; determine dosage tolerance and optimal dosage; and identify
possible adverse effects and safety risks.
When a
product candidate is found in phase 2 evaluation to have an effect and an
acceptable safety profile, phase 3 trials are undertaken in order to further
evaluate clinical efficacy and test for safety within an expanded population.
The FDA may suspend clinical trials at any point in this process if it concludes
that clinical subjects are being exposed to an unacceptable health
risk.
A New Drug Application, or NDA, is an application to the
FDA to market a new drug. A Biologic License Application,
or BLA, is an
application to market a biological product. The new drug or biological product
may not be marketed in the U.S. until the FDA has approved the NDA or issued a
biologic license. The NDA must contain, among other things, information on
chemistry, manufacturing and controls; non-clinical pharmacology and toxicology;
human pharmacokinetics and bioavailability; and clinical data. The BLA must
contain, among other things, data derived from nonclinical laboratory and
clinical studies which demonstrate that the product meets prescribed standards
of safety, purity and potency, and a full description of manufacturing
methods.
The
results of the pre-clinical studies and clinical studies, the chemistry and
manufacturing data, and the proposed labeling, among other things, are submitted
to the FDA in the form of an NDA or BLA. The FDA may refuse to accept the
application for filing if certain administrative and content criteria are not
satisfied, and even after accepting the application for review, the FDA may
require additional testing or information before approval of the application.
Our analysis of the results of our clinical studies is subject to review and
interpretation by the FDA, which may differ from our analysis. We cannot assure
you that our data or our interpretation of data will be accepted by the FDA. In
any event, the FDA must deny an NDA or BLA if applicable regulatory requirements
are not ultimately satisfied. In addition, we may encounter delays or rejections
based upon changes in applicable law or FDA policy during the period of product
development and FDA regulatory review. If regulatory approval of a product is
granted, such approval may be made subject to various conditions, including
post-marketing testing and surveillance to monitor the safety of the product, or
may entail limitations on the indicated uses for which it may be marketed.
Finally, product approvals may be withdrawn if compliance with regulatory
standards is not maintained or if problems occur following initial
marketing.
Both
before and after approval is obtained, a product, its manufacturer and the
sponsor of the marketing application for the product are subject to
comprehensive regulatory oversight. Violations of regulatory requirements at any
stage, including the pre-clinical and clinical testing process, the approval
process, or thereafter, may result in various adverse consequences, including
FDA delay in approving or refusal to approve a product, withdrawal of an
approved product from the market or the imposition of criminal penalties against
the manufacturer or sponsor. Later discovery of previously unknown problems may
result in restrictions on the product, manufacturer or sponsor, including
withdrawal of the product from the market. New government requirements may be
established that could delay or prevent regulatory approval of our products
under development.
Regulation
Outside the U.S. Whether or not FDA approval has been obtained, approval
of a pharmaceutical product by comparable government regulatory authorities in
foreign countries must be obtained prior to marketing the product there. The
approval procedure varies from country to country, and the time required may be
longer or shorter than that required for FDA approval. The requirements we must
satisfy to obtain regulatory approval by governmental agencies in other
countries prior to commercialization of our products there can be rigorous,
costly and uncertain, and there can be no assurance that approvals will be
granted on a timely basis or at all. We do not currently have any facilities or
personnel outside of the U.S.
In the
European countries, Canada and Australia, regulatory requirements and approval
processes are similar in principle to those in the United States. Additionally,
depending on the type of drug for which approval is sought, there are currently
two potential tracks for marketing approval in the EU countries: mutual
recognition and the centralized procedure. These review mechanisms may
ultimately lead to approval in all EU countries, but each method grants all
participating countries some decision-making authority in product
approval. The centralized procedure, which is mandatory for biotechnology
derived products, results in a recommendation in all member states, while the EU
mutual recognition process involves country-by-country approval.
In other
countries, regulatory requirements may require us to perform additional
pre-clinical or clinical testing regardless of whether FDA approval has been
obtained. If the particular product is manufactured in the U.S., we must
also comply with FDA and other U.S. export provisions.
In most
countries outside the U.S., coverage, pricing and reimbursement approvals are
also required. There can be no assurance that the resulting pricing of our
products would be sufficient to generate an acceptable return to
us.
Other Regulation.
In addition to regulations enforced by the FDA, we are also subject to
regulation under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act, the Resource Conservation and
Recovery Act and various other present and potential future federal, state or
local regulations. Our research and development involves the controlled use of
hazardous materials, chemicals, viruses and various radioactive compounds.
Although we believe that our safety procedures for storing, handling, using and
disposing of such materials comply with the standards prescribed by applicable
regulations, we cannot completely eliminate the risk of accidental
contaminations or injury from these materials. In the event of such an accident,
we could be held liable for any legal and regulatory violations as well as
damages that result. Any such liability could have a material adverse effect on
Progenics.
Manufacturing
We have
transferred to Wyeth our prior agreement with Mallinckrodt for the supply of
both bulk and finished-form RELISTOR. Wyeth is currently solely responsible for
the supply of those materials for the balance of the clinical trial and
commercial supply requirements under the Collaboration Agreement.
We
currently manufacture PRO 140 in our biologics pilot production facilities in
Tarrytown, New York and have entered into an agreement with a third-party
contract manufacturing organization (CMO) to produce additional quantities of
PRO 140 for our ongoing clinical trials. We currently have two 150-liter
bioreactors in operation to support our clinical programs. We have also acquired
a 1,500 liter bioreactor, and we are considering the appropriate time and manner
for installing and deploying this additional resource. We have supplemented our
existing production facilities with capacity from the CMO to meet our needs for
clinical trials for this product candidate. These facilities may, however, be
insufficient for all of our late-stage clinical trials and would be insufficient
for commercial-scale requirements. We may be required to further expand our
manufacturing staff and facilities, obtain new facilities or contract with third
parties or corporate collaborators to assist with production.
In order
to establish a full-scale commercial manufacturing facility for any of our
product candidates, we would need to spend substantial additional funds, hire
and train significant numbers of employees and comply with the extensive FDA
regulations applicable to such a facility.
Sales
and Marketing
We plan
to market products for which we obtain regulatory approval through co-marketing,
co-promotion, licensing and distribution arrangements with third-party
collaborators. We may also consider contracting with a third-party professional
pharmaceutical detailing and sales organization to perform the marketing
function for our products. Under the terms of our Collaboration Agreement with
Wyeth, Wyeth granted us an option to enter into a co-promotion agreement to
co-promote any of the RELISTOR products developed under the Collaboration
Agreement, subject to certain conditions. The extent of our co-promotion
activities and the fee that we will be paid by Wyeth for these activities will
be established if, as and when we exercise our option. Wyeth will record all
sales of products worldwide (including those sold by us, if any, under a
co-promotion agreement).
Competition
Competition
in the biopharmaceutical industry is intense and characterized by ongoing
research and development and technological change. We face competition from many
companies and major universities and research institutions in the U.S. and
abroad. We will face competition from companies marketing existing products or
developing new products for diseases targeted by our technologies. Many of our
competitors have substantially greater resources, experience in conducting
pre-clinical studies and clinical trials and obtaining regulatory approvals for
their products, operating experience, research and development and marketing
capabilities and production capabilities than we do. Our products under
development may not compete successfully with existing products or products
under development by other companies, universities and other institutions. Our
competitors may succeed in obtaining FDA marketing approval for products more
rapidly than we do. Drug manufacturers that are first in the market with a
therapeutic for a specific indication generally obtain and maintain a
significant competitive advantage over later entrants. Accordingly, we believe
that the speed with which we develop products, complete the clinical trials and
approval processes and ultimately supply commercial quantities of the products
to the market will be an important competitive factor.
There are
currently no FDA-approved products for reversing the debilitating side effects
of opioid pain therapy (and specifically, opioid-induced constipation) or for
the treatment of post-operative ileus, to which RELISTOR is directed. We are,
however, aware of a product candidate that targets these therapeutic
indications. This product, Entereg™ (alvimopan), is under development by Adolor
Corporation, in collaboration with an affiliate of GlaxoSmithKline plc. Entereg
is in advanced clinical development and Adolor has received an approvable letter
from the FDA for Entereg regarding the treatment of post-operative ileus.
Five
classes of products made by our competitors have been approved for marketing by
the FDA for the treatment of HIV infection and AIDS: nucleoside and
non-nucleoside reverse transcriptase inhibitors, protease inhibitors, entry
inhibitors and integrase inhibitors. These drugs have shown efficacy in reducing
the concentration of HIV in the blood and prolonging asymptomatic periods in
HIV-positive individuals, especially when administered in combination. We are
aware of several competitors that are marketing or developing small-molecule
viral-entry-inhibition-based treatments directed against CCR5 for HIV infection,
including Pfizer Inc.’s SELZENTRY™, but unaware of any antibody-based
treatments at our stage of clinical development.
Radiation
and surgery are two principal traditional forms of treatment for prostate
cancer, to which our PSMA-based development efforts are directed. If the
disease spreads, however, the traditional forms of treatment can be ineffective.
We are aware of several competitors who are developing alternative treatments
for prostate cancer, including in vivo and ex vivo therapies, some of
which are directed against PSMA.
A
significant amount of research in the biopharmaceutical field is also being
carried out at academic and government institutions. An element of our research
and development strategy is to in-license technology and product candidates from
academic and government institutions. These institutions are becoming
increasingly sensitive to the commercial value of their findings and are
becoming more aggressive in pursuing patent protection and negotiating licensing
arrangements to collect royalties for use of technology that they have
developed. These institutions may also market competitive commercial products on
their own or in collaboration with competitors and will compete with us in
recruiting highly qualified scientific personnel. Any resulting increase in the
cost or decrease in the availability of technology or product candidates from
these institutions may adversely affect our business strategy.
Competition
with respect to our technologies and product candidates is and will be based on,
among other things: (i) efficacy and safety of our products; (ii) timing and
scope of regulatory approval; (iii) product reliability and availability; (iv)
sales, marketing and manufacturing capabilities; (v) capabilities of our
collaborators; (vi) reimbursement coverage from insurance companies and others;
(vii) degree of clinical benefits of our product candidates relative to their
costs; (viii) method of administering a product; (ix) price; and (x) patent
protection.
Our
competitive position will also depend upon our ability to attract and retain
qualified personnel, obtain patent protection or otherwise develop proprietary
products or processes, and secure sufficient capital resources for the typically
substantial period between technological conception and commercial sales.
Competitive disadvantages in any of these factors could materially harm our
business and financial condition.
Product
Liability
The
testing, manufacturing and marketing of our product candidates and products
involves an inherent risk of product liability attributable to unwanted and
potentially serious health effects. To the extent we elect to test, manufacture
or market product candidates and products independently, we will bear the risk
of product liability directly. We have obtained product liability insurance
coverage in the amount of $10.0 million per occurrence, subject to a deductible
and a $10.0 million aggregate limitation. In addition, where the local statutory
requirements exceed the limits of our existing insurance or local policies of
insurance are required, we maintain additional clinical trial liability
insurance to meet these requirements. This insurance is subject to deductibles
and coverage limitations. We may not be able to continue to maintain insurance
at a reasonable cost, or in adequate amounts.
Human
Resources
At
December 31, 2007, we had 245 full-time employees, 41 of whom hold Ph.D.
degrees, six of whom hold M.D. degrees and three of whom, including Dr. Paul
J. Maddon, our Chief Executive Officer and Chief Science Officer, hold
both Ph.D. and M.D. degrees. At such date, 200 employees were engaged in
research and development, medical, regulatory affairs and manufacturing
activities and 45 were engaged in finance, legal, administration and business
development. We consider our relations with our employees to be good. None of
our employees is covered by a collective bargaining agreement.
Our
business and operations entail a variety of serious risks and uncertainties,
including those described below.
Our
product development programs are inherently risky.
We are
subject to the risks of failure inherent in the development of product
candidates based on new technologies.
RELISTOR,
which is designed to reverse certain side effects induced by opioids and to
manage postoperative ileus and is being developed through a collaboration with
Wyeth, is based on a novel method of action that has not yet been deemed safe or
effective by any regulatory authorities. No drug with RELISTOR’s method of
action has ever received marketing approval. Additionally, our principal HIV
product candidate, the monoclonal antibody PRO 140, is designed to block viral
entry. To our knowledge, there are two approved drugs designed to treat HIV
infection by blocking viral entry (Trimeris’ FUZEON™ and Pfizer’s SELZENTRY™)
that have been approved for marketing in the U.S., but neither are monoclonal
antibodies. Our other research and development programs, including those related
to PSMA, involve novel approaches to human therapeutics. Consequently, there is
little precedent for the successful commercialization of products based on our
technologies. There are a number of technological challenges that we must
overcome to complete most of our development efforts. We may not be able to
develop successfully any of our products.
We
have granted to Wyeth the exclusive rights to develop and commercialize
RELISTOR, our lead product candidate, and our resulting dependence upon Wyeth
exposes us to significant risks.
In
December 2005, we entered into a license and co-development agreement with
Wyeth. Under this agreement, we granted to Wyeth the exclusive worldwide right
to develop and commercialize RELISTOR, our lead product candidate. As a result,
we are dependent upon Wyeth to perform and fund development, including clinical
testing, to make certain regulatory filings and to manufacture and market
products containing RELISTOR. Our collaboration with Wyeth may not be
scientifically, clinically or commercially successful.
Any
revenues from the sale of RELISTOR, if approved for marketing by the FDA, will
depend almost entirely upon the efforts of Wyeth. Wyeth has significant
discretion in determining the efforts and resources it applies to sales of the
RELISTOR products and may not be effective in marketing such products. In
addition, Wyeth is a large, diversified pharmaceutical company with global
operations and its own corporate objectives, which may not be consistent with
our best interests. For example, Wyeth may change its strategic focus or pursue
alternative technologies in a manner that results in reduced revenues to us. We
will receive milestone and contingent payments from Wyeth only if RELISTOR
achieves specified clinical, regulatory and commercialization milestones, and we
will receive royalty payments from Wyeth only if RELISTOR receives regulatory
approval and is commercialized by Wyeth. Many of these milestone events will
depend upon the efforts of Wyeth. As of December 31, 2007, we have received
$14.0 million in milestone payments from Wyeth. We may not receive any further
milestone, contingent or royalty payments from Wyeth.
The
Collaboration Agreement extends, unless terminated earlier, on a
country-by-country and product-by-product basis, until the last-to-expire
royalty period, as defined, for any product. Progenics may terminate the
Collaboration Agreement at any time upon 90 days of written notice to Wyeth (30
days in the case of breach of a payment obligation) upon material breach that is
not cured. Wyeth may, with or without cause, following the second anniversary of
the first commercial sale, as defined, of the first commercial product in the
U.S., terminate the Collaboration Agreement by providing Progenics with at least
360 days prior written notice of such termination. Wyeth may also terminate the
agreement (i) upon 30 days written notice following one or more serious safety
or efficacy issues that arise, as defined, and (ii) at any time, upon 90 days
written notice of a material breach that is not cured by Progenics. Upon
termination of the Collaboration Agreement, the ownership of the license we
granted to Wyeth will depend on the party that initiates the termination and the
reason for the termination.
If our
relationship with Wyeth were to terminate, we would have to either enter into a
license and co-development agreement with another party or develop and
commercialize RELISTOR ourselves. We may not be able to enter into such an
agreement with another suitable company on acceptable terms or at all. To
develop and commercialize RELISTOR on our own, we would have to develop a sales
and marketing organization and a distribution infrastructure, neither of which
we currently have. Developing these resources would be an expensive and lengthy
process and would have a material adverse effect on our revenues and
profitability.
A
termination of our relationship with Wyeth could seriously compromise the
development program for RELISTOR and possibly our other product candidates. For
example, we could experience significant delays in the development of RELISTOR
and would have to assume full funding and other responsibility for further
development and eventual commercialization.
Any of
these outcomes would result in delays in our ability to distribute RELISTOR and
would increase our expenses, which would have a material adverse effect on our
business, results of operations and financial condition.
Our
collaboration with Wyeth is multi-faceted and involves a complex sharing of
control over decisions, responsibilities, costs and benefits. There are numerous
potential sources of disagreement between us and Wyeth, including with respect
to product development, marketing strategies, manufacturing and supply issues
and rights relating to intellectual property. Wyeth has significantly greater
financial and managerial resources than we do, which it could draw upon in the
event of a dispute. A disagreement between Wyeth and us could lead to lengthy
and expensive litigation or other dispute-resolution proceedings as well as to
extensive financial and operational consequences to us, and have a material
adverse effect on our business, results of operations and financial
condition.
If
testing does not yield successful results, our products will not be
approved.
We will
need to obtain regulatory approval before our product candidates can be
marketed. To obtain marketing approval from regulatory authorities, we or our
collaborators must demonstrate a product’s safety and efficacy through extensive
pre-clinical and clinical testing. Numerous adverse events may arise during, or
as a result of, the testing process, including the following:
· the
results of pre-clinical studies may be inconclusive, or they may not be
indicative of results that will be obtained in
human
clinical trials;
· potential
products may not have the desired efficacy or may have undesirable side effects
or other characteristics that
preclude
marketing approval or limit their commercial use if approved;
· after
reviewing test results, we or our collaborators may abandon projects which we
previously believed to be
promising;
and
· we,
our collaborators or regulators may suspend or terminate clinical trials if we
or they believe that the participating
subjects
are being exposed to unacceptable health risks.
Clinical
testing is very expensive and can take many years. Results attained in early
human clinical trials may not be indicative of results that are obtained in
later clinical trials. In addition, many of our investigational or experimental
drugs, such as PRO 140 and the PSMA product candidates, are at an early stage of
development. The successful commercialization of early stage product candidates
will require significant further research, development, testing and approvals by
regulators and additional investment. Our products in the research or
pre-clinical development stage may not yield results that would permit or
justify clinical testing. Our failure to demonstrate adequately the safety and
efficacy of a product under development would delay or prevent marketing
approval of the product, which could adversely affect our operating results and
credibility.
A
setback in our clinical development programs could adversely affect
us.
We and
Wyeth are conducting clinical trials of RELISTOR. If the results of any of
these ongoing trials or of other future trials of RELISTOR are not satisfactory,
or if we encounter problems enrolling subjects, or if clinical trial supply
issues or other difficulties arise, our entire RELISTOR development program
could be adversely affected, resulting in delays in commencing or completing
clinical trials or in making our regulatory filing for marketing approval. The
need to conduct additional clinical trials or significant revisions to our
clinical development plan would lead to delays in filing for the regulatory
approvals necessary to market RELISTOR. If the clinical trials indicate a
serious problem with the safety or efficacy of a RELISTOR product, then Wyeth
has the right under our license and co-development agreement to terminate the
agreement or to stop the development or commercialization of the affected
products. Since RELISTOR is our most clinically advanced product, any setback of
these types would have a material adverse effect on our stock price and
business.
We are
conducting a clinical trial of PRO 140 and are planning trials of PSMA ADC and
prostate cancer vaccine candidates. If the results of our future clinical
studies of PRO 140 or the pre-clinical and clinical studies involving the PSMA
vaccine and antibody candidates are not satisfactory, we would need to
reconfigure our clinical trial programs to conduct additional trials or abandon
the program involved.
We
have a history of operating losses, and we may never be profitable.
We have
incurred substantial losses since our inception. As of December 31, 2007, we had
an accumulated deficit of $254.0 million. We have derived no significant
revenues from product sales or royalties. We may not achieve significant product
sales or royalty revenue for a number of years, if ever. We expect to incur
additional operating losses in the future, which could increase significantly as
we expand our clinical trial programs and other product development
efforts.
Our
ability to achieve and sustain profitability is dependent in part on obtaining
regulatory approval to market our products and then commercializing, either
alone or with others, our products. We may not be able to develop and
commercialize products. Our operations may not be profitable even if any of our
products under development are commercialized.
We
are likely to need additional financing, but our access to capital funding is
uncertain.
As of
December 31, 2007, we had cash, cash equivalents and marketable securities,
including non-current portion, totaling $170.4 million. This includes proceeds
of $57.1 million, net of underwriter commissions, discounts and other offering
expenses, raised during the third quarter of 2007 in a follow-on public offering
of 2.6 million shares of common stock. During the year ended December 31,
2007, we had a net loss of $43.7 million and cash used in operating activities
was $39.1 million. Our accumulated deficit is expected to increase in the
future.
Under our
agreement with Wyeth, Wyeth is responsible for all future development and
commercialization costs relating to RELISTOR starting January 1, 2006. As a
result, although our spending on RELISTOR has been significant during 2006 and
2007 and is expected to continue at a similar level in the future, our net
expenses for RELISTOR have been and will continue to be reimbursed by
Wyeth.
With
regard to our other product candidates, we expect that we will continue to incur
significant expenditures for their development, and we do not have committed
external sources of funding for most of these projects. These expenditures will
be funded from our cash on hand, or we may seek additional external funding for
these expenditures, most likely through collaborative agreements, or other
license or sale transactions, with one or more pharmaceutical companies, through
the issuance and sale of securities or through additional government grants or
contracts. We cannot predict with any certainty when we will need additional
funds or how much we will need or if additional funds will be available to us.
Our need for future funding will depend on numerous factors, many of which are
outside our control.
Our
access to capital funding is always uncertain. Despite previous experience, we
may not be able at the necessary time to obtain additional funding on acceptable
terms, or at all. Our inability to raise additional capital on terms reasonably
acceptable to us would seriously jeopardize the future success of our
business.
If we
raise funds by issuing and selling securities, it may be on terms that are not
favorable to our existing stockholders. If we raise additional funds by selling
equity securities, our current stockholders will be diluted, and new investors
could have rights superior to our existing stockholders. If we raise funds by
selling debt securities, we could be subject to restrictive covenants and
significant repayment obligations.
We
believe that existing balances of cash, cash equivalents and marketable
securities, cash generated from operations and funds potentially available to us
by issuing and selling securities are sufficient to finance our current
operations and working capital requirements on both a short-term and long-term
basis. We cannot, however, predict the amount or timing of our need for
additional funds under various circumstances, which could include new product
development projects, other opportunities or other factors that may require us
to raise additional funds in the future.
Our
marketable securities, which include corporate debt securities, securities of
government-sponsored entities and auction rate securities (“ARS”), are
classified as available for sale. The ARS that we purchase consist of municipal
bonds with maturities greater than five years and, in accordance with our
investment guidelines, have credit ratings of at least Aa3/AA-, and do not
include mortgage-backed instruments. We have a history of holding all
marketable securities, other than ARS, to maturity. As of December 31,
2007, we had not experienced failed auctions of our ARS due to lack of investor
interest.
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, we began to reduce the principal
amount of ARS in our portfolio from $38.8 million at 2007 year-end. While our
portfolio was not affected by the auction process deterioration in 2007, some of
the ARS we hold experienced auction failures during the first quarter of 2008.
As a result, when we attempted to liquidate them through auction, we were unable
to do so as to approximately $10.1 million principal amount, which we continue
to hold. In the event of an auction failure, the interest rate on the security
is reset according to the contractual terms in the underlying indenture. As of
March 14, 2008, we have received all scheduled interest payments associated with
these securities.
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. We believe that the failed auctions experienced to date are not a
result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and
liquidity. We believe that any unrealized gain or loss associated
with these securities will be temporary and will be recorded in accumulated
other comprehensive income (loss) in our financial statements.
The
credit and capital markets have continued to deteriorate in
2008. Continuation or acceleration of the current instability in these
markets and/or deterioration in the ratings of our investments may affect our
ability to liquidate these securities, and therefore may affect our financial
condition, cash flows and earnings. We believe that based on our current cash,
cash equivalents and marketable securities balances of $170.4 million at
December 31, 2007, the current lack of liquidity in the credit and capital
markets will not have a material impact on our liquidity, cash flows, financial
flexibility or ability to fund our obligations.
We
continue to monitor the market for auction rate securities and consider its
impact (if any) on the fair market value of our investments. If the current
market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, we may be required to
record unrealized losses or impairment charges in 2008. As auctions have closed
successfully, we have converted our investments in ARS to money market funds. We
believe we will have the ability to hold any auction rate securities for which
auctions fail until the market recovers. We do not anticipate having to sell
these securities in order to operate our business.
Our
clinical trials could take longer than we expect.
Although
for planning purposes we forecast the commencement and completion of clinical
trials, and have included many of those forecasts in reports filed with the SEC
and in other public disclosures, the actual timing of these events can vary
dramatically. For example, we have experienced delays in our RELISTOR clinical
development program in the past as a result of slower than anticipated
enrollment. These delays may recur. Delays can be caused by, among other
things:
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deaths
or other adverse medical events involving subjects in our clinical
trials;
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regulatory
or patent issues;
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·
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interim
or final results of ongoing clinical
trials;
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·
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failure
to enroll clinical sites as
expected;
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competition
for enrollment from clinical trials conducted by others in similar
indications;
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scheduling
conflicts with participating clinicians and clinical institutions;
and
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manufacturing
problems.
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In
addition, we may need to delay or suspend our clinical trials if we are unable
to obtain additional funding when needed. Clinical trials involving our product
candidates may not commence or be completed as forecasted.
We have
limited experience in conducting clinical trials, and we rely on others to
conduct, supervise or monitor some or all aspects of some of our clinical
trials. In addition, certain clinical trials for our product candidates may be
conducted by government-sponsored agencies, and consequently will be dependent
on governmental participation and funding. Under our agreement with Wyeth
relating to RELISTOR, Wyeth has the responsibility to conduct some of the
clinical trials for that product candidate, including all trials outside of the
United States. We will have less control over the timing and other aspects of
these clinical trials than if we conducted them entirely on our
own.
As a
result of these and other factors, our clinical trials may not commence or be
completed as we expect or may not be conducted successfully, in which event
investors’ confidence in our ability to develop products may be impaired and our
stock price may decline.
We
are subject to extensive regulation, which can be costly and time consuming and
can subject us to unanticipated fines and delays.
We and
our products are subject to comprehensive regulation by the FDA in the U.S. and
by comparable authorities in other countries. These national agencies and other
federal, state and local entities regulate, among other things, the pre-clinical
and clinical testing, safety, approval, manufacture, labeling, marketing,
export, storage, record keeping, advertising and promotion of pharmaceutical
products. If we violate regulatory requirements at any stage, whether before or
after marketing approval is obtained, we may be subject to forced removal of a
product from the market, product seizure, civil and criminal penalties and other
adverse consequences.
Our
product candidates do not yet have, and may never obtain, the regulatory
approvals needed for marketing.
None of
our product candidates has been approved by applicable regulatory authorities
for marketing. The process of obtaining FDA and foreign regulatory approvals
often takes many years and can vary substantially based upon the type,
complexity and novelty of the products involved. We have had only limited
experience in filing and pursuing applications and other submissions necessary
to gain marketing approvals. Our products under development may never obtain the
marketing approval from the FDA or any other regulatory authority necessary for
commercialization.
Even
if our products receive regulatory approval:
·
|
they
might not obtain labeling claims necessary to make the product
commercially viable (in general, labeling claims define the medical
conditions for which a drug product may be marketed, and are therefore
very important to the commercial success of a
product);
|
·
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approval
may be limited to uses of the product for treatment or prevention of
diseases or conditions that are relatively less financially advantageous
to us than approval of greater or different
scope;
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we
or our collaborators might be required to undertake post-marketing trials
to verify the product’s efficacy or
safety;
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we,
our collaborators or others might identify side effects after the product
is on the market, or we or our collaborators might experience
manufacturing problems, either of which could result in subsequent
withdrawal of marketing approval, reformulation of the product, additional
pre-clinical testing or clinical trials, changes in labeling of the
product or the need for additional marketing applications;
and
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we
and our collaborators will be subject to ongoing FDA obligations and
continuous regulatory review.
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If our products fail to receive marketing approval or lose previously received
approvals, our financial results would be adversely affected.
Even
if our products obtain marketing approval, they might not be accepted in the
marketplace.
The
commercial success of our products will depend upon their acceptance by the
medical community and third party payors as clinically useful, cost effective
and safe. If health care providers believe that patients can be managed
adequately with alternative, currently available therapies, they may not
prescribe our products, especially if the alternative therapies are viewed as
more effective, as having a better safety or tolerability profile, as being more
convenient to the patient or health care providers or as being less expensive.
For pharmaceuticals administered in an institutional setting, the ability of the
institution to be adequately reimbursed could also play a significant role in
demand for our products. Even if our products obtain marketing approval, they
may not achieve market acceptance. If any of our products do not achieve market
acceptance, we will likely lose our entire investment in that
product.
Marketplace
acceptance will depend in part on competition in our industry, which is
intense.
The
extent to which any of our products achieves market acceptance will depend on
competitive factors. Competition in our industry is intense, and it is
accentuated by the rapid pace of technological development. There are products
currently in the market that will compete with the products that we are
developing, including AIDS drugs and chemotherapy drugs for treating cancer. As
described below, Adolor Corporation is developing a drug that would compete with
RELISTOR. Many of our competitors have substantially greater research and
development capabilities and experience and greater manufacturing, marketing,
financial and managerial resources than we do. These competitors may develop
products that are superior to those we are developing and render our products or
technologies non-competitive or obsolete. If our product candidates receive
marketing approval but cannot compete effectively in the marketplace, our
operating results and financial position would suffer.
One
or more competitors developing an opioid antagonist may reach the market ahead
of us and adversely affect the market potential for RELISTOR.
We are
aware that Adolor Corporation, in collaboration with Glaxo Group Limited, or
Glaxo, a subsidiary of GlaxoSmithKline plc, is developing Entereg™ (alvimopan), an
opioid antagonist, for postoperative ileus, which has completed phase 3 clinical
trials, and for opioid-induced bowel dysfunction, which has been the subject of
phase 3 clinical trials. Entereg is further along in the clinical development
process than RELISTOR, and Adolor Corporation has received an approvable letter
from the FDA for Entereg regarding the treatment of post-operative ileus. If
Entereg reaches the market before RELISTOR, it could achieve a significant
competitive advantage relative to our product. In any event, the considerable
marketing and sales capabilities of Glaxo may impair our ability to penetrate
the market.
Under the
terms of our collaboration with Wyeth with respect to RELISTOR, Wyeth is
developing the oral formulation of RELISTOR worldwide. We are leading the U.S.
development of the subcutaneous and intravenous formulations of RELISTOR, while
Wyeth is leading development of these parenteral products outside the U.S.
Decisions regarding the timelines for development of the three RELISTOR
formulations are being be made by a Joint Development Committee, and endorsed by
the Joint Steering Committee, each committee formed under the terms of the
license and co-development agreement, consisting of members from both Wyeth and
Progenics.
If
we are unable to negotiate collaborative agreements, our cash burn rate could
increase and our rate of product development could decrease.
Our
business strategy includes as an element entering into collaborations with
pharmaceutical and biotechnology companies to develop and commercialize our
products and technologies. We entered into such a collaboration with Wyeth, but
we may not be successful in negotiating additional collaborative arrangements.
If we do not enter into new collaborative arrangements, we would have to devote
more of our resources to clinical product development and product-launch
activities, and our cash burn rate would increase or we would need to take steps
to reduce our rate of product development.
If
we do not remedy our failure to achieve milestones or satisfy conditions
regarding some of our product candidates, we may not maintain our rights under
our licenses relating to these product candidates.
We are
required to make substantial cash payments, achieve specified milestones and
satisfy other conditions, including filing for and obtaining marketing approvals
and introducing products, to maintain rights under our intellectual property
licenses. Due to the nature of these agreements and the uncertainties of
research and development, we may not be able to achieve milestones or satisfy
conditions to which we have contractually committed, and as a result may be
unable to maintain our rights under these licenses.
If we do
not comply with our obligations under our license agreements, the licensors may
terminate them. Termination of any of our licenses could result in our losing
our rights to, and therefore being unable to commercialize, any related
product.
We
have limited manufacturing capabilities, which could adversely affect our
ability to commercialize products.
We have
limited manufacturing capabilities, which may result in increased costs of
production or delay product development or commercialization. In order to
commercialize our product candidates successfully, we or our collaborators must
be able to manufacture products in commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. The
manufacture of our product candidates can be complex, difficult to accomplish
even in small quantities, difficult to scale-up for large-scale production and
subject to delays, inefficiencies and low yields of quality products. The cost
of manufacturing some of our products may make them prohibitively expensive. If
adequate supplies of any of our product candidates or related materials are not
available to us on a timely basis or at all, our clinical trials could be
seriously delayed, since these materials are time consuming to manufacture and
cannot be readily obtained from third-party sources.
We
operate pilot-scale manufacturing facilities for the production of vaccines and
recombinant proteins. We believe that, for these types of product candidates,
these facilities will be sufficient to meet our initial needs for clinical
trials. These facilities may, however, be insufficient for late-stage clinical
trials for these types of product candidates, and would be insufficient for
commercial-scale manufacturing requirements. We may be required to expand
further our manufacturing staff and facilities, obtain new facilities or
contract with corporate collaborators or other third parties to assist with
production.
In the
event that we decide to establish a commercial-scale manufacturing facility, we
will require substantial additional funds and will be required to hire and train
significant numbers of employees and comply with applicable regulations, which
are extensive. We may not be able to build a manufacturing facility that both
meets regulatory requirements and is sufficient for our clinical trials or
commercial scale manufacturing.
We have
entered into arrangements with third parties for the manufacture of some of our
products. Our third-party sourcing strategy may not result in a cost-effective
means for manufacturing products. In employing third-party manufacturers, we
will not control many aspects of the manufacturing process, including compliance
by these third parties with the FDA’s current Good Manufacturing Practices and
other regulatory requirements. We may not be able to obtain adequate supplies
from third-party manufacturers in a timely fashion for development or
commercialization purposes, and commercial quantities of products may not be
available from contract manufacturers at acceptable costs.
We
are dependent on our patents and other intellectual property rights. The
validity, enforceability and commercial value of these rights are highly
uncertain.
Our
success is dependent in part upon obtaining, maintaining and enforcing patent
and other intellectual property rights. The patent position of biotechnology and
pharmaceutical firms is highly uncertain and involves many complex legal and
technical issues. There is no clear policy involving the breadth of claims
allowed, or the degree of protection afforded, under patents in this area.
Accordingly, the patent applications owned by or licensed to us may not result
in patents being issued. We are aware of other groups that have patent
applications or patents containing claims similar to or overlapping those in our
patents and patent applications. We do not expect to know for several years the
relative strength or scope of our patent position as compared to these other
groups. Patents that we own or license may not enable us to preclude competitors
from commercializing drugs, and consequently may not provide us with any
meaningful competitive advantage.
We own or
have licenses to several issued patents. The issuance of a patent, however, is
not conclusive as to its validity or enforceability. The validity or
enforceability of a patent after its issuance by the patent office can be
challenged in litigation. Our patents may be successfully challenged. We may
incur substantial costs in litigation to uphold the validity of patents or to
prevent infringement. If the outcome of litigation is adverse to us, third
parties may be able to use our patented invention without payment to us. Third
parties may also avoid our patents through design innovation.
Most of
our product candidates, including RELISTOR, PRO 140 and our PSMA and HCV program
products, incorporate to some degree intellectual property licensed from third
parties. We can lose the right to patents and other intellectual property
licensed to us if the related license agreement is terminated due to a breach by
us or otherwise. Our ability, and that of our collaboration partners, to
commercialize products incorporating licensed intellectual property would be
impaired if the related license agreements were terminated.
Generally,
we have the right to defend and enforce patents licensed by us, either in the
first instance or if the licensor chooses not to do so. In addition, our license
agreement with the University of Chicago regarding methylnaltrexone gives us the
right to prosecute and maintain the licensed patents. We bear the cost of
engaging in some or all of these activities with respect to our license
agreements with the University of Chicago for methylnaltrexone. Under our
Collaboration Agreement, Wyeth has the right, at its expense, to defend and
enforce the RELISTOR patents licensed to Wyeth by us. With most of our other
license agreements, the licensor bears the cost of engaging in all of these
activities, although we may share in those costs under specified circumstances.
Historically, our costs of defending patent rights, both our own and those we
license, have not been material.
We also
rely on unpatented technology, trade secrets and confidential information. Third
parties may independently develop substantially equivalent information and
techniques or otherwise gain access to our technology or disclose our
technology, and we may be unable to effectively protect our rights in unpatented
technology, trade secrets and confidential information. We require each of our
employees, consultants and advisors to execute a confidentiality agreement at
the commencement of an employment or consulting relationship with us. These
agreements may, however, not provide effective protection in the event of
unauthorized use or disclosure of confidential information.
If
we infringe third-party patent or other intellectual property rights, we may
need to alter or terminate a product development program.
There may
be patent or other intellectual property rights belonging to others that require
us to alter our products, pay licensing fees or cease certain activities. If our
products infringe patent or other intellectual property rights of others, the
owners of those rights could bring legal actions against us claiming damages and
seeking to enjoin manufacturing and marketing of the affected products. If these
legal actions are successful, in addition to any potential liability for
damages, we could be required to obtain a license in order to continue to
manufacture or market the affected products. We may not prevail in any action
brought against us, and any license required under any rights that we infringe
may not be available on acceptable terms or at all. We are aware of intellectual
property rights held by third parties that relate to products or technologies we
are developing. For example, we are aware of other groups investigating
methylnaltrexone and other peripheral opioid antagonists, PSMA or related
compounds and CCR5 monoclonal antibodies and of patents held, and patent
applications filed, by these groups in those areas. While the validity of these
issued patents, patentability of these pending patent applications and
applicability of any of them to our programs are uncertain, if asserted against
us, any related patent or other intellectual property rights could adversely
affect our ability to commercialize our products.
The
research, development and commercialization of a biopharmaceutical often involve
alternative development and optimization routes, which are presented at various
stages in the development process. The preferred routes cannot be predicted at
the outset of a research and development program because they will depend on
subsequent discoveries and test results. There are numerous third-party patents
in our field, and we may need to obtain a license to a patent in order to pursue
the preferred development route of one or more of our products. The need to
obtain a license would decrease the ultimate profitability of the applicable
product. If we cannot negotiate a license, we might have to pursue a less
desirable development route or terminate the program
altogether.
We
are dependent upon third parties for a variety of functions. These arrangements
may not provide us with the benefits we expect.
We rely
in part on third parties to perform a variety of functions. We are party to
numerous agreements which place substantial responsibility on clinical research
organizations, consultants and other service providers for the development of
our products. We also rely on medical and academic institutions to perform
aspects of our clinical trials of product candidates. In addition, an element of
our research and development strategy is to in-license technology and product
candidates from academic and government institutions in order to minimize
investments in early research. We entered into an agreement under which we
depend on Wyeth for the commercialization and development of RELISTOR, our lead
product candidate. We may not be able to maintain any of these relationships or
establish new ones on beneficial terms. We may not be able to enter new
arrangements without undue delays or expenditures, and these arrangements may
not allow us to compete successfully.
We
lack sales and marketing infrastructure and related staff, which will require
significant investment to establish and in the meantime may make us dependent on
third parties for their expertise in this area.
We have
no established sales, marketing or distribution infrastructure. If we receive
marketing approval, significant investment, time and managerial resources will
be required to build the commercial infrastructure required to market, sell and
support a pharmaceutical product. Should we choose to commercialize any product
directly, we may not be successful in developing an effective commercial
infrastructure or in achieving sufficient market acceptance. Alternatively, we
may choose to market and sell our products through distribution, co-marketing,
co-promotion or licensing arrangements with third parties. We may also consider
contracting with a third party professional pharmaceutical detailing and sales
organization to perform the marketing function for our products. Under our
license and co-development agreement with Wyeth, Wyeth is responsible for
commercializing RELISTOR. To the extent that we enter into distribution,
co-marketing, co-promotion, detailing or licensing arrangements for the
marketing and sale of our other products, any revenues we receive will depend
primarily on the efforts of third parties. We will not control the amount and
timing of marketing resources these third parties devote to our
products.
If
we lose key management and scientific personnel on whom we depend, our business
could suffer.
We are
dependent upon our key management and scientific personnel. In particular, the
loss of Dr. Maddon could cause our management and operations to suffer. In late
2007, we concluded a renewal employment agreement with Dr. Maddon, with an
effective date of July 1, 2007, for an initial term of one year, which is
subject to automatic renewal provided both we and Dr. Maddon agree. Employment
agreements do not assure the continued employment of an employee. We maintain
key-man life insurance on Dr. Maddon in the amount of $2.5 million.
Competition
for qualified employees among companies in the biopharmaceutical industry is
intense. Our future success depends upon our ability to attract, retain and
motivate highly skilled employees. In order to commercialize our products
successfully, we may be required to expand substantially our personnel,
particularly in the areas of manufacturing, clinical trials management,
regulatory affairs, business development and marketing. We may not be successful
in hiring or retaining qualified personnel.
If
we are unable to obtain sufficient quantities of the raw and bulk materials
needed to make our products, our product development and commercialization could
be slowed or stopped.
In
accordance with our collaboration agreement with Wyeth, we have transferred to
Wyeth the responsibility for manufacturing RELISTOR for clinical and commercial
use. We currently obtain supplies of critical raw materials used in production
of other of our product candidates from single sources. We do not have long-term
contracts with any of these other suppliers. Wyeth may not be able to fulfill
its manufacturing obligations, either on its own or through third-party
suppliers. Our existing arrangements with suppliers for our other product
candidates may not result in the supply of sufficient quantities of our product
candidates needed to accomplish our clinical development programs, and we may
not have the right or capability to manufacture sufficient quantities of these
products to meet our needs if our suppliers are unable or unwilling to do so.
Any delay or disruption in the availability of raw materials would slow or stop
product development and commercialization of the relevant
product.
A
substantial portion of our funding comes from federal government grants and
research contracts. We cannot rely on these grants or contracts as a continuing
source of funds.
A
substantial portion of our revenues to date has been derived from federal
government grants and research contracts. During 2006 and 2007, we were awarded,
in the aggregate, approximately $4.4 million in NIH grants. During 2005, we were
also awarded a $3.0 million and a $9.7 million grant from the NIH to partially
fund our hepatitis C virus and PRO 140 programs, respectively. In 2004 we were
awarded, in the aggregate, approximately $9.2 million in NIH grants and research
contracts in addition to previous years’ awards. We cannot rely on grants or
additional contracts as a continuing source of funds. Funds available under
these grants and contracts must be applied by us toward the research and
development programs specified by the government rather than for all our
programs generally. For example, the contract awarded to us by the NIH in
September 2003, which provided for up to $28.6 million in funding over a five
year period, must be used by us in furtherance of our efforts to develop an HIV
vaccine. The government’s obligation to make payments under these grants and
contracts is subject to appropriation by the U.S. Congress for funding in each
year. It is possible that Congress or the government agencies that administer
these government research programs will decide to scale back these programs or
terminate them due to their own budgetary constraints. Additionally, these
grants and research contracts are subject to adjustment based upon the results
of periodic audits performed on behalf of the granting authority. Consequently,
the government may not award grants or research contracts to us in the future,
and any amounts that we derive from existing grants or contracts may be less
than those received to date. We have recently been informed by the NIH that it
has decided not to fund the 2003 contract beyond the $15.5 million approved
through September 2008. To continue to develop the HIV vaccine after that time,
therefore, we will need to provide funding on our own or obtain new governmental
or other funding. If we choose not to provide our own or cannot secure
governmental or other funding, we will discontinue this project.
If
health care reform measures are enacted, our operating results and our ability
to commercialize products could be adversely affected.
In
recent years, there have been numerous proposals to change the health care
system in the U.S. and in foreign jurisdictions. Some of these proposals have
included measures that would limit or eliminate payments for medical procedures
and treatments or subject the pricing of pharmaceuticals to government control.
In some foreign countries, particularly countries of the European Union, the
pricing of prescription pharmaceuticals is subject to governmental control. In
addition, as a result of the trend towards managed health care in the U.S., as
well as legislative proposals to reduce government insurance programs,
third-party payors are increasingly attempting to contain health care costs by
limiting both coverage and the level of reimbursement of new drug products.
Consequently, significant uncertainty exists as to the reimbursement status of
newly approved health care products.
If we or
any of our collaborators succeed in bringing one or more of our products to
market, third party payors may establish and maintain price levels insufficient
for us to realize an appropriate return on our investment in product
development. Significant changes in the health care system in the U.S. or
elsewhere, including changes resulting from adverse trends in third-party
reimbursement programs, could have a material adverse effect on our operating
results and our ability to raise capital and commercialize
products.
We
are exposed to product liability claims, and in the future we may not be able to
obtain insurance against these claims at a reasonable cost or at
all.
Our
business exposes us to product liability risks, which are inherent in the
testing, manufacturing, marketing and sale of pharmaceutical products. We may
not be able to avoid product liability exposure. If a product liability claim is
successfully brought against us, our financial position may be adversely
affected.
Product
liability insurance for the biopharmaceutical industry is generally expensive,
when available at all. We have obtained product liability insurance in the
amount of $10.0 million per occurrence, subject to a deductible and a $10.0
million annual aggregate limitation. Where local statutory requirements exceed
the limits of our existing insurance or where local policies of insurance are
required, we maintain additional clinical trial liability insurance to meet
these requirements. Our present insurance coverage may not be adequate to cover
claims brought against us. Some of our license and other agreements require us
to obtain product liability insurance. Adequate insurance coverage may not be
available to us at a reasonable cost in the future.
We
handle hazardous materials and must comply with environmental laws and
regulations, which can be expensive and restrict how we do business. If we are
involved in a hazardous waste spill or other accident, we could be liable for
damages, penalties or other forms of censure.
Our
research and development work and manufacturing processes involve the use of
hazardous, controlled and radioactive materials. We are subject to federal,
state and local laws and regulations governing the use, manufacture, storage,
handling and disposal of these materials. Despite procedures that we implement
for handling and disposing of these materials, we cannot eliminate the risk of
accidental contamination or injury. In the event of a hazardous waste spill or
other accident, we could be liable for damages, penalties or other forms of
censure. We may be required to incur significant costs to comply with
environmental laws and regulations in the future.
Our
stock price has a history of volatility. You should consider an investment in
our stock as risky and invest only if you can withstand a significant
loss.
Our
stock price has a history of significant volatility. Between January 1, 2005 and
December 31, 2007, our stock price has ranged from $14.09 to $30.83 per share.
In the first quarter of 2008, it has ranged to as low as approximately $5.00 per
share. Historically, our stock price has fluctuated through an even greater
range. At times, our stock price has been volatile even in the absence of
significant news or developments relating to us. The stock prices of
biotechnology companies and the stock market generally have been subject to
dramatic price swings in recent years. Factors that may have a significant
impact on the market price of our common stock include:
· the
results of clinical trials and pre-clinical studies involving our products or
those of our competitors;
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·
changes in the status of any of our drug development programs,
including delays in clinical trials or
program terminations;
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· developments regarding our efforts to achieve marketing
approval for our products;
|
·
developments in our relationship with Wyeth regarding the
development and commercialization of
RELISTOR;
|
· announcements
of technological innovations or new commercial products by us, our collaborators
or our competitors;
·
developments in our relationships with other collaborative
partners;
· developments
in patent or other proprietary rights;
· governmental
regulation;
· changes
in reimbursement policies or health care legislation;
· public
concern as to the safety and efficacy of products developed by us, our
collaborators or our competitors;
· our
ability to fund on-going operations;
· fluctuations
in our operating results; and
· general
market conditions.
Our
principal stockholders are able to exert significant influence over matters
submitted to stockholders for approval.
At
December 31, 2007, our directors and executive officers and stockholders
affiliated with Tudor Investment Corporation together beneficially own or
control approximately one-fifth of our outstanding shares of common stock. At
that date, our six largest stockholders, excluding our directors and executive
officers and stockholders affiliated with Tudor, beneficially own or control in
the aggregate approximately half of our outstanding shares. Our directors and
executive officers and Tudor-related stockholders, should they choose to act
together, could exert significant influence in determining the outcome of
corporate actions requiring stockholder approval and otherwise control our
business. This control could have the effect of delaying or preventing a change
in control of us and, consequently, could adversely affect the market price of
our common stock. Other significant but unrelated stockholders could also exert
influence in such matters.
Anti-takeover
provisions may make the removal of our Board of Directors or management more
difficult and discourage hostile bids for control of our company that may be
beneficial to our stockholders.
Our
Board of Directors is authorized, without further stockholder action, to issue
from time to time shares of preferred stock in one or more designated series or
classes. The issuance of preferred stock, as well as provisions in certain of
our stock options that provide for acceleration of exercisability upon a change
of control, and Section 203 and other provisions of the Delaware General
Corporation Law could:
· make the takeover of Progenics or the removal of our Board
of Directors or management more difficult;
· discourage hostile bids for control of Progenics in which
stockholders may receive a premium for their shares of common stock;
and
· otherwise dilute the rights of holders of our common stock
and depress the market price of our common stock.
If
there are substantial sales of our common stock, the market price of our common
stock could decline.
Sales of
substantial numbers of shares of common stock could cause a decline in the
market price of our stock. We require substantial external funding to finance
our research and development programs and may seek such funding through the
issuance and sale of our common stock. We filed a shelf registration statement
to permit the sale by us of up to 4.0 million shares of our common stock,
pursuant to which we sold 2.6 million shares on September 25, 2007. We also
filed registration statements with respect to sales of 286,000 shares of our
common stock by certain stockholders, all of which have been sold. Additional
sales of our common stock pursuant to our shelf registration statement could,
even at then-current market prices, cause the market price of our stock to
decline. In addition, some of our other stockholders are entitled to require us
to register their shares of common stock for offer or sale to the public, and we
have filed Form S-8 registration statements registering shares issuable pursuant
to our equity compensation plans. Any sales by existing stockholders or holders
of options may have an adverse effect on our ability to raise capital and may
adversely affect the market price of our common stock.
There
were no unresolved SEC staff comments regarding our periodic or current reports
under the Exchange Act as of December 31, 2007.
As of
December 31, 2007, we occupy in total approximately 145,800 square feet of
laboratory, manufacturing and office space on a single campus in Tarrytown, New
York, as follows:
Leased
Space
|
|
Area
(Square Feet)
|
|
Base
Monthly Rent
|
|
Termination
Date
|
|
Other
Terms
|
|
|
|
|
|
|
|
|
|
Sublease
1
|
|
91,600
|
|
$140,000
|
|
December
30, 2009
|
|
|
Lease
1
|
|
32,600
|
|
$66,000
|
|
December
31, 2009
|
|
Renewable
for two five year terms
|
Sublease
2
|
|
5,900
|
|
$13,000
through June 30, 2010;
$15,000
through June 30, 2011;
$16,000
through June 29, 2012
|
|
June
29, 2012
|
|
Four
months rent-free beginning April 1, 2006; converts to Lease
2
|
Lease
2
|
|
|
|
$16,000
|
|
December
31, 2014
|
|
|
Lease
3
|
|
9,200
|
|
$12,000
through November 12, 2008;
annual
3% increases thereafter
|
|
June
29, 2012
|
|
Three
months rent-free beginning August 13, 2007; renewable for two five year
terms; lease incentive of $276,300 provided by landlord
|
Lease
4
|
|
6,500
|
|
$14,000
|
|
August
31, 2012
|
|
Renewable
for two terms coterminous with Lease 1
|
Total
|
|
145,800
|
|
|
|
|
|
|
In
addition to rents due under these agreements, we are obligated to pay additional
facilities charges, including utilities, taxes and operating
expenses.
Item
3. Legal Proceedings
We are
not a party to any material legal proceedings.
Item
4. Submission of Matters to a Vote of Security
Holders
No
matters were submitted to a vote of stockholders during the fourth quarter of
2007.
PART
II
Item
5. Market for Registrant’s Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity Securities
Price
Range of Common Stock
Our
common stock is quoted on The NASDAQ Stock Market LLC under the symbol “PGNX.”
The following table sets forth, for the periods indicated, the high and low
sales price per share of the common stock, as reported on The NASDAQ Stock
Market LLC. Such prices reflect inter-dealer prices, without retail mark-up,
markdown or commission and may not represent actual transactions.
|
High
|
Low
|
Year
ended December 31, 2006
|
|
|
First
quarter
|
$
30.83
|
$
24.92
|
Second
quarter
|
26.72
|
19.95
|
Third
quarter
|
26.07
|
19.80
|
Fourth
quarter
|
29.55
|
22.51
|
Year
ended December 31, 2007
|
|
|
First
quarter
|
30.31
|
22.02
|
Second
quarter
|
27.59
|
21.14
|
Third
quarter
|
26.10
|
20.55
|
Fourth
quarter
|
23.98
|
17.77
|
On
March 13, 2008, the last sale price for our common stock, as reported by
The NASDAQ Stock Market LLC, was $5.09. There were approximately 122 holders of record of our
common stock as of March 13, 2008.
Comparative
Stock Performance Graph
The graph
below compares the cumulative stockholder return on our common stock with the
cumulative stockholder return of (i) the Nasdaq Stock Market (U.S.) Index and
(ii) the Nasdaq Pharmaceutical Index, assuming the investment in each equaled
$100 on December 31, 2002.
Dividends
We have
not paid any dividends since our inception and currently anticipate that all
earnings, if any, will be retained for development of our business and that no
dividends on our common stock will be declared in the foreseeable
future.
The
selected financial data presented below as of December 31, 2006 and 2007 and for
each of the three years in the period ended December 31, 2007 are derived from
the Company’s audited financial statements, included elsewhere herein. The
selected financial data presented below with respect to the balance sheet data
as of December 31, 2003, 2004 and 2005 and for each of the two years in the
period ended December 31, 2004 are derived from the Company’s audited financial
statements not included herein. The data set forth below should be read in
conjunction with Management’s Discussion and Analysis of Financial Condition and
Results of Operations and the Financial Statements and related Notes included
elsewhere herein.
|
|
Years
Ended December 31,
|
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
|
(in
thousands, except per share data)
|
|
Statement
of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development from collaborator
|
|
|
|
|
|
|
|
|
|
|
$ |
58,415 |
|
|
$ |
65,455 |
|
Research
and development, joint venture
|
|
$ |
2,486 |
|
|
$ |
2,008 |
|
|
$ |
988 |
|
|
|
|
|
|
|
|
|
Research
grants and contracts
|
|
|
4,826 |
|
|
|
7,483 |
|
|
|
8,432 |
|
|
|
11,418 |
|
|
|
10,075 |
|
Product
sales
|
|
|
149 |
|
|
|
85 |
|
|
|
66 |
|
|
|
73 |
|
|
|
116 |
|
Total
revenues
|
|
|
7,461 |
|
|
|
9,576 |
|
|
|
9,486 |
|
|
|
69,906 |
|
|
|
75,646 |
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
26,374 |
|
|
|
35,673 |
|
|
|
43,419 |
|
|
|
61,711 |
|
|
|
95,123 |
|
In-process
research and development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,209 |
|
|
|
|
|
License
fees – research and development
|
|
|
867 |
|
|
|
390 |
|
|
|
20,418 |
|
|
|
390 |
|
|
|
1,053 |
|
General
and administrative
|
|
|
8,029 |
|
|
|
12,580 |
|
|
|
13,565 |
|
|
|
22,259 |
|
|
|
27,901 |
|
Loss
in joint venture
|
|
|
2,525 |
|
|
|
2,134 |
|
|
|
1,863 |
|
|
|
121 |
|
|
|
|
|
Depreciation
and amortization
|
|
|
1,273 |
|
|
|
1,566 |
|
|
|
1,748 |
|
|
|
1,535 |
|
|
|
3,027 |
|
Total
expenses
|
|
|
39,068 |
|
|
|
52,343 |
|
|
|
81,013 |
|
|
|
99,225 |
|
|
|
127,104 |
|
Operating
loss
|
|
|
(31,607 |
) |
|
|
(42,767 |
) |
|
|
(71,527 |
) |
|
|
(29,319 |
) |
|
|
(51,458 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
625 |
|
|
|
780 |
|
|
|
2,299 |
|
|
|
7,701 |
|
|
|
7,770 |
|
Interest
expense
|
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
on sale of marketable securities
|
|
|
|
|
|
|
(31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total
other income
|
|
|
621 |
|
|
|
749 |
|
|
|
2,299 |
|
|
|
7,701 |
|
|
|
7,770 |
|
Net
loss before income taxes
|
|
|
(30,986 |
) |
|
|
(42,018 |
) |
|
|
(69,228 |
) |
|
|
(21,618 |
) |
|
|
(43,688 |
) |
Income
taxes
|
|
|
|
|
|
|
|
|
|
|
(201 |
) |
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(30,986 |
) |
|
$ |
(42,018 |
) |
|
$ |
(69,429 |
) |
|
$ |
(21,618 |
) |
|
$ |
(43,688 |
) |
Per
share amounts on net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(2.32 |
) |
|
$ |
(2.48 |
) |
|
$ |
(3.33 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.60 |
) |
|
|
December
31,
|
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
|
(in
thousands)
|
|
Balance
Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable
securities
|
|
$ |
65,663 |
|
|
$ |
31,207 |
|
|
$ |
173,090 |
|
|
$ |
149,100 |
|
|
$ |
170,370 |
|
Working
capital
|
|
|
56,228 |
|
|
|
25,667 |
|
|
|
137,101 |
|
|
|
91,827 |
|
|
|
102,979 |
|
Total
assets
|
|
|
72,886 |
|
|
|
39,545 |
|
|
|
184,003 |
|
|
|
165,911 |
|
|
|
189,539 |
|
Deferred
revenue, long-term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,101 |
|
|
|
9,131 |
|
Other
liabilities, long-term
|
|
|
50 |
|
|
|
42 |
|
|
|
49 |
|
|
|
123 |
|
|
|
359 |
|
Total
stockholders’ equity
|
|
|
67,683 |
|
|
|
31,838 |
|
|
|
112,732 |
|
|
|
110,846 |
|
|
|
147,499 |
|
Item
7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
Overview
We are a
biopharmaceutical company focusing on the development and commercialization of
innovative therapeutic products to treat the unmet medical needs of patients
with debilitating conditions and life-threatening diseases. Our principal
programs are directed toward gastroenterology, virology and oncology. See Business – Overview, above. We commenced principal
operations in late 1988, and since that time we have been engaged primarily in
research and development efforts, development of our manufacturing capabilities,
establishment of corporate collaborations and raising capital. We do not
currently have any commercial products. In order to commercialize the principal
products that we have under development, we have been and continue to be
required to address a number of technological and clinical challenges and comply
with comprehensive regulatory requirements. Accordingly, we cannot predict the
amount of funds that we will require, or the length of time that will pass,
before we receive significant revenues from sales of any of our products, if
ever.
Our most advanced product candidate and
likeliest source of product revenue is methylnaltrexone. See Business – Gastroenterology –
RELISTOR and Business –
Licenses – Progenics Licenses – Wyeth, above.
In the
area of virology, we are developing viral entry inhibitors for HIV and Hepatitis
C virus (“HCV”) infection, which are molecules designed to inhibit a virus’
ability to enter certain types of immune cells and liver cells, respectively.
See Business – Virology – PRO 140 and ProVax and Business – Virology – Hepatitis C
Viral Entry Inhibitor, above.
We are
developing therapies for prostate cancer. See Business – Oncology – PSMA,
above. Our PSMA programs are conducted through our wholly-owned
subsidiary, PSMA Development Company LLC, which prior to April 2006 was a joint
venture with Cytogen. Although we are continuing to conduct the PSMA-related
research and development activities, we will no longer recognize revenue from
PSMA LLC.
Prior to our acquisition of Cytogen’s
interest, PSMA LLC’s intellectual property, which was equally owned by us and
Cytogen, was used in two research and development programs, a vaccine program
and a monoclonal antibody program, both of which were in the pre-clinical or
early clinical phases of development. We conducted most of the research and
development for those two programs prior to the acquisition and are continuing
those research and development activities and will incur all the expenses of
those programs.
Before
any products resulting from the vaccine and the monoclonal antibody programs
that were jointly under development at the date of our acquisition of Cytogen’s
interest can be commercialized, PSMA LLC must complete pre-clinical studies and
phases 1 through 3 clinical trials for each project and file and receive
approval of New Drug Applications with the FDA. Due to the complexities and
uncertainties of scientific research and the early stage of the PSMA programs,
the timing and costs of such further development efforts and the anticipated
completion dates of those programs, if ever, cannot reliably be determined at
the acquisition date. Those efforts are currently expected to require at least
three years, based upon the timing of our other early stage development
projects. There can be no assurance that either of the PSMA programs will reach
technological feasibility or that they will ever be commercially viable. The
risks associated with development and commercialization of these programs
include delay or failure of basic research, failure to obtain regulatory
approvals to conduct clinical trials and market products, and patent
litigation.
We
discontinued our GMK melanoma vaccine program during the second quarter of 2007.
An independent data monitoring committee recommended that treatment in the
European-based phase 3 trial, which began in 2001, be stopped because lack of
efficacy was observed after an interim analysis. We have subsequently terminated
our license agreement with Memorial Sloan-Kettering Cancer Center relating to
this program.
Our
sources of revenues through December 31, 2007 have been payments under our
current and former collaboration agreements, from PSMA LLC, from research grants
and contracts from the National Institutes of Health (“NIH”) related to our
cancer and virology programs and from interest income. Beginning in January
2006, we have been recognizing revenues from Wyeth for reimbursement of our
development expenses for RELISTOR as incurred, for the $60 million upfront
payment we received from Wyeth over the period of our development obligations
and for any milestones or contingent events that are achieved during our
collaboration with Wyeth. We have not recognized revenue from PSMA LLC for the
years ended December 31, 2006 or 2007, since during 2006, prior to our
acquisition of Cytogen’s membership interest in PSMA LLC on April 20, 2006, we
and Cytogen had not approved a work plan and budget for 2006 and subsequently
PSMA LLC has become our wholly owned subsidiary. To date, our product sales have
consisted solely of limited revenues from the sale of research reagents. We
expect that sales of research reagents in the future will not significantly
increase over current levels.
A
majority of our expenditures to date have been for research and development
activities. During 2007, expenses for our PRO 140, HCV and PSMA research
programs have increased significantly over those in 2005 and 2006. We expect
that during 2008 our research and development expenses for these programs will
continue to increase as our programs progress and we make filings with
regulators to conduct clinical trials of our product candidates. A portion of
these expenses is reimbursed under our NIH grants and contract. Our development
and commercialization expenses for RELISTOR are being funded by Wyeth, which
allows us to devote our current and future resources to our other research and
development programs.
During
the year ended December 31, 2007, we received net proceeds of $57.1 million from
a public offering totaling 2.6 million shares of our common stock. At December
31, 2007, we had cash, cash equivalents and marketable securities totaling
$170.4 million. We expect that cash, cash equivalents and marketable securities
on hand at December 31, 2007 will be sufficient to fund operations at current
levels beyond one year. Cash used in operating
activities for the year ended December 31, 2007 was $39.1 million. We have had
recurring losses and had, at December 31, 2007, an accumulated deficit of $254.0
million. During the year ended December 31, 2007, we had a net loss of $43.7
million. Other than potential revenues from RELISTOR, we do not anticipate
generating significant recurring revenues, from product sales or otherwise, in
the near term, and we expect our expenses to increase. Consequently, we may
require significant additional external funding to continue our operations at
their current levels in the future. Such funding may be derived from additional
collaboration or licensing agreements with pharmaceutical or other companies or
from the sale of our common stock or other securities to investors, but may also
not be available to us on acceptable terms or at all.
Results
of Operations (amounts in
thousands)
Revenues:
Our
sources of revenue during the years ended December 31, 2007 and 2006, included
our collaboration with Wyeth, which was effective on January 1, 2006, our
research grants and contracts from the NIH and, to a small extent, our sale of
research reagents. During 2005 we recognized revenue from our NIH grants and
contract, from our PSMA LLC joint venture and from our sale of research reagents
but we did not recognize revenue from Wyeth.
Sources
of Revenue
|
|
2007
|
|
2006
|
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
|
|
|
Percent
Change
|
Research
from collaborator
|
|
$65,455
|
|
$58,415
|
|
|
|
12%
|
N/A
|
Research
from PSMA LLC
|
|
|
|
|
|
$988
|
|
N/A
|
(100%)
|
Research
grants and contract
|
|
10,075
|
|
11,418
|
|
8,432
|
|
(12)%
|
35%
|
Product
sales
|
|
116
|
|
73
|
|
66
|
|
59%
|
11%
|
|
|
$75,646
|
|
$69,906
|
|
$9,486
|
|
8%
|
637%
|
2007 vs. 2006
Research
revenues from collaborator
Research
revenue from collaborator relates to our Collaboration Agreement with Wyeth.
During the years ended December 31, 2007 and 2006, we recognized $65,455 and
$58,415, respectively, of revenue from Wyeth, including $16,378 and $18,831,
respectively, of the $60,000 upfront payment we received upon entering into our
collaboration in December 2005, $40,077 and $34,584, respectively, as
reimbursement of our development expenses and $9,000 and $5,000, respectively,
of non-refundable payments earned upon the achievement of milestones defined in
the Collaboration Agreement. We recognize a portion of the upfront payment in a
reporting period in accordance with the proportionate performance method, which
is based on the percentage of actual effort performed on our development
obligations in that period relative to total effort expected for all of our
performance obligations under the arrangement, as reflected in the most recent
development plan and budget approved by Wyeth and us. During the third quarter
of 2007, a revised budget was approved, which extended our performance period to
the end of 2009 and, thereby, decreased the amount of revenue we are recognizing
in each reporting period. Reimbursement of development costs is recognized as
revenue as the costs are incurred under the development plan agreed to by us and
Wyeth. The milestones were recognized according to the Substantive Milestone
Method. See Critical
Accounting Policies – Revenue Recognition,
below.
Research
revenues from PSMA LLC
On April
20, 2006, PSMA LLC became our wholly owned subsidiary and, accordingly, since
that date we no longer recognize revenue related to research and development
activities performed by us for PSMA LLC. During 2006, prior to our acquisition
of Cytogen’s membership interest in PSMA LLC, we and Cytogen had not approved a
work plan and budget for 2006 and, therefore, we were not reimbursed for our
research and development services to PSMA LLC and did not recognize any revenue
from PSMA LLC in 2006.
Research
grants and contract
Revenues
from research grants and contract from the NIH decreased to $10,075 for the year
ended December 31, 2007 from $11,418 for the year ended December 31, 2006;
$6,185 and $8,052 from grants and $3,890 and $3,366 from the contract awarded to
us by the NIH in September 2003 (the “NIH Contract”) for the years ended
December 31, 2007 and 2006, respectively. The decrease in grant revenue resulted
from completion of certain grants in 2006 and fewer reimbursable expenses in
2007 than in 2006 on new and continuing grants in 2007. In addition, there was
increased activity under the NIH Contract. The NIH Contract provides for the
development of a prophylactic vaccine designed to prevent HIV from becoming
established in uninfected individuals exposed to the virus. Funding under the
NIH Contract provides for pre-clinical research, development and early clinical
testing. These funds are being used principally in connection with our ProVax
HIV vaccine program. The NIH Contract originally provided for up to $28.6
million in funding to us, subject to annual funding approvals and compliance
with its terms, over five years. The total of our approved award under the
NIH Contract through September 2008 is $15.5 million. Funding under this
contract includes the payment of an aggregate of $1.6 million in fees, subject
to achievement of specified milestones. Through December 31, 2007, we had
recognized revenue of $13.3 million from this contract, including $180,000 for
the achievement of two milestones. We have recently been informed by the NIH
that it has decided not to fund this Contract beyond September 2008. To continue
to develop the HIV vaccine after that time, therefore, we will need to provide
funding on our own or obtain new governmental or other funding. If we choose not
to provide our own or cannot secure governmental or other funding, we will
discontinue this project.
Product
sales
Revenues
from product sales increased to $116 for the year ended December 31, 2007 from
$73 for the year ended December 31, 2006. We received more orders for research
reagents during 2007.
2006
vs. 2005
Research
revenues from collaborator
Research
revenue from collaborator relates to our Collaboration Agreement with Wyeth.
During the year ended December 31, 2006, we recognized $58,415 of revenue from
Wyeth, including $18,831 of the $60,000 upfront payment we received upon
entering into the Collaboration Agreement, $34,584, as reimbursement of our
development expenses and $5,000 of a non-refundable payment earned upon the
achievement of a milestone defined in the Collaboration Agreement. We did not
recognize revenue for this collaboration in 2005 since it was not effective
until January 1, 2006.
Research
revenues from PSMA LLC
On April
20, 2006, PSMA LLC became our wholly owned subsidiary and, accordingly, since
that date we no longer recognize revenue related to research and development
activities performed by PSMA LLC. During 2006, prior to our acquisition of
Cytogen’s membership interest in PSMA LLC, we and Cytogen had not approved a
work plan and budget for 2006 and, therefore, we were not reimbursed for our
research and development services to PSMA LLC and did not recognize any revenue
from PSMA LLC in 2006. We recognized $988 of revenue for research and
development services performed for PSMA LLC during the year ended December 31,
2005. That amount reflects a decrease from prior years. The decrease was due to
the slower pace of research and development activities on the PSMA projects in
2005 and an increase in grant revenue recognized by the Company from awards
related to research and development services performed for PSMA LLC, which
effectively decreases research and development revenue from PSMA LLC. Proceeds
received from grants related to PSMA LLC and for which we have also been
compensated by PSMA LLC for services provided were $1,311 in the 2005 period. We
have reflected in the accompanying consolidated financial statements adjustments
to decrease both joint venture losses and contract revenue from PSMA LLC in
respect of such amounts.
Research
grants and contract
Revenues
from research grants and contract from the NIH increased to $11,418 for the year
ended December 31, 2006 from $8,432 for the year ended December 31, 2005; $8,052
and $5,480 from grants and $3,366 and $2,952 from the NIH Contract for the years
ended December 31, 2006 and 2005, respectively. The increase resulted from a
greater amount of work performed under the grants in the 2006 period, some of
which allowed greater spending limits, including $12.7 million in new grants we
were awarded during 2005, $9.7 million of which was to partially fund PRO 140
program over a three and a half year period. In addition, there was increased
activity under the NIH Contract.
Product
sales
Revenues
from product sales increased to $73 for the year ended December 31, 2006 from
$66 for the year ended December 31, 2005. We received more orders for research
reagents during 2006.
Expenses:
Research and Development Expenses:
Research
and development expenses include scientific labor, supplies, facility costs,
clinical trial costs and product manufacturing costs. Research and development
expenses, including in-process research and development and license fees,
increased to $96,176 for the year ended December 31, 2007 from $75,310 for the
year ended December 31, 2006, and from $63,837 in the year ended December 31,
2005. Research and development expenses for 2006 include a one-time charge of
$13,209 related to our purchase of Cytogen’s equity interest in PSMA LLC
(see Business – Oncology
– PSMA ), and for 2005 include a one-time charge of $18,755 related to
our purchase of license rights related to RELISTOR (see Business – Progenics’ Licenses – UR
Labs/University of Chicago). During 2007, the majority of the increase in
research and development expenses over those in 2006 and 2005, net of those
one-time charges, was related to the PRO 140, HCV and PSMA clinical and research
programs. The increases were the result of analysis of the clinical data from
the phase 1b study of PRO 140, preparation of materials for a phase 2 clinical
trial of PRO 140, increased basic research to identify targets for an HCV
therapeutic agent and basic research and preparation of materials for clinical
trials of PSMA-directed therapeutics. Expenses for RELISTOR in 2007 were also
greater than in 2006 and 2005, although the increase in those expenses was not
as great as for the other research programs. The increase in RELISTOR expenses
was primarily due to the conduct of a phase 3 clinical trial of the intravenous
formulation as well as preparation of clinical data for the NDA submission for
the subcutaneous formulation in March 2007. See Liquidity and Capital Resources –
Uses of Cash, below, for details of the changes in these expenses by
project. Beginning in 2006, Wyeth is reimbursing us for development expenses we
incur related to RELISTOR under the development plan agreed to between Wyeth and
us. A portion of our expenses related to our HIV, HCV and PSMA programs is
funded through grants and a contract from the NIH (see Revenues- Research Grants and
Contract, above). During 2008,
we expect that research and development expenses for projects other than
RELISTOR will continue to increase and that expenses for RELISTOR
development will be similar to those in 2007. The changes in research and
development expense, by category of expense, are as follows:
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Salaries
and benefits (cash)
|
$24,061
|
$17,013
|
$13,412
|
|
41%
|
27%
|
2007 vs. 2006 Company-wide
compensation increases and an increase in average headcount to 190 from 134
for the years ended December 31, 2007 and 2006, respectively, in the
research and development, manufacturing and clinical departments.
2006 vs. 2005 Company-wide
compensation increases and an increase in average headcount to 134 from 117 for
the years ended December 31, 2006 and 2005, respectively, in the research and
development, manufacturing and clinical departments, including the hiring of our
Vice President, Quality in July 2005.
|
|
|
|
|
|
|
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Share-based
compensation (non-cash)
|
$7,104
|
$5,814
|
$1,237
|
|
22%
|
370%
|
2007 vs.
2006 Increase due to increase in headcount and changes
in the fair value of our common stock (see Critical Accounting Policies −
Share-Based Payment Arrangements, below). The amount of
non-cash compensation expense is expected to change in future years commensurate
with future headcount levels.
2006 vs.
2005 Increase due to the adoption of SFAS No. 123(R) on
January 1, 2006, which requires the recognition of non-cash compensation expense
related to share-based payment arrangements (see Critical Accounting Policies −
Share-Based Payment Arrangements, below).
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Clinical
trial costs
|
$19,225
|
$9,485
|
$10,493
|
|
103%
|
(10%)
|
2007 vs.
2006 Increase primarily related to RELISTOR ($10,901)
due to the global pivotal phase 3 clinical trial of the intravenous formulation
of RELISTOR which began in the fourth quarter of 2006 and Other projects ($2).
The increases were partially offset by decreases in Cancer ($778), due to our
decision to terminate the GMK study in the second quarter of 2007, and
HIV-related costs ($385), resulting from a decline in clinical site payments and
other clinical expenses related to the phase 1b clinical trial of PRO 140 for
which enrollment and dosing of subjects was complete by December 2006. During
2007, data from that trial was analyzed. During 2008, overall clinical
trial costs are expected to decrease as clinical trials of RELISTOR conclude and
we conduct the phase 2 trial of PRO 140.
2006 vs.
2005 Decrease primarily related to RELISTOR ($1,429) due
to completion of the RELISTOR phase 3 trials (301 and 302 and the extension
studies) in the second half of 2005 and first quarter of 2006 and Cancer ($335),
due to achievement of full enrollment in our GMK phase 3 trial during the fourth
quarter of 2005, which resulted in more subjects having completed the full
course of treatment during 2005 than remained to be treated in 2006. The
decreases were partially offset by an increase in HIV-related costs ($756),
resulting from an increase in the PRO 140 trial activity and a decline in a
previous collaboration activity in the 2006 period.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Laboratory
supplies
|
$7,876
|
$6,337
|
$5,292
|
|
24%
|
20%
|
2007 vs. 2006 Increase in
HIV-related costs ($1,132), due to internal manufacture of drug materials for
the phase 2 PRO 140 clinical trial, and in Other projects ($1,731),
primarily Hepatitis C virus research costs. The increases were partially
offset by a decrease in RELISTOR ($814) due to the purchase of more
RELISTOR drug in the 2006 period than in the 2007 period, net of increased
computer software costs in 2007 related to the preparation for submission of a
New Drug Application in March 2007. In addition, there was a decrease in basic
research costs in 2007 for Cancer (primarily PSMA) ($510). Laboratory supply
costs for HIV, Cancer and Other project related costs are expected to increase
in 2008.
2006 vs.
2005 Increase in HIV-related costs ($175), due to
preparation of materials for the phase 1b PRO 140 clinical trial, and an
increase in basic research in 2006 for Cancer ($609) and Other projects
($561) partially offset by a decrease in RELISTOR ($300) due to the
purchase of more RELISTOR drug in the 2005 period than in the 2006
period.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Contract
manufacturing and subcontractors
|
$25,940
|
$12,448
|
$5,836
|
|
108%
|
113%
|
2007 vs. 2006 Increase in HIV
($8,228), Cancer ($5,163) and Other projects ($1,791), which was partially
offset by a decrease in RELISTOR ($1,690) related to clinical trials under our
collaboration with Wyeth. These expenses are related to the conduct of clinical
trials, including manufacture by third parties of drug materials, testing,
analysis, formulation and toxicology services, and vary as the timing and level
of such services are required. We expect these costs to increase in 2008 as we
expand our clinical trial costs for PRO 140, PSMA and Other projects, while
costs for RELISTOR are expected to be similar to those in
2007.
2006 vs.
2005 Increase in RELISTOR ($1,939) related to clinical
trials under our collaboration with Wyeth, HIV ($1,672), Cancer ($2,637) and
Other projects ($364). These expenses are related to the conduct of clinical
trials, including testing, analysis, formulation and toxicology services, and
vary as the timing and level of such services are required.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Consultants
|
$4,722
|
$5,286
|
$2,969
|
|
(11%)
|
78%
|
2007
vs. 2006 Decrease in
RELISTOR ($1,351), partially offset by increases in HIV ($350), Cancer
($107) and Other projects ($330). These expenses are related to the monitoring
of clinical trials as well as the analysis of data from completed clinical
trials and vary as the timing and level of such services are required. In 2008,
consultant expenses are expected to change approximately porportionately with
spending levels for all of our research and development
programs.
2006 vs.
2005 Increases in RELISTOR ($2,351), Cancer ($47) and
Other projects ($20), partially offset by a decrease in HIV ($101). These
expenses are related to the monitoring and conduct of clinical trials, including
analysis of data from completed clinical trials and vary as the timing and level
of such services are required.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
License
fees
|
$1,053
|
$390
|
$20,418
|
|
170%
|
(98%)
|
2007 vs.
2006 Increase primarily related to our HIV program
($30), Cancer ($523) related to PSMA license agreements and RELISTOR ($110),
related to payments to the University of Chicago.
2006 vs.
2005 Decrease primarily related to payments in 2005 but
not 2006 to UR Labs and the Goldberg Distributees (see Overview – Purchase of Rights from RELISTOR Licensors), licensors of
RELISTOR ($19,205) and related to our HIV program ($1,098), partially offset by
increases in Cancer ($225) related to PSMA license agreements and RELISTOR
($50), related to payments to the University of Chicago.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Operating
expenses
|
$6,195
|
$18,537
|
$4,180
|
|
(67%)
|
343%
|
2007 vs.
2006 Decrease primarily due to expenses in 2006 related
to our purchase of Cytogen’s equity interest in PSMA LLC, which are included in
in-process research and development ($13,209), travel ($21) and an increase
in rent and facilities expenses ($579), insurance costs ($128) and other
operating expenses ($181). In 2008, operating expenses are expected to increase
over those of 2007, without the effect of our purchase of Cytogen’s interest in
PSMA LLC, due to higher rent and facility expenses.
2006 vs.
2005 Increase primarily due to expenses in 2006 related
to our purchase of Cytogen’s equity interest in PSMA LLC, which are included in
in-process research and development ($13,209) and an increase in rent ($420),
facilities expenses ($242), seminar costs ($102), travel ($296) other operating
expenses ($88).
General and Administrative Expenses:
General
and administrative expenses increased to $27,901 in the year ended December 31,
2007 from $22,259 in the year ended December 31, 2006 and from $13,565 in the
year ended December 31, 2005, as follows:
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Salaries
and benefits (cash)
|
$7,243
|
$5,942
|
$4,614
|
|
22%
|
29%
|
2007
vs. 2006 Increase due to compensation increases and an
increase in average headcount to 43 from 32 in the general and administrative
departments for the years ended December 31, 2007 and 2006, respectively,
including the hiring of our Vice President, Commercial Development and
Operations in January 2007.
2006 vs. 2005 Increase
due to compensation increases and an increase in average headcount to 32 from 22
in the general and administrative departments for the years ended December 31,
2006 and 2005, respectively, including the hiring of our Senior Vice President
and General Counsel in June 2005 and the departure of one senior executive in
April 2005.
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Share-based
compensation (non-cash)
|
$8,202
|
$6,840
|
$1,281
|
|
20%
|
434%
|
2007 vs.
2006 Increase due to increase in headcount and changes
in the fair value of our common stock (see Critical Accounting Policies −
Share-Based Payment Arrangements, below). The amount of
non-cash compensation expense is expected to increase in future years in
conjunction with increased headcount.
2006 vs.
2005 Increase due to the adoption of SFAS No. 123(R) on
January 1, 2006, which requires the recognition of non-cash compensation expense
related to share-based payment arrangements (see Critical Accounting Policies −
Share-Based Payment Arrangements, below).
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Consulting
and professional fees
|
$7,356
|
$5,566
|
$4,488
|
|
32%
|
24%
|
2007
vs. 2006 Increase due primarily to increases in
consultants ($632), recruiting fees ($125), legal and patent fees ($1,138) and
other miscellaneous costs ($89), which were partially offset by a decrease in
audit and tax fees ($194).
2006
vs. 2005 Increase due primarily to increases in audit
and tax fees ($255), recruiting fees ($286), legal and patent fees ($606) and
other miscellaneous costs ($21), which were partially offset by a decrease in
consultants ($90).
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
Other
operating expenses
|
$5,100
|
$3,911
|
$3,182
|
|
30%
|
23%
|
2007
vs. 2006 Increase in computer supplies and software
($219), rent ($184), investor relations ($175), travel ($69), conference costs
($4), utilities and facilities costs ($466) and other operating expenses
($212), partially offset by decreases in insurance ($101) and corporate sales
and franchise taxes ($39).
2006
vs. 2005 Increase in insurance ($144), corporate sales
and franchise taxes ($144), other operating expenses ($262), rent ($218),
conference costs ($28) and utilities and facilities costs ($53), partially
offset by a decrease in investor relations ($120).
We expect
general and administrative expenses during 2008 to remain at approximately
2007 levels.
Loss
in Joint Venture:
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
|
$0
|
$121
|
$1,863
|
|
(100%)
|
(94%)
|
2007
vs. 2006 Loss in joint venture decreased to
$0 for the year ended December 31, 2007 from $121 for the year ended
December 31, 2006. On April 20, 2006, PSMA LLC became our wholly owned
subsidiary and, accordingly, we did not recognize loss in joint venture from the
date of acquisition.
2006
vs. 2005 Loss in joint venture decreased to
$121 for the year ended December 31, 2006 from $1,863 for the year
ended December 31, 2005. On April 20, 2006, PSMA LLC became our wholly owned
subsidiary and, accordingly, we did not recognize loss in joint venture from the
date of acquisition. During 2006, prior to our acquisition of Cytogen’s
membership interest in PSMA LLC, research and development expenses and general
and administrative expenses of PSMA LLC were lower than in the comparable period
in 2005 due to the lack of a work plan and budget for PSMA LLC for
2006.
Depreciation
and Amortization:
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
|
$3,027
|
$1,535
|
$1,748
|
|
97%
|
(12%)
|
2007
vs. 2006 Depreciation expense increased to $3,027 for
the year ended December 31, 2007 from $1,535 for the year ended December 31,
2006. We purchased capital assets and made leasehold improvements in both years
to increase our research and manufacturing capacity. During 2007, $5.8 million
of machinery and equipment and leasehold improvements that had been included in
construction in progress at December 31, 2006, representing about 28% of the
December 31, 2006 balance of fixed assets, were placed in operation and
depreciated.
2006
vs. 2005 Depreciation expense decreased to $1,535 for
the year ended December 31, 2006 to $1,748 for the year ended December 31, 2005.
We purchased capital assets and made leasehold improvements in both years to
increase our research and manufacturing capacity but a larger percentage of
fixed assets was included in construction in progress, and not yet depreciable,
during 2006 than during 2005. There was also an increase in fully
depreciated capital assets during 2006 relative to 2005.
Other
Income:
|
2007
|
2006
|
2005
|
|
2007
vs. 2006
|
2006
vs. 2005
|
|
|
|
|
|
Percent
change
|
|
$7,770
|
$7,701
|
$2,299
|
|
1%
|
235%
|
2007
vs. 2006 Interest income increased to $7,770 for the
year ended December 31, 2007 from $7,701 for the year ended December 31, 2006.
Interest income, as reported, is primarily the result of investment income from
our marketable securities, increased by the amortization of premiums we paid or
decreased by the amortization of discounts we received for those marketable
securities. For the years ended December 31, 2007 and 2006, investment income
decreased to $7,325 from $7,710, respectively, due to a lower average balance of
cash equivalents and marketable securities in 2007 than in 2006. Amortization of
premiums, net of discounts, was $445 and $9 for the years ended December 31,
2007 and 2006, respectively.
2006
vs. 2005 Interest income increased to $7,701 for the
year ended December 31, 2006 from $2,299 for the year ended December 31, 2005.
Interest income, as reported, is primarily the result of investment income from
our marketable securities, offset by the amortization of premiums we paid for
those marketable securities. For the years ended December 31, 2006 and 2005,
investment income increased to $7,710 from $2,569, respectively, due to a higher
average balance of cash equivalents and marketable securities in 2006 than in
2005, resulting from our three public offerings in 2005, and higher
interest rates in 2006. Amortization of discounts net of premiums, which is
included in interest income, decreased to $9 from $270 for the years ended
December 31, 2006 and 2005, respectively.
Income
Taxes:
For the
years ended December 31, 2007 and 2006, we had losses both for book and tax
purposes. For the year ended December 31, 2005, although we had a pre-tax net
loss of $69.2 million for book purposes, we had taxable income due primarily to
the $60 million upfront payment received from Wyeth and the $18.4 million cash
and common stock paid to UR Labs and the Goldberg Distributees, which were
treated differently for book and tax purposes. For book purposes, payments made
to UR Labs and the Goldberg Distributees were expensed in the period the
payments were made. For tax purposes, however, the UR Labs transaction was a
tax-free reorganization and will never result in a deduction for tax purposes
and the payments to the Goldberg Distributees have been capitalized as an
intangible license asset and will be deducted for tax purposes over a fifteen
year period. For book purposes, we deferred recognition of revenue for the $60
million at December 31, 2005 and are recognizing revenue for that amount over
the development period for RELISTOR (expected through the end of 2009). For tax
purposes, since cash was received, the $60 million was included in taxable
income in 2005. We, therefore, recognized an income tax provision in 2005 for
the effect of the Federal and state alternative minimum tax. We do not recognize
deferred tax assets considering our history of taxable losses and the
uncertainty regarding our ability to generate sufficient taxable income in the
future to utilize these deferred tax assets.
Net
Loss:
Our net
loss was $43,688 for the year ended December 31, 2007, $21,618 for the year
ended December 31, 2006 and $69,429 for the year ended December 31,
2005.
Liquidity
and Capital Resources
Overview
We have,
to date, generated no meaningful amounts of product revenue, and consequently we
have relied principally on external funding to finance our operations. We have
funded our operations since inception primarily through private placements of
equity securities, payments received under collaboration agreements, public
offerings of common stock, funding under government research grants and
contracts, interest on investments, the proceeds from the exercise of
outstanding options and warrants and the sale of our common stock under our
Employee Stock Purchase Plans. At December 31, 2007, we had cash, cash
equivalents and marketable securities, including non-current portion, totaling
$170.4 million compared with $149.1 million at December 31, 2006. Our existing
cash, cash equivalents and marketable securities at December 31, 2007 are
sufficient to fund current operations for at least one year. Our cash flow from
operating activities was negative for the years ended December 31, 2007, 2006
and 2005 due primarily to the excess of expenditures on our research and
development programs and general and administrative costs related to those
programs over cash received from collaborators and government grants and
contracts to fund such programs, as described below.
Sources of Cash
Operating
Activities. Our current collaboration with Wyeth provided us with
a $60 million upfront payment in December 2005. In addition, since January 2006,
Wyeth has been reimbursing us for development expenses we incur related to
RELISTOR under the development plan agreed to between us and Wyeth, which is
currently expected to continue through 2009. For the years ended December 31,
2007 and 2006, we received $40.1 million and $34.6 million, respectively, of
reimbursement of our development costs. Since inception of the Collaboration
Agreement, Wyeth has made $14.0 million in milestone payments upon the
achievement of certain events which are specified in the Collaboration
Agreement. In May 2007, we earned $9.0 million of milestone payments related to
the acceptance for review of applications submitted for marketing approval of a
subcutaneous formulation of RELISTOR for the treatment of opioid-induced
constipation in patients receiving palliative care in the U.S. and the European
Union. Wyeth has also submitted applications for the marketing of this product
in Australia and Canada. In October 2006, we earned a $5.0 million milestone
payment in connection with the start of a phase 3 clinical trial of intravenous
RELISTOR for the treatment of post-operative ileus. Wyeth is obligated to make
up to $342.5 million in additional payments to us upon the achievement of
milestones and other contingent events in the development and commercialization
of RELISTOR. Wyeth is
also responsible for all commercialization activities related to RELISTOR
products. The FDA review of the subcutaneous formulation of RELISTOR is expected
to be completed by its Prescription Drug User Fee Act (“PDUFA”) date of April
30, 2008. If approval for marketing of the subcutaneous formulation of RELISTOR
for the treatment of opioid-induced constipation in patients receiving
palliative care is approved by U.S. and/or other regulatory agencies, we will
receive royalty payments from Wyeth as the product is sold in the respective
countries. We will also receive royalty payments upon the sale of all other
products developed under the Collaboration Agreement.
The
funding by Wyeth of our development costs for RELISTOR enables us to devote our
current and future resources to our other research and development programs. We
may also enter into collaboration agreements with respect to other of our
product candidates. We cannot forecast with any degree of certainty, however,
which products or indications, if any, will be subject to future collaborative
arrangements, or how such arrangements would affect our capital requirements.
The consummation of other collaboration agreements would further allow us to
advance other projects with our current funds.
In
September 2003, we were awarded a contract by the NIH to develop a prophylactic
vaccine designed to prevent HIV from becoming established in uninfected
individuals exposed to the virus. Funding under the NIH Contract provided for
pre-clinical research, development and early clinical testing. These funds are
being used principally in connection with our ProVax HIV vaccine program. The
NIH Contract originally provided for up to $28.6 million in funding to us,
subject to annual funding approvals and compliance with its terms, over
five years. The total of our approved award under the NIH Contract through
September 2008 is $15.5 million. Funding under this contract includes the
payment of an aggregate of $1.6 million in fees, subject to achievement of
specified milestones. Through December 31, 2007, we had recognized revenue of
$13.3 million from this contract, including $180,000 for the achievement of two
milestones. We have recently been informed by the NIH that it has decided not to
fund this contract beyond September 2008. To continue to develop the HIV vaccine
after that time, therefore, we will need to provide funding on our own or obtain
new government or other funding. If we choose not to provide our own or cannot
secure governmental or other funding, we will discontinue this
project.
We have
also been awarded grants from the NIH, which provide ongoing funding for a
portion of our virology and cancer research programs for periods including the
years ended December 31, 2007, 2006 and 2005. Among those grants were an
aggregate of $4.4 million in grants made in 2006 and 2007, which extend over
two- and three-year periods. Two awards were made during 2005, which provide for
up to $3.0 million and $9.7 million in support of our HCV research program and
PRO 140 HIV development program, respectively, to be awarded over a three year
and a three and a half year period, respectively. Funding under all of our NIH
grants is subject to compliance with their terms, and is subject to annual
funding approvals. For the years ended December 31, 2007, 2006 and 2005, we
recognized $6.2 million, $8.1 million and $5.5 million, respectively, of revenue
from all of our NIH grants.
Changes
in Accounts receivable and Accounts payable for the years ended December 31,
2007, 2006 and 2005 resulted from the timing of receipts from the NIH and
payments made to trade vendors in the normal course of business.
Other
than amounts to be received from Wyeth and from currently approved grants and
contracts, we have no committed external sources of capital. Other than
potential revenues from RELISTOR, we expect no significant product revenues for
a number of years as it will take at least that much time, if ever, to bring our
products to the commercial marketing stage.
Investing
Activities. We purchase and sell marketable securities in order to
provide funding for our operations and to achieve appreciation of our unused
cash in a low risk environment. Our marketable securities, which include
corporate debt securities, securities of government-sponsored entities and
auction rate securities (“ARS”), are classified as available for sale. The ARS
that we purchase consist of municipal bonds with maturities greater than five
years, and do not include mortgage-backed instruments. As of December 31,
2007, we had not experienced failed auctions of our ARS due to lack of investor
interest. The majority of our marketable securities investments have short
maturities and, in accordance with our investment guidelines, all have credit
ratings of at least Aa3/AA-. Therefore, credit market conditions through
December 31, 2007 did not have a material negative impact on our financial
condition, results of operations or the liquidity of our marketable securities.
Rather, interest rate increases during 2007 and 2006 have generally resulted in
a decrease in the market value of our portfolio.
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, we began to reduce the principal
amount of ARS in our portfolio from $38.8 million at 2007 year-end. While our
portfolio was not affected by the auction process deterioration in 2007, some of
the ARS we hold experienced auction failures during the first quarter of 2008.
As a result, when we attempted to liquidate them through auction, we were unable
to do so as to approximately $10.1 million principal amount, which we continue
to hold. In the event of an auction failure, the interest rate on the security
is reset according to the contractual terms in the underlying indenture. As of
March 14, 2008, we have received all scheduled interest payments associated with
these securities.
Our
marketable securities are purchased and, in the case of ARS, sold by third-party
brokers in accordance with our investment policy guidelines. Our brokerage
account requires that all marketable securities, other than ARS, be held to
maturity unless authorization is obtained from us to sell earlier. In fact, we
have a history of holding all marketable securities, other than ARS, to
maturity. We, therefore, consider that we have the intent and ability to hold
any securities with unrealized losses until a recovery of fair value, which may
be maturity and we do not consider these marketable securities to be
other-than-temporarily impaired at December 31, 2007 and 2006.
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. We believe that the failed auctions experienced to date are not a
result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. We
believe that any unrealized gain or loss associated with these securities will
be temporary and will be recorded in accumulated other comprehensive income
(loss) in our financial statements.
The
credit and capital markets have continued to deteriorate in
2008. Continuation or acceleration of the current instability in these
markets and/or deterioration in the ratings of our investments may affect our
ability to liquidate these securities, and therefore may affect our financial
condition, cash flows and earnings. We believe that based on our current cash,
cash equivalents and marketable securities balances of $170.4 million at
December 31, 2007, the current lack of liquidity in the credit and capital
markets will not have a material impact on our liquidity, cash flows, financial
flexibility or ability to fund our obligations.
We continue to monitor the market for auction rate securities and consider its
impact (if any) on the fair market value of our investments. If the current
market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, we may be required to
record unrealized losses or impairment charges in 2008. As auctions have closed
successfully, we have converted our investments in ARS to money market funds. We
believe we will have the ability to hold any auction rate securities for which
auctions fail until the market recovers. We do not anticipate having to sell
these securities in order to operate our business.
Financing
Activities
On
September 25, 2007, we completed a public offering of 2.6 million shares of our
common stock, pursuant to a shelf registration statement that had been filed
with the Securities and Exchange Commission (“SEC”) in 2006, which had
registered 4.0 million shares of our common stock. We received proceeds of $57.3
million, or $22.04 per share, which was net of underwriting discounts and
commissions of approximately $2.9 million, and paid approximately $0.2 million
in other offering expenses. We anticipate using the net proceeds to fund
clinical trials of our product candidates and for research and development
projects. We may also use the proceeds for other corporate purposes, including
potential acquisitions of technology or companies in complementary fields.
During the year ended December 31, 2005, we completed three public offerings of
common stock, pursuant to shelf registrations covering up to $130 million in
securities issuances that we had filed with the SEC in 2004 and 2005, which
provided us with a total of $121.6 million in net proceeds from the sale of 6.3
million shares.
Unless we
obtain regulatory approval from the FDA for at least one of our product
candidates and/or enter into agreements with corporate collaborators with
respect to the development of our technologies in addition to that for RELISTOR,
we will be required to fund our operations for periods in the future, by seeking
additional financing through future offerings of equity or debt securities or
funding from additional grants and government contracts. Adequate additional
funding may not be available to us on acceptable terms or at all. Our inability
to raise additional capital on terms reasonably acceptable to us would seriously
jeopardize the future success of our business.
During
the years ended December 31, 2007, 2006 and 2005, we received cash of $7.8
million, $7.1 million and $10.5 million, respectively, from the exercise of
stock options by employees, directors and non-employee consultants and from the
sale of our common stock under our Employee Stock Purchase Plans. The amount of
cash we receive from these sources is greater with increases in headcount and
with increases in the price of our common stock on the grant date for options
exercised, and on the sale date for shares sold under our Employee Stock
Purchase Plans.
Uses of Cash
Operating
Activities. The majority of our cash has been used to advance our
research and development programs. We currently have major research and
development programs investigating gastroenterology, virology and oncology,
and are conducting several smaller research projects in the areas of
virology and oncology. Our total expenses for research and development from
inception through December 31, 2007 have been approximately $393.4 million. For
various reasons, many of which are outside of our control, including the early
stage of certain of our programs, the timing and results of our clinical trials
and our dependence in certain instances on third parties, we cannot estimate the
total remaining costs to be incurred and timing to complete our research and
development programs. Under our Collaboration Agreement with Wyeth, however, we
are able to estimate that those remaining costs for the subcutaneous and
intravenous formulations of RELISTOR, based upon the development plan and budget
approved by us and Wyeth, which defines the totality of our obligations, are
$67.9 million over the period from January 1, 2008 to December 31,
2009.
For the
years ended December 31, 2007, 2006 and 2005, research and development costs
incurred, by project, were as follows. Expenses for RELISTOR for 2005 include
$18.7 million related to our purchase of rights from RELISTOR licensors (see
Business – Licenses –
Progenics’ Licenses – UR Labs/University of Chicago, above for more
details). Expenses for Cancer for 2006 include $13.2 million related to our
purchase of Cytogen’s interest in our PSMA joint venture, (see Business – Oncology – Prostate
Cancer – PSMA,
above for more details):
|
|
|
For
the Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
(in
millions)
|
RELISTOR
|
|
|
$
41.5
|
|
|
$
32.1
|
|
|
$ 43.8
|
HIV
|
|
|
29.0
|
|
|
15.8
|
|
|
11.7
|
Cancer
|
|
|
16.1
|
|
|
23.2
|
|
|
6.6
|
Other
programs
|
|
|
9.6
|
|
|
4.2
|
|
|
1.7
|
Total
|
|
|
$
96.2
|
|
|
$
75.3
|
|
|
$ 63.8
|
Although
we expect that our spending on RELISTOR during 2008 will be similar to that in
2007, our cash outlays in accordance with the agreed upon development plan will
be reimbursed by Wyeth. We also expect that spending on our PRO 140, PSMA and
HCV programs will increase during 2008 and beyond. Consequently, we may
require additional funding to continue our research and product development
programs, to conduct pre-clinical studies and clinical trials, for operating
expenses, to pursue regulatory approvals for our product candidates, for the
costs involved in filing and prosecuting patent applications and enforcing or
defending patent claims, if any, for the cost of product in-licensing and for
any possible acquisitions. Manufacturing and commercialization expenses for
RELISTOR will be funded by Wyeth. However, if we exercise our option to
co-promote RELISTOR products in the U.S., which must be approved by Wyeth, we
will be required to establish and fund a sales force, which we currently do not
have. If we commercialize any other product candidate other than with a
corporate collaborator, we would also require additional funding to establish
manufacturing and marketing capabilities.
Our
purchase of rights from our methylnaltrexone licensors in December 2005 (see
Business – Licenses –
Progenics’ Licenses – UR Labs/University of Chicago, above) has
extinguished our cash payments that would have been due to those licensors in
the future upon the achievement of certain events, including sales of RELISTOR
products. We continue, however, to be responsible to make payments (including
royalties) to the University of Chicago upon the occurrence of certain
events.
Prior to
our acquisition of PSMA LLC on April 20, 2006, all costs of PSMA LLC’s research
and development efforts were funded equally by us and Cytogen through capital
contributions. Our and Cytogen’s level of commitment to fund PSMA LLC was based
on an annual budget that was developed and approved by the parties. During the
year ended December 31, 2005, we and Cytogen each contributed $0.5 million to
fund work under the 2004 approved budget and $3.45 million to fund work under
the 2005 approved budget. During 2006, prior to our acquisition of Cytogen’s
interest in PSMA LLC, we and Cytogen had not approved a work plan and budget for
2006 and, therefore, no further capital contributions were made by Cytogen or us
subsequent to December 31, 2005. However, we and Cytogen were required to
fulfill obligations under existing contractual commitments as of December 31,
2005. Since PSMA LLC has become our wholly owned subsidiary as of April 20,
2006, we no longer have contractual obligations to make capital
contributions.
Costs
incurred by PSMA LLC from January 1, 2006 to April 20, 2006 were funded from
PSMA LLC’s cash reserves. We are continuing to conduct the PSMA research and
development projects on our own subsequent to our acquisition of PSMA LLC and
are required to fund the entire amount of such efforts; thus, increasing our
cash expenditures. We are funding PSMA-related research and development efforts
from our internally-generated cash flows. We are also continuing to receive
funding from the NIH for a portion of our PSMA-related research and development
costs.
Investing
Activities. During the years ended December 31, 2007, 2006 and
2005, we have spent $5.2 million, $8.8 million and $1.2 million, respectively,
on capital expenditures. Those expenditures have been related to the
expansion of our office, laboratory and manufacturing facilities and the
purchase of more laboratory equipment for our ongoing and future research and
development projects, including the purchase of a second 150-liter
bioreactor for the manufacture of research and clinical products. During 2008,
we expect that capital expenditures will continue to the extent we lease
and renovate additional laboratory, manufacturing and office space and increase
headcount of our research and development and administrative staff.
Contractual
Obligations
Our
funding requirements, both for the next 12 months and beyond, will include
required payments under operating leases and licensing and collaboration
agreements. The following table summarizes our contractual obligations as of
December 31, 2007 for future payments under these agreements:
|
|
|
|
|
|
Payments
due by December 31,
|
|
|
|
Total
|
|
|
2008
|
|
|
2009-2010
|
|
|
2011-2012
|
|
|
Thereafter
|
|
|
|
|
|
|
( in
millions)
|
Operating
leases
|
|
$
|
8.0
|
|
$
|
3.1
|
|
$
|
3.6
|
|
$
|
0.9
|
|
$
|
0.4
|
License
and collaboration agreements (1)
|
|
|
99.2
|
|
|
3.0
|
|
|
6.5
|
|
|
6.4
|
|
|
83.3
|
Total
|
|
$
|
107.2
|
|
$
|
6.1
|
|
$
|
10.1
|
|
$
|
7.3
|
|
$
|
83.7
|
_______________
(1)
|
Assumes
attainment of milestones covered under each agreement, including those by
PSMA LLC. The timing of the achievement of the related milestones is
highly uncertain, and accordingly the actual timing of payments, if any,
is likely to vary, perhaps significantly, relative to the timing
contemplated by this table.
|
For each of our programs, we
periodically assess the scientific progress and merits of the programs to
determine if continued research and development is economically viable. Certain
of our programs have been terminated due to the lack of scientific progress and
lack of prospects for ultimate commercialization. Because of the uncertainties
associated with research and development of these programs, the duration and
completion costs of our research and development projects are difficult to
estimate and are subject to considerable variation. Our inability to complete
our research and development projects in a timely manner or our failure to enter
into collaborative agreements could significantly increase our capital
requirements and adversely affect our liquidity.
Our cash
requirements may vary materially from those now planned because of results of
research and development and product testing, changes in existing relationships
or new relationships with, licensees, licensors or other collaborators, changes
in the focus and direction of our research and development programs, competitive
and technological advances, the cost of filing, prosecuting, defending and
enforcing patent claims, the regulatory approval process, manufacturing and
marketing and other costs associated with the commercialization of products
following receipt of regulatory approvals and other factors.
The above
discussion contains forward-looking statements based on our current operating
plan and the assumptions on which it relies. There could be changes that would
consume our assets earlier than planned.
Off-Balance
Sheet Arrangements and Guarantees
We have
no off-balance sheet arrangements and do not guarantee the obligations of any
other unconsolidated entity.
Critical
Accounting Policies
We
prepare our financial statements in conformity with accounting principles
generally accepted in the United States of America. Our significant accounting
policies are disclosed in Note 2 to our financial statements included in this
Annual Report on Form 10-K for the year ended December 31, 2007. The selection
and application of these accounting principles and methods requires us to make
estimates and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses, as well as certain financial statement
disclosures. On an ongoing basis, we evaluate our estimates. We base our
estimates on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances. The results of our evaluation
form the basis for making judgments about the carrying values of assets and
liabilities that are not otherwise readily apparent. While we believe that the
estimates and assumptions we use in preparing the financial statements are
appropriate, these estimates and assumptions are subject to a number of factors
and uncertainties regarding their ultimate outcome and, therefore, actual
results could differ from these estimates.
We have
identified our critical accounting policies and estimates below. These are
policies and estimates that we believe are the most important in portraying our
financial condition and results of operations, and that require our most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effect of matters that are inherently uncertain. We
have discussed the development, selection and disclosure of these critical
accounting policies and estimates with the Audit Committee of our Board of
Directors.
Revenue Recognition
We
recognize revenue from all sources based on the provisions of the Securities and
Exchange Commission’s Staff Accounting Bulletin No. 104 (“SAB 104”) “Revenue
Recognition,” Emerging Issues Task Force Issue No. 00-21 (“EITF 00-21”)
“Accounting for Revenue Arrangements with Multiple Deliverables” and EITF Issue
No. 99-19 (“EITF 99-19”) “Reporting Revenue Gross as a Principal Versus Net as
an Agent.” Our license and co-development agreement with Wyeth includes a
non-refundable upfront license fee, reimbursement of development costs, research
and development payments based upon our achievement of clinical development
milestones, contingent payments based upon the achievement by Wyeth of defined
events and royalties on product sales. We began recognizing research revenue
from Wyeth on January 1, 2006. During the years ended December 31, 2007, 2006
and 2005, we also recognized revenue from government research grants and
contracts, which are used to subsidize a portion of certain of our research
projects (“Projects”), exclusively from the NIH. We also recognized revenue
from the sale of research reagents during those periods. We recognized research
and development revenue exclusively from PSMA LLC for the year ended December
31, 2005.
Non-refundable
upfront license fees are recognized as revenue when we have a contractual right
to receive such payment, the contract price is fixed or determinable, the
collection of the resulting receivable is reasonably assured and we have no
further performance obligations under the license agreement. Multiple element
arrangements, such as license and development arrangements are analyzed to
determine whether the deliverables, which often include a license and
performance obligations, such as research and steering or other committee
services, can be separated in accordance with EITF 00-21. We would recognize
upfront license payments as revenue upon delivery of the license only if the
license had standalone value and the fair value of the undelivered performance
obligations, typically including research or steering or other committee
services, could be determined. If the fair value of the undelivered performance
obligations could be determined, such obligations would then be accounted for
separately as performed. If the license is considered to either (i) not have
standalone value or (ii) have standalone value but the fair value of any of the
undelivered performance obligations could not be determined, the upfront license
payments would be recognized as revenue over the estimated period of when our
performance obligations are performed.
We must
determine the period over which our performance obligations will be performed
and revenue related to upfront license payments will be recognized. Revenue will
be recognized using either a proportionate performance or straight-line method.
We recognize revenue using the proportionate performance method provided that we
can reasonably estimate the level of effort required to complete our performance
obligations under an arrangement and such performance obligations are provided
on a best-efforts basis. Direct labor hours or full-time equivalents will
typically be used as the measure of performance. Under the proportionate
performance method, revenue related to upfront license payments is recognized in
any period as the percent of actual effort expended in that period relative to
total effort for all of our performance obligations under the arrangement. We
are recognizing revenue related to the upfront license payment we received from
Wyeth using the proportionate performance method since we can reasonably
estimate the level of effort required to complete our performance obligations
under the Collaboration Agreement with Wyeth based upon the most current budget
approved by both Wyeth and us. Such performance obligations are provided by us
on a best-efforts basis. Full-time equivalents are being used as the measure of
performance. Significant judgment is required in determining the nature and
assignment of tasks to be accomplished by each of the parties and the level of
effort required for us to complete our performance obligations under the
arrangement. The nature and assignment of tasks to be performed by each party
involves the preparation, discussion and approval by the parties of a
development plan and budget. Since we have no obligation to develop the
subcutaneous and intravenous formulations of RELISTOR outside the U.S. or the
oral formulation at all and have no significant commercialization obligations
for any product, recognition of revenue for the upfront payment is not required
during those periods, if they extend beyond the period of our development
obligations.
During the course of a collaboration
agreement, e.g., the
Collaboration Agreement with Wyeth, that involves a development plan and budget,
the amount of the upfront license payment that is recognized as revenue in any
period will increase or decrease as the percentage of actual effort increases or
decreases, as described above. When a new budget is approved, generally
annually, the remaining unrecognized amount of the upfront license fee will be
recognized prospectively, using the methodology described above and applying any
changes in the total estimated effort or period of development that is specified
in the revised approved budget. The amounts of the upfront license payment that
we recognized as revenue for each fiscal quarter prior to the third quarter of
2007 were based upon several revised approved budgets, although the revisions to
those budgets did not materially affect the amounts of revenue recognized in
those periods. During the third quarter of 2007, however, the estimate of our
total remaining effort to complete our development obligations was increased
significantly based upon a revised development budget approved by both us and
Wyeth.
As a
result, the period over which our obligations will extend, and over which the
upfront payment will be amortized, was extended from the end of 2008 to the end
of 2009. Consequently, the amount of revenue recognized from the upfront payment
in the second half of 2007 declined relative to that in the comparable period of
2006. Due to the significant judgments involved in determining the level of
effort required under an arrangement and the period over which we expect to
complete our performance obligations under the arrangement, further changes in
any of those judgments are reasonably likely to occur in the future which could
have a material impact on our revenue recognition. If a collaborator terminates
an agreement in accordance with the terms of the agreement, we would recognize
any unamortized remainder of an upfront payment at the time of the
termination.
If we
cannot reasonably estimate the level of effort required to complete our
performance obligations under an arrangement and the performance obligations are
provided on a best-efforts basis, then the total upfront license payments would
be recognized as revenue on a straight-line basis over the period we expect to
complete our performance obligations.
If we are
involved in a steering or other committee as part of a multiple element
arrangement, we assess whether our involvement constitutes a performance
obligation or a right to participate. For those committees that are deemed
obligations, we will evaluate our participation along with other obligations in
the arrangement and will attribute revenue to our participation through the
period of our committee responsibilities. In relation to the Collaboration
Agreement with Wyeth, we have assessed the nature of our involvement with the
Joint Steering, Joint Development and Joint Commercialization Committees. Our
involvement in the first two such Committees is one of several obligations to
develop the subcutaneous and intravenous formulations of RELISTOR through
regulatory approval in the U.S. We have combined the committee obligations with
the other development obligations and are accounting for these obligations
during the development phase as a single unit of accounting. After the
development period, however, we have assessed the nature of our involvement with
the three Committees to be a right, rather than an obligation. Our assessment is
based upon the fact we negotiated to be on these Committees as an accommodation
for our granting of the license for RELISTOR to Wyeth. Further, Wyeth has been
granted by us an exclusive license (even as to us) to the technology and
know-how regarding RELISTOR and has been assigned the agreements for the
manufacture of RELISTOR by third parties. Following regulatory approval of the
subcutaneous and intravenous formulations of RELISTOR, Wyeth will continue to
develop the oral formulation and to commercialize all formulations, for which it
is capable and responsible. During those periods, the activities of these
Committees will be focused on Wyeth’s development and commercialization
obligations.
Collaborations
may also contain substantive milestone payments. Substantive milestone payments
are considered to be performance payments that are recognized upon achievement
of the milestone only if all of the following conditions are met: (i) the
milestone payment is non-refundable; (ii) achievement of the milestone involves
a degree of risk and was not reasonably assured at the inception of the
arrangement; (iii) substantive effort is involved in achieving the milestone,
(iv) the amount of the milestone payment is reasonable in relation to the effort
expended or the risk associated with achievement of the milestone and (v) a
reasonable amount of time passes between the upfront license payment and the
first milestone payment as well as between each subsequent milestone payment
(the “Substantive Milestone Method”). During October 2006 and May 2007, we
earned $5.0 million and $9.0 million, respectively, upon achievement of
non-refundable milestones anticipated in the Collaboration Agreement with Wyeth;
the first in connection with the commencement of a phase 3 clinical trial of the
intravenous formulation of RELISTOR and the second in connection with the
submission and acceptance for review of an NDA for a subcutaneous formulation of
RELISTOR with the FDA and a comparable submission in the European Union. We
considered those milestones to be substantive based on the significant degree of
risk at the inception of the Collaboration Agreement related to the conduct and
successful completion of clinical trials and, therefore, of not achieving the
milestones; the amount of the payment received relative to the significant costs
incurred since inception of the Collaboration Agreement and amount of effort
expended to achieve the milestones; and the passage of ten and seventeen months,
respectively, from inception of the Collaboration Agreement to the achievement
of those milestones. Therefore, we recognized the milestone payments as revenue
in the respective periods in which the milestones were earned.
Determination
as to whether a milestone meets the aforementioned conditions involves
management’s judgment. If any of these conditions are not met, the resulting
payment would not be considered a substantive milestone and, therefore, the
resulting payment would be considered part of the consideration and be
recognized as revenue as such performance obligations are performed under either
the proportionate performance or straight-line methods, as applicable, and in
accordance with the policies described above.
We will
recognize revenue for payments that are contingent upon performance solely by
our collaborator immediately upon the achievement of the defined event if we
have no related performance obligations.
Reimbursement
of costs is recognized as revenue provided the provisions of EITF 99-19 are met,
the amounts are determinable and collection of the related receivable is
reasonably assured.
Royalty
revenue is recognized upon the sale of related products, provided that the
royalty amounts are fixed or determinable, collection of the related receivable
is reasonably assured and we have no remaining performance obligations under the
arrangement. If royalties are received when we have remaining performance
obligations, the royalty payments would be attributed to the services being
provided under the arrangement and, therefore, would be recognized as such
performance obligations are performed under either the proportionate performance
or straight-line methods, as applicable, and in accordance with the policies
described above.
Amounts
received prior to satisfying the above revenue recognition criteria are recorded
as deferred revenue in the accompanying consolidated balance sheets. Amounts not
expected to be recognized within one year of the balance sheet date are
classified as long-term deferred revenue. The estimate of the classification of
deferred revenue as short-term or long-term is based upon management’s current
operating budget for the Wyeth collaboration agreement for our total effort
required to complete our performance obligations under that arrangement. That
estimate may change in the future and such changes to estimates would be
accounted for prospectively and would result in a change in the amount of
revenue recognized in future periods.
NIH grant
and contract revenue is recognized as efforts are expended and as related
subsidized Project costs are incurred. We perform work under the NIH grants and
contract on a best-effort basis. The NIH reimburses us for costs associated with
Projects in the fields of virology and cancer, including pre-clinical research,
development and early clinical testing of a prophylactic vaccine designed to
prevent HIV from becoming established in uninfected individuals exposed to the
virus, as requested by the NIH. Substantive at-risk milestone payments are
uncommon in these arrangements, but would be recognized as revenue on the same
basis as the Substantive Milestone Method.
Prior to
our acquisition of Cytogen’s membership interest in PSMA LLC on April 20, 2006,
both we and Cytogen were required to fund PSMA LLC equally to support ongoing
research and development efforts that we conducted on behalf of PSMA LLC. We
recognized payments for research and development as revenue as services were
performed. During the quarter ended March 31, 2006, however, we and Cytogen had
not approved a work plan or budget for 2006. Beginning on January 1, 2006,
therefore, we had not been reimbursed by PSMA LLC for our services and we did
not recognize revenue from PSMA LLC for the quarter ended March 31, 2006.
Beginning in the second quarter of 2006, PSMA LLC became our wholly owned
subsidiary and, accordingly, we no longer recognize revenue from PSMA
LLC.
Share-Based Payment Arrangements
Our
share-based compensation to employees includes non-qualified stock options and
restricted stock (nonvested shares) issued under our 1989 Non-Qualified Stock
Option Plan, the 1993 Stock Option Plan, the 1996 Amended Stock Incentive Plan
and the 2005 Stock Incentive Plan (collectively, the “Plans”) and shares issued
under our Employee Stock Purchase Plans (the “Purchase Plans”), which are
compensatory under Statement of Financial Accounting Standards No. 123 (revised
2004) (“SFAS No. 123(R)”) “Share-Based Payment.” We account for
share-based compensation to non-employees, including non-qualified stock options
and restricted stock (nonvested shares), in accordance with Emerging Issues Task
Force Issue No. 96-18 “Accounting for Equity Instruments that are Issued to
Other Than Employees for Acquiring, or in Connection with Selling, Goods or
Services.”
Historically,
in accordance with SFAS No.123 and Statement of Financial Accounting Standards
No.148 (“SFAS No. 148”) “Accounting for Stock-Based Compensation-Transition
and Disclosure,” we had elected to follow the disclosure-only provisions of
SFAS No.123 and, accordingly, accounted for share-based compensation under the
recognition and measurement principles of APB Opinion No. 25 (“APB 25”)
“Accounting for Stock Issued to Employees” and related interpretations. Under
APB 25, when stock options were issued to employees with an exercise price equal
to or greater than the market price of the underlying stock price on the date of
grant, no compensation expense was recognized in the financial statements and
pro forma compensation expense in accordance with SFAS No. 123 was only
disclosed in the footnotes to the financial statements. The cumulative effect of
adjustments upon adoption of SFAS No. 123(R) was not material. Compensation
expense recorded on a pro forma basis for periods prior to adoption of SFAS No.
123(R) is not revised and is not reflected in the financial statements of those
prior periods. Accordingly, there was no effect of the change from applying the
original provisions of SFAS No. 123 on net income, cash flow from operations,
cash flows from financing activities or basic or diluted net loss per share of
periods prior to the adoption of SFAS No. 123(R).
We
adopted SFAS No. 123(R) using the modified prospective application, under which
compensation cost for all share-based awards that were unvested as of January 1,
2006, the adoption date, and those newly granted or modified after the
adoption date will be recognized in our financial statements over the related
requisite service periods; usually the vesting periods for awards with a service
condition. Compensation cost is based on the grant-date fair value of awards
that are expected to vest. As of December 31, 2007, there was $14.3 million,
$8.6 million and $37,000 of total unrecognized compensation cost related to
nonvested stock options under the Plans, the nonvested shares and the Purchase
Plans, respectively. Those costs are expected to be recognized over weighted
average periods of 3.0 years, 2.6 years and 0.5 years,
respectively.
We apply
a forfeiture rate to the number of unvested awards in each reporting period in
order to estimate the number of awards that are expected to vest. Estimated
forfeiture rates are based upon historical data on vesting behavior of
employees. We adjust the total amount of compensation cost recognized for each
award, in the period in which each award vests, to reflect the actual
forfeitures related to that award. Changes in our estimated forfeiture rate will
result in changes in the rate at which compensation cost for an award is
recognized over its vesting period. We have made an accounting policy decision
to use the straight-line method of attribution of compensation expense, under
which the grant date fair value of share-based awards will be recognized on a
straight-line basis over the total requisite service period for the total
award.
Under
SFAS No. 123(R), the fair value of each non-qualified stock option award is
estimated on the date of grant using the Black-Scholes option pricing model,
which requires input assumptions of stock price on the date of grant, exercise
price, volatility, expected term, dividend rate and risk-free interest
rate.
·
|
We
use the closing price of our common stock on the date of grant, as quoted
on The NASDAQ Stock Market LLC, as the exercise
price.
|
·
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Historical
volatilities are based upon daily quoted market prices of our common stock
on The NASDAQ Stock Market LLC over a period equal to the expected term of
the related equity instruments. We rely only on historical volatility
since it provides the most reliable indication of future volatility.
Future volatility is expected to be consistent with historical; historical
volatility is calculated using a simple average calculation method;
historical data is available for the length of the option’s expected term
and a sufficient number of price observations are used consistently. Since
our stock options are not traded on a public market, we do not use implied
volatility. For the years ended December 31, 2007 , 2006 and 2005, the
volatility of our common stock has been high, 50%-89%, 69%-94% and 92%-97%
, respectively, which is common for entities in the biotechnology industry
that do not have commercial products. A higher volatility input to the
Black-Scholes model increases the resulting compensation
expense.
|
·
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The
expected term of options granted represents the period of time that
options granted are expected to be outstanding. For the year ended
December 31, 2007, our expected term was calculated based upon historical
data related to exercise and post-termination cancellation activity for
each of two groups of recipients of stock options: employees, and officers
and directors. Accordingly, for grants made to each of the groups
mentioned above, we are using expected terms of 5.25 and 7.5 years,
respectively. Expected term for options granted to non-employee
consultants was ten years, which is the contractual term of those options.
For the year ended December 31, 2006, our expected term was calculated
based upon the simplified method as detailed in Staff Accounting Bulletin
No. 107 (“SAB 107”). Accordingly, we used an expected term of 6.5 years
based upon the vesting period of the outstanding options of four or five
years and a contractual term of ten years. For the year ended December 31,
2005, our expected term of 6.5 years was based upon the average of the
vesting term and the original contractual term. A shorter expected term
would result in a lower compensation
expense.
|
·
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We
have never paid dividends and do not expect to pay dividends in the
future. Therefore, our dividend rate is
zero.
|
·
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The
risk-free rate for periods within the expected term of the options is
based on the U.S. Treasury yield curve in effect at the time of
grant.
|
A portion
of the options granted to our Chief Executive Officer on July 1, 2002, 2003,
2004 and 2005, on July 3, 2006 and on July 2, 2007 cliff vests after nine years
and eleven months from the respective grant date. Vesting of a defined portion
of each award will occur earlier if a defined performance condition is achieved;
more than one condition may be achieved in any period. In accordance with SFAS
No. 123(R), at the end of each reporting period, we estimate the probability of
achievement of each performance condition and use those probabilities to
determine the requisite service period of each award. The requisite service
period for the award is the shortest of the explicit or implied service periods.
In the case of the executive’s options, the explicit service period is nine
years and eleven months from the respective grant dates. The implied service
periods related to the performance conditions are the estimated times for each
performance condition to be achieved. Thus, compensation expense will be
recognized over the shortest estimated time for the achievement of performance
conditions for that award (assuming that the performance conditions will be
achieved before the cliff vesting occurs). Changes in the estimate of
probability of achievement of any performance condition will be reflected in
compensation expense of the period of change and future periods affected by the
change.
The fair
value of shares purchased under the Purchase Plans was estimated on the date of
grant in accordance with FASB Technical Bulletin No. 97-1 “Accounting under
Statement 123 for Certain Employee Stock Purchase Plans with a Look-Back
Option.” The same option valuation model was used for the Purchase Plans as for
non-qualified stock options, except that the expected term for the Purchase
Plans is six months and the historical volatility is calculated over the six
month expected term.
In
applying the treasury stock method for the calculation of diluted earnings per
share (“EPS”), amounts of unrecognized compensation expense and windfall tax
benefits are required to be included in the assumed proceeds in the denominator
of the diluted earnings per share calculation unless they are anti-dilutive. We
incurred a net loss for the years ended December 31, 2007, 2006 and 2005, and,
therefore, such amounts have not been included for those periods in the
calculation of diluted EPS since they would be anti-dilutive. Accordingly, basic
and diluted EPS are the same for those periods. We have made an accounting
policy decision to calculate windfall tax benefits/shortfalls for purposes of
diluted EPS calculations, excluding the impact of pro forma deferred tax assets.
This policy decision will apply when we have net income.
Research and Development Expenses Including Clinical Trial
Expenses
Clinical
trial expenses, which are included in research and development expenses,
represent obligations resulting from our contracts with various clinical
investigators and clinical research organizations in connection with conducting
clinical trials for our product candidates. Such costs are expensed based on the
expected total number of subjects in the trial, the rate at which the subjects
enter the trial and the period over which the clinical investigators and
clinical research organizations are expected to provide services. We believe
that this method best approximates the efforts expended on a clinical trial with
the expenses we record. We adjust our rate of clinical expense recognition if
actual results differ from our estimates. Our collaboration agreement with
Wyeth regarding RELISTOR in which Wyeth has assumed all of the financial
responsibility for further development will mitigate those costs. In
addition to clinical trial expenses, we estimate the amounts of other research
and development expenses, for which invoices have not been received at the end
of a period, based upon communication with third parties that have provided
services or goods during the period.
Impact
of Recently Issued Accounting Standards
On
September 15, 2006, the FASB issued FASB Statement No. 157 (“FAS 157”) “Fair
Value Measurements,” which addresses how companies should measure the fair value
of assets and liabilities when they are required to use a fair value measure for
recognition or disclosure purposes under generally accepted accounting
principles. FAS 157 does not expand the use of fair value in any new
circumstances. Under FAS 157, fair value refers to the price that would be
received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants in the market in which the reporting
entity transacts. FAS 157 clarifies the principle that fair value should be
based on the assumptions market participants would use when pricing the asset or
liability. In support of this principle, the standard establishes a fair value
hierarchy that prioritizes the information used to develop those assumptions.
The fair value hierarchy gives the highest priority to quoted prices in active
markets and the lowest priority to unobservable data, for example, the reporting
entity’s own data. FAS 157 requires disclosures intended to provide information
about (i) the extent to which companies measure assets and liabilities at fair
value, (ii) the methods and assumptions used to measure fair value, and (iii)
the effect of fair value measures on earnings. We adopted FAS 157 on January 1,
2008 for all financial assets and liabilities and recurring non-financial assets
and liabilities that are carried at fair value. Adoption of FAS 157 for all
non-recurring non-financial assets and liabilities that are carried at fair
value (such as in the determination of impairment of fixed assets or goodwill)
will occur on January 1, 2009. We do not expect the impact of the adoption of
FAS 157 to be material to our financial position or results of
operations.
In
February 2007, the FASB issued FASB Statement No. 159 (“FAS 159”) “The Fair
Value Option for Financial Assets and Financial Liabilities,” which provides
companies with an option to report certain financial assets and liabilities at
fair value. Unrealized gains and losses on items for which the fair value option
has been elected are reported in earnings. FAS 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar types
of assets and liabilities. The objective of FAS 159 is to reduce both
complexity in accounting for financial instruments and the volatility in
earnings caused by measuring related assets and liabilities differently. FAS 159
is effective for fiscal years beginning after November 15, 2007. We do not
expect the impact of the adoption of FAS 159 to be material to our financial
position or results of operations since we do not currently have any financial
assets or liabilities that are subject to FAS 159.
The
Emerging Issues Task Force reached a final consensus on Issue 07-1 (“EITF 07-1”)
“Accounting for Collaborative Arrangements.” This issue affects entities that
have entered into arrangements which are not conducted through a separate
legal entity. The Task Force reached a conclusion that a collaborative
arrangement is within the scope of EITF 07-1 if (i) the parties are active
participants in the arrangement and (ii) the participants are exposed to
significant risks and rewards that depend on the endeavor’s ultimate commercial
success. The Task Force also reached a conclusion that transactions with third
parties (i.e., revenue
generated and costs incurred by the partners) should be reported in the
appropriate line item in each company’s financial statement pursuant to the
guidance in EITF 99-19 “Reporting Revenue Gross as a Principal versus Net as an
Agent” or other applicable generally acceptable accounting principle applied
consistently. The Task Force also concluded that the equity method of accounting
under Accounting Principles Board Opinion 18, “The Equity Method of Accounting
for Investments in Common Stock,” should not be applied to arrangements that are
not conducted through a separate legal entity. The guidance in EITF 07-1 will be
effective for periods that begin after December 15, 2008 and be accounted for as
a change in accounting principle through retrospective application. We do not
expect the impact of the adoption of EITF 07-01 to be a material to our
financial position or results of operations.
On
September 27, 2007, the FASB reached a final consensus on Emerging Issues Task
Force Issue 07-3 (“EITF 07-03”) “Accounting for Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities.” Currently, under FASB Statement No. 2, “Accounting for Research and
Development Costs,” non-refundable advance payments for future research and
development activities for materials, equipment, facilities and purchased
intangible assets that have no alternative future use are expensed as incurred.
EITF 07-03 addresses whether such non-refundable advance payments for goods or
services that have no alternative future use and that will be used or rendered
for research and development activities should be expensed when the advance
payments are made or when the research and development activities have been
performed. The consensus reached by the FASB requires companies involved in
research and development activities to capitalize such non-refundable advance
payments for goods and services pursuant to an executory contractual arrangement
because the right to receive those services in the future represents a probable
future economic benefit. Those advance payments will be capitalized and expensed
as the goods are delivered or the related services are performed. Entities
will be required to evaluate whether they expect the goods or services to be
rendered. If an entity does not expect the goods to be delivered or services to
be rendered, the capitalized advance payment will be charged to
expense. The consensus on EITF 07-03 is effective for financial statements
issued for fiscal years beginning after December 15, 2007, and interim periods
within those fiscal years. Earlier application is not permitted. Entities are
required to recognize the effects of applying the guidance in EITF 07-03
prospectively for new contracts entered into after the effective date. We do not
expect the impact of the adoption of EITF 07-03 to be material to our financial
position or results of operations.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
141 (revised 2007) (“SFAS No. 141(R)”) “Business Combinations,” which supersedes
Statement of Financial Accounting Standards No. 141 (“SFAS No. 141”) “Business
Combinations.” SFAS No. 141(R) applies to all transactions or other events in
which an entity (the acquirer) obtains control of one or more businesses
(acquiree). SFAS No. 141(R) retains the fundamental requirements in SFAS No.141
that the acquisition method of accounting be used for all business combinations
and for an acquirer to be identified for each business combination. However,
many of the provisions of SFAS No. 141(R) are different from those of SFAS No.
141, such as the establishment of the acquisition date as the date that the
acquirer achieves control rather than the date assets and liabilities are
transferred. In addition, SFAS No. 141(R) requires an acquirer to recognize the
assets acquired, the liabilities assumed, and any noncontrolling interest in the
acquiree at the acquisition date, measured at their fair values as of that date,
with limited exceptions, as specified. That replaces SFAS No.141’s
cost-allocation process, which required the cost of an acquisition to be
allocated to the individual assets acquired and liabilities assumed based on
their estimated fair values. Among the amendments that SFAS No. 141(R) makes to
existing authoritative guidance, it supersedes FASB Interpretation No. 4,
“Applicability of FASB Statement No. 2 to Business Combinations Accounted for by
the Purchase Method,” which required research and development assets acquired in
a business combination that have no alternative future use to be measured at
their acquisition-date fair values and then immediately charged to expense.
Under SFAS No. 141(R), the acquirer will recognize separately from goodwill the
acquisition-date fair values of research and development assets acquired in a
business combination as long-lived intangible assets. Those assets are subject
to testing for impairment, such as completion or abandonment of an acquired
research project, at which time the impaired asset will be expensed. SFAS No.
141(R) provides guidance on the impairment testing of acquired research and
development intangible assets and assets that the acquirer intends not to use.
SFAS No. 141(R) applies prospectively to business combinations for which the
acquisition date is on or after the beginning of fiscal years beginning on or
after December 15, 2008. An entity may not apply it before that date. We expect
that the adoption of SFAS No. 141(R) will have a material impact on our
financial position and results of operations in the event that we enter into a
business combination that falls within the scope of this
pronouncement.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
160 (“SFAS No. 160”) “Noncontrolling Interests in Consolidated Financial
Statements—an amendment of ARB No. 51,” which establishes accounting and
reporting standards for a noncontrolling interest (previously referred to as a
minority interest) in a subsidiary and for the deconsolidation of a subsidiary.
A noncontrolling interest is the portion of equity in a subsidiary not
attributable, directly or indirectly, to a parent. SFAS No. 160 clarifies that a
noncontrolling interest in a subsidiary is an ownership interest in the
consolidated entity that should be reported as equity in the consolidated
financial statements. Before SFAS No. 160 was issued, limited guidance existed
for reporting noncontrolling interests, which were reported in the consolidated
statement of financial position as liabilities or in the mezzanine section
between liabilities and equity. SFAS No. 160 establishes accounting and
reporting standards that require (a) the ownership interests in subsidiaries
held by parties other than the parent be clearly identified, labeled, and
presented in the consolidated statement of financial position within equity, but
separate from the parent’s equity; (b) the amount of consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of income;
(c) changes in a parent’s ownership interest while the parent retains its
controlling financial interest in its subsidiary be accounted for consistently;
(d) when a subsidiary is deconsolidated, any retained noncontrolling equity
investment in the former subsidiary be initially measured at fair value; (e) the
gain or loss on the deconsolidation of the subsidiary is measured using the fair
value of any noncontrolling equity investment rather than the carrying amount of
that retained investment and (f) entities provide sufficient disclosures that
clearly identify and distinguish between the interests of the parent and the
interests of the noncontrolling owners. SFAS No. 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008; earlier adoption is prohibited. SFAS No. 160 will be applied
prospectively as of the beginning of the fiscal year in which it is initially
applied, except for the presentation and disclosure requirements, which will be
applied retrospectively for all periods presented. We will evaluate the impact
of the adoption of SFAS No. 160 if there are noncontrolling interests in future
business combinations.
Item
7A. Quantitative and Qualitative Disclosures about
Market Risk
Our
primary investment objective is to preserve principal while maximizing yield
without significantly increasing our risk. Our investments consist of taxable
ARS, corporate notes and issues of government-sponsored entities. Our
investments totaled $164.2 million at December 31, 2007. Approximately $122.3
million of these investments had fixed interest rates, and $41.9 million
had interest rates that were variable.
Due to
the conservative nature of our short-term fixed interest rate investments, we do
not believe that we have a material exposure to interest rate risk. Our
fixed-interest-rate long-term investments are sensitive to changes in interest
rates. Interest rate changes would result in a change in the fair value of these
investments due to differences between the market interest rate and the rate at
the date of purchase of the investment. A 100 basis point increase in the
December 31, 2007 market interest rates would result in a decrease of
approximately $0.094 million in the market values of these
investments.
At
December 31, 2007, we did not hold any market risk sensitive
instruments.
Our
marketable securities, which include corporate debt securities, securities of
government-sponsored entities and auction rate securities (“ARS”), are
classified as available for sale. The ARS that we purchase consist of municipal
bonds with maturities greater than five years and, in accordance with our
investment guidelines, have credit ratings of at least Aa3/AA-, and do not
include mortgage-backed instruments. As of December 31, 2007, we had not
experienced failed auctions of our ARS due to lack of investor
interest.
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, we began to reduce the principal
amount of ARS in our portfolio from $38.8 million at 2007 year-end. While our
portfolio was not affected by the auction process deterioration in 2007, some of
the ARS we hold experienced auction failures during the first quarter of 2008.
As a result, when we attempted to liquidate them through auction, we were unable
to do so as to approximately $10.1 million principal amount, which we continue
to hold. In the event of an auction failure, the interest rate on the security
is reset according to the contractual terms in the underlying indenture. As of
March 14, 2008, we have received all scheduled interest payments associated with
these securities.
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. We believe that the failed auctions experienced to date are not a
result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. We
believe that any unrealized gain or loss associated with these securities will
be temporary and will be recorded in accumulated other comprehensive income
(loss) in our financial statements.
The
credit and capital markets have continued to deteriorate in
2008. Continuation or acceleration of the current instability in these
markets and/or deterioration in the ratings of our investments may affect our
ability to liquidate these securities, and therefore may affect our financial
condition, cash flows and earnings. We believe that based on our current cash,
cash equivalents and marketable securities balances of $170.4 million at
December 31, 2007, the current lack of liquidity in the credit and capital
markets will not have a material impact on our liquidity, cash flows, financial
flexibility or ability to fund our obligations.
We
continue to monitor the market for auction rate securities and consider its
impact (if any) on the fair market value of our investments. If the current
market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, we may be required to
record unrealized losses or impairment charges in 2008. As auctions have closed
successfully, we have converted our investments in ARS to money market funds. We
believe we will have the ability to hold any auction rate securities for which
auctions fail until the market recovers. We do not anticipate having to sell
these securities in order to operate our business.
Item
8. Financial Statements and Supplementary
Data
See page
F-1, “Index to Consolidated Financial Statements.”
Item
9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
None.
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Exchange Act reports is recorded,
processed, summarized and reported within the timelines specified in the SEC’s
rules and forms, and that such information is accumulated and communicated to
our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well
designed and operated, can only provide reasonable assurance of achieving the
desired control objectives, and in reaching a reasonable level of assurance,
management necessarily was required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
As
required by SEC Rule 13a-15(b), we carried out an evaluation, under the
supervision and with the participation of the Company’s management, including
our Chief Executive Officer and our Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures as of the end of the year covered by this report. Based on the
foregoing, our Chief Executive Officer and Chief Financial Officer concluded
that our current disclosure controls and procedures, as designed and
implemented, were effective at the reasonable assurance level.
Changes
in Internal Control over Financial Reporting
There
have been no significant changes in our internal control over financial
reporting, as such term is defined in the Exchange Act Rules 13a-15(f) and
15d-15(f) during our fiscal quarter ended December 31, 2007 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Management’s
Report on Internal Control Over Financial Reporting
Internal
control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f)
promulgated under the Exchange Act as a process designed by, or under the
supervision of, the Company’s principal executive and principal financial
officers and effected by the Company’s Board, management and other personnel to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles, and includes those policies and
procedures that:
·
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Pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of our
assets;
|
·
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Provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles, and that our receipts and expenditures are being
made only in accordance with authorization of our management and
directors; and
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Provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have
a material effect on the financial
statements.
|
Because
of its inherent limitations, internal control over financial reporting may
not prevent or detect misstatements. Projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may
become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
Management
has used the framework set forth in the report entitled Internal Control
– Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission, known
as COSO, to evaluate the effectiveness of our internal control over financial
reporting. Management has concluded that our internal control over financial
reporting was effective as of December 31, 2007. The effectiveness of our
internal control over financial reporting as of December 31, 2007 has been
audited by PricewaterhouseCoopers LLP, an independent registered public
accounting firm, as stated in their report which appears herein.
Item
9B. Other Information
None
PART
III
Item
10. Directors, Executive Officers and Corporate
Governance
The
information required by this item (other than the information set forth in the
next paragraph of this Item 10) will be included under the captions
“Election of Directors,” “Board and Committee Meetings,” “Executive Officers of
the Company,” “Section 16(a) Beneficial Ownership Reporting and
Compliance,” and “Code of Business Ethics and Conduct” in our definitive proxy
statement with respect to our 2008 Annual Meeting of Shareholders to be filed
with the SEC (our “2008 Proxy Statement”).
We have
adopted a code of business conduct and ethics that applies to our officers,
directors and employees. The full text of our code of business conduct and
ethics can be found on the Company’s website (http://www.progenics.com) under the
Investor Relations heading.
The
information called for by this item will be included under the captions
“Executive Compensation,” “Compensation Committee Report” and “Compensation
Committee Interlocks and Insider Participation” in our 2008 Proxy
Statement.
Item
12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
The
information called for by this item will be included under the captions “Equity
Compensation Plan Information” and “Security Ownership of Certain
Beneficial Owners and Management” in our 2008 Proxy
Statement.
Item 13. Certain Relationships and Related Transactions, and
Director Independence
The
information called for by this item will be included under the captions “Certain
Relationships and Related Transactions” and “Affirmative Determinations
Regarding Director Independence and Other Matters” in our 2008 Proxy
Statement.
Item
14. Principal Accounting Fees and Services
The
information called for by this item will be included under the caption “Fees
Billed for Services Rendered by our Independent Registered Public Accounting
Firm” and “Pre-approval of Audit and Non-Audit Services by the Audit Committee”
in our 2008 Proxy Statement.
PART
IV
Item
15. Exhibits, Financial Statement Schedules
The
following documents or the portions thereof indicated are filed as a part of
this Report.
|
a)
|
Documents
filed as part of this Report:
|
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1.
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Consolidated
Financial Statements of Progenics Pharmaceuticals,
Inc.
|
Report of
Independent Registered Public Accounting Firm
Consolidated
Balance Sheets at December 31, 2006 and 2007
Consolidated
Statements of Operations for the years ended December 31, 2005, 2006 and
2007
Consolidated
Statements of Stockholders’ Equity and Comprehensive Loss for the years ended
December 31, 2005, 2006 and 2007
Consolidated
Statements of Cash Flows for the years ended December 31, 2005, 2006 and
2007
Notes to
Consolidated Financial Statements
Those
exhibits required to be filed by Item 601 of Regulation S-K are listed in the
Exhibit Index immediately preceding the exhibits filed herewith, and such
listing is incorporated herein by reference.
PROGENICS
PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
Page
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Financial
Statements:
|
|
Consolidated
Balance Sheets at December 31, 2006 and 2007
|
F-3
|
Consolidated
Statements of Operations for the years ended December 31, 2005, 2006
and 2007
|
F-4
|
Consolidated
Statements of Stockholders’ Equity and Comprehensive Loss
for
the years ended December 31, 2005, 2006 and 2007
|
F-5
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2005, 2006
and 2007
|
F-6
|
Notes
to Consolidated Financial Statements
|
F-7
|
Report
of Independent Registered Public Accounting Firm
To
the Board of
Directors and Stockholders of
Progenics
Pharmaceuticals, Inc.:
In our
opinion, the consolidated financial statements listed in the
index appearing under Item 15(a)(1) present fairly, in all material
respects, the financial position of Progenics Pharmaceuticals, Inc. and its
subsidiaries at December 31, 2007 and 2006, and the results of their operations
and their cash flows for each of the three years in the period ended December
31, 2007 in conformity with accounting principles generally accepted in the
United States of America. Also in our opinion, the Company maintained, in
all material respects, effective internal control over financial reporting as of
December 31, 2007, based on criteria established in Internal Control - Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO). The Company's management is responsible for
these financial statements and for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness of internal
control over financial reporting, included in Management's Report on Internal
Control Over Financial Reporting appearing under Item 9A. Our
responsibility is to express opinions on these financial statements, and on the
Company's internal control over financial reporting based on our integrated
audits. We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audits to obtain reasonable assurance about
whether the financial statements are free of material misstatement and whether
effective internal control over financial reporting was maintained in all
material respects. Our audits of the financial statements included
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, and evaluating the overall financial
statement presentation. Our audit of internal control over financial
reporting included obtaining an understanding of internal control over financial
reporting, assessing the risk that a material weakness exists, and testing and
evaluating the design and operating effectiveness of internal control based on
the assessed risk. Our audits also included performing such other
procedures as we considered necessary in the circumstances. We believe that our
audits provide a reasonable basis for our opinions.
As
discussed in Note 2 and Note 14, respectively, to the consolidated financial
statements, the Company changed the manner in which it accounts for share-based
compensation in 2006 and the manner in which it accounts for uncertainties in
income taxes in 2007.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures that
(i) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of
the company; (ii) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with
authorizations of management and directors of the company; and
(iii) provide reasonable assurance regarding prevention or timely detection
of unauthorized acquisition, use, or disposition of the company’s assets that
could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
/s/
PricewaterhouseCoopers LLP
New York,
New York
March 13,
2008
PROGENICS PHARMACEUTICALS,
INC.
CONSOLIDATED
BALANCE SHEETS
(in
thousands, except for par value and share amounts)
|
|
December 31,
|
|
|
|
2006
|
|
|
2007
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
11,947 |
|
|
$ |
10,423 |
|
Marketable
securities
|
|
|
113,841 |
|
|
|
120,000 |
|
Accounts
receivable
|
|
|
1,699 |
|
|
|
1,995 |
|
Other
current assets
|
|
|
3,181 |
|
|
|
3,111 |
|
Total
current assets
|
|
|
130,668 |
|
|
|
135,529 |
|
Marketable
securities
|
|
|
23,312 |
|
|
|
39,947 |
|
Fixed
assets, at cost, net of accumulated depreciation and
amortization
|
|
|
11,387 |
|
|
|
13,511 |
|
Restricted
cash
|
|
|
544 |
|
|
|
552 |
|
Total
assets
|
|
$ |
165,911 |
|
|
$ |
189,539 |
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$ |
11,852 |
|
|
$ |
14,765 |
|
Deferred
revenue ¾
current
|
|
|
26,989 |
|
|
|
17,728 |
|
Other
current liabilities
|
|
|
|
|
|
|
57 |
|
Total
current liabilities
|
|
|
38,841 |
|
|
|
32,550 |
|
Deferred
revenue —long term
|
|
|
16,101 |
|
|
|
9,131 |
|
Other
liabilities
|
|
|
123 |
|
|
|
359 |
|
Total
liabilities
|
|
|
55,065 |
|
|
|
42,040 |
|
Commitments
and contingencies (Note 11)
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $.001 par value; 20,000,000 shares authorized; issued, and
outstanding—none
|
|
|
|
|
|
|
|
|
Common
stock, $.0013 par value; 40,000,000 shares authorized; issued and
outstanding— 26,199,016 in 2006 and 29,753,820 in 2007
|
|
|
34 |
|
|
|
39 |
|
Additional
paid-in capital
|
|
|
321,315 |
|
|
|
401,500 |
|
Accumulated
deficit
|
|
|
(210,358 |
) |
|
|
(254,046 |
) |
Accumulated
other comprehensive (loss) income
|
|
|
(145 |
) |
|
|
6 |
|
Total
stockholders’ equity
|
|
|
110,846 |
|
|
|
147,499 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
165,911 |
|
|
$ |
189,539 |
|
The
accompanying notes are an integral part of the financial
statements.
PROGENICS PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except for loss per share data)
|
|
Years
Ended December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Research
and development from collaborator
|
|
|
|
|
$ |
58,415 |
|
|
$ |
65,455 |
|
Research
and development from joint venture
|
|
$ |
988 |
|
|
|
|
|
|
|
|
|
Research
grants and contracts
|
|
|
8,432 |
|
|
|
11,418 |
|
|
|
10,075 |
|
Product
sales
|
|
|
66 |
|
|
|
73 |
|
|
|
116 |
|
Total
revenues
|
|
|
9,486 |
|
|
|
69,906 |
|
|
|
75,646 |
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
43,419 |
|
|
|
61,711 |
|
|
|
95,123 |
|
In-process
research and development
|
|
|
|
|
|
|
13,209 |
|
|
|
|
|
License
fees — research and development
|
|
|
20,418 |
|
|
|
390 |
|
|
|
1,053 |
|
General
and administrative
|
|
|
13,565 |
|
|
|
22,259 |
|
|
|
27,901 |
|
Loss
in joint venture
|
|
|
1,863 |
|
|
|
121 |
|
|
|
|
|
Depreciation
and amortization
|
|
|
1,748 |
|
|
|
1,535 |
|
|
|
3,027 |
|
Total
expenses
|
|
|
81,013 |
|
|
|
99,225 |
|
|
|
127,104 |
|
Operating
loss
|
|
|
(71,527 |
) |
|
|
(29,319 |
) |
|
|
(51,458 |
) |
Other
income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
2,299 |
|
|
|
7,701 |
|
|
|
7,770 |
|
Net
loss before income taxes
|
|
|
(69,228 |
) |
|
|
(21,618 |
) |
|
|
(43,688 |
) |
Income
taxes
|
|
|
(201 |
) |
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(69,429 |
) |
|
$ |
(21,618 |
) |
|
$ |
(43,688 |
) |
Net
loss per share — basic and diluted
|
|
$ |
(3.33 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.60 |
) |
Weighted-average
shares — basic and diluted
|
|
|
20,864 |
|
|
|
25,669 |
|
|
|
27,378 |
|
The
accompanying notes are an integral part of the financial
statements.
PROGENICS PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY AND COMPREHENSIVE LOSS
For
the Years Ended December 31, 2005, 2006 and 2007
(in
thousands)
|
|
Common
Stock
|
|
|
Additional
Paid-in
|
|
|
Unearned
|
|
|
Accumulated
|
|
|
Accumulated
Other Comprehensive
|
|
|
|
|
|
Comprehensive
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Deficit
|
|
|
Income
(Loss)
|
|
|
Total
|
|
|
(Loss)
|
|
Balance
at December 31, 2004
|
|
|
17,281 |
|
|
$ |
22 |
|
|
$ |
153,469 |
|
|
$ |
(2,251 |
) |
|
$ |
(119,311 |
) |
|
$ |
(91 |
) |
|
$ |
31,838 |
|
|
|
|
Issuance
of restricted stock, net of forfeited shares, and compensatory stock
options to employees
|
|
|
134 |
|
|
|
|
|
|
|
4,125 |
|
|
|
(4,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
of unearned compensation – employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,878 |
|
|
|
|
|
|
|
|
|
|
|
1,878 |
|
|
|
|
Issuance
of compensatory stock options to non-employees
|
|
|
|
|
|
|
|
|
|
|
640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
640 |
|
|
|
|
Sale
of common stock under employee stock purchase plans and exercise of stock
options
|
|
|
821 |
|
|
|
1 |
|
|
|
10,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,468 |
|
|
|
|
Sale
of common stock in public offerings, net of offering expenses of
$4,768
|
|
|
6,307 |
|
|
|
9 |
|
|
|
121,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
121,555 |
|
|
|
|
Issuance
of common stock for license rights (see Note 10)
|
|
|
686 |
|
|
|
1 |
|
|
|
15,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,839 |
|
|
|
|
Net
loss for the year ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(69,429 |
) |
|
|
|
|
|
|
(69,429 |
) |
|
$ |
(69,429 |
) |
Change
in unrealized gain on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(57 |
) |
|
|
(57 |
) |
|
|
(57 |
) |
Balance
at December 31, 2005
|
|
|
25,229 |
|
|
|
33 |
|
|
|
306,085 |
|
|
|
(4,498 |
) |
|
|
(188,740 |
) |
|
|
(148 |
) |
|
|
112,732 |
|
|
|
(69,486 |
) |
Compensation
expense for vesting of share-based payment arrangements
|
|
|
|
|
|
|
|
|
|
|
12,034 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,034 |
|
|
|
|
|
Issuance
of restricted stock, net of forfeitures
|
|
|
228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of common stock under employee stock purchase plans and exercise of stock
options
|
|
|
742 |
|
|
|
1 |
|
|
|
7,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,075 |
|
|
|
|
|
Issuance
of compensatory stock options to non-employees
|
|
|
|
|
|
|
|
|
|
|
620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
620 |
|
|
|
|
|
Elimination
of unearned compensation upon adoption of SFAS No. 123(R)
|
|
|
|
|
|
|
|
|
|
|
(4,498 |
) |
|
|
4,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,618 |
) |
|
|
|
|
|
|
(21,618 |
) |
|
|
(21,618 |
) |
Change
in unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
3 |
|
|
|
3 |
|
Balance
at December 31, 2006
|
|
|
26,199 |
|
|
|
34 |
|
|
|
321,315 |
|
|
|
0 |
|
|
|
(210,358 |
) |
|
|
(145 |
) |
|
|
110,846 |
|
|
|
(21,615 |
) |
Compensation
expense for vesting of share-based payment arrangements
|
|
|
|
|
|
|
|
|
|
|
15,306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,306 |
|
|
|
|
|
Issuance
of restricted stock, net of forfeitures
|
|
|
267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of common stock in a public offering ($23.15 per share, net of
underwriting discounts and commissions and other offering expenses of
$3,112) (see Note 8)
|
|
|
2,600 |
|
|
|
3 |
|
|
|
57,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,078 |
|
|
|
|
|
Sale
of common stock under employee stock purchase plans and exercise of stock
options
|
|
|
688 |
|
|
|
2 |
|
|
|
7,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,825 |
|
|
|
|
|
Repurchase
of restricted stock
|
|
|
|
|
|
|
|
|
|
|
(19 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19 |
) |
|
|
|
|
Net
loss for the year ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(43,688 |
) |
|
|
|
|
|
|
(43,688 |
) |
|
|
(43,688 |
) |
Change
in unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151 |
|
|
|
151 |
|
|
|
151 |
|
Balance
at December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,754 |
|
|
$ |
39 |
|
|
$ |
401,500 |
|
|
$ |
0 |
|
|
$ |
(254,046 |
) |
|
$ |
6 |
|
|
$ |
147,499 |
|
|
$ |
(43,537 |
) |
The
accompanying notes are an integral part of the financial
statements.
PROGENICS PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
|
|
Years
Ended December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(69,429 |
) |
|
$ |
(21,618 |
) |
|
$ |
(43,688 |
) |
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
1,748 |
|
|
|
1,535 |
|
|
|
3,027 |
|
Write-off
of fixed assets
|
|
|
|
|
|
|
2 |
|
|
|
|
|
Amortization
of discounts, net of premiums, on marketable securities
|
|
|
270 |
|
|
|
9 |
|
|
|
(445 |
) |
Amortization
of unearned compensation
|
|
|
1,878 |
|
|
|
|
|
|
|
|
|
Noncash
expenses incurred in connection with vesting of share-based compensation
awards
|
|
|
640 |
|
|
|
12,654 |
|
|
|
15,306 |
|
Expense
of purchased technology (see Note 12c)
|
|
|
|
|
|
|
13,209 |
|
|
|
|
|
Loss
in joint venture
|
|
|
1,863 |
|
|
|
121 |
|
|
|
|
|
Adjustment
to loss in joint venture (See Note 12b)
|
|
|
1,311 |
|
|
|
|
|
|
|
|
|
Purchase
of license rights for common stock (see Note 10)
|
|
|
15,839 |
|
|
|
|
|
|
|
|
|
Changes
in assets and liabilities, net of effects of purchase of PSMA
LLC:
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase)
decrease in accounts receivable
|
|
|
(2,175 |
) |
|
|
1,588 |
|
|
|
(296 |
) |
Decrease
in amount due from joint venture
|
|
|
189 |
|
|
|
|
|
|
|
|
|
(Increase)
decrease in other current assets and other assets
|
|
|
(751 |
) |
|
|
(620 |
) |
|
|
70 |
|
Increase
in accounts payable and accrued expenses
|
|
|
2,978 |
|
|
|
1,533 |
|
|
|
2,913 |
|
Increase
(decrease) in due to joint venture
|
|
|
194 |
|
|
|
(194 |
) |
|
|
|
|
(Increase)
decrease in investment in joint venture
|
|
|
(3,950 |
) |
|
|
250 |
|
|
|
|
|
Increase
(decrease) in other current liabilities
|
|
|
790 |
|
|
|
(790 |
) |
|
|
57 |
|
Increase
(decrease) in deferred revenue
|
|
|
60,000 |
|
|
|
(16,910 |
) |
|
|
(16,231 |
) |
Increase
in other liabilities
|
|
|
7 |
|
|
|
74 |
|
|
|
236 |
|
Net
cash provided by (used in) operating activities
|
|
|
11,402 |
|
|
|
(9,157 |
) |
|
|
(39,051 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
(1,212 |
) |
|
|
(8,768 |
) |
|
|
(5,151 |
) |
Purchases
of marketable securities
|
|
|
(205,301 |
) |
|
|
(299,075 |
) |
|
|
(275,048 |
) |
Sales
of marketable securities
|
|
|
124,936 |
|
|
|
267,934 |
|
|
|
252,850 |
|
Acquisition
of PSMA LLC, net of cash acquired (see Note 12c)
|
|
|
|
|
|
|
(13,128 |
) |
|
|
|
|
Increase
in restricted cash
|
|
|
(3 |
) |
|
|
(6 |
) |
|
|
(8 |
) |
Net
cash (used in) investing activities
|
|
|
(81,580 |
) |
|
|
(53,043 |
) |
|
|
(27,357 |
) |
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from the sale of common stock in a public offering (see Note
8)
|
|
|
126,323 |
|
|
|
|
|
|
|
60,190 |
|
Expenses
related to the sale of common stock in a public offering
|
|
|
(4,768 |
) |
|
|
|
|
|
|
(3,112 |
) |
Proceeds
from the exercise of stock options and sale of Common Stock under the
Employee Stock Purchase Plans
|
|
|
10,468 |
|
|
|
7,075 |
|
|
|
7,825 |
|
Repurchase
of restricted stock
|
|
|
|
|
|
|
|
|
|
|
(19 |
) |
Net
cash provided by financing activities
|
|
|
132,023 |
|
|
|
7,075 |
|
|
|
64,884 |
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
61,845 |
|
|
|
(55,125 |
) |
|
|
(1,524 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
5,227 |
|
|
|
67,072 |
|
|
|
11,947 |
|
Cash
and cash equivalents at end of period
|
|
$ |
67,072 |
|
|
$ |
11,947 |
|
|
$ |
10,423 |
|
Supplemental
disclosure of noncash investing activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair
value of assets, including purchased technology, acquired from PSMA
LLC (see Note 12c)
|
|
|
|
|
|
$ |
13,674 |
|
|
|
|
|
Cash
paid for acquisition of PSMA LLC
|
|
|
|
|
|
|
(13,459 |
) |
|
|
|
|
Liabilities
assumed from PSMA LLC
|
|
|
|
|
|
$ |
215 |
|
|
|
|
|
The
accompanying notes are an integral part of the financial
statements.
PROGENICS PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in thousands, except per share amounts or unless otherwise noted)
1.
Organization and Business
Progenics
Pharmaceuticals, Inc. (the “Company” or “Progenics”) is a biopharmaceutical
company focusing on the development and commercialization of innovative
therapeutic products to treat the unmet medical needs of patients with
debilitating conditions and life-threatening diseases. The Company’s principal
programs are directed toward gastroenterology, virology and oncology. The
Company was incorporated in Delaware on December 1, 1986 and commenced principal
operations in late 1988. On April 20, 2006, the Company acquired full ownership
of PSMA Development Company LLC (“PSMA LLC”) by acquiring from Cytogen
Corporation (“Cytogen”) its 50% interest in PSMA LLC (see Note 12c). Certain of
the Company’s intellectual property rights are held by wholly owned subsidiaries
of Progenics. None of the Company’s subsidiaries, other than PSMA LLC, had
operations during the years ended December 31, 2005, 2006 or 2007. Currently,
all of the Company’s operations are conducted at one location in New York State.
The Company’s chief operating decision maker reviews financial analyses and
forecasts relating to all of the Company’s research programs as a single unit
and allocates resources and assesses performance of such programs as a whole.
Therefore, the Company operates under a single research and development
segment.
The
Company’s lead product candidate is methylnaltrexone. Both the U.S. Food and
Drug Administration (“FDA”) and the European Medicines Agency have provisionally
accepted the name RELISTOR™ as the
proprietary name for methylnaltrexone. The
Company has entered into a license and co-development agreement (“Collaboration
Agreement”) with Wyeth Pharmaceuticals (“Wyeth”) for the development and
commercialization of RELISTOR (see Note 9). Under that agreement, the Company
(i) has received an upfront payment from Wyeth, (ii) has received, and is
entitled to receive further, additional payments as certain developmental
milestones for RELISTOR are achieved, (iii) has been and will be reimbursed by
Wyeth for expenses the Company incurs in connection with the development of
RELISTOR under the development plan for RELISTOR agreed to between the Company
and Wyeth and (iv) will receive commercialization payments and royalties if, and
when, RELISTOR is sold. These payments will depend on the successful development
and commercialization of RELISTOR, which is itself dependent on the actions of
Wyeth and the FDA and other regulatory bodies and the outcome of clinical and
other testing of RELISTOR. Many of these matters are outside the control of the
Company. Manufacturing and commercialization expenses for RELISTOR will be
funded by Wyeth.
During
March 2007, the Company submitted a New Drug Application to the FDA for
marketing approval in the United States for a subcutaneous formulation of
RELISTOR for the treatment of opioid-induced constipation in patients receiving
palliative care. In May 2007, Wyeth submitted a regulatory marketing application
in the European Union for the subcutaneous formulation in the same patient
population. Both applications were accepted for review in May 2007, which
resulted in the Company earning a total of $9.0 million in milestone payments
under its Collaboration Agreement with Wyeth. The FDA review is expected to be
completed by its Prescription Drug User Fee Act (“PDUFA”) date of April 30,
2008. Wyeth has also submitted marketing applications for the subcutaneous
formulation in Australia and Canada. The Company and Wyeth are also developing
intravenous and oral formulations of RELISTOR.
The
Company’s other product candidates, including those for treatment of Human
Immunodeficiency virus
(“HIV”) infection, therapy for prostate cancer involving prostate-specific
membrane antigen (“PSMA”) and treatment of Hepatitis C virus (“HCV”) infection,
are not as advanced in development as RELISTOR, and the Company does not expect
any recurring revenues from sales or otherwise with respect to these product
candidates in the near term. As a result of Wyeth’s agreement to reimburse
Progenics for RELISTOR development expenses, the Company is able to devote its
current and future resources to its other research and development
programs.
As a
result of its development expenses and other needs, the Company may require
additional funding to continue its operations. The Company may enter into a
collaboration agreement, or a license or sale transaction, with respect to its
product candidates other than RELISTOR. The Company may also seek to raise
additional capital through the sale of its common stock or other securities and
expects to fund certain aspects of its operations through government grants and
contracts.
On
September 25, 2007, the Company received $57.1 million, net of underwriting
discounts and offering expenses, from the sale of 2.6 million shares of its
common stock in a public offering. During the year ended December 31, 2005, the
Company received $121.6 million, net of underwriting discounts and offering
expenses, from the sale of approximately 6.3 million shares of its common stock
in three public offerings.
The
Company has had recurring losses. At December 31, 2007, the Company had cash,
cash equivalents and marketable securities, including non-current portion,
totaling $170.4 million. The Company expects that cash, cash equivalents and
marketable securities at December 31, 2007 will be sufficient to fund current
operations beyond one year. During the year ended December 31, 2007, the Company
had a net loss of $43.7 million and cash used in operating activities was $39.1
million.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Pending
use in its business, the Company’s revenues and proceeds of financing activities
are held in cash, cash equivalents and marketable securities. Its marketable
securities, which include corporate debt securities, securities of
government-sponsored entities and auction rate securities (“ARS”), are
classified as available for sale. The ARS the Company purchases consist of
municipal bonds with maturities greater than five years and, in accordance with
its investment guidelines, have credit ratings of at least Aa3/AA-, and do not
include mortgage-backed instruments. As of December 31, 2007, Progenics had not
experienced failed auctions of its ARS due to lack of investor
interest.
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, Progenics began to reduce the
principal amount of ARS in its portfolio from $38.8 million at 2007 year-end.
While its portfolio was not affected by the auction process deterioration in
2007, some of the ARS the Company holds experienced auction failures during the
first quarter of 2008. As a result, when the Company attempted to liquidate them
through auction, it was unable to do so as to approximately $10.1 million
principal amount, which it continues to hold. In the event of an auction
failure, the interest rate on the security is reset according to the contractual
terms in the underlying indenture. As of March 14, 2008, Progenics has received
all scheduled interest payments associated with these securities.
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. The Company believes that the failed auctions experienced to date are
not a result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. Progenics
believes that any unrealized gain or loss associated with these securities will
be temporary and will be recorded in accumulated other comprehensive income
(loss) in its financial statements.
The
credit and capital markets have continued to deteriorate in 2008. Continuation
or acceleration of the current instability in these markets and/or deterioration
in the ratings of the Company’s investments may affect its ability to liquidate
these securities, and therefore may affect its financial condition, cash flows
and earnings. Progenics believes that based on its current cash, cash
equivalents and marketable securities balances of $170.4 million at December 31,
2007, the current lack of liquidity in the credit and capital markets will not
have a material impact on its liquidity, cash flows, financial flexibility or
ability to fund its obligations.
Progenics
continues to monitor the market for auction rate securities and consider its
impact (if any) on the fair market value of its investments. If the current
market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, the Company may be
required to record unrealized losses or impairment charges in 2008. As auctions
have closed successfully, the Company has converted its investments in ARS to
money market funds. Progenics believes it will have the ability to hold any
auction rate securities for which auctions fail until the market recovers. It
does not anticipate having to sell these securities in order to operate its
business.
2.
Summary of Significant Accounting Policies
Basis
of Consolidation
The
consolidated financial statements include the accounts of Progenics, as of and
for the years ended December 31, 2005, 2006 and 2007, the balance sheet accounts
of PSMA LLC as of December 31, 2006 and 2007 and the statement of operations
accounts of PSMA LLC from April 20, 2006 to December 31, 2006 and for the year
ended December 31, 2007 (see Notes 1 and 12c). Inter-company transactions have
been eliminated in consolidation. The Company will consolidate the accounts of
PSMA LLC and the Company’s other majority owned subsidiaries that have operating
results in future periods.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Revenue
Recognition
The
Company recognizes revenue from all sources based on the provisions of the
Securities and Exchange Commission’s Staff Accounting Bulletin No.
104 (“SAB 104”) “Revenue Recognition,” Emerging Issues Task Force Issue No.
00-21 (“EITF 00-21”) “Accounting for Revenue Arrangements with Multiple
Deliverables” and EITF Issue No. 99-19 (“EITF 99-19”) “Reporting Revenue Gross
as a Principal Versus Net as an Agent.” During the years ended December 31, 2006
and 2007, the Company recognized revenue from its collaboration agreement
with Wyeth (see Note 9), from government research grants and contracts, which
are used to subsidize a portion of certain of its research projects
(“Projects”), exclusively from the National Institutes of Health (the
“NIH”) and from the sale of research reagents. During the year ended December
31, 2005, the Company recognized revenue from government grants and contracts,
research and development revenue exclusively from PSMA LLC (see Note 12) and
from the sale of research reagents.
Non-refundable
upfront license fees are recognized as revenue when the Company has a
contractual right to receive such payment,
the contract price is fixed or determinable, the collection of the resulting
receivable is reasonably assured and the Company has no further performance
obligations under the license agreement. Multiple element arrangements, such as
license and development arrangements, are analyzed to determine whether the
deliverables, which often include a license and performance obligations, such as
research and steering or other committee services, can be separated in
accordance with EITF 00-21. The Company would recognize upfront license payments
as revenue upon delivery of the license only if the license had standalone value
and the fair value of the undelivered performance obligations, typically
including research or steering or other committee services, could be determined.
If the fair value of the undelivered performance obligations could be
determined, such obligations would then be accounted for separately as
performed. If the license is considered to either (i) not have standalone value
or (ii) have standalone value but the fair value of any of the undelivered
performance obligations could not be determined, the upfront license payments
would be recognized as revenue over the estimated period of when the Company’s
performance obligations are performed.
The Company must determine the period
over which its performance obligations will be performed and revenue related to
upfront license payments will be recognized. Revenue will be recognized using
either a proportionate performance or straight-line method. The Company
recognizes revenue using the proportionate performance method provided that the
Company can reasonably estimate the level of effort required to complete its
performance obligations under an arrangement and such performance obligations
are provided on a best-efforts basis. Direct labor hours or full-time
equivalents will typically be used as the measure of performance. Under the
proportionate performance method, revenue related to upfront license payments is
recognized in any period as the percent of actual effort expended in that period
relative to total effort (as may be estimated in the most current budget
approved by both the collaborator and the Company) for all of the Company’s
performance obligations under the arrangement. Significant judgment is required
in determining the nature and assignment of tasks to be accomplished by each of
the parties and the level of effort required for the Company to complete its
performance obligations under the arrangement. The nature and assignment of
tasks to be performed by each party involves the preparation, discussion and
approval by the parties of a development plan and budget. When a new budget is
approved, generally annually, the remaining unrecognized amount of the upfront
license fee will be recognized prospectively, using the methodology described
above and applying any changes in the total estimated effort or period of
development that is specified in the revised approved budget. If a collaborator
terminates an agreement in accordance with the terms of the agreement, the
Company would recognize any unamortized remainder of an upfront payment at the
time of the termination.
If the
Company cannot reasonably estimate the level of effort required to complete its
performance obligations under an arrangement and the performance obligations are
provided on a best-efforts basis, then the total upfront license payments would
be recognized as revenue on a straight-line basis over the period the Company
expects to complete its performance obligations.
If the
Company is involved in a steering or other committee as part of a multiple
element arrangement, the Company will assess whether its involvement constitutes
a performance obligation or a right to participate. For those committees that
are deemed obligations, the Company will evaluate its participation along with
other obligations in the arrangement and will attribute revenue to its
participation through the period of its committee
responsibilities.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
Collaborations
may also contain substantive milestone payments. Substantive milestone payments
are considered to be performance payments that are recognized upon achievement
of the milestone only if all of the following conditions are met: (i) the
milestone payment is non-refundable; (ii) achievement of the milestone involves
a degree of risk and was not reasonably assured at the inception of the
arrangement; (iii) substantive effort is involved in achieving the milestone,
(iv) the amount of the milestone payment is reasonable in relation to the effort
expended or the risk associated with achievement of the milestone and (v) a
reasonable amount of time passes between the upfront license payment and the
first milestone payment as well as between each subsequent milestone payment
(the “Substantive Milestone Method”).
Determination
as to whether a milestone meets the aforementioned conditions involves
management’s judgment. If any of these conditions are not met, the resulting
payment would not be considered a substantive milestone and, therefore, the
resulting payment would be considered part of the consideration and be
recognized as revenue as such performance obligations are performed under either
the proportionate performance or straight-line methods, as applicable, and in
accordance with the policies described above.
The
Company will recognize revenue for payments that are contingent upon performance
solely by our collaborator immediately upon the achievement of the defined event
if the Company has no related performance obligations.
Reimbursement
of costs is recognized as revenue provided the provisions of EITF 99-19 are met,
the amounts are determinable and collection of the related receivable is
reasonably assured.
Royalty
revenue is recognized upon the sale of related products, provided that the
royalty amounts are fixed or determinable,
collection of the related receivable is reasonably assured and the Company has
no remaining performance obligations under the arrangement. If royalties are
received when the Company has remaining performance obligations, the royalty
payments would be attributed to the services being provided under the
arrangement and, therefore, would be recognized as such performance obligations
are performed under either the proportionate performance or straight-line
methods, as applicable, and in accordance with the policies described
above.
Amounts
received prior to satisfying the above revenue recognition criteria are recorded
as deferred revenue in the accompanying consolidated balance sheets. Amounts not
expected to be recognized within one year of the balance sheet date are
classified as long-term deferred revenue. The estimate of the classification of
deferred revenue as short-term or long-term is based upon management’s current
operating budget for the collaboration agreement for its total effort required
to complete its performance obligations under that arrangement. That estimate
may change in the future and such changes to estimates would be accounted for
prospectively and would result in a change in the amount of revenue recognized
in future periods.
NIH grant
and contract revenue is recognized as efforts are expended and as related
subsidized Project costs are incurred. The Company performs work under the NIH
grants and contract on a best-effort basis. The NIH reimburses the Company for
costs associated with Projects in the fields of virology and cancer, including
pre-clinical research, development and early clinical testing of a prophylactic
vaccine designed to prevent HIV from becoming established in uninfected
individuals exposed to the virus, as requested by the NIH. Substantive at-risk
milestone payments are uncommon in these arrangements, but would be recognized
as revenue on the same basis as the Substantive Milestone Method.
Research
and Development Expenses
Research
and development expenses include costs directly attributable to the conduct of
research and development programs, including the cost of salaries, payroll
taxes, employee benefits, materials, supplies, maintenance of research
equipment, costs related to research collaboration and licensing agreements, the
purchase of in-process research and development, the cost of services provided
by outside contractors, including services related to the Company’s clinical
trials, clinical trial expenses, the full cost of
manufacturing drug for use in research, pre-clinical development and clinical
trials. All costs associated with research and development are expensed as
incurred.
For each
clinical trial that the Company conducts, certain costs, which are included in
research and development expenses, are expensed based on the total number of
subjects in the trial, the estimated rate at which subjects enter the trial, and
the estimated period over which clinical investigators or contract research
organizations provide services. At each period end, the Company evaluates the
accrued expense balance related to these activities based upon information
received from the suppliers and estimated progress towards completion of the
research or development objectives to ensure that the balance is reasonably
stated. Such estimates are subject to change as additional information becomes
available.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
certain estimates and assumptions that affect the amounts reported in the
financial statements and the accompanying notes. Actual results could differ
from those estimates. Significant estimates include useful lives of fixed
assets, the periods over which certain revenues and expenses will be recognized,
including research and development revenue recognized from non-refundable
up-front licensing payments and expense recognition of certain clinical trial
costs which are included in research and development expenses, the amount of
non-cash compensation costs related to share-based payments
to employees and non-employees and the periods over which those costs are
expensed and the likelihood of realization of deferred tax assets.
Patents
As a
result of research and development efforts conducted by the Company, the Company
has applied, or is applying, for a number of patents to protect proprietary
inventions. All costs associated with patents are expensed as
incurred.
Net
Loss Per Share
The
Company prepares its per share data in accordance with Statement of Financial
Accounting Standards No.128 (“SFAS No.128”) “Earnings Per Share.” Basic net loss
per share is computed on the basis of net loss for the period divided by the
weighted average number of shares of common stock outstanding during the period,
which includes restricted shares only as the restrictions lapse. Potential
common shares, amounts of unrecognized compensation expense and windfall tax
benefits have been excluded from diluted net loss per share since they would be
anti-dilutive.
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit
risk consist of cash, cash equivalents, marketable securities and receivables
from Wyeth and the NIH. The Company invests its excess cash in taxable auction
rate securities, corporate notes and federal agency issues. The Company has
established guidelines that relate to credit quality, diversification and
maturity and that limit exposure to any one issue of securities. The Company
holds no collateral for these financial instruments.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments which have maturities of three
months or less, when acquired, to be cash equivalents. The carrying amount
reported in the balance sheet for cash and cash equivalents approximates its
fair value. Cash and cash equivalents subject the Company to concentrations of
credit risk. At December 31, 2006 and 2007, the Company had invested
approximately $6,408 and $4,249 respectively, in cash equivalents in the form of
money market funds with two major investment companies and held approximately
$5,539 and $6,174, respectively, in a single commercial bank. Restricted cash
represents amounts held in escrow for security deposits and credit
cards.
Marketable
Securities
In
accordance with Statement of Financial Accounting Standards No.115, “Accounting
for Certain Debt and Equity Securities,” investments are classified as
available-for-sale. Available-for-sale securities are carried at fair value,
with the unrealized
gains and losses reported in comprehensive income (loss). The amortized cost of
debt securities in this category is adjusted for amortization of premiums and
accretion of discounts to maturity. Such amortization is included in interest
income or expense. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in
other income or expense. In computing realized gains and losses, the Company
computes the cost of its investments on a specific identification basis. Such
cost includes the direct costs to acquire the securities, adjusted for the
amortization of any
discount
or premium. The fair value of marketable securities has been estimated based on
quoted market prices. Interest and dividends on securities classified as
available-for-sale are included in interest income (see Note
4).
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
At
December 31, 2006 and 2007, the Company’s investment in marketable securities in
the current assets section of the consolidated balance sheets included $29.0
million and $38.8 million, respectively, of ARS. The Company’s investments in
these securities are recorded at cost, which approximates fair market value due
to their variable interest rates, which typically reset every 7 to 35 days, and,
despite the long-term nature of their stated contractual maturities, in the past
the Company had the ability to quickly liquidate these securities. As a result,
the Company had no cumulative gross unrealized holding gains (or losses) or
gross realized gains (or losses) from these securities in the periods presented.
All income generated from these current investments was recorded as interest
income. (see Note 4).
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, Progenics began to reduce the
principal amount of ARS in its portfolio from $38.8 million at 2007 year-end.
While its portfolio was not affected by the auction process deterioration in
2007, some of the ARS the Company holds experienced auction failures during the
first quarter of 2008. As a result, when the Company attempted to liquidate them
through auction, it was unable to do so as to approximately $10.1 million
principal amount, which it continues to hold. In the event of an auction
failure, the interest rate on the security is reset according to the contractual
terms in the underlying indenture. As of March 14, 2008, Progenics has received
all scheduled interest payments associated with these securities.
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. The Company believes that the failed auctions experienced to date are
not a result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. Progenics
believes that any unrealized gain or loss associated with these securities will
be temporary and will be recorded in accumulated other comprehensive income
(loss) in its financial statements.
The
credit and capital markets have continued to deteriorate in 2008. Continuation
or acceleration of the current instability in these markets and/or deterioration
in the ratings of the Company’s investments may affect its ability to liquidate
these securities, and therefore may affect its financial condition, cash flows
and earnings. Progenics believes that based on its current cash, cash
equivalents and marketable securities balances of $170.4 million at December 31,
2007, the current lack of liquidity in the credit and capital markets will not
have a material impact on its liquidity, cash flows, financial flexibility or
ability to fund its obligations.
Progenics
continues to monitor the market for auction rate securities and consider its
impact (if any) on the fair market value of its investments. If the current
market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, the Company may be
required to record unrealized losses or impairment charges in 2008. As auctions
have closed successfully, the Company has converted its investments in ARS to
money market funds. Progenics believes it will have the ability to hold any
auction rate securities for which auctions fail until the market recovers. It
does not anticipate having to sell these securities in order to operate its
business.
Fixed
Assets
Leasehold
improvements, furniture and fixtures, and equipment are stated at cost.
Furniture, fixtures and equipment are depreciated on a straight-line basis over
their estimated useful lives. Leasehold improvements are amortized on a
straight-line basis over the
life of the lease or of the improvement, whichever is shorter. Costs of
construction of long-lived assets are capitalized but are not depreciated until
the assets are placed in service.
Expenditures
for maintenance and repairs which do not materially extend the useful lives of
the assets are charged to expense as incurred. The cost and accumulated
depreciation of assets retired or sold are removed from the respective accounts
and any gain or loss is recognized in operations. The estimated useful lives of
fixed assets are as follows:
Computer
equipment
|
3
years
|
Machinery
and equipment
|
5-7
years
|
Furniture
and fixtures
|
5
years
|
Leasehold
improvements
|
Earlier
of life of improvement or lease
|
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Impairment
of Long-Lived Assets
The
Company periodically assesses the recoverability of fixed assets and evaluates
such assets for impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. In accordance with
SFAS No. 144 “Accounting for the Impairment or Disposal of Long-Lived Assets,”
if indicators of impairment exist, the Company assesses the recoverability of
the affected long-lived assets by determining whether the carrying value of such
assets can be recovered through undiscounted future operating cash flows. If the
carrying amount is not recoverable, the Company measures the amount of any
impairment by comparing the carrying value of the asset to the present value of
the expected future cash flows associated with the use of the asset. No
impairments occurred as of December 31, 2005, 2006 or 2007.
Income
Taxes
The Company accounts for income taxes in accordance with the provisions of
Statement of Financial Accounting Standards No.109 (“SFAS No.109”) “Accounting
for Income Taxes,” requires that the Company recognize deferred tax liabilities
and assets for the expected future tax consequences of events that have been
included in the financial statements or tax returns. Under this method, deferred
tax liabilities and assets are determined on the basis of the difference between
the tax basis of assets and liabilities and their respective financial reporting
amounts (“temporary differences”) at enacted tax rates in effect for the years
in which the temporary differences are expected to reverse. A valuation
allowance is established for deferred tax assets for which realization is
uncertain.
In connection with the adoption of SFAS No. 123(R) “Share-Based Payment” (see Note 3), the
Company has made a policy decision related to intra-period tax allocation, to
account for utilization of windfall tax benefits based on provisions in the tax
law that identify the sequence in which amounts of tax benefits are used for tax
purposes (i.e., tax law ordering).
Uncertain
tax positions are accounted for in accordance with FASB Interpretation No.
48 (“FIN 48”) “Accounting for Uncertainty in Income Taxes—an Interpretation
of FASB Statement 109,” which was adopted on January 1, 2007. FIN 48 prescribes
a comprehensive model for the manner in which a company should recognize,
measure, present and disclose in its financial statements all material
uncertain tax positions that the Company has taken or expects to take on a tax
return. FIN 48 applies to income taxes and is not intended to be applied by
analogy to other taxes, such as sales taxes, value-add taxes, or property taxes.
The Company reviews its nexus in various tax jurisdictions and its tax positions
related to all open tax years for events that could change the status of its FIN
48 liability, if any, or require an additional liability to be recorded. Such
events may be the resolution of issues raised by a taxing authority, expiration
of the statute of limitations for a prior open tax year or new transactions for
which a tax position may be deemed to be uncertain. Those positions, for which
management’s assessment is that there is more than a 50 percent probability of
sustaining the position upon challenge by a taxing authority based upon its
technical merits, are subjected to the measurement criteria of FIN 48. The
Company records the largest amount of tax benefit that is greater than 50
percent likely of being realized upon ultimate settlement with a taxing
authority having full knowledge of all relevant information. Any FIN 48
liabilities for which the Company expects to make cash payments within the next
twelve months are classified as “short term.” In the event that the Company
concludes that it is subject to interest and/or penalties arising from uncertain
tax positions, the Company will record interest and penalties as a component of
income taxes (see Note 14).
Risks
and Uncertainties
The
Company has no products approved by the FDA for marketing. There can be no
assurance that the Company’s research and development will be successfully
completed, that any products developed will obtain necessary marketing approval
by regulatory authorities or that any approved products will be commercially
viable. In addition, the Company operates in an environment of rapid change in
technology, and it is dependent upon the continued services of its current
employees, consultants and subcontractors. In accordance with its collaboration
agreement with Wyeth, the Company has transferred to Wyeth the responsibility
for manufacturing RELISTOR for clinical and commercial use in both bulk and
finished form. Wyeth may not be able to fulfill its manufacturing obligations,
either on its own or through third-party suppliers. For the years ended December
31, 2007 and 2006, the primary sources of the Company’s revenues were Wyeth and
research grants and contract revenues from the NIH. For the year ended December
31, 2005, the primary sources of the Company’s revenues were research and
development revenue from PSMA LLC and research grants and contract revenue from
the NIH. There can be no assurance that revenues from Wyeth or from research
grants and contract will continue. Beginning on January 1, 2006, the Company was
no longer reimbursed by PSMA LLC for its services and the Company did not
recognize revenue from PSMA LLC for the quarter ended March 31, 2006. Beginning
in the second quarter of 2006, PSMA LLC became the Company’s wholly owned
subsidiary and, accordingly, the Company no longer recognizes revenue from PSMA
LLC. Substantially all of the Company’s accounts receivable at December 31, 2006
and 2007 were from the above-named sources.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Comprehensive
Loss
Comprehensive
loss represents the change in net assets of a business enterprise during a
period from transactions and other events and circumstances from non-owner
sources. The Company’s comprehensive loss includes net loss adjusted for the
change in
net unrealized gain or loss on marketable securities. The disclosures required
by Statement of Financial Accounting Standards No.130, “Reporting Comprehensive
Income” for the years ended December 31, 2005, 2006 and 2007 have been included
in the Statements of Stockholders’ Equity and Comprehensive Loss. There was no
income tax expense/benefit allocated to any component of Other Comprehensive
Loss (see Note 14).
Impact
of Recently Issued Accounting Standards
On
September 15, 2006, the FASB issued FASB Statement No. 157 (“FAS 157”) “Fair
Value Measurements,” which addresses how companies should measure the fair value
of assets and liabilities when they are required to use a fair value measure for
recognition or disclosure purposes under generally accepted accounting
principles. FAS 157 does not expand the use of fair value in any new
circumstances. Under FAS 157, fair value refers to the price that would be
received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants in the market in which the reporting
entity transacts. FAS 157 clarifies
the principle that fair value should be based on the assumptions market
participants would use when pricing the asset or liability. In support of this
principle, the standard establishes a fair value hierarchy that prioritizes the
information used to develop those assumptions. The fair value hierarchy gives
the highest priority to quoted prices in active markets and the lowest priority
to unobservable data, for example, the reporting entity’s own data. FAS 157
requires disclosures intended to provide information about (i) the extent to
which companies measure assets and liabilities at fair value, (ii) the methods
and assumptions used to measure fair value and (iii) the effect of fair value
measures on earnings. The Company adopted FAS 157 on January 1, 2008 for all
financial assets and liabilities and recurring non-financial assets and
liabilities that are carried at fair value. Adoption of FAS 157 for all
non-recurring non-financial assets and liabilities that are carried at fair
value (such as in the determination of impairment
of fixed assets or goodwill) will occur on January 1, 2009. The Company does not
expect the impact of the adoption of FAS 157 to be material to its financial
position or results of operations.
In
February, 2007, the FASB issued FASB Statement No. 159 (“FAS 159”) “The Fair
Value Option for Financial Assets and Financial Liabilities,” which provides
companies with an option to report certain financial assets and liabilities at
fair value. Unrealized gains and losses on items for which the fair value option
has been elected are reported in earnings. FAS 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar types
of assets and liabilities. The objective of FAS 159 is to reduce both
complexity in accounting for financial instruments and the volatility in
earnings caused by measuring related assets and liabilities differently. FAS 159
is effective for fiscal years beginning after November 15, 2007. The Company
does not expect the impact of the adoption of FAS 159 to be material to its
financial position or results of operations since it does not currently have any
financial assets or liabilities that are subject to FAS 159.
In
November 2007, the Emerging Issues Task Force reached a final consensus on Issue
07-1 (“EITF 07-1”) “Accounting for Collaborative Arrangements.” This issue
affects entities that have entered into arrangements which are not
conducted through a separate legal entity. The Task Force reached a conclusion
that a collaborative arrangement is within the scope of EITF 07-1 if (i) the
parties are active participants in the arrangement and (ii) the participants are
exposed to significant risks and rewards that depend on the endeavor’s ultimate
commercial success. The Task Force also reached a conclusion that transactions
with third parties (i.e., revenue generated and
costs incurred by the partners) should be reported in the appropriate line item
in each company’s financial statement pursuant to the guidance in EITF 99-19,
“Reporting Revenue Gross as a Principal versus Net as an Agent” or other
applicable generally acceptable accounting principle applied consistently. The
Task Force also concluded that the equity method of accounting under Accounting
Principles Board Opinion 18, “The Equity Method of Accounting for Investments in
Common Stock,” should not be applied to arrangements that are not conducted
through a separate legal entity. The guidance in EITF 07-1 will be effective for
periods that begin after December 15, 2008 and be accounted for as a change in
accounting principle through retrospective application. The Company does not
expect the impact of the adoption of EITF 07-01 to be a material to its
financial position or results of operations.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
On
September 27, 2007, the FASB reached a final consensus on Emerging Issues Task
Force Issue 07-3 (“EITF 07-03”) “Accounting for Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities.” Currently, under FASB Statement No. 2, “Accounting for
Research and Development Costs,” non-refundable advance payments for future
research and development activities for materials, equipment, facilities and
purchased intangible assets that have no alternative future use are expensed as
incurred. EITF 07-03 addresses whether such non-refundable advance payments for
goods or services that have no alternative future use and that will be used or
rendered for research and development activities should be expensed when the
advance payments are made or when the research and development activities have
been performed. The consensus reached by the FASB requires companies
involved in research and development activities to capitalize such
non-refundable advance payments for goods and services pursuant to an executory
contractual arrangement because the right to receive those services in the
future represents a probable future economic benefit. Those advance payments
will be capitalized and expensed as the goods are delivered or the related
services are performed. Entities will be required to evaluate whether they
expect the goods or services to be rendered. If an entity does not expect the
goods to be delivered or services to be rendered, the capitalized advance
payment will be charged to expense. The consensus on EITF 07-03 is
effective for financial statements issued for fiscal years beginning after
December 15, 2007, and interim periods within those fiscal years. Earlier
application is not permitted. Entities are required to recognize the effects of
applying the guidance in EITF 07-03 prospectively for new contracts entered into
after the effective date. The Company does not expect the impact of the adoption
of EITF 07-03 to be material to its financial position or results of
operations.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
141 (revised 2007) (“SFAS No. 141(R)”) “Business Combinations,” which supersedes
Statement of Financial Accounting Standards No. 141 (“SFAS 141”) “Business
Combinations.” SFAS No. 141(R) applies to all transactions or other events in
which an entity (the acquirer) obtains control of one or more businesses
(acquiree). SFAS No. 141(R) retains the fundamental requirements in SFAS No. 141
that the acquisition method of accounting be used for all business combinations
and for an acquirer to be identified for each business combination. However,
many of the provisions of SFAS No. 141(R) are different from those of SFAS No.
141, such as the establishment of the acquisition date as the date that the
acquirer achieves control rather than the date assets and liabilities are
transferred. In addition, SFAS No. 141(R) requires an acquirer to recognize the
assets acquired, the liabilities assumed, and any noncontrolling interest in the
acquiree at the acquisition date, measured at their fair values as of that date,
with limited exceptions, as specified. That replaces SFAS No.141’s
cost-allocation process, which required the cost of an acquisition to be
allocated to the individual assets acquired and liabilities assumed based on
their estimated fair values. Among the amendments that SFAS No. 141(R) makes to
existing authoritative guidance, it supersedes FASB Interpretation No. 4,
“Applicability of FASB Statement No. 2 to Business Combinations Accounted for by
the Purchase Method,” which required research and development assets acquired in
a business combination that have no alternative future use to be measured at
their acquisition-date fair values and then immediately charged to expense.
Under SFAS No. 141(R), the acquirer will recognize separately from goodwill the
acquisition-date fair values of research and development assets acquired in a
business combination as long-lived intangible assets. Those assets are subject
to testing for impairment, such as completion or abandonment of an acquired
research project, at which time the impaired asset will be expensed. SFAS No.
141(R) provides guidance on the impairment testing of acquired research and
development intangible assets and assets that the acquirer intends not to use.
SFAS No. 141(R) applies prospectively to business combinations for which the
acquisition date is on or after the beginning of fiscal years beginning on or
after December 15, 2008. An entity may not apply it before that date. The
Company expects that the adoption of SFAS No. 141(R) will have a material impact
on its financial position and results of operations in the event that it enters
into a business combination that falls within the scope of this
pronouncement.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
160 (“SFAS No. 160”) “Noncontrolling Interests in Consolidated Financial
Statements—an amendment of ARB No. 51,” which establishes accounting and
reporting standards for a noncontrolling interest (previously referred to as a
minority interest) in a subsidiary and for the deconsolidation of a subsidiary.
A noncontrolling interest is the portion of equity in a subsidiary not
attributable, directly or indirectly, to a parent. SFAS No. 160 clarifies that a
noncontrolling interest in a subsidiary is an ownership interest in the
consolidated entity that should be reported as equity in the consolidated
financial statements. Before SFAS No. 160 was issued, limited guidance existed
for reporting noncontrolling interests, which were reported in the consolidated
statement of financial position as liabilities or in the mezzanine section
between liabilities and equity. SFAS No. 160 establishes accounting and
reporting standards that require (a) the ownership interests in subsidiaries
held by parties other than the parent be clearly identified, labeled, and
presented in the consolidated statement of financial position within equity, but
separate from the parent’s equity; (b) the amount of consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of income;
(c) changes in a parent’s ownership interest while the parent retains its
controlling financial interest in its subsidiary be accounted for consistently;
(d) when a subsidiary is deconsolidated, any retained noncontrolling equity
investment in the former subsidiary be initially measured at fair
value;
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
(e) the
gain or loss on the deconsolidation of the subsidiary is measured using the fair
value of any noncontrolling equity investment rather than the carrying amount of
that retained investment and (f) entities provide sufficient disclosures that
clearly identify and distinguish between the interests of the parent and the
interests of the noncontrolling owners. SFAS No. 160 is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after
December 15, 2008; earlier adoption is prohibited. SFAS No. 160 will be applied
prospectively as of the beginning of the fiscal year in which it is initially
applied, except for the presentation and disclosure requirements, which will be
applied retrospectively for all periods presented. The Company will evaluate the
impact of the adoption of SFAS No. 160 if there are noncontrolling interests in
future business combinations.
3. Share-Based
Payment Arrangements
On
January 1, 2006, the Company adopted Statement of Financial Accounting Standards
No. 123 (revised 2004) (“SFAS No. 123(R)”) “Share-Based Payment,” which is
a revision of SFAS No.123, (“SFAS No.123”) “Accounting for Stock Based
Compensation.” SFAS No. 123(R) supersedes APB Opinion No. 25 (“APB 25”)
“Accounting for Stock Issued to Employees,” and amends FASB Statement No. 95,
“Statement of Cash Flows.” The Company’s share-based payment arrangements
with employees include non-qualified stock options, restricted stock (nonvested
shares) and shares issued under Employee Stock Purchase Plans, which are
compensatory under SFAS No. 123(R), as described below. The Company accounts for
share-based payment arrangements with non-employees, including
non-qualified stock options and restricted stock (nonvested shares), in
accordance with Emerging Issues Task Force Issue No. 96-18 “Accounting for
Equity Instruments that are Issued to Other Than Employees
for Acquiring, or in Connection with Selling, Goods or Services,” which
accounting is unchanged as a result of the Company’s adoption of SFAS No.
123(R).
Prior
to 2006, in accordance with SFAS No.123 and Statement of Financial Accounting
Standards No.148 (“SFAS No. 148”) “Accounting for Stock-Based
Compensation-Transition and Disclosure,” the Company had elected to follow the
disclosure-only provisions of SFAS No.123 and, accordingly, accounted for
share-based compensation under the recognition and measurement principles of APB
25 and related interpretations. Under APB 25, when stock options were issued to
employees with an exercise price equal to or greater than the market price of
the underlying stock price on the date of grant, no compensation expense
was recognized in the financial statements and pro forma compensation expense in
accordance with SFAS No. 123 was only disclosed in the footnotes to the
financial statements.
The
Company adopted SFAS No. 123(R) using the modified prospective application,
under which compensation cost for all share-based awards that were unvested as
of the adoption date and those newly granted or modified after the adoption date
are being recognized over the related requisite service period, usually the
vesting period for awards with a service condition. The Company has made an
accounting policy decision to use the straight-line method of attribution of
compensation expense, under which the grant date fair value of share-based
awards is recognized on a straight-line basis over the total requisite service
period for the total award. Upon adoption of SFAS No. 123(R), the Company
eliminated $4,498 of unearned compensation, related to share-based awards
granted prior to the adoption date that were unvested as of January 1, 2006,
against additional paid-in capital. The cumulative effect of adjustments upon
adoption of SFAS No. 123(R) was not material. Compensation expense recorded on a
pro forma basis for periods prior to adoption of SFAS No. 123(R) is not revised
and is not reflected in the financial statements of those prior periods.
Accordingly, there was no effect of the change from applying the original
provisions of SFAS No. 123 on net income, cash flow from operations, cash flows
from financing activities or basic or diluted net loss per share of periods
prior to the adoption of SFAS No. 123(R).
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
The
following table summarizes the pro forma operating results and compensation
costs for the period prior to the Company’s adoption of SFAS No. 123(R) for the
Company’s incentive stock option and stock purchase plans, which have been
determined in accordance with the fair value-based method of accounting for
stock-based compensation as prescribed by SFAS No. 123. The fair value of
options granted to non-employees for services, determined using the
Black-Scholes option pricing model with the input assumptions presented below,
is included in the Company’s historical financial statements and expensed as
they vest. Net loss and pro forma net loss include $640 of non-employee
compensation expense in the year ended December 31, 2005.
|
|
Year
Ended December 31, 2005
|
|
Net
loss, as reported
|
|
$ |
(69,429 |
) |
Add:
Stock-based employee compensation expense included in reported net
loss
|
|
|
1,878 |
|
Deduct:
Total share-based employee compensation expense determined under fair
value based method for all awards
|
|
|
(10,148 |
) |
Pro
forma net loss
|
|
$ |
(77,699 |
) |
|
|
|
|
|
Net
loss per share amounts, basic and diluted:
|
|
|
|
|
As
reported
|
|
$ |
(3.33 |
) |
Pro
forma
|
|
$ |
(3.72 |
) |
The Company has adopted four stock
incentive plans, the 1989 Non-Qualified Stock Option Plan, the 1993 Stock Option
Plan, the 1996 Amended Stock Incentive Plan and the 2005 Stock Incentive Plan
(the “Plans”). Under each of these Plans as amended, a maximum of 375, 750,
5,000 and 3,950 shares of common stock, respectively, are available for awards
to employees, consultants, directors and other individuals who render services
to the Company (collectively, “Awardees”). The Plans contain certain
anti-dilution provisions in the event of a stock split, stock dividend or other
capital adjustment as defined. The 1989 Plan and 1993 Plan provide for the
Board, or the Compensation Committee (“Committee”) of the Board, to grant stock
options to Awardees and to determine the exercise price, vesting term and
expiration date. The 1996 Plan and the 2005 Plan provide for the Board or
Committee to grant to Awardees stock options, stock appreciation rights,
restricted stock, performance awards or phantom stock, as defined (collectively,
“Awards”). The Committee is also authorized to determine the term and vesting of
each Award and the Committee may in its discretion accelerate the vesting of an
Award at any time. Stock options granted under the Plans generally vest pro rata
over four to ten years and have terms of ten to twenty years. Restricted stock
issued under the 96 Plan or 05 Plan usually vests annually over a four year
period, unless specified otherwise by the Committee. The exercise price of
outstanding non-qualified stock options is usually equal to the fair value of
the Company’s common stock on the date of grant. The exercise price of
non-qualified stock options granted from the 05 Plan and incentive stock options
(“ISO”) granted from the Plans may not be lower than the fair value of the
Company’s common stock on the dates of grant. At December 31, 2005, 2006 and
2007, all outstanding stock options were non-qualified options. The 1989, 1993
and 1996 Plans terminated in April 1994, December
2003 and October 2006, respectively, and the 2005 Plan will terminate in April
2015; options granted before termination of the Plans will continue under the
respective Plans until exercised, cancelled or expired.
The Company applies a forfeiture rate
to the number of unvested awards in each reporting period in order to estimate
the number of awards that are expected to vest. Estimated forfeiture rates are
based upon historical data on vesting behavior of employees. The Company adjusts
the total amount of compensation cost recognized for each award, in the period
in which each award vests, to reflect the actual forfeitures related to that
award.
Under
SFAS No. 123 and SFAS No. 123(R), the fair value of each option award granted
under the Plans is estimated on the date of grant using the Black-Scholes option
pricing model with the input assumptions noted in the following table. Ranges of
assumptions for inputs are disclosed where the value of such assumptions varied
during the related period. Historical volatilities are based upon daily quoted
market prices of the Company’s common stock on The NASDAQ Stock Market LLC over
a period equal to the expected term of the related equity instruments. The
Company relies only on historical volatility since it provides the most reliable
indication of future volatility. Future volatility is expected to be consistent
with historical; historical volatility is calculated using a simple average
calculation method; historical data is available for the length of the option’s
expected term and a sufficient number of price observations are used
consistently.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Since the
Company’s stock options are not traded on a public market, the Company does not
use implied volatility. For the year ended December 31, 2007, expected term was
calculated based upon historical data related to exercise and post-termination
cancellation activity for each of two groups of recipients of stock options:
employees, and officers and directors, for which expected terms were 5.25 and
7.5 years, respectively. Expected term for options granted to non-employee
consultants was ten years, which is the contractual term of those options. The
expected term of options granted in 2006 was based upon the simplified method of
calculating expected term, as detailed in Staff Accounting Bulletin No. 107
(“SAB 107”) and represents the period of time that options granted are expected
to be outstanding. Accordingly, the Company used an expected term of 6.5 years
based upon the vesting period of the outstanding options of four or five years
and a contractual term of ten years. For the year ended December 31, 2005, the
expected term of 6.5 years was based upon the average of the vesting term and
the original contractual term. The Company has never paid dividends and does not
expect to pay dividends in the future. Therefore, the Company’s dividend rate is
zero. The risk-free rate for periods within the expected term of the option is
based on the U.S. Treasury yield curve in effect at the time of
grant.
|
|
For
the Years Ended
December
31,
|
|
|
2005
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
Expected
volatility
|
|
92%
- 97%
|
|
69%
- 94%
|
|
50%
- 89%
|
Expected
dividends
|
|
zero
|
|
zero
|
|
zero
|
Expected
term (years)
|
|
6.5
|
|
6.5
|
|
5.25
- 10
|
Weighted
average expected term (years)
|
|
6.5
|
|
6.5
|
|
6.90
|
Risk-free
rate
|
|
3.29%
- 3.98%
|
|
4.56%
- 5.06%
|
|
3.88%
- 4.93%
|
A summary
of option activity under the Plans as of December 31, 2007 and changes during
the year then ended is presented below:
Options
|
|
Shares
|
|
Weighted
Average Exercise Price
|
|
Weighted
Average Remaining Contractual Term (Yr.)
|
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
Outstanding
at January 1, 2007
|
|
4,495
|
|
$16.89
|
|
|
|
|
Granted
|
|
703
|
|
23.05
|
|
|
|
|
Exercised
|
|
(233)
|
|
10.07
|
|
|
|
|
Forfeited
or expired
|
|
(257)
|
|
17.08
|
|
|
|
|
Outstanding
at December 31, 2007
|
|
4,708
|
|
$18.14
|
|
5.62
|
|
$12,999
|
Exercisable
at December 31, 2007
|
|
3,434
|
|
$16.32
|
|
4.64
|
|
$12,550
|
The
weighted average grant-date fair value of options granted under the Plans during
the years ended December 31, 2005, 2006 and 2007 was $17.07, $19.32 and $16.18,
respectively. The total intrinsic value of options exercised during the years
ended December 31, 2005, 2006 and 2007 was $6,368, $6,591 and $3,766,
respectively.
The
options granted under the Plans, described above, include 33, 113, 38, 75, 145
and 113 non-qualified stock options granted to the Company’s Chief Executive
Officer on July 1, 2002, 2003, 2004 and 2005, on July 3, 2006 and on July 2,
2007, respectively, which cliff vest after nine years and eleven months from the
respective grant dates. Vesting of a defined portion of each award will occur
earlier if a defined performance condition is achieved; more than one condition
may be achieved in any period. Upon adoption of SFAS No. 123(R) on January 1,
2006, 21, zero, 8 and 36 options were unvested under the 2002, 2003, 2004 and
2005 awards, respectively. The 2005 award was fully vested in 2006 upon the
achievement of one of the performance milestones. In accordance with SFAS No.
123(R), at the end of each reporting period, the Company estimates the
probability of achievement of each performance condition and uses those
probabilities to determine the requisite service period of each award. The
requisite service period for the award is the shortest of the explicit or
implied service periods. In the case of the Chief Executive Officer’s options,
the explicit service period is nine years and eleven months from the respective
grant dates. The implied service periods related to the performance conditions
are the estimated times for each performance condition to be achieved. Thus,
compensation expense will be recognized over the shortest estimated time for the
achievement of performance conditions for that award (assuming that the
performance conditions will be achieved before the cliff vesting
occurs).
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
To the
extent that, for each of the 2002, 2004, 2006 and 2007 awards, it is probable
that 100% of the remaining unvested award will vest based on achievement of the
remaining performance conditions, compensation expense will be recognized over
the estimated periods of achievement. To the extent that it is probable that
less than 100% of the award will vest based upon remaining performance
conditions, the shortfall will be recognized through the remaining period to
nine years and eleven months from the grant date (i.e., the remaining service
period). Changes in the estimate of probability of achievement of any
performance condition will be reflected in compensation expense of the period of
change and future periods affected by the change.
At
December 31, 2007, the estimated requisite service periods for the 2002, 2004,
2006 and 2007 awards, described above, were 0.5, 0.5 – 1.25, 0.5 – 8.5 and 0.25
– 0.75 years, respectively. For the year ended December 31, 2007, 9, 2,
2 and 83 options vested under the 2002, 2004, 2006 and 2007 awards,
respectively, which resulted in compensation expense of $70, $21, $(38) and
$1,449, respectively. The reduction in compensation expense recognized for the
2006 award resulted from a change in the estimate of the period of vesting of
the related performance milestones, as described above. Prior to the adoption of
SFAS No. 123(R), these awards were accounted for as variable awards under APB 25
and, therefore, compensation expense, based on the intrinsic value of the vested
awards on each reporting date, was recognized in the Company’s financial
statements.
A summary
of the status of the Company’s nonvested shares (i.e., restricted stock
awarded under the Plans which has not yet vested) as of December 31, 2007 and
changes during the year then ended is presented below:
Nonvested
Shares
|
|
Shares
|
|
Weighted
Average Grant-Date
Fair
Value
|
|
|
|
|
|
Nonvested
at January 1, 2007
|
|
388
|
|
$
22.37
|
Granted
|
|
309
|
|
22.47
|
Vested
|
|
(133)
|
|
22.46
|
Forfeited
|
|
(41)
|
|
23.09
|
Nonvested
at December 31, 2007
|
|
523
|
|
22.35
|
During
1993, the Company adopted an Executive Stock Option Plan (the “Executive Plan”),
under which a maximum of 750 shares of common stock, adjusted for stock splits,
stock dividends and other capital adjustments, are available for stock option
awards. Awards issued under the Executive Plan may qualify as incentive stock
options (“ISO’s”), as defined by the Internal Revenue Code, or may be granted as
non-qualified stock options. Under the Executive Plan, the Board may award
options to senior executive employees (including officers who may be members of
the Board) of the Company. The Executive Plan terminated on December 15, 2003;
any options outstanding as of the termination date shall remain outstanding
until such option expires in accordance with the terms of the respective grant.
During December 1993, the Board awarded a total of 750 stock options under the
Executive Plan to the Company’s current Chief Executive Officer, of which 665
were non-qualified options (“NQO’s”) and 85 were ISO’s. The ISO’s have been
exercised in December 1998. The NQO’s have a term of 14 years and entitle the
officer to purchase shares of common stock at $5.33 per share, which represented
the estimated fair market value, of the Company’s common stock at the date of
grant, as determined by the Board of Directors. As of January 1 and December 31,
2007, 231 and zero NQO’s, respectively, were outstanding and fully vested. The
total intrinsic value of NQO’s under the Executive Plan exercised during the
years ended December 31, 2005, 2006 and 2007 was zero, $4,662 and $4,402,
respectively. At December 31, 2007, the weighted average remaining contractual
term of the NQO’s was zero years and the aggregate intrinsic value was
zero.
The
Company’s two employee stock purchase plans (the “Purchase Plans”), the 1998
Employee Stock Purchase Plan (the “Qualified Plan”) and the 1998 Non-Qualified
Employee Purchase Plan (the “Non-Qualified Plan”), as amended, provide for the
issuance of up to 1,600 and 500 shares of common stock, respectively. The
Purchase Plans provide for the grant to all employees of options to use an
amount equal to up to 25% of their quarterly compensation, as such percentage is
determined by the Board of Directors prior to the date of grant, to purchase
shares of the common stock at a price per share equal to the lesser of the fair
market value of the common stock on the date of grant or 85% of the fair market
value on the date of exercise. Options are granted automatically on the first
day of each fiscal quarter and expire six months after the date of grant. The
Qualified Plan is not available to employees owning more than five percent of
the common stock and imposes certain other quarterly limitations on the option
grants. Options under the Non-Qualified Plan are granted to the extent that
option grants are restricted under the Qualified Plan.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
The fair
value of shares purchased under the Purchase Plans is estimated on the date of
grant in accordance with FASB Technical Bulletin No. 97-1 “Accounting under
Statement 123 for Certain Employee Stock Purchase Plans with a Look-Back
Option,” using the same option valuation model used for options granted under
the Plans, except that the assumptions noted in the following table were used
for the Purchase Plans:
|
|
For
the Years Ended
December
31,
|
|
|
2005
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
Expected
volatility
|
|
29%-
47%
|
|
37%
- 43%
|
|
40%
- 46%
|
Expected
dividends
|
|
zero
|
|
zero
|
|
zero
|
Expected
term
|
|
6
months
|
|
6
months
|
|
6
months
|
Risk-free
rate
|
|
2.53%
- 3.29%
|
|
3.25%
- 4.75%
|
|
3.91%
- 5.10%
|
Purchases of common stock under the Purchase Plans during the years ended
December 31, 2005, 2006 and 2007 are summarized as follows:
|
Qualified
Plan
|
|
Non-Qualified
Plan
|
|
Shares
Purchased
|
|
Price
Range
|
|
Weighted
Average
Grant-Date Fair Value
|
|
Shares
Purchased
|
|
Price
Range
|
|
Weighted
Average
Grant-Date Fair Value
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
130
|
|
$13.60 - $24.67
|
|
$7.07
|
|
27
|
|
$13.60 - $24.67
|
|
$7.08
|
2006
|
126
|
|
$17.80
- $25.84
|
|
$3.30
|
|
27
|
|
$18.61
- $25.84
|
|
$3.25
|
2007
|
179
|
|
$16.27
- $23.46
|
|
$3.41
|
|
45
|
|
$17.80 - $23.46
|
|
$3.43
|
The total
compensation expense of shares, granted to both employees and non-employees,
under all of the Company’s share-based payment arrangements that was recognized
in operations during the years ended December 31, 2005, 2006 and 2007
was:
|
|
Years
Ended December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
Recognized
as:
|
|
|
|
|
|
|
|
|
|
Research
and Development
|
|
$ |
1,237 |
|
|
$ |
5,814 |
|
|
$ |
7,104 |
|
General
and Administrative
|
|
|
1,281 |
|
|
|
6,840 |
|
|
|
8,202 |
|
Total
|
|
$ |
2,518 |
|
|
$ |
12,654 |
|
|
$ |
15,306 |
|
No tax
benefit was recognized related to such compensation cost because the Company had
a net loss for the periods presented and the related deferred tax assets were
fully offset by valuation allowances. Accordingly, no amounts related to
windfall
tax benefits have been reported in cash flows from operations or cash flows from
financing activities for the periods presented.
As of
December 31, 2007, there was $14.3 million, $8.6 million and $37 of total
unrecognized compensation cost related to nonvested stock options under the
Plans, the nonvested shares and the Purchase Plans, respectively. Those costs
are expected to be recognized over weighted average periods of 3.0 years, 2.6
years and 0.5 years, respectively. Cash received from exercises under all
share-based payment arrangements for the year ended December 31, 2007 was $7.8
million. No tax benefit was realized for the tax deductions from those option
exercises of the share-based payment arrangements because the Company had a net
loss for the period and the related deferred tax assets were fully offset by a
valuation allowance. During the year ended December 31, 2007, the Company used
$19 to settle shares of restricted stock granted to two employees under the 05
Plan. The Company issues new shares of its common stock upon share option
exercise and share purchase.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
In applying the treasury stock method
for the calculation of diluted earnings per share (“EPS”), amounts of
unrecognized compensation expense and windfall tax benefits are required to be
included in the assumed proceeds in the denominator of the diluted earnings per
share calculation unless they are anti-dilutive. The Company incurred a net loss
for the years ended December 31, 2005, 2006 and 2007 and, therefore, such
amounts have not been included for those periods in the calculation of diluted
EPS since they would be anti-dilutive. Accordingly, basic and diluted EPS are
the same for those periods. The Company has made an accounting policy decision
to calculate windfall tax benefits/shortfalls for purposes of diluted EPS
calculations, excluding the impact of pro forma deferred tax assets. This policy
decision will apply when the Company has net income.
4.
Marketable Securities
The
Company considers its marketable securities to be “available-for-sale,” as
defined by Statement of Financial Accounting Standards No.115, “Accounting for
Certain Investments in Debt and Equity Securities,” and, accordingly, unrealized
holding gains and losses are excluded from operations and reported as a net
amount in a separate component of stockholders’ equity (see Note 2). The
following table summarizes the amortized cost basis, the aggregate fair value
and gross unrealized holding gains and losses at December 31, 2006 and
2007:
|
|
Amortized
|
|
|
Fair
|
|
|
Unrealized
Holding
|
|
|
|
Cost
Basis
|
|
|
Value
|
|
|
Gains
|
|
|
(Losses)
|
|
|
Net
|
|
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturities
less than one year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
$ |
75,907 |
|
|
$ |
75,833 |
|
|
$ |
6 |
|
|
$ |
(80 |
) |
|
$ |
(74 |
) |
Government-sponsored
entities
|
|
|
9,000 |
|
|
|
8,979 |
|
|
|
|
|
|
|
(21 |
) |
|
|
(21 |
) |
Maturities
between one and five years:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
|
20,366 |
|
|
|
20,319 |
|
|
|
|
|
|
|
(47 |
) |
|
|
(47 |
) |
Government-sponsored
entities
|
|
|
3,000 |
|
|
|
2,993 |
|
|
|
|
|
|
|
(7 |
) |
|
|
(7 |
) |
Maturities
greater than five years:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Municipal
Bonds (ARS) see Note 2
–Marketable Securities
|
|
|
29,025 |
|
|
|
29,029 |
|
|
|
4 |
|
|
|
|
|
|
|
4 |
|
|
|
$ |
137,298 |
|
|
$ |
137,153 |
|
|
$ |
10 |
|
|
$ |
(155 |
) |
|
$ |
(145 |
) |
|
|
Amortized
|
|
|
Fair
|
|
|
Unrealized
Holding
|
|
|
|
Cost
Basis
|
|
|
Value
|
|
|
Gains
|
|
|
(Losses)
|
|
|
Net
|
|
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturities
less than one year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
$ |
76,854 |
|
|
$ |
76,892 |
|
|
$ |
84 |
|
|
$ |
(46 |
) |
|
$ |
38 |
|
Government-sponsored
entities
|
|
|
4,295 |
|
|
|
4,278 |
|
|
|
|
|
|
|
(17 |
) |
|
|
(17 |
) |
Maturities
between one and five years:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
|
39,962 |
|
|
|
39,947 |
|
|
|
65 |
|
|
|
(80 |
) |
|
|
(15 |
) |
Maturities
greater than five years:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Municipal
Bonds (ARS) see Note 2
–Marketable Securities
|
|
|
38,830 |
|
|
|
38,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
159,941 |
|
|
$ |
159,947 |
|
|
$ |
149 |
|
|
$ |
(143 |
) |
|
$ |
6 |
|
The
Company computes the cost of its investments on a specific identification basis.
Such cost includes the direct costs to acquire the securities, adjusted for the
amortization of any discount or premium. The fair value of marketable securities
has been estimated based on quoted market prices.
The
auction process for ARS historically provided a liquid market for these
securities. In the second half of 2007, however, this process began to
deteriorate. During the first quarter of 2008, Progenics began to reduce the
principal amount of ARS in its portfolio from $38.8 million at 2007 year-end.
While its portfolio was not affected by the auction process deterioration in
2007, some of the ARS the Company holds experienced auction failures during the
first quarter of 2008. As a result, when the Company attempted to liquidate them
through auction, it was unable to do so as to approximately $10.1 million
principal amount, which it continues to hold. In the event of an auction
failure, the interest rate on the security is reset according to the contractual
terms in the underlying indenture. As of March 14, 2008, Progenics has received
all scheduled interest payments associated with these
securities.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
The funds
associated with failed auctions will not be accessible until a successful
auction occurs, the issuer calls or restructures the underlying security, the
underlying security matures and is paid or a buyer outside the auction process
emerges. The Company believes that the failed auctions experienced to date are
not a result of the deterioration of the underlying credit quality of these
securities, although valuation of them is subject to uncertainties that are
difficult to predict, such as changes to credit ratings of the securities and/or
the underlying assets supporting them, default rates applicable to the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. Progenics
believes that any unrealized gain or loss associated with these securities will
be temporary and will be recorded in accumulated other comprehensive income
(loss) in its financial statements.
The
credit and capital markets have continued to deteriorate in 2008. Continuation
or acceleration of the current instability in these markets and/or deterioration
in the ratings of the Company’s investments may affect its ability to liquidate
these securities, and therefore may affect its financial condition, cash flows
and earnings. Progenics believes that based on its current cash, cash
equivalents and marketable securities balances of $170.4 million at December 31,
2007, the current lack of liquidity in the credit and capital markets will not
have a material impact on its liquidity, cash flows, financial flexibility or
ability to fund its obligations.
Progenics continues to monitor the market for auction rate securities and
consider its impact (if any) on the fair market value of its investments. If the
current market conditions continue, in which some auctions for ARS fail, or the
anticipated recovery in market values does not occur, the Company may be
required to record unrealized losses or impairment charges in 2008. As auctions
have closed successfully, the Company has converted its investments in ARS to
money market funds. Progenics believes it will have the ability to hold any
auction rate securities for which auctions fail until the market recovers. It
does not anticipate having to sell these securities in order to operate its
business.
The
following table shows the gross unrealized losses and fair value of the
Company’s marketable securities with unrealized losses that are not deemed to be
other-than-temporarily impaired, aggregated by investment category and length of
time that individual securities have been in a continuous unrealized loss
position, at December 31, 2006 and 2007.
At
December 31, 2006:
|
|
Less
than 12 Months
|
|
|
12
Months or Greater
|
|
|
Total
|
|
Description of Securities
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
$ |
78,944 |
|
|
$ |
(123 |
) |
|
$ |
6,095 |
|
|
$ |
(4 |
) |
|
$ |
85,039 |
|
|
$ |
(127 |
) |
Government-sponsored
entities
|
|
|
11,972 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
11,972 |
|
|
|
(28 |
) |
Total
|
|
$ |
90,916 |
|
|
$ |
(151 |
) |
|
$ |
6,095 |
|
|
$ |
(4 |
) |
|
$ |
97,011 |
|
|
$ |
(155 |
) |
|
|
Less
than 12 Months
|
|
|
12
Months or Greater
|
|
|
Total
|
|
Description of Securities
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
Fair
Value
|
|
|
Unrealized
Losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
debt securities
|
|
$ |
50,511 |
|
|
$ |
(118 |
) |
|
$ |
9,479 |
|
|
$ |
(7 |
) |
|
$ |
59,990 |
|
|
$ |
(125 |
) |
Government-sponsored
entities
|
|
|
4,278 |
|
|
|
(17 |
) |
|
|
|
|
|
|
|
|
|
|
4,278 |
|
|
|
(17 |
) |
Total
|
|
$ |
54,789 |
|
|
$ |
(135 |
) |
|
$ |
9,479 |
|
|
$ |
(7 |
) |
|
$ |
64,268 |
|
|
$ |
(142 |
) |
Corporate debt
securities. The Company’s investments in corporate debt
securities with unrealized losses at December 31, 2007 include 9 securities with
maturities of less than one year ($17,282 of the total fair value and $13 of the
total unrealized losses in corporate debt securities) and 26 securities with
maturities between one and two years ($42,708 of the total fair value and $112
of the total unrealized losses in corporate debt securities). The severity of
the unrealized losses (fair value is approximately 0.00017 percent to 0.84
percent less than cost) and duration of the unrealized losses (weighted average
of 5.0 months) correlate with the short maturities of the majority of these
investments.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
At
December 31, 2007, the credit ratings of these securities were in compliance
with the Company’s investment policy, which requires that its investments in
corporate debt securities maintain credit ratings
of not less than Aa3/AA-. The decrease in the market value of the Company’s
portfolio in 2007 was, therefore, not attributable to a decline in credit
ratings but rather to interest rate increases. The Company’s corporate debt
securities are purchased by third-party brokers in accordance with its
investment policy guidelines. The Company’s brokerage account requires that all
corporate debt securities be held to maturity unless authorization is obtained
from the Company to sell earlier. In fact, the Company has a history of holding
corporate debt securities to maturity. The Company, therefore, considers that it
has the intent and ability to hold any corporate debt securities with unrealized
losses until a recovery of fair value, which may be maturity and it does not
consider these marketable securities to be other-than-temporarily impaired at
December 31, 2007.
Government-sponsored
entities. The unrealized losses on the Company’s investments in
government-sponsored entities during a period of less than 12 months were
primarily caused by interest rate increases, which have generally resulted in a
decrease in the market value of the Company’s portfolio. At December 31, 2007,
the credit ratings of these securities were in compliance with the Company’s
investment policy, which requires that its investments in securities of
government-sponsored entities maintain credit ratings of not less than AAA.
Therefore, the decline in fair value of these securities was not attributable to
a decrease in credit ratings. Similar to corporate debt securities, discussed
above, the Company considers that it has the intent and ability to hold any
investments in government-sponsored entities with unrealized losses until a
recovery of fair value, which may be maturity and it does not consider these
marketable securities to be other-than-temporarily impaired at December 31,
2007.
5.
Accounts Receivable
|
|
|
|
|
|
|
|
|
|
|
National
Institutes of Health
|
|
$ |
1,697 |
|
|
$ |
1,956 |
|
|
|
|
2 |
|
|
|
39 |
|
|
|
$ |
1,699 |
|
|
$ |
1,995 |
|
6.
Fixed Assets
|
|
December
31,
|
|
|
|
2006
|
|
|
2007
|
|
Computer
equipment
|
|
$ |
1,690 |
|
|
$ |
1,935 |
|
Machinery
and equipment
|
|
|
6,890 |
|
|
|
11,695 |
|
Furniture
and fixtures
|
|
|
726 |
|
|
|
726 |
|
Leasehold
improvements
|
|
|
4,950 |
|
|
|
10,448 |
|
Construction
in progress
|
|
|
6,361 |
|
|
|
874 |
|
|
|
|
20,617 |
|
|
|
25,678 |
|
Less,
accumulated depreciation and amortization
|
|
|
(9,230 |
) |
|
|
(12,167 |
) |
Total
|
|
$ |
11,387 |
|
|
$ |
13,511 |
|
At December 31, 2006, $1.6 million and
$0.7 million of leasehold improvements, made to the Company’s leased laboratory
and office space (see Note 11a), were being amortized over periods of 5.3 – 5.8
years and 8.5 years, respectively, under leases with terms through December 31,
2009 and December 31, 2014, respectively. At December 31, 2007, $5.7 million,
$0.9 million and $0.7 million of leasehold improvements were being amortized
over periods of 2.3 – 5.8 years, 4.7 years and 8.5 years, respectively, under
leases with terms through December 31, 2009, June 29, 2012 and December 31,
2014, respectively.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
7.
Accounts Payable and Accrued Expenses
|
|
December
31,
|
|
|
|
2006
|
|
|
2007
|
|
Accounts
payable
|
|
$ |
1,559 |
|
|
$ |
1,158 |
|
Accrued
consulting and clinical trial costs
|
|
|
7,404 |
|
|
|
10,848 |
|
Accrued
payroll and related costs
|
|
|
990 |
|
|
|
1,489 |
|
Legal
and professional fees
|
|
|
1,301 |
|
|
|
1,127 |
|
Other
|
|
|
598 |
|
|
|
143 |
|
Total
|
|
$ |
11,852 |
|
|
$ |
14,765 |
|
8.
Stockholders’ Equity
The
Company is authorized to issue 40,000 shares of common stock, par value $.0013
(“Common Stock”), and 20,000 shares of preferred stock, par value $.001. The
Board has the authority to issue common and preferred shares, in series, with
rights and privileges as determined by the Board.
On
September 25, 2007, the Company completed a public offering of 2.6 million
shares of its Common Stock, pursuant to a shelf registration statement that had
been filed with the Securities and Exchange Commission in 2006, which had
registered 4.0 million shares of the Company’s Common Stock. The Company
received proceeds of $57.3 million, or $22.04 per share, which was net of
underwriting discounts and commissions of approximately $2.9 million, and paid
approximately $0.2 million in other offering expenses. During the second and
third quarters of 2005, the Company completed a series of public offerings of
Common Stock, which provided it with $121.6 million in net proceeds from the
sale of 6,307 shares of Common Stock, at prices ranging from $15.25 to $23.90
per share, and incurred related expenses of $4.8 million.
On
December 22, 2005, the Company entered into a series of agreements with the
licensors of the Company’s sublicense for the methylnaltrexone technology (see
Note 10). The Company issued a total of 686 shares of Common Stock to the
licensors, valued at $15,839, based upon the closing price of the Company’s
Common Stock on the date of the transaction of $23.09 per share.
In
connection with the adoption of SFAS 123(R) on January 1, 2006, the Company
eliminated $4,498 of unearned compensation, related to share-based awards
granted prior to the adoption date that were unvested as of that date, against
additional paid-in-capital.
9.
License and Co-Development Agreement with Wyeth
Pharmaceuticals
On December 23, 2005, the Company
entered into the Collaboration Agreement with Wyeth (collectively, the
“Parties”) for the purpose of developing and commercializing RELISTOR, the
Company’s lead investigational drug, for the treatment of opioid-induced side
effects, including constipation and post-operative ileus, associated with
chronic pain and in patients receiving palliative care. The Collaboration
Agreement involves three formulations of RELISTOR: (i) a subcutaneous
formulation to be used in patients
with opioid-induced constipation, (ii) an intravenous formulation to be used in
patients with post-operative ileus and (iii) an oral formulation to be used in
patients with opioid-induced constipation.
The collaboration is being administered
by a Joint Steering Committee and a Joint Development Committee, each with equal
representation by the Parties. The Steering Committee is responsible for
coordinating the key activities of Wyeth and the Company under the Collaboration
Agreement. The Development Committee is responsible for overseeing, coordinating
and expediting the development of RELISTOR by the Parties. In addition, a Joint
Commercialization Committee was established, composed of representatives of both
Wyeth and the Company in number and function according to each of their
responsibilities, which is responsible for facilitating open communication
between Wyeth and the Company on matters relating to the commercialization of
products.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
The Company has assessed the nature of its involvement with the Committees. The
Company’s involvement in the Steering and Development Committees is one of
several obligations to develop the subcutaneous and intravenous formulations of
RELISTOR through regulatory approval in the U.S. The Company has combined the
committee obligations with the other development obligations and is accounting
for these obligations during the development phase as a single unit of
accounting. After the development period, however, the Company has assessed the
nature of its involvement with the Committees to be a right, rather than an
obligation. The Company’s assessment is based upon the fact the Company
negotiated to be on the Committees as an accommodation for its granting of the
license for RELISTOR to Wyeth. Wyeth has been granted by the Company an
exclusive license (even as to the Company) to the technology and know-how
regarding RELISTOR and has been assigned the agreements for the manufacture of
RELISTOR by third parties. Following regulatory approval of the subcutaneous and
intravenous formulations of RELISTOR, Wyeth will continue to develop the oral
formulation and to commercialize all formulations, for which it is capable and
responsible. During those periods, the activities of the Committees will be
focused on Wyeth’s development and commercialization obligations.
Under the Collaboration Agreement,
Progenics granted to Wyeth an exclusive, worldwide license, even as to
Progenics, to develop and commercialize RELISTOR. Progenics is responsible for
developing the subcutaneous and intravenous formulations in the United States,
until the drug formulations receive regulatory approval. Progenics has
transferred to Wyeth all existing supply agreements with third parties for
RELISTOR and has sublicensed intellectual property rights to permit Wyeth
to manufacture or have manufactured RELISTOR, during the development and
commercialization phases of the Collaboration Agreement, in both bulk and
finished form for all products worldwide. Progenics has no further manufacturing
obligations under the Collaboration Agreement. Progenics has and will continue
to transfer to Wyeth all know-how, as defined, related to RELISTOR. Based upon
the Company’s research and development programs, such period will cease upon
completion of the Company’s development obligations under the Collaboration
Agreement.
Wyeth is developing the oral
formulation worldwide and the subcutaneous and intravenous formulations outside
the U.S. In the event the Joint Steering Committee approves any formulation of
RELISTOR other than subcutaneous, intravenous or oral or any other indication
for a product using any formulation of RELISTOR, Wyeth will be responsible for
development of such products, including conducting clinical trials and obtaining
and maintaining regulatory approval and the Company will receive royalties on
all sales of such products.
Wyeth is responsible for the
commercialization of the subcutaneous, intravenous and oral products, and any
other products developed upon approval by the Joint Steering Committee,
throughout the world. Wyeth will pay all costs of commercialization of all
products, including manufacturing costs, and will retain all proceeds from the
sale of the products, subject to the royalties payable by Wyeth to the Company.
Decisions with respect to commercialization of any products developed under the
Collaboration Agreement will be made solely by Wyeth.
Wyeth granted to Progenics an option
(the “Co-Promotion Option”) to enter into a Co-Promotion Agreement to co-promote
any of the products developed under the Collaboration Agreement, subject to
certain conditions. The extent of the Company’s co-promotion activities and the
fee that the Company will be paid by Wyeth for these activities will be
established if, as and when the Company exercises its option. Wyeth will record all
sales of products worldwide (including those sold by the Company, if any, under
a Co-Promotion Agreement). Wyeth may terminate any Co-Promotion Agreement if a
top 15 pharmaceutical company acquires control of Progenics. Progenics’
potential right to commercialize any product, including its Co-Promotion Option,
is not essential to the usefulness of the already delivered products or services
(i.e., Progenics’
development obligations) and Progenics’ failure to fulfill its co-promotion
obligations would not result in a full or partial refund of any payments made by
Wyeth to Progenics or reduce the consideration due to Progenics by Wyeth or give
Wyeth the right to reject the products or services previously delivered by
Progenics.
The
Company is recognizing revenue in connection with the Collaboration Agreement
under SAB 104 and will apply the Substantive Milestone Method (see Note 2). In
accordance with EITF 00-21, all of the Company’s deliverables under the
Collaboration Agreement, consisting of granting the license for RELISTOR,
transfer of supply contracts with third party manufacturers of RELISTOR,
transfer of know-how related to RELISTOR development and manufacturing, and
completion of development for the subcutaneous and intravenous formulations in
the U.S., represent one unit of accounting since none of those components have
standalone value to Wyeth prior to regulatory approval of at least one product;
that unit of accounting comprises the development phase, through regulatory
approval, for the subcutaneous and intravenous formulations in the
U.S.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
Within five business days of execution of the Collaboration Agreement, Wyeth
made a non-refundable, non-creditable upfront payment of $60 million, for which
the Company deferred revenue at December 31, 2005. Subsequently, the Company is
recognizing revenue related to the upfront license payment over the period
during which the performance obligations, noted above, are being performed using
the proportionate performance method. The Company expects that period to extend
through 2009. The Company is recognizing revenue using the proportionate
performance method since it can reasonably estimate the level of effort required
to complete its performance obligations under the Collaboration Agreement with
Wyeth and such performance obligations are provided on a best-efforts basis.
Full-time equivalents are being used as the measure of performance. Under the
proportionate performance method, revenue related to the upfront license payment
is recognized in any period as the percent of actual effort expended in that
period relative to expected total effort. The total effort expected is based
upon the most current budget and development plan which is approved by both the
Company and Wyeth and includes all of the performance obligations under the
arrangement. Significant judgment is required in determining the nature and
assignment of tasks to be accomplished by each of the parties and the level of
effort required for the Company to complete its performance obligations under
the arrangement. The nature and assignment of tasks to be performed by each
party involves the preparation, discussion and approval by the parties of a
development plan and budget. Since the Company has no obligation to develop the
subcutaneous and intravenous formulations of RELISTOR outside the U.S. or the
oral formulation at all and has no significant commercialization obligations for
any product, recognition of revenue for the upfront payment is not required
during those periods, if they extend beyond the period of the Company’s
development obligations. If Wyeth terminates the Collaboration Agreement in
accordance with its terms, the Company will recognize any unamortized remainder
of the upfront payment at the time of the termination.
The
amounts of the upfront license payment that the Company recognized as revenue
for each fiscal quarter prior to the third quarter of 2007 were based upon
several revised approved budgets, although the revisions to those budgets did
not materially affect
the amounts of revenue recognized in those periods. During the third quarter of
2007, however, the estimate of the Company’s total remaining effort to complete
its development obligations was increased significantly based upon a revised
development budget approved by both the Company and Wyeth. As a result, the
period over which the Company’s obligations will extend, and over which the
upfront payment will be amortized, was extended from the end of 2008 to the end
of 2009. Consequently, the amount of revenue recognized from the upfront payment
in the second half of 2007 declined relative to that in the comparable period of
2006.
Beginning in January 2006, costs
for the development of RELISTOR incurred by Wyeth or the Company are being paid
by Wyeth. Wyeth has the right once annually to engage an independent public
accounting firm to audit expenses for which the Company has been reimbursed
during the prior three years. If the accounting firm concludes that any such
expenses have been understated or overstated, a reconciliation will be made. The
Company is recognizing as research and development revenue from collaborator,
amounts received from Wyeth for reimbursement of the Company’s development
expenses for RELISTOR as incurred under the development plan agreed to between
the Company and Wyeth. In addition to the upfront payment and reimbursement of
the Company’s development costs, Wyeth has made or will make the following
payments to the Company: (i) development and sales milestones and contingent
payments, consisting of defined non-refundable, non-creditable payments,
totaling $356.5 million, including clinical and regulatory events and combined
annual worldwide net sales, as defined and (ii) sales royalties during each
calendar year during the royalty period, as defined, based on certain
percentages of net sales in the U.S. and worldwide. Upon achievement of defined
substantive development milestones by the Company for the subcutaneous and
intravenous formulations in the U.S., the milestone payments will be recognized
as revenue. Recognition of revenue for developmental contingent events related
to the subcutaneous and intravenous formulations outside the U.S. and for the
oral formulation, which are the responsibility of Wyeth, will be recognized as
revenue when Wyeth achieves those events, if they occur subsequent to completion
by the Company of its development obligations, since Progenics would have no
further obligations related to those products. Otherwise, if Wyeth achieves any
of those events before the Company has completed its development obligations,
recognition of revenue for the Wyeth contingent events will be recognized over
the period from the effective date of the Collaboration Agreement to the
completion of the Company’s development obligations. All sales milestones and
royalties will be recognized as revenue when earned.
During
the years ended December 31, 2006 and 2007, the Company recognized $18.8 million
and $16.4 million, respectively, of revenue from the $60 million upfront payment
and $34.6 million and $40.1 million, respectively, as reimbursement for its
out-of-pocket development costs, including its labor costs. In October 2006, the
Company earned a $5.0 million milestone payment in connection with the start of
a phase 3 clinical trial of intravenous RELISTOR for the treatment of
post-operative ileus, for which revenue was recognized in the fourth quarter of
2006. In March 2007, the Company earned $9.0 million in milestone payments upon
the submission and approval for review of applications for marketing in the U.S.
and European Union of the subcutaneous formulation of RELISTOR in patients
receiving palliative care.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
The
Company considered those milestones to be substantive based on the significant
degree of risk at the inception of the Collaboration Agreement related to the
conduct and successful completion of clinical trials and, therefore, of not
achieving the milestones; the amount of the payment received relative to the
significant costs incurred since inception of the Collaboration Agreement and
amount of effort expended to achieve the milestones; and the passage of ten and
seventeen months, respectively, from inception of the Collaboration Agreement to
the achievement of those milestones. Therefore, the Company recognized the
milestone payments as revenue in the respective periods in which the milestones
were earned. As of December 31, 2007, relative to the $60 million upfront
license payment received from Wyeth, the Company has recorded $15.7 million as
short-term deferred revenue and $9.1 million and long-term deferred revenue,
which is expected to be recognized as revenue through 2009. In addition, at
December 31, 2007, the Company recorded $2.1 million of short term deferred
revenue related to payments we have received from Wyeth for development
costs.
The Collaboration Agreement extends,
unless terminated earlier, on a country-by-country and product-by-product basis,
until the last to expire royalty period, as defined, for any product. Progenics
may terminate the Collaboration Agreement at any time upon 90 days of written
notice to Wyeth (30 days in the case of breach of a payment obligation) upon
material breach that is not cured. Wyeth may, with or without cause, following
the second anniversary of the first commercial sale, as defined, of the first
commercial product in the U.S., terminate the Collaboration Agreement by
providing Progenics with at least 360 days prior written notice of such
termination. Wyeth may also terminate the agreement (i) upon 30 days written
notice following one or more serious safety or efficacy issues that arise, as
defined, and (ii) at any time, upon 90 days written notice of a material breach
that is not cured by Progenics. Upon termination of the Collaboration Agreement,
the ownership of the license the Company granted to Wyeth will depend on the
party that initiates the termination and the reason for the
termination.
10.
Acquisition of Contractual Rights from Methylnaltrexone Licensors
In 2001,
Progenics entered into an exclusive sublicense agreement with UR Labs, Inc.
(“URL” or “UR Labs”) (see Note 11(b)(v)) to develop and commercialize
methylnaltrexone (the “Methylnaltrexone Sublicense”) in exchange for rights to
future payments resulting from this Sublicense. In 1989, URL obtained an
exclusive license to methylnaltrexone, as amended, from the University of
Chicago (“UC”) under an Option and License Agreement dated May 8, 1985, as
amended (the “URL-Chicago License”). In 2001, URL also entered into an agreement
with certain heirs of Dr. Leon Goldberg (the “Goldberg Distributees”), which
provided them with the right to receive payments based upon revenues received by
URL from the development of the Methylnaltrexone Sublicense (the “URL-Goldberg
Agreement”).
On December 22, 2005, Progenics and Progenics Nevada entered into an
Agreement and Plan of Reorganization (the “Purchase Agreement”) by and among
Progenics Pharmaceuticals, Inc., Progenics Pharmaceuticals Nevada, Inc., UR
Labs, Inc. and the shareholders of UR Labs, Inc. (the “URL Shareholders”), under
which Progenics Nevada acquired substantially all of the assets of
URL, comprised of its rights under the URL-Chicago License, the Methylnaltrexone
Sublicense and the URL-Goldberg Agreement, thus assuming URL’s rights and
responsibilities under those agreements and extinguishing Progenics’ obligation
to make royalty and other payments to URL.
On
December 22, 2005, Progenics and Progenics Nevada entered into an Assignment and
Assumption Agreement with the Goldberg Distributees, under which Progenics
Nevada assumed all rights and obligations of the Goldberg Distributees under
the
URL-Goldberg Agreement, thereby extinguishing URL’s (and consequentially, the
Company’s) obligations to make payments to the Goldberg Distributees. Although
the Company is no longer obligated to make payments to URL or the Goldberg
Distributees, the Company is required to make future payments to the University
of Chicago that would have been made by URL.
In
consideration for the assignment of the Goldberg Distributees’ rights and of the
acquisition of the assets of URL described above, Progenics issued, on December
22, 2005, a total of 686 shares of its common stock, with a fair value of $15.8
million, based on a closing price of the Company’s common stock of $23.09, and
paid a total of $2.6 million in cash (representing the opening market value,
$22.85 per share, of 114 shares of Progenics’ common stock on the date of the
acquisition) to the URL Shareholders and the Goldberg Distributees and paid $310
in transaction fees. The Company has registered for resale, using its best
efforts, a portion of the consideration, totaling 286 shares of its common
stock, with the Securities and Exchange Commission using the shelf registration
process.
The
Company accounted for the acquisition of the rights described above from the
licensors, the only asset acquired, as an asset purchase. The acquired rights
relate to the Methylnaltrexone Sublicense and the Company’s research and
development activities for methylnaltrexone, for which technological feasibility
has not yet been established, for which there is no identified alternative
future use and, which has not received regulatory approval for marketing.
Accordingly, the entire purchase price of $18.7 million was recorded as license
fees- research and development, as a separate line item in the Company’s 2005
Consolidated Statement of Operations.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
11.
Commitments and Contingencies
a.
Operating Leases
As of
December 31, 2007, the Company leases office and laboratory space, as
follows:
Leased
Space
|
|
Area
(Square Feet)
|
|
Base
Monthly Rent
|
|
Termination
Date
|
|
Other
Terms
|
|
|
|
|
|
|
|
|
|
Sublease
1
|
|
91.6
|
|
$140
|
|
December
30, 2009
|
|
|
Lease
1
|
|
32.6
|
|
$66
|
|
December
31, 2009
|
|
Renewable
for two five year terms
|
Sublease
2
|
|
5.9
|
|
$13
through June 30, 2010;
$15
through June 30, 2011;
$16
through June 29, 2012
|
|
June
29, 2012
|
|
Four
months rent-free beginning April 1, 2006; converts to Lease
2
|
Lease
2
|
|
|
|
$16
|
|
December
31, 2014
|
|
|
Lease
3
|
|
9.2
|
|
$12
through November 12, 2008; annual 3% increases thereafter
|
|
June
29, 2012
|
|
Three
months rent-free beginning August 13, 2007; renewable for two five year
terms; lease incentive of $276 provided by the landlord
|
Lease
4
|
|
6.5
|
|
$14
|
|
August
31, 2012
|
|
Renewable
for two terms coterminous with Lease 1
|
Total
|
|
145.8
|
|
|
|
|
|
|
Such
amounts are recognized as rent expense on a straight-line basis over the term of
the respective leases, including rent-free periods. In addition to rents due
under these agreements, the Company is obligated to pay additional facilities
charges, including utilities, taxes and operating expenses. The Company also
leases certain office equipment under non-cancelable operating leases, which
expire at various times through August 2009. At the inception of Lease 3, in
August 2007, the landlord agreed to pay $276 of leasehold improvements related
to the renovation of that office space. That lease incentive, which was
initially recorded as a debit to Fixed Assets - leasehold improvements and
credits to Other Current Liabilities of $57 and Other Liabilities of $219,
is being amortized as a reduction of rent expense on a straight-line basis over
the initial term of the lease.
As of
December 31, 2007, future minimum annual payments under all operating lease
agreements are as follows:
Years
ending December 31,
|
|
Minimum
Annual
Payments
|
2008
|
|
$3,136
|
2009
|
|
3,100
|
2010
|
|
504
|
2011
|
|
517
|
2012
|
|
391
|
Thereafter
|
|
388
|
Total
|
|
$8,036
|
Rental
expense totaled approximately $1,675, $1,694 and $2,415 for the years ended
December 31, 2005, 2006 and 2007, respectively. For the years ended December 31,
2005, 2006 and 2007, the Company recognized rent expense in excess of amounts
paid of $21, $74 and $38, respectively. Additional facility charges, including
utilities, taxes and operating expenses, for the years ended December 31, 2005,
2006 and 2007 were approximately $2,257, $2,932 and $2,974,
respectively.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
b.
Licensing, Service and Supply Agreements of Progenics Pharmaceuticals,
Inc.
The
Company has entered into a variety of intellectual property-based license and
service agreements in connection with its product development programs. During
2005, the Company also entered into a supply agreement for methylnaltrexone.
During 2006, the Company transferred that agreement and the obligation for the
manufacture of methylnaltrexone, in bulk and finished form, to Wyeth. In
connection with all the agreements discussed below, the Company has recognized
milestone, license and sublicense fees and supply costs, which are included in
research and development expenses, totaling approximately $22,375, $1,825 and
$350 for the years ended December 31, 2005, 2006 and 2007, respectively. In
addition, as of December 31, 2007, remaining payments, including amounts
accrued, associated with milestones and defined objectives as well as annual
maintenance fees with respect to the agreements referred to below total
approximately $20,832.
The
Company is a party to a license agreement with Columbia University under which
it obtained exclusive, worldwide rights to specified technology and materials
relating to CD4, an immune cell receptor. In general, the license agreement
terminates (unless
sooner terminated) upon the expiration of the last to expire of the licensed
patents, which is currently 2021; patent applications that the Company has also
licensed and patent term extensions may extend the period of its license rights,
when and if the patent applications are allowed and issued or patent term
extensions are granted.
The
Company’s license agreement requires it to achieve development milestones,
including filing for marketing approval of a drug by June 2001 and manufacturing
a drug for commercial distribution by June 2004. The Company has not achieved
either of these milestones due to delays that it believes could not have been
reasonably avoided and are reasonably beyond its control.
As of
December 31, 2006, the Company was obligated to pay Columbia a milestone fee of
$225 and four annual maintenance fees of $50 each, which had been accrued but
not paid, in accordance with an oral understanding that suspended its obligation
to make such payments until a time in the future to be agreed upon by the
parties. In addition, the Company was required to pay royalties based on the
sale of products it develops under the license, if any.
The
Company has had discussions with Columbia regarding the terms of an agreement
under which it would relinquish all rights related to the license agreement with
Columbia in exchange for making a one-time payment of $300, which was accrued at
December 31, 2007 and previously due milestone and maintenance fees as well as
future royalty payments would be cancelled. Those discussions have not yet
resulted in a formal agreement.
ii.
Sloan-Kettering Institute for Cancer Research
The
Company was party to a license agreement with Sloan-Kettering under which it
obtained the worldwide, exclusive rights to specified technology relating to
ganglioside conjugate vaccines, including GMK, and its use to treat or prevent
cancer. The license was terminated on February 15, 2008.
iii.
Aquila Biopharmaceuticals, Inc.
The
Company has entered into a license and supply agreement with Aquila
Biopharmaceuticals, Inc., a wholly owned subsidiary of Antigenics Inc.
(“Antigenics”), pursuant to which Aquila agreed to supply the Company with all
of its requirements for the QS-21™ adjuvant for use
in ganglioside-based cancer vaccines, including GMK, a program that the Company
terminated in development in the second quarter of 2007. QS-21 is the lead
compound in the Stimulon® family of
adjuvants developed and owned by Aquila. In general, the license agreement
terminates upon the expiration of the last to expire of the licensed patents,
unless sooner terminated. In the U.S. the licensed patent will expire in
2008.
The
Company’s license agreement requires it to achieve development milestones. The
agreement states that the Company is required to have filed for marketing
approval of a drug by 2001 and to commence the manufacture and distribution of a
drug by 2003. The Company has not achieved these milestones due to delays that
it believes could not have been reasonably avoided. The Company believes that
these delays satisfy the criteria for a revision, contemplated by the agreement,
of the milestone dates. Aquila has not consented to a revision of the milestone
dates as of this time.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
The
Company has the right to terminate the agreement without cause upon 90 days
prior written notice, with the obligation to pay only those liabilities that
have accrued prior to such termination. In the event of a default by one party,
the agreement may also be terminated, after an opportunity to cure, by
non-defaulting party upon 60 days prior written notice.
The
Company has received a written communication from Antigenics alleging that
Progenics is in default of certain of its obligations under the license
agreement and asserting that Antigenics has an interest in certain intellectual
property of Progenics. Progenics
has responded in writing denying Antigenics’ allegations. The Company does not
believe that this dispute will have any material effect on it.
iv.
Development and License Agreement with PDL BioPharma, Inc. (formerly, Protein
Design Labs, Inc.)
The
Company has entered into a development and license agreement with PDL BioPharma,
Inc., or PDL, for the humanization by PDL of PRO 140. Pursuant to the agreement,
PDL granted the Company exclusive and nonexclusive worldwide licenses
under patents, patent applications and know-how relating to the humanized PRO
140. In general, the license agreement terminates on the later of 10 years from
the first commercial sale of a product developed under the agreement or the last
date on which there is an unexpired patent or a patent application that has been
pending for less than ten years, unless sooner terminated. Thereafter the
license is fully paid. The last of the currently issued patents expires in 2014;
patent applications filed in the U.S. and internationally that the Company has
also licensed and patent term extensions may extend the period of our license
rights when and if such patent applications are allowed and issued or patent
term extensions are granted. The Company has the right to terminate the
agreement without cause upon 60 days prior written notice. In the event of a
default by one party, the agreement may also be terminated, after an opportunity
to cure, by non-defaulting party upon 30 days prior written notice.
v.
UR Labs, Inc./ University of Chicago
In 2001,
the Company entered into an agreement with UR Labs to obtain worldwide exclusive
rights to intellectual property rights related to methylnaltrexone. UR
Labs had exclusively licensed methylnaltrexone from
the University of Chicago. In consideration for the license, the Company paid a
nonrefundable, noncreditable license fee and was obligated to make additional
payments upon the occurrence of defined milestones. On December 22, 2005, the
Company entered into a series of agreements with UR Labs, which extinguished
Progenics’ obligation to make royalty and other payments to UR Labs (see Note
10). The Company is responsible to make certain payments to the University of
Chicago, associated with the RELISTOR product development and commercialization
program, which would have been made by UR Labs. In addition, during 2006 and
2007, the Company entered into two agreements with the University of Chicago
which give the Company options to license certain of the University of Chicago’s
intellectual property over defined option periods.
vi.
Hoffmann-LaRoche
On December 23, 1997, the Company
entered into an agreement (the “Roche Agreement”) to conduct a research
collaboration with F. Hoffmann-LaRoche Ltd and Hoffmann-LaRoche, Inc.
(collectively “Roche”) to identify novel HIV therapeutics (the “Compound”). The
Roche Agreement granted to Roche an exclusive worldwide license to use certain
of the Company’s intellectual property rights related to HIV to develop, make,
use and sell products resulting from the collaboration.
In March
2002, Roche exercised its right to discontinue funding the research being
conducted under the Roche Agreement. Discussions between Roche and the Company
resulted in an agreement by which the Company gained the exclusive rights to
develop and market the Compound, as defined. Roche is entitled to receive
certain milestone payments and royalties, as defined, provided Roche has not
elected its option to resume joint development and commercialization of the
Compound. As of December 31, 2007, Roche had not elected to resume its
option.
vii.
Cornell Research Foundation
The
Company is party to an Exclusive License Agreement with Cornell Research
Foundation, Inc. (“Cornell”) regarding a patent application (the “Patent”) which
is jointly owned by the Company and Cornell involving HIV. Under the agreement,
Cornell granted to the Company an exclusive worldwide license to Cornell’s
rights in the Patent and in further inventions and patents arising from research
and development conducted by the Company or its sublicensees under the
agreement. In consideration for Cornell granting the Exclusive License, the
Company paid an upfront license fee and a minimum royalty payment and will make
defined future annual minimum royalty payments, milestone payments upon the
achievement of certain defined development and regulatory events and will pay
royalties on net sales, as defined of products arising from the Exclusive
License. If not terminated earlier, the agreement terminates upon the expiration
of the last valid claim, as defined, covering a product. Thereafter, the license
is fully-paid and royalty-free. Cornell may terminate the agreement if the
Company is in default of contractual payments or is in material breach of the
agreement that is not cured within 30 days of written notice. The Company may
terminate the agreement at any time upon 60 days written
notice.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
viii.
Mallinckrodt Inc.
In March
2005, the Company entered into an agreement with Mallinckrodt Inc. for the
supply of the bulk form of methylnaltrexone. The contract provided for
Mallinckrodt to supply product based on a rolling forecast to be provided by the
Company to Mallinckrodt with respect to the Company’s anticipated needs and for
the Company’s purchase of product on specified pricing terms. In connection with
the Company’s Collaboration Agreement with Wyeth (see Note 9), during
2006 the Company
transferred its agreement with Mallinckrodt and the obligation for the
manufacture of methylnaltrexone, in bulk and finished form, to
Wyeth.
ix.
KMT Hepatech, Inc.
On
October 11, 2006, the Company and KMT Hepatech, Inc. (“KMT”) entered into a
Research Services Agreement, under which KMT will test compounds (“Compounds”),
as defined, related to the Company’s Hepatitis C Virus research program. In
consideration for KMT’s services, the Company made an upfront payment for
certain defined services, will reimburse KMT for direct costs incurred by KMT in
rendering the services and will make additional payments upon the Company’s
request for additional services. The Company will also make one-time development
milestone payments upon the occurrence of defined events in respect of any
Compound. In the event that the Company terminates development of a Compound,
certain of those development milestone payments will be credited to the
development milestones achieved by the next Compound. The KMT agreement will
terminate upon its second anniversary unless terminated sooner. The parties may
extend the term of the KMT agreement by mutual written consent. Either party may
terminate the KMT agreement upon 60 days of written notice to the other party.
In the event of an uncured default by either party, including non-performance,
bankruptcy or liquidation or dissolution, the non-defaulting party may terminate
the KMT agreement upon 30 days written notice.
c.
Licensing and Collaboration Agreements of PSMA Development Company
LLC
In
connection with all the agreements discussed below, PSMA LLC, which became the
Company’s wholly owned subsidiary on April 20, 2006 (see Note 12c) has
recognized milestone, license and annual maintenance fees, which are included in
research and development expenses of PSMA LLC, totaling approximately $2,100,
$200 and $600 for the years ended December
31, 2005, 2006 and 2007, respectively. In addition, in connection with the
Company’s acquisition of Cytogen’s interest in PSMA LLC (see Note 12c), Cytogen
granted an exclusive license to PSMA LLC, under which PSMA LLC recognized $25
and $38 in license fees for the years ended December 31, 2006 and 2007,
respectively. As of December 31, 2007, remaining payments associated with
milestones and defined objectives with respect to the agreements referred to
below, as well as with respect to the license granted by Cytogen to PSMA LLC,
total approximately $78.4 million.
i. Amgen Fremont, Inc. (formerly Abgenix)
In
February 2001, PSMA LLC entered into a worldwide exclusive licensing agreement
with Abgenix to use its XenoMouse™ technology for generating fully human
antibodies to PSMA LLC’s proprietary PSMA antigen. In consideration for the
license, PSMA LLC paid a nonrefundable, non-creditable license fee and is
obligated to make additional payments upon the occurrence
of defined milestones associated with the development and commercialization
program for products incorporating an antibody generated utilizing the XenoMouse
technology. This agreement may be terminated, after an opportunity to cure, by
Abgenix for cause upon 30 days prior written notice. PSMA LLC has the right to
terminate this agreement upon 30 days prior written notice. If not terminated
early, this agreement continues until the later of the expiration of the
XenoMouse technology patents that may result from pending patent applications or
seven years from the first commercial sale of the products.
ii. AlphaVax Human Vaccines
In
September 2001, PSMA LLC entered into a worldwide exclusive license agreement
with AlphaVax Human Vaccines to use the AlphaVax Replicon Vector system to
create a therapeutic prostate cancer vaccine incorporating PSMA LLC ’s
proprietary PSMA antigen. In consideration for the license, PSMA LLC paid a
nonrefundable, noncreditable license fee and is obligated to make additional
payments upon the occurrence of certain defined milestones associated with the
development and commercialization program for products incorporating AlphaVax’s
system. This agreement may be terminated, after an opportunity to cure, by
AlphaVax under specified circumstances that include PSMA LLC ’s failure to
achieve milestones; the consent of AlphaVax to revisions to the milestones due
dates may not, however, be unreasonably withheld. PSMA LLC has the right to
terminate the agreement upon 30 days prior written notice. If not terminated
early, this agreement continues until the later of the expiration of the patents
relating to AlphaVax’s system or seven years from the first commercial sale of
the products developed using AlphaVax’s system. The last of the currently issued
patents expire in 2015; patent applications filed in the U.S. and
internationally that PSMA LLC has also licensed and patent term extensions may
extend the period of PSMA LLC’s license rights, when and if such patent
applications are allowed and issued or patent term extensions are
granted.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise noted)
iii. Seattle Genetics, Inc.
In June
2005, PSMA LLC entered into a collaboration agreement with Seattle Genetics,
Inc. (“SGI”). Under this agreement, SGI provided an exclusive worldwide license
to its proprietary antibody-drug conjugate technology (the “ADC Technology”) to
PSMA LLC. Under the license, PSMA LLC has the right to use the ADC Technology to
link cell-killing drugs to PSMA LLC’s monoclonal antibodies that target
prostate-specific membrane antigen. During the initial research term of the
agreement, SGI also is required to provide technical information to PSMA LLC
related to implementation of the licensed technology, which period may be
extended for an additional period upon payment of an additional fee. PSMA LLC
may replace prostate-specific membrane antigen with another antigen, subject to
certain restrictions, upon payment of an antigen replacement fee. The ADC
Technology is based, in part, on technology licensed by SGI from third parties.
PSMA LLC is responsible for research, product development, manufacturing and
commercialization of all products under the SGI agreement. PSMA LLC may
sublicense the ADC Technology to a third party to manufacture the ADC’s for both
research and commercial use. PSMA LLC made a technology access payment to SGI
upon execution of the SGI agreement and will make additional maintenance
payments during its term. In addition, PSMA LLC will make payments upon the
achievement of certain defined milestones and will pay royalties to SGI and its
licensors, as applicable, on a percentage of net sales, as defined. In the event
that SGI provides materials or services to PSMA LLC under the SGI agreement, SGI
will receive supply and/or labor cost payments from PSMA LLC at agreed-upon
rates. The SGI agreement terminates at the latest of (i) the tenth anniversary
of the first commercial sale of each licensed product in each country or (ii)
the latest date of expiration of patents underlying the licensed products. PSMA
LLC may terminate the SGI agreement upon advance written notice to SGI. SGI may
terminate the agreement if PSMA LLC breaches an SGI in-license that is not cured
within a specified time period after written notice. In addition, either party
may terminate the SGI agreement upon breach by the other party that is not cured
within a specified time period after written notice or in the event of
bankruptcy of the other party.
d.
Consulting Agreements
As part
of the Company’s research and development efforts, it enters into consulting
agreements with external scientific specialists (“Scientists”). These agreements
contain various terms and provisions, including fees to be paid by the Company
and royalties, in the event of future sales, and milestone payments, upon
achievement of defined events, payable by the Company. Certain Scientists are
members of the Company’s Scientific Advisory Board (the “SAB Members”),
including Stephen P. Goff, Ph.D. and David A. Scheinberg, M.D., Ph.D., both of
whom are also members of the Company’s Board of Directors. Some Scientists have
purchased Common Stock or received stock options which are subject to vesting
provisions. The Company has recognized expenses with regard to the consulting
agreements of the SAB Members totaling approximately $877, $893 and $1,092 for
the years ended December 31, 2005, 2006 and 2007, respectively. Those expenses
include the fair value of stock options granted during 2005, 2006 and 2007,
which were fully vested at grant date, of approximately $640, $620 and $691,
respectively. For the year ended December 31, 2007, those expenses include a
portion of restricted stock, granted in 2007, that vested in 2007, of
approximately $127. Such amounts of fair value are included in research and
development compensation expense for each year presented (see Note
3).
12.
PSMA Development Company LLC
a. Introduction
PSMA
LLC was formed on June 15, 1999 as a joint venture between the Company and
Cytogen (each a “Member” and collectively,
the “Members”) for the purposes of conducting research, development,
manufacturing and marketing of products related
to prostate-specific membrane antigen (“PSMA”). Prior to the Company’s
acquisition of Cytogen’s membership interest (see below), each Member had equal
ownership and equal representation on PSMA LLC’s management committee and equal
voting rights and rights to profits and losses of PSMA LLC. In connection with
the formation of PSMA LLC, the Members entered into a series of agreements,
including an LLC Agreement and a Licensing Agreement (collectively, the
“Agreements”), which generally defined the rights and obligations of each
Member, including the obligations of the Members with respect to capital
contributions
and funding of research and development of PSMA LLC for each coming
year.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
b. Research
and Development Revenue from PSMA LLC
Amounts
received by the Company from PSMA LLC, during the year ended December 31, 2005,
as payment for research and development services performed by the Company on
behalf of PSMA LLC , and reimbursement of related costs in excess of the initial
$3.0 million provided by the Company were recognized as research and development
revenue. For the year ended December 31, 2005, such amount totaled approximately
$1.0 million. According to the Agreements, the Company was allowed
to directly pursue and obtain government grants directed to the conduct of
research utilizing PSMA related technologies. In consideration of the Company’s
initial incremental capital contribution of $3.0 million of joint venture
research expenditures, the Company was permitted to retain $3.0 million of such
government grant funding. To the extent that the Company retained grant
revenue in respect of work for which it had also been compensated by PSMA LLC,
the remainder of the $3.0 million to be retained by the Company was reduced and
the Company recorded an adjustment in its financial statements to reduce both
joint venture losses and contract revenue from PSMA LLC. Such adjustment was
$1,311 for the year ended December 31, 2005 and $3.0 million cumulatively
through December 31, 2005. During 2006, prior to the acquisition by the Company
of Cytogen’s membership interest in PSMA LLC on April 20, 2006 (see below), the
Members had not approved a work plan or budget for 2006 and, therefore, the
Company was not reimbursed for its services to PSMA LLC and did not recognize
revenue from PSMA LLC. Subsequent to the acquisition, PSMA LLC has become the
Company’s wholly owned subsidiary.
c.
Acquisition of Cytogen’s Membership Interest
On
April 20, 2006, the
Company acquired Cytogen’s 50% membership interest in PSMA LLC, including
Cytogen’s economic interests in capital, profits, losses and distributions of
PSMA LLC and its voting rights, in exchange for a cash payment of $13.2
million (the “Acquisition”). The Company also paid $259 in transaction
costs related to the Acquisition. In connection with the Acquisition, the
Licensing Agreement entered into by the Members upon the formation of PSMA LLC,
under which Cytogen had granted a license to PSMA LLC for certain PSMA-related
intellectual property, was amended. Prior to the Acquisition, each of
the
Members owned 50% of the rights to such intellectual property through their
interests in PSMA LLC. Under the amended License Agreement, Cytogen granted an
exclusive, even as to Cytogen, worldwide license to PSMA LLC to use certain
PSMA-related
intellectual property in a defined field (the “Amended License Agreement”). In
addition, under the terms of the Amended License Agreement, PSMA LLC will pay to
Cytogen upon the achievement of certain defined regulatory and sales milestones,
if ever, amounts totaling $52 million, and will pay royalties, if ever, on net
sales, as defined. Since the likelihood of such payments was
remote at the date of the Acquisition, given that PSMA LLC’s research projects
were in the pre-clinical phase at that time, such amounts, if any, in the future
will be recorded as an additional expense when the contingency is resolved and
consideration becomes
issuable.
Subsequent
to the Acquisition, PSMA LLC has continued as a wholly owned subsidiary of
Progenics. Cytogen has no further involvement or obligations in PSMA LLC or in
the PSMA-related research and development conducted by Progenics. The Company no
longer recognizes revenue from PSMA LLC or Loss in Joint Venture.
Prior to the Acquisition, PSMA LLC’s
intellectual property, which was equally owned by each of the Members, was used
in two research and development programs, a vaccine program and a monoclonal
antibody program, both of which were in the pre-clinical or early clinical
phases of development at the time of the Acquisition. Progenics conducted most
of the research and development for those two programs prior to the Acquisition
and, subsequent to the Acquisition, is continuing those research and development
activities and will incur all the expenses of those programs.
Since the acquired intellectual
property and license rights relate to research and development projects that, at
the acquisition date, had not reached technological feasibility, did not have an
identified alternative future use and had not received regulatory approval from
the FDA for marketing, at the acquisition date the Company
charged $13,209 to research and development expense after consideration of
the transaction costs and net tangible assets acquired.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
13.
Employee Savings Plan
The
terms of the amended and restated Progenics Pharmaceuticals 401(k) Plan (the
“Amended Plan”), among other things, allow eligible employees to participate in
the Amended Plan by electing to contribute to the Amended Plan a percentage of
their compensation to be set aside to pay their future retirement benefits. The
Company has agreed to match 100% of those employee contributions that are equal
to 5%-8% of compensation and are made by eligible employees to the Amended Plan
(the “Matching Contribution”). In addition, the Company may also make a
discretionary contribution each year on behalf of all participants who are
non-highly compensated employees. The Company made Matching Contributions of
approximately $875, $1,135
and $1,538 to the Amended Plan for the years ended December 31, 2005, 2006 and
2007, respectively. No discretionary contributions were made during those
years.
14.
Income Taxes
The
Company accounts for income taxes using the liability method in accordance with
Statement of Financial Accounting Standards No. 109 (“SFAS 109”) “Accounting for
Income Taxes.” Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes.
There is
no provision or benefit for federal or state income taxes for the years ended
December 31, 2006 or 2007. For the year ended December 31, 2005, although the
Company had a pre-tax net loss of $69.2 million, it had taxable income due
primarily to the $60 million upfront payment received from Wyeth (see Note 9)
and the $18.4 million cash and common stock paid to UR Labs and the Goldberg
Distributees (see Note 10), which were treated differently for book and tax
purposes. For book purposes, payments made to UR Labs and the Goldberg
Distributees were expensed in the period the payments were made. For tax
purposes, however, the UR Labs transaction was a tax-free reorganization and
will never result in a deduction for tax purposes and the payments to the
Goldberg Distributees have been capitalized as an intangible license asset and
will be deducted for tax purposes over a
fifteen year period. For book purposes, the Company deferred recognition of
revenue for the $60 million at December 31, 2005 and is recognizing revenue for
that amount over the development period for RELISTOR (expected through the end
of 2009). For tax purposes, since cash was received, the $60 million was
included in taxable income in 2005.
The
Company has completed a calculation, under Internal Revenue Code Section 382,
the results of which indicate that past ownership changes will limit utilization
of net operating loss carry-forwards (“NOL’s”) in the future. However, the
Company had sufficient NOL’s at December 31, 2005 to fully offset 2005 taxable
income. The Company, therefore, recognized an income
tax provision for the effect of the Federal and state alternative minimum tax at
December 31, 2005. Future ownership changes may further limit the future
utilization of net operating loss and tax credit carry-forwards as defined by
the federal and state tax codes.
Deferred
tax assets consist of the following:
|
|
December
31,
|
|
|
|
2006
|
|
|
2007
|
|
Depreciation
and amortization
|
|
$ |
6,030 |
|
|
$ |
5,912 |
|
R&E
tax credit carry-forwards
|
|
|
5,417 |
|
|
|
8,203 |
|
AMT
credit carry-forwards
|
|
|
306 |
|
|
|
306 |
|
Net
operating loss carry-forwards
|
|
|
55,882 |
|
|
|
73,792 |
|
Deferred
revenue
|
|
|
17,171 |
|
|
|
10,632 |
|
Stock
compensation
|
|
|
4,162 |
|
|
|
8,155 |
|
Other
items
|
|
|
2,930 |
|
|
|
2,713 |
|
|
|
|
91,898 |
|
|
|
109,713 |
|
Valuation
allowance
|
|
|
(91,898 |
) |
|
|
(109,713 |
) |
|
|
$ |
— |
|
|
$ |
— |
|
The
Company does not recognize deferred tax assets considering its history of
taxable losses and the uncertainty regarding the Company’s ability to generate
sufficient taxable income in the future to utilize these deferred tax
assets. The increase in the valuation allowance resulted primarily from the
additional net operating loss carry-forwards.
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
The
following is a reconciliation of income taxes computed at the Federal statutory
income tax rate to the actual effective income tax provision:
|
|
Year
Ended December 31,
|
|
|
2005
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
U.S.
Federal statutory rate
|
|
(34.0)%
|
|
(34.0)%
|
|
(34.0)%
|
State
income taxes, net of Federal benefit
|
|
(4.9)
|
|
(5.8)
|
|
(5.6)
|
Research
and experimental tax credit
|
|
(1.0)
|
|
(6.4)
|
|
(4.2)
|
UR
Labs license purchase
|
|
5.7
|
|
|
|
|
Change
in valuation allowance
|
|
34.4
|
|
43.1
|
|
40.8
|
Other
|
|
|
|
3.1
|
|
3.0
|
Income
tax provision
|
|
0.2%
|
|
0.0%
|
|
0.0%
|
As of
December 31, 2007, the Company had available, for tax return purposes, unused
NOL’s of approximately $204.6 million, which will expire in various years from
2018 to 2027, $18.2 million of which were generated from deductions that, when
realized, will reduce taxes payable and will increase
paid-in-capital.
The
Company has reviewed its nexus in various tax jurisdictions and its tax
positions related to all open tax years for events that could change the status
of its FIN 48 liability, if any, or require an additional liability to be
recorded. Such events may be the resolution of issues raised by a taxing
authority, expiration of the statute of limitations for a prior open tax year or
new transactions for which a tax position may be deemed to be uncertain. Upon
adoption of FIN 48 on January 1, 2007 and during the year ended December 31,
2007, the Company had no unrecognized tax benefits resulting from tax positions
during a prior or current period, settlements with taxing authorities or the
expiration of the applicable statute of limitations. As of the date of adoption
and at December 31, 2007, there were no amounts of unrecognized tax benefits
that, if recognized, would affect the effective tax rate and there were no tax
positions for which it is reasonably possible that the total amounts of
unrecognized tax benefits will significantly increase or decrease within twelve
months from the respective date. As of December 31, 2007, the Company is subject
to federal and state income tax in the United States. Open tax years relate
to years in which unused net operating losses were generated or, if used, for
which the statute of limitation for examination by taxing authorities has
not expired. Thus, upon adoption of FIN 48 and at December 31, 2007, the
Company’s open tax years extend back to 1995, with the exception of 1997, during
which the Company reported net income. No amounts of interest or penalties were
recognized in the Company’s Consolidated Statements of Operations or
Consolidated Balance Sheets upon adoption of FIN 48 or as of and for the year
ended December 31, 2007.
In
connection with the Company’s adoption of SFAS No. 123(R) on January 1, 2006
(see Note 3), the Company elected to implement the short cut method of
calculating its pool of windfall tax benefits. Accordingly, the Company’s pool
of windfall tax benefits on January 1, 2006 was zero because it had NOL’s since
inception and, therefore, had never recognized any net increases in additional
paid-in capital in the Company’s annual financial statements related to tax
benefits from stock-based employee compensation during fiscal periods subsequent
to the adoption of SFAS No.123 but prior to the adoption of SFAS
No.123(R).
The
Company’s research and experimental (“R&E”) tax credit carry-forwards of
approximately $8.2 million at December 31, 2007 expire in various years from
2008 to 2027. During the year ended December 31, 2007, research and experimental
tax credit carry-forwards of approximately $23 expired.
15.
Net Loss Per Share
The
Company’s basic net loss per share amounts have been computed by dividing net
loss by the weighted-average number of common shares outstanding during the
period. For the years ended December 31, 2005, 2006 and 2007, the Company
reported a net loss and, therefore, potential common shares were not included
since such inclusion would have been anti-dilutive. The calculations of net loss
per share, basic and diluted, are as follows:
PROGENICS PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS ¾ continued
(amounts
in thousands, except per share amounts or unless otherwise
noted)
|
|
Net
Loss
(Numerator)
|
|
|
Weighted
Average
Common
Shares
(Denominator)
|
|
|
Per
Share
Amount
|
|
2005:
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(69,429 |
) |
|
|
20,864 |
|
|
$ |
(3.33 |
) |
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(21,618 |
) |
|
|
25,669 |
|
|
$ |
(0.84 |
) |
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(43,688 |
) |
|
|
27,378 |
|
|
$ |
(1.60 |
) |
For the
years ended December 31, 2005, 2006 and 2007, potential common shares which have
been excluded from diluted per share amounts because their effect would have
been anti-dilutive include the following:
|
|
Years Ended
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
|
Weighted
Average
Number
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Number
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Number
|
|
|
Weighted
Average
Exercise
Price
|
|
Options
and warrants
|
|
|
4,640 |
|
|
$ |
13.08 |
|
|
|
4,663 |
|
|
$ |
15.13 |
|
|
|
4,703 |
|
|
$ |
17.56 |
|
Restricted
stock
|
|
|
204 |
|
|
|
|
|
|
|
312 |
|
|
|
|
|
|
|
454 |
|
|
|
|
|
Total
|
|
|
4,844 |
|
|
|
|
|
|
|
4,975 |
|
|
|
|
|
|
|
5,157 |
|
|
|
|
|
16.
Unaudited Quarterly Results
Summarized
quarterly financial data for the years ended December 31, 2006 and 2007 are as
follows:
|
|
Quarter
Ended
March
31,
2006
(unaudited)
|
|
|
Quarter
Ended
June
30,
2006
(unaudited)
|
|
|
Quarter
Ended
September
30,
2006
(unaudited)
|
|
|
Quarter
Ended
December
31,
2006
(unaudited)
|
|
Revenue
|
|
$ |
11,001 |
|
|
$ |
19,122 |
|
|
$ |
17,848 |
|
|
$ |
21,935 |
|
Net
loss
|
|
|
(2,643 |
) |
|
|
(14,328 |
) |
|
|
(2,935 |
) |
|
|
(1,712 |
) |
Net
loss per share (basic and diluted)
|
|
|
(0.10 |
) |
|
|
(0.56 |
) |
|
|
(0.11 |
) |
|
|
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended
March
31,
2007
(unaudited)
|
|
|
Quarter
Ended
June
30,
2007
(unaudited)
|
|
|
Quarter
Ended
September 30,
2007
(unaudited)
|
|
|
Quarter
Ended
December
31,
2007
(unaudited)
|
|
Revenue
|
|
$ |
17,637 |
|
|
$ |
25,457 |
|
|
$ |
17,018 |
|
|
$ |
15,534 |
|
Net
loss
|
|
|
(10,433 |
) |
|
|
(2,383 |
) |
|
|
(15,600 |
) |
|
|
(15,272 |
) |
Net
loss per share (basic and diluted)
|
|
|
(0.40 |
) |
|
|
(0.09 |
) |
|
|
(0.58 |
) |
|
|
(0.53 |
) |
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
|
PROGENICS
PHARMACEUTICALS, INC.
|
|
By:
|
/s/
PAUL J. MADDON, M.D., PH.D.
|
|
|
Paul
J. Maddon, M.D., Ph.D.
(Duly
authorized officer of the
Registrant
and Chief Executive Officer, Chief Science Officer and
Director)
|
Date:
March 17, 2008
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant in the
capacities and on the dates indicated.
Signature
|
|
Capacity
|
Date
|
/s/
KURT W. BRINER
|
|
Co-Chairman
|
March 17,
2008
|
Kurt
W. Briner
|
|
|
|
/s/
PAUL F. JACOBSON
|
|
Co-Chairman
|
March 17,
2008
|
Paul
F. Jacobson
|
|
|
|
/s/
PAUL J. MADDON, M.D., PH.D.
|
|
Chief
Executive Officer, Chief Science
|
March 17,
2008
|
Paul
J. Maddon, M.D., Ph.D.
|
|
Officer
and Director (Principal Executive Officer)
|
|
/s/
CHARLES A. BAKER
|
|
Director
|
March 17,
2008
|
Charles
A. Baker
|
|
|
|
/s/
MARK F. DALTON
|
|
Director
|
March 17,
2008
|
Mark
F. Dalton
|
|
|
|
/s/
STEPHEN P. GOFF, PH.D.
|
|
Director
|
March 17,
2008
|
Stephen
P. Goff, Ph.D.
|
|
|
|
/s/
DAVID A. SCHEINBERG, M.D., PH.D.
|
|
Director
|
March 17,
2008
|
David
A. Scheinberg, M.D., Ph.D.
|
|
|
|
/s/
NICOLE S. WILLIAMS
|
|
Director
|
March
17, 2008
|
Nicole
S. Williams
|
|
|
|
/s/
ROBERT A. MCKINNEY, CPA
|
|
Chief
Financial Officer, Senior Vice President,
|
March 17,
2008
|
Robert
A. McKinney, CPA
|
|
Finance
& Operations and Treasurer
|
|
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
Exhibit
|
|
|
Number
*
|
|
Description
|
3.1(14)
|
|
Restated
Certificate of Incorporation of the Registrant.
|
3.2(14)
|
|
Amended
and Restated By-laws of the Registrant.
|
4.1(1)
|
|
Specimen
Certificate for Common Stock, $0.0013 par value per share, of the
Registrant.
|
10.1(1)
|
|
Form
of Registration Rights Agreement.
|
10.2(1)
|
|
1989
Non-Qualified Stock Option Plan‡
|
10.3(1)
|
|
1993
Stock Option Plan, as amended‡
|
10.4(1)
|
|
1993
Executive Stock Option Plan‡
|
10.5(3)
|
|
Amended
and Restated 1996 Stock Incentive Plan‡
|
10.6(14)
|
|
2005
Stock Incentive Plan‡
|
10.6.1(10)
|
|
Form
of Non-Qualified Stock Option Award Agreement‡
|
10.6.2(10)
|
|
Form
of Restricted Stock Award Agreement‡
|
10.6.3(16)
|
|
Amended
2005 Stock Incentive Plan ‡
|
10.7(15)
|
|
Form
of Indemnification Agreement‡
|
10.8
|
|
Employment
Agreement, dated December 31, 2007, between the Registrant and
Dr. Paul J. Maddon‡
|
10.9(1)
|
|
Letter
dated August 25, 1994 between the Registrant and Dr. Robert J.
Israel‡
|
10.10(8)
|
|
Amended
1998 Employee Stock Purchase Plan‡
|
10.11(8)
|
|
Amended
1998 Non-qualified Employee Stock Purchase Plan‡
|
10.13(1)†
|
|
QS-21
License and Supply Agreement, dated August 31, 1995, between the
Registrant and Cambridge Biotech Corporation, a wholly owned subsidiary of
bioMerieux, Inc.
|
10.14(1)†
|
|
License
Agreement, dated March 1, 1989, between the Registrant and the
Trustees of Columbia University, as amended by a Letter Agreement dated
March 1, 1989 and as amended by a Letter Agreement dated
October 22, 1996.
|
10.15(5)
|
|
Amended
and Restated Sublease, dated June 6, 2000, between the Registrant and
Crompton Corporation.
|
10.16(2)†
|
|
Development
and License Agreements, dated April 30, 1999, between Protein Design
Labs, Inc. and the Registrant.
|
10.16.1(11)
|
|
Letter
Agreement, dated November 24, 2003, relating to the Development and
License Agreement between Protein Design Labs, Inc. and the
Registrant.
|
10.17(2)†
|
|
PSMA/PSMP
License Agreement dated June 15, 1999, by and among the Registrant,
Cytogen Corporation and PSMA Development Company LLC
|
10.18(4)
|
|
Director
Stock Option Plan‡
|
10.19(6)†
|
|
Exclusive
Sublicense Agreement, dated September 21, 2001, between the
Registrant and UR Labs, Inc.
|
10.19.1(9)
|
|
Amendment
to Exclusive Sublicense Agreement, dated September 21, 2001, between
the Registrant and UR Labs, Inc.
|
10.20(7)
|
|
Research
and Development Contract, dated September 26, 2003, between the
National Institutes of Health and the Registrant.
|
10.21(7)
|
|
Agreement
of Lease, dated September 30, 2003, between Eastview Holdings LLC and
the Registrant.
|
10.22(7)
|
|
Letter
Agreement, dated October 23, 2003, amending Agreement of Lease
between Eastview Holdings LLC and the Registrant.
|
10.23(11)
|
|
Summary
of Non-Employee Director Compensation‡
|
10.24(12)
†
|
|
License
and Co-Development Agreement, dated December 23, 2005, by and among
Wyeth, acting through Wyeth Pharmaceuticals Division, Wyeth-Whitehall
Pharmaceuticals, Inc. and Wyeth-Ayerst Lederle, Inc. and the Registrant
and Progenics Pharmaceuticals Nevada, Inc.
|
10.25(12)
†
|
|
Option
and License Agreement, dated May 8, 1985, by and between the
University of Chicago and UR Labs, Inc., as amended by the Amendment to
Option and License Agreement, dated September 17, 2005, by and
between the University of Chicago and UR Labs, Inc., by the Second
Amendment to Option and License Agreement, dated March 3, 1989, by
and among the University of Chicago, ARCH Development Corporation and UR
Labs, Inc. and by the Letter Agreement Related to Progenics’ RELISTOR
In-License dated, December 22, 2005, by and among the University of
Chicago, acting on behalf of itself and ARCH Development Corporation, the
Registrant, Progenics Pharmaceuticals Nevada, Inc. and Wyeth, acting
through its Wyeth Pharmaceuticals Division.
|
10.26(13)
|
|
Membership
Interest Purchase Agreement, dated April 20, 2006, between the
Registrant Inc. and Cytogen Corporation.
|
10.27(13)
†
|
|
Amended
and Restated PSMA/PSMP License Agreement, dated April 20, 2006, by
and among the Registrant, Cytogen Corporation and PSMA Development Company
LLC.
|
10.28(17)
|
|
Consulting
Agreement, dated May 1, 1995, between Active Biotherapies, Inc. and
Dr. David A. Scheinberg, M.D., Ph.D., as amended on June 13,
1995, as assigned to the Registrant, and as amended on January 1,
2001‡
|
21.1
|
|
Subsidiaries
of the Registrant.
|
Exhibit
|
|
|
Number
|
|
Description
|
|
|
|
23.1
|
|
Consent
of PricewaterhouseCoopers LLP.
|
31.1
|
|
Certification
of Paul J. Maddon, M.D., Ph.D., Chief Executive Officer of the Registrant
pursuant to 13a-14(a) and Rule 15d-14(a) under the Securities
Exchange Act of 1934, as amended.
|
31.2
|
|
Certification
of Robert A. McKinney, Chief Financial Officer, Senior Vice President,
Finance and Operations and Treasurer of the Registrant pursuant to
13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as
amended.
|
32.1
|
|
Certification
of Paul J. Maddon, M.D., Ph.D., Chief Executive Officer of the Registrant
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
|
|
Certification
of Robert A. McKinney, Chief Financial Officer, Senior Vice President,
Finance and Operations and Treasurer of the Registrant pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
*
|
|
Exhibits
footnoted as previously filed have been filed as an exhibit to the
document of the Registrant referenced in the footnote below, and are
incorporated by reference herein.
|
|
|
|
(1)
|
|
Previously
filed in Registration Statement on Form S-1, Commission File
No. 333-13627.
|
|
(2)
|
|
Previously
filed in Quarterly Report on Form 10-Q for the quarterly period ended
June 30, 1999.
|
|
(3)
|
|
Previously
filed in Registration Statement on Form S-8, Commission File
No. 333-120508.
|
|
(4)
|
|
Previously
filed in Annual Report on Form 10-K for the year ended
December 31, 1999.
|
|
(5)
|
|
Previously
filed in Quarterly Report on Form 10-Q for the quarterly period ended
June 30, 2000.
|
|
(6)
|
|
Previously
filed in Annual Report on Form 10-K for the year ended
December 31, 2002.
|
|
(7)
|
|
Previously
filed in Quarterly Report on Form 10-Q for the quarterly period
ending September 30, 2003.
|
|
(8)
|
|
Previously
filed in Registration Statement on Form S-8, Commission File
No. 333-143671.
|
|
(9)
|
|
Previously
filed in Current Report on Form 8-K filed on September 20,
2004.
|
|
(10)
|
|
Previously
filed in Current Report on Form 8-K filed on June 29,
2005.
|
|
(11)
|
|
Previously
filed in Annual Report on Form 10-K for the year ended
December 31, 2004.
|
|
(12)
|
|
Previously
filed in Annual Report on Form 10-K for the year ended
December 31, 2005.
|
|
(13)
|
|
Previously
filed in Quarterly Report on Form 10-Q for the quarterly period
ending June 30, 2006.
|
|
(14)
|
|
Previously
filed in Current Report on Form 8-K filed on May 13,
2005.
|
|
(15)
|
|
Previously
filed in Quarterly Report on Form 10-Q for the quarterly period
ending March 31, 2007.
|
|
(16)
|
|
Previously
filed in Registration Statement on Form S-8, Commission File
No. 333-143670.
|
|
(17)
|
|
Previously
filed in Annual Report on Form 10-K/A for the year ended
December 31, 2006.
|
|
|
|
†
|
|
Confidential
treatment granted as to certain portions, which portions are omitted and
filed separately with the Commission.
|
|
‡
|
|
Management
contract or compensatory plan or
arrangement.
|