Avanir Pharmaceuticals
Filed Pursuant to Rule 424(b)(2)
Registration Nos: 333-114389
333-123867
Prospectus Supplement
(To Prospectus Dated May 25, 2004)
7,770,000 Shares
Class A Common Stock
We are offering 7,770,000 shares of our Class A common
stock directly to investors. In connection with this offering,
we will pay fees to our placement agents, CIBC World Markets
Corp. and Leerink Swann & Co. See Plan of
Distribution on page S-9 of this prospectus
supplement for more information regarding these arrangements.
Our Class A common stock is listed on the American Stock
Exchange under the symbol AVN. The last reported
sale price of our Class A common stock on the American
Stock Exchange on April 5, 2005 was $2.47 per share.
Investing in our Class A common
stock involves a high degree of risk.
See Risk Factors beginning
on page S-2 of this prospectus supplement and in the
Registration Statement on Form S-3 (No. 333-114389)
and the documents incorporated by reference herein.
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Per Share | |
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Total | |
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Public offering price
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$ |
2.20 |
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$ |
17,094,000 |
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Placement agents fees
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$ |
0.13 |
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$ |
1,025,640 |
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Proceeds, before expenses, to us
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$ |
2.07 |
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$ |
16,068,360 |
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We have engaged CIBC World Markets Corp. and Leerink
Swann & Co. as our exclusive placement agents to use
reasonable efforts to solicit offers to purchase our
Class A common stock in this offering. The placement agents
are not purchasing or selling any shares of our Class A
common stock pursuant to this prospectus supplement or the
accompanying prospectus, nor are we requiring any minimum
purchase or sale of any specific number of shares of
Class A common stock. We expect that delivery of the shares
of Class A common stock being offered pursuant to this
prospectus supplement will be made to investors on or about
April 8, 2005. Unless the purchasers instruct otherwise,
the shares of Class A common stock will be delivered in
book-entry form through The Depository Trust Company, New York,
New York.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus
supplement or the accompanying prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
Sole Bookrunning Agent
CIBC World Markets
Leerink Swann & Co.
The date of this prospectus supplement is April 5, 2005.
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-2 |
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S-5 |
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S-6 |
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S-7 |
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S-8 |
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S-9 |
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S-10 |
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S-10 |
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S-10 |
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S-11 |
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S-12 |
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Prospectus |
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1 |
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1 |
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3 |
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11 |
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12 |
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12 |
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13 |
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13 |
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13 |
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14 |
Unless otherwise mentioned or unless the context requires
otherwise, all references in this prospectus supplement and the
accompanying prospectus to the company,
Avanir, we, us,
our, or similar references mean Avanir
Pharmaceuticals.
This document is in two parts. The first part is this prospectus
supplement, which describes the terms of this offering of our
Class A common stock and also adds to and updates
information contained in or incorporated by reference into the
accompanying prospectus. The second part is the accompanying
prospectus, which gives more information about us and the shares
of Class A common stock we may offer from time to time
under our shelf registration statement. To the extent there is a
conflict between the information contained, or referred to, in
this prospectus supplement, on the one hand, and the information
contained, or referred to, in the accompanying prospectus or any
document incorporated by reference therein, on the other hand,
the information in this prospectus supplement shall control.
We have not authorized any broker, dealer, salesperson or other
person to give any information or to make any representation
other than those contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus. You must
not rely upon any information or representation not contained or
incorporated by reference in this prospectus supplement or the
accompanying prospectus. This prospectus supplement and the
accompanying prospectus do not constitute an offer to sell or
the solicitation of an offer to buy Class A common stock,
nor do this prospectus supplement and the accompanying
prospectus constitute an offer to sell or the solicitation of an
offer to buy Class A common stock in any jurisdiction to
any person to whom it is unlawful to make such offer or
solicitation in such jurisdiction. You
S-i
should not assume that the information contained in this
prospectus supplement and the accompanying prospectus is
accurate on any date subsequent to the date set forth on the
front of the document or that any information we have
incorporated by reference is correct on any date subsequent to
the date of the document incorporated by reference, even though
this prospectus supplement and any accompanying prospectus is
delivered or Class A common stock is sold on a later date.
It is important for you to read and consider all information
contained in this prospectus supplement and the accompanying
prospectus, including the documents we have referenced in the
section entitled Incorporation of Certain Information by
Reference in this prospectus supplement.
S-ii
THE OFFERING
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Class A common stock offered by us |
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7,770,000 shares |
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Class A common stock to be outstanding after this offering |
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105,474,586 shares |
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Use of proceeds |
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We intend to use the proceeds of this offering primarily for
general working capital, the commercialization of Neurodex (if
and when Neurodex receives regulatory approval), clinical
trials, research and development expenses, administrative
expenses and for potential acquisitions of, or investments in,
complementary businesses, products and technologies. See
Use of Proceeds on page S-6. |
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American Stock Exchange symbol |
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AVN |
The information above and elsewhere in this prospectus
supplement regarding outstanding shares of our Class A
common stock is based on 97,704,586 shares of Class A
common stock outstanding as of December 31, 2004 and
excludes the following shares of Class A common stock:
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5,909,040 shares of Class A common stock issuable upon
the exercise of stock options outstanding as of
December 31, 2004 at a weighted-average exercise price of
$2.13 per share; |
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2,330,906 shares of Class A common stock reserved for
future awards under our stock plans as of December 31, 2004; |
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5,295,261 shares of Class A common stock issuable upon
the exercise of warrants outstanding as of December 31,
2004 with a weighted-average exercise price of $1.83 per
share; |
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2,000,000 shares of Class A common stock issued
March 8, 2005 in connection with our acquisition of certain
contract rights from IriSys, Inc.; and |
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2,000,000 shares of Class A common stock initially
reserved for issuance under our 2005 Equity Incentive Plan,
which was approved by our shareholders on March 17, 2005. |
S-1
RISK FACTORS
Investing in our securities involves significant risk, including
the risks identified below and in our SEC filings that are
incorporated by reference into this prospectus and prospectus
supplement. Set forth on Page 3 of the prospectus are
certain risks and uncertainties, as of the date of the
prospectus, related to our business and to our industry. These
risk factors have been updated in our quarterly report on
Form 10-Q for the quarter ended December 31, 2004,
which is incorporated by reference into this prospectus
supplement and prospectus. Set forth below are certain
additional risk factors that you should consider. Prospective
investors should review all of these risk factors before making
an investment decision. If any of these risks or uncertainties
actually occurs, our business, financial condition or results of
operations could be materially adversely affected. Additional
risks and uncertainties of which we are unaware or that we
currently believe are immaterial could also materially adversely
affect our business, financial condition or results of
operations. In any case, the trading price of our Class A
common stock could decline, and you could lose all or part of
your investment. See also Note Regarding
Forward-Looking Statements.
We are currently in the process of submitting our Neurodex
clinical trial results to the FDA for review and approval prior
to U.S. commercialization. Any delay or adverse decisions
in the regulatory review or approval process may harm our
prospects and could harm our stock price.
We began submission of a new drug application, or NDA, for
Neurodex to the FDA in December 2004 under a rolling
submission basis, and we must obtain FDA approval prior to
commercialization in the United States. A rolling submission
allows us to submit the NDA in reviewable modules. To date, we
have submitted 2 of 3 modules and we currently expect to
complete our submission in mid-2005. We may not be able to
maintain our planned schedule and may not complete our
submission in a timely manner. Any delays in our submission or
in the FDAs review or approval could delay market launch
and increase the volatility of our stock price and may result in
additional operating losses, which would likely increase our
cash requirements.
Based on communications with the FDA, we expect that the final
submission will activate a priority review by the FDA, which is
a six-month review period for the NDA. However, the process of
obtaining FDA approval often takes more than one year and can
vary substantially based upon the type, complexity and novelty
of the products involved. If we complete the submission of an
NDA for Neurodex, the FDA must decide whether to accept or
reject the submission for filing. The FDAs official filing
of an NDA is the action that begins the applications
substantive review. The FDA may refuse to file an NDA for review
for many reasons, including if the submission contains
insufficient data to demonstrate efficacy and/or safety. We
cannot be certain that our NDA submission would be accepted for
filing and reviewed by the FDA or that we would be able to
respond to any requests during the review period in a timely
manner without delaying potential action on our request for
approval.
We also cannot be certain that Neurodex will receive a favorable
recommendation from any FDA advisory committees or be approved
for marketing by the FDA. Even if the FDA grants marketing
approval for Neurodex, we cannot be certain that we will be able
to obtain the labeling claims necessary or desirable for the
promotion of the product. In addition, delays in approvals or
rejections of marketing applications may be based upon many
factors, including regulatory requests for additional analyses,
reports, data and/or studies, regulatory questions regarding
data and results, changes in regulatory policy during the period
of product development and/or the emergence of new information
regarding our products or other products. Recent public
announcements regarding safety problems with certain approved
drugs may affect the FDAs policies regarding safety data
for new drug applications and may result in the FDA requiring
additional safety data before accepting our planned NDA
submission, as well as closer surveillance after
commercialization if the drug is approved.
S-2
Our stock price is highly volatile and investors may not
be able to sell their shares at or above the price they pay for
them.
The market price of our Class A common stock has been, and
is likely to continue to be, highly volatile. The following
factors, among others, could have a significant impact on the
market price of our Class A common stock:
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Unfavorable announcements by us regarding our NDA submission for
Neurodex, clinical trial results or results of operations; |
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Our success or failure in entering into license and/or
co-promotion arrangements for our products and product
candidates; |
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Delays in meeting goals or performance milestones by us or our
marketing partners; |
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Comments made by securities analysts, including changes in their
recommendations; |
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Announcements of financing transactions and/or future sales of
equity or debt securities; |
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Announcements by us of significant acquisitions, strategic
partnerships, joint ventures or capital commitments; |
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Sales of our Class A common stock by our directors,
officers or significant shareholders; |
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Announcements by our competitors of clinical trial results or
product approvals; and |
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Market and economic conditions. |
In addition, the market for biotechnology and pharmaceutical
stocks has experienced significant price and volume fluctuations
that are frequently unrelated to operating performance. This
price volatility is often more pronounced for companies with a
low stock price and a small market capitalization, such as ours.
These broad market and industry factors might seriously harm the
market price of our Class A common stock, regardless of our
operating performance.
A significant decline in our stock price could also result in
our Class A common stock being delisted from the American
Stock Exchange and could lead to the filing of lawsuits,
including securities class action lawsuits. Any such lawsuits
against us would result in substantial costs, potential
liabilities and the diversion of managements attention and
resources.
We expect that we will need to raise additional capital to
fund ongoing operations through at least 2006. If we are unable
to raise additional capital, we may be forced to curtail
operations. If we succeed in raising additional capital through
a licensing or financing transaction, it may affect our stock
price and future revenues.
In order to maintain sufficient cash and investments to fund
future operations and to prepare for the commercialization of
Neurodex, we will need to raise significant additional capital.
We expect to seek to raise additional capital over the next 12
to 24 months through various alternatives, including
licensing or sales of our technologies and drug candidates and
selling shares of our Class A common stock.
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If we raise capital through licensing or sales of one or more of
our technologies or drug candidates, then we may not realize
revenues from sales of any of our products that are successfully
developed, approved by the FDA and marketed, or our share of
such revenues may be substantially reduced. If we license any of
our technologies or drug candidates, then the development of
these products or technologies will no longer be in our control.
A licensee might never reach any of the payment milestones in a
license agreement. Further, if we sell any of our technologies
or drug candidates, the sales price may not fully cover our
investment in such technology or drug candidate. |
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If we raise capital by issuing additional shares of Class A
common stock at a price per share less than the then-current
market price per share, the value of the shares of Class A
common stock then outstanding may be reduced. Further, even if
we were to sell shares of common stock at prices equal |
S-3
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to or higher than the current market price, the issuance of
additional shares may depress the market price of our
Class A common stock and will dilute voting rights of our
other shareholders. |
We may not be able to raise capital on terms that we find
acceptable, or at all. If we are unable to raise additional
capital to fund future operations, then we may not be able to
execute our commercialization plans for Neurodex and may be
required to reduce operations or defer or abandon one or more of
our clinical or pre-clinical research programs. Any of these
actions could decrease our stock price.
Changes in board and management composition could
adversely affect our operations.
Since September 2004, three new directors have joined our board
and we have recently appointed a new chairman. Our Corporate
Governance Committee is also currently conducting a search for a
director candidate who may replace one of our incumbent
directors. Additionally, we are currently recruiting
senior-level sales and marketing personnel to add to our
management and we anticipate that we could experience other
changes in management and infrastructure as we expand our
organization, prepare for the commercialization of Neurodex, and
effect the transition of the Company from a research and
development company to a specialty pharmaceutical company. These
changes may be disruptive, and we may experience difficulties in
retaining new directors, attracting and integrating new members
of the management team, and in transitioning the operating
activities of the Company.
Our inability to attract and retain key management and
scientific personnel could negatively affect our
business.
The industry in which we compete has a high level of employee
mobility and aggressive recruiting of skilled personnel. This
type of environment creates intense competition for qualified
personnel, particularly in product research and development,
sales and marketing, and accounting and finance, and the loss of
any of our executive officers or other key employees could
adversely affect our operations. Other than our chief executive
officer, we do not have employment agreements with any of our
executive officers and do not have key person life
insurance policies for any of our executives.
In order to expand our company as planned and effect our
transition to a specialty pharmaceutical company, we will need
to hire, train, retain and motivate high quality personnel,
including sales and marketing personnel for the
commercialization of Neurodex. Any inability to hire qualified
sales and marketing personnel would harm our commercialization
plans. Additionally, if we were to lose one or more of our key
scientists, then we would likely lose some portion of our
institutional knowledge and technical know-how, potentially
causing a substantial delay in one or more of our development
programs until adequate replacement personnel could be hired and
trained.
We depend on third parties to manufacture compounds for
our drugs and drug candidates. The failure of these third
parties to perform successfully could harm our business.
We have utilized, and intend to continue utilizing, third
parties to manufacture docosanol 10% cream, Neurodex, active
pharmaceutical ingredients, and supplies for our other drug
candidates. We have no experience in manufacturing and do not
have any manufacturing facilities. Currently, we have only a
single supplier for the raw material docosanol and the finished
product for Neurodex and we do not have any long-term agreements
in place with either of these suppliers. Any delays or
difficulties in obtaining Neurodex could delay our clinical
trials for neuropathic pain and delay the commercialization of
Neurodex for pseudobulbar affect. Additionally, although we and
GlaxoSmithKline maintain a strategic reserve of docosanol to
mitigate against a short-term supply disruption, any sustained
disruption of our docosanol supply could harm our operations.
S-4
The board of directors has the authority to effect a
reverse stock split within a stated range until March 16,
2006. If implemented, the reverse stock split may negatively
affect the price and liquidity of our Class A common
stock.
At our 2005 Annual Meeting of Shareholders, the board of
directors received the authority to implement, within its
discretion and for a period of one year, a reverse split of our
Class A common stock within a range of 1:2 to 1:5. If
the board of directors were to effect a reverse stock split, the
bid price of the Class A common stock may not continue at a
level in proportion to the reduction in the number of
outstanding shares resulting from the reverse stock split. For
example, if the board of directors decided to implement a
reverse stock split at a ratio of 1-for-5, the post-split market
price of our Class A common stock might not continue at a
level at least five times greater than the pre-split price.
Accordingly, the total market capitalization of our Class A
common stock after a reverse stock split, if implemented, could
be lower than the total market capitalization before the reverse
stock split. Additionally, the liquidity of our Class A
common stock could be affected adversely by the reduced number
of shares outstanding after the reverse stock split.
Management will have broad discretion as to the use of the
proceeds from this offering, and the use of the proceeds may not
yield positive results.
Although we intend to use the proceeds from this offering
principally to fund ongoing operations and prepare for the
commercialization of Neurodex (if and when Neurodex receives
regulatory approval), we have not designated the amount of net
proceeds we will use for any particular purpose. As a result,
our management will have broad discretion as to the application
of the net proceeds. We have eight significant research and
development programs under development, and the use of offering
proceeds on any one of these programs may not yield positive
results. Accordingly, the use of net proceeds from this offering
may not increase our market value or make us profitable.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
The prospectus supplement and prospectus contain or incorporate
by reference forward-looking statements that involve risks and
uncertainties. The statements contained or incorporated by
reference in the prospectus supplement and prospectus that are
not purely historical are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, or
the 1933 Act, and Section 21E of the Securities Exchange
Act of 1934, or the 1934 Act, including, without limitation,
statements regarding our expectations, beliefs, intentions or
strategies regarding the future. All forward-looking statements
included in this document are based on information available to
us on the date hereof, and all forward-looking statements in
documents incorporated by reference are based on information
available to us as of the date of such documents. We assume no
obligation to update any such forward-looking statements. Our
actual results may differ materially from those discussed in the
forward-looking statements as a result of certain factors,
including those set forth above under Risk Factors
and elsewhere in this prospectus supplement and prospectus and
in the documents incorporated herein by reference. In evaluating
our business, prospective investors should carefully consider
these factors in addition to the other information set forth in
this prospectus supplement and prospectus and incorporated
herein by reference.
S-5
USE OF PROCEEDS
We estimate that the net proceeds we will receive from this
offering will be approximately $15.8 million after
deducting the placement agents fees and estimated offering
expenses and assuming that we sell the maximum number of shares
offered hereby.
We will retain broad discretion over the use of the net proceeds
from the sale of our Class A common stock offered hereby.
We currently anticipate using the net proceeds from this
offering for general working capital and for our marketing and
pre-launch activities for the anticipated commercialization of
Neurodex for the treatment of pseudobulbar affect, assuming that
Neurodex receives regulatory approval from the FDA. We may also
use the proceeds raised from this offering for any of the
following additional purposes:
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clinical trials; |
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research and development expenses; |
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general and administrative expenses; and |
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potential acquisitions of, or investments in, complementary
businesses, products and technologies. |
The amounts and timing of the expenditures may vary
significantly depending on numerous factors, including the
timing of completion of the NDA submission, regulatory review
for Neurodex, progress of our other research and development
efforts, technological advances and the competitive environment
for our products and technologies.
Pending the use of the net proceeds from this offering, we
intend to invest the proceeds in short-term, interest-bearing,
investment-grade securities.
S-6
CAPITALIZATION
The following table sets forth our capitalization as of
December 31, 2004:
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on an actual basis; and |
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on an as-adjusted basis, to give effect to the sale of
7,770,000 shares of Class A common stock offered by us
in this offering, at a price of $2.20 per share in this
offering and after deducting the placement agents fees and
estimated offering expenses payable by us. |
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As of December 31, 2004 | |
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Actual | |
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As Adjusted | |
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Cash, cash equivalents and short-term investments in securities
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$ |
22,607,605 |
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$ |
38,448,965 |
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Shareholders equity (deficit):
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Preferred stock no par value, 10,000,000 shares
authorized
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Series C Junior Participating
1,000,000 shares authorized; no shares issued or outstanding
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Class A Common stock no par value;
200,000,000 shares authorized; shares issued and
outstanding: 97,704,586 shares actual;
105,474,586 shares as adjusted
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$ |
141,745,826 |
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$ |
157,587,186 |
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Accumulated deficit
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(131,494,491 |
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(131,494,491 |
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Accumulated other comprehensive loss
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(43,439 |
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(43,439 |
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Total shareholders equity
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10,207,896 |
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26,049,256 |
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TOTAL CAPITALIZATION
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$ |
10,207,896 |
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$ |
26,049,256 |
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S-7
DILUTION
Our pro forma net tangible book value as of December 31,
2004 was approximately $7.2 million, or $0.07 per
share of Class A common stock. Pro forma net tangible book
value per share is calculated by subtracting our total
liabilities from our total tangible assets, which is total
assets less intangible assets, and dividing this amount by the
number of shares of Class A common stock outstanding. After
giving effect to the sale by us of the 7,770,000 shares of
Class A common stock offered in this offering at a price of
$2.20 per share, and after deducting the placement
agents fees and estimated offering expenses payable by us,
our pro forma, as-adjusted net tangible book value as of
December 31, 2004 would have been approximately
$23.0 million, or $0.22 per share of Class A
common stock. This represents an immediate increase in the pro
forma net tangible book value of $0.15 per share to our
existing shareholders and an immediate and substantial dilution
in pro forma net tangible book value of $1.98 per share to
new investors. The following table illustrates this per-share
dilution:
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Offering price per share
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$ |
2.20 |
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Pro forma net tangible book value per share as of
December 31, 2004
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$ |
0.07 |
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Increase per share attributable to new investors
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$ |
0.15 |
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Pro forma, as-adjusted net tangible book value per share after
this offering
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$ |
0.22 |
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Dilution per share to new investors
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$ |
1.98 |
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S-8
PLAN OF DISTRIBUTION
We have engaged CIBC World Markets and Leerink Swann &
Co. as our exclusive placement agents to use reasonable efforts
to solicit offers from investors to purchase our Class A
common stock in this offering. The placement agents are not
obligated to, and have advised us that they will not, purchase
any shares of our Class A common stock for their own
accounts or otherwise participate in any direct purchases of
shares with the company. We will enter into purchase agreements
directly with investors in connection with this offering, and we
will only sell to investors who have entered into purchase
agreements.
Our obligation to issue and sell shares to purchasers is subject
to the conditions set forth in the purchase agreements, which
may be waived by us in our discretion. A purchasers
obligation to purchase shares is subject to conditions set forth
in the purchase agreements, which may be waived by the purchaser.
Unless purchasers instruct us otherwise, we will deliver the
shares of common stock being issued to the investors
electronically upon receipt of investor funds for the purchase
of the shares of our Class A common stock offered pursuant
to this prospectus supplement. We expect to deliver the shares
of our Class A common stock being offered pursuant to this
prospectus supplement on or about April 8, 2005.
We have agreed to pay the placement agents a total placement fee
equal to 6% of the gross proceeds of this offering and to
reimburse the placement agents for all reasonable costs and
expenses incurred by them in connection with this offering. The
following table shows the per share and total placement fees we
will pay to the placement agents in connection with this
offering.
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Per Share | |
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Total Offering | |
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CIBC World Markets Corp.
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$ |
0.09 |
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$ |
687,179 |
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Leerink Swann & Co.
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$ |
0.04 |
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$ |
338,461 |
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Because there is no minimum offering amount required as a
condition to closing of this offering, the actual total offering
commissions, if any, may be substantially less than the total
offering amounts set forth above.
The placement agents have informed us that they will not engage
in over-allotment, stabilizing transactions or syndicate
covering transactions in connection with this offering.
The placement agency agreement provides that the obligations of
the placement agents are subject to certain conditions
precedent, including the absence of any material adverse change
in our business and the receipt of certain certificates,
opinions and letters from us, our counsel and our auditors.
We have agreed to indemnify the placement agents and specified
other persons against some civil liabilities, including
liabilities under the 1933 Act or the 1934 Act, and to
contribute to payments that the placement agents may be required
to make in respect of those liabilities.
All of our directors and executive officers and IriSys, Inc.,
which received 2 million shares of our Class A common
stock on March 8, 2005 in connection with our acquisition
of certain of its assets, have signed lock-up agreements,
pursuant to which they have agreed to not, directly or
indirectly, offer, sell, agree to sell or otherwise transfer or
dispose of any shares of our Class A common stock or any
securities convertible into or exchangeable for shares of our
Class A common stock, without the prior written consent of
CIBC World Markets Corp. for a period of 90 days after the
completion of this offering; provided, however, that IriSys may,
during this 90-day period and subject to compliance with
applicable securities laws, distribute shares of our
Class A common stock to its shareholders, directors,
employees and/or service providers.
We have agreed that, without the prior written consent of CIBC
World Markets Corp., we will not, during the 60 days after
the date of this prospectus supplement, issue, sell, or register
with the Securities and Exchange Commission, or otherwise
dispose of, directly or indirectly, any of our equity securities
(or any securities convertible into, exercisable for or
exchangeable for our equity securities), except for the
following:
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the issuance of the shares of our Class A common stock
offered under this prospectus supplement; |
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the issuance of shares pursuant to our existing employee benefit
plans or upon exercise of outstanding warrants; |
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the registration of shares on Form S-8 or any successor
form; |
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the issuance of shares in connection with any corporate
strategic development transaction, provided that any such shares
may not be transferred or sold by the corporate partner until
60 days after the date of this prospectus
supplement; and |
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the registration of the shares of our Class A common stock
issued to IriSys, provided that these shares may not be sold by
IriSys or certain of its transferees until the expiration of the
90-day lock-up period described above. |
The placement agents do not expect sales of shares of
Class A common stock offered by this prospectus supplement
and the accompanying prospectus to any accounts over which they
exercise discretionary authority to exceed five percent of the
shares offered.
The placement agency agreement with CIBC World Markets Corp. and
Leerink Swann & Co. will be included as an exhibit to a
Current Report on Form 8-K that we will file with the SEC
and that will be incorporated by reference into the registration
statement of which this prospectus supplement forms a part.
The placement agents or their affiliates may in the future
provide investment banking, commercial banking and/or other
services to us from time to time, for which they may in the
future receive customary fees and expenses.
DESCRIPTION OF SECURITIES
Holders of Class A common stock are entitled to one vote
for each share held on all matters submitted to a vote of
shareholders and do not have cumulative voting rights. Holders
of Class A common stock are entitled to receive ratably
such dividends, if any, as may be declared by the board of
directors out of funds legally available therefor, subject to
any preferential dividend rights of outstanding preferred stock.
Upon the liquidation, dissolution or winding up of our company,
the holders of Class A common stock are entitled to receive
ratably our net assets available after the payment of all our
debts and other liabilities, subject to the prior rights of any
outstanding preferred stock. Holders of our Class A common
stock have no preemptive, subscription, redemption, conversion
or registration rights, nor are they entitled to the benefit of
any sinking fund. The outstanding shares of Class A common
stock are, and the shares offered by us in this offering will
be, when issued and paid for, validly issued, fully paid and
non-assessable. The rights, powers, preferences and privileges
of holders of common stock are subject to, and may be adversely
affected by, the rights of the holders of shares of any series
of preferred stock which our board of directors may designate
and issue in the future.
LEGAL MATTERS
The validity of the Class A common stock offered hereby has
been passed upon by Heller Ehrman LLP, San Diego,
California. Wilson Sonsini Goodrich & Rosati, a
Professional Corporation, Palo Alto, California will pass upon
certain legal matters in connection with this offering for the
placement agents.
EXPERTS
The consolidated financial statements incorporated in this
prospectus by reference from Avanir Pharmaceuticals Annual
Report on Form 10-K have been audited by
Deloitte & Touche LLP, an independent registered public
accounting firm, as stated in their report, which is
incorporated herein by reference, and has
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been so incorporated in reliance upon the report of such firm
given upon their authority as experts in accounting and auditing.
With respect to the unaudited interim financial information for
the periods ended December 31, 2004 and 2003 which is
incorporated herein by reference, Deloitte & Touche
LLP, an independent registered public accounting firm, have
applied limited procedures in accordance with the standards of
the Public Company Accounting Oversight Board (United States)
for a review of such information. However, as stated in their
report included in the Companys Quarterly Report on
Form 10-Q for the quarter ended December 31, 2004 and
incorporated by reference herein, they did not audit and they do
not express an opinion on that interim financial information.
Accordingly, the degree of reliance on their report on such
information should be restricted in light of the limited nature
of the review procedures applied. Deloitte & Touche LLP
are not subject to the liability provisions of Section 11
of the Securities Act of 1933 for their report on the unaudited
interim financial information because the report is not a
report or a part of the registration
statement prepared or certified by an accountant within the
meaning of Sections 7 and 11 of the Act.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference into this
prospectus supplement and prospectus the information contained
in other documents we file with the SEC, which means that we can
disclose important information to you by referring you to those
documents. Any statement contained in any document incorporated
or deemed to be incorporated by reference herein shall be deemed
to be modified or superseded, for purposes of this prospectus
supplement or prospectus, to the extent that a statement
contained in or omitted from this prospectus supplement and
prospectus, or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein,
modifies or supersedes such statement. Any such statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute a part of this prospectus
supplement or prospectus. We incorporate by reference the
documents listed below and any future filings we make with the
SEC under Sections 13(a), 13(c), 14 or 15(d) of the 1934
Act until the offering is completed:
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1. Our Annual Report on Form 10-K for the year ended
September 30, 2004; |
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2. Our Definitive Proxy Statement on Schedule 14A,
filed January 28, 2005; |
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3. Our Quarterly Report on Form 10-Q for the quarter
ended December 31, 2004; |
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4. Our Current Reports on Form 8-K filed on
December 13, 2004, December 15, 2004,
December 21, 2004, January 19, 2005, February 10,
2005, March 14, 2005, and March 23, 2005; and |
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5. The description of our Class A common stock
contained in our registration statement on Form 8-A (File
No. 001-15803) filed with the SEC on April 13, 2000,
including any amendment or report filed for the purpose of
updating such description. |
Upon written or oral request, we will provide without charge to
each person to whom a copy of the prospectus supplement and
prospectus is delivered a copy of the documents incorporated by
reference herein (other than exhibits to such documents unless
such exhibits are specifically incorporated by reference
herein). You may request a copy of these filings, at no cost, by
writing or telephoning us at the following address: Avanir
Pharmaceuticals, 11388 Sorrento Valley Road, San Diego,
California 92121, Attention: Chief Financial Officer, telephone:
(858) 622-5200. We have authorized no one to provide you
with any information that differs from that contained in this
prospectus. Accordingly, you should not rely on any information
that is not
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contained in this prospectus supplement or prospectus.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the
1934 Act and in accordance therewith file reports, proxy
statements and other information with the Securities and
Exchange Commission. Our filings are available to the public
over the Internet at the Securities and Exchange
Commissions website at www.sec.gov, as well as at
our website at www.avanir.com. You may also read and
copy, at prescribed rates, any document we file with the
Securities and Exchange Commission at the Public Reference Room
of the Securities and Exchange Commission located at
450 Fifth Street, N.W., Suite 1024,
Washington, D.C. 20549. Please call the Securities and
Exchange Commission at (800) SEC-0330 for further
information on the Securities and Exchange Commissions
Public Reference Room.
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DATED MAY 25, 2004
Prospectus
$50,000,000
Class A Common Stock
This prospectus and any accompanying prospectus supplement will
allow us to sell shares of our Class A common stock over
time in one or more offerings up to a maximum aggregate offering
price of $50,000,000. Each time we offer securities under this
prospectus, we will provide you with a supplement to this
prospectus. You should read this prospectus and any prospectus
supplement, together with additional information described under
the heading Where You Can Find More Information,
before you make your investment decision.
Our Class A common stock trades on the American Stock
Exchange under the symbol AVN. On May 25, 2004,
the closing price for our Class A common stock, as reported
on the American Stock Exchange, was $1.33 per share.
Investing in our Class A common stock involves certain
risks. See Risk Factors beginning on Page 3 of
this prospectus for certain risks you should consider. You
should read the entire prospectus and any accompanying
prospectus supplement carefully before you make your investment
decision.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
We may sell shares to or through underwriters or dealers,
through agents, or directly to investors. For additional
information on the methods of sale, you should refer to the
section entitled, Plan of Distribution in this
prospectus.
TABLE OF CONTENTS
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ii
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we
filed with the Securities and Exchange Commission, or SEC, using
a shelf registration process. Under this shelf
registration process, we may, from time to time, issue and sell
any part of the shares described in this prospectus in one or
more offerings up to a total dollar amount of $50,000,000.
This prospectus provides you with a general description of the
Class A common stock we may offer. Each time we sell the
Class A common stock, we will provide a prospectus
supplement containing specific information about the terms of
that offering. The prospectus supplement may also add, update or
change information in this prospectus or in documents
incorporated by reference in this prospectus. To the extent that
any statement that we make in a prospectus supplement is
inconsistent with statements made in this prospectus or in
documents incorporated by reference in this prospectus, the
statements made or incorporated by reference in this prospectus
will be deemed modified or superseded by those made in the
prospectus supplement. You should carefully read both this
prospectus and any prospectus supplement, together with the
additional information described under the heading Where
You Can Find More Information, before buying any
securities in this offering.
The registration statement containing this prospectus, including
exhibits to the registration statement, provides additional
information about us and the Class A common stock offered
under this prospectus. The registration statement can be read at
the SEC website or at the SEC offices mentioned under the
heading Where You Can Find More Information.
We have not authorized any broker-dealer, salesperson or other
person to give any information or to make any representation
other than those contained or incorporated by reference in this
prospectus and the accompanying supplement to this prospectus.
You must not rely upon any information or representation not
contained or incorporated by reference in this prospectus or the
accompanying prospectus supplement. This prospectus and the
accompanying supplement to this prospectus do not constitute an
offer to sell or the solicitation of an offer to buy common
stock, nor do this prospectus and the accompanying supplement to
this prospectus constitute an offer to sell or the solicitation
of an offer to buy common stock in any jurisdiction to any
person to whom it is unlawful to make such offer or
solicitation. The information contained in this prospectus and
the accompanying prospectus supplement speaks only as of the
date set forth on the cover page and may not reflect subsequent
changes in our business, financial condition, results of
operations and prospects even though this prospectus and any
accompanying prospectus supplement is delivered or common stock
is sold on a later date.
ABOUT AVANIR PHARMACEUTICALS
We are a drug discovery and development company focused
primarily on novel treatments for chronic diseases. We have one
product that has been approved by the U.S. Food and Drug
Administration (FDA) for the treatment of cold
sores, docosanol 10% cream (sold as Abreva® by our
marketing partner, GlaxoSmithKline Consumer Healthcare, in North
America), and have several product candidates in clinical
development. Our most advanced product candidate,
Neurodextm,
is in Phase III clinical development for the treatment of
pseudobulbar affect (PBA), also known as
pathological laughing or crying. Neurodex is also in
Phase II clinical development for the treatment of
neuropathic pain. A potential product for allergy and asthma,
AVP-13358, is in Phase I clinical development. We also have
preclinical research programs targeting inflammatory diseases,
atherosclerosis, and cancer. Our preclinical research and drug
discovery programs are focused primarily on small molecules that
can be taken orally as therapeutic treatments. Using our
proprietary
Xenerextm
technology, we are also conducting research to develop
injectable human monoclonal antibody products for infectious
diseases, such as anthrax and cytomegalovirus, and for other
therapeutic applications.
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The following graph illustrates the development status of our
product candidates.
The continued development of our product candidates, and the
potential launch of a new drug, will require substantial
additional capital. We intend to partner with pharmaceutical
companies that can help fund our research and potential product
launch in exchange for sharing in the rights to commercialize
new drugs. We have licensed certain rights to docosanol 10%
cream and continue to seek licensees for that product and
potential products in our pipeline. Research collaborations also
represent an important way to achieve our development goals by
sharing the risks and the opportunities that come from such
development efforts.
We expect that our development and operational costs will
continue to exceed revenues from existing sources at least until
the end of 2005. We will have to raise significant amounts of
additional capital to finance our research and development
activities and operations if we are unable to enter into
partnership or collaborative arrangements with pharmaceutical
companies that will share our drug development costs. The
offering that may be made pursuant to this prospectus could
satisfy some portion of our capital needs. If we are unable to
raise capital as needed to fund our operations, or if we are
unable to enter into collaborative arrangements, then we may
need to slow the rate of development of some of our programs or
sell the rights to one or more our drug candidates.
Our offices and research facilities are located at 11388
Sorrento Valley Road, San Diego, California 92121. Our
telephone number is (858) 622-5200 and our e-mail address
is info@Avanir.com. Additional information about Avanir can be
found on our website, at www.avanir.com, and in our
periodic and current reports filed with the Securities and
Exchange Commission (SEC). Copies of our current and
periodic reports filed with the SEC are available at the SEC
Public Reference Room at 450 Fifth Street, N.W.,
Washington, D.C. 20549, and online at www.sec.gov
and our website at www.avanir.com.
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RISK FACTORS
Investing in our securities involves significant risk, including
the risks identified below. We have organized the following risk
factors into three categories Risks Related to
the Offering, Risks Related to Our Business,
and Risks Related to Our Industry. You should
carefully consider the following risks and uncertainties before
you invest in our securities. If any of the following risks or
uncertainties actually occurs, our business, financial condition
or results of operations could be materially adversely affected.
Additional risks and uncertainties of which we are unaware or
that we currently believe are immaterial could also materially
adversely affect our business, financial condition or results of
operations. In any case, the trading price of our Class A
common stock could decline, and you could lose all or part of
your investment. See also Note Regarding Forward-Looking
Statements.
Risks Relating to the Offering
We expect to complete our Phase III clinical trial
soon for Neurodex and any negative results in this trial could
harm our stock price.
In March 2004, we announced that we had completed enrollment in
our Phase III clinical trial for Neurodex, our late-stage
candidate for the treatment of pseudobulbar affect. We expect to
announce preliminary data from this trial later in 2004.
Neurodex is our most developed drug candidate and we believe it
represents the most immediate opportunity to produce significant
revenue for the Company. If the clinical trial data are negative
or inconclusive, then we may be required to conduct one or more
additional clinical trials and may not be able to seek
regulatory approval to market the compound. If this were to
happen, we expect our stock price would be negatively affected.
Assuming favorable results from our Phase III trial
for Neurodex in Multiple Sclerosis patients with PBA, we must
submit our results to the FDA for review and approval prior to
U.S. commercialization. Any delay in the regulatory review or
approval process may harm our prospects and could harm our stock
price..
Assuming positive results from our Phase III trial of
Neurodex in patients suffering from PBA with Multiple Sclerosis,
we will have to seek FDA approval prior to commercialization in
the Unites States. Any delays in our submission or in the
FDAs review or approval would delay market launch and
increase our cash requirements and could increase the volatility
of our stock price and result in additional operating losses.
The process of obtaining FDA approval often takes many years and
can vary substantially based upon the type, complexity and
novelty of the products involved. FDAs review and approval
of the actual NDA application is expensive and uncertain. If we
submit an NDA for Neurodex, the FDA must decide wether to accept
or reject the submission for filing. The FDAs official
filing of an NDA begins the applications substantive
review. The FDA may refuse to file an NDA for review for many
reasons, including if the submission contains insufficient data
to demonstrate efficacy and safety. We cannot be certain that
our NDA submission would be accepted for filing and reviewed by
the FDA or that we would be able to respond to any requests
during the review period in a timely manner without delaying
potential action on our request for approval. We also cannot be
certain that Neurodex will receive a favorable recommendation
from any FDA advisory committees or be approved for marketing by
the FDA. Even if the FDA grants us marketing approval for
Neurodex, we cannot be certain that we will be able to obtain
the labeling claims necessary or desirable for the promotion of
the product. In addition, delays in approvals or rejections of
marketing applications may be based upon many factors, including
regulatory requests for additional analyses, reports, data
and/or studies, regulatory questions regarding data and results,
changes in regulatory policy during the period of product
development and/or the emergence of new information regarding
our products or other products.
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Our stock price is highly volatile and you may not be able
to resell your shares at or above the price you pay for
them.
The market price of our Class A common stock has been, and
is likely to continue to be, highly volatile. The following
factors, among others, could have a significant impact on the
market price of our Class A common stock:
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our success or failure in entering into license and/or
co-promotion arrangements for our products and product
candidates; |
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unfavorable or delayed announcements by us regarding clinical
trial results or results of operations, or favorable
announcements by our competitors; |
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delays in meeting goals or performance milestones by us or our
marketing partners; |
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comments made by securities analysts, including changes in, or
failure to achieve, financial estimates or milestones; |
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announcements of financing transactions and/or future sales of
equity or debt securities; |
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announcements by us of significant acquisitions, strategic
partnerships, joint ventures or capital commitments; |
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sales of our Class A common stock by our directors,
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market and economic conditions. |
In addition, the market for biotechnology and pharmaceutical
stocks has experienced significant price and volume fluctuations
that are frequently unrelated to operating performance. This
price volatility is often more pronounced for companies with a
low stock price and a small market capitalization, such as ours.
These broad market and industry factors might seriously harm the
market price of our Class A common stock, regardless of our
operating performance.
A significant decline in our stock price could also result in
our Class A common stock being delisted from the American
Stock Exchange and could initiate litigation, including a
securities class action lawsuit. Such a lawsuit against us could
result in substantial costs, potential liabilities and the
diversion of managements attention and resources.
We may sell additional shares of capital stock in the
future, which could dilute your investment.
Our Amended and Restated Articles of Incorporation authorize the
issuance of up to 200,000,000 shares of Class A common
stock and up to 10,000,000 shares of preferred stock.
Currently, there are approximately 71,000,000 shares of
Class A common stock outstanding. We intend to seek to
raise additional capital to continue meeting our financial needs
and anticipate that we will do so, at least in part, through the
sale of equity securities. Our Board of Directors is able to
issue a substantial number of additional shares of Class A
common stock without shareholder approval. Potential investors
should be aware that any such stock issuance will reduce the
proportionate ownership and voting power of existing
shareholders and may result in a reduction of the market price
of the outstanding shares of our Class A common stock.
The Board of Directors has the authority to effect a
reverse stock split within a stated range until March 18,
2005. If implemented, the reverse stock split may negatively
affect the price and liquidity of our Class A common
stock.
At our 2004 Annual Meeting of Shareholders, the Board of
Directors received the authority to implement, within its
discretion and for a period of one year, a reverse split of our
Class A common stock within a range of 1:2 to 1:12.5. If
the Board of Directors were to effect a reverse stock split, the
bid price of the Class A common stock may not continue at a
level in proportion to the reduction in the number of
outstanding shares resulting from the reverse stock split. For
example, if the Board of Directors decided to implement a
reverse stock split at a ratio of 1-for-5, that the post-split
market price of our Class A common
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stock may not be at least five times greater than the pre-split
price. Accordingly, the total market capitalization of our
Class A common stock after a reverse stock split, if
implemented, could be lower than the total market capitalization
before the proposed reverse stock split. Additionally, the
liquidity of our Class A common stock could be affected
adversely by the reduced number of shares outstanding after the
reverse stock split.
Management will have broad discretion as to the use of the
proceeds from this offering, and the use of the proceeds may not
yield positive results.
We have not designated the amount of net proceeds we will use
for any particular purpose. As a result, our management will
have broad discretion as to the application of the net proceeds.
We have eight significant research and development programs
under development, and the use of offering proceeds on any one
of these programs may not yield positive results. Accordingly,
the use of net proceeds from this offering may not increase our
market value or make us profitable.
Provisions in our charter documents and our shareholder
rights plan could prevent or delay a change of control in a
transaction that offers our shareholders a premium for their
stock.
Certain provisions of our charter documents may have an
anti-takeover effect and could discourage a third party from
acquiring control of us without approval of our board of
directors. Additionally, we adopted a Shareholder Rights Plan in
1999 for the purpose of requiring bidders to negotiate with our
Board of Directors before attempting a takeover of our company.
Although the Shareholder Rights Plan is intended to prevent
coercive or low offers, it could have the effect of
discouraging, delaying or preventing a third party from
acquiring us in a transaction that may otherwise offer a premium
over our then-current stock price.
Risks Relating to Our Business
We have a history of losses and we may never achieve or
maintain profitability.
To date, we have experienced significant operating losses in
funding the research, development and clinical testing of our
drug candidates and we expect to continue to incur substantial
operating losses through at least 2005. As of December 31,
2003, our accumulated deficit was approximately
$102.5 million. To achieve profitability, we would need to
generate significant additional revenue with positive gross
margins. Although we are seeking to negotiate revenue-generating
licenses and/or co-promotion arrangements for docosanol 10%
cream, Neurodex and other product candidates, we may not be
successful in doing so, and any such arrangements may not
generate the anticipated revenue. Additionally, our sales and
marketing and general and administrative expenses are expected
to increase over the next several quarters. These increases in
expenses may not be offset by new or increased revenue, and, as
a result, we may not achieve or maintain profitability.
Developing and testing a drug candidate is a very
expensive and time-consuming process that may not ultimately
lead to a marketable product.
The drug development process is lengthy and capital-intensive.
Since September 1998, we have spent approximately
$55 million in preclinical and clinical studies researching
the safety and efficacy of our drug candidates and potential
drug candidates. If any of our drug candidates fail to
demonstrate the desired safety and efficacy, we may abandon the
development of the compound, in which event we would not recover
our expenditures incurred to date for that compound. If a
compound appears to be safe and effective in preclinical
studies, we may decide to proceed with human clinical trials.
The full complement of clinical trials required to obtain
regulatory approval for a new drug may involve tens-of-millions
of dollars. Because of our limited financial resources, we may
be required to license the compound to a pharmaceutical company
with greater financial resources in order to complete
development of the drug. We may be unable to find a large
pharmaceutical company interested in licensing the drug or, if
we do locate such a licensee, that the proposed license terms
will be acceptable to the Company. In the event that we are
unable to find a large
5
pharmaceutical partner or licensee on acceptable terms, we may
be forced to abandon one or more of our drug candidates.
We expect that we will need to raise additional capital to
fund ongoing operations through at least 2005. If we are unable
to raise additional capital, we may be forced to curtail
operations. If we succeed in raising additional capital through
a licensing or financing transaction, it may affect our stock
price and future revenues.
In order to maintain sufficient cash and investments to fund
future operations, we will need to raise additional capital,
including through this offering. We expect to seek to raise
additional capital over the next 12 to 24 months through
various alternatives, including licensing or sales of our
technologies and drug candidates and through the sale of shares
of our Class A common stock.
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If we raise capital through licensing or sales of one or more of
our technologies and drug candidates, then we may lose an
opportunity for product sales if a product is successfully
developed, approved by the FDA and marketed. If we license any
of our technologies or drug candidates, then the development of
that product or technology may no longer be in our control. A
licensee might not ever reach any of the milestones in a license
agreement and we would not earn any additional payments in such
an event. Further, if we sell any of our technologies or drug
candidates, the sales price may not cover our investment in such
technology or drug candidate. |
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If we raise capital by issuing additional shares of Class A
common stock at a price per share less than the then-current
market price per share, then the value of the shares of
Class A common stock outstanding may be diluted or reduced.
Further, even if we were to sell shares of common stock at
prices equal to or higher than the current market price, the
issuance of additional shares may depress the market price of
our Class A common stock and dilute your voting rights in
the Company. |
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We may not be able raise capital on terms that we find
acceptable, if at all. If we are unable to raise additional
capital to fund future operations, then we might have to reduce
operations or defer or abandon one or more of our clinical or
preclinical research programs. Any of these actions could be
expected to have an adverse effect on our stock price. |
We expect our quarterly operating results to fluctuate
significantly from period-to-period for a number of
reasons.
Historically, we have had only limited recurring revenue. As a
result, operating results have been, and will continue to be,
subject to significant quarterly fluctuations based on a variety
of factors, including:
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Co-promotion or License Arrangements We are
currently seeking co-promotion or licensing partners for
docosanol 10% cream and Neurodex, as well as for our compounds
targeting IgE (allergy and asthma), MIF (inflammation) and
apolipoprotein A1 (cholesterol). It is difficult to predict
whether any of these discussions will result in a partnering or
license arrangement and what the financial terms of such an
arrangement might be. If we do enter into any such arrangements,
the recognition of revenue under that arrangement may depend on
the efforts and performance of our licensees or partners in
reaching milestones that are outside of our control. Such
milestones may include specific events, such as regulatory
approval, product launch, the passage of time, or reaching a
sales threshold. |
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Limited Rights to Future Abreva Royalties In
December 2002 we sold to Drug Royalty USA the rights to a
substantial portion of our future royalty revenues from sales of
Abreva by GlaxoSmithKline. We will not receive any future
royalty payments unless and until annual Abreva wholesale sales
exceed $62 million, at which time we will receive one-half
of the stated royalty rate on any excess sales. We expect that
any royalty payments on these excess sales, if any, would occur
only once a year, after the end of each calendar year. |
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Concentration of Significant Customers, Suppliers and
Industries Milestone payments, royalties earned,
and revenues recognized from the sale of rights to royalties
from a single licensee (GlaxoSmithKline) accounted for
approximately 73% and 95% of our fiscal 2003 and 2002 revenues, |
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respectively. We have now received all of the milestone payments
from GlaxoSmithKline for North America. With the sale of our
Abreva royalty rights to Drug Royalty USA, future royalty
payments from GlaxoSmithKline will come exclusively from our
remaining 50% share of Abreva royalties on contract sales in
excess of $62 million a year. Additionally, we purchase our
raw materials from a sole foreign supplier that has been
approved for manufacture by the FDA. Any disturbances or delays
in the manufacture of the raw materials could seriously and
adversely affect our business. |
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Acquisitions/Alliances If, in the future, we
acquire technologies, products, or businesses, or we form
alliances with companies requiring technology investments or
commitments, we will face a number of risks to our business. The
risks that we may encounter include those associated with
integrating operations, personnel, and technologies acquired or
licensed, and the potential for unknown liabilities of the
acquired business. Our business and operating results on a
quarterly basis could be adversely affected if any of our
acquisition or alliance activities, to the extent they exist in
the future, are not successful. |
Avanir and its licensees may not be successful in
obtaining regulatory approval of docosanol 10% cream immediately
as an over-the-counter (OTC) product in the rest of
the world, or in licensing, marketing and selling the product in
foreign countries.
Currently, docosanol 10% cream is approved for sale in the
United States, Canada, Korea, Israel and Sweden and we are
currently seeking regulatory approval in various other countries
in the European Union and intend to seek approval in Japan.
Avanir and its licensees face a wide variety of risks in foreign
countries in obtaining regulatory approval and in marketing and
selling docosanol 10% cream, including:
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Regulatory approval requirements differ by country, and
obtaining approvals to market the drug in foreign countries may
be difficult to obtain, may require additional costly and time
consuming clinical trials, or may require prescription status
first before obtaining sufficient experience to warrant approval
as an OTC product; |
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Building product awareness of a new drug, whether prescription
or OTC, among customers or retail store decision makers may
require a substantial amount of product promotion, which does
not guarantee success; |
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Consumers may not perceive that docosanol 10% cream is superior
to existing and potentially new OTC products for oral herpes; |
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Acceptance of docosanol 10% cream in the OTC consumer market may
not be widespread; and |
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Potential price erosion could occur due to competitive products
and responses to our products introduction. |
Foreign sales of docosanol 10% cream and other potential
products are subject to various foreign trade risks.
Our license agreement with GlaxoSmithKline is for the United
States and Canada. We also have exclusive license agreements for
docosanol 10% cream for Israel, South Korea, Italy and
Egypt. We are holding discussions with other potential licensees
for marketing and selling docosanol 10% cream in other countries
not already licensed. However, we may not finalize any license
or distribution arrangements for other territories on a timely
basis or on favorable terms, if at all. Further, our foreign
licensees expose us to various foreign trade risks relating to
development and marketing of docosanol 10% cream. We may arrange
for contracts in the future for the manufacture, marketing and
distribution of docosanol 10% cream overseas by foreign
licensees, which will be substantially outside our control. Even
if we are able to obtain experienced licensees in foreign
markets, specific risks that could impact significantly our
potential revenues on foreign sales include:
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difficulties in obtaining regulatory approval of docosanol 10%
cream in foreign countries; |
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changes in the regulatory and competitive environments in
foreign countries; |
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changes in a specific countrys or regions political
or economic conditions, including related to terrorism; |
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difficulty in finding foreign partners with sufficient capital
to effectively launch, market and promote the product; |
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shipping delays; |
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difficulties in managing operations across disparate geographic
areas; |
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fluctuations in foreign currency exchange rates; |
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prices of competitive products; |
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difficulties associated with enforcing agreements through
foreign legal systems; |
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trade protection measures, including customs duties and export
quotas; and |
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foreign tax withholding laws. |
Our inability to attract and retain key management and
scientific personnel could negatively affect our
business.
Our success depends on the performance of a small core staff of
key management and scientific employees with biotechnology
experience. Given our small staff size and programs currently
under development, we depend substantially on our ability to
hire, train, retain and motivate high quality personnel,
especially our scientists and management team in this field. If
we were to lose one or more of our key scientists, then we would
likely lose some portion of our institutional knowledge and
technical know-how, potentially causing a substantial delay in
one or more of our development programs until adequate
replacement personnel could be hired and trained. Other than our
chief executive officer, our executives do not have employment
agreements. We do not have key person life insurance
policies for any of our executives. The industry in which we
compete has a high level of employee mobility and aggressive
recruiting of skilled personnel. This type of environment
creates intense competition for qualified personnel,
particularly in product research and development, sales and
marketing, and accounting and finance.
Our patents may be challenged and our pending patents may
be denied. Either result would seriously jeopardize our ability
to compete in the intended markets for our proposed
products.
We rely substantially on the protection of our intellectual
property through our ownership or control of 82 issued patents
and 213 patent applications. Patents and patent applications
owned or controlled by the Company are for docosanol-related
products and technologies, Neurodex, compounds capable of
regulating the target IgE in controlling symptoms of allergy and
asthma, compounds capable of regulating the target MIF in the
treatment of inflammatory diseases, compounds targeting
apolipoprotein A1 for the treatment of cholesterol, and Xenerex
technologies for developing monoclonal antibodies. Because of
the competitive nature of the biopharmaceutical industry, we
cannot assure you that:
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the claims in any pending patent applications will be allowed or
that patents will be granted; |
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present and future competitors will not develop similar or
superior technologies independently, duplicate our technologies
or design around the patented aspects of our technologies; |
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our proposed technologies will not infringe other patents or
rights owned by others, including licenses that may not be
available to us; |
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any of our issued patents will provide us with significant
competitive advantages; or |
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challenges will not be instituted against the validity or
enforceability of any patent that we own or, if instituted, that
these challenges will not be successful. |
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Our inability to obtain or maintain patent protections for
our products in foreign markets may negatively affect our
financial condition.
The process for the approval of patent applications in foreign
countries may differ significantly from the process in the
U.S. These differences may delay our plans to market and
sell docosanol 10% cream and other products in the international
marketplace. Approval in one country does not indicate that
approval will be obtained in other countries. The patent
authorities in each country administer that countrys laws
and regulations relating to patents independently of the laws
and regulations of any other country and we must seek and obtain
the patents separately. Our inability to obtain or maintain
patent protections for docosanol 10% cream and other products in
foreign markets would severely hamper our ability to generate
international sales from our first product and other products
still under development.
We are dependent on third parties to manufacture our drug
and drug-candidate compounds. The failure of these third parties
to perform successfully could harm our business.
We have utilized, and intend to continue utilizing, third
parties to manufacture docosanol 10% cream, Neurodex and our
other drug candidates. We have no experience in manufacturing
and do not have any manufacturing facilities. Currently, we have
only a single supplier for docosanol 10% cream and we do not
have any long-term supply agreements in place with this
manufacturer. Although we and GlaxoSmithKline maintain a
strategic reserve of docosanol 10% cream to mitigate against a
short-term supply disruption, any sustained disruption of our
supply could result in shipping and sales delays and additional
costs that could harm our operations.
Developing new pharmaceutical products for human use
involves product liability risks, for which we currently have
limited insurance coverage.
The testing, marketing, and sale of pharmaceutical products
involves the risk of product liability claims by consumers and
other third parties. We maintain product liability insurance
coverage for our clinical trials in the amount of
$5 million per incident and $5 million in the
aggregate. However, product liability claims can be high in the
pharmaceutical industry and our insurance may not sufficiently
cover our actual liabilities. If a suit against our business or
proposed products is successful, then the lack or insufficiency
of insurance coverage could affect materially and adversely our
business and financial condition. Furthermore, various
distributors of pharmaceutical products require minimum product
liability insurance coverage before their purchase or acceptance
of products for distribution. Failure to satisfy these insurance
requirements could impede our ability to achieve broad
distribution of our proposed products.
Abreva faces competition from a number of existing and
well-established products and the companies that market their
products.
We have the opportunity to earn royalties on Abreva product
wholesale sales if sales exceed $62 million a year. Abreva
competes with several other products for oral-facial herpes
currently on the market in the U.S., as well as other products
or potential products that are or may be under development or
undergoing FDA review. Most of the competing products are
manufactured by companies having substantial financial
resources, research and development facilities and manufacturing
and marketing experience. Even with Abreva being marketed by one
of the worlds largest consumer healthcare companies,
GlaxoSmithKline, not all competitive responses and the impacts
of those responses can be foreseen.
Business interruptions could adversely affect our
business.
Our operations are vulnerable to interruption by fire,
earthquake, power loss, telecommunications failure, and other
events beyond our control. For example, during 2001 and again in
2003, we experienced electrical power outages lasting several
hours. The loss of electrical power for any significant periods
of time could adversely affect our ability to conduct
experiments and could also harm our vendors. Further, we could
lose valuable data made to date in experiments currently
underway. We have mitigated the severity of power losses by
installing emergency power equipment, which we have used on
several occasions to supply electricity in the areas that we
consider to be the most critical to our operations. However, the
emergency power units do not cover all of our electrical needs
and, further, they might not operate properly in the event of a
power loss.
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Our financial results could be affected by potential
changes in the accounting rules governing the recognition of
stock-based compensation expense.
We measure compensation expense for our employee stock
compensation plans under the intrinsic value method of
accounting prescribed by Accounting Principles Board Opinion
No. 25, Accounting for Stock Issued to
Employees. In addition, we provide pro forma disclosures
of our operating results in our Notes to Consolidated Financial
Statements as if the fair value method of accounting had been
applied in accordance with SFAS No. 123,
Accounting for Stock-based Compensation. Had we
accounted for our compensation expense under the fair value
method of accounting prescribed by SFAS No. 123, the
charges would have been significantly higher, by approximately
$1,554,000, $2,176,000, and $1,540,000 during fiscal 2003, 2002,
and 2001, respectively. Recently, the Financial Accounting
Standards Board proposed changes to accounting rules concerning
the recognition of stock option compensation expense. If these
proposals are implemented, we and other companies would be
required to measure compensation expense using the fair value
method, which would adversely affect our results of operations
by reducing our income or increasing our losses by an amount
equal to the difference in the two measurement methods.
Risks Relating to Our Industry
The pharmaceutical industry is highly competitive and most
of our competitors are larger and have greater resources. As a
result, we face significant competitive hurdles.
The pharmaceutical and biotechnology industries are highly
competitive and subject to significant and rapid technological
change. We compete with hundreds of companies that develop and
market products and technologies in similar areas as our
research. For example, docosanol 10% cream faces worldwide
competition from the following products:
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OTC monograph preparations, including Carmex®,
Zilactin®, Campho®, Orajel®, Herpecin® and
others; |
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Zovirax® acyclovir (oral and topical) and Valtrex®
valacyclovir (oral) prescription products marketed by
Biovail Corporation and GlaxoSmithKline, respectively, and |
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Famvir® famciclovir (oral) and Denavir®
penciclovir (topical) prescription products marketed by
Novartis. |
Our competitors may have specific expertise and technologies
that are better than ours and many of these companies, either
alone or together with their research partners, have
substantially greater financial resources, larger research and
development staffs, and substantially greater experience than we
do. Accordingly, our competitors may develop superior products
or may develop competing products more rapidly. If we commence
commercial sales of our products, we will also be competing with
respect to manufacturing efficiencies and marketing
capabilities, areas in which we have limited or no direct
experience.
Our industry is highly regulated and our failure or
inability to comply with government regulations regarding the
development, production, testing, manufacturing and marketing of
our products may adversely affect our operations.
Governmental authorities in the U.S., including the FDA, and
other countries highly regulate the development, production,
testing, manufacturing and marketing of pharmaceutical products.
The clinical testing and regulatory approval process can take a
number of years and requires the expenditure of substantial
resources. Failure to obtain, or delays in obtaining, these
approvals will adversely affect our business operations,
including our ability to commence marketing of any of the
proposed products. We may find it necessary to use a significant
portion of our financial resources for research and development
and the clinical trials necessary to obtain these approvals for
our proposed products. We will continue to incur costs of
development without any assurance that we will ever obtain
regulatory approvals for any of our products under development.
Additionally, we cannot predict the extent to which adverse
governmental regulation might arise from future U.S. or
foreign legislative or administrative action. Moreover, we
cannot predict with accuracy the effects of any future changes
in the regulatory approval process and in the domestic health
care
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system for which we develop our products, or the costs of
on-going compliance regulations after marketing approval has
been obtained. Future changes could affect adversely the time
frame required for regulatory review, our financial resources,
and the sale prices of our proposed products, if approved for
sale.
Companies in our industry must protect their intellectual
property rights and operate without infringing on or
misappropriating the proprietary rights of others. Our inability
to do so could be costly and could significantly affect our
business prospects.
Biotechnology companies such as Avanir rely heavily on
intellectual property rights to protect their innovations.
Although we attempt to protect these rights by regularly filing
patent applications and requiring all employees to sign
confidentiality agreements, we cannot assure you that patents
will issue, that secrecy obligations will be honored, or that
others will not independently develop similar or superior
technology. Additionally, if our consultants, key employees or
other third parties apply to our projects technological
information independently developed by them or by others, then
disputes may arise as to the ownership rights of these
innovations.
Even if we successfully preserve our intellectual property
rights, other biotechnology or pharmaceutical companies may
allege that our technology infringes on their rights.
Intellectual property litigation is costly, and, even if we were
to prevail in such a dispute, the cost of such litigation would
adversely affect our business, financial condition and results
of operations. Litigation is also time consuming and would
divert managements attention and resources away from our
operations and other activities. If we were not to prevail in
any litigation, in addition to any damages we would have to pay,
we could be required to stop the infringing activity or obtain a
license. Any required license might not be available to us on
acceptable terms. Some licenses might be non-exclusive, and our
competitors could have access to the same technology licensed to
us. If we were to fail to obtain a required license or were
unable to design around a competitors patent, we would be
unable to sell or continue to develop some of our products,
which would have a material adverse affect on our business,
financial condition and results of operations.
Companies in our industry are frequently subjected to
product liability claims, which can be very costly to defend
against.
In the ordinary course of business, biotechnology and
pharmaceutical companies face various claims brought by third
parties, including claims relating to the safety or efficacy of
products. Any of these claims could subject us to costly
litigation and, while we generally believe that we have adequate
insurance to cover many different types of liabilities, our
insurance carriers may deny coverage or our policy limits may be
inadequate to fully satisfy any damage awards or settlements. If
this were to happen, the payment of any such awards could have a
material adverse effect on our operations and financial
position. Additionally, any such claims, whether or not
successful, could damage our reputation and business.
NOTE REGARDING FORWARD LOOKING STATEMENTS
This prospectus contains or incorporates by reference
forward-looking statements that involve risks and uncertainties.
The statements contained or incorporated by reference in this
prospectus that are not purely historical are forward-looking
statements within the meaning of Section 27A of the
Securities Act of 1933 (the 1933 Act)
and Section 21E of the Securities Exchange Act of 1934 (the
1934 Act), including without limitation
statements regarding our expectations, beliefs, intentions or
strategies regarding the future. All forward-looking statements
included in this document are based on information available to
us on the date hereof, and all forward-looking statements in
documents incorporated by reference are based on information
available to us as of the date of such documents. We assume no
obligation to update any such forward-looking statements. Our
actual results may differ materially from those discussed in the
forward-looking statements as a result of certain factors,
including those set forth above under Risk Factors
and elsewhere in this prospectus and in the documents
incorporated by reference into this prospectus. In evaluating
our business, prospective investors should carefully consider
these factors in addition to the other information set forth in
this prospectus and incorporated herein by reference.
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USE OF PROCEEDS
We will retain broad discretion over the use of the net proceeds
from the sale of our Class A common stock offered hereby.
Except as described in any prospectus supplement, we currently
anticipate using the net proceeds from the sale of our
Class A common stock hereby primarily to fund clinical
trials and for research and development, marketing and general
and administrative expenses. The amounts and timing of the
expenditures may vary significantly depending on numerous
factors, such as the progress of our research and development
efforts, regulatory approval status of Neurodex, technological
advances and the competitive environment for our products. We
may also use a portion of the net proceeds to acquire or invest
in complementary businesses, products and technologies. Although
we have no specific agreements, commitments or understandings
with respect to any acquisition, we evaluate acquisition
opportunities and engage in related discussions with other
companies from time to time.
Pending the use of the net proceeds, we intend to invest the net
proceeds in short-term, interest-bearing, investment-grade
securities.
PLAN OF DISTRIBUTION
We may sell the Class A common stock:
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to or through one or more underwriters or dealers; |
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directly to purchasers, through agents; or |
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through a combination of any of these methods of sale. |
We may distribute the Class A common stock:
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from time to time in one or more transactions at a fixed price
or prices, which may be changed from time to time; |
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at market prices prevailing at the times of sale; |
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at prices related to such prevailing market prices; or |
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at negotiated prices. |
We will describe the method of distribution of the Class A
common stock in the applicable prospectus supplement.
We may determine the price or other terms of the Class A
common stock offered under this prospectus by use of an
electronic auction. We will describe how any auction will
determine the price or any other terms, how potential investors
may participate in the auction and the nature of the obligations
of the underwriter, dealer or agent in the applicable prospectus
supplement.
Underwriters, dealers or agents may receive compensation in the
form of discounts, concessions or commissions from us or our
purchasers (as their agents in connection with the sale of the
Class A common stock). In addition, underwriters may sell
common stock to or through dealers, and those dealers may
receive compensation in the form of discounts, concessions or
commissions from the underwriters and/or commissions from the
purchasers for whom they act as agent. These underwriters,
dealers or agents may be considered to be underwriters under the
1933 Act. As a result, discounts, concessions or
commissions on resale received by the underwriters, dealers or
agents may be treated as underwriting discounts and commissions.
Each applicable prospectus supplement will identify any such
underwriter, dealer or agent, and describe any compensation
received by them from us. Any initial public offering price and
any discounts or concessions allowed or reallowed or paid to
dealers may be changed from time to time.
We may enter into agreements that provide for indemnification
against certain civil liabilities, including liabilities under
the 1933 Act, or for contribution with respect to payments
made by the underwriters, dealers or agents and to reimburse
these persons for certain expenses.
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We may grant underwriters who participate in the distribution of
the Class A common stock an option to purchase additional
shares of common stock to cover over-allotments, if any, in
connection with the distribution. Underwriters or agents and
their associates may be customers of, engage in transactions
with, or perform services for us in the ordinary course of
business.
In connection with the offering of the Class A common
stock, certain underwriters and selling group members and their
respective affiliates, may engage in transactions that
stabilize, maintain or otherwise affect the market price of the
Class A common stock. These transactions may include
stabilization transactions effected in accordance with
Rule 104 of Regulation M promulgated by the SEC
pursuant to which these persons may bid for or purchase common
stock for the purpose of stabilizing its market price.
The underwriters in an offering of the Class A common stock
may also create a short position for their account
by selling more common stock in connection with the offering
than they are committed to purchase from us. In that case, the
underwriters could cover all or a portion of the short position
by either purchasing common stock in the open market or by
exercising any over-allotment option granted to them by us. In
addition, any managing underwriter may impose penalty
bids under contractual arrangements with other
underwriters, which means that they can reclaim from an
underwriter (or any selling group member participating in the
offering) for the account of the other underwriters, the selling
concession for the Class A common stock that are
distributed in the offering but subsequently purchased for the
account of the underwriters in the open market. Any of the
transactions described in this paragraph or comparable
transactions that are described in any accompanying prospectus
supplement may result in the maintenance of the price of the
Class A common stock at a level above that which might
otherwise prevail in the open market. None of the transactions
described in this paragraph or in an accompanying prospectus
supplement are required to be taken by any underwriters and, if
they are undertaken, may be discontinued at any time.
LEGAL MATTERS
The legality of the issuance of the Class A common stock
being offered hereby will be passed upon by Heller Ehrman
White & McAuliffe, LLP, San Diego, California.
EXPERTS
The consolidated financial statements incorporated in this
prospectus by reference from Avanir Pharmaceuticals Annual
Report on Form 10-K have been audited by
Deloitte & Touche LLP, independent auditors, as stated
in their report, which is incorporated herein by reference, and
has been so incorporated in reliance upon the report of such
firm given upon their authority as experts in accounting and
auditing.
With respect to the unaudited interim financial information
which is incorporated herein by reference, Deloitte &
Touche LLP have applied limited procedures in accordance with
professional standards for a review of such information.
However, as stated in their report included in the
Companys Quarterly Report on Form 10-Q and
incorporated by reference herein, they did not audit and they do
not express an opinion on that interim financial information.
Accordingly, the degree of reliance on their reports on such
information should be restricted in light of the limited nature
of the review procedures applied. Deloitte & Touche LLP
are not subject to the liability provisions of Section 11
of the Securities Act of 1933 for their reports on the unaudited
interim financial information because those reports are not
reports or a part of the registration
statement prepared or certified by an accountant within the
meaning of Sections 7 and 11 of the Act.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference into this
prospectus the information contained in other documents we file
with the SEC, which means that we can disclose important
information to you by referring you to those documents. Any
statement contained in any document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified
or superseded, for purposes of this prospectus, to the
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extent that a statement contained in or omitted from this
prospectus, or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein,
modifies or supersedes such statement. Any such statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute a part of this prospectus.
We incorporate by reference the documents listed below and any
future filings we make with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Exchange Act until the offering is
completed:
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1. Our Annual Report on Form 10-K for the year ended
September 30, 2003; |
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2. Our Definitive Proxy Statement on Schedule 14A,
filed January 28, 2004; |
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3. Our Quarterly Reports on Form 10-Q for the quarters
ended December 31, 2003 and March 31, 2004; |
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4. Our Current Report on Form 8-K filed April 6,
2004; |
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5. The description of our Class A common stock
contained in our registration statement on Form 8-A (File
No. 001-15803) filed with the SEC on April 13, 2000,
including any amendment or report filed for the purpose of
updating such description. |
All other documents we file with the Securities and Exchange
Commission pursuant to Section 13(a), 13(c), 14 or 15(d) of
the 1934 Act after the date of this prospectus and prior to
the termination of the offering shall be deemed to be
incorporated by reference into this prospectus and to be a part
hereof from the date of filing of such documents. Any statement
contained in any document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified
or superseded for purposes of this prospectus to the extent that
a statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by
reference herein modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except
as modified or superseded, to constitute a part of this
prospectus.
Upon written or oral request, we will provide without charge to
each person to whom a copy of the prospectus is delivered a copy
of the documents incorporated by reference herein (other than
exhibits to such documents unless such exhibits are specifically
incorporated by reference herein). You may request a copy of
these filings, at no cost, by writing or telephoning us at the
following address: Avanir Pharmaceuticals, 11388 Sorrento
Valley Road, Suite 200, San Diego,
California 92121, Attention: Chief Financial Officer,
telephone: (858)622-5200. We have authorized no one to provide
you with any information that differs from that contained in
this prospectus. Accordingly, you should not rely on any
information that is not contained in this prospectus. You should
not assume that the information in this prospectus is accurate
as of any date other than the date of the front cover of this
prospectus.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the
1934 Act and in accordance therewith file reports, proxy
statements and other information with the Securities and
Exchange Commission. Our filings are available to the public
over the Internet at the Securities and Exchange
Commissions website at www.sec.gov, as well as at
our website at www.avanir.com. You may also read and
copy, at prescribed rates, any document we file with the
Securities and Exchange Commission at the Public Reference Room
of the Securities and Exchange Commission located at
450 Fifth Street, N.W., Suite 1024,
Washington, D.C. 20549. Please call the Securities and
Exchange Commission at (800) SEC-0330 for further
information on the Securities and Exchange Commissions
Public Reference Rooms.
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14
7,770,000 Shares
Class A Common Stock
PROSPECTUS SUPPLEMENT
April 5, 2005
CIBC World Markets
Leerink Swann & Co.