e424b5
The information in this preliminary prospectus supplement is not complete and may be changed.
This preliminary prospectus supplement and the accompanying prospectuses do not constitute an offer
to sell these securities and we are not soliciting offers to buy these securities in any
jurisdiction where the offer or sale is not permitted.
Filed Pursuant to Rule 424(b)(5)
Registration Nos. 333-161789 and 333-169175
SUBJECT TO COMPLETION, DATED NOVEMBER 16, 2010
PROSPECTUS SUPPLEMENT
(To Prospectuses dated September 23, 2009 and October 27, 2010)
Shares
Common Stock
We are offering shares of our common stock. Our common stock is quoted on the
NASDAQ Global Market under the symbol AVNR. On November 15, 2010, the last reported sale price of
our common stock on the NASDAQ Global Market was $4.76 per share.
Investing in our common stock involves a high degree of risk. Please read Risk Factors beginning on page S-6 of this prospectus supplement and in the documents incorporated by reference into this
prospectus supplement.
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
prospectuses is truthful or complete. Any representation to the contrary is a criminal offense.
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Proceeds to AVANIR Pharmaceuticals, Inc., Before Expenses
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Delivery of the shares of common stock is expected to be made on or about . We
have granted the underwriters an option for a period of 30 days to purchase up to an additional
shares of our common stock solely to cover over-allotments. If the underwriters exercise
the option in full, the total underwriting discount payable by us will be $ and the total
proceeds to us, before expenses, will be $ .
Sole Book-Running Manager
Jefferies & Company
Co-Managers
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Canaccord Genuity
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Wedbush PacGrow Life Sciences |
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Summer Street Research Partners
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Merriman Capital |
Prospectus Supplement dated November , 2010.
Table of Contents
PROSPECTUS SUPPLEMENT
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You should rely only on the information contained in or incorporated by reference in this
prospectus supplement, the accompanying prospectuses and in any free writing prospectus that we have
authorized for use in connection with this offering. We have not, and the underwriter has not,
authorized anyone to provide you with different information. If anyone provides you with different
or inconsistent information, you should not rely on it. We are not, and the underwriter is not,
making an offer to sell these securities in any jurisdiction where the offer or sale is not
permitted. You should assume that the information in this prospectus supplement, the accompanying
prospectuses, the documents incorporated by reference in the accompanying prospectuses, and in any free
writing prospectus that we have authorized for use in connection with this offering, is accurate
only as of the date of those respective documents. Our business, financial condition, results of
operations and prospects may have changed since those dates. You should read this prospectus
supplement, the accompanying prospectuses, the documents incorporated by reference in the
accompanying prospectuses, and any free writing prospectus that we have authorized for use in
connection with this offering, in their entirety before making an investment decision. You should
also read and consider the information in the documents to which we have referred you in the
sections of the accompanying prospectuses entitled Where You Can Find More Information and
Incorporation of Certain Information by Reference.
i
About This Prospectus Supplement
This prospectus supplement and the accompanying prospectuses form part of a registration statement on
Form S-3 that we filed with the Securities and Exchange Commission, or the SEC, using a shelf
registration process. This document contains two parts. The first part consists of this prospectus
supplement, which provides you with specific information about this offering. The second part, the
accompanying prospectuses, provides more general information, some of which may not apply to this
offering. Generally, when we refer only to the prospectus, we are referring to both parts
combined. This prospectus supplement may add, update or change information contained in the
accompanying prospectuses. To the extent that any statement we make in this prospectus supplement is
inconsistent with statements made in the accompanying prospectuses or any documents incorporated by
reference herein or therein, the statements made in this prospectus supplement will be deemed to
modify or supersede those made in the accompanying prospectuses and such documents incorporated by
reference herein and therein.
In this
prospectus supplement, Avanir, the Company, we, us, and our and similar terms refer to
Avanir Pharmaceuticals, Inc. and its subsidiaries on a consolidated basis. References to our
common stock refer to the common stock of Avanir Pharmaceuticals, Inc.
All references in this prospectus supplement to our consolidated financial statements include,
unless the context indicates otherwise, the related notes.
The industry and market data and other statistical information contained in this prospectus
supplement, the accompanying prospectuses and the documents we incorporate by reference are based on
managements own estimates, independent publications, government publications, reports by market
research firms or other published independent sources, and, in each case, are believed by
management to be reasonable estimates. Although we believe these sources are reliable, we have not
independently verified the information.
Cautionary Statement About Forward-Looking Information
Certain information set forth in this prospectus supplement, set forth in the accompanying
prospectuses or incorporated by reference in the accompanying
prospectuses, may contain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the
Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the
Exchange Act), that are intended to be covered by the safe harbor created by those sections.
Forward-looking statements, which are based on certain assumptions and describe our future plans,
strategies and expectations, can generally be identified by the use of forward-looking terms such
as believe, expect, may, will, should, would, could, seek, intend, plan,
estimate, goal, anticipate, project or other comparable terms. These statements include,
but are not limited to, our ability to successfully market and sell NUEDEXTA in the United States,
the safety and efficacy of NUEDEXTA, and the anticipated timing and success of the commercial
launch of NUEDEXTA. Forward-looking statements involve inherent risks and uncertainties, which
could cause actual results to differ materially from those in the forward-looking statements.
Risks that could cause actual results to differ from those anticipated in forward-looking
statements include the occurrence of adverse safety events with NUEDEXTA, our limited capital
resources, our dependence on third parties for manufacturing and distribution of NUEDEXTA, that we
may not adequately build or maintain the necessary sales, marketing, supply chain management and
reimbursement capabilities on our own or enter into arrangements with third parties to perform
these functions in a timely manner or on acceptable terms, and other risks that are described below
under the caption Risk Factors and those risks and uncertainties described in the documents
incorporated by reference into the accompanying prospectuses. We urge you to consider those risks and
uncertainties in evaluating our forward-looking statements. All subsequent written and oral
forward-looking statements attributable to us or to persons acting on our behalf are expressly
qualified in their entirety by the applicable cautionary statements. We further caution readers not
to place undue reliance upon any such forward-looking statements, which speak only as of the date
made. Except as otherwise required by the federal securities laws, we disclaim any intent to
publicly release any updates or revisions to any forward-looking statement contained herein or in
the accompanying prospectuses (or elsewhere) to reflect any change in our expectations with regard
thereto or any change in events, conditions or circumstances on which any such statement is based.
S-1
Prospectus Summary
The following summary of our business highlights some of the information contained elsewhere in or
incorporated by reference into the accompanying prospectuses. Because this is only a summary,
however, it does not contain all of the information that may be important to you. You should
carefully read this prospectus supplement and the accompanying prospectuses, including the documents
incorporated by reference, which are described under Where You Can Find More Information and
Incorporation of Certain Information by Reference in the accompanying prospectuses. You should also
carefully consider the matters discussed in the section in this prospectus supplement entitled
Risk Factors and in the accompanying prospectuses and in other periodic reports incorporated herein
by reference.
Our Company
AVANIR Pharmaceuticals, Inc. is a pharmaceutical company focused on acquiring, developing and
commercializing novel therapeutic products for the treatment of central nervous system disorders.
Our recently approved product, NUEDEXTA (formerly referred to as AVP-923 or its
previously proposed trade name Zenvia), is the first and only FDA-approved treatment for
pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated neurological
conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or
crying. PBA episodes typically occur out of proportion or incongruent to the patients underlying
emotional state.
NUEDEXTA is an innovative combination of two well-characterized components: dextromethorphan
hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate
(10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts
on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts
therapeutic effects in patients with PBA is unknown.
Studies to support the effectiveness of NUEDEXTA in PBA were performed in patients with amyotrophic
lateral sclerosis, or ALS, and multiple sclerosis, or MS. NUEDEXTA has not been shown to be safe
and effective in other types of emotional lability that can commonly occur, for example, in
Alzheimers disease and other dementias. The primary outcome measure, laughing and crying episodes,
was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the
Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean
decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
Higher dose formulations of AVP-923 also successfully completed a Phase III trial for the treatment
of patients with diabetic peripheral neuropathic pain, or DPN pain.
We may also pursue the
development of AVP-923 for the treatment of other neurological indications, such as pain secondary
to MS or anger/agitation secondary to dementia.
In addition to our focus on products for the central nervous system, we also have a number of
partnered programs in other therapeutic areas which may generate future income for us. Our first
commercialized product, docosanol 10% cream, (sold in the United States and Canada as Abreva® by
our marketing partner GlaxoSmithKline Consumer Healthcare) is the only over-the-counter treatment
for cold sores that has been approved by the FDA. In 2008, we out-licensed all of our monoclonal
antibodies and we remain eligible to receive milestone payments and royalties related to the sale
of these assets. Avanir was incorporated in California in August 1988 and was
reincorporated in Delaware in March 2009.
The PBA Market
There are an estimated 18 to 20 million people in the United States who suffer from the underlying
neurological conditions that can give rise to PBA. These underlying neurologic conditions include
but are not limited to ALS, MS, Alzheimers disease, Parkinsons disease, stroke and traumatic
brain injury. Extrapolating from the epidemiologic medical literature, physician estimates and an
Avanir-sponsored patient survey, which surveyed a total of 2,464 patients and caregivers of patients with underlying neurologic conditions associated with PBA (including
ALS, Alzheimers disease/dementias, MS, Parkinsons disease, stroke and traumatic brain injury), we estimate that between 1.8 and 2.0 million people in the United States suffer from
moderate to severe PBA, with many more suffering from mild PBA.
Other than NUEDEXTA, there are no approved therapies indicated to treat PBA. Currently, some
physicians treat PBA using a range of drugs off-label, including: SSRIs/SNRIs, antidepressants,
atypical antipsychotics, atypical
S-2
antipsychotics/tranquilizers and mood stabilizers. According to our market research, physicians
are generally only moderately satisfied with these off-label therapies as a treatment for PBA, with
physician satisfaction scores on a scale of 1 to 10 ranging from 4.8 to 6.0, and with an average
score of 5.4 (on this scale, 10 represents completely satisfied and 1 represents not at all
satisfied). We conducted this market research through an Internet-based survey of 215 physicians, consisting of
Neurologists, Internal Medicine/Geriatrics, Psychiatrists and Physical Medicine and Rehabilitation
specialists.
We believe that NUEDEXTA represents a more attractive treatment option for patients suffering from
PBA. In our Phase III STAR trial that was completed in 2009 with patients suffering from either
ALS or MS as the underlying neurological condition, patients treated with NUEDEXTA reported an
average overall 80% reduction in episodes at the end of the 12-week study compared to baseline,
with an average 50% reduction in episodes in the first week of treatment. Over the course of the
12-week study, patients receiving NUEDEXTA experienced significantly lower PBA episode rates
versus placebo (P<.001). Over the final two weeks of the STAR trial, one-half of patients treated
with NUEDEXTA achieved episode-free remission.
Our market research, conducted pursuant to the physician survey described above, indicates that 85% of surveyed physicians within targeted physician specialties
would likely or very likely prescribe NUEDEXTA to treat their patients suffering from PBA. Of the
surveyed physicians, the highest use was expected to be in PBA patients who have underlying
conditions of either stroke or traumatic brain injury, but physicians expect to treat all PBA
patient populations with NUEDEXTA. Among those physicians expressing an intent to prescribe
NUEDEXTA, 78% indicated that NUEDEXTA would likely be used as a first-line therapy or an add-on
therapy.
Commercialization Strategy
We intend to market NUEDEXTA initially to approximately 14,000 physicians who primarily specialize in
psychiatry and neurology. Our commercialization strategy for NUEDEXTA includes the following
elements:
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Increase awareness of PBA. We are seeking to increase awareness, recognition and
diagnosis of PBA through advertising, sales force efforts, involvement in patient advocacy
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Promote trial and adoption of NUEDEXTA. We plan to promote the initial trial and
adoption of NUEDEXTA with a number of tactics, including: trial samples, sales force
promotion to healthcare practitioners, participation in medical meetings and peer-to-peer
physician speaker events. |
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Increase brand awareness of NUEDEXTA. Through involvement in patient advocacy groups,
targeted direct-to-patient advertising and use of digital and social media, we hope to
increase brand awareness for NUEDEXTA and to motivate patients and caregivers to request
NUEDEXTA as a treatment option. |
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Minimize payment and distribution barriers. We have hired an experienced national sales
accounts team in an effort to establish third party payor coverage and reimbursement. We
plan to make use of co-pay cards, coupons and reimbursement counseling services, as well as
preparing an informational kit for the use of Pharmacy and Therapeutics (P&T) committees
conducting formulary reviews. |
Our market research on third party payor adoption of NUEDEXTA indicates that the imposition of
utilization restrictions would be primarily driven by price. We currently expect that the annual price will range between $3,000 to $5,000, although final pricing has not yet
been determined. We expect that a majority of plans will place NUEDEXTA on the 3rd tier
formulary on an unrestricted basis or on the 2nd tier formulary with a prior
authorization. We expect that certain third party payors may not be familiar with PBA.
Accordingly, we will also seek to educate managed care decision makers about the PBA disease state
and the NUEDEXTA value proposition, based on the clinical data from our STAR trial.
Recent Developments
On October 29, 2010, we received approval from the U.S. Food and Drug Administration for the
commercialization of NUEDEXTA. Since that time, we have begun
to hire our sales force and expect that approximately 75 sales
representatives will be hired by the end of November 2010. As of the date
of this prospectus supplement, approximately 72 sales
representatives had accepted offers of employment. We currently expect to commercially launch NUEDEXTA in February 2011.
S-3
On November 1, 2010, we announced selected preliminary unaudited financial results for the fiscal
year ended September 30, 2010. We estimate that our total cash, cash equivalents and restricted
investments as of September 30, 2010 was approximately $39.4 million, which does not include, among
other things, approximately $5.1 million of proceeds received by us subsequent to September 30,
2010 upon the exercise of outstanding common stock warrants.
On September 13, 2010, the U.S. Securities and Exchange Commission, or SEC, issued a disciplinary
order affecting our independent registered public accounting firm, KMJ Corbin & Company LLP, or
KMJ. The SEC order prohibits KMJ from accepting new audit engagements through March 31, 2011. The
SEC order did not prohibit the firm from practicing before the SEC and providing audit
and other attestation services for its existing audit clients. The SEC order related to deficiencies in the audit of
another KMJ audit client, unrelated to Avanir. In light of the disciplinary order, our Audit
Committee investigated the matter, including KMJs policies and procedures as they related to the
audit of our financial statements. Based on that investigation, the Audit Committee concluded that
no other additional procedures, related to previously issued audit opinions by KMJ, were found
to be necessary.
Corporate Information
Our principal executive offices are located at 101 Enterprise, Suite 300, Aliso Viejo, California
92656. Our telephone number is 949-389-6700. Our Internet website address is www.avanir.com. Our
Internet website and the information contained therein or connected thereto are not part of this
prospectus supplement, the accompanying prospectuses or any document incorporated or deemed
incorporated by reference herein.
S-4
The Offering
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Common stock offered by us
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Common stock to be outstanding after this offering
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Over-Allotment Option
We have granted the underwriters an option to purchase up to additional
shares of our common stock to cover over-allotments, if any. This option is exercisable, in
whole or in part, for a period of 30 days from the date of this prospectus supplement.
Use of Proceeds
We intend to use the net proceeds from this offering for sales and marketing activities
relating to the launch of NUEDEXTA, the further development of NUEDEXTA for other indications
(such as pain secondary to MS, anger/agitation secondary to dementia or diabetic peripheral
neuropathic pain), and for general working capital and business development activities. 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. We expect the proceeds
from this offering together with existing cash and cash equivalents to be sufficient to support
our operations, including the commercial launch of NUEDEXTA, for at least the next 24 months.
See Use of Proceeds on page S-19.
Risk Factors
This investment involves a high degree of risk. See the information contained in or
incorporated by reference under Risk Factors beginning on page S-6 of this prospectus
supplement, page 3 of the accompanying September 23, 2009 prospectus and page 4 of the accompanying October 27, 2010 prospectus and in the documents incorporated by
reference into this prospectus supplement.
NASDAQ Global Market Symbol
Our common stock is listed on the NASDAQ Global Market under the symbol AVNR.
The number of shares of common stock to be outstanding after this offering is based on 93,968,532
shares outstanding on June 30, 2010 and excludes as of that date:
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options representing the right to purchase a total of 6,257,087 shares of common stock
at a weighted average exercise price of $1.66 per share; |
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restricted stock units representing a total of 980,964 shares of common stock issuable
upon vesting; |
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restricted stock units representing a total of 1,069,680 vested shares of common stock
issuable to directors; and |
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warrants representing the right to purchase a total of 12,240,437 shares of common stock
at a weighted-average exercise price of $1.43 per share. |
Subsequent to June 30, 2010, an additional 3.5 million shares of common stock were issued upon
exercise of outstanding warrants, resulting in proceeds to the
company of approximately $5,100,000,
and a total of approximately 2.9 million shares were sold pursuant to our July 30, 2009 prospectus for
our at-the-market offering facility, resulting in gross offering proceeds of approximately
$10,500,000.
If the underwriters over-allotment option is exercised in full, we will issue and sell an
additional shares of our common stock and will have shares
outstanding after the offering.
S-5
Except as otherwise noted, all information in this prospectus supplement assumes no exercise of the
underwriters over-allotment option.
Risk Factors
An investment in our common stock involves a high degree of risk. Before deciding whether to invest
in our common stock, you should consider carefully the risks described below and discussed under
the sections captioned Risk Factors contained in our Annual Report on Form 10-K for the year
ended September 30, 2009 and our subsequent Quarterly Reports on Form 10-Q, which are incorporated
by reference in the accompanying prospectuses in their entirety, together with other information in
this prospectus supplement, the accompanying prospectuses, the information and documents incorporated
by reference, and in any free writing prospectus that we have authorized for use in connection with
this offering. If any of these risks actually occurs, our business, financial condition, results of
operations or cash flow could be seriously harmed. This could cause the trading price of our common
stock to decline, resulting in a loss of all or part of your investment.
Our business, financial condition or results of operations could be materially adversely affected
by any of these risks. The trading price of our securities could decline due to any of these risks,
and you may lose part or all of your investment. This prospectus supplement, the accompanying
prospectuses and the incorporated documents also contain forward-looking statements that involve
risks and uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of certain factors, including the risks mentioned below.
Forward-looking statements included in this prospectus supplement 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 disclaim
any intent to update any forward-looking statements.
Risks Relating to Our Business
Our near-term prospects are dependent on NUEDEXTA. If we are unable to successfully commercialize NUEDEXTA, including successfully maintaining adequate sales, marketing or distribution capabilities
or entering into agreements with third parties to perform some of these functions, we will not be
able to commercialize NUEDEXTA effectively and our ability to generate significant revenue or
achieve profitability will be adversely affected.
Although NUEDEXTA has been approved for marketing, our ability to generate significant
revenue in the near to medium term is entirely dependent upon our ability to commercialize
NUEDEXTA. As we prepare for the launch of NUEDEXTA, we may not be able to adequately build or
maintain the necessary sales, marketing, supply chain management or reimbursement capabilities on
our own or enter into arrangements with third parties to perform these functions in a timely manner
or on acceptable terms. Additionally, maintaining sales, marketing and distribution capabilities
may be more expensive than we anticipate, requiring us to divert capital from other intended
purposes or preventing us from building our sales, marketing and distribution capabilities to the
desired levels. To be successful we must:
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recruit and retain adequate numbers of effective sales personnel; |
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effectively train our sales personnel on NUEDEXTA; |
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establish and maintain successful sales and marketing and education programs for our targeted physicians; |
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manage geographically dispersed sales and marketing operations; and |
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maintain and defend our patent protection and maintain regulatory exclusivity for NUEDEXTA. |
The commercialization of NUEDEXTA requires us to manage relationships with an increasing
number of collaborative partners, suppliers and third-party contractors. If we are unable to
successfully establish and maintain the required infrastructure, either internally or through third
parties, and successfully manage an increasing number of relationships, we will have difficulty
growing our business. In addition, we may enter into co-promotion or out-licensing arrangements
with other pharmaceutical or biotechnology partners where necessary
to reach customers in domestic or foreign
S-6
market segments and when deemed strategically and economically advisable. To the extent that we
enter into co-promotion or other licensing arrangements, our product revenues are likely to be
lower than if we directly marketed and sold NUEDEXTA, and some or all of the revenues we receive
will depend upon the efforts of third parties, which may not be successful. If we are unable to
develop and maintain adequate sales, marketing and distribution capabilities, independently or with
others, we may not be able to generate significant product revenue or become profitable.
We have a history of net losses and an accumulated deficit, and we may never generate sufficient
revenue to achieve or maintain profitability in the future.
We have experienced significant net losses and negative cash flows from operations and we
expect our negative cash flow from operations to continue until we are able to generate significant
revenues from sales of NUEDEXTA. As of June 30, 2010, we had an accumulated deficit of
approximately $295.0 million. We have incurred these losses principally from costs incurred in
funding the research, development and clinical testing of our drug candidates and from our general
and administrative expenses. We may continue incurring net losses for the foreseeable future and we
expect our operating losses to increase for at least the short term as we increase our total
expenditures in preparation for the commercial launch of NUEDEXTA.
Our ability to generate revenue and achieve profitability is dependent on our ability,
alone or with partners, to successfully manufacture and market NUEDEXTA for the treatment of
patients with PBA. We expect to continue to spend substantial amounts on preparing for the
commercial launch of NUEDEXTA in PBA, as well as seeking regulatory approvals for use of NUEDEXTA
in other geographic markets and indications. As a result, we may never generate sufficient revenue
from product sales to become profitable or generate positive cash flows.
PBA is a new market and estimates vary significantly over the potential market size and our
anticipated revenues over the near and long term.
Our
drug is being made available to patients to treat PBA, an indication for which there is no established
pharmaceutical market. Industry sources and equity research analysts have a wide divergence of
estimates for the near- and long-term market potential of our product. A variety of assumptions
directly impact the estimates for our drugs market potential, including estimates of underlying
neurologic condition prevalence, severity of PBA prevalence among these conditions, rates of
physician adoption of our drug for treatment of PBA among these populations, drug pricing
assumptions, and patient adherence and compliance rates within each underlying neurologic
condition. Small differences in these assumptions can lead to widely divergent estimates of the
market potential of our product. Accordingly, investors are cautioned not to place undue reliance
on any particular estimates of equity research analysts or industry sources.
We have limited capital resources and may need to raise additional funds to support our operations.
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 for the foreseeable future. As of September 30, 2010, we had approximately $39.4 million in
cash and cash equivalents and restricted investments in marketable securities (which does not
include, among other things, approximately $10.0 million of proceeds received by the Company
subsequent to September 30, 2010 upon the exercise of
outstanding common stock warrants and sales under our Cantor
Fitzgerald & Co. at-the-market offering facility).
Additionally, we currently do not have any meaningful sources of recurring revenue or cash flow
from operations.
In light of our current capital resources, lack of near-term revenue opportunities and
substantial long-term capital needs, including significant costs relating to the expected launch of
NUEDEXTA in early 2011, we may need to partner (either in the U.S. or outside the U.S.) or raise
additional capital in the future, including in connection with this
offering, to finance our long-term operations, including the
commercialization of NUEDEXTA, until we expect to be able to generate meaningful amounts of revenue
from product sales. Based on our current loss rate and existing capital resources as of the date of
this prospectus supplement, we estimate that we have sufficient funds to sustain our operations at their
current levels through at least the next 12 months, which includes the initial planned launch of
NUEDEXTA for PBA in 2011. If this offering is completed, we expect that we will have sufficient
funds to sustain our operations, including funding the launch of NUEDEXTA, for at least the next 24
months. Although we expect to be able to raise additional capital,
including through this offering, there can be no assurance that
we will be able to do so or that the available terms of any financing would be acceptable to us. If
we are unable to raise additional capital to fund future operations, then we may be unable to fully
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execute our development and commercialization plans for NUEDEXTA. This may result in significant
delays or cutbacks in the commercialization of NUEDEXTA and may force us to further curtail our
operations.
Any transactions that we may engage in to raise capital could dilute our stockholders and diminish
certain commercial prospects.
Although we believe that, upon completion of this offering, we will have adequate capital
reserves to sustain our operations, including funding the launch of NUEDEXTA, for at least the next
24 months, we expect that we may need to raise additional capital in the future. We may do so
through various financing alternatives, including licensing or sales of our technologies, drugs
and/or drug candidates, selling shares of common or preferred stock, through the acquisition of
other companies, or through the issuance of debt. Each of these financing alternatives carries
certain risks. Raising capital through the issuance of common stock may depress the market price of
our stock. Any such financing will dilute our existing stockholders and, if our stock price is
relatively depressed at the time of any such offering, the levels of dilution would be greater. In
addition, debt financing, to the extent available, may involve agreements that include covenants
limiting or restricting our ability to take specific actions, such as making capital expenditures
or entering into licensing transactions. If we seek to raise capital through licensing transactions
or sales of one or more of our technologies, drugs or drug candidates, as we have previously done
with certain investigational compounds and docosanol 10% cream, then we will likely need to share a
significant portion of future revenues from these drug candidates with our licensees. Additionally,
the development of any drug candidates licensed or sold to third parties will no longer be in our
control and thus we may not realize the full value of any such relationships.
In July 2009, we entered into a financing facility with Cantor Fitzgerald & Co., providing for
the sale of up to 12.5 million shares of our common stock from time to time into the open market at
prevailing prices. Through the date of this prospectus supplement, we have sold a total of
approximately 7.6 million shares under this facility. Additionally, as of the date of this
prospectus supplement, we have effective shelf registration statements registering the sale of up
to approximately $136,000,000 of our common stock, preferred stock, debt securities and warrants, which
includes amounts that may be offered hereunder. Although we do not expect to make use of the
financing facility after this offering, a significant number of shares of common stock could be
issued in a short period of time under our existing registration statements. These sales, or the
perceived risk of dilution from potential sales of stock through this facility, may cause holders
of our common stock to sell their shares, or it may encourage short selling by market participants,
which could contribute to a decline in our stock price. A decline in our stock price might impede
our ability to raise capital through the issuance of additional shares of common stock or other
equity securities, and may cause our stockholders to lose part or all of the value of their
investment in our stock.
Significant safety or drug interaction problems could arise with respect to NUEDEXTA, which could
result in restrictions in NUEDEXTAs label, recalls, withdrawal of NUEDEXTA from the market, an
adverse impact on potential sales of NUEDEXTA, or cause us to alter or terminate current or future
NUEDEXTA clinical development programs, any of which would adversely impact our future business
prospects.
Discovery of previously unknown safety or drug interaction problems with an approved product
may result in a variety of adverse regulatory actions. Under the Food and Drug Administration
Amendments Act of 2007, the FDA has broad authority to force drug manufacturers to take any number
of actions if previously unknown safety or drug interaction problems arise, including, but not
limited to: (i) requiring manufacturers to conduct post-approval clinical studies to assess known
risks or signals of serious risks, or to identify unexpected serious risks; (ii) mandating labeling
changes to a product based on new safety information; or (iii) requiring manufacturers to implement
a Risk Evaluation Mitigation Strategy, or REMS, where necessary to assure safe use of the drug. In
addition, previously unknown safety or drug interaction problems could result in product recalls,
restrictions on the products permissible uses, or withdrawal of the product from the market.
The combination of dextromethorphan and quinidine has never been marketed for the treatment of
any condition until the approval of NUEDEXTA. NUEDEXTA has only been studied in a limited number
of patients in clinical studies and the data submitted to the FDA as part of our New Drug
Application was obtained in controlled clinical trials of limited duration. In connection with the
approval of NUEDEXTA, the FDA has required that we conduct certain post-approval studies, which
include both non-clinical studies and a pediatric study. New safety or drug interaction issues may
arise from these studies or as NUEDEXTA is used over longer periods of time by a wider group of
patients. In addition, as we conduct other clinical trials for NUEDEXTA in other indications, new
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safety problems may be identified which could negatively impact both our ability to
successfully complete these studies and the use and/or regulatory status of NUEDEXTA for the
treatment of PBA. New safety or drug interaction issues may result in product liability lawsuits
and may require us to, among other things, provide additional warnings and/or restrictions on the
NUEDEXTA package insert, including a boxed warning, directly alert healthcare providers of new
safety information, narrow our approved indications, or alter or terminate current or planned
trials for additional uses of NUEDEXTA, any of which could have a significant adverse impact on
potential sales of NUEDEXTA.
In addition, if we are required to conduct additional post-approval clinical studies,
implement a REMS, or take other similar actions, such requirements or restrictions could have a
material adverse impact on our ability to generate revenues from sales of NUEDEXTA, or require us
to expend significant additional funds.
We have
out-licensed or sold most of our non-core drug development programs and related assets and
these and other possible future dispositions carry certain risks.
We have entered into agreements for the licensing out or sale of our non-core assets,
including FazaClo, our anthrax antibody program, and other antibodies in our infectious disease
program, as well as docosanol in the U.S. and other markets worldwide. As a result, we do not currently have a
diversified pipeline of product candidates and our long-term success is currently dependent on
NUEDEXTA. From time to time, we have been and will continue to be engaged in discussions with
potential licensing or development partners for NUEDEXTA for PBA and/or other indications and we
may choose to pursue a partnership or license involving NUEDEXTA, if the terms are attractive.
However, these transactions involve numerous risks, including:
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diversion of managements attention from normal daily operations of the business; |
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disputes over earn-outs, working capital adjustments or contingent payment obligations; |
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insufficient proceeds to offset expenses associated with the transactions; and |
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the potential loss of key employees following such a transaction. |
Transactions such as these carry significant risks where a large portion of the total
consideration is contingent upon post-closing events, such as commercialization or sales
milestones. We may not exercise control over whether these milestones are met and, if they are not
met, then a potentially large portion of the value of the transaction may not be realized. Disputes
may also develop over these and other terms, such as representations and warranties, indemnities,
earn-outs, and other provisions in the transaction agreements. If disputes are resolved
unfavorably, our financial condition and results of operations may be adversely affected and we may
not realize the anticipated benefits from the transactions.
Disputes relating to these transactions can lead to expensive and time-consuming
litigation and may subject us to unanticipated liabilities or risks, disrupt our operations, divert
managements attention from day-to-day operations, and increase our operating expenses.
The FDAs safety concerns regarding our prior formulation of AVP-923 for the treatment of PBA
extend to other clinical indications that we have been pursuing, including DPN pain. Due to these
concerns, any future development of AVP-923 for other indications is expected to use an alternative
lower-dose quinidine formulation, which may negatively affect efficacy.
We have successfully completed a single Phase III trial for AVP-923 in the treatment of
DPN pain. In communications regarding the continued development of AVP-923 for this indication, the
FDA has expressed that the safety concerns and questions raised in the PBA approvable letter
necessitate the testing of a low-dose quinidine formulation in the DPN pain indication as well.
Additionally, based on feedback we have received from the FDA on the proposed continued development
of AVP-923 for this indication, we believe it is likely that two large well-controlled Phase III
trials would be needed to support a supplemental NDA filing for this indication. Due to our limited capital
resources, we do not expect that we will be able to conduct the trials needed for this indication
without additional capital or a development partner for NUEDEXTA. Moreover, although we achieved
positive results in our initial Phase III trial, an alternative low-dose quinidine formulation may
not yield the same levels of efficacy as seen in the
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earlier trials or as predicted based on our subsequent pharmacokinetic study. Any decrease in efficacy may be so
great that the drug does not demonstrate a statistically significant
improvement over placebo or an active comparator.
Additionally, any alternative low-dose quinidine formulation that we develop may not sufficiently
satisfy the FDAs safety concerns. If this were to happen, we may not be able to pursue the
development of AVP-923 for other indications or may need to undertake significant additional
clinical trials, which would be costly and cause potentially substantial delays.
Our issued patents may be challenged and our patent applications may be denied. Either result would
seriously jeopardize our ability to compete in the intended markets for our proposed products.
We have invested in an extensive patent portfolio and we rely substantially on the
protection of our intellectual property through our ownership or control of issued patents and
patent applications. 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 patent applications will be granted; |
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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 technologies will not infringe on other patents or rights owned by others, including
licenses to other intellectual property that may not be available to us; |
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any of our issued patents will provide us with significant competitive advantages; |
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challenges will not be instituted against the validity or enforceability of any patent that
we own or have licensed, and, if challenged, that we will be
successful in defending ourselves against these challenges; or |
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we will be able to secure additional worldwide intellectual property protection for our
NUEDEXTA patent portfolio. |
Even if we successfully secure our intellectual property rights, third parties, including
other biotechnology or pharmaceutical companies, may allege that our technology infringes on their
rights or that our patents are invalid or not enforceable. Intellectual property litigation is costly, and even if we
were to prevail in such a dispute, the cost of litigation could 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 to
lose 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, or at all. 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 effect on our business, financial
condition and results of operations.
It is unclear whether we would be eligible for patent-term restoration in the U.S. under applicable
law and we therefore do not know whether our patent-term can be extended.
Some of our U.S. patents may be eligible for limited patent term extension under the Drug
Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman
Amendments. Due to receipt of approval for NUEDEXTA, the Hatch-Waxman Amendments permit a patent
restoration term of up to five years for one of our patents covering NUEDEXTA as compensation for
the patent term lost during product development and the regulatory review process. The patent term
restoration period is generally one-half the time between the effective date of an IND and the
submission date of an NDA, plus the time between the submission date of an NDA and the approval of
that application with a maximum of five years. We intend to apply for patent term restoration.
However, because NUEDEXTA is not a new chemical entity, but is a combination of two previously
approved products, it is uncertain whether NUEDEXTA will be granted any patent term restoration
under the U.S. Patent and Trademark Office guidelines. In addition, the patent term restoration
cannot extend the remaining term of a patent beyond a total of 14 years after the products
approval date.
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Market exclusivity provisions under the Federal Food, Drug and Cosmetic Act, or the FDCA,
also may delay the submission or the approval of certain applications for competing product
candidates. The FDCA provides three years of non-patent marketing exclusivity for an NDA if new
clinical investigations, other than bioavailability studies, that were conducted or sponsored by
the applicant are deemed by the FDA to be essential to the approval of the application. This
three-year exclusivity covers only the conditions associated with the new clinical investigations
and does not prohibit the FDA from approving abbreviated NDAs (ANDA) for drugs containing the original
active agent.
Once the three-year FDCA exclusivity period has passed and after the patents (including
the patent restoration term, if any) that cover NUEDEXTA expire or have been invalidated, generic drug companies would be
able to introduce competing versions of the drug. If we are unsuccessful in defending our patents
against generic competition, our long-term revenues from NUEDEXTA sales may be less than expected,
we may have greater difficulty finding a development partner or licensee for NUEDEXTA and the costs
to defend the patents would be significant.
NUEDEXTA may face competition from lower cost generic or follow-on products.
NUEDEXTA is approved under the provisions of the FDCA, which renders it susceptible to potential competition from generic manufacturers via
the Abbreviated New Drug Application, or ANDA, procedure. Generic manufacturers pursuing ANDA
approval are not required to conduct costly and time-consuming clinical trials to establish the
safety and efficacy of their products; rather, they are permitted to rely on the innovators data
regarding safety and efficacy. Thus, generic manufacturers can sell their products at prices much
lower than those charged by the innovative pharmaceutical or biotechnology companies who have
incurred substantial expenses associated with the research and development of the drug product.
The ANDA procedure includes provisions allowing generic manufacturers to challenge the
innovators patent protection by submitting Paragraph IV certifications to the FDA in which the
generic manufacturer claims that the innovators patent is invalid or will not be infringed by the
manufacture, use, or sale of the generic product. A patent owner who receives a Paragraph IV
certification may choose to sue the generic applicant for patent infringement. In recent years,
generic manufacturers have used Paragraph IV certifications extensively to challenge the
applicability of patents listed in the FDAs Approved Drug Products List with Therapeutic
Equivalence Evaluations, commonly referred to as the Orange Book, on a wide array of innovative
therapeutic products. We expect this trend to continue and to implicate drug products with even
relatively modest revenues.
If an ANDA filer were to receive approval to sell a generic version of NUEDEXTA, NUEDEXTA
would become subject to increased competition and our revenue would be adversely affected.
Additionally, it is possible that compounding pharmacies could formulate a generic version of
NUEDEXTA in violation of our patent rights, which could also adversely affect our revenues.
We may be unable to protect our unpatented proprietary technology and information.
In addition to our patented intellectual property, we also rely on trade secrets and
confidential information. We may be unable to effectively protect our rights to such proprietary
technology or information. Other parties may independently develop or gain access to equivalent
technologies or information and disclose it for others to use. Disputes may arise about
inventorship and corresponding rights to know-how and inventions resulting from the joint creation
or use of intellectual property by us and our corporate partners, licensees, scientific and
academic collaborators and consultants. In addition, confidentiality agreements and material
transfer agreements we have entered into with these parties and with employees and advisors may not
provide effective protection of our proprietary technology or information or, in the event of
unauthorized use or disclosure, may not provide adequate remedies.
If we fail to obtain regulatory approval in foreign jurisdictions, we would not be able to market
our products abroad and our revenue prospects would be limited.
We may seek to have our products or product candidates marketed outside the United States.
In order to market our products in the European Union and many other foreign jurisdictions, we must
obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.
The approval procedure varies among countries and jurisdictions and can involve additional testing.
The time required to obtain approval may differ from that required to obtain FDA approval. The
foreign regulatory approval processes may include all of the risks
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associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely
basis, if at all. For example, our development partner in Japan encountered significant difficulty
in seeking approval of docosanol in that country and was forced to abandon efforts to seek approval
in that country. Approval by the FDA does not ensure approval by regulatory authorities in other
countries or jurisdictions, and approval by one foreign regulatory authority does not ensure
approval by regulatory authorities in other foreign countries or jurisdictions or by the FDA. We
may not be able to file for regulatory approvals and may not receive necessary approvals to
commercialize our products in any market. The failure to obtain these approvals could materially
adversely affect our business, financial condition and results of operations.
We face challenges recruiting and retaining members of management and other key personnel.
The industry in which we compete has a high level of employee mobility and aggressive
recruiting of skilled employees. This type of environment creates intense competition for qualified
personnel, particularly in commercial, clinical and regulatory affairs, research and development
and accounting and finance. Because we have a relatively small organization, the loss of any
executive officers, including the Chief Executive Officer, key members of senior management or
other key employees, could adversely affect our operations. For example, if we were to lose one or
more of the senior members of our sales and marketing team, the success of the NUEDEXTA launch
could be adversely affected.
Risks Relating to Our Industry
There are a number of difficulties and risks associated with clinical trials and our trials may not
yield the expected results.
There are a number of difficulties and risks associated with conducting clinical trials.
For instance, we may discover that a product candidate does not exhibit the expected therapeutic
results, may cause harmful side effects or have other unexpected characteristics that may delay or
preclude regulatory approval or limit commercial use if approved. It typically takes several years
to complete a late-stage clinical trial and a clinical trial can fail at any stage of testing. If
clinical trial difficulties or failures arise, our product candidates may never be approved for
sale or become commercially viable.
In addition, the possibility exists that:
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the results from earlier clinical trials may not be predictive of results
that will be obtained from subsequent clinical trials, particularly larger
trials; |
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institutional review boards or regulators, including the FDA, may hold,
suspend or terminate our clinical research or the clinical trials of our
product candidates for various reasons, including noncompliance with
regulatory requirements or if, in their opinion, the participating subjects
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subjects may drop out of our clinical trials; |
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our preclinical studies or clinical trials may produce negative,
inconsistent or inconclusive results, and we may decide, or regulators may
require us, to conduct additional preclinical studies or clinical trials; |
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trial results derived from top-line data, which is based on a preliminary
analysis of efficacy and safety data related to primary and secondary
endpoints, may change following a more comprehensive review of the complete
data set derived from a particular clinical trial or may change due to FDA
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the cost of our clinical trials may be greater than we currently anticipate. |
It is possible that earlier clinical and pre-clinical trial results may not be predictive
of the results of subsequent clinical trials. If earlier clinical and/or pre-clinical trial results
cannot be replicated or are inconsistent with subsequent results, our development programs may be
cancelled or deferred. In addition, the results of these prior
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clinical trials may not be acceptable to the FDA or similar foreign regulatory authorities because
the data may be incomplete, outdated or not otherwise acceptable for inclusion in our submissions
for regulatory approval.
Additionally, the FDA has substantial discretion in the approval process and may reject
our data or disagree with our interpretations of regulations or draw different conclusions from our
clinical trial data or ask for additional information at any time during their review. For example,
the use of different statistical methods to analyze the efficacy data from our Phase III trial of
AVP-923 in DPN pain results in significantly different conclusions about the efficacy of the drug.
Although we believe we have legitimate reasons to use the methods that we have adopted as outlined
in our SPA with the FDA, the FDA may not agree with these reasons and may disagree with our
conclusions regarding the results of these trials.
Although we would work to be able to fully address any such FDA concerns, we may not be
able to resolve all such matters favorably, if at all. Disputes that are not resolved favorably
could result in one or more of the following:
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delays in our ability to submit an NDA; |
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the refusal by the FDA to accept for filing any NDA we may submit; |
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requests for additional studies or data; |
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delays in obtaining an approval; |
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the rejection of an application; or |
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the approval of the drug, but with adverse labeling claims that
could adversely affect the commercial market. |
If we do not receive regulatory approval to sell our product candidates or cannot
successfully commercialize our product candidates, we would not be able to generate meaningful
levels of sustainable revenues.
The pharmaceutical industry is highly competitive and most of our competitors have larger
operations 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 areas similar to those in which we are performing our research.
For example, we expect that NUEDEXTA will face competition from antidepressants, atypical
anti-psychotic agents and other agents in the treatment of PBA.
Our competitors may have specific expertise and development technologies that are better
than ours and many of these companies, which include large pharmaceutical companies, either alone
or together with their research partners, have substantially greater financial resources, larger
research and development capabilities and substantially greater experience than we do. Accordingly,
our competitors may successfully develop competing products. We are also competing with other
companies and their products with respect to manufacturing efficiencies and marketing capabilities,
areas where we have limited or no direct experience.
If we fail to comply with regulatory requirements, regulatory agencies may take action against us,
which could significantly harm our business.
Marketed products, along with the manufacturing processes, post-approval clinical data,
labeling, advertising and promotional activities for these products, are subject to continual
requirements and review by the FDA and other regulatory bodies. In addition, regulatory
authorities subject a marketed product, its manufacturer and the manufacturing facilities to
ongoing review and periodic inspections. We will be subject to ongoing FDA requirements, including
required submissions of safety and other post-market information and reports, registration
requirements, current Good Manufacturing Practices (cGMP) regulations, requirements regarding the
distribution of samples to physicians and recordkeeping requirements.
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The cGMP regulations also include requirements relating to quality control and
quality assurance, as well as the corresponding maintenance of records and documentation. We rely
on the compliance by our contract manufacturers with cGMP regulations and other regulatory
requirements relating to the manufacture of products. We are also subject to state laws and
registration requirements covering the distribution of our products. Regulatory agencies may change
existing requirements or adopt new requirements or policies. We may be slow to adapt or may not be
able to adapt to these changes or new requirements.
We face uncertainty related to healthcare reform, pricing and reimbursement, which could reduce our
revenue.
In the United States, President Obama signed in March 2010 the Patient Protection and
Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act
(collectively, PPACA), which is expected to substantially change the way health care is financed
by both governmental and private payors. PPACA provides for changes to extend medical benefits to
those who currently lack insurance coverage, encourages improvements in the quality of health care
items and services, and significantly impacts the U.S. pharmaceutical industry in a number of ways,
further listed below. By extending coverage to a larger population, PPACA may substantially change
the structure of the health insurance system and the methodology for reimbursing medical services,
drugs and devices. These structural changes could entail modifications to the existing system of
private payors and government programs, such as Medicare, Medicaid and State Childrens Health
Insurance Program, as well as the creation of a government-sponsored healthcare insurance source,
or some combination of both. Such restructuring of the coverage of medical care in the United
States could impact the extent of reimbursement for prescribed drugs, including our product
candidates, biopharmaceuticals, and medical devices. Some of the specific PPACA provisions, among
other things:
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Establish annual, non-deductible fees on any entity that manufactures or imports
certain branded prescription drugs and biologics, beginning 2011; |
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Increase minimum Medicaid rebates owed by manufacturers under the Medicaid Drug
Rebate Program; |
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Extend manufacturers Medicaid rebate liability to covered drugs dispensed to
individuals who are enrolled in Medicaid managed care organizations; |
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Establish a new Patient-Centered Outcomes Research Institute to oversee, identify
priorities in and conduct comparative clinical effectiveness research; |
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Require manufacturers to participate in a coverage gap discount program, under
which they must agree to offer 50 percent point-of-sale discounts off negotiated
prices of applicable brand drugs to eligible beneficiaries during their coverage gap
period, as a condition for the manufacturers outpatient drugs to be covered under
Medicare Part D, beginning 2011; and |
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Increase the number of entities eligible for discounts under the Public Health
Service pharmaceutical pricing program, effective January 2010. |
If future reimbursement for our approved product candidates, if any, is substantially less
than we project, or rebate obligations associated with them are substantially increased, our
business could be materially and adversely impacted.
Sales of NUEDEXTA for treatment of patients with PBA will depend in part on the
availability of coverage and reimbursement from third-party payors such as government insurance
programs, including Medicare and Medicaid, private health insurers, health maintenance
organizations and other health care related organizations. Accordingly, coverage and reimbursement
may be uncertain.
Adoption of NUEDEXTA by the medical community may be limited if third-party payors will
not offer coverage. Cost control initiatives may decrease coverage and payment levels for NUEDEXTA
and, in turn, the price that we will be able to charge. We are unable to predict all changes to the
coverage or reimbursement methodologies that will be applied by private or government payors to
NUEDEXTA. Any denial of private or government payor coverage or inadequate reimbursement for
procedures performed using NUEDEXTA could harm our business and reduce our revenue.
In addition, both the federal and state governments in the United States and foreign
governments continue to propose and pass new legislation affecting coverage and reimbursement
policies, which are designed to contain or reduce the cost of health care. Further federal and
state proposals and healthcare reforms are likely, which could limit the prices that can be charged
for the product candidates that we develop and may further limit our commercial opportunity. There
may be future changes that result in reductions in current coverage and reimbursement levels for
our products, if commercialized, and we cannot predict the scope of any future changes or the
impact that those changes would have on our operations.
We rely on insurance companies to mitigate our exposure for business activities, including
developing and marketing pharmaceutical products for human use.
The conduct of our business, including the testing, marketing and sale of pharmaceutical
products, involves the risk of liability claims by consumers, stockholders, and other third
parties. Although we maintain various types of insurance, including product liability and director
and officer liability, claims can be high and our insurance may not sufficiently cover our actual
liabilities. If liability claims were made against us, it is possible that our insurance carriers
may deny, or attempt to deny, coverage in certain instances. If a lawsuit against us is successful,
then the lack or insufficiency of insurance coverage could materially and adversely affect 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 and the imposition of higher insurance
requirements could impose additional costs on us. Additionally, we are potentially at risk if our
insurance carriers become insolvent. Although we have historically obtained coverage through highly
rated and
capitalized firms, the ongoing financial crisis may affect our ability to obtain coverage under
existing policies or purchase insurance under new policies at reasonable rates.
If we market products in a manner that violates health care fraud and abuse laws, we may be subject
to civil or criminal penalties.
We are also subject to healthcare fraud and abuse regulation and enforcement by both the
federal government and the states in which we conduct our business. The laws that may affect our
ability to operate include:
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the federal healthcare programs Anti-Kickback Law, which prohibits, among other things,
persons from knowingly and willfully soliciting, receiving, offering or paying
remuneration, directly or indirectly, in exchange for or to induce either the referral of
an individual for, or the purchase, order or recommendation of, any good or service for
which payment may be made under federal healthcare programs such as the Medicare and
Medicaid programs; |
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federal false claims laws which prohibit, among other things, individuals or entities
from knowingly presenting, or causing to be presented, claims for payment from Medicare,
Medicaid, or other third-party payors that are false or fraudulent; |
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which
created federal criminal laws that prohibit executing a scheme to defraud any healthcare
benefit program or making false statements relating to healthcare matters; and |
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state law equivalents of each of the above federal laws, such as anti-kickback and false
claims laws that may apply to items or services reimbursed by any third-party payor,
including commercial insurers. |
If our operations are found to be in violation of any of the laws described above or any other
governmental regulations that apply to us, we may be subject to penalties, including civil and
criminal penalties, damages, fines, exclusion from governmental health care programs, and the
curtailment or restructuring of our operations, any of which could adversely affect our ability to
operate our business and our financial results. The risk of our being found in violation of these
laws is increased by the fact that many of them have not been fully interpreted by the regulatory
authorities or the courts, and their provisions are open to a variety of interpretations. Further,
the recently enacted PPACA, among other things, amends the intent requirement of the federal
anti-kickback and criminal health care fraud statutes. A person or entity no longer needs to have
actual knowledge of this statute or specific intent to violate it. In addition, the PPACA provides
that the government may assert that a claim including items or services resulting from a violation
of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the
false claims statutes. Moreover, some states, such as California, Massachusetts and Vermont,
mandate implementation of commercial compliance programs to ensure compliance with these laws. Any
action against us for violation of these laws, even if we successfully defend against it, could
cause us to incur significant legal expenses and divert our managements attention from the
operation of our business.
In addition, there has been a recent trend of increased federal and state regulation of
payments made to physicians for marketing, including the tracking and reporting of gifts,
compensation, and other remuneration to
physicians. The shifting commercial compliance environment
and the need to build and maintain robust and expandable systems to comply with multiple
jurisdictions with different compliance and/or reporting requirements increases the possibility
that a healthcare company may run afoul of one or more of the requirements.
The PPACA also imposes new reporting and disclosure requirements on drug manufacturers for any
transfer of value made or distributed to prescribers and other healthcare providers, effective
March 30, 2013. Such information will be made publicly available in a searchable format beginning
September 30, 2013. In addition, drug manufacturers will also be required to report and disclose
any investment interests held by physicians and their immediate family members during the preceding
calendar year. Failure to submit required information may result in civil monetary penalties of up
to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for knowing
failures), for all payments, transfers of value or ownership or investment interests not reported
in an annual submission. Finally, under PPACA, effective April 1, 2012, pharmaceutical
manufacturers and distributors must provide the U.S. Department of Health and Human Services with
an annual report on the drug samples they provide to physicians.
S-14
Risks Related to Reliance on Third Parties
We depend on third parties to manufacture, package and distribute 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, package
and distribute NUEDEXTA and the Active Pharmaceutical Ingredient (API) for docosanol 10% cream
and to provide clinical supplies of our drug candidates. We have no experience in manufacturing and
do not have any manufacturing facilities. Currently, we have sole suppliers for the API for
docosanol and NUEDEXTA, and a sole manufacturer for the finished form of NUEDEXTA. In addition,
these materials are custom and available from only a limited number of sources. Any material
disruption in manufacturing could cause a delay in shipments and possible loss of sales. We do not
have any long-term agreements in place with our current docosanol supplier or NUEDEXTA supplier. If
we are required to change manufacturers, we may experience delays associated with finding an
alternate manufacturer that is properly qualified to produce supplies of our products and product
candidates in accordance with FDA requirements and our specifications. Any delays or difficulties
in obtaining APIs or in manufacturing, packaging or distributing NUEDEXTA could delay our clinical
trials of this product candidate for DPN pain, MS-related pain or other potential indications. The
third parties we rely on for manufacturing and packaging are also subject to regulatory review, and
any regulatory compliance problems with these third parties could significantly delay or disrupt
our commercialization activities. Additionally, the ongoing economic crisis creates risk for us if
any of these third parties suffer liquidity or operational problems. If a key third party vendor
becomes insolvent or is forced to lay off workers assisting with our projects, our results and
development timing could suffer.
Because we depend on clinical research centers and other contractors for clinical testing and for
certain research and development activities, the results of our clinical trials and such research
activities are, to a certain extent, beyond our control.
The nature of clinical trials and our business strategy of outsourcing a substantial
portion of our research require that we rely on clinical research centers and other contractors to
assist us with research and development, clinical testing activities, patient enrollment and
regulatory submissions to the FDA. As a result, our success depends partially on the success of
these third parties in performing their responsibilities. Although we pre-qualify our contractors
and we believe that they are fully capable of performing their contractual obligations, we cannot
directly control the adequacy and timeliness of the resources and expertise that they apply to
these activities. Additionally, the current global economic slowdown may affect our development
partners and vendors, which could adversely affect their ability to timely perform their tasks. If
our contractors do not perform their obligations in an adequate and timely manner, the pace of
clinical development, regulatory approval and commercialization of our drug candidates could be
significantly delayed and our prospects could be adversely affected.
We generally do not control the development of compounds licensed to third parties and, as a
result, we may not realize a significant portion of the potential value of any such license
arrangements.
Under our typical license arrangement we have no direct control over the development of
drug candidates and have only limited, if any, input on the direction of development efforts. These
development efforts are made by our licensing partner, and if the results of their development
efforts are negative or inconclusive, it is possible that our licensing partner could elect to
defer or abandon further development of these programs. We similarly rely on licensing partners to
obtain regulatory approval for docosanol in foreign jurisdictions. Because much of the potential
value of these license arrangements is contingent upon the successful development and
commercialization of the licensed technology, the ultimate value of these licenses will depend on
the efforts of licensing partners. If our licensing partners do not succeed in developing the
licensed technology for whatever reason, or elect to discontinue the development of these programs,
we may be unable to realize the potential value of these arrangements. If we were to license
NUEDEXTA to a third party or a development partner, it is likely that much of the long-term success
of that drug will similarly depend on the efforts of the licensee.
We expect to rely entirely on third parties for international registration, sales and marketing
efforts.
In the event that we attempt to enter into international markets, we expect to rely on
collaborative partners to obtain regulatory approvals and to market and sell our product(s) in
those markets. We have not yet entered into any collaborative arrangement with respect to marketing
or selling NUEDEXTA, with the exception of one such
S-15
agreement relating to Israel. We may be unable
to enter into any other arrangements on terms favorable to us, or at all, and even if we are able
to enter into sales and marketing arrangements with collaborative partners, we cannot assure you
that their sales and marketing efforts will be successful. If we are unable to enter into favorable
collaborative arrangements with respect to marketing or selling NUEDEXTA in international markets,
or if our collaborators efforts are unsuccessful, our ability to generate revenues from
international product sales will suffer.
Risks Relating to Our Stock and this Offering
Our stock price has historically been volatile and we expect that this volatility will continue for
the foreseeable future.
The market price of our common stock has been, and is likely to continue to be, highly
volatile. This volatility can be attributed to many factors independent of our operating results,
including the following:
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comments made by securities analysts, including changes in their recommendations; |
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short selling activity by certain investors, including any failures to timely settle short sale transactions; |
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announcements by us of financing transactions and/or future sales of equity or debt securities; |
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sales of our common stock by our directors, officers or significant stockholders, including sales effected
pursuant to predetermined trading plans adopted under the safe-harbor afforded by Rule 10b5-1; |
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regulatory developments in the U.S. and foreign countries; |
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lack of volume of stock trading leading to low liquidity; and |
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market and economic conditions. |
If a substantial number of shares are sold into the market at any given time,
particularly following any significant announcements or large swings in our stock price (whether
sales are under our existing shelf registration statements, from an existing stockholder, or the
result of warrant or stock options exercised), there may not be sufficient demand in the market to
purchase the shares without a decline in the market price for our common stock. Moreover,
continuous sales into the market of a number of shares in excess of the typical trading volume for
our common stock, or even the availability of such a large number of shares, could depress the
trading market for our common stock over an extended period of time.
Additionally, our stock price has been volatile as a result of announcements of
regulatory actions and decisions relating to NUEDEXTA, and periodic variations in our operating
results. We expect that our operating results will continue to vary from quarter to quarter,
particularly as we commercially launch NUEDEXTA. Our operating results and prospects may also vary
depending on the status of our partnering arrangements.
As a result of these factors, we expect that our stock price may continue to be volatile
and investors may be unable to sell their shares at a price equal to, or above, the price paid.
Additionally, any significant drops in our stock price could give rise to stockholder lawsuits,
which are costly and time consuming to defend against and which may adversely affect our ability to
raise capital while the suits are pending, even if the suits are ultimately resolved in favor of
the Company. We have, from time to time, been a party to such suits and although none have been
material to date, there can be no assurance that any such suit will not have an adverse effect on
the Company.
We will have discretion as to the use of the proceeds from this offering, and we may not use the
proceeds effectively.
Although we intend to use the proceeds from this offering principally to support the launch of
NUEDEXTA, we will retain discretion as to the application of the net proceeds and could use them
for purposes other than those
contemplated at the time of this offering. Our stockholders may not agree with the manner in which
we choose to allocate and spend the net proceeds. Moreover, we may use the net
proceeds for corporate
S-16
purposes that may not increase our profitability or our market value. See
Use of Proceeds on page S-19 for a description of our managements intended use of the proceeds
from this offering.
You will experience immediate dilution in the book value per share of the common stock you
purchase.
Because the price per share of our common stock being offered is substantially higher than the book
value per share of our common stock, you will suffer substantial dilution in the net tangible book
value of the common stock you purchase in this offering. Based on an assumed public offering price
of $ per share, if you purchase shares of common stock in this offering, you will suffer
immediate and substantial dilution of $ per share in the net tangible book value of the common
stock. See Dilution on page S-20 for a more detailed discussion of the dilution you will incur
in this offering.
If our internal controls over financial reporting are not considered effective, our business and
stock price could be adversely affected.
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to evaluate the effectiveness
of our internal controls over financial reporting as of the end of each fiscal year, and to include
a management report assessing the effectiveness of our internal controls over financial reporting
in our annual report on Form 10-K for that fiscal year. Section 404 also requires our independent
registered public accounting firm to attest to, and report on, managements assessment of our
internal controls over financial reporting, and we again became subject to these requirements
starting with the year ended September 30, 2010.
Our management, including our chief executive officer and principal financial officer,
does not expect that our internal controls over financial reporting will prevent all errors and all
fraud. A control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control systems objectives will be met. Further, the design of a
control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud involving a company have been, or will be, detected. The design of any
system of controls is based in part on certain assumptions about the likelihood of future events,
and we cannot assure you that any design will succeed in achieving its stated goals under all
potential future conditions. Over time, controls may become ineffective because of changes in
conditions or deterioration in the degree of compliance with policies or procedures. Because of the
inherent limitations in a cost-effective control system, misstatements due to error or fraud may
occur and not be detected. We cannot assure you that we or our independent registered public
accounting firm will not identify a material weakness in our internal controls in the future. A
material weakness in our internal controls over financial reporting would require management and
our independent registered public accounting firm to consider our internal controls as ineffective.
If our internal controls over financial reporting are not considered effective, we may experience a
loss of public confidence, which could have an adverse effect on our business and on the market
price of our common stock.
Because we do not expect to pay dividends in the foreseeable future, you must rely on stock
appreciation for any return on your investment.
We have paid no cash dividends on our common stock to date, and we currently intend to
retain our future earnings, if any, to fund the development and growth of our business. As a
result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash
dividends, if any, will also depend on our financial condition, results of operations, capital
requirements and other factors and will be at the discretion of our board of directors.
Furthermore, we may in the future become subject to contractual restrictions on, or prohibitions
against, the payment of dividends. Accordingly, the success of your investment in our common stock
will likely depend entirely upon any future appreciation. There is no guarantee that our common
stock will appreciate in value or even maintain the price at which you purchased your shares, and
you may not realize a return on your investment in our common stock.
S-17
Our corporate governance documents, rights agreement and Delaware law may delay or prevent an
acquisition of us that stockholders may consider favorable, which could decrease the value of our
common stock.
Our certificate of incorporation and bylaws and Delaware law contain provisions that
could make it more difficult for a third party to acquire us without the consent of our board of
directors. These provisions include restrictions on the ability of our stockholders to remove
directors and supermajority voting requirements for stockholders to amend our organizational
documents and a classified board of directors. In addition, our board of directors has the right to
issue preferred stock without stockholder approval, which could be used to dilute the stock
ownership of a potential hostile acquirer. Delaware law, for instance, also imposes some
restrictions on mergers and other business combinations between any holder of 15% or more of our
outstanding common stock and us. Although we believe these provisions protect our stockholders from
coercive or otherwise unfair takeover tactics and thereby provide for an opportunity to receive a
higher bid by requiring potential acquirers to negotiate with our board of directors, these
provisions apply even if the offer may be considered beneficial by some stockholders. We have also
adopted a stockholder rights agreement intended to deter hostile or coercive attempts to acquire
us. Under the agreement, if a person becomes an acquiring person, each holder of a right (other
than the acquiring person) will be entitled to purchase, at the then-current exercise price, such
number of shares of our preferred stock which are equivalent to shares of common stock having twice
the exercise price of the right. If we are acquired in a merger or other business combination
transaction after any such event, each holder of a right will then be entitled to purchase, at the
then-current exercise price, shares of the acquiring companys common stock having a value of twice
the exercise price of the right. Our stockholder rights agreement could make it more difficult for
a third party to acquire, or could discourage a third party from acquiring, us or a large block of
our common stock without the support of our board of directors. Therefore, the agreement makes an
acquisition much more costly to a potential acquirer.
S-18
Use of Proceeds
We estimate that the net proceeds from the sale of the shares of common stock that we are
offering will be approximately $ million, or approximately $ million if the underwriters
exercise in full their option to purchase additional shares of common stock, based on the
public offering price of $ per share and after deducting the underwriting discounts and
commissions and estimated offering expenses payable by us. We expect the proceeds from this
offering together with existing cash and cash equivalents to be sufficient to support our
operations, including the commercial launch of NUEDEXTA, for at least the next 24 months.
We intend to use the net proceeds from this offering for sales and marketing activities relating to
the launch of NUEDEXTA, the further development of NUEDEXTA for other indications (such as pain
secondary to MS, anger/agitation secondary to dementia or diabetic peripheral neuropathic pain),
and for general working capital and business development activities. 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.
The amounts and timing of these expenditures will depend on a number of factors, such as the timing
for the commercial launch of NUEDEXTA, the degree of market acceptance, initial revenues following
the launch of NUEDEXTA, additional studies that may be required by foreign regulatory authorities,
the timing and expenses of post-marketing commitments required by the FDA, the progress and results
of our research and development efforts and the timing and progress of any partnering efforts. As
of the date of this prospectus supplement, we cannot specify with certainty all of the particular
uses of the proceeds from this offering. Accordingly, we will retain broad discretion over the use
of such proceeds.
Until we use the net proceeds from this offering, we intend to invest the funds in short-term,
investment-grade, interest-bearing securities.
S-19
Dilution
Our net tangible book value as of June 30, 2010 was approximately $31.5 million, or $0.33 per
share. Net tangible book value per share is determined by dividing our total tangible assets, less
total liabilities, by the number of shares of our common stock outstanding as of June 30, 2010.
Dilution in net tangible book value per share represents the difference between the amount per
share paid by purchasers of shares of common stock in this offering and the net tangible book value
per share of our common stock immediately after this offering.
After giving effect to the sale of shares of our common stock in this offering at the
public offering price of $ per share and after deducting the underwriting discounts and
commissions and estimated offering expenses payable by us, our as adjusted net tangible book value
as of June 30, 2010 would have been approximately $ million, or $ per share. This represents
an immediate increase in net tangible book value of $ per share to existing stockholders and
immediate dilution in net tangible book value of $ per share to new investors purchasing our
common stock in this offering. The following table illustrates this dilution on a per share basis:
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Public offering price per share |
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$ |
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Net tangible book value per share as of June 30, 2010 |
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0.33 |
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Increase per share attributable to new investors |
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As adjusted net tangible book value per share after this offering |
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$ |
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Dilution per share to new investors |
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$ |
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If the underwriters exercise in full their option to purchase additional shares of common
stock at the public offering price of $ per share, the as adjusted net tangible book value after
this offering would be $ per share, representing an increase in net tangible book value of $
per share to existing stockholders and immediate dilution in net tangible book value of $ per
share to new investors purchasing our common stock in this offering.
The number of shares of common stock to be outstanding after this offering is based on 93,968,532
shares outstanding on June 30, 2010 and excludes as of that date:
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options representing the right to purchase a total of 6,257,087 shares of common stock
at a weighted average exercise price of $1.66 per share; |
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restricted stock units representing a total of 980,964 shares of common stock issuable
upon vesting; |
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restricted stock units representing a total of 1,069,680 vested shares of common stock
issuable to directors; and |
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warrants representing the right to purchase a total of 12,240,437 shares of common stock
at a weighted-average exercise price of $1.43 per share. |
Subsequent to June 30, 2010, an additional 3.5 million shares of common stock were issued upon
exercise of outstanding warrants, resulting in proceeds to the company of approximately $5,100,000,
and a total of approximately 2.9 million shares were sold pursuant to our July 30, 2009 prospectus for
our at-the-market offering facility, resulting in gross offering proceeds of approximately
$10,500,000.
To the extent that outstanding options or warrants are exercised, investors purchasing our common
stock in this offering will experience further dilution. In addition, we may choose to raise
additional capital due to market conditions or strategic considerations even if we believe we have
sufficient funds for our current or future operating plans. To the extent that additional capital
is raised through the sale of equity or convertible debt securities, the issuance of these
securities could result in further dilution to our stockholders.
S-20
Underwriting
Under the terms and subject to the conditions contained in an underwriting agreement dated November
, 2010, by and among us and the underwriters named below, the underwriters have agreed to
purchase, and we have agreed to sell shares of our common stock. Jefferies &
Company, Inc. is the sole book-running manager of the offering. Each underwriter has severally
agreed to purchase the number of shares of common stock indicated in the table below:
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Jefferies & Company, Inc. |
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Canaccord Genuity Inc. |
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Wedbush Securities Inc. |
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Summer Street Research Partners |
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The underwriters are offering the common stock subject to their acceptance of the shares from us
and subject to prior sale. The underwriting agreement provides that the obligations of the
underwriters to pay for and accept delivery of the common stock offered by this prospectus
supplement are subject to the approval of certain legal matters by their counsel and to certain
other conditions. The underwriting agreement provides that the underwriters are obligated to take
and pay for all of the common stock if any such shares are purchased, other than those shares
covered by the overallotment option described below.
Commissions and Expenses
The underwriters have advised us that they propose to offer the shares to the public at the public
offering price set forth on the cover page of this prospectus supplement and to certain dealers at
that price less a concession not in excess of $ per share. After the offering, the public
offering price and concession to dealers may be reduced by the underwriters. No such reduction
shall change the amount of proceeds to be received by us as set forth on the cover page of this
prospectus supplement. The shares are offered by the underwriters as stated herein, subject to
receipt and acceptance by them and subject to their right to reject any order in whole or in part.
The following table shows the public offering price, the underwriting discounts and commissions
payable to the underwriters by us and the proceeds, before expenses, to us.
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Per Share |
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Proceeds to us, before expenses |
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We estimate expenses payable by us in connection with the offering of common stock, other than the
underwriting discounts and commissions referred to above, will be approximately $150,000. Pursuant
to the underwriting agreement, we have agreed to reimburse the underwriters for certain of their
expenses in connection with this offering.
Option to Purchase Additional Shares
We have granted to the underwriters an option, exercisable for 30 days from the date of this
prospectus supplement, to purchase up to an aggregate of additional shares at the same
price they are paying for the shares shown in the table above. The underwriters may exercise this
option at any time and from time to time, in whole or in part, within 30 days after the date of
this prospectus supplement. If the underwriters exercise the option in full, the total
underwriting discounts and commissions payable by us will be $ , or $ per share, and the
total proceeds to us, before expenses, will be $ .
S-21
Indemnification
We have agreed to indemnify the underwriters against certain liabilities, including liabilities
under the Securities Act, and liabilities arising from certain breaches by us of the underwriting
agreement. We have also agreed to contribute to payments that the underwriters may be required to
make in respect of those liabilities.
Lock-up Agreements
We, our executive officers and directors and certain of our stockholders have agreed, subject to
specified exceptions, not to directly or indirectly:
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sell, offer, contract or grant any option to sell (including, without limitation, any
short sale), pledge, transfer or establish an open put equivalent position within the
meaning of Rule 16a-1(h) under the Securities Exchange Act of 1934, as amended, or the
Exchange Act, or otherwise dispose of or transfer, or announce the offering of, or file any
registration statement under the Securities Act of 1933, as amended, in respect of, any
shares of common stock, options, rights or warrants to acquire shares of common stock or
securities exchangeable or exercisable for or convertible into shares of common stock, or |
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publicly announce the intention to do any of the foregoing. |
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transfers by gift, will or intestate succession to the immediate family of a holder or
to a trust the beneficiaries of which are exclusively the holder and/or a member or members
of the holders immediate family and transfers subject to a qualified domestic relations
order; |
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in certain cases, sales or transfers of shares made pursuant to any trading plan
established pursuant to Rule 10b5-1 of the Exchange Act that has been entered into prior to
the date of this prospectus supplement; or |
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with respect to certain executives, the sale or transfer of a certain number of shares
acquired in connection with the exercise of outstanding options to purchase shares. |
The above restrictions terminate after the close of trading of the shares on and including the
90th day after the date of this prospectus supplement. However, subject to certain
exceptions, in the event that either (i) during the last 17 days of each respective restricted
period, we issue an earnings release or material news or a material event relating to us occurs or
(ii) prior to the expiration of each respective restricted period, we announce that we will release
earnings results during the 16-day period beginning on the last day of each respective restricted
period, then in either case the expiration of each respective restricted period will be extended
until the expiration of the 18-day period beginning on the date of the issuance of an earnings
release or the occurrence of the material news or event, as applicable.
Jefferies & Company, Inc. may, at any time or from time to time before the termination of the
restricted period, without notice, release all or any portion of the securities subject to lock-up
agreements. There are no existing agreements between the underwriters and any of our stockholders
who will execute a lock-up agreement, providing consent to the sale of shares (other than under one
of the exceptions described above) prior to the expiration of the lock-up period.
Electronic Distribution
This prospectus supplement and the accompanying prospectuses in electronic format may be made
available on websites or through other online services maintained by the underwriters of the
offering, or by their affiliates. Other than the prospectus supplement and the accompanying
prospectuses in electronic format, the information on the underwriters websites and any information
contained in any other website maintained by the underwriters is not part of the prospectus
supplement, the accompanying prospectuses or the registration statement of which this prospectus
supplement and the accompanying prospectuses form a part, has not been approved and/or endorsed by us
or any of the underwriters in its capacity as an underwriter and should not be relied upon by
investors.
S-22
Price Stabilization, Short Positions and Penalty Bids
Until the distribution of the shares of common stock is completed, SEC rules may limit the
underwriters from bidding for and purchasing shares of our common stock.
In connection with this offering, the underwriters may engage in transactions that stabilize,
maintain or otherwise make short sales of our common stock and may purchase our common stock on the
open market to cover positions created by short sales. Short sales involve the sale by an
underwriter of a greater number of shares than it is required to purchase in this offering. The
underwriters may close out any short position by purchasing shares in the open market or exercising
their overallotment option.
A short position is more likely to be created if the underwriters are concerned that there may be
downward pressure on the price of the shares in the open market after pricing that could adversely
affect investors who purchase in this offering. A stabilizing bid is a bid for or the purchase of
common stock on behalf of the underwriters in the open market prior to the completion of this
offering for the purpose of fixing or maintaining the price of the shares of common stock. A
syndicate covering transaction is the bid for or purchase of common stock on behalf of the
underwriters to reduce a short position incurred by the underwriters in connection with the
offering.
Similar to other purchase transactions, the underwriters purchases to cover the syndicate short
sales may have the effect of raising or maintaining the market price of our shares or preventing or
retarding a decline in the market price of our shares. As a result, the price of our shares may be
higher than the price that might otherwise exist in the open market.
In connection with this offering, the underwriters may also engage in passive market making
transactions in our common stock on the NASDAQ Global Market in accordance with Rule 103 of
Regulation M during a period before the commencement of offers or sales of shares of our common
stock in this offering and extending through the completion of distribution. A passive market
maker must display its bid at a price not in excess of the highest independent bid of that
security. However, if all independent bids are lowered below the passive market makers bid, that
bid must then be lowered when specified purchase limits are exceeded.
Neither we, nor any of the underwriters, makes any representation or prediction as to the direction
or magnitude of any effect that the transactions described above may have on the price of our
common stock. In addition, none of we or any of the underwriters makes any representation that the
underwriters will engage in these transactions or that any transaction, if commenced, will not be
discontinued without notice.
Other Relationships
In the future, the underwriters and their affiliates may provide various investment banking,
commercial banking, financial advisory and other services to us and our affiliates for which
services they have received, and may in the future receive, customary fees. In the course of its
businesses, the underwriters and their affiliates may actively trade our securities or loans for
their own account or for the accounts of customers, and, accordingly, the underwriters and their
affiliates may at any time hold long or short positions in such securities or loans.
S-23
Notice to Investors
European Economic Area
In relation to each Member State of the European Economic Area which has implemented the Prospectus
Directive (as defined below) (each, a Relevant Member State), with effect from and including the
date on which the Prospectus Directive is implemented in that Relevant Member State, or the
Relevant Implementation Date, an offer of our common stock to the public may not be made in that
Relevant Member State prior to the publication of a prospectus in relation to our common stock
which has been approved by the competent authority in that Relevant Member State or, where
appropriate, approved in another Relevant Member State and notified to the competent authority in
that Relevant Member State, all in accordance with the Prospectus Directive, except that an offer
to the public in that Relevant Member State of any shares of our common stock may be made at any
time under the following exemptions under the Prospectus Directive if they have been implemented in
the Relevant Member State:
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to legal entities which are authorized or regulated to operate in the
financial markets or, if not so authorized or regulated, whose
corporate purpose is solely to invest in securities; |
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to any legal entity which has two or more of (1) an average of at
least 250 employees during the last financial year; (2) a total
balance sheet of more than 43,000,000 and (3) an annual net turnover
of more than 50,000,000, as shown in its last annual or consolidated
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to fewer than 100 natural or legal persons per Relevant Member State
(other than qualified investors as defined in the Prospectus
Directive); or |
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in any other circumstances falling within Article 3(2) of the Prospectus Directive, |
provided that no such offer of our common stock shall result in a requirement for the publication
by us or any underwriter of a prospectus pursuant to Article 3 of the Prospectus Directive.
For the purposes of this provision, the expression an offer of our common stock to the public in
relation to any shares of our common stock in any Relevant Member State means the communication in
any form and by any means of sufficient information on the terms of the offer and our common stock
to be offered so as to enable an investor to decide to purchase or subscribe for our common stock,
as the same may be varied in that Member State by any measure implementing the Prospectus Directive
in that Member State and the expression Prospectus Directive means Directive 2003/71/EC and
includes any relevant implementing measure in each Relevant Member State.
France
This prospectus supplement has not been, and will not be, submitted to the clearance procedures of
the Autorité des marchés financiers (the AMF) in France and may not be directly or indirectly
released, issued, or distributed to the public in France, or used in connection with any offer for
subscription or sale of our common stock to the public in France, in each case within the meaning
of Article L. 411-1 of the French Code monétaire et financier (the French Financial and Monetary
Code).
The securities have not been, and will not be, offered or sold to the public in France, directly or
indirectly, and will only be offered or sold in France (i) to qualified investors (investisseurs
qualifiés) investing for their own account, in accordance with all applicable rules and
regulations, and in particular in accordance with Articles L. 411-2 and D. 411-2 of the French
Financial and Monetary Code; (ii) to investment services providers authorized to engage in
portfolio investment on behalf of third parties, in accordance with Article L.411-2 of the French
Financial and Monetary Code; or (iii) in a transaction that, in accordance with all applicable
rules and regulations, does not otherwise constitute an offer to the public (appel public à
lépargne) in France within the meaning of Article L.411-1 of the French Financial and Monetary
Code.
This prospectus supplement is not to be further distributed or reproduced (in whole or in part) in
France by any recipient, and this prospectus supplement has been distributed to the recipient on
the understanding that such recipient is a qualified investor or otherwise meets the requirements
set forth above, and will only participate in the issue or sale of the securities for their own
account, and undertakes not to transfer, directly or indirectly, the
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securities to the public in France, other than in compliance with all applicable laws and
regulations and in particular with Articles L.411-1, L.411-2, D.411-1 and D.411-2 of the French
Financial and Monetary Code.
United Kingdom
Shares of our common stock may not be offered or sold and will not be offered or sold to any
persons in the United Kingdom other than to persons whose ordinary activities involve them in
acquiring, holding, managing or disposing of investments (as principal or as agent) for the
purposes of their businesses or otherwise in circumstances which have not resulted or will not
result in an offer to the public in the United Kingdom within the meaning of the Financial Services
and Markets Act 2000, or the FSMA.
In addition, any invitation or inducement to engage in investment activity (within the meaning of
section 21 of the FSMA) in connection with the issue or sale of shares of our common stock may only
be communicated or caused to be communicated in circumstances in which Section 21(1) of the FSMA
does not apply to us. Without limitation to the other restrictions referred to herein, this
prospectus supplement and the accompanying prospectus are directed only at (1) persons outside the
United Kingdom or (2) persons who:
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are qualified investors as defined in section 86(7) of FSMA, being
persons falling within the meaning of article 2.1(e)(i), (ii) or
(iii) of the Prospectus Directive; and |
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are either persons who fall within article 19(1) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005, as
amended, or Order, or are persons who fall within article 49(2)(a) to
(d) (high net worth companies, unincorporated associations, etc.) of
the Order; or |
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which Section 21(1) of the FSMA does not apply. |
Without limitation to the other restrictions referred to herein, any investment or investment
activity to which this prospectus supplement and the accompanying prospectus relate is available
only to, and will be engaged in only with, such persons, and persons within the United Kingdom who
receive this communication (other than persons who fall within (2) above) should not rely or act
upon this communication.
Italy
This prospectus supplement has not been and will not be filed with or cleared by the Italian
securities exchange commission (Commissione Nazionale per le societa e la Borsathe CONSOB)
pursuant to Legislative Decree No. 58 of 24 February 1998 (as amended, the Finance Law) and to
CONSOB Regulation No. 11971 of 14 May 1999 (as amended, the Issuers Regulation). Accordingly,
copies of this prospectus supplement or any other document relating to our common stock may not be
distributed, made available or advertised in Italy, nor may our common stock be offered, purchased,
sold, promoted, advertised or delivered, directly or indirectly, to the public other than (i) to
Professional Investors (such being the persons and entities as defined pursuant to article 31(2)
of CONSOB Regulation No. 11522 of 1 July 1998, as amended, the Intermediaries Regulation)
pursuant to article 100 of the Finance Law; (ii) to prospective investors where the offer of our
common stock relies on the exemption from the investment solicitation rules pursuant to, and in
compliance with the conditions set out by article 100 of the Finance Law and article 33 of the
Issuers Regulation, or by any applicable exemption; provided that any such offer, sale, promotion,
advertising or delivery of our common stock or distribution of the prospectus supplement, or any
part thereof, or of any other document or material relating to our common stock in Italy is made:
(a) by investment firms, banks or financial intermediaries authorized to carry out such activities
in the Republic of Italy in accordance with the Finance Law, the Issuers Regulation, Legislative
Decree No. 385 of 1 September 1993 (as amended, the Banking Law), the Intermediaries Regulation,
and any other applicable laws and regulations; and (b) in compliance with any applicable
notification requirement or duty which may, from time to time, be imposed by CONSOB, Bank of Italy
or by any other competent authority.
S-25
Germany
Any offer or solicitation of securities within Germany must be in full compliance with the German
Securities Prospectus Act (Wertpapierprospektgesetz WpPG). The offer and solicitation of
securities to the public in Germany requires the publication of a prospectus that has to be filed
with and approved by the German Federal Financial Services Supervisory Authority (Bundesanstalt für
Finanzdienstleistungsaufsicht BaFin). This prospectus supplement and the accompanying prospectus
have not been and will not be submitted for filing and approval to the BaFin and, consequently,
will not be published. Therefore, this prospectus supplement and the accompanying prospectus do
not constitute a public offer under the German Securities Prospectus Act
(Wertpapierprospektgesetz). This prospectus supplement, the accompanying prospectus and any other
document relating to our common stock, as well as any information contained therein, must therefore
not be supplied to the public in Germany or used in connection with any offer for subscription of
our common stock to the public in Germany, any public marketing of our common stock or any public
solicitation for offers to subscribe for or otherwise acquire our common stock. This prospectus
supplement, the accompanying prospectus and other offering materials relating to the offer of our
common stock are strictly confidential and may not be distributed to any person or entity other
than the designated recipients hereof.
Sweden
This is not a prospectus under, and has not been prepared in accordance with the prospectus
requirements provided for in, the Swedish Financial Instruments Trading Act [lagen (1991:980) om
handel med finasiella instrument] nor any other Swedish enactment. Neither the Swedish Financial
Supervisory Authority nor any other Swedish public body has examined, approved, or registered this
document.
Legal matters
Goodwin Procter LLP of San Francisco, California will issue an opinion with respect to the validity
of the issuance of the securities being offered hereby. Latham & Watkins LLP of Costa Mesa,
California is counsel to the underwriters in connection with this offering.
S-26
PROSPECTUS
$75,000,000
AVANIR
Pharmaceuticals, Inc.
Common
Stock
Preferred Stock
Debt Securities
Warrants
We may offer and sell an indeterminate number of shares of our
common stock and preferred stock, debt securities and warrants
from time to time under this prospectus. We may offer these
securities separately or as units, which may include
combinations of the securities. We will describe in a prospectus
supplement the securities we are offering and selling, as well
as the specific terms of the securities.
We may offer these securities in amounts, at prices and on terms
determined at the time of offering. We may sell the securities
directly to you, through agents we select, or through
underwriters and dealers we select. If we use agents,
underwriters or dealers to sell the securities, we will name
them and describe their compensation in a prospectus supplement.
Our common stock trades on the NASDAQ Global Market under the
symbol AVNR. On September 4, 2009, the closing
price for our common stock, as reported on the NASDAQ Global
Market, was $1.97 per share.
Investing in our securities involves certain
risks. See Risk Factors beginning on
Page 3 of this prospectus and in the applicable prospectus
supplement for certain risks you should consider. You should
read the entire prospectus 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.
TABLE OF
CONTENTS
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i
ABOUT
THIS PROSPECTUS
This prospectus is part of a registration statement that we
filed with the Securities and Exchange Commission
(SEC), utilizing a shelf registration process. Under
the shelf registration process, we may offer shares of our
common stock and preferred stock, various series of debt
securities and warrants to purchase any of such securities with
a total value of up to $75,000,000 from time to time under this
prospectus at prices and on terms to be determined by market
conditions at the time of offering. This prospectus provides you
with a general description of the securities we may offer. Each
time we offer a type or series of securities, we will provide a
prospectus supplement that will describe the specific amounts,
prices and other important terms of the securities, including,
to the extent applicable:
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designation or classification;
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aggregate principal amount or aggregate offering price;
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maturity;
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original issue discount, if any;
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rates and times of payment of interest, dividends or other
payments, if any;
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redemption, conversion, exchange, settlement or sinking fund
terms, if any;
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conversion, exchange or settlement prices or rates, if any, and,
if applicable, any provisions for changes to or adjustments in
the conversion, exchange or settlement prices or rates and in
the securities or other property receivable upon conversion,
exchange or settlement;
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ranking;
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restrictive covenants, if any;
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voting or other rights, if any; and
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important federal income tax considerations.
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A prospectus supplement may include a discussion of risks or
other special considerations applicable to us or the offered
securities. A prospectus supplement may also add, update or
change information in this prospectus. If there is any
inconsistency between the information in this prospectus and the
applicable prospectus supplement, you must rely on the
information in the prospectus supplement. Please carefully read
both this prospectus and the applicable prospectus supplement
together with additional information described under the heading
Where You Can Find More Information. This prospectus
may not be used to offer or sell any securities unless
accompanied by a prospectus supplement.
The registration statement containing this prospectus, including
exhibits to the registration statement, provides additional
information about us and the common stock offered under this
prospectus. The registration statement can be read at the SEC
website or at the SECs public reading room 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 securities,
nor do this prospectus and the accompanying supplement to this
prospectus constitute an offer to sell or the solicitation of an
offer to buy securities 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 securities are sold on a
later date.
1
We may sell the securities directly to or through underwriters,
dealers or agents. We, and our underwriters or agents, reserve
the right to accept or reject all or part of any proposed
purchase of securities. If we do offer securities through
underwriters or agents, we will include in the applicable
prospectus supplement:
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the names of those underwriters or agents;
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applicable fees, discounts and commissions to be paid to them;
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details regarding over-allotment options, if any; and
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the net proceeds to us.
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Common Stock. We may issue shares of our
common stock from time to time. Holders of our common stock are
entitled to one vote per share for the election of directors and
on all other matters that require stockholder approval. Subject
to any preferential rights of any outstanding preferred stock,
in the event of our liquidation, dissolution or winding up,
holders of our common stock are entitled to share ratably in the
assets remaining after payment of liabilities and the
liquidation preferences of any outstanding preferred stock. Our
common stock does not carry any redemption rights or any
preemptive rights enabling a holder to subscribe for, or receive
shares of, any class of our common stock or any other securities
convertible into shares of any class of our common stock.
Preferred Stock. We may issue shares of our
preferred stock from time to time, in one or more series. Under
our certificate of incorporation, our board of directors has the
authority, without further action by stockholders, to designate
up to 10,000,000 shares of preferred stock in one or more
series and to fix the rights, preferences, privileges,
qualifications and restrictions granted to or imposed upon the
preferred stock, including dividend rights, conversion rights,
voting rights, rights and terms of redemption, liquidation
preference and sinking fund terms, any or all of which may be
greater than the rights of the common stock.
If we issue preferred stock, we will fix the rights,
preferences, privileges, qualifications and restrictions of the
preferred stock of each series that we sell under this
prospectus and applicable prospectus supplements in the
certificate of designations relating to that series. If we issue
preferred stock, we will incorporate by reference into the
registration statement of which this prospectus is a part the
form of any certificate of designations that describes the terms
of the series of preferred stock we are offering before the
issuance of the related series of preferred stock. We urge you
to read the prospectus supplement related to any series of
preferred stock we may offer, as well as the complete
certificate of designations that contains the terms of the
applicable series of preferred stock.
Debt Securities. We may issue debt securities
from time to time, in one or more series, as either senior or
subordinated debt or as senior or subordinated convertible debt.
The senior debt securities will rank equally with any other
unsubordinated debt that we may have and may be secured or
unsecured. The subordinated debt securities will be subordinate
and junior in right of payment, to the extent and in the manner
described in the instrument governing the debt, to all or some
portion of our indebtedness. Any convertible debt securities
that we issue will be convertible into or exchangeable for our
common stock or other securities of ours. Conversion may be
mandatory or at your option and would be at prescribed
conversion rates.
If we issue debt securities, they will be issued under one or
more documents called indentures, which are contracts between us
and a trustee for the holders of the debt securities. We urge
you to read the prospectus supplement related to the series of
debt securities being offered, as well as the complete indenture
that contains the terms of the debt securities (which will
include a supplemental indenture). If we issue debt securities,
indentures and forms of debt securities containing the terms of
debt securities being offered will be incorporated by reference
into the registration statement of which this prospectus is a
part from reports we would subsequently file with the SEC.
Warrants. We may issue warrants for the
purchase of common stock, preferred stock
and/or debt
securities in one or more series, from time to time. We may
issue warrants independently or together with common stock,
preferred stock
and/or debt
securities, and the warrants may be attached to or separate from
those securities.
If we issue warrants, they will be evidenced by warrant
agreements or warrant certificates issued under one or more
warrant agreements, which are contracts between us and an agent
for the holders of the warrants. We urge you to read the
prospectus supplement related to any series of warrants we may
offer, as well as the complete warrant agreement and warrant
certificate that contain the terms of the warrants. If we issue
warrants, forms of warrant
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agreements and warrant certificates relating to warrants for the
purchase of common stock, preferred stock and debt securities
will be incorporated by reference into the registration
statement of which this prospectus is a part from reports we
would subsequently file with the SEC.
ABOUT
AVANIR PHARMACEUTICALS, INC.
Avanir
Pharmaceuticals, Inc., a Delaware corporation originally
incorporated in California in August 1988 and reincorporated in
Delaware in March 2009, is a pharmaceutical company focused on
developing, acquiring and commercializing novel therapeutic
products for the treatment of chronic diseases. Our product
candidates address therapeutic markets that include the central
nervous system and inflammatory diseases. Our lead product
candidate,
Zenviatm
(dextromethorphan hydrobromide/quinidine sulfate), is currently
in Phase III clinical development for the treatment of
pseudobulbar affect (PBA) and diabetic peripheral
neuropathic pain (DPN pain). Our first
commercialized product, docosanol 10% cream, (sold as
Abreva®
by our marketing partner GlaxoSmithKline Consumer Healthcare in
North America) is the only over-the-counter treatment for cold
sores that has been approved by the FDA. Our inflammatory
disease program, which targets macrophage migration inhibitory
factor (MIF), is currently partnered with Novartis.
Our infectious disease program has historically been focused
primarily on monoclonal antibodies. In 2008, we sold our rights
to substantially all of these monoclonal antibodies to two
biotechnology companies. As of June 30, 2008, we ceased all
future research and development work related to our infectious
disease program and remain eligible to receive additional
milestone payments and royalties related to the program.
For additional information about our company, please refer to
other documents we have filed with the SEC and that are
incorporated by reference into this prospectus, as listed under
the heading Incorporation of Certain Information by
Reference.
Our offices are located at 101 Enterprise, Suite 300, Aliso
Viejo, California 92656. Our telephone number is
(949) 389-6700
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 SEC. Copies of
our current and periodic reports filed with the SEC are
available at the SEC Public Reference Room at
100 F Street, N.E., Washington, D.C. 20549, and
online at www.sec.gov and our website at
www.avanir.com. No portion of our website is incorporated
by reference into this prospectus.
RISK
FACTORS
Before making an investment decision, you should carefully
consider the risks described under Risk Factors in
the applicable prospectus supplement, together with all of the
other information appearing in this prospectus or incorporated
by reference into this prospectus and any applicable prospectus
supplement, in light of your particular investment objectives
and financial circumstances. Our business, financial condition
or results of operations could be materially adversely affected
by any of these risks. The trading price of our securities could
decline due to any of these risks, and you may lose all or part
of your investment. This prospectus and the incorporated
documents also contain forward-looking statements that involve
risks and uncertainties. Our actual results could differ
materially from those anticipated in these forward-looking
statements as a result of certain factors, including the risks
mentioned above.
NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus contains or incorporates by reference
forward-looking statements and readers are cautioned that our
actual results may differ materially from those discussed in the
forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the progress
and timing of clinical trials, the safety and efficacy of our
product candidates, the goals of our development activities,
estimates of the potential markets for our product candidates,
projected cash needs and our expected future revenues,
operations and expenditures. These statements relate to future
events or our future financial performance and involve known and
unknown risks, uncertainties and other factors that could cause
our actual results, levels of activity, performance or
3
achievement to differ materially from those expressed or implied
by these forward-looking statements. These risks and
uncertainties include, among others:
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risks relating to the uncertainty around the conduct of clinical
trials generally and, more specifically, around our ongoing and
future clinical trials for Zenvia for both PBA and DPN pain;
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risks of delay in meeting our development plans, including
delays in patient enrollment in our clinical trials;
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risks relating to our lack of profitability, our significant
historical operating losses and our ability to obtain additional
funding to continue to operate our business, which funding may
not be available on commercially reasonable terms, or at all;
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risks relating to our patent portfolio and the patent portfolios
of competitors;
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risks relating to turnover in senior management and our reliance
on key employees;
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risks around our reliance on third parties to conduct our
clinical trials and manufacture our product candidates; and
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competitive risks in our industry.
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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, including under the caption, Risk
Factors. 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 disclaim any intent to
update any forward-looking statements.
DESCRIPTION
OF SECURITIES
We may offer shares of our common stock and preferred stock,
various series of debt securities and warrants to purchase any
such securities with a total value of up to $75,000,000 from
time to time under this prospectus at prices and on terms to be
determined by market conditions at the time of offering. Each
time we offer a type or series of securities, we will provide a
prospectus supplement that will describe the specific amounts,
prices and other important terms of the securities.
USE OF
PROCEEDS
We will retain broad discretion over the use of the net proceeds
from the sale of our securities offered hereby. Except as
described in any prospectus supplement, we currently anticipate
using the net proceeds from the sale of our securities hereby
primarily to fund the development and commercialization of
Zenvia for PBA and DPN pain, for our ongoing and future clinical
trials and for general and administrative expenses. We may also
use a portion of the net proceeds to pay off outstanding
indebtedness
and/or
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.
RATIO OF
EARNINGS TO FIXED CHARGES
If we offer debt securities
and/or
preference equity securities under this prospectus, then we
will, at that time, provide a ratio of earnings to fixed charges
and/or ratio
of combined fixed charges and preference dividends to earnings,
respectively, in the applicable prospectus supplement for such
offering.
4
PLAN OF
DISTRIBUTION
We may sell the securities covered by this prospectus from time
to time in one or more offerings. Registration of the securities
covered by this prospectus does not mean, however, that those
securities will necessarily be offered or sold.
We may sell the securities separately or together:
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through one or more underwriters or dealers in a public offering
and sale by them;
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directly to investors; or
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through agents.
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We may sell the securities from time to time:
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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.
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We will describe the method of distribution of the securities
and the terms of the offering in the prospectus supplement.
Any discounts or concessions allowed or re-allowed or paid to
dealers may be changed from time to time.
If underwriters are used in the sale of any securities, the
securities will be acquired by the underwriters for their own
account and may be resold from time to time in one or more
transactions described above. The securities may be either
offered to the public through underwriting syndicates
represented by managing underwriters, or directly by
underwriters. Generally, the underwriters obligations to
purchase the securities will be subject to conditions precedent
and the underwriters will be obligated to purchase all of the
securities if they purchase any of the securities. We may use
underwriters with whom we have a material relationship. We will
describe in the prospectus supplement, naming the underwriter,
the nature of any such relationship.
We may authorize underwriters, dealers or agents to solicit
offers by certain purchasers to purchase the securities from us
at the public offering price set forth in the prospectus
supplement pursuant to delayed delivery contracts providing for
payment and delivery on a specified date in the future. The
contracts will be subject only to those conditions set forth in
the prospectus supplement, and the prospectus supplement will
set forth any commissions we pay for solicitation of these
contracts.
We may enter into derivative transactions with third parties, or
sell securities not covered by this prospectus to third parties
in privately negotiated transactions. If the applicable
prospectus supplement indicates, in connection with those
derivatives, the third parties may sell securities covered by
this prospectus and the applicable prospectus supplement,
including in short sale transactions. If so, the third party may
use securities pledged by us or borrowed from us or others to
settle those sales or to close out any related open borrowings
of stock, and may use securities received from us in settlement
of those derivatives to close out any related open borrowings of
stock. The third party in such sale transactions will be an
underwriter and will be identified in the applicable prospectus
supplement or in a post-effective amendment.
Underwriters, dealers and agents may be entitled to
indemnification by us against certain civil liabilities,
including liabilities under the Securities Act, or to
contribution with respect to payments made by the underwriters,
dealers or agents, under agreements between us and the
underwriters, dealers and agents.
We may grant underwriters who participate in the distribution of
securities an option to purchase additional securities to cover
over-allotments, if any, in connection with the distribution.
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
securities. These underwriters, dealers or agents may be
considered to be underwriters under the Securities Act. As a
result, discounts, commissions
5
or profits on resale received by the underwriters, dealers or
agents may be treated as underwriting discounts and commissions.
The 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 re-allowed or paid to dealers may be
changed from time to time.
Unless otherwise specified in the related prospectus supplement,
all securities we offer, other than common stock, will be new
issues of securities with no established trading market. Any
underwriters may make a market in these securities, but will not
be obligated to do so and may discontinue any market making at
any time without notice. Any common stock sold pursuant to a
prospectus supplement will be listed for trading on the NASDAQ
Stock Market or other principal market for our common stock. We
may apply to list any series of debt securities, preferred stock
or warrants on an exchange, but we are not obligated to do so.
Therefore, there may not be liquidity or a trading market for
any series of securities.
Any underwriter may engage in over-allotment transactions,
stabilizing transactions, short-covering transactions and
penalty bids in accordance with Regulation M under the
Exchange Act. Over-allotment involves sales in excess of the
offering size, which create a short position. Stabilizing
transactions permit bids to purchase the underlying security so
long as the stabilizing bids do not exceed a specified maximum.
Short covering transactions involve purchases of the securities
in the open market after the distribution is completed to cover
short positions. Penalty bids permit the underwriters to reclaim
a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a covering
transaction to cover short positions. Those activities may cause
the price of the securities to be higher than it would otherwise
be. If commenced, the underwriters may discontinue any of the
activities at any time. We make no representation or prediction
as to the direction or magnitude of any effect that such
transactions may have on the price of the securities. For a
description of these activities, see the information under the
heading Underwriting or Plan of
Distribution in the applicable prospectus supplement.
Underwriters, broker-dealers or agents who may become involved
in the sale of the common stock may engage in transactions with
and perform other services for us in the ordinary course of
their business for which they receive compensation.
LEGAL
MATTERS
The legality of the issuance of the securities being offered
hereby and the binding nature of any debt securities or warrants
being offered hereby is being passed upon by Goodwin Procter
LLP, San Francisco, California.
EXPERTS
The consolidated financial statements incorporated in this
prospectus by reference from Avanir Pharmaceuticals, Inc.s
predecessor California corporations Annual Report on
Form 10-K
for the year ended September 30, 2008 have been audited by
KMJ Corbin & Company LLP, an independent registered
public accounting firm, 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.
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 extent
that a statement contained in or omitted from this prospectus,
or in any other subsequently filed document that 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 which have
been filed by us or our predecessor
6
California corporation (the Predecessor Registrant)
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:
1. Our Predecessor Registrants Annual Report on
Form 10-K
for the year ended September 30, 2008, as amended;
2. Our Predecessor Registrants Definitive Proxy
Statement on Schedule 14A filed with the SEC on January 9,
2009;
3. Our Predecessor Registrants Quarterly Report on
Form 10-Q
for the period ended December 31, 2008 and our Quarterly
Reports on
Form 10-Q
for the periods ended March 31, 2009 and June 30, 2009;
4. Our Predecessor Registrants Current Reports on
Form 8-K
filed with the SEC on November 12, 2008 and
February 25, 2009 and our Current Reports on
Form 8-K
filed with the SEC on March 25, 2009, April 2, 2009
and August 11, 2009; and
5. The description of our common stock contained in our
registration statement on
Form 8-A/A
(File
No. 001-15803)
filed with the SEC on March 25, 2009, 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 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, Inc., 101 Enterprise,
Suite 300, Aliso Viejo, California 92656, Attention:
Investor Relations, telephone:
(949) 389-6700.
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
100 F Street, N.E., 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.
* * *
7
PROSPECTUS
$75,000,000
AVANIR Pharmaceuticals, Inc.
Common Stock
Preferred Stock
Debt Securities
Warrants
We may offer and sell an indeterminate number of shares of our common stock and
preferred stock, debt securities and warrants from time to time under this prospectus. We may offer
these securities separately or as units, which may include combinations of the securities. We will
describe in a prospectus supplement the securities we are offering and selling, as well as the
specific terms of the securities.
We may offer these securities in amounts, at prices and on terms determined at the time
of offering. We may sell the securities directly to you, through agents we select, or through
underwriters and dealers we select. If we use agents, underwriters or dealers to sell the
securities, we will name them and describe their compensation in a prospectus supplement.
Our common stock trades on the NASDAQ Global Market under the symbol AVNR. On
September 28, 2010, the closing price for our common stock, as reported on the NASDAQ Global
Market, was $3.32 per share.
Investing in our securities involves certain risks. See Risk Factors beginning on
Page 3 of this prospectus and in the applicable prospectus supplement for certain risks you should
consider. You should read the entire prospectus 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.
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, utilizing a shelf registration process. Under the shelf registration
process, we may offer shares of our common stock and preferred stock, various series of debt
securities and warrants to purchase any of such securities with a total value of up to $75,000,000
from time to time under this prospectus at prices and on terms to be determined by market
conditions at the time of offering. This prospectus provides you with a general description of the
securities we may offer. Each time we offer a type or series of securities, we will provide a
prospectus supplement that will describe the specific amounts, prices and other important terms of
the securities, including, to the extent applicable:
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aggregate principal amount or aggregate offering price; |
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maturity; |
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original issue discount, if any; |
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rates and times of payment of interest, dividends or other payments, if any; |
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redemption, conversion, exchange, settlement or sinking fund terms, if any; |
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conversion, exchange or settlement prices or rates, if any, and, if
applicable, any provisions for changes to or adjustments in the conversion,
exchange or settlement prices or rates and in the securities or other
property receivable upon conversion, exchange or settlement; |
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ranking; |
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restrictive covenants, if any; |
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voting or other rights, if any; and |
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important federal income tax considerations. |
A prospectus supplement may include a discussion of risks or other special
considerations applicable to us or the offered securities. A prospectus supplement may also add,
update or change information in this prospectus. If there is any inconsistency between the
information in this prospectus and the applicable prospectus supplement, you must rely on the
information in the prospectus supplement. Please carefully read both this prospectus and the
applicable prospectus supplement together with additional information described under the heading
Where You Can Find More Information. This prospectus may not be used to offer or sell any
securities unless accompanied by a prospectus supplement.
The registration statement containing this prospectus, including exhibits to the
registration statement, provides additional information about us and the common stock offered under
this prospectus. The registration statement can be read at the SEC website or at the SECs public
reading room 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 securities,
nor do this prospectus and the accompanying supplement to this prospectus constitute an offer to
sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it
is unlawful to make such offer or solicitation. The information contained in this
2
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 securities are sold on a later date.
We may sell the securities directly to or through underwriters, dealers or agents. We, and our
underwriters or agents, reserve the right to accept or reject all or part of any proposed purchase
of securities. If we do offer securities through underwriters or agents, we will include in the
applicable prospectus supplement:
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the names of those underwriters or agents; |
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applicable fees, discounts and commissions to be paid to them; |
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details regarding over-allotment options, if any; and |
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the net proceeds to us. |
Common Stock . We may issue shares of our common stock from time to time. Holders of
our common stock are entitled to one vote per share for the election of directors and on all other
matters that require stockholder approval. Subject to any preferential rights of any outstanding
preferred stock, in the event of our liquidation, dissolution or winding up, holders of our common
stock are entitled to share ratably in the assets remaining after payment of liabilities and the
liquidation preferences of any outstanding preferred stock. Our common stock does not carry any
redemption rights or any preemptive rights enabling a holder to subscribe for, or receive shares
of, any class of our common stock or any other securities convertible into shares of any class of
our common stock.
Preferred Stock. We may issue shares of our preferred stock from time to time, in
one or more series. Under our certificate of incorporation, our board of directors has the
authority, without further action by stockholders, to designate up to 10,000,000 shares of
preferred stock in one or more series and to fix the rights, preferences, privileges,
qualifications and restrictions granted to or imposed upon the preferred stock, including dividend
rights, conversion rights, voting rights, rights and terms of redemption, liquidation preference
and sinking fund terms, any or all of which may be greater than the rights of the common stock.
If we issue preferred stock, we will fix the rights, preferences, privileges,
qualifications and restrictions of the preferred stock of each series that we sell under this
prospectus and applicable prospectus supplements in the certificate of designations relating to
that series. If we issue preferred stock, we will incorporate by reference into the registration
statement of which this prospectus is a part the form of any certificate of designations that
describes the terms of the series of preferred stock we are offering before the issuance of the
related series of preferred stock. We urge you to read the prospectus supplement related to any
series of preferred stock we may offer, as well as the complete certificate of designations that
contains the terms of the applicable series of preferred stock.
Debt Securities. We may issue debt securities from time to time, in one or more
series, as either senior or subordinated debt or as senior or subordinated convertible debt. The
senior debt securities will rank equally with any other unsubordinated debt that we may have and
may be secured or unsecured. The subordinated debt securities will be subordinate and junior in
right of payment, to the extent and in the manner described in the instrument governing the debt,
to all or some portion of our indebtedness. Any convertible debt securities that we issue will be
convertible into or exchangeable for our common stock or other securities of ours. Conversion may
be mandatory or at your option and would be at prescribed conversion rates.
If we issue debt securities, they will be issued under one or more documents called
indentures, which are contracts between us and a trustee for the holders of the debt securities. We
urge you to read the prospectus supplement related to the series of debt securities being offered,
as well as the complete
3
indenture that contains the terms of the debt securities (which will include a supplemental
indenture). If we issue debt securities, indentures and forms of debt securities containing the
terms of debt securities being offered will be incorporated by reference into the registration
statement of which this prospectus is a part from reports we would subsequently file with the SEC.
Warrants. We may issue warrants for the purchase of common stock, preferred stock and/or debt
securities in one or more series, from time to time. We may issue warrants independently or
together with common stock, preferred stock and/or debt securities, and the warrants may be
attached to or separate from those securities.
If we issue warrants, they will be evidenced by warrant agreements or warrant
certificates issued under one or more warrant agreements, which are contracts between us and an
agent for the holders of the warrants. We urge you to read the prospectus supplement related to any
series of warrants we may offer, as well as the complete warrant agreement and warrant certificate
that contain the terms of the warrants. If we issue warrants, forms of warrant agreements and
warrant certificates relating to warrants for the purchase of common stock, preferred stock and
debt securities will be incorporated by reference into the registration statement of which this
prospectus is a part from reports we would subsequently file with the SEC.
ABOUT AVANIR PHARMACEUTICALS, INC.
Avanir Pharmaceuticals, Inc., is a pharmaceutical company focused on
acquiring, developing and commercializing novel therapeutic products for the treatment of central
nervous system disorders. Our lead product candidate, AVP-923 (formerly referred to by the proposed
trade name, Zenvia), is a unique proprietary combination of dextromethorphan and quinidine.
AVP-923 has successfully completed three Phase III clinical trials for the treatment of
pseudobulbar affect and has successfully completed a Phase III trial for the treatment of patients
with diabetic peripheral neuropathic pain. In addition to our focus on products for the central
nervous system, we also have partnered programs in other therapeutic areas which may generate
future income. Our first commercialized product, docosanol 10% cream, (sold as
Abreva® by our marketing partner GlaxoSmithKline Consumer Healthcare in North
America) is the only over-the-counter product approved by the FDA for the treatment of cold sores.
In 2008, we licensed all of our monoclonal antibodies and we remain eligible to receive milestone
payments and royalties related to the sale of these assets. Avanir was incorporated in
California in August 1988 and was reincorporated in Delaware in March 2009.
For additional information about our company, please refer to other documents we
have filed with the SEC and that are incorporated by reference into this prospectus, as listed
under the heading Incorporation of Certain Information by Reference.
Our offices are located at 101 Enterprise, Suite 300, Aliso Viejo, California 92656.
Our telephone number is (949) 389-6700 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 SEC. Copies of our current and periodic reports filed with the SEC
are available at the SEC Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549, and
online at www.sec.gov and our website at www.avanir.com . No portion of our website is incorporated
by reference into this prospectus.
RISK FACTORS
Before making an investment decision, you should carefully consider the risks
described under Risk Factors in the applicable prospectus supplement, together with all of the
other information appearing in this prospectus or incorporated by reference into this prospectus
and any applicable prospectus supplement, in light of your particular investment objectives and
financial circumstances. Our business, financial condition or results of operations could be
materially adversely affected by any of these risks. The trading price of our securities could
decline due to any of these risks, and you may lose all or part of your investment. This prospectus
and the incorporated documents also contain forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of certain factors, including the risks mentioned elsewhere
in this prospectus.
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NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains or incorporates by reference forward-looking statements and readers
are cautioned that our actual results may differ materially from those discussed in the
forward-looking statements. These forward-looking statements include, without limitation,
statements regarding the potential approval of our new drug application for AVP-923, the safety and
efficacy of our product candidates, including AVP-923, the goals of our development activities,
estimates of the potential markets for our product candidates, projected cash needs and our
expected future cash, revenues, operations and expenditures. These statements relate to future
events or our future financial performance and involve known and unknown risks, uncertainties and
other factors that could cause our actual results, levels of activity, performance or achievement
to differ materially from those expressed or implied by these forward-looking statements. These
risks and uncertainties include, among others:
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risks that the FDA may not approve or may delay the approval of our new drug application
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risks relating to the product label or conditions that the FDA may impose on the marketing
of AVP-923, if approved; |
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risks that we may not be able to successfully commercialize AVP-923, if approved by the FDA; |
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risks relating to our lack of profitability, our significant historical operating losses
and our ability to obtain additional funding to continue to operate our business, which
funding may not be available on commercially reasonable terms, or at all; |
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risks relating to our patent portfolio and the patent portfolios of competitors; |
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risks relating to turnover in senior management and our reliance on key employees; |
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risks around our reliance on third parties to conduct our clinical trials and manufacture
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competitive risks in our industry. |
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, including under the caption, Risk Factors. 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 disclaim any intent to update any forward-looking statements.
DESCRIPTION OF SECURITIES
We may offer shares of our common stock and preferred stock, various series of debt securities
and warrants to purchase any such securities with a total value of up to $75,000,000 from time to
time under this prospectus at prices and on terms to be determined by market conditions at the time
of offering. Each time we offer a type or series of securities, we will provide a prospectus
supplement that will describe the specific amounts, prices and other important terms of the
securities.
Description of Debt Securities
The paragraphs below describe the general terms and provisions of the debt securities we may
issue. When we offer to sell a particular series of debt securities, we will describe the specific
terms of the
5
securities in a supplement to this prospectus, including any additional covenants or
changes to existing covenants relating to such series. The prospectus supplement also will indicate
whether the general terms
and provisions described in this prospectus apply to a particular series of debt securities. You
should read the actual indenture if you do not fully understand a term or the way we use it in this
prospectus.
We may offer senior or subordinated debt securities. Each series of debt securities may have
different terms. The senior debt securities will be issued under one or more senior indentures,
dated as of a date prior to such issuance, between us and a trustee, as amended or supplemented
from time to time. We will refer to any such indenture throughout this prospectus as the senior
indenture. Any subordinated debt securities will be issued under one or more separate indentures,
dated as of a date prior to such issuance, between us and a trustee, as amended or supplemented
from time to time. We will refer to any such indenture throughout this prospectus as the
subordinated indenture and to the trustee under the senior or subordinated indenture as the
trustee. The senior indenture and the subordinated indenture are sometimes collectively referred
to in this prospectus as the indentures. The indentures will be subject to and governed by the
Trust Indenture Act of 1939, as amended. We included copies of the forms of the indentures as
exhibits to our registration statement and they are incorporated into this prospectus by reference.
If we issue debt securities at a discount from their principal amount, then, for purposes of
calculating the aggregate initial offering price of the offered securities issued under this
prospectus, we will include only the initial offering price of the debt securities and not the
principal amount of the debt securities.
We have summarized below the material provisions of the indentures and the debt securities, or
indicated which material provisions will be described in the related prospectus supplement. The
prospectus supplement relating to any particular securities offered will describe the specific
terms of the securities, which may be in addition to or different from the general terms summarized
in this prospectus. Because the summary in this prospectus and in any prospectus supplement does
not contain all of the information that you may find useful, you should read the documents relating
to the securities that are described in this prospectus or in any applicable prospectus supplement.
Please read Where You Can Find More Information to find out how you can obtain a copy of those
documents. Except as otherwise indicated, the terms of the indentures are identical. As used under
this caption, the term debt securities includes the debt securities being offered by this
prospectus and all other debt securities issued by us under the indentures.
General
The indentures:
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do not limit the amount of debt securities that we may issue; |
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allow us to issue debt securities in one or more series; |
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do not require us to issue all of the debt securities of a series at the same time; |
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allow us to reopen a series to issue additional debt securities without the
consent of the holders of the debt securities of such series; and |
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provide that the debt securities will be unsecured, except as may be set forth in
the applicable prospectus supplement. |
Unless we give you different information in the applicable prospectus supplement, the senior
debt securities will be unsubordinated obligations and will rank equally with all of our other
unsecured and unsubordinated indebtedness. Payments on the subordinated debt securities will be
subordinated to the prior payment in full of all of our senior indebtedness, as described under
Description of the Debt SecuritiesSubordination and in the applicable prospectus supplement.
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Each indenture provides that we may, but need not, designate more than one trustee under an
indenture. Any trustee under an indenture may resign or be removed and a successor trustee may be
appointed to act with respect to the series of debt securities administered by the resigning or
removed trustee. If two or more
persons are acting as trustee with respect to different series of debt securities, each trustee
shall be a trustee of a trust under the applicable indenture separate and apart from the trust
administered by any other trustee. Except as otherwise indicated in this prospectus, any action
described in this prospectus to be taken by each trustee may be taken by each trustee with respect
to, and only with respect to, the one or more series of debt securities for which it is trustee
under the applicable indenture.
The prospectus supplement for each offering will provide the following terms, where
applicable:
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the title of the debt securities and whether they are senior or subordinated; |
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the aggregate principal amount of the debt securities being offered, the aggregate principal amount
of the debt securities outstanding as of the most recent practicable date and any limit on their
aggregate principal amount, including the aggregate principal amount of debt securities authorized; |
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the price at which the debt securities will be issued, expressed as a percentage of the principal
and, if other than the principal amount thereof, the portion of the principal amount thereof
payable upon declaration of acceleration of the maturity thereof or, if applicable, the portion of
the principal amount of such debt securities that is convertible into common stock or preferred
stock or the method by which any such portion shall be determined; |
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if convertible, the terms on which such debt securities are convertible, including the initial
conversion price or rate and the conversion period and any applicable limitations on the ownership
or transferability of common stock or preferred stock received on conversion; |
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the date or dates, or the method for determining the date or dates, on which the principal of the
debt securities will be payable; |
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the fixed or variable interest rate or rates of the debt securities, or the method by which the
interest rate or rates is determined; |
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the date or dates, or the method for determining the date or dates, from which interest will accrue; |
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the dates on which interest will be payable; |
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the record dates for interest payment dates, or the method by which we will determine those dates; |
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the persons to whom interest will be payable; |
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the basis upon which interest will be calculated if other than that of a 360-day year of twelve
30-day months; |
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any make-whole amount, which is the amount in addition to principal and interest that is required
to be paid to the holder of a debt security as a result of any optional redemption or accelerated
payment of such debt security, or the method for determining the make-whole amount; |
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the place or places where the principal of, and any premium, or make-whole amount, and interest on,
the debt securities will be payable; |
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where the debt securities may be surrendered for registration of transfer or conversion or exchange; |
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where notices or demands to or upon us in respect of the debt securities and the applicable
indenture may be served; |
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the times, prices and other terms and conditions upon which we may redeem the debt securities; |
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any obligation we have to redeem, repay or purchase the debt securities pursuant to any sinking
fund or analogous provision or at the option of holders of the debt securities, and the times and
prices at which we must redeem, repay or purchase the debt securities as a result of such an
obligation; |
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the currency or currencies in which the debt securities are
denominated and payable if other than United States
dollars, which may be a foreign currency or units of two or
more foreign currencies or a composite currency or
currencies and the terms and conditions relating thereto,
and the manner of determining the equivalent of such
foreign currency in United States dollars; |
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whether the principal of, and any premium, or make-whole
amount, or interest on, the debt securities of the series
are to be payable, at our election or at the election of a
holder, in a currency or currencies other than that in
which the debt securities are denominated or stated to be
payable, and other related terms and conditions; |
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whether the amount of payments of principal of, and any
premium, or make-whole amount, or interest on, the debt
securities may be determined according to an index, formula
or other method and how such amounts will be determined; |
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whether the debt securities will be in registered form,
bearer form or both and (1) if in registered form, the
person to whom any interest shall be payable, if other than
the person in whose name the security is registered at the
close of business on the regular record date for such
interest, or (2) if in bearer form, the manner in which, or
the person to whom, any interest on the security shall be
payable if otherwise than upon presentation and surrender
upon maturity; |
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any restrictions applicable to the offer, sale or delivery
of securities in bearer form and the terms upon which
securities in bearer form of the series may be exchanged
for securities in registered form of the series and vice
versa if permitted by applicable laws and regulations; |
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whether any debt securities of the series are to be
issuable initially in temporary global form and whether any
debt securities of the series are to be issuable in
permanent global form with or without coupons and, if so,
whether beneficial owners of interests in any such
permanent global security may or shall be required to
exchange their interests for other debt securities of the
series, and the manner in which interest shall be paid; |
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the identity of the depositary for securities in registered
form, if such series are to be issuable as a global
security; |
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the date as of which any debt securities in bearer form or
in temporary global form shall be dated if other than the
original issuance date of the first security of the series
to be issued; |
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the applicability, if any, of the defeasance and covenant
defeasance provisions described in this prospectus or in
the applicable indenture; |
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whether and under what circumstances we will pay any
additional amounts on the debt securities in respect of any
tax, assessment or governmental charge and, if so, whether
we will have the option to redeem the debt securities in
lieu of making such a payment; |
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whether and under what circumstances the debt securities
being offered are convertible into common stock or
preferred stock, as the case may be, including the
conversion price or rate or manner or calculation thereof; |
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the circumstances, if any, specified in the applicable
prospectus supplement, under which beneficial owners of
interests in the global security may obtain definitive debt
securities and the manner in which payments on a permanent
global debt security will be made if any debt securities
are issuable in temporary or permanent global form; |
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any provisions granting special rights to holders of
securities upon the occurrence of such events as specified
in the applicable prospectus supplement; |
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if the debt securities of such series are to be issuable in
definitive form only upon receipt of certain certificates
or other documents or satisfaction of other conditions,
then the form and/or terms of such certificates, documents
or conditions; |
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the name of the applicable trustee and the nature of any
material relationship with us or any of our affiliates, and
the percentage of debt securities of the class necessary to
require the trustee to take action; |
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any deletions from, modifications of, or additions to our
events of default or covenants and any change in the right
of any trustee or any of the holders to declare the
principal amount of any of such debt securities due and
payable; |
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applicable CUSIP numbers; and |
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any other terms of such debt securities not inconsistent with the
provisions of the applicable indenture. |
We may issue debt securities at a discount below their principal amount and provide for less
than the entire principal amount thereof to be payable upon declaration of acceleration of the
maturity of the debt securities. We refer to any such debt securities throughout this prospectus as
original issue discount securities. The applicable prospectus supplement will describe the United
States federal income tax consequences and other relevant considerations applicable to original
issue discount securities.
We also may issue indexed debt securities. Payments of principal of and premium and interest
on, indexed debt securities are determined with reference to the rate of exchange between the
currency or currency unit in which the debt security is denominated and any other currency or
currency unit specified by us, to the relationship between two or more currencies or currency units
or by other similar methods or formulas specified in the prospectus supplement.
Except as described under Merger, Consolidation or Sale of Assets or as may be set forth
in any prospectus supplement, the debt securities will not contain any provisions that (1) would
limit our ability to incur indebtedness or (2) would afford holders of debt securities protection
in the event of (a) a highly leveraged or similar transaction involving us, or (b) a change of
control or reorganization, restructuring, merger or similar transaction involving us that may
adversely affect the holders of the debt securities. In the future, we may enter into transactions,
such as the sale of all or substantially all of our assets or a merger or consolidation, that may
have an adverse effect on our ability to service our indebtedness, including the debt securities,
by, among other things, substantially reducing or eliminating our assets.
Neither the Delaware General Corporation Law nor our governing instruments define the term
substantially all as it relates to the sale of assets. Additionally, Delaware cases interpreting
the term substantially all rely upon the facts and circumstances of each particular case.
Consequently, to determine whether a sale of substantially all of our assets has occurred, a
holder of debt securities must review the financial and other information that we have disclosed to
the public.
We will provide you with more information in the applicable prospectus supplement regarding
any deletions, modifications, or additions to the events of default or covenants that are described
below, including any addition of a covenant or other provision providing event risk or similar
protection.
Payment
Unless we give you different information in the applicable prospectus supplement, the
principal of, and any premium, or make-whole amount, and interest on, any series of the debt
securities will be payable at
9
the corporate trust office of the trustee. We will provide you with
the address of the trustee in the applicable prospectus supplement. We may also pay interest by
mailing a check to the address of the person entitled to
it as it appears in the applicable register for the debt securities or by wire transfer of funds to
that person at an account maintained within the United States.
All monies that we pay to a paying agent or a trustee for the payment of the principal of, and
any premium, or make-whole amount, or interest on, any debt security will be repaid to us if
unclaimed at the end of two years after the obligation underlying payment becomes due and payable.
After funds have been returned to us, the holder of the debt security may look only to us for
payment, without payment of interest for the period which we hold the funds.
Denomination, Interest, Registration and Transfer
Unless otherwise described in the applicable prospectus supplement, the debt securities of any
series will be issuable in denominations of $1,000 and integral multiples of $1,000.
Subject to the limitations imposed upon debt securities that are evidenced by a computerized entry
in the records of a depository company rather than by physical delivery of a note, a holder of debt
securities of any series may:
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exchange them for any authorized denomination of other debt
securities of the same series and of a like aggregate
principal amount and kind upon surrender of such debt
securities at the corporate trust office of the applicable
trustee or at the office of any transfer agent that we
designate for such purpose; and |
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surrender them for registration of transfer or exchange at
the corporate trust office of the applicable trustee or at
the office of any transfer agent that we designate for such
purpose. |
Every debt security surrendered for registration of transfer or exchange must be duly endorsed
or accompanied by a written instrument of transfer satisfactory to the applicable trustee or
transfer agent. Payment of a service charge will not be required for any registration of transfer
or exchange of any debt securities, but we or the trustee may require payment of a sum sufficient
to cover any tax or other governmental charge payable in connection therewith. If in addition to
the applicable trustee, the applicable prospectus supplement refers to any transfer agent initially
designated by us for any series of debt securities, we may at any time rescind the designation of
any such transfer agent or approve a change in the location through which any such transfer agent
acts, except that we will be required to maintain a transfer agent in each place of payment for
such series. We may at any time designate additional transfer agents for any series of debt
securities.
Neither we, nor any trustee, will be required to:
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issue, register the transfer of or exchange debt securities
of any series during a period beginning at the opening of
business 15 days before the day that the notice of
redemption of any debt securities selected for redemption
is mailed and ending at the close of business on the day of
such mailing; |
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register the transfer of or exchange any debt security, or
portion thereof, so selected for redemption, in whole or in
part, except the unredeemed portion of any debt security
being redeemed in part; and |
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issue, register the transfer of or exchange any debt
security that has been surrendered for repayment at the
option of the holder, except the portion, if any, of such
debt security not to be so repaid. |
Merger, Consolidation or Sale of Assets
The indentures provide that we may, without the consent of the holders of any outstanding debt
securities, (1) consolidate with, (2) sell, lease or convey all or substantially all of our assets
to, or (3) merge with or into, any other entity provided that:
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either we are the continuing entity, or the successor
entity, if other than us, assumes the obligations (A) to
pay the principal of, and any premium (or make-whole
amount) and interest on, all of the debt securities and (B)
to duly perform and observe all of the covenants and
conditions contained in each indenture; |
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after giving effect to the transaction, there is no event
of default under the indentures and no event which, after
notice or the lapse of time, or both, would become such an
event of default, occurs and continues; and |
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an officers certificate and legal opinion covering such
conditions are delivered to each applicable trustee. |
Covenants
Existence. Except as permitted under Merger, Consolidation or Sale of Assets, the
indentures require us to do or cause to be done all things necessary to preserve and keep in full
force and effect our existence, rights and franchises. However, the indentures do not require us to
preserve any right or franchise if we determine that any right or franchise is no longer desirable
in the conduct of our business.
Provision of financial information. The indentures require us to (1) within 15 days of each of
the respective dates by which we are required to file our annual reports, quarterly reports and
other documents with the SEC, file with the trustee copies of the annual report, quarterly report
and other documents that we file with the SEC under Section 13 or 15(d) of the Exchange Act, (2)
file with the trustee and the SEC any additional information, documents and reports regarding
compliance by us with the conditions and covenants of the indentures, as required, (3) within 30
days after the filing with the trustee, mail to all holders of debt securities, as their names and
addresses appear in the applicable register for such debt securities, without cost to such holders,
summaries of any documents and reports required to be filed by us pursuant to (1) and (2) above,
and (4) supply, promptly upon written request and payment of the reasonable cost of duplication and
delivery, copies of such documents to any prospective holder.
Additional covenants. The applicable prospectus supplement will set forth any additional
covenants of Avanir relating to any series of debt securities.
Events of Default, Notice and Waiver
Unless the applicable prospectus supplement states otherwise, when we refer to events of
default as defined in the indentures with respect to any series of debt securities, we mean:
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default in the payment of any installment of interest on any debt security of such series
continuing for 30 days; |
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default in the payment of principal of, or any premium, or make-whole amount, on any debt
security of such series for five business days at its stated maturity; |
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default in making any sinking fund payment as required for any debt security of such
series for five business days; |
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default in the performance or breach of any covenant or warranty in the debt securities or
in the indenture by Avanir continuing for 60 days after written notice as provided in the
applicable indenture, but not of a covenant added to the indenture solely for the benefit
of a series of debt securities issued thereunder other than such series; |
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bankruptcy, insolvency or reorganization, or court appointment of a receiver, liquidator
or trustee of Avanir or any significant subsidiary of Avanir; and |
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any other event of default provided with respect to a particular series of debt securities. |
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When we use the term significant subsidiary, we refer to the meaning ascribed to such term
in Rule 1-02 of Regulation S-X promulgated under the Securities Act of 1933, as amended, or
Securities Act.
If an event of default occurs and is continuing with respect to debt securities of any series
outstanding, then the applicable trustee or the holders of 25% or more in principal amount of the
debt securities of that series will have the right to declare the principal amount of all the debt
securities of that series to be due and payable. If the debt securities of that series are original
issue discount securities or indexed securities, then the applicable trustee or the holders of 25%
or more in principal amount of the debt securities of that series will have the right to declare
the portion of the principal amount as may be specified in the terms thereof to be due and payable.
However, at any time after such a declaration of acceleration has been made, but before a judgment
or decree for payment of the money due has been obtained by the applicable trustee, the holders of
at least a majority in principal amount of outstanding debt securities of such series or of all
debt securities then outstanding under the applicable indenture may rescind and annul such
declaration and its consequences if:
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we have deposited with the applicable trustee all required
payments of the principal, any premium, or make-whole
amount, interest and, to the extent permitted by law,
interest on overdue installment of interest, plus
applicable fees, expenses, disbursements and advances of
the applicable trustee; and |
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all events of default, other than the non-payment of
accelerated principal, or a specified portion thereof, and
any premium, or make-whole amount, have been cured or
waived. |
The indentures also provide that the holders of at least a majority in principal amount of the
outstanding debt securities of any series or of all debt securities then outstanding under the
applicable indenture may, on behalf of all holders, waive any past default with respect to such
series and its consequences, except a default:
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in the payment of the principal, any premium, or make-whole amount, or interest; |
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in respect of a covenant or provision contained in the applicable indenture
that cannot be modified or amended without the consent of the holders of the
outstanding debt security that is affected by the default; or |
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in respect of a covenant or provision for the benefit or protection of the
trustee, without its express written consent. |
The indentures require each trustee to give notice to the holders of debt securities within 90
days of a default unless such default has been cured or waived. However, the trustee may withhold
notice if specified persons of such trustee consider such withholding to be in the interest of the
holders of debt securities. The trustee may not withhold notice of a default in the payment of
principal, any premium or interest on any debt security of such series or in the payment of any
sinking fund installment in respect of any debt security of such series.
The indentures provide that holders of debt securities of any series may not institute any
proceedings, judicial or otherwise, with respect to such indenture or for any remedy under the
indenture, unless the trustee fails to act for a period of 60 days after the trustee has received a
written request to institute proceedings in respect of an event of default from the holders of 25%
or more in principal amount of the outstanding debt securities of such series, as well as an offer
of indemnity reasonably satisfactory to the trustee. However, this provision will not prevent any
holder of debt securities from instituting suit for the enforcement of payment of the principal of,
and any premium, or make-whole amount, and interest on, such debt securities at the respective due
dates thereof.
The indentures provide that, subject to provisions in each indenture relating to its duties in
the case of a default, a trustee has no obligation to exercise any of its rights or powers at the
request or direction of any holders of any series of debt securities then outstanding under the
indenture, unless the holders have offered
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to the trustee reasonable security or indemnity. The
holders of at least a majority in principal amount of the outstanding debt securities of any series
or of all debt securities then outstanding under an indenture shall
have the right to direct the time, method and place of conducting any proceeding for any remedy
available to the applicable trustee, or of exercising any trust or power conferred upon such
trustee. However, a trustee may refuse to follow any direction which: |
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is in conflict with any law or the applicable indenture; |
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upon a good faith determination of a responsible officer of
the trustee, may involve the trustee in personal liability;
or |
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upon a good faith determination of a responsible officer of
the trustee, may be unduly prejudicial to the holders of
debt securities of the series not joining the proceeding. |
Within 120 days after the close of each fiscal year, we will be required to deliver to each
trustee a certificate, signed by one of our several specified officers, stating whether or not that
officer has knowledge of any default under the applicable indenture. If the officer has knowledge
of any default, the notice must specify the nature and status of the default.
Modification of the Indentures
The indentures provide that modifications and amendments may be made only with the consent of
the affected holders of at least a majority in principal amount of all outstanding debt securities
issued under that indenture. However, no such modification or amendment may, without the consent of
the holders of the debt securities affected by the modification or amendment:
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change the stated maturity of the principal of, or any
premium, or make-whole amount, on, or any installment of
principal of or interest on, any such debt security; |
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reduce the principal amount of, the rate or amount of
interest on or any premium, or make-whole amount, payable
on redemption of any such debt security; |
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reduce the amount of principal of an original issue
discount security that would be due and payable upon
declaration of acceleration of the maturity thereof or
would be provable in bankruptcy, or adversely affect any
right of repayment of the holder of any such debt security; |
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change the place of payment or the coin or currency for
payment of principal of, or any premium, or make-whole
amount, or interest on, any such debt security; |
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impair the right to institute suit for the enforcement of
any payment on or with respect to any such debt security; |
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reduce the percentage in principal amount of any
outstanding debt securities necessary to modify or amend
the applicable indenture with respect to such debt
securities, to waive compliance with particular provisions
thereof or defaults and consequences thereunder or to
reduce the quorum or voting requirements set forth in the
applicable indenture; and |
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modify any of the foregoing provisions or any of the
provisions relating to the waiver of particular past
defaults or covenants, except to increase the required
percentage to effect such action or to provide that some of
the other provisions may not be modified or waived without
the consent of the holder of such debt security. |
The holders of a majority in aggregate principal amount of the outstanding debt securities of
each series may, on behalf of all holders of debt securities of that series, waive, insofar as that
series is concerned, our compliance with material restrictive covenants of the applicable
indenture.
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We and our respective trustee may make modifications and amendments of an indenture without
the consent of any holder of debt securities for any of the following purposes:
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to evidence the succession of another person to us as obligor under such indenture; |
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to add to our covenants for the benefit of the holders of all or any series of debt securities
or to surrender any right or power conferred upon us in such indenture; |
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to add events of default for the benefit of the holders of all or any series of debt securities; |
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to add or change any provisions of an indenture (1) to change or eliminate restrictions on the
payment of principal of, or premium, or make-whole amount, or interest on, debt securities in
bearer form, or (2) to permit or facilitate the issuance of debt securities in uncertificated
form, provided that such action shall not adversely affect the interests of the holders of the
debt securities of any series in any material respect; |
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to change or eliminate any provisions of an indenture, provided that any such change or
elimination shall become effective only when there are no debt securities outstanding of any
series created prior thereto which are entitled to the benefit of such provision; |
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to secure the debt securities; |
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to establish the form or terms of debt securities of any series; |
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to provide for the acceptance of appointment by a successor trustee or facilitate the
administration of the trusts under an indenture by more than one trustee; |
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to cure any ambiguity, defect or inconsistency in an indenture, provided that such action shall
not adversely affect the interests of holders of debt securities of any series issued under
such indenture; and |
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to supplement any of the provisions of an indenture to the extent necessary to permit or
facilitate defeasance and discharge of any series of such debt securities, provided that such
action shall not adversely affect the interests of the holders of the outstanding debt
securities of any series. |
Voting
The indentures provide that in determining whether the holders of the requisite principal
amount of outstanding debt securities of a series have given any request, demand, authorization,
direction, notice, consent or waiver under the indentures or whether a quorum is present at a
meeting of holders of debt securities:
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the principal amount of an original issue discount security
that shall be deemed to be outstanding shall be the amount
of the principal thereof that would be due and payable as
of the date of such determination upon declaration of
acceleration of the maturity thereof; |
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the principal amount of any debt security denominated in a
foreign currency that shall be deemed outstanding shall be
the United States dollar equivalent, determined on the
issue date for such debt |
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security, of the principal amount or, in the case of an
original issue discount security, the United States dollar
equivalent on the issue date of such debt security of the
amount determined as provided in the preceding bullet
point; |
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the principal amount of an indexed security that shall be
deemed outstanding shall be the principal face amount of
such indexed security at original issuance, unless
otherwise provided for such indexed security under such
indenture; and |
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debt securities owned by us or any other obligor upon the
debt securities or by any affiliate of ours or of such
other obligor shall be disregarded. |
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The indentures contain provisions for convening meetings of the holders of debt securities of
a series. A meeting will be permitted to be called at any time by the applicable trustee, and also,
upon request, by us or the holders of at least 25% in principal amount of the outstanding debt
securities of such series, in any such case upon notice given as provided in such indenture. Except
for any consent that must be given by the holder of each debt security affected by the
modifications and amendments of an indenture described above, any resolution presented at a meeting
or adjourned meeting duly reconvened at which a quorum is present may be adopted by the affirmative
vote of the holders of a majority of the aggregate principal amount of the outstanding debt
securities of that series represented at such meeting.
Notwithstanding the preceding paragraph, except as referred to above, any resolution relating
to a request, demand, authorization, direction, notice, consent, waiver or other action that may be
made, given or taken by the holders of a specified percentage, which is less than a majority of the
aggregate principal amount of the outstanding debt securities of a series, may be adopted at a
meeting or adjourned meeting duly reconvened at which a quorum is present by the affirmative vote
of such specified percentage.
Any resolution passed or decision taken at any properly held meeting of holders of debt
securities of any series will be binding on all holders of such series. The quorum at any meeting
called to adopt a resolution, and at any reconvened meeting, will be persons holding or
representing a majority in principal amount of the outstanding debt securities of a series.
However, if any action is to be taken relating to a consent or waiver which may be given by the
holders of at least a specified percentage in principal amount of the outstanding debt securities
of a series, the persons holding such percentage will constitute a quorum.
Notwithstanding the foregoing provisions, the indentures provide that if any action is to be
taken at a meeting with respect to any request, demand, authorization, direction, notice, consent,
waiver or other action that such indenture expressly provides may be made, given or taken by the
holders of a specified percentage in principal amount of all outstanding debt securities affected
by such action, or of the holders of such series and one or more additional series:
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there shall be no minimum quorum requirement for such meeting; and |
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the principal amount of the outstanding debt securities of such
series that vote in favor of such request, demand, authorization,
direction, notice, consent, waiver or other action shall be taken
account in determining whether such request, demand,
authorization, direction, notice, consent, waiver or other action
has been made, given or taken under such indenture. |
Subordination
Unless otherwise provided in the applicable prospectus supplement, subordinated securities
will be subject to the following subordination provisions.
Upon any distribution to our creditors in a liquidation, dissolution or reorganization, the
payment of the principal of and interest on any subordinated securities will be subordinated to the
extent provided in the applicable indenture in right of payment to the prior payment in full of all
senior debt. However, our obligation to make payments of the principal of and interest on such
subordinated securities otherwise will not be affected. No payment of principal or interest will be
permitted to be made on subordinated securities at any time if a default on senior debt exists that
permits the holders of such senior debt to accelerate its maturity and the default is the subject
of judicial proceedings or we receive notice of the default. After all senior debt is paid in full
and until the subordinated securities are paid in full, holders of subordinated securities will be
subrogated to the rights of holders of senior debt to the extent that distributions otherwise
payable to holders of subordinated securities have been applied to the payment of senior debt. The
subordinated indenture will not restrict the amount of senior debt or other indebtedness of Avanir
and its
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subsidiaries. As a result of these subordination provisions, in the event of a distribution
of assets upon insolvency, holders of subordinated securities may recover less, ratably, than our
general creditors.
The term senior debt will be defined in the applicable indenture as the principal of and
interest on, or substantially similar payments to be made by us in respect of, other outstanding
indebtedness, whether outstanding at the date of execution of the applicable indenture or
subsequently incurred, created or assumed. The prospectus supplement may include a description of
additional terms implementing the subordination feature.
No restrictions will be included in any indenture relating to subordinated securities upon the
creation of additional senior debt.
If this prospectus is being delivered in connection with the offering of a series of
subordinated securities, the accompanying prospectus supplement or the information incorporated in
this prospectus by reference will set forth the approximate amount of senior debt outstanding as of
the end of our most recent fiscal quarter.
Discharge, Defeasance and Covenant Defeasance
Unless otherwise indicated in the applicable prospectus supplement, the indentures allow us to
discharge our obligations to holders of any series of debt securities issued under any indenture
when:
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either (1) all securities of such series have already been
delivered to the applicable trustee for cancellation; or (2)
all securities of such series have not already been
delivered to the applicable trustee for cancellation but (A)
have become due and payable, (B) will become due and payable
within one year, or (C) if redeemable at our option, are to
be redeemed within one year, and we have irrevocably
deposited with the applicable trustee, in trust, funds in
such currency or currencies, currency unit or units or
composite currency or currencies in which such debt
securities are payable, an amount sufficient to pay the
entire indebtedness on such debt securities in respect of
principal and any premium, or make-whole amount, and
interest to the date of such deposit if such debt securities
have become due and payable or, if they have not, to the
stated maturity or redemption date; |
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we have paid or caused to be paid all other sums payable; and |
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an officers certificate and an opinion of counsel stating
the conditions to discharging the debt securities have been
satisfied has been delivered to the trustee. |
Unless otherwise indicated in the applicable prospectus supplement, the indentures provide
that, upon our irrevocable deposit with the applicable trustee, in trust, of an amount, in such
currency or currencies, currency unit or units or composite currency or currencies in which such
debt securities are payable at stated maturity, or government obligations, or both, applicable to
such debt securities, which through the scheduled payment of principal and interest in accordance
with their terms will provide money in an amount sufficient to pay the principal of, and any
premium, or make-whole amount, and interest on, such debt securities, and any mandatory sinking
fund or analogous payments thereon, on the scheduled due dates therefor, the issuing company may
elect either:
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to defease and be discharged from any and all obligations with respect to such debt securities; or |
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to be released from its obligations with respect to such debt securities under the applicable
indenture or, if provided in the applicable prospectus supplement, its obligations with respect
to any other covenant, and any omission to comply with such obligations shall not constitute an
event of default with respect to such debt securities. |
Notwithstanding the above, we may not elect to defease and be discharged from the obligation
to pay any additional amounts upon the occurrence of particular events of tax, assessment or
governmental charge with respect to payments on such debt securities and the obligations to
register the transfer or exchange of
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such debt securities, to replace temporary or mutilated,
destroyed, lost or stolen debt securities, to maintain an office or agency in respect of such debt
securities, or to hold monies for payment in trust.
The indentures only permit us to establish the trust described in the paragraph above if,
among other things, it has delivered to the applicable trustee an opinion of counsel to the effect
that the holders of such debt securities will not recognize income, gain or loss for United States
federal income tax purposes as a result of such defeasance or covenant defeasance and will be
subject to United States federal income tax on the same amounts, in the same manner and at the same
times as would have been the case if such defeasance or covenant defeasance had not occurred. Such
opinion of counsel, in the case of defeasance, will be required to refer to and be based upon a
ruling received from or published by the Internal Revenue Service or a change in applicable United
States federal income tax law occurring after the date of the indenture. In the event of such
defeasance, the holders of such debt securities would be able to look only to such trust fund for
payment of principal, any premium, or make-whole amount, and interest.
When we use the term government obligations, we mean securities that are:
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direct obligations of the United States or the government
that issued the foreign currency in which the debt
securities of a particular series are payable, for the
payment of which its full faith and credit is pledged; or |
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obligations of a person controlled or supervised by and
acting as an agency or instrumentality of the United States
or other government that issued the foreign currency in
which the debt securities of such series are payable, the
payment of which is unconditionally guaranteed as a full
faith and credit obligation by the United States or such
other government, which are not callable or redeemable at
the option of the issuer thereof and shall also include a
depository receipt issued by a bank or trust company as
custodian with respect to any such government obligation or
a specific payment of interest on or principal of any such
government obligation held by such custodian for the
account of the holder of a depository receipt. However,
except as required by law, such custodian is not authorized
to make any deduction from the amount payable to the holder
of such depository receipt from any amount received by the
custodian in respect of the government obligation or the
specific payment of interest on or principal of the
government obligation evidenced by such depository receipt. |
Unless otherwise provided in the applicable prospectus supplement, if after we have deposited
funds and/or government obligations to effect defeasance or covenant defeasance with respect to
debt securities of any series, (1) the holder of a debt security of such series is entitled to, and
does, elect under the terms of the applicable indenture or the terms of such debt security to
receive payment in a currency, currency unit or composite currency other than that in which such
deposit has been made in respect of such debt security, or (2) a conversion event occurs in respect
of the currency, currency unit or composite currency in which such deposit has been made, the
indebtedness represented by such debt security will be deemed to have been, and will be, fully
discharged and satisfied through the payment of the principal of, and premium, or make-whole
amount, and interest on, such debt security as they become due out of the proceeds yielded by
converting the amount so deposited in respect of such debt security into the currency, currency
unit or composite currency in which such debt security becomes payable as a result of such election
or such cessation of usage based on the applicable market exchange rate.
When we use the term conversion event, we mean the cessation of use of:
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a currency, currency unit or composite currency both by the
government of the country that issued such currency and for
the settlement of transactions by a central bank or other
public institutions of or within the international banking
community; |
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the European Currency Unit both within the European
Monetary System and for the settlement of transactions by
public institutions of or within the European Communities;
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any currency unit or composite currency other than the
European Currency Unit for the purposes for which it was
established. |
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Unless otherwise provided in the applicable prospectus supplement, all payments of principal
of, and any premium, or make-whole amount, and interest on, any debt security that is payable in a
foreign currency that ceases to be used by its government of issuance shall be made in United
States dollars.
In the event that (1) we effect covenant defeasance with respect to any debt securities and
(2) those debt securities are declared due and payable because of the occurrence of any event of
default, the amount in the currency, currency unit or composite currency in which such debt
securities are payable, and government obligations on deposit with the applicable trustee, will be
sufficient to pay amounts due on such debt securities at the time of their stated maturity but may
not be sufficient to pay amounts due on such debt securities at the time of the acceleration
resulting from such event of default. However, the issuing company would remain liable to make
payments of any amounts due at the time of acceleration.
If a trustee or paying agent is unable to apply any money in accordance with the foregoing
paragraphs describing discharge and defeasance by reason of any order or judgment of any court or
governmental authority enjoining, restraining or otherwise prohibiting such application, then the
obligations under the indentures and such securities from which Avanir has been discharged or
released pursuant to the foregoing shall be revived and reinstated as though no deposit had
occurred with respect to such securities, until such time as the trustee or paying agent is
permitted to apply all money held in trust with respect to such securities in accordance with the
foregoing; provided, that if Avanir makes any payment of principal of or any premium or interest on
any such security following such reinstatement of its obligations, Avanir shall be subrogated to
the rights (if any) of the holders of such securities to receive such payment from the money so
held in trust.
The applicable prospectus supplement may further describe the provisions, if any, permitting
such defeasance or covenant defeasance, including any modifications to the provisions described
above, with respect to the debt securities of or within a particular series.
Conversion Rights
The terms and conditions, if any, upon which the debt securities are convertible into common
stock or preferred stock will be set forth in the applicable prospectus supplement. The terms will
include whether the debt securities are convertible into shares of common stock or preferred stock,
the conversion price, or manner of calculation thereof, the conversion period, provisions as to
whether conversion will be at the issuing companys option or the option of the holders, the events
requiring an adjustment of the conversion price and provisions affecting conversion in the event of
the redemption of the debt securities and any restrictions on conversion.
Global Securities
The debt securities of a series may be issued in whole or in part in the form of one or more
global securities that will be deposited with, or on behalf of, a depository identified in the
applicable prospectus supplement relating to such series. Global securities, if any, issued in the
United States are expected to be deposited with The Depository Trust Company, or DTC, as
depository. We may issue global securities in either registered or bearer form and in either
temporary or permanent form. We will describe the specific terms of the depository arrangement with
respect to a series of debt securities in the applicable prospectus supplement relating to such
series. We expect that unless the applicable prospectus supplement provides otherwise, the
following provisions will apply to depository arrangements.
Once a global security is issued, the depository for such global security or its nominee will
credit on its book-entry registration and transfer system the respective principal amounts of the
individual debt securities represented by such global security to the accounts of participants that
have accounts with such depository. Such accounts shall be designated by the underwriters, dealers
or agents with respect to such debt securities or by us if we offer such debt securities directly.
Ownership of beneficial interests in such global security will be limited to participants with the
depository or persons that may hold interests through those participants.
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We expect that, under procedures established by DTC, ownership of beneficial interests in any
global security for which DTC is the depository will be shown on, and the transfer of that
ownership will be effected only through, records maintained by DTC or its nominee, with respect to
beneficial interests of participants with the depository, and records of participants, with respect
to beneficial interests of persons who hold through participants with the depository. Neither we
nor the trustee will have any responsibility or liability for any aspect of the records of DTC or
for maintaining, supervising or reviewing any records of DTC or any of its participants relating to
beneficial ownership interests in the debt securities. The laws of some states require that certain
purchasers of securities take physical delivery of such securities in definitive form. Such limits
and laws may impair the ability to own, pledge or transfer beneficial interest in a global
security.
So long as the depository for a global security or its nominee is the registered owner of such
global security, such depository or such nominee, as the case may be, will be considered the sole
owner or holder of the debt securities represented by the global security for all purposes under
the applicable indenture. Except as described below or in the applicable prospectus supplement,
owners of beneficial interest in a global security will not be entitled to have any of the
individual debt securities represented by such global security registered in their names, will not
receive or be entitled to receive physical delivery of any such debt securities in definitive form
and will not be considered the owners or holders thereof under the applicable indenture. Beneficial
owners of debt securities evidenced by a global security will not be considered the owners or
holders thereof under the applicable indenture for any purpose, including with respect to the
giving of any direction, instructions or approvals to the trustee under the indenture. Accordingly,
each person owning a beneficial interest in a global security with respect to which DTC is the
depository must rely on the procedures of DTC and, if such person is not a participant with the
depository, on the procedures of the participant through which such person owns its interests, to
exercise any rights of a holder under the applicable indenture. We understand that, under existing
industry practice, if DTC requests any action of holders or if an owner of a beneficial interest in
a global security desires to give or take any action which a holder is entitled to give or take
under the applicable indenture, DTC would authorize the participants holding the relevant
beneficial interest to give or take such action, and such participants would authorize beneficial
owners through such participants to give or take such actions or would otherwise act upon the
instructions of beneficial owners holding through them.
Payments of principal of, and any premium, or make-whole amount, and interest on, individual
debt securities represented by a global security registered in the name of a depository or its
nominee will be made to or at the direction of the depository or its nominee, as the case may be,
as the registered owner of the global security under the applicable indenture. Under the terms of
the applicable indenture, we and the trustee may treat the persons in whose name debt securities,
including a global security, are registered as the owners thereof for the purpose of receiving such
payments. Consequently, neither we nor the trustee have or will have any responsibility or
liability for the payment of such amounts to beneficial owners of debt securities including
principal, any premium, or make-whole amount, or interest. We believe, however, that it is
currently the policy of DTC to immediately credit the accounts of relevant participants with such
payments, in amounts proportionate to their respective holdings of beneficial interests in the
relevant global security as shown on the records of DTC or its nominee. We also expect that
payments by participants to owners of beneficial interests in such global security held through
such participants will be governed by standing instructions and customary practices, as is the case
with securities held for the account of customers in bearer form or registered in street name, and
will be the responsibility of such participants. Redemption notices with respect to any debt
securities represented by a global security will be sent to the depository or its nominee. If less
than all of the debt securities of any series are to be redeemed, we expect the depository to
determine the amount of the interest of each participant in such debt securities to be redeemed to
be determined by lot. Neither we, the trustee, any paying agent nor the security registrar for such
debt securities will have any responsibility or liability for any aspect of the records relating to
or payments made on account of beneficial ownership interests in the global security for such debt
securities or for maintaining any records with respect thereto.
Neither we nor the trustee will be liable for any delay by the holders of a global security or
the depository in identifying the beneficial owners of debt securities, and we and the trustee may
conclusively
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rely on, and will be protected in relying on, instructions from the holder of a global security or
the depository for all purposes. The rules applicable to DTC and its participants are on file with
the SEC.
If a depository for any debt securities is at any time unwilling, unable or ineligible to
continue as depository and we do not appoint a successor depository within 90 days, we will issue
individual debt securities in exchange for the global security representing such debt securities.
In addition, we may at any time and in their sole discretion, subject to any limitations described
in the applicable prospectus supplement relating to such debt securities, determine not to have any
of such debt securities represented by one or more global securities and in such event will issue
individual debt securities in exchange for the global security or securities representing such debt
securities. Individual debt securities so issued will be issued in denominations of $1,000 and
integral multiples of $1,000.
The debt securities of a series may also be issued in whole or in part in the form of one or
more bearer global securities that will be deposited with a depository, or with a nominee for such
depository, identified in the applicable prospectus supplement. Any such bearer global securities
may be issued in temporary or permanent form. The specific terms and procedures, including the
specific terms of the depositary arrangement, with respect to any portion of a series of debt
securities to be represented by one or more bearer global securities will be described in the
applicable prospectus supplement.
No Recourse
There is no recourse under any obligation, covenant or agreement in the applicable indenture
or with respect to any security against any of our or our successors past, present or future
stockholders, employees, officers or directors.
USE OF PROCEEDS
We will retain broad discretion over the use of the net proceeds from the sale of our
securities offered hereby. Except as described in any prospectus supplement, we currently
anticipate using the net proceeds from the sale of our securities offered hereby primarily for
general corporate purposes which include, but are not limited to, funding the further development
and commercialization of AVP-923, any of our ongoing and future clinical trials and for general and
administrative expenses. We may also use a portion of the net proceeds to pay off outstanding
indebtedness, if any, and/or 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.
RATIO OF EARNINGS TO FIXED CHARGES
If we offer debt securities and/or preference equity securities under this prospectus, then we
will, if required at that time, provide a ratio of earnings to fixed charges and/or ratio of
combined fixed charges and preference dividends to earnings, respectively, in the applicable
prospectus supplement for such offering.
PLAN OF DISTRIBUTION
We may sell the securities covered by this prospectus from time to time in one or more
offerings. Registration of the securities covered by this prospectus does not mean, however, that
those securities will necessarily be offered or sold.
We may sell the securities separately or together:
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through one or more underwriters or dealers in a public offering and sale by them; |
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directly to investors; or |
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through agents. |
We may sell the securities from time to time:
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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 securities and the terms of the offering in
the prospectus supplement.
Any discounts or concessions allowed or re-allowed or paid to dealers may be changed from time
to time.
If underwriters are used in the sale of any securities, the securities will be acquired by the
underwriters for their own account and may be resold from time to time in one or more transactions
described above. The securities may be either offered to the public through underwriting syndicates
represented by managing underwriters, or directly by underwriters. Generally, the underwriters
obligations to purchase the securities will be subject to conditions precedent and the underwriters
will be obligated to purchase all of the securities if they purchase any of the securities. We may
use underwriters with whom we have a material relationship. We will describe in the prospectus
supplement, naming the underwriter, the nature of any such relationship.
We may authorize underwriters, dealers or agents to solicit offers by certain purchasers to
purchase the securities from us at the public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and delivery on a specified date in
the future. The contracts will be subject only to those conditions set forth in the prospectus
supplement, and the prospectus supplement will set forth any commissions we pay for solicitation of
these contracts.
We may enter into derivative transactions with third parties, or sell securities not covered
by this prospectus to third parties in privately negotiated transactions. If the applicable
prospectus supplement indicates, in connection with those derivatives, the third parties may sell
securities covered by this prospectus and the applicable prospectus supplement, including in short
sale transactions. If so, the third party may use securities pledged by us or borrowed from us or
others to settle those sales or to close out any related open borrowings of stock, and may use
securities received from us in settlement of those derivatives to close out any related open
borrowings of stock. The third party in such sale transactions will be an underwriter and will be
identified in the applicable prospectus supplement or in a post-effective amendment.
Underwriters, dealers and agents may be entitled to indemnification by us against certain
civil liabilities, including liabilities under the Securities Act, or to contribution with respect
to payments made by the underwriters, dealers or agents, under agreements between us and the
underwriters, dealers and agents.
We may grant underwriters who participate in the distribution of securities an option to
purchase additional securities to cover over-allotments, if any, in connection with the
distribution.
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
securities. These underwriters, dealers or agents may be considered to be underwriters under the
Securities Act. As a result,
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discounts, commissions or profits on resale received by the underwriters, dealers or agents may be
treated as underwriting discounts and commissions. The 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 re-allowed or paid to dealers may
be changed from time to time.
Unless otherwise specified in the related prospectus supplement, all securities we offer,
other than common stock, will be new issues of securities with no established trading market. Any
underwriters may make a market in these securities, but will not be obligated to do so and may
discontinue any market making at any time without notice. Any common stock sold pursuant to a
prospectus supplement will be listed for trading on the NASDAQ Stock Market or other principal
market for our common stock. We may apply to list any series of debt securities, preferred stock or
warrants on an exchange, but we are not obligated to do so. Therefore, there may not be liquidity
or a trading market for any series of securities.
Any underwriter may engage in over-allotment transactions, stabilizing transactions,
short-covering transactions and penalty bids in accordance with Regulation M under the Exchange
Act. Over-allotment involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing
bids do not exceed a specified maximum. Short covering transactions involve purchases of the
securities in the open market after the distribution is completed to cover short positions. Penalty
bids permit the underwriters to reclaim a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a covering transaction to cover short positions.
Those activities may cause the price of the securities to be higher than it would otherwise be. If
commenced, the underwriters may discontinue any of the activities at any time. We make no
representation or prediction as to the direction or magnitude of any effect that such transactions
may have on the price of the securities. For a description of these activities, see the information
under the heading Underwriting or Plan of Distribution in the applicable prospectus supplement.
Underwriters, broker-dealers or agents who may become involved in the sale of the common stock
may engage in transactions with and perform other services for us in the ordinary course of their
business for which they receive compensation.
LEGAL MATTERS
The legality of the issuance of the securities being offered hereby and the binding nature of
any debt securities or warrants being offered hereby is being passed upon by Goodwin Procter LLP,
San Francisco, California.
EXPERTS
The consolidated financial statements incorporated in this prospectus by reference from our
Annual Report on Form 10-K for the year ended September 30, 2009 have been audited by KMJ Corbin &
Company LLP, an independent registered public accounting firm, 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.
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 extent that a statement contained in or omitted from this
prospectus, or in any other subsequently filed document that 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
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documents listed below which have been filed by us 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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Our Annual Report on Form 10-K for the year ended September 30, 2009; |
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Our Definitive Proxy Statement on Schedule 14A filed with the SEC on December 28, 2009; |
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Our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009, March 31,
2010 and June 30, 2010; |
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Our Current Reports on Form 8-K filed with the SEC on November 17, 2009, February 23,
2010, May 6, 2010, May 11, 2010 and May 28, 2010; and |
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The description of our common stock contained in our registration statement on Form
8-A/A (File No. 001-15803) filed with the SEC on March 25, 2009, 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 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, Inc., 101 Enterprise, Suite 300, Aliso Viejo, California 92656,
Attention: Investor Relations, telephone: (949) 389-6700. 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 100 F
Street, N.E., 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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Shares
Common Stock
Prospectus Supplement
Sole Book-Running Manager
Jefferies & Company
Co-Managers
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Canaccord Genuity
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Wedbush PacGrow Life Sciences |
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Summer Street Research Partners
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Merriman Capital |
November , 2010