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| AVNR > SEC Filings for AVNR > Form 10-Q on 14-May-2008 | All Recent SEC Filings |
14-May-2008
Quarterly Report
In October 2006, we received an "approvable" letter from the FDA for Zenvia in
the treatment of patients with PBA. The approvable letter raised certain safety
and efficacy concerns and the safety concerns will require additional clinical
development to resolve. Based on discussions with the FDA, we were able to
successfully resolve the outstanding efficacy concern of the original dose
formulation. However, in order to address safety concerns, we agreed to
re-formulate Zenvia and conduct one additional confirmatory Phase III clinical
trial using lower dose formulations. The goal of the study is to demonstrate
improved safety while maintaining significant efficacy. In October 2007, we
reached agreement with the FDA under the Special Protocol Assessment ("SPA")
process, on the design of a single confirmatory Phase III clinical trial of
Zenvia for the treatment of patients with PBA. We enrolled our first patient in
this trial in December 2007 and as of May 2008, we are on target with our
expected enrollment numbers. In May 2008, we informed the FDA of our intention
to increase the planned patient enrollment numbers from 270 to approximately 300
in order to provide additional statistical power to the trial and increase the
size of our safety database. We continue to expect this study to be completed
(as defined as top-line safety and efficacy data becomes available) during the
second half of calendar 2009, even after allowing for the increase in the size
of the trial.
In April 2007, we announced positive top-line data results from our first Phase
III clinical trial of Zenvia for DPN pain. We are currently conducting a formal
pharmacokinetic ("PK") study to identify a lower quinidine dose formulation that
may have similar efficacy to the doses tested in the Phase III study before
discussing a further Phase III trial with the FDA. While we have received no
formal direction from the FDA to lower quinidine dose formulation for DPN pain,
we believe it is the most prudent course of action given the current regulatory
environment and the FDA's concerns raised over Zenvia for PBA.
Docosanol 10% Cream
Docosanol 10% cream is a topical treatment for cold sores. In 2000, we received
FDA approval for marketing docosanol 10% cream as an over-the-counter product.
Since that time, docosanol 10% cream has been approved by regulatory agencies in
Canada, Denmark, Finland, Israel, Korea, Norway, Portugal, Spain, Poland, Greece
and Sweden and is sold by our marketing partners in these territories. In 2000,
we granted a subsidiary of GlaxoSmithKline, SB Pharmco Puerto Rico, Inc.
("GlaxoSmithKline") the exclusive rights to market docosanol 10% cream in North
America. GlaxoSmithKline markets the product under the name AbrevaŽ in the
United States and Canada. In fiscal 2003, we sold an undivided interest in our
GlaxoSmithKline license agreement for docosanol 10% cream to Drug Royalty USA,
Inc. ("Drug Royalty USA") for $24.1 million. We retained the right to receive
50% of all royalties under the GlaxoSmithKline license agreement for annual net
sales of Abreva in North America in excess of $62 million. Starting in fiscal
2007, annual Abreva sales exceeded this threshold and we began participating in
the excess royalties at that time.
Inflammation Program
In April 2005, we entered into an exclusive Research Collaboration and License
Agreement with Novartis regarding the license of certain compounds that regulate
macrophage migration inhibitory factor ("MIF") in the treatment of various
inflammatory diseases. We initially provided contract research services to
Novartis to support this program for two years and, in March 2007, Novartis made
the decision to continue the MIF research program internally and to allow the
research collaboration portion of this agreement to expire without renewal.
Under the terms of the license agreement, we are eligible to receive over
$200 million in combined upfront and milestone payments upon achievement of
development, regulatory, and sales objectives. We are also eligible to receive
escalating royalties on any worldwide product sales generated from this program.
Xenerex Human Antibody Technology - Anthrax/Other Infectious Diseases
Our patented Xenerex antibody technology can be used to develop human monoclonal
antibodies for use as prophylactic and therapeutic drugs, which may be used to
prevent or treat anthrax and other infectious diseases. This proprietary
technology provides a platform for accessing human monoclonal antibodies against
disease antigens. The Xenerex technology is capable of generating fully human
antibodies to target antigens and draws on the natural diversity of the human
donor population. Using Xenerex technology, we have discovered a human
monoclonal antibody, AVP-21D9, that provides immediate post-exposure
neutralization and immediate immunity to animals exposed to a lethal dose of
recombinant anthrax toxins.
In March 2008, we entered into an Asset Purchase and License Agreement with
Emergent Biosolutions for the sale of the Company's anthrax antibodies and
license to use our proprietary Xenerex Technology platform. Under the terms of
the Agreement, we are obligated to complete the remaining work under the
Company's NIH/NIAID grant ("NIH grant"). As such, revenue resulting from upfront
payments totaling $250,000 that were received in the second fiscal quarter of
2008 will be deferred until the third fiscal 2008 quarter until the remaining
work is completed under the NIH grant. The $2 million NIH grant was awarded to
the Company in July 2006 in order to establish a cGMP manufacturing process for
AVP-21D9 and test efficacy of the fully human monoclonal antibody in non-human
primates.
Restructuring Activities
In May 2006, we acquired FazaCloŽ (clozapine, USP), a product marketed for the
management of treatment-resistant schizophrenia and the reduction in the risk of
recurrent suicidal behavior in schizophrenia or schizoaffective disorders. We
had intended to leverage the FazaClo sales force to assist with the commercial
launch of Zenvia for PBA, a launch that was planned for early 2007. However, due
to the receipt of the approvable letter and the resulting delay in the planned
launch of Zenvia, the strategic rationale for continued marketing of FazaClo by
Avanir no longer existed. Therefore, we entered into an agreement in July 2007
to sell FazaClo to Azur Pharma. The sale, which closed August 3, 2007, provided
approximately $43.9 million in an up-front cash payment and may provide up to an
additional $10.0 million in contingent payments to be paid in calendar year
2009, subject to certain regulatory conditions. In addition, the Company is
eligible to receive up to $2.0 million in royalties, based on 3% of annualized
net product revenues in excess of $17.0 million. Azur acquired the FazaClo sales
force and support operations, representing approximately 80 employees in total.
As a result, we became a substantially smaller organization following the sale
of FazaClo, as well as the divestiture of our drug discovery operations in San
Diego, and will be principally focused over the next two to three years on
seeking regulatory approval of Zenvia for the treatment of patients with PBA and
patients with DPN pain. We have suspended all funding activities for our
selective cytokine inhibitor program and have also ended all further prosecution
and maintenance of associated patents.
As a result of these initiatives, we have undergone significant organizational
changes since fiscal 2007. Our principal focus is currently on gaining
regulatory approval for Zenvia TM, first for the treatment of patients with PBA
and then for patients with DPN pain. We believe that the proceeds from the sale
of FazaClo and the proceeds from the April 2008 common stock offering will be
sufficient to fund our operations, including our ongoing confirmatory Phase III
trial for Zenvia in patients with PBA, through the anticipated date the decision
is made by the FDA. For additional information about the risks and uncertainties
that may affect our business and prospects, please see "Risk Factors."
Our principal executive 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. Our Internet website address is www.avanir.com. We
make our periodic and current reports available on our Internet website, free of
charge, as soon as reasonably practicable after such material is electronically
filed with, or furnished to, the SEC. No portion of our website is incorporated
by reference into this Quarterly Report on Form 10-Q. The public may read and
copy the materials we file with the SEC at the SEC's Public Reference Room,
located at 100 F Street, NE, Washington, D.C. 20549. The public may obtain
information regarding the operation of the Public Reference Room by calling the
SEC at 1-800-SEC-0330. The public may also read and copy the materials we file
with the SEC by visiting the SEC's website, www.sec.gov.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
To understand our financial statements, it is important to understand our
critical accounting policies and estimates. The preparation of our financial
statements in conformity with accounting principles generally accepted in the
United States requires us to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. Significant estimates and
assumptions are required in the determination of revenue recognition and sales
deductions for estimated chargebacks, rebates, sales incentives and allowances,
certain royalties and returns and losses. Significant estimates and assumptions
are also required in the appropriateness of capitalization and amortization
periods for identifiable intangible assets, inventories, the potential
impairment of goodwill and other intangible assets, income taxes, contingencies,
estimate on net working capital adjustment and stock-based compensation. Some of
these judgments can be subjective and complex, and, consequently, actual results
may differ from these estimates. For any given individual estimate or assumption
made by us, there may also be other estimates or assumptions that are
reasonable. Although we believe that our estimates and assumptions are
reasonable, they are based upon information available at the time the estimates
and assumptions are made. Actual results may differ significantly from our
estimates.
A summary of significant accounting policies and a description of accounting
policies that are considered critical may be found in Part II, Item 7 of our
Annual Report on Form 10-K for the year ended September 30, 2007 in the
"Critical Accounting Policies and Estimates" section and in Note 2 of the Notes
to our condensed consolidated financial statements included herein.
RESULTS OF OPERATIONS
COMPARISON OF THREE MONTHS ENDED MARCH 31, 2008 AND 2007
Three Months ended
March 31,
2008 2007 $ Change % Change
PRODUCT SALES
Net revenues $ 90,270 $ - $ 90,270 100 %
Cost of revenues 15,510 - 15,510 100 %
Gross margin $ 74,760 $ - $ 74,760 100 %
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LICENSES, RESEARCH SERVICES AND GRANTS Revenues: Research services $ - $ 920,448 $ (920,448 ) -100 % Government research grant 311,758 266,728 45,030 17 % License agreements 56,643 56,019 624 1 % Royalty and sale of royalty rights 571,825 779,673 (207,848 ) -27 % Revenues from licenses, research services and grants 940,226 2,022,868 (1,082,642 ) -54 % Costs: Research services 26,817 607,164 (580,347 ) -96 % Government research grant 431,948 369,261 62,687 17 % Costs from research services and grants 458,765 976,425 (517,660 ) -53 % Research services and other gross margin 481,461 1,046,443 (564,982 ) -54 % Total gross margin $ 556,221 $ 1,046,443 $ (490,222 ) -47 % |
Revenues
Net product revenues for the three months ended March 31, 2008 include sales of
docosanol 10% cream of $90,000. Revenues from licenses, royalties, research
services and grants declined by $1.1 million to $940,000 for the second quarter
of fiscal 2008 compared to $2.0 million in the second quarter of fiscal 2007.
The decrease in revenues is attributed to a decline in revenue of $920,000 from
research services from our agreements with AstraZeneca and Novartis and a
decline in revenue related to royalties of $208,000. The decline in royalties is
primarily attributed to a decrease in royalty revenue recognized related to the
GSK license agreement. In the second fiscal quarter of 2008, neither the
AstraZeneca and Novartis agreements were still active.
Potential revenue-generating contracts that remained active as of March 31, 2008
include several docosanol 10% cream license agreements and our license agreement
with Novartis for the Company's MIF technology. Partnering, licensing and
research collaborations have been, and may continue to be, an important part of
our business development strategy. We may continue to seek partnerships with
pharmaceutical companies that can help fund our operations in exchange for
sharing in the success of any licensed compounds or technologies.
Cost of Revenues
Cost of product revenues for the three months ended March 31, 2008 include the
cost of docosanol 10% cream. Cost of licenses, research services and grants
declined to $459,000 or 49% of revenues for the second quarter of fiscal 2008
compared with $976,000 or 48% of revenues for the second quarter of fiscal 2007.
The decline in cost of revenues is primarily attributed to a 96% decline in the
cost of research services due to the termination of the AstraZeneca agreement
and non-renewal of the Novartis agreement. The cost of licenses, research
services and grants includes primarily direct and indirect payroll costs and the
costs of outside vendors.
Three Months ended
March 31,
2008 2007 $ Change % Change
OPERATING EXPENSES
Research and development $ 3,524,665 $ 5,967,739 $ (2,443,074 ) -41 %
Selling, general and administrative 2,418,894 2,157,245 261,649 12 %
Total Operating Expenses $ 5,943,559 $ 8,124,984 $ (2,181,425 ) -27 %
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Research and Development Expenses
Research and development expenses decreased by $2.5 million from $6.0 million in
the second quarter of fiscal 2007 to $3.5 million for the second quarter of
fiscal 2008. The decrease is primarily due to decreased costs incurred for
Zenvia as the Company was completing a study in the second quarter of fiscal
2007 for the DPN pain indication of Zenvia.
Over the next two years, we expect that our research and development costs will
consist mainly of expenses related to the confirmatory Phase III trial for
Zenvia for PBA.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased slightly by $277,000 from
$2.2 million for the second quarter of fiscal 2007 compared to $2.4 million for
the second quarter of fiscal 2008. In the second quarter of fiscal 2007, we
adjusted forfeiture rates used in the calculated of share-based compensation
expense which resulted in a decrease of non-cash expenses of $151,000.
In September 2007, a court awarded us reimbursement of attorneys fees spent over
a four-year period in connection with the enforcement of a settlement agreement
entered into with a former employee. In April 2008, the Company received the
settlement in the amount of $1.25 million. The settlement will be recorded in
Other Income in the third quarter of fiscal 2008.
Share-Based Compensation
During the second quarter of fiscal 2007, the Company updated its projected
forfeiture rates as it applies to stock-based compensation considering recent
actual data. Forfeiture rates for the six month periods ended March 31, 2008 and
2007 were estimated to be approximately 30% based on our historical experience.
Future estimates may differ substantially from the Company's current estimates.
Total compensation expense for our share-based payments in the three month
period ended March 31, 2008 and the same period in 2007 was $477,000 and
$673,000, respectively. Selling, general and administrative expense in the three
month periods ended March 31, 2008 and 2007 include share-based compensation
expense of $284,000 and $420,000, respectively. Research and development expense
in the three month periods ended March 31, 2008 and 2007 include share-based
compensation expense of $187,000 and $85,000, respectively. As of March 31,
2008, $4.5 million of total unrecognized compensation costs related to nonvested
options and awards is expected to be recognized over a weighted average period
of 2.3 years. See Note 11, "Employee Equity Incentive Plans" in the Notes to
Condensed Consolidated Financial Statements (Unaudited) for further discussion.
Interest Expense and Interest Income
For the three month period ended March 31, 2008, interest expense increased to
$191,000, compared to $135,000 for the same period in the prior year. The
increase in interest expense in 2008 is primarily due to $4 million in Seller
Notes issued in the last six months of fiscal 2007. The Seller Notes were issued
in connection with the purchase of Alamo.
For the three month period ended March 31, 2008, interest income increased to
$283,000, compared to $145,000 for the same period in the prior year. The
increase is due to approximately a 103% increase in the average balance of cash,
cash equivalents and investments in securities for the quarter ended March 31,
2008, compared to the same period in the prior year.
Loss from Discontinued Operations
Loss from discontinued operations was $12,000 in the three month period ended
March 31, 2008, compared to loss from discontinued operations of $3.3 million
for the three month period ended March 31, 2007. The loss recognized in the
three month period ended March 31, 2008 is attributed to the additional trailing
costs of $12,000 related to the operations of FazaClo during the quarter ended
March 31, 2008.
Net Loss
Net loss was $5.3 million, or $0.12 per share, in the three month period ended
March 31, 2008, compared to a net loss of $10.3 million, or $0.26 per share for
the three month period ended March 31, 2007.
COMPARISON OF SIX MONTHS ENDED MARCH 31, 2008 AND 2007
Six Months ended
March 31,
2008 2007 $ Change % Change
PRODUCT SALES
Net revenues $ 126,270 $ - $ 126,270 100 %
Cost of revenues 21,714 - 21,714 100 %
Gross margin $ 104,556 $ - $ 104,556 100 %
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LICENSES, RESEARCH SERVICES AND GRANTS Revenues: Research services $ - $ 2,190,692 $ (2,190,692 ) -100 % Government research grant 479,404 353,076 126,328 36 % License agreements 113,907 113,284 623 1 % Royalty and sale of royalty rights 2,409,678 1,502,713 906,965 60 % Revenues from licenses, research services and grants 3,002,989 4,159,765 (1,156,776 ) -28 % Costs: Research services 76,807 1,771,239 (1,694,432 ) -96 % Government research grant 557,534 464,988 92,546 20 % Costs from research services and grants 634,341 2,236,227 (1,601,886 ) -72 % Research services and other gross margin 2,368,648 1,923,538 445,110 23 % Total gross margin $ 2,473,204 $ 1,923,538 $ 549,666 29 % |
Revenues
Net product revenues for the six months ended March 31, 2008 include sales of
docosanol 10% cream of $126,000. Revenues from licenses, royalties, research
services and grants declined by $1.2 million to $3.0 million for the first six
months of fiscal 2008 compared to $4.2 million in the first six months of fiscal
2007. The decrease in revenues is attributed to a decline in revenue of
$2.2 million from research services from our agreements with AstraZeneca and
Novartis. In the second fiscal quarter of 2008, neither of the collaboration
services agreements with AstraZeneca or Novartis were still active, although our
license agreement with Novartis remained in effect at that time.
The revenue decrease was partially offset by an increase in revenue from
royalties of $907,000. The increase in royalty revenue is related to royalty
revenue from GSK of $934,000 recorded in the first quarter of 2008 pursuant to
the royalty sale arrangement relating to our GSK license agreement in which we
are entitled to receive 50% of all royalties for annual net sales of Abreva in
North America in excess of $62 million.
Potential revenue-generating contracts that remained active as of March 31, 2008
include several docosanol 10% cream license agreements and our license agreement
with Novartis for the Company's MIF technology. Partnering, licensing and
research collaborations have been, and may continue to be, an important part of
our business development strategy. We may continue to seek partnerships with
pharmaceutical companies that can help fund our operations in exchange for
sharing in the success of any licensed compounds or technologies.
Cost of Revenues
Cost of product revenues for the six months ended March 31, 2008 include the
cost of docosanol 10% cream. Cost of licenses, research services and grants
declined to $634,000 or 21% of revenues for the first six months of second
quarter of fiscal 2008 compared with $2.2 million or 54% of revenues for the
first six months of fiscal 2007. The decline in cost of revenues is primarily
attributed to a 96% decline in the cost of research services due to the
termination of the AstraZeneca agreement and non-renewal of the Novartis
agreement. The cost of licenses, research services and grants includes primarily
direct and indirect payroll costs and the costs of outside vendors.
Six Months ended
March 31,
2008 2007 $ Change % Change
OPERATING EXPENSES
Research and development $ 6,950,925 $ 11,164,992 $ (4,214,067 ) -38 %
Selling, general and administrative 5,547,013 11,415,839 (5,868,826 ) -51 %
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