Edgar Filing: AVANIR PHARMACEUTICALS, INC.

e10vq

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


þ		QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended June 30, 2009


o		TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the transition period from to .

Commission File No. 1-15803

AVANIR PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)


Delaware (State or other jurisdiction of incorporation or organization)		33-0314804 (I.R.S. Employer Identification No.)

101 Enterprise Suite 300, Aliso Viejo, California (Address of principal executive offices)		92656 (Zip Code)

(949) 389-6700

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities and Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES þ NO o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

o YES o NO

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. (See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act). (Check one):

Large accelerated filer o

Accelerated filer o

Non-accelerated filer o
(Do not check if a smaller reporting company)

Smaller reporting company þ

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO þ

As of July 17, 2009 the registrant had 78,462,298 shares of common stock issued and outstanding.

Table of Contents


		Page
PART I. FINANCIAL INFORMATION

Item 1.	Financial Statements	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations	4
	Condensed Consolidated Statements of Cash Flows	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	32
Item 4.	Controls and Procedures	32

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	42
Item 3.	Defaults Upon Senior Securities	42
Item 4.	Submission of Matters to a Vote of Security Holders	42
Item 5.	Other Information	43
Item 6.	Exhibits	43
Signatures		44
EX-5.1
EX-10.1
EX-10.2
EX-31.1
EX-31.2
EX-32.1

PART I. FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

AVANIR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS


	June 30,			September 30,
	2009			2008
	(unaudited)

ASSETS
Current assets:
Cash and cash equivalents	$	26,141,175		$	41,383,930
Inventories		17,000			17,000
Prepaid expenses		401,777			1,030,630
Other current assets		109,706			237,334
Current portion of restricted investments in marketable securities		—			388,122

Total current assets		26,669,658			43,057,016
Restricted investments in marketable securities, net of current portion		468,475			468,475
Property and equipment, net		615,579			806,909
Non-current inventories		1,283,458			1,316,277
Other assets		241,400			257,484

TOTAL ASSETS	$	29,278,570		$	45,906,161


LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,025,090		$	451,846
Accrued expenses and other liabilities		910,515			1,881,401
Accrued compensation and payroll taxes		877,876			1,192,457
Current portion of deferred revenues		2,282,560			2,333,932
Notes payable		—			25,744

Total current liabilities		5,096,041			5,885,380
Accrued expenses and other liabilities, net of current portion		613,374			868,517
Deferred revenues, net of current portion		8,393,392			10,152,100

Total liabilities		14,102,807			16,905,997

Commitments and contingencies Stockholders’ equity:
Preferred stock — $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2009 (unaudited) and September 30, 2008, respectively		—			—
Common stock -$0.0001 par value, 200,000,000 shares authorized; 78,244,987 and 78,213,986 shares issued and outstanding as of June 30, 2009 (unaudited) and September 30, 2008, respectively		7,824			7,821
Additional paid-in-capital		286,207,067			284,986,815
Accumulated deficit		(271,039,128	)		(255,994,472	)

Total stockholders’ equity		15,175,763			29,000,164


TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	29,278,570		$	45,906,161

The accompanying notes to condensed consolidated financial statements are an integral part of this statement.

AVANIR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)


	Three Months Ended June 30,						Nine Months Ended June 30,
	2009			2008			2009			2008
REVENUES FROM PRODUCT SALES
Net revenues	$	—		$	3,550		$	—		$	129,820
Cost of revenues		—			—			—			21,714

Product gross margin		—			3,550			—			108,106


REVENUES AND COST OF RESEARCH SERVICES AND OTHER
Revenue from royalties and royalty rights		420,376			584,314			2,872,827			2,993,992
Revenues from license agreements		170,549			1,534,552			283,834			1,648,459
Revenues from government research grant services		—			527,517			—			1,006,922

Revenues from research services and other		590,925			2,646,383			3,156,661			5,649,373
Cost of research and development services		—			155,450			9,746			232,257
Cost of government research grant services		—			358,028			—			915,563

Research services and other gross margin		590,925			2,132,905			3,146,915			4,501,553

Total gross margin		590,925			2,136,455			3,146,915			4,609,659


OPERATING EXPENSES
Research and development		3,358,387			3,139,685			11,683,701			10,090,610
General and administrative		2,204,435			2,350,071			6,679,027			7,910,990

Total operating expenses		5,562,822			5,489,756			18,362,728			18,001,600


Loss from continuing operations		(4,971,897	)		(3,353,301	)		(15,215,813	)		(13,391,941	)

OTHER INCOME (EXPENSES)
Interest income		15,492			315,818			196,338			1,026,204
Interest expense		—			(114,375	)		(516	)		(539,589	)
Gain on early extinguishment of debt		—			967,547			—			967,547
Other, net		436			1,249,764			(21,465	)		1,250,950


Loss from continuing operations before provision for income taxes		(4,955,969	)		(934,547	)		(15,041,456	)		(10,686,829	)

Provision for income taxes		—			22,148			3,200			37,307


Loss from continuing operations		(4,955,969	)		(956,695	)		(15,044,656	)		(10,724,136	)

Loss from discontinued operations		—			(483,680	)		—			(1,555,257	)


Net loss	$	(4,955,969	)	$	(1,440,375	)	$	(15,044,656	)	$	(12,279,393	)


BASIC AND DILUTED NET LOSS PER SHARE:

Continuing operations	$	(0.06	)	$	(0.01	)	$	(0.19	)	$	(0.20	)
Discontinued operations		—			(0.01	)		—			(0.03	)
Net loss	$	(0.06	)	$	(0.02	)	$	(0.19	)	$	(0.23	)


Basic and diluted weighted average number of common shares outstanding		78,236,153			71,069,841			78,225,891			52,418,695

The accompanying notes to condensed consolidated financial statements are an integral part of this statement.

AVANIR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)


	Nine Months Ended June 30,
	2009			2008
OPERATING ACTIVITIES:
Net loss	$	(15,044,656	)	$	(12,279,393	)
Loss from discontinued operations		—			1,555,257
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Depreciation and amortization		203,761			335,049
Share-based compensation expense		1,224,182			1,271,443
Amortization of debt discount		—			232,776
Gain on extinguishment of debt		—			(967,547	)
Loss on disposal of assets		4,792			638
Changes in operating assets and liabilities (net of effects of acquisition/disposition of business):
Receivables		—			(722,528	)
Inventories		32,819			21,714
Prepaid expenses and other assets		772,565			134,849
Accounts payable		573,244			1,344,022
Accrued expenses and other liabilities		(1,226,029	)		(939,163	)
Accrued compensation and payroll taxes		(314,581	)		(236,383	)
Deferred revenues		(1,810,080	)		(1,906,292	)

Net cash used in operating activities of continuing operations		(15,583,983	)		(12,155,558	)
Net cash used in operating activities of discontinued operations		—			(203,608	)

Net cash used in operating activities		(15,583,983	)		(12,359,166	)


INVESTING ACTIVITIES:
Proceeds from sales and maturities of investments in securities		388,122			2,300,107
Purchases of property and equipment		(19,173	)		(16,550	)
Proceeds from disposal of assets		1,950			4,900

Net cash provided by investing activities		370,899			2,288,457


FINANCING ACTIVITIES:
Proceeds from issuances of common stock and warrants, net of commissions and offering costs		—			37,851,772
Tax withholding payments reimbursed by restricted stock payments on debt		(3,927	)		(28,779	)
Payments on notes and capital lease obligations		(25,744	)		(11,243,003	)

Net cash (used in) provided by financing activities		(29,671	)		26,579,990


Net (decrease) increase in cash and cash equivalents		(15,242,755	)		16,509,281
Cash and cash equivalents at beginning of period		41,383,930			30,487,962

Cash and cash equivalents at end of period	$	26,141,175		$	46,997,243


SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Interest paid	$	516		$	446,058
Income taxes paid	$	6,208		$	37,307
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Accrued liabilities of discontinued operations in connection with the Working Capital Adjustment	$	—		$	1,351,649

The accompanying notes to condensed consolidated financial statements are an integral part of this statement.

AVANIR PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

1. BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements of Avanir Pharmaceuticals, Inc. (“Avanir,” “we,” or the “Company”) have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim reporting including the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. These condensed statements do not include all disclosures for annual audited financial statements required by accounting principles generally accepted in the United States of America (“U.S. GAAP”) and should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2008. The Company believes these condensed consolidated financial statements reflect all adjustments (consisting only of normal, recurring adjustments) that are necessary for a fair presentation of the financial position and results of operations for the periods presented. Results of operations for the interim periods presented are not necessarily indicative of results to be expected for the year. Certain prior period amounts have been reclassified to conform to the current period presentation.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts, and the disclosures of commitments and contingencies in the financial statements and accompanying notes. Actual results could differ from those estimates.

On March 27, 2009, the Company effected a change of domicile from California to Delaware. In the change of domicile, Avanir Pharmaceuticals, a California corporation (“Avanir California”), merged with and into Avanir Pharmaceuticals, Inc., a Delaware corporation (“Avanir Delaware”) and a wholly-owned subsidiary of Avanir California. As a result of the merger, Avanir Delaware succeeded to the assets and liabilities of Avanir California. In the merger, each share of Avanir California Class A common stock, no par value, was converted into one share of Avanir Delaware common stock, $0.0001 par value, and all options, warrants and purchase rights issued by Avanir California and outstanding at the time of the merger were assumed by Avanir Delaware. Due to the change in the par value of the Company’s common stock, the Company attributed $7,824 to stockholders’ equity for common stock as of March 31, 2009, which amount is equal to the aggregate par value of the shares of common stock issued and outstanding on that date, and reclassified the balance of $285,814,402 as additional paid-in-capital as of that date. No change was made to stockholders’ equity for preferred stock as no shares were outstanding as of March 31, 2009. Prior period amounts have been reclassified to conform to the current period presentation. The reclassifications had no effect on total stockholders’ equity.

2. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Nature of Business

Avanir was incorporated in California in August 1988 and was reincorporated in Delaware in March 2009. Avanir is a pharmaceutical company focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. The Company’s product candidates address therapeutic markets that include the central nervous system and inflammatory diseases. The Company’s lead product candidate, Zenvia™ (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”). The Company’s 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 U.S. Food and Drug Administration (“FDA”). The Company’s inflammatory disease program, which targets macrophage migration inhibitory factor (“MIF”), is currently partnered with Novartis. The Company’s infectious disease program has historically been focused primarily on monoclonal antibodies. In 2008, the Company sold its rights to substantially all of these antibodies to two biotechnology companies. As of June 30, 2008, we ceased all future research and development work related to the infectious disease program and we remain eligible to receive milestone payments and royalties related to the sale of these assets.

The Company’s operations are subject to certain risks and uncertainties frequently encountered by companies in similar stages of operations, particularly in the evolving market for small biotech and specialty pharmaceuticals companies. Such risks and uncertainties include, but are not limited to, timing and uncertainty of achieving milestones in clinical trials and in obtaining approvals by the FDA and regulatory agencies in other countries. The Company’s ability to generate revenues in the future will depend on license arrangements, the timing and success of reaching development milestones, and obtaining regulatory approvals and ultimately market acceptance of Zenvia™ for the treatment of PBA, assuming the FDA approves our new drug application. The Company’s operating expenses depend substantially on the level of expenditures for clinical development activities for Zenvia for the treatment of PBA and the rate of progress being made on such programs.

Significant Accounting Policies

The following represents an update for the nine months ended June 30, 2009 to the significant accounting policies described in our Annual Report on Form 10-K for the fiscal year ended September 30, 2008.

Concentrations

As of June 30, 2009, $25.6 million of our cash and cash equivalents were maintained in six separate money market mutual funds, and approximately $500,000 of our cash and cash equivalents were maintained at two major financial institutions in the United States. At times, deposits held with the financial institutions may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, are believed to bear low risk. Effective October 3, 2008, the Emergency Economic Stabilization Act of 2008 raised the Federal Deposit Insurance Corporation (“FDIC”) deposit coverage limits to $250,000 per owner from $100,000 per owner. This program is currently available through December 31, 2009.

Effective September 19, 2008, the U.S. Treasury commenced its Temporary Guarantee Program for Money Market Mutual Funds. This program, which is offered to all money market mutual funds that are regulated under Rule 2A-7 of the Investment Company Act of 1940, guarantees the share price of any publicly offered eligible money market fund that applies for and pays a fee to participate in the program. As of June 30, 2009, three of the money market mutual funds in which we had invested approximately 83% of our cash and cash equivalents were participating in the U.S. Treasury program. The current termination date for this program is September 18, 2009.

After giving effect to the increased FDIC insurance and the Temporary Guarantee Program, at June 30, 2009, our uninsured cash and cash equivalents totaled approximately $4.2 million.

Fair value of financial instruments

At June 30, 2009 and September 30, 2008, the Company’s financial instruments included cash and cash equivalents, investments in marketable securities, accounts payable, accrued expenses, and accrued compensation and payroll taxes. In addition, at September 30, 2008, the Company’s financial instruments also included receivables and notes payable. The carrying amount of cash and cash equivalents, receivables, accounts payable, accrued expenses and accrued compensation and payroll taxes approximates fair value due to the short-term maturities of these instruments. The Company’s short- and long-term investments in marketable securities are carried at fair value based on quoted market prices. The fair value of the Company’s notes payable and capital lease obligations were estimated based on quoted market prices or pricing models using current market rates. At September 30, 2008, the fair value of the Company’s notes payable and capital lease obligations approximate the carrying value of the notes and obligations.

Income Taxes

We account for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is applied against any net deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

We account for uncertainty in income taxes in accordance with Financial Accounting Standards Board Interpretation No. (“FIN”) 48, Accounting for Uncertainty in Income Taxes—An Interpretation of FASB Statement No. 109. Under FIN 48, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained.

The total amount of unrecognized tax benefits as of the date of adoption of FIN 48 was $3.0 million. The total unrecognized tax benefit resulting in a decrease in deferred tax assets and corresponding decrease in the valuation allowance at June 30, 2009 is $3.2 million. There are no unrecognized tax benefits included in the condensed consolidated balance sheets that would, if recognized, affect the effective tax rate.

The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had $0 accrued for interest and penalties on the Company’s condensed consolidated balance sheets at June 30, 2009 and September 30, 2008.

The Company is subject to taxation in the U.S. and various state jurisdictions. The Company’s tax years for 1992 and forward are subject to examination by the U.S. and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits.

The Company does not foresee material changes to its gross FIN 48 liability within the next twelve months.

Revenue Recognition

The Company has historically generated revenues from product sales, collaborative research and development arrangements, and other commercial arrangements such as royalties, the sale of royalty rights and sales of technology rights. Payments received under such arrangements may include non-refundable fees at the inception of the arrangements, milestone payments for specific achievements designated in the agreements, royalties on sales of products resulting from collaborative arrangements, and payments for the sale of rights to future royalties.

The Company recognizes revenue in accordance with the SEC’s Staff Accounting Bulletin (“SAB”) Topic 13 (“Topic 13”), “Revenue Recognition.” Revenue is recognized when all of the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price to the buyer is fixed and determinable; and (4) collectability is reasonably assured. Certain product sales are subject to rights of return. In accordance with Statement of Financial Accounting Standards No. 48, “Revenue Recognition When Right of Return Exists” (“FAS 48”), the Company recognizes such product revenues at the time of sale only if it has met all the criteria of FAS 48, including the ability to reasonably estimate future returns. FAS 48 states that revenue from sales transactions where the buyer has the right to return the product shall be recognized at the time of sale only if (1) the seller’s price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product, (3) the buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product, (4) the buyer acquiring the product for resale has economic substance apart from that provided by the seller, (5) the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer, and (6) the amount of future returns can be reasonably estimated. The Company recognizes such product revenues when either it has met all the criteria of FAS 48, including that ability to reasonably estimate future returns, when it can reasonably estimate that the return privilege has substantially expired, or when the return privilege has substantially expired, whichever occurs first.

Certain sales transactions include multiple deliverables. The Company allocates amounts to separate elements in multiple element arrangements in accordance with Emerging Issues Task Force Issue No. 00-21 (“EITF 00-21”), “Accounting for Revenue Arrangements with Multiple Deliverables.” Revenues are allocated to a delivered product or service when all of the following criteria are met: (1) the delivered item has value to the customer on a standalone basis; (2) there is objective and reliable evidence of the fair value of the undelivered item; and (3) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. The Company uses the relative fair values of the

separate deliverables to allocate revenue. For arrangements with multiple elements that are separated, the Company recognizes revenues in accordance with Topic 13.

Product Sales

Active Pharmaceutical Ingredient Docosanol (“API Docosanol”). Revenue from sales of the Company’s API Docosanol is recorded when title and risk of loss have passed to the buyer and provided the criteria in SAB Topic 13 are met. The Company sells the API Docosanol to various licensees upon receipt of a written order for the materials. Shipments generally occur fewer than five times a year. The Company’s contracts for sales of the API Docosanol include buyer acceptance provisions that give the Company’s buyers the right of replacement if the delivered product does not meet specified criteria. That right requires that they give the Company notice within 30 days after receipt of the product. The Company has the option to refund or replace any such defective materials; however, it has historically demonstrated that the materials shipped from the same pre-inspected lot have consistently met the specified criteria and no buyer has rejected any of the Company’s shipments from the same pre-inspected lot to date. Therefore, the Company recognizes revenue at the time of delivery without providing any returns reserve.

Multiple Element Arrangements

The Company has arrangements whereby it delivers to the customer multiple elements including technology and/or services. Such arrangements have generally included some combination of the following: antibody generation services; licensed rights to technology, patented products, compounds, data and other intellectual property; and research and development services. In accordance with EITF 00-21, the Company analyzes its multiple element arrangements to determine whether the elements can be separated. The Company performs its analysis at the inception of the arrangement and as each product or service is delivered. If a product or service is not separable, the combined deliverables will be accounted for as a single unit of accounting.

When a delivered element meets the criteria for separation in accordance with EITF 00-21, the Company allocates amounts based upon the relative fair values of each element. The Company determines the fair value of a separate deliverable using the price it charges other customers when it sells that product or service separately; however, if the Company does not sell the product or service separately, it uses third-party evidence of fair value. The Company considers licensed rights or technology to have standalone value to its customers if it or others have sold such rights or technology separately or its customers can sell such rights or technology separately without the need for the Company’s continuing involvement.

License Arrangements- License arrangements may consist of non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive licensed rights to patented or patent pending compounds, technology access fees, various performance or sales milestones. These arrangements are often multiple element arrangements.

Non-refundable, up-front fees that are not contingent on any future performance by the Company, and require no consequential continuing involvement on its part, are recognized as revenue when the license term commences and the licensed data, technology and/or compound is delivered. Such deliverables may include physical quantities of compounds, design of the compounds and structure-activity relationships, the conceptual framework and mechanism of action, and rights to the patents or patents pending for such compounds. The Company defers recognition of non-refundable upfront fees if it has continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable fee has no utility to the licensee that is separate and independent of the Company’s performance under the other elements of the arrangement. In addition, if the Company has required continuing involvement through research and development services that are related to its proprietary know-how and expertise of the delivered technology, or can only be performed by the Company, then such up-front fees are deferred and recognized over the period of continuing involvement.

Payments related to substantive, performance-based milestones in a research and development arrangement are recognized as revenues upon the achievement of the milestones as specified in the underlying agreements when they represent the culmination of the earnings process.

Research Services Arrangements- Revenues from research services are recognized during the period in which the services are performed and are based upon the number of full-time-equivalent personnel working on the specific project at the agreed-upon rate. Reimbursements from collaborative partners for agreed upon direct costs including direct materials and outsourced services, or subcontracted, pre-clinical studies are classified as revenues in accordance with EITF Issue No. 99-19, “Reporting Revenue Gross as a Principal versus Net as an Agent,” and recognized in the period the reimbursable expenses are incurred. Payments received in advance are deferred until the research services are performed or costs are incurred. These arrangements are often multiple element arrangements.

Royalty Arrangements- The Company recognizes royalty revenues from licensed products when earned in accordance with the terms of the license agreements. Net sales amounts generally required to be used for calculating royalties include deductions for returned product, pricing allowances, cash discounts, freight and warehousing. These arrangements are often multiple element arrangements.

Certain royalty arrangements require that royalties are earned only if a sales threshold is exceeded. Under these types of arrangements, the threshold is typically based on annual sales. The Company recognizes royalty revenue in the period in which the threshold is exceeded.

When the Company sells its rights to future royalties under license agreements and also maintains continuing involvement in earning such royalties, it defers recognition of any upfront payments and recognizes them as revenues over the life of the license agreement. The Company recognizes revenues for the sale of an undivided interest of its Abreva^® license agreement to Drug Royalty USA under the “units-of-revenue method.” Under this method, the amount of deferred revenues to be recognized in each period is calculated by multiplying the ratio of the royalty payments due to Drug Royalty USA by GlaxoSmithKline (“GSK”) for the period to the total remaining royalties that is expected GSK will pay Drug Royalty USA over the remaining term of the agreement by the unamortized deferred revenues.

In March 2000, the Company granted a subsidiary of GSK, SB Pharmco Puerto Rico, Inc. the exclusive rights to market docosanol 10% cream in North America. GSK markets the product under the name Abreva^® in the United States and Canada. In November 2002, the Company sold an undivided interest in our GSK license agreement for docosanol 10% cream to Drug Royalty USA, Inc. (“Drug Royalty USA”) for $24.1 million in an upfront payment. The Company retained the right to receive 50% of all royalties (a net of 4%) under the GSK license agreement for annual net sales of Abreva^® in the U.S. and Canada in excess of $62 million. The Company also retained the rights to develop and license docosanol 10% cream outside the U.S. and Canada for the treatment of cold sores and other potential indications. The Company currently has several other collaborations for docosanol around the world. Two of these collaborations currently generate royalty revenue and the others may generate future royalty revenue for the Company depending on clinical and regulatory success outside of the United States.

Government Research Grant Revenues- The Company recognizes revenues from federal research grants during the period in which the related expenditures are incurred.

Cost of Revenues

Cost of revenues includes direct and indirect costs to manufacture product sold, including the write-off of obsolete inventory, and to provide research and development services.

Recognition of Expenses in Outsourced Contracts

Pursuant to management’s assessment of the services that have been performed on clinical trials and other contracts, the Company recognizes expenses as the services are provided. Such management assessments include, but are not limited to: (1) an evaluation by the project manager of the work that has been completed during the period, (2) measurement of progress prepared internally and/or provided by the third-party service provider, (3) analyses of data that justify the progress, and (4) management’s judgment. Several of the Company’s contracts,

including subsequent amendments, extend across multiple reporting periods, including its largest contract, representing a $7.1 million Phase III clinical trial contract that was entered into in the first fiscal quarter of 2008.

Share-Based Compensation

We grant options, restricted stock units and restricted stock awards to purchase our common stock to certain of our employees, directors and consultants under our stock option plans. The benefits provided under these plans are share-based payments subject to the provisions of revised FAS No. 123, “Share-Based Payment” (“FAS 123R”), including the provisions of the SEC’s Staff Accounting Bulletin No. 107 (“SAB 107”), that require the fair value method to account for share-based payments.

The fair value of each option award is estimated on the date of grant using a Black-Scholes-Merton option pricing model (“Black-Scholes model”) that uses assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, our expected stock price volatility, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. Expected volatilities are based on historical volatility of our common stock and other factors. The expected terms of options granted are based on analyses of historical employee termination rates and option exercises. The risk-free interest rates are based on the U.S. Treasury yield in effect at the time of the grant. Since we do not expect to pay dividends on our common stock in the foreseeable future, we estimated the dividend yield to be 0%.

If factors change and we employ different assumptions in the application of FAS 123R in future periods, the compensation expense that we record under FAS 123R may differ significantly from what we have recorded in the current period. There is a risk that our estimates of the fair values of our share-based compensation awards on the grant dates may bear little resemblance to the actual values realized upon the exercise, early termination or forfeiture of those share-based payments in the future. Certain share-based payments, such as employee stock options, may expire worthless or otherwise result in zero intrinsic value as compared to the fair values originally estimated on the grant date and reported in our financial statements. For awards with a longer vesting period, such as three-year cliff vesting awards issued to certain officers, the actual forfeiture rate and related expense may not be known for a longer period of time, which can result in more significant accounting adjustments once the awards are either vested or forfeited.

Share-based compensation expense recognized during a period is based on the value of the portion of share-based payment awards that is ultimately expected to vest amortized under the straight-line attribution method. As share-based compensation expense recognized in the consolidated statements of operations for fiscal 2009 and 2008 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. FAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. We estimate forfeitures based on our historical experience.

Total compensation expense related to all of our share-based awards, recognized under FAS 123R, for the three and nine months ended June 30, 2009 and 2008 was comprised of the following:


	For the three months ended				For the nine months ended
	June 30,				June 30,
	2009		2008		2009		2008
From Continuing Operations:
General and administrative expense	$	311,142	$	279,074	$	973,598	$	865,973
Research and development expense		84,802		71,713		250,584		405,470

Total	$	395,944	$	350,787	$	1,224,182	$	1,271,443


	For the three months ended				For the nine months ended
	June 30,				June 30,
	2009		2008		2009		2008
Share-based compensation expense from:
Stock options	$	184,442	$	139,010	$	557,750	$	500,186
Restricted stock units		211,502		200,066		666,432		642,878
Restricted stock awards		—		11,711		—		128,379

Total	$	395,944	$	350,787	$	1,224,182	$	1,271,443

Since the Company has a net operating loss carryforward as of June 30, 2009, no excess tax benefits for the tax deductions related to share-based awards were recognized in the condensed consolidated statements of operations. Additionally, no incremental tax benefits were recognized from stock options exercised in the three and nine month periods ended June 30, 2009 and 2008 that would have resulted in a reclassification to reduce net cash used in operating activities with an offsetting increase in net cash provided by financing activities. (See Note 13 “Employee Equity Incentive Plans.”)

Recently Issued Accounting Pronouncements

Financial Accounting Standards No. 168 (“FAS 168”). In June 2009, the Financial Accounting Standards Board (“FASB”) issued FAS 168, The FASB Accounting Standards Codification^TM and the Hierarchy of Generally Accepted Accounting Principles. FAS 168 replaces FAS 162, “The Hierarchy of Generally Accepted Accounting Principles,” and establishes the FASB Accounting Standards Codification^TM as the source of authoritative accounting guidance under U.S. GAAP. The rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. FAS 168 is effective for periods ending after September 15, 2009. We do not expect FAS 168 to have a material effect on our results of operations, consolidated financial position, and cash flows.

Financial Accounting Standards No. 165 (“FAS 165”). In May 2009, the FASB issued FAS 165, Subsequent Events, which establishes the standards for accounting for and disclosure of events that occur after the balance sheet date, but before the financial statements are issued or are available to be issued. The statement sets forth the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements. The statement also identifies the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. FAS 165 is effective for interim and annual periods ending after June 15, 2009. Our adoption of FAS 165 in the third quarter ended June 30, 2009 did not have a material impact on our results of operations, consolidated financial position and cash flows.

FASB Staff Position 157-4. In April 2009, FASB issued FASB Staff Position (“FSP”) FAS 157-4, Determining Fair Value when the Volume and Level of Activity for the Asset or Liability have Significantly Decreased and Identifying Transactions that are not Orderly (“FSP 157-4”), which is effective for the Company for the quarterly period beginning April 1, 2009. FSP 157-4 affirms that the objective of fair value when the market for an asset is not active is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date under current market conditions. The FSP provides guidance for estimating fair value when the volume and level of market activity for an asset or liability have significantly decreased and determining whether a transaction was orderly. This FSP applies to all fair value measurements when

appropriate. Our adoption of FSP 157-4 did not have a material impact on our results of operations, consolidated financial position and cash flows.

FASB Staff Position 115-2. In April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments (“FSP 115-2”), which is effective for the Company for the quarterly period beginning April 1, 2009. FSP 115-2 amends existing guidance for determining whether an other-than-temporary impairment of debt securities has occurred. Among other changes, the FASB replaced the existing requirement that an entity’s management assert it has both the intent and ability to hold an impaired security until recovery with a requirement that management assert (a) it does not have the intent to sell the security, and (b) it is more likely than not it will not have to sell the security before recovery of its cost basis. Our adoption of FSP 115-2 did not have a material impact on our results of operations, consolidated financial position and cash flows.

FASB Staff Position No. 107-1. In April 2009, the FASB issued FSP FAS 107-1, Interim Disclosures about Fair Value of Financial Instruments (“FSP 107-1”), which increases the frequency of fair value disclosures to a quarterly basis instead of an annual basis. The guidance relates to fair value disclosures for any financial instruments that are not currently reflected on the balance sheet at fair value. FSP 107-1 is effective for interim and annual periods ending after June 15, 2009. Our adoption of FSP 107-1 in the third quarter ended June 30, 2009 did not have a material impact on our results of operations, consolidated financial position and cash flows.

EITF Issue No. 07-5. In June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity’s Own Stock” (“EITF 07-5”). EITF 07-5 provides that an entity should use a two step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. It also clarifies the impact of foreign currency denominated strike prices and market-based employee stock option valuation instruments on the evaluation. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. Therefore, we will adopt EITF 07-5 in the fiscal year beginning October 1, 2009. We do not expect the adoption of EITF 07-5 to have a material impact on our results of operations, consolidated financial position and cash flows.

Financial Accounting Standards No. 160 (“FAS 160”). In December 2007, the FASB issued FAS 160, "Noncontrolling Interests in Consolidated Financials, an Amendment of ARB No. 51,” which is intended to improve the relevance, comparability and transparency of the financial information that a reporting entity provides in its consolidated financial statements by establishing certain required accounting and reporting standards. FAS 160 is effective for fiscal years beginning on or after December 15, 2008. Therefore, we will adopt FAS 160 in the fiscal year beginning October 1, 2009. We do not expect the adoption of FAS 160 to have a material impact on our results of operations, consolidated financial position and cash flows.

Financial Accounting Standards No. 159 (“FAS 159”). In February 2007, the FASB issued FAS 159, The Fair Value Option for Financial Assets and Financial Liabilities— Including an amendment of FASB Statement 115, which provides companies with an option to measure eligible financial assets and liabilities in their entirety at fair value. The fair value option may be applied instrument by instrument, and may be applied only to entire instruments. If a company elects the fair value option for an eligible item, changes in the item’s fair value must be reported as unrealized gains and losses in earnings at each subsequent reporting. We adopted FAS 159 on October 1, 2008. The adoption of FAS 159 did not have a material impact on our results of operations, consolidated financial position and cash flows.

Financial Accounting Standards No. 157. (“FAS 157”) In September 2006, the FASB issued FAS No. 157, Fair Value Measurements, which defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. FAS 157 is effective for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. In February 2008, the FASB released FSP FAS 157-2, “Effective Date of FASB Statement No. 157,” which provides for delayed application of FAS 157 for non-financial assets and non-financial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually), until fiscal years beginning after November 15, 2008, and interim periods within those years. We adopted certain provisions of FAS 157 effective October 1, 2008 (see Note 3, Fair Value of Financial Instruments). We are currently evaluating the effect that the adoption of the provisions deferred by FSP FAS 157-2 will have on our consolidated financial position and results of operations.

3. FAIR VALUE OF FINANCIAL INSTRUMENTS

As of October 1, 2008, the Company adopted FAS 157 to measure the fair value of certain of its financial assets required to be measured at fair value on a recurring basis. FAS 157 requires the Company to provide information related to the methods used to value its financial assets based on the fair value hierarchy contained in FAS 157. The fair value hierarchy ranks the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories:

	•		Level 1-Quoted prices in active markets for identical assets and liabilities.

	•		Level 2- Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets and liabilities, quoted prices in the markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

	•		Level 3-Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

In addition, as of April 1, 2009, the Company adopted FSP FAS 157-4 which provides guidance for estimating fair value when the volume and level of market activity for an asset or liability have significantly decreased as well as guidance for determining whether a transaction was orderly.

As of June 30, 2009, the Company’s cash equivalents of $25.6 million are all valued using quoted prices generated by market transactions involving identical assets, or Level 1, as defined under FAS 157.

4. DISCONTINUED OPERATIONS — SALE OF FAZACLO

On May 24, 2006, pursuant to a Unit Purchase Agreement dated May 22, 2006 (the “Acquisition Agreement”), we acquired all of the outstanding equity interests in Alamo from the former members of Alamo (the “Selling Holders”). The Company intended to leverage the FazaClo sales force to assist with the commercial launch of Zenvia, which was planned for early 2007; however, due to the receipt of the approvable letter and resulting delay in the planned launch of Zenvia, we entered into an agreement to sell FazaClo and its related assets and operations to Azur Pharma, Inc. (“Azur”) in July 2007.

In connection with the sale, the Company received approximately $43.9 million in upfront consideration. In addition, the Company could receive up to $2 million in royalties, based on 3% of Azur’s annualized net product revenues in excess of $17 million. The Company’s earn-out obligations that would have been payable to the prior owner of Alamo upon the achievement of certain milestones were assumed by Azur; however, the Company is contingently liable in the event of default. The Company transferred all FazaClo related business operations to Azur in August 2007. During the second quarter of fiscal 2009, the Company received a royalty payment in the amount of approximately $395,000.

In accordance with FAS 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” the financial results relating to FazaClo have been classified as discontinued operations in the accompanying condensed consolidated statements of operations for all periods presented.

In the first nine months of fiscal 2008, the Company recognized a loss from discontinued operations of $1.6 million. The loss is attributed to a working capital adjustment of $1.4 million as well as additional costs of $206,000 related to the operations of FazaClo.

5. RELOCATION OF COMMERCIAL AND GENERAL AND ADMINISTRATIVE OPERATIONS

In fiscal 2006, we relocated all operations other than research and development from San Diego, California to Aliso Viejo, California. In fiscal 2007, the Company subleased a total of approximately 49,000 square feet of laboratory and office space in San Diego. Restructuring expenses included recognition of the estimated loss due to the exit of the Company’s leases of approximately $2.1 million. No further costs were incurred related to these

restructuring events either in fiscal 2008 or in the first nine months of fiscal 2009. In April 2009, we entered into a sublease with Halozyme, Inc. for 9,187 square feet of office space located in San Diego. The lease term commences in September 2009 and ends in January 2013.

The following table presents the restructuring activities for the nine months ended June 30, 2009:


	Balance at						Balance at
	September 30,			Payments/			June 30,
	2008			Reductions			2009

Accrued Restructuring
Lease restructuring liability	$	1,135,965		$	(242,053	)	$	893,912

Less current portion		(316,086	)					(301,160	)

Non-current portion	$	819,879					$	592,752

The current portion of the lease restructuring liabilities of approximately $316,000 and $301,000 at September 30, 2008 and June 30, 2009, respectively, are included in “Accrued expenses and other liabilities” and the non-current portion of lease restructuring liability of approximately $820,000 and $593,000 at September 30, 2008 and June 30, 2009, respectively, are included in “Accrued expenses and other liabilities, net of current portion” in the accompanying condensed consolidated balance sheets.

6. INVENTORIES

Inventories are comprised of the active pharmaceutical ingredient docosanol and the active pharmaceutical ingredients of Zenvia which consists of dextromethorphan and quinidine.

The composition of inventories is as follows:


	June 30,			September 30,
	2009			2008

Raw materials	$	1,300,458		$	1,333,277
Less: current portion		(17,000	)		(17,000	)

Non-current portion	$	1,283,458		$	1,316,277

The amount classified as non-current inventories is comprised of docosanol and the raw material components for Zenvia, dextromethorphan and quinidine, which will be used in the manufacture of Zenvia capsules in the future.

7. OTHER ASSETS

Other assets consist of the following:


	June 30,			September 30,
	2009			2008

Current receivables from subtenants	$	80,026		$	167,546
Current receivable from license and royalty agreements		29,680			68,251
Deposits		241,400			241,400
Other		—			17,621

Total other assets		351,106			494,818
Less: current		(109,706	)		(237,334	)


Non current total other assets	$	241,400		$	257,484

8. ACCRUED EXPENSES AND OTHER LIABILITIES

Accrued expenses and other liabilities are as follows:


	June 30,			September 30,
	2009			2008

Accrued research and development expenses	$	310,330		$	1,404,556
Accrued general and administrative expenses		214,425			160,759
Deferred rent		20,622			48,638
Lease restructuring liability		893,912			1,135,965
Other		84,600			—

Total accrued expenses and other liabilities		1,523,889			2,749,918
Less: current		(910,515	)		(1,881,401	)


Non-current total accrued expenses and other liabilities	$	613,374		$	868,517

9. DEFERRED REVENUES

The following table sets forth as of June 30, 2009 the deferred revenue balances for the Company’s sale of future Abreva^® royalty rights to Drug Royalty USA and other agreements:


	Drug Royalty
	USA			Other
	Agreement			Agreements			Total
Net deferred revenues as of October 1, 2008	$	12,202,198		$	283,834		$	12,486,032
Changes during the period:
Recognized as revenues during period		(1,526,246	)		(283,834	)		(1,810,080	)

Net deferred revenues as of June 30, 2009	$	10,675,952		$	—		$	10,675,952


Classified and reported as:
Current portion of deferred revenues	$	2,282,560		$	—		$	2,282,560
Deferred revenues, net of current portion		8,393,392			—			8,393,392

Total deferred revenues	$	10,675,952		$	—		$	10,675,952

Included in the amount recognized as revenues under “Other Agreements” above is approximately $171,000 that was recognized upon termination of a license agreement with Kobayashi Pharmaceutical Co. Ltd. in April 2009.

10. COMPUTATION OF NET LOSS PER COMMON SHARE

Basic net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period plus additional weighted average common equivalent shares outstanding during the period. Common equivalent shares result from the assumed exercise of outstanding stock options and warrants (the proceeds of which are then presumed to have been used to repurchase outstanding stock using the treasury stock method) and the vesting of restricted shares of common stock. In loss periods, certain of the common equivalent shares have been excluded from the computation of diluted net loss per share, because their effect would have been anti-dilutive.

For the nine month periods ended June 30, 2009 and 2008, the following options and warrants to purchase shares of common stock, restricted stock units and restricted stock awards were excluded from the computation of diluted net loss per share, as the inclusion of such shares would be anti-dilutive:


	2009		2008

Stock options		2,204,438		648,803
Performance stock options		2,031,218		—
Stock warrants		12,240,437		12,509,742
Restricted stock units (1)		2,816,780		2,296,809
Restricted stock awards		—		3,000


(1)		Includes 536,868 and 148,035 shares of restricted stock, respectively, awarded to directors that have vested but are still restricted until the directors resign.

11. COMPREHENSIVE LOSS

Comprehensive loss consists of the following:


	For the three months						For the nine months
	ended June 30,						ended June 30,
	2009			2008			2009			2008
Net loss	$	(4,955,969	)	$	(1,440,375	)	$	(15,044,656	)	$	(12,279,393	)
Other comprehensive income, net of tax:
Unrealized gain on available-for-sale securities		—			—			—			3,272

Total comprehensive loss	$	(4,955,969	)	$	(1,440,375	)	$	(15,044,656	)	$	(12,276,121	)

12. STOCKHOLDERS’ EQUITY

During the nine month period ended June 30, 2009, the Company issued 34,945 shares of common stock in connection with the vesting of restricted stock units. In connection with the vesting, two officers exercised options to pay for minimum required withholding taxes associated with the vesting of restricted stock by surrendering 3,944 shares of common stock at an average market price of $1.00 per share.

As of June 30, 2009, warrants to purchase 12,240,437 shares of the Company’s common stock at a weighted-average exercise price per share of $1.43 remained outstanding, all of which are exercisable.

13. EMPLOYEE EQUITY INCENTIVE PLANS

The Company currently has five equity incentive plans (the “Plans”), two of which are currently in active use as described below. The Plans are: the 2005 Equity Incentive Plan (the “2005 Plan”), the 2003 Equity Incentive Plan (the “2003 Plan”), the 2000 Stock Option Plan (the “2000 Plan”), the 1998 Stock Option Plan (the “1998 Plan”) and the 1994 Stock Option Plan (the “1994 Plan”), which are described in the Company’s Annual Report on Form 10-K for the year ended September 30, 2008. All of the Plans were approved by the stockholders, except for the 2003 Equity Incentive Plan, which was approved solely by the Board of Directors. Share-based awards are subject to terms and conditions established by the Compensation Committee of the Company’s Board of Directors. The Company’s policy is to issue new common shares upon the exercise of stock options, conversion of share units or purchase of restricted stock.

During the nine month periods ended June 30, 2009 and 2008, the Company granted share-based awards under both the 2003 Plan and the 2005 Plan. Under the 2003 Plan and 2005 Plan, options to purchase shares, restricted stock units, restricted stock and other share-based awards may be granted to the Company’s employees and consultants. Under the Plans, as of June 30, 2009, the Company had an aggregate of 12,133,076 shares of its common stock reserved for future issuance. Of those shares, 7,052,436 were subject to outstanding options and other awards and 5,080,640 shares were available for future grants of share-based awards. As of June 30, 2009, no options were outstanding to consultants. The Company may also, from time to time, issue share-based awards outside of the Plans to the extent permitted by NASDAQ rules. As of June 30, 2009, there were no options to purchase shares of the Company’s common stock that were issued outside of the Plans (inducement option grants) outstanding. None of the share-based awards are classified as a liability as of June 30, 2009.

Stock Options. Stock options are granted with an exercise price equal to the current market price of the Company’s common stock at the grant date and have 10-year contractual terms. For option grants to employees in general, 25% of the option shares vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the option shares vest and become exercisable quarterly in equal installments thereafter over three years; for option grants to non-employee directors, one-third of the option shares vest and become exercisable on the first anniversary of the grant date and the remaining two-thirds of the option shares vest and become exercisable daily or quarterly in equal installments thereafter over two years; and for certain option grants to non-employee directors, options have been granted as fully vested and exercisable at the date of grant. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the Plans).

Summaries of stock options outstanding and changes during the nine month period ended June 30, 2009 are presented below.


						Weighted Average
				Weighted Average		Remaining		Aggregate
	Number			Exercise Price per		Contractual Term		Intrinsic
	of Shares			Share		(In Years)		Value
Outstanding October 1, 2008		624,027		$	6.61
Granted		1,613,110		$	0.53
Forfeited		(30,539	)	$	7.20
Expired		(2,160	)	$	5.22

Outstanding June 30, 2009		2,204,438		$	2.16		8.8	$	2,881,000

Vested and expected to vest in the future, June 30, 2009		1,453,621		$	2.92		8.5	$	1,711,000

Exercisable, June 30, 2009		288,407		$	10.78		6.0	$	11,000

The weighted average grant-date fair value of options granted during the nine month period ended June 30, 2009 was $0.40 per share. There were no options granted during the nine month period ended June 30, 2008. There were no options exercised in the nine month periods ended June 30, 2009 and 2008. As of June 30, 2009, the total unrecognized compensation cost related to unvested options was $1,076,000 which, based on the vesting schedules, is expected to be recognized over the weighted-average period of 3.1 years.

The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model (“Black-Scholes model”), which uses the assumptions noted in the following table. Expected volatilities are based on historical volatility of the Company’s common stock and other factors. The expected term of options granted is based on analyses of historical employee termination rates and option exercises. The risk-free

interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant.

Assumptions used in the Black-Scholes model for options granted during the nine month period ended June 30, 2009 were as follows:


	2009
Expected volatility		101	%
Expected term in years		5.0
Risk-free interest rate (zero coupon U.S. Treasury Note)		1.6% -2.3	%
Expected dividend yield		0	%

The following table summarizes information concerning outstanding and exercisable stock options as of June 30, 2009:


	Options Outstanding						Options Exercisable
			Weighted
			Average		Weighted				Weighted
			Remaining		Average				Average
	Number		Contractual		Exercise		Number		Exercise
Range of Exercise Prices	Outstanding		Life in Years		Price		Exercisable		Price
$0.47-$0.53		1,436,510		9.5	$	0.53		—	$	—
$0.54-$1.29		337,960		8.8	$	0.88		11,250	$	1.20
$2.41-$11.76		349,718		6.9	$	7.22		203,938	$	10.00
$12.12-$13.60		39,000		4.9	$	12.86		39,000	$	12.86
$15.84-$19.38		41,250		6.1	$	16.16		34,219	$	16.23

		2,204,438		8.8	$	2.16		288,407	$	10.78

Performance stock options. During fiscal 2008, we granted stock options to purchase a target of 2,048,200 shares of common stock from the 2003 Stock Option Plan. The performance stock options are not included in the above outstanding and exercisable stock options table. The contractual terms are ten years. The stock options have a performance goal that determines when vesting begins and the actual number of shares to be awarded ranging from 0% to 115% of target. Vesting is over 3.75 years beginning on the date the performance goal is achieved (“Achievement Date”), with 6.25% vesting on the Achievement Date and 6.25% quarterly from the Achievement Date for the following fifteen quarters. During the nine months ended June 30, 2009, the performance goals related to 777,725 performance options previously granted were met and vesting began.

Summaries of performance stock options outstanding and changes during the nine month period ended June 30, 2009 are presented below.


						Weighted Average
				Weighted Average		Remaining		Aggregate
	Number			Exercise Price per		Contractual Term		Intrinsic
	of Shares			Share		(In Years)		Value
Outstanding October 1, 2008		2,048,200		$	0.88
Forfeited		(16,982	)	$	0.88

Outstanding June 30, 2009		2,031,218		$	0.88		9.0	$	2,722,000

Vested and expected to vest in the future, June 30, 2009		988,418		$	0.88		9.0	$	1,324,000

Exercisable, June 30, 2009		109,343		$	0.88		9.0	$	147,000

As of June 30, 2009, the total unrecognized compensation cost related to unvested performance options was $1,191,000, which is expected to be recognized over the weighted-average period of 3.8 years, based on the vesting schedules and the likelihood of meeting performance criteria.

Restricted stock units. RSUs generally vest based on three years of continuous service. The following table summarizes the RSU activities for the nine months ended June 30, 2009:


				Weighted Average
				Grant Date
	Number of Shares			Fair Value
Unvested, October 1, 2008		2,259,042		$	1.85
Granted		420,000		$	0.44
Vested		(398,430	)	$	1.32
Forfeited		(700	)	$	2.06

Unvested, June 30, 2009		2,279,912		$	1.69

During the nine month period ended June 30, 2009, the Company awarded 420,000 shares of restricted stock units to directors with a weighted average grant date fair value of $0.44 and exercisable at a purchase price of $0.0001 per share. During the nine month period ended June 30, 2008, the Company awarded 867,351 shares of restricted stock units to employees and directors with a weighted average grant date fair value of $1.49 and exercisable at a purchase price of $0.0001 per share.

At June 30, 2009, there were 536,868 shares of restricted stock with a weighted-average grant date fair value of $2.17 awarded to directors that have vested but are still restricted until the directors resign.

The grant-date fair value of RSUs granted during the nine month periods ended June 30, 2009 and 2008 was $184,800 and $1,292,400, respectively. As of June 30, 2009, the total unrecognized compensation cost related to unvested shares was $2,418,000, which based on the vesting schedules, is expected to be recognized over a weighted-average period of 1.0 year. The Company received no cash from exercised options and restricted stock awards under all share-based payment arrangements during the nine month periods ended June 30, 2009 and 2008. No tax benefit was realized for the tax deductions from option exercise of the share-base payment arrangements in the nine month periods ended June 30, 2009 and 2008.

14. COMMITMENTS AND CONTINGENCIES

Center for Neurologic Study (“CNS”) — The Company holds the exclusive worldwide marketing rights to Zenvia for certain indications pursuant to an exclusive license agreement with CNS. The Company will be obligated to pay CNS up to $400,000 in the aggregate in milestones to continue to develop Zenvia for both PBA and DPN pain, assuming they are both approved for marketing by the FDA. The Company is not currently developing, nor does it have an obligation to develop, any other indications under the CNS license agreement. The Company will need to pay a $75,000 milestone if the FDA approves Zenvia for the treatment of PBA. In addition, the Company is obligated to pay CNS a royalty on commercial sales of Zenvia with respect to each indication, if the drug is approved by the FDA for commercialization. Under certain circumstances, the Company may have the obligation to pay CNS a portion of net revenues received if it sublicenses Zenvia to a third party. Under the agreement with CNS, the Company is required to make payments on achievements of up to a maximum of ten milestones, based upon five specific medical indications. Maximum payments for these milestone payments could total approximately $2.1 million if the Company pursued the development of Zenvia for all of the licensed indications. Of the clinical indications that the Company currently plans to pursue, expected milestone payments could total $800,000. In general, individual milestones range from $150,000 to $250,000 for each accepted new drug application (“NDA”) and a similar amount for each approved NDA. In addition the Company is obligated to pay CNS a royalty ranging from approximately 5% to 8% of net revenues.

Contingencies — In the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims or take legal actions to assert the Company’s rights, including intellectual property rights as well as claims relating to employment and the safety or efficacy of its products. Any of these claims could subject the Company to costly litigation and, while the Company generally believes that it has adequate insurance to cover many different types of liabilities, the Company’s insurance carriers may deny coverage or the Company’s policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s operations, cash flows and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s

reputation and business. Management believes the outcomes of currently pending claims and lawsuits are not likely to have a material effect on the Company’s operations or financial position.

In addition, it is possible that the Company could incur termination fees and penalties if it elected to terminate contracts with certain vendors, including clinical research organizations.

Guarantees and Indemnities — The Company indemnifies its directors and officers to the maximum extent permitted under the laws of the State of Delaware, and various lessors in connection with facility leases for certain claims arising from such facilities or leases. Additionally, the Company periodically enters into contracts that contain indemnification obligations, including contracts for the purchase and sale of assets, clinical trials, pre-clinical development work and securities offerings. These indemnification obligations provide the contracting parties with the contractual right to have the Company pay for the costs associated with the defense and settlement of claims, typically in circumstances where the Company has failed to meet its contractual performance obligations in some fashion.

The maximum amount of potential future payments under such indemnification obligations is not determinable. The Company has not incurred significant costs related to these guarantees and indemnifications, and no liability has been recorded in the condensed consolidated financial statements for guarantees and indemnifications as of June 30, 2009.

15. SEGMENT INFORMATION

The Company operates its business on the basis of a single reportable segment, which is the business of discovery, development and commercialization of novel therapeutics for chronic diseases. The Company’s chief operating decision-maker is the Chief Executive Officer, who evaluates the Company as a single operating segment.

The Company categorizes revenues by geographic area based on selling location. All the Company’s operations are currently located in the U.S.; therefore, total revenues for the three and nine month periods ended June 30, 2009 and 2008 are attributed to the U.S. All long-lived assets at June 30, 2009 and September 30, 2008 are located in the U.S.

For the three month period ended June 30, 2009, revenues were comprised of the recognition of deferred revenues attributed to license agreements with GSK and Kobayashi, which accounted for 71% and 29% of total net revenues, respectively. For the three month period ended June 30, 2008, revenues were comprised of the recognition of deferred revenues attributed to license agreements with GSK and Kobayashi, which accounted for 22% and 2% of total net revenues, respectively. In addition, revenues in the three month period ended June 30, 2008 included milestone revenue from HBI and government grant revenue, which accounted for 56% and 20% of total net revenues, respectively.

For the nine month periods ended June 30, 2009 and 2008, revenues from royalties under the GSK license agreement were 79% and 49% of total net revenues, respectively. For the nine month periods ended June 30, 2009 and 2008, royalty revenues from Azur were 13% and 1% of total net revenues, respectively. In the nine month period ended June 30, 2008, revenues from our license agreement with HBI and government grant revenue accounted for 26% and 17% of total net revenues, respectively. Both GSK and Azur royalties as a percentage of total revenue increased in the first nine months of 2009 as compared to the same period in the prior year primarily due to the absence of certain revenue sources in 2009 including government grant revenue, milestone revenue product revenue.

16. SUBSEQUENT EVENTS

The Company has evaluated events that occurred through July 30, 2009, the date of issuance of these condensed consolidated financial statements, for inclusion or disclosure in its condensed consolidated financial statements.

In July 2009 the Company issued 217,311 shares of common stock to employees in connection with the vesting of restricted stock units.

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report on Form 10-Q contains forward-looking statements concerning future events and performance of the Company. When used in this report, the words “intend,” “estimate,” “anticipate,” “believe,” “plan” or “expect” and similar expressions are included to identify forward-looking statements. These forward-looking statements are based on our current expectations and assumptions and many factors could cause our actual results to differ materially from those indicated in these forward-looking statements. You should review carefully the factors identified in this report under the caption “Risk Factors” and in our most recent Annual Report on Form 10-K filed with the SEC. We disclaim any intent to update or announce revisions to any forward-looking statements to reflect actual events or developments. Except as otherwise indicated herein, all dates referred to in this report represent periods or dates fixed with reference to the calendar year, rather than our fiscal year ending September 30. The three month period ended June 30, 2009 is also referred to as the third quarter of fiscal 2009.

EXECUTIVE OVERVIEW

We are a pharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic diseases. Our product candidates address therapeutic markets in the areas of the central nervous system and inflammatory diseases. Our lead product candidate, Zenvia™ (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 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 milestone payments and royalties related to the sale of the assets.

Zenvia for the treatment of PBA

Zenviais currently in Phase III clinical development for the treatment of two conditions: (1) PBA, also known as emotional lability and (2) DPN pain.

In October 2006, we received an “approvable” letter from the FDA for Zenviain the treatment of patients with PBA. The approvable letter raised certain safety and efficacy concerns that have required additional clinical development to resolve. Based on discussions with the FDA, we were able to successfully resolve the outstanding efficacy concerns relating to the original dose formulation that was tested in our earlier trials. However, to address the remaining safety concern, we agreed to re-formulate Zenviaand conduct one additional confirmatory Phase III clinical trial using a low quinidine dose formulation. The goal of the study is to demonstrate improved safety while maintaining significant efficacy at a low quinidine dose.

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 Zenviafor the treatment of patients with PBA. We enrolled our first patient in this trial in December 2007 and as of March 2009, we have completed enrollment with 326 patients in total. We currently expect top-line safety and efficacy data from the blinded phase to become available during August 2009.

In April 2009, we reported results from pre-clinical and clinical safety studies that we conducted in order to enhance our complete response to the approvable letter and to assist with planned label discussions with the FDA. Management believes data generated in these studies suggest an improved cardiac safety margin of the new lower dose formulation of Zenvia compared to the dose previously tested. However, the FDA approval decision for Zenvia is expected to depend to a significant degree on the agency’s overall assessment of benefits versus potential risks, including the risks assessed in these studies. (See additional information in this report under the caption “Risk Factors”.)

Zenvia for the treatment of DPN pain

In April 2007, we announced positive top-line data results from our first Phase III clinical trial of Zenviafor DPN pain. Before discussing a further Phase III trial with the FDA, we made the decision to conduct a formal pharmacokinetic (“PK”) study to identify a low quinidine dose formulation that may have similar efficacy to the doses tested in the Phase III study, anticipating that some of the concerns raised in the PBA approvable letter could affect the development of this indication as well.

In May 2008, we reported a positive outcome of the formal PK study and announced that we identified an alternative low quinidine dose formulation of Zenvia for the next DPN pain phase III clinical trial. The new doses are intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested in DPN pain.

In September 2008, we submitted a Phase III protocol and related program questions for Zenvia in the treatment of DPN pain to the FDA under an SPA. We received the FDA’s initial response to the SPA and we are currently engaged in discussions with the FDA regarding the design of the next Phase III study and overall neuropathic pain program requirements. In recent communications regarding the continued development of Zenvia for DPN pain, the FDA has expressed that the safety concerns and questions raised in the PBA approvable letter would be expected to necessitate the testing of a lower dose in the DPN pain indication as well. Additionally, based on feedback we have received from the FDA on the proposed continued development of Zenvia for DPN pain, it is possible that two large well controlled Phase III trials utilizing a new low-dose formulation would be needed to support an NDA filing for this indication. However, due to our limited capital resources and current focus on gaining approval for the PBA indication, 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 Zenvia.

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. (“GSK”) the exclusive rights to market docosanol 10% cream in North America. GSK markets the product under the name Abreva^® in the United States and Canada. In fiscal 2003, we sold an undivided interest in our GSK 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 (a net of 4%) under the GSK license agreement for annual net sales of Abreva^® in the U.S. and Canada in excess of $62 million. We also retained the rights to develop and license docosanol 10% cream outside the U.S. and Canada for the treatment of cold sores and other potential indications. We currently have several other collaborations for docosanol around the world. Two of these collaborations currently generate royalty revenue and the others may generate future royalty revenue for the Company depending on clinical and regulatory success outside of the United States.

Under the terms of our docosanol license agreements, our partners are generally responsible for all regulatory approvals, sales and marketing activities, and manufacturing and distribution of the product in the licensed territories. The terms of the license agreements typically provide for us to receive a data transfer fee, potential milestone payments and royalties on product sales. We purchase the active pharmaceutical ingredient (“API”), docosanol, from a large supplier in Western Europe and sell the material to our licensees for commercialization. We currently store our API in the United States. Any material disruption in manufacturing could cause a delay in shipments and possible loss of sales.

In January 2006, we signed an exclusive license agreement with Kobayashi Pharmaceutical Co., Ltd., a Japanese corporation, to allow Kobayashi to market in Japan certain medical products that are curative of episodic outbreaks of herpes simplex or herpes labialis and that contain a therapeutic concentration of our docosanol 10% cream. In April 2009, the license agreement with Kobayashi was terminated and no termination fees were incurred. In the third quarter of fiscal 2009, we recognized approximately $171,000 in revenue which was previously deferred relating to the $860,000 data transfer fee received in March 2006 upon initiation of the agreement.

Macrophage Migration Inhibitory Factor (“MIF”) Inflammation

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

In March 2008, we entered into an Asset Purchase and License Agreement with Emergent Biosolutions for the sale of our anthrax antibodies and license to use our proprietary Xenerex Technology platform which was used to generate fully human antibodies to target antigens. Under the terms of the Agreement, we completed the remaining work under our NIH/NIAID grant (“NIH grant”) and transferred all materials to Emergent. Under the terms of the agreement, we are eligible to receive milestone payments and royalties on any product sales generated from this program. In connection with the sale of the anthrax antibody program, we also ceased all future research and development work related to other infectious diseases on June 30, 2008.

In September 2008, we entered into an Asset Purchase Agreement with a privately held San Diego based biotechnology company for the sale of our non-anthrax related antibodies as well as the remaining equipment and supplies associated with the Xenerex Technology platform. In connection with this sale, we received an upfront payment of $210,000 and are eligible to receive future royalties on potential product sales, if any.

General Information

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 allowances, certain royalties and returns and losses. Significant estimates and assumptions are also required in inventories, income taxes, contingencies, 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, 2008 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 JUNE 30, 2009 AND 2008

Revenues and Cost of Revenues


	Three months ended
	June 30,
	2009		2008		$ Change			% Change
PRODUCT SALES
Net revenues	$	—	$	3,550	$	(3,550	)		-100	%
Cost of revenues		—		—		—			0	%

Product gross margin		—		3,550		(3,550	)		-100	%


REVENUES AND COST OF RESEARCH SERVICES AND OTHER
Revenues:
Revenue from royalties and royalty rights		420,376		584,314		(163,938	)		-28	%
Revenues from license agreements		170,549		1,534,552		(1,364,003	)		-89	%
Revenues from government research grant services		—		527,517		(527,517	)		-100	%

Revenues from research services and other		590,925		2,646,383		(2,055,458	)		-78	%

Costs:
Cost of research and development services		—		155,450		(155,450	)		100	%
Cost of government research grant services		—		358,028		(358,028	)		100	%

Costs from research services and grants		—		513,478		(513,478	)		100	%

Research services and other gross margin		590,925		2,132,905		(1,541,980	)		-72	%

Total gross margin	$	590,925	$	2,136,455	$	(1,545,530	)		-72	%

Revenues

There were no revenues from product sales to report for the three month period ended June 30, 2009. Net product revenues for the three months ended June 30, 2008 include sales of docosanol 10% cream of $4,000. In the third quarter of fiscal 2009, revenues from research services and other were comprised of royalty and license revenue of $591,000, of which $171,000 was earned pursuant to the termination of the Kobayashi license agreement and $420,000 was primarily related to the recognition of deferred revenue. In the third quarter of fiscal 2008, revenues from research services and other were comprised of royalty and license revenue of $2.6 million, of which $1.5 million was related to a milestone payment received from Health Brands International (“HBI”), $580,000 was related to the recognition of deferred revenue, $57,000 was related to the Kobayashi license agreement and $7,000

arose from other sources. Revenues from research services and other also included $528,000 in government grant revenue.

Revenues from research services and other decreased by $2.1 million for the third quarter of fiscal 2009 compared to the third quarter of fiscal 2008. The decrease is attributable to the $1.5 million milestone payment received from HBI in fiscal 2008 and the termination of the anthrax antibody program which provided $528,000 of government research grant services revenue in fiscal 2008 for which there are no comparable fiscal 2009 revenues.

Potential revenue-generating contracts that remained active as of June 30, 2009 include several docosanol 10% cream license agreements, including the license agreement with GSK, potential royalties from our agreement with Azur Pharma and our license agreement with Novartis for our MIF technology. 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 research services and grants declined by $513,000 for the third quarter of fiscal 2009 compared to the third quarter of fiscal 2008. The decline in cost of revenues is primarily attributable to the completion of the remaining work under the NIH grant and the termination of all future research and development work related to other infectious diseases on June 30, 2008.

Operating Expenses


	Three months ended
	June 30,
	2009		2008		$ Change			% Change
OPERATING EXPENSES
Research and development	$	3,358,387	$	3,139,685	$	218,702			7	%
General and administrative		2,204,435		2,350,071		(145,636	)		-6	%

Total operating expenses	$	5,562,822	$	5,489,756	$	73,066			1	%

Research and Development Expenses

Research and development expenses remained relatively unchanged with a slight increase of $219,000 from $3.1 million in the third quarter of fiscal 2008 to $3.4 million for the third quarter of fiscal 2009.

During the current fiscal year we expect that our research and development costs will continue to consist mainly of expenses related to the confirmatory Phase III trial for Zenvia for PBA and initial regulatory work to prepare for the complete response to the FDA approvable letter. As we complete the open-label portion of the STAR study in the first quarter of fiscal 2010, we expect that our research and development costs will decrease modestly from that time and over the balance of the fiscal year.

General and Administrative Expenses

General and administrative expenses decreased by $146,000 from $2.4 million for the third quarter of fiscal 2008 compared to $2.2 million for the third quarter of fiscal 2009. The decrease is primarily attributed to a decrease in our overall general and administrative expenses as a result of our focused efforts to contain costs and negotiate discounts with our principal vendors.

Share-Based Compensation

Total compensation expense for our share-based payments in the three month period ended June 30, 2009 and the same period in 2008 was approximately $396,000 and $351,000, respectively. General and administrative expense in the three month periods ended June 30, 2009 and 2008 include share-based compensation expense of approximately $311,000 and $279,000, respectively. Research and development expense in the three month periods ended June 30, 2009 and 2008 include share-based compensation expense of approximately $85,000 and $72,000, respectively. As of June 30, 2009, $4.7 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 13, “Employee Equity Incentive Plans” in the Notes to Condensed Consolidated Financial Statements (Unaudited) for further discussion.

Other Income (Expenses)

Interest expense decreased by $114,000 in third quarter fiscal 2009 compared to third quarter fiscal 2008. The decrease in interest expense is primarily due to a decrease in the balance in notes payable, mostly attributed to the accelerated repayment of the remaining outstanding principal in June 2008. The notes payable were issued in connection with the purchase of Alamo.

For the three month period ended June 30, 2009, interest income decreased to approximately $15,000 compared to approximately $316,000 for the same period in the prior year. The decrease is due to a 51 % decrease in the average cash balance of our investment accounts in the third quarter of 2009 as compared to the same period in the prior year, coupled with a lower investment yield in fiscal 2009.

In the three months ended June 30, 2008, a gain on extinguishment of debt was recorded in the amount of $968,000 resulting from the Company’s accelerated repayment of the outstanding principal of the Senior Notes issued in connection with the purchase of Alamo. There was no corresponding gain in the three months ended June 30, 2009.

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, we received the settlement in the amount of $1.25 million. The settlement is recorded in Other, net in the three months ended June 30, 2008. Other, net amounts in the three months ended June 30, 2009 were not significant.

Loss from Discontinued Operations

Loss from discontinued operations was $484,000 in the three month period ended June 30, 2008. There was no loss recognized from discontinued operations in the three month period ended June 30, 2009.

Net Loss

Net loss was $5.0 million or $0.06 per share in the three month period ended June 30, 2009 compared to a net loss of $1.4 million or $0.02 per share for the three month period ended June 30, 2008.

COMPARISON OF NINE MONTHS ENDED JUNE 30, 2009 AND 2008

Revenues and Cost of Revenues


	Nine months ended
	June 30,
	2009		2008		$ Change			% Change
PRODUCT SALES
Net revenues	$	—	$	129,820	$	(129,820	)		-100	%
Cost of revenues		—		21,714		(21,714	)		-100	%

Product gross margin		—		108,106		(108,106	)		-100	%


REVENUES AND COST OF RESEARCH SERVICES AND OTHER
Revenues:
Revenue from royalties and royalty rights		2,872,827		2,993,992		(121,165	)		-4	%
Revenues from license agreements		283,834		1,648,459		(1,364,625	)		-83	%
Revenues from government research grant services		—		1,006,922		(1,006,922	)		-100	%

Revenues from research services and other		3,156,661		5,649,373		(2,492,712	)		-44	%

Costs:
Cost of research and development services		9,746		232,257		(222,511	)		96	%
Cost of government research grant services		—		915,563		(915,563	)		100	%

Costs from research services and grants		9,746		1,147,820		(1,138,074	)		99	%

Research services and other gross margin		3,146,915		4,501,553		(1,354,638	)		-30	%

Total gross margin	$	3,146,915	$	4,609,659	$	(1,462,744	)		-32	%

Revenues

There were no revenues from product sales to report for the nine month period ended June 30, 2009. Net product revenues for the nine months ended June 30, 2008 include sales of docosanol 10% cream of $130,000. In the first nine months of fiscal 2009, revenues from research services and other included royalty and license revenue of $395,000 related to the Azur license agreement, royalty revenue of $951,000 related to the GSK license agreement and $1.5 million primarily related to the recognition of deferred revenue.

Revenues from research services and other declined by $2.5 million for the first nine months of fiscal 2009 compared to the first nine months of fiscal 2008. The decrease in revenues is attributed to a milestone payment received from HBI of $1.5 million in fiscal 2008 and a decline in grant revenue received from NIH of $1.0 million due to the termination of the anthrax antibody program which ended in June 30, 2008 for which there are no comparable revenues in the nine months ended June 30, 2009.

Potential revenue-generating contracts that remained active as of June 30, 2009 include several docosanol 10% cream license agreements, including the license agreement with GSK, potential royalties from our agreement with Azur Pharma 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

Costs of research services and grants declined to $9,700 for the first nine months of fiscal 2009 compared to $1.1 million for the first nine months of fiscal 2008. The decline in cost of revenues is primarily attributable to the completion of the remaining work under the NIH grant and the termination of all future research and development work related to other infectious diseases in June 30, 2008.


	Nine months ended
	June 30,
	2009		2008		$ Change			% Change
OPERATING EXPENSES
Research and development	$	11,683,701	$	10,090,610	$	1,593,091			16	%
General and administrative		6,679,027		7,910,990		(1,231,963	)		-16	%

Total operating expenses	$	18,362,728	$	18,001,600	$	361,128			2	%

Research and Development Expenses

Research and development expenses increased by $1.6 million from $10.1 million in the first nine months of fiscal 2008 to $11.7 million for the first nine months of fiscal 2009. The increase is primarily due to increased costs incurred for Zenvia due to the confirmatory Phase III trial for the PBA indication of Zenvia.

General and Administrative Expenses

General and administrative expenses decreased by $1.2 million from $7.9 million for the first nine months of fiscal 2008 compared to $6.7 million for the first nine months of fiscal 2009. The decrease is primarily attributed to a decrease in our overall general and administrative expenses as a result of the restructuring and the significant organizational changes that we made to our infrastructure. In addition, our general and administrative costs have decreased as a result of our focused efforts to contain costs and negotiate discounts with our principal vendors.

Share-Based Compensation

The Company re-examines forfeiture rates as they apply to stock-based compensation on an annual basis. Forfeiture rates for the nine month periods ended June 30, 2009 and 2008 were estimated to be approximately 30% based on our historical experience. Future estimates may differ substantially from the Company’s current estimates.

Compensation expense for our share-based payments in the nine month period ended June 30, 2009 and the same period in 2008 was $1.2 million and $1.3 million, respectively. Selling, general and administrative expense in the nine month periods ended June 30, 2009 and 2008 include share-based compensation expense of $974,000 and $866,000, respectively. Research and development expense in the nine month periods ended June 30, 2009 and 2008 include share-based compensation expense of $251,000 and $405,000, respectively. As of June 30, 2009, $4.7 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 13, “Employee Equity Incentive Plans” in the Notes to Condensed Consolidated Financial Statements (Unaudited) for further discussion.

Interest Expense and Interest Income

For the nine month period ended June 30, 2009, interest expense decreased to $516 compared to $540,000 for the same period in the prior year. The decrease in interest expense in 2009 is primarily due to a decrease in the balance on the notes payable as compared to the prior year, mostly attributed to the accelerated repayment of the remaining outstanding principal under the notes payable in June 2008. The notes payable were issued in connection with the purchase of Alamo.

For the nine month period ended June 30, 2009, interest income decreased to $196,000, compared to $1.0 million for the same period in the prior year. The decrease is due to a 13 % decrease in the average cash balance of our investment accounts in the first nine months of 2009 as compared to the same period in the prior year, coupled with a lower investment yield in fiscal 2009.

In the nine months ended June 30, 2008, a gain on extinguishment of debt was recorded in the amount of $968,000 resulting from the Company’s accelerated re-payment of the outstanding principal of the Senior Notes issued in connection with the purchase of Alamo. There was no corresponding gain in the nine months ended June 30, 2009.

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, we received the settlement in the amount of $1.25 million. The settlement is recorded in Other, net in the nine months ended June 30, 2008. Other, net amounts in the nine months ended June 30, 2009 were not significant.

Loss from Discontinued Operations

There was no activity related to discontinued operations in the nine month period ended June 30, 2009. Loss from discontinued operations was $1.6 million in the nine month period ended June 30, 2008. The loss recognized in the nine month period ended June 30, 2008 is attributed to the accrual for the Net Working Capital Adjustment of $1.4 million as well as additional costs related to the operations of FazaClo during the nine months ended June 30, 2008.

Net Loss

Net loss was $15.0 million, or $0.19 per share, in the nine months ended June 30, 2009, compared to a net loss of $12.3 million, or $0.23 per share for the nine months ended June 30, 2008.

LIQUIDITY AND CAPITAL RESOURCES

We assess our liquidity by our ability to utilize existing cash and to generate additional cash to fund future operations. Key factors in the management of our liquidity are: cash required to fund operating activities including expected operating losses and the levels of accounts receivable, inventories, accounts payable and capital expenditures; the timing and extent of cash received from milestone payments under license agreements; available credit facilities; and financial flexibility to attract equity capital on favorable terms. Historically, cash required to fund on-going business operations has been provided by financing activities.

Cash, cash equivalents and investments, as well as net cash provided by or used in operating, investing and financing activities, are summarized in the table below.


			Increase
	June 30,		(Decrease)			September 30,
	2009		During Period			2008
Cash, cash equivalents and investment in securities	$	26,609,650	$	(15,630,877	)	$	42,240,527
Cash and cash equivalents	$	26,141,175	$	(15,242,755	)	$	41,383,930
Net working capital	$	21,573,617	$	(15,598,019	)	$	37,171,636


	Nine Months						Nine Months
	Ended			Change			Ended
	June 30,			Between			June 30,
	2009			Periods			2008
Net cash used in operating activities	$	(15,583,983	)	$	(3,224,817	)	$	(12,359,166	)
Net cash provided by investing activities		370,899			(1,917,558	)		2,288,457
Net cash (used in) provided by financing activities		(29,671	)		(26,609,661	)		26,579,990

Net (decrease) increase in cash and cash equivalents	$	(15,242,755	)	$	(31,752,036	)	$	16,509,281

Operating activities. Net cash used in operating activities amounted to $15.6 million in the first nine months of fiscal 2009 compared to $12.4 million in the first nine months of fiscal 2008. The increase is primarily due to expenses related to the confirmatory Phase III trial and advanced cardiac safety study for the PBA indication of Zenvia.

Investing activities. Net cash provided by investing activities was $371,000 in the first nine months of fiscal 2009, compared to $2.3 million provided in the first nine months of fiscal 2008. The decrease in cash provided by investing activities is primarily related to the decrease in proceeds from the sale and maturities of investments.

Financing activities. Net cash used in financing activities was $30,000 in the first nine months of fiscal 2009 compared to net cash provided by financing activities of $26.6 million in the first nine months of fiscal 2008. In the first nine months of fiscal 2008, we received $40.0 million of gross proceeds from the sale of our common stock through a registered common stock offering in April 2008 (before commissions and offering costs) and paid $11.2 million related to notes payable and other debt. In the first nine months of fiscal 2009, no proceeds were received from financing and debt payments totaled approximately $30,000.

In April 2009, we filed a shelf registration statement on Form S-3 with the SEC to sell an aggregate of up to $35 million in common stock, preferred stock, debt securities and warrants. On May 6, 2009, the registration statement was declared effective. No offerings have been made there under to date and we currently do not anticipate selling securities under this registration statement prior to the release of top-line safety and efficacy data from our PBA trial, if at all.

On July 30, 2009 we entered into a financing facility with Cantor Fitzgerald & Co., providing for the sale of up to 12,500,000 shares of our common stock from time to time into the open market at prevailing prices. We may or may not sell shares under this facility opportunistically, depending on the volume and price of our common stock, as well as our capital needs and potential alternative sources of capital, such as a development partner for Zenvia. Sales made under this facility will be made under our shelf registration statement declared effective in May 2009.

As of June 30, 2009, we have contractual obligations for trade accounts payable, trade related accrued expenses and operating lease obligations, as summarized in the table that follows.


	Payments Due by Period
			Less than						More than
	Total		1 Year		1-3 Years		3-5 Years		5 Years
Operating lease obligations (1)	$	4,961,290	$	1,516,292	$	2,787,702	$	657,296	$	—
Purchase obligations (2)		917,101		917,101		—		—		—

Total	$	5,878,391	$	2,433,393	$	2,787,702	$	657,296	$	—


(1)		Operating leases obligations are exclusive of payments we expect to receive under subleases.

(2)		Purchase obligations consist of the total of trade accounts payable and trade related accrued expenses at June 30, 2009 which approximates our contractual commitments for goods and services in the normal course of our business.

Zenvia License Milestone Payments. We hold the exclusive worldwide marketing rights to Zenvia for certain indications pursuant to an exclusive license agreement with CNS. The Company will be obligated to pay CNS up to $400,000 in the aggregate in milestones to continue to develop Zenvia for both PBA and DPN pain, assuming they are both approved for marketing by the FDA. The Company is not currently developing, nor does it have an obligation to develop, any other indications under the CNS license agreement. The Company will need to pay a $75,000 milestone if the FDA approves Zenvia for the treatment of PBA. In addition, the Company is obligated to pay CNS a royalty on commercial sales of Zenvia with respect to each indication, if the drug is approved by the FDA for commercialization. Under certain circumstances, the Company may have the obligation to pay CNS a portion of net revenues received if it sublicenses Zenvia to a third party. Under the agreement with CNS, the Company is required to make payments on achievements of up to a maximum of ten milestones, based upon five specific medical indications. Maximum payments for these milestone payments could total approximately $2.1 million if the Company pursued the development of Zenvia for all of the licensed indications. Of the clinical indications that the Company currently plans to pursue, expected milestone payments could total $800,000. In general, individual milestones range from $150,000 to $250,000 for each accepted new drug application (“NDA”) and a similar amount for each approved NDA. In addition the Company is obligated to pay CNS a royalty ranging from approximately 5% to 8% of net revenues.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Management Outlook

We believe that cash and cash equivalents and investments in securities of approximately $26.6 million at June 30, 2009 will be sufficient to sustain our planned level of operations for at least the next twelve months and through the clinical development of Zenvia and the anticipated FDA approval decision for Zenvia for PBA. However, we cannot provide assurances that our plans will not change, or that changed circumstances or delays in clinical development will not result in the depletion of capital resources more rapidly than anticipated.

For information regarding the risks associated with our need to raise capital to fund our ongoing and planned operations, please see Part II, Item 1A, “Risk Factors.”

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As described below, we are exposed to market risks related to changes in interest rates. Because substantially all of our revenue, expenses and capital purchasing activities are transacted in U.S. dollars, our exposure to foreign currency exchange rates is immaterial. However, in the future we could face increasing exposure to foreign currency exchange rates as we expand international distribution of docosanol 10% cream and purchase additional services from outside the U.S. Until such time as we are faced with material amounts of foreign currency exchange rate risks, we do not plan to use derivative financial instruments, which can be used to hedge such risks. We will evaluate the use of derivative financial instruments to hedge our exposure as the needs and risks should arise.

Interest rate sensitivity

Our investment portfolio consists primarily of fixed income instruments invested in government money market funds. The primary objective of our investments in debt securities is to preserve principal, without significantly increasing risk. We classify our restricted investments in securities as of June 30, 2009 as held-to-maturity. Based on the average duration of our investments as of June 30, 2009 and 2008, an increase of one percentage point in the interest rates would have resulted in increases in interest income of approximately $261,000 and $464,000, respectively.

As of June 30, 2009, $25.6 million of our cash and cash equivalents were maintained in six separate money market mutual funds, and approximately $500,000 of our cash and cash equivalents were maintained at two major financial institutions in the United States. At times, deposits held with the financial institutions may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, are believed to bear low risk. Effective October 3, 2008, the Emergency Economic Stabilization Act of 2008 raised the Federal Deposit Insurance Corporation deposit coverage limits to $250,000 per owner from $100,000 per owner. This program is currently available through December 31, 2009.

After giving effect to the increased FDIC insurance and the Temporary Guarantee Program, at June 30, 2009, our uninsured cash totaled approximately $4.2 million.

Other financial instruments that potentially subject us to concentrations of credit risk consist of accounts receivable. We perform ongoing credit evaluations of our customers’ financial condition and would limit the amount of credit extended if necessary but usually we have required no collateral.

Item 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Vice President, Finance, of the effectiveness of our “disclosure controls and procedures” as of the end of the period covered by this report, pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended.

In connection with that evaluation, our CEO and Vice President, Finance concluded that our disclosure controls and procedures were effective and designed to provide reasonable assurance that the information required to be disclosed is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms as of June 30, 2009. For the purpose of this review, disclosure controls and procedures means controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that we file or submit is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. These disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that we file or submit is accumulated and communicated to management, including our principal executive officer, principal financial and accounting officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Controls over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during our fiscal quarter ended June 30, 2009, that has materially affected, or is reasonably likely to materially affect our internal control over financial reporting.

PART II OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

In the ordinary course of business, we may face various claims brought by third parties. Any of these claims could subject us to costly litigation. Management believes the outcome of currently identified claims and lawsuits will not have a material adverse effect on our financial condition or results of operations.

Item 1A. RISK FACTORS

Risks Relating to Our Business

We need additional positive clinical data from the confirmatory Phase III trial for Zenvia for PBA and there can be no assurance that the FDA will approve Zenvia.

In October 2006, we received an “approvable letter” from the FDA for our NDA submission for Zenvia in the treatment of patients with PBA. The approvable letter raised certain safety and efficacy concerns. Based on discussions with the FDA, we were able to successfully resolve the outstanding efficacy concern of the original dose formulation that was tested in earlier clinical trials. However, the safety concerns require additional clinical development to resolve. To address the safety concerns, we agreed to re-formulate Zenvia and conduct one additional confirmatory Phase III clinical trial using a new low quinidine dose formulation. The goal of the study is to demonstrate an improved safety profile and significant efficacy using a low- dose quinidine formulation. We have completed patient enrollment and expect top-line safety and efficacy data from the blinded phase to be available in August 2009. It is possible that the efficacy will be so reduced at low quinidine dose formulations that we will not be able to satisfy the FDA’s efficacy requirements. It is also possible that the FDA will continue to have safety concerns relating to potential cardiac risks associated with Zenvia in light of the findings from our recently completed Advanced Cardiac Safety Study, the results of which were summarized in our quarterly report on Form

10-Q filed on May 8, 2009. Management believes data generated in these studies suggest an improved cardiac safety margin of the new lower dose formulation of Zenvia compared to the dose previously tested. However, the FDA approval decision for Zenvia is expected to depend to a significant degree on the agency’s overall assessment of benefits versus potential risks, including the risks assessed in these studies. Accordingly, there can be no assurance that the FDA will approve Zenvia for commercialization.

Additionally, although we have a Special Protocol Assessment (“SPA”) from the FDA for our confirmatory Phase III trial for Zenvia for PBA, there can be no assurance that the terms of the SPA will ultimately be binding on the FDA. An SPA is intended to serve as a binding agreement with the FDA on the adequacy of the design of a planned clinical trial. Even where an SPA has been granted, however, additional data may subsequently become available that causes the FDA to reconsider the previously agreed upon SPA and the FDA may have subsequent safety or efficacy concerns that override this agreement. For example, it is possible that we will not obtain enough data on cardiac risks through our ongoing Phase III trials to satisfy FDA safety concerns, which could necessitate further clinical trials. Additionally, the expansion in the planned number of patients enrolled in the ongoing PBA Phase III trial, may result in the FDA requesting other amendments to the trial design that could add to the trial’s cost and/or time, as well as degree of difficulty in reaching clinical endpoints. As a result, even with an SPA, we cannot be certain that the trial results will be found to be adequate enough to demonstrate the safety and efficacy required for product approval.

The FDA’s safety concerns regarding Zenvia for the treatment of PBA are expected to extend to other clinical indications that we are pursuing, including DPN pain. Due to these concerns, any future development of Zenvia for other indications is expected to use an alternative low- dose quinidine formulation, which may negatively affect efficacy.

We have successfully completed a single Phase III trial for Zenvia in the treatment of DPN pain. In recent communications regarding the continued development of Zenvia for this indication, the FDA has expressed that the safety concerns and questions raised in the PBA approvable letter would be expected to 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 Zenvia for this indication, it is possible that two large well controlled Phase III trials would be needed to support an NDA filing for this indication. However, due to our limited capital resources and current focus on gaining approval for the PBA indication, 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 Zenvia. Moreover, although we achieved positive results in our initial Phase III trial, an alternative low quinidine dose formulation may not yield the same levels of efficacy as seen in the earlier trials or as predicted based on our subsequent PK study. Any decrease in efficacy may be so great that the drug does not demonstrate a statistically significant improvement over placebo. Additionally, any alternative low quinidine dose formulation that we develop may not sufficiently satisfy the FDA’s safety concerns. If this were to happen, we may not be able to pursue the development of Zenvia for other indications or may need to undertake significant additional clinical trials, which would be costly and cause potentially substantial delays.

Even if Zenvia receives marketing approval from the FDA, the approval may not be on the terms that we seek and could limit the marketability of the drug.

Even if the FDA approves Zenvia for marketing in one or more indications, any side effects associated with this product candidate could cause the approval to be granted on terms less favorable than those we are seeking. This may, in turn, limit our ability to enter into licensing, partnering or collaboration arrangements with respect to Zenvia and to commercialize Zenvia and generate revenues from its sales. In addition to the confirmatory Phase III trial in PBA, we recently completed additional pre-clinical and clinical cardiac safety studies designed to enhance our response to the FDA’s approvable letter and to support planned label discussions with the FDA. Although we believe these studies showed an improvement in the cardiac safety margin with the low- dose of quinidine that we are currently testing, it did show QTc prolongation of a duration that is above the FDA’s threshold of concern (5 ms mean increase) in approving new drugs. As a result, we could face one or more of the following risks:

	•		regulatory authorities may require the addition of labeling statements, such as a “black box” warning, which is the strongest type of warning that the FDA can require for a drug and is generally reserved for warning prescribers about adverse drug reactions that can cause serious injury or death;

	•		regulatory authorities may withdraw approval of the product after its initial approval;

	•		product labeling may be amended to restrict use in certain populations;

	•		physicians may be required to conduct additional tests prior to dispensing product or monitor patients taking Zenvia;

	•		we may be required to conduct additional studies either post-marketing or before approval; and

	•		Zenvia may not be approved by the FDA for commercialization as the FDA may perceive that the benefit does not outweigh the potential risk, particularly if the efficacy is marginal at the new lower dose currently being tested.

Any of these events could prevent us from achieving or maintaining market acceptance of our product, even if it receives marketing approval, or could substantially increase the cost of commercialization, which in turn could impair our ability to generate revenues from the product candidate.

We have limited capital resources and will 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, accumulating losses totaling $271 million as of June 30, 2009, and we expect to continue to incur substantial operating losses for the foreseeable future. As of June 30, 2009, we had approximately $26.6 million in cash and cash equivalents and restricted investments in marketable securities. Additionally, we currently do not have any meaningful sources of recurring revenue or cash flow.

In light of our current capital resources, lack of near-term revenue opportunities and substantial long-term capital needs, we will need to raise additional capital in the future to finance our long-term operations 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 filing, we estimate that we have sufficient funds to sustain our operations at their current levels through the anticipated timing of the FDA approval decision for Zenvia in PBA in the second half of calendar year 2010. Although we expect to be able to raise additional capital, 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 execute our development plans for Zenvia. This may result in significant delays in the development of Zenvia 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 we will have adequate capital reserves to fund operations through the anticipated timing of the FDA approval decision for Zenvia in PBA, we expect that we will 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 (including through our Controlled Equity Offering facility described below), 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.

We recently entered into a financing facility with Cantor Fitzgerald & Co., providing for the sale of up to 12,500,000 shares of our common stock from time to time into the open market at prevailing prices. We may or

may not sell shares under this facility opportunistically, depending on the volume and price of our common stock, as well as our capital needs and potential alternative sources of capital, such as a development partner for Zenvia. If we actively sell shares under this “Controlled Equity Offering” facility, a significant number of shares of common stock (up to approximately 16% of our total shares outstanding) could be issued in a short period of time, although we would attempt to structure the volume and price thresholds in a way that minimizes market impact. Notwithstanding these control efforts, these sales, or the perceived risk of dilution from potential sales of stock through this facility, may depress our stock price or 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.

We have licensed out 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, macrophage migration inhibitory factor (“MIF”), our anthrax antibody program, and other antibodies in our infectious disease program, as well as docosanol in major markets worldwide. We are considering a suitable license or development partner for Zenvia for PBA and/or other indications. These transactions involve numerous risks, including:

	•		diversion of management’s attention from normal daily operations of the business;

	•		disputes over earn-outs, working capital adjustments or contingent payment obligations;

	•		insufficient proceeds to offset expenses associated with the transactions; and

	•		the potential loss of key employees following such a transaction.

Transactions such as these may result in disputes regarding 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 management’s attention from day-to-day operations, and increase our operating expenses.

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:

	•		the claims in any pending patent applications will be allowed or that patents will be granted;

	•		competitors will not develop similar or superior technologies independently, duplicate our technologies, or design around the patented aspects of our technologies;

	•		our technologies will not infringe on other patents or rights owned by others, including licenses that may not be available to us;

	•		any of our issued patents will provide us with significant competitive advantages;

	•		challenges will not be instituted against the validity or enforceability of any patent that we own or, if instituted, that these challenges will not be successful; or

•

we will be able to secure additional worldwide intellectual property protection for our Zenvia 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. 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 management’s 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 competitor’s 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.

We currently have only a limited term of patent coverage and exclusivity protection for Zenvia in the U.S., which could result in the introduction of generic competition within a few years of product launch.

Our PBA related patents for Zenvia in the U.S. expire at various times from 2011 through 2012 and our DPN pain patent for Zenvia expires in 2016 (we have longer patent protection for Zenvia in certain European markets). Depending upon the timing, duration and specifics of FDA approval, if any, of Zenvia, 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. If Zenvia is approved, the Hatch-Waxman Amendments may permit a patent restoration term of up to five years for one of our patents covering Zenvia 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. We intend to apply for patent term restoration. However, because Zenvia is not a new chemical entity, but is a combination of two previously approved products, it is uncertain whether Zenvia 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 product’s approval date.

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 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 Zenvia expire, generic drug companies would be able to introduce competing versions of the drug. Although we have filed additional new patent applications for Zenvia, there can be no assurance that these patents will issue or that any patents will have claims that are broad enough to prevent generic competition. In January 2009, the U.S. Patent and Trademark Office (“USPTO”) issued an office action on one of the Zenvia applications. We recently amended the claims in an effort to address the objections made by the USPTO examiner and filed a request for continued examination (“RCE”). Although revisions to a patent application like this are common during a patent prosecution process, there is no guarantee that our amended claims will be accepted by the USPTO. If we are unsuccessful in strengthening our patent portfolio on a timely basis to secure sufficient protection against generic competition, our long-term revenues from Zenvia sales may be less than expected and we are likely to have greater difficulty finding a development partner or licensee for Zenvia.

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 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 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 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 clinical and regulatory affairs team, the pace of clinical development for Zenvia could be slowed significantly. We have experienced employee turnover and the loss of key employees could adversely affect our business and cause significant disruption in our operations.

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:

	•		the results from earlier clinical trials may not be predictive of results that will be obtained from subsequent clinical trials, particularly larger trials;

	•		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 are being exposed to unacceptable health risks;

	•		subjects may drop out of our clinical trials;

	•		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;

	•		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 requests to analyze the data differently; and

•

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 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 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 Zenvia 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:

	•		delays in our ability to submit an NDA;

	•		the refusal by the FDA to accept for file any NDA we may submit;

	•		requests for additional studies or data;

	•		delays of an approval;

	•		the rejection of an application; or

	•		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 similar areas as our research. For example, we expect that Zenvia will face competition from antidepressants, atypical anti-psychotic agents and other agents in the treatment of PBA and from a variety of pain medications and narcotic agents for the treatment of DPN pain.

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. Even if we receive regulatory approval for one of our product candidates, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product.

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.

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 rely on insurance companies to mitigate our exposure for business activities, including developing and marketing pharmaceutical products for human use.

The testing, marketing and sale of pharmaceutical products involves the risk of product liability claims by consumers and other third parties. Although we maintain product liability insurance coverage, product liability claims can be high in the pharmaceutical industry and our insurance may not sufficiently cover our actual liabilities. If product 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 affect materially and adversely our business and financial condition. Furthermore, various distributors of pharmaceutical products require minimum product liability insurance coverage before their purchase or acceptance of products for distribution. Failure to satisfy these insurance requirements could impede our ability to achieve broad distribution of our proposed products 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 well 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.

Risks Related to Reliance on Third Parties

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 our ability to complete our trials within projected time periods. 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 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 Zenvia 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 Zenvia, and a sole manufacturer for the finished form of Zenvia. 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 Zenvia 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 Zenvia could delay our clinical trials of this product candidate for PBA and/or DPN pain. 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.

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 license arrangement for our MIF compound, we have no direct control over the development of this drug candidate and have only limited, if any, input on the direction of development efforts. These development efforts are ongoing 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 Zenvia 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 Zenvia, with the exception of one such 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 Zenvia 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

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:

•

announcements by us regarding our non-compliance with continued listing standards on the NASDAQ Stock Market;

	•		comments made by securities analysts, including changes in their recommendations;

	•		short selling activity by certain investors, including any failures to timely settle short sale transactions;

	•		announcements by us of financing transactions, including our Controlled Equity Offering facility, and/or future sales of equity or debt securities;

	•		sales of our common stock by our directors, officers or significant stockholders;

	•		lack of volume of stock trading leading to low liquidity; and

	•		market and economic conditions.

If a substantial number of shares is sold into the market at any given time, particularly following any significant announcements or large swings in our stock price (whether sales are through the Controlled Equity Offering facility or from an existing stockholder), 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 our product candidates, including Zenvia, and periodic variations in our operating results. We expect that our operating results will continue to vary from quarter-to-quarter. 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, such as the one we experienced following the announcement of the Zenvia approvable letter, 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.

The trading price for our common stock has been volatile and we have previously had difficulty satisfying the continued listing standards for the NASDAQ Global Market.

Our common stock is currently listed on the NASDAQ Global Market. On June 3, 2009 we regained compliance with the $1.00 minimum bid price requirement for continued listing on the NASDAQ Global Market. If we fail to comply with the $1.00 minimum bid price requirement for continued listing, we will be given an initial cure period of 180 calendar days to regain compliance. If we fail to comply with the listing standards following the initial cure period, our common stock listing may be moved to the NASDAQ Capital Market, which is a lower tier market, or our common stock may be delisted and traded on the over-the-counter bulletin board network. Moving our listing to the NASDAQ Capital Market could adversely affect the liquidity of our common stock and the delisting of our common stock would significantly affect the ability of investors to trade our securities and could significantly negatively affect the value of our common stock. In addition, the delisting of our common stock could further depress our stock price and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting from NASDAQ could also have other negative results, including the potential loss of confidence by suppliers and employees, the loss of institutional investor interest and fewer business development opportunities.

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

Item 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

Not applicable.

Item 5. OTHER INFORMATION

On July 30, 2009, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), providing for the sale of up to 12,500,000 shares of our common stock from time to time into the open market at prevailing prices. Pursuant to the Sales Agreement, sales of common stock will be made in such quantities and on such minimum price terms as we may set from time to time. Cantor will use commercially reasonable efforts to sell shares of the Company’s common stock on such terms and will be compensated at a rate of 4% for the first $10,000,000 in gross offering proceeds and 3% for any amounts raised in excess of $10,000,000. Sales made under this facility will be made under the Company’s effective shelf registration filed on Form S-3 (File No. 333-158665), which registered the sale of up to $35,000,000 of securities. We have agreed to reimburse Cantor for certain expenses incurred in connection with entering into the Sales Agreement and have provided Cantor with customary indemnification rights. A copy of the Sales Agreement is filed herewith as Exhibit 10.2. A copy of the legal opinion relating to the securities that may be sold pursuant to the Sales Agreement is filed herewith as Exhibit 5.1.

Item 6. EXHIBITS


Exhibits

5.1		Opinion of Goodwin Procter, LLP

10.1		Form of Director and Officer Indemnification Agreement for Avanir Pharmaceuticals, Inc. a Delaware corporation

10.2		Controlled Equity Offering Sales Agreement, dated July 30, 2009, by and between Avanir Pharmaceuticals, Inc. and Cantor Fitzgerald & Co.

23.1		Consent of Goodwin Procter, LLP (filed as part of Exhibit 5.1)

31.1		Certification of Principal Executive Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.

31.2		Certification of Principal Financial Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.

32.1		Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


Signature	Title	Date

/s/ Keith A. Katkin Keith A. Katkin	President and Chief Executive Officer (Principal Executive Officer)	July 30, 2009

/s/ Christine G. Ocampo Christine G. Ocampo	Vice President, Finance (Principal Financial and Accounting Officer)	July 30, 2009