Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Sep. 30, 2014 | Dec. 01, 2014 | Mar. 31, 2014 |
Document And Entity Information [Abstract] | ' | ' | ' |
Document Type | '10-K | ' | ' |
Amendment Flag | 'false | ' | ' |
Document Period End Date | 30-Sep-14 | ' | ' |
Document Fiscal Year Focus | '2014 | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Trading Symbol | 'AVNR | ' | ' |
Entity Registrant Name | 'AVANIR PHARMACEUTICALS, INC. | ' | ' |
Entity Central Index Key | '0000858803 | ' | ' |
Current Fiscal Year End Date | '--09-30 | ' | ' |
Entity Well-known Seasoned Issuer | 'No | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' |
Entity Voluntary Filers | 'No | ' | ' |
Entity Filer Category | 'Accelerated Filer | ' | ' |
Entity Common Stock, Shares Outstanding | ' | 193,758,703 | ' |
Entity Public Float | ' | ' | $586.50 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $271,870 | $55,259 |
Restricted cash and cash equivalents | 1,320 | 966 |
Trade receivables, net | 22,831 | 12,526 |
Inventories, net | 799 | 710 |
Prepaid expenses | 1,631 | 1,391 |
Other current assets | 2,366 | 992 |
Total current assets | 300,817 | 71,844 |
Restricted investments | 1,304 | 1,304 |
Property and equipment, net | 3,631 | 1,593 |
Non-current inventories, net | 620 | 784 |
Other assets | 611 | 554 |
Total assets | 306,983 | 76,079 |
Current liabilities: | ' | ' |
Accounts payable | 6,724 | 5,876 |
Accrued expenses | 15,370 | 11,909 |
Accrued compensation and payroll taxes | 9,999 | 7,776 |
Deferred royalty revenues | 0 | 1,289 |
Current portion of notes payable, net of debt discount | 0 | 7,943 |
Total current liabilities | 32,093 | 34,793 |
Other liabilities | 1,501 | 1,393 |
Notes payable, net of current portion and debt discount | ' | 21,422 |
Total liabilities | 33,594 | 57,608 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock - $0.0001 par value, 10,000,000 shares authorized, no shares issued | 0 | 0 |
Common stock - $0.0001 par value, 300,000,000 and 200,000,000 shares authorized as of September 30, 2014 and 2013, respectively; 193,672,800 and 152,063,621 shares issued and outstanding as of September 30, 2014 and 2013, respectively | 19 | 15 |
Additional paid-in capital | 824,342 | 518,992 |
Accumulated deficit | -550,972 | -500,536 |
Total stockholders' equity | 273,389 | 18,471 |
Total liabilities and stockholders' equity | $306,983 | $76,079 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Sep. 30, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 300,000,000 | 200,000,000 |
Common stock, shares issued | 193,672,800 | 152,063,621 |
Common stock, shares outstanding | 193,672,800 | 152,063,621 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenues: | ' | ' | ' |
Net product sales | $105,441 | $70,692 | $37,075 |
Revenues from royalties | 2,743 | 4,454 | 4,200 |
Revenues from co-promote activities | 6,735 | 0 | 0 |
Revenues from research grant services | 110 | 220 | 0 |
Total revenues | 115,029 | 75,366 | 41,275 |
Operating expenses: | ' | ' | ' |
Cost of product sales | 3,324 | 4,002 | 2,120 |
Cost of research grant services | 198 | 148 | 0 |
Research and development | 44,004 | 49,506 | 23,066 |
Selling and marketing | 77,656 | 63,202 | 52,463 |
General and administrative | 36,191 | 29,935 | 22,028 |
Total operating expenses | 161,373 | 146,793 | 99,677 |
Loss from operations | -46,344 | -71,427 | -58,402 |
Other income (expense): | ' | ' | ' |
Interest income | 20 | 52 | 43 |
Interest expense | -3,312 | -4,098 | -1,386 |
Loss on early extinguishment of debt | -789 | 0 | 0 |
Other, net | -8 | 0 | 4 |
Loss before provision for income taxes | -50,433 | -75,473 | -59,741 |
Provision for income taxes | 3 | 3 | 3 |
Net loss | ($50,436) | ($75,476) | ($59,744) |
Basic and diluted net loss per share | ($0.31) | ($0.53) | ($0.45) |
Basic and diluted weighted average number of common shares outstanding | 161,269,021 | 142,269,399 | 133,358,571 |
Consolidated_Statements_of_Sto
Consolidated Statements of Stockholders' Equity (USD $) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
In Thousands, except Share data, unless otherwise specified | ||||
Beginning Balance at Sep. 30, 2011 | $71,340 | $13 | $436,643 | ($365,316) |
Beginning Balance, Shares at Sep. 30, 2011 | ' | 125,443,788 | ' | ' |
Net loss | -59,744 | 0 | 0 | -59,744 |
Issuance of common stock in connection with: | ' | ' | ' | ' |
Exercise of stock options | 1,345 | 0 | 1,345 | 0 |
Exercise of stock options, Shares | 1,673,811 | 1,673,811 | ' | ' |
Exercise of warrants | 7,787 | 1 | 7,786 | 0 |
Exercise of warrants, Shares | ' | 5,445,061 | ' | ' |
Sale of stock, net of offering costs | 10,063 | 0 | 10,063 | 0 |
Sale of stock, net of offering costs, Shares | 3,668,656 | 3,668,656 | ' | ' |
Vesting of restricted stock units | 0 | 0 | 0 | 0 |
Vesting of restricted stock units, Shares | ' | 204,176 | ' | ' |
Issuance of warrants to purchase common stock in connection with notes payable | 1,169 | 0 | 1,169 | 0 |
Share-based compensation expense | 4,877 | 0 | 4,877 | 0 |
Ending Balance at Sep. 30, 2012 | 36,837 | 14 | 461,883 | -425,060 |
Ending Balance, Shares at Sep. 30, 2012 | ' | 136,435,492 | ' | ' |
Net loss | -75,476 | 0 | 0 | -75,476 |
Issuance of common stock in connection with: | ' | ' | ' | ' |
Exercise of stock options | 1,497 | 0 | 1,497 | 0 |
Exercise of stock options, Shares | 1,033,833 | 1,033,833 | ' | ' |
Exercise of warrants | 1,015 | 0 | 1,015 | 0 |
Exercise of warrants, Shares | 1,147,159 | 782,294 | ' | ' |
Sale of stock, net of offering costs | 48,752 | 1 | 48,751 | 0 |
Sale of stock, net of offering costs, Shares | ' | 12,965,465 | ' | ' |
Vesting of restricted stock units | 0 | 0 | 0 | 0 |
Vesting of restricted stock units, Shares | ' | 846,537 | ' | ' |
Issuance of warrants to purchase common stock in connection with notes payable | 0 | ' | ' | ' |
Share-based compensation expense | 5,846 | 0 | 5,846 | 0 |
Ending Balance at Sep. 30, 2013 | 18,471 | 15 | 518,992 | -500,536 |
Ending Balance, Shares at Sep. 30, 2013 | 152,063,621 | 152,063,621 | ' | ' |
Net loss | -50,436 | 0 | 0 | -50,436 |
Issuance of common stock in connection with: | ' | ' | ' | ' |
Exercise of stock options | 3,316 | 0 | 3,316 | 0 |
Exercise of stock options, Shares | 1,425,419 | 1,425,419 | ' | ' |
Exercise of warrants | 0 | 0 | 0 | 0 |
Exercise of warrants, Shares | 53,957 | 25,548 | ' | ' |
Sale of stock, net of offering costs | 295,354 | 4 | 295,350 | 0 |
Sale of stock, net of offering costs, Shares | ' | 39,354,687 | ' | ' |
Vesting of restricted stock units | 0 | 0 | 0 | 0 |
Vesting of restricted stock units, Shares | ' | 803,525 | ' | ' |
Issuance of warrants to purchase common stock in connection with notes payable | 0 | ' | ' | ' |
Share-based compensation expense | 6,684 | 0 | 6,684 | 0 |
Ending Balance at Sep. 30, 2014 | $273,389 | $19 | $824,342 | ($550,972) |
Ending Balance, Shares at Sep. 30, 2014 | 193,672,800 | 193,672,800 | ' | ' |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ' | ' | ' |
Net loss | ($50,436) | ($75,476) | ($59,744) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 1,402 | 826 | 700 |
Allowance for doubtful accounts | 0 | 208 | 0 |
Amortization of debt discount and debt issuance costs | 401 | 596 | 213 |
Share-based compensation expense | 6,684 | 5,846 | 4,877 |
Loss on disposal of assets | 9 | 0 | 0 |
Non-cash loss on early extinguishment of debt | 345 | 0 | 0 |
Changes in operating assets and liabilities: | ' | ' | ' |
Trade receivables, net | -10,305 | -5,502 | -5,221 |
Inventories, net | 75 | -170 | -279 |
Prepaid expenses and other assets | -1,782 | 484 | -209 |
Accounts payable | 372 | 2,888 | -328 |
Accrued expenses and other liabilities | 3,647 | 5,466 | 4,723 |
Accrued compensation and payroll taxes | 2,223 | 2,173 | 1,352 |
Deferred product revenues, net | 0 | 0 | -1,653 |
Deferred royalty revenues | -1,289 | -2,761 | -2,089 |
Net cash used in operating activities | -48,654 | -65,422 | -57,658 |
Cash flows from investing activities: | ' | ' | ' |
Purchases of property and equipment | -3,058 | -449 | -813 |
Purchases of restricted investments and restricted cash and cash equivalents | -354 | -315 | -104 |
Proceeds from maturities of restricted short-term investments | 0 | 402 | 0 |
Proceeds from disposal of fixed asset | 7 | 0 | 0 |
Net cash used in investing activities | -3,405 | -362 | -917 |
Cash flows from financing activities: | ' | ' | ' |
Repayments of notes payable | -30,000 | 0 | 0 |
Proceeds from debt, net of issuance costs | 0 | 0 | 29,615 |
Proceeds from issuances of common stock, net of commissions and offering costs | 295,354 | 48,753 | 10,063 |
Proceeds from exercise of stock options and warrants | 3,316 | 2,512 | 9,132 |
Net cash provided by financing activities | 268,670 | 51,265 | 48,810 |
Net change in cash and cash equivalents | 216,611 | -14,519 | -9,765 |
Cash and cash equivalents at beginning of year | 55,259 | 69,778 | 79,543 |
Cash and cash equivalents at end of year | 271,870 | 55,259 | 69,778 |
Supplemental disclosures of cash flow information: | ' | ' | ' |
Interest paid | 4,251 | 2,685 | 649 |
Income taxes paid | 3 | 3 | 3 |
Supplemental disclosures of non-cash investing and financing activities: | ' | ' | ' |
Purchases of property and equipment in accounts payable and accrued expenses | 561 | 163 | 0 |
Issuance of warrants for common stock in connection with notes payable | $0 | $0 | $1,169 |
Description_of_Business_and_Ba
Description of Business and Basis of Presentation | 12 Months Ended | |
Sep. 30, 2014 | ||
Accounting Policies [Abstract] | ' | |
Description of Business and Basis of Presentation | ' | |
1 | Description of Business and Basis of Presentation | |
Description of Business | ||
Avanir Pharmaceuticals, Inc. and subsidiaries (“Avanir”, the “Company” or “we”) is a biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutic products for the treatment of central nervous system disorders. The Company’s lead product, NUEDEXTA® (referred to as AVP-923 during clinical development) is a first-in-class dual N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 agonist. NUEDEXTA 20/10mg (dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg) is approved in the United States for the treatment of pseudobulbar affect (“PBA”). It is also approved for the symptomatic treatment of PBA in the European Union in two dose strengths, NUEDEXTA 20/10 mg and NUEDEXTA 30/10 mg. The Company commercially launched NUEDEXTA in the United States in February 2011 and is currently assessing plans regarding the potential commercialization of NUEDEXTA in the European Union. | ||
The Company is studying the clinical utility of AVP-923 in other mood/behavior disorders and movement disorders, including the potential treatment of agitation in patients with Alzheimer’s disease and the potential treatment of levodopa-induced dyskinesia in Parkinson’s disease (“LID”). The Phase 2 LID study is supported by a grant from the Michael J. Fox Foundation. The Phase 2 study of agitation in Alzheimer’s disease was recently completed and, on September 15, 2014, the Company announced positive results for this study (see “AVP-923 for the treatment of Agitation in patients with Alzheimer’s disease,” below). | ||
The Company is also developing AVP-786, an investigational drug product containing deuterium-modified dextromethorphan and quinidine for the potential treatment of neurologic and psychiatric disorders. The Company completed pharmacokinetic studies with AVP-786 and, based on these data, the Company has identified a formulation of AVP-786 to move forward into clinical studies. This AVP-786 formulation contains significantly less quinidine than used in AVP-923. In June 2013, the U.S. Food and Drug Administration (“FDA”) agreed to an expedited development pathway for AVP-786, requiring only a limited non-clinical package as part of the Investigational New Drug (“IND”) application. In August 2014, the Company initiated a Phase 2 study for AVP-786 as an adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (“MDD”.) | ||
The Company is also developing a novel Breath Powered™ intranasal delivery system containing low-dose sumatriptan powder acute treatment of migraine, AVP-825. If approved, this product would be the first and only fast-acting dry-powder nasal delivery form of sumatriptan. AVP-825 is licensed from OptiNose AS (“OptiNose”). Under the terms of the agreement, the Company assumed responsibility for regulatory, manufacturing, supply-chain and commercialization activities for the investigational product. In March 2014, the FDA accepted the Company’s New Drug Application (“NDA”) of AVP-825. In November 2014, the Company received a Complete Response Letter from the FDA, which requested that the Company assess the root cause(s) of device use errors observed in the previously conducted human factors testing. The Company is currently working to address these issues and intends to conduct a new human factors study, with input from the FDA, with a goal to respond to the Complete Response Letter in the first half of calendar 2015. The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval. | ||
The Company entered into a multi-year agreement with Merck Sharp & Dohme Corp. (“Merck”) to co-promote Merck’s type 2 diabetes therapies JANUVIA® (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States beginning October 1, 2013. The term of the Agreement will continue for three years following the launch date of the co-promotion activities, unless terminated earlier pursuant to the terms of the agreement. Under the terms of the Agreement, the Company will be compensated via a (i) fixed monthly fee and (ii) performance fee based on the amount of the Products sold by the Company above a predetermined baseline. A significant majority of the fee is performance-based. Over the three years of the agreement, Avanir could receive up to $46.7 million in compensation, including revenue earned in the first contract year. See Note 11, “Research, License, Supply and other Agreements.” | ||
The Company developed and licensed certain intellectual property rights relating to NUEDEXTA and the existing drug candidates (AVP-923, AVP-786 and AVP-825) and the Company continues to actively seek to acquire rights to other complementary products and technologies, particularly following the successful defense of the patents underlying NUEDEXTA. As a result, the Company intends to seek to in-license or acquire through other means, such as mergers, stock purchases or asset purchases, complementary products and technologies, as well as sales and marketing infrastructure and other assets or resources. There can be no assurance, however, that the Company will be successful in acquiring any additional assets, or that the Company will receive the anticipated benefits of any such acquisitions. | ||
Avanir was incorporated in California in August 1988 and was reincorporated in Delaware in March 2009. | ||
Basis of presentation | ||
The consolidated financial statements include the accounts of Avanir Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. The Company’s fiscal year ends on September 30 of each year. The years ended September 30, 2014, 2013, and 2012 are herein referred to as fiscal 2014, fiscal 2013 and fiscal 2012, respectively. | ||
The Company has evaluated subsequent events through the filing date of this Form 10-K, and determined that no subsequent events have occurred that would require recognition in the consolidated financial statements or disclosure in the notes thereto other than as discussed in the accompanying notes. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||
Summary of Significant Accounting Policies | ' | ||||||||||||
2 | Summary of Significant Accounting Policies | ||||||||||||
Management estimates | |||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Significant estimates made by management include, among others, sales returns, discounts and allowances, provisions for uncollectible receivables, realizability of inventories, valuation of investments, recoverability of long-lived assets, recognition of deferred revenue, the fair value of stock options, warrants and shares issued for non-cash consideration, determination of expenses in outsourced contracts, and realization of deferred tax assets. | |||||||||||||
Cash and cash equivalents | |||||||||||||
Cash and cash equivalents consist of cash and highly liquid investments with maturities of three months or less at the date of acquisition. | |||||||||||||
Concentration of credit risk and sources of supply | |||||||||||||
Financial assets that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and trade receivables. The Company’s cash and cash equivalents are placed in various money market mutual funds and at financial institutions of high credit standing. At times, deposits held with these financial institutions may exceed the amount of insurance provided by the Federal Deposit Insurance Corporation (FDIC). Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. The Company performs ongoing credit evaluations of customers’ financial condition and may limit the amount of credit extended if necessary; however, the Company has historically required no collateral from its customers. | |||||||||||||
The Company currently has sole suppliers for the active pharmaceutical ingredients (“APIs”) for NUEDEXTA and a sole manufacturer for the finished form of NUEDEXTA. In addition, these materials are custom and available from only a limited number of sources. Any material disruption in manufacturing could cause a delay in shipments and possible loss of revenue. If the Company is required to change manufacturers, the Company may experience delays associated with finding an alternative manufacturer that is properly qualified to produce NUEDEXTA in accordance with FDA requirements and the Company’s specifications. | |||||||||||||
Inventories | |||||||||||||
Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out (“FIFO”) basis. The Company evaluates the carrying value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets compared with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories. | |||||||||||||
The Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such factors as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf life of products and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories as required based on its analyses. | |||||||||||||
Property and equipment | |||||||||||||
Property and equipment, net, is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful life of the asset. Computer equipment and related software are depreciated over three to five years. Office equipment, furniture and fixtures are depreciated over five years. Manufacturing equipment is depreciated over eight years. Leasehold improvements are amortized over the estimated useful life or remaining lease term, whichever is shorter. | |||||||||||||
Valuation of long-lived assets | |||||||||||||
Long-lived assets are evaluated for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. If the review indicates that a long-lived asset is not recoverable (i.e. the carrying amount is less than the future projected undiscounted cash flows), its carrying amount would be reduced to fair value. Factors management considers important that could trigger an impairment review include the following: | |||||||||||||
• | A significant underperformance relative to expected historical or projected future operating results; | ||||||||||||
• | A significant change in the manner of the Company’s use of the acquired asset or the strategy for its overall business; and/or | ||||||||||||
• | A significant negative industry or economic trend. | ||||||||||||
Based on its analysis, the Company’s management believes that no impairment of the carrying value of its long-lived assets existed at September 30, 2014 and 2013. | |||||||||||||
Deferred rent | |||||||||||||
The Company accounts for rent expense related to operating leases by determining total minimum rent payments on the leases over their respective periods and recognizing the rent expense on a straight-line basis. The difference between the actual amount paid and the amount recorded as rent expense in each fiscal year is recorded as an adjustment to deferred rent. Deferred rent as of September 30, 2014 and 2013 was approximately $681,000 and $367,000, respectively, and is included in accrued expenses and other liabilities in the accompanying consolidated balance sheets. | |||||||||||||
Fair value of financial instruments | |||||||||||||
The Company measures the fair value of certain of its financial assets on a recurring basis. A fair value hierarchy is used to rank 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 (unadjusted) in active markets for identical assets and liabilities. | ||||||||||||
• | Level 2-Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted 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. | ||||||||||||
At September 30, 2014 and 2013, the Company’s financial instruments include cash and cash equivalents, restricted cash and cash equivalents, trade receivables, restricted investments, accounts payable, accrued expenses, accrued compensation and payroll taxes, and other liabilities. In addition, at September 30, 2013, the Company’s financial instruments included notes payable. The carrying amount of cash and cash equivalents, restricted cash and cash equivalents, trade receivables, accounts payable, accrued expenses, accrued compensation and payroll taxes, and other liabilities approximates fair value due to the short-term maturities of these instruments. The Company’s restricted investments are carried at amortized cost which approximates fair value. Based on borrowing rates available to the Company at September 30, 2013, the carrying value of notes payable approximated fair value. | |||||||||||||
Restricted cash and cash equivalents and restricted investments | |||||||||||||
Restricted cash and cash equivalents and restricted investments consist of certificates of deposit, which are classified as held-to-maturity. | |||||||||||||
Restricted cash and cash equivalents consist of a certificate of deposit relating to the Company’s corporate credit card agreement and automatically renews every three months. | |||||||||||||
Long-term restricted investments consist of two certificates of deposit related to irrevocable standby letters of credit connected to fleet rentals and an office lease with an expiration date in 2018. The certificates of deposit automatically renew annually. | |||||||||||||
Debt issuance costs and debt discount | |||||||||||||
Debt issuance costs are stated at cost, net of accumulated amortization in other assets in the consolidated balance sheets. Debt discount is recorded within notes payable in the consolidated balance sheets. Amortization expense of debt issuance costs and the debt discount is calculated using the interest method over the term of the debt and is recorded in interest expense in the accompanying consolidated statements of operations. | |||||||||||||
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 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 Company’s price to the buyer is fixed or determinable; and (4) collectability is reasonably assured. In addition, certain product sales are subject to rights of return. For products sold where the buyer has the right to return the product, the Company recognizes revenue at the time of sale only if (1) the Company’s price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid the Company, or is obligated to pay the Company and the obligation is not contingent on resale of the product, (3) the buyer’s obligation to the Company 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 Company 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 above criteria, including the ability to reasonably estimate future returns, or when it can reasonably estimate that the return privilege has substantially expired, whichever occurs first. | |||||||||||||
Product Sales — NUEDEXTA. NUEDEXTA is sold primarily to third-party wholesalers that, in turn, sell this product to retail pharmacies, hospitals, and other dispensing organizations. The Company has entered into agreements with wholesale customers, group purchasing organizations and third-party payers throughout the United States. These agreements frequently contain commercial terms, which may include favorable product pricing and discounts and rebates payable upon dispensing the product to patients. Additionally, these agreements customarily provide the customer with rights to return the product, subject to the terms of each contract. Consistent with pharmaceutical industry practice, wholesale customers can return purchased product during an 18-month period that begins six months prior to the product’s expiration date and ends 12 months after the expiration date. The Company recognizes revenue upon delivery of NUEDEXTA to its wholesalers and other customers. | |||||||||||||
The Company records allowances for customer credits, including estimated discounts, co-pay assistance, rebates and chargebacks. These allowances provided by the Company to a customer are presumed to be a reduction of the selling prices of the Company’s products and, therefore, are characterized as a reduction of revenue when recognized in the Company’s consolidated statement of operations. The Company believes the assumptions used to estimate these allowances are reasonable considering known facts and circumstances. However, actual rebates, chargebacks and returns could differ materially from estimated amounts because of, among other factors, unanticipated changes in prescription trends and any change in assumptions affecting sell-through and research data purchased from third parties. Product shipping and handling costs are included in cost of product sales. | |||||||||||||
The Company offers discounts to certain of its customers, including discounts to wholesalers for certain services, cash discounts to customers for the early payment of trade receivables and patient discounts in the form of co-pay assistance for the purchase of NUEDEXTA through the use of coupons. The Company accrues for discounts based on the contractual terms of agreements with customers and historical experience. The estimated redemption cost of the coupons accrued is based on the historical experience for NUEDEXTA and sell-through data purchased from third parties. Cash discount accruals for early payment of trade receivables are recorded as a contra asset to trade receivables in the Company’s consolidated balance sheets. All other discount accruals are recorded in accrued expenses in the Company’s consolidated balance sheets. | |||||||||||||
The Company participates in various managed care access rebate programs, the largest of which relate to Medicaid, Medicare and commercial insurers. The Company also incurs chargebacks which are contractual discounts given primarily to federal government agencies and group purchasing organizations. The Company estimates rebate and chargeback accruals using quantitative factors such as contractual terms of agreements with its customers, historical experience, estimated percentages of product sold to qualified patients and estimated levels of inventory in the distribution channel. These quantitative factors are supplemented by additional factors such as management’s judgment with respect to many factors, including but not limited to, current market dynamics, changes in sales trends, an evaluation of current laws and regulations and product pricing. The Company evaluates percentages of NUEDEXTA sold to qualified patients primarily through analysis of wholesaler and other third party sell-through and research data. Additionally, there is a significant time lag between the date the Company estimates the accrual and when the Company actually pays the accrual. Due to this time lag, the Company records adjustments to estimated accruals over several periods, which can result in a net increase to net loss or a decrease to net loss in those periods. The rebate and chargeback accruals are recorded in accrued expenses in the Company’s consolidated balance sheets. | |||||||||||||
The Company estimates future returns and records a returns reserve as a reduction to revenue. The returns reserve represents a reserve for NUEDEXTA that may be returned primarily due to product expiration and is estimated based on contractual terms with customers and historical return trends as a percentage of gross sales. The returns reserve is recorded as a contra asset to trade receivables in the Company’s consolidated balance sheets. The Company has experienced annual returns of approximately 1% of gross product sales over the past two years. | |||||||||||||
Prior to the second quarter of fiscal 2012, the Company was unable to reasonably estimate future returns due to the lack of sufficient historical return data for NUEDEXTA. Accordingly, the Company invoiced the wholesaler, recorded deferred revenue at gross invoice sales price less estimated cash discounts and distribution fees, and classified the inventory shipped as finished goods. The Company previously deferred recognition of revenue and the related cost of product sales on shipments of NUEDEXTA until the right of return no longer existed, i.e. when the Company received evidence that the products had been dispensed to patients. The Company estimated patient prescriptions dispensed using an analysis of third-party information. | |||||||||||||
Multiple Element Arrangements. The Company has, in the past, entered into arrangements whereby it delivers to the customer multiple elements including technology and/or services. Such arrangements have included some combination of the following: licensed rights to technology, patented products, compounds, data and other intellectual property; and research and development services. At the inception of each such arrangement, the Company analyzes the multiple elements contained within the arrangement to determine whether the elements can be separated. If a product or service is not separable, the combined deliverables will be accounted for as a single unit of accounting. | |||||||||||||
A delivered element can be separated from other elements when it meets both of the following criteria: (1) the delivered item has value to the customer on a standalone basis; and (2) 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. If an element can be separated, the Company allocates amounts based upon the selling price of each element. The Company determines the selling price 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 selling price of a similar product or service to a similarly situated customer. 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. The Company has not entered into any multiple element arrangements which have required the Company to estimate selling prices during fiscal 2014, 2013 and 2012. | |||||||||||||
License Arrangements. License arrangements may consist of non-refundable up-front license fees, data transfer fees, research reimbursement payments, exclusive licensed rights to patented or patent pending compounds, technology access fees, and 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 up-front 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. | |||||||||||||
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 provide that royalties are earned only if a sales threshold is exceeded. Under these types of arrangements, the threshold is typically based on annual sales. For royalty revenue generated from the license agreement with GlaxoSmithKline (“GSK”), the Company recognized royalty revenue in the period in which the threshold is exceeded. For royalty revenue generated from the license agreement with Azur Pharma (“Azur”), the Company recognized revenue when it had determined that the threshold had been 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 up-front 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 GSK for the period to the total remaining royalties the Company expects GSK will pay Drug Royalty USA over the remaining term of the agreement. The GSK license agreement expired in April 2014 and the Company does not expect any future revenues from royalties under this agreement. | |||||||||||||
Co-Promotion Arrangements. The Company recognizes both a fixed monthly fee and a performance fee as revenues from co-promote activities in the consolidated statements of operations. The fixed monthly fee is recognized ratably over the period earned. The performance fee is recognized when the products sold exceeds a predetermined baseline for the period. The receivable from the co-promotion fee is recorded in other current assets in the consolidated balance sheets. | |||||||||||||
Cost of product sales | |||||||||||||
Cost of product sales includes third-party royalties and direct and indirect costs to manufacture product sold, including packaging, storage, shipping and handling costs and the write-off of obsolete inventory. | |||||||||||||
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 expense 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 extend across multiple reporting periods. | |||||||||||||
Research and development expenses | |||||||||||||
Research and development expenses consist of expenses incurred in performing research and development activities including salaries and benefits and other overhead expenses, clinical trials, contract services and other outsourced contracts. Research and development expenses are charged to operations as they are incurred. Up-front payments to collaborators made in exchange for the avoidance of potential future milestone and royalty payments on licensed technology are also charged to research and development expense when the drug is still in the development stage, has not been approved by the FDA for commercialization and has no alternative uses. | |||||||||||||
The Company assesses its obligations to make milestone payments that may become due under licensed or acquired technology to determine whether the payments should be expensed or capitalized. The Company charges milestone payments to research and development expense when: | |||||||||||||
• | The technology is in the early stage of development and has no alternative uses; | ||||||||||||
• | There is substantial uncertainty regarding the future success of the technology or product; | ||||||||||||
• | There will be difficulty in completing the remaining development; and | ||||||||||||
• | There is substantial cost to complete the work. | ||||||||||||
Acquired contractual rights. Payments to acquire contractual rights to a licensed technology or drug candidate are expensed as incurred when there is uncertainty in receiving future economic benefits from the acquired contractual rights. The Company considers the future economic benefits from the acquired contractual rights to a drug candidate to be uncertain until such drug candidate is approved by the FDA or when other significant risk factors are abated. | |||||||||||||
Share-based compensation | |||||||||||||
The Company grants options, restricted stock units and restricted stock awards to purchase the Company’s common stock to employees, directors and consultants under stock option plans. The benefits provided under these plans are share-based payments that the Company accounts for using the fair value method. | |||||||||||||
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, expected stock price volatility, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. Expected volatilities are based on the historical volatility of the Company’s 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 rate is based on the U.S. Treasury yield in effect at the time of the grant. Since the Company does not expect to pay dividends on common stock in the foreseeable future, it estimated the dividend yield to be 0%. | |||||||||||||
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 and is amortized under the straight-line attribution method. As share-based compensation expense recognized in the accompanying consolidated statements of operations for fiscal 2014, 2013, and 2012 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. The fair value method requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company estimates forfeitures based on historical experience. Changes to the estimated forfeiture rate are accounted for as a cumulative effect of change in the period the change occurred. | |||||||||||||
Total compensation expense related to all of the Company’s share-based awards for fiscal 2014, 2013 and 2012 was comprised of the following (in thousands): | |||||||||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation classified as: | |||||||||||||
Research and development expense | $ | 1,326 | $ | 1,072 | $ | 965 | |||||||
Selling and marketing expense | 2,136 | 1,650 | 908 | ||||||||||
General and administrative expense | 3,222 | 3,124 | 3,004 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation expense from: | |||||||||||||
Stock options | $ | 4,540 | $ | 4,233 | $ | 3,643 | |||||||
Restricted stock units | 2,144 | 1,613 | 1,234 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Since the Company has a net operating loss carry-forward as of September 30, 2014, 2013, and 2012, no excess tax benefits for tax deductions related to share-based awards were recognized in the accompanying consolidated statements of operations. Additionally, no incremental tax benefits were recognized from stock options exercised in fiscal 2014, 2013, and 2012 that would have resulted in a reclassification from cash flows from operating activities to cash flows from financing activities. | |||||||||||||
Advertising expenses | |||||||||||||
Advertising costs are expensed as incurred, and these costs are included in selling and marketing expenses, which include promotional materials for physicians. Advertising costs were approximately $11.2 million, $8.9 million, and $7.3 million for fiscal 2014, 2013, and 2012, respectively. | |||||||||||||
Income taxes | |||||||||||||
The Company accounts for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the consolidated financial statement carrying amounts and the income tax bases 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. | |||||||||||||
The Company recognizes any uncertain income tax positions on income tax returns 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 unrecognized tax benefit resulting in a decrease in deferred tax assets and corresponding decrease in the valuation allowance at September 30, 2014 is $3.7 million. There are no unrecognized tax benefits included in the consolidated balance sheet 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 consolidated balance sheets at September 30, 2014 and 2013. | |||||||||||||
The Company is subject to taxation in the U.S. and various state jurisdictions. The Company’s tax years for 1995 and forward for federal purposes and 1989 and forward for California purposes 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 uncertain income tax position liability within the next twelve months. | |||||||||||||
Recent authoritative guidance | |||||||||||||
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers.” ASU No. 2014-09 establishes a core principle requiring the recognition of revenue to depict the transfer of promised goods or services to customers in an amount reflecting the consideration to which the entity expects to be entitled in exchange for such goods or services Specifically, to apply the core principle, an entity must (1) identify the contract, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations, and (5) recognize revenue as each performance obligation is satisfied. In addition, ASU No. 2014-09 requires reporting companies to disclose the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. ASU No. 2014-09 is required to be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying it recognized at the date of initial application. ASU No. 2014-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Early adoption is prohibited. The Company is required to adopt this guidance at the beginning of its first quarter of fiscal year 2018, and is currently evaluating the impact on its consolidated financial statements and disclosures. | |||||||||||||
In July 2013, the FASB issued ASU No. 2013-11, “Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists.” ASU No. 2013-11 provides explicit guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with an option for early adoption. The Company intends to adopt this guidance at the beginning of its first quarter of fiscal year 2015, and is currently evaluating the impact on its consolidated financial statements and disclosures. |
Inventories
Inventories | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Inventory Disclosure [Abstract] | ' | ||||||||||||
Inventories | ' | ||||||||||||
3 | Inventories | ||||||||||||
Inventories are comprised of NUEDEXTA finished goods and the active pharmaceutical ingredients of NUEDEXTA, dextromethorphan hydrobromide (“DM”) and quinidine sulfate (“Q”), as well as the active pharmaceutical ingredient docosanol, and sumatriptan. | |||||||||||||
The composition of inventories as of September 30, 2014 and 2013 is as follows (in thousands): | |||||||||||||
September 30, | |||||||||||||
2014 | 2013 | ||||||||||||
Raw materials | $ | 954 | $ | 937 | |||||||||
Work in progress | 148 | 36 | |||||||||||
Finished goods | 317 | 521 | |||||||||||
Total inventory | 1,419 | 1,494 | |||||||||||
Less: current portion | (799 | ) | (710 | ) | |||||||||
Non-current portion | $ | 620 | $ | 784 | |||||||||
The amount classified as non-current inventories is comprised of the raw material components for NUEDEXTA, DM and Q, which will be used in the manufacture of NUEDEXTA capsules beyond our one year operating cycle. | |||||||||||||
The following table presents the activity in inventory reserves for the last three fiscal years (in thousands): | |||||||||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2013 | 2014 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 41 | $ | (29 | ) | $ | 12 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 736 | $ | (29 | ) | $ | 707 | ||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2012 | 2013 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 57 | $ | (16 | ) | $ | 41 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 752 | $ | (16 | ) | $ | 736 | ||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2011 | 2012 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 82 | $ | (25 | ) | $ | 57 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 777 | $ | (25 | ) | $ | 752 | ||||||
Property_and_Equipment
Property and Equipment | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
Property and Equipment | ' | ||||||||
4 | Property and Equipment | ||||||||
Property and equipment as of September 30, 2014 and 2013 consist of the following (in thousands): | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Computer equipment and related software | $ | 4,618 | $ | 2,988 | |||||
Leasehold improvements | 820 | 309 | |||||||
Office equipment, furniture and fixtures | 1,539 | 1,460 | |||||||
Manufacturing equipment | 1,407 | 232 | |||||||
8,384 | 4,989 | ||||||||
Accumulated depreciation | (4,753 | ) | (3,396 | ) | |||||
$ | 3,631 | $ | 1,593 | ||||||
Depreciation and amortization expense associated with property and equipment was approximately $1.4 million, $826,000 and $700,000 for fiscal 2014, 2013, and 2012, respectively. In fiscal 2014, the Company evaluated the estimated remaining useful life of certain assets and recorded an additional depreciation expense of approximately $276,000. |
Accrued_Expenses
Accrued Expenses | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
Accrued Expenses | ' | ||||||||
5 | Accrued Expenses | ||||||||
Accrued expenses at September 30, 2014 and 2013 are as follows (in thousands): | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Accrued royalties, rebates, chargebacks, and distribution fees(1) | $ | 9,450 | $ | 5,525 | |||||
Accrued research and development expenses | 2,355 | 2,146 | |||||||
Accrued selling and marketing expenses | 1,731 | 2,139 | |||||||
Accrued general and administrative expenses | 1,474 | 1,753 | |||||||
Other current liabilities | 360 | 346 | |||||||
Total accrued expenses | $ | 15,370 | $ | 11,909 | |||||
-1 | Accrued royalties, rebates, chargebacks and distribution fees are directly impacted by product revenue and will fluctuate over time in relation to the change in product revenue. |
Deferred_Revenues
Deferred Revenues | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Deferred Revenue Disclosure [Abstract] | ' | ||||||||
Deferred Revenues | ' | ||||||||
6 | Deferred Revenues | ||||||||
The following table sets forth as of September 30, 2014 and 2013 the net deferred revenue balances for the Company’s sale of future Abreva® royalty rights to Drug Royalty USA (in thousands): | |||||||||
2014 | 2013 | ||||||||
Net deferred revenues as of October 1 | $ | 1,289 | $ | 4,049 | |||||
Recognized as revenues during period | (1,289 | ) | (2,760 | ) | |||||
Net deferred revenues as of September 30 | $ | — | $ | 1,289 | |||||
In November 2002, the Company sold to Drug Royalty USA an undivided interest in the Company’s rights to receive future Abreva royalties under the license agreement with GSK for $24.1 million (the “Drug Royalty Agreement” and the “GSK License Agreement,” respectively). Under the Drug Royalty Agreement, Drug Royalty USA had the right to receive royalties from GSK on sales of Abreva until the expiration of the patent for Abreva on April 28, 2014. 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 $62.0 million through April 28, 2014. In fiscal 2014, 2013, and 2012, the Company recognized royalties related to the annual net Abreva sales in excess of $62.0 million in the amount of approximately $1.5 million, $1.7 million and $1.6 million, respectively, which is included in the accompanying consolidated statements of operations as revenues from royalties. The GSK License Agreement expired in April 2014 and the Company does not expect any future revenues from royalties under this agreement. | |||||||||
Revenues are recognized when earned, collection is reasonably assured and no additional performance of services is required. The Company classified the proceeds received from Drug Royalty USA as deferred revenue, and recognized the revenue over the life of the license agreement because of the Company’s continued involvement over the term of the Drug Royalty Agreement. Such continued involvement included overseeing the performance of GSK and its compliance with the covenants in the GSK License Agreement, monitoring patent infringement, adverse claims or litigation involving Abreva, and undertaking to find a new license partner in the event that GSK terminated the agreement. The deferred revenue was recognized as revenue using the “units-of-revenue method” over the life of the license agreement. Based on a review of the Company’s continued involvement, the Company concluded that the sale proceeds did not meet any of the rebuttable presumptions that would require classification of the proceeds as debt. |
Notes_Payable
Notes Payable | 12 Months Ended | |
Sep. 30, 2014 | ||
Debt Disclosure [Abstract] | ' | |
Notes Payable | ' | |
7 | Notes Payable | |
In May 2012, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC and Silicon Valley Bank. The Loan Agreement provided for a term loan of $30.0 million which was funded upon closing of the transaction in June 2012. Under the terms of the Loan Agreement, interest accrued on the outstanding balance at a rate of 8.95% per annum. In the third fiscal quarter of 2013, the Company met the criteria to extend the interest only payment for six months. Therefore, until January 1, 2014 (the “Amortization Date”) the Company made monthly payments of interest only. In addition to the original principal, a final payment equal to 7% of the original purchase amount of the loan would have been due thirty months from the Amortization Date. The final payment was accreted as interest expense over the term of the debt using the interest method and the related liability of approximately $1.1 million was reported as of September 30, 2013. | ||
The term loan under the Loan Agreement was repaid and terminated in September 2014 and the Company recorded a loss on early extinguishment of debt of approximately $789,000 comprised of the unamortized debt issuance costs, debt discount, and final payment fee. | ||
In accordance with the terms of the Loan Agreement, the Company issued to the lenders warrants to purchase shares of the Company’s common stock equal to 4.55% of the original principal at a price per share equal to the lower of the 10-day average share price prior to closing or the price per share on the day of funding. Accordingly, the Company issued to the lenders warrants to purchase 491,007 shares of the Company’s common stock at an exercise price of $2.78 per share. As of September 30, 2014, none of the lenders’ warrants are outstanding. The relative fair value of the warrants was approximately $1.2 million and was estimated using the Black-Scholes model with the following assumptions: fair value of the Company’s common stock at issuance of $2.80 per share; ten-year contractual term; 96.7% volatility; 0% dividend rate; and a risk-free interest rate of 1.8%. The relative fair value of the warrants was recorded as a debt discount, decreasing notes payable and increasing additional paid-in capital on the accompanying consolidated balance sheets. The debt discount was being amortized to interest expense over the term of the debt using the interest method. For the years ended September 30, 2014, 2013, and 2012 debt discount amortization was approximately $340,000, $505,000 and $180,000, respectively. |
Computation_of_Net_Loss_Per_Sh
Computation of Net Loss Per Share | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||
Computation of Net Loss Per Share | ' | ||||||||||||
8 | Computation of Net Loss Per 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. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common and dilutive common equivalent shares outstanding during the period. In the loss periods, the shares of common stock issuable upon exercise of stock options and warrants or upon vesting of restricted stock units are excluded from the computation of diluted net loss per share, as their effect is anti-dilutive. | |||||||||||||
For fiscal 2014, 2013, and 2012, the following options and warrants to purchase shares of common stock and restricted stock units were excluded from the computation of diluted net loss per share, as the inclusion of such shares would be anti-dilutive: | |||||||||||||
Fiscal 2014 | Fiscal 2013 | Fiscal 2012 | |||||||||||
Stock options | 9,627,683 | 8,823,041 | 8,142,468 | ||||||||||
Stock warrants | — | 53,957 | 1,201,116 | ||||||||||
Restricted stock units(1) | 3,303,082 | 2,904,423 | 2,617,188 | ||||||||||
-1 | Includes 1,155,422, 1,267,215, and 1,600,564 shares of restricted stock in fiscal 2014, 2013, and 2012, respectively, awarded to directors that have vested but are still restricted until the directors resign. |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||||||||||
Commitments and Contingencies | ' | ||||||||||||
9 | Commitments and Contingencies | ||||||||||||
Operating lease commitments. The Company leases approximately 61,000 square feet of office space in Aliso Viejo, California. The lease has scheduled rent increases each year and expires in December 2020. | |||||||||||||
The Company also leases an additional approximately 38,000 square feet of office space in Aliso Viejo, California. The lease has scheduled rent increases each year and expires in October 2018. Approximately 30,000 square feet of office space is subleased through October 31, 2018. The sublease has scheduled rent increases each year. | |||||||||||||
Rent expense, excluding common area charges and other costs, was approximately $2.4 million, $1.1 million and $2.0 million in fiscal 2014, 2013, and 2012, respectively. Sublease rent income totaled approximately $113,000, $294,000 and $997,000 in fiscal 2014, 2013 and 2012, respectively. Future minimum rental payments under non-cancelable operating lease commitments, net of sublease payments as of September 30, 2014 are as follows (in thousands): | |||||||||||||
Year Ending September 30, | Minimum | Lease | Net Payments | ||||||||||
Payments | Payments to be | ||||||||||||
Received from | |||||||||||||
Subleases | |||||||||||||
2015 | $ | 2,943 | $ | (794 | ) | $ | 2,149 | ||||||
2016 | 3,031 | (919 | ) | 2,112 | |||||||||
2017 | 3,138 | (955 | ) | 2,183 | |||||||||
2018 | 3,230 | (982 | ) | 2,248 | |||||||||
2019 | 2,202 | (82 | ) | 2,120 | |||||||||
Thereafter | 2,718 | — | 2,718 | ||||||||||
Total | $ | 17,262 | $ | (3,732 | ) | $ | 13,530 | ||||||
Legal contingencies. | |||||||||||||
Stockholder Class-Action Litigation Regarding Our Pending Acquisition by Otsuka | |||||||||||||
On December 1, 2014, Avanir entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Otsuka Pharmaceutical Co., Ltd., a Japanese joint stock company (“Otsuka”), and Bigarade Corporation, a Delaware corporation and a wholly-owned subsidiary of Otsuka (“Acquisition Sub”), pursuant to which, and on the terms and subject to the conditions thereof, among other things, Acquisition Sub will commence a tender offer (“Offer”) as soon as practicable after the date of the Merger Agreement, but in no event later than ten business days after the date of the Merger Agreement, to acquire all of the outstanding shares of common stock of the Company (the “Company Shares”) at a purchase price of $17.00 per Company Share net to the holder thereof in cash, subject to reduction for any applicable withholding taxes, without interest (the “Offer Price”). See Note 15, “Subsequent Events” for information regarding the Merger. | |||||||||||||
Following the announcement of the Merger Agreement on December 2, 2014, five putative stockholder class action complaints have been filed in the Delaware Court of Chancery against the Company, the Company’s board of directors, Otsuka and Acquisition Sub challenging the proposed Merger. The actions, brought by named plaintiffs John Kim, filed December 4, 2014; Adeline Speer, filed December 5, 2014; Henri Minette, filed December 5, 2014; Douglas Las Wengell, filed December 5, 2014; and Samuel Shoneye, filed December 9, 2014, allege that members of the Company’s board of directors breached their fiduciary duties by agreeing to sell the Company for inadequate consideration, by including terms providing for their continued employment in the post-transaction company, and/or by utilizing deal protection measures that discouraged competing bids. The complaints further allege that the Company, Otsuka, and Acquisition Sub aided and abetted these alleged breaches. Among other remedies, the plaintiffs seek to enjoin the Merger. The Company and Otsuka believe the allegations in the complaints are without merit and intend to defend vigorously against them. | |||||||||||||
Additional lawsuits may be filed against the Company, Otsuka, and/or the directors of either company in connection with the Merger. | |||||||||||||
NUEDEXTA ANDA Litigation | |||||||||||||
In fiscal 2011 and 2012, the Company received Paragraph IV certification notices from five separate companies contending that certain of its patents listed in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluation” (“FDA Orange Book”) (U.S. Patents 7,659,282 (“’282 Patent”), 8,227,484 (“’484 Patent”) and RE 38,115 (“’115 Patent”), which expire in August 2026, July 2023 and January 2016, respectively) are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of NUEDEXTA as described in those companies’ abbreviated new drug application (“ANDA”). The FDA Orange Book provides potential competitors, including generic drug companies, with a list of issued patents covering approved drugs. In August 2011 and March 2012, the Company filed lawsuits in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. (collectively “Par”), Actavis South Atlantic LLC and Actavis, Inc. (collectively “Actavis”), Wockhardt USA, LLC and Wockhardt, Ltd. (collectively, “Wockhardt”), Impax Laboratories, Inc. (“Impax”) and Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Watson Pharma, Inc. (collectively “Watson”) (Par, Actavis, Wockhardt, Impax and Watson, collectively the “Defendants”). In September and October 2012, the Company filed lawsuits in the U.S. District Court for the District of Delaware against the Defendants. All lawsuits (collectively, the “ANDA Actions”) were filed on the basis that the Defendants’ submissions of their respective ANDAs to obtain approval to manufacture, use, sell, or offer for sale generic versions of NUEDEXTA prior to the expiration of the ‘282 Patent, the ‘484 Patent and the ‘115 Patent listed in the FDA Orange Book constitute infringement of one or more claims of those patents. On October 31, 2012, Watson announced the divestiture of its ANDA for a generic form of NUEDEXTA to Sandoz, Inc. (“Sandoz”). As a result of Sandoz’ acquisition and maintenance of said ANDA, on May 30, 2013, the Company filed suit in the U.S. District Court for the District of Delaware against Sandoz. This suit was filed on the basis that Sandoz’ ANDA to obtain approval to manufacture, use, sell, or offer for sale generic versions of NUEDEXTA prior to the expiration of the ’282 Patent, the ’484 Patent and the ’115 Patent listed in the FDA Orange Book constitutes infringement of one or more claims of those patents. | |||||||||||||
A bench trial was held in September 2013 and concluded on October 15, 2013. | |||||||||||||
On August 9, August 30, and September 6, 2013, Avanir entered into settlement agreements with Sandoz, Actavis and Wockhardt, respectively, to resolve pending patent litigation in response to their ANDAs seeking approval to market generic versions of NUEDEXTA capsules. The settlement agreements grant Sandoz, Actavis and Wockhardt the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances. The parties also filed stipulations and orders of dismissal with the United States District Court for the District of Delaware which conclude the litigation with respect to Sandoz, Actavis and Wockhardt. | |||||||||||||
On April 30, 2014, the United States District Court for the District of Delaware issued an Order finding the Company’s latest to expire patents to be valid and infringed. On May 14, 2014, the Court issued a judgment in favor of Avanir and a permanent injunction enjoining Par and Impax from manufacturing, using, offering to sell, or selling a generic version of NUEDEXTA during the terms of the ‘282 Patent and ‘484 Patent. The judgment also ordered that the FDA shall not approve Par’s and Impax’s generic product earlier than the latest date of expiration of the ‘282 Patent and ‘484 Patent, August 13, 2026. | |||||||||||||
On June 16, 2014, the Company entered into a settlement agreement with Impax to resolve all outstanding issues pertaining to the patent litigation case. The settlement agreement grants Impax the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances. The parties also filed stipulations and orders of dismissal with the United States District Court for the District of Delaware which concludes the litigation with respect to Impax. | |||||||||||||
On August 20, 2014, the United States District Court for the District of Delaware entered its Final Judgment triggering the appealability of the underlying decision. On September 11, 2014, Par filed a Notice of Appeal in the United States Court of Appeals for the Federal Circuit to the district court’s Order. | |||||||||||||
General and Other | |||||||||||||
In the ordinary course of business, the Company may face various claims brought by third parties and the Company 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 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 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 consolidated 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 will not likely have a material effect on the Company’s consolidated 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, officers and certain executives 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, wholesale distribution agreements, clinical trials, pre-clinical development work and securities offerings. These indemnification obligations provide the contracting parties with the contractual right to have Avanir pay for the costs associated with the defense and settlement of claims, typically in circumstances where Avanir has failed to meet its contractual performance obligations in some fashion. | |||||||||||||
The maximum amount of potential future payments under such indemnifications is not determinable. The Company has not incurred significant costs related to these guarantees and indemnifications, and no liability has been recorded in the consolidated financial statements for guarantees and indemnifications as of September 30, 2014 and 2013. | |||||||||||||
Center for Neurologic Study (“CNS”) — The Company is party to an exclusive license agreement with CNS pursuant to which the Company licensed rights to certain patents relating to the use of DM/Q to treat neurological conditions. | |||||||||||||
The Company paid to CNS a $75,000 milestone upon FDA approval of NUEDEXTA for the treatment of PBA in fiscal 2011. In addition, the Company has been obligated to pay CNS a royalty ranging from approximately 5% to 8% of net U.S. GAAP revenue generated by sales of NUEDEXTA. Effective with the ANDA ruling on April 30, 2014, the Company no longer has a royalty obligation on revenue generated by sales of NUEDEXTA. Under certain circumstances, the Company may have the obligation to pay CNS a portion of net revenues received if the Company sublicenses NUEDEXTA 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 clinical indications. Maximum payments for these milestone payments could total approximately $1.1 million if the Company pursued the development of NUEDEXTA for all five of the licensed indications. In general, individual milestones range from $75,000 to $125,000 for each accepted new drug application (“NDA”) and a similar amount for each approved NDA in addition to the royalty discussed above on net U.S. GAAP revenues. The Company does not have the obligation to develop additional indications under the CNS license agreement. | |||||||||||||
Concert Pharmaceuticals, Inc. — The Company holds the exclusive worldwide marketing rights to develop and commercialize Concert’s deuterium-modified dextromethorphan (“d-DM”) compounds for the potential treatment of neurological and psychiatric disorders, as well as certain rights to other deuterium-modified dextromethorphan compounds pursuant to a license agreement with Concert. | |||||||||||||
Under the agreement with Concert, the Company is obligated to make milestone and royalty payments to Concert based on successful advancement of d-DM products for one or more indications in the United States, Europe, and Japan. Individual milestone payments range from $2.0 — $6.0 million, $1.5 — $15.0 million, and $25.0 — $60.0 million for clinical, regulatory and commercial targets respectively, and in aggregate could total over $200 million. Royalty payments are tiered, beginning in the single-digits and increasing to the low double-digits for worldwide net sales of d-DM products exceeding $1.0 billion annually. As of September 30, 2014, the Company has paid $2.0 million in fiscal 2014 and 2013 for milestones that have been achieved pursuant to this agreement, which were recorded to research and development expense in the accompanying consolidated statement of operations. | |||||||||||||
OptiNose AS — In July 2013, the Company entered into an exclusive license agreement for the development and commercialization of a novel Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine, AVP-825. | |||||||||||||
AVP-825 is licensed from OptiNose. Under the terms of the agreement, the Company paid OptiNose an up-front cash payment of $20.0 million in fiscal 2013, which was recorded to research and development expense in the accompanying consolidated statement of operations. The Company and OptiNose will share certain development costs. OptiNose is eligible to receive up to an additional $90.0 million in aggregate milestone payments resulting from the achievement of future clinical, regulatory and commercial milestones. In fiscal 2014, the Company paid to OptiNose $2.5 million for milestones that have been achieved pursuant to this agreement, and is included in research and development expenses in the consolidated statements of operations. In addition, following product approval, Avanir will be required to make tiered royalty payments to OptiNose of a low double-digits percentage of net sales in the United States, Canada and Mexico. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
Stockholders' Equity | ' | ||||||||||||||||
10 | Stockholders’ Equity | ||||||||||||||||
Common stock | |||||||||||||||||
Fiscal 2014. In September 2014, the Company filed with the SEC a shelf registration statement on Form S-3 to sell an aggregate of up to $200.0 million in common stock, preferred stock, debt securities and warrants. Included in this shelf registration on Form S-3 is a prospectus relating to an underwriting agreement with JP Morgan Securities LLC, Deutsche Bank Securities Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated (the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of 18,200,000 shares of the Company’s common stock to the Underwriters. The shares were sold at a public offering price of $11.00 per share, and were purchased by the Underwriters at a price of $10.38125 per share. In September 2014, the Underwriters exercised their option to purchase an additional 2,730,000 shares of the Company’s common stock. This public offering was completed in September 2014 and the Company issued 20,930,000 shares of common stock and raised net proceeds of approximately $217.0 million, after deducting the Underwriter’s discounts and commissions and estimated offering expenses. | |||||||||||||||||
In August 2012, the Company filed with the SEC a shelf registration statement on Form S-3 to sell an aggregate of up to $100.0 million in common stock, preferred stock, debt securities and warrants. Included in this shelf registration on Form S-3 is a prospectus relating to a financing facility with Cowen and Company, LLC (“Cowen”), providing for the sale of up to $25.0 million worth of shares of the Company’s common stock from time to time into the open market at prevailing prices in accordance with the terms of a sales agreement entered into on August 8, 2012. On May 7, 2014, the Company amended its sales agreement with Cowen and filed with the SEC a prospectus providing for the sale of up to an additional $50.0 million worth of shares of the Company’s common stock from time to time in the open market at prevailing prices. On May 9, 2014, the Company concluded the offering and, accordingly, no further sales of common stock will be made pursuant to the Company’s prospectus dated May 7, 2014. During fiscal 2014, the Company issued approximately 11.3 million shares of common stock under the sales agreement raising net proceeds of approximately $49.1 million. | |||||||||||||||||
In July 2013, the Company filed with the SEC a shelf registration statement on Form S-3 to sell an aggregate of up to $150.0 million in common stock, preferred stock, debt securities and warrants. Included in this shelf registration on Form S-3 is a prospectus relating to a financing facility with Cowen, providing for the sale of up to $55.0 million worth of shares of the Company’s common stock from time to time into the open market at prevailing prices in accordance with the terms of a sales agreement entered into on August 8, 2012 and amended in July and December 2013. During fiscal 2014, approximately 7.2 million shares of common stock had been sold under this facility raising net proceeds of approximately $29.3 million. | |||||||||||||||||
During fiscal 2014, the Company issued 290,286 shares of common stock underlying restricted stock units previously awarded to a director and vested at September 30, 2013, but were subject to deferred delivery until resignation of the director, 513,239 shares of common stock in connection with the vesting of restricted stock units and 1,425,419 shares of common stock in connection with the exercise of stock options resulting in proceeds of approximately $3.3 million. | |||||||||||||||||
During the fiscal 2014, restricted stock unit awards issued to directors vested, representing a total of 188,218 shares of the Company’s common stock, but the issuance and delivery of these shares are deferred until the director resigns. | |||||||||||||||||
Fiscal 2013. In August 2012, the Company filed with the SEC a shelf registration statement on Form S-3 to sell an aggregate of up to $100.0 million in common stock, preferred stock, debt securities and warrants. Included in this shelf registration on Form S-3 is a prospectus relating to a financing facility with Cowen and Company, LLC (“Cowen”), providing for the sale of up to $25.0 million worth of shares of our common stock from time to time into the open market at prevailing prices in accordance with the terms of a sales agreement entered into with Cowen in August 2012. During fiscal 2013, the Company issued 7,935,395 shares of common stock under the sales agreement at an average price of $3.15 per share raising proceeds of approximately $25.0 million ($24.4 million after offering expenses, including commissions). | |||||||||||||||||
In July 2013, the Company filed with the SEC a shelf registration statement on Form S-3 to sell an aggregate of up to $150.0 million in common stock, preferred stock, debt securities and warrants. Included in this shelf registration on Form S-3 is a prospectus relating to a financing facility with Cowen, providing for the sale of up to an additional $25.0 million worth of shares of our common stock from time to time into the open market at prevailing prices in accordance with the terms of a sales agreement entered into with Cowen in August 2012 and amended in July 2013. During fiscal 2013, the Company issued 5,030,070 shares of common stock under the sales agreement at an average price of $4.97 per share raising proceeds of approximately $25.0 million ($24.4 million after offering expenses, including commissions). | |||||||||||||||||
During fiscal 2013, the Company issued 510,188 shares of common stock in connection with restricted stock units which were awarded to directors and vested at September 30, 2012, but were restricted until the resignation of the directors, 336,349 shares of common stock in connection with the vesting of restricted stock units and 1,033,833 shares of common stock in connection with the exercise of stock options resulting in proceeds of approximately $1.5 million. | |||||||||||||||||
During fiscal 2013, restricted stock unit awards for a total of 176,839 shares awarded to directors vested, but the issuance and delivery of these shares are deferred until the director resigns. | |||||||||||||||||
Fiscal 2012. 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 common stock from time to time in the open market at prevailing prices. Pursuant to the Sales Agreement, sales of common stock are made in such quantities and on such minimum price terms as the Company may set from time to time. During fiscal 2012, 3,668,656 shares of common stock were sold under the Sales Agreement at an average price of $2.81 per share raising proceeds of approximately $10.3 million ($10.1 million after offering expenses, including commissions). As of September 30, 2012, a total of 12,355,166 shares of common stock were sold under the Sales Agreement at an average price of $2.83 per share raising gross proceeds of approximately $35.0 million ($33.8 million after offering expenses, including commissions). | |||||||||||||||||
During fiscal 2012, the Company received proceeds of approximately $7.8 million from the exercise of warrants to purchase 5,445,061 shares of the Company’s common stock. The warrants had been issued in connection with the Company’s registered securities offering in April 2008 at an exercise price of $1.43 per share. | |||||||||||||||||
During fiscal 2012, the Company issued 204,176 shares of common stock in connection with the vesting of restricted stock units and 1,673,811 shares of the Company’s common stock upon the exercise of outstanding options resulting in proceeds of approximately $1.3 million. | |||||||||||||||||
During fiscal 2012, restricted stock unit awards for a total of 187,083 shares awarded to directors vested, but the issuance and delivery of these shares are deferred until the director resigns. | |||||||||||||||||
Warrants | |||||||||||||||||
During fiscal 2014, 53,957 warrants were exercised in a cashless transaction resulting in the issuance of 25,548 shares of the Company’s common stock. The warrants were originally issued in May 2012 at an exercise price of $2.78 per share in connection with the Company’s financing transaction in May 2012. (See Note 7, “Notes Payable”). As of September 30, 2014 there were no warrants outstanding. | |||||||||||||||||
During fiscal 2013, the Company received proceeds of approximately $1.0 million from the exercise of warrants to purchase 710,109 shares of the Company’s common stock. The warrants had been issued in connection with the Company’s registered securities offering in April 2008 at an exercise price of $1.43 per share. | |||||||||||||||||
A following table summarizes all warrant activity for fiscal 2014 and 2013: | |||||||||||||||||
Shares of | Weighted | Range of | |||||||||||||||
Common Stock | Average | Exercise Prices | |||||||||||||||
Purchasable Upon | Exercise Price | ||||||||||||||||
Exercise of Warrants | per Share | ||||||||||||||||
Outstanding at September 30, 2012 | 1,201,116 | $ | 1.98 | $ | 1.43-$2.78 | ||||||||||||
Exercised | (1,147,159 | ) | $ | 1.94 | $ | 1.43-$2.78 | |||||||||||
Outstanding at September 30, 2013 | 53,957 | $ | 2.78 | $ | 2.78 | ||||||||||||
Exercised | (53,957 | ) | $ | 2.78 | $ | 2.78 | |||||||||||
Outstanding at September 30, 2014 | — | $ | — | $ | 0 | ||||||||||||
Employee equity incentive plans | |||||||||||||||||
The Company currently has two equity incentive plans, which are the 2005 Equity Incentive Plan (the “2005 Plan”) and the 2014 Incentive Plan (the “2014 Plan”). The 2000 Stock Option Plan (the “2000 Plan”) and the 2003 Equity Incentive Plan (the “2003 Plan”) are expired and the Company no longer grants share-based awards from these plans, however, grants are still outstanding under each of these plans at September 30, 2014. Together, the 2000 Plan, 2003 Plan, 2005 Plan and the 2014 Plan are referred to as the “Plans.” All of the Plans were approved by the stockholders, except for the 2003 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 fiscal 2014, the Company granted share-based awards under the 2005 Plan and the 2014 Plan. During fiscal 2013 and 2012, the Company granted share-based awards under the 2003 Plan and the 2005 Plan. Under the 2005 Plan and 2014 Plan, options to purchase shares, restricted stock units, restricted stock and other share-based awards may be granted to the Company’s directors, employees and consultants. Pursuant to the provisions for annual increases of the 2005 Plan, the number of authorized shares of common stock for issuance increased by 325,000 shares effective November 15, 2013. In February 2014, the Company’s shareholders approved the 2014 Plan and the initial authorized shares under the 2014 Plan are 17,000,000. As of September 30, 2014, the Company had an aggregate of 27,268,512 shares of its common stock reserved for future issuance under the Plans. Of those shares, 12,213,165 shares were related to outstanding options and other awards and 15,055,347 shares were available for future grants of share-based awards. 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 September 30, 2014, there were 717,600 equity awards outstanding that were issued outside of the Plans as inducement option grants. None of the share-based awards are classified as a liability as of September 30, 2014. | |||||||||||||||||
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, generally 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. 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 fiscal 2014 are presented below. | |||||||||||||||||
Number of | Weighted Average | Weighted Average | Aggregate | ||||||||||||||
Shares | Exercise Price Per | Remaining | Intrinsic | ||||||||||||||
Share | Contractual Term | Value | |||||||||||||||
(In Years) | |||||||||||||||||
Outstanding at September 30, 2013 | 8,823,041 | $ | 2.85 | ||||||||||||||
Granted | 2,611,556 | $ | 3.98 | ||||||||||||||
Exercised | (1,425,419 | ) | $ | 2.33 | |||||||||||||
Forfeited | (381,495 | ) | $ | 3.15 | |||||||||||||
Outstanding at September 30, 2014 | 9,627,683 | $ | 3.22 | 7.1 | $ | 83,907,973 | |||||||||||
Vested and expected to vest in the future at September 30, 2014 | 9,279,640 | $ | 3.2 | 7.1 | $ | 81,073,221 | |||||||||||
Exercisable at September 30, 2014 | 5,149,145 | $ | 2.98 | 5.9 | $ | 46,220,186 | |||||||||||
The weighted average grant-date fair values of options granted during fiscal 2014, 2013, and 2012 were $2.68, $1.95 and $1.89 per share, respectively. The total intrinsic value of options exercised during fiscal 2014, 2013 and 2012 was $7.1 million, $2.2 million and $3.7 million, respectively, based on the differences in market prices on the dates of exercise and the option exercise prices. As of September 30, 2014, the total unrecognized compensation cost related to options was approximately $9.7 million, which is expected to be recognized over a weighted-average period of 2.7 years, based on the vesting schedules. | |||||||||||||||||
The fair value of each option award is estimated on the date of grant using the Black-Scholes model that 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 rates are 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 fiscal 2014, 2013, and 2012 were as follows: | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Expected volatility | 78.6% — 85.6% | 82.7% — 84.1% | 103.7% — 108.7% | ||||||||||||||
Weighted-average volatility | 82.60% | 83.70% | 107.90% | ||||||||||||||
Average expected term in years | 5.4 | 5.4 | 5.8 | ||||||||||||||
Risk-free interest rate (zero coupon U.S. Treasury Note) | 1.5% — 1.8% | 0.8% — 1.7% | 0.9% — 1.3% | ||||||||||||||
Expected dividend yield | 0% | 0% | 0% | ||||||||||||||
Restricted stock units (“RSU”). RSUs granted to employees generally vest based on three or four years of continuous service from the date of grant. RSUs granted to non-employee directors generally vest over the term of one year from the grant date and are not released until the awardee’s termination of service. Vesting for non-employee director grants allow for accelerated vesting of RSUs in the case of a non-employee director’s resignation where either: (i) he/she has served for at least four years as a member of the Board and is in good standing at the time of resignation, or (ii) he/she resigns for reasons related to health or family matters and is otherwise in good standing at the time of resignation. The following table summarizes the RSU activities for fiscal 2014. | |||||||||||||||||
Number of Shares | Weighted Average | ||||||||||||||||
Grant Date Fair | |||||||||||||||||
Value | |||||||||||||||||
Unvested at September 30, 2013 | 1,637,210 | $ | 2.4 | ||||||||||||||
Granted | 1,637,190 | $ | 3.91 | ||||||||||||||
Vested | (691,732 | ) | $ | 2.61 | |||||||||||||
Forfeited | (435,008 | ) | $ | 3.72 | |||||||||||||
Unvested at September 30, 2014 | 2,147,660 | $ | 3.22 | ||||||||||||||
The weighted average grant-date fair value of RSUs granted during fiscal 2014, 2013, and 2012 was $3.91, $2.65 and $2.15 per unit, respectively. The fair value of RSUs vested during fiscal 2014, 2013, and 2012 was approximately $1.8 million, $1.4 million and $1.2 million, respectively. As of September 30, 2014, the total unrecognized compensation cost related to unvested stock units was approximately $5.6 million, which is expected to be recognized over a weighted-average period of 2.5 years, based on the vesting schedules and assuming no forfeitures. | |||||||||||||||||
At September 30, 2014, there were 1,155,422 shares of restricted stock with a weighted-average grant date fair value of $2.27 per share awarded to directors that have vested but are still restricted until the directors resign. In fiscal 2014, 2013, and 2012, 188,218 176,839 and 187,083 shares of restricted stock, respectively, vested but remained restricted. | |||||||||||||||||
During fiscal 2014, the Company granted performance RSUs to purchase 464,024 shares of common stock from the 2014 Plan. The performance RSUs are included in the above unvested RSU table. The RSUs had a performance goal related to fiscal 2014 performance that determines when vesting begins and the actual number of shares to be awarded ranging from 0% to 100% of target. Vesting is over three years beginning on the date the performance goal is achieved (“Achievement Date”), with 50% of the RSU shares vesting on the first anniversary of the Achievement Date and the remaining 50% of the RSU shares vesting annually in equal installments thereafter over two years. At September 30, 2014, the performance goal related to 371,791 performance RSUs had not been met and were cancelled and the performance goal related to 88,789 performance RSUs had been met, began vesting and are outstanding at September 30, 2014. | |||||||||||||||||
During fiscal 2012, the Company granted performance-based RSUs to purchase 30,000 shares of common stock from the 2003 Stock Option Plan. These performance-based RSUs are included in the above unvested RSU table. The RSUs have a performance goal related to revenue that determines when vesting begins and the actual number of shares to be awarded ranging from 0% to 100% of target. Vesting is over 4 years beginning on the Achievement Date, with 25% of the RSU shares vesting on the first anniversary of the Achievement Date and the remaining 75% of the RSU shares vesting quarterly in equal installments thereafter over three years. During fiscal 2014, the performance goal was met and vesting began, and all 30,000 performance-based RSUs were outstanding at September 30, 2014. |
Research_License_Supply_and_ot
Research, License, Supply and other Agreements | 12 Months Ended | |
Sep. 30, 2014 | ||
Text Block [Abstract] | ' | |
Research, License, Supply and other Agreements | ' | |
11 | Research, License, Supply and other Agreements | |
Center for Neurologic Study. The Company is party to an exclusive license agreement with CNS pursuant to which the Company licensed rights to certain patents relating to the use of DM/Q to treat neurological conditions. | ||
The Company paid to CNS a $75,000 milestone upon FDA approval of NUEDEXTA for the treatment of PBA in fiscal 2011. In addition, the Company has been obligated to pay CNS a royalty ranging from approximately 5% to 8% of net U.S. GAAP revenue generated by sales of NUEDEXTA. During fiscal 2014, 2013 and 2012, royalties of approximately $2.7 million, $3.5 million and $1.8 million respectively, were recorded to cost of product sales in the accompanying consolidated statements of operations. Effective with the ANDA ruling on April 30, 2014, the Company no longer has a royalty obligation on revenue generated by sales of NUEDEXTA. Under certain circumstances, the Company may have the obligation to pay CNS a portion of net revenues received if the Company sublicenses NUEDEXTA 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 clinical indications. Maximum payments for these milestone payments could total approximately $1.1 million if the Company pursued the development of NUEDEXTA for all five of the licensed indications. In general, individual milestones range from $75,000 to $125,000 for each accepted NDA and a similar amount for each approved NDA in addition to the royalty discussed above on net U.S. GAAP revenues. The Company does not have the obligation to develop additional indications under the CNS license agreement. | ||
Concert Pharmaceuticals, Inc. — The Company holds the exclusive worldwide marketing rights to develop and commercialize Concert’s d-DM compounds for the potential treatment of neurological and psychiatric disorders, as well as certain rights to other deuterium-modified dextromethorphan compounds pursuant to a license agreement with Concert. | ||
Under the agreement with Concert, the Company is obligated to make milestone and royalty payments to Concert based on successful advancement of d-DM products for one or more indications in the United States, Europe, and Japan. Individual milestone payments range from $2.0 — $6.0 million, $1.5 — $15.0 million, and $25.0 — $60.0 million for clinical, regulatory and commercial targets respectively, and in aggregate could total over $200 million. Royalty payments are tiered, beginning in the single-digits and increasing to the low double-digits for worldwide net sales of d-DM products exceeding $1.0 billion annually. As of September 30, 2014, the Company has paid $4.0 million for milestones that have been achieved pursuant to this agreement, which were recorded to research and development expense in the accompanying consolidated statement of operations. | ||
OptiNose AS. In July 2013, the Company entered into an exclusive license agreement for the development and commercialization of a novel Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine, AVP-825. AVP-825 is licensed from OptiNose. | ||
Under the terms of the agreement, the Company paid OptiNose an up-front cash payment of $20.0 million in fiscal 2013, which was recorded to research and development expense in the accompanying consolidated statements of operations. The Company and OptiNose will share certain development costs. OptiNose is eligible to receive up to an additional $90.0 million in aggregate milestone payments resulting from the achievement of future clinical, regulatory and commercial milestones. As of September 30, 2014, the Company has paid $2.5 million for milestones that have been achieved pursuant to this agreement, and is included in research and development expenses in the consolidated statements of operations. In addition, following product approval, the Company will be required to make tiered royalty payments to OptiNose of a low double-digit percentage of net sales in the United States, Canada and Mexico. | ||
Merck. In August 2013, the Company entered into a multi-year agreement with Merck to co-promote Merck’s type 2 diabetes therapies JANUVIA® (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States beginning October 1, 2013. The term of the Agreement will continue for three years following the launch date of the co-promotion activities. | ||
Under the terms of the Agreement, the Company will be compensated via a (i) fixed monthly fee and (ii) performance fee based on the amount of the products sold by the Company above a predetermined baseline. A significant majority of the fee is performance based. Over the three years of the agreement, the Company could receive up to a maximum of $46.7 million in compensation, including revenue earned in the first contract year. | ||
The parties will jointly develop a product marketing and promotion plan. The Company will lead sales implementation with its institutional sales force. Merck will be required to provide a specific level of marketing and promotional support, and the Company is required to provide predetermined level of sales efforts. Merck will continue to be responsible for all other aspects of research, manufacturing, supply, regulatory, medical, managed care and marketing activities for the products. | ||
The Agreement may be terminated without cause by either party upon 90 days written notice, at any time after the first anniversary of the launch date. If after the first anniversary, Merck terminates the Agreement without cause, Merck will be required to continue paying a portion of the performance based fee that would otherwise be due for a period of twelve months (though not beyond the expiration of three years following the launch date.) The Agreement may be terminated with cause by either party based on certain events, including a material uncured breach by either party, a failure to achieve certain sales thresholds by the Company, an assignment for the benefit of creditors, or upon mutual agreement. Additionally, Merck may terminate the Agreement (a) upon change of control of the Company; (b) if the Company adds promotional responsibilities for additional products to its sales representatives promoting the products; or (c) upon a violation of applicable law. | ||
GlaxoSmithKline Subsidiary, SB Pharmco Puerto Rico, Inc. On March 31, 2000, the Company signed an exclusive license agreement with GSK for rights to manufacture and sell Abreva (docosanol 10% cream) as an over-the-counter product in the United States and Canada as a treatment for cold sores. Under the terms of the license agreement, GSK Consumer Healthcare is responsible for all sales and marketing activities and the manufacturing and distribution of Abreva in the U.S. and Canada. The terms of the license agreement provide for the Company to earn royalties on product sales. In October 2000 and August 2005, GSK launched Abreva in the United States and Canada, respectively. All milestones under the agreement were earned and paid prior to fiscal 2003. During fiscal 2003, the Company sold an undivided interest in the GSK license agreement to Drug Royalty with a term until the later of December 13, 2013 or until the expiration of the patent for Abreva on April 28, 2014. (See Note 6, “Deferred Revenues.”) The GSK License Agreement expired in April 2014 and the Company does not expect any future revenues from royalties under this agreement. | ||
Azur Pharma. In August 2007, the Company entered into a license agreement with Azur, where the Company could receive up to $2.0 million in royalties, based on 3% of annualized net product revenues in excess of $17.0 million. During fiscal 2012 the Company recorded royalty revenues of approximately $492,000 in connection with this agreement. As of September 30, 2012, the Company had received $2.0 million in royalties related to annual revenue in excess of $17.0 million and no further royalties will be recognized related under this license agreement. |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||||||
Income Taxes | ' | ||||||||||||
12 | Income Taxes | ||||||||||||
Components of the income tax provision are as follows for the fiscal years ended September 30, 2014, 2013 and 2012 (in thousands): | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Current: | |||||||||||||
State | $ | 3 | $ | 3 | $ | 3 | |||||||
Deferred: | |||||||||||||
Federal | (16,455 | ) | (23,056 | ) | (15,487 | ) | |||||||
State | (2,844 | ) | (4,939 | ) | (2,731 | ) | |||||||
(19,299 | ) | (27,995 | ) | (18,218 | ) | ||||||||
Increase in deferred tax asset valuation allowance | 19,299 | 27,995 | 18,218 | ||||||||||
Total income tax provision | $ | 3 | $ | 3 | $ | 3 | |||||||
Deferred income taxes reflect the income tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred income tax balance are as follows (in thousands): | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Net operating loss carryforwards | $ | 170,660 | $ | 155,961 | $ | 135,430 | |||||||
Deferred Revenue | — | 504 | 1,570 | ||||||||||
Research credit carryforwards | 9,178 | 9,186 | 11,203 | ||||||||||
Capitalized license fees and patents | 11,160 | 10,176 | 2,017 | ||||||||||
Capitalized research and development costs | — | 30 | 100 | ||||||||||
Share-based compensation and options | 10,347 | 8,452 | 6,980 | ||||||||||
Other | 5,505 | 3,405 | 2,579 | ||||||||||
Deferred income tax assets | 206,850 | 187,714 | 159,879 | ||||||||||
Deferred tax liabilities: | |||||||||||||
Other | — | (163 | ) | (323 | ) | ||||||||
Deferred tax liabilities | — | (163 | ) | (323 | ) | ||||||||
Less valuation allowance for net deferred income tax assets | (206,850 | ) | (187,551 | ) | (159,556 | ) | |||||||
Net deferred tax assets/(liabilities) | $ | — | $ | — | $ | — | |||||||
The Company has provided a full valuation allowance against the net deferred income tax assets recorded as of September 30, 2014, 2013 and 2012 as the Company concluded that they are unlikely to be realized. As of September 30, 2014 the Company had federal and state net operating loss carryforwards of $446.6 million and $392.9 million, respectively. As of September 30, 2014 the Company had federal and California research and development credits of $7.6 million and $7.0 million, respectively. The net operating loss and research credit carryforwards will expire on various dates through 2029, unless previously utilized. The Company also has no foreign tax credit carryforwards at September 30, 2014. In the event of certain ownership changes, the Tax Reform Act of 1986 imposes certain restrictions on the amount of net operating loss and credit carryforwards that the Company may use in any year. | |||||||||||||
Pursuant to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event of a cumulative change in ownership of more than 50% within a three-year period. The Company has completed an analysis under IRC Sections 382 and 383 through September 30, 2014, and has determined that it has not experienced an ownership change as defined by Section 382. The Company continues to monitor changes in our ownership as any future ownership changes may significantly reduce the utilization of the net operating loss carryforwards and research tax credits before they expire. | |||||||||||||
A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the fiscal years ended September 30: | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Federal statutory rate | (34 | )% | (34 | )% | (34 | )% | |||||||
Increase in deferred income tax asset valuation allowance | 38 | 37 | 31 | ||||||||||
State income taxes, net of federal effect | (6 | ) | (5 | ) | (5 | ) | |||||||
Research and development credits | — | 3 | 1 | ||||||||||
Expired net operating loss and other credits | — | — | 6 | ||||||||||
Other | 2 | (1 | ) | 1 | |||||||||
Effective income tax rate | 0 | % | 0 | % | 0 | % | |||||||
Employee_Savings_Plan
Employee Savings Plan | 12 Months Ended | |
Sep. 30, 2014 | ||
Postemployment Benefits [Abstract] | ' | |
Employee Savings Plan | ' | |
13 | Employee Savings Plan | |
The Company has established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. The plan allows participating employees to deposit into tax deferred investment accounts up to 50% of their salary, subject to annual limits. The Company is not required to make matching contributions under the plan. However, the Company voluntarily contributed approximately $601,000, $401,000 and $412,000 in fiscal 2014, 2013, and 2012, respectively, to the plan. |
Segment_Information
Segment Information | 12 Months Ended | |
Sep. 30, 2014 | ||
Segment Reporting [Abstract] | ' | |
Segment Information | ' | |
14 | Segment Information | |
The Company operates the 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 operations are currently located in the United States; therefore, total revenues for fiscal 2014, 2013, and 2012 are attributed to the United States. All long-lived assets at September 30, 2014 and 2013 are located in the United States. | ||
The Company sells NUEDEXTA to a limited number of wholesalers. Three wholesalers accounted for 88%, 88% and 89% of gross product sales in fiscal 2014, 2013 and 2012, respectively. In addition, the three wholesalers accounted for 93% and 91% of trade receivables at September 30, 2014 and 2013, respectively. |
Subsequent_Events
Subsequent Events | 12 Months Ended | |
Sep. 30, 2014 | ||
Subsequent Events [Abstract] | ' | |
Subsequent Events | ' | |
15 | Subsequent Events | |
Merger Agreement | ||
On December 1, 2014, Avanir entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Otsuka Pharmaceutical Co., Ltd., a Japanese joint stock company (“Otsuka”), and Bigarade Corporation, a Delaware corporation and a wholly-owned subsidiary of Otsuka (“Acquisition Sub”), pursuant to which, and on the terms and subject to the conditions thereof, among other things, Acquisition Sub will commence a tender offer (“Offer”) as soon as practicable after the date of the Merger Agreement, but in no event later than ten business days after the date of the Merger Agreement, to acquire all of the outstanding shares of common stock of the Company (the “Company Shares”) at a purchase price of $17.00 per Company Share net to the holder thereof in cash, subject to reduction for any applicable withholding taxes, without interest (the “Offer Price”). The Offer is not subject to a financing condition. | ||
Acquisition Sub’s obligation to purchase the Company Shares validly tendered pursuant to the Offer is subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, including (i) the expiration or termination of any waiting period (and extensions thereof) applicable to the transactions contemplated by the Merger Agreement under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, (ii) that the number of Company Shares validly tendered and not withdrawn in accordance with the terms of the Offer, together with the Company Shares then owned by Otsuka, Acquisition Sub and their respective controlled affiliates, represents at least a majority of all then outstanding Company Shares (not including Company Shares tendered pursuant to guaranteed delivery procedures), (iii) the absence of any law or order by any governmental authority that would make illegal or otherwise prohibit the Offer, the acquisition of Company Shares by Otsuka or Acquisition Sub or the Merger (as defined below) within the United States, (iv) the accuracy of the representations and warranties of the Company contained in the Merger Agreement, subject to customary exceptions, (v) the Company’s material compliance with its covenants contained in the Merger Agreement, (vi) there not having been a material adverse effect on the Company following the execution of the Merger Agreement that is continuing, and (vii) other customary conditions. | ||
Following the completion of the Offer and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Acquisition Sub will merge with and into the Company, with the Company surviving as a wholly-owned subsidiary of Otsuka, pursuant to the procedure provided for under Section 251(h) of the Delaware General Corporation Law without any stockholder approvals (the “Merger”). The Merger Agreement contains certain customary termination rights in favor of each of the Company and Otsuka, including under certain circumstances, the requirement for the Company to pay to Otsuka a termination fee of $90 million. | ||
Following the announcement of the Merger Agreement on December 2, 2014, five putative stockholder class action complaints have been filed in the Delaware Court of Chancery against the Company, the Company’s board of directors, Otsuka and Acquisition Sub challenging the proposed Merger. The actions, brought by named plaintiffs John Kim, filed December 4, 2014; Adeline Speer, filed December 5, 2014; Henri Minette, filed December 5, 2014; Douglas Las Wengell, filed December 5, 2014; and Samuel Shoneye, filed December 9, 2014, allege that members of the Company’s board of directors breached their fiduciary duties by agreeing to sell the Company for inadequate consideration, by including terms providing for their continued employment in the post-transaction company, and/or by utilizing deal protection measures that discouraged competing bids. The complaints further allege that the Company, Otsuka, and Acquisition Sub aided and abetted these alleged breaches. Among other remedies, the plaintiffs seek to enjoin the Merger. The Company and Otsuka believe the allegations in the complaints are without merit and intend to defend vigorously against them. | ||
The Merger Agreement contains customary representations, warranties and covenants, including covenants obligating the Company to continue to conduct its business in the ordinary course and to cooperate in seeking regulatory approvals. |
Description_of_Business_and_Ba1
Description of Business and Basis of Presentation (Policies) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||
Basis of presentation | ' | ||||||||||||
Basis of presentation | |||||||||||||
The consolidated financial statements include the accounts of Avanir Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. The Company’s fiscal year ends on September 30 of each year. The years ended September 30, 2014, 2013, and 2012 are herein referred to as fiscal 2014, fiscal 2013 and fiscal 2012, respectively. | |||||||||||||
The Company has evaluated subsequent events through the filing date of this Form 10-K, and determined that no subsequent events have occurred that would require recognition in the consolidated financial statements or disclosure in the notes thereto other than as discussed in the accompanying notes. | |||||||||||||
Management estimates | ' | ||||||||||||
Management estimates | |||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Significant estimates made by management include, among others, sales returns, discounts and allowances, provisions for uncollectible receivables, realizability of inventories, valuation of investments, recoverability of long-lived assets, recognition of deferred revenue, the fair value of stock options, warrants and shares issued for non-cash consideration, determination of expenses in outsourced contracts, and realization of deferred tax assets. | |||||||||||||
Cash and cash equivalents | ' | ||||||||||||
Cash and cash equivalents | |||||||||||||
Cash and cash equivalents consist of cash and highly liquid investments with maturities of three months or less at the date of acquisition. | |||||||||||||
Concentration of credit risk and sources of supply | ' | ||||||||||||
Concentration of credit risk and sources of supply | |||||||||||||
Financial assets that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and trade receivables. The Company’s cash and cash equivalents are placed in various money market mutual funds and at financial institutions of high credit standing. At times, deposits held with these financial institutions may exceed the amount of insurance provided by the Federal Deposit Insurance Corporation (FDIC). Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. The Company performs ongoing credit evaluations of customers’ financial condition and may limit the amount of credit extended if necessary; however, the Company has historically required no collateral from its customers. | |||||||||||||
The Company currently has sole suppliers for the active pharmaceutical ingredients (“APIs”) for NUEDEXTA and a sole manufacturer for the finished form of NUEDEXTA. In addition, these materials are custom and available from only a limited number of sources. Any material disruption in manufacturing could cause a delay in shipments and possible loss of revenue. If the Company is required to change manufacturers, the Company may experience delays associated with finding an alternative manufacturer that is properly qualified to produce NUEDEXTA in accordance with FDA requirements and the Company’s specifications. | |||||||||||||
Inventories | ' | ||||||||||||
Inventories | |||||||||||||
Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out (“FIFO”) basis. The Company evaluates the carrying value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets compared with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories. | |||||||||||||
The Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such factors as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf life of products and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories as required based on its analyses. | |||||||||||||
Property and equipment | ' | ||||||||||||
Property and equipment | |||||||||||||
Property and equipment, net, is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful life of the asset. Computer equipment and related software are depreciated over three to five years. Office equipment, furniture and fixtures are depreciated over five years. Manufacturing equipment is depreciated over eight years. Leasehold improvements are amortized over the estimated useful life or remaining lease term, whichever is shorter. | |||||||||||||
Valuation of long-lived assets | ' | ||||||||||||
Valuation of long-lived assets | |||||||||||||
Long-lived assets are evaluated for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. If the review indicates that a long-lived asset is not recoverable (i.e. the carrying amount is less than the future projected undiscounted cash flows), its carrying amount would be reduced to fair value. Factors management considers important that could trigger an impairment review include the following: | |||||||||||||
• | A significant underperformance relative to expected historical or projected future operating results; | ||||||||||||
• | A significant change in the manner of the Company’s use of the acquired asset or the strategy for its overall business; and/or | ||||||||||||
• | A significant negative industry or economic trend. | ||||||||||||
Based on its analysis, the Company’s management believes that no impairment of the carrying value of its long-lived assets existed at September 30, 2014 and 2013. | |||||||||||||
Deferred rent | ' | ||||||||||||
Deferred rent | |||||||||||||
The Company accounts for rent expense related to operating leases by determining total minimum rent payments on the leases over their respective periods and recognizing the rent expense on a straight-line basis. The difference between the actual amount paid and the amount recorded as rent expense in each fiscal year is recorded as an adjustment to deferred rent. Deferred rent as of September 30, 2014 and 2013 was approximately $681,000 and $367,000, respectively, and is included in accrued expenses and other liabilities in the accompanying consolidated balance sheets. | |||||||||||||
Fair value of financial instruments | ' | ||||||||||||
Fair value of financial instruments | |||||||||||||
The Company measures the fair value of certain of its financial assets on a recurring basis. A fair value hierarchy is used to rank 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 (unadjusted) in active markets for identical assets and liabilities. | ||||||||||||
• | Level 2-Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted 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. | ||||||||||||
At September 30, 2014 and 2013, the Company’s financial instruments include cash and cash equivalents, restricted cash and cash equivalents, trade receivables, restricted investments, accounts payable, accrued expenses, accrued compensation and payroll taxes, and other liabilities. In addition, at September 30, 2013, the Company’s financial instruments included notes payable. The carrying amount of cash and cash equivalents, restricted cash and cash equivalents, trade receivables, accounts payable, accrued expenses, accrued compensation and payroll taxes, and other liabilities approximates fair value due to the short-term maturities of these instruments. The Company’s restricted investments are carried at amortized cost which approximates fair value. Based on borrowing rates available to the Company at September 30, 2013, the carrying value of notes payable approximated fair value. | |||||||||||||
Restricted cash and cash equivalents and restricted investments | ' | ||||||||||||
Restricted cash and cash equivalents and restricted investments | |||||||||||||
Restricted cash and cash equivalents and restricted investments consist of certificates of deposit, which are classified as held-to-maturity. | |||||||||||||
Restricted cash and cash equivalents consist of a certificate of deposit relating to the Company’s corporate credit card agreement and automatically renews every three months. | |||||||||||||
Long-term restricted investments consist of two certificates of deposit related to irrevocable standby letters of credit connected to fleet rentals and an office lease with an expiration date in 2018. The certificates of deposit automatically renew annually. | |||||||||||||
Debt issuance costs and debt discount | ' | ||||||||||||
Debt issuance costs and debt discount | |||||||||||||
Debt issuance costs are stated at cost, net of accumulated amortization in other assets in the consolidated balance sheets. Debt discount is recorded within notes payable in the consolidated balance sheets. Amortization expense of debt issuance costs and the debt discount is calculated using the interest method over the term of the debt and is recorded in interest expense in the accompanying consolidated statements of operations. | |||||||||||||
Revenue recognition | ' | ||||||||||||
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 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 Company’s price to the buyer is fixed or determinable; and (4) collectability is reasonably assured. In addition, certain product sales are subject to rights of return. For products sold where the buyer has the right to return the product, the Company recognizes revenue at the time of sale only if (1) the Company’s price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid the Company, or is obligated to pay the Company and the obligation is not contingent on resale of the product, (3) the buyer’s obligation to the Company 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 Company 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 above criteria, including the ability to reasonably estimate future returns, or when it can reasonably estimate that the return privilege has substantially expired, whichever occurs first. | |||||||||||||
Product Sales — NUEDEXTA. NUEDEXTA is sold primarily to third-party wholesalers that, in turn, sell this product to retail pharmacies, hospitals, and other dispensing organizations. The Company has entered into agreements with wholesale customers, group purchasing organizations and third-party payers throughout the United States. These agreements frequently contain commercial terms, which may include favorable product pricing and discounts and rebates payable upon dispensing the product to patients. Additionally, these agreements customarily provide the customer with rights to return the product, subject to the terms of each contract. Consistent with pharmaceutical industry practice, wholesale customers can return purchased product during an 18-month period that begins six months prior to the product’s expiration date and ends 12 months after the expiration date. The Company recognizes revenue upon delivery of NUEDEXTA to its wholesalers and other customers. | |||||||||||||
The Company records allowances for customer credits, including estimated discounts, co-pay assistance, rebates and chargebacks. These allowances provided by the Company to a customer are presumed to be a reduction of the selling prices of the Company’s products and, therefore, are characterized as a reduction of revenue when recognized in the Company’s consolidated statement of operations. The Company believes the assumptions used to estimate these allowances are reasonable considering known facts and circumstances. However, actual rebates, chargebacks and returns could differ materially from estimated amounts because of, among other factors, unanticipated changes in prescription trends and any change in assumptions affecting sell-through and research data purchased from third parties. Product shipping and handling costs are included in cost of product sales. | |||||||||||||
The Company offers discounts to certain of its customers, including discounts to wholesalers for certain services, cash discounts to customers for the early payment of trade receivables and patient discounts in the form of co-pay assistance for the purchase of NUEDEXTA through the use of coupons. The Company accrues for discounts based on the contractual terms of agreements with customers and historical experience. The estimated redemption cost of the coupons accrued is based on the historical experience for NUEDEXTA and sell-through data purchased from third parties. Cash discount accruals for early payment of trade receivables are recorded as a contra asset to trade receivables in the Company’s consolidated balance sheets. All other discount accruals are recorded in accrued expenses in the Company’s consolidated balance sheets. | |||||||||||||
The Company participates in various managed care access rebate programs, the largest of which relate to Medicaid, Medicare and commercial insurers. The Company also incurs chargebacks which are contractual discounts given primarily to federal government agencies and group purchasing organizations. The Company estimates rebate and chargeback accruals using quantitative factors such as contractual terms of agreements with its customers, historical experience, estimated percentages of product sold to qualified patients and estimated levels of inventory in the distribution channel. These quantitative factors are supplemented by additional factors such as management’s judgment with respect to many factors, including but not limited to, current market dynamics, changes in sales trends, an evaluation of current laws and regulations and product pricing. The Company evaluates percentages of NUEDEXTA sold to qualified patients primarily through analysis of wholesaler and other third party sell-through and research data. Additionally, there is a significant time lag between the date the Company estimates the accrual and when the Company actually pays the accrual. Due to this time lag, the Company records adjustments to estimated accruals over several periods, which can result in a net increase to net loss or a decrease to net loss in those periods. The rebate and chargeback accruals are recorded in accrued expenses in the Company’s consolidated balance sheets. | |||||||||||||
The Company estimates future returns and records a returns reserve as a reduction to revenue. The returns reserve represents a reserve for NUEDEXTA that may be returned primarily due to product expiration and is estimated based on contractual terms with customers and historical return trends as a percentage of gross sales. The returns reserve is recorded as a contra asset to trade receivables in the Company’s consolidated balance sheets. The Company has experienced annual returns of approximately 1% of gross product sales over the past two years. | |||||||||||||
Prior to the second quarter of fiscal 2012, the Company was unable to reasonably estimate future returns due to the lack of sufficient historical return data for NUEDEXTA. Accordingly, the Company invoiced the wholesaler, recorded deferred revenue at gross invoice sales price less estimated cash discounts and distribution fees, and classified the inventory shipped as finished goods. The Company previously deferred recognition of revenue and the related cost of product sales on shipments of NUEDEXTA until the right of return no longer existed, i.e. when the Company received evidence that the products had been dispensed to patients. The Company estimated patient prescriptions dispensed using an analysis of third-party information. | |||||||||||||
Multiple Element Arrangements. The Company has, in the past, entered into arrangements whereby it delivers to the customer multiple elements including technology and/or services. Such arrangements have included some combination of the following: licensed rights to technology, patented products, compounds, data and other intellectual property; and research and development services. At the inception of each such arrangement, the Company analyzes the multiple elements contained within the arrangement to determine whether the elements can be separated. If a product or service is not separable, the combined deliverables will be accounted for as a single unit of accounting. | |||||||||||||
A delivered element can be separated from other elements when it meets both of the following criteria: (1) the delivered item has value to the customer on a standalone basis; and (2) 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. If an element can be separated, the Company allocates amounts based upon the selling price of each element. The Company determines the selling price 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 selling price of a similar product or service to a similarly situated customer. 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. The Company has not entered into any multiple element arrangements which have required the Company to estimate selling prices during fiscal 2014, 2013 and 2012. | |||||||||||||
License Arrangements. License arrangements may consist of non-refundable up-front license fees, data transfer fees, research reimbursement payments, exclusive licensed rights to patented or patent pending compounds, technology access fees, and 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 up-front 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. | |||||||||||||
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 provide that royalties are earned only if a sales threshold is exceeded. Under these types of arrangements, the threshold is typically based on annual sales. For royalty revenue generated from the license agreement with GlaxoSmithKline (“GSK”), the Company recognized royalty revenue in the period in which the threshold is exceeded. For royalty revenue generated from the license agreement with Azur Pharma (“Azur”), the Company recognized revenue when it had determined that the threshold had been 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 up-front 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 GSK for the period to the total remaining royalties the Company expects GSK will pay Drug Royalty USA over the remaining term of the agreement. The GSK license agreement expired in April 2014 and the Company does not expect any future revenues from royalties under this agreement. | |||||||||||||
Co-Promotion Arrangements. The Company recognizes both a fixed monthly fee and a performance fee as revenues from co-promote activities in the consolidated statements of operations. The fixed monthly fee is recognized ratably over the period earned. The performance fee is recognized when the products sold exceeds a predetermined baseline for the period. The receivable from the co-promotion fee is recorded in other current assets in the consolidated balance sheets. | |||||||||||||
Cost of product sales | ' | ||||||||||||
Cost of product sales | |||||||||||||
Cost of product sales includes third-party royalties and direct and indirect costs to manufacture product sold, including packaging, storage, shipping and handling costs and the write-off of obsolete inventory. | |||||||||||||
Recognition of expenses in outsourced contracts | ' | ||||||||||||
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 expense 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 extend across multiple reporting periods. | |||||||||||||
Research and development expenses | ' | ||||||||||||
Research and development expenses | |||||||||||||
Research and development expenses consist of expenses incurred in performing research and development activities including salaries and benefits and other overhead expenses, clinical trials, contract services and other outsourced contracts. Research and development expenses are charged to operations as they are incurred. Up-front payments to collaborators made in exchange for the avoidance of potential future milestone and royalty payments on licensed technology are also charged to research and development expense when the drug is still in the development stage, has not been approved by the FDA for commercialization and has no alternative uses. | |||||||||||||
The Company assesses its obligations to make milestone payments that may become due under licensed or acquired technology to determine whether the payments should be expensed or capitalized. The Company charges milestone payments to research and development expense when: | |||||||||||||
• | The technology is in the early stage of development and has no alternative uses; | ||||||||||||
• | There is substantial uncertainty regarding the future success of the technology or product; | ||||||||||||
• | There will be difficulty in completing the remaining development; and | ||||||||||||
• | There is substantial cost to complete the work. | ||||||||||||
Acquired contractual rights. Payments to acquire contractual rights to a licensed technology or drug candidate are expensed as incurred when there is uncertainty in receiving future economic benefits from the acquired contractual rights. The Company considers the future economic benefits from the acquired contractual rights to a drug candidate to be uncertain until such drug candidate is approved by the FDA or when other significant risk factors are abated. | |||||||||||||
Share-based compensation | ' | ||||||||||||
Share-based compensation | |||||||||||||
The Company grants options, restricted stock units and restricted stock awards to purchase the Company’s common stock to employees, directors and consultants under stock option plans. The benefits provided under these plans are share-based payments that the Company accounts for using the fair value method. | |||||||||||||
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, expected stock price volatility, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. Expected volatilities are based on the historical volatility of the Company’s 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 rate is based on the U.S. Treasury yield in effect at the time of the grant. Since the Company does not expect to pay dividends on common stock in the foreseeable future, it estimated the dividend yield to be 0%. | |||||||||||||
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 and is amortized under the straight-line attribution method. As share-based compensation expense recognized in the accompanying consolidated statements of operations for fiscal 2014, 2013, and 2012 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. The fair value method requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company estimates forfeitures based on historical experience. Changes to the estimated forfeiture rate are accounted for as a cumulative effect of change in the period the change occurred. | |||||||||||||
Total compensation expense related to all of the Company’s share-based awards for fiscal 2014, 2013 and 2012 was comprised of the following (in thousands): | |||||||||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation classified as: | |||||||||||||
Research and development expense | $ | 1,326 | $ | 1,072 | $ | 965 | |||||||
Selling and marketing expense | 2,136 | 1,650 | 908 | ||||||||||
General and administrative expense | 3,222 | 3,124 | 3,004 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation expense from: | |||||||||||||
Stock options | $ | 4,540 | $ | 4,233 | $ | 3,643 | |||||||
Restricted stock units | 2,144 | 1,613 | 1,234 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Since the Company has a net operating loss carry-forward as of September 30, 2014, 2013, and 2012, no excess tax benefits for tax deductions related to share-based awards were recognized in the accompanying consolidated statements of operations. Additionally, no incremental tax benefits were recognized from stock options exercised in fiscal 2014, 2013, and 2012 that would have resulted in a reclassification from cash flows from operating activities to cash flows from financing activities. | |||||||||||||
Advertising expenses | ' | ||||||||||||
Advertising expenses | |||||||||||||
Advertising costs are expensed as incurred, and these costs are included in selling and marketing expenses, which include promotional materials for physicians. Advertising costs were approximately $11.2 million, $8.9 million, and $7.3 million for fiscal 2014, 2013, and 2012, respectively. | |||||||||||||
Income taxes | ' | ||||||||||||
Income taxes | |||||||||||||
The Company accounts for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the consolidated financial statement carrying amounts and the income tax bases 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. | |||||||||||||
The Company recognizes any uncertain income tax positions on income tax returns 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 unrecognized tax benefit resulting in a decrease in deferred tax assets and corresponding decrease in the valuation allowance at September 30, 2014 is $3.7 million. There are no unrecognized tax benefits included in the consolidated balance sheet 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 consolidated balance sheets at September 30, 2014 and 2013. | |||||||||||||
The Company is subject to taxation in the U.S. and various state jurisdictions. The Company’s tax years for 1995 and forward for federal purposes and 1989 and forward for California purposes 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 uncertain income tax position liability within the next twelve months. | |||||||||||||
Recent authoritative guidance | ' | ||||||||||||
Recent authoritative guidance | |||||||||||||
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers.” ASU No. 2014-09 establishes a core principle requiring the recognition of revenue to depict the transfer of promised goods or services to customers in an amount reflecting the consideration to which the entity expects to be entitled in exchange for such goods or services Specifically, to apply the core principle, an entity must (1) identify the contract, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations, and (5) recognize revenue as each performance obligation is satisfied. In addition, ASU No. 2014-09 requires reporting companies to disclose the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. ASU No. 2014-09 is required to be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying it recognized at the date of initial application. ASU No. 2014-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Early adoption is prohibited. The Company is required to adopt this guidance at the beginning of its first quarter of fiscal year 2018, and is currently evaluating the impact on its consolidated financial statements and disclosures. | |||||||||||||
In July 2013, the FASB issued ASU No. 2013-11, “Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists.” ASU No. 2013-11 provides explicit guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. The guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with an option for early adoption. The Company intends to adopt this guidance at the beginning of its first quarter of fiscal year 2015, and is currently evaluating the impact on its consolidated financial statements and disclosures. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||
Schedule of Total Share Compensation Classification Related to All of Company's Share-Based Awards | ' | ||||||||||||
Total compensation expense related to all of the Company’s share-based awards for fiscal 2014, 2013 and 2012 was comprised of the following (in thousands): | |||||||||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation classified as: | |||||||||||||
Research and development expense | $ | 1,326 | $ | 1,072 | $ | 965 | |||||||
Selling and marketing expense | 2,136 | 1,650 | 908 | ||||||||||
General and administrative expense | 3,222 | 3,124 | 3,004 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Schedule of Total Share Compensation Expense Related to All of Company's Share-Based Awards | ' | ||||||||||||
Years Ended September 30, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Share-based compensation expense from: | |||||||||||||
Stock options | $ | 4,540 | $ | 4,233 | $ | 3,643 | |||||||
Restricted stock units | 2,144 | 1,613 | 1,234 | ||||||||||
Total | $ | 6,684 | $ | 5,846 | $ | 4,877 | |||||||
Inventories_Tables
Inventories (Tables) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Inventory Disclosure [Abstract] | ' | ||||||||||||
Composition of Inventories | ' | ||||||||||||
The composition of inventories as of September 30, 2014 and 2013 is as follows (in thousands): | |||||||||||||
September 30, | |||||||||||||
2014 | 2013 | ||||||||||||
Raw materials | $ | 954 | $ | 937 | |||||||||
Work in progress | 148 | 36 | |||||||||||
Finished goods | 317 | 521 | |||||||||||
Total inventory | 1,419 | 1,494 | |||||||||||
Less: current portion | (799 | ) | (710 | ) | |||||||||
Non-current portion | $ | 620 | $ | 784 | |||||||||
Activity in Inventory Reserves | ' | ||||||||||||
The following table presents the activity in inventory reserves for the last three fiscal years (in thousands): | |||||||||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2013 | 2014 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 41 | $ | (29 | ) | $ | 12 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 736 | $ | (29 | ) | $ | 707 | ||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2012 | 2013 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 57 | $ | (16 | ) | $ | 41 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 752 | $ | (16 | ) | $ | 736 | ||||||
Balance at | Usage | Balance at | |||||||||||
September 30, | September 30, | ||||||||||||
2011 | 2012 | ||||||||||||
Reserve for excess and obsolete inventory | |||||||||||||
Reserve for NUEDEXTA | $ | 82 | $ | (25 | ) | $ | 57 | ||||||
Reserve for docosanol | 316 | — | 316 | ||||||||||
Reserve for DM and Q | 379 | — | 379 | ||||||||||
Total | $ | 777 | $ | (25 | ) | $ | 752 | ||||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
Component of Property and Equipment | ' | ||||||||
Property and equipment as of September 30, 2014 and 2013 consist of the following (in thousands): | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Computer equipment and related software | $ | 4,618 | $ | 2,988 | |||||
Leasehold improvements | 820 | 309 | |||||||
Office equipment, furniture and fixtures | 1,539 | 1,460 | |||||||
Manufacturing equipment | 1,407 | 232 | |||||||
8,384 | 4,989 | ||||||||
Accumulated depreciation | (4,753 | ) | (3,396 | ) | |||||
$ | 3,631 | $ | 1,593 | ||||||
Accrued_Expenses_Tables
Accrued Expenses (Tables) | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
Schedule of Accrued Expenses | ' | ||||||||
Accrued expenses at September 30, 2014 and 2013 are as follows (in thousands): | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Accrued royalties, rebates, chargebacks, and distribution fees(1) | $ | 9,450 | $ | 5,525 | |||||
Accrued research and development expenses | 2,355 | 2,146 | |||||||
Accrued selling and marketing expenses | 1,731 | 2,139 | |||||||
Accrued general and administrative expenses | 1,474 | 1,753 | |||||||
Other current liabilities | 360 | 346 | |||||||
Total accrued expenses | $ | 15,370 | $ | 11,909 | |||||
-1 | Accrued royalties, rebates, chargebacks and distribution fees are directly impacted by product revenue and will fluctuate over time in relation to the change in product revenue. |
Deferred_Revenues_Tables
Deferred Revenues (Tables) | 12 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Deferred Revenue Disclosure [Abstract] | ' | ||||||||
Changes in Deferred Revenue Balances | ' | ||||||||
The following table sets forth as of September 30, 2014 and 2013 the net deferred revenue balances for the Company’s sale of future Abreva® royalty rights to Drug Royalty USA (in thousands): | |||||||||
2014 | 2013 | ||||||||
Net deferred revenues as of October 1 | $ | 1,289 | $ | 4,049 | |||||
Recognized as revenues during period | (1,289 | ) | (2,760 | ) | |||||
Net deferred revenues as of September 30 | $ | — | $ | 1,289 | |||||
Computation_of_Net_Loss_Per_Sh1
Computation of Net Loss Per Share (Tables) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Earnings Per Share [Abstract] | ' | ||||||||||||
Schedule of Antidilutive Securities Excluded from Computation of Net Loss per Share | ' | ||||||||||||
For fiscal 2014, 2013, and 2012, the following options and warrants to purchase shares of common stock and restricted stock units were excluded from the computation of diluted net loss per share, as the inclusion of such shares would be anti-dilutive: | |||||||||||||
Fiscal 2014 | Fiscal 2013 | Fiscal 2012 | |||||||||||
Stock options | 9,627,683 | 8,823,041 | 8,142,468 | ||||||||||
Stock warrants | — | 53,957 | 1,201,116 | ||||||||||
Restricted stock units(1) | 3,303,082 | 2,904,423 | 2,617,188 | ||||||||||
-1 | Includes 1,155,422, 1,267,215, and 1,600,564 shares of restricted stock in fiscal 2014, 2013, and 2012, respectively, awarded to directors that have vested but are still restricted until the directors resign. |
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||||||||||
Future Annual Minimum Payments under Operating Leases | ' | ||||||||||||
Future minimum rental payments under non-cancelable operating lease commitments, net of sublease payments as of September 30, 2014 are as follows (in thousands): | |||||||||||||
Year Ending September 30, | Minimum | Lease | Net Payments | ||||||||||
Payments | Payments to be | ||||||||||||
Received from | |||||||||||||
Subleases | |||||||||||||
2015 | $ | 2,943 | $ | (794 | ) | $ | 2,149 | ||||||
2016 | 3,031 | (919 | ) | 2,112 | |||||||||
2017 | 3,138 | (955 | ) | 2,183 | |||||||||
2018 | 3,230 | (982 | ) | 2,248 | |||||||||
2019 | 2,202 | (82 | ) | 2,120 | |||||||||
Thereafter | 2,718 | — | 2,718 | ||||||||||
Total | $ | 17,262 | $ | (3,732 | ) | $ | 13,530 | ||||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
Summary of Warrant Activity | ' | ||||||||||||||||
A following table summarizes all warrant activity for fiscal 2014 and 2013: | |||||||||||||||||
Shares of | Weighted | Range of | |||||||||||||||
Common Stock | Average | Exercise Prices | |||||||||||||||
Purchasable Upon | Exercise Price | ||||||||||||||||
Exercise of Warrants | per Share | ||||||||||||||||
Outstanding at September 30, 2012 | 1,201,116 | $ | 1.98 | $ | 1.43-$2.78 | ||||||||||||
Exercised | (1,147,159 | ) | $ | 1.94 | $ | 1.43-$2.78 | |||||||||||
Outstanding at September 30, 2013 | 53,957 | $ | 2.78 | $ | 2.78 | ||||||||||||
Exercised | (53,957 | ) | $ | 2.78 | $ | 2.78 | |||||||||||
Outstanding at September 30, 2014 | — | $ | — | $ | 0 | ||||||||||||
Summary of Stock Option Activity | ' | ||||||||||||||||
Summaries of stock options outstanding and changes during fiscal 2014 are presented below. | |||||||||||||||||
Number of | Weighted Average | Weighted Average | Aggregate | ||||||||||||||
Shares | Exercise Price Per | Remaining | Intrinsic | ||||||||||||||
Share | Contractual Term | Value | |||||||||||||||
(In Years) | |||||||||||||||||
Outstanding at September 30, 2013 | 8,823,041 | $ | 2.85 | ||||||||||||||
Granted | 2,611,556 | $ | 3.98 | ||||||||||||||
Exercised | (1,425,419 | ) | $ | 2.33 | |||||||||||||
Forfeited | (381,495 | ) | $ | 3.15 | |||||||||||||
Outstanding at September 30, 2014 | 9,627,683 | $ | 3.22 | 7.1 | $ | 83,907,973 | |||||||||||
Vested and expected to vest in the future at September 30, 2014 | 9,279,640 | $ | 3.2 | 7.1 | $ | 81,073,221 | |||||||||||
Exercisable at September 30, 2014 | 5,149,145 | $ | 2.98 | 5.9 | $ | 46,220,186 | |||||||||||
Assumptions Used in Black-Scholes Model for Options Granted | ' | ||||||||||||||||
Assumptions used in the Black-Scholes model for options granted during fiscal 2014, 2013, and 2012 were as follows: | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Expected volatility | 78.6% — 85.6% | 82.7% — 84.1% | 103.7% — 108.7% | ||||||||||||||
Weighted-average volatility | 82.60% | 83.70% | 107.90% | ||||||||||||||
Average expected term in years | 5.4 | 5.4 | 5.8 | ||||||||||||||
Risk-free interest rate (zero coupon U.S. Treasury Note) | 1.5% — 1.8% | 0.8% — 1.7% | 0.9% — 1.3% | ||||||||||||||
Expected dividend yield | 0% | 0% | 0% | ||||||||||||||
Summary of RSU Activity | ' | ||||||||||||||||
The following table summarizes the RSU activities for fiscal 2014. | |||||||||||||||||
Number of Shares | Weighted Average | ||||||||||||||||
Grant Date Fair | |||||||||||||||||
Value | |||||||||||||||||
Unvested at September 30, 2013 | 1,637,210 | $ | 2.4 | ||||||||||||||
Granted | 1,637,190 | $ | 3.91 | ||||||||||||||
Vested | (691,732 | ) | $ | 2.61 | |||||||||||||
Forfeited | (435,008 | ) | $ | 3.72 | |||||||||||||
Unvested at September 30, 2014 | 2,147,660 | $ | 3.22 | ||||||||||||||
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||||||
Components of the Income Tax Provision | ' | ||||||||||||
Components of the income tax provision are as follows for the fiscal years ended September 30, 2014, 2013 and 2012 (in thousands): | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Current: | |||||||||||||
State | $ | 3 | $ | 3 | $ | 3 | |||||||
Deferred: | |||||||||||||
Federal | (16,455 | ) | (23,056 | ) | (15,487 | ) | |||||||
State | (2,844 | ) | (4,939 | ) | (2,731 | ) | |||||||
(19,299 | ) | (27,995 | ) | (18,218 | ) | ||||||||
Increase in deferred tax asset valuation allowance | 19,299 | 27,995 | 18,218 | ||||||||||
Total income tax provision | $ | 3 | $ | 3 | $ | 3 | |||||||
Significant Components of Deferred Tax Assets and Liabilities | ' | ||||||||||||
Significant components of the Company’s net deferred income tax balance are as follows (in thousands): | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Net operating loss carryforwards | $ | 170,660 | $ | 155,961 | $ | 135,430 | |||||||
Deferred Revenue | — | 504 | 1,570 | ||||||||||
Research credit carryforwards | 9,178 | 9,186 | 11,203 | ||||||||||
Capitalized license fees and patents | 11,160 | 10,176 | 2,017 | ||||||||||
Capitalized research and development costs | — | 30 | 100 | ||||||||||
Share-based compensation and options | 10,347 | 8,452 | 6,980 | ||||||||||
Other | 5,505 | 3,405 | 2,579 | ||||||||||
Deferred income tax assets | 206,850 | 187,714 | 159,879 | ||||||||||
Deferred tax liabilities: | |||||||||||||
Other | — | (163 | ) | (323 | ) | ||||||||
Deferred tax liabilities | — | (163 | ) | (323 | ) | ||||||||
Less valuation allowance for net deferred income tax assets | (206,850 | ) | (187,551 | ) | (159,556 | ) | |||||||
Net deferred tax assets/(liabilities) | $ | — | $ | — | $ | — | |||||||
Reconciliation of the Federal Statutory Rate to the Effective Income Tax Rate | ' | ||||||||||||
A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the fiscal years ended September 30: | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Federal statutory rate | (34 | )% | (34 | )% | (34 | )% | |||||||
Increase in deferred income tax asset valuation allowance | 38 | 37 | 31 | ||||||||||
State income taxes, net of federal effect | (6 | ) | (5 | ) | (5 | ) | |||||||
Research and development credits | — | 3 | 1 | ||||||||||
Expired net operating loss and other credits | — | — | 6 | ||||||||||
Other | 2 | (1 | ) | 1 | |||||||||
Effective income tax rate | 0 | % | 0 | % | 0 | % | |||||||
Description_of_Business_and_Ba2
Description of Business and Basis of Presentation - Additional Information (Detail) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Sep. 30, 2014 |
Merck Sharp & Dohme Corp. [Member] | ' |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ' |
Agreement period term | '3 years |
Maximum revenue to be received | $46.70 |
California [Member] | ' |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ' |
Incorporation date | 1-Aug-88 |
Delaware [Member] | ' |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ' |
Incorporation date | 1-Mar-09 |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Certificates_of_Deposits | |||
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' |
Deferred rent | $681,000 | $367,000 | ' |
Number of certificates of deposit | 2 | ' | ' |
Restricted long-term investment expiration year | '2018 | ' | ' |
Returns policy, minimum compared to expiration data | 'Wholesale customers can return purchased product during an 18-month period that begins six months prior to the product's expiration date | ' | ' |
Returns policy, maximum compared to expiration data | 'Wholesale customers can return purchased product during an 18-month period that ends 12 months after the expiration date. | ' | ' |
Percentage of returns from gross product sales | 1.00% | ' | ' |
Estimated dividend yield | 0.00% | 0.00% | 0.00% |
Excess tax benefits for the tax deductions related to share-based awards | 0 | 0 | 0 |
Recognized incremental tax benefits from stock options exercised | 0 | 0 | 0 |
Advertising costs | 11,200,000 | 8,900,000 | 7,300,000 |
Uncertain income tax position | 50.00% | ' | ' |
Unrecognized tax benefit, decrease in deferred tax assets and valuation allowance | 3,700,000 | ' | ' |
Unrecognized tax benefits that would, if recognized, affect the effective tax rate | 0 | ' | ' |
Accrued for interest and penalties | $0 | $0 | ' |
Computer equipment and related software [Member] | Minimum [Member] | ' | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' |
Property, plant and equipment, useful life | '3 years | ' | ' |
Computer equipment and related software [Member] | Maximum [Member] | ' | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' |
Property, plant and equipment, useful life | '5 years | ' | ' |
Office equipment, furniture and fixtures [Member] | ' | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' |
Property, plant and equipment, useful life | '5 years | ' | ' |
Manufacturing equipment [Member] | ' | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' |
Property, plant and equipment, useful life | '8 years | ' | ' |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Schedule of Total Share Compensation Classification Related to All of Company's Share-Based Awards (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Share-based compensation classified as: | ' | ' | ' |
Share-based compensation expense, total | $6,684 | $5,846 | $4,877 |
Research and development expense [Member] | ' | ' | ' |
Share-based compensation classified as: | ' | ' | ' |
Share-based compensation expense, total | 1,326 | 1,072 | 965 |
Selling and marketing expense [Member] | ' | ' | ' |
Share-based compensation classified as: | ' | ' | ' |
Share-based compensation expense, total | 2,136 | 1,650 | 908 |
General and administrative expense [Member] | ' | ' | ' |
Share-based compensation classified as: | ' | ' | ' |
Share-based compensation expense, total | $3,222 | $3,124 | $3,004 |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies - Schedule of Total Share Compensation Expense Related to All of Company's Share-Based Awards (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Share-based compensation expense from: | ' | ' | ' |
Share-based compensation expense, total | $6,684 | $5,846 | $4,877 |
Stock options [Member] | ' | ' | ' |
Share-based compensation expense from: | ' | ' | ' |
Share-based compensation expense, total | 4,540 | 4,233 | 3,643 |
Restricted stock units [Member] | ' | ' | ' |
Share-based compensation expense from: | ' | ' | ' |
Share-based compensation expense, total | $2,144 | $1,613 | $1,234 |
Inventories_Composition_of_Inv
Inventories - Composition of Inventories (Detail) (USD $) | Sep. 30, 2014 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $954 | $937 |
Work in progress | 148 | 36 |
Finished goods | 317 | 521 |
Total inventory | 1,419 | 1,494 |
Less: current portion | -799 | -710 |
Non-current portion | 620 | 784 |
Total inventory | $1,419 | $1,494 |
Inventories_Activity_in_Invent
Inventories - Activity in Inventory Reserves (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Inventory [Line Items] | ' | ' | ' |
Inventory Reserves, Beginning balance | $736 | $752 | $777 |
Usage | -29 | -16 | -25 |
Inventory Reserves, Ending balance | 707 | 736 | 752 |
NUEDEXTA [Member] | ' | ' | ' |
Inventory [Line Items] | ' | ' | ' |
Inventory Reserves, Beginning balance | 41 | 57 | 82 |
Usage | -29 | -16 | -25 |
Inventory Reserves, Ending balance | 12 | 41 | 57 |
Docosanol [Member] | ' | ' | ' |
Inventory [Line Items] | ' | ' | ' |
Inventory Reserves, Beginning balance | 316 | 316 | 316 |
Usage | 0 | 0 | 0 |
Inventory Reserves, Ending balance | 316 | 316 | 316 |
DM and Q [Member] | ' | ' | ' |
Inventory [Line Items] | ' | ' | ' |
Inventory Reserves, Beginning balance | 379 | 379 | 379 |
Usage | 0 | 0 | 0 |
Inventory Reserves, Ending balance | $379 | $379 | $379 |
Property_and_Equipment_Compone
Property and Equipment - Component of Property and Equipment (Detail) (USD $) | Sep. 30, 2014 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ' | ' |
Property and Equipment, Gross | $8,384 | $4,989 |
Accumulated depreciation | -4,753 | -3,396 |
Property and Equipment, Net | 3,631 | 1,593 |
Computer equipment and related software [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and Equipment, Gross | 4,618 | 2,988 |
Leasehold improvements [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and Equipment, Gross | 820 | 309 |
Office equipment, furniture and fixtures [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and Equipment, Gross | 1,539 | 1,460 |
Manufacturing equipment [Member] | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' |
Property and Equipment, Gross | $1,407 | $232 |
Property_and_Equipment_Additio
Property and Equipment - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Property Plant and Equipment Useful Life And Values [Abstract] | ' | ' | ' |
Depreciation and amortization | $1,402,000 | $826,000 | $700,000 |
Additional depreciation expense | $276,000 | ' | ' |
Accrued_Expenses_Schedule_of_A
Accrued Expenses - Schedule of Accrued Expenses (Detail) (USD $) | Sep. 30, 2014 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities, Current [Abstract] | ' | ' |
Accrued royalties, rebates, chargebacks, and distribution fees | $9,450 | $5,525 |
Accrued research and development expenses | 2,355 | 2,146 |
Accrued selling and marketing expenses | 1,731 | 2,139 |
Accrued general and administrative expenses | 1,474 | 1,753 |
Other current liabilities | 360 | 346 |
Total accrued expenses | $15,370 | $11,909 |
Deferred_Revenues_Changes_in_D
Deferred Revenues - Changes in Deferred Revenue Balances (Detail) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenues, Ending Balance | $0 | $1,289 |
Drug Royalty USA Agreement [Member] | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Deferred revenues, Beginning Balance | 1,289 | 4,049 |
Recognized as revenues during period | -1,289 | -2,760 |
Deferred revenues, Ending Balance | $0 | $1,289 |
Deferred_Revenues_Additional_I
Deferred Revenues - Additional Information (Detail) (USD $) | 12 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Nov. 30, 2002 | |
Deferred Revenue Arrangement [Line Items] | ' | ' | ' | ' |
Sales price for undivided interest in the Company's rights to future Abreva royalties | ' | ' | ' | $24,100,000 |
Expiration of the patent for Abreva | 28-Apr-14 | ' | ' | ' |
Annual net sales of Abreva | 62,000,000 | 62,000,000 | 62,000,000 | ' |
Revenues from royalties | 2,743,000 | 4,454,000 | 4,200,000 | ' |
GSK License Agreement [Member] | ' | ' | ' | ' |
Deferred Revenue Arrangement [Line Items] | ' | ' | ' | ' |
Right to receive royalties | 50.00% | ' | ' | ' |
Right to receive royalties, net | 4.00% | ' | ' | ' |
Revenues from royalties | $1,500,000 | $1,700,000 | $1,600,000 | ' |
Notes_Payable_Additional_Infor
Notes Payable - Additional Information (Detail) (USD $) | 12 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | 1-May-12 | |
Debt Instrument [Line Items] | ' | ' | ' | ' |
Loss on early extinguishment of debt | ($789,000) | $0 | $0 | ' |
Warrant exercise price | ' | ' | ' | $2.78 |
Warrants outstanding | 0 | 53,957 | 1,201,116 | ' |
Relative fair value of warrants | 0 | 0 | 1,169,000 | ' |
Loan Agreement [Member] | ' | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' | ' |
Date of Loan Agreement | 31-May-12 | ' | ' | ' |
Loan Agreement of term loan | 30,000,000 | ' | ' | ' |
Loan Agreement, interest rate | 8.95% | ' | ' | ' |
Final payment of interest | 7.00% | ' | ' | ' |
Amortization period for monthly principal and interest | '30 months | ' | ' | ' |
Debt instrument final payment accrued | ' | 1,100,000 | ' | ' |
Percentage of principal to calculate warrants to issue | 4.55% | ' | ' | ' |
Warrants to purchase shares | 491,007 | ' | ' | ' |
Warrant exercise price | $2.78 | ' | ' | ' |
Warrants outstanding | 0 | ' | ' | ' |
Debt discount amortization | 340,000 | 505,000 | 180,000 | ' |
Loan Agreement [Member] | Black-Scholes model [Member] | ' | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' | ' |
Relative fair value of warrants | $1,200,000 | ' | ' | ' |
Common stock at issuance, fair value | $2.80 | ' | ' | ' |
Period of contractual term | '10 years | ' | ' | ' |
Weighted average volatility rate | 96.70% | ' | ' | ' |
Dividend rate | 0.00% | ' | ' | ' |
Risk-free interest rate | 1.80% | ' | ' | ' |
Computation_of_Net_Loss_Per_Sh2
Computation of Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Net Loss per Share (Detail) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Stock warrants [Member] | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' |
Securities not included in the computation of diluted EPS | 0 | 53,957 | 1,201,116 |
Stock options [Member] | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' |
Securities not included in the computation of diluted EPS | 9,627,683 | 8,823,041 | 8,142,468 |
Restricted stock units [Member] | ' | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' |
Securities not included in the computation of diluted EPS | 3,303,082 | 2,904,423 | 2,617,188 |
Computation_of_Net_Loss_Per_Sh3
Computation of Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Net Loss per Share (Parenthetical) (Detail) | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Earnings Per Share [Abstract] | ' | ' | ' |
Shares awarded to directors that have vested | 1,155,422 | 1,267,215 | 1,600,564 |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 12 Months Ended | 12 Months Ended | ||||||||||
Apr. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2011 | Sep. 30, 2014 | Sep. 30, 2014 | Dec. 01, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | |
sqft | Research and development expense [Member] | Sublease [Member] | Subsequent Event [Member] | Fiscal 2014 [Member] | Fiscal 2013 [Member] | Aliso Viejo [Member] | U.S. 282 Patent [Member] | U.S. 484 Patent [Member] | RE 115 Patent [Member] | |||||
Licenses | sqft | sqft | ||||||||||||
Milestone | ||||||||||||||
Other Commitments [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Office space commencing | ' | 38,000 | ' | ' | ' | ' | 30,000 | ' | ' | ' | 61,000 | ' | ' | ' |
Operating lease expiration period | ' | '2018-10 | ' | ' | ' | ' | '2018-10 | ' | ' | ' | '2020-12 | ' | ' | ' |
Rent expense, excluding other area charges | ' | $2,400,000 | $1,100,000 | $2,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Sublease rent income | ' | 113,000 | 294,000 | 997,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Date of merger agreement | ' | 1-Dec-14 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock acquired, share price | ' | ' | ' | ' | ' | ' | ' | $17 | ' | ' | ' | ' | ' | ' |
Patent expiration date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1-Aug-26 | 1-Jul-23 | 1-Jan-16 |
Liability for guarantees and indemnifications | ' | 0 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone payment | ' | ' | ' | ' | 75,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty percentage range, minimum | ' | 5.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty percentage range, maximum | ' | 8.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty obligation on revenue generated by sales | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of maximum milestones | ' | 10 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum payments for milestone | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of specific licensed medical indication | ' | 5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestones range, Minimum | ' | 75,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestones range, Maximum | ' | 125,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments clinical, minimum | ' | 2,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments clinical, maximum | ' | 6,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments regulatory, minimum | ' | 1,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments regulatory, maximum | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments commercial targets, minimum | ' | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments commercial targets, maximum | ' | 60,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments, aggregate | ' | 200,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty payments are tiered, minimum | ' | 1,000,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Paid milestone agreement expenses | ' | 4,000,000 | ' | ' | ' | 2,500,000 | ' | ' | 2,000,000 | 2,000,000 | ' | ' | ' | ' |
Up-front cash payment | ' | ' | 20,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum additional payments from future milestones | ' | $90,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Commitments_and_Contingencies_2
Commitments and Contingencies - Future Annual Minimum Payments under Operating Leases (Detail) (USD $) | Sep. 30, 2014 |
In Thousands, unless otherwise specified | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Minimum Payments, 2015 | $2,943 |
Minimum Payments, 2016 | 3,031 |
Minimum Payments, 2017 | 3,138 |
Minimum Payments, 2018 | 3,230 |
Minimum Payments, 2019 | 2,202 |
Minimum Payments, Thereafter | 2,718 |
Minimum Payments, Total | 17,262 |
Lease Payments to be Received from Subleases, 2015 | -794 |
Lease Payments to be Received from Subleases, 2016 | -919 |
Lease Payments to be Received from Subleases, 2017 | -955 |
Lease Payments to be Received from Subleases, 2018 | -982 |
Lease Payments to be Received from Subleases, 2019 | -82 |
Lease Payments to be Received from Subleases, Thereafter | 0 |
Lease Payments to be Received from Subleases, Total | -3,732 |
Net Payments, 2015 | 2,149 |
Net Payments, 2016 | 2,112 |
Net Payments, 2017 | 2,183 |
Net Payments, 2018 | 2,248 |
Net Payments, 2019 | 2,120 |
Net Payments, Thereafter | 2,718 |
Net Payments, Total | $13,530 |
Stockholders_Equity_Additional
Stockholders' Equity - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | 0 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | ||||||||||||||||||||||
Sep. 30, 2012 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Feb. 28, 2014 | 1-May-12 | Jul. 30, 2009 | Jun. 30, 2009 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2012 | Nov. 15, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2014 | Sep. 30, 2012 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2014 | Jul. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jul. 31, 2013 | 7-May-14 | Aug. 31, 2012 | Sep. 30, 2014 | Sep. 30, 2013 | Aug. 31, 2012 | Sep. 30, 2014 | |
Warrant One [Member] | Warrant One [Member] | Cantor [Member] | 2005 Equity Incentive Plan [Member] | Inducement Grants [Member] | Stock options [Member] | Restricted stock units [Member] | Restricted stock units [Member] | Restricted stock units [Member] | Performance RSUs [Member] | Performance RSUs [Member] | Performance RSUs [Member] | Performance RSUs [Member] | 2003 Stock Option Plan [Member] | 2003 Stock Option Plan [Member] | 2003 Stock Option Plan [Member] | Performance RSUs [Member] | July 2013 [Member] | July 2013 [Member] | July 2013 [Member] | July 2013 [Member] | August 2012 [Member] | August 2012 [Member] | August 2012 [Member] | August 2012 [Member] | August 2012 [Member] | September 2014 [Member] | |||||||||
Maximum [Member] | Minimum [Member] | Maximum [Member] | Minimum [Member] | Cowen and Company, LLC [Member] | Cowen and Company, LLC [Member] | ||||||||||||||||||||||||||||||
Stockholders Equity [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate of common stock preferred stock debt securities and warrants limit under shelf registration | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $150,000,000 | ' | ' | ' | ' | $100,000,000 | ' | ' | ' | $200,000,000 |
Common stock issued to underwriters | ' | 193,672,800 | 152,063,621 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 18,200,000 |
Public offering price per share | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $11 |
Underwriter offering price per share | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $10.38 |
Additional shares of common stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,730,000 |
Common stock issued | 12,355,166 | ' | ' | 3,668,656 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 7,200,000 | 5,030,070 | ' | ' | ' | 11,300,000 | 7,935,395 | ' | 20,930,000 |
Gross proceeds from issuance of common stock | 35,000,000 | 295,354,000 | 48,753,000 | 10,063,000 | ' | ' | ' | ' | ' | ' | 10,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 29,300,000 | 25,000,000 | ' | ' | ' | 49,100,000 | 25,000,000 | ' | 217,000,000 |
Maximum proceeds from the sale of common stock though an at-the-market facility | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 55,000,000 | ' | ' | 25,000,000 | 50,000,000 | 25,000,000 | ' | ' | 25,000,000 | ' |
Restricted stock units released, previously vested | ' | 290,286 | 510,188 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock issued in connection with vesting of restricted stock units | ' | 513,239 | 336,349 | 204,176 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock issued during period, stock options exercised | ' | 1,425,419 | 1,033,833 | 1,673,811 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,425,419 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds form stock options exercised | ' | 3,300,000 | 1,500,000 | 1,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted stock unit awards | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 188,218 | 176,839 | 187,083 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock issued average price per share | ' | ' | ' | $2.81 | ' | ' | ' | $2.83 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $4.97 | ' | ' | ' | ' | $3.15 | ' | ' |
Proceeds from issuance of common stock, net of offering costs | 33,800,000 | ' | ' | 10,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 24,400,000 | ' | ' | ' | ' | 24,400,000 | ' | ' |
Maximum shares of common stock to be sold through an at-the-market facility | ' | ' | ' | ' | ' | ' | 12,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from warrant exercises | ' | ' | 1,000,000 | 7,800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock issued upon cashless exercise of warrants | ' | 25,548 | ' | ' | ' | ' | ' | ' | 710,109 | 5,445,061 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Average exercise price of warrants outstanding | ' | ' | $1.43 | $1.43 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrant exercise price | ' | ' | ' | ' | ' | $2.78 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants exercised | ' | 53,957 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants outstanding to purchase shares | ' | 0 | 53,957 | 1,201,116 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional authorized shares for issuance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 325,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock reserved for future issuance | ' | 27,268,512 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock reserved for future issuance related to outstanding options and other awards | ' | 12,213,165 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock reserved for future grants | ' | 15,055,347 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Share-based awards liability | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Option grants outstanding | ' | 9,627,683 | 8,823,041 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 717,600 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Initial authorized shares | ' | ' | ' | ' | 17,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Contractual terms | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Period stock options vest quarterly | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '3 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage shares vesting on first anniversary date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage shares vesting quarterly after first anniversary date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 75.00% | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Option grants to employees, description | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '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, generally 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. | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted average grant-date fair value of option granted | ' | $2.68 | $1.95 | $1.89 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Total intrinsic value of option exercised based on the differences in market prices | ' | 7,100,000 | 2,200,000 | 3,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Total unrecognized compensation cost related to unvested options | ' | 9,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted-average period for total unrecognized compensation cost related to unvested options | ' | '2 years 8 months 12 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '2 years 6 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted stock units grant to employees, description | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'RSUs granted to employees generally vest based on three or four years of continuous service from the date of grant. RSUs granted to non-employee directors generally vest over the term of one year from the grant date and are not released until the awardee's termination of service. | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted average grant-date fair value per unit | ' | $3.91 | $2.65 | $2.15 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Grant date fair value of restricted stock units | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,800,000 | 1,400,000 | 1,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Unrecognized compensation cost related to unvested shares | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $5,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vested restricted stock units granted to directors not issued until the director resigns | ' | 1,155,422 | 1,267,215 | 1,600,564 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,155,422 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of restricted stock with a weighted-average grant date fair value, value | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $2.27 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Company awarded performance based RSUs | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,637,190 | ' | ' | 464,024 | ' | ' | ' | ' | ' | ' | 464,024 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Actual number of shares to be awarded | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100.00% | 0.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vesting Period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '3 years | ' | ' | ' | '4 years | ' | ' | '3 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted stock units balance vesting period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '2 years | ' | ' | ' | '3 years | ' | ' | '2 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
RSUs outstanding | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,147,660 | 1,637,210 | ' | 88,789 | ' | ' | ' | ' | ' | ' | 88,789 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
RSUs cancelled | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 371,791 | ' | ' | ' | ' | ' | ' | 371,791 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Company awarded performance based RSU | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional performance RSUs outstanding | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,000 | ' | ' | ' | ' | ' | ' | 30,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vesting period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '4 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Options grants to employees vest and exercisable on first anniversary of grant date | ' | ' | ' | 25.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Options grants to employees vest and exercisable in equal installments over next three years | ' | ' | ' | 75.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional actual number of shares to be awarded | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100.00% | 0.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stockholders_Equity_Summary_of
Stockholders' Equity - Summary of Warrant Activity (Detail) (USD $) | 12 Months Ended | |||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Minimum [Member] | Minimum [Member] | Maximum [Member] | Maximum [Member] | |||
Class of Warrant or Right [Line Items] | ' | ' | ' | ' | ' | ' |
Shares of Common Stock Purchasable Upon Exercise of Warrants, Beginning Balance | 53,957 | 1,201,116 | ' | ' | ' | ' |
Shares of Common Stock Purchasable Upon Exercise of Warrants, Exercised | -53,957 | -1,147,159 | ' | ' | ' | ' |
Shares of Common Stock Purchasable Upon Exercise of Warrants, Ending Balance | 0 | 53,957 | ' | ' | ' | ' |
Weighted Average Exercise Price per Share, Beginning Balance | $2.78 | $1.98 | ' | ' | ' | ' |
Weighted Average Exercise Price per Share, Exercised | $2.78 | $1.94 | ' | ' | ' | ' |
Weighted Average Exercise Price per Share, Ending Balance | $0 | $2.78 | ' | ' | ' | ' |
Range of Exercise Prices, Beginning Balance | $2.78 | ' | ' | $1.43 | ' | $2.78 |
Range of Exercise Prices, Exercised | $2.78 | ' | $1.43 | ' | $2.78 | ' |
Range of Exercise Prices, Ending Balance | $0 | $2.78 | ' | $1.43 | ' | $2.78 |
Stockholders_Equity_Summary_of1
Stockholders' Equity - Summary of Stock Option Activity (Detail) (USD $) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Summary of stock options outstanding and changes | ' | ' | ' |
Number of Shares, Outstanding Beginning Balance | 8,823,041 | ' | ' |
Number of Shares, Granted | 2,611,556 | ' | ' |
Number of Shares, Exercised | -1,425,419 | -1,033,833 | -1,673,811 |
Number of Shares, Forfeited | -381,495 | ' | ' |
Number of Shares, Outstanding Ending Balance | 9,627,683 | 8,823,041 | ' |
Number of Shares, Vested and expected to vest in the future | 9,279,640 | ' | ' |
Options Exercisable, Number of Shares | 5,149,145 | ' | ' |
Weighted Average Exercise Price Per Share, Beginning Balance | $2.85 | ' | ' |
Weighted Average Exercise Price Per Share, Granted | $3.98 | ' | ' |
Weighted Average Exercise Price Per Share, Exercised | $2.33 | ' | ' |
Weighted Average Exercise Price Per Share, Forfeited | $3.15 | ' | ' |
Weighted Average Exercise Price Per Share, Ending Balance | $3.22 | $2.85 | ' |
Weighted Average Exercise Price Per Share, Vested and expected to vest in the future | $3.20 | ' | ' |
Options Exercisable, Weighted Average Exercise Price Per Share | $2.98 | ' | ' |
Options Outstanding, Weighted Average Remaining Contractual Term | '7 years 1 month 6 days | ' | ' |
Weighted Average Remaining Contractual Term, Vested and expected to vest in the future | '7 years 1 month 6 days | ' | ' |
Weighted Average Remaining Contractual Term, Exercisable | '5 years 10 months 24 days | ' | ' |
Aggregate Intrinsic Value, Outstanding | $83,907,973 | ' | ' |
Aggregate Intrinsic Value, Vested and expected to vest in the future | 81,073,221 | ' | ' |
Aggregate Intrinsic Value, Exercisable | $46,220,186 | ' | ' |
Stockholders_Equity_Assumption
Stockholders' Equity - Assumptions Used in Black-Scholes Model for Options Granted (Detail) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ' | ' |
Expected volatility, Minimum | 78.60% | 82.70% | 103.70% |
Expected volatility, Maximum | 85.60% | 84.10% | 108.70% |
Weighted-average volatility | 82.60% | 83.70% | 107.90% |
Average expected term in years | '5 years 4 months 24 days | '5 years 4 months 24 days | '5 years 9 months 18 days |
Expected risk-free interest rate (zero coupon U.S. Treasury Note), Minimum | 1.50% | 0.80% | 0.90% |
Expected risk-free interest rate (zero coupon U.S. Treasury Note), Maximum | 1.80% | 1.70% | 1.30% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stockholders_Equity_Summary_of2
Stockholder's Equity - Summary of RSU Activities (Detail) (USD $) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Weighted Average Grant Date Fair Value, Beginning Balance | $2.40 | ' | ' |
Weighted Average Grant Date Fair Value, Granted | $3.91 | $2.65 | $2.15 |
Weighted Average Grant Date Fair Value, Vested | $2.61 | ' | ' |
Weighted Average Grant Date Fair Value, Forfeited | $3.72 | ' | ' |
Weighted Average Grant Date Fair Value, Ending Balance | $3.22 | $2.40 | ' |
Restricted stock units [Member] | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' |
Number of Shares, Unvested, Beginning Balance | 1,637,210 | ' | ' |
Number of Shares, Granted | 1,637,190 | ' | ' |
Number of Shares, Vested | -691,732 | ' | ' |
Number of Shares, Forfeited | -435,008 | ' | ' |
Number of Shares, Unvested, Ending Balance | 2,147,660 | ' | ' |
Research_License_Supply_and_ot1
Research, License, Supply and other Agreements - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | 12 Months Ended | ||||||||
Apr. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2011 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2012 | Aug. 31, 2007 | Sep. 30, 2012 | |
Milestone | Research and development expense [Member] | CNS [Member] | CNS [Member] | CNS [Member] | CNS [Member] | CNS [Member] | CNS [Member] | Merck [Member] | Azur Pharma [Member] | Azur Pharma [Member] | Azur Pharma [Member] | |||
Minimum [Member] | Maximum [Member] | |||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone paid upon FDA approval of NUEDEXTA | ' | ' | ' | ' | ' | ' | ' | $75,000 | ' | ' | ' | ' | ' | ' |
Royalties recorded to cost of product sales | 0 | ' | ' | ' | 2,700,000 | 3,500,000 | 1,800,000 | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty payable under agreement | ' | ' | ' | ' | ' | ' | ' | ' | 5.00% | 8.00% | ' | ' | ' | ' |
Individual milestone range for each accepted NDA | ' | ' | ' | ' | ' | ' | ' | ' | 75,000 | 125,000 | ' | ' | ' | ' |
Maximum milestone payments | ' | ' | ' | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum number of milestones required to make payment | ' | 10 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of basis for achievements of milestones | ' | 5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments clinical, minimum | ' | 2,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments clinical, maximum | ' | 6,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments regulatory, minimum | ' | 1,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments regulatory, maximum | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments commercial targets, minimum | ' | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments commercial targets, maximum | ' | 60,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone and royalty payments, aggregate | ' | 200,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty payments are tiered, minimum | ' | 1,000,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Paid milestone agreement expenses | ' | 4,000,000 | ' | 2,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front cash payment | ' | ' | 20,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum additional payments from future milestones | ' | 90,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Agreement date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1-Oct-13 | ' | ' | ' |
Agreement period term | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '3 years | ' | ' | ' |
Maximum revenue to be received | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 46,700,000 | ' | ' | ' |
Agreement termination period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '90 days | ' | ' | ' |
Expiration of the patent for Abreva | ' | 28-Apr-14 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Royalty receivable under agreement, Maximum | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,000,000 | 2,000,000 | 492,000 |
Recognized royalty revenue from product sales | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $17,000,000 | $17,000,000 |
Annualized net product revenues | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3.00% | ' |
Income_Taxes_Components_of_Inc
Income Taxes - Components of Income Tax Provision (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
Current: | ' | ' | ' |
State | $3 | $3 | $3 |
Deferred: | ' | ' | ' |
Federal | -16,455 | -23,056 | -15,487 |
State | -2,844 | -4,939 | -2,731 |
Deferred income tax | -19,299 | -27,995 | -18,218 |
Increase in deferred tax asset valuation allowance | 19,299 | 27,995 | 18,218 |
Total income tax provision | $3 | $3 | $3 |
Income_Taxes_Significant_Compo
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) (USD $) | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 |
In Thousands, unless otherwise specified | |||
Income Tax Disclosure [Abstract] | ' | ' | ' |
Net operating loss carryforwards | $170,660 | $155,961 | $135,430 |
Deferred Revenue | 0 | 504 | 1,570 |
Research credit carryforwards | 9,178 | 9,186 | 11,203 |
Capitalized license fees and patents | 11,160 | 10,176 | 2,017 |
Capitalized research and development costs | 0 | 30 | 100 |
Share-based compensation and options | 10,347 | 8,452 | 6,980 |
Other | 5,505 | 3,405 | 2,579 |
Deferred income tax assets | 206,850 | 187,714 | 159,879 |
Deferred tax liabilities: | ' | ' | ' |
Other | 0 | -163 | -323 |
Deferred tax liabilities | 0 | -163 | -323 |
Less valuation allowance for net deferred income tax assets | -206,850 | -187,551 | -159,556 |
Net deferred tax assets/(liabilities) | $0 | $0 | $0 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Sep. 30, 2014 |
Schedule Of Income Taxes [Line Items] | ' |
Operating loss and research credit carryforwards expiration period | '2029 |
Operating loss and research and development credit carryforwards | 'Pursuant to Internal Revenue Code ("IRC") Sections 382 and 383, annual use of the Company's net operating loss and research and development credit carryforwards may be limited in the event of a cumulative change in ownership of more than 50% within a three-year period. |
Domestic Tax Authority [Member] | ' |
Schedule Of Income Taxes [Line Items] | ' |
Net operating loss carryforwards | 446.6 |
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | ' |
Schedule Of Income Taxes [Line Items] | ' |
Research and development carryforwards | 7.6 |
State and Local Jurisdiction [Member] | ' |
Schedule Of Income Taxes [Line Items] | ' |
Net operating loss carryforwards | 392.9 |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ' |
Schedule Of Income Taxes [Line Items] | ' |
Research and development carryforwards | 7 |
Foreign Tax Authority [Member] | ' |
Schedule Of Income Taxes [Line Items] | ' |
Research and development carryforwards | 0 |
Income_Taxes_Reconciliation_of
Income Taxes - Reconciliation of the Federal Statutory Rate to the Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Income Tax Disclosure [Abstract] | ' | ' | ' |
Federal statutory rate | -34.00% | -34.00% | -34.00% |
Increase in deferred income tax asset valuation allowance | 38.00% | 37.00% | 31.00% |
State income taxes, net of federal effect | -6.00% | -5.00% | -5.00% |
Research and development credits | 0.00% | 3.00% | 1.00% |
Expired net operating loss and other credits | 0.00% | 0.00% | 6.00% |
Other | 2.00% | -1.00% | 1.00% |
Effective income tax rate | 0.00% | 0.00% | 0.00% |
Employee_Savings_Plan_Addition
Employee Savings Plan - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Postemployment Benefits [Abstract] | ' | ' | ' |
Employees to deposit into tax deferred investment accounts | 50.00% | ' | ' |
Contribution of company in employee saving plan | $601,000 | $401,000 | $412,000 |
Segment_Information_Additional
Segment Information - Additional Information (Detail) | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | |
Revenue, Major Customer [Line Items] | ' | ' | ' |
Number of wholesalers accounted for gross product sales | 3 | ' | ' |
Number of wholesalers accounted for trade receivables | 3 | ' | ' |
Net product sales [Member] | Customer Concentration Risk [Member] | ' | ' | ' |
Revenue, Major Customer [Line Items] | ' | ' | ' |
Percentage of revenue from major customer | 88.00% | 88.00% | 89.00% |
Trade receivables [Member] | Credit Concentration Risk [Member] | ' | ' | ' |
Revenue, Major Customer [Line Items] | ' | ' | ' |
Percentage of revenue from major customer | 93.00% | 91.00% | ' |
SubsequentEvent_Additional_Inf
SubsequentEvent - Additional Information (Detail) (USD $) | 12 Months Ended | |
In Millions, except Per Share data, unless otherwise specified | Sep. 30, 2014 | Dec. 01, 2014 |
Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ' | ' |
Date of merger agreement | 1-Dec-14 | ' |
Common stock acquired, share price | ' | $17 |
Termination fee | ' | $90 |