Document and Entity Information
Document and Entity Information Document - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 10, 2016 | Jun. 30, 2015 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Eagle Pharmaceuticals, Inc. | ||
Entity Central Index Key | 827,871 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 15,636,387 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 739,767,440 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Current assets: | |||
Cash and cash equivalents | $ 79,083 | $ 34,869 | $ 22,722 |
Short-term investments | 0 | 0 | 19,999 |
Accounts receivable | 26,267 | 11,956 | 7,296 |
Inventories | 15,042 | 1,242 | 1,294 |
Prepaid expenses and other current assets | 1,865 | 1,640 | 1,711 |
Total current assets | 122,257 | 49,707 | 53,022 |
Property and equipment, net | 2,205 | 342 | 344 |
Other assets | 143 | 45 | 45 |
Total assets | 124,605 | 50,094 | 53,411 |
Current liabilities: | |||
Accounts payable | 3,857 | 3,501 | 4,059 |
Accrued expenses | 24,405 | 12,165 | 9,671 |
Deferred revenue | 6,000 | 6,520 | 6,585 |
Total current liabilities | $ 34,262 | $ 22,186 | $ 20,315 |
Commitments and contingencies | |||
Stockholders' equity: | |||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of December 31, 2015 and 2014; no shares authorized, issued or outstanding as of September 30, 2014 | $ 0 | $ 0 | $ 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 15,636,387, 14,036,680, and 14,032,167 issued and outstanding as of December 31, 2015, 2014, and September 30, 2014, respectively | 15 | 14 | 14 |
Additional paid in capital | 197,440 | 137,577 | 137,259 |
Accumulated deficit | (107,112) | (109,683) | (104,177) |
Total stockholders' equity | 90,343 | 27,908 | 33,096 |
Total liabilities and stockholders' equity | $ 124,605 | $ 50,094 | $ 53,411 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Statement of Financial Position [Abstract] | |||
Preferred stock, shares authorized | 1,500,000 | 1,500,000 | 0 |
Preferred stock, shares issued | 0 | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 | 0 |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 |
Common stock, shares, issued | 15,636,387 | 14,036,680 | 14,032,167 |
Common stock, shares, outstanding | 15,636,387 | 14,036,680 | 14,032,167 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Revenue: | ||||
Product sales | $ 1,506 | $ 12,968 | $ 4,626 | $ 5,315 |
Royalty income | 4,094 | 8,259 | 10,708 | 8,364 |
License and other income | 0 | 45,000 | 3,765 | 0 |
Total revenue | 5,600 | 66,227 | 19,099 | 13,679 |
Operating expenses: | ||||
Cost of revenue | 4,489 | 15,647 | 11,714 | 7,381 |
Research and development | 3,986 | 27,855 | 16,816 | 9,795 |
Selling, general and administrative | 3,690 | 20,165 | 9,326 | 4,958 |
Total operating expenses | 12,165 | 63,667 | 37,856 | 22,134 |
Income (Loss) from operations | (6,565) | 2,560 | (18,757) | (8,455) |
Interest income | 1 | 25 | 31 | 3 |
Interest expense | (1) | (11) | (8) | (309) |
Amortization of deferred financing costs | 0 | 0 | 0 | (96) |
Amortization of debt discount | 0 | 0 | 0 | (1,091) |
Net proceeds from arbitration | 0 | 0 | 0 | 4,050 |
Change in value of warrant liability | 0 | 0 | (573) | (1,052) |
Other income | 0 | 0 | 35 | 3 |
Total other income/(expense) | 0 | 14 | (515) | 1,508 |
Income (Loss) before income tax benefit | (6,565) | 2,574 | (19,272) | (6,947) |
Income tax (provision) benefit | 1,059 | (3) | 1,295 | 899 |
Net Income (Loss) | (5,506) | 2,571 | (17,977) | (6,048) |
Less dividends on Series A, B, B-1 and C Convertible Preferred Stock | 0 | 0 | (1,666) | (3,837) |
Net income (loss) attributable to common stockholders | $ (5,506) | $ 2,571 | $ (19,643) | $ (9,885) |
Earnings per share attributable to common stockholders: | ||||
Basic (in dollars per share) | $ (0.39) | $ 0.17 | $ (1.97) | $ (3.25) |
Diluted (in dollars per share) | $ (0.39) | $ 0.16 | $ (1.97) | $ (3.25) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 14,032,828 | 15,250,154 | 9,955,937 | 3,044,308 |
Diluted (in shares) | 14,032,828 | 16,253,781 | 9,955,937 | 3,044,308 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands | Total | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series B-1 Convertible Preferred Stock | Series C Convertible Preferred Stock | Series C Preferred Stock Warrants | Common Stock | Common StockSeries A Convertible Preferred Stock | Common StockSeries B Convertible Preferred Stock | Common StockSeries B-1 Convertible Preferred Stock | Common StockSeries C Convertible Preferred Stock | Common StockSeries C Preferred Stock Warrants | Additional Paid-in Capital | Additional Paid-in CapitalSeries A Convertible Preferred Stock | Additional Paid-in CapitalSeries B Convertible Preferred Stock | Additional Paid-in CapitalSeries B-1 Convertible Preferred Stock | Additional Paid-in CapitalSeries C Convertible Preferred Stock | Additional Paid-in CapitalSeries C Preferred Stock Warrants | Accumulated Deficit |
Number of shares outstanding, beginning balance (in shares) at Sep. 30, 2012 | 1,653 | ||||||||||||||||||
Stockholders' equity attributable to parent, beginning balance at Sep. 30, 2012 | $ (93,433) | $ 2 | $ 2,102 | $ (95,537) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Stock-based compensation expense | 317 | 317 | |||||||||||||||||
Conversion of preferred shares to common stock, (in shares) | 825 | 524 | 46 | ||||||||||||||||
Conversion of preferred shares to common stock, value | $ 5,136 | $ 6,111 | $ 539 | $ 1 | $ 0 | $ 0 | $ 5,135 | $ 6,111 | $ 539 | ||||||||||
Net income (loss) | (6,048) | (6,048) | |||||||||||||||||
Dividends on Convertible Preferred Stock | (3,837) | (3,837) | |||||||||||||||||
Forfeitures of dividends on Convertible Preferred Stock | 3,286 | 3,286 | |||||||||||||||||
Number of shares outstanding, ending balance (in shares) at Sep. 30, 2013 | 3,048 | ||||||||||||||||||
Stockholders' equity attributable to parent, ending balance at Sep. 30, 2013 | (87,929) | $ 3 | 14,204 | (102,136) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Stock-based compensation expense | 606 | 606 | |||||||||||||||||
Issuance of common stock in connection with initial public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount (in shares) | 3,450 | ||||||||||||||||||
Issuance of common stock in connection with initial public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount | 46,048 | $ 3 | 46,045 | ||||||||||||||||
Conversion of preferred shares to common stock, (in shares) | 2,332 | 1,980 | 1,456 | 1,720 | 32 | ||||||||||||||
Conversion of preferred shares to common stock, value | $ 20,377 | $ 30,612 | $ 19,756 | $ 20,903 | $ 2,280 | $ 3 | $ 2 | $ 1 | $ 2 | $ 0 | $ 20,374 | $ 30,610 | $ 19,755 | $ 20,901 | $ 2,280 | ||||
Issuance of common stock upon exercise of Redeemable Series C Preferred Stock warrants (in shares) | 2 | ||||||||||||||||||
Issuance of common stock upon exercise of Redeemable Series C Preferred Stock warrants | 21 | $ 0 | 21 | ||||||||||||||||
Issuance of common stock upon exercise of stock option grants (in shares) | 12 | ||||||||||||||||||
Issuance of common stock upon exercise of stock option grants | 65 | $ 0 | 65 | ||||||||||||||||
Dividends on Convertible Preferred Stock and forfeitures of dividends on conversion to common | 0 | (17,602) | 17,602 | ||||||||||||||||
Net income (loss) | (17,977) | (17,977) | |||||||||||||||||
Dividends on Convertible Preferred Stock | (1,666) | (1,666) | |||||||||||||||||
Number of shares outstanding, ending balance (in shares) at Sep. 30, 2014 | 14,032 | ||||||||||||||||||
Stockholders' equity attributable to parent, ending balance at Sep. 30, 2014 | 33,096 | $ 14 | 137,259 | (104,177) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Stock-based compensation expense | 284 | 284 | |||||||||||||||||
Issuance of common stock upon exercise of stock option grants (in shares) | 5 | ||||||||||||||||||
Issuance of common stock upon exercise of stock option grants | 34 | $ 0 | 34 | ||||||||||||||||
Net income (loss) | (5,506) | (5,506) | |||||||||||||||||
Number of shares outstanding, ending balance (in shares) at Dec. 31, 2014 | 14,037 | ||||||||||||||||||
Stockholders' equity attributable to parent, ending balance at Dec. 31, 2014 | 27,908 | $ 14 | 137,577 | (109,683) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Stock-based compensation expense | 4,051 | 4,051 | |||||||||||||||||
Issuance of common stock in connection with initial public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount (in shares) | 1,389 | ||||||||||||||||||
Issuance of common stock in connection with initial public offering, including underwriter's over-allotment, net of offering costs and underwriter's discount | 54,331 | $ 1 | 54,330 | ||||||||||||||||
Issuance of common stock upon exercise of stock option grants (in shares) | 211 | ||||||||||||||||||
Issuance of common stock upon exercise of stock option grants | 1,482 | $ 0 | 1,482 | ||||||||||||||||
Net income (loss) | 2,571 | 2,571 | |||||||||||||||||
Number of shares outstanding, ending balance (in shares) at Dec. 31, 2015 | 15,637 | ||||||||||||||||||
Stockholders' equity attributable to parent, ending balance at Dec. 31, 2015 | $ 90,343 | $ 15 | $ 197,440 | $ (107,112) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Cash flows from operating activities: | ||||
Net income (loss) | $ (5,506) | $ 2,571 | $ (17,977) | $ (6,048) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||
Depreciation and amortization expense | 13 | 112 | 104 | 135 |
Stock-based compensation | 284 | 4,051 | 606 | 317 |
Non-cash interest expense | 0 | 0 | 0 | 309 |
Amortization of deferred financing costs | 0 | 0 | 0 | 96 |
Amortization of debt discount | 0 | 0 | 0 | 1,091 |
Change in fair value of warrant liability | 0 | 0 | 573 | 1,052 |
Loss on disposal of fixed assets | 0 | 273 | 0 | 0 |
Changes in operating assets and liabilities: | ||||
(Increase) in accounts receivable | (4,660) | (14,311) | (2,172) | (3,543) |
(Increase) decrease in inventories | 52 | (13,800) | (1,294) | 87 |
(Increase) decrease in prepaid expenses and other current assets | 71 | (225) | 192 | (1,368) |
(Increase) decrease in other assets | 0 | (98) | 1 | 30 |
Increase (decrease) in accounts payable | (558) | 356 | 2,867 | (251) |
(Decrease) increase in deferred revenue | (65) | (520) | (3,435) | 520 |
Increase in accrued expenses and other liabilities | 2,494 | 11,873 | 6,692 | 1,694 |
Net cash used in operating activities | (7,875) | (9,718) | (13,843) | (5,879) |
Cash flows from investing activities: | ||||
Purchase of property and equipment | (11) | (1,881) | (46) | (41) |
Purchase of short term investments | 0 | (105,999) | (19,999) | 0 |
Maturities of short term investments | 19,999 | 105,999 | 0 | 1,500 |
Net cash (used in) provided by investing activities | 19,988 | (1,881) | (20,045) | 1,459 |
Cash flows from financing activities: | ||||
Proceeds from issuance of Series C preferred stock, net of offering costs of $160 | 0 | 0 | 0 | 9,829 |
Deferred IPO costs | 0 | 0 | 0 | (20) |
Series C preferred stock offering costs | 0 | 0 | (1) | 0 |
Proceeds from exercise of preferred stock warrants | 0 | 0 | 21 | 0 |
Proceeds from issuance of common stock from initial public offering, net of issuance costs | 0 | 0 | 46,069 | 0 |
Proceeds from issuance of common stock from follow-on public offering, net of issuance costs | 0 | 54,331 | 0 | 0 |
Proceeds from common stock option exercise | 34 | 1,482 | 65 | 0 |
Net cash provided by financing activities | 34 | 55,813 | 46,154 | 9,809 |
Net increase in cash | 12,147 | 44,214 | 12,266 | 5,389 |
Cash and cash equivalents at beginning of period | 22,722 | 34,869 | 10,456 | 5,067 |
Cash and cash equivalents at end of period | 34,869 | 79,083 | 22,722 | 10,456 |
Cash paid during the period for: | ||||
Interest | (1) | (11) | (8) | 0 |
Financing costs | 0 | 0 | 0 | 20 |
Corporate taxes | 0 | 482 | 0 | 0 |
Franchise taxes | 0 | 91 | 9 | 20 |
Landlord contribution to leasehold improvements recorded as deferred rent | 0 | 367 | 0 | 0 |
Non-Cash Financing Activities [Abstract] | ||||
Conversion of note payable to Preferred Stock | 0 | 0 | 0 | 10,062 |
Accrued IPO costs | 0 | 0 | 0 | 152 |
Conversion of Preferred Stock and Accrued Dividends to Common Stock | ||||
Non-Cash Financing Activities [Abstract] | ||||
Conversion to Common Stock | 0 | 0 | 91,648 | 15,623 |
Conversion of Redeemable Warrant Liability to Common Stock | ||||
Non-Cash Financing Activities [Abstract] | ||||
Conversion to Common Stock | $ 0 | $ 0 | $ 2,280 | $ 0 |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) $ in Thousands | 12 Months Ended |
Sep. 30, 2013USD ($) | |
Net offering costs | $ 0 |
Series C Preferred Stock | |
Net offering costs | $ 160 |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business Activities | Organization and Business Activities Eagle Pharmaceuticals, Inc. (the Company, or Eagle) is a specialty pharmaceutical company focused on developing and commercializing injectable products, primarily in the critical care and oncology areas, using the Food and Drug Administration's ("FDA's") 505(b)(2) NDA regulatory pathway. The Company's business model is to develop proprietary innovations to FDA-approved, injectable drugs, referred to as branded reference drugs, that offer favorable attributes to patients and healthcare providers. The Company has five products currently being sold in the United States under various license agreements in place with commercial partners, including a ready-to-use formulation of Argatroban, Ryanodex ® , Diclofenac-misoprostol, launched in January 2015, and Docetaxel Injection non-alcohol formula and Bendeka ® , each launched in January 2016. The Company has a number of products currently under development and certain products may be subject to license agreements. On February 18, 2014 , the Company closed its initial public offering (the "IPO") whereby the Company sold 3,350,000 shares of common stock, at a public offering price of $15.00 per share, before underwriting discounts and expenses. On March 18, 2014 , the underwriters exercised an over-allotment option granted in connection with the offering of 100,000 shares of common stock at the initial public offering price, less the underwriter discount. The aggregate net proceeds received by the Company from the offering were $46,069 . Included in this amount is $21 received from the exercise of Series C preferred stock warrants for 1,788 shares of common stock. In connection with the IPO, the Company's board of directors approved a one-for-6.41 reverse stock split of the Company's common stock (that resulted in a proportional adjustment to the conversion ratio of the preferred stock warrants). All references to common stock, common stock equivalents and per share amounts have been changed retroactively in these condensed financial statements and accompanying footnotes have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an equal amount to the reduction in par value of common stock to additional paid-in capital. On the IPO closing date, all outstanding shares of preferred stock converted into 7,487,928 shares of common stock and the outstanding warrants were net exercised for 32,286 shares common stock at the initial public offering price. These transactions produced a significant increase in the number of shares outstanding which will impact the year-over-year comparability of the Company’s (loss) earnings per share calculations. Additionally, in connection with the closing of the IPO, the Company amended and restated its articles of incorporation to decrease the number of authorized shares of common and undesignated preferred stock to 50,000,000 and 1,500,000 , respectively. On January 20, 2015, the board of directors of the Company authorized a change in the Company’s fiscal year end from September 30 th to December 31 st . The change was intended to better align the Company’s fiscal year with the business cycles of other specialty pharmaceutical companies. As a result of the change in fiscal year, the Company’s 2015 fiscal year began on January 1, 2015 and ended on December 31, 2015. As a result of the change in fiscal year, on February 17, 2015 the Company filed a Transition Report on Form 10-Q covering the transition period from October 1, 2014 to December 31, 2014. On February 13, 2015, the Company submitted an NDA to the FDA for EP-3102 bendamustine rapid infusion product which was approved by the FDA on December, 8 2015. Also, on February 13, 2015, the Company entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. ("Cephalon"), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for U.S. and Canadian rights to bendamustine rapid infusion product for treatment of patients with CLL and patients with NHL. Pursuant to the terms of the Cephalon License, Cephalon will be responsible for all U.S. commercial activities for the product including promotion and distribution, and the Company is responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies. Additionally, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , received a $15 million milestone in January 2016, related to the FDA approval of Bendeka in December 2015 and is currently eligible to receive up to $65 million in additional milestone payments. In addition, the Company is entitled to receive royalty payments of 20% of net sales of the product. In connection with the Cephalon License, the Company has entered into a supply agreement with Cephalon, pursuant to which the Company is responsible for supplying product to Cephalon for a specified period. On March 20, 2015, the Company completed an underwritten public offering (the "Follow-on Offering") of 1,518,317 shares of common stock, including the exercise by the underwriters of a 30 -day option to purchase an additional 198,041 shares of common stock. Of the shares sold, 1,388,517 shares were issued and offered by the Company and 129,800 shares were offered by certain selling stockholders. All of the shares were offered at a price to the public of $42.00 per share. The net proceeds to Eagle from this offering, after deducting underwriting discounts and commissions and other offering expenses payable by Eagle, were approximately $54,331 . Eagle did not receive any proceeds from the shares sold by the selling stockholders. The securities described above were offered pursuant to a shelf registration statement declared effective by the Securities Exchange Commission on March 13, 2015. On October 13, 2015, the Company entered into an exclusive U.S. licensing agreement with Teikoku Pharma USA, Inc. ("Teikoku") to market, sell and distribute Docetaxel Injection Concentrate, Non-Alcohol Formula, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. The NDA for Docetaxel Injection for these indications was approved by the FDA on December 22, 2015. Under the terms of the agreement, the Company paid an upfront cash payment upon executing the agreement which was expensed and is included in research and development expense and an additional payment of $4,850 upon FDA approval and NDA transfer to Eagle, which occurred in January 2016, and 20% royalties on gross profits. |
Transition Period
Transition Period | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Transition Period | Transition Period On January 20, 2015, the board of directors of the Company authorized a change in the Company’s fiscal year end from September 30 th to December 31 st . Accordingly, the Company is presenting audited financial statements for the 3 month period ended December 31, 2014. The following table provides certain unaudited comparative financial information for the same period of the prior year. Three Months Ended 2014 2013 (unaudited) Revenue: Product sales $ 1,506 $ 2,224 Royalty income 4,094 3,268 Total revenue 5,600 5,492 Operating expenses: Cost of revenue 4,489 4,624 Research and development 3,986 2,589 Selling, general and administrative 3,690 1,344 Total operating expenses 12,165 8,557 Loss from operations (6,565 ) (3,065 ) Interest income 1 1 Interest expense (1 ) — Change in value of warrant liability — (191 ) Total other (expense) — (190 ) Loss before income tax benefit (6,565 ) (3,255 ) Income tax benefit 1,059 — Net Loss $ (5,506 ) $ (3,255 ) Less dividends on Series A, B, B-1 and — (1,132 ) Net loss attributable to common stockholders $ (5,506 ) $ (4,387 ) Loss per share attributable to common stockholders Basic and diluted $ (0.39 ) $ (1.44 ) Weighted average common shares outstanding Basic and diluted 14,032,828 3,048,131 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. The Company's critical accounting policies are those that are both most important to the Company's financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. Accounting Guidance Not Yet Adopted In May 2014, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. In July 2015, the FASB finalized a one year delay in the effective date of this standard, which will now be effective for us on January 1, 2018, however early adoption is permitted any time after the original effective date, which for us is January 1, 2017. We have not yet selected a transition method and are currently evaluating the impact of ASU 2014-09 on our financial statements. In November 2015, the FASB issued ASU 2015-17, which revises the guidance in ASC 740, Income Taxes, to simplify the presentation of deferred income taxes and require that deferred tax liabilities and assets be classified as non-current in the statement of financial position. The guidance is to be applied either prospectively or retrospectively, and is effective for reporting periods (interim and annual) beginning after December 15, 2016 for public companies. Early adoption is permitted. The implementation of this ASU is not expected to have a material impact on our financial position or results of operations. In January 2016, the FASB issued ASU 2016-01, which revises the guidance in ASC 825-10, Recognition and Measurement of Financial Assets and Financial Liabilities, and provides guidance for the recognition, measurement, presentation, and disclosure of financial assets and liabilities. The guidance is effective for reporting periods (interim and annual) beginning after December 15, 2017, for public companies. We are currently assessing the potential impact of this ASU on our financial position and results of operations. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. We are currently evaluating the impact of our pending adoption of the new standard on our financial statements. Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. Fair Value of Financial Instruments The Company's financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable, and accounts payable. The carrying values of these financial instruments approximate their fair values due to their short term maturities. Short Term Investments Investments consisted of U.S. Treasury securities that have an original maturity of greater than three months and typically less than 180 days. The Company's investments were classified as Level 1 and available-for-sale and are recorded at fair value, based upon quoted market prices. No gains or losses on investments are realized until the sale occurs or a decline in fair value is determined to be other-than-temporary. If a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established. Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in 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. The fair value of interest-bearing cash and cash equivalents and short term investments are classified as Level 1 for all periods presented. The Company is required by U.S. GAAP to record certain assets and liabilities at fair value on a recurring basis. The guidance in ASC 815 required that the Company mark the value of its warrant liability to market and recognize the change in valuation in its statement of operations each reporting period. Determining the warrant liability to be recorded required the Company to develop estimates to be used in calculating the fair value of the warrant. Since these preferred stock warrants did not trade in an active securities market, the Company recognized a warrant liability and estimated the fair value of these warrants using a Probability-Weighted Expected Returns valuation model. Therefore, the warrant liability was considered a Level 3 measurement. All warrants outstanding immediately prior to the IPO were net exercised in connection with the initial public offering. There were no outstanding warrants as of December 31, 2015 . Concentration of Major Customers and Vendors The Company is dependent on commercial partners to market and sell Argatroban. The Company's customers for Argatroban are its commercial and licensing partners, therefore, the Company's future revenues are highly dependent on these collaboration and distribution arrangements. The Company received a $30 million upfront payment during February 2015 and earned a $15 million milestone payment received in January 2016 upon product approval in December 2015 under the terms of the Cephalon License- See "revenue recognition" below for more detail. The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Net product sales, royalty and license revenues The Medicines Company 14 % 36 % 45 % 54 % Sandoz, Inc. 5 % 55 % 53 % 46 % Cephalon, Inc. (Teva) - See Revenue Recognition 68 % — % — % — % Other 13 % 9 % 2 % — % 100 % 100 % 100 % 100 % December 31, December 31, September 31, 2015 2014 2014 Accounts receivable The Medicines Company 35 % 61 % 75 % Sandoz, Inc. — % 35 % 18 % Cephalon, Inc. (Teva) - See Revenue Recognition 57 % — % — % Other 8 % 4 % 7 % 100 % 100 % 100 % Currently, for argatroban, the Company uses one vendor as its sole source supplier. Because of the unique equipment and process for manufacturing argatroban, transferring manufacturing activities for argatroban to an alternate supplier would be a time consuming and costly endeavor, and there are only a limited number of manufacturers that are capable of performing this function for the Company. Our partner, Sandoz, Inc. experienced unusually high historical returns compared to their estimates in December 2015, which have decreased accounts receivable and royalty revenue by $2.9 million . Accounts receivable as of December 31, 2015 includes a $15 million receivable related to the approval of EP-3102 Bendeka milestone from Teva Pharmaceuticals. Pre-Launch Inventory The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value, when it is reasonably certain that the pre-launch inventories will be saleable. The determination to capitalize is made once the Company (or its third party development partners) has filed a New Drug Application (an "NDA") that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal hurdles will be cleared. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered, and accordingly, the time frame within which the determination is made varies from product to product. The Company may be required to write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. Inventory Inventories, which consist of finished products, are recorded at the lower of cost or market, with cost determined on a first-in, first-out basis. The Company periodically reviews the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventory, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. In most instances, inventory is shipped from the Company's vendor directly to the Company's customers. Property and Equipment Property and equipment are stated at cost. Depreciation is computed over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. Research and Development Expense Costs incurred for research and product development, including costs incurred for technology in the development stage, are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Advance payments for goods or services that will be used for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or services performed. Deferred Financing Costs Prior to the initial public offering, costs relating to obtaining Convertible Notes were capitalized and amortized over the term of the related debt using the straight line method. Amortization of deferred financing costs charged to interest expense was $0 , $0 , $0 , and $96 for fiscal 2015, the transition period, fiscal 2014 and 2013, respectively. The unamortized balance as of December 31, 2015 , December 31, 2014 and September 30, 2014 was $0 . Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $4,752 , $1,556 , $2,506 and $0 for fiscal 2015, the transition period, fiscal 2014 and 2013, respectively. Redeemable Convertible Preferred Stock The carrying value of redeemable convertible preferred stock was increased by periodic accretions, using the interest method so that the carrying amount would equal the redemption amount at the earliest redemption date. Accounting for Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company received approval to sell a portion of the Company's New Jersey net operating losses ("NOL's") as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology firms with unused net operating loss carryovers and unused research and development credits are allowed to sell these benefits to other firms. During the transition period, fiscal 2014 and 2013, the Company sold New Jersey state NOL carry forwards, which resulted in the recognition of $1,059 , $1,295 , and $899 in tax benefits, respectively. During fiscal 2015, the Company recorded an income tax provision of $3 based upon its estimated federal AMT and state tax liability. Revenue Recognition Product revenue — The Company recognizes net revenue from Argatroban supplied to its commercial partners and Ryanodex ® and Diclofenac-misoprostol supplied to the end user, when the following four basic revenue recognition criteria under the related accounting guidance are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Prior to the shipment of manufactured products, the Company conducts initial product release and stability testing in accordance with cGMP. The Company's commercial partners can return the products within contracted specified timeframes if the products do not meet the applicable inspection tests. The Company estimates its return reserves based on its experience with historical return rates. Historically, product returns have not been material. The Company has a no return policy for Ryanodex ® . Revenues from product sales to end users are recorded net of provisions for estimated chargebacks, rebates, returns (if applicable), prompt pay discounts and other deductions, such as shelf stock adjustments, which can be reasonably estimated. When sales provisions are not considered reasonably estimable by Eagle, the revenue is deferred to a future period when more information is available to evaluate the impact. Royalties — The Company recognizes revenue from royalties based on its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. License revenue — The Company analyzes each element of our licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract. When a sale combines multiple elements upon performance of multiple services, the Company allocates revenue for transactions that include multiple elements to each unit of accounting based on its relative selling price, and recognizes revenue for each unit of accounting when the revenue recognition criteria have been met. The Company follows the selling price hierarchy as outlined in the guidance Revenue Recognition (ASC Topic 605) - Multiple-Deliverable Revenue Arrangements . The guidance provides a hierarchy to determine the selling price to be used for allocating revenue to deliverables: (i) vendor-specific objective evidence (“VSOE”), (ii) third-party evidence (“TPE”) if available and when VSOE is not available, and (iii) best estimate of the selling price (“BESP”) if neither VSOE nor TPE is available. The Company uses BESP to determine the standalone selling price for such deliverables. The Company has an established process for developing BESP, which incorporates, pricing practices, historical selling prices, the effect of market conditions as well as entity-specific factors. Estimated selling price is monitored and evaluated on a regular basis to ensure that changes in circumstances are accounted for in a timely manner. The Company recognizes milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period of performance under the contract. As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , earned a milestone payment of $15 million and is eligible to receive up to $65 million in additional milestone payments. The $30 million upfront payment was allocated between the license issued to Cephalon and obtaining and maintaining regulatory approvals and conducting post-approval clinical studies using the Company’s best estimate of selling price for each deliverable. The full $30 million was recognized as income in February 2015, as the Company substantially completed its requirements for obtaining regulatory approval, which consisted of filing the New Drug Application on February 13, 2015, and the remaining obligations were estimated to require minimal effort. On December 8, 2015, the FDA approved Bendeka TM (50 mL bendamustine hydrochloride) marking the achievement of a milestone which entitled the Company to receive a $15 million payment. The remaining milestones, if achieved, will be recognized in the period earned. In addition, the Company is entitled to receive royalty payments equal to 20% of net sales of the product, if approved by the FDA. In connection with the Cephalon License, the Company agreed to enter into a supply agreement with Cephalon, pursuant to which the Company will be responsible for supplying product to Cephalon for a specified period. Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, and its allocated overhead, as well as the research and development performed by outside contractors or consultants. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of operations. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. See Note 11 regarding Asset Sales related to Other Income of $3,500 recognized in June 2014. Stock-Based Compensation The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation — Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors. The Company uses a Black-Scholes valuation model as the most appropriate valuation method for pricing these options. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees . Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. There are customary limitations on the sale or transfer of the stock. The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, Three Months Ended December 31, Year Ended Year Ended 2015 2014 2014 2013 Risk-free interest rate 1.42% - 2.09% 2.11% - 2.16% 1.77% - 2.16% .95% - 2.53% Volatility 28.4% - 32.9% 39.45% 33.64% - 64.00% 64.00% Expected term (in years) 5.5-7.0 years 6.59 - 10.00 years 6.07 - 9.39 years 6.07 - 10.00 years Expected dividend yield 0.0% 0.0% 0.0% 0.0% The risk-free rate assumption was based on U.S. Treasury instruments whose term was consistent with the expected term of the stock options. The expected stock price volatility was determined by examining the historical volatilities for industry peers as the Company did not have sufficient trading history for its common stock. Industry peers consist of those companies in the pharmaceutical industry similar in size, stage of life-cycle and financial leverage. The expected term of stock options represents the average of the vesting period and the contractual life of the option for employees and the life of the option for consultants. The expected dividend assumption is based on the Company's history and expectation of future dividend payouts. Changes in the estimated forfeiture rates are reflected prospectively. Earnings (Loss) Per Share Basic earnings (loss) per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings (loss) per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. The anti-dilutive common shares equivalents outstanding at December 31, 2015 , the transition period, fiscal 2014 and 2013 were as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Series A — — 888,099 2,332,059 Series B — — 754,191 1,980,429 Series B-1 — — 554,382 1,455,750 Series C — — 654,896 1,719,690 Series C warrants — — 56,078 147,254 Options 96,610 1,302,685 963,495 813,529 Total 96,610 1,302,685 3,871,141 8,448,711 The following table sets forth the computation for basic and diluted net income (loss) per share for December 31, 2015 , the transition period, fiscal 2014 and 2013: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Numerator Numerator for basic earnings per share-net income (loss) $ 2,571 $ (5,506 ) $ (19,643 ) $ (9,885 ) Numerator for diluted earnings per share-net income (loss) $ 2,571 $ (5,506 ) $ (19,643 ) $ (9,885 ) Denominator Basic weighted average common shares outstanding 15,250,154 14,032,828 9,955,937 3,044,308 Dilutive effect of stock options 1,003,627 — — — Diluted weighted average common shares outstanding 16,253,781 14,032,828 9,955,937 3,044,308 Basic net income (loss) per share Basic net income (loss) per share $ 0.17 $ (0.39 ) $ (1.97 ) $ (3.25 ) Diluted net income (loss) per share Diluted net income (loss) per share $ 0.16 $ (0.39 ) $ (1.97 ) $ (3.25 ) |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: December 31, December 31, September 30, 2015 2014 2014 Raw material $ 8,687 $ — $ — Work in process 6,044 — — Finished products 311 1,242 1,294 $ 15,042 $ 1,242 $ 1,294 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment at consist of the following: December 31, December 31, September 30, Estimated Useful Life (years) 2015 2014 2014 Furniture and equipment $ 582 $ 297 $ 297 7 Office equipment 328 204 193 3 Equipment 1,182 594 593 7 Leasehold improvements 978 41 41 2 3,070 1,136 1,124 Less accumulated depreciation and amortization (865 ) (794 ) (780 ) Property and equipment, net $ 2,205 $ 342 $ 344 Depreciation and amortization expense amounted to $ 112 , $13 , $104 , and $135 for fiscal 2015, the transition period, fiscal 2014, and fiscal 2013, respectively. |
Balance Sheet Accounts
Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2015 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Prepaid and Other Current Assets Prepaid and other current assets consist of the following: December 31, December 31, September 30, 2015 2014 2014 Prepaid expenses and other current assets Prepaid product costs $ 85 $ 1,020 $ 840 Prepaid FDA user fee 551 148 197 Prepaid insurance 218 183 345 Prepaid research and development 283 — — Prepaid income taxes 508 — — All other 220 289 329 Total Prepaid expenses and other current assets $ 1,865 $ 1,640 $ 1,711 Accrued Expenses Accrued expenses consist of the following: December 31, December 31, September 30, 2015 2014 2014 Accrued expenses Royalties due to The Medicines Company $ 6,948 $ 5,880 $ 4,707 Royalties due to SciDose 1,637 2,308 1,050 Royalties due to Sandoz, Inc. 1,249 — — Accrued research & development 1,784 1,307 1,498 Accrued professional fees 792 502 591 Accrued salary and other compensation 2,242 1,025 890 Accrued product costs 9,232 839 490 Deferred rent 521 — — All other — 304 445 Total Accrued expenses $ 24,405 $ 12,165 $ 9,671 Deferred Revenue Deferred revenue consists of the following: December 31, December 31, September 30, 2015 2014 2014 Deferred revenue The Medicines Company $ — $ 520 $ 585 Deferred Revenue for ongoing business — 520 585 Par Pharmaceuticals Companies, Inc. 5,500 5,500 5,500 Par Pharmaceuticals Companies, Inc./Tech Transfer 500 500 500 Deferred Revenue from Asset Sales (See Note 12) 6,000 6,000 6,000 Total Deferred revenue $ 6,000 $ 6,520 $ 6,585 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes Payable Convertible Notes The Company entered into a Convertible Note and Warrant Purchase Agreement (the "Convertible Note Agreements"), pursuant to which it issued $9,663 of Convertible Notes (the "Convertible Notes") to existing preferred stockholders. The loan funding was completed in two tranches on August 2, 2012 and September 26, 2012, respectively. Holders of the Convertible Notes were entitled to cumulative interest at an annual rate of 6% . Such interest accrued daily and was cumulative from the respective date. In addition, the holders received warrants to purchase preferred stock, which accrued at a monthly rate of 2% of the principal amount until the completion of a Qualified Financing, as defined in the Convertible Note Agreement, or August 1, 2013, whichever was sooner. The Convertible Notes and associated accrued interest were due and payable on August 1, 2013, unless the Convertible Notes converted earlier. Conversion could occur, upon certain triggering events or the holder elects to convert. Principal and interest accrued shall convert into shares of preferred stock: a) upon the attainment of a Qualified Financing, or b) on August 1, 2013, whichever is sooner. Upon conversion pursuant to (a), the aggregate amount converted will be divided by the offering price of the Qualified Financing to arrive at the amount of preferred stock that will be issued. Upon conversion pursuant to (b), the aggregate amount converted will be divided by $1.82 to arrive at the amount of preferred stock that will be issued. The Series C Preferred Share financing (See Note 8) represented a Qualified Financing whereby the Convertible Notes for those participating investors converted to Series C Preferred Shares. The Convertible Notes agreement was structured such that a portion of the shares of the Company's Series A preferred stock, Series B preferred stock and Series B-1 preferred stock, collectively the "Special Conversion Preferred", held by a holder, that did not participate in the financing to the full extent of its pro-rata share of preferred stock ownership (a "Non-Fully Participating Holder"), was converted into shares of the Company's Common Stock, and any dividends accumulated to date were forfeited. The option for existing preferred stockholders to participate in the Convertible Notes expired on October 1, 2012. On October 2, 2012, 8,943,447 shares of preferred stock held by Non-Fully Participating Holders were converted into 1,395,226 shares of Common Stock. Warrants Prior to the initial public offering, the Company accounted for the warrants as liability instruments. The Company estimated the initial fair value of the 944,210 warrants to be $655 using a Probability-Weighted Expected Returns valuation model. At each reporting period, any changes to the fair value of the warrants were recorded in the statements of operations. As of December 31, 2015 , December 31, 2014 and September 30, 2014, there were no warrants outstanding to purchase shares of common stock. The valuation model considered three scenarios. Two of the scenarios assumed a stockholder exit, either through sale, or dissolution. The third scenario assumed operations continue as a private company and no exit transaction occurred. The following assumptions were used in the valuation: exercise price of $1.82 ; implied stock price of $1.82 ; expected volatility of 64% ; expected dividend rate of 6% ; risk free interest rate of 0.83% and expiration date of six years . The following was a description of the key terms of the warrants per the warrant purchase agreement: • Exercise period — Exercisable, in whole or in part, during the six year term commencing on the earliest to occur of: (a) the consummation of a Qualified Financing, (b) immediately prior to the consummation of a Change of Control (but subject to and contingent upon such consummation of a Change of Control) and (c) the date one year after the Initial Closing or August 1, 2013. • Exercise Price — The purchase price for the Warrant Shares issuable was: (a) $1.82 , or (b) the offering price of a Qualified Financing should this occur prior to August 1, 2013. • No Rights as Stockholders — Prior to the exercise of the warrants, no holder of warrants (solely in its capacity as a holder of warrants) is entitled to any rights as a stockholder of the Company, including, without limitation, the right to vote, receive notice of any meeting of stockholders or receive dividends, allotments or other distributions. In February 2014, proceeds in the amount of $21 were received from the exercise of Series C preferred stock warrants for 1,788 common shares. In addition, Redeemable Series C preferred stock warrants were net exercised for 32,286 shares common stock upon the closing of the initial public offering. Warrant Liability On February 18, 2014 , the initial public offering date, the estimated fair value of the Convertible Note warrant liability was $2,280 which resulted in a charge to other income and expense of $383 . The change in the value of the warrant liability was $0 , $0 , $573 and $1,052 for fiscal 2015, the transition period, fiscal 2014 and 2013, respectively. As of September 30, 2013 , the estimated fair value of the Convertible Note warrant liability was $1,707 which resulted in a charge to other income and expense of $1,052 for the year ended September 30, 2013 . Upon the completion of the qualified offering, the warrants became exercisable into Series C Preferred Shares. The increase in the fair value of the warrant liability is primarily attributable to the liquidation preference of the Series C Preferred Shares to receive 2 times the original investment upon a liquidation event under certain circumstances. Debt Discount In connection with the Convertible Notes described above and as a result of the warrants issued with the Convertible Notes, the Company determined that a discount to the debt should be recorded in the amount of $655 , representing its fair value and recorded as a discount to the debt instrument and amortized over the life of the instrument. The amount recorded as interest expense during fiscal 2015, the transition period, fiscal 2014 and 2013 was $0 , $0 , $0 , and $545 , respectively. Due to the conversion of the Convertible Notes to preferred stock, the balance of the unamortized debt discount was written off during the year ended September 30, 2013, resulting in interest expense of $545 . Beneficial Conversion Feature A convertible financial instrument includes a beneficial conversion feature if the effective conversion price is less than the Company's market price of preferred stock on the commitment date. The effective price paid for a share is the amount allocated to the convertible instrument, divided by the number of shares the holder is entitled to upon conversion. If the convertible financial instrument is issued with warrants and/or other detachable instruments, the amount allocated to the convertible instrument is the face amount less the allocation to the detachable instruments. In connection with the Convertible Notes described above and as a result of the warrants issued with the Convertible Notes, the Company determined that the conversion rate represented a beneficial conversion feature. Accordingly, a discount on the notes was recorded in the amount of $655 . The discount was amortized ratably with a corresponding non-cash charge to interest expense. The amount recorded as interest expense during fiscal 2015, the transition period, fiscal 2014 and 2013 was approximately $0 , $0 , $0 , and $545 , respectively. Due to the conversion of the Convertible Notes to preferred stock, the balance of the unamortized beneficial conversion feature was written off during the year ended September 30, 2013, resulting in interest expense of $545 . |
Shares Subject to Redemption _
Shares Subject to Redemption — Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2015 | |
Financial Instruments Subject to Mandatory Redemption, Settlement Terms, Share Value, Amount [Abstract] | |
Shares Subject to Redemption - Convertible Preferred Stock | Shares Subject to Redemption — Convertible Preferred Stock Series A Convertible preferred stock On March 8, 2007, the Company issued 20,237,911 shares of Series A Convertible preferred stock, par value $0.001 (the "Series A preferred stock"). The outstanding shares of the Series A preferred stock (as amended in connection with the issuance of the Series B preferred stock) is redeemable after August 11, 2013 at a redemption price per share equal to the Original Issue Price of $0.971 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding Series A convertible preferred stock converted into 2,332,051 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series A preferred stock were recorded at their estimated fair value of $19,651 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $180 . The fair value of the Series A preferred stock had been increased through periodic accretions using the interest method for dividends (see "Preferred Stock Dividends" below) so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on the Series A preferred stock as of fiscal 2015, the transition period, and fiscal 2014 was $0 . The liquidation value of the Series A preferred stock was $0 as of fiscal 2015, the transition period, and fiscal 2014. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 of the Series A preferred stock was $ 97 . Series B Convertible Preferred Stock On August 11, 2008, the Company issued 16,052,343 shares of Series B Convertible preferred stock, par value $0.001 (the "Series B preferred stock"). The Series B preferred stock is redeemable as described above for the Series A preferred stock at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding Series B convertible preferred stock converted into 1,980,431 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series B preferred stock were recorded at their estimated fair value of $29,215 , which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $126 . The fair value of the Series B preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares as of fiscal 2015, the transition period, and fiscal 2014 was $0 . The liquidation value of the Series B preferred stock was $ 0 as of fiscal 2015, the transition period, and fiscal 2014. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 was $ 173 . Series B-1 Convertible Preferred Stock The Company consummated an offering of Series B-1 Convertible preferred stock, par value $0.001 (the "Series B-1 Preferred Stock") to its existing investors in two stages in February 2011 and July 2011. The Company issued an aggregate of 10,177,085 shares of Series B-1 preferred stock. The Series B-1 preferred stock is redeemable at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding series B-1 convertible preferred stock converted into 1,455,753 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series B-1 preferred stock were recorded at their estimated fair value of $17,522 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $144 . On August 2, 2012, the Company entered into a Payoff and Exchange Agreement with an Officer/Director. The Company accepted a total of 549,451 shares of Series B-1 preferred stock in exchange for satisfaction of the principal amount of debt. The total number of outstanding shares of Series B-1 preferred stock was 9,331,374 as of September 30, 2013 . The fair value of the Series B preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares was $0 as of fiscal 2015, the transition period, and fiscal 2014. The liquidation value of the Series B-1 preferred stock was $0 as of fiscal 2015, the transition period, and fiscal 2014. The accumulated dividend through the closing date of the initial public offering on February 18, 2014 of the Series B-1 preferred stock was $125 . Series C Convertible Preferred Stock The Company consummated an offering of Series C Convertible preferred stock, par value $0.001 (the "Series C preferred stock") on April 11, 2013. The Company issued an aggregate of 11,023,232 shares of Series C preferred stock. The Series C preferred stock is redeemable at a redemption price per share equal to the Original Issue Price of $1.82 per share plus accrued but unpaid dividends (see "Redemption" below). The outstanding series C convertible preferred stock converted into 1,719,693 shares of common stock upon the closing of the initial public offering. The outstanding shares of the Series C preferred stock were recorded at their estimated fair value of $20,062 which equaled the sale price on the date of issuance. The amount was adjusted for net offering costs of $167 . The fair value of the Series C preferred stock had been increased through periodic accretions using the interest method so that the carrying value equals the redemption amount on the redemption date. Accumulated dividends on redeemable shares was $0 as of fiscal 2015, the transition period, and fiscal 2014. The liquidation value of the Series C preferred stock was $0 as of fiscal 2015, the transition period, and fiscal 2014. The accumulated dividend through closing date of the initial public offering on February 18, 2014 of the Series C preferred stock was $139 . On October 2, 2012, holders of preferred stock who elected not to participate in the Convertible Notes (see "Notes Payable") had their preferred stock shares convert to Common stock. Upon conversion from preferred to common, the investors forfeited all accumulated dividends from their investment date and 5,289,405 shares of Series A preferred stock were converted into 825,177 shares of Common stock and $1,718 in accumulated dividends was forfeited, 3,357,782 shares of Series B preferred stock were converted into 532,832 shares of Common Stock and $1,520 in accumulated dividends was forfeited, and 296,260 shares of Series B-1 preferred stock were converted into 46,218 shares of Common stock and $49 in accumulated dividends was forfeited. Concurrent with the conversion, the Company reduced the amounts authorized for the Series A, Series B, and Series B-1 preferred stock to 14,948,506 shares, 12,694,561 shares and 9,331,374 shares, respectively. Preferred Stock Dividends Holders of Series A, Series B, Series B-1 and Series C Preferred Stockholders were entitled to cumulative dividends at an annual rate of 6% when and if declared. Such dividends accrued daily on a cumulative basis from the respective date of issuance of each such share of Preferred Stock, whether declared or not. Dividends were to be paid only when declared by the board of directors out of legally available funds or upon the first to occur of (i) payment of the Original Issue Price of each share of Preferred Stock in connection with a redemption or liquidation event or (ii) upon conversion of the Preferred Stock into Common Stock, unless the conversion was done in connection with a Qualified IPO or the sale of the Company under certain conditions ("Qualified Sale"), which would have caused the holder to forfeit such dividends. There were no accrued dividends for Series A, Series B, Series B-1 and Series C Preferred Stock as of fiscal 2015, the transition period, and fiscal 2014. |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Common Stock and Stock-Based Compensation | Common Stock and Stock-Based Compensation In December 2007, the Company's board of directors approved the 2007 Incentive Compensation Plan (the "2007 Plan") enabling the Company to grant multiple stock based awards to employees, directors and consultants, the most common being stock options and restricted stock awards. In November 2013, the Company's board of directors approved the 2014 Equity Incentive Plan (the "2014 Plan") which became effective on February 11, 2014. The 2007 Plan was terminated upon the effectiveness of the 2014 Plan and all shares available for issuance under the 2007 Plan were made available under the 2014 Plan. The 2014 Plan provides for the awards of incentive stock options, non-qualified stock options, restricted stock, restricted stock units and other stock-based awards. Awards generally vest equally over a period of four years from grant date. Vesting is accelerated under a change in control of the Company or in the event of death or disability to the recipient. In the event of termination, any unvested shares or options are forfeited. At the Company's annual meeting of stockholders held on August 4, 2015, the stockholders approved an amendment to the 2014 Plan to, among other things, increase the number of shares of common stock authorized for issuance thereunder by 500,000 shares. After accounting for such increase, and as of such amendment, the Company has reserved and made available 2,876,702 shares of common stock for issuance under the 2014 Plan. The Company recognized share-based compensation in its statements of operations for the year ended December 31, 2015 , the transition period, fiscal 2014 and 2013 as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Selling, general and administrative $ 2,780 $ 144 $ 303 $ 153 Research and development 1,271 140 303 164 Total $ 4,051 $ 284 $ 606 $ 317 The following table is a summary of the Company's stock options issued to employees, directors and consultants (amounts in thousands except per share amounts): Number of Stock Option Shares Weighted Average Exercise Price Non- Exercisable Exercisable Outstanding at September 30, 2013 813,259 $ 5.58 302,603 510,656 Granted 558,699 11.72 Exercised (12,034 ) 5.34 Forfeited or expired (50,931 ) Outstanding at September 30, 2014 1,308,993 $ 8.16 712,901 596,092 Granted 29,000 12.61 Exercised (4,513 ) 7.62 Forfeited or expired (11,310 ) Outstanding at December 31, 2014 1,322,170 $ 8.29 710,486 611,684 Granted 773,458 48.65 Exercised (211,190 ) 7.06 Forfeited or expired (39,596 ) Outstanding at December 31, 2015 1,844,842 $ 25.16 1,176,140 668,702 The weighted-average grant-date fair value of options granted during the year ended December 31, 2015 , the transition period, fiscal 2014 and 2013 was $15.92 , $6.73 , $4.61 and $1.73 , respectively. As of December 31, 2015 , there was $8,287 of unrecognized compensation cost, which will be expensed over the next 4 fiscal years. The total intrinsic value of options exercised during the year ended December 31, 2015 was $10,815 . There were 211,190 options exercised during the year ended December 31, 2015 . The weighted average contractual terms of options outstanding as of December 31, 2015 , the transition period, fiscal 2014 and 2013 was 7.5 , 7.5 and 7.5 and 7.0 years, respectively. The aggregate pre-tax intrinsic value of options outstanding as of December 31, 2015 , the transition period, fiscal 2014 and 2013 was $54.7 million , $9.6 million , $5.9 million , and $0.2 thousand , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The (benefit) provision for income taxes shown in the statement of operations is net of $3 , $4 , $4 and $2 for minimum state taxes for the years ended December 31, 2015 , the transition period, fiscal 2014 , and fiscal 2013 , respectively. A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, 2015 2014 2014 2013 Federal tax provision (benefit) at statutory rate 34.00 % (34.00 )% (34.00 )% (34.00 )% State tax benefit, net of Federal benefits 0.12 % (19.18 )% (6.72 )% (12.95 )% Non-cash interest and change in fair value of warrants liability — % (0.01 )% 1.07 % 13.82 % Meals and entertainment and other 0.91 % 0.08 % — % — % Change in valuation allowance (25.15 )% 31.25 % 32.25 % 25.11 % Other — % — % 0.06 % 0.22 % Research & Development Credit (9.76 )% 2.68 % 0.62 % (5.14 )% Tax provision (benefit) 0.12 % (19.18 )% (6.72 )% (12.94 )% Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets were as follows: December 31, September 30, 2015 2014 2014 2013 Deferred tax assets Net operating loss carryforward $ 30,837 $ 33,286 $ 32,527 $ 26,984 Research & development credit 2,790 2,790 1,886 2,033 Prepaid research & development expenses 1,884 2,264 2,354 2,573 Deposit Reserve 93 — — — Charitable contribution carryforward 64 71 80 28 Patent costs 57 68 70 77 Accrued vacation pay 36 34 54 — Other intangibles 26 33 34 39 Stock based compensation 2,100 1,057 944 688 Fixed assets 12 12 — 161 Other 2 11 2 2 Accrued bonus 705 309 204 — Advance billings — 208 234 208 Deferred compensation — 109 — — Returns and allowances — — — 24 Total deferred tax assets 38,606 40,252 38,389 32,817 Deferred tax liabilities Prepaid expenses 81 66 138 47 Other 7 7 — — Fixed assets — — 5 — Total deferred tax liabilities 88 73 143 47 Net deferred tax assets 38,518 40,179 38,246 32,770 Valuation allowance $ (38,518 ) $ (40,179 ) $ (38,246 ) $ (32,770 ) United States federal and state net operating losses of $10,300 represent excess tax benefits from the exercise of share based awards which will be recorded in additional paid-in capital when realized. Realization of the net deferred tax asset is dependent upon future taxable income, if any, the amount and timing of which are uncertain. Accordingly, the net deferred tax asset has been offset by a full valuation allowance. The valuation allowance decreased by $(1,661) as of December 31, 2015 . As of December 31, 2015 , the Company had federal and state net operating loss carryforwards of approximately $99,453 and $26,285 , respectively. As of December 31, 2015 , the Company also had a federal and state research and development tax credit carryforwards of approximately $2,790 and $0 , respectively. These net operating loss carryforwards and credits expire at various times through 2035. Section 382 of the Internal Revenue Code generally requires a corporation to limit the amount of its income in future years that can be offset by historic losses, i.e. net operating loss (NOL) carryforwards and certain built-in losses, after a corporation has undergone an ownership change. The Company has not been subject to a Section 382 limitation. In July 2006, the Financial Accounting Standards Board (“FASB”) issued ASC 740-10, Uncertainty in Income Taxes, which defines the threshold for recognizing the benefits of tax-return positions in the financial statements as “more-likely-than-not” to be sustained by the taxing authorities. This statement also requires explicit disclosure requirements about a Company’s uncertainties related to their income tax position, including a detailed roll-forward of tax benefits taken that do not qualify for financial statement recognition. The Company files income tax returns in the U.S. federal jurisdiction and several states. Given that the company has incurred tax losses since its inception, all of the Company’s tax years are effectively open to examination. The Company has no amount recorded for any unrecognized tax benefits as of December 31, 2015 nor did the Company record any amount for the implementation of ASC 740-10-25. The Company regularly evaluates its tax positions for additional unrecognized tax benefits and associated interest and penalties, if applicable. The Company believes that its accrual for tax liabilities is adequate for all open years. There are many factors that are considered when evaluating these tax positions including: interpretation of tax laws, recent tax litigation on a position, past audit or examination history, and subjective estimates and assumptions. In making these estimates and assumptions, the Company relies on advice from industry and subject matter experts, analyzes actions taken by taxing authorities, as well as the Company’s industry and audit experience. These evaluations are based on estimates and assumptions that have been deemed reasonable by management. However, if management’s estimates are not representative of actual outcomes, the Company’s results could be materially impacted. The Company received approval to sell a portion of the Company's New Jersey net operating losses and tax credits as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology firms with unused net operating loss carryovers and unused research and development credits are allowed to sell these benefits to other firms. The Company has participated in the Technology Business Tax Certificate Program since 2009. The most recent sales are detailed below: There were no New Jersey state net operating carryforwards sold during 2015. During the three months ended December 31, 2014 the Company sold New Jersey state net operating loss (NJ NOL) carry forwards and tax credits totaling $12,588 and $15 , respectively for net proceeds of $1,059 which is reflected as a tax benefit in the transition period. During the year ended September 30, 2014, the Company sold New Jersey state net operating loss (NJ NOL) carry forwards and tax credits totaling $25,389 and $177 , respectively for net proceeds of $1,295 which is reflected as a tax benefit in fiscal year 2014. In fiscal year ended September 30, 2013, the Company sold net operating losses and tax credits totaling $11,029 and $95 , respectively for net proceeds of $899 which is reflected as a tax benefit in fiscal year 2013. |
License Agreements of Developme
License Agreements of Development and Commercialization Rights | 12 Months Ended |
Dec. 31, 2015 | |
Research and Development [Abstract] | |
License Agreements of Development and Commercialization Rights | License Agreements of Development and Commercialization Rights Development On February 13, 2015, Eagle entered into an Exclusive License Agreement (the “Cephalon License”) with Cephalon, Inc. ("Cephalon"), a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for U.S. and Canadian rights to the Company's bendamustine hydrochloride (HCl) rapid infusion product for treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma. Pursuant to the terms of the Cephalon License, Cephalon is responsible for all U.S. commercial activities for the product including promotion and distribution, and Eagle is responsible for obtaining and maintaining all regulatory approvals and conducting post-approval clinical studies. Under the terms of the Cephalon License, Eagle received an upfront cash payment of $30.0 million , earned a milestone payment of $15.0 million and Eagle is currently eligible to receive up to $65.0 million in additional milestone payments. In addition, Eagle is entitled to receive royalty payments of 20% on net sales of the product, if approved by the FDA. In connection with the Cephalon License, Eagle entered into a supply agreement with Cephalon, pursuant to which Eagle will be responsible for supplying product to Cephalon for a specified period. Additionally, on February 13, 2015, Eagle and Cephalon entered into a Settlement and License Agreement (the "Cephalon Settlement Agreement"), pursuant to which the parties agreed to settle the pending patent infringement claims against each other regarding Cephalon's US Patent No. 8,791,270 and Cephalon filed a consent judgment between Cephalon and Eagle acknowledging the validity and enforceability of the ‘270 patent (the "Consent Judgment"). On October 13, 2015, the Company entered into an exclusive U.S. licensing agreement with Teikoku Pharma USA, Inc. ("Teikoku") to market, sell and distribute Docetaxel Injection Concentrate, Non-Alcohol Formula, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. The NDA for Docetaxel Injection for these indications was approved by the FDA on December 22, 2015. Under the terms of the agreement, the Company paid an upfront cash payment upon executing the agreement which was expensed and is included in research and development and an additional payment of $4,850 upon FDA approval and NDA transfer to Eagle, which occurred in January 2016, and double-digit royalties on gross profits. The Company has entered into several product development agreements with development partners whereby the Company acquired the exclusive rights in the United States and, in most cases, worldwide rights to a total of thirty-three products for ten years following first commercial sale of each product. The Company will share varying percentages of the profits after, in most cases, recapturing development, legal and certain operating costs, from the sales of the products with the development partners if the products are commercialized. The Company expenses these costs as incurred. Commercialization Rights In May 2008, the Company entered into a collaborative product development agreement with a Branded product company, whereby the Company has agreed to develop a product for the Brand Company. Under the terms of the agreement, the Brand Company acquired the exclusive worldwide rights to market the product for ten years following approval. The Company will receive a royalty on net sales of the product, dependent upon the achievement of certain goals. In addition, the Company received $750 upon signing which was non-refundable and recorded as revenue in the year it was received and it will receive milestones of up to $13,000 upon the achievement of certain goals. The Brand Company is also required to pay all out of pocket costs related to the project and also made payments to the Company totaling $2,000 for the development of the product, payable at $200 per month commencing in April 2008. In July 2013, an arbitration settlement between the two companies was reached. The Company then terminated the contract; therefore, no additional revenues will be recognized. |
Asset Sales
Asset Sales | 12 Months Ended |
Dec. 31, 2015 | |
Deferred Revenue Disclosure [Abstract] | |
Asset Sales | Asset Sales On March 28, 2012, the Company entered into an Asset Purchase Agreement (“APA”) with Hikma Pharmaceutical Co. LTD, or Hikma. Under the terms of the agreement, Hikma acquired exclusive U.S. rights to market diclofenac-misoprostol following regulatory approval. The Company received $3,500 upon signing the APA. This amount was included in deferred revenue until FDA approval, since it was otherwise refundable. In addition, the Company was entitled to receive another $1,000 upon regulatory approval, validation batch manufacturing with inventory released for launch, and sufficient launch inventory. Before approval, this approval milestone was to be reduced for each generic competitor that received regulatory approval (excluding an "authorized generic" version of the Brand Product); however, the milestone was not to be reduced to an amount less than $500 . The Company was to receive a royalty on Net Profits of the product for a period of ten years from the date of the first commercial sale of the product, with the royalty percentage varying depending upon certain events and competition. On June 24, 2013, Hikma filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging that the Company (a) breached the Hikma, APA by failing to refund the purchase price following Hikma's purported termination of the Hikma APA as a result of the Company failing to receive timely ANDA approval, and (b) intentionally failed to disclose alleged manufacturing product defects to Hikma. The Company believed that it did not fail to receive timely ANDA approval and therefore that Hikma was not entitled to (a) terminate the Hikma APA or (b) receive a refund of the purchase price. The Company also believed that it did not intentionally fail to disclose alleged manufacturing product defects to Hikma. If Hikma had prevailed on its claims, the Company could have been required to return the $3,500 purchase price plus interest, as well as other damages. The Company could not estimate the possible loss or range of loss related to the Hikma litigation beyond the $3,500 purchase price. On March 14, 2014, the Company received FDA approval of our Abbreviated New Drug Application for diclofenac-misoprostol tablets. The Company had not yet recognized the $3,500 as revenue since it was required to submit additional data to the FDA. In May 2014, under a CBE-30 supplement, the Company submitted additional data to the FDA with respect to manufacturing procedures of the product and achieved final approval in June 2014. On June 30, 2014, the Company had recognized the $3,500 purchase price as revenue in Other income as it had received FDA approval and subsequently complied with all FDA requirements. Pursuant to the in-license agreement for diclofenac-misoprostol, the Company estimated amounts due to the licensor. On August 8, 2014, the Company settled the lawsuit with Hikma related to the APA. Pursuant to the terms of the settlement the Company retained ownership of diclofenac-misoprostol including the rights to launch and commercialize the Product, and the Company will pay to Hikma a percentage of Net Profits after recovery of certain of the Company's expenses. During fiscal year 2010 and 2011, the Company divested another non-core product and received proceeds of $6,500 , comprised of $5,500 as a signing milestone which is recorded in deferred revenues and $500 for the initiation of Tech Transfer of which $250 remains in deferred revenues and a second payment of $500 for the completion of the Tech Transfer of which $250 remains in deferred revenues. Under the terms of this agreement, the licensor must obtain all of the following milestones in order for the Company to earn the revenues. These milestones are a) the receipt of an approval letter from the FDA, b) acknowledgment from the FDA that no further clinical studies will be needed and c) an approval letter from the FDA. If these milestones are not met, then the $6,000 in total included in deferred revenue on the balance sheet at December 31, 2015 , December 31, 2014 and September 31, 2014 must be refunded and the product rights are returned to the Company. Recent communications between the Company and purchaser have taken place and further clarification is required to determine if the amounts previously recorded as deferred revenue may be recognized as revenue. In addition, the Company may receive additional milestones of up to $3,000 in the future, dependent on the licensor's actively selling the product in an exclusive market position. See Note 6 for a summary of Deferred Revenue related to the Asset Sales. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments At December 31, 2015 , the Company has purchase obligations in the amount of $6,879 which represent the contractual commitments under Contract Manufacturing and Supply Agreements with suppliers. The obligation under the supply agreement is primarily for finished product and research and development. The Company leases its office space under a lease agreement that expires on June 30, 2020 . Rental expense was $514 , $68 , $277 and $314 for fiscal 2015, the transition period, fiscal 2014 and 2013, respectively. The remaining future lease payments under the operating lease are $ 2,488 as of December 31, 2015 , payable monthly through June 30, 2020 as follows: Total 2016 2017 2018 2019 2020 Beyond Operating lease obligations $ 2,488 515 564 564 564 281 — |
Arbitration
Arbitration | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Arbitration | Arbitration On October 26, 2011, the Company filed a Demand for Arbitration with the American Arbitration Association against a commercial partner that licensed one of its products. Eagle's claims include breach of contract relating to the development of a new formulation of the product and lack of effort to seek and obtain regulatory approval, ultimately impacting the marketing and sale of that new formulation. As a result, Eagle alleged that it had been significantly damaged. A three person arbitration panel was appointed. The trial was completed on January 25, 2013. In April 2013, the Company successfully renegotiated the terms of our legal fees to a contingent settlement as opposed to an hourly billing rate. As a result of the renegotiated terms, the Company recognized a $1,993 benefit. On July 19, 2013, the American Arbitration Association panel awarded the Company $5,000 for damages plus $24 for apportioned costs related to the arbitration for breach of contract. The Company received the funds in September 2013 and the amount was recorded in the results of operations, net of expenses of $974 in the fourth quarter of fiscal year 2013. |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings Claims and lawsuits may be filed against the Company from time to time. Although the results of pending claims are always uncertain, the Company believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from such actions. In September 2013, the Company filed a New Drug Application under Section 505(b)(2) for EP-3101, the Company's bendamustine hydrochloride injection, in a ready-to-dilute concentrate solution, product ("bendamustine RTD") and notified Cephalon, the holder of Treanda ® , the referenced approved drug in our application, of the Company's 505(b)(2) filing and paragraph IV certification. Cephalon filed a patent infringement lawsuit against the Company in the United States District Court for the District of Delaware on October 21, 2013 to defer the approval of the bendamustine indication alleging that the Company's tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents, U.S. Patent No. 8,445,524 (the "First Cephalon Lawsuit"). In July 2014, the FDA had granted tentative approval and orphan drug designation to the Company’s New Drug Application for patented bendamustine RTD for the treatment of NHL. In September 2014, Cephalon moved to dismiss with prejudice the First Cephalon Lawsuit. On August 12, 2014, Cephalon filed a second lawsuit in the District of Delaware alleging that bendamustine RTD infringes Cephalon’s newly-issued U.S. Patent No. 8,791,270 (the "Second Cephalon Lawsuit"). On February 13, 2015, the Company and Cephalon entered into the Cephalon Settlement Agreement pursuant to which the parties agreed to settle the Second Cephalon Lawsuit, under which the Company has agreed to enter into the Consent Judgment regarding the ‘270 patent. As part of the Cephalon Settlement Agreement, Cephalon has agreed to waive its orphan drug exclusivities for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma with EP-3102. In February 2016, The Medicines Company (“MDCO”) filed a complaint against the Company, SciDose LLC and TherDose Pharma Pvt. Ltd. (collectively the “Defendants”) relating to the Defendants’ work on a novel ready-to-use bivalirudin injection product (the “Bivalirudin Product”). The suit cites the May 7, 2008 License and Development Agreement (the “LDA”) between the Defendants and MDCO. In the lawsuit, MDCO alleges that the Company violated the terms of the LDA by, inter alia , developing the Bivalirudin Product, and that the Company's Bivalirudin Product infringes two patents that are jointly-owned by the Company and MDCO and violates an exclusive license that MDCO claims exists under the LDA. The Company disputes the allegations and believes it has meritorious defenses to all of MDCO’s allegations. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data - Unaudited | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data - Unaudited | Selected Quarterly Financial Data - Unaudited A summary of quarterly financial information for fiscal 2015 and fiscal 2014 is as follows: For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2015 2015 2015 2015 2015 (in thousands except share and per share amounts) Revenue $ 36,309 $ 6,002 $ 5,736 $ 18,180 $ 66,227 Income (Loss) from operations $ 20,090 $ (8,335 ) $ (10,388 ) $ 1,193 $ 2,560 Net income (loss) attributable to common stockholders $ 19,697 $ (8,177 ) $ (10,167 ) $ 1,218 $ 2,571 Income (loss) per share attributable to common stockholders- basic $ 1.38 $ (0.53 ) $ (0.65 ) $ 0.08 $ 0.17 Income (loss) per share attributable to common stockholders- diluted $ 1.31 $ (0.53 ) $ (0.65 ) $ 0.07 $ 0.16 For the Quarter Ended December 31, March 31, June 30, September 30, Total Fiscal Year 2014 2013 2014 2014 2014 (in thousands except share and per share amounts) Revenue $ 5,492 $ 5,005 $ 5,792 $ 2,810 $ 19,099 Loss from operations $ (3,065 ) $ (3,603 ) $ (2,982 ) $ (9,107 ) $ (18,757 ) Net loss attributable to common stockholders $ (4,387 ) $ (3,218 ) $ (2,934 ) $ (9,104 ) $ (19,643 ) Loss per share attributable to common stockholders- basic $ (1.44 ) $ (0.36 ) $ (0.21 ) $ (0.65 ) $ (1.97 ) Loss per share attributable to common stockholders- diluted $ (1.44 ) $ (0.36 ) $ (0.21 ) $ (0.65 ) $ (1.97 ) |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates These financial statements are presented in U.S. dollars and are prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements including disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period and accompanying notes. The Company's critical accounting policies are those that are both most important to the Company's financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. |
Accounting Guidance Not Yet Adopted | Accounting Guidance Not Yet Adopted In May 2014, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. In July 2015, the FASB finalized a one year delay in the effective date of this standard, which will now be effective for us on January 1, 2018, however early adoption is permitted any time after the original effective date, which for us is January 1, 2017. We have not yet selected a transition method and are currently evaluating the impact of ASU 2014-09 on our financial statements. In November 2015, the FASB issued ASU 2015-17, which revises the guidance in ASC 740, Income Taxes, to simplify the presentation of deferred income taxes and require that deferred tax liabilities and assets be classified as non-current in the statement of financial position. The guidance is to be applied either prospectively or retrospectively, and is effective for reporting periods (interim and annual) beginning after December 15, 2016 for public companies. Early adoption is permitted. The implementation of this ASU is not expected to have a material impact on our financial position or results of operations. In January 2016, the FASB issued ASU 2016-01, which revises the guidance in ASC 825-10, Recognition and Measurement of Financial Assets and Financial Liabilities, and provides guidance for the recognition, measurement, presentation, and disclosure of financial assets and liabilities. The guidance is effective for reporting periods (interim and annual) beginning after December 15, 2017, for public companies. We are currently assessing the potential impact of this ASU on our financial position and results of operations. In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. We are currently evaluating the impact of our pending adoption of the new standard on our financial statements. |
Reclassifications | Reclassifications Certain reclassifications have been made to prior year amounts to conform with the current year presentation |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. The Company, at times, maintains balances with financial institutions in excess of the FDIC limit. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company's financial instruments consist of cash and cash equivalents, short-term investments, accounts receivable, and accounts payable. The carrying values of these financial instruments approximate their fair values due to their short term maturities. |
Short Term Investments | Short Term Investments Investments consisted of U.S. Treasury securities that have an original maturity of greater than three months and typically less than 180 days. The Company's investments were classified as Level 1 and available-for-sale and are recorded at fair value, based upon quoted market prices. No gains or losses on investments are realized until the sale occurs or a decline in fair value is determined to be other-than-temporary. If a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established. |
Fair Value Measurements | Fair Value Measurements U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in 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. The fair value of interest-bearing cash and cash equivalents and short term investments are classified as Level 1 for all periods presented. The Company is required by U.S. GAAP to record certain assets and liabilities at fair value on a recurring basis. The guidance in ASC 815 required that the Company mark the value of its warrant liability to market and recognize the change in valuation in its statement of operations each reporting period. Determining the warrant liability to be recorded required the Company to develop estimates to be used in calculating the fair value of the warrant. Since these preferred stock warrants did not trade in an active securities market, the Company recognized a warrant liability and estimated the fair value of these warrants using a Probability-Weighted Expected Returns valuation model. Therefore, the warrant liability was considered a Level 3 measurement. |
Concentration of Major Customers and Vendors | Concentration of Major Customers and Vendors The Company is dependent on commercial partners to market and sell Argatroban. The Company's customers for Argatroban are its commercial and licensing partners, therefore, the Company's future revenues are highly dependent on these collaboration and distribution arrangements. The Company received a $30 million upfront payment during February 2015 and earned a $15 million milestone payment received in January 2016 upon product approval in December 2015 under the terms of the Cephalon License- See "revenue recognition" below for more detail. Currently, for argatroban, the Company uses one vendor as its sole source supplier. Because of the unique equipment and process for manufacturing argatroban, transferring manufacturing activities for argatroban to an alternate supplier would be a time consuming and costly endeavor, and there are only a limited number of manufacturers that are capable of performing this function for the Company. Our partner, Sandoz, Inc. experienced unusually high historical returns compared to their estimates in December 2015, which have decreased accounts receivable and royalty revenue by $2.9 million . Accounts receivable as of December 31, 2015 includes a $15 million receivable related to the approval of EP-3102 Bendeka milestone from Teva Pharmaceuticals. |
Pre-Launch Inventory | Pre-Launch Inventory The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value, when it is reasonably certain that the pre-launch inventories will be saleable. The determination to capitalize is made once the Company (or its third party development partners) has filed a New Drug Application (an "NDA") that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal hurdles will be cleared. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered, and accordingly, the time frame within which the determination is made varies from product to product. The Company may be required to write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. |
Inventory | Inventory Inventories, which consist of finished products, are recorded at the lower of cost or market, with cost determined on a first-in, first-out basis. The Company periodically reviews the composition of inventory in order to identify obsolete, slow-moving or otherwise non-saleable items. If non-saleable items are observed and there are no alternate uses for the inventory, the Company will record a write-down to net realizable value in the period that the decline in value is first recognized. In most instances, inventory is shipped from the Company's vendor directly to the Company's customers. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation is computed over the estimated useful lives of the assets utilizing the straight-line method. Leasehold improvements are being amortized over the shorter of their useful lives or the lease term. |
Research and Development Expense | Research and Development Expense Costs incurred for research and product development, including costs incurred for technology in the development stage, are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Advance payments for goods or services that will be used for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or services performed. |
Deferred Financing Costs | Deferred Financing Costs Prior to the initial public offering, costs relating to obtaining Convertible Notes were capitalized and amortized over the term of the related debt using the straight line method. |
Advertising and Marketing | Advertising and Marketing Advertising and marketing costs are expensed as incurred. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock The carrying value of redeemable convertible preferred stock was increased by periodic accretions, using the interest method so that the carrying amount would equal the redemption amount at the earliest redemption date. |
Accounting for Income Taxes | Accounting for Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company received approval to sell a portion of the Company's New Jersey net operating losses ("NOL's") as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology firms with unused net operating loss carryovers and unused research and development credits are allowed to sell these benefits to other firms. |
Revenue Recognition | Revenue Recognition Product revenue — The Company recognizes net revenue from Argatroban supplied to its commercial partners and Ryanodex ® and Diclofenac-misoprostol supplied to the end user, when the following four basic revenue recognition criteria under the related accounting guidance are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Prior to the shipment of manufactured products, the Company conducts initial product release and stability testing in accordance with cGMP. The Company's commercial partners can return the products within contracted specified timeframes if the products do not meet the applicable inspection tests. The Company estimates its return reserves based on its experience with historical return rates. Historically, product returns have not been material. The Company has a no return policy for Ryanodex ® . Revenues from product sales to end users are recorded net of provisions for estimated chargebacks, rebates, returns (if applicable), prompt pay discounts and other deductions, such as shelf stock adjustments, which can be reasonably estimated. When sales provisions are not considered reasonably estimable by Eagle, the revenue is deferred to a future period when more information is available to evaluate the impact. Royalties — The Company recognizes revenue from royalties based on its commercial partners' net sales of products. Royalties are recognized as earned in accordance with contract terms when they can be reasonably estimated and collectability is reasonably assured. The Company's commercial partners are obligated to report their net product sales and the resulting royalty due to the Company within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company accrues royalty revenue each quarter and subsequently determines a true-up when it receives royalty reports from its commercial partners. Historically, these true-up adjustments have been immaterial. License revenue — The Company analyzes each element of our licensing agreements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments over the period of significant involvement under the related agreements unless the fee is in exchange for products delivered or services rendered that represent the culmination of a separate earnings process and no further performance obligation exists under the contract. When a sale combines multiple elements upon performance of multiple services, the Company allocates revenue for transactions that include multiple elements to each unit of accounting based on its relative selling price, and recognizes revenue for each unit of accounting when the revenue recognition criteria have been met. The Company follows the selling price hierarchy as outlined in the guidance Revenue Recognition (ASC Topic 605) - Multiple-Deliverable Revenue Arrangements . The guidance provides a hierarchy to determine the selling price to be used for allocating revenue to deliverables: (i) vendor-specific objective evidence (“VSOE”), (ii) third-party evidence (“TPE”) if available and when VSOE is not available, and (iii) best estimate of the selling price (“BESP”) if neither VSOE nor TPE is available. The Company uses BESP to determine the standalone selling price for such deliverables. The Company has an established process for developing BESP, which incorporates, pricing practices, historical selling prices, the effect of market conditions as well as entity-specific factors. Estimated selling price is monitored and evaluated on a regular basis to ensure that changes in circumstances are accounted for in a timely manner. The Company recognizes milestone payments as revenue upon the achievement of specified milestones only if (1) the milestone payment is non-refundable, (2) substantive effort is involved in achieving the milestone, (3) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone, and (4) the milestone is at risk for both parties. If any of these conditions are not met, we defer the milestone payment and recognize it as revenue over the estimated period of performance under the contract. As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million , earned a milestone payment of $15 million and is eligible to receive up to $65 million in additional milestone payments. The $30 million upfront payment was allocated between the license issued to Cephalon and obtaining and maintaining regulatory approvals and conducting post-approval clinical studies using the Company’s best estimate of selling price for each deliverable. The full $30 million was recognized as income in February 2015, as the Company substantially completed its requirements for obtaining regulatory approval, which consisted of filing the New Drug Application on February 13, 2015, and the remaining obligations were estimated to require minimal effort. On December 8, 2015, the FDA approved Bendeka TM (50 mL bendamustine hydrochloride) marking the achievement of a milestone which entitled the Company to receive a $15 million payment. The remaining milestones, if achieved, will be recognized in the period earned. In addition, the Company is entitled to receive royalty payments equal to 20% of net sales of the product, if approved by the FDA. In connection with the Cephalon License, the Company agreed to enter into a supply agreement with Cephalon, pursuant to which the Company will be responsible for supplying product to Cephalon for a specified period. Collaborative licensing and development revenue — The Company recognizes revenue from reimbursements received in connection with feasibility studies and development work for third parties when its contractual services are performed, provided collectability is reasonably assured. Its principal costs under these agreements include its personnel conducting research and development, and its allocated overhead, as well as the research and development performed by outside contractors or consultants. Upon termination of a collaboration agreement, any remaining non-refundable license fees received by the Company, which had been deferred, are generally recognized in full. All such recognized revenues are included in collaborative licensing and development revenue in its statements of operations. The Company recognizes revenue from milestone payments received under collaboration agreements when earned, provided that the milestone event is substantive, its achievability was not reasonably assured at the inception of the agreement, the Company has no further performance obligations relating to the event, and collectability is reasonably assured. If these criteria are not met, the Company recognizes milestone payments ratably over the remaining period of its performance obligations under the collaboration agreement. See Note 11 regarding Asset Sales related to Other Income of $3,500 recognized in June 2014. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation using the fair value provisions of ASC 718, Compensation — Stock Compensation that requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based payments including stock options and restricted stock. This topic requires companies to estimate the fair value of the stock-based awards on the date of grant for options issued to employees and directors. The Company uses a Black-Scholes valuation model as the most appropriate valuation method for pricing these options. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees . Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. There are customary limitations on the sale or transfer of the stock. The risk-free rate assumption was based on U.S. Treasury instruments whose term was consistent with the expected term of the stock options. The expected stock price volatility was determined by examining the historical volatilities for industry peers as the Company did not have sufficient trading history for its common stock. Industry peers consist of those companies in the pharmaceutical industry similar in size, stage of life-cycle and financial leverage. The expected term of stock options represents the average of the vesting period and the contractual life of the option for employees and the life of the option for consultants. The expected dividend assumption is based on the Company's history and expectation of future dividend payouts. Changes in the estimated forfeiture rates are reflected prospectively. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share Basic earnings (loss) per common share is computed using the weighted average number of shares outstanding during the period. Diluted earnings per share is computed in a manner similar to the basic earnings (loss) per share, except that the weighted-average number of shares outstanding is increased to include all common shares, including those with the potential to be issued by virtue of warrants, options, convertible debt and other such convertible instruments. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if they are dilutive in nature with regards to earnings per share. |
Transition Period (Tables)
Transition Period (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Comparative Financial Information | The following table provides certain unaudited comparative financial information for the same period of the prior year. Three Months Ended 2014 2013 (unaudited) Revenue: Product sales $ 1,506 $ 2,224 Royalty income 4,094 3,268 Total revenue 5,600 5,492 Operating expenses: Cost of revenue 4,489 4,624 Research and development 3,986 2,589 Selling, general and administrative 3,690 1,344 Total operating expenses 12,165 8,557 Loss from operations (6,565 ) (3,065 ) Interest income 1 1 Interest expense (1 ) — Change in value of warrant liability — (191 ) Total other (expense) — (190 ) Loss before income tax benefit (6,565 ) (3,255 ) Income tax benefit 1,059 — Net Loss $ (5,506 ) $ (3,255 ) Less dividends on Series A, B, B-1 and — (1,132 ) Net loss attributable to common stockholders $ (5,506 ) $ (4,387 ) Loss per share attributable to common stockholders Basic and diluted $ (0.39 ) $ (1.44 ) Weighted average common shares outstanding Basic and diluted 14,032,828 3,048,131 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule of Revenue by Major Customers by Reporting Segments | The total revenues and accounts receivables broken down by major customers as a percentage of the total are as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Net product sales, royalty and license revenues The Medicines Company 14 % 36 % 45 % 54 % Sandoz, Inc. 5 % 55 % 53 % 46 % Cephalon, Inc. (Teva) - See Revenue Recognition 68 % — % — % — % Other 13 % 9 % 2 % — % 100 % 100 % 100 % 100 % December 31, December 31, September 31, 2015 2014 2014 Accounts receivable The Medicines Company 35 % 61 % 75 % Sandoz, Inc. — % 35 % 18 % Cephalon, Inc. (Teva) - See Revenue Recognition 57 % — % — % Other 8 % 4 % 7 % 100 % 100 % 100 % |
Schedule of Fair Value Assumptions of Stock Options Granted | The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Year Ended December 31, Three Months Ended December 31, Year Ended Year Ended 2015 2014 2014 2013 Risk-free interest rate 1.42% - 2.09% 2.11% - 2.16% 1.77% - 2.16% .95% - 2.53% Volatility 28.4% - 32.9% 39.45% 33.64% - 64.00% 64.00% Expected term (in years) 5.5-7.0 years 6.59 - 10.00 years 6.07 - 9.39 years 6.07 - 10.00 years Expected dividend yield 0.0% 0.0% 0.0% 0.0% |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The anti-dilutive common shares equivalents outstanding at December 31, 2015 , the transition period, fiscal 2014 and 2013 were as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Series A — — 888,099 2,332,059 Series B — — 754,191 1,980,429 Series B-1 — — 554,382 1,455,750 Series C — — 654,896 1,719,690 Series C warrants — — 56,078 147,254 Options 96,610 1,302,685 963,495 813,529 Total 96,610 1,302,685 3,871,141 8,448,711 |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation for basic and diluted net income (loss) per share for December 31, 2015 , the transition period, fiscal 2014 and 2013: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Numerator Numerator for basic earnings per share-net income (loss) $ 2,571 $ (5,506 ) $ (19,643 ) $ (9,885 ) Numerator for diluted earnings per share-net income (loss) $ 2,571 $ (5,506 ) $ (19,643 ) $ (9,885 ) Denominator Basic weighted average common shares outstanding 15,250,154 14,032,828 9,955,937 3,044,308 Dilutive effect of stock options 1,003,627 — — — Diluted weighted average common shares outstanding 16,253,781 14,032,828 9,955,937 3,044,308 Basic net income (loss) per share Basic net income (loss) per share $ 0.17 $ (0.39 ) $ (1.97 ) $ (3.25 ) Diluted net income (loss) per share Diluted net income (loss) per share $ 0.16 $ (0.39 ) $ (1.97 ) $ (3.25 ) |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories consist of the following: December 31, December 31, September 30, 2015 2014 2014 Raw material $ 8,687 $ — $ — Work in process 6,044 — — Finished products 311 1,242 1,294 $ 15,042 $ 1,242 $ 1,294 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment at consist of the following: December 31, December 31, September 30, Estimated Useful Life (years) 2015 2014 2014 Furniture and equipment $ 582 $ 297 $ 297 7 Office equipment 328 204 193 3 Equipment 1,182 594 593 7 Leasehold improvements 978 41 41 2 3,070 1,136 1,124 Less accumulated depreciation and amortization (865 ) (794 ) (780 ) Property and equipment, net $ 2,205 $ 342 $ 344 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following: December 31, December 31, September 30, 2015 2014 2014 Prepaid expenses and other current assets Prepaid product costs $ 85 $ 1,020 $ 840 Prepaid FDA user fee 551 148 197 Prepaid insurance 218 183 345 Prepaid research and development 283 — — Prepaid income taxes 508 — — All other 220 289 329 Total Prepaid expenses and other current assets $ 1,865 $ 1,640 $ 1,711 |
Schedule of Accrued Expenses | Accrued expenses consist of the following: December 31, December 31, September 30, 2015 2014 2014 Accrued expenses Royalties due to The Medicines Company $ 6,948 $ 5,880 $ 4,707 Royalties due to SciDose 1,637 2,308 1,050 Royalties due to Sandoz, Inc. 1,249 — — Accrued research & development 1,784 1,307 1,498 Accrued professional fees 792 502 591 Accrued salary and other compensation 2,242 1,025 890 Accrued product costs 9,232 839 490 Deferred rent 521 — — All other — 304 445 Total Accrued expenses $ 24,405 $ 12,165 $ 9,671 |
Schedule of Deferred Revenue | Deferred revenue consists of the following: December 31, December 31, September 30, 2015 2014 2014 Deferred revenue The Medicines Company $ — $ 520 $ 585 Deferred Revenue for ongoing business — 520 585 Par Pharmaceuticals Companies, Inc. 5,500 5,500 5,500 Par Pharmaceuticals Companies, Inc./Tech Transfer 500 500 500 Deferred Revenue from Asset Sales (See Note 12) 6,000 6,000 6,000 Total Deferred revenue $ 6,000 $ 6,520 $ 6,585 |
Common Stock and Stock-Based 30
Common Stock and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Recognized Share-based Compensation in Statements of Operations | The Company recognized share-based compensation in its statements of operations for the year ended December 31, 2015 , the transition period, fiscal 2014 and 2013 as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, Year Ended September 30, 2015 2014 2014 2013 Selling, general and administrative $ 2,780 $ 144 $ 303 $ 153 Research and development 1,271 140 303 164 Total $ 4,051 $ 284 $ 606 $ 317 |
Schedule of Stock Option Activity | The following table is a summary of the Company's stock options issued to employees, directors and consultants (amounts in thousands except per share amounts): Number of Stock Option Shares Weighted Average Exercise Price Non- Exercisable Exercisable Outstanding at September 30, 2013 813,259 $ 5.58 302,603 510,656 Granted 558,699 11.72 Exercised (12,034 ) 5.34 Forfeited or expired (50,931 ) Outstanding at September 30, 2014 1,308,993 $ 8.16 712,901 596,092 Granted 29,000 12.61 Exercised (4,513 ) 7.62 Forfeited or expired (11,310 ) Outstanding at December 31, 2014 1,322,170 $ 8.29 710,486 611,684 Granted 773,458 48.65 Exercised (211,190 ) 7.06 Forfeited or expired (39,596 ) Outstanding at December 31, 2015 1,844,842 $ 25.16 1,176,140 668,702 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows: Year Ended December 31, Three Months Ended December 31, Year Ended September 30, 2015 2014 2014 2013 Federal tax provision (benefit) at statutory rate 34.00 % (34.00 )% (34.00 )% (34.00 )% State tax benefit, net of Federal benefits 0.12 % (19.18 )% (6.72 )% (12.95 )% Non-cash interest and change in fair value of warrants liability — % (0.01 )% 1.07 % 13.82 % Meals and entertainment and other 0.91 % 0.08 % — % — % Change in valuation allowance (25.15 )% 31.25 % 32.25 % 25.11 % Other — % — % 0.06 % 0.22 % Research & Development Credit (9.76 )% 2.68 % 0.62 % (5.14 )% Tax provision (benefit) 0.12 % (19.18 )% (6.72 )% (12.94 )% |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company's deferred tax assets were as follows: December 31, September 30, 2015 2014 2014 2013 Deferred tax assets Net operating loss carryforward $ 30,837 $ 33,286 $ 32,527 $ 26,984 Research & development credit 2,790 2,790 1,886 2,033 Prepaid research & development expenses 1,884 2,264 2,354 2,573 Deposit Reserve 93 — — — Charitable contribution carryforward 64 71 80 28 Patent costs 57 68 70 77 Accrued vacation pay 36 34 54 — Other intangibles 26 33 34 39 Stock based compensation 2,100 1,057 944 688 Fixed assets 12 12 — 161 Other 2 11 2 2 Accrued bonus 705 309 204 — Advance billings — 208 234 208 Deferred compensation — 109 — — Returns and allowances — — — 24 Total deferred tax assets 38,606 40,252 38,389 32,817 Deferred tax liabilities Prepaid expenses 81 66 138 47 Other 7 7 — — Fixed assets — — 5 — Total deferred tax liabilities 88 73 143 47 Net deferred tax assets 38,518 40,179 38,246 32,770 Valuation allowance $ (38,518 ) $ (40,179 ) $ (38,246 ) $ (32,770 ) |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | The remaining future lease payments under the operating lease are $ 2,488 as of December 31, 2015 , payable monthly through June 30, 2020 as follows: Total 2016 2017 2018 2019 2020 Beyond Operating lease obligations $ 2,488 515 564 564 564 281 — |
Selected Quarterly Financial 33
Selected Quarterly Financial Data - Unaudited (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | A summary of quarterly financial information for fiscal 2015 and fiscal 2014 is as follows: For the Quarter Ended March 31, June 30, September 30, December 31, Total Fiscal Year 2015 2015 2015 2015 2015 (in thousands except share and per share amounts) Revenue $ 36,309 $ 6,002 $ 5,736 $ 18,180 $ 66,227 Income (Loss) from operations $ 20,090 $ (8,335 ) $ (10,388 ) $ 1,193 $ 2,560 Net income (loss) attributable to common stockholders $ 19,697 $ (8,177 ) $ (10,167 ) $ 1,218 $ 2,571 Income (loss) per share attributable to common stockholders- basic $ 1.38 $ (0.53 ) $ (0.65 ) $ 0.08 $ 0.17 Income (loss) per share attributable to common stockholders- diluted $ 1.31 $ (0.53 ) $ (0.65 ) $ 0.07 $ 0.16 For the Quarter Ended December 31, March 31, June 30, September 30, Total Fiscal Year 2014 2013 2014 2014 2014 (in thousands except share and per share amounts) Revenue $ 5,492 $ 5,005 $ 5,792 $ 2,810 $ 19,099 Loss from operations $ (3,065 ) $ (3,603 ) $ (2,982 ) $ (9,107 ) $ (18,757 ) Net loss attributable to common stockholders $ (4,387 ) $ (3,218 ) $ (2,934 ) $ (9,104 ) $ (19,643 ) Loss per share attributable to common stockholders- basic $ (1.44 ) $ (0.36 ) $ (0.21 ) $ (0.65 ) $ (1.97 ) Loss per share attributable to common stockholders- diluted $ (1.44 ) $ (0.36 ) $ (0.21 ) $ (0.65 ) $ (1.97 ) |
Organization and Business Act34
Organization and Business Activities (Details) | Mar. 20, 2015USD ($)$ / sharesshares | Feb. 13, 2015USD ($) | Mar. 18, 2014shares | Feb. 18, 2014$ / sharesshares | Oct. 02, 2012shares | Jan. 31, 2016USD ($) | Mar. 18, 2014USD ($)shares | Feb. 28, 2014USD ($)shares | Dec. 31, 2014USD ($)shares | Dec. 31, 2015USD ($)productshares | Sep. 30, 2014USD ($)shares | Sep. 30, 2013USD ($) |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of products being sold | product | 5 | |||||||||||
Aggregate net proceeds received from IPO | $ | $ 46,069,000 | $ 0 | $ 0 | $ 46,069,000 | $ 0 | |||||||
Proceeds from exercise of preferred stock warrants | $ | $ 21,000 | $ 21,000 | $ 0 | $ 0 | $ 21,000 | $ 0 | ||||||
Issuance of common stock upon exercise of Redeemable Series C preferred stock warrants, shares | 1,788 | 1,788 | ||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | |||||||||
Preferred stock, shares authorized | 1,500,000 | 1,500,000 | 0 | |||||||||
Other offering expenses payable | $ | $ 0 | |||||||||||
IPO | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Reverse stock split in connection with IPO | 0.1560 | |||||||||||
Common stock, shares authorized | 50,000,000 | |||||||||||
Preferred stock, shares authorized | 1,500,000 | |||||||||||
Follow-on Offering | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Other offering expenses payable | $ | $ 54,331,000 | |||||||||||
Common stock | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Conversion of preferred shares to common stock | 1,395,226 | |||||||||||
Common stock | IPO | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Issuance of common stock in connection with initial public offering, net of offering costs | 3,350,000 | |||||||||||
IPO share price | $ / shares | $ 15 | |||||||||||
Common stock | Over-allotment option | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Issuance of common stock in connection with initial public offering, net of offering costs | 100,000 | |||||||||||
Common stock | Follow-on Offering | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Issuance of common stock in connection with initial public offering, net of offering costs | 1,388,517 | |||||||||||
IPO share price | $ / shares | $ 42 | |||||||||||
Underwritten public offering (in shares) | 1,518,317 | |||||||||||
Issuance of common stock, additional period underwriters may purchase | 30 days | |||||||||||
Issuance of common stock, number of shares underwriters may purchase during additional period | 198,041 | |||||||||||
Issuance of common stock, portion from company in SPO (in shares) | 129,800 | |||||||||||
Preferred stock | IPO | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Conversion of preferred shares to common stock | 7,487,928 | |||||||||||
Warrants | IPO | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Conversion of preferred shares to common stock | 32,286 | |||||||||||
Cephalon, Inc. | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Upfront cash (payment) proceeds for license agreement | $ | $ 30,000,000 | |||||||||||
Maximum additional milestone payments | $ | $ 65,000,000 | |||||||||||
Royalty payments if product is approved, percentage of net sales | 20.00% | |||||||||||
Cephalon, Inc. | Subsequent Event | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Milestone payment received | $ | $ 15,000,000 | |||||||||||
Teikoku | Subsequent Event | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Milestone payment received | $ | $ 4,850,000 | |||||||||||
Royalty revenue, percentage of gross profits | 20.00% |
Transition Period (Details)
Transition Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Revenue: | ||||||||||||
Product sales | $ 1,506 | $ 2,224 | $ 12,968 | $ 4,626 | $ 5,315 | |||||||
Royalty income | 4,094 | 3,268 | 8,259 | 10,708 | 8,364 | |||||||
Total revenue | $ 18,180 | $ 5,736 | $ 6,002 | $ 36,309 | 5,600 | $ 2,810 | $ 5,792 | $ 5,005 | 5,492 | 66,227 | 19,099 | 13,679 |
Operating expenses: | ||||||||||||
Cost of revenue | 4,489 | 4,624 | 15,647 | 11,714 | 7,381 | |||||||
Research and development | 3,986 | 2,589 | 27,855 | 16,816 | 9,795 | |||||||
Selling, general and administrative | 3,690 | 1,344 | 20,165 | 9,326 | 4,958 | |||||||
Total operating expenses | 12,165 | 8,557 | 63,667 | 37,856 | 22,134 | |||||||
Income (Loss) from operations | 1,193 | (10,388) | (8,335) | 20,090 | (6,565) | (9,107) | (2,982) | (3,603) | (3,065) | 2,560 | (18,757) | (8,455) |
Interest income | 1 | 1 | 25 | 31 | 3 | |||||||
Interest expense | (1) | 0 | (11) | (8) | (309) | |||||||
Change in value of warrant liability | 0 | (191) | 0 | (573) | (1,052) | |||||||
Total other income/(expense) | 0 | (190) | 14 | (515) | 1,508 | |||||||
Income (Loss) before income tax benefit | (6,565) | (3,255) | 2,574 | (19,272) | (6,947) | |||||||
Income tax (provision) benefit | 1,059 | 0 | (3) | 1,295 | 899 | |||||||
Net Income (Loss) | (5,506) | (3,255) | 2,571 | (17,977) | (6,048) | |||||||
Less dividends on Series A, B, B-1 and C Convertible Preferred Stock | 0 | (1,132) | 0 | (1,666) | (3,837) | |||||||
Net income (loss) attributable to common stockholders | $ 1,218 | $ (10,167) | $ (8,177) | $ 19,697 | $ (5,506) | $ (9,104) | $ (2,934) | $ (3,218) | $ (4,387) | $ 2,571 | $ (19,643) | $ (9,885) |
Loss per share attributable to common stockholders Basic and diluted (in dollars per share) | $ (0.39) | $ (1.44) | ||||||||||
Weighted average common shares outstanding Basic and diluted (in shares) | 14,032,828 | 3,048,131 |
Summary of Significant Accoun36
Summary of Significant Accounting Policies - Narrative (Details) | Feb. 13, 2015USD ($) | Jun. 30, 2014USD ($) | Jan. 31, 2016USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | Dec. 31, 2015USD ($)vendorshares | Sep. 30, 2014USD ($)shares | Sep. 30, 2013USD ($) | Sep. 26, 2012shares |
Short-term Debt [Line Items] | ||||||||||
Warrants outstanding (in shares) | shares | 0 | |||||||||
Decrease in accounts receivable | $ (4,660,000) | $ (14,311,000) | $ (2,172,000) | $ (3,543,000) | ||||||
Decrease in royalty revenue | (4,094,000) | $ (3,268,000) | (8,259,000) | (10,708,000) | (8,364,000) | |||||
Accounts receivable | 11,956,000 | 26,267,000 | 7,296,000 | |||||||
Amortization of deferred financing costs | 0 | 0 | 0 | 96,000 | ||||||
Advertising and marketing costs | 1,556,000 | 4,752,000 | 2,506,000 | 0 | ||||||
Income tax (provision) benefit | $ (1,059,000) | $ 0 | $ 3,000 | $ (1,295,000) | $ (899,000) | |||||
Reporting term for partners' net product sales, royalty revenue | 60 days | |||||||||
Convertible Note and Warrant Purchase Agreement | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Warrants outstanding (in shares) | shares | 0 | 0 | 0 | 944,210 | ||||||
Convertible Note and Warrant Purchase Agreement | Convertible notes payable | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Unamortized deferred financing costs | $ 0 | $ 0 | $ 0 | |||||||
Cephalon, Inc. | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Upfront cash proceeds for license agreement | $ 30,000,000 | |||||||||
Accounts receivable | 15,000,000 | |||||||||
Maximum additional milestone payments | $ 65,000,000 | |||||||||
Royalty payments if product is approved, percentage of net sales | 20.00% | |||||||||
Sandoz, Inc. | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Decrease in accounts receivable | $ 2,900,000 | |||||||||
Decrease in royalty revenue | $ 2,900,000 | |||||||||
Hikma Pharmaceuticals, Co. Ltd. | Asset sales | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Deferred revenue | $ 3,500,000 | $ 3,500,000 | ||||||||
Argatroban | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Number of vendors | vendor | 1 | |||||||||
Subsequent Event | Cephalon, Inc. | ||||||||||
Short-term Debt [Line Items] | ||||||||||
Milestone payment received | $ 15,000,000 |
Summary of Significant Accoun37
Summary of Significant Accounting Policies - Major Customers as a Percentage (Details) - Customer Concentration Risk | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Net Revenues | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 100.00% | 100.00% | 100.00% | 100.00% |
Net Revenues | The Medicines Company | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 36.00% | 14.00% | 45.00% | 54.00% |
Net Revenues | Sandoz, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 55.00% | 5.00% | 53.00% | 46.00% |
Net Revenues | Cephalon, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 0.00% | 68.00% | 0.00% | 0.00% |
Net Revenues | Other | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 9.00% | 13.00% | 2.00% | 0.00% |
Accounts Receivable | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 100.00% | 100.00% | 100.00% | |
Accounts Receivable | The Medicines Company | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 61.00% | 35.00% | 75.00% | |
Accounts Receivable | Sandoz, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 35.00% | 0.00% | 18.00% | |
Accounts Receivable | Cephalon, Inc. | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 0.00% | 57.00% | 0.00% | |
Accounts Receivable | Other | ||||
Concentration Risk [Line Items] | ||||
Percentage of concentration | 4.00% | 8.00% | 7.00% |
Summary of Significant Accoun38
Summary of Significant Accounting Policies - Assumption of Stock Options Granted (Details) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 2.11% | 1.42% | 1.77% | 0.95% |
Risk-free interest maximum rate | 2.16% | 2.09% | 2.16% | 2.53% |
Volatility | 39.45% | 64.00% | ||
Volatility minimum | 28.40% | 33.64% | ||
Volatility maximum | 32.90% | 64.00% | ||
Expected dividend yield | 0.00% | |||
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term | 6 years 215 days | 5 years 182 days | 6 years 26 days | 6 years 26 days |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term | 10 years | 7 years | 9 years 142 days | 10 years |
Summary of Significant Accoun39
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) - shares | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 1,302,685 | 96,610 | 3,871,141 | 8,448,711 |
Series A | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 0 | 0 | 888,099 | 2,332,059 |
Series B | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 0 | 0 | 754,191 | 1,980,429 |
Series B-1 | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 0 | 0 | 554,382 | 1,455,750 |
Series C | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 0 | 0 | 654,896 | 1,719,690 |
Series C warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 0 | 0 | 56,078 | 147,254 |
Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding | 1,302,685 | 96,610 | 963,495 | 813,529 |
Summary of Significant Accoun40
Summary of Significant Accounting Policies - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Accounting Policies [Abstract] | ||||||||||||
Net income (loss) attributable to common stockholders | $ 1,218 | $ (10,167) | $ (8,177) | $ 19,697 | $ (5,506) | $ (9,104) | $ (2,934) | $ (3,218) | $ (4,387) | $ 2,571 | $ (19,643) | $ (9,885) |
Basic weighted average common shares outstanding (in shares) | 14,032,828 | 15,250,154 | 9,955,937 | 3,044,308 | ||||||||
Dilutive effect of stock options (in shares) | 0 | 1,003,627 | 0 | 0 | ||||||||
Diluted weighted average common shares outstanding (in shares) | 14,032,828 | 16,253,781 | 9,955,937 | 3,044,308 | ||||||||
Income (loss) per share attributable to common stockholders- basic (in dollars per share) | $ 0.08 | $ (0.65) | $ (0.53) | $ 1.38 | $ (0.39) | $ (0.65) | $ (0.21) | $ (0.36) | $ (1.44) | $ 0.17 | $ (1.97) | $ (3.25) |
Income (loss) per share attributable to common stockholders- diluted (in dollars per share) | $ 0.07 | $ (0.65) | $ (0.53) | $ 1.31 | $ (0.39) | $ (0.65) | $ (0.21) | $ (0.36) | $ (1.44) | $ 0.16 | $ (1.97) | $ (3.25) |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Inventory Disclosure [Abstract] | |||
Raw material | $ 8,687 | $ 0 | $ 0 |
Work in process | 6,044 | 0 | 0 |
Finished products | 311 | 1,242 | 1,294 |
Inventories | $ 15,042 | $ 1,242 | $ 1,294 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Property, Plant and Equipment [Line Items] | ||||
Property and equipment | $ 1,136 | $ 3,070 | $ 1,124 | |
Less accumulated depreciation and amortization | (794) | (865) | (780) | |
Property and equipment, net | 342 | 2,205 | 344 | |
Depreciation expense | 13 | 112 | 104 | $ 135 |
Furniture and equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment | 297 | $ 582 | 297 | |
Estimated Useful Life (years) | 7 years | |||
Office equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment | 204 | $ 328 | 193 | |
Estimated Useful Life (years) | 3 years | |||
Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment | 594 | $ 1,182 | 593 | |
Estimated Useful Life (years) | 7 years | |||
Leasehold improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property and equipment | $ 41 | $ 978 | $ 41 | |
Estimated Useful Life (years) | 2 years |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Balance Sheet Related Disclosures [Abstract] | |||
Prepaid product costs | $ 85 | $ 1,020 | $ 840 |
Prepaid FDA user fee | 551 | 148 | 197 |
Prepaid insurance | 218 | 183 | 345 |
Prepaid research and development | 283 | 0 | 0 |
Prepaid income taxes | 508 | 0 | 0 |
All other | 220 | 289 | 329 |
Total Prepaid expenses and other current assets | $ 1,865 | $ 1,640 | $ 1,711 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Components of Accrued Expenses [Line Items] | |||
Accrued research & development | $ 1,784 | $ 1,307 | $ 1,498 |
Accrued professional fees | 792 | 502 | 591 |
Accrued salary and other compensation | 2,242 | 1,025 | 890 |
Accrued product costs | 9,232 | 839 | 490 |
Deferred rent | 521 | 0 | 0 |
All other | 0 | 304 | 445 |
Total Accrued expenses | 24,405 | 12,165 | 9,671 |
The Medicines Company | |||
Components of Accrued Expenses [Line Items] | |||
Royalties due | 6,948 | 5,880 | 4,707 |
SciDose | |||
Components of Accrued Expenses [Line Items] | |||
Royalties due | 1,637 | 2,308 | 1,050 |
Sandoz, Inc. | |||
Components of Accrued Expenses [Line Items] | |||
Royalties due | $ 1,249 | $ 0 | $ 0 |
Balance Sheet Accounts - Deferr
Balance Sheet Accounts - Deferred Revenue (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | $ 6,000 | $ 6,520 | $ 6,585 |
Ongoing business | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 0 | 520 | 585 |
Ongoing business | The Medicines Company | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 0 | 520 | 585 |
Asset sales | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 6,000 | 6,000 | 6,000 |
Asset sales excluding Tech Transfers | Par Pharmaceuticals Companies, Inc. | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 5,500 | 5,500 | 5,500 |
Tech Transfer | Par Pharmaceuticals Companies, Inc. | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | $ 500 | $ 500 | $ 500 |
Notes Payable (Details)
Notes Payable (Details) | Feb. 18, 2014USD ($)shares | Feb. 18, 2014USD ($)shares | Oct. 02, 2012shares | Mar. 18, 2014USD ($)shares | Feb. 28, 2014USD ($)shares | Dec. 31, 2014USD ($)shares | Sep. 30, 2014USD ($)shares | Dec. 31, 2013USD ($) | Dec. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2014USD ($)shares | Sep. 30, 2013USD ($) | Dec. 31, 2012tranche | Sep. 26, 2012USD ($)shares | Aug. 02, 2012$ / shares |
Short-term Debt [Line Items] | ||||||||||||||
Warrants outstanding (in shares) | shares | 0 | |||||||||||||
Expected term of warrants | 6 years | |||||||||||||
Warrant, term commencement option, period after closing date | 1 year | |||||||||||||
Proceeds from exercise of preferred stock warrants | $ 21,000 | $ 21,000 | $ 0 | $ 0 | $ 21,000 | $ 0 | ||||||||
Issuance of common stock upon exercise of Redeemable Series C preferred stock warrants, shares | shares | 1,788 | 1,788 | ||||||||||||
Change in fair value of warrant liability | 0 | $ 191,000 | 0 | 573,000 | 1,052,000 | |||||||||
Debt interest expense | 0 | $ 0 | 0 | 0 | 545,000 | |||||||||
Amortization of debt discount | $ 0 | $ 0 | $ 0 | 1,091,000 | ||||||||||
Redeemable Convertible Preferred Stock | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Conversion of stock, shares converted | shares | 8,943,447 | |||||||||||||
Common stock | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Conversion of preferred shares to common stock | shares | 1,395,226 | |||||||||||||
Series C Convertible Preferred Stock | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Conversion of preferred shares to common stock | shares | 1,719,693 | |||||||||||||
Convertible Note and Warrant Purchase Agreement | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Warrants monthly accrual rate | 2.00% | |||||||||||||
Warrants outstanding (in shares) | shares | 0 | 0 | 0 | 0 | 944,210 | |||||||||
Warrants liability | $ 2,280,000 | $ 2,280,000 | 1,707,000 | |||||||||||
Warrants exercise price | $ / shares | $ 1.82 | |||||||||||||
Change in fair value of warrant liability | $ 0 | $ 0 | $ 573,000 | 1,052,000 | ||||||||||
Amortization of debt discount | $ 0 | $ 0 | 545,000 | |||||||||||
Convertible Note and Warrant Purchase Agreement | Other income and expense | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Change in fair value of warrant liability | $ 383,000 | $ 1,052,000 | ||||||||||||
Convertible Note and Warrant Purchase Agreement | Warrants | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Fair value assumptions, exercise price | $ / shares | $ 1.82 | |||||||||||||
Fair value assumptions, implied stock price | $ / shares | $ 1.82 | |||||||||||||
Fair value assumptions, expected volatility | 64.00% | |||||||||||||
Fair value assumptions, expected dividend rate | 6.00% | |||||||||||||
Fair value assumptions, risk free interest rate | 0.83% | |||||||||||||
Fair value assumptions, expiration term | 6 years | |||||||||||||
Convertible Note and Warrant Purchase Agreement | Series C Convertible Preferred Stock | Warrants | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Convertible preferred stock, liquidation preference multiple | 2 | 2 | ||||||||||||
Convertible Note and Warrant Purchase Agreement | Convertible notes payable | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Convertible Notes issued | $ 9,662,755 | |||||||||||||
Number of tranches | tranche | 2 | |||||||||||||
Annual interest rate | 6.00% | |||||||||||||
Conversion price pursuant to conversion terms at maturity date | $ / shares | $ 1.82 | |||||||||||||
Debt instrument, unamortized discount | 655,000 | |||||||||||||
IPO | Warrants | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Conversion of preferred shares to common stock | shares | 32,286 | |||||||||||||
Probability-Weighted Expected Returns Valuation Model | Convertible Note and Warrant Purchase Agreement | ||||||||||||||
Short-term Debt [Line Items] | ||||||||||||||
Warrants liability | $ 655,000 |
Shares Subject to Redemption 47
Shares Subject to Redemption — Convertible Preferred Stock (Details) - USD ($) | Feb. 18, 2014 | Apr. 11, 2013 | Oct. 02, 2012 | Aug. 11, 2008 | Mar. 08, 2007 | Dec. 31, 2014 | Jul. 31, 2011 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | Oct. 03, 2012 | Aug. 02, 2012 |
Temporary Equity [Line Items] | ||||||||||||
Offering cost | $ 0 | $ 0 | $ 1,000 | $ 0 | ||||||||
Forfeitures of dividends on Convertible Preferred Stock | $ 3,286,000 | |||||||||||
Preferred stockholder annual dividend rate | 6.00% | |||||||||||
Series A Convertible Preferred Stock | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Convertible preferred stock, shares issued | 20,237,911 | |||||||||||
Par value per share of Convertible Preferred Stock | $ 0.001 | |||||||||||
Convertible Preferred Stock original issue price per share | $ 0.971 | |||||||||||
Conversion of preferred shares to common stock | 2,332,051 | 825,177 | ||||||||||
Estimated fair value of convertible preferred stock | $ 19,651,000 | |||||||||||
Offering cost | $ 180,000 | |||||||||||
Accumulated dividends on the Preferred Stock | $ 97,000 | 0 | $ 0 | 0 | ||||||||
The liquidation value of the Preferred Stock | 0 | 0 | 0 | |||||||||
Conversion of stock, shares converted | 5,289,405 | |||||||||||
Forfeitures of dividends on Convertible Preferred Stock | $ 1,718,000 | |||||||||||
Convertible preferred stock, shares authorized | 14,948,506 | |||||||||||
Accrued dividends | 0 | 0 | 0 | |||||||||
Series B Convertible Preferred Stock | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Convertible preferred stock, shares issued | 16,052,343 | |||||||||||
Par value per share of Convertible Preferred Stock | $ 0.001 | |||||||||||
Convertible Preferred Stock original issue price per share | $ 1.82 | |||||||||||
Conversion of preferred shares to common stock | 1,980,431 | 532,832 | ||||||||||
Estimated fair value of convertible preferred stock | $ 29,215,000 | |||||||||||
Offering cost | $ 126,000 | |||||||||||
Accumulated dividends on the Preferred Stock | $ 173,000 | 0 | 0 | 0 | ||||||||
The liquidation value of the Preferred Stock | 0 | 0 | 0 | |||||||||
Conversion of stock, shares converted | 3,357,782 | |||||||||||
Forfeitures of dividends on Convertible Preferred Stock | $ 1,520,000 | |||||||||||
Convertible preferred stock, shares authorized | 12,694,561 | |||||||||||
Accrued dividends | 0 | 0 | 0 | |||||||||
Series B-1 Convertible Preferred Stock | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Convertible preferred stock, shares issued | 10,177,085 | |||||||||||
Par value per share of Convertible Preferred Stock | $ 0.001 | |||||||||||
Convertible Preferred Stock original issue price per share | $ 1.82 | |||||||||||
Conversion of preferred shares to common stock | 1,455,753 | 46,218 | ||||||||||
Estimated fair value of convertible preferred stock | $ 17,522,000 | |||||||||||
Offering cost | $ 144,000 | |||||||||||
Accumulated dividends on the Preferred Stock | $ 125,000 | 0 | 0 | 0 | ||||||||
The liquidation value of the Preferred Stock | 0 | 0 | 0 | |||||||||
Shares of Series B-1 Preferred Stock in exchange for satisfaction of the principal amount of debt | 549,451 | |||||||||||
Convertible preferred stock, shares outstanding | 9,331,374 | |||||||||||
Conversion of stock, shares converted | 296,260 | |||||||||||
Forfeitures of dividends on Convertible Preferred Stock | $ 49,000 | |||||||||||
Convertible preferred stock, shares authorized | 9,331,374 | |||||||||||
Accrued dividends | 0 | 0 | 0 | |||||||||
Series C Convertible Preferred Stock | ||||||||||||
Temporary Equity [Line Items] | ||||||||||||
Convertible preferred stock, shares issued | 11,023,232 | |||||||||||
Par value per share of Convertible Preferred Stock | $ 0.001 | |||||||||||
Convertible Preferred Stock original issue price per share | $ 1.82 | |||||||||||
Conversion of preferred shares to common stock | 1,719,693 | |||||||||||
Estimated fair value of convertible preferred stock | $ 20,062,000 | |||||||||||
Offering cost | $ 167,000 | |||||||||||
Accumulated dividends on the Preferred Stock | $ 139,000 | 0 | 0 | 0 | ||||||||
The liquidation value of the Preferred Stock | 0 | 0 | 0 | |||||||||
Accrued dividends | $ 0 | $ 0 | $ 0 |
Common Stock and Stock-Based 48
Common Stock and Stock-Based Compensation - Recognized Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | $ 284 | $ 4,051 | $ 606 | $ 317 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | 144 | 2,780 | 303 | 153 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | $ 140 | $ 1,271 | $ 303 | $ 164 |
Common Stock and Stock-Based 49
Common Stock and Stock-Based Compensation - Share-based Compensation, Options (Details) - $ / shares | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||
Number of Stock Option Shares Outstanding, Beginning Balance (in shares) | 1,308,993 | 1,322,170 | 813,259 | |
Weighted Average Exercise Price of Options Outstanding, Beginning Balance (in usd per share) | $ 8.16 | $ 8.29 | $ 5.58 | |
Non- Exercisable Options Outstanding (in shares) | 710,486 | 1,176,140 | 712,901 | 302,603 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number | 611,684 | 668,702 | 596,092 | 510,656 |
Number of Stock Option Shares Granted (in shares) | 29,000 | 773,458 | 558,699 | |
Weighted Average Exercise Price of Stock Options Granted (in usd per share) | $ 12.61 | $ 48.65 | $ 11.72 | |
Number of Stock Option Shares Exercised (in shares) | (4,513) | (211,190) | (12,034) | |
Number of Stock Option Shares Forfeited or expired (in shares) | (11,310) | (39,596) | (50,931) | |
Weighted Average Exercise Price of Stock Options Exercised (in usd per share) | $ 7.62 | $ 7.06 | $ 5.34 | |
Number of Stock Option Shares Outstanding, Ending Balance (in shares) | 1,322,170 | 1,844,842 | 1,308,993 | |
Weighted Average Exercise Price of Options Outstanding, Ending Balance (in usd per share) | $ 8.29 | $ 25.16 | $ 8.16 |
Common Stock and Stock-Based 50
Common Stock and Stock-Based Compensation - Narrative (Details) - USD ($) | Aug. 04, 2015 | Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based payment award, award vesting period | 4 years | ||||
Number of shares available for grant (in shares) | 2,876,702 | ||||
Weighted-average grant-date fair value of options granted (in usd per share) | $ 6.73 | $ 15.92 | $ 4.61 | $ 1.73 | |
Unrecognized compensation cost | $ 8,287,000 | ||||
Total intrinsic value of options exercised | $ 10,815,000 | ||||
Number of stock options exercised (in shares) | (4,513) | (211,190) | (12,034) | ||
Weighted average contractual terms of options outstanding | 7 years 6 months | 7 years 6 months | 7 years 6 months | 7 years | |
Aggregate pre-tax intrinsic value of options outstanding | $ 9,600,000 | $ 54,700,000 | $ 5,900,000 | $ 200 | |
Common stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based payment award, number of additional shares authorized (in shares) | 500,000 | ||||
Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost expense term | 4 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Operating Loss Carryforwards [Line Items] | |||||
Minimum state tax (benefit) provision | $ 4,000 | $ 3,000 | $ 4,000 | $ 2,000 | |
Adjustment to additional paid-in capital, excess tax benefits | 10,300,000 | ||||
Decrease in valuation allowance | (1,661,000) | ||||
Research & development credit | 2,790,000 | 2,790,000 | 1,886,000 | 2,033,000 | |
Unrecognized tax benefits | 0 | ||||
Sale of NOL | 12,588,000 | 25,389,000 | 11,029,000 | ||
Sale of tax credit carryforward | 15,000 | 177,000 | 95,000 | ||
Income tax (provision) benefit | $ 1,059,000 | $ 0 | (3,000) | $ 1,295,000 | $ 899,000 |
Federal | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating loss carryforwards | 99,453,000 | ||||
Research & development credit | 2,790,000 | ||||
State | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating loss carryforwards | 26,285,000 | ||||
Research & development credit | $ 0 |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Tax Disclosure [Abstract] | ||||
Federal tax provision (benefit) at statutory rate | (34.00%) | 34.00% | (34.00%) | (34.00%) |
State tax benefit, net of Federal benefits | (19.18%) | 0.12% | (6.72%) | (12.95%) |
Non-cash interest and change in fair value of warrants liability | (0.01%) | 0.00% | 1.07% | 13.82% |
Meals and entertainment and other | 0.08% | 0.91% | 0.00% | 0.00% |
Change in valuation allowance | 31.25% | (25.15%) | 32.25% | 25.11% |
Other | 0.00% | 0.00% | 0.06% | 0.22% |
Research & Development Credit | 2.68% | (9.76%) | 0.62% | (5.14%) |
Tax provision (benefit) | (19.18%) | 0.12% | (6.72%) | (12.94%) |
Income Taxes - Deferred Income
Income Taxes - Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Sep. 30, 2013 |
Income Tax Disclosure [Abstract] | ||||
Net operating loss carryforward | $ 30,837 | $ 33,286 | $ 32,527 | $ 26,984 |
Research & development credit | 2,790 | 2,790 | 1,886 | 2,033 |
Prepaid research & development expenses | 1,884 | 2,264 | 2,354 | 2,573 |
Deposit Reserve | 93 | 0 | 0 | 0 |
Charitable contribution carryforward | 64 | 71 | 80 | 28 |
Patent costs | 57 | 68 | 70 | 77 |
Accrued vacation pay | 36 | 34 | 54 | 0 |
Other intangibles | 26 | 33 | 34 | 39 |
Stock based compensation | 2,100 | 1,057 | 944 | 688 |
Fixed assets | 12 | 12 | 0 | 161 |
Other | 2 | 11 | 2 | 2 |
Accrued bonus | 705 | 309 | 204 | 0 |
Advance billings | 0 | 208 | 234 | 208 |
Deferred compensation | 0 | 109 | 0 | 0 |
Returns and allowances | 0 | 0 | 0 | 24 |
Total deferred tax assets | 38,606 | 40,252 | 38,389 | 32,817 |
Prepaid expenses | 81 | 66 | 138 | 47 |
Other | 7 | 7 | 0 | 0 |
Fixed assets | 0 | 0 | 5 | 0 |
Total deferred tax liabilities | 88 | 73 | 143 | 47 |
Net deferred tax assets | 38,518 | 40,179 | 38,246 | 32,770 |
Valuation allowance | $ (38,518) | $ (40,179) | $ (38,246) | $ (32,770) |
License Agreements of Develop54
License Agreements of Development and Commercialization Rights (Details) | Feb. 13, 2015USD ($) | Jan. 31, 2016USD ($) | May. 31, 2008USD ($) | Apr. 30, 2008USD ($) | Dec. 31, 2015USD ($)product | Jul. 31, 2013USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Number of products with exclusivity rights | product | 33 | |||||
Marketing rights, term | 10 years | |||||
Collaborative product development agreement, non-refundable revenue for signing | $ 750,000 | |||||
Cumulative milestones upon achievement of goals | 13,000,000 | |||||
Collaborative product development agreement, payment for product development | $ 2,000,000 | |||||
Collaborative product development agreement monthly revenue | $ 200,000 | |||||
Collaborative Arrangement, Product | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaborative product development agreement, term of exclusive marketing rights for partner | 10 years | |||||
Contract Termination | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaborative product development agreement, expected future receivables | $ 0 | |||||
Cephalon, Inc. | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront cash (payment) proceeds for license agreement | $ 30,000,000 | |||||
Maximum additional milestone payments | $ 65,000,000 | |||||
Royalty payments if product is approved, percentage of net sales | 20.00% | |||||
Cephalon, Inc. | Subsequent Event | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payment received | $ 15,000,000 | |||||
Teikoku | Subsequent Event | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payment received | $ 4,850,000 |
Asset Sales (Details)
Asset Sales (Details) - USD ($) | Jun. 30, 2014 | Mar. 28, 2012 | Jun. 30, 2014 | Sep. 30, 2011 | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 |
Deferred Revenue Arrangement [Line Items] | |||||||
Cash proceeds due to regulatory | $ 1,000,000 | ||||||
Milestone reduction limit | $ 500,000 | ||||||
Royalty revenue term | 10 years | ||||||
Divestiture of businesses proceeds | $ 6,500,000 | ||||||
Divestiture of business if milestones unattained | $ 6,000,000 | $ 6,000,000 | $ 6,000,000 | ||||
Milestone addition limit | $ 3,000,000 | ||||||
Asset sales | Hikma Pharmaceuticals, Co. Ltd. | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Deferred revenue | $ 3,500,000 | $ 3,500,000 | |||||
Asset sales excluding Tech Transfers | Par Pharmaceuticals Companies, Inc. | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Deferred revenue, noncurrent | 5,500,000 | ||||||
Initiation of Tech Transfer | Par Pharmaceuticals Companies, Inc. | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Divestiture of businesses proceeds | 500,000 | ||||||
Deferred revenue, noncurrent | 250,000 | ||||||
Completion of Tech Transfer | Par Pharmaceuticals Companies, Inc. | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Divestiture of businesses proceeds | 500,000 | ||||||
Deferred revenue, noncurrent | $ 250,000 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Purchase obligation | $ 6,879 | |||
Operating leases rent expense | $ 68 | 514 | $ 277 | $ 314 |
Future minimum lease payments | $ 2,488 |
Commitments - Future Minimum Le
Commitments - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease obligation, Total | $ 2,488 |
Operating lease obligation, 2016 | 515 |
Operating lease obligation, 2017 | 564 |
Operating lease obligation, 2018 | 564 |
Operating lease obligation, 2019 | 564 |
Operating lease obligation, 2020 | 281 |
Operating lease obligation, Beyond | $ 0 |
Arbitration (Details)
Arbitration (Details) - USD ($) $ in Thousands | Jul. 19, 2013 | Apr. 30, 2013 | Sep. 30, 2013 |
Loss Contingencies [Line Items] | |||
Professional fee benefit | $ (1,993) | ||
Arbitration October 2011 | |||
Loss Contingencies [Line Items] | |||
Damages awarded to the Company | $ 5,000 | ||
Apportioned costs awarded to the Company | $ 24 | ||
Arbitration expense | $ 974 |
Legal Proceedings (Details)
Legal Proceedings (Details) - patent | Oct. 21, 2013 | Feb. 29, 2016 |
Subsequent Event [Line Items] | ||
Patents allegedly infringed upon, number | 1 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Patents allegedly infringed upon, number | 2 |
Selected Quarterly Financial 60
Selected Quarterly Financial Data - Unaudited (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Sep. 30, 2014 | Sep. 30, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||
Revenue | $ 18,180 | $ 5,736 | $ 6,002 | $ 36,309 | $ 5,600 | $ 2,810 | $ 5,792 | $ 5,005 | $ 5,492 | $ 66,227 | $ 19,099 | $ 13,679 |
Income (Loss) from operations | 1,193 | (10,388) | (8,335) | 20,090 | (6,565) | (9,107) | (2,982) | (3,603) | (3,065) | 2,560 | (18,757) | (8,455) |
Net income (loss) attributable to common stockholders | $ 1,218 | $ (10,167) | $ (8,177) | $ 19,697 | $ (5,506) | $ (9,104) | $ (2,934) | $ (3,218) | $ (4,387) | $ 2,571 | $ (19,643) | $ (9,885) |
Income (loss) per share attributable to common stockholders- basic (in dollars per share) | $ 0.08 | $ (0.65) | $ (0.53) | $ 1.38 | $ (0.39) | $ (0.65) | $ (0.21) | $ (0.36) | $ (1.44) | $ 0.17 | $ (1.97) | $ (3.25) |
Income (loss) per share attributable to common stockholders- diluted (in dollars per share) | $ 0.07 | $ (0.65) | $ (0.53) | $ 1.31 | $ (0.39) | $ (0.65) | $ (0.21) | $ (0.36) | $ (1.44) | $ 0.16 | $ (1.97) | $ (3.25) |