Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 10, 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 | Non-accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding (in shares) | 15,589,844 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 71,979 | $ 34,869 |
Short term investments | 24,000 | 0 |
Accounts receivable | 12,218 | 11,956 |
Inventories | 7,348 | 1,242 |
Prepaid expenses and other current assets | 4,757 | 1,640 |
Total current assets | 120,302 | 49,707 |
Property and equipment, net | 1,803 | 342 |
Other assets | 111 | 45 |
Total assets | 122,216 | 50,094 |
Current liabilities: | ||
Accounts payable | 14,148 | 3,501 |
Accrued expenses | 14,439 | 12,165 |
Deferred revenue | 6,000 | 6,520 |
Total current liabilities | $ 34,587 | $ 22,186 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of September 30, 2015 and December 31, 2014 | $ 0 | $ 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 15,589,844 and 14,036,680 issued and outstanding as of September 30, 2015 and December 31, 2014, respectively | 15 | 14 |
Additional paid in capital | 195,945 | 137,577 |
Accumulated deficit | (108,331) | (109,683) |
Total stockholders' equity | 87,629 | 27,908 |
Total liabilities and stockholders' equity | $ 122,216 | $ 50,094 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Common Stock, par value per share (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares, issued (in shares) | 15,589,844 | 14,036,680 |
Common stock, shares, outstanding (in shares) | 15,589,844 | 14,036,680 |
Preferred Stock, shares authorized (in shares) | 1,500,000 | 1,500,000 |
Preferred Stock, shares issued (in shares) | 0 | 0 |
Preferred Stock, shares outstanding (in shares) | 0 | 0 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue: | ||||
Product sales | $ 3,314 | $ 877 | $ 10,099 | $ 2,402 |
Royalty income | 2,422 | 1,934 | 7,947 | 7,440 |
License and other income | 0 | 0 | 30,000 | 3,765 |
Total revenue | 5,736 | 2,811 | 48,046 | 13,607 |
Operating expenses: | ||||
Cost of revenue | 3,753 | 2,175 | 13,049 | 7,090 |
Research and development | 6,911 | 5,888 | 19,073 | 14,227 |
Selling, general and administrative | 5,460 | 3,854 | 14,557 | 7,981 |
Total operating expenses | 16,124 | 11,917 | 46,679 | 29,298 |
Income (Loss) from operations | (10,388) | (9,106) | 1,367 | (15,691) |
Interest income | 8 | 4 | 22 | 30 |
Interest expense | (5) | (2) | (9) | (8) |
Change in value of warrant liability | 0 | 0 | 0 | (383) |
Other income | 0 | 0 | 0 | 35 |
Total other income (expense) | 3 | 2 | 13 | (326) |
Income (Loss) before income tax benefit(provision) | (10,385) | (9,104) | 1,380 | (16,017) |
Income tax benefit (provision) | 218 | 0 | (28) | 1,295 |
Net Income (Loss) | (10,167) | (9,104) | 1,352 | (14,722) |
Less dividends on Series A, B, B-1 and C Convertible Preferred Stock | 0 | 0 | $ 0 | (534) |
Net income (loss) attributable to common stockholders | $ (10,167) | $ (9,104) | $ (15,256) | |
Earnings per share attributable to common stockholders: | ||||
Basic (in usd per share) | $ (0.65) | $ (0.65) | $ 0.09 | $ (1.24) |
Diluted (in usd per share) | $ (0.65) | $ (0.65) | $ 0.08 | $ (1.24) |
Weighted average number of common shares outstanding: | ||||
Basic (in shares) | 15,589,818 | 14,021,933 | 15,132,797 | 12,320,311 |
Diluted (in shares) | 15,589,818 | 14,021,933 | 16,123,729 | 12,320,311 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity Statement - 9 months ended Sep. 30, 2015 - USD ($) shares in Thousands, $ in Thousands | Total | Follow-on Offering | Common stock | Additional Paid-in Capital | Accumulated Deficit |
Number of shares outstanding, beginning balance (in shares) at Dec. 31, 2014 | 14,037 | ||||
Stockholders' equity attributable to parent, beginning balance at Dec. 31, 2014 | $ 27,908 | $ 14 | $ 137,577 | $ (109,683) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 2,942 | 2,942 | |||
Issuance of common stock upon exercise of stock option grants (in shares) | 164 | ||||
Issuance of common stock upon exercise of stock option grants | 1,096 | $ 0 | 1,096 | ||
Issuance of common stock in connection with initial public offering, net of offering costs (in shares) | 1,389 | ||||
Stock Issued During Period, Value, New Issues | $ 1 | ||||
Adjustments to Additional Paid in Capital, Other | $ 54,331 | 54,330 | |||
Net Income (Loss) Available to Common Stockholders, Basic | 1,352 | ||||
Net income (loss) | 1,352 | ||||
Number of shares outstanding, ending balance (in shares) at Sep. 30, 2015 | 15,590 | ||||
Stockholders' equity attributable to parent, ending balance at Sep. 30, 2015 | $ 87,629 | $ 15 | $ 195,945 | $ (108,331) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 1,352 | $ (14,722) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation expense | 31 | 73 |
Stock-based compensation | 2,942 | 528 |
Change in fair value of warrant liability | 0 | 383 |
Loss on disposal of fixed assets | 273 | 0 |
Changes in operating assets and liabilities: | ||
Increase in accounts receivable | (262) | (704) |
Increase in inventories | (6,106) | (1,294) |
Increase in prepaid expenses and other current assets | (3,117) | (1,342) |
(Increase) decrease in other assets | (66) | 0 |
Increase in accounts payable | 10,647 | 1,713 |
Decrease in deferred revenue | (520) | (3,435) |
Increase in accrued expenses and other liabilities | 1,907 | 4,934 |
Net cash provided by (used in) operating activities | 7,081 | (13,866) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (1,398) | (39) |
Purchase of short term investments | (105,999) | (19,999) |
Maturities of short term investments | 81,999 | 0 |
Net cash used in investing activities | (25,398) | (20,038) |
Cash flows from financing activities: | ||
Series C preferred stock offering costs | 0 | (1) |
Proceeds from common stock option exercise | 1,096 | 65 |
Proceeds from exercise of preferred stock warrants | 0 | 21 |
Net cash provided by financing activities | 55,427 | 46,652 |
Net increase in cash | 37,110 | 12,748 |
Cash and cash equivalents at beginning of period | 34,869 | 9,974 |
Cash and cash equivalents at end of period | 71,979 | 22,722 |
Cash paid during the period for: | ||
Interest | (9) | (8) |
Corporate taxes | 482 | 0 |
Franchise taxes | 91 | 8 |
Non-cash operating activities | ||
Landlord contribution to leasehold improvements recorded as deferred rent | 367 | 0 |
Conversion of preferred stock and accrued dividends to Common stock | ||
Non-cash financing activities | ||
Conversion of stock | 0 | 91,648 |
Conversion of redeemable warrant liability to Common stock | ||
Non-cash financing activities | ||
Conversion of stock | 0 | 2,280 |
SPO | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock from initial public offering, net of issuance costs | 54,331 | 0 |
IPO | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock from initial public offering, net of issuance costs | $ 0 | $ 46,567 |
Interim Condensed Financial Sta
Interim Condensed Financial Statements | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Interim Condensed Financial Statements | Interim Condensed Financial Statements The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the financial information for the interim periods reported have been made. Results of operations for the three and nine months ended September 30, 2015 are not necessarily indicative of the results for the year ending December 31, 2015 or any period thereafter. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and related notes included in our annual report on Form 10-K for the fiscal year ended September 30, 2014, filed with the Securities and Exchange Commission on December 22, 2014. 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 will end 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. |
Organization and Business Activ
Organization and Business Activities | 9 Months Ended |
Sep. 30, 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 three products currently being sold in the United States under various license agreements in place with commercial partners, including Ryanodex ® , Diclofenac-misoprostol, launched in January 2015, and a ready-to-use formulation of Argatroban. 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 all 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 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 will be responsible for all U.S. commercial activities for the product including promotion and distribution, and Eagle will be 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 , and Eagle is currently eligible to receive up to $80.0 million in additional milestone payments. In addition, Eagle is entitled to receive royalty payments in the double digit range 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 the Company 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 condensed consolidated 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, 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, cash equivalents and short term investments are classified as Level 1 at September 30, 2015 and December 31, 2014 . 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 IPO. There were no outstanding warrants as of September 30, 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 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: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Net revenues The Medicines Company 37 % 50 % 15 % 26 % Sandoz, Inc. 28 % 42 % 10 % 45 % Cephalon, Inc. (Teva) - See Revenue Recognition — % — % 62 % — % Hikma Pharmaceuticals — % — % — % 28 % Other 35 % 8 % 13 % 1 % 100 % 100 % 100 % 100 % September 30, December 31, 2015 2014 Accounts receivable The Medicines Company 76 % 61 % Sandoz, Inc. 13 % 35 % Other 11 % 4 % 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. 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. As of September 30, 2015 the Company had $6,960 in inventories related to product that was not yet available to be sold but could be converted to other uses. 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. Advertising and Marketing Advertising and marketing costs are expensed as incurred. Advertising and marketing costs were $1,310 and $1,820 for the three months ended September 30, 2015 and 2014 , respectively, and $3,880 and $2,485 for the nine months ended September 30, 2015 and 2014 , 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 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 nine months ended September 30, 2014 , the Company sold New Jersey state NOL carry forwards, which resulted in the recognition of a $1,295 tax benefit. During the nine months ended September 30, 2015 , the Company recorded an income tax provision of $28 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 , and is eligible to receive up to $80 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. The remaining milestones, if achieved, will be recognized in the period earned. In addition, the Company is entitled to receive royalty payments in the double digit range 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. 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: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Risk-free interest rate 1.68% - 1.71% 1.89% - 1.89% 1.42% - 2.09% 1.69% - 2.21% Volatility 31.17% 53.71% 30.33% 54.58% Expected term (in years) 5.58 - 6.08 years 6.08 - 6.08 years 5.50 - 7.00 years 5.50 - 7.00 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 dilutive and anti-dilutive common shares equivalents outstanding at the three and nine months ended September 30, 2015 and 2014 were as follows: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Series A — — — 362,765 Series B — — — 308,067 Series B-1 — — — 226,450 Series C — — — 267,507 Series C warrants — — — 22,906 Options 1,882,171 1,144,751 1,665,494 995,540 Total 1,882,171 1,144,751 1,665,494 2,183,235 The following table sets forth the computation for basic and diluted net income (loss) per share for the three and nine months ended September 30, 2015 and 2014 : Three Months Ended Nine Months Ended 2015 2014 2015 2014 Numerator Numerator for basic earnings per share-net income (loss) $ (10,167 ) $ (9,104 ) $ 1,352 $ (15,256 ) Numerator for diluted earnings per share-net income (loss) $ (10,167 ) $ (9,104 ) $ 1,352 $ (15,256 ) Denominator Basic weighted average common shares outstanding 15,589,818 14,021,933 15,132,797 12,320,311 Dilutive effect of stock options — — 990,932 — Diluted weighted average common shares outstanding 15,589,818 14,021,933 16,123,729 12,320,311 Basic net income (loss) per share Basic net income (loss) per share $ (0.65 ) $ (0.65 ) $ 0.09 $ (1.24 ) Diluted net income (loss) per share Diluted net income (loss) per share $ (0.65 ) $ (0.65 ) $ 0.08 $ (1.24 ) |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: September 30, December 31, 2015 2014 Raw material - pre launch inventory $ 2,791 $ — Work in process - pre launch inventory 4,169 — Finished products 388 1,242 $ 7,348 $ 1,242 During the nine months ended September 30, 2015 , the Company recorded total write-offs of $1.1 million attributable to expiring Ryanodex inventory. |
Balance Sheet Accounts
Balance Sheet Accounts | 9 Months Ended |
Sep. 30, 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: September 30, December 31, 2015 2014 Prepaid expenses and other current assets Prepaid product costs $ 68 $ 1,020 Prepaid FDA user fee 716 148 Prepaid insurance 331 183 Prepaid research and development 3,000 — Prepaid income taxes 483 — All other 159 289 Total Prepaid expenses and other current assets $ 4,757 $ 1,640 Accrued Expenses Accrued expenses consist of the following: September 30, December 31, 2015 2014 Accrued expenses Royalties due to The Medicines Company $ 7,584 $ 5,880 Royalties due to SciDose 1,524 2,308 Accrued research & development 1,360 1,307 Accrued professional fees 639 502 Accrued salary and other compensation 1,345 1,025 Accrued product costs 1,365 839 Accrued provision for income tax — — Accrued insurance 142 — Deferred rent 480 — All other — 304 Total Accrued expenses $ 14,439 $ 12,165 Deferred Revenue Deferred revenue consists of the following: September 30, December 31, 2015 2014 Deferred revenue The Medicines Company $ — $ 520 Deferred Revenue for ongoing business — 520 Par Pharmaceuticals Companies, Inc. 5,500 5,500 Par Pharmaceuticals Companies, Inc./Tech Transfer 500 500 Deferred Revenue from Asset Sales 6,000 6,000 Total Deferred revenue $ 6,000 $ 6,520 |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 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, the Company has reserved and made available 2,035,598 shares of common stock for issuance under the 2014 Plan. The Company recognized share-based compensation in its statements of operations for the three and nine months ended September 30, 2015 and 2014 as follows: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Selling, general and administrative $ 1,050 $ 112 $ 2,012 $ 262 Research and development 299 112 930 266 Total $ 1,349 $ 224 $ 2,942 $ 528 |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments At September 30, 2015 , the Company has purchase obligations in the amount of $9,397 which represent the contractual commitments under a Contract Manufacturing and Supply Agreements with suppliers. The obligation under the supply agreement is primarily for finished product, inventory, and research and development. The Company leases its office space under a lease agreement that expires on June 30, 2020 . Rental expense was $180 and $68 for the three months ended September 30, 2015 and 2014 , respectively, and $343 and $208 for the nine months ended September 30, 2015 and 2014 , respectively. The future lease payments under the operating lease are $2,556 as of September 30, 2015 , payable monthly through June 30, 2020. |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 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. |
Subsequent Events Subsequent Ev
Subsequent Events Subsequent Events | 9 Months Ended |
Sep. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events 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 is currently under review with the FDA and the Prescription Drug User Fee Act action date is December 27, 2015. Under the terms of the agreement, the Company paid an upfront cash payment, will pay a near-term milestone based upon the timing of an FDA approval and double-digit royalties on gross profits. On November 4, 2015, the Company entered into a co-promotion agreement with Spectrum Pharmaceuticals (“Spectrum”) under which the Spectrum 32 -person Corporate Accounts Sales Team will dedicate 80 percent of its time to selling and marketing up to six of the Company's products over a period of at least 18 months (the "Spectrum Agreement"). The Company will pay Spectrum a base fee of $12.8 million over 18 months, and additional payments of up to $9 million if specified targets for annual net sales of the Products are met during the initial term of the Spectrum Agreement, for a potential total payment of up to $22 million during the initial term. The Company may extend the initial term of this agreement by six months to December 31, 2017 at its sole election. Any extensions after December 31, 2017 require mutual consent and will be for six months per extension. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 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. |
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. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company's financial instruments consist of cash and cash equivalents, 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, cash equivalents and short term investments are classified as Level 1 at September 30, 2015 and December 31, 2014 . 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. |
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. |
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. |
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 , and is eligible to receive up to $80 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. The remaining milestones, if achieved, will be recognized in the period earned. In addition, the Company is entitled to receive royalty payments in the double digit range 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. |
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 fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Risk-free interest rate 1.68% - 1.71% 1.89% - 1.89% 1.42% - 2.09% 1.69% - 2.21% Volatility 31.17% 53.71% 30.33% 54.58% Expected term (in years) 5.58 - 6.08 years 6.08 - 6.08 years 5.50 - 7.00 years 5.50 - 7.00 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 | 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. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 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: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Net revenues The Medicines Company 37 % 50 % 15 % 26 % Sandoz, Inc. 28 % 42 % 10 % 45 % Cephalon, Inc. (Teva) - See Revenue Recognition — % — % 62 % — % Hikma Pharmaceuticals — % — % — % 28 % Other 35 % 8 % 13 % 1 % 100 % 100 % 100 % 100 % September 30, December 31, 2015 2014 Accounts receivable The Medicines Company 76 % 61 % Sandoz, Inc. 13 % 35 % Other 11 % 4 % 100 % 100 % |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | The fair value of stock options granted to employees, directors, and consultants is estimated using the following assumptions: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Risk-free interest rate 1.68% - 1.71% 1.89% - 1.89% 1.42% - 2.09% 1.69% - 2.21% Volatility 31.17% 53.71% 30.33% 54.58% Expected term (in years) 5.58 - 6.08 years 6.08 - 6.08 years 5.50 - 7.00 years 5.50 - 7.00 years Expected dividend yield 0.0% 0.0% 0.0% 0.0% |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The dilutive and anti-dilutive common shares equivalents outstanding at the three and nine months ended September 30, 2015 and 2014 were as follows: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Series A — — — 362,765 Series B — — — 308,067 Series B-1 — — — 226,450 Series C — — — 267,507 Series C warrants — — — 22,906 Options 1,882,171 1,144,751 1,665,494 995,540 Total 1,882,171 1,144,751 1,665,494 2,183,235 |
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 the three and nine months ended September 30, 2015 and 2014 : Three Months Ended Nine Months Ended 2015 2014 2015 2014 Numerator Numerator for basic earnings per share-net income (loss) $ (10,167 ) $ (9,104 ) $ 1,352 $ (15,256 ) Numerator for diluted earnings per share-net income (loss) $ (10,167 ) $ (9,104 ) $ 1,352 $ (15,256 ) Denominator Basic weighted average common shares outstanding 15,589,818 14,021,933 15,132,797 12,320,311 Dilutive effect of stock options — — 990,932 — Diluted weighted average common shares outstanding 15,589,818 14,021,933 16,123,729 12,320,311 Basic net income (loss) per share Basic net income (loss) per share $ (0.65 ) $ (0.65 ) $ 0.09 $ (1.24 ) Diluted net income (loss) per share Diluted net income (loss) per share $ (0.65 ) $ (0.65 ) $ 0.08 $ (1.24 ) |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories consist of the following: September 30, December 31, 2015 2014 Raw material - pre launch inventory $ 2,791 $ — Work in process - pre launch inventory 4,169 — Finished products 388 1,242 $ 7,348 $ 1,242 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following: September 30, December 31, 2015 2014 Prepaid expenses and other current assets Prepaid product costs $ 68 $ 1,020 Prepaid FDA user fee 716 148 Prepaid insurance 331 183 Prepaid research and development 3,000 — Prepaid income taxes 483 — All other 159 289 Total Prepaid expenses and other current assets $ 4,757 $ 1,640 |
Schedule of Accrued Expenses | Accrued expenses consist of the following: September 30, December 31, 2015 2014 Accrued expenses Royalties due to The Medicines Company $ 7,584 $ 5,880 Royalties due to SciDose 1,524 2,308 Accrued research & development 1,360 1,307 Accrued professional fees 639 502 Accrued salary and other compensation 1,345 1,025 Accrued product costs 1,365 839 Accrued provision for income tax — — Accrued insurance 142 — Deferred rent 480 — All other — 304 Total Accrued expenses $ 14,439 $ 12,165 |
Schedule of Deferred Revenue | Deferred revenue consists of the following: September 30, December 31, 2015 2014 Deferred revenue The Medicines Company $ — $ 520 Deferred Revenue for ongoing business — 520 Par Pharmaceuticals Companies, Inc. 5,500 5,500 Par Pharmaceuticals Companies, Inc./Tech Transfer 500 500 Deferred Revenue from Asset Sales 6,000 6,000 Total Deferred revenue $ 6,000 $ 6,520 |
Common Stock and Stock-Based 20
Common Stock and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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 three and nine months ended September 30, 2015 and 2014 as follows: Three Months Ended Nine Months Ended 2015 2014 2015 2014 Selling, general and administrative $ 1,050 $ 112 $ 2,012 $ 262 Research and development 299 112 930 266 Total $ 1,349 $ 224 $ 2,942 $ 528 |
Organization and Business Act21
Organization and Business Activities (Details) | Mar. 20, 2015$ / sharesshares | Feb. 13, 2015USD ($) | Mar. 18, 2014shares | Feb. 18, 2014USD ($)$ / sharesshares | Sep. 30, 2015USD ($)shares | Sep. 30, 2014USD ($) | Dec. 31, 2014shares |
Subsidiary, Sale of Stock [Line Items] | |||||||
Aggregate net proceeds received from IPO | $ | $ 46,069,000 | ||||||
Proceeds from exercise of preferred stock warrants | $ | $ 21,000 | $ 0 | $ 21,000 | ||||
Issuance of common stock upon exercise of stock option grants (in shares) | 1,788 | ||||||
Decrease in number of authorized common shares in connection with IPO (in shares) | 50,000,000 | 50,000,000 | |||||
Decrease in number of authorized preferred shares in connection with IPO (in shares) | 1,500,000 | 1,500,000 | |||||
Upfront cash payment for license agreement | $ | $ 30,000,000 | ||||||
Maximum additional milestone payments | $ | $ 80,000,000 | ||||||
IPO | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Reverse stock split in connection with IPO | 0.1560 | ||||||
Decrease in number of authorized common shares in connection with IPO (in shares) | 50,000,000 | ||||||
Decrease in number of authorized preferred shares in connection with IPO (in shares) | 1,500,000 | ||||||
Follow-on Offering | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Other offering expenses payable | $ | $ 54,331,000 | ||||||
Common stock | IPO | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Issuance of common stock in connection with initial IPO/SPO, net of offering costs (in shares) | 3,350,000 | ||||||
IPO/SPO share price (in usd per share) | $ / shares | $ 15 | ||||||
Common stock | Over-allotment option | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Issuance of common stock in connection with initial IPO/SPO, net of offering costs (in shares) | 100,000 | ||||||
Common stock | Follow-on Offering | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Issuance of common stock in connection with initial IPO/SPO, net of offering costs (in shares) | 1,388,517 | ||||||
IPO/SPO share price (in usd per share) | $ / 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 (in shares) | 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 (in shares) | 7,487,928 | ||||||
Warrants | IPO | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Conversion of preferred shares to common stock (in shares) | 32,286 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Major Customers as a Percentage (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100.00% | 100.00% | |||
Accounts Receivable | The Medicines Company | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 76.00% | 61.00% | |||
Accounts Receivable | Sandoz, Inc. | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 13.00% | 35.00% | |||
Accounts Receivable | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 11.00% | 4.00% | |||
Customer Concentration Risk | Net Revenues | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 100.00% | 100.00% | 100.00% | 100.00% | |
Customer Concentration Risk | Net Revenues | The Medicines Company | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 37.00% | 50.00% | 15.00% | 26.00% | |
Customer Concentration Risk | Net Revenues | Sandoz, Inc. | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 28.00% | 42.00% | 10.00% | 45.00% | |
Customer Concentration Risk | Net Revenues | Cephalon, Inc. | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 0.00% | 0.00% | 62.00% | 0.00% | |
Customer Concentration Risk | Net Revenues | Hikma Pharmaceuticals, Co. Ltd. | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 0.00% | 0.00% | 0.00% | 28.00% | |
Customer Concentration Risk | Net Revenues | Other | |||||
Concentration Risk [Line Items] | |||||
Percentage of concentration | 35.00% | 8.00% | 13.00% | 1.00% |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | Feb. 13, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 |
Accounting Policies [Abstract] | |||||
Warrants outstanding (in warrants) | 0 | 0 | |||
Upfront cash payment for license agreement | $ 30,000,000 | ||||
Work in process | $ 6,960,000 | $ 6,960,000 | |||
Advertising and marketing costs | 1,310,000 | $ 1,820,000 | 3,880,000 | $ 2,485,000 | |
Income tax benefit (provision) | $ 218,000 | $ 0 | $ (28,000) | $ 1,295,000 | |
Period after quarter commercial partners report net product sales | 60 days | ||||
Maximum additional milestone payments | $ 80,000,000 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies - Assumption of Stock Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest minimum rate | 1.68% | 1.89% | 1.42% | 1.69% |
Risk-free interest maximum rate | 1.71% | 1.89% | 2.09% | 2.21% |
Volatility | 30.80% | 53.71% | 30.33% | 54.58% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term | 5 years 6 months 29 days | 6 years 29 days | 5 years 6 months | 5 years 6 months |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term | 6 years 29 days | 6 years 29 days | 7 years | 7 years |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 1,882,171 | 1,144,751 | 1,665,494 | 2,183,235 |
Series A | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 0 | 0 | 0 | 362,765 |
Series B | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 0 | 0 | 0 | 308,067 |
Series B-1 | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 0 | 0 | 0 | 226,450 |
Series C | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 0 | 0 | 0 | 267,507 |
Series C warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 0 | 0 | 0 | 22,906 |
Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common shares equivalents outstanding (in shares) | 1,882,171 | 1,144,751 | 1,665,494 | 995,540 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net Income (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Numerator | ||||
Numerator for basic earnings per share-net income (loss) | $ (10,167) | $ (9,104) | $ (15,256) | |
Numerator for diluted earnings per share-net income (loss) | $ (10,167) | $ (9,104) | $ 1,352 | $ (15,256) |
Denominator | ||||
Basic weighted average common shares outstanding (in shares) | 15,589,818 | 14,021,933 | 15,132,797 | 12,320,311 |
Dilutive effect of stock options (in shares) | 0 | 0 | 990,932 | 0 |
Diluted weighted average common shares outstanding (in shares) | 15,589,818 | 14,021,933 | 16,123,729 | 12,320,311 |
Basic net income (loss) per share | ||||
Basic net income (loss) per share (in usd per share) | $ (0.65) | $ (0.65) | $ 0.09 | $ (1.24) |
Diluted net income (loss) per share | ||||
Diluted net income (loss) per share (in usd per share) | $ (0.65) | $ (0.65) | $ 0.08 | $ (1.24) |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Dec. 31, 2014 | |
Inventory Disclosure [Abstract] | ||
Raw material - pre launch inventory | $ 2,791 | $ 0 |
Work in process - pre launch inventory | 4,169 | 0 |
Finished products | 388 | 1,242 |
Inventories | 7,348 | $ 1,242 |
Inventory write-offs | $ 1,100 |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid product costs | $ 68 | $ 1,020 |
Prepaid FDA user fee | 716 | 148 |
Prepaid insurance | 331 | 183 |
Prepaid research and development | 3,000 | 0 |
Prepaid income taxes | 483 | 0 |
All other | 159 | 289 |
Total Prepaid expenses and other current assets | $ 4,757 | $ 1,640 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Components of Accrued Expenses [Line Items] | ||
Royalties Due | $ 1,524 | |
Accrued research & development | $ 1,307 | |
Accrued professional fees | 639 | 502 |
Accrued salary and other compensation | 1,345 | 1,025 |
Accrued product costs | 1,360 | 839 |
Accrued provision for income tax | 0 | 0 |
Accrued insurance | 142 | 0 |
Deferred rent | 480 | 0 |
All other | 0 | 304 |
Total Accrued expenses | 14,439 | 12,165 |
The Medicines Company | ||
Components of Accrued Expenses [Line Items] | ||
Royalties Due | 1,365 | 5,880 |
SciDose | ||
Components of Accrued Expenses [Line Items] | ||
Royalties Due | $ 7,584 | $ 2,308 |
Balance Sheet Accounts - Deferr
Balance Sheet Accounts - Deferred Revenue (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | $ 6,000 | $ 6,520 |
Ongoing business | ||
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | 0 | 520 |
Ongoing business | The Medicines Company | ||
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | 0 | 520 |
Asset sales excluding Tech Transfers | Par Pharmaceuticals Companies, Inc. | ||
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | 5,500 | 5,500 |
Tech Transfer | Par Pharmaceuticals Companies, Inc. | ||
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | 500 | 500 |
Asset sales | ||
Deferred Revenue Arrangement [Line Items] | ||
Deferred revenue | $ 6,000 | $ 6,000 |
Common Stock and Stock-Based 31
Common Stock and Stock-Based Compensation - Narrative (Details) - shares | Aug. 04, 2015 | Sep. 30, 2015 |
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) | 2,035,598 | |
Common stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional shares authorized (in shares) | 500,000 |
Common Stock and Stock-Based 32
Common Stock and Stock-Based Compensation - Recognized Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | $ 1,349 | $ 224 | $ 2,942 | $ 528 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | 1,050 | 112 | 2,012 | 262 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | $ 299 | $ 112 | $ 930 | $ 266 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Purchase obligation | $ 9,397 | $ 9,397 | ||
Operating leases rent expense | 180 | $ 68 | 343 | $ 208 |
Amended Operating Lease Agreement | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Future operating lease payments | $ 2,556 | $ 2,556 |
Subsequent Events Subsequent 34
Subsequent Events Subsequent Events (Details) - Collaborative Arrangement, Co-promotion - Subsequent Event | Nov. 04, 2015USD ($)productperson |
Subsequent Event [Line Items] | |
Number of sales people | person | 32 |
Percentage of time sales team will sell and market | 80.00% |
Number of products | product | 6 |
Contractual agreement selling and marketing period | 18 months |
Payments for fees over course of agreement | $ 12,800,000 |
Payment term | 18 months |
Maximum target payment | $ 9,000,000 |
Maximum selling, marketing and target payment | $ 22,000,000 |
Contractual agreement extension period | 6 months |