Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 08, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | REPH | ||
Entity Registrant Name | Recro Pharma, Inc. | ||
Entity Central Index Key | 1,588,972 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Common Stock, Shares Outstanding | 19,050,966 | ||
Entity Public Float | $ 36.1 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 64,483 | $ 19,779 |
Accounts receivable | 10,411 | 8,580 |
Inventory | 8,746 | 8,982 |
Prepaid expenses and other current assets | 1,118 | 793 |
Deferred equity costs | 542 | |
Total current assets | 84,758 | 38,676 |
Property, plant and equipment, net | 37,300 | 37,922 |
Deferred income taxes | 17,060 | 15,637 |
Intangible assets, net | 37,433 | 40,016 |
Goodwill | 6,446 | 6,446 |
Total assets | 182,997 | 138,697 |
Current liabilities: | ||
Accounts payable | 4,132 | 1,553 |
Accrued expenses | 9,893 | 3,418 |
Current portion of long-term debt, net | 2,236 | 4,516 |
Total current liabilities | 16,261 | 9,487 |
Long-term debt, net | 22,152 | 25,244 |
Warrants | 3,397 | 3,770 |
Contingent consideration | 69,574 | 59,846 |
Total liabilities | 111,384 | 98,347 |
Commitments and contingencies (Note 11) | ||
Shareholders’ equity: | ||
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and outstanding | ||
Common stock, $0.01 par value. Authorized, 50,000,000 shares; issued and outstanding, 19,043,216 shares at December 31, 2016 and 9,224,315 shares at December 31, 2015 | 190 | 92 |
Additional paid-in capital | 132,691 | 71,321 |
Accumulated deficit | (61,268) | (31,063) |
Total shareholders’ equity | 71,613 | 40,350 |
Total liabilities and shareholders’ equity | $ 182,997 | $ 138,697 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 19,043,216 | 9,224,315 |
Common stock, shares outstanding | 19,043,216 | 9,224,315 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue: | ||
Manufacturing, royalty and profit sharing revenue | $ 67,594 | $ 49,284 |
Research and development revenue | 1,743 | 2,668 |
Total revenues | 69,337 | 51,952 |
Operating expenses: | ||
Cost of sales (excluding amortization of intangible assets) | 37,152 | 28,054 |
Research and development | 33,278 | 12,281 |
General and administrative | 12,742 | 13,017 |
Amortization of intangible assets | 2,583 | 1,884 |
Change in warrant valuation | (373) | (1,560) |
Change in contingent consideration valuation | 9,728 | 5,246 |
Total operating expenses | 95,110 | 58,922 |
Operating loss | (25,773) | (6,970) |
Other income (expense): | ||
Interest income | 49 | 12 |
Interest expense | (5,588) | (5,560) |
Net loss before income taxes | (31,312) | (12,518) |
Income tax benefit | 1,107 | 15,551 |
Net income (loss) | $ (30,205) | $ 3,033 |
Basic net income (loss) per common share | $ (2.82) | $ 0.36 |
Diluted net income (loss) per common share | $ (2.82) | $ 0.21 |
Weighted average basic common shares outstanding | 10,721,928 | 8,491,025 |
Weighted average diluted common shares outstanding | 10,721,928 | 8,749,234 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Aspire Equity Facility [Member] | Equity Financing Facility [Member] | Public Offering [Member] | Private Placement [Member] | Common Stock [Member] | Common Stock [Member]Aspire Equity Facility [Member] | Common Stock [Member]Equity Financing Facility [Member] | Common Stock [Member]Public Offering [Member] | Common Stock [Member]Private Placement [Member] | Additional Paid in Capital [Member] | Additional Paid in Capital [Member]Aspire Equity Facility [Member] | Additional Paid in Capital [Member]Equity Financing Facility [Member] | Additional Paid in Capital [Member]Public Offering [Member] | Additional Paid in Capital [Member]Private Placement [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2014 | $ 18,928 | $ 77 | $ 52,947 | $ (34,096) | ||||||||||||
Balance, Shares at Dec. 31, 2014 | 7,707,600 | |||||||||||||||
Sale of common stock | $ 285 | $ 14,812 | $ 1 | $ 14 | $ 284 | $ 14,798 | ||||||||||
Sale of common stock, Shares | 96,463 | 1,379,311 | ||||||||||||||
Stock option exercise | $ 228 | 228 | ||||||||||||||
Stock option exercise, Shares | 38,000 | 38,000 | ||||||||||||||
Stock-based compensation expense | $ 3,064 | 3,064 | ||||||||||||||
Cashless warrant exercises, Shares | 2,941 | |||||||||||||||
Net income (loss) | 3,033 | 3,033 | ||||||||||||||
Balance at Dec. 31, 2015 | 40,350 | $ 92 | 71,321 | (31,063) | ||||||||||||
Balance, Shares at Dec. 31, 2015 | 9,224,315 | |||||||||||||||
Sale of common stock | $ 7,375 | $ 50,255 | $ 11 | $ 87 | $ 7,364 | $ 50,168 | ||||||||||
Sale of common stock, Shares | 1,143,940 | 8,656,666 | ||||||||||||||
Issuance of restricted stock units, net of shares withheld for income taxes | (51) | (51) | ||||||||||||||
Issuance of restricted stock units, net of shares withheld for income taxes, Shares | 18,295 | |||||||||||||||
Stock-based compensation expense | 3,889 | 3,889 | ||||||||||||||
Net income (loss) | (30,205) | (30,205) | ||||||||||||||
Balance at Dec. 31, 2016 | $ 71,613 | $ 190 | $ 132,691 | $ (61,268) | ||||||||||||
Balance, Shares at Dec. 31, 2016 | 19,043,216 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (30,205) | $ 3,033 |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Stock-based compensation | 3,889 | 3,064 |
Non-cash interest expense | 1,071 | 668 |
Depreciation expense | 4,993 | 4,120 |
Amortization | 2,583 | 1,884 |
Change in warrant valuation | (373) | (1,560) |
Change in contingent consideration valuation | 9,728 | 5,246 |
Deferred income taxes | (1,423) | (15,637) |
Changes in operating assets and liabilities, net of effect of acquisition: | ||
Inventory | 237 | 1,271 |
Prepaid expenses and other current assets | (325) | 225 |
Accounts receivable | (1,831) | 3,992 |
Accounts payable and accrued expenses | 8,454 | 2,152 |
Net cash provided by (used in) operating activities | (3,202) | 8,458 |
Cash flows from investing activities: | ||
Acquisition of Gainesville, net of cash acquired | (52,690) | |
Purchase of property and equipment | (3,770) | (2,411) |
Net cash used in investing activities | (3,770) | (55,101) |
Cash flows from financing activities: | ||
Proceeds from sales of common stock, net of offering costs | 50,255 | 14,812 |
Proceeds from Aspire facility | 7,796 | |
Proceeds from long-term debt | 50,000 | |
Payments on long-term debt | (6,324) | (16,329) |
Payment of debt issuance costs | (1,718) | |
Payment of deferred equity costs | (253) | |
Payments of withholdings on shares withheld for income taxes | (51) | |
Proceeds from option exercise | 228 | |
Net cash provided by financing activities | 51,676 | 46,740 |
Net increase in cash and cash equivalents | 44,704 | 97 |
Cash and cash equivalents, beginning of year | 19,779 | 19,682 |
Cash and cash equivalents, end of year | 64,483 | 19,779 |
Supplemental disclosure of cash flow information: | ||
Common stock issued in connection with equity facility | 285 | |
Cash paid for interest | 4,517 | 4,892 |
Amortization of deferred equity costs | 421 | |
Purchase of property, plant and equipment included in accrued expenses and accounts payable | $ 808 | $ 208 |
Background
Background | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Background | (1) Background Recro Pharma, Inc., or the Company, was incorporated in Pennsylvania on November 15, 2007. The Company is a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating contract development and manufacturing, or CDMO, division. Each of these divisions are deemed to be reportable segments (see Note 3(n) and Note 14). The Acute Care division is primarily focused on developing innovative products for hospital and related settings, and the CDMO division leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. On April 10, 2015, the Company acquired from Alkermes plc, or Alkermes, worldwide rights to intravenous and intramuscular or injectable meloxicam, a proprietary, Phase III-ready, long-acting preferential COX-2 inhibitor for the treatment of moderate to severe acute pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, Georgia. The acquisition is referred to herein as the Gainesville Transaction. |
Development-Stage Risks and Liq
Development-Stage Risks and Liquidity | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Development-Stage Risks and Liquidity | (2) Development-Stage Risks and Liquidity The Company has incurred losses from operations since inception and has an accumulated deficit of $61,268 as of December 31, 2016. Though its CDMO segment has been profitable, the Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its products currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates including Gainesville Transaction contingent payments which may become due. The Company’s future operations are highly dependent on a combination of factors, including (i) the continued profitability of the CDMO segment; (ii) the timely and successful completion of additional financing and/or alternative sources of capital, debt and partnering transactions; (iii) the success of its research and development, including the results and timing of its clinical trials; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately (v) regulatory approval and market acceptance of the Company’s proposed future products. However, management believes that the Company’s existing cash as of December 31, 2016 will be sufficient to fund its operations through March 2018. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (3) Summary of Significant Accounting Principles (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2016 and its results of operations for the twelve months ended December 31, 2016 and 2015 and cash flows for the twelve months ended December 31, 2016 and 2015. (b) Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. (c) Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents as of December 31, 2016 and 2015 consisted of money market mutual funds and government and agency bonds. (d) Fair Value of Financial Instruments Management believes that the carrying amounts of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments. Management believes the carrying value of debt approximates fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. (e) Inventory Inventory is stated at the lower of cost or market value. Cost is determined using the first-in, first-out method. Included in inventory are raw materials used in production of commercial products. (f) Property and Equipment Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred. (g) Goodwill and Intangible Assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a two-step method for determining impairment. The first step compares a reporting unit’s fair value to its carrying amount to identify potential goodwill impairment. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the second step of the impairment test must be completed to measure the amount of the reporting unit’s goodwill impairment loss, if any. Step two requires an assignment of the reporting unit’s fair value to the reporting unit’s assets and liabilities to determine the implied fair value of the reporting unit’s goodwill. The implied fair value of the reporting unit’s goodwill is then compared with the carrying amount of the reporting unit’s goodwill to determine the goodwill impairment loss to be recognized, if any. Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an in-process research and development, or IPR&D, asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is amortized on a straight-line basis over a useful lives of six years. Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off and the Company will record a noncash impairment loss on its consolidated statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a triggering event occurs between annual assessments which would then require an assessment in the period which a triggering event occurred. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30th. As a result of the impairment tests, the Company determined that there was no impairment to goodwill or indefinite-lived intangible assets for the year ended December 31, 2016. (h) Revenue Recognition The Company generates revenues from manufacturing, packaging and related services for multiple pharmaceutical companies. The agreements that the Company has with its commercial partners provide for manufacturing revenues, royalties and/or profit sharing components. Manufacturing and other related services revenue is recognized when persuasive evidence of an arrangement exists, shipment has occurred and the title to the product and associated risk of loss has passed to the customer, the sales price is fixed or determinable and collectability is reasonably assured. In addition to manufacturing and packaging revenue, the customer agreements have royalties and/or profit sharing payments, computed on the net product sales of the partner. Royalty and profit sharing revenues are generally recognized under the terms of the license and supply agreement in the period the products are sold and expenses are incurred by our commercial partner and collectability is reasonably assured. Revenues related to research and development are generally recognized as the related services or activities are performed, in accordance with the contract terms. To the extent that the agreements specify services are to be performed on a fixed basis, revenues are recognized consistent with the pattern of the work performed. (i) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company’s policy is to limit the amount of credit exposure to any one financial institution and place its cash and cash equivalents with financial institutions evaluated as being creditworthy. To date, the Company has not experienced any losses on its cash equivalents. Five customers represent 100% of the Company’s trade accounts receivable at December 31, 2016 and four customers represent approximately 96.8% of the Company’s 2016 revenues. (j) Research and Development Research and development costs for the Company’s proprietary products/ product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for manufacturing of clinical supplies, drug development, clinical trials, statistical analysis and report writing, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use. (k) Stock-Based Awards The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Nonemployee stock-based awards are revalued until an award vests and recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, or the accelerated attribution method. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are revised. (l) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company accrues interest and related penalties are classified as income tax expense in the Consolidated Statements of Operations. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. (m) Net Income (Loss) Per Common Share Basic net income (loss) per common share is determined by dividing net income (loss) applicable to common shareholders by the weighted average common shares outstanding during the period. For all periods presented, the outstanding common stock options, unvested restricted stock units and warrants have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2016 and 2015, as they would be anti-dilutive: December 31, 2016 2015 Options and restricted stock units outstanding 2,619,679 1,153,950 Warrants 784,928 490,000 The following table sets forth the computation of basic earnings per share and diluted earnings per share: December 31, 2016 2015 Basic Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Common stock outstanding (weighted average) 10,721,928 8,491,025 Basic net income (loss) per share $ (2.82 ) $ 0.36 Diluted Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Add change in warrant valuation — (1,174 ) Diluted net income (loss) $ (30,205 ) $ 1,859 Common stock outstanding (weighted average) 10,721,928 8,491,025 Add shares from outstanding warrants and stock options — 258,209 Common stock equivalents 10,721,928 8,749,234 Diluted net income (loss) per share $ (2.82 ) $ 0.21 (n) Segment Information The Company determined its reportable segments based on its strategic business units, the commonalities among the products and services within each segment and the manner in which the Company reviews and evaluates operating performance. The Company has identified CDMO and Acute Care as reportable segments. Segment disclosures are included in Note 14. Segment operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of general and administrative expenses, research and development expenses, and the change in valuation of contingent consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and expense, and income tax benefit (expense). Segment assets are those assets and liabilities that are recorded and reported by segment operations. Segment operating capital employed represents segment assets less segment liabilities. (o) Recent Accounting Pronouncements In January 2017, the Financial Accounting Standards Board or, FASB, issued updated guidance on the annual goodwill impairment test. The amended guidance allows companies to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The amendments of the Accounting Standards Update (ASU) are effective for annual or interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In August 2016, the FASB issued updated guidance in the classification of certain cash receipts and payments in the statement of cash flows where diversity in practice exists. This new guidance is effective for annual periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures. In March 2016, the FASB issued updated guidance on the accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, employee tax withholding, calculation of shares for use in diluted earnings per share and the classification on the statement of cash flows. The new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The Company early adopted the guidance effective July 1, 2016. The guidance did not have a material impact to the consolidated financial statements upon adoption. In February 2016, the FASB issued updated guidance regarding the accounting for and disclosures of leases. This new ASU represents a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The effective for annual and interim periods begins after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In November 2015, the FASB issued updated guidance on the presentation requirements for deferred income tax liabilities and assets to be classified as noncurrent in a classified statement of financial position. The update is effective for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years, and early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. The Company adopted this guidance during the year ended December 31, 2015. In September 2015, the FASB issued updated guidance regarding the accounting for and disclosure of measurement-period adjustments that occur in periods after a business combination is consummated. This update requires that the acquirer recognize measurement-period adjustments in the reporting period in which they are determined. Prior period information should not be revised. This update also requires an entity to present separately on the face of the income statement or disclose in the notes the amount recorded in the current-period income statement that would have been recorded in previous reporting periods if the adjustments had been recognized as of the acquisition date. The effective date for annual and interim periods begins after December 15, 2016. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In August 2014, the FASB issued updated guidance regarding the going concern assumption. The amendments in this update will explicitly require a company’s management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. This new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The Company adopted this new standard effective for the year ended December 31, 2016. In July 2015, the FASB issued updated guidance which changes the measurement principle for inventory from the lower of cost or market to the lower of cost and net realizable value. The amendments in this guidance do not apply to inventory that is measured using last-in, first-out or, LIFO, or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out or average cost. Within the scope of this new guidance, an entity should measure inventory at the lower of cost and net realizable value; where, net realizable value is defined as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The new guidance must be applied on a prospective basis. The Company is evaluating the effect that the new guidance will have on its consolidated financial statements and related disclosures. In May 2014, the FASB issued updated guidance regarding the accounting for and disclosures of revenue recognition, with an effective date for annual and interim periods beginning after December 15, 2016. The update provides a single comprehensive model for accounting for revenue from contracts with customers. The model requires that revenue recognized reflect the actual consideration to which the entity expects to be entitled in exchange for the goods or services defined in the contract, including in situations with multiple performance obligations. In July 2015, the FASB deferred the effective date by one year. The guidance will be effective for annual and interim periods beginning after December 15, 2017. The new standard permits two methods of adoption: the full retrospective method, which requires the standard to be applied to each prior period presented, or the modified retrospective method, which requires the cumulative effect of adoption to be recognized as an adjustment to opening retained earnings in the period of adoption. The Company currently anticipates adopting the standard using the modified retrospective method. The Company plans to complete an analysis of existing contracts with its customers and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards by the end of the second quarter. The new standard will result in additional revenue-related disclosures in the footnotes to the consolidated financial statements. The Company will continue to assess new customer contracts during 2017. Adoption of this standard will require changes to business processes, systems and controls to support the additional required disclosures. The Company is in the process of identifying such changes. |
Acquisition of Gainesville Faci
Acquisition of Gainesville Facility and Meloxicam | 12 Months Ended |
Dec. 31, 2016 | |
Gainesville [Member] | |
Acquisition of Gainesville Facility and Meloxicam | (4) Acquisition of Gainesville Facility and Meloxicam On April 10, 2015, the Company completed the Gainesville Transaction. The consideration paid in connection with the Acquisition consisted of $50.0 million cash at closing, a $4.0 million working capital adjustment and a seven-year warrant to purchase 350,000 shares of the Company’s common stock at an exercise price of $19.46 per share. In addition, the Company may be required to pay up to an additional $125.0 million in milestone payments (including, the Company’s election, either (i) $10 million upon a new drug application or, NDA, filing and $30 million upon regulatory approval or (ii) an aggregate of $45 million upon regulatory approval, as well as net sales milestones) and a percentage of future product net sales related to injectable meloxicam. Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and royalties are allocated to the fair value of the assets acquired and liabilities assumed. The contingent consideration obligation is remeasured each reporting date with changes in fair value recognized as a period charge within the statement of operations (see note 5 for further information regarding fair value). The following was the purchase price allocation for the Gainesville Transaction: Purchase price agreement $ 50,000 Fair value of warrants 2,470 Fair value of contingent consideration 54,600 Working capital adjustment 4,010 $ 111,080 The contingent consideration consists of three separate components. The first component consists of two potential payments, which will be payable upon the submission of the NDA for meloxicam, and the related regulatory approval, respectively. The second component consists of three potential payments, based on the achievement of specified annual revenue targets. The third component consists of a royalty payment for a defined term on future meloxicam net sales. The fair value of the first contingent consideration component recognized on the acquisition date was estimated by applying a risk adjusted discount rate to the probability adjusted contingent payments and the expected approval dates. The fair value of the second contingent consideration component recognized on the acquisition date was estimated by applying a risk adjusted discount rate to the potential payments resulting from probability weighted revenue projections and expected revenue target attainment dates. The fair value of the third contingent consideration component recognized on the acquisition date was estimated by applying a risk adjusted discount rate to the potential payments resulting from probability weighted revenue projections and the defined royalty percentage. These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs. The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair value through the results of operations. The results of operations of the acquired business, which has become the CDMO division, have been included in the consolidated statement of operations beginning April 10, 2015. The following represents the assets acquired and the liabilities assumed in connection with the Gainesville Transaction, reconciled to the purchase price: Amount Accounts receivable $ 12,519 Inventory 10,253 Prepaid expenses 380 Property, plant and equipment 39,424 Intangible assets 41,900 Goodwill 6,446 Total assets acquired 110,922 Accounts payable and accrued expenses 1,162 Warrants 2,470 Contingent consideration 54,600 Total liabilities assumed 58,232 Cash paid, net of $1,320 of cash acquired $ 52,690 The fair value of the property, plant and equipment and their weighted-average useful lives are as follows: Estimated Fair Value Estimated Useful Life Buildings and improvements $ 16,371 35 years Land 3,263 N/A Furniture, office & computer equipment 2,510 4-5 years Vehicles 30 2 years Manufacturing equipment 17,250 6-7 years $ 39,424 The estimated fair value of property, plant and equipment was determined using the cost and sales approaches. The fair value of the identifiable intangible assets and their weighted-average useful lives are as follows: Estimated Fair Value Weighted Average Estimated Useful Life Royalties and contract manufacturing relationships 15,500 6 In-process research and development 26,400 N/A Total intangible assets 41,900 The IPR&D asset and customer relationships were valued using the multi-period excess earnings method, which is an income approach in which excess earnings are the earnings remaining after deducting the market rates of return on the estimated values of contributory assets, including debt-free net working capital, tangible and intangible assets. The excess earnings are thereby calculated for each quarter of a multi-quarter projection period discounted to a present value utilizing an appropriate discount rate for the subject asset. The unaudited pro forma combined results of operations for the year ended December 31, 2015 (assuming the closing of the Gainesville Transaction had occurred on January 1, 2015) are as follows: For the year ended December 31, 2015 Revenue $ 71,684 Net income 6,016 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (5) Fair Value of Financial Instruments The Company follows FASB accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. The guidance requires fair value measurements to maximize the use of “observable inputs.” The three-level hierarchy of inputs to measure fair value are as follows: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities • Level 2: Significant other observable inputs other than Level 1 prices such as quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity) The Company has classified assets and liabilities measured at fair value on a recurring basis as follows: Fair value measurements at reporting date using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) At December 31, 2015: Assets: Money market mutual funds $ 5,081 $ — $ — Government and agency bonds 10,250 — — Cash equivalents $ 15,331 $ — $ — Liabilities: Warrants — — $ 3,770 Contingent consideration — — 59,846 $ — $ — $ 63,616 At December 31, 2016: Assets: Money market mutual funds $ 37,079 $ — $ — Government and agency bonds 20,517 — — Cash equivalents $ 57,596 $ — $ — Liabilities: Warrants — — $ 3,397 Contingent consideration — — 69,574 $ — $ — $ 72,971 The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows: Warrants Contingent Consideration Balance at December 31, 2015 $ 3,770 $ 59,846 Additions — — Remeasurement (373 ) 9,728 Balance at December 31, 2016 $ 3,397 $ 69,574 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | (6) Inventory Inventory consists of the following: December 31, 2016 December 31, 2015 Raw materials $ 2,557 $ 2,933 Work in process 4,396 4,340 Finished goods 1,793 1,709 $ 8,746 $ 8,982 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | (7) Property, Plant and Equipment Property, plant and equipment consists of the following: December 31, 2016 December 31, 2015 Land $ 3,263 $ 3,263 Building and improvements 15,613 15,412 Furniture, office and computer equipment 3,811 2,888 Vehicles 30 30 Manufacturing equipment 21,508 19,504 Construction in Progress 2,198 955 46,423 42,052 Less: accumulated depreciation and amortization 9,123 4,130 Property, plant and equipment, net $ 37,300 $ 37,922 Depreciation expense for the years ended December 31, 2016 and 2015 was $4,993 and $4,120. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2016 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | (8) Intangible Assets The following represents the balance of the intangible assets at December 31, 2016: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships: $ 15,500 $ 4,467 $ 11,033 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 4,467 $ 37,433 Amortization expense for the years ended December 31, 2016 and 2015 was $2,583 and $1,884, respectively. The amortization expense for the next four years will be $2,583 per year and $701 in the final year. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | (9) Accrued Expenses Accrued expenses consist of the following: December 31, 2016 2015 Clinical trial and related costs $ 2,564 $ 1,364 Professional and consulting fees 360 863 Payroll and related costs 4,547 697 Property plant and equipment 720 — Deferred revenue 418 — Income tax payable 311 86 Other 973 408 $ 9,893 $ 3,418 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | (10) Long-Term Debt The Company financed the Gainesville Transaction with cash on hand and a $50,000 five-year senior secured term loan, pursuant to a credit agreement, entered into on April 10, 2015, with OrbiMed Royalty Opportunities II, LP, or OrbiMed. The unpaid principal amount under the credit agreement is due and payable on the five year anniversary of the loan provided thereunder by OrbiMed. The credit agreement also provides for certain mandatory prepayment events, including a quarterly excess cash flow prepayment requirement at OrbiMed’s request. The Company may make voluntary prepayments in whole or in part, subject to: (i) on or prior to the 36 month anniversary of the closing of the credit agreement, payment of a buy-out premium amount equal to (A) for full prepayments of the unpaid principal amount, $75,000 less all previously prepaid principal amounts and all previously paid interest or (B) for partial prepayments of the unpaid principal amount, 0.5 times the partial prepayment amount less interest payments previously paid in respect to the partial prepayment amount and (ii) after the 36 month anniversary of the closing of the credit agreement, payment of an exit fee amount equal to 10% of the amount of any prepayments. As defined by the agreement, based upon the CDMO segment financial results, OrbiMed has the option to require the Company to prepay a portion of the loan balance based upon an Excess Cash Flow. No payments under this option shall be subject to the buy-out premium As of December 31, 2016, the Company has paid $22,653 of principal payments on the senior secured loan from the Excess Cash Flow calculation. The credit agreement carries interest at three month LIBOR plus 14.0% with a 1.0% floor. The Company’s obligations under the senior term loan are secured by substantially all of the Company’s assets. The credit agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis. As of December 31, 2016, the Company was in compliance with the covenants. The Company issued to OrbiMed a warrant to purchase 294,928 shares of common stock, with an exercise price of $3.28 per share. The warrant is exercisable through April 10, 2022. The initial fair value of the warrant of $2,861 was recorded as debt issuance costs. Debt issuance costs related to the term loan of $4,579, including the initial warrant fair value of $2,861, are being amortized to interest expense over the five year term of the loan and netted with the loan principal amount. The unamortized balance of debt issuance costs is $2,959 as of December 31, 2016. As of December 31, 2016, the long-term debt balance is comprised of the following: Principal balance outstanding $ 27,347 Unamortized deferred issuance costs (2,959 ) $ 24,388 Current portion (2,236 ) $ 22,152 The Company has estimated the amount of the Excess Cash Flow payments that could be payable within one year of December 31, 2016 upon request of OrbiMed and has classified that amount as a current debt in the accompanying consolidated balance sheet. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (11) Commitments and Contingencies (a) License and Supply Agreements In August 2008, the Company entered into a License Agreement with Orion Corporation (Orion) for Non-Injectable Dexmedetomidine. Under the Dexmedetomidine License Agreement, the Company was granted an exclusive license under the Orion Know-How and Cygnus/Farmos Patent to commercialize products in the territory, as defined in such agreement, and to use, research, develop, and manufacture products worldwide, except for Europe, Turkey, and the CIS (currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan), referred to herein as the Territory, and to use, research, develop, and manufacture products worldwide solely for purposes of commercialization. The Company also entered into a supply agreement with Orion in which Orion will supply the Company with Dexmedetomidine at no cost during the product development period and upon FDA approval, Orion will supply commercial quantities of bulk active pharmaceutical ingredient Dexmedetomidine, for commercialization. The Company will pay up to €20,500 ($21.6 million as of December 31, 2016) in contingent milestones upon the achievement of certain regulatory and commercialization events. There are also royalty payments to be paid at varying percentages of net sales, which generally range from 10% to 20% depending on annual sales levels. No amounts were due or payable during 2016 or 2015. In July 2010, the Company entered into a License Agreement with Orion for Fadolmidine. Under the Fadolmidine License Agreement, the Company was granted an exclusive license under the Orion Know-How and Orion Patent Rights (each as defined in the License Agreement) to commercialize products in the territory, as defined in such agreement, and to use, research, develop, and manufacture products worldwide solely for purposes of commercialization. The Company will pay up to an additional €12,200 ($12.9 million as of December 31, 2016) in contingent milestones upon the achievement of certain regulatory and commercialization events. There are also royalty payments to be paid at varying percentages, which range from 10% to 15% of net sales. No amounts were due or payable during 2016 or 2015. As of December 31, 2016, the Company had $3,329 of non-cancellable commitments at our CDMO segment facility for capital expenditures and material and services. (b) Agreements with Alkermes Pursuant to the purchase and sale agreement governing the Gainesville Transaction, the Company agreed to pay to Alkermes up to an additional $125.0 million in milestone payments (including, at the Company’s election, either (i) $10 million upon NDA filing and $30 million upon regulatory approval or (ii) an aggregate of $45 million upon regulatory approval, as well as net sales milestones related to injectable meloxicam and royalties on future product sales of injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). In July 2015, the Company also entered into a Development, Manufacturing and Supply Agreement, or Supply Agreement, with Alkermes (through a subsidiary of Alkermes), pursuant to which Alkermes will (i) provide clinical and, if elected by the Company, commercial bulk supplies of injectable meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls section of a NDA for injectable meloxicam. Pursuant to the Supply Agreement, Alkermes will supply the Company with such quantities of bulk injectable meloxicam formulation as shall be reasonably required for the completion of clinical trials of injectable meloxicam, subject to a maximum of eight clinical batches in any twelve-month period unless otherwise agreed by the parties. The Company has elected to have Alkermes supply its initial commercial requirements of bulk injectable meloxicam formulation. During the term of the Supply Agreement, the Company will purchase its clinical and commercial supplies of bulk injectable meloxicam formulation exclusively from Alkermes, subject to certain exceptions, for a period of time. (c) Litigation The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. As part of the Gainesville Transaction, the Company acquired the rights to Zohydro ER®, which the Company licenses to its commercial partner, Pernix Therapeutics Holdings, Inc., or Pernix, in the United States, and which is subject to ongoing intellectual property litigation and proceedings. Zohydro ER® is subject to six paragraph IV certifications, two of which were filed in 2014 by Actavis plc, or Actavis, and Alvogen Pine Brook, Inc., or Alvogen, regarding the filing of Abbreviated NDAs, or ANDAs, with the FDA for a generic version of Zohydro ER®, one of which was filed in April 2015, by Actavis regarding the filing of a supplemental ANDA, or sANDA, and another three of which were filed in November 2015 and October 2016, by Actavis, and in December 2015, by Alvogen regarding one of our recently issued patents relating to a formulation of Zohydro ER®. These certification notices allege that three U.S. patents listed in the FDA’s Orange Book for Zohydro ER®, with an expiration date of November 2019 and September 2034, will not be infringed by Actavis’ or Alvogen’s proposed products, are invalid and/or are unenforceable. In 2014, Davrata Limited (a subsidiary of Alkermes and the Company’s predecessor in interest) filed suit against each of Actavis and Alvogen in the U.S. District Court for the District of Delaware based on the ANDAs, and in 2015, the Company filed suit against Actavis in the U.S. District Court of the District of Delaware based on the sANDA. Under the Company’s license agreement with Pernix, the Company has the right to control the enforcement of the Company’s patents and related proceedings involving Zohydro ER® and any prospective generic entrant, and Pernix has the obligation to reimburse the Company for all reasonable costs of paragraph IV certification actions. On September 29, 2016, the Company entered into a settlement agreement with Alvogen pursuant to which the case against Alvogen was dismissed. In February 2017, the Court in the Actavis case ruled in the Company’s favor and enjoined Actavis from selling the proposed generic version of Zohydro ER (d) Leases In August 2016, the Company entered into a six-year lease commencing on January 1, 2017 for the Malvern facility that expires on December 31, 2022. In the life of the lease term, the Company may be liable for up to $1,999 of rent expense as well as additional operating and tenant improvement expenses. Future minimum lease payments, excluding operating expenses and tenant improvements for the lease are as follows: Lease payments 2017 $ 244 2018 329 2019 340 2020 351 2021 362 2022 373 Total $ 1,999 |
Capital Structure
Capital Structure | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Capital Structure | (12) Capital Structure (a) Common Stock The Company is authorized to issue 50,000,000 shares of common stock, with a par value of $0.01 per share. On March 12, 2014, the Company completed an IPO in which the Company sold 4,312,500 shares of common stock at $8.00 per share resulting in gross proceeds of $34,500. In connection with the IPO, the Company paid $4,244 in underwriting discounts, commissions and offering costs resulting in net proceeds of $30,256. Also in connection with the IPO, all of the outstanding shares of the Company’s Series A Redeemable Convertible Preferred Stock, or Series A Stock, including accreted dividends, and Bridge Notes, including accrued interest, were converted into common stock. On July 7, 2015, the Company closed a private placement with certain accredited investors in which the Company sold 1,379,311 shares of common stock at a price of $11.60 per share, for net proceeds of $14,812. The Company paid the placement agents a fee equal to 6.0% of the aggregate gross proceeds from the private placement, plus reimbursement of certain expenses. On August 19, 2016, the Company closed an underwritten public offering in which the company sold 1,986,666 shares of common stock at a price per share of $7.50 for net proceeds of $13,367 after deducting underwriting commissions and offering expenses. On December 16, 2016, the Company closed an underwritten public offering in which the company sold 6,670,000 shares of common stock at a price per share of $6.00 for net proceeds of $36,888 after deduction underwriting commissions and offering expenses. (b) Common Stock Purchase Agreement On February 2, 2015, the Company entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, pursuant to which Aspire Capital is committed to purchase, at the Company’s election, up to an aggregate of $10,000 of shares of the Company’s common stock over the 24-month term of the Purchase Agreement. On the execution of the Purchase Agreement, the Company issued 96,463 shares of common stock to Aspire Capital with a fair value of $285, as consideration for entering in the Purchase Agreement. In addition, the Company incurred $253 of costs in connection with the Aspire Capital facility, which, along with the fair value of the common stock has been recorded as deferred equity costs. During 2016, the Company sold 1,143,940 shares of common stock under the Purchase Agreement for $7,796. (c) Preferred Stock The Company is authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.01 per share. As of December 31, 2016, no preferred stock was issued or outstanding. (d) Warrants As of December 31, 2016, the Company had the following warrants outstanding to purchase shares of the Company’s common stock: Number of Shares Exercise Price per Share Expiration Date 140,000 $ 12.00 March 2018 350,000 $ 19.46 April 2022 294,928 $ 3.28 April 2022 The warrant to purchase 350,000 shares is liability classified since it contains a contingent net cash settlement feature. The warrant to purchase 294,928 shares is liability classified since it contains an anti-dilution provision. The fair value of both warrants will be remeasured through settlement or expiration with changes in fair value recognized as a period charge within the statement of operations. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | (13) Stock-Based Compensation The Company established the 2008 Stock Option Plan, or the 2008 Plan, which allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common stock to designated employees, nonemployee directors, and consultants and advisors. As of December 31, 2016, no stock appreciation rights have been issued. Subsequent to adoption, the 2008 Plan was amended to increase the authorized number of shares available for grant to 444,000 shares of common stock. In October 2013, the Company established the 2013 Equity Incentive Plan, or the 2013 Plan, which allows for the grant of stock options, stock appreciation rights and stock awards for a total of 600,000 shares of common stock. In June 2015, the Company’s shareholders approved the Amended and Restated Equity Incentive Plan, or the A&R Plan, which amended and restated the 2013 Plan and increased the aggregate amount of shares available for issuance to 2,000,000. In December 2016 and 2015, per the “Evergreen” provision of the plan, shares were increased by 619,181 and 461,215, respectively, which represents 5% of outstanding common stock at the time of increase. The total number of options in the 2013 plan as of December 31, 2016 is 3,080,396. Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of December 31, 2016, 1,212,248 shares and 174 shares are available for future grants under the 2013 Plan and 2008 Plan, respectively. The weighted average grant-date fair value of the options awarded to employees during the years ended December 31, 2016 and 2015 was $5.08 and $8.10, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: 2016 2015 Range of expected option life 6 years 6-7 years Expected volatility 82.47% 77.39% Risk-free interest rate 1.07-2.09% 2.06-2.51% Expected dividend yield — — The following table summarizes stock option activity during the year ended December 31, 2016: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2014 1,033,300 $ 5.77 Granted 1,079,550 8.26 Exercised (38,000 ) 6.00 Expired/forfeited/cancelled (32,656 ) 11.20 Balance, December 31, 2015 2,042,194 7.00 Granted 596,106 7.21 Exercised — — Expired/forfeited/cancelled (26,371 ) 10.86 Balance, December 31, 2016 2,611,929 $ 7.01 7.4 years Vested 1,410,596 $ 6.41 6.2 years Vested and expected to vest 2,530,261 $ 6.67 7.4 years Included in the table above are 364,000 of options granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4). Also included in the table above are 105,300 performance based options granted to the Chief Executive Officer in December 2015. As of December 31, 2016, all 105,300 of these options vested upon meeting the performance targets, resulting in compensation expense of $551. The following table summarizes restricted stock units activity during the year ended December 31, 2016. Number of shares Balance, December 31, 2015 32,200 Granted — Vested (24,450 ) Balance, December 31, 2016 7,750 Expected to vest 7,750 In December 2015, the Company granted 32,200 performance-based restricted stock units, or RSUs, which vest based on attaining clinical and operational goals during 2016. Included in the 24,450 units of restricted stock vested during the year ended December 31, 2016 are 6,155 shares with a weighted average fair value of $8.30 per share that were withheld for withholding tax purposes upon vesting of such awards from stockholders who elected to net share settle such tax withholding obligation. The remaining 7,750 restricted stock units outstanding as of December 31, 2016 vested upon the achievement of the 2016 performance goals as determined by the Board of Directors in January 2017. Stock-based compensation expense for the years ended December 31, 2016 and 2015 was $3,889 and $3,064, respectively. As of December 31, 2016, there was $7,198 of unrecognized compensation expense related to unvested options and RSUs that are expected to vest and will be expensed over a weighted average period of 2.8 years. The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. As of December 31, 2016, the aggregate intrinsic value of the vested and unvested options was $2,881 and $1,382, respectively. In January 2017, the Company granted 465,250 options, as well as 91,150 performance-based restricted stock units, and 147,400 time-based restricted stock units which are not included in the above table. |
Segment Reporting
Segment Reporting | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Segment Reporting | (14) Segment Reporting The Company operates through two business segments: an Acute Care segment and a revenue-generating CDMO segment. The Acute Care segment is primarily focused on developing innovative products for hospital and related settings, and the CDMO segment leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. Acute Care has no revenue and its costs consist primarily of expenses incurred in conducting the Company’s clinical and preclinical studies, acquiring clinical trial materials, regulatory activities and personnel costs. CDMO revenue streams are derived from manufacturing, royalty and profit sharing revenues as well as our CDMO’s research and development of services performed for commercial partners. The accounting policies of the segments are the same as those described in the summary of significant account policies (see Note 3). The Company evaluates performance of its reportable segments based on revenue and operating income (loss). The Company does not allocate interest income, interest expense or income taxes to its operating segments. The following table summarizes segment information as of and for the years ended December 31, 2016 and 2015: Years Ended December 31, 2016 2015 Revenues: CDMO $ 69,337 $ 51,952 Acute Care — — Total $ 69,337 $ 51,952 Operating income (loss): CDMO $ 24,232 $ 17,558 Acute Care (50,005 ) (24,528 ) Total $ (25,773 ) $ (6,970 ) Depreciation and amortization: CDMO $ 7,572 $ 6,004 Acute Care 4 — Total $ 7,576 $ 6,004 Capital expenditures: CDMO $ 3,735 $ 2,411 Acute Care 35 — Total $ 3,770 $ 2,411 December 31, 2016 2015 Total assets: CDMO $ 77,828 $ 81,430 Acute Care 105,169 57,267 Total $ 182,997 $ 138,697 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (15) Income Taxes The components of loss before income tax are as follows: December 31, 2016 2015 Domestic $ 1,207 $ (10,002 ) Foreign (32,519 ) (2,516 ) Loss before income taxes $ (31,312 ) $ (12,518 ) The components of income tax provision (benefit) are as follows: December 31, 2016 2015 Current: Federal $ 298 $ 83 State and local 18 3 Foreign — — 316 86 Deferred: Federal $ (1,607 ) $ (13,418 ) State and local 184 (2,219 ) Foreign — — (1,423 ) (15,637 ) $ (1,107 ) $ (15,551 ) A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2016 2015 U.S. federal statutory income tax rate 34.0 % 34.0 % Foreign tax rate differential (22.3 )% (4.3 )% State taxes, net of federal benefit (0.1 )% 2.6 % Nondeductible expenses 0.5 % 4.2 % Research and development credits 4.5 % 1.7 % Change in valuation allowance (13.1 )% 86.1 % Effective income tax rate 3.5 % 124.3 % The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2016 2015 Net operating loss carryforwards $ 6,742 $ 5,754 Research and development credits 3,108 1,343 Capitalized start-up costs 2,343 2,590 Intangibles 2,181 597 Contingent consideration 5,364 1,932 Stock-based compensation 2,718 1,256 Other temporary differences 517 2,480 Gross deferred tax asset 22,973 15,952 Valuation allowance (4,379 ) (315 ) Net deferred tax asset 18,594 15,637 Deferred tax liability (1,534 ) — Net deferred taxes $ 17,060 $ 15,637 In assessing the realizability of the net deferred tax asset, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. During 2015, in connection with an international corporate restructuring, it was determined that the Company would more likely than not realize its deferred tax assets associated with its US operations. Accordingly, the Company recorded a benefit associated with the release of its prior year valuation allowance in the amount of $11,087. The Company believes that it is more likely than not that the Company’s deferred income tax asset associated with its foreign net operating losses will not be realized in the immediate future. As such, there is a full valuation allowance against the net deferred tax assets associated with foreign operations as of December 31, 2016 and 2015. The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2016: Amount Expiration Federal net operating losses $ 4,206 2030 – 2035 State net operating losses $ 14,149 2030 – 2035 Foreign net operating losses $ 35,035 No expiration Research and development credits $ 2,817 2028 – 2034 Under the Tax Reform Act of 1986 (the Act), the utilization of a corporation’s net operating loss and research and development tax credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any unused annual limitation may be carried forward to future years for the balance of the carryforward period. The Company has done an analysis to determine whether or not ownership changes, as defined by the Act, have occurred since inception. The Company determined that it experienced ownership changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past financings; accordingly, the Company’s ability to utilize the aforementioned carryforwards will be limited. Although the carryforwards will be limited, the Company has determined that none of the net operating losses will expire prior to being utilized as a result of the changes. In addition, state net operating loss carryforwards may be further limited, including Pennsylvania, which has a limitation equal to the greater of 30.0% of taxable income after modifications and apportionment or $5,000,000 on state net operating losses utilized in any one year. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2016, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. Due to net operating loss and tax credit carry forwards that remain unutilized, income tax returns for tax years from inception through 2015 remain subject to examination by the taxing jurisdictions. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | (16) Related Party Transactions The Company’s President and Chief Executive Officer, or CEO, owns a majority of the stock of Malvern Consulting Group, or MCG, a pharmaceutical incubator and consulting firm. The CEO’s husband, who is also a shareholder of the Company, is a consultant and a shareholder of MCG. In addition, the CEO’s son is the President and a shareholder of MCG. During 2015 and 2016, certain immediate family members of the CEO were employees of MCG, including the CEO’s brother and sister-in-law. Since formation, the Company entered into various transactions with MCG, as detailed below. However, since becoming a public company, the Company sought to decrease its involvement with MCG and as of December 31, 2016, the Company no longer has any involvement or transactions with MCG. During 2016 and 2015, certain of the Company’s executive officers, our CEO, our Senior Vice President, Development and our Senior Vice President, Regulatory Affairs and Quality Assurance, who is also the CEO's sister, provided minimal consulting services from time to time to MCG. Until December 31, 2016, the Company was a party to a Master Consulting Services Agreement with MCG. Pursuant to the agreement, MCG provided the Company with certain consulting services for a fee based upon hourly rates previously approved by our Board of Directors. In consideration for such services, the Company recorded $363 and $465 in 2016 and 2015, respectively. A portion of these amounts were used during 2016 and 2015 to pay a portion of the respective salaries of MCG employees that, as described above, included immediate family members of the Company’s CEO. Until December 31, 2016, the Company was party to an Office Services Agreement with MCG for the lease of an aggregate of 8,458 square feet of office and lab space located at our Malvern, facility and the provision of IT services and general office support. Pursuant to the Office Services Agreement, the Company paid MCG $206 and $114 in 2016 and 2015, respectively. The Company terminated this agreement on December 31, 2016 and are now party to a six-year lease directly with the landlord of the Company’s Malvern facility (see Note 11). As of December 31, 2016, the Company has terminated the Master Consulting Agreement, the Office Services Agreement and MCG no longer provides any services or has any contracts with the Company. The Company’s Senior Vice President, Regulatory and Quality, who is the CEO’s sister, has held that position since 2014. Effective January 1, 2017, the CEO’s sister-in-law and brother, respectively, terminated their employment with MCG and were hired as the Company’s Director of Human Resources and our Vice President, Manufacturing. The Board approved these hires consistent with the Company’s related person transaction policy. |
Summary of Significant Accoun23
Summary of Significant Accounting Principles (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2016 and its results of operations for the twelve months ended December 31, 2016 and 2015 and cash flows for the twelve months ended December 31, 2016 and 2015. |
Use of Estimates | (b) Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. |
Cash and Cash Equivalents | (c) Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents as of December 31, 2016 and 2015 consisted of money market mutual funds and government and agency bonds. |
Fair Value of Financial Instruments | (d) Fair Value of Financial Instruments Management believes that the carrying amounts of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments. Management believes the carrying value of debt approximates fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. |
Inventory | (e) Inventory Inventory is stated at the lower of cost or market value. Cost is determined using the first-in, first-out method. Included in inventory are raw materials used in production of commercial products. |
Property and Equipment | (f) Property and Equipment Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred. |
Goodwill and Intangible Assets | (g) Goodwill and Intangible Assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a two-step method for determining impairment. The first step compares a reporting unit’s fair value to its carrying amount to identify potential goodwill impairment. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the second step of the impairment test must be completed to measure the amount of the reporting unit’s goodwill impairment loss, if any. Step two requires an assignment of the reporting unit’s fair value to the reporting unit’s assets and liabilities to determine the implied fair value of the reporting unit’s goodwill. The implied fair value of the reporting unit’s goodwill is then compared with the carrying amount of the reporting unit’s goodwill to determine the goodwill impairment loss to be recognized, if any. Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an in-process research and development, or IPR&D, asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is amortized on a straight-line basis over a useful lives of six years. Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off and the Company will record a noncash impairment loss on its consolidated statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a triggering event occurs between annual assessments which would then require an assessment in the period which a triggering event occurred. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30th. As a result of the impairment tests, the Company determined that there was no impairment to goodwill or indefinite-lived intangible assets for the year ended December 31, 2016. |
Revenue Recognition | (h) Revenue Recognition The Company generates revenues from manufacturing, packaging and related services for multiple pharmaceutical companies. The agreements that the Company has with its commercial partners provide for manufacturing revenues, royalties and/or profit sharing components. Manufacturing and other related services revenue is recognized when persuasive evidence of an arrangement exists, shipment has occurred and the title to the product and associated risk of loss has passed to the customer, the sales price is fixed or determinable and collectability is reasonably assured. In addition to manufacturing and packaging revenue, the customer agreements have royalties and/or profit sharing payments, computed on the net product sales of the partner. Royalty and profit sharing revenues are generally recognized under the terms of the license and supply agreement in the period the products are sold and expenses are incurred by our commercial partner and collectability is reasonably assured. Revenues related to research and development are generally recognized as the related services or activities are performed, in accordance with the contract terms. To the extent that the agreements specify services are to be performed on a fixed basis, revenues are recognized consistent with the pattern of the work performed. |
Concentration of Credit Risk | (i) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company’s policy is to limit the amount of credit exposure to any one financial institution and place its cash and cash equivalents with financial institutions evaluated as being creditworthy. To date, the Company has not experienced any losses on its cash equivalents. Five customers represent 100% of the Company’s trade accounts receivable at December 31, 2016 and four customers represent approximately 96.8% of the Company’s 2016 revenues. |
Research and Development | (j) Research and Development Research and development costs for the Company’s proprietary products/ product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for manufacturing of clinical supplies, drug development, clinical trials, statistical analysis and report writing, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use. |
Stock-Based Awards | (k) Stock-Based Awards The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Nonemployee stock-based awards are revalued until an award vests and recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, or the accelerated attribution method. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are revised. |
Income Taxes | (l) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company accrues interest and related penalties are classified as income tax expense in the Consolidated Statements of Operations. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. |
Net Income (Loss) Per Common Share | (m) Net Income (Loss) Per Common Share Basic net income (loss) per common share is determined by dividing net income (loss) applicable to common shareholders by the weighted average common shares outstanding during the period. For all periods presented, the outstanding common stock options, unvested restricted stock units and warrants have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, the weighted average shares used to calculate both basic and diluted net loss per share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2016 and 2015, as they would be anti-dilutive: December 31, 2016 2015 Options and restricted stock units outstanding 2,619,679 1,153,950 Warrants 784,928 490,000 The following table sets forth the computation of basic earnings per share and diluted earnings per share: December 31, 2016 2015 Basic Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Common stock outstanding (weighted average) 10,721,928 8,491,025 Basic net income (loss) per share $ (2.82 ) $ 0.36 Diluted Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Add change in warrant valuation — (1,174 ) Diluted net income (loss) $ (30,205 ) $ 1,859 Common stock outstanding (weighted average) 10,721,928 8,491,025 Add shares from outstanding warrants and stock options — 258,209 Common stock equivalents 10,721,928 8,749,234 Diluted net income (loss) per share $ (2.82 ) $ 0.21 |
Segment Information | (n) Segment Information The Company determined its reportable segments based on its strategic business units, the commonalities among the products and services within each segment and the manner in which the Company reviews and evaluates operating performance. The Company has identified CDMO and Acute Care as reportable segments. Segment disclosures are included in Note 14. Segment operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of general and administrative expenses, research and development expenses, and the change in valuation of contingent consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and expense, and income tax benefit (expense). Segment assets are those assets and liabilities that are recorded and reported by segment operations. Segment operating capital employed represents segment assets less segment liabilities. |
Recent Accounting Pronouncements | (o) Recent Accounting Pronouncements In January 2017, the Financial Accounting Standards Board or, FASB, issued updated guidance on the annual goodwill impairment test. The amended guidance allows companies to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The amendments of the Accounting Standards Update (ASU) are effective for annual or interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In August 2016, the FASB issued updated guidance in the classification of certain cash receipts and payments in the statement of cash flows where diversity in practice exists. This new guidance is effective for annual periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures. In March 2016, the FASB issued updated guidance on the accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, employee tax withholding, calculation of shares for use in diluted earnings per share and the classification on the statement of cash flows. The new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The Company early adopted the guidance effective July 1, 2016. The guidance did not have a material impact to the consolidated financial statements upon adoption. In February 2016, the FASB issued updated guidance regarding the accounting for and disclosures of leases. This new ASU represents a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The effective for annual and interim periods begins after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In November 2015, the FASB issued updated guidance on the presentation requirements for deferred income tax liabilities and assets to be classified as noncurrent in a classified statement of financial position. The update is effective for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years, and early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. The Company adopted this guidance during the year ended December 31, 2015. In September 2015, the FASB issued updated guidance regarding the accounting for and disclosure of measurement-period adjustments that occur in periods after a business combination is consummated. This update requires that the acquirer recognize measurement-period adjustments in the reporting period in which they are determined. Prior period information should not be revised. This update also requires an entity to present separately on the face of the income statement or disclose in the notes the amount recorded in the current-period income statement that would have been recorded in previous reporting periods if the adjustments had been recognized as of the acquisition date. The effective date for annual and interim periods begins after December 15, 2016. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements. In August 2014, the FASB issued updated guidance regarding the going concern assumption. The amendments in this update will explicitly require a company’s management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. This new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The Company adopted this new standard effective for the year ended December 31, 2016. In July 2015, the FASB issued updated guidance which changes the measurement principle for inventory from the lower of cost or market to the lower of cost and net realizable value. The amendments in this guidance do not apply to inventory that is measured using last-in, first-out or, LIFO, or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out or average cost. Within the scope of this new guidance, an entity should measure inventory at the lower of cost and net realizable value; where, net realizable value is defined as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The new guidance is effective for annual periods beginning after December 15, 2016, with early adoption permitted. The new guidance must be applied on a prospective basis. The Company is evaluating the effect that the new guidance will have on its consolidated financial statements and related disclosures. In May 2014, the FASB issued updated guidance regarding the accounting for and disclosures of revenue recognition, with an effective date for annual and interim periods beginning after December 15, 2016. The update provides a single comprehensive model for accounting for revenue from contracts with customers. The model requires that revenue recognized reflect the actual consideration to which the entity expects to be entitled in exchange for the goods or services defined in the contract, including in situations with multiple performance obligations. In July 2015, the FASB deferred the effective date by one year. The guidance will be effective for annual and interim periods beginning after December 15, 2017. The new standard permits two methods of adoption: the full retrospective method, which requires the standard to be applied to each prior period presented, or the modified retrospective method, which requires the cumulative effect of adoption to be recognized as an adjustment to opening retained earnings in the period of adoption. The Company currently anticipates adopting the standard using the modified retrospective method. The Company plans to complete an analysis of existing contracts with its customers and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards by the end of the second quarter. The new standard will result in additional revenue-related disclosures in the footnotes to the consolidated financial statements. The Company will continue to assess new customer contracts during 2017. Adoption of this standard will require changes to business processes, systems and controls to support the additional required disclosures. The Company is in the process of identifying such changes. |
Summary of Significant Accoun24
Summary of Significant Accounting Principles (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Schedule of Anti-Dilutive Securities | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2016 and 2015, as they would be anti-dilutive: December 31, 2016 2015 Options and restricted stock units outstanding 2,619,679 1,153,950 Warrants 784,928 490,000 |
Computation of Basic Earnings Per Share and Diluted Earnings Per Share | The following table sets forth the computation of basic earnings per share and diluted earnings per share: December 31, 2016 2015 Basic Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Common stock outstanding (weighted average) 10,721,928 8,491,025 Basic net income (loss) per share $ (2.82 ) $ 0.36 Diluted Earnings Per Share Net income (loss) $ (30,205 ) $ 3,033 Add change in warrant valuation — (1,174 ) Diluted net income (loss) $ (30,205 ) $ 1,859 Common stock outstanding (weighted average) 10,721,928 8,491,025 Add shares from outstanding warrants and stock options — 258,209 Common stock equivalents 10,721,928 8,749,234 Diluted net income (loss) per share $ (2.82 ) $ 0.21 |
Acquisition of Gainesville Fa25
Acquisition of Gainesville Facility and Meloxicam (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Schedule of Fair Value of Property, Plant and Equipment and Their Weighted-Average Useful Lives | Property, plant and equipment consists of the following: December 31, 2016 December 31, 2015 Land $ 3,263 $ 3,263 Building and improvements 15,613 15,412 Furniture, office and computer equipment 3,811 2,888 Vehicles 30 30 Manufacturing equipment 21,508 19,504 Construction in Progress 2,198 955 46,423 42,052 Less: accumulated depreciation and amortization 9,123 4,130 Property, plant and equipment, net $ 37,300 $ 37,922 |
Schedule of Fair Value of Identifiable Intangible Assets and Their Weighted-Average Useful Lives | The following represents the balance of the intangible assets at December 31, 2016: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships: $ 15,500 $ 4,467 $ 11,033 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 4,467 $ 37,433 |
Unaudited Pro Forma Results of Operations | The unaudited pro forma combined results of operations for the year ended December 31, 2015 (assuming the closing of the Gainesville Transaction had occurred on January 1, 2015) are as follows: For the year ended December 31, 2015 Revenue $ 71,684 Net income 6,016 |
Gainesville [Member] | |
Schedule of Purchase Price Allocation | The following was the purchase price allocation for the Gainesville Transaction: Purchase price agreement $ 50,000 Fair value of warrants 2,470 Fair value of contingent consideration 54,600 Working capital adjustment 4,010 $ 111,080 |
Schedule of Assets Acquired and Liabilities Assumed and Reconciled to Purchase Price | The following represents the assets acquired and the liabilities assumed in connection with the Gainesville Transaction, reconciled to the purchase price: Amount Accounts receivable $ 12,519 Inventory 10,253 Prepaid expenses 380 Property, plant and equipment 39,424 Intangible assets 41,900 Goodwill 6,446 Total assets acquired 110,922 Accounts payable and accrued expenses 1,162 Warrants 2,470 Contingent consideration 54,600 Total liabilities assumed 58,232 Cash paid, net of $1,320 of cash acquired $ 52,690 |
Schedule of Fair Value of Property, Plant and Equipment and Their Weighted-Average Useful Lives | The fair value of the property, plant and equipment and their weighted-average useful lives are as follows: Estimated Fair Value Estimated Useful Life Buildings and improvements $ 16,371 35 years Land 3,263 N/A Furniture, office & computer equipment 2,510 4-5 years Vehicles 30 2 years Manufacturing equipment 17,250 6-7 years $ 39,424 |
Schedule of Fair Value of Identifiable Intangible Assets and Their Weighted-Average Useful Lives | The fair value of the identifiable intangible assets and their weighted-average useful lives are as follows: Estimated Fair Value Weighted Average Estimated Useful Life Royalties and contract manufacturing relationships 15,500 6 In-process research and development 26,400 N/A Total intangible assets 41,900 |
Fair Value of Financial Instr26
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis | The Company has classified assets and liabilities measured at fair value on a recurring basis as follows: Fair value measurements at reporting date using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) At December 31, 2015: Assets: Money market mutual funds $ 5,081 $ — $ — Government and agency bonds 10,250 — — Cash equivalents $ 15,331 $ — $ — Liabilities: Warrants — — $ 3,770 Contingent consideration — — 59,846 $ — $ — $ 63,616 At December 31, 2016: Assets: Money market mutual funds $ 37,079 $ — $ — Government and agency bonds 20,517 — — Cash equivalents $ 57,596 $ — $ — Liabilities: Warrants — — $ 3,397 Contingent consideration — — 69,574 $ — $ — $ 72,971 |
Reconciliation of Contingent Consideration and Warrants Measured at Fair Value on Recurring Basis Using Unobservable Inputs | The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows: Warrants Contingent Consideration Balance at December 31, 2015 $ 3,770 $ 59,846 Additions — — Remeasurement (373 ) 9,728 Balance at December 31, 2016 $ 3,397 $ 69,574 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventory consists of the following: December 31, 2016 December 31, 2015 Raw materials $ 2,557 $ 2,933 Work in process 4,396 4,340 Finished goods 1,793 1,709 $ 8,746 $ 8,982 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |
Schedule of Fair Value of Property, Plant and Equipment and Their Weighted-Average Useful Lives | Property, plant and equipment consists of the following: December 31, 2016 December 31, 2015 Land $ 3,263 $ 3,263 Building and improvements 15,613 15,412 Furniture, office and computer equipment 3,811 2,888 Vehicles 30 30 Manufacturing equipment 21,508 19,504 Construction in Progress 2,198 955 46,423 42,052 Less: accumulated depreciation and amortization 9,123 4,130 Property, plant and equipment, net $ 37,300 $ 37,922 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Fair Value of Identifiable Intangible Assets and Their Weighted-Average Useful Lives | The following represents the balance of the intangible assets at December 31, 2016: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships: $ 15,500 $ 4,467 $ 11,033 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 4,467 $ 37,433 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consist of the following: December 31, 2016 2015 Clinical trial and related costs $ 2,564 $ 1,364 Professional and consulting fees 360 863 Payroll and related costs 4,547 697 Property plant and equipment 720 — Deferred revenue 418 — Income tax payable 311 86 Other 973 408 $ 9,893 $ 3,418 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt Balance | As of December 31, 2016, the long-term debt balance is comprised of the following: Principal balance outstanding $ 27,347 Unamortized deferred issuance costs (2,959 ) $ 24,388 Current portion (2,236 ) $ 22,152 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements | Future minimum lease payments, excluding operating expenses and tenant improvements for the lease are as follows: Lease payments 2017 $ 244 2018 329 2019 340 2020 351 2021 362 2022 373 Total $ 1,999 |
Capital Structure (Tables)
Capital Structure (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Purchase Shares of Common Stock | As of December 31, 2016, the Company had the following warrants outstanding to purchase shares of the Company’s common stock: Number of Shares Exercise Price per Share Expiration Date 140,000 $ 12.00 March 2018 350,000 $ 19.46 April 2022 294,928 $ 3.28 April 2022 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model | The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: 2016 2015 Range of expected option life 6 years 6-7 years Expected volatility 82.47% 77.39% Risk-free interest rate 1.07-2.09% 2.06-2.51% Expected dividend yield — — |
Summary of Stock Option Activity | The following table summarizes stock option activity during the year ended December 31, 2016: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2014 1,033,300 $ 5.77 Granted 1,079,550 8.26 Exercised (38,000 ) 6.00 Expired/forfeited/cancelled (32,656 ) 11.20 Balance, December 31, 2015 2,042,194 7.00 Granted 596,106 7.21 Exercised — — Expired/forfeited/cancelled (26,371 ) 10.86 Balance, December 31, 2016 2,611,929 $ 7.01 7.4 years Vested 1,410,596 $ 6.41 6.2 years Vested and expected to vest 2,530,261 $ 6.67 7.4 years |
Summary of Restricted Stock Units Activity | The following table summarizes restricted stock units activity during the year ended December 31, 2016. Number of shares Balance, December 31, 2015 32,200 Granted — Vested (24,450 ) Balance, December 31, 2016 7,750 Expected to vest 7,750 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Summary of Segment Information | The following table summarizes segment information as of and for the years ended December 31, 2016 and 2015: Years Ended December 31, 2016 2015 Revenues: CDMO $ 69,337 $ 51,952 Acute Care — — Total $ 69,337 $ 51,952 Operating income (loss): CDMO $ 24,232 $ 17,558 Acute Care (50,005 ) (24,528 ) Total $ (25,773 ) $ (6,970 ) Depreciation and amortization: CDMO $ 7,572 $ 6,004 Acute Care 4 — Total $ 7,576 $ 6,004 Capital expenditures: CDMO $ 3,735 $ 2,411 Acute Care 35 — Total $ 3,770 $ 2,411 December 31, 2016 2015 Total assets: CDMO $ 77,828 $ 81,430 Acute Care 105,169 57,267 Total $ 182,997 $ 138,697 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Tax | The components of loss before income tax are as follows: December 31, 2016 2015 Domestic $ 1,207 $ (10,002 ) Foreign (32,519 ) (2,516 ) Loss before income taxes $ (31,312 ) $ (12,518 ) |
Components of Income Tax Provision (Benefit) | The components of income tax provision (benefit) are as follows: December 31, 2016 2015 Current: Federal $ 298 $ 83 State and local 18 3 Foreign — — 316 86 Deferred: Federal $ (1,607 ) $ (13,418 ) State and local 184 (2,219 ) Foreign — — (1,423 ) (15,637 ) $ (1,107 ) $ (15,551 ) |
Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate | A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2016 2015 U.S. federal statutory income tax rate 34.0 % 34.0 % Foreign tax rate differential (22.3 )% (4.3 )% State taxes, net of federal benefit (0.1 )% 2.6 % Nondeductible expenses 0.5 % 4.2 % Research and development credits 4.5 % 1.7 % Change in valuation allowance (13.1 )% 86.1 % Effective income tax rate 3.5 % 124.3 % |
Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2016 2015 Net operating loss carryforwards $ 6,742 $ 5,754 Research and development credits 3,108 1,343 Capitalized start-up costs 2,343 2,590 Intangibles 2,181 597 Contingent consideration 5,364 1,932 Stock-based compensation 2,718 1,256 Other temporary differences 517 2,480 Gross deferred tax asset 22,973 15,952 Valuation allowance (4,379 ) (315 ) Net deferred tax asset 18,594 15,637 Deferred tax liability (1,534 ) — Net deferred taxes $ 17,060 $ 15,637 |
Summary of Federal Net Operating Losses and Tax Credits Carryforwards | The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2016: Amount Expiration Federal net operating losses $ 4,206 2030 – 2035 State net operating losses $ 14,149 2030 – 2035 Foreign net operating losses $ 35,035 No expiration Research and development credits $ 2,817 2028 – 2034 |
Background - Additional Informa
Background - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2016Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Entity incorporation date | Nov. 15, 2007 |
Number of operating divisions | 2 |
Development-Stage Risks and L38
Development-Stage Risks and Liquidity - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Business Developments Risks And Uncertainties Liquidity [Abstract] | ||
Accumulated deficit | $ 61,268 | $ 31,063 |
Summary of Significant Accoun39
Summary of Significant Accounting Principles - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2016USD ($)Customer | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Goodwill impairment | $ | $ 0 |
Indefinite-lived intangible assets impairment | $ | $ 0 |
Trade Accounts Receivable [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | Customer | 5 |
Trade Accounts Receivable [Member] | Customer Concentration Risk [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Concentration risk percentage | 100.00% |
Sales Revenue, Net [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | Customer | 4 |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Concentration risk percentage | 96.80% |
Royalties and Contract Manufacturing [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Definite-lived intangible asset, useful lives | 6 years |
Furniture, Office & Computer Equipment [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 3 years |
Furniture, Office & Computer Equipment [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
Manufacturing Equipment [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 6 years |
Manufacturing Equipment [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
Vehicles [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 2 years |
Vehicles [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 5 years |
Buildings [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 35 years |
Buildings [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 40 years |
Leasehold Improvements [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment useful life | the shorter of the lease term or useful life |
Summary of Significant Accoun40
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Options [Member] | Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 2,619,679 | 1,153,950 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 784,928 | 490,000 |
Summary of Significant Accoun41
Summary of Significant Accounting Principles - Computation of Basic Earnings Per Share and Diluted Earnings Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Basic Earnings Per Share | ||
Net income (loss) | $ (30,205) | $ 3,033 |
Common stock outstanding (weighted average) | 10,721,928 | 8,491,025 |
Basic net income (loss) per share | $ (2.82) | $ 0.36 |
Diluted Earnings Per Share | ||
Net income (loss) | $ (30,205) | $ 3,033 |
Add change in warrant valuation | (1,174) | |
Diluted net income (loss) | $ (30,205) | $ 1,859 |
Common stock outstanding (weighted average) | 10,721,928 | 8,491,025 |
Add shares from outstanding warrants and stock options | 258,209 | |
Common stock equivalents | 10,721,928 | 8,749,234 |
Diluted net income (loss) per share | $ (2.82) | $ 0.21 |
Acquisition of Gainesville Fa42
Acquisition of Gainesville Facility and Meloxicam - Additional Information (Detail) - Gainesville [Member] $ / shares in Units, $ in Millions | Apr. 10, 2015USD ($)$ / sharesshares |
Business Acquisition [Line Items] | |
Business acquisition upfront payment in cash | $ 50 |
Working capital adjustment | 4 |
Business acquisition contingent consideration possible milestone payments | 125 |
NDA [Member] | |
Business Acquisition [Line Items] | |
Business acquisition contingent consideration possible milestone payments | 10 |
Regulatory Approval [Member] | |
Business Acquisition [Line Items] | |
Business acquisition contingent consideration possible milestone payments | 30 |
Regulatory Approval and Net Sales Milestones [Member] | |
Business Acquisition [Line Items] | |
Business acquisition contingent consideration possible milestone payments | $ 45 |
Seven Year Warrant [Member] | |
Business Acquisition [Line Items] | |
Purchase common stock with warrant issue | shares | 350,000 |
Warrant, exercise price per share | $ / shares | $ 19.46 |
Acquisition of Gainesville Fa43
Acquisition of Gainesville Facility and Meloxicam - Schedule of Purchase Price Allocation (Detail) - Gainesville [Member] $ in Thousands | Apr. 10, 2015USD ($) |
Business Acquisition [Line Items] | |
Purchase price agreement | $ 50,000 |
Fair value of warrants | 2,470 |
Fair value of contingent consideration | 54,600 |
Working capital adjustment | 4,010 |
Estimated Fair Value | $ 111,080 |
Acquisition of Gainesville Fa44
Acquisition of Gainesville Facility and Meloxicam - Schedule of Assets Acquired and Liabilities Assumed and Reconciled to Purchase Price (Detail) - USD ($) $ in Thousands | Apr. 10, 2015 | Dec. 31, 2015 | Dec. 31, 2016 |
Business Acquisition [Line Items] | |||
Goodwill | $ 6,446 | $ 6,446 | |
Cash paid, net of $1,320 of cash acquired | $ 52,690 | ||
Gainesville [Member] | |||
Business Acquisition [Line Items] | |||
Accounts receivable | $ 12,519 | ||
Inventory | 10,253 | ||
Prepaid expenses | 380 | ||
Property, plant and equipment | 39,424 | ||
Intangible assets | 41,900 | ||
Goodwill | 6,446 | ||
Total assets acquired | 110,922 | ||
Accounts payable and accrued expenses | 1,162 | ||
Warrants | 2,470 | ||
Contingent consideration | 54,600 | ||
Total liabilities assumed | 58,232 | ||
Cash paid, net of $1,320 of cash acquired | $ 52,690 |
Acquisition of Gainesville Fa45
Acquisition of Gainesville Facility and Meloxicam - Schedule of Assets Acquired and Liabilities Assumed and Reconciled to Purchase Price (Parenthetical) (Detail) $ in Thousands | Apr. 10, 2015USD ($) |
Gainesville [Member] | |
Business Acquisition [Line Items] | |
Cash acquired | $ 1,320 |
Acquisition of Gainesville Fa46
Acquisition of Gainesville Facility and Meloxicam - Schedule of Fair Value of Property, Plant and Equipment and Their Weighted-Average Useful Lives (Detail) - Gainesville [Member] $ in Thousands | Apr. 10, 2015USD ($) |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 39,424 |
Buildings and Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 16,371 |
Estimated Useful Life of Property, Plant and Equipment | 35 years |
Land [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 3,263 |
Furniture, Office & Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 2,510 |
Furniture, Office & Computer Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life of Property, Plant and Equipment | 4 years |
Furniture, Office & Computer Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life of Property, Plant and Equipment | 5 years |
Vehicles [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 30 |
Estimated Useful Life of Property, Plant and Equipment | 2 years |
Manufacturing Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Fair Value of Property, Plant and Equipment | $ 17,250 |
Manufacturing Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life of Property, Plant and Equipment | 6 years |
Manufacturing Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life of Property, Plant and Equipment | 7 years |
Acquisition of Gainesville Fa47
Acquisition of Gainesville Facility and Meloxicam - Schedule of Fair Value of Identifiable Intangible Assets and Their Weighted-Average Useful Lives (Detail) - USD ($) $ in Thousands | Apr. 10, 2015 | Dec. 31, 2016 |
Royalties and Contract Manufacturing [Member] | ||
Schedule Of Finite And Indefinite Lived Assets Acquired And Liabilities Assumed By Major Class [Line Items] | ||
Total intangible assets, Weighted Average Estimated Useful Life | 6 years | |
Gainesville [Member] | ||
Schedule Of Finite And Indefinite Lived Assets Acquired And Liabilities Assumed By Major Class [Line Items] | ||
Total intangible assets | $ 41,900 | |
Gainesville [Member] | In-Process Research and Development [Member] | ||
Schedule Of Finite And Indefinite Lived Assets Acquired And Liabilities Assumed By Major Class [Line Items] | ||
Intangible assets, indefinite | 26,400 | |
Gainesville [Member] | Royalties and Contract Manufacturing [Member] | ||
Schedule Of Finite And Indefinite Lived Assets Acquired And Liabilities Assumed By Major Class [Line Items] | ||
Intangible assets, finite | $ 15,500 | |
Total intangible assets, Weighted Average Estimated Useful Life | 6 years |
Acquisition of Gainesville Fa48
Acquisition of Gainesville Facility and Meloxicam - Schedule of Unaudited Pro Forma Combined Results of Operations (Detail) - Gainesville [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Business Acquisition [Line Items] | |
Revenue | $ 71,684 |
Net income | $ 6,016 |
Fair Value of Financial Instr49
Fair Value of Financial Instruments - Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Mutual Funds [Member] | ||
Assets: | ||
Fair value of assets, recurring basis | $ 37,079 | $ 5,081 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Government and Agency Bonds [Member] | ||
Assets: | ||
Fair value of assets, recurring basis | 20,517 | 10,250 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Cash Equivalents [Member] | ||
Assets: | ||
Fair value of assets, recurring basis | 57,596 | 15,331 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | 72,971 | 63,616 |
Significant Unobservable Inputs (Level 3) [Member] | Warrants [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | 3,397 | 3,770 |
Significant Unobservable Inputs (Level 3) [Member] | Contingent Consideration [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | $ 69,574 | $ 59,846 |
Fair Value of Financial Instr50
Fair Value of Financial Instruments - Reconciliation of Contingent Consideration and Warrants Measured at Fair Value on Recurring Basis Using Unobservable Inputs (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Warrants [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2015 | $ 3,770 |
Remeasurement | (373) |
Balance at December 31, 2016 | 3,397 |
Contingent Consideration [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2015 | 59,846 |
Remeasurement | 9,728 |
Balance at December 31, 2016 | $ 69,574 |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,557 | $ 2,933 |
Work in process | 4,396 | 4,340 |
Finished goods | 1,793 | 1,709 |
Inventory | $ 8,746 | $ 8,982 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 46,423 | $ 42,052 |
Less: accumulated depreciation and amortization | 9,123 | 4,130 |
Property, plant and equipment, net | 37,300 | 37,922 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,263 | 3,263 |
Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 15,613 | 15,412 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,811 | 2,888 |
Vehicles [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 30 | 30 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 21,508 | 19,504 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 2,198 | $ 955 |
Property, Plant and Equipment53
Property, Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 4,993 | $ 4,120 |
Intangible Assets - Summary of
Intangible Assets - Summary of Balance of Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Total | $ 41,900 | |
Accumulated Amortization | 4,467 | |
Net Intangible Assets, Total | 37,433 | $ 40,016 |
Royalties and Contract Manufacturing [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Definite-lived | 15,500 | |
Accumulated Amortization | 4,467 | |
Net Intangible Assets, Definite-lived | 11,033 | |
In-Process Research and Development [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Indefinite-lived | $ 26,400 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Intangible Assets Net Excluding Goodwill [Abstract] | ||
Amortization expense | $ 2,583 | $ 1,884 |
Amortization expense for the year 2017 | 2,583 | |
Amortization expense for the year 2018 | 2,583 | |
Amortization expense for the year 2019 | 2,583 | |
Amortization expense for the year 2020 | 2,583 | |
Amortization expense for the year 2021 | $ 701 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Payables And Accruals [Abstract] | ||
Clinical trial and related costs | $ 2,564 | $ 1,364 |
Professional and consulting fees | 360 | 863 |
Payroll and related costs | 4,547 | 697 |
Property plant and equipment | 720 | |
Deferred revenue | 418 | |
Income tax payable | 311 | 86 |
Other | 973 | 408 |
Total accrued expenses | $ 9,893 | $ 3,418 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Debt Instrument [Line Items] | ||
Principal payments of senior secured loan, excess of cash flow calculation | $ 6,324 | $ 16,329 |
Unamortized balance of debt issuance costs | $ 2,959 | |
OrbiMed [Member] | Seven Year Warrant [Member] | ||
Debt Instrument [Line Items] | ||
Purchase common stock with warrant issue | 294,928 | |
Warrant, exercise price per share | $ 3.28 | |
Warrants, exercisable date | Apr. 10, 2022 | |
OrbiMed Senior Secured Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Debt issuance costs related to term loan | $ 4,579 | |
Unamortized balance of debt issuance costs | 2,959 | |
OrbiMed Senior Secured Term Loan [Member] | Warrants [Member] | ||
Debt Instrument [Line Items] | ||
Initial warrant fair value | 2,861 | |
OrbiMed Senior Secured Term Loan [Member] | Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Term loan face amount | $ 50,000 | |
Term loan maturity term | 5 years | |
Term loan interest rate, Description | Interest at three month LIBOR plus 14.0% with a 1.0% floor | |
Term loan agreement date | Apr. 10, 2015 | |
Credit agreement prepayment terms | The Company may make voluntary prepayments in whole or in part, subject to: (i) on or prior to the 36 month anniversary of the closing of the credit agreement, payment of a buy-out premium amount equal to (A) for full prepayments of the unpaid principal amount, $75,000 less all previously prepaid principal amounts and all previously paid interest or (B) for partial prepayments of the unpaid principal amount, 0.5 times the partial prepayment amount less interest payments previously paid in respect to the partial prepayment amount and (ii) after the 36 month anniversary of the closing of the credit agreement, payment of an exit fee amount equal to 10% of the amount of any prepayments. | |
Credit agreement unpaid principal amount | $ 75,000 | |
Exit fee percentage | 10.00% | |
Principal payments of senior secured loan, excess of cash flow calculation | $ 22,653 | |
OrbiMed Senior Secured Term Loan [Member] | Term Loan [Member] | LIBOR [Member] | ||
Debt Instrument [Line Items] | ||
Term loan variable interest rate | 14.00% | |
OrbiMed Senior Secured Term Loan [Member] | Term Loan [Member] | Floor [Member] | ||
Debt Instrument [Line Items] | ||
Term loan variable interest rate | 1.00% |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt Balance (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Debt Disclosure [Abstract] | ||
Principal balance outstanding | $ 27,347 | |
Unamortized deferred issuance costs | (2,959) | |
Long-term debt | 24,388 | |
Long-term debt: | ||
Current portion | (2,236) | $ (4,516) |
Long-term debt, non current | $ 22,152 | $ 25,244 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2015USD ($) | |
Malvern Consulting Group, Inc. (MCG) [Member] | ||||
Supply Commitment [Line Items] | ||||
Lease commenced date | Jan. 1, 2017 | Jan. 1, 2017 | ||
Lease expiration date | Dec. 31, 2022 | Dec. 31, 2022 | ||
Rent, operating and tenant improvement expenses | $ 206,000 | $ 114,000 | ||
Term of contract | 6 years | 6 years | 6 years | |
Gainesville Transaction [Member] | ||||
Supply Commitment [Line Items] | ||||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 125,000,000 | |||
Maximum future net product sales milestone percentage | 30.00% | 30.00% | ||
Gainesville Transaction [Member] | NDA [Member] | ||||
Supply Commitment [Line Items] | ||||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 10,000,000 | |||
Gainesville Transaction [Member] | Regulatory Approval [Member] | ||||
Supply Commitment [Line Items] | ||||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | 30,000,000 | |||
Gainesville Transaction [Member] | Regulatory Approval and Net Sales Milestones [Member] | ||||
Supply Commitment [Line Items] | ||||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | 45,000,000 | |||
CDMO [Member] | ||||
Supply Commitment [Line Items] | ||||
Non-cancellable commitments to be paid on capital expenditures, material and services | $ 3,329,000 | |||
Minimum [Member] | Gainesville Transaction [Member] | ||||
Supply Commitment [Line Items] | ||||
Future net product sales milestone percentage | 10.00% | 10.00% | ||
Maximum [Member] | Malvern Consulting Group, Inc. (MCG) [Member] | ||||
Supply Commitment [Line Items] | ||||
Rent, operating and tenant improvement expenses | $ 1,999,000 | |||
Maximum [Member] | Gainesville Transaction [Member] | ||||
Supply Commitment [Line Items] | ||||
Future net product sales milestone percentage | 12.00% | 12.00% | ||
Dexmedetomidine License Agreement [Member] | ||||
Supply Commitment [Line Items] | ||||
Contingent milestone payments, maximum | $ 21,600,000 | € 20,500,000 | ||
Amount of royalty payments due or payable | $ 0 | 0 | ||
Dexmedetomidine License Agreement [Member] | Minimum [Member] | ||||
Supply Commitment [Line Items] | ||||
Percentage of royalty payments | 10.00% | 10.00% | ||
Dexmedetomidine License Agreement [Member] | Maximum [Member] | ||||
Supply Commitment [Line Items] | ||||
Percentage of royalty payments | 20.00% | 20.00% | ||
Fadolmidine License Agreement [Member] | ||||
Supply Commitment [Line Items] | ||||
Amount of royalty payments due or payable | $ 0 | $ 0 | ||
Additional contingent milestones payment | $ 12,900,000 | € 12,200,000 | ||
Fadolmidine License Agreement [Member] | Minimum [Member] | ||||
Supply Commitment [Line Items] | ||||
Percentage of royalty payments | 10.00% | 10.00% | ||
Fadolmidine License Agreement [Member] | Maximum [Member] | ||||
Supply Commitment [Line Items] | ||||
Percentage of royalty payments | 15.00% | 15.00% |
Commitments and Contingencies60
Commitments and Contingencies - Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements (Detail) $ in Thousands | Dec. 31, 2016USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,017 | $ 244 |
2,018 | 329 |
2,019 | 340 |
2,020 | 351 |
2,021 | 362 |
2,022 | 373 |
Lease payments, Total | $ 1,999 |
Capital Structure - Additional
Capital Structure - Additional Information (Detail) - USD ($) | Dec. 16, 2016 | Aug. 19, 2016 | Jul. 07, 2015 | Feb. 02, 2015 | Mar. 12, 2014 | Dec. 31, 2016 | Dec. 31, 2015 |
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock, shares authorized to issue | 50,000,000 | 50,000,000 | |||||
Common stock, par value | $ 0.01 | $ 0.01 | |||||
Aggregate net proceeds from private placement | $ 7,796,000 | ||||||
Net proceeds from sale of common stock | $ 50,255,000 | $ 14,812,000 | |||||
Stock issued at fair value | $ 285,000 | ||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||
Preferred stock, par value | $ 0.01 | $ 0.01 | |||||
Preferred stock, shares issued | 0 | 0 | |||||
Preferred stock, shares outstanding | 0 | 0 | |||||
Warrants, Exercise Price $19.46, Expiring on April 2022 [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Warrants outstanding to purchase shares, Number of Shares | 350,000 | ||||||
Warrants, Exercise Price $19.46, Expiring on April 2022 [Member] | Liability Contingent Net Cash Settlement Feature [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Warrants outstanding to purchase shares, Number of Shares | 350,000 | ||||||
Warrants, Exercise Price $3.28, Expiring on April 2022 [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Warrants outstanding to purchase shares, Number of Shares | 294,928 | ||||||
Warrants, Exercise Price $3.28, Expiring on April 2022 [Member] | Liability Anti-Dilution Provision [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Warrants outstanding to purchase shares, Number of Shares | 294,928 | ||||||
Aspire Capital [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance, shares | 96,463 | 1,143,940 | |||||
Common stock issuance | $ 7,796,000 | ||||||
Term of purchase agreement | 24 months | ||||||
Stock issued at fair value | $ 285,000 | ||||||
Cost incurred in stock issuance | 253,000 | ||||||
Maximum [Member] | Aspire Capital [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance | $ 10,000,000 | ||||||
Investor [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Aggregate net proceeds from private placement | $ 14,812,000 | ||||||
Placement agents fee percentage | 6.00% | ||||||
Initial Public Offering (IPO) [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance, shares | 4,312,500 | ||||||
Sale of stock, price per share | $ 8 | ||||||
Gross proceeds on sale of common stock in initial public offering | $ 34,500,000 | ||||||
Payments on underwriting discounts, commissions and offering costs | 4,244,000 | ||||||
Common stock issuance | $ 30,256,000 | ||||||
Private Placement [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance | $ 14,812,000 | ||||||
Private Placement [Member] | Investor [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance, shares | 1,379,311 | ||||||
Common stock issuance price | $ 11.60 | ||||||
Underwritten Public Offering [Member] | |||||||
Schedule Of Capitalization Equity [Line Items] | |||||||
Common stock issuance, shares | 6,670,000 | 1,986,666 | |||||
Common stock issuance price | $ 6 | $ 7.50 | |||||
Net proceeds from sale of common stock | $ 36,888,000 | $ 13,367,000 |
Capital Structure - Schedule of
Capital Structure - Schedule of Warrants Outstanding to Purchase Shares of Common Stock (Detail) | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Warrants, Exercise Price $12.00, Expiring on March 2018 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Warrants outstanding to purchase shares, Number of Shares | shares | 140,000 |
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares | $ 12 |
Warrants outstanding to purchase shares, Expiration Date | 2018-03 |
Warrants, Exercise Price $19.46, Expiring on April 2022 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Warrants outstanding to purchase shares, Number of Shares | shares | 350,000 |
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares | $ 19.46 |
Warrants outstanding to purchase shares, Expiration Date | 2022-04 |
Warrants, Exercise Price $3.28, Expiring on April 2022 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Warrants outstanding to purchase shares, Number of Shares | shares | 294,928 |
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares | $ 3.28 |
Warrants outstanding to purchase shares, Expiration Date | 2022-04 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Jan. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 | Oct. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Total number of options outstanding | 2,611,929 | 2,042,194 | 2,611,929 | 2,042,194 | 1,033,300 | |||
Stock options exercisable period | 10 years | |||||||
Stock options vest period | 4 years | |||||||
Weighted average grant-date fair value of the options awarded to employees | $ 5.08 | $ 8.10 | ||||||
Number of options vested excluding restricted stock units | 1,410,596 | 1,410,596 | ||||||
Stock-based compensation | $ 3,889 | $ 3,064 | ||||||
Aggregate intrinsic value of vested options | $ 2,881 | 2,881 | ||||||
Aggregate intrinsic value of unvested options | $ 1,382 | $ 1,382 | ||||||
Subsequent Event [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of options, Granted | 465,250 | |||||||
Stock Options Granted Outside Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of options, Granted | 364,000 | |||||||
Performance Based Options [Member] | Chief Executive Officer [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of options, Granted | 105,300 | |||||||
Number of options vested excluding restricted stock units | 105,300 | 105,300 | ||||||
Stock-based compensation | $ 551 | |||||||
Performance-based RSUs [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of restricted stock units granted | 32,200 | |||||||
Number of restricted stock units vested | 24,450 | |||||||
Number of restricted stock units withheld | 6,155 | |||||||
Weighted average fair value per share of shares withheld | $ 8.30 | |||||||
Unrecognized compensation expense related to unvested options, expected to vest | $ 7,198 | $ 7,198 | ||||||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 9 months 18 days | |||||||
Performance-based RSUs [Member] | Subsequent Event [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of restricted stock units granted | 91,150 | |||||||
Number of restricted stock units vested | 7,750 | |||||||
Time Based Restricted Stock [Member] | Subsequent Event [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of restricted stock units granted | 147,400 | |||||||
2008 Stock Option Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of stock appreciation rights issued in period | 0 | |||||||
Additional number of shares authorized for grant | 444,000 | 444,000 | ||||||
Shares available for future grants | 174 | 174 | ||||||
2013 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares available for grant | 600,000 | |||||||
Total number of options outstanding | 3,080,396 | 3,080,396 | ||||||
Shares available for future grants | 1,212,248 | 1,212,248 | ||||||
A&R Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares available for grant | 2,000,000 | |||||||
Increase in share per "Evergreen" provision | 619,181 | 461,215 | ||||||
Percentage of outstanding common stock | 5.00% | 5.00% |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model (Detail) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Range of expected option life | 6 years | |
Expected volatility | 82.47% | 77.39% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Range of expected option life | 6 years | |
Risk-free interest rate | 1.07% | 2.06% |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Range of expected option life | 7 years | |
Risk-free interest rate | 2.09% | 2.51% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of shares, beginning balance | 2,042,194 | 1,033,300 |
Number of shares, Granted | 596,106 | 1,079,550 |
Number of shares, Exercised | (38,000) | |
Number of shares, Expired/forfeited/cancelled | (26,371) | (32,656) |
Number of shares, ending balance | 2,611,929 | 2,042,194 |
Number of shares, Vested | 1,410,596 | |
Number of shares, Vested and expected to vest | 2,530,261 | |
Weighted average exercise price, beginning balance | $ 7 | $ 5.77 |
Weighted average exercise price, Granted | 7.21 | 8.26 |
Weighted average exercise price, Exercised | 6 | |
Weighted average exercise price, Expired/forfeited/cancelled | 10.86 | 11.20 |
Weighted average exercise price, ending balance | 7.01 | $ 7 |
Weighted average exercise price, Vested | 6.41 | |
Weighted average exercise price, Vested and expected to vest | $ 6.67 | |
Weighted average remaining contractual life | 7 years 4 months 24 days | |
Weighted average remaining contractual life, Vested | 6 years 2 months 12 days | |
Weighted average remaining contractual life, Vested and expected to vest | 7 years 4 months 24 days |
Stock-Based Compensation - Su66
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units [Member] - shares | 1 Months Ended | 12 Months Ended |
Dec. 31, 2015 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares, beginning balance | 32,200 | |
Number of shares, Granted | 32,200 | |
Number of shares, Vested | (24,450) | |
Number of shares, ending balance | 32,200 | 7,750 |
Number of shares, Expected to vest | 7,750 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2016USD ($)Segment | Dec. 31, 2015USD ($) | |
Segment Reporting Information [Line Items] | ||
Number of business segments | Segment | 2 | |
Revenue | $ 69,337,000 | $ 51,952,000 |
Acute Care [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenue | $ 0 |
Segment Reporting - Summary of
Segment Reporting - Summary of Segment Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Segment Reporting Information [Line Items] | ||
Revenues | $ 69,337,000 | $ 51,952,000 |
Operating income (loss) | (25,773,000) | (6,970,000) |
Depreciation and amortization | 7,576,000 | 6,004,000 |
Capital expenditures | 3,770,000 | 2,411,000 |
Total assets | 182,997,000 | 138,697,000 |
CDMO [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 69,337,000 | 51,952,000 |
Operating income (loss) | 24,232,000 | 17,558,000 |
Depreciation and amortization | 7,572,000 | 6,004,000 |
Capital expenditures | 3,735,000 | 2,411,000 |
Total assets | 77,828,000 | 81,430,000 |
Acute Care [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenues | 0 | |
Operating income (loss) | (50,005,000) | (24,528,000) |
Depreciation and amortization | 4,000 | |
Capital expenditures | 35,000 | |
Total assets | $ 105,169,000 | $ 57,267,000 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Tax (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ 1,207 | $ (10,002) |
Foreign | (32,519) | (2,516) |
Net loss before income taxes | $ (31,312) | $ (12,518) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Provision (Benefit) (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Current: | ||
Federal | $ 298 | $ 83 |
State and local | 18 | 3 |
Foreign | 0 | 0 |
Current income tax expense benefit | 316 | 86 |
Deferred: | ||
Federal | (1,607) | (13,418) |
State and local | 184 | (2,219) |
Foreign | 0 | 0 |
Deferred income tax expense benefit | (1,423) | (15,637) |
Income tax benefit | $ (1,107) | $ (15,551) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory income tax rate | 34.00% | 34.00% |
Foreign tax rate differential | (22.30%) | (4.30%) |
State taxes, net of federal benefit | (0.10%) | 2.60% |
Nondeductible expenses | 0.50% | 4.20% |
Research and development credits | 4.50% | 1.70% |
Change in valuation allowance | (13.10%) | 86.10% |
Effective income tax rate | 3.50% | 124.30% |
Income Taxes - Schedule of Tax
Income Taxes - Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | |||
Net operating loss carryforwards | $ 6,742 | $ 5,754 | |
Research and development credits | 3,108 | 1,343 | |
Capitalized start-up costs | 2,343 | 2,590 | |
Intangibles | 2,181 | 597 | |
Contingent consideration | 5,364 | 1,932 | |
Stock-based compensation | 2,718 | 1,256 | |
Other temporary differences | 517 | 2,480 | |
Gross deferred tax asset | 22,973 | 15,952 | |
Valuation allowance | (4,379) | (315) | $ (11,087) |
Net deferred tax asset | 18,594 | 15,637 | |
Deferred tax liability | (1,534) | ||
Net deferred taxes | $ 17,060 | $ 15,637 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Valuation allowance | $ (4,379,000) | $ (315,000) | $ (11,087,000) |
Operating loss and research and development tax credit carryforwards percentage of change in ownership | 50.00% | ||
Operating loss and research and development tax credit carryforwards percentage of change in ownership period | 3 years | ||
Percentage of limitation on taxable income after modification and apportionment | 30.00% | ||
Net operating losses subject to limitation | $ 5,000,000 | ||
Net operating loss carryforwards, limitation | State net operating loss carryforwards may be further limited, including Pennsylvania, which has a limitation equal to the greater of 30.0% of taxable income after modifications and apportionment or $5,000,000 on state net operating losses utilized in any one year. | ||
Accrued interest or penalties related to uncertain tax positions | $ 0 | ||
Recognized amounts of interest or penalties related to uncertain tax positions | $ 0 | ||
Income tax examination | Due to net operating loss and tax credit carry forwards that remain unutilized, income tax returns for tax years from inception through 2015 remain subject to examination by the taxing jurisdictions. |
Income Taxes - Summary of Feder
Income Taxes - Summary of Federal Net Operating Losses and Tax Credits Carryforwards (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses, Expiration period | State net operating loss carryforwards may be further limited, including Pennsylvania, which has a limitation equal to the greater of 30.0% of taxable income after modifications and apportionment or $5,000,000 on state net operating losses utilized in any one year. |
Research and development credits, Amount | $ 2,817 |
Research and development credits, Expiration period start | 2,028 |
Research and development credits, Expiration period end | 2,034 |
Federal [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 4,206 |
Net operating losses, Expiration period start | 2,030 |
Net operating losses, Expiration period end | 2,035 |
State [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 14,149 |
Net operating losses, Expiration period start | 2,030 |
Net operating losses, Expiration period end | 2,035 |
Foreign [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 35,035 |
Net operating losses, Expiration period | No expiration |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Malvern Consulting Group, Inc. (MCG) [Member] $ in Thousands | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2016 | Dec. 31, 2016USD ($)ft² | Dec. 31, 2015USD ($) | |
Related Party Transaction [Line Items] | |||
Related party transaction expenses | $ 363 | $ 465 | |
MCG consultants service fee description | MCG provided the Company with certain consulting services for a fee based upon hourly rates | ||
Aggregate area of office and lab space | ft² | 8,458 | ||
Payment of rental fees | $ 206 | $ 114 | |
Lease directly with the landlord | 6 years | 6 years |