Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | May 07, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | REPH | |
Entity Registrant Name | Recro Pharma, Inc. | |
Entity Central Index Key | 1,588,972 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 20,507,616 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 46,284 | $ 60,984 |
Short-term investments | 4,989 | 3,498 |
Accounts receivable | 9,833 | 9,686 |
Contract asset | 5,508 | 3,755 |
Inventory | 10,028 | 9,839 |
Prepaid expenses and other current assets | 2,686 | 3,276 |
Total current assets | 79,328 | 87,283 |
Property, plant and equipment, net | 38,486 | 39,074 |
Deferred income taxes | 19,989 | 18,573 |
Intangible assets, net | 34,204 | 34,850 |
Goodwill | 6,446 | 6,446 |
Total assets | 178,453 | 186,226 |
Current liabilities: | ||
Accounts payable | 4,336 | 7,954 |
Accrued expenses and other current liabilities | 6,361 | 9,897 |
Current portion of contingent consideration | 33,957 | 32,053 |
Total current liabilities | 44,654 | 49,904 |
Long-term debt, net | 53,957 | 53,598 |
Warrants and other long-term liabilities | 4,290 | 3,516 |
Long-term portion of contingent consideration | 50,976 | 50,360 |
Total liabilities | 153,877 | 157,378 |
Commitments and contingencies (Note 13) | ||
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, 19,550,414 shares at March 31, 2018 and 19,127,435 shares at December 31, 2017 | 195 | 191 |
Additional paid-in capital | 145,367 | 140,006 |
Accumulated deficit | (120,985) | (111,348) |
Accumulated other comprehensive loss | (1) | (1) |
Total shareholders’ equity | 24,576 | 28,848 |
Total liabilities and shareholders’ equity | $ 178,453 | $ 186,226 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
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 | 19,550,414 | 19,127,435 |
Common stock, shares outstanding | 19,550,414 | 19,127,435 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Income Statement [Abstract] | ||
Revenue | $ 19,542 | $ 18,742 |
Operating expenses: | ||
Cost of sales (excluding amortization of intangible assets) | 10,490 | 10,498 |
Research and development | 8,442 | 7,763 |
General and administrative | 9,518 | 4,032 |
Amortization of intangible assets | 646 | 646 |
Change in warrant valuation | 773 | 291 |
Change in contingent consideration valuation | 2,520 | 2,814 |
Total operating expenses | 32,389 | 26,044 |
Operating loss | (12,847) | (7,302) |
Other income (expense): | ||
Interest income | 142 | 105 |
Interest expense | (2,103) | (1,183) |
Net loss before income taxes | (14,808) | (8,380) |
Income tax benefit | 2,353 | 293 |
Net loss | $ (12,455) | $ (8,087) |
Per share information: | ||
Net loss per share of common stock, basic and diluted | $ (0.65) | $ (0.42) |
Weighted average common shares outstanding, basic and diluted | 19,219,257 | 19,049,416 |
Net Loss | $ (12,455) | $ (8,087) |
Other comprehensive loss: | ||
Unrealized loss on available-for-sale securities | (57) | |
Comprehensive loss | $ (12,455) | $ (8,144) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Unaudited) - 3 months ended Mar. 31, 2018 - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Balance at Dec. 31, 2017 | $ 28,848 | $ 191 | $ 140,006 | $ (111,348) | $ (1) |
Balance, Shares at Dec. 31, 2017 | 19,127,435 | ||||
Stock-based compensation expense | 1,584 | 1,584 | |||
Stock option exercise | $ 65 | 65 | |||
Stock option exercise, Shares | 14,575 | 14,575 | |||
Issuance of restricted stock units, net of shares withheld for income taxes | $ (86) | (86) | |||
Issuance of restricted stock units, net of shares withheld for income taxes, Shares | 25,364 | ||||
Sale of common stock under equity facility, net of transaction costs | 3,802 | $ 4 | 3,798 | ||
Sale of common stock under equity facility, net of transaction costs, Shares | 383,040 | ||||
Net loss | (12,455) | (12,455) | |||
Cumulative effect of adoption of new accounting standards, net of tax | 2,818 | 2,818 | |||
Balance at Mar. 31, 2018 | $ 24,576 | $ 195 | $ 145,367 | $ (120,985) | $ (1) |
Balance, Shares at Mar. 31, 2018 | 19,550,414 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (12,455) | $ (8,087) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,584 | 892 |
Non-cash interest expense | 319 | 158 |
Depreciation expense | 1,216 | 1,196 |
Amortization | 646 | 646 |
Change in warrant valuation | 773 | 291 |
Change in contingent consideration valuation | 2,520 | 2,814 |
Deferred income taxes | (2,353) | (1,235) |
Inventory | (189) | 936 |
Contract Asset | (1,753) | |
Prepaid expenses and other current assets | 912 | (518) |
Accounts receivable | (147) | (1,867) |
Accounts payable, accrued expenses and other liabilities | (5,870) | (2,363) |
Net cash used in operating activities | (14,797) | (7,137) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (1,654) | (1,744) |
Purchase of short-term investments | (4,981) | (36,117) |
Proceeds from maturity of investments | 3,500 | |
Net cash used in investing activities | (3,135) | (37,861) |
Cash flows from financing activities: | ||
Payment of deferred financing costs | (261) | |
Proceeds from sale of common stock, net of transaction costs | 3,514 | |
Payments of withholdings on shares withheld for income taxes | (86) | |
Proceeds from option exercise | 65 | |
Net cash provided by financing activities | 3,232 | |
Net decrease in cash and cash equivalents | (14,700) | (44,998) |
Cash and cash equivalents, beginning of period | 60,984 | 64,483 |
Cash and cash equivalents, end of period | 46,284 | 19,485 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 2,546 | 1,026 |
Purchase of property, plant and equipment included in accrued expenses and accounts payable | 249 | $ 237 |
Retirement of fully depreciated property, plant and equipment | 30 | |
Common stock issued in connection with equity facility | $ 357 |
Background
Background | 3 Months Ended |
Mar. 31, 2018 | |
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(m) and Note 17). The Acute Care division is primarily focused on developing innovative products for hospital and other acute care 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 long-acting preferential COX-2 inhibitor being developed for the management of moderate to severe 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. In July 2017, the Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or the FDA, for its lead investigational product candidate intravenous, or IV, meloxicam 30 mg for the management of moderate to severe pain. The FDA has accepted the NDA for review and has set a Prescription Drug User Fee Act, or PDUFA, date of May 26, 2018. |
Development-Stage Risks and Liq
Development-Stage Risks and Liquidity | 3 Months Ended |
Mar. 31, 2018 | |
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 $120,985 as of March 31, 2018. 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. Additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates, including the payment of the Gainesville Transaction contingent payments, which may become due upon achievement of certain development and commercialization milestones for meloxicam (see Note 4). Insufficient funds may cause the Company to delay, reduce the scope of or eliminate one or more of its development, commercialization or expansion activities. The Company may raise such funds through debt refinancing, bank or other loans, through strategic research and development, licensing (including out-licensing) and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and failure to raise capital when needed could materially adversely impact the Company’s growth plans and its financial condition or results of operations. Additional equity financing, if available, may be dilutive to the holders of its common stock and may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate its business. 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, partnering or out-licensing 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. Management believes that the Company’s existing cash, cash equivalents and short-term investments as of March 31, 2018 and other expected financing sources will be sufficient to fund its operations over the next twelve months. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (3) Summary of Significant Accounting Principles (a) Basis of Presentation and Principles of Consolidation The accompanying unaudited 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, for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. 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 results for the interim periods. Operating results for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2018. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017. (b) Use of Estimates The preparation of financial statements and the notes to the 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 Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of the changes in interest rates. (d) 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 and office equipment; six to ten or more 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. (e) Business Combinations In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805, “Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. (f) 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 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 life 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 and Comprehensive Loss. 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 30 th (g) Revenue Recognition The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components. The Company’s revenue policies listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “ Revenue from Contracts with Customers,” Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments. In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s commercial partners. Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. (h) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four largest customers having generated 99% of its revenues for three months ended March 31, 2018. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the U.S. ( i ) 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 pre-commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing and regulatory filing fees and 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 expenses 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 product 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. (j) 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/or 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 the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Non-employee stock-based awards are revalued until an award vests and the Company recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, which is known as 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. (k) 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 does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. (l) Net Loss Per Common Share Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period. For all periods presented, the outstanding common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. There are no dilutive common stock equivalents for the three months ended March 31, 2018 The following table sets forth the computation of basic and diluted loss per share: Three Months Ended March 31, 2018 2017 Basic and Diluted Loss Per Share Net loss $ (12,455 ) $ (8,087 ) Weighted average common shares outstanding, basic and diluted 19,219,257 19,049,416 Net loss per share of common stock, basic and diluted $ (0.65 ) $ (0.42 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive: March 31, 2018 2017 Options and restricted stock units outstanding 4,973,043 3,337,461 Warrants 1,133,592 784,928 Amounts in the table above reflect the common stock equivalents of the noted instruments. (m) 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 its CDMO and Acute Care divisions as reportable segments. Segment disclosures are included in Note 17. 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. 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. (n) Recent Accounting Pronouncements In May 2017, the FASB issued ASU No. 2017-09, “ Stock Compensation - Scope of Modification Accounting” In January 2017, the FASB issued ASU No. 2017-04 “ Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment In February 2016, the FASB issued ASU No. 2016-02, “ Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In January 2018, the Company adopted the standard using the modified retrospective method. See Footnote 18 for additional information on the impact of the transition on the Company’s financial statements. |
Acquisition of Gainesville Faci
Acquisition of Gainesville Facility and Meloxicam | 3 Months Ended |
Mar. 31, 2018 | |
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 Gainesville Transaction consisted of $50,000 cash at closing, a $4,000 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 $125,000 in milestone payments including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and a percentage of future product net sales related to injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and royalties were 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 6 for further information regarding fair value). The contingent consideration consists of three separate components. The first component will be payable upon regulatory approval. The second component consists of three potential payments, based on the achievement of specified annual revenue targets, the last of which represents over 60% of these milestone payments and currently does not have a fair value assigned to its achievement. The third component consists of a royalty payment between 10% and 12% (subject to a 30% reduction when no longer covered by patent) 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 using the Monte Carlo simulation method and applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections based upon the 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 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. |
NMB Related License Agreement
NMB Related License Agreement | 3 Months Ended |
Mar. 31, 2018 | |
Business Combinations [Abstract] | |
NMB Related License Agreement | (5) NMB Related License Agreement In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBs, and a proprietary reversal agent from Cornell University, or Cornell. The NMBs and reversal agent are referred to herein as the NMB Related Compounds. The NMB Related Compounds include one novel intermediate-acting NMB that has initiated Phase I clinical trials and two other agents, a novel short-acting NMB, and a rapid-acting reversal agent specific to these NMBs. The transaction was accounted for as an asset acquisition, with the total cost of the acquisition of $766 allocated to acquired IPR&D. The Company recorded an upfront payment obligation of $350, as well as operational liabilities and acquisition-related costs of $416, primarily consisting of reimbursement to Cornell for specified past patent, legal and pre-clinical costs, of which $247 is reported as a component of Accrued expenses and other current liabilities and Other non-current liabilities on the Consolidated Balance Sheet as of March 31, 2018. In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the NMB Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each NMB, of $5,000 for U.S. regulatory approval and commercialization milestones and $3,000 for European regulatory approval and commercialization milestones. The Company is also obligated to pay Cornell royalties on net sales of the NMB Related Compounds at a rate ranging from low to mid-single digits, depending on the applicable NMB Related Compounds and whether there is a valid patent claim in the applicable country, subject to an annual minimum royalty amount. Further, the Company will reimburse Cornell ongoing patent costs related to prosecution and maintenance of the patents related to the Cornell patents for the NMB Related Compounds. The Company accounted for the transaction as an asset acquisition based on an evaluation of the accounting guidance (ASC Topic 805) and considered the early clinical stage of the novel and unproven NMB Related Compounds. The Company concluded that the acquired IPR&D of Cornell did not constitute a business as defined under ASC 805 due to the incomplete nature of the inputs and the absence of processes from a market participant perspective. Substantial additional research and development will be required to develop any NMB Related Compounds into a commercially viable drug candidate, including completion of pre-clinical testing and clinical trials, and, if such clinical trials are successful, application for regulatory approvals and manufacturing repeatability and scale-up. There is risk that a marketable compound may not be well tolerated and may never be approved. Acquired IPR&D in the asset acquisition was accounted for in accordance with FASB ASC Topic 730, “Research and Development.” At the date of acquisition, the Company determined that the development of the projects underway at Cornell had not yet reached technological feasibility and that the research in process had no alternative future uses. Accordingly, the acquired IPR&D was charged to expense in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. The acquired IPR&D charge is expected to be deductible over a 15-year period for income tax purposes. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (6) Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments, warrants and the contingent consideration. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows: • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. 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, 2017: Assets: Cash equivalents Money market mutual funds $ 38,959 $ — $ — Total cash equivalents $ 38,959 $ — $ — Short-term investments U.S. Treasury obligations $ 3,498 $ — $ — Total financial assets $ 42,457 $ — $ — Liabilities: Warrants — — $ 3,406 Contingent consideration — — 82,413 $ — $ — $ 85,819 At March 31, 2018: Assets: Cash equivalents Money market mutual funds (See Note 7) $ 4,162 $ — $ — U.S. Treasury obligations (See Note 7) $ 9,989 Commercial Paper (See Note 7) $ 17,972 Total cash equivalents $ 14,151 $ 17,972 $ — Short-term investments U.S. Treasury obligations (See Note 7) $ 1,998 $ — $ — Commercial Paper (See Note 7) $ 2,991 $ — Total financial assets $ 16,149 $ 20,963 $ — Liabilities: Warrants (See Note 14(d)) — — $ 4,179 Contingent consideration (See Note 4) — — 84,933 $ — $ — $ 89,112 The Company developed its own assumptions to determine the value of the warrants that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility, the contractual term of the warrants, risk free interest rates and dividend yield. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement. 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, 2017 $ 3,406 $ 82,413 Additions — — Remeasurement 773 2,520 Total at March 31, 2018 $ 4,179 $ 84,933 Current portion as of March 31, 2018 — 33,957 Long-term portion as of March 31, 2018 4,179 50,976 The current portion of the contingent consideration represents the estimated probability adjusted fair value that is expected to become payable within one year as of March 31, 2018 (see Note 4 for additional information). The Company follows the disclosure provisions of FASB ASC Topic 825, “Financial Instruments” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of March 31, 2018, the financial assets and liabilities recorded on the Consolidated Balance Sheets that are not measured at fair value on a recurring basis include accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of these instruments. The fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of long-term debt approximated fair value at March 31, 2018 due to the comparison of the terms of the debt, including borrowing rates available to the Company through its recent completed debt refinancing process, availability of additional term loan tranches, and maturity. |
Short-term Investments
Short-term Investments | 3 Months Ended |
Mar. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Short-term Investments | (7) Short-term Investments Short-term investments as of March 31, 2018 consist of government money market funds, U.S. Treasury obligations and commercial paper. A portion of short term investments is included in Cash and cash equivalents due to its original maturity of three months or less when acquired. In accordance with FASB ASC Topic 320, “ Investments – Debt and Equity Securities March 31, 2018 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 4,162 $ — $ — $ 4,162 U.S. Treasury obligations 11,987 — — 11,987 Commercial Paper 20,963 1 (1 ) 20,963 Total investments $ 37,112 $ 1 $ (1 ) $ 37,112 As of March 31, 2018, the Company’s investments had maturities ranging from one to four months. As of December 31, 2017, all of the Company’s investments in U.S. Treasury obligations had original maturities of less than two months. The fair value of the Company’s U.S. Treasury obligations is determined by taking into consideration valuations obtained from third-party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, and other observable inputs. To derive the fair value of its commercial paper, the Company uses benchmark inputs and industry standard analytical models. Certain investment securities as of March 31, 2018 had fair values less than their amortized costs and, therefore, contained unrealized losses. The Company has evaluated these investments and has determined that the decline in value was not related to any Company or industry specific event. As of March 31, 2018, there were two investments with unrealized losses. The gross unrealized losses related to these investments were due to changes in interest rates. Given that the Company has no intent to sell any of these investments until a recovery of its fair value, which may be at maturity, and there are no current requirements to sell any of these investments, the Company did not consider these investments to be other-than-temporarily impaired as of March 31, 2018. The Company anticipates full recovery of amortized costs with respect to these investments at maturity or sooner in the event of a more favorable market interest rate environment. The duration of time the investments had been in a continuous unrealized loss position as of March 31, 2018 was less than six months. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | (8) Inventory Inventory is stated at the lower of cost and net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Cost is determined using the first-in, first-out method. The Company expenses costs related to inventory until such time as it receives approval from the FDA to market a product, at which time the Company commences capitalization of costs relating to that product. Inventory was as follows as of March 31, 2018 and December 31, 2017: March 31, 2018 December 31, 2017 Raw materials $ 2,645 $ 2,130 Work in process 4,672 3,931 Finished goods 3,551 4,488 10,868 10,549 Provision for inventory obsolescence (840 ) (710 ) $ 10,028 $ 9,839 Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Inventory is ordered to meet specific customer orders and largely reflects demand. Factors influencing inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns. |
Property, Plant and Equipment
Property, Plant and Equipment | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | (9) Property, Plant and Equipment Property, plant and equipment consists of the following: March 31, 2018 December 31, 2017 Land $ 3,263 $ 3,263 Building and improvements 15,771 15,751 Furniture, office and computer equipment 4,633 4,406 Manufacturing equipment 24,603 24,153 Construction in progress 5,227 5,326 53,497 52,899 Less: accumulated depreciation and amortization 15,011 13,825 Property, plant and equipment, net $ 38,486 $ 39,074 Depreciation expense for the three months ended March 31, 2018 and 2017 was $1,216 and $1,196, respectively. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | (10) Intangible Assets The following represents the balance of the intangible assets at March 31, 2018: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 7,696 $ 7,804 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 7,696 $ 34,204 The following represents the balance of intangible assets at December 31, 2017: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 7,050 $ 8,450 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 7,050 $ 34,850 Amortization expense for each of the three months ended March 31, 2018 and 2017 was $646. As of March 31, 2018, future amortization expense is as follows: Amortization 2018 1,937 2019 2,583 2020 2,583 2021 701 Total $ 7,804 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | (11) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: March 31, December 31, 2018 2017 Clinical trial and related costs $ 367 $ 383 Professional and consulting fees 926 1,010 Payroll and related costs 3,247 6,387 Property plant and equipment 6 216 Deferred revenue 818 546 Interest payable — 802 Other 997 553 $ 6,361 $ 9,897 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | (12) Long-Term Debt On November 17, 2017, the Company entered into a $10,000 Credit Agreement, or the Credit Agreement, with Athyrium Opportunities III Acquisition LP, or Athyrium. The Credit Agreement provides for an initial term loan in the original principal amount of $60,000 funded at closing. Pursuant to the terms of the Credit Agreement, there are two additional tranches of term loans, each in an aggregate original principal amount of $20,000. The second tranche term loan may be drawn upon on or before December 31, 2018 provided that the Company receives regulatory approval of the Company’s IV meloxicam product candidate and will have at least $20,000 in unrestricted cash after payment of the milestone payment due to Alkermes. The third tranche term loan may be drawn upon at any time on or prior to March 31, 2020 provided that the second term loan has been drawn upon and net sales of IV Meloxicam achieve $20,000 for the most recent trailing twelve-month period. The maturity date of the Credit Agreement is November 17, 2022, the five-year anniversary of the closing. The Term Loans will bear interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum, with quarterly, interest-only payments until the maturity date. The unpaid principal amount of the Term Loans is due and payable on the maturity date. In addition, in accordance with the Credit Agreement the Company will have to pay a 1% exit fee of $600, which will be accreted to the carrying amount of the debt using the effective interest method over the term of the loan. In addition, if there is an early repayment, there is a sliding scale of prepayment penalties. 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 March 31, 2018, the Company was in compliance with the covenants. As of March 31, 2018, the remaining payments due under the Credit Agreement include a principal payment of $60,000 and an exit fee of $600 due at the maturity date. In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP, or Athyrium II, to purchase an aggregate of 348,664 shares of the Company’s common stock with an exercise price of $8.6043 per share. See Note 14(d) for additional information. The warrants are exercisable through November 17, 2024. The initial fair value of the warrant of $2,143 was recorded as a debt issuance cost. In addition, the Company recorded debt issuance costs for the Credit Agreement of $4,439, which, along with the fair value of warrants, are being amortized using the effective interest method over the term of the Credit Agreement. Debt issuance cost amortization is included in interest expense within the Consolidated Statements of Operations and Comprehensive Loss. As of March 31, 2018, the effective interest rate was 15.04%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt issuance cost. The components of the carrying value of the debt as of March 31, 2018, are detailed below: Principal balance outstanding $ 60,000 Unamortized deferred issuance costs (6,088 ) Exit fee accretion 45 Total $ 53,957 The Company used proceeds from the $60,000 initial term loan to (i) repay in full all outstanding indebtedness under its previous credit facility governed by the Credit Agreement, dated April 10, 2015, between the Company’s subsidiary, Recro Gainesville LLC and OrbiMed Royalty Opportunities II, LP, or the OrbiMed Credit Agreement of $31,767, which included the remaining debt principal balance of $27,347 and early termination charges of $4,420 and (ii) pay transaction fees associated with the Athyrium Credit Agreement of $4,178. Associated with the refinancing of the OrbiMed Credit Agreement and in accordance with ASC 405-20 “Extinguishments of Liabilities”, the Company booked one-time loss on extinguishment of $6,772 as of December 31, 2017, which was reflected in the interest expense line within the Consolidated Statement of Operations and Comprehensive Loss. The Company recorded debt issuance cost amortization for both credit agreements of $329 and $158 for the three months ended March 31, 2018 and 2017, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (13) Commitments and Contingencies (a) Licenses The Company is party to an exclusive license with Orion for the development and commercialization of Dexmedetomidine, or Dex, for use in the treatment of pain in humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational) delivery, but specifically excluding delivery vehicles for administration by injection or infusion, 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. The Company is required to pay Orion lump sum payments of up to €20,500 ($25,257 as of March 31, 2018) on the achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 20% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved. The Company is also party to an exclusive license agreement with Orion for the development and commercialization of Fadolmidine, or Fado, for use as a human therapeutic, in any dosage form in the Territory. The Company is required to pay Orion lump sum payments of up to €12,200 ($15,031 as of March 31, 2018) on achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 15% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved. The Company is party to a license agreement with Cornell University for the exclusive license of the NMB Related Compounds. Under the terms of the agreement, the Company will pay Cornell an initial upfront fee and Cornell is also entitled to receive additional milestone payments, annual license maintenance fees as well as royalties. See Note 5 for further information regarding these payment obligations. (b) Contingent Consideration for the Gainesville Transaction Pursuant to the purchase and sale agreement governing the Gainesville Transaction, the Company agreed to pay to Alkermes up to an additional $125,000 in milestone payments including $45,000 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). The Company is party to 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 commercial bulk supplies of injectable meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls section of an 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. 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, Inc., or Pernix, in the United States, and which is subject to ongoing intellectual property litigation and proceedings. Zohydro ER® has been subject to four paragraph IV certifications with Actavis plc, or Actavis, regarding the filing of Abbreviated NDAs, or ANDAs, with the FDA for a generic version of Zohydro ER®, the filing of a supplemental ANDA, one of the Company’s issued patents relating to a formulation of Zohydro ER®. These certification notices alleged that the three U.S. patents listed in the FDA’s Orange Book for Zohydro ER® will not be infringed by Actavis’ proposed products, are invalid and/or are unenforceable. In 2014 and 2015, the Company, by itself and through Daravita Limited (a subsidiary of Alkermes and the Company’s predecessor in interest), filed two suits against Actavis in the U.S. District Court for the District of Delaware based on the ANDAs and the sANDA, respectively. In February 2017, the District Court in the Actavis case ruled in the Company’s favor and enjoined Actavis from selling the proposed generic version of Zohydro ER®, which Actavis subsequently appealed to the U.S. Court of Appeals for the Federal Circuit. In October 2017, the Company filed suit against Actavis in the U.S. District Court for the District of Delaware based upon another issued patent relating to a formulation of Zohydro ER®. All litigation with Actavis settled in January 2018 via a multi-party settlement agreement among the Company, Pernix and Actavis, in which Actavis was granted a license to begin selling a generic version of Zohydro® ER on March 1, 2029, or earlier under certain circumstances. (d) Leases On January 1, 2017, the Company entered into a six-year lease for its Malvern, Pennsylvania facility that expires on December 31, 2022. In February 2017, the Company also entered into a three-year lease for office space in Dublin, Ireland that expires April 2020. The Company is also a party to operating leases for office equipment and storage. Rent expense includes rent as well as additional operating and tenant improvement expenses. As of March 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the leases, are as follows: Lease payments 2018 411 2019 508 2020 408 2021 362 2022 374 Total $ 2,063 (e) Purchase Commitments As of March 31, 2018, the Company had outstanding non-cancelable and cancelable purchase commitments in the aggregate amount of $27,228 related to inventory, capital expenditures and other goods and services, including pre-commercial/manufacturing scale-up and clinical activities. (f) Certain Compensation and Employment Agreements The Company has entered into employment agreements with certain of its named executive officers. As of March 31, 2018, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $734, from that date through calendar year 2018. |
Capital Structure
Capital Structure | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Capital Structure | (14) 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. Reflected below are the Company’s capital raises since its initial public offering, or IPO: On March 12, 2014, the Company completed an initial public offering, or 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, 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 deducting underwriting commissions and offering expenses. On December 29, 2017, the Company entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which the Company may sell from time to time, at its option, shares of its common stock, $0.01 par value per share, having an aggregate offering price of up to $40,000 through Cowen, as the placement agent. As of March 31, 2018, the Company did not have any sales of common stock under the Sales Agreement. (b) Common Stock Purchase Agreement On February 2, 2015, the Company entered into a Common Stock Purchase Agreement, or the 2015 Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, pursuant to which Aspire Capital was 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 2015 Purchase Agreement. On the execution of the 2015 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 2015 Purchase Agreement. In addition, the Company incurred $253 of costs in connection with the 2015 Purchase Agreement, 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 2015 Purchase Agreement for $7,796. The agreement expired in February 2017. On March 2, 2018, the Company entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth in the Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate of $20,000 of shares of the Company’s common stock over the approximately 30-month term of the Purchase Agreement. On the execution of the Purchase Agreement, the Company agreed to issue 33,040 shares of common stock to Aspire Capital as consideration for entering into the Purchase Agreement. As of March 31, 2018, the Company sold 350,000 shares of common stock under the Purchase Agreement for proceeds of $3,514. (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 March 31, 2018, no preferred stock was issued or outstanding. (d) Warrants As of March 31, 2018, 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 2019 350,000 $ 19.46 April 2022 294,928 $ 3.28 April 2022 348,664 $ 8.60 November 2024 The warrants to purchase 140,000 and 348,664 shares related to Aegis Capital Corporation and Athyrium, respectively, are equity classified. The warrants to purchase 350,000 and 294,928 shares related to Alkermes and OrbiMed, respectively, are liability classified since they contain a contingent net cash settlement feature. 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. The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for these liability classified warrants. March 31, 2018 December 31, 2017 Fair value $ 4,179 $ 3,406 Expected dividend yield — % — % Expected volatility 74 % 75 % Risk-free interest rates 2.48 % 2.09 % Remaining contractual term 4.00 years 4.25 years |
Comprehensive Loss
Comprehensive Loss | 3 Months Ended |
Mar. 31, 2018 | |
Comprehensive Income Net Of Tax [Abstract] | |
Comprehensive Loss | (15) Comprehensive Loss The Company’s comprehensive loss is shown on the Consolidated Statements of Operations and Comprehensive Loss as of March 31, 2018, and is comprised of net unrealized gains and losses on the Company’s available-for-sale securities. The total of comprehensive loss for the three months ended March 31, 2018 and 2017 was $12,455 and $8,144, respectively. There was no tax effect of other comprehensive loss for the three months ended March 31, 2018. The tax effect of other comprehensive loss for the three months ended March 31, 2017 was $19. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | (16) 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, non-employee directors, and consultants and advisors. As of March 31, 2018, 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. On December 1 st st Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of March 31, 2018, 254,420 shares and 174 shares are available for future grants under the A&R Plan and 2008 Plan, respectively. The weighted average grant-date fair value of the options awarded to employees during the three months ended March 31, 2018 and 2017 was $6.08 and $5.29, 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: March 31, 2018 2017 Range of expected option life 6 years 6 years Expected volatility 74.01% - 74.60% 84.71% Risk-free interest rate 2.32 - 2.73% 2.05 - 2.17% Expected dividend yield — — The following table summarizes stock option activity during the three months ended March 31, 2018: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2017 3,594,875 $ 7.17 7.1 years Granted 713,226 9.16 Exercised (14,575 ) 4.49 Expired/forfeited/cancelled (46,805 ) 8.51 Balance, March 31, 2018 4,246,721 $ 7.50 7.3 years Vested 2,213,374 $ 6.82 5.7 years Vested and expected to vest 4,246,721 $ 7.50 7.3 years Included in the table above are 961,750 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). During the year ending December 31, 2016, the Company adopted ASU 2016-09 and elected to account for forfeitures as they occur. The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2018. Number of shares Balance, December 31, 2017 270,593 Granted 500,120 Vested and settled (35,025 ) Expired/forfeited/cancelled (9,366 ) Balance, March 31, 2018 726,322 Expected to vest 726,322 Included in the table above are 44,500 time-based RSUs granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4). In March 2018, the Company granted 240,224 performance-based RSUs, which may vest based on attaining 2018 financial, clinical and operational goals, as well as 259,896 time-based RSUs, which vest over four years. Stock-based compensation expense for the three months ended March 31, 2018 and 2017 was $1,584 and $892, respectively. As of March 31, 2018, there was $14,870 of unrecognized compensation expense related to unvested options and time-based RSUs that are expected to vest and will be expensed over a weighted average period of 2.6 years. As of March 31, 2018, there was $2,671 of unrecognized compensation expense related to unvested performance-based RSUs and will be expensed when the performance criteria are met. 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 March 31, 2018, the aggregate intrinsic value of the vested and unvested options was $9,522 and $5,746, respectively. |
Segment Reporting
Segment Reporting | 3 Months Ended |
Mar. 31, 2018 | |
Segment Reporting [Abstract] | |
Segment Reporting | (17) Segment Reporting The Company operates through two business divisions that are treated as separate financial 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, personnel costs and pre-commercialization of meloxicam. CDMO revenue streams are derived from manufacturing, royalty revenues, as well as CDMO’s research and development services performed for commercial partners. The accounting policies of the segments are the same as those described in the summary of significant accounting 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 three months ended March 31, 2018: For the Three Months Ended March 31, 2018 2017 Revenues: CDMO $ 19,542 $ 18,742 Acute Care — — Total $ 19,542 $ 18,742 Operating income (loss): CDMO $ 6,566 $ 6,199 Acute Care (19,413 ) (13,501 ) Total $ (12,847 ) $ (7,302 ) Depreciation and amortization: CDMO $ 1,819 $ 1,837 Acute Care 43 5 Total $ 1,862 $ 1,842 Capital expenditures: CDMO $ 329 $ 1,530 Acute Care 1,325 214 Total $ 1,654 $ 1,744 March 31, December 31, 2018 2017 Total assets: CDMO $ 80,300 $ 78,136 Acute Care 98,153 108,090 Total $ 178,453 $ 186,226 |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | (18) Revenue Recognition Effective January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method applied to contracts existing as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under the new guidance while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance. See Note 3 for additional information on the Company’s revenue recognition policies. The Company uses the practical expedient to not account for significant financing components because the period between recognition and collection does not exceed one year in any contract. Upon adoption, the Company recorded a decrease of $2,818 to the opening balance of accumulated deficit as of January 1, 2018. This adjustment resulted from a change in revenue recognition associated with a variable portion of certain of its royalty revenue. Under the new accounting standard, estimated royalty revenue to be received in the future that is deemed predominantly related to product sales rather than the license for intellectual property, is included as a component of the product sale transaction consideration to the extent such consideration is not probable to significant reversal. Prior to adoption of the new guidance, the Company recognized this royalty revenue in the period the products were sold by the commercial partner. The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09 were as follows: Balance at December 31, 2017 Adoption of ASU 2014-09 Balance at January 1, 2018 Contract asset $ — $ 3,755 $ 3,755 Deferred income taxes 18,573 (937 ) 17,636 Total shareholders' equity 28,848 (2,818 ) 26,030 The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed consolidated balance sheet was as follows: For the Three Months Ended March 31, 2018 Previous Revenue Standard Adoption of ASU 2014-09 As Reported Revenue $ 17,789 $ 1,753 $ 19,542 Income tax benefit 2,790 (437 ) 2,353 Net loss (13,771 ) 1,316 (12,455 ) March 31, 2018 Previous Revenue Standard Adoption of ASU 2014-09 As Reported Contract assets $ — $ 5,508 $ 5,508 Deferred income taxes 21,363 (1,374 ) 19,989 Total assets 174,319 4,134 178,453 Accumulated deficit (125,119 ) 4,134 (120,985 ) Total shareholders' equity 20,442 4,134 24,576 Total liabilities and shareholders' equity 174,319 4,134 178,453 Contract assets represent revenue recognized for performance obligations completed before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract assets were $5,508 and $3,755 at March 31, 2018 and January 1, 2018, respectively. Generally, the contract assets balance is impacted by the recognition of additional contract assets, offset by amounts invoiced to customers or actual net product sale amounts reported by the commercial partner for the period. For the three months ended March 31, 2018, actual net product sale amounts reported by the Company’s commercial partner exceeded estimates of royalty amounts attributed to manufactured product shipped as of January 1, 2018 for the related arrangements by approximately $817. The following table presents changes in the Company’s contract assets for the three months ended March 31, 2018: Contract asset, beginning of year $ 3,755 Change in estimate arising from changes in transaction price 817 Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional (4,572 ) Contract assets recognized 5,508 Contract asset, end of period $ 5,508 The following table disaggregates revenue by business segment and timing of revenue recognition: For the Three Months Ended March 31, 2018 Point in time Overtime Total CDMO $ 19,413 $ 129 $ 19,542 Acute Care — — — Revenue 19,413 129 19,542 Adoption of ASU 2014-09 did not require capitalization of any costs to obtain or fulfill contracts. In general, the Company’s payment terms for manufacturing revenue and research and development services is 30 days. Royalty revenue is recorded to accounts receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment terms are generally 45 days after quarter end. Based on the adoption of ASU 2014-09, the timing difference between recognition of certain royalty revenues as a contract asset and cash receipt is increased by an estimated 90 days. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | (19) Related Party Transactions A Non-Executive Director of the Company’s Irish subsidiary is a Managing Director and a majority shareholder of HiTech Health Ltd, or HiTech Health, a consultancy firm for the biotech, pharmaceutical and medical device industry. Since 2016, HiTech Health has provided the Company with certain consulting services and in November 2017 both parties entered into a Service Agreement to engage in regulatory project support and consultancy. In consideration for such services, the Company recorded $109 for the three months ended March 31, 2018. A portion of the amount relates to consultancy services provided by the Non-Executive Director. |
Retirement Plan
Retirement Plan | 3 Months Ended |
Mar. 31, 2018 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan | (20) Retirement Plan The Company has a voluntary 401(k) Savings Plan (the 401(k) Plan) in which all employees are eligible to participate. The Company’s policy is to match 100% of the employee contributions up to a maximum of 5% of employee compensation. Total Company contributions to the 401(k) plan for the three months ended March 31, 2018 and 2017 were $390 and $343, respectively. |
Summary of Significant Accoun27
Summary of Significant Accounting Principles (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | (a) Basis of Presentation and Principles of Consolidation The accompanying unaudited 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, for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. 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 results for the interim periods. Operating results for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2018. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017. |
Use of Estimates | (b) Use of Estimates The preparation of financial statements and the notes to the 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 Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of the changes in interest rates. |
Property and Equipment | (d) 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 and office equipment; six to ten or more 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. |
Business Combinations | (e) Business Combinations In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805, “Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. |
Goodwill and Intangible Assets | (f) 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 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 life 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 and Comprehensive Loss. 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 30 th |
Revenue Recognition | (g) Revenue Recognition The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components. The Company’s revenue policies listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “ Revenue from Contracts with Customers,” Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments. In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s commercial partners. Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. |
Concentration of Credit Risk | (h) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four largest customers having generated 99% of its revenues for three months ended March 31, 2018. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the U.S. |
Research and Development | ( i ) 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 pre-commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing and regulatory filing fees and 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 expenses 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 product 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 | (j) 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/or 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 the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Non-employee stock-based awards are revalued until an award vests and the Company recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, which is known as 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 | (k) 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 does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. |
Net Income Per Common Share | (l) Net Loss Per Common Share Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period. For all periods presented, the outstanding common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. There are no dilutive common stock equivalents for the three months ended March 31, 2018 The following table sets forth the computation of basic and diluted loss per share: Three Months Ended March 31, 2018 2017 Basic and Diluted Loss Per Share Net loss $ (12,455 ) $ (8,087 ) Weighted average common shares outstanding, basic and diluted 19,219,257 19,049,416 Net loss per share of common stock, basic and diluted $ (0.65 ) $ (0.42 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive: March 31, 2018 2017 Options and restricted stock units outstanding 4,973,043 3,337,461 Warrants 1,133,592 784,928 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Segment Information | (m) 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 its CDMO and Acute Care divisions as reportable segments. Segment disclosures are included in Note 17. 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. 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 | (n) Recent Accounting Pronouncements In May 2017, the FASB issued ASU No. 2017-09, “ Stock Compensation - Scope of Modification Accounting” In January 2017, the FASB issued ASU No. 2017-04 “ Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment In February 2016, the FASB issued ASU No. 2016-02, “ Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In January 2018, the Company adopted the standard using the modified retrospective method. See Footnote 18 for additional information on the impact of the transition on the Company’s financial statements. |
Summary of Significant Accoun28
Summary of Significant Accounting Principles (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Computation of Basic and Diluted Loss Per Share | The following table sets forth the computation of basic and diluted loss per share: Three Months Ended March 31, 2018 2017 Basic and Diluted Loss Per Share Net loss $ (12,455 ) $ (8,087 ) Weighted average common shares outstanding, basic and diluted 19,219,257 19,049,416 Net loss per share of common stock, basic and diluted $ (0.65 ) $ (0.42 ) |
Schedule of Anti-Dilutive Securities | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive: March 31, 2018 2017 Options and restricted stock units outstanding 4,973,043 3,337,461 Warrants 1,133,592 784,928 |
Fair Value of Financial Instr29
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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, 2017: Assets: Cash equivalents Money market mutual funds $ 38,959 $ — $ — Total cash equivalents $ 38,959 $ — $ — Short-term investments U.S. Treasury obligations $ 3,498 $ — $ — Total financial assets $ 42,457 $ — $ — Liabilities: Warrants — — $ 3,406 Contingent consideration — — 82,413 $ — $ — $ 85,819 At March 31, 2018: Assets: Cash equivalents Money market mutual funds (See Note 7) $ 4,162 $ — $ — U.S. Treasury obligations (See Note 7) $ 9,989 Commercial Paper (See Note 7) $ 17,972 Total cash equivalents $ 14,151 $ 17,972 $ — Short-term investments U.S. Treasury obligations (See Note 7) $ 1,998 $ — $ — Commercial Paper (See Note 7) $ 2,991 $ — Total financial assets $ 16,149 $ 20,963 $ — Liabilities: Warrants (See Note 14(d)) — — $ 4,179 Contingent consideration (See Note 4) — — 84,933 $ — $ — $ 89,112 |
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, 2017 $ 3,406 $ 82,413 Additions — — Remeasurement 773 2,520 Total at March 31, 2018 $ 4,179 $ 84,933 Current portion as of March 31, 2018 — 33,957 Long-term portion as of March 31, 2018 4,179 50,976 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Available-for-sale Securities | The following is a summary of available-for-sale securities as of March 31, 2018. March 31, 2018 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 4,162 $ — $ — $ 4,162 U.S. Treasury obligations 11,987 — — 11,987 Commercial Paper 20,963 1 (1 ) 20,963 Total investments $ 37,112 $ 1 $ (1 ) $ 37,112 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventory was as follows as of March 31, 2018 and December 31, 2017: March 31, 2018 December 31, 2017 Raw materials $ 2,645 $ 2,130 Work in process 4,672 3,931 Finished goods 3,551 4,488 10,868 10,549 Provision for inventory obsolescence (840 ) (710 ) $ 10,028 $ 9,839 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following: March 31, 2018 December 31, 2017 Land $ 3,263 $ 3,263 Building and improvements 15,771 15,751 Furniture, office and computer equipment 4,633 4,406 Manufacturing equipment 24,603 24,153 Construction in progress 5,227 5,326 53,497 52,899 Less: accumulated depreciation and amortization 15,011 13,825 Property, plant and equipment, net $ 38,486 $ 39,074 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Balance of Intangible Assets | The following represents the balance of the intangible assets at March 31, 2018: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 7,696 $ 7,804 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 7,696 $ 34,204 The following represents the balance of intangible assets at December 31, 2017: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 7,050 $ 8,450 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 7,050 $ 34,850 |
Schedule of Future Amortization Expense | As of March 31, 2018, future amortization expense is as follows: Amortization 2018 1,937 2019 2,583 2020 2,583 2021 701 Total $ 7,804 |
Accrued Expenses and Other Cu34
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: March 31, December 31, 2018 2017 Clinical trial and related costs $ 367 $ 383 Professional and consulting fees 926 1,010 Payroll and related costs 3,247 6,387 Property plant and equipment 6 216 Deferred revenue 818 546 Interest payable — 802 Other 997 553 $ 6,361 $ 9,897 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt Balance | The components of the carrying value of the debt as of March 31, 2018, are detailed below: Principal balance outstanding $ 60,000 Unamortized deferred issuance costs (6,088 ) Exit fee accretion 45 Total $ 53,957 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements | As of March 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the leases, are as follows: Lease payments 2018 411 2019 508 2020 408 2021 362 2022 374 Total $ 2,063 |
Capital Structure (Tables)
Capital Structure (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Purchase Shares of Common Stock | As of March 31, 2018, 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 2019 350,000 $ 19.46 April 2022 294,928 $ 3.28 April 2022 348,664 $ 8.60 November 2024 |
Summary of Fair Value and Assumptions Used for Black-Scholes Option-pricing Model for Liability Classified Warrants | The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for these liability classified warrants. March 31, 2018 December 31, 2017 Fair value $ 4,179 $ 3,406 Expected dividend yield — % — % Expected volatility 74 % 75 % Risk-free interest rates 2.48 % 2.09 % Remaining contractual term 4.00 years 4.25 years |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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: March 31, 2018 2017 Range of expected option life 6 years 6 years Expected volatility 74.01% - 74.60% 84.71% Risk-free interest rate 2.32 - 2.73% 2.05 - 2.17% Expected dividend yield — — |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2018: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2017 3,594,875 $ 7.17 7.1 years Granted 713,226 9.16 Exercised (14,575 ) 4.49 Expired/forfeited/cancelled (46,805 ) 8.51 Balance, March 31, 2018 4,246,721 $ 7.50 7.3 years Vested 2,213,374 $ 6.82 5.7 years Vested and expected to vest 4,246,721 $ 7.50 7.3 years |
Summary of Restricted Stock Units Activity | The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2018. Number of shares Balance, December 31, 2017 270,593 Granted 500,120 Vested and settled (35,025 ) Expired/forfeited/cancelled (9,366 ) Balance, March 31, 2018 726,322 Expected to vest 726,322 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Segment Reporting [Abstract] | |
Summary of Segment Information | The following table summarizes segment information as of and for the three months ended March 31, 2018: For the Three Months Ended March 31, 2018 2017 Revenues: CDMO $ 19,542 $ 18,742 Acute Care — — Total $ 19,542 $ 18,742 Operating income (loss): CDMO $ 6,566 $ 6,199 Acute Care (19,413 ) (13,501 ) Total $ (12,847 ) $ (7,302 ) Depreciation and amortization: CDMO $ 1,819 $ 1,837 Acute Care 43 5 Total $ 1,862 $ 1,842 Capital expenditures: CDMO $ 329 $ 1,530 Acute Care 1,325 214 Total $ 1,654 $ 1,744 March 31, December 31, 2018 2017 Total assets: CDMO $ 80,300 $ 78,136 Acute Care 98,153 108,090 Total $ 178,453 $ 186,226 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Schedule of Changes in Contract Assets | The following table presents changes in the Company’s contract assets for the three months ended March 31, 2018: Contract asset, beginning of year $ 3,755 Change in estimate arising from changes in transaction price 817 Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional (4,572 ) Contract assets recognized 5,508 Contract asset, end of period $ 5,508 |
Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition | The following table disaggregates revenue by business segment and timing of revenue recognition: For the Three Months Ended March 31, 2018 Point in time Overtime Total CDMO $ 19,413 $ 129 $ 19,542 Acute Care — — — Revenue 19,413 129 19,542 |
ASU 2014-09 [Member] | |
Impact of Adoption of ASU on Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet | The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09 were as follows: Balance at December 31, 2017 Adoption of ASU 2014-09 Balance at January 1, 2018 Contract asset $ — $ 3,755 $ 3,755 Deferred income taxes 18,573 (937 ) 17,636 Total shareholders' equity 28,848 (2,818 ) 26,030 The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed consolidated balance sheet was as follows: For the Three Months Ended March 31, 2018 Previous Revenue Standard Adoption of ASU 2014-09 As Reported Revenue $ 17,789 $ 1,753 $ 19,542 Income tax benefit 2,790 (437 ) 2,353 Net loss (13,771 ) 1,316 (12,455 ) March 31, 2018 Previous Revenue Standard Adoption of ASU 2014-09 As Reported Contract assets $ — $ 5,508 $ 5,508 Deferred income taxes 21,363 (1,374 ) 19,989 Total assets 174,319 4,134 178,453 Accumulated deficit (125,119 ) 4,134 (120,985 ) Total shareholders' equity 20,442 4,134 24,576 Total liabilities and shareholders' equity 174,319 4,134 178,453 |
Background - Additional Informa
Background - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2018Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Entity incorporation date | Nov. 15, 2007 |
Number of operating divisions | 2 |
Development-Stage Risks and L42
Development-Stage Risks and Liquidity - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Business Developments Risks And Uncertainties Liquidity [Abstract] | ||
Accumulated deficit | $ 120,985 | $ 111,348 |
Summary of Significant Accoun43
Summary of Significant Accounting Principles - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2018USD ($)Customershares | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Goodwill impairment | $ | $ 0 |
Indefinite-lived intangible assets impairment | $ | $ 0 |
Dilutive common stock equivalent | shares | 0 |
Accounts Receivable [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | Customer | 5 |
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 | 99.00% |
Royalties and Contract Manufacturing Relationships [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Definite-lived intangible asset, useful lives | 6 years |
Furniture and Office Equipment [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 3 years |
Furniture and Office 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 useful life | ten or more 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 Accoun44
Summary of Significant Accounting Principles - Computation of Basic and Diluted Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Basic and Diluted Loss Per Share | ||
Net loss | $ (12,455) | $ (8,087) |
Weighted average common shares outstanding, basic and diluted | 19,219,257 | 19,049,416 |
Net loss per share of common stock, basic and diluted | $ (0.65) | $ (0.42) |
Summary of Significant Accoun45
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
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 | 4,973,043 | 3,337,461 |
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 | 1,133,592 | 784,928 |
Acquisition of Gainesville Fa46
Acquisition of Gainesville Facility and Meloxicam - Additional Information (Detail) - Gainesville [Member] $ / shares in Units, $ in Thousands | Apr. 10, 2015USD ($)$ / sharesshares |
Business Acquisition [Line Items] | |
Business acquisition upfront payment in cash | $ 50,000 |
Working capital adjustment | 4,000 |
Business acquisition contingent consideration possible milestone payments | $ 125,000 |
Maximum future net product sales milestone percentage | 30.00% |
Minimum milestone payments percentage | 60.00% |
Maximum royalty payment percentage | 30.00% |
Minimum [Member] | |
Business Acquisition [Line Items] | |
Future net product sales milestone percentage | 10.00% |
Royalty payment percentage | 10.00% |
Maximum [Member] | |
Business Acquisition [Line Items] | |
Future net product sales milestone percentage | 12.00% |
Royalty payment percentage | 12.00% |
Regulatory Approval and Net Sales Milestones [Member] | |
Business Acquisition [Line Items] | |
Business acquisition contingent consideration possible milestone payments | $ 45,000 |
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 |
NMB Related License Agreement -
NMB Related License Agreement - Additional Information (Detail) - Cornell University [Member] - Neuromuscular Blocking Agents License Agreement [Member] - USD ($) | 1 Months Ended | |
Jun. 30, 2017 | Mar. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Acquired IPR&D | $ 766,000 | |
Upfront payment obligation | 350,000 | |
Operational liabilities and acquisition-related costs | $ 416,000 | |
Acquired IPR&D charge expected deductible period for income tax purposes | 15 years | |
U.S [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Regulatory approval and commercialization milestones | $ 5,000,000 | |
European [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Regulatory approval and commercialization milestones | $ 3,000,000 | |
Component of Accrued Expenses and Other Current Liabilities and Other Non-current Liabilities [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Operational liabilities and acquisition-related costs | $ 247,000 |
Fair Value of Financial Instr48
Fair Value of Financial Instruments - Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Warrants [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | $ 4,179 | $ 3,406 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 16,149 | 42,457 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Mutual Funds [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 4,162 | 38,959 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Cash Equivalents [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 14,151 | 38,959 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Obligations [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 9,989 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Obligations [Member] | Short-term Investments [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 1,998 | 3,498 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 20,963 | |
Significant Other Observable Inputs (Level 2) [Member] | Cash Equivalents [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 17,972 | |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 17,972 | |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | Short-term Investments [Member] | ||
Assets: | ||
Fair value of total financial assets, recurring basis | 2,991 | |
Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | 89,112 | 85,819 |
Significant Unobservable Inputs (Level 3) [Member] | Warrants [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | 4,179 | 3,406 |
Significant Unobservable Inputs (Level 3) [Member] | Contingent Consideration [Member] | ||
Liabilities: | ||
Fair value of liabilities, recurring basis | $ 84,933 | $ 82,413 |
Fair Value of Financial Instr49
Fair Value of Financial Instruments - Reconciliation of Contingent Consideration and Warrants Measured at Fair Value on Recurring Basis Using Unobservable Inputs (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Warrants [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2017 | $ 3,406 |
Remeasurement | 773 |
Total at March 31, 2018 | 4,179 |
Long-term portion as of March 31, 2018 | 4,179 |
Contingent Consideration [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2017 | 82,413 |
Remeasurement | 2,520 |
Total at March 31, 2018 | 84,933 |
Current portion as of March 31, 2018 | 33,957 |
Long-term portion as of March 31, 2018 | $ 50,976 |
Short-term Investments - Summar
Short-term Investments - Summary of Available-for-sale Securities (Detail) $ in Thousands | Mar. 31, 2018USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | $ 37,112 |
Gross Unrealized Gain | 1 |
Gross Unrealized Loss | (1) |
Estimated Fair Value | 37,112 |
Money Market Mutual Funds [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 4,162 |
Estimated Fair Value | 4,162 |
U.S. Treasury Obligations [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 11,987 |
Estimated Fair Value | 11,987 |
Commercial Paper [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 20,963 |
Gross Unrealized Gain | 1 |
Gross Unrealized Loss | (1) |
Estimated Fair Value | $ 20,963 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - Investment | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Number of investments with unrealized losses position, less than 12 months | 2 | |
Minimum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Investments maturities period | 1 month | |
Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Investments maturities period | 4 months | |
U.S. Treasury Obligations [Member] | Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Investments maturities period | 2 months | |
Duration of time, investments in continuous unrealized loss position | 6 months |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,645 | $ 2,130 |
Work in process | 4,672 | 3,931 |
Finished goods | 3,551 | 4,488 |
Inventory | 10,868 | 10,549 |
Provision for inventory obsolescence | (840) | (710) |
Inventory, net | $ 10,028 | $ 9,839 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 53,497 | $ 52,899 |
Less: accumulated depreciation and amortization | 15,011 | 13,825 |
Property, plant and equipment, net | 38,486 | 39,074 |
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 | 15,771 | 15,751 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 4,633 | 4,406 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 24,603 | 24,153 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,227 | $ 5,326 |
Property, Plant and Equipment54
Property, Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 1,216 | $ 1,196 |
Intangible Assets - Summary of
Intangible Assets - Summary of Balance of Intangible Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Total | $ 41,900 | $ 41,900 |
Accumulated Amortization | 7,696 | 7,050 |
Net Intangible Assets, Total | 34,204 | 34,850 |
Royalties and Contract Manufacturing Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Definite-lived | 15,500 | 15,500 |
Accumulated Amortization | 7,696 | 7,050 |
Net Intangible Assets, Definite-lived | 7,804 | 8,450 |
In-Process Research and Development [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Indefinite-lived | $ 26,400 | $ 26,400 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Intangible Assets Net Excluding Goodwill [Abstract] | ||
Amortization expense | $ 646 | $ 646 |
Intangible Assets - Summary o57
Intangible Assets - Summary of Future Amortization Expense (Detail) - Royalties and Contract Manufacturing Relationships [Member] - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
2,018 | $ 1,937 | |
2,019 | 2,583 | |
2,020 | 2,583 | |
2,021 | 701 | |
Total | $ 7,804 | $ 8,450 |
Accrued Expenses and Other Cu58
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Clinical trial and related costs | $ 367 | $ 383 |
Professional and consulting fees | 926 | 1,010 |
Payroll and related costs | 3,247 | 6,387 |
Property plant and equipment | 6 | 216 |
Deferred revenue | 818 | 546 |
Interest payable | 802 | |
Other | 997 | 553 |
Total accrued expenses and other current liabilities | $ 6,361 | $ 9,897 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) | Nov. 17, 2017USD ($)Tranche | Apr. 10, 2015 | Mar. 31, 2018USD ($)$ / sharesshares | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee | $ 45,000 | |||||
Principal balance outstanding | 60,000,000 | |||||
Payments of debt transaction fees | 261,000 | |||||
Amortization of debt issuance costs | $ 329,000 | $ 158,000 | ||||
Athyrium Opportunities II Acquisition LP | Seven Year Warrant [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Purchase common stock with warrant issue | shares | 348,664 | |||||
Warrant, exercise price per share | $ / shares | $ 8.6043 | |||||
Warrants, exercisable date | Nov. 17, 2024 | |||||
Athyrium Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 10,000,000 | |||||
Number of additional tranches | Tranche | 2 | |||||
Debt instrument, maturity date | Nov. 17, 2022 | |||||
Debt instrument, maturity term | 5 years | |||||
Term loan interest rate, Description | interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum | |||||
Debt instrument, frequency of interest payment | quarterly | |||||
Exit fee percentage | 1.00% | |||||
Debt instrument, exit fee | $ 600,000 | $ 600,000 | ||||
Debt instrument, covenant description | 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 March 31, 2018, the Company was in compliance with the covenants | |||||
Principal balance outstanding | $ 60,000,000 | |||||
Debt issuance costs related to credit agreement | $ 4,439,000 | |||||
Effective interest rate | 15.04% | |||||
Payments of debt transaction fees | $ 4,178,000 | |||||
Athyrium Credit Agreement [Member] | Warrants [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Initial warrant fair value | $ 2,143,000 | |||||
Athyrium Credit Agreement [Member] | Floor [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 1.00% | |||||
Athyrium Credit Agreement [Member] | LIBOR [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 9.75% | |||||
Athyrium Credit Agreement [Member] | Tranche One Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | 60,000,000 | |||||
Athyrium Credit Agreement [Member] | Tranche Two Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | 20,000,000 | |||||
Athyrium Credit Agreement [Member] | Tranche Two Term Loan [Member] | Alkermes Plc [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, unrestricted cash | $ 20,000,000 | |||||
Athyrium Credit Agreement [Member] | Tranche Three Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 20,000,000 | |||||
Athyrium Credit Agreement [Member] | Tranche Three Term Loan [Member] | Scenario, Forecast [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, net sales | $ 20,000,000 | |||||
OrbiMed Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of initial term loan | 60,000,000 | |||||
Term loan agreement date | Apr. 10, 2015 | |||||
Repayments of debt and early termination charges | 31,767,000 | |||||
Repayments of debt Principal balance | 27,347,000 | |||||
Prepayment of debt and debt extinguishment costs | $ 4,420,000 | |||||
OrbiMed Credit Agreement [Member] | Interest Expense [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loss on early extinguishment of debt | $ 6,772,000 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt Balance (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Debt Disclosure [Abstract] | ||
Principal balance outstanding | $ 60,000 | |
Unamortized deferred issuance costs | (6,088) | |
Exit fee accretion | 45 | |
Total | $ 53,957 | $ 53,598 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Jan. 02, 2017 | Feb. 28, 2017 | Mar. 31, 2018USD ($) | Mar. 31, 2018EUR (€) |
Purchase Commitment [Member] | ||||
Supply Commitment [Line Items] | ||||
Purchase commitment non cancelable and cancelable | $ 27,228,000 | |||
Dublin [Member] | ||||
Supply Commitment [Line Items] | ||||
Lease commenced date | Feb. 28, 2017 | |||
Lease expiration date | Apr. 16, 2020 | |||
Term of contract | 3 years | |||
Malvern Consulting Group, Inc. (MCG) [Member] | Pennsylvania [Member] | ||||
Supply Commitment [Line Items] | ||||
Lease commenced date | Jan. 1, 2017 | |||
Lease expiration date | Dec. 31, 2022 | |||
Term of contract | 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] | 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 | |||
Minimum [Member] | Gainesville Transaction [Member] | ||||
Supply Commitment [Line Items] | ||||
Future net product sales milestone percentage | 10.00% | 10.00% | ||
Maximum [Member] | Executive Officer [Member] | ||||
Supply Commitment [Line Items] | ||||
Aggregate annual base salaries of employment agreement | $ 734,000 | |||
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 | $ 25,257,000 | € 20,500,000 | ||
Amount of royalty payments due or payable | $ 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 | |||
Additional contingent milestones payment | $ 15,031,000 | € 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 Contingencies62
Commitments and Contingencies - Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements (Detail) $ in Thousands | Mar. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,018 | $ 411 |
2,019 | 508 |
2,020 | 408 |
2,021 | 362 |
2,022 | 374 |
Lease payments, Total | $ 2,063 |
Capital Structure - Additional
Capital Structure - Additional Information (Detail) - USD ($) | Mar. 02, 2018 | Dec. 29, 2017 | Dec. 16, 2016 | Aug. 19, 2016 | Jul. 07, 2015 | Feb. 02, 2015 | Mar. 12, 2014 | Mar. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2017 |
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | ||||||||
Common stock, par value | $ 0.01 | $ 0.01 | ||||||||
Common stock issuance | $ 3,802,000 | |||||||||
Proceeds from sale of common stock, net of transaction costs | 3,514,000 | |||||||||
Stock issued at fair value | $ 357,000 | |||||||||
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 $12.00, Expiring on March 2019 [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Warrants outstanding to purchase shares, Number of Shares | 140,000 | |||||||||
Warrants, Exercise Price $8.60, Expiring on November 2024 [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Warrants outstanding to purchase shares, Number of Shares | 348,664 | |||||||||
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 $3.28, Expiring on April 2022 [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Warrants outstanding to purchase shares, Number of Shares | 294,928 | |||||||||
Cowen and Company, LLC [member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Common stock, par value | $ 0.01 | |||||||||
Common stock issuance, shares | 0 | |||||||||
Cowen and Company, LLC [member] | Maximum [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Common stock issuance | $ 40,000,000 | |||||||||
Aspire Capital [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Common stock issuance, shares | 33,040 | 96,463 | 350,000 | 1,143,940 | ||||||
Common stock issuance | $ 7,796 | |||||||||
Proceeds from sale of common stock, net of transaction costs | $ 3,514,000 | |||||||||
Term of purchase agreement | 30 months | 24 months | ||||||||
Stock issued at fair value | $ 285,000 | |||||||||
Cost incurred in stock issuance | 253,000 | |||||||||
Aspire Capital [Member] | Maximum [Member] | ||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||
Common stock issuance | $ 20,000,000 | $ 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] | 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 | ||||||||
Proceeds from sale of common stock, net of transaction costs | $ 36,888,000 | $ 13,367,000 |
Capital Structure - Schedule of
Capital Structure - Schedule of Warrants Outstanding to Purchase Shares of Common Stock (Detail) | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Warrants, Exercise Price $12.00, Expiring on March 2019 [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 | 2019-03 |
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 |
Warrants, Exercise Price $8.60, Expiring on November 2024 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Warrants outstanding to purchase shares, Number of Shares | shares | 348,664 |
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares | $ 8.60 |
Warrants outstanding to purchase shares, Expiration Date | 2024-11 |
Capital Structure - Summary of
Capital Structure - Summary of Fair Value and Assumptions Used for Black-Scholes Option-pricing Model for Liability Classified Warrants (Detail) - Warrants [Member] - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Fair value | $ 4,179 | $ 3,406 |
Expected volatility | 74.00% | 75.00% |
Risk-free interest rates | 2.48% | 2.09% |
Remaining contractual term | 4 years | 4 years 3 months |
Comprehensive Loss - Additional
Comprehensive Loss - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Comprehensive Income Net Of Tax [Abstract] | ||
Total comprehensive loss | $ 12,455,000 | $ 8,144,000 |
Tax effect of other comprehensive loss | $ 0 | $ 19,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Dec. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2018 | Mar. 31, 2017 | May 09, 2018 | Jun. 30, 2015 | Oct. 31, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock options exercisable period | 10 years | ||||||
Stock options vest period | 4 years | ||||||
Weighted average grant-date fair value of the options awarded to employees | $ 6.08 | $ 5.29 | |||||
Stock-based compensation | $ 1,584 | $ 892 | |||||
Aggregate intrinsic value of vested options | 9,522 | ||||||
Aggregate intrinsic value of unvested options | $ 5,746 | ||||||
Stock Options Granted Outside Plan [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of options, Granted | 961,750 | ||||||
Time-based RSUs Granted Outside Plan [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of restricted stock units granted | 44,500 | ||||||
Performance-based RSUs [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of restricted stock units granted | 240,224 | ||||||
Unrecognized compensation expense related to unvested performance RSUs, expected to vest | $ 2,671 | ||||||
Time Based Restricted Stock [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock options vest period | 4 years | ||||||
Number of restricted stock units granted | 259,896 | ||||||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 7 months 6 days | ||||||
Stock Options And Time-based RSUs [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Unrecognized compensation expense related to unvested options and time-based RSUs, expected to vest | $ 14,870 | ||||||
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 | ||||||
Shares available for future grants | 174 | ||||||
2013 Equity Incentive Plan [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares available for grant | 600,000 | ||||||
A&R Plan [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares available for grant | 4,036,737 | 7,036,737 | 2,000,000 | ||||
Percentage of outstanding common stock | 5.00% | 5.00% | |||||
Increase in share per "Evergreen" provision | 956,341 | 619,181 | |||||
Shares available for future grants | 254,420 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model (Detail) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Range of expected option life | 6 years | 6 years |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 74.01% | 75.10% |
Risk-free interest rate | 2.32% | 1.87% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 74.60% | 84.71% |
Risk-free interest rate | 2.73% | 2.27% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of shares, beginning balance | 3,594,875 | |
Number of shares, Granted | 713,226 | |
Number of shares, Exercised | (14,575) | |
Number of shares, Expired/forfeited/cancelled | (46,805) | |
Number of shares, ending balance | 4,246,721 | 3,594,875 |
Number of shares, Vested | 2,213,374 | |
Number of shares, Vested and expected to vest | 4,246,721 | |
Weighted average exercise price, beginning balance | $ 7.17 | |
Weighted average exercise price, Granted | 9.16 | |
Weighted average exercise price, Exercised | 4.49 | |
Weighted average exercise price, Expired/forfeited/cancelled | 8.51 | |
Weighted average exercise price, ending balance | 7.50 | $ 7.17 |
Weighted average exercise price, Vested | 6.82 | |
Weighted average exercise price, Vested and expected to vest | $ 7.50 | |
Weighted average remaining contractual life | 7 years 3 months 18 days | 7 years 1 month 6 days |
Weighted average remaining contractual life, Vested | 5 years 8 months 12 days | |
Weighted average remaining contractual life, Vested and expected to vest | 7 years 3 months 18 days |
Stock-Based Compensation - Su70
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units [Member] | 3 Months Ended |
Mar. 31, 2018shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares, beginning balance | 270,593 |
Number of shares, Granted | 500,120 |
Number of shares, Vested and settled | (35,025) |
Number of shares, Expired/forfeited/cancelled | (9,366) |
Number of shares, ending balance | 726,322 |
Number of shares, Expected to vest | 726,322 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2018USD ($)Segment | Mar. 31, 2017USD ($) | |
Segment Reporting Information [Line Items] | ||
Number of business segments | Segment | 2 | |
Revenue | $ 19,542,000 | $ 18,742,000 |
Acute Care [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenue | $ 0 |
Segment Reporting - Summary of
Segment Reporting - Summary of Segment Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Segment Reporting Information [Line Items] | |||
Revenue | $ 19,542,000 | $ 18,742,000 | |
Operating income (loss) | (12,847,000) | (7,302,000) | |
Depreciation and amortization | 1,862,000 | 1,842,000 | |
Capital expenditures | 1,654,000 | 1,744,000 | |
Total assets | 178,453,000 | $ 186,226,000 | |
CDMO [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue | 19,542,000 | 18,742,000 | |
Operating income (loss) | 6,566,000 | 6,199,000 | |
Depreciation and amortization | 1,819,000 | 1,837,000 | |
Capital expenditures | 329,000 | 1,530,000 | |
Total assets | 80,300,000 | 78,136,000 | |
Acute Care [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue | 0 | ||
Operating income (loss) | (19,413,000) | (13,501,000) | |
Depreciation and amortization | 43,000 | 5,000 | |
Capital expenditures | 1,325,000 | $ 214,000 | |
Total assets | $ 98,153,000 | $ 108,090,000 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accumulated deficit | $ (120,985) | $ (111,348) | |
Contract asset | 5,508 | $ 3,755 | $ 3,755 |
Contract asset, increase in estimates arising from changes in transaction price | 817 | ||
ASU 2014-09 [Member] | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Contract asset | 3,755 | ||
ASU 2014-09 [Member] | Adoption of ASU 2014-09 [Member] | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accumulated deficit | 4,134 | (2,818) | |
Contract asset | $ 5,508 | $ 3,755 |
Revenue Recognition - Cumulativ
Revenue Recognition - Cumulative Effect Of Changes Made to Consolidated Balance Sheet for Adoption of ASU (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Contract asset | $ 5,508 | $ 3,755 | $ 3,755 |
Deferred income taxes | 19,989 | 18,573 | |
Total shareholders' equity | 24,576 | $ 28,848 | |
ASU 2014-09 [Member] | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Contract asset | 3,755 | ||
Deferred income taxes | 17,636 | ||
Total shareholders' equity | 26,030 | ||
Adoption of ASU 2014-09 [Member] | ASU 2014-09 [Member] | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Contract asset | 5,508 | 3,755 | |
Deferred income taxes | (1,374) | (937) | |
Total shareholders' equity | $ 4,134 | $ (2,818) |
Revenue Recognition - Impact of
Revenue Recognition - Impact of Adoption of ASU on Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | Jan. 01, 2018 | Dec. 31, 2017 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenue | $ 19,542 | |||
Income tax benefit | 2,353 | $ 293 | ||
Net loss | (12,455) | $ (8,087) | ||
Contract asset | 5,508 | $ 3,755 | $ 3,755 | |
Deferred income taxes | 19,989 | 18,573 | ||
Total assets | 178,453 | 186,226 | ||
Accumulated deficit | (120,985) | (111,348) | ||
Total shareholders' equity | 24,576 | 28,848 | ||
Total liabilities and shareholders' equity | 178,453 | $ 186,226 | ||
ASU 2014-09 [Member] | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Contract asset | 3,755 | |||
Deferred income taxes | 17,636 | |||
Total shareholders' equity | 26,030 | |||
Previous Revenue Standard [Member] | ASU 2014-09 [Member] | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenue | 17,789 | |||
Income tax benefit | 2,790 | |||
Net loss | (13,771) | |||
Deferred income taxes | 21,363 | |||
Total assets | 174,319 | |||
Accumulated deficit | (125,119) | |||
Total shareholders' equity | 20,442 | |||
Total liabilities and shareholders' equity | 174,319 | |||
Adoption of ASU 2014-09 [Member] | ASU 2014-09 [Member] | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Revenue | 1,753 | |||
Income tax benefit | (437) | |||
Net loss | 1,316 | |||
Contract asset | 5,508 | 3,755 | ||
Deferred income taxes | (1,374) | (937) | ||
Total assets | 4,134 | |||
Accumulated deficit | 4,134 | (2,818) | ||
Total shareholders' equity | 4,134 | $ (2,818) | ||
Total liabilities and shareholders' equity | $ 4,134 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Changes in Contract Assets (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Revenue From Contract With Customer [Abstract] | |
Contract asset, beginning of year | $ 3,755 |
Change in estimate arising from changes in transaction price | 817 |
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional | (4,572) |
Contract assets recognized | 5,508 |
Contract asset, end of period | $ 5,508 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Disaggregation Of Revenue [Line Items] | |
Revenue | $ 19,542 |
CDMO [Member] | |
Disaggregation Of Revenue [Line Items] | |
Revenue | 19,542 |
Point In Time [Member] | |
Disaggregation Of Revenue [Line Items] | |
Revenue | 19,413 |
Point In Time [Member] | CDMO [Member] | |
Disaggregation Of Revenue [Line Items] | |
Revenue | 19,413 |
Overtime [Member] | |
Disaggregation Of Revenue [Line Items] | |
Revenue | 129 |
Overtime [Member] | CDMO [Member] | |
Disaggregation Of Revenue [Line Items] | |
Revenue | $ 129 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Irish Subsidiary [Member] - Managing Director [Member] - HiTech Health [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Related Party Transaction [Line Items] | |
Related party transaction expenses | $ 109 |
Service agreement date | 2017-11 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Compensation And Retirement Disclosure [Abstract] | ||
Percentage of company's matching contribution with respect to each participant's contribution | 100.00% | |
Company matching contributions to maximum employees eligible compensation | 5.00% | |
Total company contributions to 401 (k) plan | $ 390 | $ 343 |