Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 08, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | REPH | |
Entity Registrant Name | Recro Pharma, Inc. | |
Entity Central Index Key | 0001588972 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 22,181,119 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 45,981 | $ 38,514 |
Short-term investments | 12,034 | |
Accounts receivable | 16,218 | 12,866 |
Contract asset | 5,108 | 5,201 |
Inventory | 10,168 | 10,699 |
Prepaid expenses and other current assets | 5,128 | 3,861 |
Total current assets | 94,637 | 71,141 |
Property, plant and equipment, net | 46,622 | 45,640 |
Right-of-use asset | 1,693 | |
Intangible assets, net | 31,620 | 32,266 |
Goodwill | 6,446 | 6,446 |
Total assets | 181,018 | 155,493 |
Current liabilities: | ||
Accounts payable | 10,540 | 4,510 |
Accrued expenses and other current liabilities | 10,137 | 14,165 |
Current operating lease liability | 636 | |
Current portion of contingent consideration | 5,235 | 10,354 |
Total current liabilities | 26,548 | 29,029 |
Long-term debt, net | 105,939 | 64,243 |
Warrants and other long-term liabilities | 838 | 1,163 |
Long-term operating lease liability | 1,136 | |
Long-term portion of contingent consideration | 65,585 | 80,558 |
Total liabilities | 200,046 | 174,993 |
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, 22,133,388 shares at March 31, 2019 and 21,799,961 shares at December 31, 2018 | 221 | 218 |
Additional paid-in capital | 170,982 | 168,535 |
Accumulated deficit | (190,230) | (188,253) |
Accumulated other comprehensive loss | (1) | |
Total shareholders’ equity | (19,028) | (19,500) |
Total liabilities and shareholders’ equity | $ 181,018 | $ 155,493 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
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 | 22,133,388 | 21,799,961 |
Common stock, shares outstanding | 22,133,388 | 21,799,961 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Revenue | $ 25,065 | $ 19,542 |
Operating expenses: | ||
Cost of sales (excluding amortization of intangible assets) | 14,391 | 10,490 |
Research and development | 9,554 | 8,442 |
General and administrative | 14,179 | 9,518 |
Amortization of intangible assets | 646 | 646 |
Change in warrant valuation | (263) | 773 |
Change in contingent consideration valuation | (15,092) | 2,520 |
Total operating expenses | 23,415 | 32,389 |
Operating income (loss) | 1,650 | (12,847) |
Other income (expense): | ||
Interest income | 138 | 142 |
Interest expense | (3,765) | (2,103) |
Net loss before income taxes | (1,977) | (14,808) |
Income tax benefit | 2,353 | |
Net loss | $ (1,977) | $ (12,455) |
Per share information: | ||
Net loss per share of common stock, basic | $ (0.09) | $ (0.65) |
Net loss per share of common stock, diluted | $ (0.10) | $ (0.65) |
Weighted average common shares outstanding, basic | 21,918,175 | 19,219,257 |
Weighted average common shares outstanding, diluted | 21,978,606 | 19,219,257 |
Net loss | $ (1,977) | $ (12,455) |
Other comprehensive loss: | ||
Unrealized gain/(loss) on available-for-sale securities | (1) | |
Comprehensive loss | $ (1,978) | $ (12,455) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Unaudited) - 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 | ||||
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) | ||||
Issuance of common stock for equity facility | 3,802 | $ 4 | 3,798 | ||
Issuance of common stock for equity facility, 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 | ||||
Balance at Dec. 31, 2018 | (19,500) | $ 218 | 168,535 | (188,253) | |
Balance, Shares at Dec. 31, 2018 | 21,799,961 | ||||
Stock-based compensation expense | 2,826 | 2,826 | |||
Stock option exercise | $ 185 | 185 | |||
Stock option exercise, Shares | 29,750 | 29,750 | |||
Issuance of restricted stock units, net of shares withheld for income taxes | $ (862) | $ 3 | (865) | ||
Issuance of restricted stock units, net of shares withheld for income taxes, Shares | (268,915) | ||||
Issuance of common stock for equity facility | 301 | 301 | |||
Issuance of common stock for equity facility, Shares | 34,762 | ||||
Change in other comprehensive loss | (1) | (1) | |||
Net loss | (1,977) | (1,977) | |||
Balance at Mar. 31, 2019 | $ (19,028) | $ 221 | $ 170,982 | $ (190,230) | $ (1) |
Balance, Shares at Mar. 31, 2019 | 22,133,388 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (1,977) | $ (12,455) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,826 | 1,584 |
Non-cash interest expense | 1,017 | 319 |
Depreciation expense | 1,440 | 1,216 |
Amortization | 646 | 646 |
Change in warrant valuation | (263) | 773 |
Change in contingent consideration valuation | (15,092) | 2,520 |
Deferred income taxes | (2,353) | |
Changes in operating assets and liabilities: | ||
Inventory | 531 | (189) |
Contract asset | 93 | (1,753) |
Prepaid expenses and other current assets | (963) | 912 |
Right-of-use asset | 173 | |
Accounts receivable | (3,352) | (147) |
Accounts payable, accrued expenses and other liabilities | 2,612 | (5,870) |
Operating lease liability | (175) | |
Net cash used in operating activities | (12,484) | (14,797) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (2,932) | (1,654) |
Purchase of short-term investments | (12,021) | (4,981) |
Proceeds from maturity of investments | 3,500 | |
Acquisition of license agreement | (82) | |
Net cash used in investing activities | (15,035) | (3,135) |
Cash flows from financing activities: | ||
Proceeds from issuance of long-term debt, net of original issue discount of $11,400 | 43,600 | |
Payment of deferred financing costs | (2,936) | (261) |
Proceeds from sale of common stock, net of transaction costs | 3,514 | |
Payments of withholdings on shares withheld for income taxes | (864) | (86) |
Payment of contingent consideration | (5,000) | |
Proceeds from option exercise | 186 | 65 |
Net cash provided by financing activities | 34,986 | 3,232 |
Net decrease in cash and cash equivalents | 7,467 | (14,700) |
Cash and cash equivalents, beginning of period | 38,514 | 60,984 |
Cash and cash equivalents, end of period | 45,981 | 46,284 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 2,734 | 2,546 |
Purchase of property, plant and equipment included in accrued expenses and accounts payable | 2,071 | 249 |
Retirement of fully depreciated property, plant and equipment | 30 | |
Common stock issued in connection with equity facility | $ 301 | $ 357 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) (Unaudited) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Statement Of Cash Flows [Abstract] | |
Issuance of long-term debt, original issue discount | $ 11,400 |
Background
Background | 3 Months Ended |
Mar. 31, 2019 | |
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 pharmaceutical company that operates through two business segments: a revenue-generating contract development and manufacturing, or CDMO, segment and an Acute Care segment. Each of these segments are deemed to be reportable segments (see Note 3(m) and Note 17). 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 and the Acute Care segment develops proprietary product candidates including IV, Meloxicam, for which the Company is pursuing resolution of a received from the . In April 2019, after receipt of the second CRL for IV meloxicam, the Company announced it had implemented a strategic restructuring initiative, and corresponding reduction in workforce, aimed at reducing operating expenses, while maintaining key personnel needed to partner and obtain FDA approval of IV meloxicam. |
Development-Stage Risks and Liq
Development-Stage Risks and Liquidity | 3 Months Ended |
Mar. 31, 2019 | |
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 $190,230 as of March 31, 2019. Although its CDMO segment has been profitable, the Company 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, spin-off transactions, partnering or out-licensing transactions; (iii) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (iv) regulatory approval and market acceptance of the Company’s proposed future products, including IV meloxicam. Management believes that it is probable that the Company will be able to meet its obligations as they become due within one year after the date the financial statements are issued |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2019. 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, 2018 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018. (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 represent 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 costs 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 (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 one-step method for determining impairment. The one-step quantitative test calculates the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. 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 judgment is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing and 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 for our CDMO segment 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 primarily concentrated amongst four 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 98% of its revenues for three months ended March 31, 2019. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the United States. (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. The Company accounts for forfeitures as they occur. 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 our 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 . For non-employee stock-based awards, 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 basis, operating losses 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 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. Dilutive common stock equivalents for the three months ended March 31, 2019 include warrants using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. For the three months ended March 31, 2018, 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. The following table sets forth the computation of basic and diluted loss per share: Three Months Ended March 31, 2019 2018 Basic Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Net loss per share of common stock, basic $ (0.09 ) $ (0.65 ) Diluted Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Add change in warrant valuation (263 ) — Diluted net loss $ (2,240 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Add shares from outstanding warrants 60,431 — Weighted average common shares outstanding, diluted 21,978,606 19,219,257 Net loss per share of common stock, diluted $ (0.10 ) $ (0.65 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2019 and 2018, as they would be anti-dilutive: March 31, 2019 2018 Options and restricted stock units outstanding 6,249,662 4,973,043 Warrants 698,664 1,133,592 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 CDMO and Acute Care 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 (expense). Segment assets are those assets and liabilities that are recorded and reported by segment operations . (n) Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2018, the FASB issued ASU No. 2018-07, “ Compensation – Stock Compensation (Topic 718) Compensation—Stock Compensation Equity-Based Payments to Non-Employees Revenue from Contracts with Customers (Topic 606) . 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) Targeted Improvements 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 that 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 Note 18 for additional information on the impact of the transition on the Company’s financial statements. Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, Fair Value Measurement |
Acquisition of Gainesville Faci
Acquisition of Gainesville Facility and Meloxicam | 3 Months Ended |
Mar. 31, 2019 | |
Gainesville Facility [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 of injectable meloxicam, 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). In December 2018, the Company entered in to an Amendment to the Purchase and Sale Agreement that restructured the $45,000 milestone to $60,000 therefore increasing the amount the Company may be required to pay Alkermes to $140,000, however, the amendment spread the payments of the development milestone over a seven-year period. In addition, the Company amended the warrant agreement with Alkermes, which decreased the exercise price of the warrant to $8.26 per share. Based on the amended terms of the Alkermes agreement, the contingent consideration consists of four separate components. The first component is (i) a $5,000 payment made in the first quarter of 2019 and (ii) a $5,000 payment due in the second quarter of 2019. The second components will be payable upon certain regulatory approval and include (i) a $5,000 payment due within 180 days following regulatory approval for IV meloxicam and (ii) $45,000 payable in seven equal annual payments of approximately $6,400 beginning on the first anniversary of such approval. The third 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 fourth 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. During the three months ended March 31, 2019, the Company paid the first milestone payment of $5,000 to Alkermes. The fair value of the remaining first and second contingent consideration components is estimated by applying a risk-adjusted discount rate to the probability-adjusted contingent payments and the expected approval dates. The fair value of the third contingent consideration component is 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 fourth contingent consideration component is estimated by applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections and the defined royalty percentage. These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs. The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair value through the results of operations. |
NMBA Related License Agreement
NMBA Related License Agreement | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
NMBA Related License Agreement | (5) NMBA Related License Agreement In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBAs, and a proprietary reversal agent from Cornell University, or Cornell. The NMBAs and reversal agent are referred to herein as the NMBA Related Compounds. The NMBA Related Compounds include one novel intermediate-acting NMBA that has initiated Phase I clinical trials and two other agents, a novel short-acting NMBA, and a rapid-acting reversal agent specific to these NMBAs. 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. In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the NMBA Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each NMBA, 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 NMBA Related Compounds at a rate ranging from low to mid-single digits, depending on the applicable NMBA 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 NMBA 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 NMBA 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 NMBA 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 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2019 | |
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 • 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, 2018: Assets: Cash equivalents (See Note 7) Money market mutual funds $ 24,720 $ — $ — Commercial paper — 2,247 — U.S. Treasury obligations 2,748 — $ — Total cash equivalents $ 27,468 $ 2,247 $ — Liabilities: Warrants (See Note 14(d)) $ — $ — $ 1,101 Contingent consideration (See Note 4) — — 90,912 $ — $ — $ 92,013 At March 31, 2019: Assets: Cash equivalents (See Note 7) Money market mutual funds $ 6,672 $ — $ — U.S. Treasury obligations 9,985 — — Commercial Paper — 9,616 — Total cash equivalents $ 16,657 $ 9,616 $ — Short-term investments (See Note 7) U.S. Treasury obligations $ 2,492 $ — $ — Commercial Paper — 9,542 — Total financial assets $ 19,149 $ 19,158 $ — Liabilities: Warrants (See Note 14(d)) $ — $ — $ 838 Contingent consideration (See Note 4) — — 70,820 $ — $ — $ 71,658 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, 2018 $ 1,101 $ 90,912 Additions — — Payment of contingent consideration — (5,000 ) Remeasurement (263 ) (15,092 ) Total at March 31, 2019 $ 838 $ 70,820 Current portion as of March 31, 2019 — 5,235 Long-term portion as of March 31, 2019 838 65,585 The current portion of the contingent consideration approximates the probability adjusted fair value amount that the Company currently expects to become payable within one year as of March 31, 2019 (see Note 4 for additional information). The Company plans to continue to reevaluate this classification and measurement as it progresses through discussions with the FDA regarding IV meloxicam. The Company follows the disclosure provisions of FASB ASC Topic 825, “ Financial Instruments |
Cash Equivalents and Short-term
Cash Equivalents and Short-term Investments | 3 Months Ended |
Mar. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Cash Equivalents and Short-term Investments | (7) Cash Equivalents and Short-term Investments Cash equivalents and short-term investments as of March 31, 2019 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 their original maturity of three months or less when acquired. In accordance with FASB ASC Topic 320, “ Investments – Debt and Equity Securities March 31, 2019 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 6,672 $ — $ — $ 6,672 U.S. Treasury obligations 12,477 — — 12,477 Commercial Paper 19,159 — (1 ) 19,158 Total investments $ 38,308 $ — $ (1 ) $ 38,307 December 31, 2018 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 24,720 $ — $ — $ 24,720 Commercial paper 2,247 — — 2,247 U.S. Treasury obligations 2,747 1 — 2,748 Total investments $ 29,714 $ 1 $ — $ 29,715 As of March 31, 2019, the Company’s investments had maturities ranging from two to four months. As of December 31, 2018, all of the Company’s investments 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, 2019 As of March 31, 2019, there were six investments with unrealized losses. March 31, 2019 March 31, 2019 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
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 within the Research and development line in the Consolidated Statements of Operations and Comprehensive Loss until 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, 2019 and December 31, 2018: March 31, 2019 December 31, 2018 Raw materials $ 2,748 $ 2,611 Work in process 5,027 4,935 Finished goods 3,234 3,440 11,009 10,986 Provision for inventory obsolescence (841 ) (287 ) $ 10,168 $ 10,699 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, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | (9) Property, Plant and Equipment Property, plant and equipment consists of the following: March 31, 2019 December 31, 2018 Land $ 3,263 $ 3,263 Building and improvements 19,079 17,880 Furniture, office and computer equipment 7,480 7,226 Manufacturing equipment 30,826 30,197 Construction in progress 6,418 6,078 67,066 64,644 Less: accumulated depreciation and amortization 20,444 19,004 Property, plant and equipment, net $ 46,622 $ 45,640 Depreciation expense for the three months ended March 31, 2019 and 2018 was $1,440 and $1,216, respectively. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | (10) Intangible Assets The following represents the balance of the intangible assets at March 31, 2019: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 10,280 $ 5,220 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 10,280 $ 31,620 The following represents the balance of intangible assets at December 31, 2018: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 9,634 $ 5,866 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 9,634 $ 32,266 Amortization expense for each of the three months ended March 31, 2019 and 2018 was $646. As of March 31, 2019, future amortization expense is as follows: Amortization 2019 $ 1,937 2020 2,583 2021 700 Total $ 5,220 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 2018 Clinical trial and related costs $ 1,015 $ 683 Professional and consulting fees 1,196 672 Payroll and related costs 2,840 4,782 Property, plant and equipment 1,200 1,737 Deferred revenue 548 66 Pre-commercialization scale-up costs 1,337 4,445 Other research and development costs 557 678 Other 1,444 1,102 $ 10,137 $ 14,165 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | (12) Long-Term Debt On November 17, 2017, the Company entered into a $100,000 Credit Agreement, or the Credit Agreement, with Athyrium Opportunities III Acquisition LP, or Athyrium. The Credit Agreement provided for a term loan in the original principal amount of $60,000 funded at closing. In December 2018, the Company amended the Credit Agreement, (as amended, the “Amended Credit Agreement”). Pursuant to the Amended Credit Agreement, the $20,000 term B loan and $20,000 term C loan provided for under the Credit Agreement, which were contingent on the Company receiving approval of IV meloxicam by December 31, 2018, were restructured into (i) a $10,000 term B-1 loan, funded on December 28, 2018; (ii) a $15,000 term B-2 loan; and (iii) a $15,000 term C loan. On February 28, 2019, the Company entered into a Second Amendment to Credit Agreement (the “Second Amendment”) with Athyrium. Pursuant to the Second Amendment, (i) the total commitments of the term loan credit facility governed by the Amended Credit Agreement was increased from $100,000 to $125,000, (ii) the $15,000 term B-2 loan and $15,000 term C loan provided for under the Amended Credit Agreement were restructured into a $55,000 term B-2 loan, which was funded on the date of execution of the Second Amendment and (iii) the maturity date was extended to March 31, 2023 (the “Maturity Date”). Beginning on March 31, 2021, the Company must repay the outstanding principal amount in quarterly installments of $3,000 with the outstanding principal balance due on the Maturity Date. 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. In addition, in accordance with the Credit Agreement the Company will have to pay a 1% exit fee, which is $1,250 at the current outstanding loan balance and is being 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 beginning with a 10% penalty and including a make-whole interest payment. No prepayment penalties are assessed for payments made after March 31, 2022. The Amended 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, 2019, the Company was in compliance with the covenants. As of March 31, 2019, the remaining payments due under the Amended Credit Agreement include a principal payment of $125,000 and an exit fee of $1,250 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. In connection with the Amended Credit Agreement, the warrants were amended to decrease the exercise price to $6.84 per share. and revaluation adjustment from the repricing of the warrants In addition, the Company recorded debt issuance costs for the Amended Credit Agreement at original signing, an amendment fee of $500 as well as certain other fees and expenses in December 2018, and recorded debt issuance costs for the Second Amendment of $2,500 amendment fee, $436 closing fee and $11,400 original issue discount which, along with the fair value of warrants, are being amortized using the effective interest method over the term of the Second Amendment. The components of the carrying value of the debt as of March 31, 2019, are detailed below: Principal balance outstanding $ 125,000 Unamortized deferred issuance costs (19,251 ) Exit fee accretion 190 Total $ 105,939 The Company recorded debt issuance cost amortization related to the credit agreements of $978 and $329 for the three months ended March 31, 2019 and 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
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 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 ($22,995 as of March 31, 2019) 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, 2019, 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 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 ($13,685 as of March 31, 2019) 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, 2019, no such milestones have been achieved. The Company is party to a license agreement with Cornell for the exclusive license of the NMBA 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 and subsequent amendment governing the Gainesville Transaction, the Company agreed to pay to Alkermes up to an additional $140,000 in milestone payments including $50,000 , 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). As of March 31, 2019, the Company has paid $5,000 in milestone payments to Alkermes 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. On May 31, 2018, a securities class action lawsuit was filed against the Company and certain of its officers and directors in the U.S. District Court for the Eastern District of Pennsylvania (Case No. 2:18-cv-02279-MMB) that purported to state a claim for alleged violations of Section 10(b) and 20(a) of the Exchange Act and Rule 10(b)(5) promulgated thereunder, based on statements made by the Company concerning the NDA for IV meloxicam. The complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, lead plaintiff filed an amended complaint that asserted the same claims and sought the same relief but included new allegations and named additional officers and directors as defendants. On February 8, 2019, the Company filed a motion to dismiss the amended complaint in its entirety, which the lead plaintiff opposed on April 9, 2019. On May 9, 2019, the Company filed its response and briefing was completed on the motion to dismiss. No hearing date has been set. The Company believes that the lawsuit is without merit and intends to vigorously defend against it. The lawsuit is in the early stages and, at this time, no assessment can be made as to its likely outcome or whether the outcome will be material to the Company. (d) Leases The Company is a party to various operating leases in Malvern, Pennsylvania, Gainesville, Georgia and Dublin, Ireland for office, manufacturing, and chemistry, manufacturing and controls development space. The Company is also a party to leases for office equipment and storage. The Company determines if an arrangement is a lease at inception. The arrangement is a lease if it conveys the right to the Company to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Lease terms vary based on the nature of operations, however, all leased facilities are classified as operating leases with remaining lease terms between 1 and 6 years. Most leases contain specific renewal options where notice to renew must be provided in advance of lease expiration or automatic renewals where no advance notice is required. Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. Costs determined to be variable and not based on an index or rate were not included in the measurement of operating lease liabilities. As most leases do not provide an implicit rate, the Company's effective interest rate was used to discount its lease liabilities. The Company’s leases with an initial term of 12 months or less that do not have a purchase option or extension that is reasonably certain to be exercised are not included in the right of use asset or lease liability on the Consolidated Balance Sheets. Lease expense is recognized on a straight-line basis over the lease term . As of March 31, 2019, undiscounted future lease payments for non-cancellable operating leases are as follows: Lease payments 2019 $ 557 2020 601 2021 523 2022 529 2023 156 2024 and thereafter 247 Total lease payments 2,613 Less imputed interest (841 ) Total operating liabilities $ 1,772 As of December 31, 2018 under legacy ASC 840 “ Leases Lease payments 2019 $ 781 2020 613 2021 523 2022 529 2024 and thereafter 403 Total $ 2,849 For the three months ended March 31, 2019, the weighted average remaining lease term was 4 years and the weighted average discount rate was 16%. The components of the Company’s lease cost were as follows for the three months ended March 31, 2019: Operating lease cost $ 184 Short-term lease cost 15 Variable lease cost 8 Total lease cost $ 207 (e) Purchase Commitments As of March 31, 2019, the Company had outstanding non-cancelable and cancelable purchase commitments in the aggregate amount of $17,404 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, 2019, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $748, from that date through calendar year 2019. |
Capital Structure
Capital Structure | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Capital Structure | (14) Capital Structure (a) Common Stock The Company is authorized to issue up to 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 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 expenses, 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 certain 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 discounts, 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 discounts, 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, 2019, 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 2018 Purchase Agreement, with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth in the 2018 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 2018 Purchase Agreement. On the execution of the 2018 Purchase Agreement, the Company agreed to issue 33,040 shares of common stock to Aspire Capital as consideration for entering into the 2018 Purchase Agreement. As of March 31, 2019, the Company sold 1,950,000 shares of common stock under the 2018 Purchase Agreement for proceeds of $16,999, at an average per share price of $8.72 On February 19, 2019, the Company entered into a common stock purchase agreement, or the 2019 Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth in the 2019 Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate of $20,000 of its shares of common stock over the approximately 30-month term of the 2019 Purchase Agreement. On the execution of the 2019 Purchase Agreement, the Company agreed to issue 34,762 shares of common stock to Aspire Capital as consideration for entering into the 2019 Purchase Agreement. As of March 31, 2019, the Company did not have any sales of common stock under the 2019 Purchase Agreement. (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, 2019, no preferred stock was issued or outstanding. (d) Warrants As of March 31, 2019, 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 350,000 $ 8.26 April 2022 348,664 $ 6.84 November 2024 The warrant to purchase 348,664 shares related to Athyrium is equity classified. During March 2019, the warrant to purchase 140,000 shares originally issued to Aegis Capital Corporation, which was equity classified, was forfeited upon expiration. The warrant to purchase 350,000 shares related to Alkermes is liability classified since they contain a contingent net cash settlement feature. The fair value of the 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 the liability classified warrants. March 31, 2019 December 31, 2018 Fair value $ 838 $ 1,101 Expected dividend yield — % — % Expected volatility 75 % 69 % Risk-free interest rates 2.21 % 2.49 % Remaining contractual term 3.00 years 3.25 years In April 2015, the Company issued a warrant to purchase 294,928 shares of common stock at an exercise price of $3.28 per share to OrbiMed in connection with the OrbiMed Credit Agreement, which was liability classified. In April 2018, the warrant was exercised on a cashless basis, with OrbiMed surrendering 80,213 shares to cover the aggregate exercise price, resulting in the issuance of 214,715 shares of common stock based on the closing bid price of the Company’s common stock on April 27, 2018 of $12.06. |
Comprehensive Loss
Comprehensive Loss | 3 Months Ended |
Mar. 31, 2019 | |
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 for the three months ended March 31, 2019 and 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, 2019 and 2018 was $1,978 and $12,455, respectively. There was no tax effect of other comprehensive loss for the three months ended March 31, 2019 and 2018. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
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 allowed 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, 2019, 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. This plan expired in 2018. 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, 2019, 2,106,861 shares are available for future grants under the A&R Plan. The weighted average grant-date fair value of the options awarded to employees during the three months ended March 31, 2019 and 2018 was $5.51 and $6.08, 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, 2019 2018 Range of expected option life 6 years 6 years Expected volatility 79.11% - 81.54% 74.01% - 74.60% Risk-free interest rate 2.27 - 2.66% 2.32 - 2.73% Expected dividend yield — — The following table summarizes stock option activity during the three months ended March 31, 2019: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2018 3,775,065 $ 7.62 7.4 years Granted 1,312,935 7.91 Exercised (29,750 ) 6.23 Expired/forfeited/cancelled (8,758 ) 8.08 Balance, March 31, 2019 5,049,492 $ 7.70 7.8 years Vested 2,454,131 $ 7.34 6.6 years Vested and expected to vest 5,049,492 $ 7.70 7.8 years Included in the table above are 980,000 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). The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2019. Number of shares Balance, December 31, 2018 1,103,396 Granted 687,001 Vested and settled (369,646 ) Expired/forfeited/cancelled (220,581 ) Balance, March 31, 2019 1,200,170 Expected to vest 900,220 Included in the table above are 47,000 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 January 2019, the Company granted 1,184,655 stock options at a price of $7.99 per share, as well as 328,985 time-based RSUs, which vest over four years, and 299,950 performance-based RSUs, which may vest based on attaining 2019 financial, clinical and operational goals. Stock-based compensation expense for the three months ended March 31, 2019 and 2018 was $2,826 and $1,584, respectively. As of March 31, 2019, there was $19,769 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, 2019, there was $2,397 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, 2019, the aggregate intrinsic value of the vested and unvested options was $1,477 and $16, respectively. As a result of the Company’s reduction in workforce announced in April 2019, the Company expects approximately 1,200,000 shares related to stock options and RSUs to be affected, of which approximately 900,000 shares are expected to be cancelled upon termination and 300,000 shares will be cancelled if not exercised within the exercisable period in the termination agreements. |
Segment Reporting
Segment Reporting | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Reporting | (17) Segment Reporting The Company operates through two business segments that are treated as separate financial segments: a revenue-generating CDMO segment and an Acute Care segment. 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. and its costs historically have consisted 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. Following the receipt of the second CRL for IV meloxicam, the Company announced a strategic restructuring initiative that will reduce the Acute Care operating expenses, including the reduction of staff of approximately 50 employees. CDMO revenue streams are derived from manufacturing, royalty and profit-sharing 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, 2019: For the Three Months Ended March 31, 2019 2018 Revenues: CDMO $ 25,065 $ 19,542 Acute Care — — Total $ 25,065 $ 19,542 Operating income (loss): CDMO $ 9,066 $ 6,566 Acute Care (7,416 ) (19,413 ) Total $ 1,650 $ (12,847 ) Depreciation and amortization: CDMO $ 1,963 $ 1,819 Acute Care 123 43 Total $ 2,086 $ 1,862 Capital expenditures: CDMO $ 2,655 $ 329 Acute Care 277 1,325 Total $ 2,932 $ 1,654 March 31, December 31, 2019 2018 Total goodwill: CDMO $ 4,319 $ 4,319 Acute Care 2,127 2,127 Total $ 6,446 $ 6,446 Total assets: CDMO $ 96,203 $ 87,879 Acute Care 84,815 67,614 Total $ 181,018 $ 155,493 |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2019 | |
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. 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. 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 $5,108 and $5,201 at March 31, 2019 and December 31, 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, 2019, actual net product sale amounts reported by the Company’s commercial partner exceeded estimates of royalty amounts attributed to manufactured product shipped as of December 31, 2018 for the related arrangements by approximately $670. The following table presents changes in the Company’s contract assets for the three months ended March 31, 2019: Contract asset, beginning of year $ 5,201 Change in estimate arising from changes in transaction price 670 Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional (6,905 ) Contract assets recognized 6,142 Contract asset, end of period $ 5,108 The following table disaggregates revenue by business segment and timing of revenue recognition: Three Months Ended March 31, 2019 Point in time Over time Total CDMO $ 24,444 $ 621 $ 25,065 Acute Care — — — Revenue 24,444 621 25,065 Three Months Ended March 31, 2018 Point in time Over time 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, 2019 | |
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 both regulatory and supply chain project support and consultancy. In consideration for such services, the Company recorded $75 and $109 for the three months ended March 31, 2019 and 2018, respectively. A portion of the amount relates to consultancy services provided by the Non-Executive Director. |
Retirement Plan
Retirement Plan | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 and 2018 were $396 and $390, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | (21) Subsequent Events On April 3, 2019, the Company implemented a strategic restructuring initiative, and corresponding reduction in workforce, aimed at reducing operating expenses, while maintaining key personnel needed to select a partner and obtain FDA approval of IV meloxicam. The Company is taking this action following its receipt of a CRL from the FDA regarding the Company’s NDA for IV meloxicam. The restructuring initiative includes a reduction of a majority of the Company’s Acute Care Segment workforce by approximately 50 positions. The Company estimates that it will incur approximately $4,000 of costs in connection with the reduction in workforce related to severance pay and other related termination benefits. The Company communicated the workforce reduction on April 3, 2019 and expects the majority of the costs to be incurred during the quarter ending June 30, 2019. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2019. 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, 2018 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018. |
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 represent 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 costs 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 |
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 one-step method for determining impairment. The one-step quantitative test calculates the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. 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 judgment is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing and 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 for our CDMO segment 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 primarily concentrated amongst four 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 98% of its revenues for three months ended March 31, 2019. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the United States. |
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. The Company accounts for forfeitures as they occur. 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 our 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 . For non-employee stock-based awards, 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 basis, operating losses 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 Loss 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 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. Dilutive common stock equivalents for the three months ended March 31, 2019 include warrants using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. For the three months ended March 31, 2018, 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. The following table sets forth the computation of basic and diluted loss per share: Three Months Ended March 31, 2019 2018 Basic Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Net loss per share of common stock, basic $ (0.09 ) $ (0.65 ) Diluted Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Add change in warrant valuation (263 ) — Diluted net loss $ (2,240 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Add shares from outstanding warrants 60,431 — Weighted average common shares outstanding, diluted 21,978,606 19,219,257 Net loss per share of common stock, diluted $ (0.10 ) $ (0.65 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2019 and 2018, as they would be anti-dilutive: March 31, 2019 2018 Options and restricted stock units outstanding 6,249,662 4,973,043 Warrants 698,664 1,133,592 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 CDMO and Acute Care 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 (expense). Segment assets are those assets and liabilities that are recorded and reported by segment operations . |
Recent Accounting Pronouncements | (n) Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2018, the FASB issued ASU No. 2018-07, “ Compensation – Stock Compensation (Topic 718) Compensation—Stock Compensation Equity-Based Payments to Non-Employees Revenue from Contracts with Customers (Topic 606) . 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) Targeted Improvements 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 that 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 Note 18 for additional information on the impact of the transition on the Company’s financial statements. Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, Fair Value Measurement |
Summary of Significant Accoun_3
Summary of Significant Accounting Principles (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 2018 Basic Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Net loss per share of common stock, basic $ (0.09 ) $ (0.65 ) Diluted Loss Per Share Net loss $ (1,977 ) $ (12,455 ) Add change in warrant valuation (263 ) — Diluted net loss $ (2,240 ) $ (12,455 ) Weighted average common shares outstanding, basic 21,918,175 19,219,257 Add shares from outstanding warrants 60,431 — Weighted average common shares outstanding, diluted 21,978,606 19,219,257 Net loss per share of common stock, diluted $ (0.10 ) $ (0.65 ) |
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, 2019 and 2018, as they would be anti-dilutive: March 31, 2019 2018 Options and restricted stock units outstanding 6,249,662 4,973,043 Warrants 698,664 1,133,592 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2018: Assets: Cash equivalents (See Note 7) Money market mutual funds $ 24,720 $ — $ — Commercial paper — 2,247 — U.S. Treasury obligations 2,748 — $ — Total cash equivalents $ 27,468 $ 2,247 $ — Liabilities: Warrants (See Note 14(d)) $ — $ — $ 1,101 Contingent consideration (See Note 4) — — 90,912 $ — $ — $ 92,013 At March 31, 2019: Assets: Cash equivalents (See Note 7) Money market mutual funds $ 6,672 $ — $ — U.S. Treasury obligations 9,985 — — Commercial Paper — 9,616 — Total cash equivalents $ 16,657 $ 9,616 $ — Short-term investments (See Note 7) U.S. Treasury obligations $ 2,492 $ — $ — Commercial Paper — 9,542 — Total financial assets $ 19,149 $ 19,158 $ — Liabilities: Warrants (See Note 14(d)) $ — $ — $ 838 Contingent consideration (See Note 4) — — 70,820 $ — $ — $ 71,658 |
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, 2018 $ 1,101 $ 90,912 Additions — — Payment of contingent consideration — (5,000 ) Remeasurement (263 ) (15,092 ) Total at March 31, 2019 $ 838 $ 70,820 Current portion as of March 31, 2019 — 5,235 Long-term portion as of March 31, 2019 838 65,585 |
Cash Equivalents and Short-te_2
Cash Equivalents and Short-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Cash Equivalents and Available-for-Sale Securities | The following is a summary of available-for-sale securities: March 31, 2019 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 6,672 $ — $ — $ 6,672 U.S. Treasury obligations 12,477 — — 12,477 Commercial Paper 19,159 — (1 ) 19,158 Total investments $ 38,308 $ — $ (1 ) $ 38,307 December 31, 2018 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 24,720 $ — $ — $ 24,720 Commercial paper 2,247 — — 2,247 U.S. Treasury obligations 2,747 1 — 2,748 Total investments $ 29,714 $ 1 $ — $ 29,715 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventory was as follows as of March 31, 2019 and December 31, 2018: March 31, 2019 December 31, 2018 Raw materials $ 2,748 $ 2,611 Work in process 5,027 4,935 Finished goods 3,234 3,440 11,009 10,986 Provision for inventory obsolescence (841 ) (287 ) $ 10,168 $ 10,699 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following: March 31, 2019 December 31, 2018 Land $ 3,263 $ 3,263 Building and improvements 19,079 17,880 Furniture, office and computer equipment 7,480 7,226 Manufacturing equipment 30,826 30,197 Construction in progress 6,418 6,078 67,066 64,644 Less: accumulated depreciation and amortization 20,444 19,004 Property, plant and equipment, net $ 46,622 $ 45,640 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Balance of Intangible Assets | The following represents the balance of the intangible assets at March 31, 2019: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 10,280 $ 5,220 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 10,280 $ 31,620 The following represents the balance of intangible assets at December 31, 2018: Cost Accumulated Amortization Net Intangible Assets Royalties and contract manufacturing relationships $ 15,500 $ 9,634 $ 5,866 In-process research and development 26,400 — 26,400 Total $ 41,900 $ 9,634 $ 32,266 |
Schedule of Future Amortization Expense | As of March 31, 2019, future amortization expense is as follows: Amortization 2019 $ 1,937 2020 2,583 2021 700 Total $ 5,220 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 2018 Clinical trial and related costs $ 1,015 $ 683 Professional and consulting fees 1,196 672 Payroll and related costs 2,840 4,782 Property, plant and equipment 1,200 1,737 Deferred revenue 548 66 Pre-commercialization scale-up costs 1,337 4,445 Other research and development costs 557 678 Other 1,444 1,102 $ 10,137 $ 14,165 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt Balance | The components of the carrying value of the debt as of March 31, 2019, are detailed below: Principal balance outstanding $ 125,000 Unamortized deferred issuance costs (19,251 ) Exit fee accretion 190 Total $ 105,939 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases | As of March 31, 2019, undiscounted future lease payments for non-cancellable operating leases are as follows: Lease payments 2019 $ 557 2020 601 2021 523 2022 529 2023 156 2024 and thereafter 247 Total lease payments 2,613 Less imputed interest (841 ) Total operating liabilities $ 1,772 |
Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases under Legacy ASC 840 | As of December 31, 2018 under legacy ASC 840 “ Leases Lease payments 2019 $ 781 2020 613 2021 523 2022 529 2024 and thereafter 403 Total $ 2,849 |
Schedule of Components Least Cost | The components of the Company’s lease cost were as follows for the three months ended March 31, 2019: Operating lease cost $ 184 Short-term lease cost 15 Variable lease cost 8 Total lease cost $ 207 |
Capital Structure (Tables)
Capital Structure (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Purchase Shares of Common Stock | As of March 31, 2019, 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 350,000 $ 8.26 April 2022 348,664 $ 6.84 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 the liability classified warrants. March 31, 2019 December 31, 2018 Fair value $ 838 $ 1,101 Expected dividend yield — % — % Expected volatility 75 % 69 % Risk-free interest rates 2.21 % 2.49 % Remaining contractual term 3.00 years 3.25 years |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019 2018 Range of expected option life 6 years 6 years Expected volatility 79.11% - 81.54% 74.01% - 74.60% Risk-free interest rate 2.27 - 2.66% 2.32 - 2.73% Expected dividend yield — — |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2019: Number of shares Weighted average exercise price Weighted average remaining contractual life Balance, December 31, 2018 3,775,065 $ 7.62 7.4 years Granted 1,312,935 7.91 Exercised (29,750 ) 6.23 Expired/forfeited/cancelled (8,758 ) 8.08 Balance, March 31, 2019 5,049,492 $ 7.70 7.8 years Vested 2,454,131 $ 7.34 6.6 years Vested and expected to vest 5,049,492 $ 7.70 7.8 years |
Summary of Restricted Stock Units Activity | The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2019. Number of shares Balance, December 31, 2018 1,103,396 Granted 687,001 Vested and settled (369,646 ) Expired/forfeited/cancelled (220,581 ) Balance, March 31, 2019 1,200,170 Expected to vest 900,220 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Summary of Segment Information | The following table summarizes segment information as of and for the three months ended March 31, 2019: For the Three Months Ended March 31, 2019 2018 Revenues: CDMO $ 25,065 $ 19,542 Acute Care — — Total $ 25,065 $ 19,542 Operating income (loss): CDMO $ 9,066 $ 6,566 Acute Care (7,416 ) (19,413 ) Total $ 1,650 $ (12,847 ) Depreciation and amortization: CDMO $ 1,963 $ 1,819 Acute Care 123 43 Total $ 2,086 $ 1,862 Capital expenditures: CDMO $ 2,655 $ 329 Acute Care 277 1,325 Total $ 2,932 $ 1,654 March 31, December 31, 2019 2018 Total goodwill: CDMO $ 4,319 $ 4,319 Acute Care 2,127 2,127 Total $ 6,446 $ 6,446 Total assets: CDMO $ 96,203 $ 87,879 Acute Care 84,815 67,614 Total $ 181,018 $ 155,493 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Changes in Contract Assets | The following table presents changes in the Company’s contract assets for the three months ended March 31, 2019: Contract asset, beginning of year $ 5,201 Change in estimate arising from changes in transaction price 670 Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional (6,905 ) Contract assets recognized 6,142 Contract asset, end of period $ 5,108 |
Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition | The following table disaggregates revenue by business segment and timing of revenue recognition: Three Months Ended March 31, 2019 Point in time Over time Total CDMO $ 24,444 $ 621 $ 25,065 Acute Care — — — Revenue 24,444 621 25,065 Three Months Ended March 31, 2018 Point in time Over time Total CDMO $ 19,413 $ 129 $ 19,542 Acute Care — — — Revenue 19,413 129 19,542 |
Background - Additional Informa
Background - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2019Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Entity incorporation date | Nov. 15, 2007 |
Number of operating segments | 2 |
Development-Stage Risks and L_2
Development-Stage Risks and Liquidity - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Business Developments Risks And Uncertainties Liquidity [Abstract] | ||
Accumulated deficit | $ 190,230 | $ 188,253 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2019USD ($)Customer | Jan. 01, 2019USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Goodwill impairment | $ 0 | |
Indefinite-lived intangible assets impairment | 0 | |
Operating lease right-of-use asset | 1,693,000 | |
Operating lease liability | $ 1,772,000 | |
ASU 2016-02 [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease right-of-use asset | $ 1,866,000 | |
Operating lease liability | $ 1,947,000 | |
Accounts Receivable [Member] | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Number of customers | Customer | 4 | |
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 | 98.00% | |
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 Accoun_5
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, 2019 | Mar. 31, 2018 | |
Basic Loss Per Share | ||
Net loss | $ (1,977) | $ (12,455) |
Weighted average common shares outstanding, basic | 21,918,175 | 19,219,257 |
Net loss per share of common stock, basic | $ (0.09) | $ (0.65) |
Diluted Loss Per Share | ||
Net loss | $ (1,977) | $ (12,455) |
Add change in warrant valuation | (263) | |
Diluted net loss | $ (2,240) | $ (12,455) |
Weighted average common shares outstanding, basic | 21,918,175 | 19,219,257 |
Add shares from outstanding warrants | 60,431 | |
Weighted average common shares outstanding, diluted | 21,978,606 | 19,219,257 |
Net loss per share of common stock, diluted | $ (0.10) | $ (0.65) |
Summary of Significant Accoun_6
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
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 | 6,249,662 | 4,973,043 |
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 | 698,664 | 1,133,592 |
Acquisition of Gainesville Fa_2
Acquisition of Gainesville Facility and Meloxicam - Additional Information (Detail) - Gainesville Facility [Member] $ / shares in Units, $ in Thousands | Apr. 10, 2015USD ($)$ / sharesshares | Dec. 31, 2018USD ($)MilestonePayment$ / shares | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) |
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% | |||
Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | ||||
Business Acquisition [Line Items] | ||||
Warrant, exercise price per share | $ / shares | $ 8.26 | |||
Business acquisition contingent consideration possible milestone payments | $ 140,000 | |||
Business acquisition contingent consideration, first milestone payment | $ 5,000 | |||
Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, First Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition contingent consideration, first milestone payment | $ 5,000 | |||
Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, First Component [Member] | Scenario Forecast [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition contingent consideration possible milestone payments | $ 5,000 | |||
Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Third Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Minimum milestone payments percentage | 60.00% | |||
Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Fourth Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Maximum royalty payment percentage | 30.00% | |||
Minimum [Member] | ||||
Business Acquisition [Line Items] | ||||
Future net product sales milestone percentage | 10.00% | |||
Minimum [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Fourth Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Royalty payment percentage | 10.00% | |||
Maximum [Member] | ||||
Business Acquisition [Line Items] | ||||
Future net product sales milestone percentage | 12.00% | |||
Maximum [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Fourth Component [Member] | ||||
Business Acquisition [Line Items] | ||||
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 | $ 60,000 | ||
Development Milestone [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition contingent consideration milestone payments period | 7 years | |||
Milestone Payments Due, Following Regulatory Approval [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Second Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition contingent consideration possible milestone payments | $ 5,000 | |||
Milestone Payments Due, Following Regulatory Approval [Member] | Maximum [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Second Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition, contingent consideration, milestone payments due period following regulatory approval | 180 days | |||
Milestone Payments Due, Beginning on First Anniversary of Regulatory Approval [Member] | Alkermes Plc [Member] | Amendment to Purchase and Sale Agreement [Member] | Contingent Consideration, Second Component [Member] | ||||
Business Acquisition [Line Items] | ||||
Business acquisition contingent consideration possible milestone payments | $ 45,000 | |||
Business acquisition, contingent consideration, number of equal annual milestone payments | MilestonePayment | 7 | |||
Business acquisition, contingent consideration, equal annual milestone payments | $ 6,400 | |||
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 |
NMBA Related License Agreement
NMBA Related License Agreement - Additional Information (Detail) - Cornell University [Member] - Neuromuscular Blocking Agents License Agreement [Member] | 1 Months Ended |
Jun. 30, 2017USD ($) | |
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 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Total financial assets | $ 38,307 | $ 29,715 |
Fair Value, Measurements, Recurring [Member] | ||
Liabilities: | ||
Warrants | 838 | 1,101 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Assets: | ||
Total cash equivalents | 16,657 | 27,468 |
Total financial assets | 19,149 | |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Mutual Funds [Member] | ||
Assets: | ||
Total cash equivalents | 6,672 | 24,720 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Obligations [Member] | ||
Assets: | ||
Total cash equivalents | 9,985 | 2,748 |
Short-term investments | 2,492 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Assets: | ||
Total cash equivalents | 9,616 | 2,247 |
Total financial assets | 19,158 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Assets: | ||
Total cash equivalents | 9,616 | 2,247 |
Short-term investments | 9,542 | |
Fair Value, Measurements, Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Warrants | 838 | 1,101 |
Contingent consideration | 70,820 | 90,912 |
Liabilities | $ 71,658 | $ 92,013 |
Fair Value of Financial Instr_4
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, 2019USD ($) | |
Warrants [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2018 | $ 1,101 |
Remeasurement | (263) |
Total at March 31, 2019 | 838 |
Long-term portion as of March 31, 2019 | 838 |
Contingent Consideration [Member] | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | |
Balance at December 31, 2018 | 90,912 |
Payment of contingent consideration | (5,000) |
Remeasurement | (15,092) |
Total at March 31, 2019 | 70,820 |
Current portion as of March 31, 2019 | 5,235 |
Long-term portion as of March 31, 2019 | $ 65,585 |
Cash Equivalents and Short-te_3
Cash Equivalents and Short-term Investments - Summary of Cash Equivalents and Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 38,308 | $ 29,714 |
Gross Unrealized Gain | 1 | |
Gross Unrealized Loss | (1) | |
Estimated Fair Value | 38,307 | 29,715 |
Money Market Mutual Funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 6,672 | 24,720 |
Estimated Fair Value | 6,672 | 24,720 |
U.S. Treasury Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,477 | 2,747 |
Gross Unrealized Gain | 1 | |
Estimated Fair Value | 12,477 | 2,748 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 19,159 | 2,247 |
Gross Unrealized Loss | (1) | |
Estimated Fair Value | $ 19,158 | $ 2,247 |
Cash Equivalents and Short-te_4
Cash Equivalents and Short-term Investments - Additional Information (Detail) - Investment | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Number of investments with unrealized losses position, less than 12 months | 6 | |
Minimum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Investments maturities period | 2 months | |
Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Investments maturities period | 4 months | 2 months |
Maximum [Member] | U.S. Treasury Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Duration of time, investments in continuous unrealized loss position | 3 months |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,748 | $ 2,611 |
Work in process | 5,027 | 4,935 |
Finished goods | 3,234 | 3,440 |
Inventory | 11,009 | 10,986 |
Provision for inventory obsolescence | (841) | (287) |
Inventory, net | $ 10,168 | $ 10,699 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 67,066 | $ 64,644 |
Less: accumulated depreciation and amortization | 20,444 | 19,004 |
Property, plant and equipment, net | 46,622 | 45,640 |
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 | 19,079 | 17,880 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 7,480 | 7,226 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 30,826 | 30,197 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 6,418 | $ 6,078 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 1,440 | $ 1,216 |
Intangible Assets - Summary of
Intangible Assets - Summary of Balance of Intangible Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Total | $ 41,900 | $ 41,900 |
Accumulated Amortization | 10,280 | 9,634 |
Net Intangible Assets, Total | 31,620 | 32,266 |
Royalties and Contract Manufacturing Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Definite-lived | 15,500 | 15,500 |
Accumulated Amortization | 10,280 | 9,634 |
Net Intangible Assets, Definite-lived | 5,220 | 5,866 |
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, 2019 | Mar. 31, 2018 | |
Intangible Assets Net Excluding Goodwill [Abstract] | ||
Amortization expense | $ 646 | $ 646 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Future Amortization Expense (Detail) - Royalties and Contract Manufacturing Relationships [Member] - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
2019 | $ 1,937 | |
2020 | 2,583 | |
2021 | 700 | |
Total | $ 5,220 | $ 5,866 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Clinical trial and related costs | $ 1,015 | $ 683 |
Professional and consulting fees | 1,196 | 672 |
Payroll and related costs | 2,840 | 4,782 |
Property, plant and equipment | 1,200 | 1,737 |
Deferred revenue | 548 | 66 |
Pre-commercialization scale-up costs | 1,337 | 4,445 |
Other research and development costs | 557 | 678 |
Other | 1,444 | 1,102 |
Total accrued expenses and other current liabilities | $ 10,137 | $ 14,165 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) | Feb. 28, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Nov. 17, 2017 |
Debt Instrument [Line Items] | |||||
Debt instrument, exit fee | $ 190,000 | ||||
Principal balance outstanding | 125,000,000 | ||||
Amortization of debt issuance costs | $ 978,000 | $ 329,000 | |||
Athyrium Opportunities II Acquisition LP | Seven Year Warrant [Member] | |||||
Debt Instrument [Line Items] | |||||
Purchase common stock with warrant issue | 348,664 | ||||
Warrant, exercise price per share | $ 8.6043 | ||||
Warrants, exercisable date | Nov. 17, 2024 | ||||
Athyrium Credit Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 100,000,000 | ||||
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 | ||||
Exit fee percentage | 1.00% | ||||
Debt instrument, exit fee | $ 1,250,000 | $ 1,250,000 | |||
Debt instrument, covenant description | The Amended 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, 2019, the Company was in compliance with the covenants. | ||||
Debt instrument early repayment of prepayment penalty percentage | 10.00% | ||||
Debt instrument, early repayment terms | if there is an early repayment, there is a sliding scale of prepayment penalties beginning with a 10% penalty and including a make-whole interest payment. | ||||
Prepayment penalties assessed for payments after March 31, 2022 | $ 0 | ||||
Principal balance outstanding | 125,000,000 | ||||
Debt issuance costs related to credit agreement | $ 4,439,000 | ||||
Amendment and other fees and expenses | 500,000 | ||||
Athyrium Credit Agreement [Member] | Warrants [Member] | |||||
Debt Instrument [Line Items] | |||||
Initial warrant fair value and revaluation adjustment | $ 2,232,000 | ||||
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] | Term B Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | 20,000,000 | ||||
Athyrium Credit Agreement [Member] | Term C Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 20,000,000 | ||||
Athyrium Amended Credit Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Warrant, exercise price per share | $ 6.84 | ||||
Athyrium Amended Credit Agreement [Member] | Term C Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | 15,000,000 | ||||
Athyrium Amended Credit Agreement [Member] | Term B-1 Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | 10,000,000 | ||||
Athyrium Amended Credit Agreement [Member] | Term B-2 Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 15,000,000 | ||||
Athyrium Existing Credit Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 100,000,000 | ||||
Athyrium Existing Credit Agreement [Member] | Term C Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | 15,000,000 | ||||
Athyrium Existing Credit Agreement [Member] | Term B-2 Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | 15,000,000 | ||||
Athyrium Second Amendment Credit Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Increase in borrowing capacity | $ 125,000,000 | ||||
Debt instrument, extended maturity date | Mar. 31, 2023 | ||||
Debt instrument, quarterly installment outstanding principal payment | $ 3,000,000 | ||||
Debt instrument, date of first required payment | Mar. 31, 2021 | ||||
Debt instrument, frequency of interest payment | quarterly | ||||
Debt issuance costs related to credit agreement | $ 11,400,000 | ||||
Effective interest rate | 16.91% | ||||
Amendment and other fees and expenses | $ 2,500,000 | ||||
Debt instrument closing fee | $ 436,000 | ||||
Athyrium Second Amendment Credit Agreement [Member] | Term B-2 Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 55,000,000 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt Balance (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Principal balance outstanding | $ 125,000 | |
Unamortized deferred issuance costs | (19,251) | |
Exit fee accretion | 190 | |
Total | $ 105,939 | $ 64,243 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - 3 months ended Mar. 31, 2019 | USD ($) | EUR (€) |
Supply Commitment [Line Items] | ||
Lessee, operating lease, option to extend | Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. | Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. |
Lessee, operating lease, existence of option to extend | true | true |
Operating lease, weighted average remaining term | 4 years | |
Operating lease, weighted average discount rate percent | 16.00% | |
Purchase Commitment [Member] | ||
Supply Commitment [Line Items] | ||
Purchase commitment non cancelable and cancelable | $ 17,404,000 | |
Gainesville Facility [Member] | ||
Supply Commitment [Line Items] | ||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 140,000,000 | |
Maximum future net product sales milestone percentage | 30.00% | 30.00% |
Gainesville Facility [Member] | Regulatory Approval and Net Sales Milestones [Member] | ||
Supply Commitment [Line Items] | ||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 50,000,000 | |
Collaborative arrangements, milestone payments period | 7 years | 7 years |
Alkemes [Member] | ||
Supply Commitment [Line Items] | ||
Collaborative Arrangements Milestone Payments upon Achievement of Regulatory and Sales Milestones | $ 5,000,000 | |
Minimum [Member] | ||
Supply Commitment [Line Items] | ||
Operating leases with remaining lease term | 1 year | |
Minimum [Member] | Gainesville Facility [Member] | ||
Supply Commitment [Line Items] | ||
Future net product sales milestone percentage | 10.00% | 10.00% |
Maximum [Member] | ||
Supply Commitment [Line Items] | ||
Operating leases with remaining lease term | 6 years | |
Maximum [Member] | Executive Officer [Member] | ||
Supply Commitment [Line Items] | ||
Aggregate annual base salaries of employment agreement | $ 748,000 | |
Maximum [Member] | Gainesville Facility [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 | $ 22,995,000 | € 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 | $ 13,685,000 | € 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 Contingencies_2
Commitments and Contingencies - Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 557 |
2020 | 601 |
2021 | 523 |
2022 | 529 |
2023 | 156 |
2024 and thereafter | 247 |
Total lease payments | 2,613 |
Less imputed interest | (841) |
Operating lease liability | $ 1,772 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases under Legacy ASC 840 (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 781 |
2020 | 613 |
2021 | 523 |
2022 | 529 |
2024 and thereafter | 403 |
Lease payments, Total | $ 2,849 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Components Least Cost (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 184 |
Short-term lease cost | 15 |
Variable lease cost | 8 |
Total lease cost | $ 207 |
Capital Structure - Additional
Capital Structure - Additional Information (Detail) - USD ($) | Feb. 19, 2019 | Mar. 02, 2018 | Dec. 29, 2017 | Dec. 16, 2016 | Aug. 19, 2016 | Jul. 07, 2015 | Feb. 02, 2015 | Mar. 12, 2014 | Mar. 31, 2019 | Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2018 | Apr. 27, 2018 | Apr. 30, 2015 |
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Common stock, shares authorized to issue | 50,000,000 | 50,000,000 | 50,000,000 | |||||||||||||
Common stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||||||
Common stock issuance | $ 301,000 | $ 3,802,000 | ||||||||||||||
Proceeds from sale of common stock, net of transaction costs | 3,514,000 | |||||||||||||||
Stock issued at fair value | $ 301,000 | $ 357,000 | ||||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||||||
Preferred stock, shares issued | 0 | 0 | 0 | |||||||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||||||||||
Common Stock [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Common stock issuance, shares | 34,762 | 383,040 | ||||||||||||||
Common stock issuance | $ 4,000 | |||||||||||||||
Warrants, Exercise Price $6.84, Expiring on November 2024 [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Warrants outstanding to purchase shares, Number of Shares | 348,664 | 348,664 | ||||||||||||||
Warrants, Exercise Price $12.00, Expiring on March 2019 [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Warrant to purchase shares forfeited upon expiration | 140,000 | |||||||||||||||
Warrants, Exercise Price $8.26, Expiring on April 2022 [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Warrants outstanding to purchase shares, Number of Shares | 350,000 | 350,000 | ||||||||||||||
Warrant, exercise price per share | $ 8.26 | $ 8.26 | ||||||||||||||
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 | 34,762 | 33,040 | 96,463 | 1,950,000 | 1,143,940 | |||||||||||
Common stock issuance | $ 7,796,000 | |||||||||||||||
Common stock issuance price | $ 8.72 | $ 8.72 | ||||||||||||||
Proceeds from sale of common stock, net of transaction costs | $ 16,999,000 | |||||||||||||||
Term of purchase agreement | 30 months | 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 | $ 20,000,000 | $ 10,000,000 | |||||||||||||
Alkermes Plc [Member] | Warrants, Exercise Price $8.26, Expiring on April 2022 [Member] | Liability Contingent Net Cash Settlement Feature [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Warrants outstanding to purchase shares, Number of Shares | 350,000 | 350,000 | ||||||||||||||
OrbiMed [Member] | Common Stock [Member] | ||||||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||||||
Warrant to purchase shares of common stock | 294,928 | |||||||||||||||
Warrant, exercise price per share | $ 3.28 | |||||||||||||||
Common stock warrants repurchase | 80,213 | |||||||||||||||
Cashless warrants exercised for shares of common stock | 214,715 | |||||||||||||||
Common stock share price | $ 12.06 | |||||||||||||||
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, 2019$ / sharesshares | |
Warrants, Exercise Price $8.26, 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 | $ 8.26 |
Warrants outstanding to purchase shares, Expiration Date | 2022-04 |
Warrants, Exercise Price $6.84, 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 | $ 6.84 |
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) $ in Thousands | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Warrants and Rights Outstanding, Type [Extensible List] | reph:BlackScholesOptionPricingModelMember | reph:BlackScholesOptionPricingModelMember |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Fair value | $ 838 | $ 1,101 |
Expected Volatility [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Estimated fair value assumptions | 75 | 69 |
Risk-Free Interest Rates [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Estimated fair value assumptions | 2.21 | 2.49 |
Remaining Contractual Term [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Remaining contractual term | 3 years | 3 years 3 months |
Comprehensive Income_Loss - Add
Comprehensive Income/Loss - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Comprehensive Income Net Of Tax [Abstract] | ||
Total comprehensive loss | $ 1,978,000 | $ 12,455,000 |
Tax effect of other comprehensive loss | $ 0 | $ 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||||
Apr. 30, 2019 | Jan. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | May 31, 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 | $ 5.51 | $ 6.08 | |||||||
Number of options, Granted | 1,184,655 | ||||||||
Stock option price per share | $ 7.99 | $ 7.91 | |||||||
Stock-based compensation | $ 2,826 | $ 1,584 | |||||||
Aggregate intrinsic value of vested options | 1,477 | ||||||||
Aggregate intrinsic value of unvested options | $ 16 | ||||||||
Stock Options Granted Outside Plan [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of options, Granted | 980,000 | ||||||||
Time-based RSUs Granted Outside Plan [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of restricted stock units granted | 47,000 | ||||||||
Performance-based RSUs [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of restricted stock units granted | 299,950 | ||||||||
Unrecognized compensation expense related to unvested performance RSUs, expected to vest | $ 2,397 | ||||||||
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 | 328,985 | ||||||||
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 | $ 19,769 | ||||||||
Stock Options and RSUs [Member] | Subsequent Event [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Cancellation of shares | 1,200,000 | ||||||||
Cancellation upon termination, shares | 900,000 | ||||||||
Cancellation if not exercised within the exercisable period, shares | 300,000 | ||||||||
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 | ||||||||
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 | 2,000,000 | ||||||||
Percentage of outstanding common stock | 5.00% | 5.00% | |||||||
Increase in share per "Evergreen" provision | 1,082,972 | 956,341 | |||||||
Shares available for grant | 2,106,861 | 8,119,709 |
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, 2019 | Mar. 31, 2018 | |
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 | 79.11% | 74.01% |
Risk-free interest rate | 2.27% | 2.32% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 81.54% | 74.60% |
Risk-free interest rate | 2.66% | 2.73% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Jan. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of shares, beginning balance | 3,775,065 | 3,775,065 | |
Number of shares, Granted | 1,312,935 | ||
Number of shares, Exercised | (29,750) | ||
Number of shares, Expired/forfeited/cancelled | (8,758) | ||
Number of shares, ending balance | 5,049,492 | 3,775,065 | |
Number of shares, Vested | 2,454,131 | ||
Number of shares, Vested and expected to vest | 5,049,492 | ||
Weighted average exercise price, beginning balance | $ 7.62 | $ 7.62 | |
Weighted average exercise price, Granted | $ 7.99 | 7.91 | |
Weighted average exercise price, Exercised | 6.23 | ||
Weighted average exercise price, Expired/forfeited/cancelled | 8.08 | ||
Weighted average exercise price, ending balance | 7.70 | $ 7.62 | |
Weighted average exercise price, Vested | 7.34 | ||
Weighted average exercise price, Vested and expected to vest | $ 7.70 | ||
Weighted average remaining contractual life | 7 years 9 months 18 days | 7 years 4 months 24 days | |
Weighted average remaining contractual life, Vested | 6 years 7 months 6 days | ||
Weighted average remaining contractual life, Vested and expected to vest | 7 years 9 months 18 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units [Member] | 3 Months Ended |
Mar. 31, 2019shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares, beginning balance | 1,103,396 |
Number of shares, Granted | 687,001 |
Number of shares, Vested and settled | (369,646) |
Number of shares, Expired/forfeited/cancelled | (220,581) |
Number of shares, ending balance | 1,200,170 |
Number of shares, Expected to vest | 900,220 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2019USD ($)SegmentEmployee | |
Segment Reporting Information [Line Items] | |
Number of business segments | Segment | 2 |
Acute Care [Member] | |
Segment Reporting Information [Line Items] | |
Revenue | $ | $ 0 |
Restructuring initiative, reduction of staff | Employee | 50 |
Segment Reporting - Summary of
Segment Reporting - Summary of Segment Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Segment Reporting Information [Line Items] | |||
Revenue | $ 25,065 | $ 19,542 | |
Operating income (loss) | 1,650 | (12,847) | |
Depreciation and amortization | 2,086 | 1,862 | |
Capital expenditures | 2,932 | 1,654 | |
Total goodwill | 6,446 | $ 6,446 | |
Total assets | 181,018 | 155,493 | |
CDMO [Member] | |||
Segment Reporting Information [Line Items] | |||
Revenue | 25,065 | 19,542 | |
Operating income (loss) | 9,066 | 6,566 | |
Depreciation and amortization | 1,963 | 1,819 | |
Capital expenditures | 2,655 | 329 | |
Total goodwill | 4,319 | 4,319 | |
Total assets | 96,203 | 87,879 | |
Acute Care [Member] | |||
Segment Reporting Information [Line Items] | |||
Operating income (loss) | (7,416) | (19,413) | |
Depreciation and amortization | 123 | 43 | |
Capital expenditures | 277 | $ 1,325 | |
Total goodwill | 2,127 | 2,127 | |
Total assets | $ 84,815 | $ 67,614 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |||
Contract asset | $ 5,108 | $ 5,201 | $ 5,201 |
Contract asset, increase in estimates arising from changes in transaction price | $ 670 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Changes in Contract Assets (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |||
Contract asset | $ 5,108 | $ 5,201 | $ 5,201 |
Change in estimate arising from changes in transaction price | 670 | ||
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional | (6,905) | ||
Contract assets recognized | $ 6,142 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 25,065 | $ 19,542 |
CDMO [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 25,065 | 19,542 |
Point In Time [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 24,444 | 19,413 |
Point In Time [Member] | CDMO [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 24,444 | 19,413 |
Overtime [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 621 | 129 |
Overtime [Member] | CDMO [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 621 | $ 129 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Managing Director [Member] - Irish Subsidiary [Member] - HiTech Health [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Related Party Transaction [Line Items] | ||
Related party transaction expenses | $ 75 | $ 109 |
Service agreement date | 2017-11 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
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 | $ 396 | $ 390 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Employee Severance [Member] - Subsequent Event [Member] $ in Thousands | Apr. 03, 2019USD ($)Position |
Subsequent Event [Line Items] | |
Restructuring initiative, reduction of staff | Position | 50 |
Expected costs in connection with reduction in workforce | $ | $ 4,000 |