Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | Recro Pharma, Inc. | |
Entity Central Index Key | 0001588972 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 46,515,916 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Trading Symbol | REPH | |
Entity File Number | 001-36329 | |
Entity Tax Identification Number | 26-1523233 | |
Entity Address, Address Line One | 1 E. Uwchlan Ave, Suite 112 | |
Entity Address, City or Town | Exton | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19341 | |
City Area Code | 770 | |
Local Phone Number | 534-8239 | |
Entity Incorporation, State or Country Code | PA | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, par value $0.01 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 45,724 | $ 23,760 |
Accounts receivable | 12,813 | 9,033 |
Contract asset | 7,350 | 7,330 |
Inventory | 7,878 | 11,612 |
Prepaid expenses and other current assets | 2,028 | 2,334 |
Total current assets | 75,793 | 54,069 |
Property, plant and equipment, net | 41,867 | 43,841 |
Intangible assets, net | 700 | |
Goodwill | 4,319 | 4,319 |
Other assets | 451 | 486 |
Total assets | 122,430 | 103,415 |
Current liabilities: | ||
Accounts payable | 1,155 | 1,804 |
Current portion of debt | 1,474 | |
Accrued expenses and other current liabilities | 4,148 | 4,525 |
Total current liabilities | 5,303 | 7,803 |
Debt, net | 89,780 | 108,097 |
Other liabilities | 931 | 1,615 |
Total liabilities | 96,014 | 117,515 |
Commitments and contingencies (note 8) | ||
Shareholders’ deficit: | ||
Preferred stock, $0.01 par value. 10,000,000 shares authorized, none issued or outstanding | ||
Common stock, $0.01 par value. 50,000,000 shares authorized, 31,013,319 and 28,601,358 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 465 | 286 |
Additional paid-in capital | 265,862 | 219,998 |
Accumulated deficit | (239,911) | (234,384) |
Total shareholders equity (deficit) | 26,416 | (14,100) |
Total liabilities and shareholders equity (deficit) | $ 122,430 | $ 103,415 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 | 95,000,000 | 95,000,000 |
Common stock, shares issued | 46,501,849 | 28,601,358 |
Common stock, shares outstanding | 46,501,849 | 28,601,358 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenue | $ 18,017 | $ 15,522 | $ 34,820 | $ 37,299 |
Operating expenses: | ||||
Cost of sales (excluding amortization of intangible assets) | 12,334 | 11,634 | 26,671 | 29,888 |
Selling, general and administrative | 3,787 | 4,259 | 8,470 | 9,705 |
Amortization of intangible assets | 54 | 646 | 700 | 1,292 |
Total operating expenses | 16,175 | 16,539 | 35,841 | 40,885 |
Operating income (loss) | 1,842 | (1,017) | (1,021) | (3,586) |
Interest expense | (3,960) | (4,995) | (7,858) | (10,118) |
Gain on extinguishment of debt | 3,352 | 3,352 | ||
Net income (loss) | $ 1,234 | $ (6,012) | $ (5,527) | $ (13,704) |
Income (Loss) per share, basic and diluted | $ 0.03 | $ (0.25) | $ (0.16) | $ (0.58) |
Weighted average common shares outstanding, basic | 39,018,730 | 23,577,255 | 34,403,935 | 23,486,011 |
Weighted average common shares outstanding, diluted | 39,352,054 | 23,577,255 | 34,403,935 | 23,486,011 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Deficit (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2019 | $ (6,712) | $ 233 | $ 199,938 | $ (206,883) |
Balance, Shares at Dec. 31, 2019 | 23,312,928 | |||
Stock-based compensation expense | 3,231 | 3,231 | ||
Exercise of stock options, net | (105) | (105) | ||
Exercise of stock options, net, Shares | 37,063 | |||
Vesting of restricted stock units, net | (916) | $ 1 | (917) | |
Vesting of restricted stock units, net, Shares | 105,242 | |||
Net income (loss) | (7,692) | (7,692) | ||
Balance at Mar. 31, 2020 | (12,194) | $ 234 | 202,147 | (214,575) |
Balance, Shares at Mar. 31, 2020 | 23,455,233 | |||
Balance at Dec. 31, 2019 | (6,712) | $ 233 | 199,938 | (206,883) |
Balance, Shares at Dec. 31, 2019 | 23,312,928 | |||
Net income (loss) | (13,704) | |||
Balance at Jun. 30, 2020 | (15,411) | $ 236 | 204,940 | (220,587) |
Balance, Shares at Jun. 30, 2020 | 23,638,906 | |||
Balance at Mar. 31, 2020 | (12,194) | $ 234 | 202,147 | (214,575) |
Balance, Shares at Mar. 31, 2020 | 23,455,233 | |||
Stock-based compensation expense | 2,446 | 2,446 | ||
Exercise of stock options, net | 379 | $ 1 | 378 | |
Exercise of stock options, net, Shares | 105,606 | |||
Vesting of restricted stock units, net | (30) | $ 1 | (31) | |
Vesting of restricted stock units, net, Shares | 78,067 | |||
Net income (loss) | (6,012) | (6,012) | ||
Balance at Jun. 30, 2020 | (15,411) | $ 236 | 204,940 | (220,587) |
Balance, Shares at Jun. 30, 2020 | 23,638,906 | |||
Balance at Dec. 31, 2020 | (14,100) | $ 286 | 219,998 | (234,384) |
Balance, Shares at Dec. 31, 2020 | 28,601,358 | |||
Issuance of common stock, net of costs | 9,340 | $ 22 | 9,318 | |
Issuance of common stock, net of costs, Shares | 2,202,420 | |||
Stock-based compensation expense | 3,133 | 3,133 | ||
Vesting of restricted stock units, net | (336) | $ 2 | (338) | |
Vesting of restricted stock units, net, Shares | 209,541 | |||
Net income (loss) | (6,761) | (6,761) | ||
Balance at Mar. 31, 2021 | (8,724) | $ 310 | 232,111 | (241,145) |
Balance, Shares at Mar. 31, 2021 | 31,013,319 | |||
Balance at Dec. 31, 2020 | (14,100) | $ 286 | 219,998 | (234,384) |
Balance, Shares at Dec. 31, 2020 | 28,601,358 | |||
Net income (loss) | (5,527) | |||
Balance at Jun. 30, 2021 | 26,416 | $ 465 | 265,862 | (239,911) |
Balance, Shares at Jun. 30, 2021 | 46,501,849 | |||
Balance at Mar. 31, 2021 | (8,724) | $ 310 | 232,111 | (241,145) |
Balance, Shares at Mar. 31, 2021 | 31,013,319 | |||
Issuance of common stock, net of costs | 32,103 | $ 153 | 31,950 | |
Issuance of common stock, net of costs, Shares | 15,333,332 | |||
Stock-based compensation expense | 1,929 | 1,929 | ||
Vesting of restricted stock units, net | (126) | $ 2 | (128) | |
Vesting of restricted stock units, net, Shares | 155,198 | |||
Net income (loss) | 1,234 | 1,234 | ||
Balance at Jun. 30, 2021 | $ 26,416 | $ 465 | $ 265,862 | $ (239,911) |
Balance, Shares at Jun. 30, 2021 | 46,501,849 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities, continuing operations: | ||
Net loss | $ (5,527) | $ (13,704) |
Adjustments to reconcile net loss to net cash provided by operating activities, continuing operations: | ||
Stock-based compensation expense | 5,062 | 5,677 |
Non-cash interest expense | 3,080 | 2,919 |
Depreciation expense | 3,033 | 3,008 |
Amortization of intangible assets | 700 | 1,292 |
Gain on extinguishment of debt | (3,352) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,780) | 2,805 |
Contract asset | (20) | (60) |
Inventory | 3,734 | 3,300 |
Prepaid expenses and other assets | 426 | (200) |
Accounts payable, accrued expenses and other liabilities | (621) | (631) |
Net cash provided by operating activities, continuing operations | 2,735 | 4,406 |
Cash flows from investing activities: | ||
Purchases of property and equipment | (2,112) | (2,239) |
Net cash used in investing activities | (2,112) | (2,239) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of costs | 32,103 | |
Proceeds from issuance of debt | 4,416 | |
Repayments of debt | (10,100) | (1,100) |
Payment of deferred financing costs | (200) | |
Net payments related to vesting of restricted stock units | (462) | (1,181) |
Net proceeds related to exercise of stock options | 509 | |
Net cash provided by financing activities | 21,341 | 2,644 |
Net increase in cash and cash equivalents from continuing operations | 21,964 | 4,811 |
Cash flows used in discontinued operating activities | (1,172) | |
Cash and cash equivalents, beginning of period | 23,760 | 19,148 |
Cash and cash equivalents, end of period | 45,724 | 22,787 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 4,833 | 7,228 |
Issuance of common stock to reduce debt principal and accrued exit fees | 6,060 | |
Issuance of common stock to settle interest obligations | 3,211 | |
Purchases of property, plant and equipment included in accrued expenses and accounts payable | $ 191 | $ 1,293 |
Background
Background | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Background | (1) Background Recro Pharma, Inc. (the “Company”) was incorporated in the Commonwealth of Pennsylvania on November 15, 2007 . The Company is a dedicated contract development and manufacturing organization (“CDMO”) solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products. It leverages its formulation and development expertise to develop and manufacture pharmaceutical products using proprietary delivery technologies and know-how for commercial partners who commercialize or plan to commercialize these products. The Company operates in one segment. The Company has incurred net losses since inception and has an accumulated deficit of $ 239,911 as of June 30, 2021 , which is primarily related to the activities of its former research and development business, which was spun-out in 2019. The Company’s future operations are highly dependent on the continued profitability of its manufacturing operations. Management believes that it is probable that the Company will be able to meet its obligations as they become due within at least one year after the date the financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (2) Summary of significant accounting principles 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 (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission ("SEC") rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. 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 interim periods are not necessarily indicative of the results that may be expected for the full year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. 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 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, plant and equipment Property, plant and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; 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. The Company reviews the carrying value of property, plant and equipment for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of individual assets or asset groups may not be recoverable. 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 analysis for goodwill consists of an optional qualitative assessment potentially followed by a quantitative analysis. If the Company determines that the carrying value of its reporting unit exceeds its fair value, an impairment charge is recorded for the excess. The Company performs its annual goodwill impairment test as of November 30 th , or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of goodwill. In performing the evaluation, the Company assesses qualitative factors such as overall financial performance, anticipated changes in industry and market conditions, and competitive environments. Definite-lived intangible assets are amortized on a straight-line basis over their estimated useful life. The Company is required to review the carrying value of definite-lived intangible assets for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Revenue recognition The Company generates revenues from manufacturing, packaging, research and development and related services for multiple pharmaceutical companies. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit-sharing components. Manufacturing 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. Profit-sharing In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based profit-sharing and/or royalties consideration, collectively referred to as profit-sharing, computed on the net product sales of the commercial partner. Profit-sharing revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based profit-sharing where the license for intellectual property is deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based profit-sharing where the license for intellectual property is not deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgment is required to calculate the estimated variable consideration from such profit-sharing using the expected value method based on historical commercial partner pricing and deductions. Estimated variable consideration is partially constrained due to the uncertainty of price adjustments made by the Company’s commercial partners, which are outside of the Company’s control. Factors causing price adjustments by the Company’s commercial partners include increased competition in the products’ markets, mix of volume between the commercial partners’ customers, and changes in government pricing. Research and development Research and development revenue includes services associated with formulation, process development, clinical trials materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that 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 are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, 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. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers. 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 is dependent on its relationships with a small number of commercial partners, with its three largest customers having generated 90 % or more of its revenues for the periods presented. Stock-based compensation expense 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,” which is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Upon exercise of stock options or vesting of restricted stock units, the holder may elect to cover tax withholdings by forfeiting shares of an equivalent value. In such cases, the Company issues net new shares to the holder, pays the tax withholding on behalf of the participant and presents the payment similar to a capital distribution: a reduction to additional paid-in-capital and a financing cash outflow in the consolidated financial statements. 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 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. A full valuation allowance was recorded as of June 30, 2021 and December 31, 2020. 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. Income or loss per share Basic income or loss per share is determined by dividing net income or loss (the numerator) by the weighted average common shares outstanding during the period (the denominator). To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For the three months ended June 30, 2021, there was no difference in the net income used to calculate basic and diluted per share results. The following table reconciles the difference in weighted average shares outstanding used for basic and diluted per share results: Weighted average shares outstanding, basic 39,018,730 Dilutive impact of: Restricted stock units 218,253 Stock options 4,024 Warrants 111,047 Weighted average shares outstanding, diluted 39,352,054 For the six months ended June 30, 2021 and for both of the 2020 periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Restricted stock units 540,942 913,220 456,344 744,185 Stock options 4,465,348 3,586,726 4,337,299 2,278,411 Warrants 348,664 348,664 348,664 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. Recently adopted accounting pronouncements On January 1, 2020, the Company adopted ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, ” or ASU 2018-13. ASU 2018-13 removes, modifies and adds certain disclosure requirements in Topic 820 “ Fair Value Measurement ”. There was no impact upon adoption because the Company is not currently required to provide any of the disclosures impacted by the new standard. On January 1, 2021, the Company adopted ASU No. 2016-13, “ Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” or ASU 2016-13, a new standard for measuring expected credit losses. That guidance impacts the measurement of doubtful accounts receivable, among other things. There was no impact upon adoption because the Company does not currently have any significant exposure to credit losses. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (3) Fair value of financial instruments The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures ,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments and certain warrants. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows: • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Items measured at fair value on a recurring basis Cash equivalents of $ 41,411 at June 30, 2021 and $ 6,583 at December 31, 2020 consisted entirely of money market mutual funds whose fair value were determined using Level 1 measurements. Fair value disclosures The Company follows the disclosure provisions of FASB ASC Topic 825, “ Financial Instruments ” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of June 30, 2021, the financial assets and liabilities recorded on the consolidated balance sheets that are not measured at fair value on a recurring basis include accounts receivable, accounts payable and accrued expenses. The carrying values of these accounts approximate fair value due to their short-term nature. The fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of its debt, a level 2 measurement, approximated fair value at June 30, 2021 due to the February 2021 amendment of the Credit Agreement and taking into consideration management's current evaluation of market conditions. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | (4) Inventory Inventory is stated at the lower of cost or net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Items are issued out of inventory using the first-in, first-out method. Inventory was as follows: June 30, 2021 December 31, 2020 Raw materials $ 2,749 $ 3,373 Work in process 1,633 5,061 Finished goods 3,826 3,544 Inventory, prior to provision 8,208 11,978 Provision for inventory obsolescence ( 330 ) ( 366 ) Inventory $ 7,878 $ 11,612 Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Inventory is primarily 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 | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | (5) Property, plant and equipment Property, plant and equipment consists of the following: June 30, 2021 December 31, 2020 Land $ 3,263 $ 3,263 Building and improvements 20,947 20,924 Furniture, office and computer equipment 5,826 5,879 Manufacturing equipment 45,339 39,349 Construction in progress 614 5,568 Property, plant and equipment, gross 75,989 74,983 Less: accumulated depreciation ( 34,122 ) ( 31,142 ) Property, plant and equipment, net $ 41,867 $ 43,841 In the first six months of 2021, $ 65 of interest expense was capitalized to construction in process. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | (6) Intangible assets The following table presents the components of the profit-sharing and contract manufacturing relationships asset, which was the only class of intangible asset for the periods presented: June 30, 2021 December 31, 2020 Cost $ 15,500 $ 15,500 Accumulated amortization ( 15,500 ) ( 14,800 ) Net intangible assets $ — $ 700 These assets were amortized over a six-year estimated useful life that ended in April 2021. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | (7) Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: June 30, 2021 December 31, 2020 Payroll and related costs $ 1,931 $ 1,481 Current portion of contract liabilities (see note 11) 1,068 1,447 Property, plant and equipment 105 551 Professional and consulting fees 201 432 Other 843 614 Total $ 4,148 $ 4,525 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (8) Commitments and contingencies 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 (the “Securities Litigation”) was filed against the Company and certain of its officers and directors (collectively, the "Defendants") in the U.S. District Court for the Eastern District of Pennsylvania (the "Court") (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 Securities Exchange Act of 1934, as amended, and Rule 10(b)(5) promulgated thereunder, based on statements made by the Company concerning the New Drug Application (“NDA”) for IV meloxicam. The complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, the lead plaintiff filed an amended complaint that asserted the same claims and sought the same relief but included new allegations and named additional officers 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. In response to questions from the Court, the parties submitted supplemental briefs regarding the motion to dismiss the amended complaint during the fall of 2019. On February 18, 2020, the motion to dismiss was granted by the Court without prejudice. On April 25, 2020, the plaintiff filed a second amended complaint. The Company filed a motion to dismiss the second amended complaint on June 18, 2020. The plaintiff filed an opposition to the Company’s motion to dismiss on August 17, 2020. On September 16, 2020, the Company filed a reply in support of its motion to dismiss. On March 1, 2021, the Court denied the Company’s second motion to dismiss. On June 21, 2021, the Defendants filed an answer and affirmative defenses to the second amended complaint. The parties are in the beginning stages of discovery. A Preliminary Pretrial Conference before the Court occurred on August 3, 2021. In connection with the separation of the Company's former acute care research and development business into a new standalone entity named Baudax Bio, Inc. ("Baudax Bio"), Baudax Bio accepted assignment by the Company of all of its obligations in connection with the Securities Litigation and agreed to indemnify it for all liabilities related to the Securities Litigation. The Company and Baudax Bio believe that the lawsuit is without merit and intend to vigorously defend against it, unless and until a resolution satisfactory to the Company can be achieved. Purchase commitments As of June 30, 2021 , the Company had outstanding cancelable and non-cancelable purchase commitments in the aggregate amount of $ 5,512 related to inventory, capital expenditures and other goods and services. Employment agreements and certain other contingencies The Company has entered into employment agreements with each of its named executive officers that provide for, among other things, severance commitments of up to $ 1,250 should the Company terminate the named executive officers for convenience or if certain events occur following a change in control. In addition, the Company is subject to other contingencies of up to $ 3,566 in the aggregate if certain events occur following a change in control. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt | (9) Debt The carrying value of debt consists of the following as of June 30, 2021: Term loans under Credit Agreement Principal balance outstanding $ 100,000 Unamortized deferred issuance costs ( 10,795 ) Exit fee accretion 575 Total 89,780 The principal balance and exit fee due of $ 101,000 matures and must be repaid in 2023. Term loans under Credit Agreement The Company is currently party to a credit agreement (the “Credit Agreement”) with Athyrium Opportunities III Acquisition LP (“Athyrium”). The Credit Agreement has been fully drawn in the form of $ 48,000 of term A loans and $ 52,000 of term B loans, all of which mature on March 31, 2023 . The Credit Agreement has been amended from time to time. An amendment in February 2021 resulted in a reduction of $ 16,000 principal, a reduction of 1.5 % in the stated interest rate, and a $ 160 settlement of accrued exit fees in exchange for $ 10,100 of cash and $ 9,271 , or 2,202,420 shares, of common stock issued, as well as certain other changes to the terms of the debt. Of the total common stock issued, $ 6,060 was applied to the principal balance and accrued exit fee, and substantially all of the remainder was added to unamortized deferred financing costs and will be amortized as interest over the remaining term of the debt. The term loans under the Credit Agreement included a rate of interest equal to the three-month LIBOR rate, with a 1 % floor plus 8.25 % per annum . The term loans require the Company to pay a 1 % exit fee on all repayments. At June 30, 2021 , the aggregate exit fee payable was $ 1,000 , and the cumulative exit fee accreted was $ 575 . The exit fees are being accreted to the carrying amount of the debt using the effective interest method over the term of the loan. In addition, if the Company makes any prepayments prior to maturity, the Company would be subject to the following prepayment premiums as a percentage of the amount repaid: (i) term A loans at 2.5 % through March 31, 2022 with no penalty thereafter; and (ii) term B loans at 5.0 % through March 31, 2022 and 2.5 % thereafter. The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis, including maintaining a permitted net leverage ratio (which is the Company’s indebtedness under the Credit Agreement, net of cash and cash equivalents, divided by EBITDA, each as defined in the Credit Agreement) and liquidity amount. As of June 30, 2021 , the Company was in compliance with its covenants under the Credit Agreement. In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP (“Athyrium II”), to purchase an aggregate of 348,664 shares of the Company’s common stock with an exercise price of $ 1.73 per share. See note 10 for additional information. The warrants are exercisable through November 17, 2024 . In connection with the Credit Agreement and five subsequent amendments, the Company has paid financing costs, has incurred costs to record and subsequently to adjust the value of the warrants described above and has been accreting the exit fee described above. These costs are being recognized in interest expense using the effective interest method over the term of the Credit Agreement, resulting in non-cash interest expense of $ 1,618 and $ 1,459 in the second quarters of 2021 and 2020, respectively, and $ 3,080 and $ 2,919 in the first six months of 2021 and 2020, respectively. At June 30, 2021 , the overall effective interest rate, including cash paid for interest and non-cash interest expense, was 15.65 %. Paycheck Protection Program (“PPP”) note In May 2020, the Company entered into a $ 4,416 promissory note with PNC Bank under the Small Business Administration (“SBA”) Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “PPP Note”). Shortly after entering into the note, the Company prepaid $ 1,100 of principal to comply with guidance from the SBA that limited the amount that could be borrowed at that time. The note had a two-year term and a stated rate of interest of 1.0 % per annum, which accrued and would have become payable beginning September 2021. In October 2020, the Company submitted a forgiveness application for the PPP Note, and in June 2021, the PPP Note and all accrued interest thereon was forgiven. Upon receiving the decision, the Company recorded a gain on extinguishment of debt of $ 3,352 , consisting of forgiveness of $ 3,316 of principal and $ 36 of accrued interest. |
Stockholders_ Equity or Deficit
Stockholders’ Equity or Deficit | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity or Deficit | (10) Shareholders’ equity or deficit Capital raises The following table presents the Company’s capital raises since its initial public offering: Date or period Shares of common stock issued Gross proceeds Offering expenses Net proceeds Initial public offering March 12, 2014 4,312,500 $ 34,500 $ ( 4,244 ) $ 30,256 Private placement July 7, 2015 1,379,311 16,000 ( 1,188 ) 14,812 Underwritten public offering August 19, 2016 1,986,666 14,900 ( 1,533 ) 13,367 Underwritten public offering December 16, 2016 6,670,000 40,020 ( 3,132 ) 36,888 2018 common stock purchase agreement with Aspire Capital Year ended December 31, 2018 1,950,000 16,999 — 16,999 2019 common stock purchase agreement with Aspire Capital Fourth quarter 2020 4,690,972 11,172 ( 78 ) 11,094 Underwritten public offering May 12, 2021 15,333,332 34,500 ( 2,397 ) 32,103 Aspire common stock purchase agreement The Company is currently party to an amended common stock purchase agreement with Aspire Capital Fund LLC (“Aspire Capital”) originally entered into during 2019, and most recently amended in February 2021 (as amended, the “2019 Common Stock Purchase Agreement”). The 2019 Common Stock Purchase Agreement provides that, upon the terms and subject to the conditions and limitations set forth in the agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate value of $ 41,172 in shares of common stock. As of June 30, 2021, there is availability to issue up to $ 30,000 or 6,199,299 shares of common stock under the 2019 Common Stock Purchase Agreement. Athyrium stock issuance agreement In February 2021, the Company entered into a stock issuance agreement with Athyrium in connection with an amendment to its Credit Agreement. See note 9 for additional details. Warrants At June 30, 2021 , warrants to purchase 348,664 shares of common stock were outstanding. The warrants are held by Athyrium, equity-classified, exercisable at $ 1.73 per share and expire in November 2024 . See note 9 for additional details. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | (11) Revenue recognition 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. 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. The following table presents changes in contract assets and liabilities: Contract assets Contract liabilities Balance at December 31, 2020 $ 7,330 $ 2,695 Changes to the beginning balance of contract assets arising from: Reclassification to receivables as a result of rights to consideration becoming unconditional ( 8,825 ) — Changes in estimate 1,502 — Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates 7,343 — Changes to contract liabilities: Cash received in advance of contract performance — 2,212 Revenue recognized — ( 3,234 ) Balance at June 30, 2021 $ 7,350 $ 1,673 Less: noncurrent portion — ( 605 ) Current portion $ 7,350 $ 1,068 The following table disaggregates revenue by timing of revenue recognition: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Point in time $ 16,439 $ 14,365 $ 31,586 $ 35,420 Over time 1,578 1,157 3,234 1,879 Total $ 18,017 $ 15,522 $ 34,820 $ 37,299 The Company’s payment terms for manufacturing revenue and development services are typically 30 to 45 days. Profit-sharing 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. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | (12) Stock-based compensation In October 2013, the Company established an equity incentive plan that has been subsequently amended and restated to become the 2018 Amended and Restated Equity Incentive Plan (the “A&R Plan”) At June 30, 2021 , a total of 2,811,406 shares were available for future grants under the A&R Plan. On December 1 st of each year, pursuant to the “Evergreen” provision of the A&R Plan, the number of shares available under the A&R Plan may be increased by the board of directors by an amount equal to 5 % of the outstanding common stock on December 1 st of that year. Stock options Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years . The following table presents information about the fair value of stock options granted: Six months ended June 30, 2021 2020 Weighted average grant date fair value $ 1.90 $ 8.24 Assumptions used to determine fair value: Range of expected option life 5.5 - 6 year s 5.5 - 6 year s Expected volatility 79 - 81 % 75 - 81 % Risk-free interest rate 0.7 - 1.2 % 0.3 - 1.4 % Expected dividend yield — — The intrinsic value of options exercised was $ 1,058 in the first half of 2020. No options were exercised in the first half of 2021. The following table presents information about stock option balances and activity: Number of shares Weighted average exercise price Aggregate intrinsic value Weighted average remaining contractual life Balance, December 31, 2020 3,907,010 $ 8.03 Granted 932,004 2.81 Forfeited or expired ( 108,040 ) 8.04 Balance, June 30, 2021 4,730,974 7.00 $ 7 5.7 years Exercisable 3,160,459 8.12 1 4.0 years Included in the table above are 761,848 options outstanding as of June 30, 2021 that were granted outside the A&R Plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4). Restricted stock units Restricted stock units (“RSUs”) vest over six months to four years depending on the purpose of the award. The fair value of RSUs on the date of grant is measured as the closing price of the Company's common stock on that date. The weighted average grant-date fair value of RSUs awarded to employees was $ 3.49 in the first half of 2021 and $ 15.11 in the first half of 2020. The fair value of RSUs vested was $ 1,537 in the first half of 2021 and $ 3,227 in the first half of 2020. The following table presents information about recent RSU activity: Number of shares Weighted average grant date fair value Balance, December 31, 2020 1,516,819 $ 5.67 Granted 743,956 3.49 Vested ( 526,191 ) 8.91 Forfeited ( 92,408 ) 10.30 Balance, June 30, 2021 1,642,176 3.39 Included in the table above are 232,822 time-based RSUs outstanding at June 30, 2021 that were granted outside of the A&R Plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4). Other information The following table presents the classification of stock-based compensation expense: Six months ended June 30, 2021 2020 Cost of sales $ 2,375 $ 1,991 Selling, general and administrative expenses 2,687 3,686 Total $ 5,062 $ 5,677 As of June 30, 2021 , there was $ 9,050 of unrecognized compensation expense related to unvested options and RSUs that are expected to vest and will be expensed over a weighted average period of 2.4 years. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Lessee Disclosure [Abstract] | |
Leases | (13) Leases 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. Options to extend the lease are included in the lease term if the options are reasonably certain to be exercised. Operating lease expense is recognized on a straight-line basis over the lease term. The following table presents the operating lease amounts recognized on the consolidated balance sheets: Balance sheet classification June 30, 2021 December 31, 2020 Asset Other assets $ 449 $ 486 Liabilities: Current Accrued expenses and other current liabilities 145 145 Noncurrent Other liabilities 327 366 The Company is a party to a seven-year operating lease for a development facility in the State of Georgia that ends in 2025 and immaterial operating leases for a storage area and office equipment. The development facility lease includes options to extend the lease for up to 15 additional years, none of which are included in the lease term. Short-term and variable lease costs were not material for the periods presented. The development facility lease does not provide an implicit rate, so the Company uses its incremental borrowing rate to discount the lease liability. Undiscounted future lease payments for the development lease, which was the only material noncancelable lease at March 31, 2021, were as follows: June 30, 2021 Remainder of 2021 $ 78 2022 156 2023 156 2024 156 2025 and thereafter 91 Total lease payments 637 Less imputed interest ( 165 ) Total operating lease liabilities $ 472 At June 30, 2021 , the weighted average remaining lease term was 4.0 years, and the weighted average discount rate was 16 %. For the second quarter, total lease cost was $ 85 in 2021 and $ 80 in 2020. For the first six months ended June 30, total lease cost was $ 186 in 2021 and $ 158 in 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | 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 (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission ("SEC") rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. 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 interim periods are not necessarily indicative of the results that may be expected for the full year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. |
Use of Estimates | 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 | 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 | Property, plant and equipment Property, plant and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; 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. The Company reviews the carrying value of property, plant and equipment for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of individual assets or asset groups may not be recoverable. |
Goodwill and Intangible Assets | 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 analysis for goodwill consists of an optional qualitative assessment potentially followed by a quantitative analysis. If the Company determines that the carrying value of its reporting unit exceeds its fair value, an impairment charge is recorded for the excess. The Company performs its annual goodwill impairment test as of November 30 th , or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of goodwill. In performing the evaluation, the Company assesses qualitative factors such as overall financial performance, anticipated changes in industry and market conditions, and competitive environments. Definite-lived intangible assets are amortized on a straight-line basis over their estimated useful life. The Company is required to review the carrying value of definite-lived intangible assets for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. |
Revenue Recognition | Revenue recognition The Company generates revenues from manufacturing, packaging, research and development and related services for multiple pharmaceutical companies. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit-sharing components. Manufacturing 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. Profit-sharing In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based profit-sharing and/or royalties consideration, collectively referred to as profit-sharing, computed on the net product sales of the commercial partner. Profit-sharing revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based profit-sharing where the license for intellectual property is deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based profit-sharing where the license for intellectual property is not deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgment is required to calculate the estimated variable consideration from such profit-sharing using the expected value method based on historical commercial partner pricing and deductions. Estimated variable consideration is partially constrained due to the uncertainty of price adjustments made by the Company’s commercial partners, which are outside of the Company’s control. Factors causing price adjustments by the Company’s commercial partners include increased competition in the products’ markets, mix of volume between the commercial partners’ customers, and changes in government pricing. Research and development Research and development revenue includes services associated with formulation, process development, clinical trials materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that 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 are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, 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. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers. 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 is dependent on its relationships with a small number of commercial partners, with its three largest customers having generated 90 % or more of its revenues for the periods presented. |
Stock-based Compensation Expense | Stock-based compensation expense 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,” which is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Upon exercise of stock options or vesting of restricted stock units, the holder may elect to cover tax withholdings by forfeiting shares of an equivalent value. In such cases, the Company issues net new shares to the holder, pays the tax withholding on behalf of the participant and presents the payment similar to a capital distribution: a reduction to additional paid-in-capital and a financing cash outflow in the consolidated financial statements. 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 | 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. A full valuation allowance was recorded as of June 30, 2021 and December 31, 2020. 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. |
Income or Loss Per Share | Income or loss per share Basic income or loss per share is determined by dividing net income or loss (the numerator) by the weighted average common shares outstanding during the period (the denominator). To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For the three months ended June 30, 2021, there was no difference in the net income used to calculate basic and diluted per share results. The following table reconciles the difference in weighted average shares outstanding used for basic and diluted per share results: Weighted average shares outstanding, basic 39,018,730 Dilutive impact of: Restricted stock units 218,253 Stock options 4,024 Warrants 111,047 Weighted average shares outstanding, diluted 39,352,054 For the six months ended June 30, 2021 and for both of the 2020 periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Restricted stock units 540,942 913,220 456,344 744,185 Stock options 4,465,348 3,586,726 4,337,299 2,278,411 Warrants 348,664 348,664 348,664 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Recently Accounting Pronouncements | Recently adopted accounting pronouncements On January 1, 2020, the Company adopted ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, ” or ASU 2018-13. ASU 2018-13 removes, modifies and adds certain disclosure requirements in Topic 820 “ Fair Value Measurement ”. There was no impact upon adoption because the Company is not currently required to provide any of the disclosures impacted by the new standard. On January 1, 2021, the Company adopted ASU No. 2016-13, “ Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” or ASU 2016-13, a new standard for measuring expected credit losses. That guidance impacts the measurement of doubtful accounts receivable, among other things. There was no impact upon adoption because the Company does not currently have any significant exposure to credit losses. |
Fair Value Measurement | The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures ,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments and certain warrants. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows: • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. |
Inventory | Inventory is stated at the lower of cost or net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Items are issued out of inventory using the first-in, first-out method. Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Inventory is primarily 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. |
Leases | 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. Options to extend the lease are included in the lease term if the options are reasonably certain to be exercised. Operating lease expense is recognized on a straight-line basis over the lease term. The following table presents the operating lease amounts recognized on the consolidated balance sheets: Balance sheet classification June 30, 2021 December 31, 2020 Asset Other assets $ 449 $ 486 Liabilities: Current Accrued expenses and other current liabilities 145 145 Noncurrent Other liabilities 327 366 |
Summary of Significant Accoun_3
Summary of Significant Accounting Principles (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Weighted Average Shares Outstanding Basic And Diluted | The following table reconciles the difference in weighted average shares outstanding used for basic and diluted per share results: Weighted average shares outstanding, basic 39,018,730 Dilutive impact of: Restricted stock units 218,253 Stock options 4,024 Warrants 111,047 Weighted average shares outstanding, diluted 39,352,054 |
Schedule of Anti-Dilutive Securities | The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Restricted stock units 540,942 913,220 456,344 744,185 Stock options 4,465,348 3,586,726 4,337,299 2,278,411 Warrants 348,664 348,664 348,664 348,664 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventory was as follows: June 30, 2021 December 31, 2020 Raw materials $ 2,749 $ 3,373 Work in process 1,633 5,061 Finished goods 3,826 3,544 Inventory, prior to provision 8,208 11,978 Provision for inventory obsolescence ( 330 ) ( 366 ) Inventory $ 7,878 $ 11,612 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following: June 30, 2021 December 31, 2020 Land $ 3,263 $ 3,263 Building and improvements 20,947 20,924 Furniture, office and computer equipment 5,826 5,879 Manufacturing equipment 45,339 39,349 Construction in progress 614 5,568 Property, plant and equipment, gross 75,989 74,983 Less: accumulated depreciation ( 34,122 ) ( 31,142 ) Property, plant and equipment, net $ 41,867 $ 43,841 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Balance of Intangible Assets | The following table presents the components of the profit-sharing and contract manufacturing relationships asset, which was the only class of intangible asset for the periods presented: June 30, 2021 December 31, 2020 Cost $ 15,500 $ 15,500 Accumulated amortization ( 15,500 ) ( 14,800 ) Net intangible assets $ — $ 700 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: June 30, 2021 December 31, 2020 Payroll and related costs $ 1,931 $ 1,481 Current portion of contract liabilities (see note 11) 1,068 1,447 Property, plant and equipment 105 551 Professional and consulting fees 201 432 Other 843 614 Total $ 4,148 $ 4,525 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Carrying Value of Debt | The carrying value of debt consists of the following as of June 30, 2021: Term loans under Credit Agreement Principal balance outstanding $ 100,000 Unamortized deferred issuance costs ( 10,795 ) Exit fee accretion 575 Total 89,780 |
Stockholders_ Equity or Defic_2
Stockholders’ Equity or Deficit (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Summary of Capital Raises Since its Initial Public Offreing | The following table presents the Company’s capital raises since its initial public offering: Date or period Shares of common stock issued Gross proceeds Offering expenses Net proceeds Initial public offering March 12, 2014 4,312,500 $ 34,500 $ ( 4,244 ) $ 30,256 Private placement July 7, 2015 1,379,311 16,000 ( 1,188 ) 14,812 Underwritten public offering August 19, 2016 1,986,666 14,900 ( 1,533 ) 13,367 Underwritten public offering December 16, 2016 6,670,000 40,020 ( 3,132 ) 36,888 2018 common stock purchase agreement with Aspire Capital Year ended December 31, 2018 1,950,000 16,999 — 16,999 2019 common stock purchase agreement with Aspire Capital Fourth quarter 2020 4,690,972 11,172 ( 78 ) 11,094 Underwritten public offering May 12, 2021 15,333,332 34,500 ( 2,397 ) 32,103 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in contract assets and liabilities: Contract assets Contract liabilities Balance at December 31, 2020 $ 7,330 $ 2,695 Changes to the beginning balance of contract assets arising from: Reclassification to receivables as a result of rights to consideration becoming unconditional ( 8,825 ) — Changes in estimate 1,502 — Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates 7,343 — Changes to contract liabilities: Cash received in advance of contract performance — 2,212 Revenue recognized — ( 3,234 ) Balance at June 30, 2021 $ 7,350 $ 1,673 Less: noncurrent portion — ( 605 ) Current portion $ 7,350 $ 1,068 |
Disaggregation of Revenue by Timing of Revenue Recognition | The following table disaggregates revenue by timing of revenue recognition: Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Point in time $ 16,439 $ 14,365 $ 31,586 $ 35,420 Over time 1,578 1,157 3,234 1,879 Total $ 18,017 $ 15,522 $ 34,820 $ 37,299 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Fair Value of Stock Options Granted | The following table presents information about the fair value of stock options granted: Six months ended June 30, 2021 2020 Weighted average grant date fair value $ 1.90 $ 8.24 Assumptions used to determine fair value: Range of expected option life 5.5 - 6 year s 5.5 - 6 year s Expected volatility 79 - 81 % 75 - 81 % Risk-free interest rate 0.7 - 1.2 % 0.3 - 1.4 % Expected dividend yield — — |
Summary of Stock Option Activity | The following table presents information about stock option balances and activity: Number of shares Weighted average exercise price Aggregate intrinsic value Weighted average remaining contractual life Balance, December 31, 2020 3,907,010 $ 8.03 Granted 932,004 2.81 Forfeited or expired ( 108,040 ) 8.04 Balance, June 30, 2021 4,730,974 7.00 $ 7 5.7 years Exercisable 3,160,459 8.12 1 4.0 years |
Summary of Restricted Stock Units Activity | The following table presents information about recent RSU activity: Number of shares Weighted average grant date fair value Balance, December 31, 2020 1,516,819 $ 5.67 Granted 743,956 3.49 Vested ( 526,191 ) 8.91 Forfeited ( 92,408 ) 10.30 Balance, June 30, 2021 1,642,176 3.39 |
Summary of Stock Based Compensation Expense | The following table presents the classification of stock-based compensation expense: Six months ended June 30, 2021 2020 Cost of sales $ 2,375 $ 1,991 Selling, general and administrative expenses 2,687 3,686 Total $ 5,062 $ 5,677 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Lessee Disclosure [Abstract] | |
Summary of Operating Lease recognized in Balance Sheet | The following table presents the operating lease amounts recognized on the consolidated balance sheets: Balance sheet classification June 30, 2021 December 31, 2020 Asset Other assets $ 449 $ 486 Liabilities: Current Accrued expenses and other current liabilities 145 145 Noncurrent Other liabilities 327 366 |
Schedule of Undiscounted Future Lease Payments for the Development Lease | Undiscounted future lease payments for the development lease, which was the only material noncancelable lease at March 31, 2021, were as follows: June 30, 2021 Remainder of 2021 $ 78 2022 156 2023 156 2024 156 2025 and thereafter 91 Total lease payments 637 Less imputed interest ( 165 ) Total operating lease liabilities $ 472 |
Background - Additional Informa
Background - Additional Information (Detail) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021USD ($)Segment | Dec. 31, 2020USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Entity incorporation date | Nov. 15, 2007 | |
Accumulated deficit | $ | $ 239,911 | $ 234,384 |
Number of operating segment | Segment | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2021Customer | |
Accounts Receivable [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | 3 |
Sales Revenue, Net [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | 3 |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Concentration risk percentage | 90.00% |
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 estimated useful lives | 10 years |
Buildings [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 - Weighted Average Shares Outstanding Basic And Diluted (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share Diluted [Line Items] | ||||
Weighted average common shares outstanding, basic | 39,018,730 | 23,577,255 | 34,403,935 | 23,486,011 |
Weighted average common shares outstanding, diluted | 39,352,054 | 23,577,255 | 34,403,935 | 23,486,011 |
Restricted stock units [Member] | ||||
Earnings Per Share Diluted [Line Items] | ||||
Weighted average common shares outstanding, diluted | 218,253 | |||
Stock options [Member] | ||||
Earnings Per Share Diluted [Line Items] | ||||
Weighted average common shares outstanding, diluted | 4,024 | |||
Warrants [Member] | ||||
Earnings Per Share Diluted [Line Items] | ||||
Weighted average common shares outstanding, diluted | 111,047 |
Summary of Significant Accoun_6
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
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 | 540,942 | 913,220 | 456,344 | 744,185 |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 4,465,348 | 3,586,726 | 4,337,299 | 2,278,411 |
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 | 348,664 | 348,664 | 348,664 | 348,664 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Money Market Mutual Funds [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Cash equivalents | $ 41,411 | $ 6,583 |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,749 | $ 3,373 |
Work in process | 1,633 | 5,061 |
Finished goods | 3,826 | 3,544 |
Inventory, prior to provision | 8,208 | 11,978 |
Provision for inventory obsolescence | (330) | (366) |
Inventory | $ 7,878 | $ 11,612 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 75,989 | $ 74,983 |
Less: accumulated depreciation | (34,122) | (31,142) |
Property, plant and equipment, net | 41,867 | 43,841 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 3,263 | 3,263 |
Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 20,947 | 20,924 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 5,826 | 5,879 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 45,339 | 39,349 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 614 | $ 5,568 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Property, Plant and Equipment [Line Items] | ||||
Interest Expense | $ 3,960 | $ 4,995 | $ 7,858 | $ 10,118 |
Construction in Progress [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Interest Expense | $ 65 |
Intangible Assets - Summary of
Intangible Assets - Summary of Balance of Intangible Assets (Detail) - Royalties and Contract Manufacturing Relationships [Member] - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Definite-lived | $ 15,500 | $ 15,500 |
Accumulated Amortization | (15,500) | (14,800) |
Net Intangible Assets, Definite-lived | $ 700 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2021 | |
Royalties and Contract Manufacturing Relationships [Member] | |
Finite Lived Intangible Assets [Line Items] | |
Estimated useful life | 6 years |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Payroll and related costs | $ 1,931 | $ 1,481 |
Current portion of contract liabilities (see note 11) | 1,068 | 1,447 |
Property, plant and equipment | 105 | 551 |
Professional and consulting fees | 201 | 432 |
Other | 843 | 614 |
Total | $ 4,148 | $ 4,525 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Jun. 30, 2021USD ($) |
Executive Officer [Member] | |
Supply Commitment [Line Items] | |
Potential severance commitments arrangement consideration | $ 1,250 |
Other Contingencies | 3,566 |
Purchase Commitment [Member] | |
Supply Commitment [Line Items] | |
Purchase commitment non cancelable and cancelable | $ 5,512 |
Debt - Schedule of Carrying Val
Debt - Schedule of Carrying Value of Debt (Detail) - Term loans under Credit Agreement [Member] $ in Thousands | Jun. 30, 2021USD ($) |
Debt Instrument [Line Items] | |
Principal balance outstanding | $ 100,000 |
Unamortized deferred issuance costs | (10,795) |
Exit fee accretion | 575 |
Total debt | $ 89,780 |
Debt - Additional Information (
Debt - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021USD ($)$ / shares | Feb. 28, 2021USD ($) | May 31, 2020USD ($) | Jun. 30, 2021USD ($)$ / shares | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)$ / sharesshares | Jun. 30, 2020USD ($) | Nov. 17, 2017 | |
Debt Instrument [Line Items] | ||||||||
Prepayment penalties assessed for payments after March 31, 2022 | $ 2,500 | |||||||
Non-cash interest expense | 3,080,000 | $ 2,919,000 | ||||||
Gain on extinguishment of debt | $ 3,352,000 | 3,352,000 | ||||||
Term loans under Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal balance and exit fee due | $ 101,000,000 | 101,000,000 | 101,000,000 | |||||
Principal balance outstanding | 100,000,000 | 100,000,000 | 100,000,000 | |||||
Debt instrument, exit fee | 575,000 | 575,000 | 575,000 | |||||
Non-cash interest expense | 1,618,000 | $ 1,459,000 | 3,080,000 | $ 2,919,000 | ||||
PPP note [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 4,416,000 | |||||||
Debt Instrument, Interest Rate, Stated Percentage | 1.00% | |||||||
Long-term Debt, Term | 2 years | |||||||
Repayments of Long-term Debt | $ 1,100,000 | |||||||
Gain on extinguishment of debt | 3,352,000 | |||||||
Debt forgiveness | 3,316,000 | |||||||
Accrued interest | 36,000 | |||||||
A Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Credit agreement | 48,000 | 48,000 | $ 48,000 | |||||
Debt instrument early repayment of prepayment penalty percentage | 2.50% | |||||||
B Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Credit agreement | $ 52,000 | $ 52,000 | $ 52,000 | |||||
Debt instrument early repayment of prepayment penalty percentage | 5.00% | |||||||
Athyrium Opportunities II Acquisition LP [Member] | Seven Year Warrant [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase common stock with warrant issue | shares | 348,664 | |||||||
Warrant, exercise price per share | $ / shares | $ 1.73 | $ 1.73 | $ 1.73 | |||||
Warrants, exercisable date | Nov. 17, 2024 | |||||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Reduction in principal amount of debt | $ 16,000,000 | |||||||
Debt instrument, maturity date | Mar. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2023 | |||||
Reduction in stated interest rate | 1.5 | |||||||
Settlement of accrued exit fees | $ 160 | |||||||
Settlement Of Accrued Exit Fees In Exchange For Cash | 10,100,000 | |||||||
Settlement Of Accrued Exit Fees In Exchange For Value | $ 9,271,000 | |||||||
Settlement Of Accrued Exit Fees In Exchange For Shares | shares | 2,202,420 | |||||||
Principal Balance And Accrued Exit Fee | $ 6,060,000 | |||||||
Debt instrument exit fee | $ 1,000 | $ 1,000 | 1,000 | |||||
Debt instrument, exit fee | $ 575 | $ 575 | $ 575 | |||||
Term loan interest rate, Description | interest equal to the three-month LIBOR rate, with a 1% floor plus 8.25% per annum | |||||||
Exit fee percentage | 1.00% | |||||||
Debt instrument, covenant description | The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis, including maintaining a permitted net leverage ratio (which is the Company’s indebtedness under the Credit Agreement, net of cash and cash equivalents, divided by EBITDA, each as defined in the Credit Agreement) and liquidity amount. As of June 30, 2021, the Company was in compliance with its covenants under the Credit Agreement. | |||||||
Debt instrument, early repayment terms | if the Company makes any prepayments prior to maturity, the Company would be subject to the following prepayment premiums as a percentage of the amount repaid: (i) term A loans at 2.5% through March 31, 2022 with no penalty thereafter; and (ii) term B loans at 5.0% through March 31, 2022 and 2.5% thereafter. | |||||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | Floor [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan variable interest rate | 1.00% | |||||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | LIBOR [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan variable interest rate | 8.25% | |||||||
Athyrium Second Amendment Credit Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Effective interest rate | 15.65% | 15.65% | 15.65% |
Stockholders Equity or Deficit
Stockholders Equity or Deficit - Summary of Capital Raises Since its Initial Public Offreing (Detail) - USD ($) $ in Thousands | May 12, 2021 | Dec. 16, 2016 | Aug. 19, 2016 | Jul. 07, 2015 | Mar. 12, 2014 | Dec. 31, 2018 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs | $ 32,103 | $ 9,340 | |||||||
Initial Public Offering [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs, Shares | 4,312,500 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 34,500 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (4,244) | ||||||||
Issuance of common stock, net of costs | $ 30,256 | ||||||||
Private Placement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs, Shares | 1,379,311 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 16,000 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (1,188) | ||||||||
Issuance of common stock, net of costs | $ 14,812 | ||||||||
Underwriters Public Offering [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs, Shares | 15,333,332 | 6,670,000 | 1,986,666 | ||||||
Gross proceeds on sale of common stock in initial public offering | $ 34,500 | $ 40,020 | $ 14,900 | ||||||
Payments on underwriting discounts, commissions and offering costs | (2,397) | (3,132) | (1,533) | ||||||
Issuance of common stock, net of costs | $ 32,103 | $ 36,888 | $ 13,367 | ||||||
2018 Common Stock Purchase Agreement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs, Shares | 1,950,000 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 16,999 | ||||||||
Issuance of common stock, net of costs | $ 16,999 | ||||||||
2019 Common Stock Purchase Agreement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs, Shares | 4,690,972 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 11,172 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (78) | ||||||||
Issuance of common stock, net of costs | $ 11,094 |
Stockholders Equity or Defici_2
Stockholders Equity or Deficit - Additional Information (Detail) - $ / shares | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | |
Common Stock [Member] | |||
Schedule Of Capitalization Equity [Line Items] | |||
Issuance of common stock, net of costs, Shares | 15,333,332 | 2,202,420 | |
Warrants, Exercise Price $6.84, Expiring on November 2024 [Member] | Equity [Member] | Athyrium Opportunities II Acquisition LP [Member] | |||
Schedule Of Capitalization Equity [Line Items] | |||
Warrants outstanding to purchase shares, Number of Shares | 348,664 | 348,664 | |
Warrant, exercise price per share | $ 1.73 | $ 1.73 | |
Warrants outstanding to purchase shares, Expiration dates | 2024-11 | ||
Aspire Capital | |||
Schedule Of Capitalization Equity [Line Items] | |||
Purchase commitment of common stock, Shares | 41,172 | ||
Aspire Capital | Minimum [Member] | |||
Schedule Of Capitalization Equity [Line Items] | |||
Issuance of common stock, net of costs, Shares | 30,000 | ||
Aspire Capital | Maximum [Member] | |||
Schedule Of Capitalization Equity [Line Items] | |||
Issuance of common stock, net of costs, Shares | 6,199,299 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Changes in Contract Assets and Liabilities (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Contract with Customer Asset | ||
Balance at December 31, 2020 | $ 7,330 | |
Changes to the beginning balance of contract assets arising from: | ||
Reclassification to receivables as a result of rights to consideration becoming unconditional | (8,825) | |
Changes in estimate | 1,502 | |
Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates | 7,343 | |
Balance at June 30, 2021 | 7,350 | |
Less: noncurrent portion | ||
Current portion | 7,350 | $ 7,330 |
Contract with Customer, Liability | ||
Balance at December 31, 2020 | 2,695 | |
Changes to contract liabilities: | ||
Cash received in advance of contract performance | 2,212 | |
Revenue recognized | (3,234) | |
Balance at June 30, 2021 | 1,673 | |
Less: noncurrent portion | (605) | |
Current portion | $ 1,068 | $ 1,447 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Timing of Revenue Recognition (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Revenue | $ 18,017 | $ 15,522 | $ 34,820 | $ 37,299 |
Point In Time [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue | 16,439 | 14,365 | 31,586 | 35,420 |
Over Time [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue | $ 1,578 | $ 1,157 | $ 3,234 | $ 1,879 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options exercisable period | 10 years | |||||
Stock options vest period | 4 years | |||||
Intrinsic value of options exercised | $ 0 | $ 1,058 | ||||
Stock Options Granted Outside Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of options, Granted | 761,848 | |||||
Restricted Stock Units [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares. Granted | 743,956 | |||||
Weighted average grant-date fair value of the RSU's awarded to employees | $ 3.49 | $ 15.11 | ||||
Fair value vested | $ 1,537 | $ 3,227 | ||||
Restricted Stock Units [Member] | Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options vest period | 6 months | |||||
Restricted Stock Units [Member] | Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options vest period | 4 years | |||||
Stock Options and Time Based Restricted Stock Units [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 | $ 9,050 | |||||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 4 months 24 days | |||||
Time Based Restricted Stock Units [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares. Granted | 232,822 | |||||
A&R Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of outstanding common stock | 5.00% | 5.00% | 5.00% | |||
Shares available for future grants | 2,811,406 | |||||
A&R Plan [Member] | Forecast [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of outstanding common stock | 5.00% |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted (Detail) - $ / shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Granted | $ 1.90 | $ 8.24 |
Assumptions used to determine fair value: | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Assumptions used to determine fair value: | ||
Range of expected option life | 5 years 6 months | 5 years 6 months |
Expected volatility | 79.00% | 75.00% |
Risk-free interest rate | 0.70% | 0.30% |
Maximum [Member] | ||
Assumptions used to determine fair value: | ||
Range of expected option life | 6 years | 6 years |
Expected volatility | 81.00% | 81.00% |
Risk-free interest rate | 1.20% | 1.40% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of shares, Beginning balance | shares | 3,907,010 |
Number of shares, Granted | shares | 932,004 |
Number of shares, Forfeited or expired | shares | (108,040) |
Number of shares, Ending balance | shares | 4,730,974 |
Number of shares, Exercisable | shares | 3,160,459 |
Weighted average exercise price, Beginning balance | $ / shares | $ 8.03 |
Weighted average exercise price, Granted | $ / shares | 2.81 |
Weighted average exercise price, Forfeited or expired | $ / shares | 8.04 |
Weighted average exercise price, Ending balance | $ / shares | 7 |
Weighted average exercise price, Exercisable | $ / shares | $ 8.12 |
Weighted average remaining contractual life | 5 years 8 months 12 days |
Weighted average remaining contractual life, Exercisable | 4 years |
Aggregate intrinsic value | $ | $ 7 |
Aggregate intrinsic value, Exercisable | $ | $ 1 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - $ / shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Granted | $ 1.90 | $ 8.24 |
Restricted Stock Units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Beginning balance | 1,516,819 | |
Number of shares. Granted | 743,956 | |
Number of shares, Vested | (526,191) | |
Number of shares, Forfeited | (92,408) | |
Number of shares, Ending balance | 1,642,176 | |
Number of shares, beginning balance | $ 5.67 | |
Number of shares, Granted | 3.49 | |
Number of shares, Vested | 8.91 | |
Number of shares, Forfeited | 10.30 | |
Number of shares, ending balance | $ 3.39 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Based Compensation Expenses (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 5,062 | $ 5,677 |
Cost of Sales [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | 2,375 | 1,991 |
Selling, General and Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 2,687 | $ 3,686 |
Leases - Summary of Operating L
Leases - Summary of Operating Lease recognized in Balance Sheet (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Lessee Lease Description [Line Items] | ||
Asset | $ 449 | $ 486 |
Accrued Expenses and Other Current Liabilities [Member] | ||
Liabilities: | ||
Current | 145 | 145 |
Other Liabilities [Member] | ||
Liabilities: | ||
Noncurrent | $ 327 | $ 366 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Lessee Lease Description [Line Items] | ||||
Operating lease, weighted average remaining term | 4 years | 4 years | ||
Operating lease, weighted average discount rate percent | 16.00% | 16.00% | ||
Total operating lease, cost | $ 85 | $ 80 | $ 186 | $ 158 |
Georgia [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, term of contract | 7 years | 7 years | ||
Operating lease, option to extend | The development facility lease includes options to extend the lease for up to 15 additional years, none of which are included in the lease term. | |||
Operating lease expiration year | 2025 |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Future Lease Payments for the Development Lease (Detail) $ in Thousands | Jun. 30, 2021USD ($) |
Lessee Lease Description [Line Items] | |
Remainder of 2021 | $ 78 |
2022 | 156 |
2023 | 156 |
2024 | 156 |
2025 and thereafter | 91 |
Total lease payments | 637 |
Less imputed interest | (165) |
Accrued Expenses and Other Current Liabilities [Member] | |
Lessee Lease Description [Line Items] | |
Operating lease liability | $ 472 |