Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 11, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | BXRX | ||
Entity Registrant Name | Baudax Bio, Inc. | ||
Entity Central Index Key | 0001780097 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 9,435,713 | ||
Entity Public Float | $ 0 | ||
Entity File Number | 001-39101 | ||
Entity Incorporation, State or Country Code | PA | ||
Entity Tax Identification Number | 47-4639500 | ||
Entity Address, Address Line One | 490 Lapp Road | ||
Entity Address, City or Town | Malvern | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19355 | ||
City Area Code | 484 | ||
Local Phone Number | 395-2440 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Security Exchange Name | NASDAQ | ||
Title of 12(b) Security | Common Stock, par value $0.01 | ||
Documents Incorporated by Reference | Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant’s proxy statement for the 2020 annual meeting of shareholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2019. |
Consolidated and Combined Balan
Consolidated and Combined Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 17,740 | |
Prepaid expenses and other current assets | 2,395 | $ 2,514 |
Total current assets | 20,135 | 2,514 |
Property, plant and equipment, net | 4,821 | 3,982 |
Right-of-use asset | 730 | |
Intangible assets | 26,400 | 26,400 |
Goodwill | 2,127 | 2,127 |
Total assets | 54,213 | 35,023 |
Current liabilities: | ||
Accounts payable | 271 | 2,653 |
Accrued expenses and other current liabilities | 3,532 | 9,773 |
Current portion of operating lease liability | 318 | |
Current portion of contingent consideration | 3,592 | 10,354 |
Total current liabilities | 7,713 | 22,780 |
Long-term operating lease liability | 455 | |
Other long-term liabilities | 32 | |
Long-term portion of contingent consideration | 62,766 | 80,558 |
Total liabilities | 70,934 | 103,370 |
Commitments and contingencies (Note 11) | ||
Shareholders’ equity: | ||
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and outstanding at December 31, 2019 | ||
Parent company net investment | (68,347) | |
Common stock, $0.01 par value. Authorized, 100,000,000 shares; issued and outstanding, 9,350,709 shares at December 31, 2019 | 94 | |
Additional paid-in capital | 19,405 | |
Accumulated deficit | (36,220) | |
Total shareholders’ equity (deficit) | (16,721) | (68,347) |
Total liabilities and shareholders’ equity | $ 54,213 | $ 35,023 |
Consolidated and Combined Bal_2
Consolidated and Combined Balance Sheets (Parenthetical) | Dec. 31, 2019$ / sharesshares |
Statement Of Financial Position [Abstract] | |
Preferred stock, par value | $ / shares | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 |
Preferred stock, shares issued | 0 |
Preferred stock, shares outstanding | 0 |
Common stock, par value | $ / shares | $ 0.01 |
Common stock, shares authorized | 100,000,000 |
Common stock, shares issued | 9,350,709 |
Common stock, shares outstanding | 9,350,709 |
Consolidated and Combined State
Consolidated and Combined Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 20,061 | $ 35,583 |
General and administrative | 27,012 | 29,453 |
Change in contingent consideration valuation | (14,554) | 8,499 |
Total operating expenses | 32,519 | 73,535 |
Operating loss | (32,519) | (73,535) |
Other income (expense): | ||
Other income (expense) | (38) | (132) |
Net loss | $ (32,557) | $ (73,667) |
Per share information: | ||
Net loss per share of common stock, basic and diluted | $ (3.48) | $ (7.88) |
Weighted average common shares outstanding, basic and diluted | 9,350,709 | 9,350,709 |
Consolidated and Combined Sta_2
Consolidated and Combined Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Recro | Parent Company Net Investment | Parent Company Net InvestmentRecro | Common Stock | Additional Paid in Capital | Accumulated Deficit |
Balance at Dec. 31, 2017 | $ (62,457) | $ (62,457) | |||||
Stock-based compensation expense | $ 4,574 | $ 4,574 | |||||
Net transfer from parent company | 63,203 | 63,203 | |||||
Net loss | (73,667) | (73,667) | |||||
Balance at Dec. 31, 2018 | (68,347) | (68,347) | |||||
Stock-based compensation expense | 499 | $ 4,964 | $ 4,964 | $ 499 | |||
Issuance of common stock upon separation | $ 94 | (94) | |||||
Issuance of common stock upon separation, Shares | 9,350,709 | ||||||
Reclassification of parent company net investment | 33,480 | $ (33,480) | |||||
Net transfer from parent company | 60,268 | 60,268 | |||||
Contribution of cash by Recro Pharma,Inc. upon separation | 19,000 | 19,000 | |||||
Separation-related adjustments | (548) | (548) | |||||
Net loss | (32,557) | $ (30,365) | (2,192) | ||||
Balance at Dec. 31, 2019 | $ (16,721) | $ 94 | $ 19,405 | $ (36,220) | |||
Balance, Shares at Dec. 31, 2019 | 9,350,709 |
Consolidated and Combined Sta_3
Consolidated and Combined Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (32,557) | $ (73,667) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 5,463 | 4,574 |
Depreciation expense | 480 | 396 |
Change in contingent consideration valuation | (14,554) | 8,499 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 119 | (46) |
Right-of-use asset | 444 | |
Accounts payable, accrued expenses and other liabilities | (8,993) | 493 |
Operating lease liability | (446) | |
Net cash used in operating activities | (50,044) | (59,751) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,319) | (3,370) |
Acquisition of license agreement | (165) | (82) |
Net cash used in investing activities | (1,484) | (3,452) |
Cash flows from financing activities: | ||
Payments of contingent consideration | (10,000) | |
Contribution upon separation | 19,000 | |
Investment from parent company | 60,268 | 63,203 |
Net cash provided by financing activities | 69,268 | 63,203 |
Net increase in cash and cash equivalents | 17,740 | |
Cash and cash equivalents, end of year | $ 17,740 | |
Supplemental disclosure of cash flow information: | ||
Purchase of property, plant and equipment included in accrued expenses and accounts payable | $ 2,581 |
Background
Background | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Background | (1) Background Business Baudax Bio, Inc. (Baudax Bio or the Company) is a pharmaceutical company primarily focused on developing and commercializing innovative products for acute care settings. Baudax Bio believes it can bring valuable therapeutic options for patients, prescribers and payers, such as its lead product candidate, intravenous (IV) meloxicam, to the acute care markets. In March 2019, the Company received a second Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding the New Drug Application (NDA), for IV meloxicam, and in April 2019 the Company announced it had implemented a strategic restructuring initiative, and corresponding reduction in workforce, aimed at reducing operating expenses, while maintaining key personnel needed to evaluate strategic partnerships On October 31, 2019, the Company announced that it had received a written decision from the FDA granting its appeal of the CRL relating to the NDA seeking approval for IV meloxicam. The FDA granted the Company’s appeal and indicated that the Company’s application provides sufficient evidence of effectiveness and safety to support approval. The letter also states that before IV meloxicam can be approved and legally marketed, agreed upon labeling (prescribing information) must be negotiated with the FDA. The Company resubmitted the NDA for IV meloxicam in December 2019 and the FDA has set a PDUFA goal date of February 20, 2020. The Separation Pursuant to the Separation Agreement between Recro Pharma, Inc. (Recro) and Baudax Bio, Recro transferred the assets, liabilities, and operations of its Acute Care business to the Company (the Separation) and, on November 21, 2019, the distribution date, each Recro shareholder received one share of the Company’s common stock for every two and one-half shares of Recro common stock held of record at the close of business on November 15, 2019, the record date for the distribution (the Distribution). Additionally, Recro contributed $19,000 of cash to Baudax Bio in connection with the Separation. Following the Distribution and Separation, Baudax Bio operates as a separate, independent company. References to “the Company” represent Baudax Bio or the Acute Care Business of Recro for periods prior to the Separation. Basis of Presentation For all periods prior to the Separation, t he accompanying combined financial statements represent the Acute Care Business of Recro and are derived from Recro’s consolidated financial statements. The Acute Care Business of Recro did not consist of a separate, standalone group of legal entities for public company reporting and certain other corporate functions in the periods prior to the Separation and, accordingly, allocations were required through the Distribution date. These combined financial statements, prior to the Separation, reflect the Company’s historical financial position, results of operations and cash flows as the business was operated as part of Recro prior to the Separation, in conformity with U.S. generally accepted accounting principles (U.S. GAAP). See Note 15 for a description of the agreements entered into between Recro and Baudax Bio following the Separation. Prior to the Separation, the combined financial statements include certain assets and liabilities that have historically been held at the Recro corporate level, but which are specifically identifiable or allocable to the Company. All intracompany transactions and accounts have been eliminated. All intercompany transactions between the Company and Recro are considered to be effectively settled in the combined financial statements at the time the transaction is recorded. The total net effect of the settlement of these intercompany transactions is reflected in the combined statements of cash flows as a financing activity and in the combined balance sheet as parent company net investment. The Company does not record interest expense on amounts funded by Recro. Long-term debt held at the Recro corporate level was retained by Recro and was not assumed by the Company. Historically, certain corporate level activity costs have been incurred and reported within the legal entity that includes the Recro Acute Care Business. The Company’s combined financial statements, prior to the Separation, include an allocation of these expenses related to these certain Recro corporate functions, including senior management, legal, human resources, finance, and information technology through the distribution date. These expenses are included in general and administrative expense and have been allocated based on direct usage or benefit where identifiable, with the remainder allocated on a pro rata basis of expenses, headcount, or other measures. The Company considers the expense allocation methodology and results to be reasonable for all periods presented, however, the allocations may not be indicative of the actual expense that would have been incurred had the Company operated as an independent, publicly-traded company for the periods presented prior to the Separation. For the years ended December 31, 2019 (prior to the Separation) and 2018, a total of $7,278 and $5,165, respectively, of costs have been allocated to Recro’s contract manufacturing and development segment (the CDMO business). The income tax amounts in these combined financial statements for periods prior to the Separation have been calculated based on a separate return methodology and are presented as if the Company was a standalone taxpayer in each of its tax jurisdictions prior to the Separation. Because of the Company’s history of losses as a standalone entity, a full valuation allowance is recorded against deferred tax assets in all periods presented. Upon the Separation, the Company adopted its own share‑based compensation plan. Recro maintains its stock-based compensation plan at a corporate level. The Company’s employees participated in Recro’s stock-based compensation plans prior to the Separation and a portion of the cost of those plans is included in the Company’s combined financial statements using an allocation methodology similar to the methodology used to allocate the cash compensation of the related employees. The parent company net investment balances in these combined financial statements represents the accumulated deficit of the Recro Acute Care Business and the net funding provided to the Company, which are reflected as net transfers from parent in the combined statements of parent company net investment prior to the Separation. Subsequent to the Separation, the accompanying consolidated financial statements are presented on a consolidated basis and include all of the accounts and operations of Baudax Bio and its subsidiaries. The consolidated financial statements reflect the financial position, results of operations and cash flows of Baudax Bio in accordance with U.S. GAAP. All significant intercompany accounts and transactions are eliminated in consolidation. The Company has determined that it operates in a single segment involved in the development of innovative products for hospital and other acute care settings. |
Development-Stage Risks and Liq
Development-Stage Risks and Liquidity | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Development-Stage Risks and Liquidity | (2) Development-Stage Risks and Liquidity The Company has incurred losses from operations since inception and has an accumulated deficit of $36,220 as of December 31, 2019. The Company has a history of operating losses and negative cash flows while operating as part of Recro and, accordingly, was dependent upon Recro for its capital funding and liquidity needs. Recro contributed $19,000 to the Company immediately prior to the Distribution. Recro has not committed any additional funding to the Company beyond the $19,000 that was contributed as of the Distribution date and the Company will be required to raise additional funds needed to operate as a standalone entity. The Company’s ability to generate cash inflows is highly dependent on the approval and commercialization of IV meloxicam and there can be no assurance that such approval will be obtained or that IV meloxicam can be successfully commercialized. In addition, development activities, clinical and pre-clinical testing and commercialization of the Company’s product candidates, if approved, will require significant additional funding. The Company could delay clinical trial activity or reduce funding of specific programs in order to reduce cash needs. Insufficient funds may cause the Company to delay, reduce the scope of or eliminate one or more of its development, commercialization or expansion activities. The Company may raise such funds, if available, through debt financings, bank or other loans, through strategic research and development, licensing (including out-licensing) and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and failure to raise capital when needed could materially adversely impact the Company’s growth plans and its financial condition or results of operations. Additional debt or equity financing, if available, may be dilutive to future holders of its common stock and may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate its business. Management believes that cash and cash equivalents are sufficient to maintain operations through at least February 14, 2021, however, the Company may be required to wind down operations if IV meloxicam is not approved in the near term or cannot be successfully commercialized. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (3) Summary of Significant Accounting Principles ( a ) 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. ( b ) Cash and Cash Equivalents Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired to be cash equivalents. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of the changes in interest rates. ( c ) Property and Equipment Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to seven years for furniture and office equipment; six to ten years for manufacturing equipment; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred. ( d ) Business Combinations In accordance with Financial Accounting Standards Board (FASB), Accounting Standards Codification (ASC), Topic 805, “ Business Combinations ( e ) Goodwill and Intangible Assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company (see Note 4). Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a one-step method for determining impairment. The one-step quantitative test calculates the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The Company has one reporting unit. The Company’s intangible asset is classified as an IPR&D asset. Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss in its Consolidated and Combined Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30 th ( f ) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. ( g ) Research and Development Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-commercialization and manufacturing scale-up activities, drug development, pre-clinical activities, clinical trials, statistical analysis and report writing and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expenses relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use. ( h ) Stock-Based Awards Baudax Awards Share-based compensation included in the consolidated financial statements following the Separation is based upon the Baudax Bio share-based compensation plan. The plan includes grants of stock options and time-based vesting restricted stock units (RSUs). The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. The Company accounts for forfeitures as they occur. Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses an estimated historical volatility 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. Recro Awards The Recro plan includes grants of stock options, time-based vesting restricted stock units (RSUs) and performance-based vesting RSUs. The combined financial statements prior to the Separation reflect share-based compensation related to Recro stock options and RSUs issued to the Company’s employees as well as an allocation of a portion of Recro share-based compensation issued to corporate employees and members of the Board of Directors until the Separation date. Recro 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. 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. Recro The expected life of stock options was estimated using the “simplified method,” as Recro Recro ( i ) Income Taxes The income tax amounts in these combined financial statements for periods prior to the Separation have been calculated based on a separate return methodology and presented as if the Company was a standalone taxpayer in each of its tax jurisdictions. 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. Because of the Company’s history of losses as a standalone entity, a full valuation allowance is recorded against deferred tax assets in all periods presented. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the combined 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. ( j ) Net Loss Per Common Share Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period. For the years ending December 31, 2019 and 2018, the outstanding common stock options and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Prior to the distribution date of November 21, 2019, there were no Baudax Bio shares outstanding, as such, the shares outstanding immediately after the Distribution were used to calculate the net loss per share for all pre-Separation periods presented. The following table sets forth the computation of basic and diluted loss per share: Year ended December 31, 2019 2018 Basic Loss Per Share Net loss $ (32,557 ) $ (73,667 ) Weighted average common shares outstanding, basic and diluted 9,350,709 9,350,709 Net loss per share of common stock, basic and diluted $ (3.48 ) $ (7.88 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2019 and 2018 as they would be anti-dilutive: December 31, 2019 Options and restricted stock units outstanding 2,023,909 Amounts in the table above reflect the common stock equivalents of the noted instruments. ( k ) Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update ( Leases (Topic 842) Targeted Improvements Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, Fair Value Measurement |
Acquisition of Gainesville Faci
Acquisition of Gainesville Facility and Meloxicam | 12 Months Ended |
Dec. 31, 2019 | |
Gainesville Facility | |
Acquisition of Gainesville Facility and Meloxicam | (4) Acquisition of Gainesville Facility and Meloxicam On April 10, 2015, the Company completed the acquisition of a manufacturing facility in Gainesville, Georgia and the licensing and commercialization rights to IV meloxicam (the Alkermes Transaction). The consideration paid in connection with the Alkermes Transaction consisted of $50,000 cash at closing, a $4,000 working capital adjustment and a seven-year warrant to purchase 350,000 shares of Recro’s common stock at an exercise price of $19.46 per share. In addition, the Company may be required to pay up to an additional $125,000 in milestone payments including $45,000 upon regulatory approval of IV meloxicam, as well as net sales milestones related to IV meloxicam and a percentage of future product net sales related to IV meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and royalties were allocated to the fair value of the assets acquired and liabilities assumed. The contingent consideration obligation is remeasured each reporting date with changes in fair value recognized as a period charge within the statement of operations (see Note 6 for further information regarding fair value). The assets acquired, including goodwill, and liabilities assumed in the Alkermes Transaction were allocated to the Company’s reporting units as of the date of the acquisition. The accompanying consolidated and combined financial statements reflect the IPR&D asset of $26,400 and goodwill of $2,127 that were recorded by the Company related to the Alkermes transaction. The warrant associated with the transaction remains on Recro’s Consolidated and Combined Balance Sheets with no allocation to the Company as it is a warrant to purchase Recro common stock. The Company did not assume any obligation in connection with the warrant as of result of the Separation. In December 2018, the Company Based on the amended terms of the Alkermes agreement, the contingent consideration consists of four separate components. The first component is (i) a $5,000 payment made in the first quarter of 2019 and (ii) a $5,000 payment made in the second quarter of 2019. The second components will be payable upon certain regulatory approval and include (i) a $5,000 payment due within 180 days following regulatory approval for IV meloxicam and (ii) $45,000 payable in seven equal annual payments of approximately $6,400 beginning on the first anniversary of such approval. The third component consists of three potential payments, based on the achievement of specified annual revenue targets, the last of which represents over 60% of these milestone payments and currently does not have a fair value assigned to its achievement. The fourth component consists of a royalty payment between 10% and 12% (subject to a 30% reduction when no longer covered by patent) for a defined term on future meloxicam net sales. During the year ended December 31, 2019, the Company paid the first component consisting of two payments of $5,000 each to Alkermes. The fair value of the contingent consideration liability is measured as the reporting date using inputs and assumptions as of the date of the financial statements. Events and circumstances impacting the fair value of the liability that occur after the balance sheet date, but before the date that the financial statements are available to be issued are adjusted in the period during which such events and circumstances occur. The fair value of the second contingent consideration component is estimated by applying a risk-adjusted discount rate to the probability-adjusted contingent payments and the expected approval dates. The fair value of the third contingent consideration component is estimated using the Monte Carlo simulation method and applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections based upon the expected revenue target attainment dates. The fair value of the fourth contingent consideration component is estimated by applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections and the defined royalty percentage. These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs. The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair value through the results of operations. |
NMBA Related License Agreement
NMBA Related License Agreement | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
NMBA Related License Agreement | (5) NMBA Related License Agreement In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBAs, and a proprietary reversal agent from Cornell University, or Cornell. The NMBAs and reversal agent are referred to herein as the NMBA Related Compounds. The NMBA Related Compounds include one novel intermediate-acting NMBA that has initiated Phase I clinical trials and two other agents, a novel short-acting NMBA, and a rapid-acting reversal agent specific to these NMBAs. The transaction was accounted for as an asset acquisition, with the total cost of the acquisition of $766 allocated to acquired IPR&D. The Company recorded an upfront payment obligation of $350, as well as operational liabilities and acquisition-related costs of $416, primarily consisting of reimbursement to Cornell for specified past patent, legal and pre-clinical costs. In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the NMBA Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each NMBA, of $5,000 for U.S. regulatory approval and commercialization milestones and $3,000 for European regulatory approval and commercialization milestones. The Company is also obligated to pay Cornell royalties on net sales of the NMBA Related Compounds at a rate ranging from low to mid-single digits, depending on the applicable NMBA Related Compounds and whether there is a valid patent claim in the applicable country, subject to an annual minimum royalty amount. Further, the Company will reimburse Cornell ongoing patent costs related to prosecution and maintenance of the patents related to the Cornell patents for the NMBA Related Compounds. The Company accounted for the transaction as an asset acquisition based on an evaluation of the accounting guidance (ASC Topic 805) and considered the early clinical stage of the novel and unproven NMBA Related Compounds. The Company concluded that the acquired IPR&D of Cornell did not constitute a business as defined under ASC 805 due to the incomplete nature of the inputs and the absence of processes from a market participant perspective. Substantial additional research and development will be required to develop any NMBA Related Compounds into a commercially viable drug candidate, including completion of pre-clinical testing and clinical trials, and, if such clinical trials are successful, application for regulatory approvals and manufacturing repeatability and scale-up. There is risk that a marketable compound may not be well tolerated and may never be approved. Acquired IPR&D in the asset acquisition was accounted for in accordance with FASB ASC Topic 730, “ Research and Development |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (6) Fair Value of Financial Instruments The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company has classified assets and liabilities measured at fair value on a recurring basis as follows: Fair value measurements at reporting date using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) At December 31, 2018: Liabilities: Contingent consideration (See Note 4) $ — $ — $ 90,912 $ — $ — $ 90,912 At December 31, 2019: Assets: Cash equivalents Money market mutual funds (See Note 7) $ 16,514 $ — $ — Total cash equivalents $ 16,514 $ — $ — Liabilities: Contingent consideration (See Note 4) $ — $ — $ 66,358 $ — $ — $ 66,358 The reconciliation of the contingent consideration measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows: Contingent Consideration Balance at December 31, 2017 $ 82,413 Remeasurement 8,499 Balance at December 31, 2018 $ 90,912 Payment of contingent consideration (10,000 ) Remeasurement (14,554 ) Total at December 31, 2019 $ 66,358 Current portion as of December 31, 2019 3,592 Long-term portion as of December 31, 2019 $ 62,766 The current portion of the contingent consideration represents the estimated probability adjusted fair value that is expected to become payable within one year as of December 31, 2019 (see Note 4 for additional information). The Company plans to reevaluate this classification as it progresses discussions with the FDA regarding the December 2019 resubmission of its NDA and approaches the new PDUFA date of February 20, 2020. The Company follows the disclosure provisions of FASB ASC Topic 825, “ Financial Instruments |
Cash Equivalents
Cash Equivalents | 12 Months Ended |
Dec. 31, 2019 | |
Cash And Cash Equivalents [Abstract] | |
Cash Equivalents | (7) Cash Equivalents Cash equivalents as of December 31, 2019 include money market funds. The following is a summary of cash equivalents: December 31, 2019 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 16,514 $ — $ — $ 16,514 Total cash equivalents $ 16,514 $ — $ — $ 16,514 As of December 31, 2019, the Company’s cash equivalents had maturities of one month. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | ( 8 ) Property, Plant and Equipment Property, plant and equipment consists of the following: December 31, 2019 December 31, 2018 Building and improvements $ 196 $ 196 Furniture, office and computer equipment 1,518 1,688 Manufacturing equipment 101 101 Construction in progress 3,846 2,469 5,661 4,454 Less: accumulated depreciation and amortization 840 472 Property, plant and equipment, net $ 4,821 $ 3,982 Depreciation expense for the years ended December 31, 2019 and 2018 was $480 and $396, respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | ( 9 ) Intangible Assets The following represents the balance of the intangible assets at December 31, 2019 and 2018: Cost In-process research and development $ 26,400 Total $ 26,400 There was no amortization expense for the years ended December 31, 2019 and 2018. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | (1 0 ) Accrued Expenses Accrued expenses consist of the following: December 31, December 31, 2019 2018 Payroll and related costs $ 2,181 $ 2,172 Professional and consulting fees 209 671 Clinical trial and related costs — 683 Property plant and equipment — 278 Pre-commercialization scale-up costs — 4,445 Other research and development costs 538 678 Guarantee liability 548 — Other 56 846 $ 3,532 $ 9,773 After the receipt of the second CRL, the Company incurred approximately $7,200 in restructuring costs (all of which were incurred in the first half of 2019. The remaining liability associated with the restructuring plan was retained by Recro and does not represent an obligation of the Company following the Separation. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (1 1 ) Commitments and Contingencies (a) License and Supply Agreements The Company is party to an exclusive license with Orion for the development and commercialization of Dexmedetomidine for use in the treatment of pain in humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational) delivery, but specifically excluding delivery vehicles for administration by injection or infusion, worldwide, except for Europe, Turkey and the CIS (currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan), referred to herein as the Territory. The Company is required to pay Orion lump sum payments of up to €20,500 ($22,990 as of December 31, 2019) on the achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 20% depending on annual sales levels. Through December 31, 2019, no such milestones have been achieved. The Company is also party to an exclusive license agreement with Orion for the development and commercialization of Fadolmidine for use as a human therapeutic, in any dosage form in the Territory. The Company is required to pay Orion lump sum payments of up to €12,200 ($13,682 as of December 31, 2019) on achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 15% depending on annual sales levels. Through December 31, 2019, no such milestones have been achieved. The Company is party to a license agreement with Cornell for the exclusive license of the NMBA Related Compounds. Under the terms of the agreement, will pay Cornell an initial upfront fee and Cornell is also entitled to receive additional milestone payments, annual license maintenance fees as well as royalties. See Note 5 for further information regarding these payment obligations. (b) Contingent Consideration for the Alkermes Transaction Pursuant to the purchase and sale agreement and subsequent amendment governing the Alkermes Transaction, the Company December 31, 2019 The Company is party to a Development, Manufacturing and Supply Agreement (Supply Agreement), with Alkermes (through a subsidiary of Alkermes), pursuant to which Alkermes will (i) provide clinical and commercial bulk supplies of IV meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls section of an NDA for IV meloxicam. Pursuant to the Supply Agreement, Alkermes will supply the Company with such quantities of bulk IV meloxicam formulation as shall be reasonably required for the completion of clinical trials of IV meloxicam. During the term of the Supply Agreement, the Company will purchase its clinical and commercial supplies of bulk IV meloxicam formulation exclusively from Alkermes, subject to certain exceptions, for a period of time. (c) Litigation The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. On May 31, 2018, a securities class action lawsuit, or the Securities Litigation, was filed against Recro and certain of Recro’s officers and directors in the U.S. District Court for the Eastern District of Pennsylvania (Case No. 2:18-cv-02279-MMB) that purported to state a claim for alleged violations of Section 10(b) and 20(a) of the Exchange Act and Rule 10(b)(5) promulgated thereunder, based on statements made by Recro concerning the NDA for IV meloxicam. The complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, lead plaintiff filed an amended complaint that asserted the same claims and sought the same relief but included new allegations and named additional officers 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 Judge, the parties submitted supplemental briefs with regard to the motion to dismiss the amended complaint during the fall of 2019. There has been no decision on the motion. In connection with the Separation, the Company accepted assignment by Recro of all of Recro ’ (d) Leases The Company is a party to various operating leases in Malvern, Pennsylvania and Dublin, Ireland for office space and office equipment. The Company determines if an arrangement is a lease at inception. The arrangement is a lease if it conveys the right to the Company to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Lease terms vary based on the nature of operations, however, all leased facilities are classified as operating leases with remaining lease terms of less than 1 year and 3 years. Most leases contain specific renewal options where notice to renew must be provided in advance of lease expiration or automatic renewals where no advance notice is required. Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. Costs determined to be variable and not based on an index or rate were not included in the measurement of operating lease liabilities. As most leases do not provide an implicit rate, the Company’s effective interest rate was used to discount its lease liabilities. The Company’s leases with an initial term of 12 months or less that do not have a purchase option or extension that is reasonably certain to be exercised are not included in the right of use asset or lease liability on the Consolidated and Combined Balance Sheets. Lease expense is recognized on a straight-line basis over the lease term. As of December 31, 2019, undiscounted future lease payments for non-cancellable operating leases are as follows: Lease payments 2020 $ 401 2021 362 2022 373 Total lease payments 1,136 Less imputed interest (363 ) Total operating liabilities $ 773 As of December 31, 2018 under legacy ASC 840 “ Leases Lease payments 2019 $ 517 2020 414 2021 367 2022 373 Total $ 1,671 For the year ended December 31, 2019, the weighted average remaining lease term was 3 years and the weighted average discount rate was 16%. The components of the Company’s lease cost were as follows for the year ended December 31, 2019: Operating lease cost $ 484 Short-term lease cost 12 Total lease cost $ 496 (e) Purchase Commitments As of December 31, 2019, the Company had outstanding non-cancelable and cancelable purchase commitments of $3,920 related to inventory and other goods and services, including pre-commercial/manufacturing scale-up and clinical activities. (f) Certain Compensation and Employment Agreements The Company has entered into employment agreements with certain of its named executive officers. As of December 31, 2019, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $1,018 from that date through calendar year 2020. |
Capital Structure
Capital Structure | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Capital Structure | (1 2 ) Capital Structure (a) Common Stock On November 21, 2019, the Company separated from Recro as a result of a special dividend distribution of all the outstanding shares of its common stock to Recro shareholders. On the distribution date, each Recro shareholder received one share of Baudax Bio’s common stock for every two and one-half shares of Recro common stock held of record at the close of business on November 15, 2019. Upon the Distribution, 9,396,583 shares of common stock were issued, of which 45,874 were distributed after December 31, 2019. The Company is authorized to issue 100,000,000 shares of common stock, with a par value of $0.01 per share. On February 13, 2020, the Company entered into a Sales Agreement (the “Agreement”) with JMP Securities LLC, as sales agent (the “Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.01 per share, in an aggregate offering price of up to $25,000 (the “Shares”) through the Agent. To date, no shares have been sold under the Agreement. (b) Preferred Stock The Company is authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.01 per share. As of December 31, 2019, no preferred stock was issued or outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | (1 3 ) Stock-Based Compensation In connection with the Separation, the Company adopted its own share‑based compensation plan, the Baudax Bio, Inc. 2019 Equity Incentive Plan, or the 2019 Plan, which allows for the grant of stock options, stock appreciation rights and stock awards for a total of 3,000,000 shares of common stock. On December 1 st st Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of December 31, 2019, 1,443,626 shares are available for future grants under the 2019 Plan. The weighted average grant-date fair value of the Baudax Bio options awarded to employees during the year ended December 31, 2019 was $4.29. Under the 2019 Plan, the fair value of the Baudax Bio options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: December 31, 2019 Range of expected option life 6 years Expected volatility 77.81% Risk-free interest rate 1.68% Expected dividend yield — Certain employees of the Company participated in Recro’s stock-based compensation plan, which provides for the grants of stock options and RSUs. The combined financial statements prior to the Separation reflect stock-based compensation expense related to Recro stock options and RSUs issued to the Company’s employees as well an allocation of a portion of Recro share-based compensation issued to corporate employees and members of the Board of Directors until the Separation date. The weighted average grant-date fair value of the options awarded to employees under the Recro plan during the years ended December 31, 2019 (prior to the Separation date) and 2018 was $5.53 and $6.07, respectively. Under the Recro equity incentive plan for the year ended December 31, 2018, the fair value of the options granted to employees of the Company was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: December 31, 2019 2018 Range of expected option life 5.5 - 6 years 5.5 - 6 years Expected volatility 74.69% - 80.59% 73.26% - 82.00% Risk-free interest rate 1.42 - 2.66% 2.32 - 3.03% Expected dividend yield — — The following table summarizes the Baudax Bio stock option activity during the year ended December 31, 2019: Number of shares Weighted average exercise price Weighted average remaining contractual life Granted 643,879 $ 6.33 Exercised — $ — Expired/forfeited/cancelled — $ — Balance, December 31, 2019 643,879 $ 6.33 9.9 years Vested — $ — Vested and expected to vest 643,879 $ 6.33 9.9 years The following table summarizes the Baudax Bio restricted stock units activity during the year ended December 31, 2019: Number of shares Granted 1,380,030 Vested and settled — Expired/forfeited/cancelled — Balance, December 31, 2019 1,380,030 Expected to vest 1,380,030 Stock-based compensation expense for the twelve months ended December 31, 2019 and 2018 was $5,463 and $4,574, respectively. This represents the allocated portion of Recro stock-based compensation expense through the Separation date in addition to the Company’s expense post-separation. As of December 31, 2019, there was $10,996 of unrecognized compensation expense related to unvested options and time-based RSUs that are expected to vest and will be expensed over a weighted average period of 2.5 years. The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. As of December 31, 2019, the aggregate intrinsic value of the unvested Baudax Bio options was $380. There are no vested options as of December 31, 2019. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (1 4 ) Income Taxes The components of loss before income tax are as follows: December 31, 2019 2018 Domestic $ (16,417 ) $ (43,505 ) Foreign (16,140 ) (30,162 ) Loss before income taxes $ (32,557 ) $ (73,667 ) The components of income tax provision (benefit) are as follows: December 31, 2019 2018 Current: Federal $ — $ — State and local — — Foreign — — — — Deferred: Federal $ (3,440 ) $ (10,034 ) State and local (1,206 ) (4,026 ) Foreign (2,018 ) (3,770 ) (6,664 ) (17,830 ) Change in valuation allowance 6,664 17,830 $ — $ — A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2019 2018 U.S. federal statutory income tax rate 21.0 % 21.0 % Foreign tax rate differential (4.2 )% (3.5 )% State taxes, net of federal benefit 3.7 % 5.5 % Nondeductible expenses — 0.3 % Research and development credits — 0.7 % Change in federal tax rate — 0.1 % Change in valuation allowance (20.5 )% (24.2 )% Other — 0.1 % Effective income tax rate — — The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2019 2018 Net operating loss carryforwards $ 1,065 $ 24,384 Research and development credits — 972 Capitalized start-up costs — 1,489 Intangibles 2,056 206 Contingent consideration 10,924 9,746 Stock-based compensation 142 3,924 Other temporary differences (12 ) 161 Gross deferred tax asset 14,175 40,882 Valuation allowance (14,094 ) (40,618 ) Net deferred tax asset 81 264 Deferred tax liability (81 ) (264 ) Net deferred taxes $ — $ — For periods prior to the Separation, the income tax provision was prepared on a separate return methodology and presented as if the Company was a standalone taxpayer in each of its tax jurisdictions. Accordingly, deferred tax assets as of December 31, 2018 represent the hypothetical deferred taxes that were applicable to the Company as it were a separate company during periods prior to the Separation. Within the Company’s deferred tax assets as of December 31, 2018 are amounts included for net operating loss carryforwards and research and development credits, as these are the amounts that would have been generated by the Company on a separate basis prior to the transaction for 2018 and 2017. These tax attributes were included as of December 31, 2018, based on the separate return methodology. As a result of the Separation, not all of the tax attributes that existed as of December 31, 2018 carried forward to the Company subsequent to the transaction. In assessing the realizability of the net deferred tax asset, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. In 2019 and 2018, the Company evaluated the need for a valuation allowance against its U.S. and state deferred tax assets based on the available positive and negative evidence available as if the Company was a standalone entity for all periods presented. An important aspect of objective negative evidence evaluated was the Company’s historical operating results over its life to date. The Company is in a three-year cumulative loss position through December 31, 2019. Thus, it is more likely than not that the Company’s U.S. and state deferred tax assets will not be realized and a full valuation allowance has been recognized against the Company’s U.S. and state deferred tax assets. The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2019: Amount Expiration Federal net operating losses - 2019 $ 1,357 No expiration State net operating losses $ 1,357 2028 – 2038 Foreign net operating losses $ 672 No expiration Under the Tax Reform Act of 1986, as amended (the “Act”), the utilization of a corporation’s net operating loss and research and development tax credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any unused annual limitation may be carried forward to future years for the balance of the carryforward period. The Company has done an analysis to determine whether or not ownership changes, as defined by the Act, have occurred since inception. The Company determined that it experienced ownership changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past financings; accordingly, the Company’s ability to utilize the aforementioned carryforwards will be limited. In addition, state net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward, respectively. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2019, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | ( 15 ) Related Party Transactions A Non-Executive Director of the Company’s Irish subsidiary is a Managing Director and a majority shareholder of HiTech Health Ltd, or HiTech Health, a consultancy firm for the biotech, pharmaceutical and medical device industry. Since 2016, HiTech Health has provided the Company with certain consulting services and in November 2017 both parties entered into a Service Agreement to engage in both regulatory and supply chain project support and consultancy. In consideration for such services, the Company recorded $171 and $309 of expenses for the twelve months ended December 31, 2019 and 2018, respectively. A portion of the amount relates to consultancy services provided by the Non-Executive Director. Recro became a related party to the Company following the Separation. As part of the Separation, the Company entered into a transition services agreement with Recro. Under the transition services agreement, the Company provides certain services to Recro, each related to corporate functions, and are charged to Recro. Additionally, Recro may incur expenses that are directly related to the Company after the Separation, which are billed to the Company. For the year ended December 31, 2019, for periods subsequent to the Separation, the Company recorded income of $206 related to the transition services agreement, which is recorded as a reduction in general and administrative expenses. The Company recorded a net receivable of $273 for such activities and other activity with Recro as of December 31, 2019. In connection with the Separation, Recro and Baudax entered into an Employee Matters Agreement. The Employee Matters Agreement allocates liabilities and responsibilities relating to employee compensation and benefits plans and programs and other related matters in connection with the Distribution including, without limitation, the treatment of outstanding Recro equity awards. In connection with the Separation, Recro and Baudax entered into a Tax Matters Agreement that governs the parties’ respective rights, responsibilities and obligations with respect to taxes, tax attributes, the preparation and filing of tax returns, the control of audits and other tax proceedings and other matters regarding taxes for any tax period ending on or before the Distribution date, as well as tax periods beginning after the Distribution date. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan | (16) Retirement Plan The Company has a voluntary 401(k) Savings Plan (the 401(k) Plan) in which all employees are eligible to participate. The Company’s policy is to match 100% of the employee contributions up to a maximum of 5% of employee compensation. Total Company contributions to the 401(k) plan for the year ended December 31, 2019 and 2018 were $307 and $540, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation For all periods prior to the Separation, t he accompanying combined financial statements represent the Acute Care Business of Recro and are derived from Recro’s consolidated financial statements. The Acute Care Business of Recro did not consist of a separate, standalone group of legal entities for public company reporting and certain other corporate functions in the periods prior to the Separation and, accordingly, allocations were required through the Distribution date. These combined financial statements, prior to the Separation, reflect the Company’s historical financial position, results of operations and cash flows as the business was operated as part of Recro prior to the Separation, in conformity with U.S. generally accepted accounting principles (U.S. GAAP). See Note 15 for a description of the agreements entered into between Recro and Baudax Bio following the Separation. Prior to the Separation, the combined financial statements include certain assets and liabilities that have historically been held at the Recro corporate level, but which are specifically identifiable or allocable to the Company. All intracompany transactions and accounts have been eliminated. All intercompany transactions between the Company and Recro are considered to be effectively settled in the combined financial statements at the time the transaction is recorded. The total net effect of the settlement of these intercompany transactions is reflected in the combined statements of cash flows as a financing activity and in the combined balance sheet as parent company net investment. The Company does not record interest expense on amounts funded by Recro. Long-term debt held at the Recro corporate level was retained by Recro and was not assumed by the Company. Historically, certain corporate level activity costs have been incurred and reported within the legal entity that includes the Recro Acute Care Business. The Company’s combined financial statements, prior to the Separation, include an allocation of these expenses related to these certain Recro corporate functions, including senior management, legal, human resources, finance, and information technology through the distribution date. These expenses are included in general and administrative expense and have been allocated based on direct usage or benefit where identifiable, with the remainder allocated on a pro rata basis of expenses, headcount, or other measures. The Company considers the expense allocation methodology and results to be reasonable for all periods presented, however, the allocations may not be indicative of the actual expense that would have been incurred had the Company operated as an independent, publicly-traded company for the periods presented prior to the Separation. For the years ended December 31, 2019 (prior to the Separation) and 2018, a total of $7,278 and $5,165, respectively, of costs have been allocated to Recro’s contract manufacturing and development segment (the CDMO business). The income tax amounts in these combined financial statements for periods prior to the Separation have been calculated based on a separate return methodology and are presented as if the Company was a standalone taxpayer in each of its tax jurisdictions prior to the Separation. Because of the Company’s history of losses as a standalone entity, a full valuation allowance is recorded against deferred tax assets in all periods presented. Upon the Separation, the Company adopted its own share‑based compensation plan. Recro maintains its stock-based compensation plan at a corporate level. The Company’s employees participated in Recro’s stock-based compensation plans prior to the Separation and a portion of the cost of those plans is included in the Company’s combined financial statements using an allocation methodology similar to the methodology used to allocate the cash compensation of the related employees. The parent company net investment balances in these combined financial statements represents the accumulated deficit of the Recro Acute Care Business and the net funding provided to the Company, which are reflected as net transfers from parent in the combined statements of parent company net investment prior to the Separation. Subsequent to the Separation, the accompanying consolidated financial statements are presented on a consolidated basis and include all of the accounts and operations of Baudax Bio and its subsidiaries. The consolidated financial statements reflect the financial position, results of operations and cash flows of Baudax Bio in accordance with U.S. GAAP. All significant intercompany accounts and transactions are eliminated in consolidation. The Company has determined that it operates in a single segment involved in the development of innovative products for hospital and other acute care settings. |
Use of Estimates | ( a ) 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 | ( b ) Cash and Cash Equivalents Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired to be cash equivalents. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of the changes in interest rates. |
Property and Equipment | ( c ) Property and Equipment Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to seven years for furniture and office equipment; six to ten years for manufacturing equipment; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred. |
Business Combinations | ( d ) Business Combinations In accordance with Financial Accounting Standards Board (FASB), Accounting Standards Codification (ASC), Topic 805, “ Business Combinations |
Goodwill and Intangible Assets | ( e ) Goodwill and Intangible Assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company (see Note 4). Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a one-step method for determining impairment. The one-step quantitative test calculates the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The Company has one reporting unit. The Company’s intangible asset is classified as an IPR&D asset. Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss in its Consolidated and Combined Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30 th |
Concentration of Credit Risk | ( f ) Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. |
Research and Development | ( g ) Research and Development Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-commercialization and manufacturing scale-up activities, drug development, pre-clinical activities, clinical trials, statistical analysis and report writing and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expenses relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use. |
Stock-Based Awards | ( h ) Stock-Based Awards Baudax Awards Share-based compensation included in the consolidated financial statements following the Separation is based upon the Baudax Bio share-based compensation plan. The plan includes grants of stock options and time-based vesting restricted stock units (RSUs). The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. The Company accounts for forfeitures as they occur. Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses an estimated historical volatility 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. Recro Awards The Recro plan includes grants of stock options, time-based vesting restricted stock units (RSUs) and performance-based vesting RSUs. The combined financial statements prior to the Separation reflect share-based compensation related to Recro stock options and RSUs issued to the Company’s employees as well as an allocation of a portion of Recro share-based compensation issued to corporate employees and members of the Board of Directors until the Separation date. Recro 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. 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. Recro The expected life of stock options was estimated using the “simplified method,” as Recro Recro |
Income Taxes | ( i ) Income Taxes The income tax amounts in these combined financial statements for periods prior to the Separation have been calculated based on a separate return methodology and presented as if the Company was a standalone taxpayer in each of its tax jurisdictions. 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. Because of the Company’s history of losses as a standalone entity, a full valuation allowance is recorded against deferred tax assets in all periods presented. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the combined financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. |
Net Loss Per Common Share | ( j ) Net Loss Per Common Share Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period. For the years ending December 31, 2019 and 2018, the outstanding common stock options and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Prior to the distribution date of November 21, 2019, there were no Baudax Bio shares outstanding, as such, the shares outstanding immediately after the Distribution were used to calculate the net loss per share for all pre-Separation periods presented. The following table sets forth the computation of basic and diluted loss per share: Year ended December 31, 2019 2018 Basic Loss Per Share Net loss $ (32,557 ) $ (73,667 ) Weighted average common shares outstanding, basic and diluted 9,350,709 9,350,709 Net loss per share of common stock, basic and diluted $ (3.48 ) $ (7.88 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2019 and 2018 as they would be anti-dilutive: December 31, 2019 Options and restricted stock units outstanding 2,023,909 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Recent Accounting Pronouncements | ( k ) Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update ( Leases (Topic 842) Targeted Improvements Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, Fair Value Measurement |
Summary of Significant Accoun_3
Summary of Significant Accounting Principles (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Computation of Basic and Diluted Loss Per Share | The following table sets forth the computation of basic and diluted loss per share: Year ended December 31, 2019 2018 Basic Loss Per Share Net loss $ (32,557 ) $ (73,667 ) Weighted average common shares outstanding, basic and diluted 9,350,709 9,350,709 Net loss per share of common stock, basic and diluted $ (3.48 ) $ (7.88 ) |
Schedule of Anti-Dilutive Securities | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of December 31, 2019 and 2018 as they would be anti-dilutive: December 31, 2019 Options and restricted stock units outstanding 2,023,909 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis | The Company has classified assets and liabilities measured at fair value on a recurring basis as follows: Fair value measurements at reporting date using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) At December 31, 2018: Liabilities: Contingent consideration (See Note 4) $ — $ — $ 90,912 $ — $ — $ 90,912 At December 31, 2019: Assets: Cash equivalents Money market mutual funds (See Note 7) $ 16,514 $ — $ — Total cash equivalents $ 16,514 $ — $ — Liabilities: Contingent consideration (See Note 4) $ — $ — $ 66,358 $ — $ — $ 66,358 |
Reconciliation of Contingent Consideration Measured at Fair Value on Recurring Basis Using Unobservable Inputs | The reconciliation of the contingent consideration measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows: Contingent Consideration Balance at December 31, 2017 $ 82,413 Remeasurement 8,499 Balance at December 31, 2018 $ 90,912 Payment of contingent consideration (10,000 ) Remeasurement (14,554 ) Total at December 31, 2019 $ 66,358 Current portion as of December 31, 2019 3,592 Long-term portion as of December 31, 2019 $ 62,766 |
Cash Equivalents (Tables)
Cash Equivalents (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Cash And Cash Equivalents [Abstract] | |
Summary of Cash Equivalents | December 31, 2019 Amortized Gross Unrealized Estimated Description Cost Gain Loss Fair Value Money market mutual funds $ 16,514 $ — $ — $ 16,514 Total cash equivalents $ 16,514 $ — $ — $ 16,514 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following: December 31, 2019 December 31, 2018 Building and improvements $ 196 $ 196 Furniture, office and computer equipment 1,518 1,688 Manufacturing equipment 101 101 Construction in progress 3,846 2,469 5,661 4,454 Less: accumulated depreciation and amortization 840 472 Property, plant and equipment, net $ 4,821 $ 3,982 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Balance of Intangible Assets | The following represents the balance of the intangible assets at December 31, 2019 and 2018: Cost In-process research and development $ 26,400 Total $ 26,400 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: December 31, December 31, 2019 2018 Payroll and related costs $ 2,181 $ 2,172 Professional and consulting fees 209 671 Clinical trial and related costs — 683 Property plant and equipment — 278 Pre-commercialization scale-up costs — 4,445 Other research and development costs 538 678 Guarantee liability 548 — Other 56 846 $ 3,532 $ 9,773 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases | As of December 31, 2019, undiscounted future lease payments for non-cancellable operating leases are as follows: Lease payments 2020 $ 401 2021 362 2022 373 Total lease payments 1,136 Less imputed interest (363 ) Total operating liabilities $ 773 |
Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases under Legacy ASC 840 | As of December 31, 2018 under legacy ASC 840 “ Leases Lease payments 2019 $ 517 2020 414 2021 367 2022 373 Total $ 1,671 |
Schedule of Components Least Cost | The components of the Company’s lease cost were as follows for the year ended December 31, 2019: Operating lease cost $ 484 Short-term lease cost 12 Total lease cost $ 496 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model | Under the 2019 Plan, the fair value of the Baudax Bio options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: December 31, 2019 Range of expected option life 6 years Expected volatility 77.81% Risk-free interest rate 1.68% Expected dividend yield — Under the Recro equity incentive plan for the year ended December 31, 2018, the fair value of the options granted to employees of the Company was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions: December 31, 2019 2018 Range of expected option life 5.5 - 6 years 5.5 - 6 years Expected volatility 74.69% - 80.59% 73.26% - 82.00% Risk-free interest rate 1.42 - 2.66% 2.32 - 3.03% Expected dividend yield — — |
Summary of Stock Option Activity | The following table summarizes the Baudax Bio stock option activity during the year ended December 31, 2019: Number of shares Weighted average exercise price Weighted average remaining contractual life Granted 643,879 $ 6.33 Exercised — $ — Expired/forfeited/cancelled — $ — Balance, December 31, 2019 643,879 $ 6.33 9.9 years Vested — $ — Vested and expected to vest 643,879 $ 6.33 9.9 years |
Summary of Restricted Stock Units Activity | The following table summarizes the Baudax Bio restricted stock units activity during the year ended December 31, 2019: Number of shares Granted 1,380,030 Vested and settled — Expired/forfeited/cancelled — Balance, December 31, 2019 1,380,030 Expected to vest 1,380,030 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Tax | The components of loss before income tax are as follows: December 31, 2019 2018 Domestic $ (16,417 ) $ (43,505 ) Foreign (16,140 ) (30,162 ) Loss before income taxes $ (32,557 ) $ (73,667 ) |
Components of Income Tax Provision (Benefit) | The components of income tax provision (benefit) are as follows: December 31, 2019 2018 Current: Federal $ — $ — State and local — — Foreign — — — — Deferred: Federal $ (3,440 ) $ (10,034 ) State and local (1,206 ) (4,026 ) Foreign (2,018 ) (3,770 ) (6,664 ) (17,830 ) Change in valuation allowance 6,664 17,830 $ — $ — |
Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate | A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2019 2018 U.S. federal statutory income tax rate 21.0 % 21.0 % Foreign tax rate differential (4.2 )% (3.5 )% State taxes, net of federal benefit 3.7 % 5.5 % Nondeductible expenses — 0.3 % Research and development credits — 0.7 % Change in federal tax rate — 0.1 % Change in valuation allowance (20.5 )% (24.2 )% Other — 0.1 % Effective income tax rate — — |
Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2019 2018 Net operating loss carryforwards $ 1,065 $ 24,384 Research and development credits — 972 Capitalized start-up costs — 1,489 Intangibles 2,056 206 Contingent consideration 10,924 9,746 Stock-based compensation 142 3,924 Other temporary differences (12 ) 161 Gross deferred tax asset 14,175 40,882 Valuation allowance (14,094 ) (40,618 ) Net deferred tax asset 81 264 Deferred tax liability (81 ) (264 ) Net deferred taxes $ — $ — |
Summary of Federal Net Operating Losses and Tax Credits Carryforwards | The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2019: Amount Expiration Federal net operating losses - 2019 $ 1,357 No expiration State net operating losses $ 1,357 2028 – 2038 Foreign net operating losses $ 672 No expiration |
Background - Additional Informa
Background - Additional Information (Details) - USD ($) $ in Thousands | Nov. 21, 2019 | Nov. 15, 2019 | Nov. 20, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
General and administrative | $ 27,012 | $ 29,453 | |||
Recro | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Right to receive common stock | 1 | ||||
Number of shares held for distribution of new shares | 2.5 | ||||
Recro | CDMO | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
General and administrative | $ 7,278 | $ 5,165 | |||
Separation | Recro | |||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||
Right to receive common stock | 1 | ||||
Number of shares held for distribution of new shares | 2.5 | ||||
Cash received from separation | $ 19,000 |
Development-Stage Risks and L_2
Development-Stage Risks and Liquidity - Additional Information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Business Developments Risks And Uncertainties Liquidity [Line Items] | |
Accumulated deficit | $ 36,220 |
Recro | |
Business Developments Risks And Uncertainties Liquidity [Line Items] | |
Contribution received immediately prior to Distribution | $ 19,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Details) | 3 Months Ended | 11 Months Ended | 12 Months Ended | ||
Mar. 31, 2019USD ($) | Nov. 30, 2019USD ($) | Dec. 31, 2019USD ($)Unitshares | Nov. 20, 2019shares | Jan. 01, 2019USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Number of reportable unit | Unit | 1 | ||||
Goodwill impairment | $ 0 | $ 0 | |||
Indefinite-lived intangible assets impairment | $ 0 | $ 0 | |||
Shares outstanding | shares | 9,350,709 | 0 | |||
Right-of-use asset | $ 730,000 | ||||
Operating lease liability | $ 773,000 | ||||
ASU 2016-02 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Right-of-use asset | $ 1,174,000 | ||||
Operating lease liability | $ 1,219,000 | ||||
Furniture and Office Equipment | Minimum | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Property, plant and equipment estimated useful lives | 3 years | ||||
Furniture and Office Equipment | Maximum | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Property, plant and equipment estimated useful lives | 7 years | ||||
Manufacturing Equipment | Minimum | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Property, plant and equipment estimated useful lives | 6 years | ||||
Manufacturing Equipment | Maximum | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Property, plant and equipment estimated useful lives | 10 years | ||||
Leasehold Improvements | |||||
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 - Schedule of Computation of Basic and Diluted Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Basic Loss Per Share | ||
Net loss | $ (32,557) | $ (73,667) |
Weighted average common shares outstanding, basic and diluted | 9,350,709 | 9,350,709 |
Net loss per share of common stock, basic and diluted | $ (3.48) | $ (7.88) |
Summary of Significant Accoun_6
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Details) | 12 Months Ended |
Dec. 31, 2019shares | |
Options [Member] | Restricted Stock Units | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 2,023,909 |
Acquisition of Gainesville Fa_2
Acquisition of Gainesville Facility and Meloxicam - Additional Information (Details) $ / shares in Units, $ in Thousands | Apr. 10, 2015USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($)MilestonePayment |
Business Acquisition [Line Items] | |||||
Goodwill | $ 2,127 | $ 2,127 | |||
Recro | Alkermes Transaction | |||||
Business Acquisition [Line Items] | |||||
Business acquisition upfront payment in cash | $ 50,000 | ||||
Working capital adjustment | 4,000 | ||||
Business acquisition contingent consideration possible milestone payments | $ 125,000 | ||||
Maximum future net product sales milestone percentage | 30.00% | 30.00% | |||
IPR&D asset | $ 26,400 | ||||
Goodwill | 2,127 | ||||
Recro | Alkermes Transaction | Alkermes Plc | Second Amendment to Purchase and Sale Agreement | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | 140,000 | ||||
Recro | Alkermes Transaction | Alkermes Plc | Amendment to Purchase and Sale Agreement | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration, first milestone payment | $ 5,000 | ||||
Recro | Alkermes Transaction | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, First Component | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | $ 5,000 | ||||
Business acquisition contingent consideration, first milestone payment | $ 5,000 | ||||
Recro | Alkermes Transaction | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Third Component | |||||
Business Acquisition [Line Items] | |||||
Minimum milestone payments percentage | 60.00% | ||||
Recro | Alkermes Transaction | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Fourth Component | |||||
Business Acquisition [Line Items] | |||||
Maximum royalty payment percentage | 30.00% | ||||
Recro | Alkermes Transaction | Minimum | |||||
Business Acquisition [Line Items] | |||||
Future net product sales milestone percentage | 10.00% | 10.00% | |||
Recro | Alkermes Transaction | Minimum | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Fourth Component | |||||
Business Acquisition [Line Items] | |||||
Royalty payment percentage | 10.00% | ||||
Recro | Alkermes Transaction | Maximum | |||||
Business Acquisition [Line Items] | |||||
Future net product sales milestone percentage | 12.00% | 12.00% | |||
Recro | Alkermes Transaction | Maximum | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Second Component | |||||
Business Acquisition [Line Items] | |||||
Business acquisition, contingent consideration, milestone payments due period following regulatory approval | 180 days | ||||
Recro | Alkermes Transaction | Maximum | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Fourth Component | |||||
Business Acquisition [Line Items] | |||||
Royalty payment percentage | 12.00% | ||||
Recro | Alkermes Transaction | Regulatory Approval and Net Sales Milestones | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | $ 45,000 | ||||
Recro | Alkermes Transaction | Regulatory Approval and Net Sales Milestones | Second Amendment to Purchase and Sale Agreement | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | $ 45,000 | $ 60,000 | |||
Recro | Alkermes Transaction | Development Milestone | Alkermes Plc | Second Amendment to Purchase and Sale Agreement | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration milestone payments period | 7 years | ||||
Recro | Alkermes Transaction | Milestone Payments Due, Following Regulatory Approval | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Second Component | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | $ 5,000 | ||||
Recro | Alkermes Transaction | Milestone Payments Due, Beginning on First Anniversary of Regulatory Approval | Alkermes Plc | Amendment to Purchase and Sale Agreement | Contingent Consideration, Second Component | |||||
Business Acquisition [Line Items] | |||||
Business acquisition contingent consideration possible milestone payments | $ 45,000 | ||||
Business acquisition, contingent consideration, number of equal annual milestone payments | MilestonePayment | 7 | ||||
Business acquisition, contingent consideration, equal annual milestone payments | $ 6,400 | ||||
Recro | Alkermes Transaction | Seven Year Warrant | |||||
Business Acquisition [Line Items] | |||||
Purchase common stock with warrant issue | shares | 350,000 | ||||
Warrant, exercise price per share | $ / shares | $ 19.46 |
NMBA Related License Agreement
NMBA Related License Agreement - Additional Information (Details) - Cornell University - Neuromuscular Blocking Agents License Agreement | 1 Months Ended |
Jun. 30, 2017USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Acquired IPR&D | $ 766,000 |
Upfront payment obligation | 350,000 |
Operational liabilities and acquisition-related costs | $ 416,000 |
Acquired IPR&D charge expected deductible period for income tax purposes | 15 years |
U.S | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Regulatory approval and commercialization milestones | $ 5,000,000 |
European | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Regulatory approval and commercialization milestones | $ 3,000,000 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total cash equivalents | $ 16,514 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Mutual Funds | ||
Assets: | ||
Total cash equivalents | 16,514 | |
Significant Unobservable Inputs (Level 3) | ||
Liabilities: | ||
Contingent consideration | 66,358 | $ 90,912 |
Liabilities | $ 66,358 | $ 90,912 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Reconciliation of Contingent Consideration Measured at Fair Value on Recurring Basis Using Unobservable Inputs (Details) - Contingent Consideration - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Balance at December 31, 2017 | $ 90,912 | $ 82,413 |
Remeasurement | (14,554) | 8,499 |
Payment of contingent consideration | (10,000) | |
Balance at December 31, 2018 | 66,358 | $ 90,912 |
Current portion as of December 31, 2019 | 3,592 | |
Long-term portion as of December 31, 2019 | $ 62,766 |
Cash Equivalents - Summary of C
Cash Equivalents - Summary of Cash Equivalents (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Cash And Cash Equivalents [Line Items] | |
Amortized Cost | $ 16,514 |
Estimated Fair Value | 16,514 |
Money Market Mutual Funds | |
Cash And Cash Equivalents [Line Items] | |
Amortized Cost | 16,514 |
Estimated Fair Value | $ 16,514 |
Cash Equivalents - Additional I
Cash Equivalents - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Cash And Cash Equivalents [Abstract] | |
Cash equivalents maturities period | 1 month |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,661 | $ 4,454 |
Less: accumulated depreciation and amortization | 840 | 472 |
Property, plant and equipment, net | 4,821 | 3,982 |
Buildings and Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 196 | 196 |
Furniture, Office and Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,518 | 1,688 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 101 | 101 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 3,846 | $ 2,469 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 480 | $ 396 |
Intangible Assets - Summary of
Intangible Assets - Summary of Balance of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost, Total | $ 26,400 | $ 26,400 |
In-Process Research and Development | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Indefinite-lived | $ 26,400 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Intangible Assets Net Excluding Goodwill [Abstract] | ||
Amortization expense | $ 0 | $ 0 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Payroll and related costs | $ 2,181 | $ 2,172 |
Professional and consulting fees | 209 | 671 |
Clinical trial and related costs | 683 | |
Property plant and equipment | 278 | |
Pre-commercialization scale-up costs | 4,445 | |
Other research and development costs | 538 | 678 |
Guarantee liability | 548 | |
Other | 56 | 846 |
Total accrued expenses | $ 3,532 | $ 9,773 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Payables And Accruals [Abstract] | |
Restructuring costs | $ 7,200 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Apr. 10, 2015 | Dec. 31, 2019USD ($) | Dec. 31, 2019EUR (€) |
Supply Commitment [Line Items] | |||
Lessee, operating lease, option to extend | Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. | Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. | |
Lessee, operating lease, existence of option to extend | true | true | |
Operating lease, weighted average remaining term | 3 years | ||
Operating lease, weighted average discount rate percent | 16.00% | ||
Purchase Commitment | |||
Supply Commitment [Line Items] | |||
Purchase commitment non cancelable and cancelable | $ 3,920,000 | ||
Minimum | |||
Supply Commitment [Line Items] | |||
Operating leases with remaining lease term | 1 year | ||
Maximum | |||
Supply Commitment [Line Items] | |||
Operating leases with remaining lease term | 3 years | ||
Maximum | Executive Officer | |||
Supply Commitment [Line Items] | |||
Aggregate annual base salaries of employment agreement | $ 1,018,000 | ||
Recro | Alkermes Plc | |||
Supply Commitment [Line Items] | |||
Collaborative arrangements milestone payments upon achievement of regulatory and sales milestones | 10,000,000 | ||
Recro | Alkermes Transaction | |||
Supply Commitment [Line Items] | |||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 140,000,000 | ||
Maximum future net product sales milestone percentage | 30.00% | 30.00% | 30.00% |
Recro | Alkermes Transaction | Regulatory Approval and Net Sales Milestones | |||
Supply Commitment [Line Items] | |||
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones | $ 50,000,000 | ||
Collaborative arrangements, milestone payments period | 7 years | 7 years | |
Recro | Minimum | Alkermes Transaction | |||
Supply Commitment [Line Items] | |||
Future net product sales milestone percentage | 10.00% | 10.00% | 10.00% |
Recro | Maximum | Alkermes Transaction | |||
Supply Commitment [Line Items] | |||
Future net product sales milestone percentage | 12.00% | 12.00% | 12.00% |
Recro | Dexmedetomidine License Agreement | |||
Supply Commitment [Line Items] | |||
Contingent milestone payments, maximum | $ 22,990,000 | € 20,500,000 | |
Amount of royalty payments due or payable | $ 0 | ||
Recro | Dexmedetomidine License Agreement | Minimum | |||
Supply Commitment [Line Items] | |||
Percentage of royalty payments | 10.00% | 10.00% | |
Recro | Dexmedetomidine License Agreement | Maximum | |||
Supply Commitment [Line Items] | |||
Percentage of royalty payments | 20.00% | 20.00% | |
Recro | Fadolmidine License Agreement | |||
Supply Commitment [Line Items] | |||
Amount of royalty payments due or payable | $ 0 | ||
Additional contingent milestones payment | $ 13,682,000 | € 12,200,000 | |
Recro | Fadolmidine License Agreement | Minimum | |||
Supply Commitment [Line Items] | |||
Percentage of royalty payments | 10.00% | 10.00% | |
Recro | Fadolmidine License Agreement | Maximum | |||
Supply Commitment [Line Items] | |||
Percentage of royalty payments | 15.00% | 15.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2020 | $ 401 |
2021 | 362 |
2022 | 373 |
Total lease payments | 1,136 |
Less imputed interest | (363) |
Total operating liabilities | $ 773 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Undiscounted Future Lease Payments for Non-Cancellable Operating Leases under Legacy ASC 840 (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 517 |
2020 | 414 |
2021 | 367 |
2022 | 373 |
Total | $ 1,671 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Components Least Cost (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 484 |
Short-term lease cost | 12 |
Total lease cost | $ 496 |
Capital Structure - Additional
Capital Structure - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 13, 2020 | Jan. 01, 2020 | Nov. 21, 2019 | Nov. 15, 2019 | Dec. 31, 2019 |
Schedule Of Capitalization Equity [Line Items] | |||||
Common stock, shares authorized to issue | 100,000,000 | ||||
Common stock, par value | $ 0.01 | ||||
Preferred stock, shares authorized | 10,000,000 | ||||
Preferred stock, par value | $ 0.01 | ||||
Preferred stock, shares issued | 0 | ||||
Preferred stock, shares outstanding | 0 | ||||
The Agreement | |||||
Schedule Of Capitalization Equity [Line Items] | |||||
Issuance of common stock upon separation | 0 | ||||
Subsequent Event | The Agreement | |||||
Schedule Of Capitalization Equity [Line Items] | |||||
Common stock, par value | $ 0.01 | ||||
Proceeds from issuance of common stock | $ 25,000 | ||||
Recro | |||||
Schedule Of Capitalization Equity [Line Items] | |||||
Right to receive common stock | 1 | ||||
Number of shares held for distribution of new shares | 2.5 | ||||
Issuance of common stock upon separation | 9,396,583 | ||||
Recro | Subsequent Event | |||||
Schedule Of Capitalization Equity [Line Items] | |||||
Issuance of common stock upon separation | 45,874 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2019 | Dec. 31, 2019 | Nov. 20, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 11, 2019 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options exercisable period | 10 years | |||||
Stock options vest period | 4 years | |||||
Weighted average grant-date fair value of the options awarded to employees | $ 4.29 | |||||
Stock-based compensation | $ 5,463 | $ 4,574 | ||||
Aggregate intrinsic value of unvested options | $ 380 | $ 380 | $ 380 | |||
Number of vested options | 0 | |||||
Stock Options And Time-based RSUs | ||||||
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 | $ 10,996 | $ 10,996 | $ 10,996 | |||
Time Based Restricted Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 6 months | |||||
2019 Equity Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares available for grant | 3,467,535 | 3,467,535 | 3,467,535 | 3,000,000 | ||
Percentage of outstanding common stock | 5.00% | |||||
Increase in share per "Evergreen" provision | 467,535 | |||||
Shares available for future grants | 1,443,626 | 1,443,626 | 1,443,626 | |||
Recro Equity Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted average grant-date fair value of the options awarded to employees | $ 5.53 | $ 6.07 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
2019 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Range of expected option life | 6 years | |
Expected volatility | 77.81% | |
Risk-free interest rate | 1.68% | |
Recro Equity Incentive Plan | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Range of expected option life | 5 years 6 months | 5 years 6 months |
Expected volatility | 74.69% | 73.26% |
Risk-free interest rate | 1.42% | 2.32% |
Recro Equity Incentive Plan | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Range of expected option life | 6 years | 6 years |
Expected volatility | 80.59% | 82.00% |
Risk-free interest rate | 2.66% | 3.03% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of shares, Granted | shares | 643,879 |
Number of shares, balance | shares | 643,879 |
Number of shares, Vested and expected to vest | shares | 643,879 |
Weighted average exercise price, Granted | $ / shares | $ 6.33 |
Weighted average exercise price, balance | $ / shares | 6.33 |
Weighted average exercise price, Vested and expected to vest | $ / shares | $ 6.33 |
Weighted average remaining contractual life | 9 years 10 months 24 days |
Weighted average remaining contractual life, Vested and expected to vest | 9 years 10 months 24 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2019shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares, Granted | 1,380,030 |
Number of shares, balance | 1,380,030 |
Number of shares, Expected to vest | 1,380,030 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ (16,417) | $ (43,505) |
Foreign | (16,140) | (30,162) |
Loss before income taxes | $ (32,557) | $ (73,667) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Current: | ||
Federal | $ 0 | $ 0 |
State and local | 0 | 0 |
Foreign | 0 | 0 |
Current income tax expense benefit | 0 | 0 |
Deferred: | ||
Federal | (3,440) | (10,034) |
State and local | (1,206) | (4,026) |
Foreign | (2,018) | (3,770) |
Deferred income tax expense benefit | (6,664) | (17,830) |
Change in valuation allowance | 6,664 | 17,830 |
Income tax benefit | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory income tax rate | 21.00% | 21.00% |
Foreign tax rate differential | (4.20%) | (3.50%) |
State taxes, net of federal benefit | 3.70% | 5.50% |
Nondeductible expenses | 0.30% | |
Research and development credits | 0.70% | |
Change in federal tax rate | 0.10% | |
Change in valuation allowance | (20.50%) | (24.20%) |
Other | 0.10% |
Income Taxes - Schedule of Tax
Income Taxes - Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 1,065 | $ 24,384 |
Research and development credits | 972 | |
Capitalized start-up costs | 1,489 | |
Intangibles | 2,056 | 206 |
Contingent consideration | 10,924 | 9,746 |
Stock-based compensation | 142 | 3,924 |
Other temporary differences | (12) | 161 |
Gross deferred tax asset | 14,175 | 40,882 |
Valuation allowance | (14,094) | (40,618) |
Net deferred tax asset | 81 | 264 |
Deferred tax liability | $ (81) | $ (264) |
Income Taxes - Summary of Feder
Income Taxes - Summary of Federal Net Operating Losses and Tax Credits Carryforwards (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses, Expiration period | State net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward, respectively. |
Federal [Member] | 2019 | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 1,357 |
Net operating losses, Expiration period | No expiration |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 1,357 |
Net operating losses, Expiration period start | 2028 |
Net operating losses, Expiration period end | 2038 |
Foreign | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 672 |
Net operating losses, Expiration period | No expiration |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Operating loss and research and development tax credit carryforwards percentage of change in ownership | 50.00% | ||
Operating loss and research and development tax credit carryforwards percentage of change in ownership period | 3 years | ||
Percentage of limitation on taxable income after modification and apportionment | 40.00% | 35.00% | 30.00% |
Net operating loss carryforwards, limitation | State net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward, respectively. | ||
Accrued interest or penalties related to uncertain tax positions | $ 0 | ||
Recognized amounts of interest or penalties related to uncertain tax positions | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | ||
Income related to the transition services agreement | $ 206 | |
Receivables, net, current | 273 | |
Irish Subsidiary | Managing Director | HiTech Health | ||
Related Party Transaction [Line Items] | ||
Related party transaction expenses | $ 171 | $ 309 |
Service agreement date | 2017-11 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Compensation And Retirement Disclosure [Abstract] | ||
Percentage of company's matching contribution with respect to each participant's contribution | 100.00% | |
Company matching contributions to maximum employees eligible compensation | 5.00% | |
Total company contributions to 401 (k) plan | $ 307 | $ 540 |