Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 28, 2020 | Jun. 28, 2019 | |
Document And Entity Information | |||
Entity Registrant Name | Nabriva Therapeutics plc | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Shares Outstanding | 94,623,564 | ||
Entity Central Index Key | 0001641640 | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 176.1 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 86,019 | $ 102,003 |
Restricted cash | 392 | |
Short-term investments | 175 | 225 |
Accounts receivable, net and other receivables | 2,744 | 3,871 |
Contract asset | 1,500 | |
Inventory | 682 | |
Prepaid expenses | 1,158 | 1,154 |
Total current assets | 91,170 | 108,753 |
Property, plant and equipment, net | 2,474 | 1,139 |
Intangible assets, net | 91 | 98 |
Long-term receivables | 378 | 428 |
Total assets | 94,113 | 110,418 |
Current liabilities: | ||
Accounts payable | 4,673 | 3,304 |
Accrued expense and other current liabilities | 11,966 | 14,502 |
Total current liabilities | 16,639 | 17,806 |
Non-current liabilities | ||
Long-term debt | 34,502 | 23,718 |
Other non-current liabilities | 1,698 | 264 |
Total non-current liabilities | 36,200 | 23,982 |
Total liabilities | 52,839 | 41,788 |
Commitments and contingencies (Note 17) | ||
Stockholders’ Equity: | ||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at December 31, 2019; 67,019,094 and 94,545,116 issued and outstanding at December 31, 2018 and December 31, 2019, respectively | 945 | 670 |
Preferred shares, par value $0.01, 100,000,000 shares authorized at December 31, 2019; None issued and outstanding | ||
Additional paid in capital | 517,044 | 461,911 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (476,742) | (393,978) |
Total stockholders’ equity | 41,274 | 68,630 |
Total liabilities and stockholders’ equity | $ 94,113 | $ 110,418 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 1,000,000,000 | 1,000,000,000 |
Ordinary stock, issued shares | 94,545,116 | 67,019,094 |
Ordinary stock, outstanding shares | 94,545,116 | 67,019,094 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 100,000,000 | 100,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | |||
Total revenue | $ 9,481 | $ 9,656 | $ 5,319 |
Operating expenses: | |||
Cost of product sales | (70) | ||
Research and development expenses | (26,415) | (82,288) | (49,615) |
Selling, general and administrative expenses | (62,485) | (41,743) | (29,472) |
Total operating expenses | (88,970) | (124,031) | (79,087) |
Loss from operations | (79,489) | (114,375) | (73,768) |
Other income (expense): | |||
Other income (expense), net | 215 | (272) | 492 |
Interest income | 255 | 49 | 318 |
Interest expense | (3,644) | (133) | (43) |
Loss before income taxes | (82,663) | (114,731) | (73,001) |
Income tax expense | (101) | (49) | (1,355) |
Net loss | (82,764) | (114,780) | (74,356) |
Other comprehensive income (loss), net of tax | |||
Unrealized losses on available-for-sale securities | (26) | ||
Reclassification to net income | (43) | ||
Other comprehensive income, net of tax | 17 | ||
Comprehensive loss | $ (82,764) | $ (114,780) | $ (74,339) |
Loss per share | |||
Basic and Diluted ($ per share) | $ (1.12) | $ (2.26) | $ (2.49) |
Weighted average number of shares: | |||
Basic and Diluted | 74,199,482 | 50,795,768 | 29,830,669 |
Product revenue, net | |||
Revenues: | |||
Total revenue | $ 1,538 | ||
Collaboration revenue | |||
Revenues: | |||
Total revenue | 6,210 | $ 6,500 | |
Research premium and grant revenue | |||
Revenues: | |||
Total revenue | $ 1,733 | $ 3,156 | $ 5,319 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock/Ordinary Shares | Additional paid in capital | Accumulated other comprehensive income | Accumulated deficit | Total |
Stockholders' equity, beginning balance at Dec. 31, 2016 | $ 2,939 | $ 279,149 | $ 10 | $ (204,842) | $ 77,256 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2016 | 2,720 | ||||
Consolidated Statements of Changes in Stockholders’ Equity | |||||
Issuance of ordinary shares | $ 94 | 79,906 | 80,000 | ||
Issuance of ordinary shares (in shares) | 9,412 | ||||
Exercise of stock options | $ 3 | 51 | 54 | ||
Exercise of stock options (in shares) | 54 | ||||
Equity transaction costs | (6,635) | (6,635) | |||
Redomiciliation share exchange | $ (2,669) | 2,669 | |||
Redomiciliation share exchange (in shares) | 24,522 | ||||
Stock-based compensation expense | 5,732 | 5,732 | |||
Other comprehensive income, net of tax | 17 | 17 | |||
Net loss | (74,356) | (74,356) | |||
Stockholders' equity, ending balance at Dec. 31, 2017 | $ 367 | 360,872 | 27 | (279,198) | 82,068 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2017 | 36,708 | ||||
Consolidated Statements of Changes in Stockholders’ Equity | |||||
Issuance of ordinary shares | $ 230 | 73,989 | 74,219 | ||
Issuance of ordinary shares (in shares) | 22,974 | ||||
Equity transaction costs | (4,933) | (4,933) | |||
Stock-based compensation expense | 5,154 | 5,154 | |||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. | $ 73 | 26,829 | 26,902 | ||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. (in shares) | 7,337 | ||||
Net loss | (114,780) | (114,780) | |||
Stockholders' equity, ending balance at Dec. 31, 2018 | $ 670 | 461,911 | 27 | (393,978) | 68,630 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2018 | 67,019 | ||||
Consolidated Statements of Changes in Stockholders’ Equity | |||||
Issuance of ordinary shares and warrants | $ 258 | 47,824 | 48,082 | ||
Issuance of ordinary shares and warrants (in shares) | 25,838 | ||||
Equity transaction costs | (2,794) | (2,794) | |||
Stock-based compensation expense | 9,748 | 9,748 | |||
Shares issued in connection with the vesting of restricted stock units | $ 7 | (7) | |||
Shares issued in connection with the vesting of restricted stock units (in shares) | 659 | ||||
Shares issued in connection with the employee stock purchase plan | $ 2 | 370 | 372 | ||
Shares issued in connection with the employee stock purchase plan (in shares) | 214 | ||||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. | $ 8 | (8) | |||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. (in shares) | 815 | ||||
Net loss | (82,764) | (82,764) | |||
Stockholders' equity, ending balance at Dec. 31, 2019 | $ 945 | $ 517,044 | $ 27 | $ (476,742) | $ 41,274 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2019 | 94,545 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | |||
Net loss | $ (82,764) | $ (114,780) | $ (74,356) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Non-cash other income/expense, net | (40) | 362 | (1,371) |
Non-cash interest income | 22 | 45 | |
Non-cash interest expense | 519 | (104) | |
Depreciation and amortization expense | 396 | 510 | 432 |
Amortization of right-of-use assets | 374 | ||
Stock-based compensation | 9,748 | 5,154 | 5,732 |
In-process research and development in connection with acquisition | 32,048 | ||
Deferred income taxes | 1,410 | ||
Other, net | 48 | 14 | 131 |
Changes in operating assets and liabilities: | |||
(Increase)/decrease in long-term receivables | 50 | (3) | (5) |
(Increase)/decrease in accounts receivable, net and other receivables and prepaid expenses | 2,582 | 1,139 | (223) |
Increase in inventory | (682) | ||
Increase/(decrease) in accounts payable | 1,310 | (2,969) | 2,585 |
Increase/(decrease) in accrued expenses and other liabilities | (3,209) | 5,742 | (3,778) |
Increase/(decrease) in other non-current liabilities | (172) | 61 | 96 |
Increase/(decrease) in income tax liabilities | (74) | 58 | (1) |
Net cash used in operating activities | (71,892) | (72,723) | (69,348) |
Cash flows from investing activities | |||
Purchases of plant and equipment and intangible assets | (61) | (229) | (1,173) |
Purchases of term deposits | (115) | (30) | |
Changes in restricted cash | 392 | ||
Proceeds from sale of property, plant and equipment | 2 | ||
Transaction costs related to Zavante acquisition, net of cash acquired | (4,260) | 50,950 | |
Net cash provided by (used in) investing activities | 331 | (4,604) | 49,749 |
Cash flows from financing activities | |||
Proceeds from equity offerings and warrants | 20,138 | 50,000 | 80,000 |
Proceeds from at-the-market facility | 27,944 | 24,219 | |
Proceeds from long-term debt, net of issuance costs | 9,980 | 23,545 | 228 |
Proceeds from exercise of stock options | 83 | ||
Proceeds from employee share purchase plan | 372 | ||
Equity transaction costs | (2,359) | (4,841) | (8,092) |
Net cash provided by financing activities | 56,075 | 92,923 | 72,219 |
Effects of foreign currency translation on cash and cash equivalents | (106) | (362) | 1,371 |
Net increase/(decrease) in cash, cash equivalents and restricted cash | (15,592) | 15,234 | 53,991 |
Cash, cash equivalents, and restricted cash at beginning of year | 102,003 | 86,769 | 32,778 |
Cash, cash equivalents and restricted cash at end of year | 86,411 | 102,003 | 86,769 |
Supplemental disclosure of cash flow information: | |||
Interest paid | (2,560) | (7) | (1) |
Taxes paid | (11) | (4) | (5) |
Equity transaction costs included in accounts payable and accrued expenses | $ 555 | $ 120 | $ 28 |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Business Activities | |
Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc (“Nabriva Ireland”), together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH (“Nabriva Austria”), Nabriva Therapeutics US, Inc., and Nabriva Therapeutics Ireland DAC, (collectively, “Nabriva”, or the “Company”) is a biopharmaceutical company engaged in the commercialization and development of novel anti-infective agents to treat serious infections. The Company’s headquarters are located at 25-28 North Wall Quay, Dublin, Ireland. On September 9, 2019, the Company announced that the oral and intravenous (“IV”) formulations of XENLETA (lefamulin) are available in the United States for the treatment of community-acquired bacterial pneumonia (“CABP”) through major specialty distributors. This followed the approval by the U.S. Food and Drug Administration (FDA) of the Company’s New Drug Application (NDA) for XENLETA on August 19, 2019 for the treatment of adults with community-acquired bacterial pneumonia (CABP). XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics available for the systematic administration in humans. On June 24, 2019, the Company announced that the European Medicines Agency ("EMA") determined that the Company's Marketing Authorization Application ("MAA") for the IV and oral formulations of lefamulin was valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process and an opinion of the EMA Committee for Medicinal Products for Human Use ("CHMP") is anticipated in the second half of 2020. The EMA's review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, XENLETA will receive marketing authorization in all member states of the European Union ("EU"), as well as in Norway, Liechtenstein and Iceland (and the UK, in the event they exit the EU). If approved, Nabriva intends to work with a commercial partner to make XENLETA available to patients in the EU. On July 23, 2018, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) for the acquisition of Zavante Therapeutics Inc., (“Zavante”) a biopharmaceutical company focused on developing CONTEPO (fosfomycin for injection). CONTEPO is potentially a first-in-class epoxide antibiotic for IV administration in the United States. The Company is developing CONTEPO IV for complicated urinary tract infections (“cUTI”) and may potentially develop XENLETA and CONTEPO for additional indications. In April 2019, the FDA issued a Complete Response Letter (“CRL”) in connection with the Company’s NDA for CONTEPO for the treatment of cUTIs, including acute pyelonephritis, stating that it was unable to approve the application in its current form. The CRL requests that issues related to facility inspections and manufacturing deficiencies at Nabriva’s active pharmaceutical ingredient contract manufacturer be addressed prior to the FDA approving the NDA. The Company requested a “Type A” meeting with the FDA to discuss its findings and this meeting occurred in July 2019. As the FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL, the purpose of the meeting was to discuss and gain clarity on the issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for CONTEPO. The Company resubmitted its NDA in December 2019 and the FDA acknowledged the resubmission in January 2020 and established a PDUFA date of June 19, 2020. However, the Company cannot predict when CONTEPO will receive marketing approval, if at all. On June 23, 2017, Nabriva Therapeutics plc, a public limited company organized under the laws of Ireland, or Nabriva Ireland, became the successor issuer to Nabriva Therapeutics AG, a stock corporation ( Aktiengesellschaft ) organized under the laws of Austria (“Nabriva Austria”), for certain purposes under both the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such succession occurred following the conclusion of a tender offer related to the exchange of American Depositary Shares and common shares of Nabriva Austria for ordinary shares of Nabriva Ireland, which resulted in Nabriva Ireland, a new Irish holding company, becoming the ultimate holding company of Nabriva Austria (the predecessor registrant and former ultimate holding company) and its subsidiaries, which we refer to as the Redomiciliation Transaction. On October 19, 2017, Nabriva Austria was converted into a limited liability company under Austrian law and renamed Nabriva Therapeutics GmbH. Throughout these notes to the consolidated financial statements, unless the context requires otherwise, all references to “Nabriva”, “the Company,” or similar terms on or prior to June 23, 2017 (the effective date of the Redomiciliation Transaction), refer to the predecessor of the Company, Nabriva Austria, together with its subsidiaries. Liquidity Since its inception, the Company has incurred net losses and generated negative cash flows from its operations which has resulted in a significant accumulated deficit to date. The Company has financed its operations through the sale of equity securities, convertible and term debt financings and research and development support from governmental grants and proceeds from its licensing agreements. As of December 31, 2019, the Company had cash and cash equivalents, restricted cash and short-term investments of $86.6 million. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40 , Presentation of Financial Statements — Going Concern (“ASC 205-40”), which requires management to assess the Company’s ability to continue as a going concern for one year after the date the consolidated financial statements are issued. The Company expects to seek additional funding in future periods for purposes of enhancing the commercial launch of XENLETA and potential launch of CONTEPO. While the Company has raised capital in the past, the ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future capital raises in their assessment of the Company’s ability to meet its obligations for the next twelve months. If the Company is not able to secure adequate additional funding in future periods, the Company may make reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. The Company may also have to delay, reduce the scope of, suspend or eliminate one or more research and development programs or its commercialization efforts. The Company’s expenses will increase if it suffers any regulatory delays or is required to conduct additional clinical trials to satisfy regulatory requirements. The Company has incurred and expects to continue to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing for XENLETA and, if approved, CONTEPO, including the recent hiring of a dedicated sales force. It is uncertain when, if ever, the Company will generate sufficient revenues from product sales to achieve profitability. As a result, based on the Company’s available cash resources, the minimum cash required under the Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., and in accordance with the requirements of ASC 205-40, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these financial statements are issued. A failure to raise the additional funding or to effectively implement cost reductions could harm the Company’s business, results of operations and future prospects. As discussed in Note 19, the Company has agreed to repay $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding debt under the Loan Agreement subsequent to December 31, 2019. Based on its current operating plans, immediately following such repayment, the Company expects that its existing cash, cash equivalents and short-term investments as of the date of this filing and anticipated net product revenues, will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements into the third quarter of 2020. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than expected. This estimate assumes, among other things, that the Company does not obtain any additional funding through grants and clinical trial support, collaboration agreements or equity or debt financings . This estimate also assumes that the Company’s NDA for CONTEPO is approved on the PDUFA date and that it remains in compliance with the covenants and no event of default occurs under the Loan Agreement. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. On June 25, 2019, the Company entered into an Open Market Sale Agreement SM (the “Jefferies ATM Agreement”) with Jefferies, pursuant to which, from time to time, the Company may offer and sell ordinary shares, for aggregate gross sale proceeds of up to $50.0 million through Jefferies by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company also filed a prospectus supplement with the Securities and Exchange Commission in connection with the Offering under the Company’s shelf Registration Statement on Form S-3 (File No. 333-219567), which became effective on August 10, 2017. As of December 31, 2019, the Company has issued and sold an aggregate of 6,505,268 ordinary shares pursuant to the Jefferies ATM Agreement and received gross proceeds of $14.4 million and net proceeds of $13.6 million, after deducting commissions to Jefferies and other offering expenses. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $35.6 million. In December 2019, the Company sold to certain institutional investors in a registered direct offering an aggregate of 13,793,106 ordinary shares (the “Shares”), and accompanying warrants to purchase up to an aggregate of 13,793,106 ordinary shares (the “Warrants,” and together with the Shares, the “Securities”). Each Share was issued and sold together with an accompanying Warrant at a combined price of $1.45. The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company were $20.1 million. Each Warrant has an exercise price of $1.90 per share, is initially exercisable six months following the date of issuance (the “Initial Exercise Date”) and will expire on the three-year anniversary of the Initial Exercise Date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for annual reporting. The consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Functional Currency Transactions and Balances In preparing the consolidated financial statements, transactions in currencies other than the U.S. dollar are recognized at the exchange rates prevailing at the dates of the transactions. Foreign currency exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations and comprehensive income (loss). Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. Restricted Cash The Company classifies funds contributed by its employees to its Employee Stock Purchase Plan (See Note 11) as restricted in nature since these amounts can only be utilized to purchase Company stock at the end of each six month offering period. Prior to the conclusion of the offering period, employees can request reimbursement of the funds they previously contributed and if they leave the Company prior to the end of the offering period the funds are returned to the employee. Short-term Investments The Company has designated its investments in securities as available-for-sale securities and measures these securities at their respective fair values. Investments that mature in one year or less are classified as short-term available-for-sale securities. Investments that are not considered available for use in current operations are classified as long-term available-for-sale securities. Changes in the fair value of available-for-sale investments are recognized in other comprehensive income (loss). Inventory Inventory is stated at the lower of cost or estimated net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company's supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and would record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. The components of our inventory at December 31, 2019 are as follows: (in thousands) Raw materials $ — Work in process 498 Finished goods 184 Total Inventory $ 682 Property, Plant and Equipment Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful lives of property, plant and equipment are as follows: 3-5 years for IT equipment, 5-10 years for laboratory equipment and 3-10 years for other plant and office equipment. The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each reporting date. When assets are sold or otherwise disposed of, the difference between the net proceeds, if any, and the net carrying amount of the asset is recognized as a gain or a loss in other operating income or expenses. Intangible Assets and Other Long-lived Assets Intangible assets, such as acquired computer software licenses, are capitalized on the basis of the costs incurred to acquire the software and bring it into use. These costs are amortized on a straight-line basis over their estimated useful lives (3-10 years). Long-lived assets are assessed for potential impairment when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. An impairment loss would be recognized when undiscounted cash flows expected to be generated by an asset, is less than its carrying amount. The impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and recognized in these financial statements. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the commercialization and development of novel anti-infective agents to treat serious and life-threatening infections. Revenue Recognition —The Company recognizes revenue from sales of its commercial products in accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"). Net Product Revenue Beginning in September 2019, the Company began selling its XENLETA product principally to a limited number of specialty distributors in the United States. The distributors place orders with the Company for sufficient quantities of its products to maintain an appropriate level of inventory based on its customers’ anticipated purchase volumes and demand. The Company recognizes revenue once it has transferred physical possession of the goods and the distributor obtains legal title to the product. Payment terms between Nabriva and its customers are generally approximately 60 days from the invoice date. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of its product. The transaction price that the Company recognizes as revenue reflects the amount it expects to be entitled to in connection with the sale and transfer of control of product to its customers. At the time that the Company’s customers take control of the product, which is when the Company’s performance obligation under the sales contracts is complete, the Company records product revenues net of applicable reserves for various types of variable consideration. The types of variable consideration are as follows: · Fees-for-service · Product returns · Chargebacks and rebates · Government rebates · Commercial payer and other rebates · Group Purchasing Organizations ("GPO") administration fees · Voluntary patient assistance programs In determining the amounts of certain allowances and accruals, the Company must make significant judgments and estimates. For example, in determining these amounts, the Company estimates prescription demand from the specialty pharmacies, hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations and the levels of inventory held by specialty distributors and customers. The Company also analyzes third party end usage product consumption patterns to gauge demand for its products. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. The Company receives data periodically from its specialty distributors and customers on inventory levels and historical channel sales mix, and the Company considers this data when determining the amount of the allowances and accruals for variable consideration, however given the recent launch of its XENLETA product this data is limited. In assessing the amount of net revenue to record, the Company considers both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations the Company uses in estimating these amounts related to variable consideration associated with the Company’s products are as follows: Fees-for-service – The Company offers discounts and pays certain distributor service fees which are recorded as a reduction of revenue in the period the related product revenue is recognized. The Company does not consider the fees separate from the distributors’ purchase of the product. The Company records its fee-for-service accruals based on distributors’ purchases and the applicable discount rate. Product returns – Generally, the Company’s customers have the right to return products during the 18-month period beginning six months prior to the labeled expiration date and ending twelve months after the labeled expiration date. Since the Company currently does not have history of XENLETA returns, the Company estimated returns based on industry data for comparable products in the market. As the Company distributes its product and establishes historical sales over a longer period of time (i.e., two to three years), the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The Company’s XENLETA product has a thirty-six-month shelf life. The Company’s customers also have the right to return excess inventory on new products that do not yield forecasted sales. The Company recently launched XENLETA and underlying demand has been below its expectations, particularly in the hospital for its IV product. To the extent the Company’s customers determine that the quantities they purchased are in excess of their customers demand, product returns could increase in excess of what the Company has currently reserved which would result in a reduction to net revenues in future periods. At the end of each reporting period for any of its products, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. Chargebacks and rebates – Although the Company primarily sells products to specialty distributors in the United States, the Company also enters into agreements with hospitals and retail pharmacies, either directly or through group purchasing organizations acting on behalf of their members, in connection with the purchase of product. Based on these agreements, certain of the Company’s customers have the right to receive a discounted price on product purchases. The Company typically provides a credit to its specialty distributors customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. The calculation of the accrual for chargebacks and rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Government rebates –The Company is subject to discount obligations primarily under state Medicaid and Medicare programs. The Company estimates its Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The calculation of the accrual for government rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Commercial payer and other rebates – The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of XENLETA and contracted formulary status. The Company estimates these rebates and records reserves for such estimates in the same period the related revenue is recognized. Currently, the reserve for customer payer rebates considers future utilization based on third party studies of payer prescription data; the utilization is applied to product that remains in the distribution and retail pharmacy channel inventories at the end of each reporting period. The calculation of the accrual for commercial payer and other rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. GPO administration fees – The Company contracts with GPOs and pays administration fees related to contacting and membership management services provided. In assessing if the consideration paid to the GPO should be recorded as a reduction in the transaction price, the Company determines whether the payment is for a distinct good or service or a combination of both. Since GPO fees are not specifically identifiable, the Company does not consider the fees separate from the purchase of the product. Additionally, the GPO services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. Patient assistance – The Company offers certain voluntary patient assistance programs for prescriptions, such as co-pay assistance programs, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product sales that have been recognized as revenue but remains in the distribution channel as inventory at the end of each reporting period. At the end of each reporting period, the Company will adjust its variable consideration estimates for product returns, chargebacks, and rebates when the Company believes actual experience may differ from current estimates. The following table summarizes balances and activity of product revenue allowances and reserves: Total Balance at December 31, 2018 $ — Provision related to current period sales 635 Adjustment related to prior period sales — Credit or payments made during the period (101) Balance at December 31, 2019 $ 534 Cost of Product Sales Cost of product sales consists primarily of the direct and indirect manufacturing costs for XENLETA. All manufacturing costs incurred prior to XENLETA’s approval in the United States on August 19, 2019 were expensed in research and development expense. Costs incurred after the approval date were capitalized as inventory. Research Premium and Grant Revenue Grant revenue comprises (a) the research premium from the Austrian government, (b) grants received from the Vienna Business Promotion Fund ( Wiener Wirtschaftsförderungsfonds, or WWFF ), (c) grants received from the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft, or FFG ), and (d) the benefit of government loans at below-market interest rates. The research premium the Company receives from the Austrian government is calculated at a specified percent of specified research and development cost base. The Company recognizes the research premium as long as it has incurred research and development expenses. The WWFF grant is paid out through the landlord in the form of a monthly reduction in lease payments and is recognized over the period from grant date in March 2010 until end of the lease termination waiver term in December 2017. All grants are non-refundable as long as the conditions of the grant are met. Nabriva is and has been in full compliance with the conditions of the grants and all related regulations. Research and Development Expenses All research and development costs are expensed as incurred. Research and development costs included direct personnel and material costs, related overheads, depreciation of equipment used for research or development purposes; costs for clinical research; costs for the utilization of third parties’ patents for research and development purposes and other taxes related to research facilities. Share-based Payments The Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award in accordance with ASC 718, Compensation—Stock Compensation . The fair value of stock options is estimated using the Black-Scholes option pricing model. All grants under share-based payment programs are accounted for at fair value and that cost is recognized over the period during which an employee is required to provide service in exchange for the award—the requisite service period (vesting period). The Company accounts for forfeitures as incurred. Compensation expense for options granted to non-employees is determined as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of awards granted to non-employees is re-measured each period until the related service is complete. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. In recognizing the benefit of tax positions, the Company has taken or expects to take, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, reducing the top U.S. federal corporate tax rate from 35 percent to 21 percent; eliminating the corporate alternative minimum tax (“AMT”) and changing how existing AMT credits can be realized; creating the base erosion anti-abuse tax (“BEAT”), a new minimum tax; creating a new limitation on deductible interest expense; and, changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017. The Tax Act reduced the U.S. corporate income tax rate from 35% to 21%, effective January 1, 2018. Deferred tax assets and liabilities were measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the Tax Act, the Company revalued the ending net deferred tax assets and liabilities of our U.S. subsidiary at December 31, 2017. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Adopted as of the current period: In February 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information has not been restated and will continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. In addition, the new lease standard provides a number of optional practical expedients in transition. The Company elected the package of practical expedients. As such, the Company did not have to reassess whether expired or existing contracts are or contain a lease; and did not have to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize right of use (“ROU”) assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office buildings). The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease ROU assets, other current liabilities, and operating lease liabilities on the Company’s consolidated balance sheet as of December 31, 2019. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term as of January 1, 2019. Since none of the Company’s lease agreements provide an implicit rate, the Company estimated an incremental borrowing rate over the lease term based on the information available at January 1, 2019 in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. On January 1, 2019, the Company recognized ROU assets and lease liabilities of approximately $2.0 million on its consolidated balance sheet using an estimated incremental borrowing rate of 9.8%. This ROU asset is recorded in property, plant and equipment, net and the ROU liability is recorded in other non-current liabilities. Pronouncements to be adopted in future periods: In August 2018, the FASB issued ASU No. 2018-15, “ Customer’s Accounting for Implementation Cost Incurred in a Cloud Computing Arrangement That Is a Service Contract ” (“ASU 2018-15”). Under the new guidance, customers will apply the same criteria for capitalizing implementation costs as they would for an arrangement that has a software license. This will result in certain implementation costs being capitalized; the associated amortization charge will, however, be recorded as an operating expense. Under the previous guidance, costs incurred when implementing a cloud computing arrangement deemed to be a service contract were recorded as an operating expense when incurred. ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Entities can choose to adopt the new guidance prospectively to eligible costs incurred on or after the date the guidance is first applied or retrospectively. The Company does expect the impact of the adoption of ASU 2018-15 on its consolidated financial statements to be material. |
Short-term investments
Short-term investments | 12 Months Ended |
Dec. 31, 2019 | |
Short-term investments | |
Short-term investments | 3. Short-term investments The Company’s short-term investments were as follows: As of December 31, 2019 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Term deposits $ 175 $ — $ — $ 175 Total $ 175 $ — $ — $ 175 As of December 31, 2018 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Available for sale securities $ 50 $ — $ — $ 50 Term deposits 175 — — 175 Total $ 225 $ — $ — $ 225 As of December 31, 2019 and 2018, the Company’s short-term investments were classified as available-for-sale and comprised of certain term deposits with maturities in excess of 90 days. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurement | |
Fair Value Measurement | 4. Fair Value Measurement US GAAP establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows: · Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities. · Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (as exchange rates). · Level 3: Valuation techniques that include inputs for the asset or liability that are not based on observable market data (those are unobservable inputs) and significant to the overall fair value measurement. The following table presents the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy: (in thousands) Level 1 Level 2 Level 3 Total December 31, 2019 Assets: Cash equivalent: Money market funds $ 15,050 $ — $ — $ 15,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 15,225 $ — $ — $ 15,225 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2018 Assets: Cash equivalent: Money market funds $ 50 $ — $ — $ 50 Short term investments: Term deposits 175 — — 175 Total Assets $ 225 $ — $ — $ 225 There were no transfers between Level 1 and 2 in the years ended December 31, 2019 and 2018. There were no changes in valuation techniques during the years ended December 31, 2019 and 2018. As of December 31, 2019 and 2018, the Company did not hold any financial instruments as liabilities that were held at fair value. Other receivables and accounts payable are carried at their historical cost which approximates fair value due to their short-term nature. |
Accounts receivable, net and ot
Accounts receivable, net and other receivables | 12 Months Ended |
Dec. 31, 2019 | |
Accounts receivable, net and other receivables | |
Accounts receivable, net and other receivables | 5. Accounts receivable, net and other receivables Accounts receivable, net and other receivables include the following: As of December 31 (in thousands) 2018 2019 Research premium $ 2,657 $ 1,530 VAT and other taxes 1,024 403 Receivables from grant revenue 104 2 Other receivables 86 809 Total accounts receivable, net and other receivables $ 3,871 $ 2,744 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 6. Property, Plant and Equipment Property, plant and equipment was comprised of the following: As of December 31 (in thousands) 2018 2019 IT equipment $ 1,079 $ 1,060 Laboratory equipment 3,392 3,375 ROU asset — 1,647 Other equipment 124 165 4,595 6,247 Less: Accumulated depreciation (3,456) (3,773) Property, plant and equipment, net $ 1,139 $ 2,474 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities include the following: As of As of (in thousands) December 31, 2018 December 31, 2019 Research and development related costs $ 5,032 $ 1,347 Payroll and related costs 7,427 6,327 Accounting, tax and audit services 398 420 Other 1,645 3,872 Total other current liabilities $ 14,502 $ 11,966 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt | |
Debt | 8. Debt In December 2018, the Company entered into the Loan Agreement by and among the Company, Nabriva Therapeutics Ireland DAC, and certain other subsidiaries of the Company and Hercules Capital, Inc. (“Hercules”), pursuant to which a term loan of up to an aggregate principal amount of $75.0 million is available to the Company. The Loan Agreement initially provided for an initial term loan advance of $25.0 million, which was funded in December 2018, and, at the Company’s option and subject to the occurrence of the funding conditions described below and other customary funding conditions, five additional term loan advances comprised of the following; 1) $10.0 million (“Tranche 2 Advance”), 2) $5.0 million (“Tranche 3 Advance”), 3) $10.0 million (“Tranche 4 Advance”), 4) $15.0 million (“Tranche 5 Advance”) and 5) $5.0 million (“Tranche 6 Advance”). The Tranche 2 Advance became available upon the approval by the FDA of the NDA for lefamulin. The Tranche 3, 4, 5 and 6 Advances are no longer available as their contingencies were not achieved. The Company may request a term loan advance of $5.0 million prior to December 31, 2021 subject to Hercules’s sole discretion. See Note 19 for a discussion of a repayment and amendment to its Loan Agreement that occurred in March 2020. The term loan bears interest at an annual rate equal to the greater of 9.80% or 9.80% plus the prime rate of interest minus 5.50%. The Loan Agreement provided for interest-only payments through July 1, 2021 and repayment of the outstanding principal balance of the term loan thereafter in monthly installments through June 1, 2023 (the “Maturity Date”). In addition, the Company is required to pay a fee of 6.95% of the aggregate amount of advances under the Loan Agreement at the Maturity Date (the “End of Term Fee”). At the Company’s option, the Company may elect to prepay any portion of the outstanding term loan that is greater than or equal to $5.0 million by paying such portion of the principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: (i) 3.0% if the term loan is prepaid during the first 12 months following the initial closing, (ii) 2.0% if the term loan is prepaid after 12 months following the initial closing but before 24 months following the initial closing and (iii) 1.0% if the term loan is prepaid any time thereafter but prior to the Maturity Date. The Company is also required to satisfy certain financial covenants, including an obligation to maintain a minimum of $10.0 million of cash and cash equivalents in accounts pledged to Hercules. Additionally, the Loan Agreement contains a performance covenant, which became effective in February 2020, that requires the Company to either (1) achieve 80% of its net product revenue sales target over a trailing six month period, or (2) maintain an amount of cash and cash equivalents in accounts pledged to Hercules plus a specified amount of eligible accounts receivables equal to the greater of the amount outstanding under the Loan Agreement or $40.0 million. The Company was in compliance with all of its Loan Agreement covenants at December 31, 2019. The Company’s obligations under the Loan Agreement are guaranteed by all current and future subsidiaries of the Company, and each of the Company and its subsidiaries has granted Hercules a security interest in all of their respective personal property, intellectual property and other assets owned or later acquired. The Loan Agreement also contains certain events of default, representations, warranties and covenants of the Company and its subsidiaries. For example, the Loan Agreement contains representations and covenants that, subject to exceptions, restrict the Company’s and its subsidiaries’ ability to do the following, among things: declare dividends or redeem or repurchase equity interests; incur additional indebtedness and liens; make loans and investments; engage in mergers, acquisitions and asset sales; certain transactions with affiliates; undergo a change in control; add or change business locations or settle in cash potential milestone payment obligations that may become payable by the Company in the future to former security holders of Zavante. The Loan Agreement also grants Hercules or its nominee an option to purchase up to an aggregate of $2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in any private financing upon the same terms and conditions afforded to such other investors for as long as there are amounts outstanding under the Loan Agreement. The Company incurred $1.3 million of costs in connection with the Loan Agreement which along with the initial fee of $0.7 million paid to Hercules were recorded as debt issuance cost and are being amortized as interest expense using the effective interest method over the term of the loan. The End of Term Fee is being accrued as additional interest expense using the effective interest method over the term of the loan. Long-term debt as December 31, 2018 and 2019 consisted of the following: As of As of December 31 December 31 (in thousands) 2018 2019 Term loan payable $ 25,000 $ 35,000 End of term fee — 443 Unamortized debt issuance costs (1,990) (1,742) Carrying value of term loan 23,010 33,701 Other long-term debt 708 Total long-term debt $ 23,718 $ 34,502 Maturities of long-term debt (inclusive of the End of Term Fee) as of December 31, 2019 were as follows: (in thousands) 2020 $ — 2021 8,895 2022 17,450 2023 11,889 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders’ Equity | |
Stockholders’ Equity | 9. Stockholders’ Equity On December 20, 2019, the Company sold to certain institutional investors in a registered direct offering an aggregate of 13,793,106 ordinary shares (the “Shares”), and accompanying warrants to purchase up to an aggregate of 13,793,106 ordinary shares (the “Warrants”). Each Share was issued and sold together with an accompanying Warrant at a combined price of $1.45. The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company were $20.1 million. Each Warrant has an exercise price of $1.90 per share, is initially exercisable six months following the date of issuance (the “Initial Exercise Date”) and will expire on the three-year anniversary of the Initial Exercise Date. On June 25, 2019, the Company entered into an Open Market Sale Agreement SM (the “Jefferies ATM Agreement”) with Jefferies, pursuant to which, from time to time, the Company may offer and sell ordinary shares, for aggregate gross sale proceeds of up to $50.0 million through Jefferies by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company also filed a prospectus supplement with the Securities and Exchange Commission in connection with the Offering under the Company’s shelf Registration Statement on Form S-3 (File No. 333-219567), which became effective on August 10, 2017. As of December 31, 2019, the Company has issued and sold an aggregate of 6,505,268 ordinary shares pursuant to the Jefferies ATM Agreement and received gross proceeds of $14.4 million and net proceeds of $13.6 million, after deducting commissions to Jefferies and other offering expenses. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $35.6 million. On July 31, 2018, the Company completed an underwritten public offering of 18,181,818 ordinary shares at a public offering price of $2.75 per share, resulting in gross proceeds of $50.0 million and net proceeds to the Company of $46.3 million, after deducting underwriting discounts and commissions and offering expenses. In March 2018, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Agreement”), with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which, from time to time, the Company may offer and sell its ordinary shares having aggregate gross proceeds of up to $50.0 million through Cantor. The Company terminated the Cantor ATM Agreement effective as of June 24, 2019. The Company did not incur any penalties as a result of the termination of the Cantor ATM Agreement. As of the effective date of the termination of the Cantor ATM Agreement, the Company had issued and sold an aggregate of 10,316,190 of our ordinary shares pursuant to the Cantor ATM Agreement for aggregate gross proceeds of $37.8 million and net proceeds of $36.3 million, after deducting commissions and offering expenses. The $12.2 million of ordinary shares that had been available for sale pursuant to the Cantor ATM Agreement remained unsold at the time of its termination. On September 22, 2017 the Company completed an underwritten public offering of 9,411,765 ordinary shares at a public offering price of $8.50 per share, resulting in gross proceeds of $80.0 million and net proceeds to the Company of $73.3 million, after deducting underwriting discounts and commissions and offering expenses. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Revenue | |
Revenue | 10. Revenue Our revenues which are described in Note 1 consist of the following categories. Year ended December 31, (in thousands) 2017 2018 2019 Product revenue, net $ — $ — $ 1,538 Collaboration revenues — 6,500 6,210 Research premium 4,842 2,594 1,311 Government grants 369 562 422 Grants from WWFF 108 — — Total $ 5,319 $ 9,656 $ 9,481 |
Share-Based Payments
Share-Based Payments | 12 Months Ended |
Dec. 31, 2019 | |
Share-Based Payments | |
Share-Based Payments | 11. Share-Based Payments Stock Option Plan 2015 On April 2, 2015, the Company’s shareholders, management board and supervisory board adopted the Stock Option Plan 2015 (the “SOP 2015”) and the shareholders approved an amended and restated version of the SOP 2015 on June 30, 2015. An amendment to the amended and restated SOP 2015 was approved by the shareholders on July 22, 2015. SOP 2015 became effective on July 3, 2015 upon the registration with the commercial register in Austria of the conditional capital increase approved by the shareholders on June 30, 2015. The SOP 2015 initially provided for the grant of options for up to 95,000 Nabriva Austria common shares to the Company’s employees, including members of the management board, and to members of the supervisory board. Following the closing of the initial public offering of the Company, the overall number of options increased to 177,499 Nabriva Austria common shares. Following approval by the Company’s shareholders at its 2016 annual general meeting, the number of shares available for issuance under the SOP 2015 was increased to 346,235 Nabriva Austria common shares. Each vested option grants the beneficiary the right to acquire one share in the Company. The vesting period for the options is four years following the grant date. On the last day of the last calendar month of the first year of the vesting period, 25% of the options attributable to each beneficiary are automatically vested. During the second, third and fourth years of the vesting period, the remaining 75% of the options vest on a monthly pro rata basis (i.e. 2.083% per month). Options granted under the SOP 2015 have a term of no more than ten years from the beneficiary’s date of participation. The following table summarizes information regarding our stock option awards under the SOP 2015: 2017 2018 2019 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in price in price in intrinsic Stock Option Plan 2015 Options $ per share Options $ per share Options $ per share value Outstanding as of January 1 1,794,360 7.83 3,044,899 8.35 2,842,913 8.34 Granted 1,458,300 9.02 — — — — Exercised — — — — — — Forfeited (207,761) 8.60 (201,986) 8.41 (552,319) 8.40 Outstanding as of December 31, 3,044,899 8.35 2,842,913 8.34 2,290,594 8.33 $ — Vested and exercisable as of December 31, 989,656 7.68 1,844,590 8.10 1,984,911 8.20 $ — No options were exercised during the years ended December 31, 2017, 2018 or 2019. The Company has 2,290,594 option grants outstanding at December 31, 2019 with exercise prices ranging from $4.06 per share to $11.00 per share and a weighted average remaining contractual life of 6.4 years. Stock-based compensation expense under the SOP 2015 was $5.6 million, $3.2 million and $4.0 million for the years ended December 31, 2017, 2018 and 2019, respectively. The weighted average fair value of the options granted during the year ended December 31, 2017 was $5.05 per share. No options have been awarded during the years ended December 31, 2018 or 2019. The grant date fair value of each option grant was estimated throughout the year using the Black-Scholes option-pricing model using the following assumptions: Input parameters 2017 Expected volatility 55.6% ‑ 62.0% Expected term of options 6.1 years Risk-free interest rate 1.9% ‑ 2.1% Expected dividend yield — Due to the limited trading history for the Company's shares, the expected price volatility was based on historical trading volatility for a set of publicly traded peer companies under consideration of the remaining life of the options. The risk free interest is based on the average yield on U.S. treasury securities that corresponds to the expected term of the options in effect at the time of grant. As of December 31, 2019, there was $1.6 million of unrecognized compensation expense, related to unvested options granted under the SOP 2015 Plan, which will be recognized over the weighted average remaining vesting period of 1.3 years. 2017 Share Incentive Plan On July 26, 2017, the Company’s board of directors adopted the 2017 Share Incentive Plan (the “2017 Plan”) and the shareholders approved the 2017 Plan at the Company’s Extraordinary General Meeting of Shareholders on September 15, 2017. Following shareholder approval of the 2017 Plan, the Company ceased making awards under the SOP 2015, and future awards will be made under the 2017 Plan. However, all outstanding awards under SOP 2015 will remain in effect and continue to be governed by the terms of the SOP 2015. The 2017 Plan permits the award of share options (both incentive and nonstatutory options), share appreciation rights (“SARs”), restricted shares, restricted share units (“RSUs”), and other share-based awards to the Company’s employees, officers, directors, consultants and advisers. The 2017 Plan is administered by the Company’s board of directors. Under the 2017 Plan, the number of ordinary shares that will be reserved for issuance will be the sum of (1) 3,000,000 ordinary shares; plus (2) a number of ordinary shares (up to 3,438,990 ordinary shares) which is equal to the sum of the number of the Company’s ordinary shares then available for issuance under the SOP 2015 and the number of ordinary shares subject to outstanding awards under the SOP 2015 that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus (3) an annual increase, to be added on the first day of each fiscal year beginning in the fiscal year ending December 31, 2018 and continuing until, and including, the fiscal year ending December 31, 2027, equal to the least of (i) 2,000,000 ordinary shares, (ii) 4% of the number of outstanding ordinary shares on such date and (iii) an amount determined by the board of directors. At December 31, 2019, 1,634,766 ordinary shares were available for future issuance under the 2017 Plan. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option or SAR will be granted with a term in excess of ten years. The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. The following table summarizes information regarding our stock option awards under the 2017 Plan at December 31, 2019: 2017 2018 2019 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in $ price in $ price in $ intrinsic 2017 Plan Options per share Options per share Options per share value Outstanding as of January 1 — — 294,100 6.92 2,398,425 5.41 Granted 294,100 6.92 2,199,225 5.27 2,463,300 1.95 Exercised — — — — — — Forfeited — — (94,900) (439,061) 4.79 Outstanding as of December 31, 294,100 2,398,425 4,422,664 3.55 — Vested and exercisable as of December 31, — — 119,287 1,120,280 5.53 — There were no options exercised during the years ended December 31, 2017, 2018 and 2019. The Company has 4,422,664 option grants outstanding at December 31, 2019 with exercise prices ranging from $1.46 per share to $8.35 per share and a weighted average remaining contractual life of 8.7 years. Stock-based compensation expense under the 2017 Plan was $0.1 million, $1.8 million and $2.6 million for the years ended December 31, 2017, 2018 and 2019, respectively. The weighted average fair value of the options granted during years ended December 31, 2017, 2018 and 2019 was $3.98, $3.06 and $1.14 per share, respectively, based on a Black Scholes option pricing model using the following assumptions: Input parameters 2017 2018 2019 Range of expected volatility 59.5% ‑ 63.0% 59.8% - 61.4% 61.4% - 63.1% Expected term of options (in years) 6 6.1 6.0 Range of risk-free interest rate 1.9% ‑ 2.3% 2.6% - 3.0% 1.9% - 2.6% Dividend yield — – — As of December, 2019, there was $4.9 million of total unrecognized compensation expense, related to unvested options granted under the 2017 Plan, which will be recognized over the weighted-average remaining vesting period of 2.7 years. Restricted Stock Units (“RSUs”) During 2019, the Company granted RSUs to certain employees that vest over a period of four years with 25% vesting upon the first anniversary of the grant date and on a monthly pro rata basis thereafter over the remaining three years. As of December 31, 2019, there were 479,000 of such RSUs outstanding. For the year ended December 31, 2019, $0.2 million of stock-based compensation expense was recognized for these RSUs. During 2018, the Company granted RSUs to certain employees where vesting of the RSUs was subject to FDA approval of an NDA for XENLETA. Fifty percent (50%) of each RSU award vested upon FDA approval, and the remaining fifty percent (50%) will vest on the one- year anniversary of such approval. As of December 31, 2019, a total of 170,400 RSUs have vested and were issued and there were 161,175 of such RSUs outstanding. In connection with the FDA approval that was received in August 2019, the Company recognized compensation expense of $1.4 million during the year ended December 31, 2019. No compensation expense was recognized on these awards prior to this date as it was determined that approval was not probable since it was outside of the Company’s control. Also during 2018, the Company granted RSUs to certain employees that will vest in three six-month increments beginning in May 2019 and ending in May 2020. As of December 31, 2019, a total of 487,181 RSUs have vested and were issued and there were 225,911 of such RSUs outstanding. During the years ended December 31, 2018 and 2019, $0.2 million and $1.1 million of compensation expense was recognized for these RSUs. The Company also granted 35,600 RSUs in 2018 to certain employees where vesting of the RSUs is subject to FDA approval of an NDA for CONTEPO. Fifty percent (50%) of each RSU award will vest upon FDA approval, and the remaining fifty percent (50%) will vest on the one- year anniversary of such approval. As of December 31, 2019, a total of 35,600 of such RSUs are outstanding. The following table summarizes information regarding our restricted stock unit awards under the 2017 Plan at December 31, 2019: 2018 2019 weighted weighted average fair average fair 2017 Plan RSUs value per share RSUs value per share Outstanding as of January 1 — — 1,222,100 3.31 Granted 1,241,450 3.36 479,000 1.90 Vested and issued — — (657,581) 3.18 Forfeited (19,350) 6.47 (141,833) 2.79 Outstanding as of December 31 1,222,100 3.31 901,686 3.69 The Company has total unrecognized compensation costs of $2.4 million associated with RSUs which are expected to be recognized over the awards average remaining vesting period of 0.8 years. 2019 Inducement Share Incentive Plan On March 12, 2019, the Company’s board of directors adopted the 2019 Inducement Share Incentive Plan (the “2019 Inducement Plan”) and, subject to the adjustment provisions of the 2019 Inducement Plan, reserved 2,000,000 ordinary shares for issuance pursuant to equity awards granted under the 2019 Inducement Plan. In accordance with Nasdaq Listing Rule 5635(c)(4), awards under the 2019 Inducement Plan may only be made to individuals who were not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company. At December 31, 2019, 1,394,350 ordinary shares were available for future issuance under the 2019 Inducement Plan. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option or SAR will be granted with a term in excess of ten years. The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. The following table summarizes information regarding the Company’s stock option awards under the 2019 Inducement Plan for the year ended December 31, 2019: Weighted average exercise Aggregate price in $ intrinsic 2019 Plan Options per share value Outstanding as of January 1, 2019 — — Granted 703,150 2.22 Exercised — — Expired Forfeited (97,500) 2.69 Outstanding as of December 31, 2019 605,650 2.14 $ — Vested and exercisable as of December 31, 2019 — — $ — Stock-based compensation expense under the 2019 Inducement Plan was $77,000 for the year ended December 31, 2019. The weighted average fair value of the options granted during the year ended December 31, 2019 was $1.30 per share. The options granted during the year ended December 31, 2019 were valued based on a Black Scholes option pricing model using the following assumptions. The significant inputs into the model were as follows: Input parameters Range of expected volatility 61.6% - 63.7% Expected term of options (in years) 6.1 Range of risk-free interest rate 1.4% - 2.3% Dividend yield — The weighted average remaining contractual life of the options as of December 31, 2019 is 9.6 years. As of December 31, 2019, there was $0.7 million of total unrecognized compensation expense, related to unvested options granted under the 2019 Inducement Plan, which will be recognized over the weighted-average remaining vesting period of 3.3 years. Inducement Awards Outside of the 2019 Inducement Plan In July 2018, the Company granted a non-statutory option to purchase 850,000 of its ordinary shares and 150,000 performance-based RSUs to the Company’s newly appointed Chief Executive Officer (the “CEO”). These equity awards were granted outside of the 2017 Plan, were approved by the Company’s compensation committee and board of directors and were made as an inducement material to the CEO entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price per share for the share option is $3.53 per share, and the option award has a ten-year term and will vest over a four-year period, with 25% of the shares underlying the award vesting on the first anniversary of the grant date and the remaining 75% of the shares underlying the option award to vest monthly over the subsequent 36-month period. The performance-based RSUs are subject to vesting as follows: 50% will vest upon certification by the board of directors of the receipt of approval by the FDA of an NDA for each of lefamulin and CONTEPO for any indication, and 50% will vest on the first anniversary of such certification by the board of directors, provided, in each case, the CEO is performing services to the Company on the applicable vesting dates. If the FDA does not approve an NDA for both lefamulin and CONTEPO by January 31, 2020, the performance-based RSUs will terminate in full. Since CONTEPO was not approved by this date the award was forfeited. The Company also issues non-statutory options to new employees upon the commencement of their employment. Stock-based compensation expense was $0.2 million and $0.4 million for the year ended December 31, 2018 and December 31, 2019. The performance-based RSUs granted to our CEO had a grant date fair value of $3.53 per share (although no expense was recognized as FDA approval was not considered probable) and the options granted to our CEO had a grant date fair value of $2.05 per share based on a Black Scholes option pricing model using the following assumptions. Input parameters Expected volatility 59.8 % Expected term of options (in years) 6.1 Range of risk-free interest rate 2.9 % Dividend yield — The weighted average remaining contractual life of the options as of December 31, 2019 is 8.6 years. As of December 31, 2019, there was $1.1 million of total unrecognized compensation expense, related to unvested inducement award options granted, which will be recognized over the weighted-average remaining vesting period of 2.6 years. Our share-based compensation expense has been allocated to research and development and selling, general and administrative expenses in the Consolidated Statement of Operations and Comprehensive Loss as follows: Year ended December 31, (in thousands) 2017 2018 2019 Research and development $ 2,128 $ 1,406 $ 2,138 Selling, general and administrative 3,604 3,748 7,610 Total $ 5,732 $ 5,154 $ 9,748 The Company recognizes the impact of forfeitures as they occur and issues new shares to satisfy share based compensation arrangements upon the exercise of stock options or vesting of restricted shares. Employee Stock Purchase Plan The Company’s board of directors adopted, and in August 2018 Company’s stockholders approved, the 2018 employee stock purchase plan (the “2018 ESPP”). The maximum aggregate number of shares of ordinary shares that may be purchased under the 2018 ESPP is 500,000 shares, (the “ESPP Share Pool”), subject to adjustment as provided for in the 2018 ESPP. The ESPP Share Pool represented 0.75% of the total number of shares of ordinary shares outstanding as of December 31, 2018. The 2018 ESPP allows eligible employees to purchase shares at a 15% discount to the then current market price of the Company’s ordinary shares during certain offering periods, which will be six -month periods commencing November 1 and ending April 30 and commencing May 1 and ending October 31 of each year. The first offering under the 2018 ESPP commenced on November 1, 2018. Expense recorded under the ESPP was not material for the year ended December 31, 2018 and was $0.1 million for the year ended December 31, 2019. |
Post-employment benefit obligat
Post-employment benefit obligations | 12 Months Ended |
Dec. 31, 2019 | |
Post-employment benefit obligations | |
Post-employment benefit obligations | 12. Post-employment benefit obligations As required under Austrian labor law, the Company makes contributions to a state plan classified as defined contribution plan (Mitarbeitervorsorgekasse) for its employees in Austria. Monthly contributions to the plan are 1.53% of salary with respect to each employee and are recognized as expense in the period incurred. For the years ended December 31, 2017, 2018 and 2019, contributions costs were $58,000, $68,000 and $68,000, respectively. For employees of Nabriva Therapeutics US, Inc., the Company makes contributions to a defined contribution plan as defined in subsection 401(k) of the Internal Revenue Code. The Company matches 100% of the first 3% of the employee’s voluntary contribution to the plan and 50% of the next 2% contributed by the employee. Contributions are recognized as expense in the period incurred. In the years ended December 31, 2017, 2018 and 2019, contributions were $213,000, $448,000 and $710,000, respectively. |
Income tax expense
Income tax expense | 12 Months Ended |
Dec. 31, 2019 | |
Income tax expense | |
Income tax expense | 13. Income tax expense Loss before income taxes attributable to domestic and international operations, consists of the following: Year ended December 31 (in thousands) 2017 2018 2019 Domestic $ (66,109) $ (113,699) $ (78,761) Foreign (6,892) (1,032) (3,902) Loss before income taxes $ (73,001) $ (114,731) $ (82,663) Income tax expense consists of the following: Year ended December 31 (in thousands) 2017 2018 2019 Current tax Domestic $ — $ — $ — Foreign 55 (49) (101) Deferred tax Domestic — — — Foreign (1,410) — — Total income tax expense $ (1,355) $ (49) $ (101) The reconciliation to our effective tax rate from the Irish statutory income tax rate of 12.5% for the years ended December 31, 2017, 2018 and 2019 is as follows: Year ended December 31 (% of pre-tax income) 2017 2018 2019 Statutory income tax rate 12.5 % 12.5 % 12.5 % Non-deductible expenses (0.8) (0.1) (0.1) Income not subject to tax 0.9 0.3 0.3 Impairment 1.4 — — Tax credits 0.2 0.1 0.4 Foreign rate differential 21.0 (3.1) 0.6 In-process research and development — (3.5) 0.0 Tax audit assessments — — (11.8) Other (1.4) 0.2 0.8 Valuation allowance (35.6) (6.5) (2.8) Effective income tax rate (1.8) % (0.1) % (0.1) % The following table summarizes the components of deferred income tax balances: As of December 31, (in thousands) 2018 2019 Deferred tax assets: Net operating loss carryforwards $ 91,995 $ 94,014 Tax loss on liquidation of subsidiary 6,245 5,024 Equity compensation 2,473 4,182 Non-deductible reserves 203 395 Total deferred tax assets 100,916 103,615 Valuation allowance (100,832) (103,185) Net deferred tax assets 84 430 Deferred tax liabilities: Financial liabilities 55 48 Property, plant and equipment 29 382 Total deferred tax liability 84 430 Deferred tax, net $ — $ — The table below summarizes changes in the deferred tax valuation allowance: Year ended December 31, (in thousands) 2017 2018 2019 Balance at beginning of year $ (54,114) $ (80,087) $ (100,832) Tax benefit (25,973) (7,301) (2,353) Acquired tax attributes — (13,444) — Balance at end of year $ (80,087) $ (100,832) $ (103,185) The following table summarizes carryforwards of net operating losses as of December 31, 2019. (in thousands) Amount Expiration Ireland $ 187,631 Indefinite Austria $ 223,827 Indefinite United States $ 10,403 Indefinite United States $ 35,680 2033 Due to uncertainty regarding the ability to realize the benefit of deferred tax assets primarily relating to net operating loss carryforwards and the fact that the Company is in a three year pretax cumulative loss position, a full valuation allowance has been established. On the basis of this evaluation, as of December 31, 2017, 2018 and 2019, the Company has recorded a valuation allowance of $80.1 million, $100.8 million and $103.2 million, respectively, to recognize only the portion of the deferred tax asset that is more likely than not to be realized. The amount of the deferred tax asset considered realizable, however, could be adjusted if estimates of future taxable income during the carryforward period are reduced or increased or if objective negative evidence in the form of cumulative losses is no longer present and additional weight is given to subjective evidence such as our projections for growth. The Tax Cuts and Jobs Act (the “TCJA”) was enacted on December 22, 2017 and became effective January 1, 2018. The Tax Act had significant changes to U.S. tax law, lowering U.S. corporate income tax rates, implementing a territorial tax system, and modified the taxation of other income and expense items. The TCJA reduces the U.S. corporate income tax rate from 35% to 21%, effective January 1, 2018. 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 reverse. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the TCJA, the Company revalued the ending net deferred tax assets and liabilities of its U.S. subsidiary as of December 31, 2017. The tax impact of the revaluation of these deferred tax assets, net was $0.8 million, which was wholly offset by a corresponding reduction in the valuation allowance for these net deferred tax assets resulting in no impact to income tax expense. At December 31, 2018, the Company had no uncertain tax positions and did not expect any material increase or decrease in income tax expense related to examinations or changes in uncertain tax positions. At December 31, 2019, the Company received a tax assessment from the government in Austria resulting in a change of deferred tax assets. The assessment does not result in a cash settlement. The Company files income tax returns in Ireland. In addition, the Company’s foreign subsidiaries file separate income tax returns in Austria and the United States and state jurisdictions in which they are located. Tax years 2017 and forward remain open for examination for Ireland tax purposes and 2015 and forward remain open for examination for Austrian tax purposes and years 2016 and forward remain open for examination for United States tax purposes. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 14. Earnings (Loss) per Share Basic and diluted loss per share Basic and diluted loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares outstanding during the year. Diluted net loss per share is the same as basic net loss per share during the periods presented as the effects of the Company’s common stock equivalents are antidilutive and thus not included in the calculation. Year ended December 31, (in thousands, except per share data) 2017 2018 2019 Net loss for the period $ (74,356) $ (114,780) $ (82,764) Weighted average number of shares outstanding 29,830,669 50,795,768 Basic and diluted loss per share $ (2.49) $ (2.26) $ (1.12) The following ordinary share equivalents were excluded from the calculations of diluted loss per share as their effect would be anti-dilutive: Year ended December 31 2017 2018 2019 Stock option awards 3,338,999 6,091,338 8,168,908 Restricted stock units — 1,372,100 1,051,686 |
Acquisition of Zavante
Acquisition of Zavante | 12 Months Ended |
Dec. 31, 2019 | |
Acquisition of Zavante | |
Acquisition of Zavante | 15. Acquisition of Zavante On July 24, 2018, the Company acquired Zavante. The acquisition was completed on July 24, 2018 (the “Closing”). In connection with the Closing, the Company issued 7,336,906 Company ordinary shares to former Zavante stockholders, which together with the 815,186 ordinary shares that were issued in July 2019 upon release of the Holdback Shares (as defined below) constitute approximately 19.9% of the Company ordinary shares outstanding as of immediately prior to the Closing (the “Upfront Shares”). Pursuant to the Merger Agreement, former Zavante stockholders and other equity holders, in the aggregate and subject to the terms and conditions of the Merger Agreement, will also be entitled to receive from the Company up to $97.5 million in contingent consideration, of which $25.0 million would become payable upon the first approval of a NDA from the FDA for CONTEPO for any indication (the “Approval Milestone Payment”) and an aggregate of up to $72.5 million would become payable upon the achievement of specified sales milestones (the “Net Sales Milestone Payments”). At the Company’s Extraordinary General Meeting of Shareholders held in October 2018, the shareholders approved the issuance of the Company’s ordinary shares in settlement of potential milestone payment obligations that may become payable in the future to former Zavante stockholders, including the Approval Milestone Payment which will be settled in Company ordinary shares. The Company also now has the right to settle the Net Sales Milestone Payments in Company ordinary shares, except as otherwise provided in the Merger Agreement. In addition, upon the Closing, we assumed certain liabilities and obligations, including contractual liabilities and obligations. Prior to the Acquisition, Zavante was obligated to make milestone payments to the former stockholders of $3.0 million payable in cash upon marketing approval by the FDA with respect to any oral, intravenous or other form of fosfomycin, or the Zavante Products, and milestone payments of up to $26.0 million that may be settled in ordinary shares in the aggregate upon the occurrence of various specified levels of net sales with respect to the Zavante Products. In addition, Zavante is obligated to make annual royalty payments of a mid-single-digit percentage of net sales of Zavante Products, subject to adjustment based on net sales thresholds and with such percentage reduced to low single-digits if generic fosfomycin products account for half of the applicable market on a product-by-product and country-by-country basis. Zavante will also pay a mid-single-digit percentage of transaction revenue in connection with the consummation of the grant, sale, license or transfer of market exclusivity rights for a qualified infectious disease product (within the meaning of the 21st Century Cures Act, or the Cures Act) related to a Zavante Product. The Company accounted for the acquisition of Zavante as an asset acquisition as the arrangement did not meet the definition of a business pursuant to the guidance prescribed in ASC Topic 805, Business Combinations because the transaction resulted in the acquisition of the exclusive rights to IV fosfomycin in the U.S. which is a single identifiable asset and represented substantially all the fair value of the assets acquired. The Company expensed the acquired intellectual property as of the acquisition date as in- process research and development with no alternative future uses. The Company recorded an in-process research and development expense of $32.0 million which represents $26.9 million for the fair value of the Upfront Shares, $4.8 million of transaction costs and $0.2 million of net liabilities assumed. In addition, the Company assumed certain liabilities and obligations, including contractual liabilities and obligations, that were assumed by the Company upon closing of the acquisition. See “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Acquisition of Zavante” for further information regarding the agreements that were assumed by the Company. |
Sinovant and Sunovion License A
Sinovant and Sunovion License Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Sinovant and Sunovion License Agreements. | |
Sinovant and Sunovion License Agreements | 16. Sinovant and Sunovion License Agreements Sinovant License Agreement In March 2018, the Company entered into the Sinovant License Agreement, with Sinovant Sciences, Ltd. (“Sinovant”), an affiliate of Roivant Sciences, Ltd., to develop and commercialize lefamulin in the greater China region. As part of the Sinovant License Agreement, Nabriva Therapeutics Ireland DAC and Nabriva Therapeutics GmbH, the Company’s wholly owned subsidiaries, granted Sinovant an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin (the “Sinovant Licensed Products”), in the People’s Republic of China, Hong Kong, Macau, and Taiwan (together the “Territory”). Under the Sinovant License Agreement, Sinovant and the Company’s subsidiaries have established a joint development committee (the “JDC’), to review and oversee development and commercialization plans in the Territory. The Company received a non-refundable $5.0 million upfront payment pursuant to the terms of the Sinovant License Agreement and will be eligible for up to an additional $91.5 million in milestone payments upon the achievement of certain regulatory and commercial milestone events related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if any Sinovant Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The first milestone was a $1.5 million payment for the submission of a clinical trial application (“CTA”), by Sinovant to the Chinese Food and Drug Administration, which was received in the first quarter of 2019. Additionally, in connection with the FDA approval for lefamulin the Company received a $5.0 million milestone payment in the third quarter of 2019. The remaining milestone payments of $86.5 million are tied to additional regulatory approvals and annual sales targets. The Company will also be eligible to receive low double-digit royalties on sales, if any, of Sinovant Licensed Products in the Territory. The Company has recorded the payments received to date as collaboration revenue in the consolidated statements of operations. The future regulatory and commercial milestone payments will be recorded during the period the milestones become probable of achievement. Sinovant will be solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing Sinovant Licensed Products in the Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Sinovant Licensed Products in the Territory. The Company is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sinovant a sufficient supply of lefamulin for Sinovant to manufacture finished drug products for development and commercialization of the Sinovant Licensed Products in the Territory. Unless earlier terminated, the Sinovant License Agreement will expire upon the expiration of the last royalty term for the last Sinovant Licensed Product in the Territory, which the Company expects will occur in 2033. Following the expiration of the last royalty term, the license granted to Sinovant will become non-exclusive, fully-paid, royalty-free and irrevocable. The Sinovant License Agreement may be terminated in its entirety by Sinovant upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the Sinovant License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the Sinovant License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the Sinovant License Agreement immediately if Sinovant does not reach certain development milestones by certain specified dates (subject to specified cure periods). The Sinovant License Agreement contemplates that the Company will enter into ancillary agreements with Sinovant, including clinical and commercial supply agreements and a pharmacovigilance agreement. Sunovion License Agreement In March 2019, the Company entered into the Sunovion License Agreement with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC, the Company’s wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize the Licensed Products in Canada in all uses in humans in community-acquired bacterial pneumonia and in any other indication for which the Licensed Products have received regulatory approval in Canada. Under the Sunovion License Agreement, Sunovion and DAC will establish a joint development committee (the “Sunovian JDC”), to review and oversee regulatory approval and commercialization plans in the Territory. Sunovion will be solely responsible for all costs related to obtaining regulatory approval of and commercializing Licensed Products in the Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Licensed Product in the Territory. The Company has identified two performance obligations at inception: (1) the delivery of the exclusive license to Sunovion, which the Company has determined is a distinct license of functional intellectual property that Sunovion has obtained control of; and, (2) the participation in the Sunovian JDC. The $1.0 million non-refundable upfront payment was allocated entirely to the delivery of the license as the Sunovian JDC deliverable was deemed to be de minimis. Any future regulatory and commercial milestone payments under the Sunovion License Agreement will be recorded during the period the milestones become probable of achievement. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 17. Commitments and Contingencies Leases The Company leases office spaces in King of Prussia, Pennsylvania, San Diego, California, Dublin, Ireland and laboratory and office space in Vienna, Austria under agreements previously classified as operating leases. The lease agreement in King of Prussia, Pennsylvania expires on December 15, 2023 and does not include any renewal options. The agreement provides for an initial monthly base amount plus annual escalations through the term of the lease. The lease agreement in San Diego, California expired on June 30, 2019 and was not renewed by the Company. In May 2019, the Company entered into a month-to-month sublease agreement for office space for two employees in San Diego, California. For the lease agreement in Vienna Austria, the Company can terminate the lease without the landlord’s consent and without paying a termination penalty by giving six months’ notice to the landlord. The agreement provides for a monthly base fixed amount. The Company is in the process of determining the appropriate space needed in the building based on its needs. As a result, the Company may negotiate a new lease or evaluate additional or alternate spaces. As such, the Company has classified the agreement as a short-term lease. During the third quarter of 2019, the Company subleased certain space at its leased cost. In March 2019, the Company entered into a lease agreement for office space in Dublin, Ireland which expires on April 30, 2021. The agreement can be automatically renewed by both parties equal to the current lease term but for no less than three months. The agreement provides for a monthly based fixed amount of 7,000 euros beginning on the commencement date which was in May 2019. In addition to the monthly base amounts under the lease agreements, the Company is required to pay its proportionate share of real estate taxes and operating expenses during the lease term for the King of Prussia lease. Lease expense was $1.3 million, $1.4 million, and $1.5 million for the years ended December 31, 2017, 2018 and 2019, respectively. As of December 31, 2019, the lease term of the King of Prussia operating leases was 4.0 years and the discount rate was 9.8%. As of December 31, 2019, other information related to the operating leases were as follows: Operating Cash Flow Supplemental Information: (in thousands) December 31, 2019 Cash paid for amounts included in the measurement of the operating lease liabilities $ 515 Right-of-use assets obtained in exchange for operating lease obligations $ 1,647 The following table sets forth by year the required future payments of operating lease liabilities: (in thousands) December 31, 2019 2020 $ 507 2021 515 2022 522 2023 533 Total lease payments 2,077 Less imputed interest (368) Present value of operating lease liabilities 1,709 Future minimum contractual obligations and commitments at December 31, 2019 are as follows: Year ending December 31, (in thousands) Total 2020 2021 2022 2023 2024 Thereafter Operating lease obligations $ 3,222 $ 1,647 $ 546 $ 522 $ 507 $ — $ — Other contractual commitments 52,406 10,274 9,043 9,690 9,911 6,744 6,744 Total $ 55,628 $ 11,921 $ 9,589 $ 10,212 $ 10,418 $ 6,744 $ 6,744 In addition to the agreements described above, the Company has other contractual commitments related primarily to contracts entered into with contract manufacturing organizations and contract research organizations in connection with the commercial manufacturing of Xenleta and other research and development activities. The estimated payments to the service providers included in the table above are based solely on the estimated work to be performed by them to complete manufacturing and other activities along with the anticipated achievement of milestones included within the agreements. Also, some of these contracts are subject to early termination clauses exercisable at the discretion of the Company. Legal Proceedings On May 8, 2019, a putative class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Southern District of New York, captioned Larry Enriquez v. Nabriva Therapeutics PLC, and Ted Schroeder, No. 19-cv-04183. The complaint purported to be brought on behalf of shareholders who purchased the Company's securities between November 1, 2018 and April 30, 2019. The complaint generally alleged that the Company and its Chief Executive Officer violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements and omitting to disclose material facts concerning the Company's submission of an NDA to the FDA for marketing approval of CONTEPO for the treatment of cUTI in the United States and the likelihood of such approval. The complaint sought unspecified damages, attorneys' fees, and other costs. On May 22, 2019, a second putative class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Southern District of New York, captioned Anthony Manna v. Nabriva Therapeutics PLC, and Ted Schroeder, No. 19-cv-04713. The complaint purported to be brought on behalf of shareholders who purchased the Company's securities between November 1, 2018 and April 30, 2019. The allegations made in the Manna complaint were similar to those made in the Enriquez complaint, and the Manna complaint sought similar relief. On May 24, 2019, these two lawsuits were consolidated by the court. The court appointed a lead plaintiff and approved plaintiff's selection of lead counsel on July 22, 2019. On September 23, 2019, plaintiff filed an amended complaint, adding the Company's Chief Financial Officer and Chief Medical Officer as defendants; the amended complaint purports to be brought on behalf of shareholders who purchased the Company's securities between January 4, 2019 through April 30, 2019, and otherwise includes allegations similar to those made in the original complaints and seeks similar relief. The Company's pre-motion letter to dismiss the amended complaint was due to plaintiff on October 21, 2019, and plaintiff responded to the Company via a letter on November 4, 2019. On November 18, 2019, the Company filed a pre-motion letter to dismiss with the Court, seeking leave to move to dismiss and setting forth why a motion to dismiss is warranted. The Company denies any and all allegations of wrongdoing and intends to vigorously defend against this lawsuit. The Company is unable, however, to predict the outcome of this matter at this time. Moreover, any conclusion of this matter in a manner adverse to the Company and for which it incurs substantial costs or damages not covered by the Company's directors' and officers' liability insurance would have a material adverse effect on its financial condition and business. In addition, the litigation could adversely impact the Company's reputation and divert management's attention and resources from other priorities, including the execution of its business plan and strategies that are important to the Company's ability to grow its business, any of which could have a material adverse effect on the Company's business. The Company has no other contingent liabilities in respect of legal claims arising in the ordinary course of business. |
Selected Quarterly Financial In
Selected Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Information (Unaudited) | |
Selected Quarterly Financial Information (Unaudited) | 18. Selected Quarterly Financial Information (Unaudited) The table summarizes the unaudited consolidated financial results of operations for the quarters ended: (amounts in thousands, except per share data) March 31 June 30 September 30 December 31 2019 Quarter Ended Revenues $ 1,703 $ 525 $ 6,920 $ 333 Operating expenses (20,947) (21,501) (24,119) (22,403) Loss from operations (19,244) (20,976) (17,199) (22,070) Other income (expense) (819) (776) (625) (954) Income tax (expense) benefit (154) 45 29 (21) Net loss (20,217) (21,707) (17,795) (23,045) Basic and diluted loss per share $ (0.29) $ (0.30) $ (0.24) $ (0.29) 2018 Quarter Ended Revenues $ 7,551 $ 847 $ 461 $ 797 Operating expenses (20,415) (18,554) (53,386) (31,676) Loss from operations (12,864) (17,707) (52,925) (30,879) Other income (expense) 28 (129) (51) (204) Income tax (expense) benefit (506) 48 151 259 Net loss (13,342) (17,788) (52,825) (30,824) Basic and diluted loss per share (1) $ (0.36) $ (0.44) $ (0.90) $ (0.46) (1) Net loss per share amounts may not agree to the per share amounts for the full year due to the use of weighted average shares for each period. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events | |
Subsequent Events | 19. Subsequent Events On March 11, 2020, the Company entered into an amendment (the “Amendment”) to its Loan Agreement with Hercules. Pursuant to the Amendment, the Company agreed to repay to Hercules between April 1, 2020 and April 3, 2020, $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement (the “Prepayment”). The Company determined to enter into the Amendment following the effectiveness of a performance covenant in February 2020 under which it became obligated to either (1) achieve 80% of its net product revenue sales target over a trailing six month period, or (2) maintain an amount of cash and cash equivalents in accounts pledged to Hercules plus a specified amount of eligible accounts receivables equal to the greater of the amount outstanding under the Loan Agreement or $40.0 million (the “Liquidity Requirement”). Since the Company did not achieve its net product sales targets, it became obligated to maintain compliance with the Liquidity Requirement. Under the Amendment, the Company and Hercules agreed to defer the end of term loan charge payment in the amount of approximately $2.3 million that would have otherwise become payable on the date of the Prepayment and to reduce the prepayment charge with respect to the Prepayment from $600,000 to $300,000 and to defer its payment, in each case, until June 1, 2023 or such earlier date on which all loans under the Loan Agreement are repaid or become due and payable. The Amendment also reset the revenue performance covenant to 70% of targeted revenue based on a revised net product revenue forecast and lowered the Company’s minimum liquidity requirement to $3.0 million in cash and cash equivalents, in each case, following the Prepayment. The new minimum liquidity requirement will not apply if CONTEPO receives regulatory approval from the U.S. Food and Drug Administration and the Company achieves at least 70% of its revised net product revenue targets under the Loan Agreement. Following the Prepayment, the Company may request to borrow an additional $5.0 million subject to the Hercules’ sole discretion. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Preparation | Basis of Preparation The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for annual reporting. The consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Functional Currency Transactions and Balances | Functional Currency Transactions and Balances In preparing the consolidated financial statements, transactions in currencies other than the U.S. dollar are recognized at the exchange rates prevailing at the dates of the transactions. Foreign currency exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations and comprehensive income (loss). |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. Restricted Cash The Company classifies funds contributed by its employees to its Employee Stock Purchase Plan (See Note 11) as restricted in nature since these amounts can only be utilized to purchase Company stock at the end of each six month offering period. Prior to the conclusion of the offering period, employees can request reimbursement of the funds they previously contributed and if they leave the Company prior to the end of the offering period the funds are returned to the employee. |
Short-term Investments | Short-term Investments The Company has designated its investments in securities as available-for-sale securities and measures these securities at their respective fair values. Investments that mature in one year or less are classified as short-term available-for-sale securities. Investments that are not considered available for use in current operations are classified as long-term available-for-sale securities. Changes in the fair value of available-for-sale investments are recognized in other comprehensive income (loss). |
Inventory | Inventory Inventory is stated at the lower of cost or estimated net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company's supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and would record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. The components of our inventory at December 31, 2019 are as follows: (in thousands) Raw materials $ — Work in process 498 Finished goods 184 Total Inventory $ 682 |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful lives of property, plant and equipment are as follows: 3-5 years for IT equipment, 5-10 years for laboratory equipment and 3-10 years for other plant and office equipment. The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each reporting date. When assets are sold or otherwise disposed of, the difference between the net proceeds, if any, and the net carrying amount of the asset is recognized as a gain or a loss in other operating income or expenses. |
Intangible Assets and Other Long-lived Assets | Intangible Assets and Other Long-lived Assets Intangible assets, such as acquired computer software licenses, are capitalized on the basis of the costs incurred to acquire the software and bring it into use. These costs are amortized on a straight-line basis over their estimated useful lives (3-10 years). Long-lived assets are assessed for potential impairment when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. An impairment loss would be recognized when undiscounted cash flows expected to be generated by an asset, is less than its carrying amount. The impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and recognized in these financial statements. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the commercialization and development of novel anti-infective agents to treat serious and life-threatening infections. |
Revenue Recognition | Revenue Recognition —The Company recognizes revenue from sales of its commercial products in accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"). Net Product Revenue Beginning in September 2019, the Company began selling its XENLETA product principally to a limited number of specialty distributors in the United States. The distributors place orders with the Company for sufficient quantities of its products to maintain an appropriate level of inventory based on its customers’ anticipated purchase volumes and demand. The Company recognizes revenue once it has transferred physical possession of the goods and the distributor obtains legal title to the product. Payment terms between Nabriva and its customers are generally approximately 60 days from the invoice date. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of its product. The transaction price that the Company recognizes as revenue reflects the amount it expects to be entitled to in connection with the sale and transfer of control of product to its customers. At the time that the Company’s customers take control of the product, which is when the Company’s performance obligation under the sales contracts is complete, the Company records product revenues net of applicable reserves for various types of variable consideration. The types of variable consideration are as follows: · Fees-for-service · Product returns · Chargebacks and rebates · Government rebates · Commercial payer and other rebates · Group Purchasing Organizations ("GPO") administration fees · Voluntary patient assistance programs In determining the amounts of certain allowances and accruals, the Company must make significant judgments and estimates. For example, in determining these amounts, the Company estimates prescription demand from the specialty pharmacies, hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations and the levels of inventory held by specialty distributors and customers. The Company also analyzes third party end usage product consumption patterns to gauge demand for its products. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. The Company receives data periodically from its specialty distributors and customers on inventory levels and historical channel sales mix, and the Company considers this data when determining the amount of the allowances and accruals for variable consideration, however given the recent launch of its XENLETA product this data is limited. In assessing the amount of net revenue to record, the Company considers both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations the Company uses in estimating these amounts related to variable consideration associated with the Company’s products are as follows: Fees-for-service – The Company offers discounts and pays certain distributor service fees which are recorded as a reduction of revenue in the period the related product revenue is recognized. The Company does not consider the fees separate from the distributors’ purchase of the product. The Company records its fee-for-service accruals based on distributors’ purchases and the applicable discount rate. Product returns – Generally, the Company’s customers have the right to return products during the 18-month period beginning six months prior to the labeled expiration date and ending twelve months after the labeled expiration date. Since the Company currently does not have history of XENLETA returns, the Company estimated returns based on industry data for comparable products in the market. As the Company distributes its product and establishes historical sales over a longer period of time (i.e., two to three years), the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The Company’s XENLETA product has a thirty-six-month shelf life. The Company’s customers also have the right to return excess inventory on new products that do not yield forecasted sales. The Company recently launched XENLETA and underlying demand has been below its expectations, particularly in the hospital for its IV product. To the extent the Company’s customers determine that the quantities they purchased are in excess of their customers demand, product returns could increase in excess of what the Company has currently reserved which would result in a reduction to net revenues in future periods. At the end of each reporting period for any of its products, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. Chargebacks and rebates – Although the Company primarily sells products to specialty distributors in the United States, the Company also enters into agreements with hospitals and retail pharmacies, either directly or through group purchasing organizations acting on behalf of their members, in connection with the purchase of product. Based on these agreements, certain of the Company’s customers have the right to receive a discounted price on product purchases. The Company typically provides a credit to its specialty distributors customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. The calculation of the accrual for chargebacks and rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Government rebates –The Company is subject to discount obligations primarily under state Medicaid and Medicare programs. The Company estimates its Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The calculation of the accrual for government rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Commercial payer and other rebates – The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of XENLETA and contracted formulary status. The Company estimates these rebates and records reserves for such estimates in the same period the related revenue is recognized. Currently, the reserve for customer payer rebates considers future utilization based on third party studies of payer prescription data; the utilization is applied to product that remains in the distribution and retail pharmacy channel inventories at the end of each reporting period. The calculation of the accrual for commercial payer and other rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. GPO administration fees – The Company contracts with GPOs and pays administration fees related to contacting and membership management services provided. In assessing if the consideration paid to the GPO should be recorded as a reduction in the transaction price, the Company determines whether the payment is for a distinct good or service or a combination of both. Since GPO fees are not specifically identifiable, the Company does not consider the fees separate from the purchase of the product. Additionally, the GPO services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. Patient assistance – The Company offers certain voluntary patient assistance programs for prescriptions, such as co-pay assistance programs, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product sales that have been recognized as revenue but remains in the distribution channel as inventory at the end of each reporting period. At the end of each reporting period, the Company will adjust its variable consideration estimates for product returns, chargebacks, and rebates when the Company believes actual experience may differ from current estimates. The following table summarizes balances and activity of product revenue allowances and reserves: Total Balance at December 31, 2018 $ — Provision related to current period sales 635 Adjustment related to prior period sales — Credit or payments made during the period (101) Balance at December 31, 2019 $ 534 Cost of Product Sales Cost of product sales consists primarily of the direct and indirect manufacturing costs for XENLETA. All manufacturing costs incurred prior to XENLETA’s approval in the United States on August 19, 2019 were expensed in research and development expense. Costs incurred after the approval date were capitalized as inventory. Research Premium and Grant Revenue Grant revenue comprises (a) the research premium from the Austrian government, (b) grants received from the Vienna Business Promotion Fund ( Wiener Wirtschaftsförderungsfonds, or WWFF ), (c) grants received from the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft, or FFG ), and (d) the benefit of government loans at below-market interest rates. The research premium the Company receives from the Austrian government is calculated at a specified percent of specified research and development cost base. The Company recognizes the research premium as long as it has incurred research and development expenses. The WWFF grant is paid out through the landlord in the form of a monthly reduction in lease payments and is recognized over the period from grant date in March 2010 until end of the lease termination waiver term in December 2017. All grants are non-refundable as long as the conditions of the grant are met. Nabriva is and has been in full compliance with the conditions of the grants and all related regulations. |
Research and Development Expenses | Research and Development Expenses All research and development costs are expensed as incurred. Research and development costs included direct personnel and material costs, related overheads, depreciation of equipment used for research or development purposes; costs for clinical research; costs for the utilization of third parties’ patents for research and development purposes and other taxes related to research facilities. |
Share-based Payments | Share-based Payments The Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award in accordance with ASC 718, Compensation—Stock Compensation . The fair value of stock options is estimated using the Black-Scholes option pricing model. All grants under share-based payment programs are accounted for at fair value and that cost is recognized over the period during which an employee is required to provide service in exchange for the award—the requisite service period (vesting period). The Company accounts for forfeitures as incurred. Compensation expense for options granted to non-employees is determined as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of awards granted to non-employees is re-measured each period until the related service is complete. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. In recognizing the benefit of tax positions, the Company has taken or expects to take, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, reducing the top U.S. federal corporate tax rate from 35 percent to 21 percent; eliminating the corporate alternative minimum tax (“AMT”) and changing how existing AMT credits can be realized; creating the base erosion anti-abuse tax (“BEAT”), a new minimum tax; creating a new limitation on deductible interest expense; and, changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017. The Tax Act reduced the U.S. corporate income tax rate from 35% to 21%, effective January 1, 2018. Deferred tax assets and liabilities were measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the Tax Act, the Company revalued the ending net deferred tax assets and liabilities of our U.S. subsidiary at December 31, 2017. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Adopted as of the current period: In February 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information has not been restated and will continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. In addition, the new lease standard provides a number of optional practical expedients in transition. The Company elected the package of practical expedients. As such, the Company did not have to reassess whether expired or existing contracts are or contain a lease; and did not have to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize right of use (“ROU”) assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office buildings). The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease ROU assets, other current liabilities, and operating lease liabilities on the Company’s consolidated balance sheet as of December 31, 2019. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term as of January 1, 2019. Since none of the Company’s lease agreements provide an implicit rate, the Company estimated an incremental borrowing rate over the lease term based on the information available at January 1, 2019 in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. On January 1, 2019, the Company recognized ROU assets and lease liabilities of approximately $2.0 million on its consolidated balance sheet using an estimated incremental borrowing rate of 9.8%. This ROU asset is recorded in property, plant and equipment, net and the ROU liability is recorded in other non-current liabilities. Pronouncements to be adopted in future periods: In August 2018, the FASB issued ASU No. 2018-15, “ Customer’s Accounting for Implementation Cost Incurred in a Cloud Computing Arrangement That Is a Service Contract ” (“ASU 2018-15”). Under the new guidance, customers will apply the same criteria for capitalizing implementation costs as they would for an arrangement that has a software license. This will result in certain implementation costs being capitalized; the associated amortization charge will, however, be recorded as an operating expense. Under the previous guidance, costs incurred when implementing a cloud computing arrangement deemed to be a service contract were recorded as an operating expense when incurred. ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Entities can choose to adopt the new guidance prospectively to eligible costs incurred on or after the date the guidance is first applied or retrospectively. The Company does expect the impact of the adoption of ASU 2018-15 on its consolidated financial statements to be material. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of inventory | (in thousands) Raw materials $ — Work in process 498 Finished goods 184 Total Inventory $ 682 |
Schedule of summary of balances and activity in each of the product revenue allowance and reserve | Total Balance at December 31, 2018 $ — Provision related to current period sales 635 Adjustment related to prior period sales — Credit or payments made during the period (101) Balance at December 31, 2019 $ 534 |
Short-term investments (Tables)
Short-term investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Short-term investments | |
Schedule of short-term investments | As of December 31, 2019 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Term deposits $ 175 $ — $ — $ 175 Total $ 175 $ — $ — $ 175 As of December 31, 2018 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Available for sale securities $ 50 $ — $ — $ 50 Term deposits 175 — — 175 Total $ 225 $ — $ — $ 225 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Measurement | |
Schedule of the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy | (in thousands) Level 1 Level 2 Level 3 Total December 31, 2019 Assets: Cash equivalent: Money market funds $ 15,050 $ — $ — $ 15,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 15,225 $ — $ — $ 15,225 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2018 Assets: Cash equivalent: Money market funds $ 50 $ — $ — $ 50 Short term investments: Term deposits 175 — — 175 Total Assets $ 225 $ — $ — $ 225 |
Accounts receivable, net and _2
Accounts receivable, net and other receivables (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounts receivable, net and other receivables | |
Schedule of other current receivables | As of December 31 (in thousands) 2018 2019 Research premium $ 2,657 $ 1,530 VAT and other taxes 1,024 403 Receivables from grant revenue 104 2 Other receivables 86 809 Total accounts receivable, net and other receivables $ 3,871 $ 2,744 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment | |
Schedule of property, plant and equipment | As of December 31 (in thousands) 2018 2019 IT equipment $ 1,079 $ 1,060 Laboratory equipment 3,392 3,375 ROU asset — 1,647 Other equipment 124 165 4,595 6,247 Less: Accumulated depreciation (3,456) (3,773) Property, plant and equipment, net $ 1,139 $ 2,474 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | As of As of (in thousands) December 31, 2018 December 31, 2019 Research and development related costs $ 5,032 $ 1,347 Payroll and related costs 7,427 6,327 Accounting, tax and audit services 398 420 Other 1,645 3,872 Total other current liabilities $ 14,502 $ 11,966 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt | |
Schedule of long-term debt | As of As of December 31 December 31 (in thousands) 2018 2019 Term loan payable $ 25,000 $ 35,000 End of term fee — 443 Unamortized debt issuance costs (1,990) (1,742) Carrying value of term loan 23,010 33,701 Other long-term debt 708 Total long-term debt $ 23,718 $ 34,502 |
Schedule of maturities of long-term debt | (in thousands) 2020 $ — 2021 8,895 2022 17,450 2023 11,889 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Revenue | |
Summary of revenue by type | Year ended December 31, (in thousands) 2017 2018 2019 Product revenue, net $ — $ — $ 1,538 Collaboration revenues — 6,500 6,210 Research premium 4,842 2,594 1,311 Government grants 369 562 422 Grants from WWFF 108 — — Total $ 5,319 $ 9,656 $ 9,481 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-Based Payments | |
Schedule of allocation of share-based compensation expense | Year ended December 31, (in thousands) 2017 2018 2019 Research and development $ 2,128 $ 1,406 $ 2,138 Selling, general and administrative 3,604 3,748 7,610 Total $ 5,732 $ 5,154 $ 9,748 |
SOP 2015 | |
Share-Based Payments | |
Summary of information regarding stock option awards | 2017 2018 2019 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in price in price in intrinsic Stock Option Plan 2015 Options $ per share Options $ per share Options $ per share value Outstanding as of January 1 1,794,360 7.83 3,044,899 8.35 2,842,913 8.34 Granted 1,458,300 9.02 — — — — Exercised — — — — — — Forfeited (207,761) 8.60 (201,986) 8.41 (552,319) 8.40 Outstanding as of December 31, 3,044,899 8.35 2,842,913 8.34 2,290,594 8.33 $ — Vested and exercisable as of December 31, 989,656 7.68 1,844,590 8.10 1,984,911 8.20 $ — |
Summary of assumptions used for valuation of options | Input parameters 2017 Expected volatility 55.6% ‑ 62.0% Expected term of options 6.1 years Risk-free interest rate 1.9% ‑ 2.1% Expected dividend yield — |
2017 Share Incentive Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | 2017 2018 2019 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in $ price in $ price in $ intrinsic 2017 Plan Options per share Options per share Options per share value Outstanding as of January 1 — — 294,100 6.92 2,398,425 5.41 Granted 294,100 6.92 2,199,225 5.27 2,463,300 1.95 Exercised — — — — — — Forfeited — — (94,900) (439,061) 4.79 Outstanding as of December 31, 294,100 2,398,425 4,422,664 3.55 — Vested and exercisable as of December 31, — — 119,287 1,120,280 5.53 — |
Summary of assumptions used for valuation of options | Input parameters 2017 2018 2019 Range of expected volatility 59.5% ‑ 63.0% 59.8% - 61.4% 61.4% - 63.1% Expected term of options (in years) 6 6.1 6.0 Range of risk-free interest rate 1.9% ‑ 2.3% 2.6% - 3.0% 1.9% - 2.6% Dividend yield — – — |
Summary of information regarding restricted stock awards | 2018 2019 weighted weighted average fair average fair 2017 Plan RSUs value per share RSUs value per share Outstanding as of January 1 — — 1,222,100 3.31 Granted 1,241,450 3.36 479,000 1.90 Vested and issued — — (657,581) 3.18 Forfeited (19,350) 6.47 (141,833) 2.79 Outstanding as of December 31 1,222,100 3.31 901,686 3.69 |
2019 Inducement Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise Aggregate price in $ intrinsic 2019 Plan Options per share value Outstanding as of January 1, 2019 — — Granted 703,150 2.22 Exercised — — Expired Forfeited (97,500) 2.69 Outstanding as of December 31, 2019 605,650 2.14 $ — Vested and exercisable as of December 31, 2019 — — $ — |
Summary of assumptions used for valuation of options | Input parameters Range of expected volatility 61.6% - 63.7% Expected term of options (in years) 6.1 Range of risk-free interest rate 1.4% - 2.3% Dividend yield — |
Inducement Awards Outside of the 2019 Inducement Plan | |
Share-Based Payments | |
Summary of assumptions used for valuation of options | Input parameters Expected volatility 59.8 % Expected term of options (in years) 6.1 Range of risk-free interest rate 2.9 % Dividend yield — |
Income tax expense (Tables)
Income tax expense (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income tax expense | |
Schedule of loss before income taxes attributable to domestic and international operations | Year ended December 31 (in thousands) 2017 2018 2019 Domestic $ (66,109) $ (113,699) $ (78,761) Foreign (6,892) (1,032) (3,902) Loss before income taxes $ (73,001) $ (114,731) $ (82,663) |
Schedule of income tax expense | Year ended December 31 (in thousands) 2017 2018 2019 Current tax Domestic $ — $ — $ — Foreign 55 (49) (101) Deferred tax Domestic — — — Foreign (1,410) — — Total income tax expense $ (1,355) $ (49) $ (101) |
Schedule of effective income tax rate reconciliation | Year ended December 31 (% of pre-tax income) 2017 2018 2019 Statutory income tax rate 12.5 % 12.5 % 12.5 % Non-deductible expenses (0.8) (0.1) (0.1) Income not subject to tax 0.9 0.3 0.3 Impairment 1.4 — — Tax credits 0.2 0.1 0.4 Foreign rate differential 21.0 (3.1) 0.6 In-process research and development — (3.5) 0.0 Tax audit assessments — — (11.8) Other (1.4) 0.2 0.8 Valuation allowance (35.6) (6.5) (2.8) Effective income tax rate (1.8) % (0.1) % (0.1) % |
Summary of the components of deferred income tax balances | As of December 31, (in thousands) 2018 2019 Deferred tax assets: Net operating loss carryforwards $ 91,995 $ 94,014 Tax loss on liquidation of subsidiary 6,245 5,024 Equity compensation 2,473 4,182 Non-deductible reserves 203 395 Total deferred tax assets 100,916 103,615 Valuation allowance (100,832) (103,185) Net deferred tax assets 84 430 Deferred tax liabilities: Financial liabilities 55 48 Property, plant and equipment 29 382 Total deferred tax liability 84 430 Deferred tax, net $ — $ — |
Summary of changes in the deferred tax valuation allowance | Year ended December 31, (in thousands) 2017 2018 2019 Balance at beginning of year $ (54,114) $ (80,087) $ (100,832) Tax benefit (25,973) (7,301) (2,353) Acquired tax attributes — (13,444) — Balance at end of year $ (80,087) $ (100,832) $ (103,185) |
Summary of carryforwards of net operating losses | (in thousands) Amount Expiration Ireland $ 187,631 Indefinite Austria $ 223,827 Indefinite United States $ 10,403 Indefinite United States $ 35,680 2033 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Year ended December 31, (in thousands, except per share data) 2017 2018 2019 Net loss for the period $ (74,356) $ (114,780) $ (82,764) Weighted average number of shares outstanding 29,830,669 50,795,768 Basic and diluted loss per share $ (2.49) $ (2.26) $ (1.12) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Year ended December 31 2017 2018 2019 Stock option awards 3,338,999 6,091,338 8,168,908 Restricted stock units — 1,372,100 1,051,686 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies | |
Schedule of Operating Cash Flow Supplemental Information | (in thousands) December 31, 2019 Cash paid for amounts included in the measurement of the operating lease liabilities $ 515 Right-of-use assets obtained in exchange for operating lease obligations $ 1,647 |
Schedule of future payments of operating lease liabilities, ASC 842 | (in thousands) December 31, 2019 2020 $ 507 2021 515 2022 522 2023 533 Total lease payments 2,077 Less imputed interest (368) Present value of operating lease liabilities 1,709 |
Schedule of future minimum contractual obligations and commitments | Year ending December 31, (in thousands) Total 2020 2021 2022 2023 2024 Thereafter Operating lease obligations $ 3,222 $ 1,647 $ 546 $ 522 $ 507 $ — $ — Other contractual commitments 52,406 10,274 9,043 9,690 9,911 6,744 6,744 Total $ 55,628 $ 11,921 $ 9,589 $ 10,212 $ 10,418 $ 6,744 $ 6,744 |
Selected Quarterly Financial _2
Selected Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Quarterly Financial Information (Unaudited) | |
Schedule of unaudited consolidated financial results of operations | (amounts in thousands, except per share data) March 31 June 30 September 30 December 31 2019 Quarter Ended Revenues $ 1,703 $ 525 $ 6,920 $ 333 Operating expenses (20,947) (21,501) (24,119) (22,403) Loss from operations (19,244) (20,976) (17,199) (22,070) Other income (expense) (819) (776) (625) (954) Income tax (expense) benefit (154) 45 29 (21) Net loss (20,217) (21,707) (17,795) (23,045) Basic and diluted loss per share $ (0.29) $ (0.30) $ (0.24) $ (0.29) 2018 Quarter Ended Revenues $ 7,551 $ 847 $ 461 $ 797 Operating expenses (20,415) (18,554) (53,386) (31,676) Loss from operations (12,864) (17,707) (52,925) (30,879) Other income (expense) 28 (129) (51) (204) Income tax (expense) benefit (506) 48 151 259 Net loss (13,342) (17,788) (52,825) (30,824) Basic and diluted loss per share (1) $ (0.36) $ (0.44) $ (0.90) $ (0.46) (1) Net loss per share amounts may not agree to the per share amounts for the full year due to the use of weighted average shares for each period. |
Organization and Business Act_2
Organization and Business Activities (Details) - USD ($) $ / shares in Units, $ in Millions | Apr. 03, 2020 | Apr. 01, 2020 | Dec. 20, 2019 | Dec. 31, 2019 | Jan. 12, 2020 | Dec. 31, 2019 | Mar. 12, 2020 | Mar. 11, 2020 | Jun. 25, 2019 |
Liquidity | |||||||||
Cash, cash equivalents and short-term investments | $ 86.6 | $ 86.6 | |||||||
Jefferies LLC | At-the-market offering | |||||||||
Liquidity | |||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50 | ||||||||
Proceeds from at-the-market facility | 14.4 | ||||||||
Net proceeds from sale of stock | $ 13.6 | ||||||||
Jefferies LLC | At-the-market offering | Ordinary Shares | |||||||||
Liquidity | |||||||||
Number of shares issued | 6,505,268 | ||||||||
Jefferies LLC | Estimate | At-the-market offering | Maximum | |||||||||
Liquidity | |||||||||
Proceeds from at-the-market facility | $ 35.6 | $ 35.6 | |||||||
Purchasers | Purchase agreement | |||||||||
Liquidity | |||||||||
Number of shares issued | 13,793,106 | 13,793,106 | |||||||
Proceeds from at-the-market facility | $ 20.1 | $ 20.1 | |||||||
Number of ordinary shares that can be purchased by warrant holders | 13,793,106 | 13,793,106 | 13,793,106 | ||||||
Share and warrant price | $ 1.45 | $ 1.45 | |||||||
Exercise price | $ 1.90 | $ 1.90 | $ 1.90 | ||||||
Term | 3 years | 3 years | 3 years | ||||||
Subsequent Event | Loan Agreement | Term loan | |||||||||
Liquidity | |||||||||
Repayment of debt | $ 30 | $ 30 | |||||||
Aggregate principal amount of debt outstanding | $ 35 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Summary of Significant Accounting Policies | |
Work in process | $ 498 |
Finished goods | 184 |
Total Inventory | $ 682 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
IT equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 3 years |
IT equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 5 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 5 years |
Laboratory equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 10 years |
Other equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 3 years |
Other equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 10 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Intangible Assets and Other Long-lived Assets and Segment Information (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Intangible assets | |
Number of operating segments | 1 |
Minimum | |
Intangible assets | |
Estimated useful life of intangible assets | 3 years |
Maximum | |
Intangible assets | |
Estimated useful life of intangible assets | 10 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Product Revenue Allowance (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Movement In Product Revenue Allowance And Reserve [Roll Forward] | |
Provision related to current period sales | $ 635 |
Credit or payments made during the period | (101) |
Balance at December 31, 2019 | $ 534 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Income Taxes (Details) | 12 Months Ended | 24 Months Ended |
Dec. 31, 2017 | Dec. 31, 2019 | |
U.S. | ||
Income taxes | ||
U.S. federal corporate tax rate | 35.00% | 21.00% |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Jan. 01, 2019 | |
Leases | ||
Operating lease liabilities | $ 1,709 | |
Operating lease liability, Statement of Financial Position | us-gaap:OtherLiabilitiesNoncurrent | |
ASU 2016-02 | ||
Leases | ||
Election of practical expedients package | true | |
ASU 2016-02 | Adjustment | ||
Leases | ||
ROU assets | $ 2,000 | |
Operating lease, ROU assets, Statement of Financial Position | us-gaap:PropertyPlantAndEquipmentNet | |
Operating lease liabilities | $ 2,000 | |
Operating lease liability, Statement of Financial Position | us-gaap:OtherLiabilitiesNoncurrent | |
Estimated incremental borrowing rate | 9.80% |
Short-term investments (Details
Short-term investments (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Short-term investments | ||
Amortized Cost | $ 175 | $ 225 |
Fair Value | 175 | 225 |
Available-for-sale securities | ||
Short-term investments | ||
Amortized Cost | 50 | |
Fair Value | 50 | |
Term deposits | ||
Short-term investments | ||
Amortized Cost | 175 | 175 |
Fair Value | $ 175 | $ 175 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Short-term investments: | ||
Transfer of assets from Level 1 to 2 | $ 0 | $ 0 |
Transfer of assets from Level 2 to 1 | 0 | 0 |
Transfer of liabilities from Level 1 to 2 | 0 | 0 |
Transfer of liabilities from Level 2 to 1 | 0 | 0 |
Recurring | ||
Cash equivalent: | ||
Money market funds | 15,050 | 50 |
Short-term investments: | ||
Term deposits | 175 | 175 |
Total Assets | 15,225 | 225 |
Level 1 | Recurring | ||
Cash equivalent: | ||
Money market funds | 15,050 | 50 |
Short-term investments: | ||
Term deposits | 175 | 175 |
Total Assets | $ 15,225 | $ 225 |
Accounts receivable, net and _3
Accounts receivable, net and other receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Other receivables | ||
Research premium | $ 1,530 | $ 2,657 |
VAT and other taxes | 403 | 1,024 |
Receivables from grant revenue | 2 | 104 |
Other receivables | 809 | 86 |
Total accounts receivable, net and other receivables | $ 2,744 | $ 3,871 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 6,247 | $ 4,595 |
Less: Accumulated depreciation | (3,773) | (3,456) |
Property, plant and equipment, net | 2,474 | 1,139 |
IT equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 1,060 | 1,079 |
Laboratory equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 3,375 | 3,392 |
ROU asset | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 1,647 | |
Other equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 165 | $ 124 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 1,347 | $ 5,032 |
Payroll and related costs | 6,327 | 7,427 |
Accounting, tax and audit services | 420 | 398 |
Other | 3,872 | 1,645 |
Total other current liabilities | $ 11,966 | $ 14,502 |
Debt - Summary (Details)
Debt - Summary (Details) - Loan Agreement - Term loan $ in Millions | Mar. 11, 2020USD ($) | Feb. 29, 2020USD ($) | Dec. 31, 2018USD ($)item | Dec. 31, 2019USD ($) |
Debt | ||||
Maximum borrowing capacity | $ 75 | |||
Number of additional term loan advances | item | 5 | |||
Interest rate (as a percent) | 9.80% | |||
Fee due at maturity, as a percentage of aggregate advances | 6.95% | |||
The amount in excess of which prepayments may be made | $ 5 | |||
Minimum cash and cash equivalents in accounts to be maintained | 10 | |||
Maximum value of lender option to purchase equity securities | 2 | |||
Loan origination costs | 1.3 | |||
Initial fee paid to lender | $ 0.7 | |||
Prime rate | ||||
Debt | ||||
Variable rate basis | interest minus 5.50% | |||
Variable interest rate margin (as a percent) | 9.80% | |||
Variable rate adjustment (as a percent) | (5.50%) | |||
Initial Advance | ||||
Debt | ||||
Principal amount of advances outstanding | $ 25 | |||
Tranche 2 Advance | ||||
Debt | ||||
Maximum borrowing capacity | 10 | |||
Tranche 3 Advance | ||||
Debt | ||||
Maximum borrowing capacity | 5 | |||
Tranche 4 Advance | ||||
Debt | ||||
Maximum borrowing capacity | 10 | |||
Tranche 5 Advance | ||||
Debt | ||||
Maximum borrowing capacity | 15 | |||
Tranche 6 Advance | ||||
Debt | ||||
Maximum borrowing capacity | 5 | |||
Tranche 7 Advance | ||||
Debt | ||||
Maximum borrowing capacity | $ 5 | |||
Prepayment during the first 12 months following initial closing | ||||
Debt | ||||
Prepayment penalty as a percentage of the amount being repaid | 3.00% | |||
Prepayment after the first 12 months following initial closing but before 24 months | ||||
Debt | ||||
Prepayment penalty as a percentage of the amount being repaid | 2.00% | |||
Prepayment after the first 24 months following initial closing but before maturity | ||||
Debt | ||||
Prepayment penalty as a percentage of the amount being repaid | 1.00% | |||
Subsequent Event | ||||
Debt | ||||
Principal amount of advances outstanding | $ 35 | |||
Percent of net product revenue sales target | 70.00% | 80.00% | ||
Minimum liquidity requirement | $ 40 | |||
Subsequent Event | Tranche 7 Advance | ||||
Debt | ||||
Maximum borrowing capacity | $ 5 |
Debt - Long-Term Debt (Details)
Debt - Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Total long-term debt | $ 34,502 | $ 23,718 |
Maturities of long-term debt | ||
2021 | 8,895 | |
2022 | 17,450 | |
2023 | 11,889 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 35,000 | 25,000 |
End of term fee | 443 | |
Unamortized debt issuance costs | (1,742) | (1,990) |
Total long-term debt | 33,701 | 23,010 |
Other long-term debt | ||
Long-term debt | ||
Total long-term debt | $ 801 | $ 708 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Millions | Dec. 20, 2019 | Jul. 31, 2018 | Sep. 22, 2017 | Dec. 31, 2019 | Jun. 30, 2019 | Jan. 12, 2020 | Dec. 31, 2019 | Mar. 12, 2020 | Jun. 25, 2019 | Mar. 31, 2018 |
Public offering | Ordinary Shares | ||||||||||
Stockholders' Equity | ||||||||||
Number of shares issued | 18,181,818 | 9,411,765 | ||||||||
Shares issued, price per share | $ 2.75 | $ 8.50 | ||||||||
Gross proceeds from sale of stock | $ 50 | $ 80 | ||||||||
Net proceeds from sale of stock | $ 46.3 | $ 73.3 | ||||||||
Cantor Fitzgerald and Co. | At-the-market offering | Ordinary Shares | ||||||||||
Stockholders' Equity | ||||||||||
Number of shares issued | 10,316,190 | |||||||||
Gross proceeds from sale of stock | $ 37.8 | |||||||||
Net proceeds from sale of stock | 36.3 | |||||||||
Value of shares unsold at termination date | $ 12.2 | |||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50 | |||||||||
Jefferies LLC | At-the-market offering | ||||||||||
Stockholders' Equity | ||||||||||
Gross proceeds from sale of stock | $ 14.4 | |||||||||
Net proceeds from sale of stock | $ 13.6 | |||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50 | |||||||||
Jefferies LLC | At-the-market offering | Ordinary Shares | ||||||||||
Stockholders' Equity | ||||||||||
Number of shares issued | 6,505,268 | |||||||||
Purchasers | Purchase agreement | ||||||||||
Stockholders' Equity | ||||||||||
Number of shares issued | 13,793,106 | 13,793,106 | ||||||||
Number of ordinary shares that can be purchased by warrant holders | 13,793,106 | 13,793,106 | 13,793,106 | |||||||
Share and warrant price | $ 1.45 | $ 1.45 | ||||||||
Per share exercise price of right | $ 1.90 | $ 1.90 | $ 1.90 | |||||||
Term | 3 years | 3 years | 3 years | |||||||
Gross proceeds from sale of stock | $ 20.1 | $ 20.1 | ||||||||
Estimate | Jefferies LLC | At-the-market offering | Maximum | ||||||||||
Stockholders' Equity | ||||||||||
Gross proceeds from sale of stock | $ 35.6 | $ 35.6 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Mar. 31, 2018 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | $ 333 | $ 6,920 | $ 525 | $ 1,703 | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 9,481 | $ 9,656 | $ 5,319 | |
Collaboration revenue | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | 6,210 | 6,500 | ||||||||||
Collaboration revenue - Upfront payment | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | 1,538 | |||||||||||
Collaboration revenue - Upfront payment | License Agreement | Sinovant Sciences, LTD | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||||||
Research premium | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | 1,311 | 2,594 | 4,842 | |||||||||
Government grants | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | $ 422 | $ 562 | 369 | |||||||||
Grants from WWFF | ||||||||||||
Revenue | ||||||||||||
Revenue accounted for under Topic 606 | $ 108 |
Share-Based Payments - SOP 2015
Share-Based Payments - SOP 2015 (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 25, 2016 | Sep. 23, 2015 | Apr. 02, 2015 | |
Additional disclosures | ||||||
Share-based compensation expense | $ 9,748 | $ 5,154 | $ 5,732 | |||
SOP 2015 | ||||||
Options | ||||||
Outstanding at beginning of year (in shares) | 2,842,913 | 3,044,899 | 1,794,360 | |||
Granted (in shares) | 1,458,300 | |||||
Forfeited (in shares) | (552,319) | (201,986) | (207,761) | |||
Outstanding at end of year (in shares) | 2,290,594 | 2,842,913 | 3,044,899 | |||
Vested and exercisable at end of year (in shares) | 1,984,911 | 1,844,590 | 989,656 | |||
Weighted average exercise price in $ per share | ||||||
Outstanding balance at beginning of year (in dollars per share) | $ 8.34 | $ 8.35 | $ 7.83 | |||
Granted (in dollars per share) | 9.02 | |||||
Forfeited (in dollars per share) | 8.40 | 8.41 | 8.60 | |||
Outstanding balance at end of year (in dollars per share) | 8.33 | 8.34 | 8.35 | |||
Vested and exercisable balance at end of year (in dollars per share) | 8.20 | $ 8.10 | $ 7.68 | |||
SOP 2015 | $4.06 per share to $11.00 per share | ||||||
Additional disclosures | ||||||
Exercise price minimum range | 4.06 | |||||
Exercise price maximum range | $ 11 | |||||
Weighted average remaining contractual life | 6 years 4 months 24 days | |||||
SOP 2015 | Stock Options | ||||||
Share-Based Payments | ||||||
Vesting period | 4 years | |||||
Options | ||||||
Granted (in shares) | 0 | 0 | ||||
Additional disclosures | ||||||
Share-based compensation expense | $ 4,000 | $ 3,200 | $ 5,600 | |||
Weighted-average grant date fair value (in dollars per share) | $ 5.05 | |||||
Fair Value Assumptions | ||||||
Expected term of options (in years) | 6 years 1 month 6 days | |||||
Dividend yield (as a percent) | 0.00% | |||||
Total unrecognized compensation related to unvested options | $ 1,600 | |||||
Recognition period | 1 year 3 months 18 days | |||||
SOP 2015 | Stock Options | Minimum | ||||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 55.60% | |||||
Risk-free interest rate (as a percent) | 1.90% | |||||
SOP 2015 | Stock Options | Maximum | ||||||
Share-Based Payments | ||||||
Exercise period | 10 years | |||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 62.00% | |||||
Risk-free interest rate (as a percent) | 2.10% | |||||
SOP 2015 | Stock Options | Vesting period, year one | ||||||
Share-Based Payments | ||||||
Percentage that vests during the period | 25.00% | |||||
SOP 2015 | Stock Options | Vesting period, years 2-4 | ||||||
Share-Based Payments | ||||||
Percentage that vests during the period | 75.00% | |||||
Monthly vesting percentage | 2.083% | |||||
Nabriva Therapeutics AG (“Nabriva Austria”) | Common Stock | SOP 2015 | ||||||
Share-Based Payments | ||||||
Maximum number of shares authorized | 346,235 | 177,499 | 95,000 |
Share-Based Payments - 2017 Sha
Share-Based Payments - 2017 Share Incentive Plan (Details) $ / shares in Units, $ in Thousands | Jul. 26, 2017shares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2019USD ($)item$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares |
Additional disclosures | |||||
Share-based compensation expense | $ | $ 9,748 | $ 5,154 | $ 5,732 | ||
2017 Share Incentive Plan | |||||
Options | |||||
Outstanding at beginning of year (in shares) | 2,398,425 | 294,100 | |||
Granted (in shares) | 2,463,300 | 2,199,225 | 294,100 | ||
Exercised (in shares) | 0 | 0 | 0 | ||
Forfeited (in shares) | (439,061) | (94,900) | |||
Outstanding at end of year (in shares) | 4,422,664 | 4,422,664 | 2,398,425 | 294,100 | |
Vested and exercisable at end of year (in shares) | 1,120,280 | 1,120,280 | 119,287 | ||
Weighted average exercise price in $ per share | |||||
Outstanding balance at beginning of year (in dollars per share) | $ / shares | $ 5.41 | $ 6.92 | |||
Granted (in dollars per share) | $ / shares | 1.95 | 5.27 | $ 6.92 | ||
Forfeited (in dollars per share) | $ / shares | 4.79 | 6.75 | |||
Outstanding balance at end of year (in dollars per share) | $ / shares | $ 3.55 | 3.55 | 5.41 | $ 6.92 | |
Vested and exercisable balance at end of year (in dollars per share) | $ / shares | $ 5.53 | $ 5.53 | $ 6.88 | ||
Additional disclosures | |||||
Weighted average remaining contractual life | 8 years 8 months 12 days | ||||
2017 Share Incentive Plan | $1.46 per share to $8.35 per share | |||||
Additional disclosures | |||||
Exercise price minimum range | $ / shares | $ 1.46 | ||||
Exercise price maximum range | $ / shares | $ 8.35 | ||||
2017 Share Incentive Plan | Ordinary Shares | |||||
Share-Based Payments | |||||
Number of shares authorized | 3,000,000 | ||||
Additional shares authorized | 3,438,990 | ||||
Shares available for grant | 1,634,766 | 1,634,766 | |||
2017 Share Incentive Plan | Ordinary Shares | Minimum | |||||
Share-Based Payments | |||||
Annual increase, to be added on the first day of each fiscal year (in shares) | 2,000,000 | ||||
Annual increase, to be added on the first day of each fiscal year (as a percent) | 4.00% | ||||
2017 Share Incentive Plan | Stock Options | |||||
Share-Based Payments | |||||
Exercise period | 10 years | ||||
Fair Value Assumptions | |||||
Expected term of options (in years) | 6 years | 6 years 1 month 6 days | 6 years | ||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | ||
Additional disclosures | |||||
Share-based compensation expense | $ | $ 2,600 | $ 1,800 | $ 100 | ||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 1.14 | $ 3.06 | $ 3.98 | ||
Total unrecognized compensation related to unvested options | $ | $ 4,900 | $ 4,900 | |||
Recognition period | 2 years 8 months 12 days | ||||
2017 Share Incentive Plan | Stock Options | Minimum | |||||
Fair Value Assumptions | |||||
Expected volatility (as a percent) | 61.40% | 59.80% | 59.50% | ||
Risk-free interest rate (as a percent) | 1.90% | 2.60% | 1.90% | ||
2017 Share Incentive Plan | Stock Options | Maximum | |||||
Fair Value Assumptions | |||||
Expected volatility (as a percent) | 63.10% | 61.40% | 63.00% | ||
Risk-free interest rate (as a percent) | 2.60% | 3.00% | 2.30% | ||
2017 Share Incentive Plan | SARs | |||||
Share-Based Payments | |||||
Exercise period | 10 years | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | |||||
Additional disclosures | |||||
Share-based compensation expense | $ | $ 200 | ||||
Recognition period | 9 months 18 days | ||||
Restricted Stock Units | |||||
Number of shares outstanding | 1,222,100 | ||||
Granted | 479,000 | 1,241,450 | |||
Vested and issued | (657,581) | ||||
Forfeited | (141,833) | (19,350) | |||
Number of shares outstanding | 901,686 | 901,686 | 1,222,100 | ||
weighted average fair value per share | |||||
Weighted average fair value at the beginning | $ / shares | $ 3.31 | ||||
Granted | $ / shares | 1.90 | $ 3.36 | |||
Vested and issued | $ / shares | 3.18 | ||||
Forfeited | $ / shares | 2.79 | 6.47 | |||
Weighted average fair value at the end | $ / shares | $ 3.69 | $ 3.69 | $ 3.31 | ||
Additional Disclosures | |||||
Unrecognized compensation costs | $ | $ 2,400 | $ 2,400 | |||
Percentage that vests during the period | 25.00% | ||||
Vesting period | 4 years | ||||
Fair Value | $ | $ 2,100 | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | XENLETA | |||||
Additional disclosures | |||||
Share-based compensation expense | $ | $ 1,400 | ||||
Restricted Stock Units | |||||
Number of shares outstanding | 161,175 | 161,175 | |||
Additional Disclosures | |||||
Number of shares vested | 170,400 | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | CONTEPO | |||||
Restricted Stock Units | |||||
Granted | 35,600 | ||||
Number of shares outstanding | 35,600 | 35,600 | |||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Employees | |||||
Additional disclosures | |||||
Share-based compensation expense | $ | $ 1,100 | $ 200 | |||
Restricted Stock Units | |||||
Number of shares outstanding | 225,911 | 225,911 | |||
Additional Disclosures | |||||
Number of shares vested | 487,181 | ||||
Number of vesting periods | item | 3 | ||||
Vesting period | 6 months | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | XENLETA | |||||
Additional Disclosures | |||||
Percentage that vests during the period | 50.00% | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | CONTEPO | |||||
Additional Disclosures | |||||
Percentage that vests during the period | 50.00% | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | XENLETA | |||||
Additional Disclosures | |||||
Percentage that vests during the period | 50.00% | ||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | CONTEPO | |||||
Additional Disclosures | |||||
Percentage that vests during the period | 50.00% |
Share-Based Payments - 2019 Ind
Share-Based Payments - 2019 Inducement Share Incentive Plan (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 12, 2019 | |
Weighted average exercise price in $ per share | ||||
Share-based compensation expense | $ 9,748,000 | $ 5,154,000 | $ 5,732,000 | |
2019 Inducement Plan | ||||
Options | ||||
Granted (in shares) | 703,150 | |||
Forfeited (in shares) | (97,500) | |||
Outstanding at end of year (in shares) | 605,650 | |||
Weighted average exercise price in $ per share | ||||
Granted (in dollars per share) | $ 2.22 | |||
Forfeited (in dollars per share) | 2.69 | |||
Outstanding balance at end of year (in dollars per share) | $ 2.14 | |||
Share-based compensation expense | $ 77,000 | |||
2019 Inducement Plan | Ordinary Shares | ||||
Share-Based Payments | ||||
Shares reserved for future issuance | 1,394,350 | 2,000,000 | ||
2019 Inducement Plan | Stock Options | ||||
Share-Based Payments | ||||
Exercise period | 10 years | |||
Weighted average exercise price in $ per share | ||||
Weighted-average grant date fair value (in dollars per share) | $ 1.30 | |||
Fair Value Assumptions | ||||
Expected term of options (in years) | 6 years 1 month 6 days | |||
Weighted-average remaining contractual life | 9 years 7 months 6 days | |||
Unrecognized compensation expense | ||||
Total unrecognized compensation related to unvested options | $ 700,000 | |||
Recognition period | 3 years 3 months 18 days | |||
2019 Inducement Plan | Stock Options | Minimum | ||||
Fair Value Assumptions | ||||
Expected volatility (as a percent) | 61.60% | |||
Risk-free interest rate (as a percent) | 1.40% | |||
2019 Inducement Plan | Stock Options | Maximum | ||||
Fair Value Assumptions | ||||
Expected volatility (as a percent) | 63.70% | |||
Risk-free interest rate (as a percent) | 2.30% | |||
2019 Inducement Plan | SARs | ||||
Share-Based Payments | ||||
Exercise period | 10 years |
Share-Based Payments - Induceme
Share-Based Payments - Inducement Awards Outside of the 2019 Inducement Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-Based Payments | ||||
Share-based compensation expense | $ 9,748 | $ 5,154 | $ 5,732 | |
Inducement Awards Outside of the 2019 Inducement Plan | ||||
Share-Based Payments | ||||
Share-based compensation expense | $ 400 | $ 200 | ||
Fair Value Assumptions | ||||
Expected volatility (as a percent) | 59.80% | |||
Expected term of options (in years) | 6 years 1 month 6 days | |||
Risk-free interest rate (as a percent) | 2.90% | |||
Dividend yield (as a percent) | 0.00% | |||
Additional disclosures | ||||
Weighted-average remaining contractual life | 8 years 7 months 6 days | |||
Total unrecognized compensation related to unvested options | $ 1,100 | |||
Recognition period | 2 years 7 months 6 days | |||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year one | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 25.00% | |||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, years 2-4 | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 75.00% | |||
Monthly vesting period | 36 months | |||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | ||||
Share-Based Payments | ||||
Vesting period | 4 years | |||
Options exercise price (in dollars per share) | $ 3.53 | |||
Exercise period | 10 years | |||
Options weighted average grant date fair value (in dollars per share) | $ 2.05 | |||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Chief Executive Officer | ||||
Share-Based Payments | ||||
Options granted during the period | 850,000 | |||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | ||||
Share-Based Payments | ||||
Granted | $ 3.53 | |||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | Chief Executive Officer | ||||
Share-Based Payments | ||||
Restricted stock granted during the period | 150,000 | |||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | Upon receipt of FDA approval | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 50.00% | |||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | First anniversary of FDA approval | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 50.00% |
Share-Based Payments - Share-Ba
Share-Based Payments - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-Based Payments | |||
Share-based compensation expense | $ 9,748 | $ 5,154 | $ 5,732 |
Research and development | |||
Share-Based Payments | |||
Share-based compensation expense | 2,138 | 1,406 | 2,128 |
General and administrative | |||
Share-Based Payments | |||
Share-based compensation expense | $ 7,610 | $ 3,748 | $ 3,604 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-Based Payments | ||||
Share-based compensation expense | $ 9,748 | $ 5,154 | $ 5,732 | |
Employee Stock Purchase Plan | ||||
Share-Based Payments | ||||
Maximum number of shares authorized under plan (in shares) | 500,000 | |||
ESPP Share Pool as a percentage of total number of ordinary shares outstanding | 0.75% | |||
Purchase discount as a percentage of current market price | 15.00% | |||
Share-based compensation expense | $ 100 |
Post-employment benefit oblig_2
Post-employment benefit obligations (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Austria | ||||
Post-employment benefit obligations | ||||
Employer monthly contribution (as a percent) | 1.53% | 1.53% | 1.53% | |
Contribution costs | $ 68,000 | $ 68,000 | $ 58,000 | |
U.S. | ||||
Post-employment benefit obligations | ||||
Contribution costs | $ 710,000 | $ 448,000 | $ 213,000 | |
Percent of match, first level | 100.00% | 100.00% | 100.00% | |
Employee voluntary contribution, first level | 3.00% | 3.00% | 3.00% | |
Percent match, second level | 50.00% | 50.00% | 50.00% | |
Employee voluntary contribution, second level | 2.00% | 2.00% | 2.00% |
Income tax expense - Components
Income tax expense - Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Loss before income taxes attributable to domestic and international operations | |||||||||||
Domestic | $ (78,761) | $ (113,699) | $ (66,109) | ||||||||
Foreign | (3,902) | (1,032) | (6,892) | ||||||||
Loss before income taxes | (82,663) | (114,731) | (73,001) | ||||||||
Current tax | |||||||||||
Foreign | (101) | (49) | 55 | ||||||||
Deferred tax | |||||||||||
Foreign | (1,410) | ||||||||||
Total income tax expense | $ (21) | $ 29 | $ 45 | $ (154) | $ 259 | $ 151 | $ 48 | $ (506) | $ (101) | $ (49) | $ (1,355) |
Effective income tax reconciliation | |||||||||||
Statutory income tax rate | 12.50% | 12.50% | 12.50% | ||||||||
Non-deductible expenses | (0.10%) | (0.10%) | (0.80%) | ||||||||
Income not subject to tax | 0.30% | 0.30% | 0.90% | ||||||||
Impairment | 1.40% | ||||||||||
Tax credits | 0.40% | 0.10% | 0.20% | ||||||||
Foreign rate differential | 0.60% | (3.10%) | 21.00% | ||||||||
In-process research and development | 0.00% | (3.50%) | |||||||||
Tax audit assessments | (11.80%) | ||||||||||
Other | 0.80% | 0.20% | (1.40%) | ||||||||
Valuation allowance | (2.80%) | (6.50%) | (35.60%) | ||||||||
Effective income tax rate | (0.10%) | (0.10%) | (1.80%) | ||||||||
Ireland | |||||||||||
Effective income tax reconciliation | |||||||||||
Statutory income tax rate | 12.50% | 12.50% | 12.50% |
Income tax expense - Deferred I
Income tax expense - Deferred Income Tax (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 94,014 | $ 91,995 | ||
Tax loss on liquidation of subsidiary | 5,024 | 6,245 | ||
Equity compensation | 4,182 | 2,473 | ||
Non-deductible reserves | 395 | 203 | ||
Total deferred tax assets | 103,615 | 100,916 | ||
Valuation allowance | (103,185) | (100,832) | $ (80,087) | $ (54,114) |
Net deferred tax assets | 430 | 84 | ||
Deferred tax liabilities: | ||||
Financial liabilities | 48 | 55 | ||
Property, plant and equipment | 382 | 29 | ||
Total deferred tax liability | 430 | 84 | ||
Deferred tax, net | $ 0 | $ 0 |
Income tax expense - Valuation
Income tax expense - Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income tax (expense) benefit | |||
Balance at beginning of year | $ (100,832) | $ (80,087) | $ (54,114) |
Balance at end of year | (103,185) | (100,832) | (80,087) |
Tax benefit | |||
Income tax (expense) benefit | |||
Change in valuation allowance | $ (2,353) | (7,301) | $ (25,973) |
Acquired tax attributes | |||
Income tax (expense) benefit | |||
Change in valuation allowance | $ (13,444) |
Income tax expense - Net Operat
Income tax expense - Net Operating Losses (Details) - USD ($) $ in Thousands | 12 Months Ended | 24 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2016 | |
Net operating losses carryforwards | |||||
Period in which the company is in cumulative loss position. | 3 years | ||||
Valuation allowance | $ 103,185 | $ 80,087 | $ 103,185 | $ 100,832 | $ 54,114 |
Uncertain tax positions disclosures | |||||
Uncertain tax positions | $ 0 | ||||
Ireland | |||||
Net operating losses carryforwards | |||||
Net operating losses carryforwards | 187,631 | 187,631 | |||
Austria | |||||
Net operating losses carryforwards | |||||
Net operating losses carryforwards | 223,827 | 223,827 | |||
U.S. | |||||
Net operating losses carryforwards | |||||
Net operating losses carryforwards | 10,403 | 10,403 | |||
Net operating losses carryforwards | 35,680 | $ 35,680 | |||
U.S. federal corporate tax rate | 35.00% | 21.00% | |||
Re-measurement of deferred tax assets, net | $ 800 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Basic and diluted loss per share | |||||||||||
Net loss for the period | $ (23,045) | $ (17,795) | $ (21,707) | $ (20,217) | $ (30,824) | $ (52,825) | $ (17,788) | $ (13,342) | $ (82,764) | $ (114,780) | $ (74,356) |
Weighted average number of shares outstanding | 74,199,482 | 50,795,768 | 29,830,669 | ||||||||
Basic and diluted loss per share | $ (0.29) | $ (0.24) | $ (0.30) | $ (0.29) | $ (0.46) | $ (0.90) | $ (0.44) | $ (0.36) | $ (1.12) | $ (2.26) | $ (2.49) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Options | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 8,168,908 | 6,091,338 | 3,338,999 |
Restricted Stock Units ("RSUs") | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,051,686 | 1,372,100 |
Acquisition of Zavante (Details
Acquisition of Zavante (Details) - Zavante Therapeutics $ in Millions | Jul. 24, 2018USD ($)shares |
Acquisition of Zavante | |
Percentage of entity shares held by subsidiary | 19.90% |
Milestone payment receivable prior acquisition | $ 3 |
Threshold milestone payment that may be settled in ordinary shares | 26 |
In-process research and development expense | 32 |
Transaction costs | 4.8 |
Net liabilities assumed | 0.2 |
Maximum | |
Acquisition of Zavante | |
Contingent consideration | 97.5 |
Upfront Shares | |
Acquisition of Zavante | |
Expense from the fair value of shares issued in the acquisition | $ 26.9 |
Upfront Shares | |
Acquisition of Zavante | |
Business acquisition, shares issued or issuable | shares | 7,336,906 |
Holdback Shares | |
Acquisition of Zavante | |
Business acquisition, shares issued or issuable | shares | 815,186 |
Approval Milestone Payment | |
Acquisition of Zavante | |
Contingent consideration | $ 25 |
Net Sales Milestone Payments | |
Acquisition of Zavante | |
Contingent consideration | $ 72.5 |
Sinovant and Sunovion License_2
Sinovant and Sunovion License Agreements (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)item | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 333 | $ 6,920 | $ 525 | $ 1,703 | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 9,481 | $ 9,656 | $ 5,319 | |
Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 1,538 | |||||||||||
Sunovion Pharmaceutics Canada, Inc. | Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue not accounted for under Topic 606 | $ 1,000 | |||||||||||
License Agreement | Sinovant Sciences, LTD | ||||||||||||
License Agreement | ||||||||||||
Notice period for termination of agreement | 180 days | |||||||||||
Number of deliverables | item | 2 | 2 | ||||||||||
License Agreement | Sinovant Sciences, LTD | Achievement of certain regulatory and commercial milestones | ||||||||||||
License Agreement | ||||||||||||
Maximum contingent milestone payment | $ 91,500 | $ 91,500 | ||||||||||
License Agreement | Sinovant Sciences, LTD | Subsequent regulatory approval | ||||||||||||
License Agreement | ||||||||||||
Maximum contingent milestone payment | 4,000 | 4,000 | ||||||||||
License Agreement | Sinovant Sciences, LTD | Clinical trial application submission | ||||||||||||
License Agreement | ||||||||||||
Proceeds from license agreement, milestone | $ 1,500 | |||||||||||
License Agreement | Sinovant Sciences, LTD | FDA approval | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||||||
License Agreement | Sinovant Sciences, LTD | Additional regulatory approvals and annual sales targets | ||||||||||||
License Agreement | ||||||||||||
Remaining milestone payments | $ 86,500 | $ 86,500 | ||||||||||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 |
Commitments and Contingencies -
Commitments and Contingencies - Operating Leases (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Leases | ||||
Operating lease liabilities | $ 1,709 | |||
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | |||
Operating lease expense | $ 1,500 | $ 1,400 | $ 1,300 | |
King of Prussia | ||||
Leases | ||||
Weighted-average remaining lease term of operating leases | 4 years | |||
Weighted-average discount rate (as a percent) | 9.80% | |||
Lease Agreement | King of Prussia, Pennsylvania | ||||
Leases | ||||
Operating lease, existence of option to renew | false | false | ||
Lease Agreement | Vienna, Austria | ||||
Leases | ||||
Operating lease, existence of option to terminate | true | true | ||
Termination notice period | 6 months | 6 months | ||
Lease Agreement | Dublin, Ireland | ||||
Leases | ||||
Operating lease, existence of option to renew | true | true | ||
Operating lease, monthly based fixed amount | € | € 7,000 | |||
Lease Agreement | Dublin, Ireland | Minimum | ||||
Leases | ||||
Operating lease, renewal term | 3 months |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Lease Disclosures and Other Commitments and Contingencies (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Operating Cash Flows Supplemental Information: | |
Cash paid for amounts included in the measurement of the operating lease liabilities | $ 515 |
Right-of-use assets obtained in exchange for operating lease obligations | 1,647 |
Future payments of operating lease liabilities, ASC 842 | |
2020 | 507 |
2021 | 515 |
2022 | 522 |
2023 | 533 |
Total lease payments | 2,077 |
Less imputed interest | (368) |
Present value of operating lease liabilities | 1,709 |
Future minimum expected lease payments under non-cancelable operating leases, ASC 840 | |
Total | 3,222 |
2020 | 1,647 |
2021 | 546 |
2022 | 522 |
2023 | 507 |
Other contractual commitments | |
Total | 52,406 |
2020 | 10,274 |
2021 | 9,043 |
2022 | 9,690 |
2023 | 9,911 |
2024 | 6,744 |
Thereafter | 6,744 |
Future minimum contractual obligations and commitments | |
Total | 55,628 |
2020 | 11,921 |
2021 | 9,589 |
2022 | 10,212 |
2023 | 10,418 |
2024 | 6,744 |
Thereafter | 6,744 |
Other Commitments and Contingencies | |
Contingent liabilities | $ 0 |
Selected Quarterly Financial _3
Selected Quarterly Financial Information (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Selected Quarterly Financial Information (Unaudited) | |||||||||||
Revenue accounted for under Topic 606 | $ 333 | $ 6,920 | $ 525 | $ 1,703 | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 9,481 | $ 9,656 | $ 5,319 |
Operating expenses | (22,403) | (24,119) | (21,501) | (20,947) | (31,676) | (53,386) | (18,554) | (20,415) | (88,970) | (124,031) | (79,087) |
Loss from operations | (22,070) | (17,199) | (20,976) | (19,244) | (30,879) | (52,925) | (17,707) | (12,864) | (79,489) | (114,375) | (73,768) |
Other income (expense) | (954) | (625) | (776) | (819) | (204) | (51) | (129) | 28 | |||
Income tax expense | (21) | 29 | 45 | (154) | 259 | 151 | 48 | (506) | (101) | (49) | (1,355) |
Net loss | $ (23,045) | $ (17,795) | $ (21,707) | $ (20,217) | $ (30,824) | $ (52,825) | $ (17,788) | $ (13,342) | $ (82,764) | $ (114,780) | $ (74,356) |
Basic and diluted loss per share | $ (0.29) | $ (0.24) | $ (0.30) | $ (0.29) | $ (0.46) | $ (0.90) | $ (0.44) | $ (0.36) | $ (1.12) | $ (2.26) | $ (2.49) |
Subsequent Events (Details)
Subsequent Events (Details) - Term loan - Loan Agreement - USD ($) | Apr. 03, 2020 | Apr. 01, 2020 | Mar. 11, 2020 | Feb. 29, 2020 | Dec. 31, 2018 |
Subsequent Event [Line Items] | |||||
Maximum borrowing capacity | $ 75,000,000 | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Repayment of debt | $ 30,000,000 | $ 30,000,000 | |||
Aggregate principal amount of debt outstanding | $ 35,000,000 | ||||
Percent of net product revenue sales target | 70.00% | 80.00% | |||
Minimum liquidity requirement | $ 40,000,000 | ||||
Minimum amount to be maintained in cash and cash equivalents | $ 3,000,000 | ||||
End of term loan charge payment | 2,300,000 | ||||
End of term loan charge | 300,000 | $ 600,000 | |||
Tranche 7 Advance | |||||
Subsequent Event [Line Items] | |||||
Maximum borrowing capacity | $ 5,000,000 | ||||
Tranche 7 Advance | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Maximum borrowing capacity | $ 5,000,000 |