Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 29, 2018 | |
Document and Entity Information | |||
Entity Registrant Name | Nabriva Therapeutics plc | ||
Entity Central Index Key | 0001641640 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 141.7 | ||
Entity Shares Outstanding | 69,699,722 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 102,003 | $ 86,769 |
Short-term investments | 225 | 110 |
Other receivables | 3,871 | 5,402 |
Contract asset | 1,500 | |
Prepaid expenses | 1,154 | 1,558 |
Total current assets | 108,753 | 93,839 |
Property, plant and equipment, net | 1,139 | 1,327 |
Intangible assets, net | 98 | 172 |
Long-term receivables | 428 | 425 |
Total assets | 110,418 | 95,763 |
Current liabilities: | ||
Accounts payable | 3,304 | 5,136 |
Accrued expense and other current liabilities | 14,502 | 8,124 |
Total current liabilities | 17,806 | 13,260 |
Non-current liabilities | ||
Long-term debt | 23,718 | 232 |
Other non-current liabilities | 264 | 203 |
Total non-current liabilities | 23,982 | 435 |
Total liabilities | 41,788 | 13,695 |
Commitments and contingencies (Note 14) | ||
Stockholders' Equity: | ||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at December 31, 2018; 36,707,685 and 67,019,094 issued and outstanding at December 31, 2017 and 2018, respectively | 670 | 367 |
Preferred shares, par value $0.01, 100,000,000 shares authorized at December 31, 2018; None issued and outstanding | ||
Additional paid in capital | 461,911 | 360,872 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (393,978) | (279,198) |
Total stockholders' equity | 68,630 | 82,068 |
Total liabilities and stockholders' equity | $ 110,418 | $ 95,763 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | |
Ordinary stock, authorized shares | 1,000,000,000 | |
Ordinary stock, issued shares | 67,019,094 | 36,707,685 |
Ordinary stock, outstanding shares | 67,019,094 | 36,707,685 |
Preferred stock, par value (in dollars per share) | $ 0.01 | |
Preferred stock, authorized shares | 100,000,000 | |
Preferred stock, issued shares | 0 | |
Preferred stock, outstanding shares | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Total revenues | $ 9,656 | $ 5,319 | $ 6,482 |
Operating expenses: | |||
Research and development | (82,288) | (49,615) | (47,994) |
General and administrative | (41,743) | (29,472) | (13,535) |
Total operating expenses | (124,031) | (79,087) | (61,529) |
Loss from operations | (114,375) | (73,768) | (55,047) |
Other income (expense): | |||
Other income (expense), net | (272) | 492 | (783) |
Interest income | 49 | 318 | 343 |
Interest expense | (133) | (43) | (75) |
Loss before income taxes | (114,731) | (73,001) | (55,562) |
Income tax (expense) benefit | (49) | (1,355) | 672 |
Net loss | (114,780) | (74,356) | (54,890) |
Other comprehensive income (loss), net of tax | |||
Unrealized losses on available-for-sale securities | (26) | (18) | |
Reclassification to net income | (43) | (68) | |
Other comprehensive income, net of tax | 17 | 50 | |
Comprehensive loss | $ (114,780) | $ (74,339) | $ (54,840) |
Loss per share | |||
Basic and diluted (in dollars per share) | $ (2.26) | $ (2.49) | $ (2.56) |
Weighted average number of shares: | |||
Basic and diluted (in shares) | 50,795,768 | 29,830,669 | 21,478,320 |
Collaboration revenue | |||
Revenues: | |||
Total revenues | $ 6,500 | ||
Research premium and grant revenue | |||
Revenues: | |||
Total revenues | $ 3,156 | $ 5,319 | $ 6,482 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock/Ordinary Shares | Treasury Shares | Additional paid in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Total |
Stockholders' equity, beginning balance at Dec. 31, 2015 | $ 2,308 | $ (22) | $ 256,412 | $ (40) | $ (149,952) | $ 108,706 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2015 | 2,120 | 3 | ||||
Consolidated Statements of Changes in Stockholders' Equity | ||||||
Issuance of common stock | $ 618 | 24,204 | 24,822 | |||
Issuance of common stock (in shares) | 588 | |||||
Exercise of stock options | $ 13 | $ 22 | 235 | 270 | ||
Exercise of stock options (in shares) | 12 | (3) | ||||
Equity transaction costs | (4,247) | (4,247) | ||||
Stock-based compensation expense | 2,545 | 2,545 | ||||
Other comprehensive income, net of tax | 50 | 50 | ||||
Net loss | (54,890) | (54,890) | ||||
Stockholders' equity, ending balance at Dec. 31, 2016 | $ 2,939 | 279,149 | 10 | (204,842) | 77,256 | |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2016 | 2,720 | |||||
Consolidated Statements of Changes in Stockholders' Equity | ||||||
Issuance of common stock | $ 94 | 79,906 | 80,000 | |||
Issuance of common stock (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 common stock | $ 230 | 73,989 | 74,219 | |||
Issuance of common stock (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 Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities | |||
Net loss | $ (114,780) | $ (74,356) | $ (54,890) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Non-cash other income, net | 362 | (1,371) | 996 |
Non-cash interest income | 45 | (52) | |
Non-cash interest expense | (104) | 35 | |
Depreciation and amortization expense | 510 | 432 | 233 |
Stock-based compensation | 5,154 | 5,732 | 2,545 |
In-process research and development | 32,048 | ||
Deferred income taxes | 1,410 | (794) | |
Other, net | 14 | 131 | 1 |
Changes in operating assets and liabilities: | |||
Changes in long-term receivables | (3) | (5) | 10 |
Changes in other receivables | 1,139 | (223) | (1,932) |
Changes in accounts payable | (2,969) | 2,585 | (383) |
Changes in accrued expenses and other liabilities | 5,742 | (3,778) | 6,034 |
Changes in other non-current liabilities | 61 | 96 | 24 |
Changes in income tax liabilities | 58 | (1) | (152) |
Net cash used in operating activities | (72,723) | (69,348) | (48,325) |
Cash flows from investing activities | |||
Purchases of plant and equipment and intangible assets | (229) | (1,173) | (603) |
Purchases of available-for-sale securities | (57,035) | ||
Purchases of term deposits | (115) | (30) | (10) |
Proceeds from sale of property, plant and equipment | 2 | ||
Proceeds from maturities of term deposits | 45,000 | ||
Proceeds from sales of available-for-sale securities | 50,950 | 36,000 | |
Transaction costs for Zavante acquisition, net of cash acquired | (4,260) | ||
Net cash provided (used in) by investing activities | (4,604) | 49,749 | 23,352 |
Cash flows from financing activities | |||
Proceeds from December 2016 financing | 24,822 | ||
Proceeds from long-term debt | 25,535 | 228 | |
Proceeds from exercise of stock options | 83 | 269 | |
Debt transaction costs | (1,990) | ||
Equity transaction costs | (4,841) | (8,092) | (2,790) |
Net cash provided by financing activities | 92,923 | 72,219 | 22,301 |
Effects of foreign currency translation on cash and cash equivalents | (362) | 1,371 | (996) |
Net increase (decrease) in cash and cash equivalents | 15,234 | 53,991 | (3,668) |
Cash and cash equivalents at beginning of year | 86,769 | 32,778 | 36,446 |
Cash and cash equivalents at end of year | 102,003 | 86,769 | 32,778 |
Supplemental disclosures of cash flow information: | |||
Interest paid | (7) | (1) | (41) |
Taxes paid | (4) | (5) | (867) |
Equity transaction costs included in accounts payable and accrued expenses | 120 | 28 | $ 1,451 |
September 2017 public offering | |||
Cash flows from financing activities | |||
Proceeds from issuance of stock | $ 80,000 | ||
July 2018 public offering | |||
Cash flows from financing activities | |||
Proceeds from issuance of stock | 50,000 | ||
At-the-market offering | |||
Cash flows from financing activities | |||
Proceeds from issuance of stock | $ 24,219 |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2018 | |
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 development of novel anti-infective agents to treat serious infections. 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). The Company has two product candidates that have been submitted to the U.S. Food and Drug Administration(the “FDA”) for approval: lefamulin, potentially the first pleuromutilin antibiotic available for systemic administration in humans, and CONTEPO, a potentially first-in-class epoxide antibiotic for intravenous (“IV”) administration in the United States. The Company is developing both IV and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (“CABP”). The Company is developing CONTEPO IV for complicated urinary tract infections (“cUTI”) and may potentially develop lefamulin and CONTEPO for additional indications. The Company’s headquarters are located at 25-28 North Wall Quay, Dublin, Ireland. 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. To date, it has financed its operations through the sale of equity securities, convertible and term debt financings and research and development support from governmental grants and loans. As of December 31, 2018, the Company had cash, cash equivalents and short-term investments of $102.2 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. As of the date of this filing, management assessed the Company’s ability to continue as a going concern and determined that it expects that its cash, cash equivalents and short-term investments as of December 31, 2018, proceeds from the sale of ordinary shares under the Company’s ATM Agreement (as defined below) of $5.9 million in the first quarter of 2019, as well as a $1.5 million milestone payment received in February 2019 under its license agreement with Sinovant Sciences, Ltd., and research premiums from the Austrian government for its qualified research and development expenditures, will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements into the second 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 it currently expects. This estimate assumes, among other things, that the Company does not obtain any additional funding through grants and clinical trial support, collaboration agreements, equity or debt financings, including additional advances under the Loan Agreement with Hercules. The Company may be eligible to borrow up an additional $50.0 million under its Loan Agreement with Hercules if it achieves specified regulatory and product revenue milestones, including $10.0 million that it will be eligible to borrow upon the approval by the FDA of an NDA for lefamulin and $5.0 million that it will be eligible to borrow upon the approval by the FDA of an NDA for CONTEPO. The Company’s expenses will increase if it suffers any regulatory delays or is required to conduct additional clinical trials to satisfy regulatory requirements. If the Company obtains marketing approval for lefamulin, CONTEPO or any other product candidate that it develops, it expects to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. The Company will continue to invest in critical commercialization and supply chain activities prior to potentially receiving marketing approval and making lefamulin and CONTEPO available to patients. The Company expects to seek additional funding in future periods for purposes of investment in its commercial and medical affairs organization as well as investing in its supply chain, including building active pharmaceutical ingredient safety stock for the commercial supply of lefamulin and CONTEPO, in an effort to enhance the potential commercial launch of lefamulin and CONTEPO. In December 2018, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., 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 provides for an initial term loan advance of $25.0 million which was funded in connection with the closing of the Loan Agreement. The remaining $50.0 million under the Loan Agreement is available to the Company from time to time subject to conditions further described in Note 8 below. 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. As of March 5, 2019, the Company has issued and sold an aggregate of 7,742,379 ordinary shares under the ATM Agreement, for gross proceeds of $30.3 million, and net proceeds of $28.9 million, after deducting commissions and offering costs. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 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. 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). 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. 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. Please refer to Note 10 for further details on all forms of grant revenue. 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. The benefit of a government loan at a below-market rate of interest is treated as a government grant. The benefit due to the difference between the market rate of interest and the rate of interest charged by the governmental organization is measured as the difference between the initial carrying value of the loan determined and the proceeds received. This benefit is deferred, and recognized through profit and loss over the term of the corresponding liabilities. 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 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 Tax Act, the Company revalued the ending net deferred tax assets and liabilities of our U.S. subsidiary at December 31, 2017. Subsequent Events Material subsequent events are evaluated and disclosed through the report issuance date. 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 May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers , an updated standard on revenue recognition. ASU 2014-09 provides enhancements to the quality and consistency of how revenue is reported by companies while also improving comparability in the financial statements of companies reporting using International Financial Reporting Standards or US GAAP. The main purpose of the new standard is for companies to recognize revenue to depict the transfer of goods or services to customers in amounts that reflect the consideration to which a company expects to be entitled in exchange for those goods or services. The new standard also results in enhanced revenue disclosures, guidance for transactions that were not previously addressed comprehensively and improve guidance for multiple-element arrangements. The effective date of ASU 2014-09 for the Company is the first quarter of fiscal year 2018. The Company recognized $1.5 million of revenue related to a contract asset (note 16) upon the adoption of this new standard during 2018 that would not have been recognized under the prior standard. · In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation : Scope of Modification Accounting . ASU 2017-09 clarifies which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718, Compensation—Stock Compensation . ASU 2017-09 is effective for annual periods beginning after December 15, 2017. An entity should apply the amendments prospectively to a modification that occurs on or after the adoption date. The Company adopted ASU 2017-09 in the first quarter of fiscal year 2018. The impact of adopting this standard did not have a material effect on the Company’s financial position, results of operation or cash flow and related disclosures. To be adopted in future periods: · In February 2016, the FASB issued Accounting Standards Update 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. Originally, entities were required to adopt ASU 2016-02 using a modified retrospective approach at the beginning of the earliest comparative period presented in the financial statements and the recognition of a cumulative-effect adjustment to the opening balance of retained earnings. The FASB subsequently issued ASU 2018-10 and ASU 2018-11 in July 2018, which provide clarifications and improvements and also provides for an optional transition method which allows companies to apply the new lease standard at the adoption date instead of at the earliest comparative period presented and continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. The new lease standard requires lessees to present a right-of-use asset and a corresponding lease liability on the balance sheet. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information will not be restated. 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 will not reassess whether expired or existing contracts are or contain a lease; will not need 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 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). On January 1, 2019, the Company expects to recognize ROU assets and lease liabilities of approximately $2.1 million. The Company does not expect the adoption of the new lease standard to materially impact its consolidated statements of operations or of cash flows. · In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): “Improvements to Nonemployee Share-Based Payment Accounting,” which largely aligns the accounting for share-based payment awards issued to nonemployees with the accounting for share-based payment awards issued to employees. Under previous GAAP, the accounting for nonemployee share-based payments differed from that applied to employee awards, particularly with regard to the measurement date and the impact of performance conditions. Under the new guidance, (i) equity-classified share-based payment awards issued to nonemployees will be measured at the grant date, instead of the previous requirement to remeasure the awards through the performance completion date, (ii) for performance conditions, compensation cost associated with the award will be recognized when the achievement of the performance condition is probable, rather than upon achievement of the performance condition, and (iii) the current requirement to reassess the classification (equity or liability) for nonemployee awards upon vesting will be eliminated, except for awards in the form of convertible instruments. This new guidance will be effective for public companies for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company does not expect the adoption of the new guidance to have a material effect on its consolidated financial statements. · In August 2018, the FASB issued AS 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements. Entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, but public companies will be required to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The guidance on fair value disclosures eliminates the following requirements for all entities: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the entity’s policy for the timing of transfers between levels of the fair value hierarchy; and, the entity’s valuation processes for Level 3 fair value measurements. The ASU adds the following disclosure requirements, but it exempts nonpublic entities from these requirements: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements of instruments held at the end of the reporting period; and, for recurring and nonrecurring Level 3 fair value measurements, the range and weighted average used to develop significant unobservable inputs and how the weighted average was calculated, with certain exceptions. The guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, but entities are permitted to early adopt either the entire standard or only the provisions that eliminate or modify the requirements. The Company does not expect the adoption of the new guidance to have a material effect on its consolidated financial statements. |
Short-term investments
Short-term investments | 12 Months Ended |
Dec. 31, 2018 | |
Short-term investments | |
Short-term investments | 3. Short-term investments The Company’s short-term investments were as follows: As of December 31, 2018 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Short-term investments: Available-for-sale securities $ 50 $ — $ — $ 50 Term deposits 175 — — 175 Total $ 225 $ — $ — $ 225 As of December 31, 2017 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Short-term investments: Available-for-sale securities $ 76 $ — $ (26) $ 50 Term deposits 60 — — 60 Total $ 136 $ — $ (26) $ 110 As of December 31, 2018 and 2017 the Company’s short-term investments were classified as available-for-sale and comprised a (i) money market fund that invests all of its assets, excluding cash and deposits, in short term USD-denominated debt securities, and (ii) a U.S. treasury note. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 175 — — 175 Total Assets $ 175 $ 50 $ — $ 225 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2017 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 60 — — 60 Total Assets $ 60 $ 50 $ — $ 110 As of December 31, 2018 and 2017, the Company held short-term investments classified as both Level 1 and Level 2, and the Company did not hold any Level 3 financial instruments measured at fair value. There were no transfers between Level 1 and 2 in the years ended December 31, 2018 and 2017. There were no changes in valuation techniques during the years ended December 31, 2018 and 2017. As of December 31, 2018 and 2017, 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. |
Other receivables
Other receivables | 12 Months Ended |
Dec. 31, 2018 | |
Other receivables | |
Other receivables | 5. Other receivables As of December 31 (in thousands) 2017 2018 Research premium $ 5,124 $ 2,657 VAT and other taxes 28 1,024 Receivables from grant revenue 231 104 Other receivables 19 86 Total current receivables $ 5,402 $ 3,871 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 6. Property, Plant and Equipment As of December 31 (in thousands) 2017 2018 IT equipment $ 1,060 $ 1,079 Laboratory equipment 3,299 3,392 Other equipment 15 124 4,374 4,595 Less: Accumulated depreciation (3,047) (3,456) Property, plant and equipment, net $ 1,327 $ 1,139 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
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 December 31 (in thousands) 2017 2018 Research and development related costs $ 2,308 $ 5,032 Payroll and related costs 4,426 7,427 Accounting, tax and audit services 231 398 Other 1,159 1,645 Total other current liabilities $ 8,124 $ 14,502 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
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. (the “Lender”), 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 provides 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 will be available to the Borrowers through September 30, 2019 upon the approval by the U.S. Food and Drug Administration (“FDA”) of a new drug application (“NDA”) for lefamulin. The Tranche 3 Advance will be available to the Borrowers through September 30, 2019 upon the approval by the FDA of an NDA for CONTEPO. The Tranche 4 Advance will be available to the Borrowers from January 1, 2020 through December 31, 2020 upon the approval by the FDA of NDAs for lefamulin and CONTEPO and upon the achievement of specified product revenue milestones. The Tranche 5 Advance will be available to the Borrowers from July 1, 2020 through June 30, 2021 upon the approval by the FDA of NDAs for lefamulin and CONTEPO and upon the achievement of specified product revenue milestones. The Tranche 6 Advance will be available to the Borrowers from January 1, 2021 through September 30, 2021 upon the approval by the FDA of NDAs for lefamulin and CONTEPO and upon the achievement of specified product revenue milestones. The Borrowers may request a seventh term loan advance of $5.0 million prior to December 31, 2021 subject to the Lender’s sole discretion. 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 provides for interest-only payments through July 1, 2020, which may be incrementally extended from time to time upon the occurrence of certain conditions through January 1, 2022, 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 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 specified minimum amounts of cash and cash equivalents in accounts pledged to Hercules. 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 the Lender 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. Under the terms of the Loan Agreement, the Company and its subsidiaries are also required to satisfy certain financial covenants, including an obligation to maintain specified minimum amounts of cash and cash equivalents in accounts pledged to the Lender. The Loan Agreement also grants Lender 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 $1,290,000 of costs in connection with the Loan Agreement which along with the initial fee of $700,000 paid to the Lender were recorded as debt issuance cost and will be amortized as interest expense using the effective interest method over the term of the loan. The End of Term Fee will also be accrued as additional interest expense using the effective interest method over the term of the loan. Long-term debt as December 31, 2017 and 2018 consisted of the following: As of December 31 (in thousands) 2017 2018 Term loan payable $ — $ 25,000 Unamortized debt issuance costs — (1,990) Carrying value of term loan — 23,010 Other long-term debt 232 708 Total long-term debt $ 232 $ 23,718 Maturities of long-term debt as of December 31, 2018 were as follows: (in thousands) 2019 $ — 2020 3,656 2021 8,592 2022 8,704 2023 4,756 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity | |
Stockholders' Equity | 9. Stockholders’ Equity 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. As of December 31, 2018, the Company has issued and sold an aggregate of 4,778,031 ordinary shares under the ATM Agreement, for gross proceeds of $24.2 million, and net proceeds of $23.0 million, after deducting commissions and offering costs. 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. On December 19, 2016, the Company completed a rights offering and a related underwritten offering for the sale of an aggregate of 588,127 common shares resulting in aggregate gross proceeds of $24.8 million and net proceeds of $20.6 million, after deducting underwriting fees and offering expenses. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2018 | |
Revenue | |
Revenue | 10. Revenue Year ended December 31, (in thousands) 2016 2017 2018 Collaboration revenue $ — $ — $ 6,500 Research premium 6,232 4,842 2,594 Government grants — 369 562 Grants from WWFF 250 108 — Total $ 6,482 $ 5,319 $ 9,656 |
Share-Based Payments
Share-Based Payments | 12 Months Ended |
Dec. 31, 2018 | |
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: 2016 2017 2018 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in price in price in intrinsic Stock Option Plan 2015 $ per share Options $ per share Options $ per share Options value Outstanding as of January 1 7.61 1,092,300 7.83 1,794,360 8.35 3,044,899 Granted 8.02 922,130 9.02 1,458,300 — — Exercised 7.21 (23,360) — — — — Forfeited 7.64 (196,710) 8.60 (207,761) 8.41 (201,986) Outstanding as of December 31 7.83 1,794,360 8.35 3,044,899 8.34 2,842,913 — Vested and exercisable as of December 31 7.52 452,210 7.68 989,656 8.10 1,844,590 — The total intrinsic value of options exercised during the year ended December 31, 2016 was $181. The Company has 2,842,913 option grants outstanding at December 31, 2018 with exercise prices ranging from $4.06 per share to $11.00 per share and a weighted average remaining contractual life of 7.4 years. Stock-based compensation expense under the SOP 2015 was $2.5 million, $5.6 million and $3.2 million for the years ended December 31, 2016, 2017 and 2018, respectively. The weighted average fair value of the options granted during the years ended December 31, 2016 and 2017 was $4.76 per share, $5.05 per share, respectively. 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 2016 2017 Expected volatility 59.8% - 67.2% 55.6% - 62.0% Expected term of options 6.0 years 6.1 years Risk-free interest rate 1.15% - 2.09% 1.89% - 2.10% Expected dividend yield – – The expected price volatility is based on historical trading volatility for the publicly traded peer companies under consideration of the remaining life of the options. The risk free interest for the years 2016 and 2017, is based on the average of 5 and 7-year market yield on U.S. treasury securities in effect at the time of grant. As of December 31, 2018, there was $5.4 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 2.1 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, 2018, 5,064,378 ordinary shares were available for 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, 2018: 2017 2018 Weighted Weighted average average exercise exercise Aggregate price in $ price in $ intrinsic Stock Option Plan 2017 per share Options per share Options value Outstanding as of January 1 — — 6.92 294,100 Granted 6.92 294,100 5.27 2,199,225 Exercised — — — — Forfeited — — (94,900) Outstanding as of December 31 6.92 294,100 2,398,425 — Vested and exercisable as of December 31 — — 119,287 — There were no options exercised during the years ended December 31, 2017 and 2018. The Company has 2,398,425 option grants outstanding at December 31, 2018 with exercise prices ranging from $1.46 per share to $8.35 per share and a weighted average remaining contractual life of 9.3 years. Stock-based compensation expense under the 2017 Plan was $0.1 million and $1.8 million for the years ended December 31, 2017 and 2018, respectively. The weighted average fair value of the options granted during years ended December 31, 2017 and 2018 was $3.98 and $3.06 per share, respectively, based on a Black Scholes option pricing model using the following assumptions: Input parameters 2017 2018 Expected volatility 59.5% - 63.0% 59.8% - 61.4% Expected term of options 6.0 6.1 Risk-free interest rate 1.93% - 2.27% 2.55% - 3.03% Expected dividend yield – – The expected price volatility is based on historical trading volatility for the publicly traded peer companies under consideration of the remaining life of the options. The risk free interest rate is based on the average of 5 and 7 year market yield on U.S. treasury securities in effect at the time of grant. As of December, 2018, there was $5.7 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 3.1 years. Restricted Stock Units (“RSUs”) During the year ended December 31, 2018, the Company granted 407,150 RSUs with a weighted average grant date fair value of $5.82 per share. As of December 31, 2018, there were 387,800 RSUs outstanding. Vesting of the RSUs is subject to FDA approval of the new drug application (“NDA”) for lefamulin. Fifty percent (50%) of each RSU award will vest upon FDA approval of an NDA for lefamulin, and the remaining fifty percent (50%) will vest on the one-year anniversary of such approval. If the FDA does not approve an NDA for lefamulin within two years of the grant date, the RSU award will terminate in full. No compensation expense was recognized for these RSUs as vesting is not probable at December 31, 2018. Also, during the year ended December 31, 2018, the Company granted 834,300 RSUs to certain employees with a grant date fair value of $2.16 per share. These RSUs will vest in three six month increments beginning in May of 2019 and ending in May 2020. As of December 31, 2018, there were 834,300 of such RSUs outstanding. As of December 31, 2018, $0.2 million of compensation expense was recognized for these RSUs. Inducement Award 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. Stock-based compensation expense was $0.2 million for the year ended December 31, 2018. The performance-based RSUs had a grant date fair value of $3.53 per share and the options 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, 2018 is 9.6 years. Our share-based compensation expense has been allocated to research and development and general and administrative expenses in the Consolidated Statement of Operations and Comprehensive Loss as follows: Year ended December 31, (in thousands) 2016 2017 2018 Research and development $ 894 $ 2,128 $ 1,406 General and administrative 1,651 3,604 3,748 Total $ 2,545 $ 5,732 $ 5,154 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 May1 and ending October 31 of each year. The first offering under the 2018 ESPP commenced on November 1, 2018. |
Post-employment benefit obligat
Post-employment benefit obligations | 12 Months Ended |
Dec. 31, 2018 | |
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. In the years ended December 31, 2016, 2017 and 2018, contribution costs amounted to $59,000, $58,000 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, 2016, 2017 and 2018 contribution expenses were $152,000, $213,000 and $448,000, respectively. |
Income tax (expense) benefit
Income tax (expense) benefit | 12 Months Ended |
Dec. 31, 2018 | |
Income tax (expense) benefit | |
Income tax (expense) benefit | 13. Income tax (expense) benefit Loss before income taxes attributable to domestic and international operations, consists of the following: Year ended December 31 (in thousands) 2016 2017 2018 Domestic $ (54,509) $ (66,109) $ (113,699) Foreign (1,053) (6,892) (1,032) Loss before income taxes $ (55,562) $ (73,001) $ (114,731) Income tax (expense) benefit consists of the following: Year ended December 31 (in thousands) 2016 2017 2018 Current tax Domestic $ (4) $ — $ — Foreign (118) 55 (49) Deferred tax Domestic — — — Foreign 794 (1,410) — Total income tax (expense) benefit $ 672 $ (1,355) $ (49) The reconciliation to our effective tax rate from the Austrian statutory income tax rate of 25% for the year ended December 31, 2016 and from the Irish statutory income tax rate of 12.5% for the years ended December 31, 2017 and 2018 is as follows: Year ended December 31 (% of pre-tax income) 2016 2017 2018 Statutory income tax rate 25.0 % 12.5 % 12.5 % Non-deductible expenses (0.2) (0.8) (0.1) Income not subject to tax 2.8 0.9 0.3 Impairment — 1.4 — Tax credits 0.4 0.2 0.1 Foreign rate differential (2.5) 21.0 (3.1) In-process research and development — — (3.5) Other 0.2 (1.4) 0.2 Valuation allowance (24.5) (35.6) (6.5) Effective income tax rate 1.2 % (1.8) % (0.1) % The following table summarizes the components of deferred income tax balances: As of December 31, (in thousands) 2017 2018 Deferred tax assets: Net operating loss carryforwards $ 70,871 $ 91,995 Tax loss on liquidation of subsidiary 7,846 6,245 Equity compensation 1,450 2,473 Non-deductible reserves 57 203 Total deferred tax assets 80,224 100,916 Valuation allowance (80,087) (100,832) Net deferred tax assets 137 84 Deferred tax liabilities: Financial liabilities 80 55 Property, plant and equipment 57 29 Total deferred tax liability 137 84 Deferred tax, net $ — $ — The table below summarizes changes in the deferred tax valuation allowance: Year ended December 31, (in thousands) 2016 2017 2018 Balance at beginning of year $ (40,487) $ (54,114) $ (80,087) Tax benefit (13,627) (25,973) (7,301) Acquired tax attributes — — (13,444) Balance at end of year $ (54,114) $ (80,087) $ (100,832) The following table summarizes carryforwards of net operating losses as of December 31, 2018. (in thousands) Amount Expiration Ireland $ 107,671 Indefinite Austria $ 259,229 Indefinite United States $ 44,728 2033 Due to uncertainty regarding the ability to realize the benefit of deferred tax assets primarily relating to net operating loss carryforwards, valuation allowances have been established to reduce deferred tax assets to an amount that is more likely than not to be realized. On the basis of this evaluation, as of December 31, 2016, 2017 and 2018, the Company has recorded a valuation allowance of $54.1 million, $80.1 million and $100.8 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 a no net impact to income tax expense. At December 31, 2017 and 2018, the Company had no uncertain tax positions and does not expect any material increase or decrease in income tax expense related to examinations or changes in uncertain tax positions. 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 2013 and forward remain open for examination for Austrian tax purposes and years 2014 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, 2018 | |
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) 2016 2017 2018 Net loss for the period $ (54,890) $ (74,356) $ Weighted average number of shares outstanding 21,478,320 29,830,669 Basic and diluted loss per share $ (2.56) $ (2.49) $ 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, 2016 2017 2018 Stock options 1,904,320 3,338,999 6,091,338 Restricted stock units — — 1,372,100 |
Acquisition of Zavante
Acquisition of Zavante | 12 Months Ended |
Dec. 31, 2018 | |
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 are issuable 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. Subject to the terms of the Merger Agreement, 10% of the Upfront Shares (the “Holdback Shares”) will serve as a source for the satisfaction of indemnification and other obligations of the former Zavante stockholders and, subject to reduction in respect of these obligations, will be issued to the former Zavante stockholders following the first anniversary of the Closing. Former Zavante stockholders who do not comply with specified procedural requirements set forth in the Merger Agreement, and former holders of Zavante options and warrants, will receive cash in lieu of any Company ordinary shares that otherwise would be issuable to them pursuant to the Merger Agreement. As of December 31, 2018 the Company did not distribute any cash in lieu of ordinary shares to former Zavante stockholders. Also, the Company anticipates that cash distributions, if any, will not be material. 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, $4.9 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 License Agreement
Sinovant License Agreement | 12 Months Ended |
Dec. 31, 2018 | |
Sinovant License Agreement | |
Sinovant License Agreement | 16. Sinovant License Agreement In March 2018, the Company entered into a license agreement (the “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 License Agreement, Nabriva Therapeutics Ireland DAC and Nabriva Therapeutics GmbH, our wholly owned subsidiaries, granted Sinovant an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin (the “Licensed Products”), in the People’s Republic of China, Hong Kong, Macau, and Taiwan (together the “Territory”). Under the 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 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 Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The first milestone is 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 February 2019. The remaining milestone payments are tied to additional regulatory approvals and annual sales targets. In addition, the Company will be eligible to receive low double-digit royalties on sales, if any, of Licensed Products in the Territory. Sinovant will be solely responsible for all costs related to developing, 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 is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sinovant sufficient supply of lefamulin for Sinovant to manufacture finished drug products for development and commercialization of the Licensed Products in the Territory. Unless earlier terminated, the License Agreement will expire upon the expiration of the last royalty term for the last 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 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 License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the License Agreement immediately if Sinovant does not reach certain development milestones by certain specified dates (subject to specified cure periods). The License Agreement contemplates that the Company will enter into ancillary agreements with Sinovant, including clinical and commercial supply agreements and a pharmacovigilance agreement. The Company has identified two performance obligations at inception: (1) the delivery of the licenses to Sinovant; and, (2) the participation in the JDC. The $5.0 million non-refundable upfront payment was allocated to the delivery of the licenses as the JDC deliverable was deemed to be de minimis. In addition, since the first $1.5 million milestone payment related to the submission of the CTA is within the control of the parties, the Company recorded such milestone as variable consideration allocated to the licenses at the inception of the arrangement as the Company believes it is probable to be met. The $1.5 million payment was received in February 2019 upon submission of the CTA. The future regulatory and commercial milestone payments will be recorded during the period the milestones become probable of achievement. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies | |
Commitments and Contingencies | 17. Commitments and Contingencies In March 2007, a lease agreement for an unlimited period starting in December 2007 was entered into for the use of business and research premises in Vienna. The contract has a six-month notice period and can be terminated every quarter end. In July 2015, a lease agreement was entered into for the use of approximately 15,000 square feet of office space in King of Prussia, PA, with the lease term continuing until December 2023 with no renewal options. In February 2018, a lease agreement starting in March 2018 was entered into for the use of office space in Dublin and has a month-to-month term. We also enter into lease agreements for equipment such as copiers and printers. Lease expense was $1.3 million, $1.3 million, and $1.4 million for the years ended December 31, 2016, 2017 and 2018, respectively. Future minimum contractual obligations and commitments at December 31, 2018 are as follows: Year ending December 31, (in thousands) Total 2019 2020 2021 2022 2023 Thereafter Operating lease obligations $ 3,507 $ 1,456 $ 507 $ 515 $ 522 $ 507 $ — Other contractual commitments 10,166 10,166 — — — — — Total $ 13,673 $ 11,622 $ 507 $ 515 $ 522 $ 507 $ — In addition to the agreements described above, the Company has other contractual commitments related primarily to contracts entered into with contract research organizations and contract manufacturing organizations in connection with the conduct of clinical trials 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 the trials 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. The Company is not obligated to make minimum required payments under these service agreements. The Company has no 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, 2018 | |
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 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 $ (0.36) $ (0.44) $ (0.90) $ (0.46) 2017 Quarter Ended Revenues $ 1,678 $ 1,051 $ 1,468 $ 1,122 Operating expenses (16,878) (16,613) (22,193) (23,403) Loss from operations (15,200) (15,562) (20,725) (22,281) Other income (expense) 326 (7) 328 120 Income tax (expense) benefit (349) 967 (1,872) (101) Net loss (15,223) (14,602) (22,269) (22,262) Basic and diluted loss per share (1) $ (0.56) $ (0.54) $ (0.79) $ (0.61) (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. Additionally, loss per share for the quarter ended March 31, 2017 is recast to reflect the Redomicilation Transaction, accordingly the loss per share presented is based on the equivalent number of Nabriva Ireland ordinary shares outstanding in all periods. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events | |
Subsequent Events | 19. Subsequent Events The Company evaluated all events or transactions that occurred subsequent to December 31, 2018 through the date the consolidated financial statements were issued, and have not identified any such events. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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 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 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 | Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. |
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). |
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. |
Research Premium and Grant Revenue | 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. Please refer to Note 10 for further details on all forms of grant revenue. 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. The benefit of a government loan at a below-market rate of interest is treated as a government grant. The benefit due to the difference between the market rate of interest and the rate of interest charged by the governmental organization is measured as the difference between the initial carrying value of the loan determined and the proceeds received. This benefit is deferred, and recognized through profit and loss over the term of the corresponding liabilities. |
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 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 Tax Act, the Company revalued the ending net deferred tax assets and liabilities of our U.S. subsidiary at December 31, 2017. |
Subsequent Events | Subsequent Events Material subsequent events are evaluated and disclosed through the report issuance date. |
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 May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers , an updated standard on revenue recognition. ASU 2014-09 provides enhancements to the quality and consistency of how revenue is reported by companies while also improving comparability in the financial statements of companies reporting using International Financial Reporting Standards or US GAAP. The main purpose of the new standard is for companies to recognize revenue to depict the transfer of goods or services to customers in amounts that reflect the consideration to which a company expects to be entitled in exchange for those goods or services. The new standard also results in enhanced revenue disclosures, guidance for transactions that were not previously addressed comprehensively and improve guidance for multiple-element arrangements. The effective date of ASU 2014-09 for the Company is the first quarter of fiscal year 2018. The Company recognized $1.5 million of revenue related to a contract asset (note 16) upon the adoption of this new standard during 2018 that would not have been recognized under the prior standard. · In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation : Scope of Modification Accounting . ASU 2017-09 clarifies which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718, Compensation—Stock Compensation . ASU 2017-09 is effective for annual periods beginning after December 15, 2017. An entity should apply the amendments prospectively to a modification that occurs on or after the adoption date. The Company adopted ASU 2017-09 in the first quarter of fiscal year 2018. The impact of adopting this standard did not have a material effect on the Company’s financial position, results of operation or cash flow and related disclosures. To be adopted in future periods: · In February 2016, the FASB issued Accounting Standards Update 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. Originally, entities were required to adopt ASU 2016-02 using a modified retrospective approach at the beginning of the earliest comparative period presented in the financial statements and the recognition of a cumulative-effect adjustment to the opening balance of retained earnings. The FASB subsequently issued ASU 2018-10 and ASU 2018-11 in July 2018, which provide clarifications and improvements and also provides for an optional transition method which allows companies to apply the new lease standard at the adoption date instead of at the earliest comparative period presented and continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. The new lease standard requires lessees to present a right-of-use asset and a corresponding lease liability on the balance sheet. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information will not be restated. 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 will not reassess whether expired or existing contracts are or contain a lease; will not need 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 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). On January 1, 2019, the Company expects to recognize ROU assets and lease liabilities of approximately $2.1 million. The Company does not expect the adoption of the new lease standard to materially impact its consolidated statements of operations or of cash flows. · In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): “Improvements to Nonemployee Share-Based Payment Accounting,” which largely aligns the accounting for share-based payment awards issued to nonemployees with the accounting for share-based payment awards issued to employees. Under previous GAAP, the accounting for nonemployee share-based payments differed from that applied to employee awards, particularly with regard to the measurement date and the impact of performance conditions. Under the new guidance, (i) equity-classified share-based payment awards issued to nonemployees will be measured at the grant date, instead of the previous requirement to remeasure the awards through the performance completion date, (ii) for performance conditions, compensation cost associated with the award will be recognized when the achievement of the performance condition is probable, rather than upon achievement of the performance condition, and (iii) the current requirement to reassess the classification (equity or liability) for nonemployee awards upon vesting will be eliminated, except for awards in the form of convertible instruments. This new guidance will be effective for public companies for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company does not expect the adoption of the new guidance to have a material effect on its consolidated financial statements. · In August 2018, the FASB issued AS 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements. Entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, but public companies will be required to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The guidance on fair value disclosures eliminates the following requirements for all entities: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the entity’s policy for the timing of transfers between levels of the fair value hierarchy; and, the entity’s valuation processes for Level 3 fair value measurements. The ASU adds the following disclosure requirements, but it exempts nonpublic entities from these requirements: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements of instruments held at the end of the reporting period; and, for recurring and nonrecurring Level 3 fair value measurements, the range and weighted average used to develop significant unobservable inputs and how the weighted average was calculated, with certain exceptions. The guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, but entities are permitted to early adopt either the entire standard or only the provisions that eliminate or modify the requirements. The Company does not expect the adoption of the new guidance to have a material effect on its consolidated financial statements. |
Short-term investments (Tables)
Short-term investments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Short-term investments | |
Schedule of short-term investments | As of December 31, 2018 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Short-term investments: Available-for-sale securities $ 50 $ — $ — $ 50 Term deposits 175 — — 175 Total $ 225 $ — $ — $ 225 As of December 31, 2017 (in thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Short-term investments: Available-for-sale securities $ 76 $ — $ (26) $ 50 Term deposits 60 — — 60 Total $ 136 $ — $ (26) $ 110 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 175 — — 175 Total Assets $ 175 $ 50 $ — $ 225 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2017 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 60 — — 60 Total Assets $ 60 $ 50 $ — $ 110 |
Other receivables (Tables)
Other receivables (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other receivables | |
Schedule of other current receivables | As of December 31 (in thousands) 2017 2018 Research premium $ 5,124 $ 2,657 VAT and other taxes 28 1,024 Receivables from grant revenue 231 104 Other receivables 19 86 Total current receivables $ 5,402 $ 3,871 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment | |
Schedule of property, plant and equipment | As of December 31 (in thousands) 2017 2018 IT equipment $ 1,060 $ 1,079 Laboratory equipment 3,299 3,392 Other equipment 15 124 4,374 4,595 Less: Accumulated depreciation (3,047) (3,456) Property, plant and equipment, net $ 1,327 $ 1,139 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | As of December 31 (in thousands) 2017 2018 Research and development related costs $ 2,308 $ 5,032 Payroll and related costs 4,426 7,427 Accounting, tax and audit services 231 398 Other 1,159 1,645 Total other current liabilities $ 8,124 $ 14,502 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt | |
Schedule of long-term debt | As of December 31 (in thousands) 2017 2018 Term loan payable $ — $ 25,000 Unamortized debt issuance costs — (1,990) Carrying value of term loan — 23,010 Other long-term debt 232 708 Total long-term debt $ 232 $ 23,718 |
Schedule of maturities of long-term debt | Maturities of long-term debt as of December 31, 2018 were as follows: (in thousands) 2019 $ — 2020 3,656 2021 8,592 2022 8,704 2023 4,756 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue | |
Summary of revenue by type | Year ended December 31, (in thousands) 2016 2017 2018 Collaboration revenue $ — $ — $ 6,500 Research premium 6,232 4,842 2,594 Government grants — 369 562 Grants from WWFF 250 108 — Total $ 6,482 $ 5,319 $ 9,656 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share-Based Payments | |
Schedule of allocation of share-based compensation expense | Year ended December 31, (in thousands) 2016 2017 2018 Research and development $ 894 $ 2,128 $ 1,406 General and administrative 1,651 3,604 3,748 Total $ 2,545 $ 5,732 $ 5,154 |
SOP 2015 | |
Share-Based Payments | |
Summary of information regarding stock option awards | 2016 2017 2018 Weighted Weighted Weighted average average average exercise exercise exercise Aggregate price in price in price in intrinsic Stock Option Plan 2015 $ per share Options $ per share Options $ per share Options value Outstanding as of January 1 7.61 1,092,300 7.83 1,794,360 8.35 3,044,899 Granted 8.02 922,130 9.02 1,458,300 — — Exercised 7.21 (23,360) — — — — Forfeited 7.64 (196,710) 8.60 (207,761) 8.41 (201,986) Outstanding as of December 31 7.83 1,794,360 8.35 3,044,899 8.34 2,842,913 — Vested and exercisable as of December 31 7.52 452,210 7.68 989,656 8.10 1,844,590 — |
Summary of assumptions used for valuation of options | Input parameters 2016 2017 Expected volatility 59.8% - 67.2% 55.6% - 62.0% Expected term of options 6.0 years 6.1 years Risk-free interest rate 1.15% - 2.09% 1.89% - 2.10% Expected dividend yield – – |
2017 Share Incentive Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | 2017 2018 Weighted Weighted average average exercise exercise Aggregate price in $ price in $ intrinsic Stock Option Plan 2017 per share Options per share Options value Outstanding as of January 1 — — 6.92 294,100 Granted 6.92 294,100 5.27 2,199,225 Exercised — — — — Forfeited — — (94,900) Outstanding as of December 31 6.92 294,100 2,398,425 — Vested and exercisable as of December 31 — — 119,287 — |
Summary of assumptions used for valuation of options | Input parameters 2017 2018 Expected volatility 59.5% - 63.0% 59.8% - 61.4% Expected term of options 6.0 6.1 Risk-free interest rate 1.93% - 2.27% 2.55% - 3.03% Expected dividend yield – – |
Inducement Awards | |
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) benefit (T
Income tax (expense) benefit (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income tax (expense) benefit | |
Schedule of loss before income taxes attributable to domestic and international operations | Year ended December 31 (in thousands) 2016 2017 2018 Domestic $ (54,509) $ (66,109) $ (113,699) Foreign (1,053) (6,892) (1,032) Loss before income taxes $ (55,562) $ (73,001) $ (114,731) |
Schedule of income tax (expense) benefit | Year ended December 31 (in thousands) 2016 2017 2018 Current tax Domestic $ (4) $ — $ — Foreign (118) 55 (49) Deferred tax Domestic — — — Foreign 794 (1,410) — Total income tax (expense) benefit $ 672 $ (1,355) $ (49) |
Schedule of effective income tax rate reconciliation | Year ended December 31 (% of pre-tax income) 2016 2017 2018 Statutory income tax rate 25.0 % 12.5 % 12.5 % Non-deductible expenses (0.2) (0.8) (0.1) Income not subject to tax 2.8 0.9 0.3 Impairment — 1.4 — Tax credits 0.4 0.2 0.1 Foreign rate differential (2.5) 21.0 (3.1) In-process research and development — — (3.5) Other 0.2 (1.4) 0.2 Valuation allowance (24.5) (35.6) (6.5) Effective income tax rate 1.2 % (1.8) % (0.1) % |
Summary of the components of deferred income tax balances | As of December 31, (in thousands) 2017 2018 Deferred tax assets: Net operating loss carryforwards $ 70,871 $ 91,995 Tax loss on liquidation of subsidiary 7,846 6,245 Equity compensation 1,450 2,473 Non-deductible reserves 57 203 Total deferred tax assets 80,224 100,916 Valuation allowance (80,087) (100,832) Net deferred tax assets 137 84 Deferred tax liabilities: Financial liabilities 80 55 Property, plant and equipment 57 29 Total deferred tax liability 137 84 Deferred tax, net $ — $ — |
Summary of changes in the deferred tax valuation allowance | Year ended December 31, (in thousands) 2016 2017 2018 Balance at beginning of year $ (40,487) $ (54,114) $ (80,087) Tax benefit (13,627) (25,973) (7,301) Acquired tax attributes — — (13,444) Balance at end of year $ (54,114) $ (80,087) $ (100,832) |
Summary of carryforwards of net operating losses | The following table summarizes carryforwards of net operating losses as of December 31, 2018. (in thousands) Amount Expiration Ireland $ 107,671 Indefinite Austria $ 259,229 Indefinite United States $ 44,728 2033 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Year ended December 31, (in thousands, except per share data) 2016 2017 2018 Net loss for the period $ (54,890) $ (74,356) $ Weighted average number of shares outstanding 21,478,320 29,830,669 Basic and diluted loss per share $ (2.56) $ (2.49) $ |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Year ended December 31, 2016 2017 2018 Stock options 1,904,320 3,338,999 6,091,338 Restricted stock units — — 1,372,100 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies | |
Schedule of future minimum contractual obligations and commitments | Future minimum contractual obligations and commitments at December 31, 2018 are as follows: Year ending December 31, (in thousands) Total 2019 2020 2021 2022 2023 Thereafter Operating lease obligations $ 3,507 $ 1,456 $ 507 $ 515 $ 522 $ 507 $ — Other contractual commitments 10,166 10,166 — — — — — Total $ 13,673 $ 11,622 $ 507 $ 515 $ 522 $ 507 $ — |
Selected Quarterly Financial _2
Selected Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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 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 $ (0.36) $ (0.44) $ (0.90) $ (0.46) 2017 Quarter Ended Revenues $ 1,678 $ 1,051 $ 1,468 $ 1,122 Operating expenses (16,878) (16,613) (22,193) (23,403) Loss from operations (15,200) (15,562) (20,725) (22,281) Other income (expense) 326 (7) 328 120 Income tax (expense) benefit (349) 967 (1,872) (101) Net loss (15,223) (14,602) (22,269) (22,262) Basic and diluted loss per share (1) $ (0.56) $ (0.54) $ (0.79) $ (0.61) (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. Additionally, loss per share for the quarter ended March 31, 2017 is recast to reflect the Redomicilation Transaction, accordingly the loss per share presented is based on the equivalent number of Nabriva Ireland ordinary shares outstanding in all periods. |
Organization and Business Act_2
Organization and Business Activities (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 31, 2018 | Sep. 22, 2017 | Feb. 28, 2019 | Mar. 31, 2019 | Mar. 05, 2019 | Dec. 31, 2018 | Mar. 31, 2018 |
Liquidity | |||||||
Cash, cash equivalents and short-term investments | $ 102,200 | ||||||
At-the-market offering | |||||||
Liquidity | |||||||
Proceeds from issuance of stock | 24,219 | ||||||
At-the-market offering | Ordinary Shares | |||||||
Liquidity | |||||||
Proceeds from issuance of stock | $ 30,300 | $ 24,200 | |||||
Number of shares issued | 7,742,379 | 4,778,031 | |||||
Net proceeds from sale of stock | $ 28,900 | $ 23,000 | |||||
Public offering | Ordinary Shares | |||||||
Liquidity | |||||||
Proceeds from issuance of stock | $ 50,000 | $ 80,000 | |||||
Number of shares issued | 18,181,818 | 9,411,765 | |||||
Shares issued, price per share | $ 2.75 | $ 8.50 | |||||
Net proceeds from sale of stock | $ 46,300 | $ 73,300 | |||||
License Agreement | Clinical trial application submission | Sinovant Sciences, LTD | |||||||
Liquidity | |||||||
Milestone payment received | $ 1,500 | ||||||
Loan Agreement | Term loan | |||||||
Liquidity | |||||||
Maximum borrowing capacity | 75,000 | ||||||
Loan Agreement | Term loan | Initial Advance | |||||||
Liquidity | |||||||
Principal amount of advances outstanding | 25,000 | ||||||
Loan Agreement | Term loan | Additional Funding Subject to Certain Conditions [Member] | |||||||
Liquidity | |||||||
Remaining amount under the loan agreement | 50,000 | ||||||
Loan Agreement | Term loan | Tranche 2 Advance | |||||||
Liquidity | |||||||
Maximum borrowing capacity | 10,000 | ||||||
Loan Agreement | Term loan | Tranche 3 Advance | |||||||
Liquidity | |||||||
Maximum borrowing capacity | $ 5,000 | ||||||
ATM Agreement | |||||||
Liquidity | |||||||
Proceeds from issuance of stock | $ 5,900 | ||||||
ATM Agreement | Cantor Fitzgerald and Co. | Ordinary Shares | |||||||
Liquidity | |||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Property, plant and equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
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_4
Summary of Significant Accounting Policies - Intangible assets and other Long-lived assets (Details) | 12 Months Ended |
Dec. 31, 2018 | |
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_5
Summary of Significant Accounting Policies - Income Taxes (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
U.S. | ||
Income taxes | ||
U.S. federal corporate tax rate | 21.00% | 35.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2019 | |
Recent Accounting Pronouncements | ||||||||||||
Revenues | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 1,122 | $ 1,468 | $ 1,051 | $ 1,678 | $ 9,656 | $ 5,319 | $ 6,482 | |
ASU 2016-02 | Restatement Adjustment | ||||||||||||
Recent Accounting Pronouncements | ||||||||||||
ROU assets | $ 2,100 | |||||||||||
Lease liabilities | $ 2,100 | |||||||||||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ASU 2014-09 | Collaboration revenue - Variable consideration | ||||||||||||
Recent Accounting Pronouncements | ||||||||||||
Revenues | $ 1,500 |
Short-term investments (Details
Short-term investments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Short-term investments | ||
Amortized Cost | $ 225 | $ 136 |
Unrealized Losses | (26) | |
Fair Value | 225 | 110 |
Available-for-sale securities | ||
Short-term investments | ||
Amortized Cost | 50 | 76 |
Unrealized Losses | (26) | |
Fair Value | 50 | 50 |
Term deposits | ||
Short-term investments | ||
Amortized Cost | 175 | 60 |
Fair Value | $ 175 | $ 60 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
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 | ||
Short-term investments: | ||
Available-for-sale securities | 50 | 50 |
Term deposits | 175 | 60 |
Total Assets | 225 | 110 |
Level 1 | Recurring | ||
Short-term investments: | ||
Term deposits | 175 | 60 |
Total Assets | 175 | 60 |
Level 2 | Recurring | ||
Short-term investments: | ||
Available-for-sale securities | 50 | 50 |
Total Assets | $ 50 | $ 50 |
Other receivables (Details)
Other receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other receivables | ||
Research premium | $ 2,657 | $ 5,124 |
VAT and other taxes | 1,024 | 28 |
Receivables from grant revenue | 104 | 231 |
Other receivables | 86 | 19 |
Total current receivables | $ 3,871 | $ 5,402 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 4,595 | $ 4,374 |
Less: Accumulated depreciation | (3,456) | (3,047) |
Property, plant and equipment, net | 1,139 | 1,327 |
IT equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 1,079 | 1,060 |
Laboratory equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 3,392 | 3,299 |
Other equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 124 | $ 15 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued expenses and other current liabilities: | ||
Research and development related costs | $ 5,032 | $ 2,308 |
Payroll and related costs | 7,427 | 4,426 |
Accounting, tax and audit services | 398 | 231 |
Other | 1,645 | 1,159 |
Total other current liabilities | $ 14,502 | $ 8,124 |
Debt -Summary (Details)
Debt -Summary (Details) - Loan Agreement - Term loan | 1 Months Ended |
Dec. 31, 2018USD ($)item | |
Debt | |
Maximum borrowing capacity | $ 75,000,000 |
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 | $ 5,000,000 |
Maximum value of lender option to purchase equity securities | 2,000,000 |
Loan origination costs | 1,290,000 |
Initial fee paid to lender | $ 700,000 |
Prime rate | |
Debt | |
Variable rate basis | prime rate of 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 | $ 25,000,000 |
Tranche 2 Advance | |
Debt | |
Maximum borrowing capacity | 10,000,000 |
Tranche 3 Advance | |
Debt | |
Maximum borrowing capacity | 5,000,000 |
Tranche 4 Advance | |
Debt | |
Maximum borrowing capacity | 10,000,000 |
Tranche 5 Advance | |
Debt | |
Maximum borrowing capacity | 15,000,000 |
Tranche 6 Advance | |
Debt | |
Maximum borrowing capacity | 5,000,000 |
Tranche 7 Advance | Prime rate | |
Debt | |
Maximum borrowing capacity | $ 5,000,000 |
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% |
Debt - Long Term Debt (Details)
Debt - Long Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Long-term debt | ||
Total long-term debt | $ 23,718 | $ 232 |
Maturities of long-term debt | ||
2020 | 3,656 | |
2021 | 8,592 | |
2022 | 8,704 | |
2023 | 4,756 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 25,000 | |
Unamortized debt issuance costs | (1,990) | |
Total long-term debt | 23,010 | |
Other long-term debt | ||
Long-term debt | ||
Total long-term debt | $ 708 | $ 232 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 31, 2018 | Sep. 22, 2017 | Dec. 19, 2016 | Mar. 31, 2019 | Mar. 05, 2019 | Dec. 31, 2018 | Dec. 31, 2016 | Mar. 31, 2018 |
Stockholders' Equity | ||||||||
Gross proceeds from December 2016 rights offering | $ 24,822 | |||||||
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 | $ 50,000 | $ 80,000 | ||||||
Net proceeds from sale of stock | $ 46,300 | $ 73,300 | ||||||
At-the-market offering | ||||||||
Stockholders' Equity | ||||||||
Gross proceeds from sale of stock | $ 24,219 | |||||||
At-the-market offering | Ordinary Shares | ||||||||
Stockholders' Equity | ||||||||
Number of shares issued | 7,742,379 | 4,778,031 | ||||||
Gross proceeds from sale of stock | $ 30,300 | $ 24,200 | ||||||
Net proceeds from sale of stock | $ 28,900 | $ 23,000 | ||||||
December 2016 Financing | Common Stock | ||||||||
Stockholders' Equity | ||||||||
Number of shares issued | 588,127 | |||||||
Net proceeds from sale of stock | $ 20,600 | |||||||
Gross proceeds from December 2016 rights offering | $ 24,800 | |||||||
ATM Agreement | ||||||||
Stockholders' Equity | ||||||||
Gross proceeds from sale of stock | $ 5,900 | |||||||
ATM Agreement | Cantor Fitzgerald and Co. | Ordinary Shares | ||||||||
Stockholders' Equity | ||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50,000 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue | |||||||||||
Revenues | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 1,122 | $ 1,468 | $ 1,051 | $ 1,678 | $ 9,656 | $ 5,319 | $ 6,482 |
Collaboration revenue | |||||||||||
Revenue | |||||||||||
Revenues | 6,500 | ||||||||||
Research premium | |||||||||||
Revenue | |||||||||||
Revenues | 2,594 | 4,842 | 6,232 | ||||||||
Government grants | |||||||||||
Revenue | |||||||||||
Revenues | $ 562 | 369 | |||||||||
Grants from WWFF | |||||||||||
Revenue | |||||||||||
Revenues | $ 108 | $ 250 |
Share-Based Payments - SOP 2015
Share-Based Payments - SOP 2015 (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Aug. 25, 2016 | Sep. 23, 2015 | Apr. 02, 2015 | |
Additional disclosures | ||||||
Share-based compensation expense | $ 5,154 | $ 5,732 | $ 2,545 | |||
SOP 2015 | ||||||
Weighted average exercise price in $ per share | ||||||
Outstanding balance at beginning of year (in dollars per share) | $ 8.35 | $ 7.83 | $ 7.61 | |||
Granted (in dollars per share) | 9.02 | 8.02 | ||||
Exercised (in dollars per share) | 7.21 | |||||
Forfeited (in dollars per share) | 8.41 | 8.60 | 7.64 | |||
Outstanding balance at end of year (in dollars per share) | 8.34 | 8.35 | 7.83 | |||
Vested and exercisable balance at end of year (in dollars per share) | $ 8.10 | $ 7.68 | $ 7.52 | |||
Options | ||||||
Outstanding at beginning of year (in shares) | 3,044,899 | 1,794,360 | 1,092,300 | |||
Granted (in shares) | 1,458,300 | 922,130 | ||||
Exercised (in shares) | (23,360) | |||||
Forfeited (in shares) | (201,986) | (207,761) | (196,710) | |||
Outstanding at end of year (in shares) | 2,842,913 | 3,044,899 | 1,794,360 | |||
Vested and exercisable at end of year (in shares) | 1,844,590 | 989,656 | 452,210 | |||
Additional disclosures | ||||||
Total intrinsic value of options exercised | $ 181 | |||||
SOP 2015 | $4.06 per share to $11.00 per share | ||||||
Additional disclosures | ||||||
Options outstanding (in shares) | 2,842,913 | |||||
Exercise price minimum range | $ 4.06 | |||||
Exercise price maximum range | $ 11 | |||||
Weighted average remaining contractual life | 7 years 4 months 24 days | |||||
SOP 2015 | Stock Options | ||||||
Share-Based Payments | ||||||
Vesting period | 4 years | |||||
Additional disclosures | ||||||
Share-based compensation expense | $ 3,200 | $ 5,600 | $ 2,500 | |||
Weighted-average grant date fair value (in dollars per share) | $ 5.05 | $ 4.76 | ||||
Fair Value Assumptions | ||||||
Expected term of options (in years) | 6 years 1 month 6 days | 6 years | ||||
Dividend yield (as a percent) | 0.00% | 0.00% | ||||
Total unrecognized compensation related to unvested options | $ 5,400 | |||||
Recognition period | 2 years 1 month 6 days | |||||
SOP 2015 | Stock Options | Minimum | ||||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 55.60% | 59.80% | ||||
Risk-free interest rate (as a percent) | 1.89% | 1.15% | ||||
Term of U.S. treasury securities used to estimate risk free interest rate | 5 years | 5 years | ||||
SOP 2015 | Stock Options | Maximum | ||||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 62.00% | 67.20% | ||||
Risk-free interest rate (as a percent) | 2.10% | 2.09% | ||||
Term of U.S. treasury securities used to estimate risk free interest rate | 7 years | 7 years | ||||
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, 2018USD ($)item$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares |
Additional disclosures | ||||
Share-based compensation expense | $ | $ 5,154 | $ 5,732 | $ 2,545 | |
2017 Share Incentive Plan | ||||
Weighted average exercise price in $ per share | ||||
Outstanding balance at beginning of year (in dollars per share) | $ / shares | $ 6.92 | $ 0 | ||
Granted (in dollars per share) | $ / shares | 5.27 | 6.92 | ||
Forfeited (in dollars per share) | $ / shares | 6.75 | |||
Outstanding balance at end of year (in dollars per share) | $ / shares | 5.41 | $ 6.92 | $ 0 | |
Vested and exercisable balance at end of year (in dollars per share) | $ / shares | $ 6.88 | |||
Options | ||||
Outstanding at beginning of year (in shares) | 294,100 | 0 | ||
Granted (in shares) | 2,199,225 | 294,100 | ||
Exercised (in shares) | 0 | 0 | ||
Forfeited (in shares) | (94,900) | |||
Outstanding at end of year (in shares) | 2,398,425 | 294,100 | 0 | |
Vested and exercisable at end of year (in shares) | 119,287 | |||
2017 Share Incentive Plan | $1.46 per share to $8.35 per share | ||||
Additional disclosures | ||||
Options outstanding (in shares) | 2,398,425 | |||
Exercise price minimum range | $ / shares | $ 1.46 | |||
Exercise price maximum range | $ / shares | $ 8.35 | |||
Weighted average remaining contractual life | 9 years 3 months 18 days | |||
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 | 5,064,378 | |||
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 1 month 6 days | 6 years | ||
Dividend yield (as a percent) | 0.00% | 0.00% | ||
Additional disclosures | ||||
Share-based compensation expense | $ | $ 1,800 | $ 100 | ||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 3.06 | $ 3.98 | ||
Total unrecognized compensation related to unvested options | $ | $ 5,700 | |||
Recognition period | 3 years 1 month 6 days | |||
2017 Share Incentive Plan | Stock Options | Minimum | ||||
Fair Value Assumptions | ||||
Expected volatility (as a percent) | 59.80% | 59.50% | ||
Risk-free interest rate (as a percent) | 2.55% | 1.93% | ||
Additional disclosures | ||||
Term of U.S. treasury securities used to estimate risk free interest rate | 5 years | |||
2017 Share Incentive Plan | Stock Options | Maximum | ||||
Fair Value Assumptions | ||||
Expected volatility (as a percent) | 61.40% | 63.00% | ||
Risk-free interest rate (as a percent) | 3.03% | 2.27% | ||
Additional disclosures | ||||
Term of U.S. treasury securities used to estimate risk free interest rate | 7 years | |||
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 | $ | $ 0 | |||
Restricted Stock Units | ||||
Restricted stock granted during the period | 407,150 | |||
Weighted average grant date fair value per share | $ / shares | $ 5.82 | |||
Number of shares outstanding | 387,800 | |||
Expiration period if drug is not approved | 2 years | |||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Employees | ||||
Additional disclosures | ||||
Share-based compensation expense | $ | $ 200 | |||
Restricted Stock Units | ||||
Restricted stock granted during the period | 834,300 | |||
Weighted average grant date fair value per share | $ / shares | $ 2.16 | |||
Number of shares outstanding | 834,300 | |||
Number of vesting periods | item | 3 | |||
Vesting period | 6 months | |||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | ||||
Restricted Stock Units | ||||
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 | ||||
Restricted Stock Units | ||||
Percentage that vests during the period | 50.00% | |||
Vesting period | 1 year |
Share-Based Payments - Induceme
Share-Based Payments - Inducement Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-Based Payments | ||||
Share-based compensation expense | $ 5,154 | $ 5,732 | $ 2,545 | |
Inducement Awards | ||||
Share-Based Payments | ||||
Share-based compensation expense | $ 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 | 9 years 7 months 6 days | |||
Inducement Awards | Vesting period, year one | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 25.00% | |||
Inducement Awards | Vesting period, years 2-4 | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 75.00% | |||
Monthly vesting period | 36 months | |||
Inducement Awards | Non-statutory option | ||||
Share-Based Payments | ||||
Options exercise price (in dollars per share) | $ 3.53 | |||
Exercise period | 10 years | |||
Vesting period | 4 years | |||
Options weighted average grant date fair value (in dollars per share) | $ 2.05 | |||
Inducement Awards | Non-statutory option | Chief Executive Officer | ||||
Share-Based Payments | ||||
Options granted during the period | 850,000 | |||
Inducement Awards | Restricted Stock Units ("RSUs") | ||||
Share-Based Payments | ||||
Restricted stock weighted average grant date fair value (in dollars per share) | $ 3.53 | |||
Inducement Awards | Restricted Stock Units ("RSUs") | Chief Executive Officer | ||||
Share-Based Payments | ||||
Restricted stock granted during the period | 150,000 | |||
Inducement Awards | Restricted Stock Units ("RSUs") | Upon receipt of FDA approval | ||||
Share-Based Payments | ||||
Percentage that vests during the period | 50.00% | |||
Inducement Awards | 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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-Based Payments | |||
Share-based compensation expense | $ 5,154 | $ 5,732 | $ 2,545 |
Research and development | |||
Share-Based Payments | |||
Share-based compensation expense | 1,406 | 2,128 | 894 |
General and administrative | |||
Share-Based Payments | |||
Share-based compensation expense | $ 3,748 | $ 3,604 | $ 1,651 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan | 1 Months Ended |
Aug. 31, 2018shares | |
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% |
Post-employment benefit oblig_2
Post-employment benefit obligations (Details) - USD ($) | 12 Months Ended | ||
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 | $ 58,000 | $ 59,000 |
U.S. | |||
Post-employment benefit obligations | |||
Contribution costs | $ 448,000 | $ 213,000 | $ 152,000 |
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) benefit -
Income tax (expense) benefit - Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Loss before income taxes attributable to domestic and international operations | |||||||||||
Domestic | $ (113,699) | $ (66,109) | $ (54,509) | ||||||||
Foreign | (1,032) | (6,892) | (1,053) | ||||||||
Loss before income taxes | (114,731) | (73,001) | (55,562) | ||||||||
Current tax | |||||||||||
Domestic | (4) | ||||||||||
Foreign | (49) | 55 | (118) | ||||||||
Deferred tax | |||||||||||
Foreign | (1,410) | 794 | |||||||||
Total income tax (expense) benefit | $ 259 | $ 151 | $ 48 | $ (506) | $ (101) | $ (1,872) | $ 967 | $ (349) | $ (49) | $ (1,355) | $ 672 |
Effective income tax reconciliation | |||||||||||
Statutory income tax rate | 12.50% | 12.50% | 25.00% | ||||||||
Non-deductible expenses | (0.10%) | (0.80%) | (0.20%) | ||||||||
Income not subject to tax | 0.30% | 0.90% | 2.80% | ||||||||
Impairment | 1.40% | ||||||||||
Tax credits | 0.10% | 0.20% | 0.40% | ||||||||
Foreign rate differential | (3.10%) | 21.00% | (2.50%) | ||||||||
In-process research and development | (3.50%) | ||||||||||
Other | 0.20% | (1.40%) | 0.20% | ||||||||
Valuation allowance | (6.50%) | (35.60%) | (24.50%) | ||||||||
Effective income tax rate | (0.10%) | (1.80%) | 1.20% | ||||||||
Austria | |||||||||||
Effective income tax reconciliation | |||||||||||
Statutory income tax rate | 25.00% | ||||||||||
Ireland | |||||||||||
Effective income tax reconciliation | |||||||||||
Statutory income tax rate | 12.50% | 12.50% |
Income tax (expense) benefit _2
Income tax (expense) benefit - Deferred income taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 91,995 | $ 70,871 | ||
Tax loss on liquidation of subsidiary | 6,245 | 7,846 | ||
Equity compensation | 2,473 | 1,450 | ||
Non-deductible reserves | 203 | 57 | ||
Total deferred tax assets | 100,916 | 80,224 | ||
Valuation allowance | (100,832) | (80,087) | $ (54,114) | $ (40,487) |
Net deferred tax assets | 84 | 137 | ||
Deferred tax liabilities: | ||||
Financial liabilities | 55 | 80 | ||
Property, plant and equipment | 29 | 57 | ||
Total deferred tax liability | 84 | 137 | ||
Deferred tax, net | $ 0 | $ 0 |
Income tax (expense) benefit _3
Income tax (expense) benefit - Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income tax (expense) benefit | |||
Balance at beginning of year | $ (80,087) | $ (54,114) | $ (40,487) |
Balance at end of year | (100,832) | (80,087) | (54,114) |
Tax benefit | |||
Income tax (expense) benefit | |||
Change in valuation allowance | (7,301) | $ (25,973) | $ (13,627) |
Acquired tax attributes | |||
Income tax (expense) benefit | |||
Change in valuation allowance | $ (13,444) |
Income tax (expense) benefit _4
Income tax (expense) benefit - Net operating losses (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net operating losses carryforwards | ||||
Valuation allowance | $ 100,832 | $ 80,087 | $ 54,114 | $ 40,487 |
Uncertain tax positions disclosures | ||||
Uncertain tax positions | 0 | $ 0 | ||
Ireland | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | 107,671 | |||
Austria | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | 259,229 | |||
U.S. | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | $ 44,728 | |||
U.S. federal corporate tax rate | 21.00% | 35.00% | ||
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, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Basic and diluted loss per share | |||||||||||
Net loss for the period | $ (30,824) | $ (52,825) | $ (17,788) | $ (13,342) | $ (22,262) | $ (22,269) | $ (14,602) | $ (15,223) | $ (114,780) | $ (74,356) | $ (54,890) |
Weighted average number of shares outstanding | 50,795,768 | 29,830,669 | 21,478,320 | ||||||||
Basic and diluted loss per share | $ (0.46) | $ (0.90) | $ (0.44) | $ (0.36) | $ (0.61) | $ (0.79) | $ (0.54) | $ (2.26) | $ (2.49) | $ (2.56) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock Options | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 6,091,338 | 3,338,999 | 1,904,320 |
Restricted Stock Units ("RSUs") | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 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% |
In-process research and development expense | $ 32 |
Fair value of upfront shares issued | 26.9 |
Research and development expense, dealing costs | 4.9 |
Net liabilities assumed | 0.2 |
Maximum | |
Acquisition of Zavante | |
Contingent consideration payment | 97.5 |
Approval Milestone Payment | |
Acquisition of Zavante | |
Contingent consideration payment | 25 |
Net Sales Milestone Payments | |
Acquisition of Zavante | |
Contingent consideration payment | $ 72.5 |
Upfront Shares | |
Acquisition of Zavante | |
Business acquisition, ordinary shares issued or issuable | shares | 7,336,906 |
Holdback Shares, as a percentage of Upfront Shares | 10.00% |
Holdback Shares | |
Acquisition of Zavante | |
Business acquisition, ordinary shares issued or issuable | shares | 815,186 |
Sinovant License Agreement (Det
Sinovant License Agreement (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Feb. 28, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)item | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)item | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
License Agreement | |||||||||||||
Revenues | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 1,122 | $ 1,468 | $ 1,051 | $ 1,678 | $ 9,656 | $ 5,319 | $ 6,482 | ||
Sinovant Sciences, LTD | License Agreement | |||||||||||||
License Agreement | |||||||||||||
Notice period for termination of agreement | 180 days | ||||||||||||
Number of deliverables | item | 2 | 2 | |||||||||||
Sinovant Sciences, LTD | License Agreement | Achievement of certain regulatory and commercial milestones | |||||||||||||
License Agreement | |||||||||||||
Maximum contingent milestone payment | $ 91,500 | $ 91,500 | |||||||||||
Sinovant Sciences, LTD | License Agreement | Subsequent regulatory approval | |||||||||||||
License Agreement | |||||||||||||
Maximum contingent milestone payment | $ 4,000 | $ 4,000 | |||||||||||
Sinovant Sciences, LTD | License Agreement | Clinical trial application submission | |||||||||||||
License Agreement | |||||||||||||
Milestone payment received | $ 1,500 | ||||||||||||
Collaboration revenue - Upfront payment | Sinovant Sciences, LTD | License Agreement | |||||||||||||
License Agreement | |||||||||||||
Revenues | $ 5,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | Jul. 31, 2015ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Lease Arrangements | ||||
Loss Contingency Accrual | $ 0 | |||
Operating lease obligations | ||||
Total | 3,507 | |||
2019 | 1,456 | |||
2020 | 507 | |||
2021 | 515 | |||
2022 | 522 | |||
2023 | 507 | |||
Other contractual commitments | ||||
Total | 10,166 | |||
2019 | 10,166 | |||
Future minimum contractual obligations and commitments | ||||
Total | 13,673 | |||
2019 | 11,622 | |||
2020 | 507 | |||
2021 | 515 | |||
2022 | 522 | |||
2023 | $ 507 | |||
Lease Agreement, Business and Research Premises | ||||
Lease Arrangements | ||||
Termination notice period | 6 months | |||
Lease Agreement, Office Premises | ||||
Lease Arrangements | ||||
Leased office space (in square feet) | ft² | 15,000 | |||
Lease Agreement, Equipment | ||||
Lease Arrangements | ||||
Lease expense | $ 1,400 | $ 1,300 | $ 1,300 |
Selected Quarterly Financial _3
Selected Quarterly Financial Information (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Selected Quarterly Financial Information (Unaudited) | |||||||||||
Revenues | $ 797 | $ 461 | $ 847 | $ 7,551 | $ 1,122 | $ 1,468 | $ 1,051 | $ 1,678 | $ 9,656 | $ 5,319 | $ 6,482 |
Operating expenses | (31,676) | (53,386) | (18,554) | (20,415) | (23,403) | (22,193) | (16,613) | (16,878) | (124,031) | (79,087) | (61,529) |
Loss from operations | (30,879) | (52,925) | (17,707) | (12,864) | (22,281) | (20,725) | (15,562) | (15,200) | (114,375) | (73,768) | (55,047) |
Other income (expense) | (204) | (51) | (129) | 28 | 120 | 328 | (7) | 326 | |||
Income tax (expense) benefit | 259 | 151 | 48 | (506) | (101) | (1,872) | 967 | (349) | (49) | (1,355) | 672 |
Net loss | $ (30,824) | $ (52,825) | $ (17,788) | $ (13,342) | $ (22,262) | $ (22,269) | $ (14,602) | $ (15,223) | $ (114,780) | $ (74,356) | $ (54,890) |
Basic and diluted loss per share | $ (0.46) | $ (0.90) | $ (0.44) | $ (0.36) | $ (0.61) | $ (0.79) | $ (0.54) | $ (2.26) | $ (2.49) | $ (2.56) | |
Restatement Adjustment | Redomiciliation Transaction | |||||||||||
Selected Quarterly Financial Information (Unaudited) | |||||||||||
Basic and diluted loss per share | $ (0.56) |