Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | Nabriva Therapeutics plc | |
Entity Central Index Key | 0001641640 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
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 Shares Outstanding | 72,557,253 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 91,042 | $ 102,003 |
Short-term investments | 225 | 225 |
Other receivables | 7,238 | 3,871 |
Contract asset | 1,000 | 1,500 |
Prepaid expenses | 973 | 1,154 |
Total current assets | 100,478 | 108,753 |
Property, plant and equipment, net | 2,972 | 1,139 |
Intangible assets, net | 99 | 98 |
Long-term receivables | 438 | 428 |
Total assets | 103,987 | 110,418 |
Current liabilities: | ||
Accounts payable | 7,562 | 3,304 |
Accrued expense and other current liabilities | 10,533 | 14,502 |
Total current liabilities | 18,095 | 17,806 |
Non-current liabilities | ||
Long-term debt | 23,945 | 23,718 |
Other non-current liabilities | 1,840 | 264 |
Total non-current liabilities | 25,785 | 23,982 |
Total liabilities | 43,880 | 41,788 |
Commitments and contingencies (Note 13) | ||
Stockholders' Equity: | ||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at March 31, 2019; 67,019,094 and 71,335,980 issued and outstanding at December 31, 2018 and March 31, 2019, respectively | 713 | 670 |
Preferred shares, par value $0.01, 100,000,000 shares authorized at March 31, 2019; None issued and outstanding | ||
Additional paid in capital | 473,562 | 461,911 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (414,195) | (393,978) |
Total stockholders' equity | 60,107 | 68,630 |
Total liabilities and stockholders' equity | $ 103,987 | $ 110,418 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 1,000,000,000 | 1,000,000,000 |
Ordinary stock, issued shares | 71,335,980 | 67,019,094 |
Ordinary stock, outstanding shares | 71,335,980 | 67,019,094 |
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 - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Total Revenue | $ 1,703,000 | $ 7,551,000 |
Operating expenses: | ||
Research and development | (7,538,000) | (10,279,000) |
General and administrative | (13,409,000) | (10,136,000) |
Total operating expenses | (20,947,000) | (20,415,000) |
Loss from operations | (19,244,000) | (12,864,000) |
Other income (expense): | ||
Other income (expense), net | 70,000 | 23,000 |
Interest income | 10,000 | 9,000 |
Interest expense | (899,000) | (4,000) |
Loss before income taxes | (20,063,000) | (12,836,000) |
Income tax expense | (154,000) | (506,000) |
Net loss | $ (20,217,000) | $ (13,342,000) |
Loss per share | ||
Basic and diluted (in dollars per share) | $ (0.29) | $ (0.36) |
Weighted average number of shares: | ||
Basic and diluted (in shares) | 68,701,599 | 36,911,604 |
Collaboration revenue | ||
Revenues: | ||
Total Revenue | $ 1,000,000 | $ 6,500,000 |
Research premium and grant revenue | ||
Revenues: | ||
Total Revenue | $ 703,000 | $ 1,051,000 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock/Ordinary Shares | Additional paid in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Total |
Stockholders' equity, beginning balance at Dec. 31, 2017 | $ 367 | $ 360,872 | $ 27 | $ (279,198) | $ 82,068 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2017 | 36,708 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock | $ 35 | 19,353 | 19,388 | ||
Issuance of common stock (in shares) | 3,526 | ||||
Equity transaction costs | (916) | (916) | |||
Stock-based compensation expense | 1,244 | 1,244 | |||
Net loss | (13,342) | (13,342) | |||
Stockholders' equity, ending balance at Mar. 31, 2018 | $ 402 | 380,553 | 27 | (292,540) | 88,442 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2018 | 40,234 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2018 | $ 670 | 461,911 | 27 | (393,978) | 68,630 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2018 | 67,019 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock | $ 43 | 10,014 | 10,057 | ||
Issuance of common stock (in shares) | 4,317 | ||||
Equity transaction costs | (270) | (270) | |||
Stock-based compensation expense | 1,907 | 1,907 | |||
Net loss | (20,217) | (20,217) | |||
Stockholders' equity, ending balance at Mar. 31, 2019 | $ 713 | $ 473,562 | $ 27 | $ (414,195) | $ 60,107 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2019 | 71,336 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (20,217) | $ (13,342) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash other expense, net | (27) | (112) |
Non-cash interest income | (13) | (10) |
Non-cash interest expense | 227 | |
Depreciation and amortization expense | 125 | 133 |
Amortization of right-of-use assets | 109 | |
Stock-based compensation | 1,907 | 1,244 |
Other, net | (8) | (6) |
Changes in operating assets and liabilities: | ||
Changes in long-term receivables | (10) | (3) |
Changes in other receivables and prepaid expenses | (2,650) | (1,992) |
Changes in accounts payable | 4,302 | (1,413) |
Changes in accrued expenses and other liabilities | (4,374) | (1,311) |
Changes in other non-current liabilities | (30) | 22 |
Changes in income tax liabilities | 18 | 451 |
Net cash used in operating activities | (20,625) | (16,339) |
Cash flows from investing activities | ||
Purchases of plant and equipment and intangible assets | (42) | (160) |
Net cash provided (used in) by investing activities | (42) | (160) |
Cash flows from financing activities | ||
Proceeds from sale of ordinary shares | 9,978 | 19,388 |
Proceeds from long-term debt | 189 | |
Equity transaction costs | (299) | (518) |
Net cash provided by (used in) financing activities | 9,679 | 19,059 |
Effects of foreign currency translation on cash and cash equivalents | 27 | 112 |
Net (decrease) increase in cash and cash equivalents | (10,961) | 2,672 |
Cash and cash equivalents at beginning of period | 102,003 | 86,769 |
Cash and cash equivalents at end of period | 91,042 | 89,441 |
Supplemental disclosures of cash flow information: | ||
Interest paid | 483 | |
Equity transaction costs incurred in prior periods and paid in current period | 49 | 28 |
Equity transaction costs included in accounts payable and accrued expenses | $ 20 | $ 426 |
Organization and Business Activ
Organization and Business Activities | 3 Months Ended |
Mar. 31, 2019 | |
Organization and Business Activities | |
Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc (“Nabriva Ireland”), together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH (“Nabriva Austria”), Nabriva Therapeutics US, Inc., and Nabriva Therapeutics Ireland DAC, (collectively, “Nabriva”, or the “Company”) is a biopharmaceutical company engaged in the 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 does not expect to obtain marketing approval for lefamulin before August 2019, if at all. In April 2019, the FDA issued a Complete Response Letter (“CRL”) in connection with the Company’s new drug application (“NDA”) for CONTEPO for the treatment of cUTIs, including acute pyelonephritis, stating that it was unable to approve the application in its current form. The CRL requests that issues related to facility inspections and manufacturing deficiencies at Nabriva’s API contract manufacturer be addressed prior to the FDA approving the NDA. The Company plans to request a “Type A” meeting with the FDA to discuss its findings but the Company cannot predict the outcome of any interactions with the FDA that it may have or when CONTEPO will receive marketing approval, if at all. The Company’s headquarters are located at 25-28 North Wall Quay, Dublin, Ireland. Throughout these notes to the consolidated financial statements, unless the context requires otherwise, all references to “Nabriva,” “the Company,” or similar terms refer to Nabriva Therapeutics plc, together with its consolidated 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 March 31, 2019, the Company had cash, cash equivalents and short-term investments of $91.3 million. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), which requires management to assess the Company’s ability to continue as a going concern for one year after the date the consolidated financial statements are issued. The Company expects to seek additional funding in future periods for purposes of 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. While the Company has raised capital in the past, the ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future capital raises in their assessment of the Company’s ability to meet its obligations for the next twelve months. If the Company is not able to secure adequate additional funding in future periods, the Company may make reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. The Company may also have to delay, reduce the scope of, suspend or eliminate one or more research and development programs or its commercialization efforts. The Company’s expenses will increase if it suffers any regulatory delays or is required to conduct additional clinical trials to satisfy regulatory requirements. 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. As a result, based on the Company’s available cash resources, the minimum cash required under the Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., and in accordance with the requirements of ASC 205-40, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these financial statements are issued. A failure to raise the additional funding or to effectively implement cost reductions could harm the Company’s business, results of operations and future prospects. The Company expects that its existing cash, cash equivalents and short‑term investments as of March 31, 2019, proceeds from the sale of ordinary shares under the our ATM Agreement between March 31, 2019 and the date of this filing of $3.5 million, the $1.0 million upfront payment it received in April 2019 pursuant to the terms of the Sunovion License Agreement 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 interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In December 2018, the Company entered into a 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 5 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 the date of this filing, the Company has issued and sold an aggregate of 10,316,190 ordinary shares under the ATM Agreement, for gross proceeds of $37.8 million, and net proceeds of $36.9 million, after deducting commissions and offering costs. In March 2019, the Company entered into a license and commercialization agreement, or the Sunovion License Agreement, with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC , our wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize certain products containing lefamulin in the forms clinically developed by the Company or any of its affiliates (“Licensed Products”) in Canada in all uses in humans in community-acquired bacterial pneumonia and in any other indication for which the Licensed Products have received regulatory approval in Canada. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) for interim financial information and U.S. Securities and Exchange Commission (“SEC”) regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of March 31, 2019 and for the three months ended March 31, 2018 and 2019 is unaudited. The December 31, 2018 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2019 and for the three months ended March 31, 2018 and 2019 The financial data and other information disclosed in these notes related to the three months ended March 31, 2018 and 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2018 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 12, 2019. The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies, other than described below related to leases. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Adopted as of the current period: In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information has not been restated and will continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. In addition, the new lease standard provides a number of optional practical expedients in transition. The Company elected the package of practical expedients. As such, the Company did not have to reassess whether expired or existing contracts are or contain a lease; and did not have to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office buildings). The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on the Company’s consolidated balance sheet as of March 31, 2019. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term as of January 1, 2019. Since none of the Company’s lease agreements provide an implicit rate, the Company estimated an incremental borrowing rate based on the information available at January 1, 2019 in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. On January 1, 2019, the Company recognized ROU assets and lease liabilities of approximately $2.0 million on its consolidated balance sheet using an estimated incremental borrowing rate of 9.8%. This ROU asset is recorded in property, plant and equipment, net and the ROU liability is recorded in other non-current liabilities. |
Fair Value Measurement
Fair Value Measurement | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Measurement | |
Fair Value Measurement | 3. 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 March 31, 2019 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 175 — — 175 Total Assets $ 175 $ 50 $ — $ 225 As of March 31, 2019 and December 31, 2018, 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 three months ended March 31, 2019 or the year ended December 31, 2018. There were no changes in valuation techniques during the three months ended March 31, 2019. As of March 31, 2019 and December 31, 2018, the Company did not hold any financial instruments as liabilities that were held at fair value. Other receivables and accounts payable are carried at their historical cost which approximates fair value due to their short-term nature. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Liabilities | 4. Accrued Expenses and Other Liabilities As of As of (in thousands) December 31, 2018 March 31, 2019 Research and development related costs $ 5,032 $ 3,026 Payroll and related costs 7,427 4,665 Accounting, tax and audit services 398 209 Other 1,645 2,633 Total other current liabilities $ 14,502 $ 10,533 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt | |
Debt | 5. 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 Company 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 Company through September 30, 2019 upon the approval by the FDA of an NDA for CONTEPO. The Tranche 4 Advance will be available to the Company from January 1, 2020 through December 31, 2020 upon the approval by the FDA of NDAs for lefamulin in addition to CONTEPO and upon the achievement of specified product revenue milestones. The Tranche 5 Advance will be available to the Company 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 Company 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 Company 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 Company is required to pay a fee of 6.95% of the aggregate amount of advances under the Loan Agreement at the Maturity Date (the “End of Term Fee”). At the Company’s option, the Company may elect to prepay any portion of the outstanding term loan that is greater than or equal to $5.0 million by paying such portion of the principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: (i) 3.0% if the term loan is prepaid during the first 12 months following the initial closing, (ii) 2.0% if the term loan is prepaid after 12 months following the initial closing but before 24 months following the initial closing and (iii) 1.0% if the term loan is prepaid any time thereafter but prior to the Maturity Date. The Company is also required to satisfy certain financial covenants, including an obligation to maintain 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, 2018 and March 31, 2019 consisted of the following: As of As of December 31 March 31 (in thousands) 2018 2019 Term loan payable $ 25,000 $ 25,000 End of term fee — 109 Unamortized debt issuance costs (1,990) Carrying value of term loan 23,010 Other long-term debt 708 Total long-term debt $ 23,718 $ Maturities of long-term debt as of March 31, 2019 were as follows: (in thousands) 2019 $ — 2020 3,656 2021 8,592 2022 8,704 2023 4,756 |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2019 | |
Revenue | |
Revenue | 6. Revenue Three Months Ended March 31, (in thousands) 2018 2019 Collaboration revenue $ 6,500 $ 1,000 Research premium 770 393 Government grants 281 311 Total $ 7,551 $ 1,703 The collaboration revenue for the three months ended March 31, 2018 reflects the amounts recorded from the Sinovant License Agreement (see Note 11) and includes the $5.0 million non-refundable upfront payment received as consideration for entering into the license agreement with Sinovant as well as $1.5 million of variable consideration related a future milestone payment that the Company received in the first quarter of 2019. The $1.0 million of collaboration revenue for the three months ended March 31, 2019 reflects the upfront payment under the Sunovion License Agreement received in April 2019 (see Note 12). |
Share-Based Payments
Share-Based Payments | 3 Months Ended |
Mar. 31, 2019 | |
Share-Based Payments | |
Share-Based Payments | 7. Share-Based Payments Stock Option Plan 2015 On April 2, 2015, the shareholders, management board and supervisory board of the Company’s predecessor, Nabriva Therapeutics AG (“Nabriva Austria”) 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. In connection with the series of transactions pursuant to which the Company became the successor to Nabriva Austria and redomiciled to Ireland, which the Company refers to as the Redomiciliation Transaction, the SOP 2015 was amended to take account of certain requirements under Irish law and assumed by the Company, with each option to acquire one Nabriva Austria common share becoming an option to acquire ten of the Company’s ordinary shares on the same terms and conditions. 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 for the three months ended March 31, 2019: Weighted average exercise price in $ Aggregate Stock Option Plan 2015 Options per share intrinsic value Outstanding as of January 1, 2019 Granted — — Exercised — — Forfeited Outstanding as of March 31, 2019 $ — Vested and exercisable as of March 31, 2019 $ — Stock-based compensation expense under the SOP 2015 was $0.9 million and $0.9 million for the three months ended March 31, 2018 and 2019, respectively. The weighted average remaining contractual life of the options as of March 31, 2019 is 7.2 years. As of March 31, 2019, there was $4.4 million of total unrecognized compensation expense, related to unvested options granted under the SOP 2015, which will be recognized over the weighted-average remaining vesting period of 1.9 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 March 31, 2019, 7,087,042 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 for the three months ended March 31, 2019: Weighted average exercise price in $ Aggregate 2017 Plan Options per share intrinsic value Outstanding as of January 1, 2019 Granted Exercised — — Forfeited Outstanding as of March 31, 2019 $ Vested and exercisable as of March 31, 2019 — Stock-based compensation expense under the 2017 Plan was $0.4 million and $0.5 million for the three months ended March 31, 2018 and 2019, respectively. The weighted average fair value of the options granted during the three months ended March 31, 2019 was $1.08 per share. The options granted in the three months ended March 31, 2019 were valued based on a Black Scholes option pricing model using the following assumptions. The significant inputs into the model were as follows: Input parameters Range of expected volatility 61.4% – 61.6% Expected term of options (in years) 6.1 Range of risk-free interest rate 2.47% – 2.58% 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 five and seven-year market yield on U.S. treasury securities in effect at the time of grant. The weighted average remaining contractual life of the options as of March 31, 2019 is 9.4 years. As of March 31, 2019, there was $7.3 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 3.4 years. Restricted Stock Units During the three months ended March 31, 2019, the Company granted 479,000 RSUs with a grant date fair value of $1.90 per share, which was the closing price of the Company’s shares on the grant date. These RSUs vest over a period of four years with 25% vesting upon the first anniversary of the grant date and on a monthly pro rata basis thereafter over the remaining three years. As of March 31, 2019, there were 479,000 of such RSUs outstanding. For the three months ended March 31, 2019, $38,000 of stock-based compensation expense was recognized for these RSUs. The Company has granted a total of 371,550 RSUs, with a grant date fair value of $6.13 per share, with vesting 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 March 31, 2019. As of March 31, 2019, there were 383,550 of such RSUs were outstanding. The Company has granted a total of 35,600 RSUs, with a grant date fair value of $2.56 per share, with vesting subject to FDA approval of the NDAs for lefamulin and CONTEPO. 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 FDA approval of CONTEPO. If the FDA does not approve an NDA for either lefamulin or CONTEPO by January 31, 2020, the RSU award will terminate in full. No compensation expense was recognized for these RSUs as vesting is not probable at March 31, 2019. As of March 31, 2019, all of such RSUs outstanding. The Company has also granted a total of 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 March 31, 2019, there were 780,300 of such RSUs outstanding. For the three months ended March 31, 2019, $268,000 of compensation expense was recognized for these RSUs. 2019 Inducement Share Incentive Plan On March 12, 2019, the Company’s board of directors adopted the 2019 Inducement Share Incentive Plan (the “2019 Inducement Plan”) and, subject to the adjustment provisions of the 2019 Inducement Plan, reserved 2,000,000 ordinary shares for issuance pursuant to equity awards granted under the 2019 Inducement Plan. In accordance with Nasdaq Listing Rule 5635(c)(4), awards under the 2019 Inducement Plan may only be made to individuals who were not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company. At March 31, 2019, 2,000,000 ordinary shares were available for issuance under the 2019 Inducement Plan. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option or SAR will be granted with a term in excess of ten years. The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. The following table summarizes information regarding our stock option awards under the 2019 Inducement Plan for the three months ended March 31, 2019: Weighted average exercise price in $ Aggregate 2019 Inducement Plan Options per share intrinsic value Outstanding as of January 1, 2019 — — Granted 41,150 2.44 Exercised — — Forfeited — — Outstanding as of March 31, 2019 41,150 2.44 $ — Vested and exercisable as of March 31, 2019 — — — The weighted average fair value of the options granted during the three months ended March 31, 2019 was $1.42 per share. The options granted in the three months ended March 31, 2019 were valued based on a Black Scholes option pricing model using the following assumptions. The significant inputs into the model were as follows: Input parameters Expected volatility 61.6% Expected term of options (in years) 6.1 Risk-free interest rate 2.27% Dividend yield — The weighted average remaining contractual life of the options as of March 31, 2019 is 10.0 years. As of March 31, 2019, there was $59,000 of total unrecognized compensation expense, related to unvested options granted under the 2019 Inducement Plan, which will be recognized over the weighted-average remaining vesting period of 4.0 years. Inducement Awards Outside of the 2019 Inducement Plan In July 2018, the Company granted a non-statutory option to purchase 850,000 of its ordinary shares and 150,000 performance-based RSUs to the Company’s newly appointed Chief Executive Officer (the “CEO”). These equity awards granted outside of the 2017 Plan and the 2019 Inducement 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 $109,000 for the three months ended March 31, 2019. 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 March 31, 2019 is 9.3 years. Our stock-based compensation expense has been allocated to research and development and general and administrative expenses in the consolidated statements of operations as follows: Three Months ended March 31, (in thousands) 2018 2019 Research and development $ 516 $ 425 General and administrative 728 1,482 Total $ 1,244 $ 1,907 Employee Stock Purchase Plan The Company’s board of directors adopted, and in August 2018 Company’s stockholders approved, the 2018 employee stock purchase plan (the “2018 ESPP”). The maximum aggregate number of shares of ordinary shares that may be purchased under the 2018 ESPP is 500,000 shares, (the “ESPP Share Pool”), subject to adjustment as provided for in the 2018 ESPP. The ESPP Share Pool represented 0.75% of the total number of shares of ordinary shares outstanding as of December 31, 2018. The 2018 ESPP allows eligible employees to purchase shares at a 15% discount to the then current market price of the Company’s ordinary shares during certain offering periods, which will be six -month periods commencing November 1 and ending April 30 and commencing May 1 and ending October 31 of each year. The first offering under the 2018 ESPP commenced on November 1, 2018. |
Income tax (expense) benefit
Income tax (expense) benefit | 3 Months Ended |
Mar. 31, 2019 | |
Income tax (expense) benefit | |
Income tax (expense) benefit | 8. Income tax (expense) benefit In accordance with the FASB Accounting Standard Codification (ASC) Topic No. 270 “Interim Reporting” and ASC Topic No. 740 “Income Taxes” (Topic No. 740) at the end of each interim period, the Company is required to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three months ended March 31, 2018 and 2019, the Company recorded income tax expense of $506,000 and $154,000, respectively. Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of its deferred tax assets. On the basis of this evaluation, as of March 31, 2019 and December 31, 2018, the Company has recorded a valuation allowance of $103.8 million and $100.8 million, respectively. The amount of the deferred tax assets 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 the Company’s projections for growth. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 9. Earnings (Loss) per Share Basic and diluted loss per share For the three months ended March 31, 2018 and 2019, basic and diluted net loss per share was determined by dividing net loss attributable to shareholders by the weighted average number of shares outstanding during the period. 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 potential ordinary share equivalents are antidilutive and thus not included in the calculation. Three Months Ended March 31, (in thousands, except share and per share data) 2018 2019 Net loss for the period $ (13,342) $ Weighted average number of shares outstanding 36,911,604 Basic and diluted loss per share $ (0.36) $ The following ordinary share equivalents were excluded from the calculations of diluted earnings per share as their effect would be anti-dilutive: Three Months Ended March 31, (in thousands) 2018 2019 Stock options 4,853,349 8,242,762 Restricted stock units 339,550 1,792,850 |
Acquisition of Zavante
Acquisition of Zavante | 3 Months Ended |
Mar. 31, 2019 | |
Acquisition of Zavante | |
Acquisition of Zavante | 10. 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 an 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”), with the first commercial milestone becoming payable when CONTEPO exceeds $125.0 million in net sales in a calendar year. 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 March 31, 2019 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 in 2018 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 | 3 Months Ended |
Mar. 31, 2019 | |
Sinovant Sciences, LTD | License Agreement | |
License Agreement | |
License Agreement | 11. Sinovant License Agreement In March 2018, the Company entered into a license agreement (the “Sinovant License Agreement”), with Sinovant Sciences, Ltd. (“Sinovant”), an affiliate of Roivant Sciences, Ltd., to develop and commercialize lefamulin in the greater China region. As part of the Sinovant License Agreement, Nabriva Therapeutics Ireland DAC and Nabriva Therapeutics GmbH, the Company’s wholly owned subsidiaries, granted Sinovant an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin (the “Licensed Products”), in the People’s Republic of China, Hong Kong, Macau, and Taiwan (together the “Territory”). Under the Sinovant License Agreement, Sinovant and the Company’s subsidiaries have established a joint development committee (the “JDC’), to review and oversee development and commercialization plans in the Territory. The Company received a non-refundable $5.0 million upfront payment pursuant to the terms of the Sinovant License Agreement and will be eligible for up to an additional $91.5 million in milestone payments upon the achievement of certain regulatory and commercial milestone events related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if any Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The first milestone was a $1.5 million payment for the submission of a clinical trial application (“CTA”), by Sinovant to the Chinese Food and Drug Administration. This payment was received in the first quarter of 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 Sinovant 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 Sinovant License Agreement may be terminated in its entirety by Sinovant upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the Sinovant License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the Sinovant License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the Sinovant License Agreement immediately if Sinovant does not reach certain development milestones by certain specified dates (subject to specified cure periods). The Sinovant License Agreement contemplates that the Company will enter into ancillary agreements with Sinovant, including clinical and commercial supply agreements and a pharmacovigilance agreement. 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 was 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 believed it was 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. |
Sunovion License Agreement
Sunovion License Agreement | 3 Months Ended |
Mar. 31, 2019 | |
License Agreement | Sunovion Pharmaceutics Canada, Inc. | |
License Agreement | |
License Agreement | 12. Sunovion License Agreement In March 2019, the Company entered into a license and commercialization agreement (the “Sunovion License Agreement”), with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC, our wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize certain products containing lefamulin in the forms clinically developed by the Company or any of its affiliates (“Licensed Products”) in Canada in all uses in humans in community-acquired bacterial pneumonia and in any other indication for which the Licensed Products have received regulatory approval in Canada. Under the Sunovion License Agreement, Sunovion and DAC will establish a joint development committee, or the JDC, to review and oversee regulatory approval and commercialization plans in the Territory. Sunovion will be solely responsible for all costs related to obtaining regulatory approval of and commercializing Licensed Products in the Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Licensed Product in the Territory. The Company has identified two performance obligations at inception: (1) the delivery of the exclusive license to Sunovion, which we have determined is a distinct license of functional intellectual property that Sunovion has obtained control of; and, (2) the participation in the JDC. The $1.0 million non-refundable upfront payment was allocated entirely to the delivery of the license as the JDC deliverable was deemed to be de minimis. Any future regulatory and commercial milestone payments under the Sunovion License Agreement will be recorded during the period the milestones become probable of achievement. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases The Company leases office spaces in King of Prussia, Pennsylvania, San Diego, California, Dublin, Ireland and laboratory and office space in Vienna, Austria under agreements previously classified as operating leases. The lease agreement in King of Prussia, Pennsylvania expires on December 15, 2023 and does not include any renewal options. The agreement provides for an initial monthly base amount plus annual escalations through the term of the lease. The lease agreement in San Diego, California expires on June 30, 2019 and provides for one renewal period of 36 months. The Company does not plan to exercise the renewal period. The agreement provides for a monthly base fixed amount through June 30, 2019. For the lease agreement in Vienna Austria, the Company can terminate the lease without the landlord’s consent and without paying a termination penalty by giving six months’ notice to the landlord. The agreement provides for a monthly base fixed amount. The Company is in the process of determining the appropriate space needed in the building based on its needs. As a result, the Company may negotiate a new lease or evaluate additional or alternate spaces. As such, the Company has classified the agreement as a short-term lease. For the lease agreement in Dublin, Ireland, the lease term is month to month and the Company has classified the lease as a short-term lease. In March 2019, the Company entered into lease agreement for office space in Dublin, Ireland which expires on April 30, 2021. The agreement can be automatically renewed by both parties equal to the current lease term but for no less than three months. The agreement provides for a monthly based fixed amount of 7,000 euros beginning on the commencement date which is in May 2019. Upon the commencement date of the lease, the Company recognized an ROU asset and lease liability of approximately $150,000. In addition to the monthly base amounts under the lease agreements, the Company is required to pay its proportionate share of real estate taxes and operating expenses during the lease terms for the King of Prussia and San Diego leases. For the three months ended March 31, 2019, the Company’s operating lease expense was $348,000 which included short term lease expense of $222,000. As of March 31, 2019 the weighted-average remaining lease term of operating leases was 4.7 years and the weighted-average discount rate was 9.8%. As of March 31, 2019, other information related to the operating leases were as follows: Operating Cash Flow Supplemental Information: (in thousands) March 31, 2019 Cash paid for amounts included in the measurement of the operating lease liabilities $ 111 Right-of-use assets obtained in exchange for operating lease obligations $ 2,021 The following table sets forth by year the required future payments of operating lease liabilities: (in thousands) March 31, 2019 Remainder of 2019 $ 404 2020 507 2021 515 2022 522 2023 533 Total lease payments 2,481 Less imputed interest (504) Present value of operating lease liabilities $ 1,977 The following table sets forth by year the minimum expected lease payments under non-cancelable operating leases as of December 31, 2018: (in thousands) December 31, 2018 2019 $ 515 2020 507 2021 515 Total lease payments $ 1,537 Legal Proceedings On May 8, 2019, a putative class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Southern District of New York, captioned Larry Enriquez v. Nabriva Therapeutics PLC, and Ted Schroeder, No. 19-cv-04183. The complaint purports to be brought on behalf of shareholders who purchased the Company’s securities between November 1, 2018 and April 30, 2019. The complaint generally alleges that the Company and its Chief Executive Officer violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements and omitting to disclose material facts concerning the Company’s submission of an NDA to the FDA for marketing approval of CONTEPO for the treatment of cUTI in the United States and the likelihood of such approval. The complaint seeks unspecified damages, attorneys’ fees, and other costs. The case is still in its initial stage and a lead plaintiff has not yet been appointed. The Company denies any and all allegations of wrongdoing and intends to vigorously defend against this lawsuit. The Company is unable, however, to predict the outcome of this matter at this time. Moreover, any conclusion of this matter in a manner adverse to the Company and for which it incurs substantial costs or damages not covered by the Company's directors’ and officers’ liability insurance would have a material adverse effect on its financial condition and business. In addition, the litigation could adversely impact the Company's reputation and divert management’s attention and resources from other priorities, including the execution of its business plan and strategies that are important to the Company's ability to grow its business, any of which could have a material adverse effect on the Company's business. Other Commitments and Contingencies 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. During the three months ended March 31, 2019, there were no material changes outside the ordinary course of the Company’s business to its contractual obligations as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, relating to contract research organizations and contract manufacturing organizations. The Company has no contingent liabilities in respect of legal claims arising in the ordinary course of business. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events The Company evaluated all events or transactions that occurred subsequent to March 31, 2019 through the date the unaudited consolidated financial statements were issued, and have not identified any such events material to an understanding of the unaudited consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Preparation | Basis of Preparation The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) for interim financial information and U.S. Securities and Exchange Commission (“SEC”) regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of March 31, 2019 and for the three months ended March 31, 2018 and 2019 is unaudited. The December 31, 2018 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2019 and for the three months ended March 31, 2018 and 2019 The financial data and other information disclosed in these notes related to the three months ended March 31, 2018 and 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2018 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 12, 2019. The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies, other than described below related to leases. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Adopted as of the current period: In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. On January 1, 2019, the Company adopted the new lease standard using the optional transition method under which comparative financial information has not been restated and will continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. In addition, the new lease standard provides a number of optional practical expedients in transition. The Company elected the package of practical expedients. As such, the Company did not have to reassess whether expired or existing contracts are or contain a lease; and did not have to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases. The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office buildings). The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on the Company’s consolidated balance sheet as of March 31, 2019. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term as of January 1, 2019. Since none of the Company’s lease agreements provide an implicit rate, the Company estimated an incremental borrowing rate based on the information available at January 1, 2019 in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. On January 1, 2019, the Company recognized ROU assets and lease liabilities of approximately $2.0 million on its consolidated balance sheet using an estimated incremental borrowing rate of 9.8%. This ROU asset is recorded in property, plant and equipment, net and the ROU liability is recorded in other non-current liabilities. |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Measurement | |
Schedule of the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy | (in thousands) Level 1 Level 2 Level 3 Total December 31, 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 March 31, 2019 Assets: Short-term investments: Available-for-sale securities $ — $ 50 $ — $ 50 Term deposits 175 — — 175 Total Assets $ 175 $ 50 $ — $ 225 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other current liabilities | As of As of (in thousands) December 31, 2018 March 31, 2019 Research and development related costs $ 5,032 $ 3,026 Payroll and related costs 7,427 4,665 Accounting, tax and audit services 398 209 Other 1,645 2,633 Total other current liabilities $ 14,502 $ 10,533 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt | |
Schedule of long-term debt | As of As of December 31 March 31 (in thousands) 2018 2019 Term loan payable $ 25,000 $ 25,000 End of term fee — 109 Unamortized debt issuance costs (1,990) Carrying value of term loan 23,010 Other long-term debt 708 Total long-term debt $ 23,718 $ |
Schedule of maturities of long-term debt | Maturities of long-term debt as of March 31, 2019 were as follows: (in thousands) 2019 $ — 2020 3,656 2021 8,592 2022 8,704 2023 4,756 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue | |
Summary of revenue by type | Three Months Ended March 31, (in thousands) 2018 2019 Collaboration revenue $ 6,500 $ 1,000 Research premium 770 393 Government grants 281 311 Total $ 7,551 $ 1,703 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Share-Based Payments | |
Schedule of allocation of share-based compensation expense | Three Months ended March 31, (in thousands) 2018 2019 Research and development $ 516 $ 425 General and administrative 728 1,482 Total $ 1,244 $ 1,907 |
SOP 2015 | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise price in $ Aggregate Stock Option Plan 2015 Options per share intrinsic value Outstanding as of January 1, 2019 Granted — — Exercised — — Forfeited Outstanding as of March 31, 2019 $ — Vested and exercisable as of March 31, 2019 $ — |
2017 Share Incentive Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise price in $ Aggregate 2017 Plan Options per share intrinsic value Outstanding as of January 1, 2019 Granted Exercised — — Forfeited Outstanding as of March 31, 2019 $ Vested and exercisable as of March 31, 2019 — |
Summary of assumptions used for valuation of options | Input parameters Range of expected volatility 61.4% – 61.6% Expected term of options (in years) 6.1 Range of risk-free interest rate 2.47% – 2.58% Dividend yield — |
2019 Inducement Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise price in $ Aggregate 2019 Inducement Plan Options per share intrinsic value Outstanding as of January 1, 2019 — — Granted 41,150 2.44 Exercised — — Forfeited — — Outstanding as of March 31, 2019 41,150 2.44 $ — Vested and exercisable as of March 31, 2019 — — — |
Summary of assumptions used for valuation of options | Input parameters Expected volatility 61.6% Expected term of options (in years) 6.1 Risk-free interest rate 2.27% Dividend yield — |
Inducement Awards Outside of the 2019 Inducement Plan | |
Share-Based Payments | |
Summary of assumptions used for valuation of options | Input parameters Expected volatility 59.8% Expected term of options (in years) 6.1 Range of risk-free interest rate 2.9% Dividend yield — |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Three Months Ended March 31, (in thousands, except share and per share data) 2018 2019 Net loss for the period $ (13,342) $ Weighted average number of shares outstanding 36,911,604 Basic and diluted loss per share $ (0.36) $ |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Three Months Ended March 31, (in thousands) 2018 2019 Stock options 4,853,349 8,242,762 Restricted stock units 339,550 1,792,850 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies | |
Schedule of Operating Cash Flow Supplemental Information | (in thousands) March 31, 2019 Cash paid for amounts included in the measurement of the operating lease liabilities $ 111 Right-of-use assets obtained in exchange for operating lease obligations $ 2,021 |
Schedule of future payments of operating lease liabilities, ASC 842 | (in thousands) March 31, 2019 Remainder of 2019 $ 404 2020 507 2021 515 2022 522 2023 533 Total lease payments 2,481 Less imputed interest (504) Present value of operating lease liabilities $ 1,977 |
Schedule of future minimum expected lease payments under non-cancelable operating leases, ASC 840 | (in thousands) December 31, 2018 2019 $ 515 2020 507 2021 515 Total lease payments $ 1,537 |
Organization and Business Act_2
Organization and Business Activities (Details) - USD ($) $ in Millions | 1 Months Ended | 14 Months Ended | ||||
May 10, 2019 | Apr. 30, 2019 | May 10, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | |
Liquidity | ||||||
Cash, cash equivalents and short-term investments | $ 91.3 | |||||
ATM Agreement | At-the-market offering | Ordinary Shares | ||||||
Liquidity | ||||||
Proceeds from at-the-market facility | $ 3.5 | $ 37.8 | ||||
Number of shares issued | 10,316,190 | |||||
Net proceeds from sale of stock | $ 36.9 | |||||
ATM Agreement | Cantor Fitzgerald and Co. | At-the-market offering | Ordinary Shares | ||||||
Liquidity | ||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50 | |||||
License Agreement | Collaboration revenue - upfront payment | Sunovion Pharmaceutics Canada, Inc. | ||||||
Liquidity | ||||||
Proceeds received from Sunovion license | $ 1 | |||||
Loan Agreement | Term loan | ||||||
Liquidity | ||||||
Maximum borrowing capacity | $ 75 | |||||
Loan Agreement | Term loan | Initial Advance | ||||||
Liquidity | ||||||
Maximum borrowing capacity | $ 25 | |||||
Loan Agreement | Term loan | Additional term loan advances | ||||||
Liquidity | ||||||
Maximum borrowing capacity | $ 50 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Jan. 01, 2019 | |
Leases | ||
Operating lease liabilities | $ 1,977 | |
ASU 2016-02 | ||
Leases | ||
Election of practical expedients package | true | |
ASU 2016-02 | Adjustment | ||
Leases | ||
ROU assets | $ 2,000 | |
Operating lease, ROU assets, Statement of Financial Position | us-gaap:PropertyPlantAndEquipmentNet | |
Operating lease liabilities | $ 2,000 | |
Operating lease liability, Statement of Financial Position | us-gaap:OtherLiabilitiesNoncurrent | |
Estimated incremental borrowing rate | 9.80% |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Short-term investments: | ||
Transfer of assets from Level 1 to 2 | $ 0 | $ 0 |
Transfer of assets from Level 2 to 1 | 0 | 0 |
Transfer of liabilities from Level 1 to 2 | 0 | 0 |
Transfer of liabilities from Level 2 to 1 | 0 | 0 |
Recurring | ||
Short-term investments: | ||
Available-for-sale securities | 50,000 | 50,000 |
Term deposits | 175,000 | 175,000 |
Total Assets | 225,000 | 225,000 |
Level 1 | Recurring | ||
Short-term investments: | ||
Term deposits | 175,000 | 175,000 |
Total Assets | 175,000 | 175,000 |
Level 2 | Recurring | ||
Short-term investments: | ||
Available-for-sale securities | 50,000 | 50,000 |
Total Assets | $ 50,000 | $ 50,000 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 3,026 | $ 5,032 |
Payroll and related costs | 4,665 | 7,427 |
Accounting, tax and audit services | 209 | 398 |
Other | 2,633 | 1,645 |
Total other current liabilities | $ 10,533 | $ 14,502 |
Debt -Summary (Details)
Debt -Summary (Details) - Loan Agreement - Term loan | 3 Months Ended | |
Mar. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | |
Debt | ||
Maximum borrowing capacity | $ 75,000,000 | |
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 | interest minus 5.50% | |
Variable interest rate margin (as a percent) | 9.80% | |
Variable rate adjustment (as a percent) | (5.50%) | |
Initial Advance | ||
Debt | ||
Maximum borrowing capacity | 25,000,000 | |
Principal amount of advances outstanding | 25,000,000 | |
Additional term loan advances | ||
Debt | ||
Number of additional term loan advances | item | 5 | |
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 | ||
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 | Mar. 31, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Total long-term debt | $ 23,945 | $ 23,718 |
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 | 25,000 |
End of term fee | 109 | |
Unamortized debt issuance costs | (1,871) | (1,990) |
Total long-term debt | 23,238 | 23,010 |
Other long-term debt | ||
Long-term debt | ||
Total long-term debt | $ 707 | $ 708 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Revenue | ||||
Revenue | $ 1,703 | $ 7,551 | ||
Collaboration revenue | ||||
Revenue | ||||
Revenue | 1,000 | 6,500 | ||
Collaboration revenue - upfront payment | License Agreement | Sinovant Sciences, LTD | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | $ 5,000 | 5,000 | ||
Collaboration revenue - upfront payment | License Agreement | Sunovion Pharmaceutics Canada, Inc. | ||||
Revenue | ||||
Revenue not accounted for under Topic 606 | $ 1,000 | 1,000 | ||
Collaboration revenue - Variable consideration | Clinical trial application submission | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 1,500 | |||
Collaboration revenue - Variable consideration | License Agreement | Clinical trial application submission | Sinovant Sciences, LTD | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 1,500 | |||
Research premium | ||||
Revenue | ||||
Revenue | 393 | 770 | ||
Government grants | ||||
Revenue | ||||
Revenue | $ 311 | $ 281 |
Share-Based Payments - SOP 2015
Share-Based Payments - SOP 2015 (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||
Mar. 31, 2019 | Mar. 31, 2018 | Jun. 23, 2017 | Aug. 25, 2016 | Sep. 23, 2015 | Apr. 02, 2015 | |
Additional disclosures | ||||||
Share-based compensation expense | $ 1,907 | $ 1,244 | ||||
SOP 2015 | ||||||
Options | ||||||
Outstanding at beginning of year (in shares) | 2,842,913 | |||||
Forfeited (in shares) | (22,664) | |||||
Outstanding at end of year (in shares) | 2,820,249 | |||||
Vested and exercisable at end of year (in shares) | 1,988,358 | |||||
Weighted average exercise price in $ per share | ||||||
Outstanding balance at beginning of year (in dollars per share) | $ 8.34 | |||||
Forfeited (in dollars per share) | 9.86 | |||||
Outstanding balance at end of year (in dollars per share) | 8.33 | |||||
Vested and exercisable balance at end of year (in dollars per share) | $ 8.12 | |||||
Additional disclosures | ||||||
Share-based compensation expense | $ 900 | $ 900 | ||||
SOP 2015 | Stock Options | ||||||
Share-Based Payments | ||||||
Vesting period | 4 years | |||||
Exercise period | 10 years | |||||
Additional disclosures | ||||||
Weighted-average remaining contractual life | 7 years 2 months 12 days | |||||
Total unrecognized compensation related to unvested options | $ 4,400 | |||||
Recognition period | 1 year 10 months 24 days | |||||
SOP 2015 | Stock Options | Vesting period, year one | ||||||
Share-Based Payments | ||||||
Vesting period | 1 year | |||||
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") | Redomiciliation Transaction | Common Stock | ||||||
Share-Based Payments | ||||||
Number of shares to be awarded for each option when exercised | 1 | |||||
Nabriva Therapeutics AG ("Nabriva Austria") | Redomiciliation Transaction | Ordinary Shares | ||||||
Share-Based Payments | ||||||
Number of shares to be awarded for each option when exercised | 10 | |||||
Nabriva Therapeutics AG ("Nabriva Austria") | SOP 2015 | Common Stock | ||||||
Share-Based Payments | ||||||
Maximum number of shares authorized | 177,499 | 95,000 | ||||
Nabriva Therapeutics AG ("Nabriva Austria") | SOP 2015 | Ordinary Shares | ||||||
Share-Based Payments | ||||||
Maximum number of shares authorized | 346,235 |
Share-Based Payments - 2017 Sha
Share-Based Payments - 2017 Share Incentive Plan (Details) | Jul. 26, 2017shares | Mar. 31, 2019USD ($)item$ / sharesshares | Mar. 31, 2018USD ($) |
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 1,907,000 | $ 1,244,000 | |
2017 Share Incentive Plan | |||
Options | |||
Outstanding at beginning of year (in shares) | 2,398,425 | ||
Granted (in shares) | 2,211,100 | ||
Forfeited (in shares) | (78,162) | ||
Outstanding at end of year (in shares) | 4,531,363 | ||
Vested and exercisable at end of year (in shares) | 549,309 | ||
Weighted average exercise price in $ per share | |||
Outstanding balance at beginning of year (in dollars per share) | $ / shares | $ 5.41 | ||
Granted (in dollars per share) | $ / shares | 1.90 | ||
Forfeited (in dollars per share) | $ / shares | 3.75 | ||
Outstanding balance at end of year (in dollars per share) | $ / shares | 3.73 | ||
Vested and exercisable balance at end of year (in dollars per share) | $ / shares | $ 6.36 | ||
Aggregate intrinsic value | |||
Aggregate intrinsic value, outstanding | $ | $ 1,272,000 | ||
2017 Share Incentive Plan | Stock Options | |||
Share-Based Payments | |||
Vesting period | 10 years | ||
Fair Value Assumptions | |||
Expected term of options (in years) | 6 years 1 month 6 days | ||
Dividend yield (as a percent) | 0.00% | ||
Weighted-average remaining contractual life | 9 years 4 months 24 days | ||
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 500,000 | $ 400,000 | |
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 1.08 | ||
Unrecognized compensation expense | |||
Total unrecognized compensation related to unvested options | $ | $ 7,300,000 | ||
Recognition period | 3 years 4 months 24 days | ||
2017 Share Incentive Plan | Stock Options | Minimum | |||
Fair Value Assumptions | |||
Expected volatility (as a percent) | 61.40% | ||
Risk-free interest rate (as a percent) | 2.47% | ||
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) | 61.60% | ||
Risk-free interest rate (as a percent) | 2.58% | ||
Term of U.S. treasury securities used to estimate risk free interest rate | 7 years | ||
2017 Share Incentive Plan | SARs | |||
Share-Based Payments | |||
Vesting period | 10 years | ||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | |||
Share-Based Payments | |||
Vesting period | 4 years | ||
Expiration period if drug is not approved | 2 years | ||
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 38,000 | ||
Restricted Stock Units | |||
Restricted stock granted during the period | 479,000 | ||
Weighted average grant date fair value per share | $ / shares | $ 1.90 | ||
Number of shares outstanding | 479,000 | ||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting period, year one | |||
Restricted Stock Units | |||
Percentage that vests during the period | 25.00% | ||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting subject to FDA approval of NDA for lefamulin | |||
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 0 | ||
Restricted Stock Units | |||
Aggregate number of shares granted under the plan | 371,550 | ||
Weighted average grant date fair value per share | $ / shares | $ 6.13 | ||
Number of shares outstanding | 383,550 | ||
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% | ||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting subject to FDA approval of NDA for lefamulin and CONTEPO | |||
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 0 | ||
Restricted Stock Units | |||
Aggregate number of shares granted under the plan | 35,600 | ||
Weighted average grant date fair value per share | $ / shares | $ 2.56 | ||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Employees | |||
Share-Based Payments | |||
Number of vesting periods | item | 3 | ||
Vesting period | 6 months | ||
Stock-Based Compensation Expense | |||
Share-based compensation expense | $ | $ 268,000,000 | ||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 2.16 | ||
Restricted Stock Units | |||
Aggregate number of shares granted under the plan | 834,300 | ||
Number of shares outstanding | 780,300 | ||
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 | 7,087,042 | ||
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% |
Share-Based Payments - 2019 Ind
Share-Based Payments - 2019 Inducement Share Incentive Plan (Details) - 2019 Inducement Plan - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 12, 2019 | |
Share-Based Payments | ||
Shares available for grant | 2,000,000 | |
Unrecognized compensation expense | ||
Total unrecognized compensation related to unvested options | $ 59,000 | |
Recognition period | 4 years | |
Ordinary Shares | ||
Share-Based Payments | ||
Shares reserved for future issuance | 2,000,000 | |
Stock Options | ||
Options | ||
Outstanding at beginning of year (in shares) | 0 | |
Granted (in shares) | 41,150 | |
Exercised (in shares) | 0 | |
Forfeited (in shares) | 0 | |
Outstanding at end of year (in shares) | 41,150 | |
Vested and exercisable at end of year (in shares) | 0 | |
Weighted average exercise price in $ per share | ||
Outstanding balance at beginning of year (in dollars per share) | $ 0 | |
Granted (in dollars per share) | 2.44 | |
Exercised (in dollars per share) | 0 | |
Forfeited (in dollars per share) | 0 | |
Outstanding balance at end of year (in dollars per share) | 2.44 | |
Vested and exercisable balance at end of year (in dollars per share) | 0 | |
Aggregate intrinsic value | ||
Weighted-average grant date fair value (in dollars per share) | $ 1.42 | |
Fair Value Assumptions | ||
Expected volatility (as a percent) | 61.60% | |
Expected term of options (in years) | 6 years 1 month 6 days | |
Risk-free interest rate (as a percent) | 2.27% | |
Dividend yield (as a percent) | 0.00% | |
Weighted-average remaining contractual life | 10 years | |
Stock Options | Maximum | ||
Share-Based Payments | ||
Exercise period | 10 years | |
SARs | Maximum | ||
Share-Based Payments | ||
Exercise period | 10 years |
Share-Based Payments - Induceme
Share-Based Payments - Inducement Awards Outside of the 2019 Inducement Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jul. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Payments | |||
Share-based compensation expense | $ 1,907 | $ 1,244 | |
Inducement Awards Outside of the 2019 Inducement Plan | |||
Share-Based Payments | |||
Share-based compensation expense | $ 109,000,000 | ||
Additional disclosures | |||
Weighted-average remaining contractual life | 9 years 3 months 18 days | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | |||
Share-Based Payments | |||
Vesting period | 4 years | ||
Options exercise price (in dollars per share) | $ 3.53 | $ 2.05 | |
Exercise period | 10 years | ||
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% | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Chief Executive Officer | |||
Share-Based Payments | |||
Options granted during the period | 850,000 | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Vesting period, year one | |||
Share-Based Payments | |||
Percentage that vests during the period | 25.00% | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Vesting period, years 2-4 | |||
Share-Based Payments | |||
Percentage that vests during the period | 75.00% | ||
Monthly vesting period | 36 months | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Upon receipt of FDA approval | |||
Share-Based Payments | |||
Percentage that vests during the period | 50.00% | ||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | First anniversary of FDA approval | |||
Share-Based Payments | |||
Percentage that vests during the period | 50.00% | ||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | |||
Share-Based Payments | |||
Options exercise price (in dollars per share) | $ 3.53 | ||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | Chief Executive Officer | |||
Share-Based Payments | |||
Options granted during the period | 150,000 |
Share-Based Payments - Share-ba
Share-Based Payments - Share-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Payments | ||
Share-based compensation expense | $ 1,907 | $ 1,244 |
Research and development | ||
Share-Based Payments | ||
Share-based compensation expense | 425 | 516 |
General and administrative | ||
Share-Based Payments | ||
Share-based compensation expense | $ 1,482 | $ 728 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Aug. 31, 2018 | Mar. 31, 2019 | Dec. 31, 2018 | |
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% |
Income tax (expense) benefit (D
Income tax (expense) benefit (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Income tax (expense) benefit | |||
Income tax expense | $ 154,000 | $ 506,000 | |
Valuation allowance - current and noncurrent | $ 103,800,000 | $ 100,800,000 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Basic and diluted loss per share | ||
Net loss for the period | $ (20,217) | $ (13,342) |
Weighted average number of shares outstanding | 68,701,599 | 36,911,604 |
Basic and diluted loss per share | $ (0.29) | $ (0.36) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock Options | ||
Anti-dilutive stock options | ||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 8,242,762 | 4,853,349 |
Restricted Stock Units ("RSUs") | ||
Anti-dilutive stock options | ||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,792,850 | 339,550 |
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 |
Transaction costs | 4.9 |
Net liabilities assumed | $ 0.2 |
Upfront Shares | |
Acquisition of Zavante | |
Business acquisition, shares issued or issuable | shares | 7,336,906 |
Expense from the fair value of shares issued in the acquisition | $ 26.9 |
Holdback Shares | |
Acquisition of Zavante | |
Business acquisition, shares issued or issuable | shares | 815,186 |
Merger Agreement | Upfront Shares | |
Acquisition of Zavante | |
Holdback Shares, as a percentage of Upfront Shares | 10.00% |
Merger Agreement | CONTEPO | |
Acquisition of Zavante | |
Threshold amount of annual net sales in one calendar year | $ 125 |
Merger Agreement | CONTEPO | Approval Milestone Payment | |
Acquisition of Zavante | |
Contingent consideration | 25 |
Merger Agreement | CONTEPO | Net Sales Milestone Payments | |
Acquisition of Zavante | |
Contingent consideration | 72.5 |
Merger Agreement | CONTEPO | Maximum | Approval Milestone Payment | |
Acquisition of Zavante | |
Contingent consideration | $ 97.5 |
Sinovant License Agreement (Det
Sinovant License Agreement (Details) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Feb. 28, 2019USD ($) | Mar. 31, 2018USD ($) | Mar. 31, 2019USD ($)item | Mar. 31, 2018USD ($) | |
Collaboration revenue - Variable consideration | Clinical trial application submission | ||||
License Agreement | ||||
Revenue accounted for under Topic 606 | $ 1.5 | |||
License Agreement | Sinovant Sciences, LTD | ||||
License Agreement | ||||
Notice period for termination of agreement | 180 days | |||
Number of deliverables | item | 2 | |||
License Agreement | Sinovant Sciences, LTD | Achievement of certain regulatory and commercial milestones | ||||
License Agreement | ||||
Maximum contingent milestone payment | $ 91.5 | $ 91.5 | ||
License Agreement | Sinovant Sciences, LTD | Subsequent regulatory approval | ||||
License Agreement | ||||
Maximum contingent milestone payment | 4 | 4 | ||
License Agreement | Sinovant Sciences, LTD | Clinical trial application submission | ||||
License Agreement | ||||
Proceeds from license agreement, milestone | $ 1.5 | |||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - upfront payment | ||||
License Agreement | ||||
Revenue accounted for under Topic 606 | $ 5 | 5 | ||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - Variable consideration | Clinical trial application submission | ||||
License Agreement | ||||
Revenue accounted for under Topic 606 | $ 1.5 |
Sunovion License Agreement (Det
Sunovion License Agreement (Details) - License Agreement - Sunovion Pharmaceutics Canada, Inc. $ in Millions | 1 Months Ended | 3 Months Ended |
Mar. 31, 2019USD ($) | Mar. 31, 2019USD ($) | |
License Agreement | ||
Number of deliverables | 2 | 2 |
Collaboration revenue - upfront payment | ||
License Agreement | ||
Revenue not accounted for under Topic 606 | $ 1 | $ 1 |
Commitments and Contingencies -
Commitments and Contingencies - Operating Leases (Details) | 3 Months Ended | ||
Mar. 31, 2019EUR (€) | Mar. 31, 2019USD ($)item | May 31, 2019USD ($) | |
Leases | |||
Operating lease liabilities | $ 1,977,000 | ||
Operating lease expense | 348,000 | ||
Short term lease expense | $ 222,000 | ||
Weighted-average remaining lease term of operating leases | 4 years 8 months 12 days | ||
Weighted-average discount rate (as a percent) | 9.80% | ||
Lease Agreement | King of Prussia, Pennsylvania | |||
Leases | |||
Operating lease, existence of option to renew | false | false | |
Lease Agreement | San Diego, California | |||
Leases | |||
Operating lease, existence of option to renew | true | true | |
Operating lease, number of renewal terms | item | 1 | ||
Operating lease, renewal term | 36 months | ||
Lease Agreement | Vienna Austria | |||
Leases | |||
Operating lease, existence of option to terminate | true | true | |
Termination notice period | 6 months | 6 months | |
Lease Agreement | Dublin, Ireland | |||
Leases | |||
Operating lease, existence of option to renew | true | true | |
Operating lease, monthly based fixed amount | € | € 7,000 | ||
Lease Agreement | Dublin, Ireland | Minimum | |||
Leases | |||
Operating lease, renewal term | 3 months | ||
Lease Agreement | Dublin, Ireland | Estimate | |||
Leases | |||
ROU assets | $ 150,000 | ||
Operating lease liabilities | $ 150,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Lease Disclosures and Other Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Operating Cash Flows Supplemental Information: | ||
Cash paid for amounts included in the measurement of the operating lease liabilities | $ 111,000 | |
Right-of-use assets obtained in exchange for operating lease obligations | 2,021,000 | |
Future payments of operating lease liabilities, ASC 842 | ||
Remainder of 2019 | 404,000 | |
2020 | 507,000 | |
2021 | 515,000 | |
2022 | 522,000 | |
2023 | 533,000 | |
Total future minimum lease payments | 2,481,000 | |
Less imputed interest | (504,000) | |
Present value of operating lease liabilities | 1,977,000 | |
Future minimum expected lease payments under non-cancelable operating leases, ASC 840 | ||
2019 | $ 515,000 | |
2020 | 507,000 | |
2021 | 515,000 | |
Total lease payments | $ 1,537,000 | |
Other Commitments and Contingencies | ||
Contingent liabilities | $ 0 |