Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-37558 | |
Entity Registrant Name | Nabriva Therapeutics plc | |
Entity Incorporation, State or Country Code | L2 | |
Entity Address, Address Line One | 25-28 North Wall Quay | |
Entity Address, Address Line Two | IFSC | |
Entity Address, City or Town | Dublin 1 | |
Entity Address, Country | IE | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Postal Zip Code | 00000 | |
City Area Code | 353 1 | |
Local Phone Number | 649 2000 | |
Title of 12(b) Security | Ordinary Shares, nominal value $0.01 per share | |
Trading Symbol | NBRV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Shares Outstanding | 143,822,279 | |
Entity Central Index Key | 0001641640 | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 49,660 | $ 86,019 |
Restricted cash | 229 | 392 |
Short-term investments | 175 | 175 |
Accounts receivable, net and other receivables | 3,228 | 2,744 |
Inventory | 5,196 | 682 |
Prepaid expenses | 3,921 | 1,158 |
Total current assets | 62,409 | 91,170 |
Property, plant and equipment, net | 2,176 | 2,474 |
Intangible assets, net | 97 | 91 |
Long-term receivables | 368 | 378 |
Total assets | 65,050 | 94,113 |
Current liabilities: | ||
Accounts payable | 2,620 | 4,673 |
Accrued expense and other current liabilities | 8,376 | 11,966 |
Total current liabilities | 10,996 | 16,639 |
Non-current liabilities | ||
Long-term debt | 7,477 | 34,502 |
Other non-current liabilities | 2,116 | 1,698 |
Total non-current liabilities | 9,593 | 36,200 |
Total liabilities | 20,589 | 52,839 |
Commitments and contingencies (Note 12) | ||
Stockholders' Equity: | ||
Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at June 30, 2020; 94,545,116 and 142,965,483 issued and outstanding at December 31, 2019 and June 30, 2020, respectively | 1,430 | 945 |
Preferred shares, par value $0.01, 100,000,000 shares authorized at June 30, 2020; None issued and outstanding | ||
Additional paid in capital | 558,446 | 517,044 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (515,442) | (476,742) |
Total stockholders' equity | 44,461 | 41,274 |
Total liabilities and stockholders' equity | $ 65,050 | $ 94,113 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
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 | 142,965,483 | 94,545,116 |
Ordinary stock, outstanding shares | 142,965,483 | 94,545,116 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 100,000,000 | 100,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Total revenue | $ 487,000 | $ 525,000 | $ 1,276,000 | $ 2,228,000 |
Operating expenses: | ||||
Cost of product sales | (368,000) | (376,000) | ||
Research and development expenses | (6,500,000) | (8,074,000) | (11,444,000) | (15,612,000) |
Selling, general and administrative expenses | (8,072,000) | (13,427,000) | (24,097,000) | (26,836,000) |
Total operating expenses | (14,940,000) | (21,501,000) | (35,917,000) | (42,448,000) |
Loss from operations | (14,453,000) | (20,976,000) | (34,641,000) | (40,220,000) |
Other income (expense): | ||||
Other income (expense), net | (634,000) | 56,000 | 164,000 | 126,000 |
Interest income | 16,000 | 72,000 | 80,000 | 82,000 |
Interest expense | (251,000) | (904,000) | (1,275,000) | (1,803,000) |
Loss on extinguishment of debt | (2,757,000) | |||
Loss before income taxes | (15,322,000) | (21,752,000) | (38,429,000) | (41,815,000) |
Income tax benefit (expense) | (119,000) | 45,000 | (271,000) | (109,000) |
Net loss | $ (15,441,000) | $ (21,707,000) | $ (38,700,000) | $ (41,924,000) |
Loss per share | ||||
Basic and Diluted ($ per share) | $ (0.14) | $ (0.30) | $ (0.37) | $ (0.59) |
Weighted average number of shares: | ||||
Basic and Diluted | 112,778,258 | 72,526,441 | 103,686,706 | 70,624,583 |
Product revenue, net | ||||
Revenues: | ||||
Total revenue | $ (48,000) | $ 108,000 | ||
Collaboration revenue | ||||
Revenues: | ||||
Total revenue | 7,000 | 152,000 | $ 1,000,000 | |
Research premium and grant revenue | ||||
Revenues: | ||||
Total revenue | $ 528,000 | $ 525,000 | $ 1,016,000 | $ 1,228,000 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock/Ordinary Shares | Additional paid in capital | Accumulated other comprehensive income | Accumulated deficit | Total |
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 ordinary shares | $ 43 | 10,014 | 10,057 | ||
Issuance of ordinary shares (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 | ||||
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 | |||||
Net loss | (41,924) | ||||
Stockholders' equity, ending balance at Jun. 30, 2019 | $ 729 | 478,551 | 27 | (435,902) | 43,405 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2019 | 72,906 | ||||
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 | ||||
Stockholders' equity, ending balance at Dec. 31, 2019 | $ 945 | 517,044 | 27 | (476,742) | 41,274 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2019 | 94,545 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2019 | $ 713 | 473,562 | 27 | (414,195) | 60,107 |
Stockholders' equity, beginning balance (in shares) at Mar. 31, 2019 | 71,336 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares | $ 16 | 3,691 | 3,707 | ||
Issuance of ordinary shares (in shares) | 1,570 | ||||
Equity transaction costs | (523) | (523) | |||
Stock-based compensation expense | 1,821 | 1,821 | |||
Net loss | (21,707) | (21,707) | |||
Stockholders' equity, ending balance at Jun. 30, 2019 | $ 729 | 478,551 | 27 | (435,902) | 43,405 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2019 | 72,906 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2019 | $ 945 | 517,044 | 27 | (476,742) | 41,274 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2019 | 94,545 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares | $ 5 | 181 | 186 | ||
Issuance of ordinary shares (in shares) | 479 | ||||
Shares issued in connection with the vesting of restricted stock units | $ 1 | (1) | |||
Shares issued in connection with the vesting of restricted stock units (in shares) | 85 | ||||
Equity transaction costs | (39) | (39) | |||
Stock-based compensation expense | 1,752 | 1,752 | |||
Net loss | (23,259) | (23,259) | |||
Stockholders' equity, ending balance at Mar. 31, 2020 | $ 951 | 518,937 | 27 | (500,001) | 19,914 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2020 | 95,109 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2019 | $ 945 | 517,044 | 27 | (476,742) | 41,274 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2019 | 94,545 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Net loss | (38,700) | ||||
Stockholders' equity, ending balance at Jun. 30, 2020 | $ 1,430 | 558,446 | 27 | (515,442) | 44,461 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2020 | 142,965 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2020 | $ 951 | 518,937 | 27 | (500,001) | 19,914 |
Stockholders' equity, beginning balance (in shares) at Mar. 31, 2020 | 95,109 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares | $ 476 | 40,891 | 41,367 | ||
Issuance of ordinary shares (in shares) | 47,578 | ||||
Shares issued in connection with the vesting of restricted stock units | $ 2 | (2) | |||
Shares issued in connection with the vesting of restricted stock units (in shares) | 185 | ||||
Shares issued in connection with the employee stock purchase plan | $ 1 | 42 | 43 | ||
Shares issued in connection with the employee stock purchase plan (in shares) | 93 | ||||
Equity transaction costs | (2,709) | (2,709) | |||
Stock-based compensation expense | 1,287 | 1,287 | |||
Net loss | (15,441) | (15,441) | |||
Stockholders' equity, ending balance at Jun. 30, 2020 | $ 1,430 | $ 558,446 | $ 27 | $ (515,442) | $ 44,461 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2020 | 142,965 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (38,700) | $ (41,924) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash other income/expense, net | (15) | (3) |
Non-cash interest income | 3 | 28 |
Non-cash interest expense | 218 | 371 |
Loss on extinguishment of debt | 2,757 | |
Depreciation and amortization expense | 209 | 245 |
Amortization of right-of-use assets | 171 | 211 |
Stock-based compensation | 3,103 | 3,728 |
Other, net | 39 | (20) |
Changes in operating assets and liabilities: | ||
Increase in long-term receivables | 10 | (282) |
Increase in accounts receivable, net and other receivables and prepaid expenses | (3,247) | 470 |
Increase in inventory | (4,514) | |
Increase/(decrease) in accounts payable | (1,950) | (346) |
Decrease in accrued expenses and other liabilities | (3,427) | (4,106) |
Increase/(decrease) in other non-current liabilities | 4 | (52) |
Increase/(decrease) in income tax liabilities | (33) | 10 |
Net cash used in operating activities | (45,372) | (41,670) |
Cash flows from investing activities | ||
Purchases of plant and equipment and intangible assets | (85) | (57) |
Changes in restricted cash | (163) | |
Net cash used in investing activities | (248) | (57) |
Cash flows from financing activities | ||
Proceeds from equity offerings and warrants | 38,414 | |
Proceeds from at-the-market facility | 3,688 | 13,592 |
Proceeds from long-term debt, net of issuance costs | 80 | |
Proceeds from employee stock purchase plan | 43 | 170 |
Repayments of long-term borrowings | (30,000) | |
Equity transaction costs | (2,977) | (414) |
Net cash provided by financing activities | 9,168 | 13,428 |
Effects of foreign currency translation on cash and cash equivalents | (70) | 40 |
Net decrease in cash, cash equivalents and restricted cash | (36,522) | (28,259) |
Cash, cash equivalents and restricted cash at beginning of period | 86,411 | 102,003 |
Cash, cash equivalents and restricted cash at end of period | 49,889 | 73,744 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 1,147 | 1,109 |
Equity transaction costs included in accounts payable and accrued expenses | $ 319 | $ 498 |
Organization and Business Activ
Organization and Business Activities | 6 Months Ended |
Jun. 30, 2020 | |
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., Zavante Therapeutics, Inc., and Nabriva Therapeutics Ireland DAC, (collectively, “Nabriva”, or the “Company”) is a biopharmaceutical company engaged in the commercialization and development of novel anti-infective agents to treat serious infections. The Company’s headquarters are located at 25-28 North Wall Quay, Dublin, Ireland. T On July 28, 2020, the Company announced that the European Commission (“EC”) issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia (“CAP”) in adults following a review by the European Medicines Agency (“EMA”). The EMA approval of XENLETA in CAP patients when it is considered inappropriate to use antibacterial agents that are commonly recommended for initial treatment or when these agents have failed paves the way for the launch of XENLETA across Europe. The Company previously announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA adopted a positive opinion recommending approval of XENLETA for the treatment of CAP. The EC approved XENLETA for all 28 countries of the European Union (“E.U.”), Norway, Iceland, and Liechtenstein. Nabriva intends to work with a commercial partner to make XENLETA available to patients in the E.U. On July 16, 2020, the Company announced that Sunovion Pharmaceuticals Canada Inc. (“Sunovion”), received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA® (lefamulin) for the treatment of CAP in adults, with the Notice of Compliance from Health Canada dated July 10, 2020. Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. On July 15, 2020, the Company announced that it entered into a Sales Promotion and Distribution Agreement (the “Distribution Agreement”) with MSD International GmbH (“MSD”) and Merck Sharp & Dohme Corp. (“Supplier”), each a subsidiary of Merck & Co. Under the Distribution Agreement, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient previously marketed and sold by Supplier and MSD under the trademark SIVEXTRO® for injection, intravenous use and oral use in the United States and its territories. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms. Nabriva has also engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA® in the United States. On June 30, 2020 the Company announced that WEP Clinical (“WEP”), a specialist pharmaceutical services company, has signed an exclusive agreement with the Company to supply XENLETA® (lefamulin) on a named patient or expanded access basis in certain countries outside of the US, China and Canada. The Named Patient Program (“NPP”) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available and have an unmet medical need. On September 9, 2019, the Company announced that the oral and intravenous (“IV”) formulations of XENLETA (lefamulin) are available in the United States for the treatment of community-acquired bacterial pneumonia (“CABP”) through major specialty distributors. This followed the approval by the U.S. Food and Drug Administration (FDA) of the Company’s New Drug Application (NDA) for XENLETA on August 19, 2019 for the treatment of adults with community-acquired bacterial pneumonia. XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics available for the systematic administration in humans. On July 23, 2018, the Company acquired Zavante Therapeutics Inc. (“Zavante”), a biopharmaceutical company focused on developing CONTEPO (fosfomycin for injection), and entered into an Agreement and Plan of Merger (the “Merger Agreement”). CONTEPO is potentially a first-in-class epoxide antibiotic for IV administration in the United States. The Company is developing CONTEPO IV for complicated urinary tract infections (“cUTI”) and may potentially develop XENLETA and CONTEPO for additional indications. In April 2019, the FDA issued a Complete Response Letter (“CRL”) in connection with the Company’s NDA for CONTEPO for the treatment of cUTIs, including acute pyelonephritis, stating that it was unable to approve the application in its current form. The CRL requests that issues related to facility inspections and manufacturing deficiencies at Nabriva’s active pharmaceutical ingredient contract manufacturer be addressed prior to the FDA approving the NDA. The Company requested a “Type A” meeting with the FDA to discuss its findings and this meeting occurred in July 2019. As the FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL, the purpose of the meeting was to discuss and gain clarity on the issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for CONTEPO. The Company resubmitted its NDA in December 2019 and the FDA acknowledged the resubmission in January 2020. On June 19, 2020, the FDA issued a second CRL on the NDA for CONTEPO. Although the Company’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at the Company’s manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions caused by the COVID-19 pandemic. In general, previously identified product quality and facility inspection related observations at the Company’s contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the second CRL. The Company’s contract manufacturers plan to interact with FDA to discuss its plans for conducting inspections at their sites. The Company plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA’s plans for completing foreign facility inspections. CONTEPO has been granted Qualified Infectious Disease Product (“QIDP”) and Fast Track designations by the FDA for the treatment of serious infections, including cUTI. However, the Company cannot predict when the CONTEPO NDA will be resubmitted or when CONTEPO would receive marketing approval, if at all. Liquidity Since its inception, the Company has incurred net losses and generated negative cash flows from its operations which has resulted in a significant accumulated deficit to date. The Company has financed its operations through the sale of equity securities, convertible and term debt financings and research and development support from governmental grants and proceeds from its licensing agreements. As of June 30, 2020, the Company had cash and cash equivalents, restricted cash and short-term investments of $50.1 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 continue to invest in critical commercial and medical affairs activities, its commitments per the agreement with Merck & Co., Inc., as well as investing in its supply chain for the commercialization of XENLETA, SIVEXTRO and the potential launch of CONTEPO. The Company expects to seek additional funding in future periods to support these activities. 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. In April 2020, the Company announced a restructuring of its hospital-based commercial sales force and transition to a community-based sales effort. The restructuring has reduced costs to align with the capabilities of the Company’s sales effort with its strategic re-focus on making sales of XENLETA to community health care professionals. The Company has incurred $676,000 of selling, general and administrative expense related to the reduction in personnel, consisting of severance, benefits and related costs, all of which were incurred in the second quarter of 2020. As of June 30, 2020, there were no outstanding liabilities associated with the restructuring. The termination of the sales force was timed, in part, to coincide with operational changes that have been implemented by the Company in response to the outbreak of the novel coronavirus, SARS-CoV-2, causing the disease referred to as “COVID-19”. In response to the COVID-19 pandemic, the Company closed its administrative offices and shifted to a remote working business model. The Company implemented a work-from-home policy for all of its employees. The commercial and medical organizations suspended in-person interactions with physicians and customers and are restricted to conducting educational and promotional activities virtually for the foreseeable future. The Company has secured a new virtual and in-person sales effort with community-based expertise with Amplity Health, who is a Contract Sales Organization, to replace its hospital-based sale force, however the Company has not determined when it would begin utilizing such a community-based sales effort, as it is currently unknown how long the operational restrictions related to COVID-19 will remain in effect. The Company’s expenses will increase if it suffers any regulatory delays or is required to conduct additional clinical trials to satisfy regulatory requirements. The Company has incurred and expects to continue to incur significant commercialization expenses related to its commitments per the agreement with Merck & Co., Inc., product sales, marketing, distribution and manufacturing for XENLETA, SIVEXTRO and CONTEPO, if approved. In light of the COVID-19 pandemic, the associated disruption to the healthcare delivery and the uncertainty of resuming direct physician promotion, future sales in 2020 are uncertain. It is also uncertain when, if ever, the Company will generate sufficient revenues from product sales to achieve profitability. As a result, based on the Company’s available cash resources, the minimum cash required under the Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., and in accordance with the requirements of ASC 205-40, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these consolidated 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. If the Company is not able to secure adequate additional funding in future periods, the Company may make additional 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. As discussed in Note 6, the Company repaid $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement with Hercules in March 2020. Based on its current operating plans, the Company expects that its existing cash, cash equivalents and short-term investments as of June 30, 2020, will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2021. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than expected. This estimate assumes, among other things, that the Company does not obtain any additional funding through grants and clinical trial support, collaboration agreements or equity or debt financings. This estimate also assumes that the Company remains in compliance with the covenants and no event of default occurs under the Loan Agreement. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. On June 25, 2019, the Company entered into an Open Market Sale Agreement SM As of June 30, 2020, the Company has issued and sold an aggregate of 13,117,034 ordinary shares pursuant to the Jefferies ATM Agreement and received gross proceeds of $18.0 million and net proceeds of $17.2 million, after deducting commissions to Jefferies and other offering expenses. During the three months ended June 30, 2020, the Company issued and sold an aggregate of 6,133,108 ordinary shares pursuant to the Jefferies ATM Agreement and received gross proceeds of $3.4 million and net proceeds of $3.3 million, after deducting commissions to Jefferies and other offering expenses. The Company has not sold or issued any ordinary shares pursuant to the Jefferies ATM Agreement from June 30, 2020 and through the date of this filing. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $32.0 million under the Jefferies ATM Agreement. In December 2019, the Company sold to certain institutional investors in a registered direct offering an aggregate of 13,793,106 ordinary shares, and accompanying warrants to purchase up to an aggregate of 13,793,106 ordinary shares. Each share was issued and sold together with an accompanying warrant at a combined price of $1.45 per security. The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company were $20.1 million. Each warrant has an exercise price of $1.90 per share, is initially exercisable six months following the date of issuance (the “Initial Exercise Date”) and will expire on the three-year anniversary of the Initial Exercise Date. In May 2020, the Company sold to certain institutional investors, including Fidelity Management & Research Company, LLC, in a registered direct offering an aggregate of 41,445,373 ordinary shares and accompanying warrants to purchase up to an aggregate of 41,445,373 ordinary shares at a combined price of $0.91686 per security. The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, were $38.0 million. Each warrant has an exercise price of $0.792 per share, is immediately exercisable and will expire on the two-year anniversary of the issuance date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020 and for the three and six months ended June 30, 2019 and 2020 are unaudited. The December 31, 2019 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 June 30, 2020 and results of operations for the three and six months ended June 30, 2019 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2019 and 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, 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, 2019 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 12, 2020. 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 fiscal year ended December 31, 2019. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. 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. The Company has not adopted any new accounting pronouncements for the six months ended June 30, 2020. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2020 | |
Inventory | |
Inventory | 3. Inventory Inventory is stated at the lower of cost or net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company's supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and would record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. During the three and six months ended June 30, 2020, the Company recorded a $0.4 million non-cash reserve for excess and obsolete inventory due to the uncertainty of commercial activities underlying XENLETA product sales. Inventory reported at December 31, 2019 and June 30, 2020 consisted of the following: As of As of December 31, 2019 June 30, 2020 (in thousands) 2019 2020 Raw materials $ — $ 1,783 Work in process 498 3,180 Finished goods 184 233 Total Inventory $ 682 $ 5,196 |
Fair Value Measurement
Fair Value Measurement | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurement | |
Fair Value Measurement | 4. Fair Value Measurement US GAAP establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows: ● Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities. ● Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (as exchange rates). ● Level 3: Valuation techniques that include inputs for the asset or liability that are not based on observable market data (those are unobservable inputs) and significant to the overall fair value measurement. The following table presents the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy: (in thousands) Level 1 Level 2 Level 3 Total December 31, 2019 Assets: Cash equivalent: Money market fund $ 15,050 $ — $ — $ 15,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 15,225 $ — $ — $ 15,225 (in thousands) Level 1 Level 2 Level 3 Total June 30, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 8,225 $ — $ — $ 8,225 There were no transfers between Level 1 and 2 in the six months ended June 30, 2020 or the year ended December 31, 2019. There were no changes in valuation techniques during the six months ended June 30, 2020. As of June 30, 2020, and December 31, 2019, 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 | 6 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Liabilities | 5. Accrued Expenses and Other Liabilities As of As of (in thousands) December 31, 2019 June 30, 2020 Research and development related costs $ 1,347 $ 1,084 Payroll and related costs 6,327 3,800 Accounting, tax and audit services 420 575 Manufacturing and inventory 639 757 Other 3,233 2,160 Total other current liabilities $ 11,966 $ 8,376 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2020 | |
Debt | |
Debt | 6. Debt In December 2018, the Company entered into the Loan Agreement by and among the Company, Nabriva Therapeutics Ireland DAC, and certain other subsidiaries of the Company and Hercules Capital, Inc. (“Hercules”), pursuant to which a term loan of up to an aggregate principal amount of $75.0 million was available to the Company. The Loan Agreement initially provided for an initial term loan advance of $25.0 million, which was funded in December 2018, and, at the Company’s option and subject to the occurrence of certain funding conditions, several additional tranches of which $5.0 million became available upon the approval by the FDA of the NDA for XENLETA, which was drawn down. The other Tranches are no longer available as their contingencies were not achieved. The Company may request a term loan advance of $5.0 million prior to December 31, 2021 subject to Hercules’s sole discretion. The term loan bears interest at an annual rate equal to the greater of 9.80% or 9.80% plus the prime rate of interest minus 5.50%. The Loan Agreement provided for interest-only payments through July 1, 2021 and repayment of the outstanding principal balance of the term loan thereafter in monthly installments through June 1, 2023 (the “Maturity Date”). In addition, the Company is required to pay a fee of 6.95% of the aggregate amount of advances under the Loan Agreement at the Maturity Date (the “End of Term Fee”). At the Company’s option, the Company may elect to prepay any portion of the outstanding term loan that is greater than or equal to $5.0 million by paying such portion of the principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: (i) 3.0% if the term loan is prepaid during the first 12 months following the initial closing, (ii) 2.0% if the term loan is prepaid after 12 months following the initial closing but before 24 months following the initial closing and (iii) 1.0% if the term loan is prepaid any time thereafter but prior to the Maturity Date. On March 11, 2020, the Company entered into an amendment, or the Amendment, to its Loan Agreement with Hercules. Pursuant to the Amendment, the Company repaid $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement (the “Prepayment”). The Company determined to enter into the Amendment following the effectiveness of a performance covenant in February 2020 under which it became obligated to either (1) achieve 80% of its net product revenue sales target over a trailing six-month period, or (2) maintain an amount of cash and cash equivalents in accounts pledged to Hercules plus a specified amount of eligible accounts receivables equal to the greater of the amount outstanding under the Loan Agreement or $40.0 million (the “Liquidity Requirement”). Under the Amendment, the Company and Hercules agreed to defer the end of term loan charge payment of $2.1 million that would have otherwise become payable on the date of the Prepayment and to reduce the prepayment charge with respect to the Prepayment from $600,000 to $300,000 and to defer its payment, in each case, until June 1, 2023 or such earlier date on which all loans under the Loan Agreement are repaid or become due and payable. The Amendment also reset the revenue performance covenant to 70% of targeted revenue based on a revised net product revenue forecast and lowered the minimum liquidity requirement to $3.0 million in cash and cash equivalents, in each case, following the Prepayment. The new minimum liquidity requirement will not apply if CONTEPO receives regulatory approval from the U.S. Food and Drug Administration and the Company achieves at least 70% of its revised net product revenue targets under the Loan Agreement. The Company was in compliance with all of its Loan Agreement covenants at June 30, 2020. The Company’s obligations under the Loan Agreement are guaranteed by all current and future subsidiaries of the Company, and each of the Company and its subsidiaries has granted Hercules a security interest in all of their respective personal property, intellectual property and other assets owned or later acquired. The Loan Agreement also contains certain events of default, representations, warranties and covenants of the Company and its subsidiaries. For example, the Loan Agreement contains representations and covenants that, subject to exceptions, restrict the Company’s and its subsidiaries’ ability to do the following, among other 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; and add or change business locations or settle in cash potential milestone payment obligations that may become payable by the Company in the future to former security holders of Zavante. The Loan Agreement also grants Hercules or its nominee an option to purchase up to an aggregate of $2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in any private financing upon the same terms and conditions afforded to such other investors for as long as there are amounts outstanding under the Loan Agreement. The Company incurred $1.3 million of costs in connection with the Loan Agreement which along with the initial fee of $0.7 million paid to Hercules were recorded as debt issuance cost and are being amortized as interest expense using the effective interest method over the term of the loan. In connection with the Amendment, the Company recognized a non-cash $2.7 million loss on the extinguishment of debt which represents the excess of the reacquisition price of the $30.0 million debt repaid over the net carrying amount of the extinguished debt. The carrying value of the term loan payable at June 30, 2020 includes the present value of the End of Term Fee and the Prepayment Fee. The End of Term Fee on the remaining $5.0 million principal balance is being accrued as additional interest expense using the effective interest method over the term of the loan. Long-term debt as December 31, 2019 and June 30, 2020 consisted of the following: As of As of December 31 June 30 (in thousands) 2019 2020 Term loan payable $ 35,000 $ 5,000 End of term fee 443 1,905 Unamortized debt issuance costs (1,742) (244) Carrying value of term loan 33,701 6,661 Other long-term debt 801 816 Total long-term debt $ 34,502 $ 7,477 Maturities of long-term debt as of June 30, 2020 were as follows: (in thousands) June 30, 2020 2020 $ — 2021 1,156 2022 2,493 2023 1,351 |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2020 | |
Revenue | |
Revenue | 7. Revenue Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2019 2020 2019 2020 Product revenue, net $ — $ (48) $ — $ 108 Collaboration revenues — 7 1,000 152 Research premium 351 301 744 591 Government grants 174 227 484 425 Total $ 525 $ 487 $ 2,228 $ 1,276 The $1.0 million of collaboration revenue for the six months ended June 30, 2019 reflects the upfront payment under the Sunovion License Agreement received in April 2019 (see Note 11). We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. For the three and six months ended June 30, 2020 product revenues, gross were $0.1 million and $0.4 million, respectively. Our product revenues, gross (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates, resulting in our reported “product revenues, net” in the accompanying consolidated statements of operations. These GTN estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred may be materially above or below the amount initially estimated when product revenues are originally recorded, then requiring prospective adjustments to our reported product revenues, net. The following tables summarizes gross-to-net (“GTN”) adjustments for the periods presented: Three Months Ended Six Months Ended (in thousands) June 30, 2020 June 30, 2020 Product revenue, gross $ 149 $ 398 GTN accruals Chargebacks and cash discounts 5 13 Medicaid and Medicare rebates 18 46 Other returns, rebates, discounts and adjustments 35 92 Total GTN accruals 58 151 Product revenue 91 247 Adjustments to prior period accruals Returns reserve (1) (349) (349) GTN accrual adjustments 210 210 Product revenue, net $ (48) $ 108 (1) The Company recorded a returns reserve adjustment for slow-moving inventory, representing 50% of XENLETA IV inventory held at our Specialty Distributors as of June 30, 2020. |
Share-Based Payments
Share-Based Payments | 6 Months Ended |
Jun. 30, 2020 | |
Share-Based Payments | |
Share-Based Payments | 8. Share-Based Payments Stock Option Plan 2015 On April 2, 2015, the Company’s shareholders, management board and supervisory board adopted the Stock Option Plan 2015 (the “SOP 2015”) and the shareholders approved an amended and restated version of the SOP 2015 on June 30, 2015. An amendment to the amended and restated SOP 2015 was approved by the shareholders on July 22, 2015. The 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 Redomiciliation Transaction, the SOP 2015 was amended to take account of certain requirements under Irish law and assumed by Nabriva Ireland, with each option to acquire one Nabriva Austria common share becoming an option to acquire ten ordinary shares of Nabriva Ireland 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 The following table summarizes information regarding the Company’s stock option awards under the SOP 2015 for the six months ended June 30, 2020: Weighted average exercise Aggregate price in intrinsic Stock Option Plan 2015 Options $ per share value Outstanding as of January 1, 2020 2,290,594 8.33 Granted — — Exercised — — Forfeited 63,179 9.02 Outstanding as of June 30, 2020 2,227,415 8.31 $ — Vested and exercisable as of June 30, 2020 2,073,469 8.23 $ — Stock-based compensation expense under the SOP 2015 was $0.7 million and $1.6 million for the three and six months ended June 30, 2019, respectively, and $0.3 million and $0.6 million for the three and six months ended June 30, 2020, respectively. The weighted average remaining contractual life of the options as of June 30, 2020 is 5.9 years. As of June 30, 2020, there was $0.8 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 0.5 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. 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 ended 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 June 30, 2020, 1,829,811 ordinary shares were available for future issuance under the 2017 Plan. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option . The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. The following table summarizes information regarding the Company’s stock option awards under the 2017 Plan for the six months ended June 30, 2020: Weighted average exercise Aggregate price in $ intrinsic 2017 Plan Options per share value Outstanding as of January 1, 2020 4,422,664 3.55 Granted 1,290,500 1.35 Exercised — — Forfeited (748,874) 2.56 Outstanding as of June 30, 2020 4,964,290 3.13 $ — Vested and exercisable as of June 30, 2020 1,968,950 4.21 $ — Stock-based compensation expense for stock options granted under the 2017 Plan was $0.8 million and $1.3 million for the three and six months ended June 30, 2019 and $0.5 million and $1.1 million for the three and six months ended June 30, 2020, respectively. The weighted average fair value of the options granted during the six months ended June 30, 2020 was $0.80 per share. The options granted in the six months ended June 30, 2020 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 63.8% - 64.0% Expected term of options (in years) 6.1 Range of risk-free interest rate 0.8% - 1.5% 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 The weighted average remaining contractual life of the options as of June 30, 2020 is 8.7 years. As of June 30, 2020, there was $3.9 million of total unrecognized compensation expense, related to unvested options granted under the 2017 Plan, which will be recognized over the weighted-average remaining vesting period of 1.1 years. Restricted Stock Units (“RSUs”) Under the 2017 Plan, the Company granted RSUs which 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. The Company also granted RSUs to certain employees that vest over a period of four years with 25% vesting upon the first anniversary of the grant date and on a monthly pro rata basis thereafter over the remaining three years. During 2018, the Company granted RSUs to certain employees where vesting of the RSUs was subject to FDA approval of an NDA for XENLETA. Fifty percent (50%) of each RSU award vested upon FDA approval, and the remaining fifty percent (50%) will vest on the one- year anniversary of such approval. In connection with the FDA approval that was received in August 2019, the Company started recognizing compensation expense, as there was no compensation expense recognized on these awards prior to the FDA approval as it was determined that approval was not probable since it was outside of the Company’s control. Also during 2018, the Company granted RSUs to certain employees that have vested in three six-month increments beginning in May 2019 and ending in May 2020. Lastly, the Company granted RSUs in 2018 to certain employees where vesting of the RSUs is subject to FDA approval of an NDA for CONTEPO. Fifty percent (50%) of each RSU award will vest upon FDA approval, and the remaining fifty percent (50%) will vest on the one- year anniversary of such approval. The following table summarizes information regarding our restricted stock unit awards under the 2017 Plan at June 30, 2020: Weighted average fair 2017 Plan RSUs value per share Outstanding as of January 1, 2020 901,686 3.69 Granted 1,557,300 1.35 Vested and issued (334,210) 2.03 Forfeited (230,792) 1.83 Outstanding as of June 30, 2020 1,893,984 1.83 For the three and six months ended June 30, 2019, $0.4 million and $0.6 million, respectively, of stock-based compensation expense was recognized for RSUs. Stock-based compensation expense for RSUs granted under the 2017 Plan was $0.4 million and $1.0 million for the three and six months ended June 30, 2020, respectively. The Company has total unrecognized compensation costs of $2.6 million associated with RSUs which are expected to be recognized over the awards average remaining vesting period of 1.3 years. The fair value of RSU’s that vested during the six months ended June 30, 2020 was $0.4 million. 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. On April 28, 2020, the board of directors resolved not to make any further awards 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 The following table summarizes information regarding the Company’s stock option awards under the 2019 Inducement Plan for the six months ended June 30, 2020: Weighted average exercise Aggregate price in $ intrinsic 2019 Inducement Plan Options per share value Outstanding as of January 1, 2020 605,650 2.14 Granted 182,000 1.35 Exercised — — Forfeited (392,000) 2.02 Outstanding as of June 30, 2020 395,650 1.96 $ — Vested and exercisable as of June 30, 2020 40,224 2.64 — Stock-based compensation expense under the 2019 Inducement Plan was less than $0.1 million for both the three and six months ended June 30, 2019 and less than $0.1 million for the three and six months ended June 30, 2020, respectively. The weighted average fair value of the options granted during the six months ended June 30, 2020 was $0.79 per share. The options granted in the six months ended June 30, 2020 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 63.7% - 64.0% Expected term of options (in years) 6.1 Risk-free interest rate 1.0% - 1.4% Dividend yield — The weighted average remaining contractual life of the options as of June 30, 2020 is 9.2 years. As of June 30, 2020, there was $0.4 million of total unrecognized compensation expense, related to unvested options granted under the 2019 Inducement Plan, which will be recognized over the weighted-average remaining vesting period of 1.5 years. Inducement Awards Outside of the 2019 Inducement Plan On July 25, 2018, the Company granted a non-statutory option to purchase 850,000 of its ordinary shares and 150,000 performance-based RSUs to the Company’s newly appointed Chief Executive Officer (the “CEO”). These equity awards were granted outside of the 2017 Plan 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 restricted share units 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. Since the FDA did not approve an NDA for both XENLETA and CONTEPO by January 31, 2020, the award was forfeited and the performance-based restricted share units terminated in full. The Company also issues non-statutory options to new employees upon the commencement of their employment Stock-based compensation expense for the inducement awards granted outside of the 2019 Inducement Plan was $0.1 million and $0.2 million for the three and six months ended June 30, 2019, respectively, and $0.1 million and $0.2 million for the three and six months ended June 30, 2020, respectively. 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. No expense has been recognized to date on the performance based RSUs. The significant inputs into the model were as follows: 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 June 30, 2020 is 8.1 years. As of June 30, 2020, there was $0.9 2020 Share Incentive Plan On March 4, 2020, the Company´s board of directors, adopted the 2020 Share Incentive Plan (the “2020 Plan”), which was approved by the Company´s shareholders at the 2020 Annual General Meeting of Shareholders in July 2020 (“AGM”). As of the date of the 2020 AGM, plus the total number of ordinary shares reserved for issuance under the 2020 Plan was for the sum of 9,300,000 ordinary shares, the number of our ordinary shares that remained available for grant under the 2017 Plan as of immediately prior to the AGM and the number of ordinary shares subject to awards granted under the 2017 Plan and our Amended and Restated Stock Option Plan 2015, that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right. Following shareholder approval of the 2020 Plan, no further awards will be made under the 2017 Plan. The 2020 Plan provides for the grant of incentive share options, nonstatutory share options, share appreciation rights, restricted share awards, restricted share units, other share-based and cash-based awards and performance awards. During the six months ended June 30, 2020, option awards to purchase 1,837,500 ordinary shares with an exercise price of $1.35 per share were granted under the 2020 Plan. Such awards would have automatically converted to cash-settled share appreciation rights if our shareholders did not approve the 2020 Plan at our AGM. As a result, the grants awarded under the 2020 Plan were liability classified until such shareholder approval was obtained. Stock-based compensation expense for the option awards under the 2020 Plan was $51 thousand and $65 thousand for the three and six months ended June 30, 2020, respectively. 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 available as of June 30, 2020, represented 0.1% of the total number of shares of ordinary shares outstanding as of June 30, 2020. The 2018 ESPP allows eligible employees to purchase shares at a 15% discount to the lower of the closing share price at the beginning and end of the six-month offering periods commencing November 1 and ending April 30 and commencing May 1 and ending October 31 of each year. As of the date of this filing, the Company has suspended the 2018 ESPP until further notice. |
Income Tax Expense
Income Tax Expense | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Expense | |
Income Tax Expense | 9. Income Tax Expense For the three and six months ended June 30, 2019 the Company recorded a tax benefit of $45 thousand, and a tax expense of $0.1 million, respectively. For the three and six months ended June 30, 2020 the Company recorded a tax expense of $0.1 million, and $0.3 million, 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 the Company has recorded a valuation allowance against all of its deferred tax assets at June 30, 2020 and December 31, 2019. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 10. Earnings (Loss) per Share Basic and diluted loss per share For the three and six months ended June 30, 2019 and 2020, 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 since the Company had net losses for each period presented below. Three Months Ended Six Months Ended June 30, June 30, (in thousands, except per share data) 2019 2020 2019 2020 Net loss for the period $ (21,707) $ (15,441) $ (41,924) $ (38,700) Weighted average number of shares outstanding 72,526,441 112,778,258 70,624,583 103,686,706 Basic and diluted loss per share $ (0.30) $ (0.14) $ (0.59) $ (0.37) The following ordinary share equivalents were excluded from the calculations of diluted earnings per share as their effect would be anti-dilutive since the Company had net losses for each period presented below: Three Months Ended Six Months Ended June 30, June 30, 2019 2020 2019 2020 Stock option awards 8,363,789 10,274,855 8,363,789 10,274,855 Restricted stock units 1,524,642 1,893,984 1,524,642 1,893,984 |
Sinovant and Sunovion License A
Sinovant and Sunovion License Agreements | 6 Months Ended |
Jun. 30, 2020 | |
Sinovant and Sunovion License Agreements | |
Sinovant and Sunovion License Agreements | 11. Sinovant and Sunovion License Agreements 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 “Sinovant Licensed Products”), in the People’s Republic of China, Hong Kong, Macau, and Taiwan (together the “Territory”). Under the Sinovant License Agreement, Sinovant and the Company’s subsidiaries have established a joint development committee (the “JDC’), to review and oversee development and commercialization plans in the Territory. The Company received a non-refundable $5.0 million upfront payment pursuant to the terms of the Sinovant License Agreement and will be eligible for up to an additional $91.5 million in milestone payments upon the achievement of certain regulatory and commercial milestone events related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if any Sinovant Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The first milestone was a $1.5 million payment for the submission of a clinical trial application (“CTA”), by Sinovant to the Chinese Food and Drug Administration, which was received in the first quarter of 2019. Additionally, in connection with the FDA approval for lefamulin the Company received a $5.0 million milestone payment in the third quarter of 2019. The remaining milestone payments of up to $86.5 million are tied to additional regulatory approvals and annual sales targets. The Company will also be eligible to receive low double-digit royalties on sales, if any, of Sinovant Licensed Products in the Territory. The Company has recorded the payments received to date as collaboration revenue in the consolidated statements of operations. The future regulatory and commercial milestone payments will be recorded during the period the milestones become probable of achievement. Sinovant will be solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing Sinovant Licensed Products in the Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Sinovant Licensed Products in the Territory. The Company is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sinovant a sufficient supply of XENLETA for Sinovant to manufacture finished drug products for development and commercialization of the Sinovant Licensed Products in the Territory. Unless earlier terminated, the Sinovant License Agreement will expire upon the expiration of the last royalty term for the last Sinovant Licensed Product in the Territory, which the Company expects will occur in 2033. Following the expiration of the last royalty term, the license granted to Sinovant will become non-exclusive, fully-paid, royalty-free and irrevocable. The Sinovant License Agreement may be terminated in its entirety by Sinovant upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the Sinovant License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the Sinovant License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the Sinovant License Agreement immediately if Sinovant does not reach certain development milestones by certain specified dates (subject to specified cure periods). The Sinovant License Agreement contemplates that the Company will enter into ancillary agreements with Sinovant, including clinical and commercial supply agreements and a pharmacovigilance agreement. Sunovion License Agreement In March 2019, the Company entered into the Sunovion License Agreement with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC, the Company’s wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize the Licensed Products in Canada in all uses in humans in community-acquired bacterial pneumonia and in any other indication for which the Licensed Products have received regulatory approval in Canada. Under the Sunovion License Agreement, Sunovion and DAC will establish a joint development committee (the “Sunovion 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. On November 7, 2019, the Company, through Sunovion, submitted a NDS. Health Canada determined there was a screening deficiency in December 2019 and a response from the Company/Sunovion was provided on December 18, 2019 and acknowledged by Health Canada on January 13, 2020. The NDS approval occurred on July 10, 2020. The Company has identified two performance obligations at inception: (1) the delivery of the exclusive license to Sunovion, which the Company has determined is a distinct license of functional intellectual property that Sunovion has obtained control of; and, (2) the participation in the Sunovion JDC. The $1.0 million non-refundable upfront payment was allocated entirely to the delivery of the license as the Sunovion JDC deliverable was deemed to be de minimis. With the NDS approval that occurred on July 10, 2020, a regulatory milestone payment of $0.5 million became payable to the Company. 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 | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies Leases The Company leases office spaces in King of Prussia, Pennsylvania, San Diego, California, Dublin, Ireland and laboratory and office space in Vienna, Austria under agreements previously classified as operating leases. The lease agreement in King of Prussia, Pennsylvania expires on December 15, 2023 and does not include any renewal options. The agreement provides for an initial monthly base amount plus annual escalations through the term of the lease. The lease agreement in San Diego, California expired on June 30, 2019 and was not renewed by the Company. In May 2019, the Company entered into a month-to-month sublease agreement for office space for two employees in San Diego, California. For the lease agreement in Vienna Austria, the Company can terminate In March 2019, the Company entered into a lease agreement for office space in Dublin, Ireland which expires on April 30, 2021. The agreement can be automatically renewed In addition to the monthly base amounts under the lease agreements, the Company is required to pay its proportionate share of real estate taxes and operating expenses during the lease term for the King of Prussia lease. For the six months ended June 30, 2020, the Company’s operating lease expense was $0.8 million. As of June 30, 2020, the lease term of the King of Prussia operating leases was 3.4 years and the discount rate was 9.8%. As of June 30, 2020, other information related to the operating leases were as follows: Operating Cash Flow Supplemental Information: (in thousands) June 30, 2020 Cash paid for amounts included in the measurement of the operating lease liabilities $ 252 Right-of-use assets obtained in exchange for operating lease obligations $ 1,476 The following table sets forth by year the required future payments of operating lease liabilities: (in thousands) June 30, 2020 2020 $ 255 2021 515 2022 522 2023 533 Total lease payments 1,825 Less imputed interest (327) Present value of operating lease liabilities $ 1,498 Legal Proceedings On May 8, 2019, a putative class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Southern District of New York, captioned Larry Enriquez v. Nabriva Therapeutics PLC, and Ted Schroeder, No. 19-cv-04183. The complaint purported to be brought on behalf of shareholders who purchased the Company's securities between November 1, 2018 and April 30, 2019. The complaint generally alleged that the Company and its Chief Executive Officer violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements and omitting to disclose material facts concerning the Company's submission of an NDA to the FDA for marketing approval of CONTEPO for the treatment of cUTI in the United States and the likelihood of such approval. The complaint sought unspecified damages, attorneys' fees, and other costs. On May 22, 2019, a second putative class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Southern District of New York, captioned Anthony Manna v. Nabriva Therapeutics PLC, and Ted Schroeder, No. 19-cv-04713. The complaint purported to be brought on behalf of shareholders who purchased the Company's securities between November 1, 2018 and April 30, 2019. The allegations made in the Manna complaint were similar to those made in the Enriquez complaint, and the Manna complaint sought similar relief. On May 24, 2019, these two lawsuits were consolidated by the court. The court appointed a lead plaintiff and approved plaintiff's selection of lead counsel on July 22, 2019. On September 23, 2019, plaintiff filed an amended complaint, adding the Company's Chief Financial Officer and Chief Medical Officer as defendants; the amended complaint purports to be brought on behalf of shareholders who purchased the Company's securities between January 4, 2019 through April 30, 2019, and otherwise includes allegations similar to those made in the original complaints and seeks similar relief. The Company's pre-motion letter to dismiss the amended complaint was due to plaintiff on October 21, 2019, and plaintiff responded to the Company via a letter on November 4, 2019. On November 18, 2019, the Company filed a pre-motion letter to dismiss with the Court, seeking leave to move to dismiss and setting forth why a motion to dismiss is warranted. On April 28, 2020, the Court dismissed the amended complaint without prejudice and granted plaintiff twenty days to show cause why the lawsuit should not be dismissed with prejudice. On May 8, 2020, the Court granted plaintiff a 21-day extension to show cause. On June 8, 2020, plaintiff filed a letter application to the court seeking leave to file a proposed second amended complaint, and on June 23, 2020, the court directed plaintiff to file the proposed second amended complaint. Plaintiff did so on June 24, 2020. The Company filed an answer to the second amended complaint on July 8, 2020. This case is currently in the discovery phase. 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 six months ended June 30, 2020, there were no material changes outside the ordinary course of the Company’s business to its contractual obligations relating to contract research organizations and contract manufacturing organizations. The Company has no |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On July 15, 2020, the Company entered into a Sales Promotion and Distribution Agreement (the “Distribution Agreement”) with MSD International GmbH (“MSD”) and Merck Sharp & Dohme Corp. (“Supplier”), each a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Under the Distribution Agreement, upon satisfaction of certain specified conditions, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient (marketed and sold by Supplier and MSD prior to the effective date of the Distribution Agreement under the trademark SIVEXTRO®) for injection, intravenous use and oral use (the “Products”) in final packaged form labeled with the Company’s National Drug Code numbers in the United States and its territories (the “Territory”). SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms. Under the Distribution Agreement and subject to the fulfillment of certain conditions, including the Company having engaged sufficient sales representatives, restrictions relating to travel and physician office access in the Territory due to COVID-19 having continued to decrease in a sufficient portion of the Territory so as not to hinder the successful detailing of SIVEXTRO, the Company is granted the right by MSD initially to promote the Products in the Territory and, upon satisfaction of additional conditions, including an increase in sales representatives, the right to exclusively distribute the Products in the Territory, including the sole right and responsibility to fill orders with respect to the Products in the Territory. Subject to applicable law, the Company is entitled to determine the final selling prices of the Products charged by the Company to its customers at its sole discretion, subject to an overall annual limit on price increases, and will be solely responsible for sales contracting and all market access activities, including bidding, hospital listing and reimbursement. The Company is responsible for all costs related to the promotion, sale and distribution of the Products by the Company, as well as all costs required to meet the Company’s staffing obligations under the Distribution Agreement. The Company is obligated to use commercially reasonable efforts to promote and distribute the Products and to maximize the sales of the Products throughout the Territory. The Company has agreed to employ a sales force or retain the services of a contract sales organization to fulfill its obligations under the Distribution Agreement. The Company also secured a virtual and in-person community-based sales effort with Amplity Health who is a Contract Sales Organization, however the Company has not determined when it would begin utilizing such a community-based sales effort, as it is currently unknown how long the operational restrictions related to COVID-19 will remain in effect. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020 and for the three and six months ended June 30, 2019 and 2020 are unaudited. The December 31, 2019 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 June 30, 2020 and results of operations for the three and six months ended June 30, 2019 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2019 and 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, 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, 2019 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 12, 2020. 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 fiscal year ended December 31, 2019. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. |
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. The Company has not adopted any new accounting pronouncements for the six months ended June 30, 2020. |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory | |
Schedule of inventory | As of As of December 31, 2019 June 30, 2020 (in thousands) 2019 2020 Raw materials $ — $ 1,783 Work in process 498 3,180 Finished goods 184 233 Total Inventory $ 682 $ 5,196 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurement | |
Schedule of the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy | (in thousands) Level 1 Level 2 Level 3 Total December 31, 2019 Assets: Cash equivalent: Money market fund $ 15,050 $ — $ — $ 15,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 15,225 $ — $ — $ 15,225 (in thousands) Level 1 Level 2 Level 3 Total June 30, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short term investments: Term deposits 175 — — 175 Total Assets $ 8,225 $ — $ — $ 8,225 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other liabilities | As of As of (in thousands) December 31, 2019 June 30, 2020 Research and development related costs $ 1,347 $ 1,084 Payroll and related costs 6,327 3,800 Accounting, tax and audit services 420 575 Manufacturing and inventory 639 757 Other 3,233 2,160 Total other current liabilities $ 11,966 $ 8,376 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Debt | |
Schedule of long-term debt | As of As of December 31 June 30 (in thousands) 2019 2020 Term loan payable $ 35,000 $ 5,000 End of term fee 443 1,905 Unamortized debt issuance costs (1,742) (244) Carrying value of term loan 33,701 6,661 Other long-term debt 801 816 Total long-term debt $ 34,502 $ 7,477 |
Schedule of maturities of long-term debt | (in thousands) June 30, 2020 2020 $ — 2021 1,156 2022 2,493 2023 1,351 |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Revenue | |
Summary of revenue by type | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2019 2020 2019 2020 Product revenue, net $ — $ (48) $ — $ 108 Collaboration revenues — 7 1,000 152 Research premium 351 301 744 591 Government grants 174 227 484 425 Total $ 525 $ 487 $ 2,228 $ 1,276 |
Summary of gross-to-net ("GTN") adjustments | Three Months Ended Six Months Ended (in thousands) June 30, 2020 June 30, 2020 Product revenue, gross $ 149 $ 398 GTN accruals Chargebacks and cash discounts 5 13 Medicaid and Medicare rebates 18 46 Other returns, rebates, discounts and adjustments 35 92 Total GTN accruals 58 151 Product revenue 91 247 Adjustments to prior period accruals Returns reserve (1) (349) (349) GTN accrual adjustments 210 210 Product revenue, net $ (48) $ 108 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-Based Payments | |
Summary of information regarding restricted stock awards | Weighted average fair 2017 Plan RSUs value per share Outstanding as of January 1, 2020 901,686 3.69 Granted 1,557,300 1.35 Vested and issued (334,210) 2.03 Forfeited (230,792) 1.83 Outstanding as of June 30, 2020 1,893,984 1.83 |
Stock Option Plan 2015 | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise Aggregate price in intrinsic Stock Option Plan 2015 Options $ per share value Outstanding as of January 1, 2020 2,290,594 8.33 Granted — — Exercised — — Forfeited 63,179 9.02 Outstanding as of June 30, 2020 2,227,415 8.31 $ — Vested and exercisable as of June 30, 2020 2,073,469 8.23 $ — |
2017 Share Incentive Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise Aggregate price in $ intrinsic 2017 Plan Options per share value Outstanding as of January 1, 2020 4,422,664 3.55 Granted 1,290,500 1.35 Exercised — — Forfeited (748,874) 2.56 Outstanding as of June 30, 2020 4,964,290 3.13 $ — Vested and exercisable as of June 30, 2020 1,968,950 4.21 $ — |
Summary of assumptions used for valuation of options | Input parameters Range of expected volatility 63.8% - 64.0% Expected term of options (in years) 6.1 Range of risk-free interest rate 0.8% - 1.5% Dividend yield — |
2019 Inducement Plan | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted average exercise Aggregate price in $ intrinsic 2019 Inducement Plan Options per share value Outstanding as of January 1, 2020 605,650 2.14 Granted 182,000 1.35 Exercised — — Forfeited (392,000) 2.02 Outstanding as of June 30, 2020 395,650 1.96 $ — Vested and exercisable as of June 30, 2020 40,224 2.64 — |
Summary of assumptions used for valuation of options | Input parameters Expected volatility 63.7% - 64.0% Expected term of options (in years) 6.1 Risk-free interest rate 1.0% - 1.4% 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) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, (in thousands, except per share data) 2019 2020 2019 2020 Net loss for the period $ (21,707) $ (15,441) $ (41,924) $ (38,700) Weighted average number of shares outstanding 72,526,441 112,778,258 70,624,583 103,686,706 Basic and diluted loss per share $ (0.30) $ (0.14) $ (0.59) $ (0.37) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, 2019 2020 2019 2020 Stock option awards 8,363,789 10,274,855 8,363,789 10,274,855 Restricted stock units 1,524,642 1,893,984 1,524,642 1,893,984 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | |
Schedule of operating cash flow supplemental information | (in thousands) June 30, 2020 Cash paid for amounts included in the measurement of the operating lease liabilities $ 252 Right-of-use assets obtained in exchange for operating lease obligations $ 1,476 |
Schedule of future payments of operating lease liabilities, ASC 842 | (in thousands) June 30, 2020 2020 $ 255 2021 515 2022 522 2023 533 Total lease payments 1,825 Less imputed interest (327) Present value of operating lease liabilities $ 1,498 |
Organization and Business Act_2
Organization and Business Activities (Details) - USD ($) | May 29, 2020 | May 08, 2020 | Mar. 20, 2020 | May 31, 2020 | Apr. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Mar. 11, 2020 | Jun. 25, 2019 |
Liquidity | ||||||||||||
Cash, cash equivalents and short-term investments | $ 50,100,000 | $ 50,100,000 | ||||||||||
Selling, General and Administrative Expense | $ 676,000 | $ 8,072,000 | $ 13,427,000 | $ 24,097,000 | $ 26,836,000 | |||||||
Nominal value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Jefferies LLC | At-the-market offering | ||||||||||||
Liquidity | ||||||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50,000,000 | |||||||||||
Proceeds from at-the-market facility | $ 3,400,000 | $ 18,000,000 | ||||||||||
Net proceeds from sale of stock | $ 3,300,000 | $ 17,200,000 | ||||||||||
Jefferies LLC | At-the-market offering | Maximum | ||||||||||||
Liquidity | ||||||||||||
Proceeds from at-the-market facility | $ 32,000,000 | |||||||||||
Jefferies LLC | At-the-market offering | Ordinary Shares | ||||||||||||
Liquidity | ||||||||||||
Number of shares issued | 6,133,108 | 13,117,034 | ||||||||||
Purchasers | Purchase agreement | ||||||||||||
Liquidity | ||||||||||||
Number of shares issued | 41,445,373 | 13,793,106 | ||||||||||
Proceeds from at-the-market facility | $ 38,000,000 | $ 20,100,000 | ||||||||||
Number of ordinary shares that can be purchased by warrant holders | 41,445,373 | 13,793,106 | ||||||||||
Share and warrant price | $ 0.91686 | $ 1.45 | ||||||||||
Exercise price | $ 0.792 | $ 1.90 | ||||||||||
Term | 2 years | 3 years | ||||||||||
Loan Agreement | Term loan | ||||||||||||
Liquidity | ||||||||||||
Repayment of debt | $ 30,000,000 | $ 30,000,000 | ||||||||||
Aggregate principal amount of debt outstanding | $ 35,000,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Inventory | ||
Raw materials | $ 1,783 | |
Work in process | 3,180 | $ 498 |
Finished goods | 233 | 184 |
Total Inventory | 5,196 | $ 682 |
Obsolete inventory non-cash reserve | $ 400 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Short-term investments: | ||
Transfer of assets from Level 1 to 2 | $ 0 | $ 0 |
Transfer of assets from Level 2 to 1 | 0 | 0 |
Transfer of liabilities from Level 1 to 2 | 0 | 0 |
Transfer of liabilities from Level 2 to 1 | 0 | 0 |
Recurring | ||
Cash equivalent: | ||
Money market funds | 8,050 | 15,050 |
Short-term investments: | ||
Term deposits | 175 | 175 |
Total Assets | 8,225 | 15,225 |
Level 1 | Recurring | ||
Cash equivalent: | ||
Money market funds | 8,050 | 15,050 |
Short-term investments: | ||
Term deposits | 175 | 175 |
Total Assets | $ 8,225 | $ 15,225 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 1,084 | $ 1,347 |
Payroll and related costs | 3,800 | 6,327 |
Accounting, tax and audit services | 575 | 420 |
Manufacturing and inventory | 757 | 639 |
Other | 2,160 | 3,233 |
Total other current liabilities | $ 8,376 | $ 11,966 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Mar. 20, 2020 | Mar. 11, 2020 | Feb. 29, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Debt | ||||||
Loss on extinguishment of debt | $ (2,757,000) | |||||
Term loan | ||||||
Debt | ||||||
End of term fee | 5,000,000 | $ 35,000,000 | ||||
Loan Agreement | Term loan | ||||||
Debt | ||||||
Maximum borrowing capacity | $ 75,000,000 | |||||
Principal amount of advances outstanding | $ 35,000,000 | |||||
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 | |||||
Repayment of debt | $ 30,000,000 | 30,000,000 | ||||
Percent of net product revenue sales target | 70.00% | 80.00% | ||||
Minimum liquidity requirement | $ 40,000,000 | |||||
Minimum amount to be maintained in cash and cash equivalents | $ 3,000,000 | |||||
Maximum value of lender option to purchase equity securities | 2,000,000 | |||||
End of term loan charge payment | 2,100,000 | |||||
End of term loan charge | $ 300,000 | $ 600,000 | ||||
Loan origination costs | 1,300,000 | |||||
Initial fee paid to lender | 700,000 | |||||
Loss on extinguishment of debt | 2,700,000 | |||||
End of term fee | 5,000,000 | |||||
Loan Agreement | Term loan | 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%) | |||||
Loan Agreement | Term loan | Initial Advance | ||||||
Debt | ||||||
Principal amount of advances outstanding | 25,000,000 | |||||
Loan Agreement | Term loan | Tranche 7 Advance | ||||||
Debt | ||||||
Maximum borrowing capacity | $ 5,000,000 | |||||
Additional tranches | $ 5,000,000 | |||||
Loan Agreement | Term loan | Prepayment during the first 12 months following initial closing | ||||||
Debt | ||||||
Prepayment penalty as a percentage of the amount being repaid | 3.00% | |||||
Loan Agreement | Term loan | 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% | |||||
Loan Agreement | Term loan | 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 | Jun. 30, 2020 | Dec. 31, 2019 |
Long-term debt | ||
Total long-term debt | $ 7,477 | $ 34,502 |
Maturities of long-term debt | ||
2021 | 1,156 | |
2022 | 2,493 | |
2023 | 1,351 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 5,000 | 35,000 |
End of term fee | 1,905 | 443 |
Unamortized debt issuance costs | (244) | (1,742) |
Total long-term debt | 6,661 | 33,701 |
Other long-term debt | ||
Long-term debt | ||
Total long-term debt | $ 816 | $ 801 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenue | ||||
Revenue accounted for under Topic 606 | $ 487 | $ 525 | $ 1,276 | $ 2,228 |
Product revenue, gross | 100 | 400 | ||
Collaboration revenue | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 7 | 152 | 1,000 | |
Collaboration revenue - Upfront payment | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | (48) | 108 | ||
Product revenue, gross | 149 | 398 | ||
Collaboration revenue - Variable consideration | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 7 | 152 | 1,000 | |
Research premium | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 301 | 351 | 591 | 744 |
Government grants | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | $ 227 | $ 174 | $ 425 | $ 484 |
Revenue - Summary of Gross-To-N
Revenue - Summary of Gross-To-Net ("GTN") Adjustments (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenue, gross | $ 100 | $ 400 | ||
Adjustments To prior period accruals | ||||
Product revenue, net | 487 | $ 525 | 1,276 | $ 2,228 |
Collaboration revenue - Upfront payment | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue, gross | 149 | 398 | ||
GTN accruals | ||||
Chargebacks and cash discounts | 5 | 13 | ||
Medicaid and Medicare rebates | 18 | 46 | ||
Other returns, rebates, discounts and adjustments | 35 | 92 | ||
Total GTN accruals | 58 | 151 | ||
Product revenue | 91 | 247 | ||
Adjustments To prior period accruals | ||||
Returns reserve | (349) | (349) | ||
GTN accrual adjustments | 210 | 210 | ||
Product revenue, net | $ (48) | $ 108 | ||
XENLETA | ||||
Adjustments To prior period accruals | ||||
Percentage of inventory held | 50.00% |
Share-Based Payments - SOP 2015
Share-Based Payments - SOP 2015 (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 23, 2017 | Aug. 25, 2016 | Sep. 23, 2015 | Apr. 02, 2015 | |
Stock Option Plan 2015 | ||||||||
Options | ||||||||
Outstanding at beginning of year (in shares) | 2,290,594 | |||||||
Forfeited (in shares) | (63,179) | |||||||
Outstanding at end of year (in shares) | 2,227,415 | 2,227,415 | ||||||
Vested and exercisable at end of year (in shares) | 2,073,469 | 2,073,469 | ||||||
Weighted average exercise price in $ per share | ||||||||
Outstanding balance at beginning of year (in dollars per share) | $ 8.33 | |||||||
Forfeited (in dollars per share) | 9.02 | |||||||
Outstanding balance at end of year (in dollars per share) | $ 8.31 | 8.31 | ||||||
Vested and exercisable balance at end of year (in dollars per share) | $ 8.23 | $ 8.23 | ||||||
Stock Option Plan 2015 | Stock Options | ||||||||
Share-Based Payments | ||||||||
Vesting period | 4 years | |||||||
Exercise period | 10 years | |||||||
Additional disclosures | ||||||||
Share-based compensation expense | $ 0.3 | $ 0.7 | $ 0.6 | $ 1.6 | ||||
Weighted-average remaining contractual life | 5 years 10 months 24 days | |||||||
Total unrecognized compensation related to unvested options | $ 0.8 | $ 0.8 | ||||||
Recognition period | 6 months | |||||||
Stock Option Plan 2015 | Stock Options | Vesting period, year one | ||||||||
Share-Based Payments | ||||||||
Vesting period | 1 year | |||||||
Percentage that vests during the period | 25.00% | |||||||
Stock Option Plan 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") | Stock Option Plan 2015 | Common Stock | ||||||||
Share-Based Payments | ||||||||
Maximum number of shares authorized | 177,499 | 95,000 | ||||||
Nabriva Therapeutics AG ("Nabriva Austria") | Stock Option Plan 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) - 2017 Share Incentive Plan $ / shares in Units, $ in Millions | Jul. 26, 2017shares | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Dec. 31, 2018item |
Options | ||||||
Outstanding at beginning of year (in shares) | 4,422,664 | |||||
Granted (in shares) | 1,290,500 | |||||
Forfeited (in shares) | (748,874) | |||||
Outstanding at end of year (in shares) | 4,964,290 | 4,964,290 | ||||
Vested and exercisable at end of year (in shares) | 1,968,950 | 1,968,950 | ||||
Weighted average exercise price in $ per share | ||||||
Outstanding balance at beginning of year (in dollars per share) | $ / shares | $ 3.55 | |||||
Granted (in dollars per share) | $ / shares | 1.35 | |||||
Forfeited (in dollars per share) | $ / shares | 2.56 | |||||
Outstanding balance at end of year (in dollars per share) | $ / shares | $ 3.13 | 3.13 | ||||
Vested and exercisable balance at end of year (in dollars per share) | $ / shares | $ 4.21 | $ 4.21 | ||||
Fair Value Assumptions | ||||||
Weighted-average remaining contractual life | 8 years 8 months 12 days | |||||
Stock Options | ||||||
Share-Based Payments | ||||||
Vesting period | 10 years | |||||
Fair Value Assumptions | ||||||
Expected term of options (in years) | 6 years 1 month 6 days | |||||
Stock-Based Compensation Expense | ||||||
Share-based compensation expense | $ | $ 0.5 | $ 0.8 | $ 1.1 | $ 1.3 | ||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 0.80 | |||||
Unrecognized compensation expense | ||||||
Total unrecognized compensation related to unvested options | $ | 3.9 | $ 3.9 | ||||
Recognition period | 1 year 1 month 6 days | |||||
Stock Options | Minimum | ||||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 63.80% | |||||
Risk-free interest rate (as a percent) | 0.80% | |||||
Term of U.S. treasury securities used to estimate risk free interest rate | 5 years | |||||
Stock Options | Maximum | ||||||
Fair Value Assumptions | ||||||
Expected volatility (as a percent) | 64.00% | |||||
Risk-free interest rate (as a percent) | 1.50% | |||||
Term of U.S. treasury securities used to estimate risk free interest rate | 7 years | |||||
SARs | ||||||
Share-Based Payments | ||||||
Vesting period | 10 years | |||||
Restricted Stock Units ("RSUs") | ||||||
Share-Based Payments | ||||||
Vesting period | 4 years | |||||
Fair Value | $ | $ 0.4 | |||||
Stock-Based Compensation Expense | ||||||
Share-based compensation expense | $ | 0.4 | $ 0.4 | 1 | $ 0.6 | ||
Unrecognized compensation expense | ||||||
Total unrecognized compensation related to unvested options | $ | $ 2.6 | $ 2.6 | ||||
Recognition period | 1 year 3 months 18 days | |||||
Restricted Stock Units | ||||||
Weighted average grant date fair value per share | $ / shares | $ 1.35 | |||||
Number of shares outstanding | 901,686 | |||||
Granted | 1,557,300 | |||||
Vested and issued | (334,210) | |||||
Forfeited | (230,792) | |||||
Number of shares outstanding | 1,893,984 | 1,893,984 | ||||
weighted average fair value per share | ||||||
Weighted average fair value at the beginning | $ / shares | $ 3.69 | |||||
Granted | $ / shares | 1.35 | |||||
Vested and issued | $ / shares | 2.03 | |||||
Forfeited | $ / shares | 1.83 | |||||
Weighted average fair value at the end | $ / shares | $ 1.83 | $ 1.83 | ||||
Restricted Stock Units ("RSUs") | Vesting period, year one | ||||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 25.00% | |||||
Restricted Stock Units ("RSUs") | Employees | ||||||
Share-Based Payments | ||||||
Number of vesting periods | item | 3 | |||||
Vesting period | 4 years | 6 months | ||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 25.00% | |||||
Ordinary Shares | ||||||
Share-Based Payments | ||||||
Number of shares authorized | 3,000,000 | |||||
Additional shares authorized | 3,438,990 | |||||
Shares available for grant | 1,829,811 | 1,829,811 | ||||
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% | |||||
XENLETA | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | ||||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 50.00% | |||||
XENLETA | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | ||||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 50.00% | |||||
CONTEPO | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | ||||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 50.00% | |||||
CONTEPO | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | ||||||
Restricted Stock Units | ||||||
Percentage that vests during the period | 50.00% |
Share-Based Payments - 2019 Ind
Share-Based Payments - 2019 Inducement Share Incentive Plan (Details) - 2019 Inducement Plan - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 12, 2019 | |
Options | |||||
Outstanding at beginning of year (in shares) | 605,650 | ||||
Granted (in shares) | 182,000 | ||||
Forfeited (in shares) | (392,000) | ||||
Outstanding at end of year (in shares) | 395,650 | 395,650 | |||
Vested and exercisable at end of year (in shares) | 40,224 | 40,224 | |||
Weighted average exercise price in $ per share | |||||
Outstanding balance at beginning of year (in dollars per share) | $ 2.14 | ||||
Granted (in dollars per share) | 1.35 | ||||
Forfeited (in dollars per share) | 2.02 | ||||
Outstanding balance at end of year (in dollars per share) | $ 1.96 | 1.96 | |||
Vested and exercisable balance at end of year (in dollars per share) | $ 2.64 | $ 2.64 | |||
Share-based compensation expense | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | |
Unrecognized compensation expense | |||||
Total unrecognized compensation related to unvested options | $ 0.4 | $ 0.4 | |||
Recognition period | 1 year 6 months | ||||
Ordinary Shares | |||||
Share-Based Payments | |||||
Shares reserved for future issuance | 2,000,000 | ||||
Weighted average exercise price in $ per share | |||||
Weighted-average grant date fair value (in dollars per share) | $ 0.79 | ||||
Stock Options | |||||
Share-Based Payments | |||||
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% | ||||
Weighted-average remaining contractual life | 9 years 2 months 12 days | ||||
Stock Options | Minimum | |||||
Fair Value Assumptions | |||||
Expected volatility (as a percent) | 63.70% | ||||
Risk-free interest rate (as a percent) | 1.00% | ||||
Stock Options | Maximum | |||||
Fair Value Assumptions | |||||
Expected volatility (as a percent) | 64.00% | ||||
Risk-free interest rate (as a percent) | 1.40% | ||||
SARs | |||||
Share-Based Payments | |||||
Exercise period | 10 years |
Share-Based Payments - Induceme
Share-Based Payments - Inducement Awards Outside of the 2019 Inducement Plan (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 25, 2018 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 |
Inducement Awards Outside of the 2019 Inducement Plan | ||||||
Share-Based Payments | ||||||
Share-based compensation expense | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 | ||
Additional disclosures | ||||||
Weighted-average remaining contractual life | 8 years 1 month 6 days | |||||
Total unrecognized compensation related to unvested options | $ 0.9 | $ 0.9 | ||||
Recognition period | 1 year 1 month 6 days | |||||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | ||||||
Share-Based Payments | ||||||
Vesting period | 4 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 3.53 | $ 2.05 | $ 2.05 | |||
Exercise period | 10 years | |||||
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 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 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 | |||||
2019 Inducement Plan | ||||||
Share-Based Payments | ||||||
Options granted during the period | 182,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 1.96 | $ 1.96 | $ 2.14 | |||
Share-based compensation expense | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | ||
Additional disclosures | ||||||
Total unrecognized compensation related to unvested options | $ 0.4 | $ 0.4 | ||||
Recognition period | 1 year 6 months |
Share-Based Payments - 2020 Sha
Share-Based Payments - 2020 Share Incentive Plan (Details) - Ordinary Shares - 2020 Share Incentive Plan - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2020 | Mar. 04, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted during the period | 1,837,500 | ||
Exercise price (in dollars per share) | $ 1.35 | ||
Stock-based compensation | $ 51 | $ 65 | |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance | 9,300,000 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 1 Months Ended | 6 Months Ended |
Aug. 31, 2018 | Jun. 30, 2020 | |
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 | 0.10% | |
Purchase discount as a percentage of current market price | 15.00% |
Income Tax Expense (Details)
Income Tax Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Tax Expense | ||||
Income tax benefit expense | $ 119 | $ (45) | $ 271 | $ 109 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Basic and diluted loss per share | ||||||
Net loss for the period | $ (15,441) | $ (23,259) | $ (21,707) | $ (20,217) | $ (38,700) | $ (41,924) |
Weighted average number of shares outstanding | 112,778,258 | 72,526,441 | 103,686,706 | 70,624,583 | ||
Basic and diluted loss per share | $ (0.14) | $ (0.30) | $ (0.37) | $ (0.59) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock Options | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 10,274,855 | 8,363,789 | 10,274,855 | 8,363,789 |
Restricted Stock Units ("RSUs") | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,893,984 | 1,524,642 | 1,893,984 | 1,524,642 |
Sinovant and Sunovion License_2
Sinovant and Sunovion License Agreements (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Mar. 31, 2018USD ($) | Jun. 30, 2020USD ($)item | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Jun. 30, 2020USD ($)item | Jun. 30, 2019USD ($) | Jul. 10, 2020USD ($) | |
License Agreement | ||||||||
Revenue accounted for under Topic 606 | $ 487 | $ 525 | $ 1,276 | $ 2,228 | ||||
Collaboration revenue - Upfront payment | ||||||||
License Agreement | ||||||||
Revenue accounted for under Topic 606 | (48) | 108 | ||||||
Collaboration revenue - Variable consideration | ||||||||
License Agreement | ||||||||
Revenue accounted for under Topic 606 | 7 | 152 | $ 1,000 | |||||
Sunovion Pharmaceutics Canada, Inc. | Collaboration revenue - Upfront payment | ||||||||
License Agreement | ||||||||
Revenue not accounted for under Topic 606 | $ 1,000 | |||||||
License Agreement | Sinovant Sciences, LTD | ||||||||
License Agreement | ||||||||
Notice period for termination of agreement | 180 days | |||||||
License Agreement | Sinovant Sciences, LTD | Achievement of certain regulatory and commercial milestones | ||||||||
License Agreement | ||||||||
Maximum contingent milestone payment | 91,500 | $ 91,500 | ||||||
License Agreement | Sinovant Sciences, LTD | Subsequent regulatory approval | ||||||||
License Agreement | ||||||||
Maximum contingent milestone payment | 4,000 | 4,000 | ||||||
License Agreement | Sinovant Sciences, LTD | Clinical trial application submission | ||||||||
License Agreement | ||||||||
Proceeds from license agreement, milestone | $ 1,500 | |||||||
License Agreement | Sinovant Sciences, LTD | FDA approval | ||||||||
License Agreement | ||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||
License Agreement | Sinovant Sciences, LTD | Additional regulatory approvals and annual sales targets | ||||||||
License Agreement | ||||||||
Remaining milestone payments | $ 86,500 | $ 86,500 | ||||||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - Upfront payment | ||||||||
License Agreement | ||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||
License Agreement | Sunovion Pharmaceutics Canada, Inc. | ||||||||
License Agreement | ||||||||
Number of deliverables | item | 2 | 2 | ||||||
License agreement regulatory milestone payment receivable | $ 500 |
Commitments and Contingencies -
Commitments and Contingencies - Operating Leases (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020EUR (€) | Jun. 30, 2020USD ($) | |
Leases | ||
Operating lease liabilities | $ 1,498 | |
Operating lease expense | $ 800 | |
King of Prussia | ||
Leases | ||
Weighted-average remaining lease term of operating leases | 3 years 4 months 24 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 | Vienna, Austria | ||
Leases | ||
Operating lease, existence of option to terminate | true | true |
Termination notice period | 6 months | 6 months |
Lease Agreement | Dublin, Ireland | ||
Leases | ||
Operating lease, existence of option to renew | true | true |
Operating lease, monthly based fixed amount | € | € 7,000 | |
Lease Agreement | Dublin, Ireland | Minimum | ||
Leases | ||
Operating lease, renewal term | 3 months |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Lease Disclosures and Other Commitments and Contingencies (Details) | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Operating Cash Flows Supplemental Information: | |
Cash paid for amounts included in the measurement of the operating lease liabilities | $ 252,000 |
Right-of-use assets obtained in exchange for operating lease obligations | 1,476,000 |
Future payments of operating lease liabilities, ASC 842 | |
2020 | 255,000 |
2021 | 515,000 |
2022 | 522,000 |
2023 | 533,000 |
Total lease payments | 1,825,000 |
Less imputed interest | (327,000) |
Present value of operating lease liabilities | 1,498,000 |
Other Commitments and Contingencies | |
Contingent liabilities | $ 0 |