Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
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 $0.01 per share | |
Trading Symbol | NBRV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Shares Outstanding | 54,316,604 | |
Entity Central Index Key | 0001641640 | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 51,995 | $ 41,359 |
Restricted cash | 179 | 231 |
Short-term investments | 16 | 16 |
Accounts receivable, net and other receivables | 15,032 | 3,909 |
Inventory | 15,581 | 5,823 |
Prepaid expenses | 5,609 | 5,880 |
Total current assets | 88,412 | 57,218 |
Property, plant and equipment, net | 289 | 768 |
Intangible assets, net | 41 | 80 |
Other non-current assets | 380 | 370 |
Total assets | 89,122 | 58,436 |
Current liabilities: | ||
Current portion of long-term debt | 2,780 | 2,041 |
Accounts payable | 1,476 | 2,889 |
Accrued expense and other current liabilities | 15,094 | 12,844 |
Deferred revenue | 375 | 750 |
Total current liabilities | 19,725 | 18,524 |
Non-current liabilities | ||
Long-term debt | 5,169 | 5,686 |
Other non-current liabilities | 938 | 1,091 |
Total non-current liabilities | 6,107 | 6,777 |
Total liabilities | 25,832 | 25,301 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Ordinary shares, nominal value $0.01, 100,000,000 ordinary shares authorized at September 30, 2021; 54,315,492 and 21,078,781 issued and outstanding at September 30, 2021 and December 31, 2021, respectively | 543 | 211 |
Preferred shares, nominal value $0.01, 100,000,000 shares authorized at September 30, 2021; None issued and outstanding | ||
Additional paid in capital | 645,333 | 579,123 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (582,613) | (546,226) |
Total stockholders' equity | 63,290 | 33,135 |
Total liabilities and stockholders' equity | $ 89,122 | $ 58,436 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 100,000,000 | 100,000,000 |
Ordinary stock, issued shares | 54,315,492 | 21,078,781 |
Ordinary stock, outstanding shares | 54,315,492 | 21,078,781 |
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 ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Total revenue | $ 8,862 | $ 1,291 | $ 19,634 | $ 2,567 |
Operating expenses: | ||||
Cost of revenues | (4,199) | (25) | (7,882) | (401) |
Research and development expenses | (3,221) | (3,486) | (10,239) | (12,261) |
Selling, general and administrative expenses | (12,256) | (10,997) | (37,157) | (37,763) |
Total operating expenses | (19,676) | (14,508) | (55,278) | (50,425) |
Loss from operations | (10,814) | (13,217) | (35,644) | (47,858) |
Other income (expense): | ||||
Other income (expense), net | 131 | 450 | 479 | 614 |
Interest income (expense), net | (221) | (256) | (678) | (1,451) |
Loss on extinguishment of debt | (2,757) | |||
Loss before income taxes | (10,904) | (13,023) | (35,843) | (51,452) |
Income tax benefit (expense) | 252 | 72 | (544) | (199) |
Net loss | $ (10,652) | $ (12,951) | $ (36,387) | $ (51,651) |
Loss per share | ||||
Basic ($ per share) | $ (0.21) | $ (0.90) | $ (0.93) | $ (4.40) |
Diluted ($ per share) | $ (0.25) | $ (0.90) | $ (0.97) | $ (4.40) |
Weighted average number of shares: | ||||
Basic (in shares) | 50,526,767 | 14,469,090 | 39,259,729 | 11,745,453 |
Diluted (in shares) | 50,526,767 | 14,469,090 | 39,259,729 | 11,745,453 |
Product revenue, net | ||||
Revenues: | ||||
Total revenue | $ 7,858 | $ (47) | $ 14,928 | $ 61 |
Collaboration revenue | ||||
Revenues: | ||||
Total revenue | 562 | 616 | 3,377 | 768 |
Research premium and grant revenue | ||||
Revenues: | ||||
Total revenue | $ 442 | $ 722 | $ 1,329 | $ 1,738 |
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, 2019 | $ 95 | $ 517,894 | $ 27 | $ (476,742) | $ 41,274 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2019 | 9,455 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | 186 | 186 | |||
Issuance of common stock & ordinary shares (in shares) | 48 | ||||
Shares issued in connection with the vesting of restricted share units (in shares) | 8 | ||||
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 | $ 95 | 519,793 | 27 | (500,001) | 19,914 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2020 | 9,511 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2019 | $ 95 | 517,894 | 27 | (476,742) | 41,274 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2019 | 9,455 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Net loss | (51,651) | ||||
Stockholders' equity, ending balance at Sep. 30, 2020 | $ 150 | 564,445 | 27 | (528,393) | 36,229 |
Stockholders' equity, ending balance (in shares) at Sep. 30, 2020 | 15,001 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2020 | $ 95 | 519,793 | 27 | (500,001) | 19,914 |
Stockholders' equity, beginning balance (in shares) at Mar. 31, 2020 | 9,511 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares and warrants | $ 48 | 41,319 | 41,367 | ||
Issuance of ordinary shares and warrants (in shares) | 4,758 | ||||
Shares issued in connection with the vesting of restricted share units (in shares) | 19 | ||||
Shares issued in connection with the employee stock purchase plan | 43 | 43 | |||
Shares issued in connection with the employee stock purchase plan (in shares) | 9 | ||||
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 | $ 143 | 559,733 | 27 | (515,442) | 44,461 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2020 | 14,297 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 7 | 4,098 | 4,105 | ||
Issuance of common stock & ordinary shares (in shares) | 689 | ||||
Shares issued in connection with the vesting of restricted share units (in shares) | 15 | ||||
Equity transaction costs | (613) | (613) | |||
Stock-based compensation expense | 1,227 | 1,227 | |||
Net loss | (12,951) | (12,951) | |||
Stockholders' equity, ending balance at Sep. 30, 2020 | $ 150 | 564,445 | 27 | (528,393) | 36,229 |
Stockholders' equity, ending balance (in shares) at Sep. 30, 2020 | 15,001 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2020 | $ 211 | 579,123 | 27 | (546,226) | 33,135 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2020 | 21,079 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 143 | 37,097 | 37,240 | ||
Issuance of common stock & ordinary shares (in shares) | 14,294 | ||||
Shares issued in connection with the vesting of restricted share units | 1 | 1 | |||
Shares issued in connection with the vesting of restricted share units (in shares) | 40 | ||||
Equity transaction costs | (2,325) | (2,325) | |||
Stock-based compensation expense | 921 | 921 | |||
Net loss | (13,981) | (13,981) | |||
Stockholders' equity, ending balance at Mar. 31, 2021 | $ 354 | 614,817 | 27 | (560,207) | 54,991 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2021 | 35,413 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2020 | $ 211 | 579,123 | 27 | (546,226) | 33,135 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2020 | 21,079 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Net loss | (36,387) | ||||
Stockholders' equity, ending balance at Sep. 30, 2021 | $ 543 | 645,333 | 27 | (582,613) | 63,290 |
Stockholders' equity, ending balance (in shares) at Sep. 30, 2021 | 54,315 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2021 | $ 354 | 614,817 | 27 | (560,207) | 54,991 |
Stockholders' equity, beginning balance (in shares) at Mar. 31, 2021 | 35,413 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 142 | 25,997 | 26,139 | ||
Issuance of common stock & ordinary shares (in shares) | 14,313 | ||||
Shares issued in connection with the vesting of restricted share units | $ 1 | (1) | |||
Shares issued in connection with the vesting of restricted share units (in shares) | 12 | ||||
Equity transaction costs | (992) | (992) | |||
Stock-based compensation expense | 817 | 817 | |||
Net loss | (11,754) | (11,754) | |||
Stockholders' equity, ending balance at Jun. 30, 2021 | $ 497 | 640,638 | 27 | (571,961) | 69,201 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2021 | 49,738 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 39 | 4,265 | 4,304 | ||
Issuance of common stock & ordinary shares (in shares) | 3,915 | ||||
Shares issued in connection with the vesting of restricted share units | $ 1 | 1 | |||
Shares issued in connection with the vesting of restricted share units (in shares) | 30 | ||||
Equity transaction costs | (349) | (343) | |||
Equity transaction costs, shares issued, value | $ 6 | ||||
Equity transaction costs, shares issued (in shares) | 632 | ||||
Stock-based compensation expense | 779 | 779 | |||
Net loss | (10,652) | (10,652) | |||
Stockholders' equity, ending balance at Sep. 30, 2021 | $ 543 | $ 645,333 | $ 27 | $ (582,613) | $ 63,290 |
Stockholders' equity, ending balance (in shares) at Sep. 30, 2021 | 54,315 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (36,387) | $ (51,651) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash other income/expense, net | 77 | (19) |
Non-cash interest income | 1 | |
Non-cash interest expense | 310 | 351 |
Loss on extinguishment of debt | 2,757 | |
Depreciation and amortization expense | 270 | 315 |
Amortization of right-of-use assets | 281 | 260 |
Stock-based compensation | 2,517 | 4,266 |
Other, net | 14 | (66) |
Changes in operating assets and liabilities: | ||
Increase/(decrease) in other non-current assets | (10) | 9 |
Increase in accounts receivable, net and other receivables and prepaid expenses | (10,852) | (3,237) |
Increase in inventory | (9,758) | (5,121) |
Decrease in accounts payable | (1,301) | (2,529) |
Increase/(decrease) in accrued expenses and other liabilities | 1,980 | (3,103) |
Decrease in deferred revenue | (375) | |
Decrease in other non-current liabilities | (205) | (156) |
Decrease in income tax liabilities | (44) | |
Net cash used in operating activities | (53,439) | (57,967) |
Cash flows from investing activities | ||
Purchases of plant and equipment and intangible assets | (17) | (95) |
Changes in restricted cash | (52) | (162) |
Net cash used in investing activities | (69) | (257) |
Cash flows from financing activities | ||
Proceeds from issuance of ordinary shares and warrants | 25,462 | 39,079 |
Proceeds from at-the-market facility | 42,280 | 7,119 |
Proceeds from employee stock purchase plan | 43 | |
Repayments of long-term borrowings | (30,000) | |
Equity transaction costs | (3,514) | (3,338) |
Net cash provided by financing activities | 64,228 | 12,903 |
Effects of exchange rate changes on the balance of cash held in foreign currencies | (136) | 262 |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 10,584 | (45,059) |
Cash, cash equivalents, and restricted cash at beginning of period | 41,590 | 86,411 |
Cash, cash equivalents and restricted cash at end of period | 52,174 | 41,352 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 409 | 1,273 |
Equity transaction costs included in accounts payable and accrued expenses | $ 923 | $ 564 |
Organization and Business Activ
Organization and Business Activities | 9 Months Ended |
Sep. 30, 2021 | |
Organization and Business Activities | |
Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc, or Nabriva Ireland, together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH, or 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. Throughout these notes to the consolidated financial statements, unless the context requires otherwise, all references to “Nabriva,” “the Company,” or similar terms refer to Nabriva Therapeutics plc, together with its consolidated subsidiaries. In September 2021, the Company and Sumitomo Pharmaceuticals (Suzhou) announced the approval received by Sumitomo Pharmaceuticals (Suzhou) to market oral and intravenous formulations of XENLETA for the treatment of community-acquired pneumonia in adults in Taiwan. In May 2021, the Company and Sumitomo Pharmaceuticals (Suzhou) announced positive topline results from Sumitomo Pharmaceuticals (Suzhou)’s Phase 3 clinical trial of lefamulin in Chinese adults with community-acquired bacterial pneumonia, or CABP. Sumitomo Pharmaceuticals (Suzhou)’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous, or IV, to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP. The results were similar to those observed in the global Phase 3 LEAP 1 and LEAP 2 clinical trials of lefamulin conducted by the Company. Consistent with previously reported clinical trial results, lefamulin was observed to be generally well-tolerated, with an overall rate of treatment-emergent adverse events, or TEAEs, comparable to that of moxifloxacin. The vast majority of TEAEs in both treatment arms were mild-to-moderate in severity, with serious adverse events occurring in 4% of lefamulin-treated patients and 10% of moxifloxacin-treated patients. TEAEs leading to discontinuation were uncommon and observed in just 5% of subjects in both treatment arms. 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 September 30, 2021, the Company had cash and cash equivalents, restricted cash and short-term investments of $52.2 million. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40 , Presentation of Financial Statements Going Concern 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 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 termination of the sales force was timed, in part, to coincide with operational changes that were 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 were restricted to conducting educational and promotional activities virtually. The Company has secured a virtual and in-person sales effort with community-based expertise with Amplity Health, which is a Contract Sales Organization, to replace its hospital-based sale force and began a small and focused sales effort for SIVEXTRO and XENLETA in September 2020. The Company expanded this effort to 60 sales representatives and may expand it further . The Company also piloted a virtual promotion effort with incremental sales representatives in the third quarter of 2021. 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. 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. In June 2019, the Company entered into an Open Market Sale Agreement SM In May 2021, the Company entered into an Open Market Sale Agreement SM As of September 30, 2021, the Company has issued and sold an aggregate of 18,232,689 ordinary shares pursuant to the New Sale Agreement and received gross proceeds of $30.5 million and net proceeds of $29.3 million, after deducting commissions to Jefferies and other offering expenses. From October 1, 2021 and through the date of this filing, the Company did not sell any shares under the New Sale Agreement. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $19.5 million under the New Sale Agreement. In March 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company agreed to issue and sell in a registered direct offering (1) an aggregate of 9,761,010 ordinary shares, $0.01 nominal value per share, and accompanying warrants to purchase up to an aggregate of 4,880,505 ordinary shares and (2) pre-funded warrants to purchase up to an aggregate of 600,000 ordinary shares and accompanying ordinary share warrants to purchase up to an aggregate of 300,000 ordinary shares. Each share was issued and sold together with an accompanying ordinary share warrant at a combined price of $2.4525 , and each pre-funded warrant was issued and sold together with an accompanying ordinary share warrant at a combined price of $2.4425 . The proceeds to us from the offering were $25.4 million gross and $23.4 million net after deducting the placement agent’s fees and other estimated offering expenses. Each pre-funded warrant had an exercise price per ordinary share equal to $0.01 and each pre-funded warrant was exercised in full on the issuance date. Each ordinary share warrant has an exercise price per ordinary share equal to $2.39 , was exercisable on the date of issuance and will expire on the five-year anniversary of the date of issuance . In September 2021, the Company entered into a purchase agreement, or Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which, subject to the terms and conditions, provides that the Company has the right to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $23.0 million of its ordinary shares. In addition, under the Purchase Agreement, the Company agreed to issue a commitment fee of 632,474 ordinary shares, or the Commitment Shares, as consideration for Lincoln Park entering into the Purchase Agreement and for the payment of $0.01 per Commitment Share. Under the Purchase Agreement, the Company may from time to time, at its discretion, direct Lincoln Park to purchase on any single business day, or a Regular Purchase, up to (i) 400,000 ordinary shares if the closing sale price of its ordinary shares is not below $0.25 per share on Nasdaq, (ii) 600,000 ordinary shares if the closing sale price of its ordinary shares is not below $2.00 per share on Nasdaq or (iii) 800,000 ordinary shares if the closing sale price of its ordinary shares is not below $3.00 per share on Nasdaq. In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases on the terms and subject to the conditions set forth in the Purchase Agreement. In any case, Lincoln Park’s commitment in any single Regular Purchase may not exceed $2.5 million absent a mutual agreement to increase such amount. Based on its current operating plans, the Company expects that its existing cash, cash equivalents, restricted cash and short-term investments as of the date of this Quarterly Report on Form 10-Q will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements substantially through the second quarter of 2022. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
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, or US GAAP, for interim financial information, and US Securities and Exchange Commission, or SEC, regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 are unaudited. The December 31, 2020 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 September 30, 2021 and results of operations for the three and nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2021, 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, 2020 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 11, 2021. 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, 2020. 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 nine months ended September 30, 2021. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2021 | |
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 records 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. As of September 30, 2021, the Company had a $0.9 million non-cash reserve for excess and obsolete finished goods inventory due to the uncertainty of commercial activities underlying XENLETA product sales. Inventory reported at September 30, 2021 and December 31, 2020 consisted of the following: As of As of September 30, December 31, (in thousands) 2021 2020 Raw materials $ 1,362 $ 952 Work in process 9,503 4,608 Finished goods 4,716 263 Total Inventory $ 15,581 $ 5,823 |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total Assets $ 8,066 $ — $ — $ 8,066 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total Assets $ 8,066 $ — $ — $ 8,066 There were no transfers between Level 1 and 2 in the nine months ended September 30, 2021 or the year ended December 31, 2020. There were no changes in valuation techniques during the nine months ended September 30, 2021. As of September 30, 2021, and December 31, 2020, the Company did not hold any financial instruments as liabilities that were held at fair value. 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 | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Liabilities | 5. Accrued Expenses and Other Liabilities September 30, December 31, (in thousands) 2021 2020 Research and development related costs $ 1,273 $ 1,055 Payroll and related costs 4,735 4,049 Accounting, tax and audit services 695 470 Manufacturing and inventory 2,317 4,779 Accrued gross to net 4,997 662 Other 1,077 1,829 Total other current liabilities $ 15,094 $ 12,844 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2021 | |
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., or 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, or the Tranche Advance, 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, or 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, or 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, or the Prepayment Fee: (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 Third Amendment, to its Loan Agreement with Hercules. Pursuant to the Third Amendment, the Company repaid $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement, or the Prepayment. The Company determined to enter into the Third 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, or the Liquidity Requirement. Under the Third 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 Fee 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 Third 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. On June 2, 2021, the Company entered into a further amendment, or the Fourth Amendment, to its Loan and Security Agreement with Hercules. Pursuant to the Fourth Amendment, the date on which the Company must commence repaying principal under the Loan Agreement was extended to April 1, 2022, or the Amortization Date, which date may be extended until July 1, 2022, subject to the receipt by the Company of a specified amount of additional net financing proceeds and the achievement of a specified product revenue milestone. Additionally, the time during which the Tranche Advance may be requested by the Company under the Loan Agreement, was extended until the Amortization Date. In addition, pursuant to the Fourth Amendment, the minimum liquidity requirement of $3.0 million in cash and cash equivalents will be waived at any time the Company has recognized $15.0 million of net product revenue during the applicable trailing three months . 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 Company was in compliance with all of its Loan Agreement covenants at September 30, 2021. 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 Third Amendment, the Company recognized a non-cash $2.7 million loss on the extinguishment of debt during the three months ended March 31, 2020 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 September 30, 2021 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 of September 30, 2021 and December 31, 2020 consisted of the following: As of As of September 30, December 31, (in thousands) 2021 2020 Term loan payable $ 5,000 $ 5,000 End of term fee 2,260 2,048 Unamortized debt issuance costs (169) (206) Carrying value of term loan 7,091 6,842 Other long-term debt 858 885 Less: Amounts due within one year (2,780) (2,041) Total long-term debt $ 5,169 $ 5,686 Maturities of long-term debt including the end of term fee as of September 30, 2021 were as follows: (in thousands) 2021 $ — 2022 $ 3,795 2023 $ 4,811 |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue | |
Revenue | 7. Revenue Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Product revenue, net $ 7,858 $ (47) $ 14,928 $ 61 Collaboration revenues 562 616 3,377 768 Research premium and grant revenue 442 722 1,329 1,738 Total $ 8,862 $ 1,291 $ 19,634 $ 2,567 Collaboration revenues for the nine months ended September 30, 2021 include $2.2 million related to the restructured China Region License Agreement, a portion of which is recognized over the estimated period the manufacturing collaboration and regulatory support will be provided to Sumitomo Pharmaceuticals (Suzhou), as well as $1.2 million of the Company’s share of revenues associated with the SIVEXTRO distribution agreement with Merck & Co., Inc. through April 11, 2021 (see Note 11). The Company sells its products to pharmaceutical wholesalers/distributors (i.e., the Company’s customers). The Company’s wholesalers/distributors in turn sell the Company’s products directly to clinics, hospitals, and private practices. Revenue from the Company’s product sales is recognized as physical delivery of product occurs (when the Company’s customer obtains control of the product), in return for agreed-upon consideration. SIVEXTRO product revenues, net of gross-to-net accruals and adjustments for returns were $15.6 million since the Company began exclusive distribution of SIVEXTRO under its own National Drug Code, or NDC, on April 12, 2021. For the nine months ended September 30, 2021 and 2020 XENLETA product revenues, net of gross-to-net accruals and adjustments for returns, were negative $0.7 million and $61,000, respectively, including revenues from the Company´s Named Patient Program of $17,000 for the nine months ended September 30, 2021. The Company´s gross-to-net, or GTN, estimates are based upon information received from external sources (such as written or oral information obtained from the Company´s 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 the Company’s reported product revenues, net. For the three and nine months ended September 30, 2021, the Company recorded a $1.2 million returns reserve adjustment for shelf life expiration of certain XENLETA products. For the three and nine months ended September 30, 2020, the Company recorded a returns reserve adjustment of $0.3 million for slow-moving inventory, representing 50% of XENLETA IV inventory held at |
Share-Based Payments
Share-Based Payments | 9 Months Ended |
Sep. 30, 2021 | |
Share-Based Payments | |
Share-Based Payments | 8. Share-Based Payments Stock Plan Activity On April 2, 2015, the Company’s shareholders, management board and supervisory board adopted the Stock Option Plan 2015, or the SOP 2015, as amended. Each vested option grants the beneficiary the right to acquire one share in the Company. The vesting period for the options is four years following the grant date. On the last day of the last calendar month of the first year of the vesting period, 25% of the options attributable to each beneficiary are automatically vested. During the second, third and fourth years of the vesting period, the remaining 75% of the options vest on a monthly pro rata basis (i.e. 2.083% per month). Options granted under the SOP 2015 have a term of no more than ten years from the beneficiary’s date of participation. With the approval of the 2017 Share Incentive Plan, there were no further shares available for issuance 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. On July 26, 2017, the Company’s board of directors adopted the 2017 Share Incentive Plan, or the 2017 Plan, and the shareholders approved the 2017 Plan at the Company’s Extraordinary General Meeting of Shareholders on September 15, 2017. The 2017 Plan permitted the award of share options (both incentive and nonstatutory options), share appreciation rights, or SARs, restricted shares, restricted share units, or 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 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. 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%) vested 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. With the approval of the 2020 Share Incentive Plan, there were no further shares available for issuance under the 2017 Plan. On March 12, 2019, the Company’s board of directors adopted the 2019 Inducement Share Incentive Plan, or the 2019 Inducement Plan and, subject to the adjustment provisions of the 2019 Inducement Plan, reserved 200,000 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. In July 2018, the Company granted a non-statutory option to purchase 85,000 of its ordinary shares and 15,000 performance-based RSUs to the Company’s newly appointed Chief Executive Officer, or 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 $35.30 per share, and the option award has a ten-year term and will vest over a four-year period, with 25% of the shares underlying the award vesting on the first anniversary of the grant date and the remaining 75% of the shares underlying the option award to vest monthly over the subsequent 36-month period. The performance-based RSUs are subject to vesting as follows: 50% will vest upon certification by the board of directors of the receipt of approval by the FDA of an NDA for each of lefamulin and CONTEPO for any indication, and 50% will vest on the first anniversary of such certification by the board of directors, provided, in each case, the CEO is performing services to the Company on the applicable vesting dates. If the FDA does not approve an NDA for both lefamulin and CONTEPO by January 31, 2020, the performance-based RSUs will terminate in full. Since CONTEPO was not approved by this date the award was forfeited. The Company also issues non-statutory options to new employees upon the commencement of their employment. On March 4, 2020, the Company´s board of directors adopted the 2020 Share Incentive Plan, or the 2020 Plan, which was approved by the Company´s shareholders at the 2020 Annual General Meeting of Shareholders in July 2020, or 2020 AGM. As of the date of the 2020 AGM, the total number of ordinary shares reserved for issuance under the 2020 Plan was for the sum of 930,000 ordinary shares, plus the number of the Company´s 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 the Company´s 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. The 2020 Plan provides for the grant of incentive share options, non-statutory share options, share appreciation rights, restricted share awards, restricted share units, other share-based and cash-based awards and performance awards. Under the 2020 Plan the Company granted RSUs to certain employees that vest in three six-month increments beginning in January 2021 and ending in January 2022. The Company also granted RSUs to certain employees, where vesting of the RSUs was subject to individual performance goals. During the nine months ended September 30, 2021, the Company granted RSUs to certain employees that vest in annual increments beginning January 2022 and ending in January 2025. Additionally, the Company granted 7,000 RSUs to its former Chief Medical Officer and to its former Chief Financial Officer, which vest as to 50% of the shares underlying the RSUs each year over the term of their respective consulting agreements. At September 30, 2021, 230,150 ordinary shares were available for future issuance under the 2020 Plan. On December 9, 2020, the Company´s board of directors adopted without stockholder approval the 2021 Inducement Share Incentive Plan, or the 2021 Inducement Plan and, subject to the adjustment provisions of the 2021 Inducement Plan, reserved 200,000 ordinary shares for issuance pursuant to equity awards granted under the 2021 Inducement Plan. In accordance with Nasdaq Listing Rule 5635(c)(4), awards under the 2021 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. In September 2021, the Company’s board of directors adopted an amendment to the 2021 Inducement Plan that increased the amount of shares reserved for issuance under the plan from 200,000 shares to 500,000 shares. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option or SAR will be granted with a term in excess of ten years . The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. Stock Options The following table summarizes information regarding the Company’s stock option awards for the nine months ended September 30, 2021: Weighted Weighted Average average Remaining Aggregate exercise Contractual intrinsic price in Term value Options $ per share (in years) (in thousands) Outstanding as of January 1, 2021 1,052,838 35.08 7.9 $ — Granted 537,880 1.25 Exercised — — Forfeited (309,077) 25.54 Outstanding as of September 30, 2021 1,281,641 22.83 8.1 $ — Vested and exercisable as of September 30, 2021 535,500 46.86 6.6 $ — As of September 30, 2021, there was $2.2 million of total unrecognized compensation expense related to unvested stock options, which will be recognized over the weighted-average remaining vesting period of 1.2 years. The stock options granted in the nine months ended September 30, 2021 had a weighted average grant date fair value of $0.83 per share based on a Black Scholes option pricing model. The significant inputs into the model were as follows Expected volatility 75.3% - 77.3% Expected term of options (in years) 5.5 - 6.1 Range of risk-free interest rate 0.85% - 1.16% Dividend yield — Restricted Share Units (“RSUs”) The following table summarizes information regarding the Company’s restricted share unit awards for the nine months ended September 30, 2021: Weighted average fair RSUs value in $ per share Outstanding as of January 1, 2021 239,384 11.63 Granted 769,132 1.83 Vested and issued (81,967) 11.73 Forfeited (129,231) 6.80 Outstanding as of September 30, 2021 797,318 3.03 The Company has total unrecognized compensation costs of $1.4 million associated with RSUs which are expected to be recognized over the awards average remaining vesting period of 2.0 years. The fair value of RSUs that vested during the nine months ended September 30, 2021 was $1.0 million. Stock-based Compensation The following table presents stock-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive income (loss): Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Research and development expense $ 96 $ 240 $ 435 $ 1,044 Selling, general and administrative expense 683 987 2,082 3,222 Total stock-based compensation expense $ 779 $ 1,227 $ 2,517 $ 4,266 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, or the 2018 ESPP. The maximum aggregate number of shares of ordinary shares that may be purchased under the 2018 ESPP is 50,000 shares, or the ESPP Share Pool, subject to adjustment as provided for in the 2018 ESPP. The ESPP Share Pool available as of December 31, 2020, represented less than 0.1% of the total number of shares of ordinary shares outstanding as of December 31, 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 Quarterly Report on Form 10-Q, the Company has suspended the 2018 ESPP until further notice. |
Income Tax Expense
Income Tax Expense | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Expense | |
Income Tax Expense | 9. Income Tax Expense For the three and nine months ended September 30, 2021, the Company recorded a tax benefit of $0.3 million and a tax expense of $0.5 million, respectively. For the three and nine months ended September 30, 2020, the Company recorded a tax benefit of $0.1 million and a tax expense of $0.2 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 September 30, 2021 and December 31, 2020. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 10. Earnings (Loss) per Share Basic and Diluted Loss per Share For the three and nine months ended September 30, 2021 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 Nine Months Ended September 30, September 30, (in thousands, except per share data) 2021 2020 2021 2020 Net loss for the period $ (10,652) $ (12,951) $ (36,387) $ (51,651) Weighted average number of shares outstanding 50,526,767 14,469,090 39,259,729 11,745,453 Basic and diluted loss per share $ (0.21) $ (0.90) $ (0.93) $ (4.40) 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 Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Stock option awards 1,281,641 1,102,564 1,281,641 1,102,564 Restricted share units 797,318 258,804 797,318 258,804 Warrants 10,619,347 5,438,842 10,619,347 5,438,842 |
Significant Arrangements and Li
Significant Arrangements and License Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Significant Arrangements and License Agreements | |
Significant Arrangements and License Agreements | 11. Significant Arrangements and License Agreements Sales Promotion and Distribution Agreement with Merck & Co. On July 15, 2020, the Company entered into a Sales Promotion and Distribution Agreement, or the Distribution Agreement, with MSD International GmbH, or MSD, and Merck Sharp & Dohme Corp., or Supplier, each a subsidiary of Merck & Co., Inc. Under the Distribution Agreement and subject to the satisfaction of certain conditions, 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, or the Products, in the United States and its territories, or the SIVEXTRO 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. On April 12, 2021, in accordance with the terms of the Distribution Agreement, the Company began exclusive distribution of SIVEXTRO under its own National Drug Code, or NDC, and the Company recognizes 100% of net product sales of SIVEXTRO in its results of operations. 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 SIVEXTRO Territory due to COVID-19 having continued to decrease in a sufficient portion of the SIVEXTRO Territory so as not to hinder the successful detailing of SIVEXTRO, the Company has been granted the right by MSD initially to promote the Products in the SIVEXTRO Territory and, upon satisfaction of additional conditions, including an increase in sales representatives, the right to exclusively distribute the Products in the SIVEXTRO Territory, including the sole right and responsibility to fill orders with respect to the Products in the SIVEXTRO Territory. The Company successfully satisfied those conditions, including the increase in the number of sales representatives, and began filling orders of SIVEXTRO with its own Nabriva NDC beginning April 12, 2021. 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 its 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 SIVEXTRO 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 has secured a virtual and in-person sales effort with community-based expertise with Amplity Health, which is a Contract Sales Organization, to replace its hospital-based sale force and began a small and focused sales effort for SIVEXTRO and XENLETA in September 2020. The Company expanded this effort to 60 sales representatives and may expand it further. The Company also piloted a virtual promotion effort with incremental sales representatives in the third quarter of 2021. Furthermore, a subsidiary of Merck will sell, and the Company has agreed to purchase, SIVEXTRO at specified prices in such quantities as the Company may specify. Although the Company is entitled, subject to appliable law, to determine the final selling prices of SIVEXTRO in its sole discretion, subject to an overall annual limit on price increases, the Company may not be able to sell SIVEXTRO at prices high enough to recoup its investment in a sales force and other commercialization activities. China Region License Agreement In March 2018, the Company entered into the China Region License Agreement, with Sinovant Sciences, Ltd., or Sinovant, an affiliate of Roivant Sciences, Ltd., to develop and commercialize lefamulin in the greater China region. As part of the China Region 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, or the China Region Licensed Products, in the People’s Republic of China, Hong Kong, Macau, and Taiwan, together the Extended China Territory. In May 2021, the Company entered into an assignment, assumption and novation agreement, or the Assignment Agreement, pursuant to which the Company consented to the assignment by Sinovant, an affiliate of Roivant Sciences, Ltd., of the China Region License Agreement to develop and commercialize lefamulin in the greater China region to Sumitomo Pharmaceuticals (Suzhou), a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo”). Pursuant to the Assignment Agreement, the Company agreed to release Sinovant and its affiliates from their obligations under the China Region License Agreement and consented to Sumitomo Pharmaceuticals (Suzhou)’s assumption of such obligations. In addition, Sumitomo Dainippon Pharma Co., Ltd., or Sumitomo, has agreed to guarantee all of the obligations of Sumitomo Pharmaceuticals (Suzhou) under the China Region License Agreement. Under the China Region License Agreement, Sumitomo Pharmaceuticals (Suzhou) and the Company’s subsidiaries have established a joint development committee, or the JDC, to review and oversee development and commercialization plans in the Extended China Territory. The China Region License Agreement includes milestone events consisting of a non-refundable $5.0 million upfront payment, 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 China Region Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The Company has received the $5.0 million upfront payment, a $1.5 million payment for the submission of a clinical trial application, or CTA, by Sinovant to the Chinese Food and Drug Administration, which was received in the first quarter of 2019 and a $5.0 million milestone payment in the third quarter of 2019 in connection with the FDA approval for lefamulin. The Company will also be eligible to receive low double-digit royalties on sales, if any, of China Region Licensed Products in the Extended China Territory. In December 2020, the Company announced the restructuring of its China Region License Agreement. The restructured agreement provided for additional manufacturing collaboration and regulatory support to be provided to the contract counterparty by the Company that is expected to help expedite the delivery of XENLETA to patients in greater China. The restructured agreement also accelerated $3.0 million of the $5.0 million milestone payment to the Company that was previously payable upon regulatory approval of XENLETA in China, including a non-refundable upfront payment of $1.0 million which was received in the fourth quarter of 2020 and a $1.0 million milestone achieved during the first quarter of 2021. As of September 30, 2021, management determined that the remaining $1.0 million milestone payment was probable of achievement and therefore the Company is recognizing the $3.0 million of accelerated payments under the restructured agreement as collaboration revenue in the consolidated statements of operations over the estimated period the manufacturing collaboration and regulatory support will be provided to the contract counterparty, which was $1.8 million during the nine months ended September 30, 2021, based on the proportional performance of the underlying performance obligation. The remaining milestones of $86.0 million are tied to additional regulatory approvals and annual sales targets. The future regulatory and commercial milestone payments under the China Region License Agreement will be recorded during the period the milestones become probable of achievement. Except for the manufacturing collaboration and regulatory support discussed above, Sumitomo Pharmaceuticals (Suzhou) will be solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing China Region Licensed Products in the Extended China Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize China Region Licensed Products in the Extended China Territory. The Company is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sumitomo Pharmaceuticals (Suzhou) a sufficient supply of lefamulin for Sumitomo Pharmaceuticals (Suzhou) to manufacture finished drug products for development and commercialization of the China Region Licensed Products in the Extended China Territory. Unless earlier terminated, the China Region License Agreement will expire upon the expiration of the last royalty term for the last China Region Licensed Product in the Extended China Territory, which the Company expects will occur in 2033. Following the expiration of the last royalty term, the license granted to Sumitomo Pharmaceuticals (Suzhou) will become non-exclusive, fully-paid, royalty-free and irrevocable. The China Region License Agreement may be terminated in its entirety by Sumitomo Pharmaceuticals (Suzhou) upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the China Region License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the China Region License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the China Region License Agreement immediately if Sumitomo Pharmaceuticals (Suzhou) does not reach certain development milestones by certain specified dates (subject to specified cure periods). The China Region License Agreement contemplates that the Company will enter into ancillary agreements with Sumitomo Pharmaceuticals (Suzhou), 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 CABP and in any other indication for which the Licensed Products have received regulatory approval in Canada. Under the Sunovion License Agreement, Sunovion and DAC established a joint development committee, or the Sunovion JDC, to review and oversee regulatory approval and commercialization plans in Canada. Sunovion will be solely responsible for all costs related to obtaining regulatory approval of and commercializing Licensed Products in the Canada and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Licensed Product in the Canada. On November 7, 2019, the Company, through Sunovion, submitted a New Drug Submission, or 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 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, the Company received a regulatory milestone payment of $0.5 million. Any future regulatory and commercial milestone payments under the Sunovion License Agreement will be recorded during the period the milestones become probable of achievement. Named Patient Program Agreement with WE Pharma Ltd. On June 30, 2020 the Company announced that WE Pharma Ltd., or WEP Clinical, a specialist pharmaceutical services company, had signed an exclusive agreement with the Company to supply XENLETA on a named patient or expanded access basis in certain countries outside of the US, China and Canada. The Named Patient Program, or 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. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies The Company has contractual commitments related primarily to contracts entered into with contract research organizations and contract manufacturing organizations in connection with the conduct of clinical trials and other research and development activities. During the three months ended September 30, 2021, other than the below, 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. On August 4, 2021, our wholly-owned subsidiary, Nabriva Therapeutics Ireland DAC, entered into an amendment, or the First Amendment, to its API Supply Agreement, or the Hovione Supply Agreement, with Hovione Limited, or Hovione, which provides for the long-term commercial supply of the active pharmaceutical ingredients, or API, for XENLETA. Under the First Amendment, Hovione agreed to cancel our May 2021 purchase order for XENLETA API, which represented our minimum purchase requirement under the Hovione Supply Agreement. In addition, pursuant to the First Amendment, Hovione agreed to reduce our annual minimum purchase requirements for XENLETA API to no minimum purchase requirement in 2021, by 50% from 2022 to 2024 and by 25% in 2025, in consideration for cash payments from us totaling €3.2 million and the right to a low single-digit royalty on total net sales of XENLETA in the United States for a period commencing on August 4, 2021 and ending on November 22, 2030, or the Royalty Term, which royalty payments shall be no greater than an aggregate of €10.0 million. If the aggregate amount of royalties payments received by Hovione under the First Amendment is less than an aggregate of €4.0 million, we are obligated to pay Hovione the difference in a lump sum payment at the end of the Royalty Term. In addition, pursuant to the First Amendment, Hovione agreed to extend the duration of the Hovione Supply Agreement from November 22, 2025 to November 22, 2030 with annual minimum purchase requirements for 2026 to 2030 at the newly agreed annual minimum purchase amount for 2025. Pursuant to the First Amendment, upon the occurrence of certain events of insolvency for us, any unpaid minimum annual commitment amounts and royalty amounts under the agreement will become immediately due and payable. The Company has no contingent liabilities in respect of legal claims arising in the ordinary course of business. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events The Company has evaluated all subsequent events through the filing date of this Form 10-Q with the SEC, to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of September 30, 2021, and events which occurred subsequently but were not recognized in the financial statements. There were no subsequent events which required recognition, adjustment to, or disclosure in the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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, or US GAAP, for interim financial information, and US Securities and Exchange Commission, or SEC, regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 are unaudited. The December 31, 2020 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 September 30, 2021 and results of operations for the three and nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2021, 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, 2020 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 11, 2021. 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, 2020. 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 nine months ended September 30, 2021. |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventory | |
Schedule of inventory | As of As of September 30, December 31, (in thousands) 2021 2020 Raw materials $ 1,362 $ 952 Work in process 9,503 4,608 Finished goods 4,716 263 Total Inventory $ 15,581 $ 5,823 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total Assets $ 8,066 $ — $ — $ 8,066 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total Assets $ 8,066 $ — $ — $ 8,066 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other liabilities | September 30, December 31, (in thousands) 2021 2020 Research and development related costs $ 1,273 $ 1,055 Payroll and related costs 4,735 4,049 Accounting, tax and audit services 695 470 Manufacturing and inventory 2,317 4,779 Accrued gross to net 4,997 662 Other 1,077 1,829 Total other current liabilities $ 15,094 $ 12,844 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt | |
Schedule of long-term debt | As of As of September 30, December 31, (in thousands) 2021 2020 Term loan payable $ 5,000 $ 5,000 End of term fee 2,260 2,048 Unamortized debt issuance costs (169) (206) Carrying value of term loan 7,091 6,842 Other long-term debt 858 885 Less: Amounts due within one year (2,780) (2,041) Total long-term debt $ 5,169 $ 5,686 |
Schedule of maturities of long-term debt | (in thousands) 2021 $ — 2022 $ 3,795 2023 $ 4,811 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenue | |
Summary of revenue by type | Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Product revenue, net $ 7,858 $ (47) $ 14,928 $ 61 Collaboration revenues 562 616 3,377 768 Research premium and grant revenue 442 722 1,329 1,738 Total $ 8,862 $ 1,291 $ 19,634 $ 2,567 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted Weighted Average average Remaining Aggregate exercise Contractual intrinsic price in Term value Options $ per share (in years) (in thousands) Outstanding as of January 1, 2021 1,052,838 35.08 7.9 $ — Granted 537,880 1.25 Exercised — — Forfeited (309,077) 25.54 Outstanding as of September 30, 2021 1,281,641 22.83 8.1 $ — Vested and exercisable as of September 30, 2021 535,500 46.86 6.6 $ — |
Summary of assumptions used for valuation of options | Expected volatility 75.3% - 77.3% Expected term of options (in years) 5.5 - 6.1 Range of risk-free interest rate 0.85% - 1.16% Dividend yield — |
Summary of information regarding restricted stock awards | Weighted average fair RSUs value in $ per share Outstanding as of January 1, 2021 239,384 11.63 Granted 769,132 1.83 Vested and issued (81,967) 11.73 Forfeited (129,231) 6.80 Outstanding as of September 30, 2021 797,318 3.03 |
Schedule of allocation of share-based compensation expense | Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Research and development expense $ 96 $ 240 $ 435 $ 1,044 Selling, general and administrative expense 683 987 2,082 3,222 Total stock-based compensation expense $ 779 $ 1,227 $ 2,517 $ 4,266 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Three Months Ended Nine Months Ended September 30, September 30, (in thousands, except per share data) 2021 2020 2021 2020 Net loss for the period $ (10,652) $ (12,951) $ (36,387) $ (51,651) Weighted average number of shares outstanding 50,526,767 14,469,090 39,259,729 11,745,453 Basic and diluted loss per share $ (0.21) $ (0.90) $ (0.93) $ (4.40) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Stock option awards 1,281,641 1,102,564 1,281,641 1,102,564 Restricted share units 797,318 258,804 797,318 258,804 Warrants 10,619,347 5,438,842 10,619,347 5,438,842 |
Organization and Business Act_2
Organization and Business Activities (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2021USD ($)$ / sharesshares | May 31, 2021USD ($)shares | Sep. 30, 2021USD ($)$ / shares | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2021USD ($)employee$ / sharesshares | Sep. 30, 2020USD ($) | Dec. 31, 2020$ / shares | Jun. 30, 2019USD ($) | |
Liquidity | |||||||||||
Percentage of lefamulin-treated patients | 4.00% | ||||||||||
Percentage of moxifloxacin-treated patients | 10.00% | ||||||||||
Percentage of TEAEs leading to discontinuation were subjects in both treatment arms | 5.00% | ||||||||||
Cash, cash equivalents and short-term investments | $ 52,200 | $ 52,200 | $ 52,200 | ||||||||
Number of sales representatives | employee | 60 | ||||||||||
Proceeds from at-the-market facility | $ 42,280 | $ 7,119 | |||||||||
Nominal value | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Shares issued | $ 4,304 | $ 26,139 | $ 37,240 | $ 4,105 | $ 186 | ||||||
Jefferies LLC | At-the-market offering | |||||||||||
Liquidity | |||||||||||
Maximum aggregate gross proceeds under the sales agreement | $ 50,000 | ||||||||||
Proceeds from at-the-market facility | $ 30,500 | ||||||||||
Net proceeds from sale of stock | $ 29,300 | ||||||||||
Jefferies LLC | At-the-market offering | Ordinary shares | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 18,232,689 | ||||||||||
Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 9,761,010 | ||||||||||
Net proceeds from sale of stock | $ 23,400 | ||||||||||
Proceeds from Issuance or Sale of Equity | $ 25,400 | ||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 4,880,505 | ||||||||||
Term | 5 years | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | |||||||||||
Liquidity | |||||||||||
Commitment shares | shares | 632,474 | ||||||||||
Commitment share price | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Regular purchase | $ 2,500 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Maximum | |||||||||||
Liquidity | |||||||||||
Shares issued | $ 23,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $ 0.25 Per Share | |||||||||||
Liquidity | |||||||||||
Share price | $ / shares | $ 0.25 | 0.25 | 0.25 | ||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $ 0.25 Per Share | Maximum | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 400,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $2.00 Per Share | |||||||||||
Liquidity | |||||||||||
Share price | $ / shares | $ 2 | 2 | 2 | ||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $2.00 Per Share | Maximum | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 600,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $3.00 Per Share | |||||||||||
Liquidity | |||||||||||
Share price | $ / shares | $ 3 | $ 3 | $ 3 | ||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Share Price Not Below $3.00 Per Share | Maximum | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 800,000 | ||||||||||
Ordinary Share Warrants | Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 300,000 | ||||||||||
Nominal value | $ / shares | $ 0.01 | ||||||||||
Share and warrant price | $ / shares | 2.4525 | ||||||||||
Exercise price | $ / shares | $ 2.39 | ||||||||||
Pre-Funded Warrants | Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 600,000 | ||||||||||
Share and warrant price | $ / shares | $ 2.4425 | ||||||||||
Exercise price | $ / shares | $ 0.01 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 5,925,699 | ||||||||||
Proceeds from at-the-market facility | $ 31,900 | ||||||||||
Aggregate gross sale proceeds for ordinary shares | 33,700 | ||||||||||
Ordinary shares remained unsold | 16,300 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | Maximum | |||||||||||
Liquidity | |||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 50,000 | ||||||||||
New Sale Agreement | Maximum | |||||||||||
Liquidity | |||||||||||
Proceeds from at-the-market facility | $ 19,500 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Inventory | ||
Raw materials | $ 1,362 | $ 952 |
Work in process | 9,503 | 4,608 |
Finished goods | 4,716 | 263 |
Total Inventory | 15,581 | $ 5,823 |
Obsolete inventory non-cash reserve | $ 900 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | 16 |
Total Assets | 8,066 | 8,066 |
Level 1 | Recurring | ||
Cash equivalent: | ||
Money market funds | 8,050 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | 16 |
Total Assets | $ 8,066 | $ 8,066 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 1,273 | $ 1,055 |
Payroll and related costs | 4,735 | 4,049 |
Accounting, tax and audit services | 695 | 470 |
Manufacturing and inventory | 2,317 | 4,779 |
Accrued gross to net | 4,997 | 662 |
Other | 1,077 | 1,829 |
Total other current liabilities | $ 15,094 | $ 12,844 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Jun. 02, 2021 | Mar. 11, 2020 | Feb. 29, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2018 |
Debt | ||||||||
Loss on extinguishment of debt | $ (2,757,000) | |||||||
Term loan | ||||||||
Debt | ||||||||
End of term fee | $ 5,000,000 | $ 5,000,000 | ||||||
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 | ||||||
Minimum cash and cash equivalents in accounts to be maintained | $ 3,000,000 | |||||||
Net product revenue | $ 15,000,000 | |||||||
Trailing period | 3 months | 6 months | ||||||
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 | Sep. 30, 2021 | Dec. 31, 2020 |
Long-term debt | ||
Less: Amounts due within one year | $ (2,780) | $ (2,041) |
Total long-term debt | 5,169 | 5,686 |
Maturities of long-term debt | ||
2022 | 3,795 | |
2023 | 4,811 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 5,000 | 5,000 |
End of term fee | 2,260 | 2,048 |
Unamortized debt issuance costs | (169) | (206) |
Total long-term debt | 7,091 | 6,842 |
Other long-term debt | ||
Long-term debt | ||
Total long-term debt | $ 858 | $ 885 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Dec. 31, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Mar. 31, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue | |||||||
Revenue accounted for under Topic 606 | $ 8,862 | $ 1,291 | $ 19,634 | $ 2,567 | |||
Merck & Co | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 1,200 | ||||||
Collaboration revenue | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 562 | 616 | 3,377 | 768 | |||
Collaboration revenue | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 2,200 | ||||||
Collaboration revenue - Upfront payment | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 7,858 | (47) | 14,928 | 61 | |||
Collaboration revenue - Upfront payment | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | $ 3,000 | $ 1,000 | $ 5,000 | ||||
Research premium and grant revenue | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | $ 442 | $ 722 | $ 1,329 | $ 1,738 |
Revenue - Summary of Gross-To-N
Revenue - Summary of Gross-To-Net ("GTN") Adjustments (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation of Revenue [Line Items] | |||||
Product revenue, gross | $ 17,000 | ||||
XENLETA | |||||
Disaggregation of Revenue [Line Items] | |||||
Returns reserve & GTN accrual adjustments | $ 1,200 | $ 300 | 1,200 | $ 300 | |
GTN accrual adjustments | $ (700) | $ 61,000 | |||
Percentage of inventory held | 50.00% | 50.00% | |||
SIVEXTRO | |||||
Disaggregation of Revenue [Line Items] | |||||
GTN accrual adjustments | $ 15,600 |
Share-Based Payments - Stock Pl
Share-Based Payments - Stock Plan Activity (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Jul. 31, 2018$ / sharesshares | Sep. 30, 2021$ / sharesshares | Dec. 31, 2020tranche$ / shares | Dec. 31, 2018tranche | Aug. 31, 2021shares | Mar. 04, 2021shares | Dec. 09, 2020shares | Mar. 12, 2019shares | |
Stock Options | ||||||||
Share-Based Payments | ||||||||
Options granted during the period | 537,880 | |||||||
Options exercise price (in dollars per share) | $ / shares | $ 22.83 | $ 35.08 | ||||||
Restricted Stock Units ("RSUs") | ||||||||
Share-Based Payments | ||||||||
Restricted stock granted during the period | 769,132 | |||||||
Stock Option Plan 2015 | Stock Options | ||||||||
Share-Based Payments | ||||||||
Vesting period | 4 years | |||||||
Stock Option Plan 2015 | Stock Options | Vesting period, year one | ||||||||
Share-Based Payments | ||||||||
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% | |||||||
Stock Option Plan 2015 | Maximum | Stock Options | ||||||||
Share-Based Payments | ||||||||
Exercise period | 10 years | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | ||||||||
Share-Based Payments | ||||||||
Vesting period | 4 years | |||||||
Percentage that vests during the period | 25.00% | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | XENLETA | ||||||||
Share-Based Payments | ||||||||
Vesting period | 6 months | |||||||
Number of vesting periods | tranche | 3 | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | XENLETA | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Immediate vesting upon regulatory approval | CONTEPO | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | XENLETA | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
2017 Share Incentive Plan | Restricted Stock Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | CONTEPO | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
2019 Inducement Plan | Ordinary shares | ||||||||
Share-Based Payments | ||||||||
Shares reserved for future issuance | 200,000 | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year one | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 25.00% | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year two | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 75.00% | |||||||
Monthly vesting period | 36 months | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | Chief Executive Officer | ||||||||
Share-Based Payments | ||||||||
Options granted during the period | 15 | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | Upon receipt of FDA approval | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Stock Units ("RSUs") | First anniversary of FDA approval | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | ||||||||
Share-Based Payments | ||||||||
Vesting period | 4 years | |||||||
Exercise period | 10 years | |||||||
Options exercise price (in dollars per share) | $ / shares | $ 35.30 | |||||||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Chief Executive Officer | ||||||||
Share-Based Payments | ||||||||
Options granted during the period | 85,000 | |||||||
2020 Share Incentive Plan | Restricted Stock Units ("RSUs") | Chief Executive Officer | ||||||||
Share-Based Payments | ||||||||
Percentage that vests during the period | 50.00% | |||||||
Restricted stock granted during the period | 7,000 | |||||||
2020 Share Incentive Plan | Restricted Stock Units ("RSUs") | Employees | ||||||||
Share-Based Payments | ||||||||
Vesting period | 6 months | |||||||
Number of vesting periods | tranche | 3 | |||||||
2020 Share Incentive Plan | Ordinary shares | ||||||||
Share-Based Payments | ||||||||
Shares reserved for future issuance | 230,150 | |||||||
2020 Share Incentive Plan | Ordinary shares | Maximum | ||||||||
Share-Based Payments | ||||||||
Shares reserved for future issuance | 930,000 | |||||||
2021 Inducement Share Incentive Plan | Maximum | ||||||||
Share-Based Payments | ||||||||
Term of Awards | P10Y | |||||||
2021 Inducement Share Incentive Plan | Ordinary shares | ||||||||
Share-Based Payments | ||||||||
Shares reserved for future issuance | 500,000 | 200,000 | 200,000 |
Share-Based Payments - Stock Op
Share-Based Payments - Stock Options (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Minimum | ||
Fair Value Assumptions | ||
Expected volatility | 75.30% | |
Expected term of options (in years) | 5 years 6 months | |
Range of risk-free interest rate | 0.85% | |
Maximum | ||
Fair Value Assumptions | ||
Expected volatility | 77.30% | |
Expected term of options (in years) | 6 years 1 month 6 days | |
Range of risk-free interest rate | 1.16% | |
Stock Options | ||
Options | ||
Outstanding at beginning of year (in shares) | 1,052,838 | |
Granted (in shares) | 537,880 | |
Forfeited (in shares) | (309,077) | |
Outstanding at end of year (in shares) | 1,281,641 | 1,052,838 |
Vested and exercisable at end of year (in shares) | 535,500 | |
Weighted average exercise price in $ per share | ||
Outstanding balance at beginning of year (in dollars per share) | $ 35.08 | |
Granted (in dollars per share) | 1.25 | |
Forfeited (in dollars per share) | 25.54 | |
Outstanding balance at end of year (in dollars per share) | 22.83 | $ 35.08 |
Vested and exercisable balance at end of year (in dollars per share) | $ 46.86 | |
Weighted Average Remaining Contractual Term (in years) | ||
Weighted average remaining contractual term, outstanding | 8 years 1 month 6 days | 7 years 10 months 24 days |
Weighted average remaining contractual term, vested and exercisable | 6 years 7 months 6 days | |
Additional disclosures | ||
Total unrecognized compensation related to unvested options | $ 2.2 | |
Recognition period | 1 year 2 months 12 days | |
Weighted-average grant date fair value (in dollars per share) | $ 0.83 |
Share-Based Payments - Restrict
Share-Based Payments - Restricted Share Units (Details) - Restricted Stock Units ("RSUs") $ / shares in Units, $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | |
Restricted Stock Units | |
Number of shares outstanding | shares | 239,384 |
Granted | shares | 769,132 |
Vested and issued | shares | (81,967) |
Forfeited | shares | (129,231) |
Number of shares outstanding | shares | 797,318 |
Weighted average fair value per share | |
Weighted average fair value at the beginning | $ / shares | $ 11.63 |
Granted | $ / shares | 1.83 |
Vested and issued | $ / shares | 11.73 |
Forfeited | $ / shares | 6.80 |
Weighted average fair value at the end | $ / shares | $ 3.03 |
Additional disclosures | |
Total unrecognized compensation related to unvested RSUs | $ | $ 1.4 |
Recognition period | 2 years |
Fair Value | $ | $ 1 |
Share-Based Payments - Share-Ba
Share-Based Payments - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-Based Payments | ||||
Share-based compensation expense | $ 779 | $ 1,227 | $ 2,517 | $ 4,266 |
Research and development | ||||
Share-Based Payments | ||||
Share-based compensation expense | 96 | 240 | 435 | 1,044 |
Selling, general and administrative | ||||
Share-Based Payments | ||||
Share-based compensation expense | $ 683 | $ 987 | $ 2,082 | $ 3,222 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 1 Months Ended | 9 Months Ended |
Aug. 31, 2018 | Sep. 30, 2021 | |
Share-Based Payments | ||
Maximum number of shares authorized under plan (in shares) | 50,000 | |
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 | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Expense | ||||
Income tax (benefit) expense | $ (252) | $ (72) | $ 544 | $ 199 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Basic and Diluted Loss per Share | ||||||||
Net loss for the period | $ (10,652) | $ (11,754) | $ (13,981) | $ (12,951) | $ (15,441) | $ (23,259) | $ (36,387) | $ (51,651) |
Weighted average number of shares outstanding, Basic | 50,526,767 | 14,469,090 | 39,259,729 | 11,745,453 | ||||
Weighted average number of shares outstanding, Diluted | 50,526,767 | 14,469,090 | 39,259,729 | 11,745,453 | ||||
Basic ($ per share) | $ (0.21) | $ (0.90) | $ (0.93) | $ (4.40) | ||||
Diluted ($ per share) | $ (0.25) | $ (0.90) | $ (0.97) | $ (4.40) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock Options | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,281,641 | 1,102,564 | 1,281,641 | 1,102,564 |
Restricted Stock Units ("RSUs") | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 797,318 | 258,804 | 797,318 | 258,804 |
Warrants | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 10,619,347 | 5,438,842 | 10,619,347 | 5,438,842 |
Significant Arrangements and _2
Significant Arrangements and License Agreements (Details) $ in Thousands | Apr. 12, 2021 | Jul. 10, 2020USD ($) | Dec. 31, 2020USD ($) | Mar. 31, 2018USD ($) | Sep. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2021USD ($)employee | Sep. 30, 2020USD ($) | May 31, 2021USD ($) |
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 8,862 | $ 1,291 | $ 19,634 | $ 2,567 | |||||||||
Number of sales representatives | employee | 60 | ||||||||||||
Percentage of lefamulin-treated patients | 4.00% | ||||||||||||
Percentage of moxifloxacin-treated patients | 10.00% | ||||||||||||
Percentage of TEAEs leading to discontinuation were subjects in both treatment arms | 5.00% | ||||||||||||
Collaboration revenue - Upfront payment | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | 7,858 | $ (47) | $ 14,928 | $ 61 | |||||||||
SIVEXTRO | |||||||||||||
License Agreement | |||||||||||||
Percentage of net product sales recognized | 100.00% | ||||||||||||
Sunovion Pharmaceutics Canada, Inc. | Collaboration revenue - Upfront payment | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 1,000 | ||||||||||||
License Agreement | Sunovion Pharmaceutics Canada, Inc. | NDS Approval | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 500 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | |||||||||||||
License Agreement | |||||||||||||
Upfront payment | $ 5,000 | ||||||||||||
Notice period for termination of agreement | 180 days | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Achievement of certain regulatory and commercial milestones | |||||||||||||
License Agreement | |||||||||||||
Maximum contingent milestone payment | 91,500 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Subsequent regulatory approval | |||||||||||||
License Agreement | |||||||||||||
Maximum contingent milestone payment | $ 4,000 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Clinical trial application submission | |||||||||||||
License Agreement | |||||||||||||
Proceeds from license agreement, milestone | $ 1,500 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | FDA approval | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Approval of XENLETA | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | ||||||||||||
Remaining probable of achieving | $ 1,000 | ||||||||||||
Additional revenue recognized | 3,000 | ||||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Additional regulatory approvals and annual sales targets | |||||||||||||
License Agreement | |||||||||||||
Remaining milestone payments | $ 86,000 | 86,000 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Collaboration revenue - Upfront payment | |||||||||||||
License Agreement | |||||||||||||
Revenue accounted for under Topic 606 | $ 3,000 | $ 1,000 | $ 5,000 | ||||||||||
Milestone achieved | $ 1,000 | ||||||||||||
Performance obligation | $ 1,800 |
Commitments and Contingencies (
Commitments and Contingencies (Details) € in Millions, $ in Millions | Aug. 04, 2021EUR (€) | Sep. 30, 2021USD ($) |
Other Commitments and Contingencies | ||
Contingent liabilities | $ | $ 0 | |
Hovione Supply Agreement [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Cash payments made for amendment of agreement | € 3.2 | |
Threshold aggregate royalty payments | 4 | |
Hovione Supply Agreement [Member] | Maximum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Royalty payment | € 10 |