Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 31, 2022 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
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 $0.01 per share | |
Trading Symbol | NBRV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Shares Outstanding | 66,544,703 | |
Entity Central Index Key | 0001641640 | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 20,041 | $ 47,659 |
Restricted cash | 122 | 175 |
Short-term investments | 16 | |
Accounts receivable, net and other receivables | 12,361 | 12,751 |
Inventory | 15,535 | 14,509 |
Prepaid expenses | 6,237 | 5,155 |
Total current assets | 54,296 | 80,265 |
Property and equipment, net | 206 | 233 |
Intangible assets, net | 13 | 31 |
Other non-current assets | 378 | 380 |
Total assets | 54,893 | 80,909 |
Current liabilities: | ||
Current portion of long-term debt | 6,624 | 3,765 |
Accounts payable | 1,073 | 4,372 |
Accrued expense and other current liabilities | 11,635 | 13,829 |
Deferred revenue | 374 | |
Total current liabilities | 19,332 | 22,340 |
Non-current liabilities: | ||
Long-term debt | 512 | 4,265 |
Other non-current liabilities | 444 | 954 |
Total non-current liabilities | 956 | 5,219 |
Total liabilities | 20,288 | 27,559 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Ordinary shares, nominal value $0.01, 300,000,000 ordinary shares authorized at June 30, 2022; 64,580,211 and 56,715,306 issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 646 | 567 |
Preferred shares, nominal value $0.01, 100,000,000 shares authorized at June 30, 2022; None issued and outstanding | ||
Additional paid in capital | 652,501 | 648,432 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (618,569) | (595,676) |
Total stockholders' equity | 34,605 | 53,350 |
Total liabilities and stockholders' equity | $ 54,893 | $ 80,909 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 300,000,000 | 300,000,000 |
Ordinary stock, issued shares | 64,580,211 | 56,715,306 |
Ordinary stock, outstanding shares | 64,580,211 | 56,715,306 |
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 9,191 | $ 8,243 | $ 17,211 | $ 10,772 |
Operating expenses: | ||||
Cost of revenues | (4,455) | (3,621) | (7,816) | (3,683) |
Research and development expenses | (4,088) | (3,150) | (7,605) | (7,018) |
Selling, general and administrative expenses | (11,047) | (12,854) | (23,747) | (24,901) |
Total operating expenses | (19,590) | (19,625) | (39,168) | (35,602) |
Loss from operations | (10,399) | (11,382) | (21,957) | (24,830) |
Other income (expense): | ||||
Other income (expense), net | (92) | 470 | 216 | 348 |
Interest expense, net | (198) | (236) | (413) | (457) |
Loss before income taxes | (10,689) | (11,148) | (22,154) | (24,939) |
Income tax expense | (385) | (606) | (739) | (796) |
Net loss | $ (11,074) | $ (11,754) | $ (22,893) | $ (25,735) |
Loss per share | ||||
Basic loss ($ per share) | $ (0.18) | $ (0.29) | $ (0.38) | $ (0.77) |
Diluted loss ($ per share) | $ (0.18) | $ (0.29) | $ (0.38) | $ (0.77) |
Weighted average number of shares: | ||||
Basic (in shares) | 63,238,080 | 40,573,848 | 61,028,388 | 33,532,837 |
Diluted (in shares) | 63,238,080 | 40,573,848 | 61,028,388 | 33,532,837 |
Product revenue, net | ||||
Revenues: | ||||
Total revenues | $ 8,680 | $ 6,940 | $ 15,720 | $ 7,070 |
Collaboration revenue | ||||
Revenues: | ||||
Total revenues | 96 | 813 | 725 | 2,815 |
Research premium and grant revenue | ||||
Revenues: | ||||
Total revenues | $ 415 | $ 490 | $ 766 | $ 887 |
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, 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 ordinary shares | $ 143 | 37,097 | 37,240 | ||
Issuance of 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 | (25,735) | ||||
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 | ||||
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 ordinary shares | $ 142 | 25,997 | 26,139 | ||
Issuance of 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 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2021 | $ 567 | 648,432 | 27 | (595,676) | 53,350 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2021 | 56,715 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares | $ 49 | 2,172 | 2,221 | ||
Issuance of ordinary shares (in shares) | 4,938 | ||||
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) | 72 | ||||
Equity transaction costs | (127) | (127) | |||
Stock-based compensation expense | 1,000 | 1,000 | |||
Net loss | (11,819) | (11,819) | |||
Stockholders' equity, ending balance at Mar. 31, 2022 | $ 617 | 651,476 | 27 | (607,495) | 44,625 |
Stockholders' equity, ending balance (in shares) at Mar. 31, 2022 | 61,725 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2021 | $ 567 | 648,432 | 27 | (595,676) | 53,350 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2021 | 56,715 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Net loss | (22,893) | ||||
Stockholders' equity, ending balance at Jun. 30, 2022 | $ 646 | 652,501 | 27 | (618,569) | 34,605 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2022 | 64,580 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2022 | $ 617 | 651,476 | 27 | (607,495) | 44,625 |
Stockholders' equity, beginning balance (in shares) at Mar. 31, 2022 | 61,725 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of ordinary shares | $ 28 | 790 | 818 | ||
Issuance of ordinary shares (in shares) | 2,843 | ||||
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 | (82) | (82) | |||
Stock-based compensation expense | 317 | 317 | |||
Net loss | (11,074) | (11,074) | |||
Stockholders' equity, ending balance at Jun. 30, 2022 | $ 646 | $ 652,501 | $ 27 | $ (618,569) | $ 34,605 |
Stockholders' equity, ending balance (in shares) at Jun. 30, 2022 | 64,580 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (22,893) | $ (25,735) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash other income (expense), net | 3 | 73 |
Non-cash interest income | (4) | |
Non-cash interest expense | 222 | 249 |
Depreciation and amortization expense | 155 | 188 |
Amortization of right-of-use assets | 281 | |
Stock-based compensation | 1,334 | 1,738 |
Other, net | (112) | 16 |
Changes in operating assets and liabilities: | ||
(Increase) decrease in other non-current assets | 2 | (10) |
Increase in accounts receivable, net and other receivables and prepaid expenses | (692) | (13,382) |
Increase in inventory | (1,026) | (4,290) |
Decrease in accounts payable | (3,265) | (1,249) |
Increase (decrease) in accrued expenses and other liabilities | (2,155) | 1,630 |
Decrease in deferred revenue | (374) | (187) |
Decrease in other non-current liabilities | (104) | (192) |
Increase in income tax liabilities | 670 | |
Net cash used in operating activities | (28,909) | (40,200) |
Cash flows from investing activities | ||
Purchases of equipment and intangible assets | (99) | (18) |
Changes in restricted cash | (53) | (51) |
Net cash used in investing activities | (152) | (69) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock and warrants | 2,046 | 25,462 |
Proceeds from at-the-market facility | 993 | 37,970 |
Repayments of unexercised warrant nominal values | (406) | |
Repayments of long-term borrowings | (949) | |
Equity transaction costs | (282) | (3,276) |
Net cash provided by financing activities | 1,402 | 60,156 |
Effects of exchange rate changes on the balance of cash held in foreign currencies | (12) | (157) |
Net increase/(decrease) in cash, cash equivalents and restricted cash | (27,671) | 19,730 |
Cash, cash equivalents, and restricted cash at beginning of period | 47,834 | 41,590 |
Cash, cash equivalents and restricted cash at end of period | 20,163 | 61,320 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 240 | 248 |
Taxes paid | 853 | |
Equity transaction costs included in accounts payable and accrued expenses | $ 639 | $ 806 |
Organization and Business Activ
Organization and Business Activities | 6 Months Ended |
Jun. 30, 2022 | |
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., or Zavante, 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. In July 2022, On April 22, 2022, the Company agreed to an extension of the Sales Promotion and Distribution Agreement with MSD International GmbH and Merck Sharp & Dohme Corp. for exclusive distribution of SIVEXTRO® for injection, intravenous use and oral use, in the SIVEXTRO Territory (as defined below) through at least December 31, 2026. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of ABSSSI caused by certain susceptible Gram-positive microorganisms. In September 2021, Sumitomo Pharmaceuticals (Suzhou) and the Company 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 September 2020, the Centers for Medicare & Medicaid Services, or CMS, granted a new technology add-on payment, or NTAP, for XENLETA® (lefamulin) for injection, when administered in the hospital inpatient setting. Both the intravenous, or IV, and oral formulations of XENLETA were granted Qualified Infectious Disease Product, or QIDP, and Fast Track designation by the U.S. Food and Drug Administration, or FDA. NTAP was also granted for CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD), making it the first QIDP antibiotic to be granted conditional NTAP approval prior to receiving FDA approval. CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections, or cUTIs, including acute pyelonephritis. In July 2020, the Company announced that the European Commission, or EC, issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia, or CAP, in adults following a review by the European Medicines Agency, or EMA. The EMA approval of XENLETA in CAP patients when it is considered inappropriate to use antibacterial agents that are commonly recommended for initial treatment or when these agents have failed paves the way for the launch of XENLETA across the European Economic Area, or EEA, and United Kingdom, or U.K. The EC approved XENLETA for all countries of the European Economic Area, or EEA, and United Kingdom, or U.K. Nabriva intends to work with a commercial partner to make XENLETA available to patients in the European Economic Area, or EEA, and United Kingdom, or U.K. In July 2020, the Company announced that Sunovion Pharmaceuticals Canada Inc., or Sunovion, received approval from Health Canada to market oral and IV formulations of XENLETA® (lefamulin) for the treatment of CAP in adults, with the Notice of Compliance from Health Canada dated July 10, 2020. Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. In July 2020, the Company announced that it 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. Under the Distribution Agreement, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient previously marketed and sold by Supplier and MSD under the trademark SIVEXTRO® for injection, intravenous use and oral use in the United States and its territories. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms. Nabriva has also engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA® in the United States. In June 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® (lefamulin) 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. In September 2019, the Company announced that the oral and IV formulations of XENLETA (lefamulin) are available in the United States for the treatment of community-acquired bacterial pneumonia, or CABP, through major specialty distributors. This followed the approval by the FDA of the Company’s New Drug Application, or NDA, for XENLETA on August 19, 2019 for the treatment of adults with CABP. XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics available for the systematic administration in humans. 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 and XENLETA and SEVEXTRO product sales. As of June 30, 2022, the Company had cash, cash equivalents and restricted cash of $20.2 million. The Company expects to seek additional funding in future periods to fund its operations. While the Company has raised capital in the past, its ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements Going Concern The Company follows the provisions of Financial Accounting Standards Board, or FASB, ASC 205-40 , In May 2021, the Company entered into an Open Market Sale Agreement SM under the Securities Act of 1933, as amended. As of June 30, 2022, the Company has issued and sold an aggregate of 21,214,105 ordinary shares pursuant to the Sale Agreement and received gross proceeds of $31.4 million and net proceeds of $30.1 million, after deducting commissions to Jefferies and other offering expenses. From July 1, 2022 and through the date of this filing, the Company has issued and sold an aggregate of 1,963,374 ordinary shares pursuant to the Sale Agreement and received gross proceeds of $0.4 million and net proceeds of $0.4 million, after deducting commissions to Jefferies and other offering expenses. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $9.8 million under the Sale Agreement. 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. As of June 30, 2022, the Company has issued and sold an aggregate of 7,200,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $4.5 million. From July 1, 2022 and through the date of this filing, the Company did not sell any shares under the Purchase Agreement. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $18.6 million under the Purchase Agreement, subject to the Nasdaq rules which may limit the Company’s ability to make sales of its ordinary shares to Lincoln Park in excess of a specified amount without prior shareholder approval. Based on its current operating plans, the Company expects that its existing cash, cash equivalents and restricted cash as of the filing date of this Quarterly Report on Form 10-Q together with its anticipated SIVEXTRO and XENLETA commercial sales receipts will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements substantially through the fourth 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 | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 are unaudited. The December 31, 2021 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2022 and results of operations for the three and six months ended June 30, 2022 and 2021. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2022 and 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, 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, 2021 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 29, 2022. 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, 2021. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company has not adopted any new accounting pronouncements for the six months ended June 30, 2022. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022, the Company had a $1.1 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 June 30, 2022 and December 31, 2021 consisted of the following: As of As of June 30, December 31, (in thousands) 2022 2021 XENLETA raw materials $ 913 $ 1,528 XENLETA work in process 9,532 9,142 XENLETA finished goods 333 18 Total XENLETA 10,778 10,688 SIVEXTRO finished goods 4,757 3,821 Total inventory $ 15,535 $ 14,509 |
Fair Value Measurement
Fair Value Measurement | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 Assets: Cash equivalent: Money market fund $ 3,066 $ — $ — $ 3,066 Total assets $ 3,066 $ — $ — $ 3,066 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2021 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 levels in the six months ended June 30, 2022 or the year ended December 31, 2021. There were no changes in valuation techniques during the six months ended June 30, 2022. As of June 30, 2022, and December 31, 2021, 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 Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities include the following: As of June 30, As of December 31, (in thousands) 2022 2021 Research and development related costs $ 1,039 $ 789 Payroll and related costs 3,345 5,085 Accounting, tax and audit services 713 736 Manufacturing and inventory 855 592 Product returns 1,087 2,282 Government rebates 2,195 1,751 Other accrued gross to net 1,428 1,090 Other 973 1,504 Total other current liabilities $ 11,635 $ 13,829 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2022 | |
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 $10.0 million became available upon the approval by the FDA of the NDA for XENLETA, which was drawn down. The other t ranches are no longer available as their contingencies were not achieved. 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 FDA 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. The Company began making interest and principal payments in April 2022. 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 certain 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 June 30, 2022. The Loan Agreement also grants Hercules or its nominee an option to purchase up to an aggregate of $2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in any private financing upon the same terms and conditions afforded to such other investors for as long as there are amounts outstanding under the Loan Agreement. The Company incurred $1.3 million of costs in connection with the Loan Agreement which along with the initial fee of $0.7 million paid to Hercules were recorded as debt issuance cost and are being amortized as interest expense using the effective interest method over the term of the loan. The carrying value of the term loan payable at June 30, 2022 includes the present value of the End of Term Fee and the Prepayment Fee. The End of Term Fee on the remaining $4.1 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 June 30, 2022 and December 31, 2021 consisted of the following: As of As of June 30, December 31, (in thousands) 2022 2021 Term loan payable $ 4,051 $ 5,000 End of term fee 2,472 2,331 Unamortized debt issuance costs (87) (145) Carrying value of term loan 6,436 7,186 Other long-term debt 700 844 Less: Amounts due within one year (6,624) (3,765) Total long-term debt $ 512 $ 4,265 Maturities of long-term debt, including the end of term fee as of June 30, 2022 were as follows: (in thousands) 2022 $ 2,060 2023 $ 4,987 2024 $ 175 2025 $ 175 |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Revenue | |
Revenue | 7. Revenues Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Product revenue, net $ 8,680 $ 6,940 $ 15,720 $ 7,070 Collaboration revenues 96 813 725 2,815 Research premium and grant revenue 415 490 766 887 Total revenues $ 9,191 $ 8,243 $ 17,211 $ 10,772 Collaboration revenues for the six months ended June 30, 2022 were $0.7 million which includes collaboration revenues related to the restructured China Region License Agreement, a portion of which was recognized over the estimated period of the manufacturing collaboration and regulatory support that has been provided to Sumitomo Pharmaceuticals (Suzhou) (see Note 11). Collaboration revenues for the six months ended June 30, 2021 included $1.6 million related to the restructured license agreement with Sinovant Sciences, Ltd., or Sinovant, which is recognized over the estimated period the manufacturing collaboration and regulatory support will be provided to Sinovant, as well as $1.2 million of the Company’s share of revenues associated with the SIVEXTRO distribution agreement with Merck & Co., Inc. 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. For the six months ended June 30, 2022 and 2021, SIVEXTRO product revenues, net of gross-to-net accruals and adjustments for returns were $15.7 million and $6.9 million, respectively. For the six months ended June 30, 2022 and 2021 XENLETA product revenues, net of gross-to-net accruals and adjustments for returns, were $14 thousand and $0.2 million, respectively. 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 six months ended June 30, 2022, the Company recorded a $0.3 million returns reserve adjustment for shelf life expiration of certain XENLETA products. For the six months ended June 30, 2021, the Company recorded a $0.1 million returns reserve adjustment for shelf life expiration of certain XENLETA products. |
Share-Based Payments
Share-Based Payments | 6 Months Ended |
Jun. 30, 2022 | |
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 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. 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 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 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 the 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 2020 AGM and the number of ordinary shares subject to awards granted under the 2017 Plan and the 2015 SOP, 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. The Company granted RSUs to certain employees which vest as to 25% of the shares underlying the RSUs in four annual increments. 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. During the six months ended June 30, 2022, option awards to purchase 592,000 ordinary shares with an exercise price of $0.45 per share and 295,900 RSUs were granted under the 2020 Plan, subject to shareholder approval, which, in the case of the options, will automatically convert to cash-settled share appreciation rights and, in the case of the RSUs, will represent the right to receive the economic equivalent of one ordinary share of the Company in cash on the applicable vesting date, in each case, if our shareholders do not approve the increase to our 2020 Plan at our 2022 Annual General Meeting of Shareholders. As a result, such grants awarded under the 2020 Plan are liability classified until such shareholder approval is obtained. Stock-based compensation expense for liability classified option awards and RSUs under the 2020 Plan was $42 thousand for the six months ended June 30, 2022. At June 30, 2022, 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 Stock Options The following table summarizes information regarding the Company’s stock option awards for the six months ended June 30, 2022: 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, 2022 1,348,477 20.46 8.0 — Granted 604,000 0.45 — Exercised — — — Cancelled and forfeited (1,284) 13.99 — Outstanding as of June 30, 2022 1,951,193 14.26 8.2 $ — Vested and exercisable as of June 30, 2022 620,517 40.57 6.8 $ — The Company has 1,951,193 option grants outstanding at June 30, 2022 with exercise prices ranging from $0.45 per share to $110.00 per share. As of June 30, 2022, there was $1.2 million of total unrecognized compensation expense related to unvested stock options, which will be recognized over the weighted-average remaining vesting period of 0.8 years. The stock options granted in the six months ended June 30, 2022 had a weighted average grant date fair value of $0.44 per share based on a Black Scholes option pricing model. The significant inputs into the model were as follows Expected volatility 76.4% - 76.9% Expected term of options (in years) 6.1 Range of risk-free interest rate 1.68% - 1.76% Dividend yield — The expected price volatility is based on historical trading volatility of our ordinary shares under consideration of the remaining life of the options. The risk-free interest rate is based on the average of five Restricted Share Units (“RSUs”) The following table summarizes information regarding the Company’s restricted share unit awards for the six months ended June 30, 2022: Weighted average fair RSUs value in $ per share Outstanding as of January 1, 2022 789,738 2.92 Granted 489,300 0.44 Vested and issued (102,013) 4.70 Forfeited (4,507) 2.21 Outstanding as of June 30, 2022 1,172,518 1.77 The Company has total unrecognized compensation costs of $0.8 million associated with RSUs which are expected to be recognized over the awards average remaining vesting period of 1.3 years. The intrinsic value of RSU’s that vested during the six months ended June 30, 2022 was $44 thousand. Stock-based Compensation The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Six Months Ended June 30, (in thousands) 2022 2021 Research and development expense $ 161 $ 339 Selling, general and administrative expense 1,173 1,399 Total stock-based compensation expense $ 1,334 $ 1,738 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 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. The Company suspended the 2018 ESPP in April 2020. |
Income Tax Expense
Income Tax Expense | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Expense | |
Income Tax Expense | 9. Income Tax Expense For the three and six months ended June 30, 2022, the Company recorded a tax expense of $0.4 million and $0.7 million, respectively. For the three and six months ended June 30, 2021, the Company recorded a tax expense of $0.6 million and $0.8 million, respectively. Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of its deferred tax assets. On the basis of this evaluation the Company has recorded a valuation allowance against all of its deferred tax assets at June 30, 2022 and December 31, 2021. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 10. Earnings (Loss) per Share Basic and Diluted Loss per Share For the three and six months ended June 30, 2022 and 2021, basic and diluted net loss per share was determined by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share is the same as basic net loss per share during the periods presented as the effects of the Company’s potential ordinary share equivalents are antidilutive since the Company had net losses for each period presented below. Three Months Ended Six Months Ended June 30, June 30, (in thousands, except per share data) 2022 2021 2022 2021 Net loss for the period $ (11,074) $ (11,754) $ (22,893) $ (25,735) Weighted average number of shares outstanding 63,238,080 40,573,848 61,028,388 33,532,837 Basic and diluted loss per share $ (0.18) $ (0.29) $ (0.38) $ (0.77) The following ordinary share equivalents were excluded from the calculations of diluted loss per share as their effect would be anti-dilutive since the Company had net losses for each period presented below: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stock option awards 1,951,193 948,682 1,951,193 948,682 Restricted share units 1,172,518 741,484 1,172,518 741,484 Warrants 6,559,815 10,619,347 6,559,815 10,619,347 |
Significant Arrangements and Li
Significant Arrangements and License Agreements | 6 Months Ended |
Jun. 30, 2022 | |
Significant Arrangements and License Agreements | |
Significant Arrangements and License Agreements | 11. Significant Arrangements and License Agreements Er-Kim License Agreement 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. On April 22, 2022, the Company agreed to an extension of the Sales Promotion and Distribution Agreement with MSD International GmbH and Merck Sharp & Dohme Corp. for exclusive distribution of SIVEXTRO® for injection, intravenous use and oral use, in the SIVEXTRO Territory through at least December 31, 2026. 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 continues to operate a virtual and in-person sales effort with community-based expertise with Amplity Health, which is a contract sales organization, with a small and focused sales effort for SIVEXTRO and XENLETA. The Company expanded this effort to 60 sales representatives and may expand it further. The Company also piloted a virtual promotion effort with its own sales representatives in the third quarter of 2021 and engaged in-house district managers in April 2022. 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., or 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. During 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 $0.6 million for the six months ended June 30, 2022, 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 certain products containing XENLETA in the forms clinically developed by us or any of our affiliates, or the Sunovion Licensed Products, in Canada in all uses in humans in CABP and in any other indication for which the Sunovion 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 Sunovion 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, Canada, Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia. 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 | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies The Company has contractual commitments related primarily to contracts entered into with contract manufacturing organizations and contract research organizations in connection with the commercial manufacturing of XENLETA, the purchase of SIVEXTRO finished product and other research and development activities. The payments to the service providers are based on the achievement of milestones included within the agreements. Also, some of these contracts are subject to early termination clauses exercisable at the discretion of the Company. XENLETA API Supply 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. Zavante Ob l igations In connection with the acquisition of Zavante in July 2018, the Company is obligated to pay up to $97.5 million in contingent consideration to the former Zavante shareholders, of which $25.0 million would become payable upon the first approval of a NDA from the FDA for CONTEPO for any indication, or the Approval Milestone Payment, and an aggregate of up to $72.5 million would become payable upon the achievement of specified sales milestones, or the Net Sales Milestone Payments. The Company’s shareholders have approved the issuance of the Company’s ordinary shares in settlement of potential milestone payment obligations that may become payable in the future to former Zavante stockholders, including the Approval Milestone Payment which will be settled in Company ordinary shares. The Company also has the right to settle the Net Sales Milestone Payments in Company ordinary shares, except as otherwise provided in the Merger Agreement. The Company is obligated to pay $3.0 million in cash upon marketing approval by the FDA with respect to any oral, intravenous or other form of fosfomycin, or the Zavante Products, and milestone payments of up to $26.0 million that may be settled in ordinary shares in the aggregate upon the occurrence of various specified levels of net sales with respect to the Zavante Products. In addition, Zavante is obligated to make annual royalty payments of a mid-single-digit percentage of net sales of Zavante Products, subject to adjustment based on net sales thresholds and with such percentage reduced to low single-digits if generic fosfomycin products account for half of the applicable market on a product-by-product and country-by-country basis. Zavante will also pay a mid-single-digit percentage of transaction revenue in connection with the consummation of the grant, sale, license or transfer of market exclusivity rights for a qualified infectious disease product (within the meaning of the 21st Century Cures Act) related to a Zavante Product. Litigation As of the date of the filing this Quarterly Report on Form 10-Q, there are no material outstanding legal proceedings against the Company or its current officers or directors. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On July 13, 2022, The Company received written notice from Nasdaq on January 4, 2022 indicating that, based on the closing bid price for the last 30 consecutive business days, the Company was not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Global Select Market, as set forth in Listing Rule 5450(a)(1) the (“Bid Price Rule”). The Notice did not result in the immediate delisting of the Company’s ordinary shares from the Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), the Company was provided a period of 180 calendar days, or until July 5, 2022 (the “Initial Compliance Date”), to regain compliance with the Bid Price Rule. The Company did not regain compliance with the Bid Price Rule by the Initial Compliance Date. On July 6, 2022, Nasdaq notified the Company that it is eligible for an additional 180 calendar day period, or until January 2, 2023 (the “Extended Compliance Date”), to regain compliance with the Bid Price Rule. Nasdaq’s determination was based on, among other things, (1) the Company’s written notice of its intention to transfer to the Nasdaq Capital Market and to cure the deficiency by the Extended Compliance Date by effecting a reverse stock split, if necessary and (2) the Company meeting the continued listing requirement for market value of publicly held shares and all other initial listing requirements for the Nasdaq Capital Market, with the exception of the Bid Price Rule. On July 6, 2022, Nasdaq approved the Company’s transfer from the Nasdaq Global Select Market to the Nasdaq Capital Market, a continuous trading market that operates in substantially the same manner as the Nasdaq Global Select Market. The transfer was effective at the opening of business on July 8, 2022. The Company’s ordinary shares continue to trade under the symbol “NBRV.” If, at any time before the Extended Compliance Date, the bid price for the Company’s ordinary shares closes at $1.00 or more for a minimum of 10 consecutive business days as required under the Compliance Period Rule, Nasdaq will provide written notification to the Company that it complies with the Bid Price Rule. If the Company does not regain compliance with the Bid Price Rule by the Extended Compliance Date, Nasdaq will provide written notification to the Company that its ordinary shares will be delisted. At that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq hearing panel. The Company expects that its ordinary shares would remain listed on the Nasdaq Capital Market pending a Nasdaq hearing panel’s decision. There can be no assurance that, if the Company does appeal a delisting determination to a Nasdaq hearing panel, that such appeal would be successful. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 are unaudited. The December 31, 2021 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2022 and results of operations for the three and six months ended June 30, 2022 and 2021. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2022 and 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, 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, 2021 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 29, 2022. 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, 2021. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company has not adopted any new accounting pronouncements for the six months ended June 30, 2022. |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory | |
Schedule of inventory | As of As of June 30, December 31, (in thousands) 2022 2021 XENLETA raw materials $ 913 $ 1,528 XENLETA work in process 9,532 9,142 XENLETA finished goods 333 18 Total XENLETA 10,778 10,688 SIVEXTRO finished goods 4,757 3,821 Total inventory $ 15,535 $ 14,509 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 Assets: Cash equivalent: Money market fund $ 3,066 $ — $ — $ 3,066 Total assets $ 3,066 $ — $ — $ 3,066 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2021 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 Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other liabilities | As of June 30, As of December 31, (in thousands) 2022 2021 Research and development related costs $ 1,039 $ 789 Payroll and related costs 3,345 5,085 Accounting, tax and audit services 713 736 Manufacturing and inventory 855 592 Product returns 1,087 2,282 Government rebates 2,195 1,751 Other accrued gross to net 1,428 1,090 Other 973 1,504 Total other current liabilities $ 11,635 $ 13,829 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt | |
Schedule of long-term debt | As of As of June 30, December 31, (in thousands) 2022 2021 Term loan payable $ 4,051 $ 5,000 End of term fee 2,472 2,331 Unamortized debt issuance costs (87) (145) Carrying value of term loan 6,436 7,186 Other long-term debt 700 844 Less: Amounts due within one year (6,624) (3,765) Total long-term debt $ 512 $ 4,265 |
Schedule of maturities of long-term debt | (in thousands) 2022 $ 2,060 2023 $ 4,987 2024 $ 175 2025 $ 175 |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue | |
Summary of revenue by type | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Product revenue, net $ 8,680 $ 6,940 $ 15,720 $ 7,070 Collaboration revenues 96 813 725 2,815 Research premium and grant revenue 415 490 766 887 Total revenues $ 9,191 $ 8,243 $ 17,211 $ 10,772 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 1,348,477 20.46 8.0 — Granted 604,000 0.45 — Exercised — — — Cancelled and forfeited (1,284) 13.99 — Outstanding as of June 30, 2022 1,951,193 14.26 8.2 $ — Vested and exercisable as of June 30, 2022 620,517 40.57 6.8 $ — |
Summary of assumptions used for valuation of options | Expected volatility 76.4% - 76.9% Expected term of options (in years) 6.1 Range of risk-free interest rate 1.68% - 1.76% Dividend yield — |
Summary of information regarding restricted stock awards | Weighted average fair RSUs value in $ per share Outstanding as of January 1, 2022 789,738 2.92 Granted 489,300 0.44 Vested and issued (102,013) 4.70 Forfeited (4,507) 2.21 Outstanding as of June 30, 2022 1,172,518 1.77 |
Schedule of allocation of share-based compensation expense | Six Months Ended June 30, (in thousands) 2022 2021 Research and development expense $ 161 $ 339 Selling, general and administrative expense 1,173 1,399 Total stock-based compensation expense $ 1,334 $ 1,738 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, (in thousands, except per share data) 2022 2021 2022 2021 Net loss for the period $ (11,074) $ (11,754) $ (22,893) $ (25,735) Weighted average number of shares outstanding 63,238,080 40,573,848 61,028,388 33,532,837 Basic and diluted loss per share $ (0.18) $ (0.29) $ (0.38) $ (0.77) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Stock option awards 1,951,193 948,682 1,951,193 948,682 Restricted share units 1,172,518 741,484 1,172,518 741,484 Warrants 6,559,815 10,619,347 6,559,815 10,619,347 |
Organization and Business Act_2
Organization and Business Activities (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
Aug. 03, 2022 USD ($) | Aug. 03, 2022 USD ($) shares | Sep. 30, 2021 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) shares | Jun. 30, 2021 USD ($) | Jul. 13, 2022 country | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Liquidity | ||||||||||||
Cash and cash equivalents and restricted cash | $ 20,163 | $ 61,320 | $ 20,163 | $ 61,320 | $ 47,834 | $ 41,590 | ||||||
Proceeds from at-the-market facility | $ 993 | $ 37,970 | ||||||||||
Shares issued | $ 818 | $ 2,221 | $ 26,139 | $ 37,240 | ||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | ||||||||||||
Liquidity | ||||||||||||
Number of shares issued | shares | 7,200,000 | |||||||||||
Net proceeds from sale of stock | $ 4,500 | |||||||||||
Commitment shares | shares | 632,474 | |||||||||||
Commitment share price | $ / shares | $ 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 | |||||||||||
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 | |||||||||||
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 | |||||||||||
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 | |||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | ||||||||||||
Liquidity | ||||||||||||
Number of shares issued | shares | 21,214,105 | |||||||||||
Proceeds from at-the-market facility | $ 30,100 | |||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 31,400 | |||||||||||
Subsequent Event | ||||||||||||
Liquidity | ||||||||||||
Number of countries, exclusive rights are distributed. | country | 9 | |||||||||||
Number of additional countries rights are distributed | country | 5 | |||||||||||
Subsequent Event | Jefferies LLC | At-the-market offering | Maximum | ||||||||||||
Liquidity | ||||||||||||
Ordinary shares remained unsold | $ 9,800 | |||||||||||
Subsequent Event | Lincoln Park Capital Fund, LLC | Purchase agreement | Maximum | ||||||||||||
Liquidity | ||||||||||||
Ordinary shares remained unsold | $ 18,600 | |||||||||||
Subsequent Event | Open Market Sale Agreement | Jefferies LLC | Ordinary shares | ||||||||||||
Liquidity | ||||||||||||
Number of shares issued | shares | 1,963,374 | |||||||||||
Proceeds from at-the-market facility | $ 400 | |||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 400 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Total inventory | $ 15,535 | $ 14,509 |
Obsolete inventory non-cash reserve | 1,100 | |
XENLETA | ||
Inventory [Line Items] | ||
Raw materials | 913 | 1,528 |
Work in process | 9,532 | 9,142 |
Finished goods | 333 | 18 |
Total inventory | 10,778 | 10,688 |
SIVEXTRO | ||
Inventory [Line Items] | ||
Finished goods | $ 4,757 | $ 3,821 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Short-term investments: | ||
Transfer of assets from Level 1 to 2 | $ 0 | $ 0 |
Transfer of assets from Level 2 to 1 | 0 | 0 |
Recurring | ||
Cash equivalent: | ||
Money market funds | 3,066 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | |
Total assets | 3,066 | 8,066 |
Level 1 | Recurring | ||
Cash equivalent: | ||
Money market funds | 3,066 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | |
Total assets | $ 3,066 | $ 8,066 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 1,039 | $ 789 |
Payroll and related costs | 3,345 | 5,085 |
Accounting, tax and audit services | 713 | 736 |
Manufacturing and inventory | 855 | 592 |
Product returns | 1,087 | 2,282 |
Government rebates | 2,195 | 1,751 |
Other accrued gross to net | 1,428 | 1,090 |
Other | 973 | 1,504 |
Total other current liabilities | $ 11,635 | $ 13,829 |
Debt - Summary (Details)
Debt - Summary (Details) - Term loan - USD ($) | 1 Months Ended | 6 Months Ended | ||||
Jun. 02, 2021 | Mar. 11, 2020 | Feb. 29, 2020 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2018 | |
Debt | ||||||
End of term fee | $ 4,051,000 | $ 5,000,000 | ||||
Loan Agreement | ||||||
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 | |||||
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% | 80% | ||||
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 | |||||
End of term fee | $ 4,100,000 | |||||
Loan Agreement | Prime rate | ||||||
Debt | ||||||
Variable rate basis | 5.50% | |||||
Variable interest rate margin (as a percent) | 9.80% | |||||
Variable rate adjustment (as a percent) | 5.50% | |||||
Loan Agreement | Initial Advance | ||||||
Debt | ||||||
Principal amount of advances outstanding | $ 25,000,000 | |||||
Loan Agreement | Tranche 7 Advance | ||||||
Debt | ||||||
Additional tranches | $ 10,000,000 | |||||
Loan Agreement | Prepayment during the first 12 months following initial closing | ||||||
Debt | ||||||
Prepayment penalty as a percentage of the amount being repaid | 3% | |||||
Loan Agreement | 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% | |||||
Loan Agreement | Prepayment after the first 24 months following initial closing but before maturity | ||||||
Debt | ||||||
Prepayment penalty as a percentage of the amount being repaid | 1% |
Debt - Long-Term Debt (Details)
Debt - Long-Term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Long-term debt | ||
Less: Amounts due within one year | $ (6,624) | $ (3,765) |
Long-term debt | 512 | 4,265 |
Maturities of long-term debt | ||
2022 | 2,060 | |
2023 | 4,987 | |
2024 | 175 | |
2025 | 175 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 4,051 | 5,000 |
End of term fee | 2,472 | 2,331 |
Unamortized debt issuance costs | (87) | (145) |
Carrying value of term loan | 6,436 | 7,186 |
Other long-term debt | ||
Long-term debt | ||
Carrying value of term loan | $ 700 | $ 844 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Dec. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2020 | Mar. 31, 2019 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue | |||||||
Revenue accounted for under Topic 606 | $ 9,191 | $ 8,243 | $ 17,211 | $ 10,772 | |||
Product revenue, net | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 8,680 | 6,940 | 15,720 | 7,070 | |||
Collaboration revenue | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 96 | 813 | 725 | 2,815 | |||
Collaboration revenue | Sinovant Sciences, LTD | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 1,600 | ||||||
Collaboration revenue | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 700 | ||||||
Collaboration revenue | Merck & Co | License Agreement | |||||||
Revenue | |||||||
Revenue accounted for under Topic 606 | 1,200 | ||||||
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 | $ 415 | $ 490 | $ 766 | $ 887 |
Revenue - Summary of Gross-To-N
Revenue - Summary of Gross-To-Net ("GTN") Adjustments (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
XENLETA | ||
Disaggregation of Revenue [Line Items] | ||
GTN accrual adjustments | $ 14 | $ 200 |
Returns reserve & GTN accrual adjustments | 300 | 100 |
SIVEXTRO | ||
Disaggregation of Revenue [Line Items] | ||
GTN accrual adjustments | $ 15,700 | $ 6,900 |
Share-Based Payments - Stock Pl
Share-Based Payments - Stock Plan Activity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Jul. 31, 2018 $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2021 USD ($) | Dec. 31, 2020 tranche | Dec. 31, 2018 | Dec. 31, 2021 $ / shares | Sep. 30, 2021 shares | Aug. 31, 2021 shares | Dec. 09, 2020 shares | Mar. 04, 2020 shares | Mar. 12, 2019 shares | |
Share-Based Payments | |||||||||||
Share-based compensation expense | $ | $ 1,334 | $ 1,738 | |||||||||
Stock Options | |||||||||||
Share-Based Payments | |||||||||||
Options granted during the period | 604,000 | ||||||||||
Options exercise price (in dollars per share) | $ / shares | $ 14.26 | $ 20.46 | |||||||||
Restricted Share Units ("RSUs") | |||||||||||
Share-Based Payments | |||||||||||
Restricted stock granted during the period | 489,300 | ||||||||||
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% | ||||||||||
Stock Option Plan 2015 | Stock Options | Vesting period, years 2-4 | |||||||||||
Share-Based Payments | |||||||||||
Percentage that vests during the period | 75% | ||||||||||
Monthly vesting percentage | 2.083% | ||||||||||
Stock Option Plan 2015 | Maximum | Stock Options | |||||||||||
Share-Based Payments | |||||||||||
Exercise period | 10 years | ||||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | |||||||||||
Share-Based Payments | |||||||||||
Vesting period | 4 years | ||||||||||
Percentage that vests during the period | 25% | ||||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Immediate vesting upon regulatory approval | CONTEPO | |||||||||||
Share-Based Payments | |||||||||||
Percentage that vests during the period | 50% | ||||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | CONTEPO | |||||||||||
Share-Based Payments | |||||||||||
Percentage that vests during the period | 50% | ||||||||||
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% | ||||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year two | |||||||||||
Share-Based Payments | |||||||||||
Percentage that vests during the period | 75% | ||||||||||
Monthly vesting period | 36 months | ||||||||||
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 | Stock Options | |||||||||||
Share-Based Payments | |||||||||||
Options granted during the period | 592,000 | ||||||||||
Options exercise price (in dollars per share) | $ / shares | $ 0.45 | ||||||||||
Share-based compensation expense | $ | $ 42 | ||||||||||
2020 Share Incentive Plan | Restricted Share Units ("RSUs") | |||||||||||
Share-Based Payments | |||||||||||
Restricted stock granted during the period | 295,900 | ||||||||||
2020 Share Incentive Plan | Restricted Share Units ("RSUs") | Chief Executive Officer | |||||||||||
Share-Based Payments | |||||||||||
Percentage that vests during the period | 50% | ||||||||||
Restricted stock granted during the period | 7,000 | ||||||||||
2020 Share Incentive Plan | Restricted Share Units ("RSUs") | Employees | |||||||||||
Share-Based Payments | |||||||||||
Vesting period | 6 months | ||||||||||
Percentage that vests during the period | 25% | ||||||||||
Number of vesting periods | tranche | 3 | ||||||||||
2020 Share Incentive Plan | Ordinary shares | |||||||||||
Share-Based Payments | |||||||||||
Shares reserved for future issuance | 83,052 | ||||||||||
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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Fair Value Assumptions | ||
Expected term of options (in years) | 6 years 1 month 6 days | |
Minimum | ||
Fair Value Assumptions | ||
Expected volatility | 76.40% | |
Range of risk-free interest rate | 1.68% | |
Maximum | ||
Fair Value Assumptions | ||
Expected volatility | 76.90% | |
Range of risk-free interest rate | 1.76% | |
Stock Options | ||
Options | ||
Outstanding at beginning of year (in shares) | 1,348,477 | |
Granted (in shares) | 604,000 | |
Cancelled and forfeited (in shares) | (1,284) | |
Outstanding at end of year (in shares) | 1,951,193 | 1,348,477 |
Vested and exercisable at end of year (in shares) | 620,517 | |
Weighted average exercise price in $ per share | ||
Outstanding balance at beginning of year (in dollars per share) | $ 20.46 | |
Granted (in dollars per share) | 0.45 | |
Cancelled and forfeited(in dollars per share) | 13.99 | |
Outstanding balance at end of year (in dollars per share) | 14.26 | $ 20.46 |
Vested and exercisable balance at end of year (in dollars per share) | $ 40.57 | |
Weighted Average Remaining Contractual Term (in years) | ||
Weighted average remaining contractual term, outstanding | 8 years 2 months 12 days | 8 years |
Weighted average remaining contractual term, vested and exercisable | 6 years 9 months 18 days | |
Additional disclosures | ||
Total unrecognized compensation related to unvested options | $ 1.2 | |
Recognition period | 9 months 18 days | |
Weighted-average grant date fair value (in dollars per share) | $ 0.44 | |
Stock Options | Exercise Price Range From 0.45 To 110.0 [Member] | ||
Additional disclosures | ||
Exercise price maximum range | 110 | |
Exercise price minimum range | $ 0.45 | |
Stock Options | Minimum | ||
Fair Value Assumptions | ||
Risk-free interest rate average market yield term | 5 years | |
Stock Options | Maximum | ||
Fair Value Assumptions | ||
Risk-free interest rate average market yield term | 7 years |
Share-Based Payments - Restrict
Share-Based Payments - Restricted Share Units (Details) - Restricted Share Units ("RSUs") $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | |
Restricted Stock Units | |
Number of shares outstanding | shares | 789,738 |
Granted | shares | 489,300 |
Vested and issued | shares | (102,013) |
Forfeited | shares | (4,507) |
Number of shares outstanding | shares | 1,172,518 |
Weighted average grant date fair value per share | |
Weighted average fair value per share at the beginning | $ / shares | $ 2.92 |
Granted | $ / shares | 0.44 |
Vested and issued | $ / shares | 4.70 |
Forfeited | $ / shares | 2.21 |
Weighted average fair value per share at the end | $ / shares | $ 1.77 |
Additional disclosures | |
Total unrecognized compensation related to unvested RSUs | $ | $ 800 |
Recognition period | 1 year 3 months 18 days |
Intrinsic value vested | $ | $ 44 |
Share-Based Payments - Share-Ba
Share-Based Payments - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share-Based Payments | ||
Share-based compensation expense | $ 1,334 | $ 1,738 |
Research and development | ||
Share-Based Payments | ||
Share-based compensation expense | 161 | 339 |
Selling, general and administrative | ||
Share-Based Payments | ||
Share-based compensation expense | $ 1,173 | $ 1,399 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 1 Months Ended | 6 Months Ended |
Aug. 31, 2018 | Jun. 30, 2022 | |
Share-Based Payments | ||
Maximum number of shares authorized under plan (in shares) | 50,000 | |
Purchase discount as a percentage of current market price | 15% |
Income Tax Expense (Details)
Income Tax Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Expense | ||||
Income tax expense | $ 385 | $ 606 | $ 739 | $ 796 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Basic and Diluted Loss per Share | ||||||
Net loss for the period | $ (11,074) | $ (11,819) | $ (11,754) | $ (13,981) | $ (22,893) | $ (25,735) |
Weighted average number of shares outstanding, Basic | 63,238,080 | 40,573,848 | 61,028,388 | 33,532,837 | ||
Weighted average number of shares outstanding, Diluted | 63,238,080 | 40,573,848 | 61,028,388 | 33,532,837 | ||
Basic loss ($ per share) | $ (0.18) | $ (0.29) | $ (0.38) | $ (0.77) | ||
Diluted loss ($ per share) | $ (0.18) | $ (0.29) | $ (0.38) | $ (0.77) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock Options | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,951,193 | 948,682 | 1,951,193 | 948,682 |
Restricted Share Units ("RSUs") | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,172,518 | 741,484 | 1,172,518 | 741,484 |
Warrants | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 6,559,815 | 10,619,347 | 6,559,815 | 10,619,347 |
Significant Arrangements and _2
Significant Arrangements and License Agreements (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Apr. 12, 2021 | Jul. 10, 2020 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2019 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Sep. 30, 2019 USD ($) | Mar. 31, 2019 USD ($) | Jun. 30, 2022 USD ($) employee | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Jul. 13, 2022 country | May 31, 2021 USD ($) | |
License Agreement | |||||||||||||||
Revenue accounted for under Topic 606 | $ 9,191 | $ 8,243 | $ 17,211 | $ 10,772 | |||||||||||
Number of sales representatives | employee | 60 | ||||||||||||||
SIVEXTRO | |||||||||||||||
License Agreement | |||||||||||||||
Percentage of net product sales recognized | 100% | ||||||||||||||
Sunovion Pharmaceutics Canada, Inc. | Collaboration revenue - Upfront payment | |||||||||||||||
License Agreement | |||||||||||||||
Revenue accounted for under Topic 606 | $ 1,000 | ||||||||||||||
Sumitomo Pharmaceuticals (Suzhou) | Collaboration revenue - Upfront payment | Approval of XENLETA | |||||||||||||||
License Agreement | |||||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | ||||||||||||||
Additional revenue recognized | $ 3,000 | ||||||||||||||
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 | |||||||||||||||
Remaining probable of achieving | $ 1,000 | ||||||||||||||
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 | $ 600 | ||||||||||||||
Subsequent Event | |||||||||||||||
License Agreement | |||||||||||||||
Number of countries, exclusive rights are distributed. | country | 9 | ||||||||||||||
Number of additional countries rights are distributed | country | 5 |
Commitments and Contingencies (
Commitments and Contingencies (Details) € in Millions, $ in Millions | 6 Months Ended | ||
Aug. 04, 2021 EUR (€) | Jun. 30, 2022 | Jul. 31, 2018 USD ($) | |
Zavante Therapeutics | |||
Acquisition of Zavante | |||
Milestone Payment Receivable Prior Acquisition | $ 3 | ||
Threshold Milestone Payment That May Be Settled In Ordinary Shares | 26 | ||
Zavante Therapeutics | Maximum | |||
Acquisition of Zavante | |||
Contingent consideration | 97.5 | ||
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 | ||
Acquisition of Zavante | |||
Percentage of annual minimum purchase requirement reduction in 2021 | 0% | ||
Percentage of annual minimum purchase requirement reduction 2022 to 2024 | 50% | ||
Percentage of annual minimum purchase requirement reduction in 2025 | 25% | ||
Hovione Supply Agreement [Member] | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Royalty payment | € | € 10 | ||
Approval Milestone Payment | Zavante Therapeutics | |||
Acquisition of Zavante | |||
Contingent consideration | 25 | ||
Net Sales Milestone Payments | Zavante Therapeutics | |||
Acquisition of Zavante | |||
Contingent consideration | $ 72.5 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event | Jul. 13, 2022 country |
Subsequent Event [Line Items] | |
Number of countries, exclusive rights are distributed. | 9 |
Number of additional countries rights are distributed | 5 |