Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 28, 2022 | Jun. 30, 2021 | |
Document And Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-37558 | ||
Entity Registrant Name | Nabriva Therapeutics plc | ||
Entity Incorporation, State or Country Code | L2 | ||
Entity Address, Address Line One | 25-28 North Wall Quay | ||
Entity Address, Address Line Two | IFSC | ||
Entity Address, City or Town | Dublin 1 | ||
Entity Address, Country | IE | ||
Entity Tax Identification Number | 00-0000000 | ||
Entity Address, Postal Zip Code | 00000 | ||
City Area Code | 353 1 | ||
Local Phone Number | 649 2000 | ||
Title of 12(b) Security | Ordinary Shares, nominal value $0.01 per share | ||
Trading Symbol | NBRV | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Shares Outstanding | 60,525,366 | ||
Entity Central Index Key | 0001641640 | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 67.5 | ||
Auditor Name | KPMG LLP | ||
Auditor Firm ID | 185 | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
ICFR Auditor Attestation Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 47,659 | $ 41,359 |
Restricted cash | 175 | 231 |
Short-term investments | 16 | 16 |
Accounts receivable, net and other receivables | 12,751 | 3,909 |
Inventory | 14,509 | 5,823 |
Prepaid expenses | 5,155 | 5,880 |
Total current assets | 80,265 | 57,218 |
Property, plant and equipment, net | 233 | 768 |
Intangible assets, net | 31 | 80 |
Other non-current assets | 380 | 370 |
Total assets | 80,909 | 58,436 |
Current liabilities: | ||
Current portion of long-term debt | 3,765 | 2,041 |
Accounts payable | 4,372 | 2,889 |
Accrued expense and other current liabilities | 13,829 | 12,844 |
Deferred revenue | 374 | 750 |
Total current liabilities | 22,340 | 18,524 |
Non-current liabilities: | ||
Long-term debt | 4,265 | 5,686 |
Other non-current liabilities | 954 | 1,091 |
Total non-current liabilities | 5,219 | 6,777 |
Total liabilities | 27,559 | 25,301 |
Commitments and contingencies (Note 15) | ||
Stockholders' equity: | ||
Ordinary shares, nominal value $0.01, 100,000,000 ordinary shares authorized at December 31, 2021; 56,715,306 and 21,078,781 issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 567 | 211 |
Preferred shares, nominal value $0.01, 100,000,000 shares authorized at December 31, 2021; None issued and outstanding | ||
Additional paid in capital | 648,432 | 579,123 |
Accumulated other comprehensive income | 27 | 27 |
Accumulated deficit | (595,676) | (546,226) |
Total stockholders' equity | 53,350 | 33,135 |
Total liabilities and stockholders' equity | $ 80,909 | $ 58,436 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 100,000,000 | 100,000,000 |
Ordinary stock, issued shares | 56,715,306 | 21,078,781 |
Ordinary stock, outstanding shares | 56,715,306 | 21,078,781 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 100,000,000 | 100,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||
Total revenue | $ 28,895 | $ 5,027 | $ 9,481 |
Operating expenses: | |||
Cost of revenues | (13,148) | (766) | (70) |
Research and development expenses | (12,630) | (15,102) | (26,415) |
Selling, general and administrative expenses | (51,645) | (55,285) | (62,485) |
Total operating expenses | (77,423) | (71,153) | (88,970) |
Loss from operations | (48,528) | (66,126) | (79,489) |
Other income (expense): | |||
Other income (expense), net | 469 | 1,187 | 215 |
Interest income (expense), net | (901) | (1,649) | (3,389) |
Loss on extinguishment of debt | (2,757) | ||
Loss before income taxes | (48,960) | (69,345) | (82,663) |
Income tax expense | (490) | (139) | (101) |
Net loss | $ (49,450) | $ (69,484) | $ (82,764) |
Loss per share | |||
Basic ($ per share) | $ (1.14) | $ (5.41) | $ (11.15) |
Diluted ($ per share) | $ (1.14) | $ (5.41) | $ (11.15) |
Weighted average number of shares: | |||
Basic (in shares) | 43,349,461 | 12,845,089 | 7,419,948 |
Diluted (in shares) | 43,349,461 | 12,845,089 | 7,419,948 |
Product revenue, net | |||
Revenues: | |||
Total revenue | $ 23,386 | $ 108 | $ 1,538 |
Collaboration revenue | |||
Revenues: | |||
Total revenue | 3,830 | 2,756 | 6,210 |
Research premium and grant revenue | |||
Revenues: | |||
Total revenue | $ 1,679 | $ 2,163 | $ 1,733 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common stock/Ordinary shares | Additional paid in capital | Accumulated other comprehensive income | Accumulated deficit | Total |
Stockholders' equity, beginning balance at Dec. 31, 2018 | $ 67 | $ 462,514 | $ 27 | $ (393,978) | $ 68,630 |
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2018 | 6,702 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 26 | 48,056 | 48,082 | ||
Issuance of common stock & ordinary shares (in shares) | 2,584 | ||||
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) | 66 | ||||
Shares issued in connection with the employee stock purchase plan | 372 | 372 | |||
Shares issued in connection with the employee stock purchase plan (in shares) | 21 | ||||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. | $ 1 | (1) | |||
Shares issued in connection with the acquisition of Zavante Therapeutics, Inc. (in shares) | 82 | ||||
Equity transaction costs | (2,794) | (2,794) | |||
Stock-based compensation expense | 9,748 | 9,748 | |||
Net loss | (82,764) | (82,764) | |||
Stockholders' equity, ending balance at Dec. 31, 2019 | $ 95 | 517,894 | 27 | (476,742) | 41,274 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2019 | 9,455 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 116 | 60,944 | 61,060 | ||
Issuance of common stock & ordinary shares (in shares) | 11,571 | ||||
Shares issued in connection with the vesting of restricted share units (in shares) | 44 | ||||
Shares issued in connection with the employee stock purchase plan | 43 | 43 | |||
Shares issued in connection with the employee stock purchase plan (in shares) | 9 | ||||
Equity transaction costs | (4,977) | (4,977) | |||
Stock-based compensation expense | 5,219 | 5,219 | |||
Net loss | (69,484) | (69,484) | |||
Stockholders' equity, ending balance at Dec. 31, 2020 | $ 211 | 579,123 | 27 | (546,226) | 33,135 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2020 | 21,079 | ||||
Consolidated Statements of Changes in Stockholders' Equity | |||||
Issuance of common stock & ordinary shares | $ 348 | 69,790 | 70,138 | ||
Issuance of common stock & ordinary shares (in shares) | 34,922 | ||||
Shares issued in connection with the vesting of restricted share units | $ 2 | 2 | |||
Shares issued in connection with the vesting of restricted share units (in shares) | 82 | ||||
Equity transaction costs, shares issued, value | $ 6 | (3,772) | (3,766) | ||
Equity transaction costs, shares issued (in shares) | 632 | ||||
Stock-based compensation expense | 3,291 | 3,291 | |||
Net loss | (49,450) | (49,450) | |||
Stockholders' equity, ending balance at Dec. 31, 2021 | $ 567 | $ 648,432 | $ 27 | $ (595,676) | $ 53,350 |
Stockholders' equity, ending balance (in shares) at Dec. 31, 2021 | 56,715 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | |||
Net loss | $ (49,450) | $ (69,484) | $ (82,764) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Non-cash other income/expense, net | 424 | 50 | (40) |
Non-cash interest income | 22 | ||
Non-cash interest expense | 404 | 636 | 519 |
Loss on extinguishment of debt | 2,757 | ||
Depreciation and amortization expense | 356 | 417 | 396 |
Decrease in right-of-use assets | 281 | 403 | 374 |
Stock-based compensation | 3,291 | 5,219 | 9,748 |
Other, net | (6) | 62 | 48 |
Changes in operating assets and liabilities: | |||
(Increase)/decrease in other non-current assets | (10) | 8 | 50 |
(Increase)/decrease in accounts receivable, net and other receivables and prepaid expenses | (8,117) | (5,887) | 2,582 |
Increase in inventory | (8,686) | (5,141) | (682) |
Increase/(decrease) in accounts payable | 1,581 | (1,813) | 1,310 |
Increase/(decrease) in accrued expenses and other liabilities | 946 | 714 | (3,209) |
Increase/(decrease) in deferred revenue | (376) | 750 | |
Decrease in other non-current liabilities | (189) | (2) | (172) |
Decrease in income tax liabilities | (6) | (20) | (74) |
Net cash used in operating activities | (59,557) | (71,331) | (71,892) |
Cash flows from investing activities | |||
Purchases of plant and equipment and intangible assets | (25) | (113) | (61) |
Other | (56) | (161) | |
Other | 392 | ||
Net cash (used in) provided by investing activities | (81) | (274) | 331 |
Cash flows from financing activities | |||
Proceeds from exercise of warrants | 665 | ||
Proceeds from issuance of ordinary shares and warrants | 27,911 | 53,460 | 20,138 |
Proceeds from at-the-market facility | 42,280 | 7,520 | 27,945 |
Proceeds from long-term debt, net of issuance costs | 9,980 | ||
Proceeds from employee stock purchase plan | 43 | 372 | |
Repayments of long-term borrowings | (30,000) | ||
Equity transaction costs | (3,825) | (4,764) | (2,360) |
Net cash provided by financing activities | 66,366 | 26,924 | 56,075 |
Effects of exchange rate changes on the balance of cash held in foreign currencies | (484) | (140) | (106) |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 6,244 | (44,821) | (15,592) |
Cash, cash equivalents, and restricted cash at beginning of year | 41,590 | 86,411 | 102,003 |
Cash, cash equivalents and restricted cash at end of year | 47,834 | 41,590 | 86,411 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 497 | 1,396 | 2,560 |
Taxes paid | 513 | 4 | 11 |
Equity transaction costs included in accounts payable and accrued expenses | $ 712 | $ 765 | $ 552 |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Business Activities | |
Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc, or Nabriva Ireland, together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH, or Nabriva Austria, Nabriva Therapeutics US, Inc., Zavante Therapeutics, Inc., 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 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. As of December 31, 2021, the Company had cash and cash equivalents, restricted cash and short-term investments of $47.9 million. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40 , Presentation of Financial Statements Going Concern The Company expects to continue to invest in critical commercial and medical affairs activities, its commitments per the agreement with Merck & Co., Inc., as well as investing in its supply chain for the commercialization of SIVEXTRO, XENLETA and the potential launch of CONTEPO, if approved. The Company expects to seek additional funding in future periods to support these activities. While the Company has raised capital in the past, the ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future capital raises in their assessment of the Company’s ability to meet its obligations for the next twelve months. In April 2020, the Company announced a restructuring of its hospital-based commercial sales force and transition to a community-based sales effort. The restructuring reduced costs to align with the capabilities of the Company’s sales effort with its strategic re-focus on making sales of XENLETA to community health care professionals. The termination of the sales force was timed, in part, to coincide with operational changes that were implemented by the Company in response to the outbreak of the novel coronavirus, SARS-CoV-2, causing the disease referred to as “COVID-19”. In response to the COVID-19 pandemic, the Company closed its administrative offices and shifted to a remote working business model. The Company implemented a hybrid-remote-working policy for all of its employees, all of which have had, and we believe will continue to have, an impact on our consolidated results of operations, financial position and cash flows. The commercial and medical organizations suspended in-person interactions with physicians and customers and were restricted to conducting educational and promotional activities virtually. The Company has secured a virtual and in-person sales effort with community-based expertise with Amplity Health, which is a contract sales organization, to replace its hospital-based sale force and began a small and focused sales effort for SIVEXTRO and XENLETA in September 2020. The Company expanded this effort to 60 sales representatives and may expand it further. The Company also piloted a virtual promotion effort with incremental sales representatives in the third quarter of 2021. The Company’s expenses will increase if it suffers any regulatory delays or is required to conduct additional clinical trials to satisfy regulatory requirements. The Company has incurred and expects to continue to incur significant commercialization expenses related to its commitments per the agreement with Merck & Co., Inc., product sales, marketing, distribution and manufacturing for SIVEXTRO, XENLETA and CONTEPO, if approved. It is also uncertain when, if ever, the Company will generate sufficient revenues from product sales to achieve profitability. As a result, based on the Company’s available cash resources, the minimum cash required under the Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., and in accordance with the requirements of ASC 205-40, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these consolidated financial statements are issued. A failure to raise the additional funding or to effectively implement cost reductions could harm the Company’s business, results of operations and future prospects. If the Company is not able to secure adequate additional funding in future periods, the Company may make additional reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. The Company may also have to delay, reduce the scope of, suspend or eliminate one or more research and development programs or its commercialization efforts. In May 2021, the Company entered into an Open Market Sale AgreementSM, or the New Sale Agreement, with Jefferies, as agent, pursuant to which the Company may offer and sell ordinary shares, for aggregate gross sale proceeds of up to $50.0 million, from time to time through Jefferies, by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. As of December 31, 2021, the Company has issued and sold an aggregate of 18,232,689 ordinary shares pursuant to the New Sale Agreement and received gross proceeds of $30.5 million and net proceeds of $29.3 million, after deducting commissions to Jefferies and other offering expenses. From January 1, 2022 and through the date of this filing, the Company has issued and sold an aggregate of 1,338,282 ordinary shares pursuant to the New Sale Agreement and received gross proceeds of $595,000 and net proceeds of $580,000, 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 $19.0 million under the New 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 December 31, 2021, the Company has issued and sold an aggregate of 2,400,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $2.4 million. From January 1, 2022 and through the date of this filing, the Company has issued and sold an aggregate of 3,600,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $1.6 million. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $19.0 million under the Purchase Agreement. Based on its current operating plans, the Company expects that its existing cash, cash equivalents, restricted cash and short-term investments as of the date of this filing will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements well into 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 | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or US GAAP, and US Securities and Exchange Commission, or SEC, regulations for annual reporting. The consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Functional Currency Transactions and Balances In preparing the consolidated financial statements, transactions in currencies other than the U.S. dollar are recognized at the exchange rates prevailing at the dates of the transactions. Foreign currency exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations. Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. Short-term Investments The Company has designated its investments in securities as available-for-sale securities and measures these securities at their respective fair values. Investments that mature in one year or less are classified as short-term available-for-sale securities. Investments that are not considered available for use in current operations are classified as long-term available-for-sale securities. Changes in the fair value of available-for-sale investments are recognized in other comprehensive income (loss). Inventory Inventory is stated at the lower of cost or net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company's supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and would record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. As of December 31, 2021, the Company had a $1.0 million non-cash reserve for excess and obsolete inventory due to timing of expiring inventory. The components of our inventory at December 31, 2021 and 2020 are as follows: As of As of December 31, December 31, (in thousands) 2021 2020 XENLETA raw materials $ 1,528 $ 952 XENLETA work in process 9,142 4,608 XENLETA finished goods 18 263 Total XENLETA 10,688 5,823 SIVEXTRO finished goods 3,821 — Total inventory $ 14,509 $ 5,823 Property, Plant and Equipment Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful lives of property, plant and equipment are as follows: 3 5 3 Intangible Assets and Other Long-lived Assets Intangible assets, such as acquired computer software licenses, are capitalized on the basis of the costs incurred to acquire the software and bring it into use. These costs are amortized on a straight-line basis over their estimated useful lives ( 3 Long-lived assets are assessed for potential impairment when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. An impairment loss would be recognized when undiscounted cash flows expected to be generated by an asset, is less than its carrying amount. The impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and recognized in these financial statements. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the commercialization and development of novel anti-infective agents to treat serious and life-threatening infections. Revenue Recognition Revenue from Contracts with Customers Net Product Revenue In September 2019, the Company launched XENLETA and in April 2021 the Company began exclusive distribution of SIVEXTRO in the United States and certain of its territories. The Company sells its products principally to a limited number of specialty distributors and wholesalers. The Company recognizes revenue once it has transferred physical possession of the goods and the customer obtains legal title to the product. Payment terms between Nabriva and its customers are generally approximately 60 days from the invoice date. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of its product. The transaction price that the Company recognizes as revenue reflects the amount it expects to be entitled to in connection with the sale and transfer of control of product to its customers. At the time that the Company’s customers take control of the product, which is when the Company’s performance obligation under the sales contracts is complete, the Company records product revenues net of applicable reserves for various types of variable consideration. The types of variable consideration are as follows: ● Fees-for-service ● Product returns ● Chargebacks and rebates ● Government rebates ● Commercial payer and other rebates ● Group Purchasing Organizations, or GPO, administration fees ● Voluntary patient assistance programs In determining the amounts of certain allowances and accruals, the Company must make significant judgments and estimates. For example, in determining these amounts, the Company estimates prescription demand from retail pharmacies, specialty pharmacies, hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations and the levels of inventory held by distributors and customers. The Company also analyzes third party end usage product consumption patterns to gauge demand for its products. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. The Company receives data periodically from its customers on inventory levels and historical channel sales mix, and the Company considers this data when determining the amount of the allowances and accruals for variable consideration. In assessing the amount of net revenue to record, the Company considers both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations the Company uses in estimating these amounts related to variable consideration associated with the Company’s products are as follows: Fees-for-service does not consider the fees separate from the distributors’ purchase of the product. The Company records its fee-for-service accruals based on distributors’ purchases and the applicable discount rate. Product returns history of SIVEXTRO and XENLETA returns, the Company estimated returns based on industry data for comparable products in the market. As the Company distributes its product and establishes historical sales over a longer period of time (i.e., two to three years), the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The Company’s XENLETA product has a forty-eight month shelf life and SIVEXTRO has a thirty-six month shelf life. their customers demand, product returns could increase in excess of what the Company has currently reserved which would result in a reduction to net revenues in future periods. At the end of each reporting period for any of its products, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. Chargebacks and rebates Chargebacks are discounts that occur when certain contracted customers, which currently consist primarily of group purchasing organizations, p ublic h ealth s ervice institutions, and Federal government entities purchasing via the Federal Supply Schedule, purchase directly from our wholesalers or specialty distributors. Contracted customers generally purchase the product at a discounted price. The Company provides a credit to its wholesaler or specialty distributor customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. The calculation of the accrual for chargebacks and rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Government rebates –The Company is subject to discount obligations primarily under state Medicaid and Medicare programs. The Company estimates its Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The calculation of the accrual for government rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Commercial payer and other rebates – The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of SIVEXTRO and XENLETA and contracted formulary status. The Company estimates these rebates and records reserves for such estimates in the same period the related revenue is recognized. Currently, the reserve for customer payer rebates considers future utilization based on third party studies of payer prescription data; the utilization is applied to product that remains in the distribution and retail pharmacy channel inventories at the end of each reporting period. The calculation of the accrual for commercial payer and other rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. GPO administration fees – The Company contracts with GPOs and pays administration fees related to contacting and membership management services provided. In assessing if the consideration paid to the GPO should be recorded as a reduction in the transaction price, the Company determines whether the payment is for a distinct good or service or a combination of both. Since GPO fees are not specifically identifiable, the Company does not consider the fees separate from the purchase of the product. Additionally, the GPO services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. Patient assistance At the end of each reporting period, the Company will adjust its variable consideration estimates for product returns, chargebacks, and rebates when the Company believes actual experience may differ from current estimates. Cost of Revenues Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. Prior to the FDA approval of XENLETA on August 19, 2019, the inventory costs for XENLETA were expensed as research and development expenses since the approval was outside of our control and therefore not considered probable. As such, the majority of the expenses incurred for our initial inventories of XENLETA has been previously expensed. For the years ended December 31, 2021 and 2020, cost of revenues include a $0.3 million and $0.7 million non-cash reserve adjustment for excess and obsolete inventory due to timing of expiry dating of inventory. Research Premium and Grant Revenue Grant revenue comprises (a) the research premium from the Austrian government, (b) grants received from the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft, or FFG The research premium the Company receives from the Austrian government is calculated at a specified percent of specified research and development cost base. The Company recognizes the research premium as long as it has incurred research and development expenses. All grants are non-refundable as long as the conditions of the grant are met. Nabriva is and has been in full compliance with the conditions of the grants and all related regulations. Research and Development Expenses All research and development costs are expensed as incurred. Research and development costs included direct personnel and material costs, related overheads, depreciation of equipment used for research or development purposes; costs for clinical research; costs for the utilization of third parties’ patents for research and development purposes and other taxes related to research facilities. Share-based Payments The Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award in accordance with ASC 718, Compensation — Stock Compensation Leases The Company follows ASC Topic 842, Leases The Company determines if an arrangement is a lease at inception. Operating lease right-of-use, or ROU, assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term. ROU assets are included in property, plant and equipment, and operating lease liabilities are included in accrued expenses on the Company’s consolidated balance sheet. The Company has elected not to recognize ROU assets or lease liabilities for short-term leases. Since none of the Company’s lease agreements provide an implicit rate, the Company estimates an incremental borrowing rate over the lease term in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. In recognizing the benefit of tax positions, the Company has taken or expects to take, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. 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 year ended December 31, 2021, nor are there any recently issued accounting pronouncements that are expected to have a material impact on the Company´s consolidated financial statements in future periods. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurement | |
Fair Value Measurement | 3. Fair Value Measurement US GAAP establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows: ● Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities. ● Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (as exchange rates). ● Level 3: Valuation techniques that include inputs for the asset or liability that are not based on observable market data (those are unobservable inputs) and significant to the overall fair value measurement. The following table presents the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy: (in thousands) Level 1 Level 2 Level 3 Total December 31, 2021 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total assets $ 8,066 $ — $ — $ 8,066 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total assets $ 8,066 $ — $ — $ 8,066 There were no transfers between Level 1 and 2 in the years ended December 31, 2021 and 2020. There were no changes in valuation techniques during the years ended December 31, 2021 and 2020. As of December 31, 2021 and 2020, the Company did not hold any financial instruments as liabilities that were held at fair value. The Company believes that the carrying value of its long-term debt approximates fair value based on current interest rates. Receivables and accounts payable are carried at their historical cost which approximates fair value due to their short-term nature. |
Accounts Receivable, net and Ot
Accounts Receivable, net and Other Receivables | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Receivable, net and Other Receivables | |
Accounts Receivable, net and Other Receivables | 4. Accounts Receivable, net and Other Receivables As of December 31 (in thousands) 2021 2020 Receivables from customers, net $ 8,778 $ 56 Receivables from collaborative arrangments 2,193 2,426 Research premium 1,237 1,308 Other receivables 543 119 Total accounts receivable, net and other receivables $ 12,751 $ 3,909 The following table summarizes balances and activity of product revenue allowances and reserves: As of December 31, 2021 2020 Receivables from customers, gross $ 10,149 $ 75 Less: fee for service (924) — Less: chargeback reserve (249) (17) Less: cash discount (198) (2) Receivables from customers, net $ 8,778 $ 56 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 5. Property, Plant and Equipment As of December 31 (in thousands) 2021 2020 IT equipment $ 1,083 $ 1,077 Laboratory equipment 3,404 3,392 ROU asset — 226 Other equipment 101 204 4,588 4,899 Less: Accumulated depreciation (4,355) (4,131) Property, plant and equipment, net $ 233 $ 768 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities include the following: As of December 31, (in thousands) 2021 2020 Research and development related costs $ 789 $ 1,055 Payroll and related costs 5,085 4,049 Accounting, tax and audit services 736 470 Manufacturing and inventory 592 4,779 Product returns 2,282 349 Government rebates 1,751 135 Other accrued gross to net 1,090 178 Other 1,504 1,829 Total other current liabilities $ 13,829 $ 12,844 Product return activity during the years ended December 31, 2021 and 2020 was as follows: 2021 2020 Balance at January 1 $ 349 $ 33 Provision recorded during the period 2,043 431 Credits issued during the period (110) (115) Balance at December 31 $ 2,282 $ 349 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Debt | 7. Debt In December 2018, the Company entered into the Loan Agreement by and among the Company, Nabriva Therapeutics Ireland DAC, and certain other subsidiaries of the Company and Hercules Capital, Inc., or Hercules, pursuant to which a term loan of up to an aggregate principal amount of $75.0 million was available to the Company. The Loan Agreement initially provided for an initial term loan advance of $25.0 million, which was funded in December 2018, and, at the Company’s option and subject to the occurrence of certain funding conditions, several additional tranches of which $5.0 million became available upon the approval by the FDA of the NDA for XENLETA, which was drawn down. The other tranches are no longer available as their contingencies were not achieved. The Company may request a term loan advance of $5.0 million, or the Tranche Advance, through the Amortization Date discussed below subject to Hercules’s sole discretion. The term loan bears interest at an annual rate equal to the greater of 9.80% or 9.80% plus the prime rate of interest minus 5.50%. The Loan Agreement provided for interest-only payments through July 1, 2021 and repayment of the outstanding principal balance of the term loan thereafter in monthly installments through June 1, 2023, or the Maturity Date. In addition, the Company is required to pay a fee of 6.95% of the aggregate amount of advances under the Loan Agreement at the Maturity Date, or the End of Term Fee. At the Company’s option, the Company may elect to prepay any portion of the outstanding term loan that is greater than or equal to $5.0 million by paying such portion of the principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid, or the Prepayment Fee: (i) 3.0% if the term loan is prepaid during the first 12 months following the initial closing, (ii) 2.0% if the term loan is prepaid after 12 months following the initial closing but before 24 months following the initial closing and (iii) 1.0% if the term loan is prepaid any time thereafter but prior to the Maturity Date. On March 11, 2020, the Company entered into an amendment, or the Third Amendment, to its Loan Agreement with Hercules. Pursuant to the Third Amendment, the Company repaid $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement, or the Prepayment. The Company determined to enter into the Third Amendment following the effectiveness of a performance covenant in February 2020 under which it became obligated to either (1) achieve 80% of its net product revenue sales target over a trailing six-month period, or (2) maintain an amount of cash and cash equivalents in accounts pledged to Hercules plus a specified amount of eligible accounts receivables equal to the greater of the amount outstanding under the Loan Agreement or $40.0 million, or the Liquidity Requirement. Under the Third Amendment, the Company and Hercules agreed to defer the end of term loan charge payment of $2.1 million that would have otherwise become payable on the date of the Prepayment and to reduce the Prepayment Fee with respect to the Prepayment from $600,000 to $300,000 and to defer its payment, in each case, until June 1, 2023 or such earlier date on which all loans under the Loan Agreement are repaid or become due and payable. The Third Amendment also reset the revenue performance covenant to 70% of targeted revenue based on a revised net product revenue forecast and lowered the minimum liquidity requirement to $3.0 million in cash and cash equivalents, in each case, following the Prepayment. The new minimum liquidity requirement will not apply if CONTEPO receives regulatory approval from the U.S. Food and Drug Administration and the Company achieves at least 70% of its revised net product revenue targets under the Loan Agreement. On June 2, 2021, the Company entered into a further amendment, or the Fourth Amendment, to its Loan and Security Agreement with Hercules. Pursuant to the Fourth Amendment, the date on which the Company must commence repaying principal under the Loan Agreement was extended to April 1, 2022, or the Amortization Date, which date may be extended until July 1, 2022, subject to the receipt by the Company of a specified amount of additional net financing proceeds and the achievement of a specified product revenue milestone. Additionally, the time during which the Tranche Advance may be requested by the Company under the Loan Agreement, was extended until the Amortization Date. In addition, pursuant to the Fourth Amendment, the minimum liquidity requirement of $3.0 million in cash and cash equivalents will be waived at any time the Company has recognized $15.0 million of net product revenue during the applicable trailing three months . The Company’s obligations under the Loan Agreement are guaranteed by all current and future subsidiaries of the Company, and each of the Company and its subsidiaries has granted Hercules a security interest in all of their respective personal property, intellectual property and other assets owned or later acquired. The Loan Agreement also contains certain events of default, representations, warranties and covenants of the Company and its subsidiaries. For example, the Loan Agreement contains representations and covenants that, subject to exceptions, restrict the Company’s and its subsidiaries’ ability to do the following, among other things: declare dividends or redeem or repurchase equity interests; incur additional indebtedness and liens; make loans and investments; engage in mergers, acquisitions and asset sales; certain transactions with affiliates; undergo a change in control; and add or change business locations or settle in cash potential milestone payment obligations that may become payable by the Company in the future to former security holders of Zavante. The Company was in compliance with all of its Loan Agreement covenants at December 31, 2021. The Loan Agreement also grants Hercules or its nominee an option to purchase up to an aggregate of $2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in any private financing upon the same terms and conditions afforded to such other investors for as long as there are amounts outstanding under the Loan Agreement. The Company incurred $1.3 million of costs in connection with the Loan Agreement which along with the initial fee of $0.7 million paid to Hercules were recorded as debt issuance cost and are being amortized as interest expense using the effective interest method over the term of the loan. In connection with the Third Amendment, the Company recognized a non-cash $2.7 million loss on the extinguishment of debt during the three months ended March 31, 2020 which represent million principal balance is being accrued as additional interest expense using the effective interest method over the term of the loan. Long-term debt as December 31, 2021 and 2020 consisted of the following: As of December 31, (in thousands) 2021 2020 Term loan payable $ 5,000 $ 5,000 End of term fee 2,331 2,048 Unamortized debt issuance costs (145) (206) Carrying value of term loan 7,186 6,842 Other long-term debt 844 885 Less: Amounts due within one year (3,765) (2,041) Total long-term debt $ 4,265 $ 5,686 As of December 31, 2021, the maturities of our long-term debt were as follows: (in thousands) 2022 $ 3,765 2023 $ 4,811 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity 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 our ordinary shares is not below $0.25 per share on Nasdaq, (ii) 600,000 ordinary shares if the closing sale price of our ordinary shares is not below $2.00 per share on Nasdaq or (iii) 800,000 ordinary shares if the closing sale price of our 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 December 31, 2021, the Company has issued and sold an aggregate of 2,400,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $2.4 million. From January 1, 2022 and through the date of this filing, the Company has issued and sold an aggregate of 3,600,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $1.6 million. As of the date of this filing, the Company may issue and sell ordinary shares for gross proceeds of up to $19.0 million under the Purchase Agreement. In May 2021, the Company entered into an Open Market Sale Agreement SM proceeds of $33.7 million and net proceeds to the Company of $31.9 million, after deducting commissions and offering expenses payable by the Compamy. The approximately $16.3 million of ordinary shares that had been available for sale pursuant to the Jefferies ATM Agreement remained unsold at the time of its replacement. The replacement of the Jefferies ATM Agreement terminated any future sales of ordinary shares through the Jefferies ATM Agreement. As of December 31, 2021, the Company has issued and sold an aggregate of 18,232,689 ordinary shares pursuant to the New Sale Agreement and received gross proceeds of $30.5 million and net proceeds of $29.3 million, after deducting commissions to Jefferies and other offering expenses. From January 1, 2022 and through the date of this filing, the Company has issued and sold an aggregate of 1,338,282 ordinary shares pursuant to the New Sale Agreement and received gross proceeds of $595,000 and net proceeds of $580,000, after deducting commissions to Jefferies and other offering expenses. In March 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company issued and sold in a registered direct offering (1) an aggregate of 9,761,010 ordinary shares, $0.01 nominal value per share, and accompanying warrants to purchase up to an aggregate of 4,880,505 ordinary shares and (2) pre-funded warrants to purchase up to an aggregate of 600,000 ordinary shares and accompanying ordinary share warrants to purchase up to an aggregate of 300,000 ordinary shares. Each share was issued and sold together with an accompanying ordinary share warrant at a combined price of $2.4525, and each pre-funded warrant was issued and sold together with an accompanying ordinary share warrant at a combined price of $2.4425. The proceeds to the Company from the offering were $25.4 million gross and $23.4 million net after deducting the placement agent’s fees and estimated offering expenses. Each pre-funded warrant had an exercise price per ordinary share equal to $0.01 and each pre-funded warrant was exercised in full on the issuance date. Each ordinary share warrant has an exercise price per ordinary share equal to $2.39, is exercisable on the date of issuance and will expire on the five-year anniversary of the date of issuance. As of December 31, 2021, there were 5,180,505 warrants outstanding from the offering at an exercise price of $2.39 per share. In December 2020, the Company completed a registered public offering in which it sold 6,000,000 ordinary shares at a public offering price of $2.50. The proceeds to the Company from the offering were $15.0 million gross and $13.3 million net, after deducting the placement agent’s fees and other offering expenses. In May 2020, the Company entered into a securities purchase agreement with certain institutional investors, including Fidelity Management & Research Company, LLC pursuant to which the Company issued and sold in a registered direct offering an aggregate of 4,144,537 ordinary shares and accompanying warrants to purchase up to an aggregate of 4,144,537 ordinary shares. Each share the Company issued and sold together with an accompanying warrant at a combined price of $9.1686. The proceeds to the Company from the offering were $38.0 million gross and $35.2 million net, after deducting the placement agent’s fees and other offering expenses. Each warrant was immediately exercisable and will expire on the two-year anniversary of the issuance date. As of December 31, 2021, there were 4,059,532 warrants outstanding from the offering at an exercise price of $7.92 per share. In December 2019, the Company sold to certain institutional investors in a registered direct offering an aggregate of 1,379,310 ordinary shares, and accompanying warrants to purchase up to an aggregate of 1,379,310 ordinary shares. Each share was issued and sold together with an accompanying warrant at a combined price of $14.50 per security. The proceeds to the Company from the offering were $20.0 million gross and $18.3 million net, after deducting the placement agent’s fees and other offering expenses. As of December 31, 2021, there were 1,379,310 warrants outstanding from the offering, where each warrant has an exercise price of $19.00 per share and will expire on the date that is three years and six months |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2021 | |
Revenue | |
Revenue | 9. Revenue Year Ended December 31, (in thousands) 2021 2020 2019 Product revenue, net $ 23,386 $ 108 $ 1,538 Collaboration revenues 3,830 2,756 6,210 Research premium and grant revenue 1,679 2,163 1,733 Total revenue $ 28,895 $ 5,027 $ 9,481 Collaboration revenues for the year ended December 31, 2021 include $2.6 million related to the restructured China Region License Agreement, a portion of which is recognized over the estimated period the manufacturing collaboration and regulatory support will be provided to Sumitomo Pharmaceuticals (Suzhou), as well as $1.2 million of the Company’s share of revenues associated with the SIVEXTRO distribution agreement with Merck & Co., Inc. through April 11, 2021 (see Note 14). Collaboration revenues for the year ended December 31, 2020 includes a $0.5 million regulatory milestone payment from Sunovion, $1.8 million for the Company´s share of revenues associated with the SIVEXTRO distribution agreement with Merck & Co., Inc., as well as collaboration revenues associated with the restructuring of the China Region License Agreement. Collaboration revenues for the year ended December 31, 2019 includes a $1.0 million upfront payment under the Sunovion License Agreement received in April 2019, and a $5.0 million milestone payment under the China Region License Agreement. The Company sells its products to pharmaceutical wholesalers/distributors (i.e., the Company’s customers). The Company’s wholesalers/distributors in turn sell the Company’s products directly to clinics, hospitals, and private practices. Revenue from the Company’s product sales is recognized as physical delivery of product occurs (when the Company’s customer obtains control of the product), in return for agreed-upon consideration. SIVEXTRO product revenues, net of gross-to-net accruals and adjustments for returns were $23.8 million since the Company began exclusive distribution of SIVEXTRO under its own National Drug Code, or NDC, on April 12, 2021. For the years ended December 31, 2021, 2020 and 2019 XENLETA product revenues, net of gross-to-net accruals and adjustments for returns, were $(0.4) million, $0.1 million and $1.5 million, respectively, including revenues from the Company´s Named Patient Program of $17,000 for the year ended December 31, 2021. The Company´s gross-to-net, or GTN, estimates are based upon information received from external sources (such as written or oral information obtained from the Company´s customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred may be materially above or below the amount initially estimated when product revenues are originally recorded, then requiring prospective adjustments to the Company’s reported product revenues, net. For the year ended December 31, 2021, the Company recorded a $1.3 million returns reserve adjustment for shelf life expiration of certain XENLETA products. For the year ended December 31, 2020, the Company recorded a returns reserve adjustment of $0.4 million for slow-moving inventory, representing 50% of XENLETA IV inventory held at its Specialty Distributors, as well as an adjustment for returns from a single mail order specialty pharmacy. |
Share-Based Payments
Share-Based Payments | 12 Months Ended |
Dec. 31, 2021 | |
Share-Based Payments | |
Share-Based Payments | 10. Share Based Payments Stock Plan Activity On April 2, 2015, the Company’s shareholders, management board and supervisory board adopted the Stock Option Plan 2015, or the SOP 2015, as amended. Each vested option grants the beneficiary the right to acquire one share in the Company. The vesting period for the options is four years following the grant date. On the last day of the last calendar month of the first year of the vesting period, 25% of the options attributable to each beneficiary are automatically vested. During the second, third and fourth years of the vesting period, the remaining 75% of the options vest on a monthly pro rata basis (i.e. 2.083% per month). Options granted under the SOP 2015 have a term of no more than ten years from the beneficiary’s date of participation. With the approval of the 2017 Share Incentive Plan, there were no further shares available for issuance under the SOP 2015. However, all outstanding awards under SOP 2015 will remain in effect and continue to be governed by the terms of the SOP 2015. On July 26, 2017, the Company’s board of directors adopted the 2017 Share Incentive Plan, or the 2017 Plan, and the shareholders approved the 2017 Plan at the Company’s Extraordinary General Meeting of Shareholders on September 15, 2017. The 2017 Plan permitted the award of share options (both incentive and nonstatutory options), share appreciation rights, or SARs, restricted shares, restricted share units, or RSUs, and other share-based awards to the Company’s employees, officers, directors, consultants and advisers. The 2017 Plan is administered by the Company’s board of directors. Under the 2017 Plan, the Company granted RSUs which vest over a period of four years with 25% vesting upon the first anniversary of the grant date and on a monthly pro rata basis thereafter over the remaining three years. During 2018, the Company granted RSUs to certain employees where vesting of the RSUs was subject to FDA approval of an NDA for XENLETA. Fifty fifty Fifty fifty On March 12, 2019, the Company’s board of directors adopted the 2019 Inducement Share Incentive Plan, or the 2019 Inducement Plan and, subject to the adjustment provisions of the 2019 Inducement Plan, reserved 200,000 ordinary shares for issuance pursuant to equity awards granted under the 2019 Inducement Plan. In accordance with Nasdaq Listing Rule 5635(c)(4), awards under the 2019 Inducement Plan may only be made to individuals who were not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company. On April 28, 2020, the board of directors resolved not to make any further awards under the 2019 Inducement Plan. In July 2018, the Company granted a non-statutory option to purchase 85,000 of its ordinary shares and 15,000 performance-based RSUs to the Company’s newly appointed Chief Executive Officer, or the CEO. These equity awards were granted outside of the 2017 Plan and the 2019 Inducement Plan, were approved by the Company’s compensation committee and board of directors and were made as an inducement material to the CEO entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price per share for the share option is $35.30 per share, and the option award has a ten-year term and will vest over a four-year period, with 25% of the shares underlying the award vesting on the first anniversary of the grant date and the remaining 75% of the shares underlying the option award to vest monthly over the subsequent 36-month period. The performance-based RSUs are subject to vesting as follows: 50% will vest upon certification by the board of directors of the receipt of approval by the FDA of an NDA for each of lefamulin and CONTEPO for any indication, and 50% will vest on the first anniversary of such certification by the board of directors, provided, in each case, the CEO is performing services to the Company on the applicable vesting dates. If the FDA does not approve an NDA for both lefamulin and CONTEPO by January 31, 2020, the performance-based RSUs will terminate in full. Since CONTEPO was not approved by this date the award was forfeited. The Company also issues non-statutory options to new employees upon the commencement of their employment. On March 4, 2020, the Company´s board of directors adopted the 2020 Share Incentive Plan, or the 2020 Plan, which was approved by the Company´s shareholders at the 2020 Annual General Meeting of Shareholders in July 2020, or 2020 AGM. As of the date of the 2020 AGM, the total number of ordinary shares reserved for issuance under the 2020 Plan was for the sum of 930,000 ordinary shares, plus the number of the Company´s ordinary shares that remained available for grant under the 2017 Plan as of immediately prior to the AGM and the number of ordinary shares subject to awards granted under the 2017 Plan and the Company´s Amended and Restated Stock Option Plan 2015, that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right. The 2020 Plan provides for the grant of incentive share options, non-statutory share options, share appreciation rights, restricted share awards, restricted share units, other share-based and cash-based awards and performance awards. Under the 2020 Plan the Company granted RSUs to certain employees that vest in three six-month increments beginning in January 2021 and ending in January 2022. The Company also granted RSUs to certain employees, where vesting of the RSUs was subject to individual performance goals. During the year ended December 31, 2021, the Company granted RSUs to certain employees that vest in annual increments beginning January 2022 and ending in January 2025. Additionally, the Company granted 7,000 RSUs to its former Chief Medical Officer and to its former Chief Financial Officer, which vest as to 50% of the shares underlying the RSUs each year over the term of their respective consulting agreements. At December 31, 2021, 271,080 ordinary shares were available for future issuance under the 2020 Plan. On December 9, 2020, the Company´s board of directors adopted without stockholder approval the 2021 Inducement Share Incentive Plan, or the 2021 Inducement Plan and, subject to the adjustment provisions of the 2021 Inducement Plan, reserved 200,000 ordinary shares for issuance pursuant to equity awards granted under the 2021 Inducement Plan. In accordance with Nasdaq Listing Rule 5635(c)(4), awards under the 2021 Inducement Plan may only be made to individuals who were not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the company), as an inducement material to the individuals’ entry into employment with the Company. In September 2021, the Company’s board of directors adopted an amendment to the 2021 Inducement Plan that increased the amount of shares reserved for issuance under the plan from 200,000 shares to 500,000 shares. Options and SARs granted will be exercisable at such times and subject to such terms and conditions as the board may specify in the applicable option agreement; provided, however, that no option or SAR will be granted with a term in excess of ten years . The board will also determine the terms and conditions of restricted shares and RSUs, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any. Stock Options The following table summarizes information regarding the Company´s stock option awards: 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, 2019 609,133 65.17 — — Granted 316,645 20.11 — — Exercised — — — — Cancelled and forfeited (108,887) 64.33 — — Outstanding as of December 31, 2019 816,891 47.82 — — Granted 465,055 11.27 — — Exercised — — — — Cancelled and forfeited (229,108) 31.92 — — Outstanding as of December 31, 2020 1,052,838 35.08 — — Granted 637,880 1.23 — — Exercised — — — — Cancelled and forfeited (342,241) 16.90 — — Outstanding as of December 31, 2021 1,348,477 20.46 8.0 $ — Vested and exercisable as of December 31, 2021 533,564 45.05 6.7 $ — The Company has 1,348,477 option grants outstanding at December 31, 2021 with exercise prices ranging from $1.06 per share to $110.00 per share. As of December 31, 2021, there was $1.8 million of total unrecognized compensation expense related to unvested stock options, which will be recognized over the weighted-average remaining vesting period of 0.9 years. The weighted average fair value of the stock options granted during years ended December 31, 2021, 2020 and 2019 was $0.82, $5.99 and $11.95 per share, respectively, based on a Black Scholes option pricing model using the following assumptions: Input parameters 2021 2020 2019 Range of expected volatility 75.3% ‑ 77.3% 63.7% ‑ 74.4% 59.8% - 63.1% Expected term of options (in years) 5.5 - 6.1 5.5 - 6.1 6.0 - 6.1 Range of risk-free interest rate 0.8% ‑ 1.3% 0.8% ‑ 1.5% 1.9% - 3.0% Dividend yield — — – The expected price volatility is based on historical trading volatility for the publicly traded peer companies under consideration of the remaining life of the options. The risk-free interest rate is based on the average of five Restricted Stock Units (“RSUs”) The following table summarizes information regarding the Company’s restricted share unit awards: Weighted average grant date fair RSUs value in $ per share Outstanding as of January 1, 2019 137,210 33.34 Granted 47,900 19.00 Vested and issued (65,758) 31.80 Forfeited (14,183) 27.87 Outstanding as of December 31, 2019 105,169 28.50 Granted 244,832 10.99 Vested and issued (52,640) 31.15 Forfeited (57,977) 21.74 Outstanding as of December 31, 2020 239,384 11.60 Granted 769,132 2.02 Vested and issued (90,330) 12.04 Forfeited (128,448) 6.93 Outstanding as of December 31, 2021 789,738 2.92 As of December 31, 2021, there was unrecognized compensation costs of $1.1 million associated with RSUs which are expected to be recognized over the awards average remaining vesting period of 1.7 years. The intrinsic value of RSU’s that vested during the years ended December 31, 2021, 2020 and 2019 was $0.2 million, $0.4 million and $1.5 million, respectively. Stock-based Compensation The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Year Ended December 31, (in thousands) 2021 2020 2019 Research and development expense $ 565 $ 1,280 $ 2,138 Selling, general and administrative expense 2,726 3,939 7,610 Total stock-based compensation expense $ 3,291 $ 5,219 $ 9,748 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 allowed 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. |
Post-employment Benefit Obligat
Post-employment Benefit Obligations | 12 Months Ended |
Dec. 31, 2021 | |
Post-employment Benefit Obligations | |
Post-employment Benefit Obligations | 11. Post-employment Benefit Obligations As required under Austrian labor law, the Company makes contributions to a state plan classified as defined contribution plan (Mitarbeitervorsorgekasse) for its employees in Austria. Monthly contributions to the plan are 1.53% of salary with respect to each employee and are recognized as expense in the period incurred. For employees of Nabriva Therapeutics US, Inc., the Company makes contributions to a defined contribution plan as defined in subsection 401(k) of the Internal Revenue Code. The Company matches 100% of the first 3% of the employee’s voluntary contribution to the plan and 50% of the next 2% contributed by the employee. Contributions are recognized as expense in the period incurred. In the years ended December 31, 2021, 2020 and 2019, contributions were $360,000, $396,000 and $710,000, respectively. |
Income Tax Expense
Income Tax Expense | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Expense | |
Income Tax Expense | 12. Income Tax Expense Income (loss) before income taxes attributable to domestic and international operations, consists of the following: Year ended December 31 (in thousands) 2021 2020 2019 Domestic $ (40,540) $ (71,344) $ (78,761) Foreign (8,420) 1,999 (3,902) Loss before income taxes $ (48,960) $ (69,345) $ (82,663) Income tax expense consists of the following: Year ended December 31 (in thousands) 2021 2020 2019 Current tax Domestic $ — $ — $ — Foreign (490) (139) (101) Deferred tax Domestic — — — Foreign — — — Total income tax expense $ (490) $ (139) $ (101) The reconciliation to our effective tax rate from the Irish statutory income tax rate of 12.5% for the years ended December 31, 2021, 2020 and 2019 is as follows: Year ended December 31 (% of pre-tax income) 2021 2020 2019 Statutory income tax rate 12.5 % 12.5 % 12.5 % Non-deductible expenses — — (0.1) Income not subject to tax 0.4 0.2 0.3 Tax credits — 0.6 0.4 Foreign operations (7.3) 3.0 0.6 Tax audit assessments — — (11.8) Other (1.7) 2.3 0.8 Valuation allowance (4.9) (18.8) (2.8) Effective income tax rate (1.0) % (0.2) % (0.1) % The following table summarizes the components of deferred income tax balances: As of December 31, (in thousands) 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 111,220 $ 108,095 Tax loss on liquidation of subsidiary 2,501 4,029 Equity compensation 4,067 4,449 Non-deductible reserves 905 447 Total deferred tax assets 118,693 117,020 Valuation allowance (118,583) (116,200) Net deferred tax assets 110 820 Deferred tax liabilities: Financial liabilities 100 757 Property, plant and equipment 10 63 Total deferred tax liability 110 820 Deferred tax, net $ — $ — The table below summarizes changes in the deferred tax valuation allowance: Year ended December 31, (in thousands) 2021 2020 2019 Balance at beginning of year $ (116,200) $ (103,185) $ (100,832) Tax benefit (2,383) (13,015) (2,353) Balance at end of year $ (118,583) $ (116,200) $ (103,185) The following table summarizes carryforwards of net operating losses as of December 31, 2021. (in thousands) Amount Expiration Ireland $ 297,453 Indefinite Austria $ 239,510 Indefinite United States $ 10,403 Indefinite United States $ 35,516 2033 Due to uncertainty regarding the ability to realize the benefit of deferred tax assets primarily relating to net operating loss carryforwards and the fact that the Company is in a three year pretax cumulative loss position, a full valuation allowance has been established. The Company’s U.S. subsidiary has net operating loss and tax credit carryforwards that may be subject to annual limitations due to ownership changes as defined by Sections 382 and 383 of the Internal Revenue Code. These limitations could restrict the amount of tax attributes that can be utilized annually to offset future U.S. taxable income or tax liabilities. On the basis of this evaluation, as of December 31, 2021, 2020 and 2019, the Company has recorded a valuation allowance of $118.6 million, $116.2 million and $103.2 million, respectively, to recognize only the portion of the deferred tax asset that is more likely than not to be realized. The amount of the deferred tax asset considered realizable, however, could be adjusted if estimates of future taxable income during the carryforward period are reduced or increased or if objective negative evidence in the form of cumulative losses is no longer present and additional weight is given to subjective evidence such as our projections for growth. At December 31, 2021, the Company had no uncertain tax positions and did not expect any material increase or decrease in income tax expense related to examinations or changes in uncertain tax positions. The Company’s U.S. subsidiary, Nabriva Therapeutics US, Inc., resolved its examination for tax year 2018 with the Internal Revenue Service with a decrease in a research and development tax credit carryforward of $0.1 million. The Company files income tax returns in Ireland. In addition, the Company’s foreign subsidiaries file separate income tax returns in Austria and the United States and state jurisdictions in which they are located. Tax years 2017 and forward remain open for examination for Ireland tax purposes and 2016 and forward remain open for examination for Austrian tax purposes and years 2018 and forward remain open for examination for United States tax purposes. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings (Loss) per Share | |
Earnings (Loss) per Share | 13. Earnings (Loss) per Share Basic and Diluted Loss per Share Basic and diluted loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares outstanding during the year. Diluted net loss per share is the same as basic net loss per share during the periods presented as the effects of the Company’s common stock equivalents are antidilutive and thus not included in the calculation. Year ended December 31, (in thousands, except per share data) 2021 2020 2019 Net loss for the period $ (49,450) $ (69,484) $ (82,764) Weighted average number of shares outstanding 43,349,461 12,845,089 7,419,948 Basic and diluted loss per share $ (1.14) $ (5.41) $ (11.15) The following ordinary share equivalents were excluded from the calculations of diluted loss per share as their effect would be anti-dilutive: Year ended December 31 2021 2020 2019 Stock option awards 1,348,477 1,052,838 816,891 Restricted share units 789,738 239,384 105,169 Warrants 10,619,347 5,438,842 1,379,310 |
Significant Arrangements and Li
Significant Arrangements and License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Significant Arrangements and License Agreements | |
Significant Arrangements and License Agreements | 14. Significant Arrangements and License Agreements Sales Promotion and Distribution Agreement with Merck & Co. On July 15, 2020, the Company entered into a Sales Promotion and Distribution Agreement, or the Distribution Agreement, with MSD International GmbH, or MSD, and Merck Sharp & Dohme Corp., or Supplier, each a subsidiary of Merck & Co., Inc. Under the Distribution Agreement and subject to the satisfaction of certain conditions, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient previously marketed and sold by Supplier and MSD under the trademark SIVEXTRO® for injection, intravenous use and oral use, or the Products, in the United States and its territories, or the SIVEXTRO Territory. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms. On April 12, 2021, in accordance with the terms of the Distribution Agreement, the Company began exclusive distribution of SIVEXTRO under its own National Drug Code, or NDC, and the Company recognizes 100% of net product sales of SIVEXTRO in its results of operations. Under the Distribution Agreement and subject to the fulfillment of certain conditions, including the Company having engaged sufficient sales representatives, restrictions relating to travel and physician office access in the SIVEXTRO Territory due to COVID-19 having continued to decrease in a sufficient portion of the SIVEXTRO Territory so as not to hinder the successful detailing of SIVEXTRO, the Company has been granted the right by MSD initially to promote the Products in the SIVEXTRO Territory and, upon satisfaction of additional conditions, including an increase in sales representatives, the right to exclusively distribute the Products in the SIVEXTRO Territory, including the sole right and responsibility to fill orders with respect to the Products in the SIVEXTRO Territory. The Company successfully satisfied those conditions, including the increase in the number of sales representatives, and began filling orders of SIVEXTRO with its own Nabriva NDC beginning April 12, 2021. Subject to applicable law, the Company is entitled to determine the final selling prices of the Products charged by the Company to its customers at its sole discretion, subject to an overall annual limit on price increases, and will be solely responsible for sales contracting and all market access activities, including bidding, hospital listing and reimbursement. The Company is responsible for all costs related to the promotion, sale and distribution of the Products by the Company, as well as all costs required to meet its staffing obligations under the Distribution Agreement. The Company is obligated to use commercially reasonable efforts to promote and distribute the Products and to maximize the sales of the Products throughout the SIVEXTRO Territory. The Company has agreed to employ a sales force or retain the services of a contract sales organization to fulfill its obligations under the Distribution Agreement. The Company has secured a virtual and in-person sales effort with community-based expertise with Amplity Health, which is a contract sales organization, to replace its hospital-based sale force and began a small and focused sales effort for SIVEXTRO and XENLETA in September 2020. The Company expanded this effort to 60 sales representatives and may expand it further. The Company also piloted a virtual promotion effort with incremental sales representatives in the third quarter of 2021. Furthermore, a subsidiary of Merck will sell, and the Company has agreed to purchase, SIVEXTRO at specified prices in such quantities as the Company may specify. Although the Company is entitled, subject to appliable law, to determine the final selling prices of SIVEXTRO in its sole discretion, subject to an overall annual limit on price increases, the Company may not be able to sell SIVEXTRO at prices high enough to recoup its investment in a sales force and other commercialization activities. China Region License Agreement In March 2018, the Company entered into the China Region License Agreement, with Sinovant Sciences, Ltd., or Sinovant, an affiliate of Roivant Sciences, Ltd., to develop and commercialize lefamulin in the greater China region. As part of the China Region License Agreement, Nabriva Therapeutics Ireland DAC and Nabriva Therapeutics GmbH, the Company’s wholly owned subsidiaries, granted Sinovant an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin, or the China Region Licensed Products, in the People’s Republic of China, Hong Kong, Macau, and Taiwan, together the Extended China Territory. In May 2021, the Company entered into an assignment, assumption and novation agreement, or the Assignment Agreement, pursuant to which the Company consented to the assignment by Sinovant, an affiliate of Roivant Sciences, Ltd., of the China Region License Agreement to develop and commercialize lefamulin in the greater China region to Sumitomo Pharmaceuticals (Suzhou), a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo”). Pursuant to the Assignment Agreement, the Company agreed to release Sinovant and its affiliates from their obligations under the China Region License Agreement and consented to Sumitomo Pharmaceuticals (Suzhou)’s assumption of such obligations. In addition, Sumitomo Dainippon Pharma Co., Ltd., or Sumitomo, has agreed to guarantee all of the obligations of Sumitomo Pharmaceuticals (Suzhou) under the China Region License Agreement. Under the China Region License Agreement, Sumitomo Pharmaceuticals (Suzhou) and the Company’s subsidiaries have established a joint development committee, or the JDC, to review and oversee development and commercialization plans in the Extended China Territory. The China Region License Agreement includes milestone events consisting of a non-refundable $5.0 million upfront payment, an additional $91.5 million in milestone payments upon the achievement of certain regulatory and commercial milestone events related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if any China Region Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The Company has received the $5.0 million upfront payment, a $1.5 million payment for the submission of a clinical trial application, or CTA, by Sinovant to the Chinese Food and Drug Administration, which was received in the first quarter of 2019 and a $5.0 million milestone payment in the third quarter of 2019 in connection with the FDA approval for lefamulin. The Company will also be eligible to receive low double-digit royalties on sales, if any, of China Region Licensed Products in the Extended China Territory. In December 2020, the Company announced the restructuring of its China Region License Agreement. The restructured agreement provided for additional manufacturing collaboration and regulatory support to be provided to the contract counterparty by the Company that is expected to help expedite the delivery of XENLETA to patients in greater China. The restructured agreement also accelerated $3.0 million of the $5.0 million milestone payment to the Company that was previously payable upon regulatory approval of XENLETA in China, including a non-refundable upfront payment of $1.0 million which was received in the fourth quarter of 2020 and a $1.0 million milestone achieved during the first quarter of 2021. 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 $2.4 million for the year ended December 31, 2021, based on the proportional performance of the underlying performance obligation. The remaining milestones of $86.0 million are tied to additional regulatory approvals and annual sales targets. The future regulatory and commercial milestone payments under the China Region License Agreement will be recorded during the period the milestones become probable of achievement. Except for the manufacturing collaboration and regulatory support discussed above, Sumitomo Pharmaceuticals (Suzhou) will be solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing China Region Licensed Products in the Extended China Territory and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize China Region Licensed Products in the Extended China Territory. The Company is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sumitomo Pharmaceuticals (Suzhou) a sufficient supply of lefamulin for Sumitomo Pharmaceuticals (Suzhou) to manufacture finished drug products for development and commercialization of the China Region Licensed Products in the Extended China Territory. Unless earlier terminated, the China Region License Agreement will expire upon the expiration of the last royalty term for the last China Region Licensed Product in the Extended China Territory, which the Company expects will occur in 2033. Following the expiration of the last royalty term, the license granted to Sumitomo Pharmaceuticals (Suzhou) will become non-exclusive, fully-paid, royalty-free and irrevocable. The China Region License Agreement may be terminated in its entirety by Sumitomo Pharmaceuticals (Suzhou) upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the China Region License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the China Region License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the China Region License Agreement immediately if Sumitomo Pharmaceuticals (Suzhou) does not reach certain development milestones by certain specified dates (subject to specified cure periods). The China Region License Agreement contemplates that the Company will enter into ancillary agreements with Sumitomo Pharmaceuticals (Suzhou), including clinical and commercial supply agreements and a pharmacovigilance agreement. Sunovion License Agreement In March 2019, the Company entered into the Sunovion License Agreement with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC, the Company’s wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize 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 and Canada. The Named Patient Program, or NPP, is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available and have an unmet medical need. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 15. Commitments and Contingencies Future minimum contractual obligations and commitments at December 31, 2021 are as follows: Year ending December 31, (in thousands) Total 2022 2023 2024 2025 2026 Thereafter Operating lease obligations $ 785 702 83 — — — $ — XENLETA API purchase 53,985 4,691 4,691 4,691 6,652 6,652 26,608 Other contractual commitments 10,913 5,072 3,983 929 929 — — Total contractual commitments and contingencies $ 65,683 $ 10,465 $ 8,757 $ 5,620 $ 7,581 $ 6,652 $ 26,608 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 estimated payments to the service providers included in the table above 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 The Company has no contingent liabilities in respect of legal claims arising in the ordinary course of business. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events Nasdaq Deficiency Notice On January 4, 2022, the Company received written notice, or the Notice, from The Nasdaq Stock Market LLC, or Nasdaq, indicating that, based on the closing bid for the last 30 consecutive business days, the Company is 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), or the Bid Price Rule. The Notice does not result in the immediate delisting of the Company’s ordinary shares from The Nasdaq Global Select Market. In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days to regain compliance with the Bid Price Rule. As a result, the Company will have until July 5, 2022, or the Compliance Date, to regain compliance with the Bid Price Rule. To regain compliance, the closing bid price of the Company’s ordinary shares must be at least $1.00 per share for a minimum of ten 180-day EGM Vote On March 24, 2022 the Company held an extraordinary general meeting of shareholders, at which time its shareholders voted by a special resolution of over 75% of the votes cast at the meeting to grant the board of directors authority under Irish law to allot and issue ordinary shares (including rights to acquire ordinary shares) for cash without first offering those ordinary shares to existing shareholders pursuant to the statutory pre-emption right that would otherwise apply through March 23, 2027. CONTEPO NDA Given the uncertainties of the timing of onsite inspection at its manufacturing partners in Europe, the Company requested to be able to resubmit the CONTEPO NDA through June 2023, which the FDA granted on March 21, 2022. This extension granted by the FDA provides the Company the flexibility to submit at any time up and through June 2023. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Preparation | Basis of Preparation The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or US GAAP, and US Securities and Exchange Commission, or SEC, regulations for annual reporting. The consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Functional Currency Transactions and Balances | Functional Currency Transactions and Balances In preparing the consolidated financial statements, transactions in currencies other than the U.S. dollar are recognized at the exchange rates prevailing at the dates of the transactions. Foreign currency exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. |
Short-term Investments | Short-term Investments The Company has designated its investments in securities as available-for-sale securities and measures these securities at their respective fair values. Investments that mature in one year or less are classified as short-term available-for-sale securities. Investments that are not considered available for use in current operations are classified as long-term available-for-sale securities. Changes in the fair value of available-for-sale investments are recognized in other comprehensive income (loss). |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company's supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and would record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. As of December 31, 2021, the Company had a $1.0 million non-cash reserve for excess and obsolete inventory due to timing of expiring inventory. The components of our inventory at December 31, 2021 and 2020 are as follows: As of As of December 31, December 31, (in thousands) 2021 2020 XENLETA raw materials $ 1,528 $ 952 XENLETA work in process 9,142 4,608 XENLETA finished goods 18 263 Total XENLETA 10,688 5,823 SIVEXTRO finished goods 3,821 — Total inventory $ 14,509 $ 5,823 |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful lives of property, plant and equipment are as follows: 3 5 3 |
Intangible Assets and Other Long-lived Assets | Intangible Assets and Other Long-lived Assets Intangible assets, such as acquired computer software licenses, are capitalized on the basis of the costs incurred to acquire the software and bring it into use. These costs are amortized on a straight-line basis over their estimated useful lives ( 3 Long-lived assets are assessed for potential impairment when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. An impairment loss would be recognized when undiscounted cash flows expected to be generated by an asset, is less than its carrying amount. The impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and recognized in these financial statements. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the commercialization and development of novel anti-infective agents to treat serious and life-threatening infections. |
Revenue Recognition | Revenue Recognition Revenue from Contracts with Customers Net Product Revenue In September 2019, the Company launched XENLETA and in April 2021 the Company began exclusive distribution of SIVEXTRO in the United States and certain of its territories. The Company sells its products principally to a limited number of specialty distributors and wholesalers. The Company recognizes revenue once it has transferred physical possession of the goods and the customer obtains legal title to the product. Payment terms between Nabriva and its customers are generally approximately 60 days from the invoice date. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of its product. The transaction price that the Company recognizes as revenue reflects the amount it expects to be entitled to in connection with the sale and transfer of control of product to its customers. At the time that the Company’s customers take control of the product, which is when the Company’s performance obligation under the sales contracts is complete, the Company records product revenues net of applicable reserves for various types of variable consideration. The types of variable consideration are as follows: ● Fees-for-service ● Product returns ● Chargebacks and rebates ● Government rebates ● Commercial payer and other rebates ● Group Purchasing Organizations, or GPO, administration fees ● Voluntary patient assistance programs In determining the amounts of certain allowances and accruals, the Company must make significant judgments and estimates. For example, in determining these amounts, the Company estimates prescription demand from retail pharmacies, specialty pharmacies, hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations and the levels of inventory held by distributors and customers. The Company also analyzes third party end usage product consumption patterns to gauge demand for its products. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. The Company receives data periodically from its customers on inventory levels and historical channel sales mix, and the Company considers this data when determining the amount of the allowances and accruals for variable consideration. In assessing the amount of net revenue to record, the Company considers both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations the Company uses in estimating these amounts related to variable consideration associated with the Company’s products are as follows: Fees-for-service does not consider the fees separate from the distributors’ purchase of the product. The Company records its fee-for-service accruals based on distributors’ purchases and the applicable discount rate. Product returns history of SIVEXTRO and XENLETA returns, the Company estimated returns based on industry data for comparable products in the market. As the Company distributes its product and establishes historical sales over a longer period of time (i.e., two to three years), the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The Company’s XENLETA product has a forty-eight month shelf life and SIVEXTRO has a thirty-six month shelf life. their customers demand, product returns could increase in excess of what the Company has currently reserved which would result in a reduction to net revenues in future periods. At the end of each reporting period for any of its products, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. Chargebacks and rebates Chargebacks are discounts that occur when certain contracted customers, which currently consist primarily of group purchasing organizations, p ublic h ealth s ervice institutions, and Federal government entities purchasing via the Federal Supply Schedule, purchase directly from our wholesalers or specialty distributors. Contracted customers generally purchase the product at a discounted price. The Company provides a credit to its wholesaler or specialty distributor customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. The calculation of the accrual for chargebacks and rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Government rebates –The Company is subject to discount obligations primarily under state Medicaid and Medicare programs. The Company estimates its Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix. These reserves are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses on the consolidated balance sheet. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The calculation of the accrual for government rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. Commercial payer and other rebates – The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of SIVEXTRO and XENLETA and contracted formulary status. The Company estimates these rebates and records reserves for such estimates in the same period the related revenue is recognized. Currently, the reserve for customer payer rebates considers future utilization based on third party studies of payer prescription data; the utilization is applied to product that remains in the distribution and retail pharmacy channel inventories at the end of each reporting period. The calculation of the accrual for commercial payer and other rebates is based on estimates of claims and their associated cost that the Company expects to receive associated with product sales that have been recognized as revenue but remain in the distribution channel as inventory at the end of each reporting period. GPO administration fees – The Company contracts with GPOs and pays administration fees related to contacting and membership management services provided. In assessing if the consideration paid to the GPO should be recorded as a reduction in the transaction price, the Company determines whether the payment is for a distinct good or service or a combination of both. Since GPO fees are not specifically identifiable, the Company does not consider the fees separate from the purchase of the product. Additionally, the GPO services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. Patient assistance At the end of each reporting period, the Company will adjust its variable consideration estimates for product returns, chargebacks, and rebates when the Company believes actual experience may differ from current estimates. Cost of Revenues Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. Prior to the FDA approval of XENLETA on August 19, 2019, the inventory costs for XENLETA were expensed as research and development expenses since the approval was outside of our control and therefore not considered probable. As such, the majority of the expenses incurred for our initial inventories of XENLETA has been previously expensed. For the years ended December 31, 2021 and 2020, cost of revenues include a $0.3 million and $0.7 million non-cash reserve adjustment for excess and obsolete inventory due to timing of expiry dating of inventory. |
Research Premium and Grant Revenue | Research Premium and Grant Revenue Grant revenue comprises (a) the research premium from the Austrian government, (b) grants received from the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft, or FFG The research premium the Company receives from the Austrian government is calculated at a specified percent of specified research and development cost base. The Company recognizes the research premium as long as it has incurred research and development expenses. All grants are non-refundable as long as the conditions of the grant are met. Nabriva is and has been in full compliance with the conditions of the grants and all related regulations. |
Research and Development Expenses | Research and Development Expenses All research and development costs are expensed as incurred. Research and development costs included direct personnel and material costs, related overheads, depreciation of equipment used for research or development purposes; costs for clinical research; costs for the utilization of third parties’ patents for research and development purposes and other taxes related to research facilities. |
Share-based Payments | Share-based Payments The Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award in accordance with ASC 718, Compensation — Stock Compensation |
Leases | Leases The Company follows ASC Topic 842, Leases The Company determines if an arrangement is a lease at inception. Operating lease right-of-use, or ROU, assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the remaining lease term. ROU assets are included in property, plant and equipment, and operating lease liabilities are included in accrued expenses on the Company’s consolidated balance sheet. The Company has elected not to recognize ROU assets or lease liabilities for short-term leases. Since none of the Company’s lease agreements provide an implicit rate, the Company estimates an incremental borrowing rate over the lease term in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. In recognizing the benefit of tax positions, the Company has taken or expects to take, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. |
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 year ended December 31, 2021, nor are there any recently issued accounting pronouncements that are expected to have a material impact on the Company´s consolidated financial statements in future periods. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Schedule of inventory | As of As of December 31, December 31, (in thousands) 2021 2020 XENLETA raw materials $ 1,528 $ 952 XENLETA work in process 9,142 4,608 XENLETA finished goods 18 263 Total XENLETA 10,688 5,823 SIVEXTRO finished goods 3,821 — Total inventory $ 14,509 $ 5,823 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurement | |
Schedule of the financial instruments measured at fair value and classified by level according to the fair value measurement hierarchy | (in thousands) Level 1 Level 2 Level 3 Total 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 (in thousands) Level 1 Level 2 Level 3 Total December 31, 2020 Assets: Cash equivalent: Money market fund $ 8,050 $ — $ — $ 8,050 Short-term investments: Term deposits 16 — — 16 Total assets $ 8,066 $ — $ — $ 8,066 |
Accounts Receivable, net and _2
Accounts Receivable, net and Other Receivables (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Receivable, net and Other Receivables | |
Schedule of other current receivables | As of December 31 (in thousands) 2021 2020 Receivables from customers, net $ 8,778 $ 56 Receivables from collaborative arrangments 2,193 2,426 Research premium 1,237 1,308 Other receivables 543 119 Total accounts receivable, net and other receivables $ 12,751 $ 3,909 |
Schedule of balances and activity of product revenue allowances and reserves | As of December 31, 2021 2020 Receivables from customers, gross $ 10,149 $ 75 Less: fee for service (924) — Less: chargeback reserve (249) (17) Less: cash discount (198) (2) Receivables from customers, net $ 8,778 $ 56 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment | |
Schedule of property, plant and equipment | As of December 31 (in thousands) 2021 2020 IT equipment $ 1,083 $ 1,077 Laboratory equipment 3,404 3,392 ROU asset — 226 Other equipment 101 204 4,588 4,899 Less: Accumulated depreciation (4,355) (4,131) Property, plant and equipment, net $ 233 $ 768 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other liabilities | As of December 31, (in thousands) 2021 2020 Research and development related costs $ 789 $ 1,055 Payroll and related costs 5,085 4,049 Accounting, tax and audit services 736 470 Manufacturing and inventory 592 4,779 Product returns 2,282 349 Government rebates 1,751 135 Other accrued gross to net 1,090 178 Other 1,504 1,829 Total other current liabilities $ 13,829 $ 12,844 |
Schedule of reserve for product returns | 2021 2020 Balance at January 1 $ 349 $ 33 Provision recorded during the period 2,043 431 Credits issued during the period (110) (115) Balance at December 31 $ 2,282 $ 349 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Schedule of long-term debt | As of December 31, (in thousands) 2021 2020 Term loan payable $ 5,000 $ 5,000 End of term fee 2,331 2,048 Unamortized debt issuance costs (145) (206) Carrying value of term loan 7,186 6,842 Other long-term debt 844 885 Less: Amounts due within one year (3,765) (2,041) Total long-term debt $ 4,265 $ 5,686 |
Schedule of maturities of long-term debt | (in thousands) 2022 $ 3,765 2023 $ 4,811 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue | |
Summary of revenue by type | Year Ended December 31, (in thousands) 2021 2020 2019 Product revenue, net $ 23,386 $ 108 $ 1,538 Collaboration revenues 3,830 2,756 6,210 Research premium and grant revenue 1,679 2,163 1,733 Total revenue $ 28,895 $ 5,027 $ 9,481 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-Based Payments | |
Summary of information regarding stock option awards | Weighted Weighted Average average Remaining Aggregate exercise Contractual intrinsic price in Term value Options $ per share (in years) (in thousands) Outstanding as of January 1, 2019 609,133 65.17 — — Granted 316,645 20.11 — — Exercised — — — — Cancelled and forfeited (108,887) 64.33 — — Outstanding as of December 31, 2019 816,891 47.82 — — Granted 465,055 11.27 — — Exercised — — — — Cancelled and forfeited (229,108) 31.92 — — Outstanding as of December 31, 2020 1,052,838 35.08 — — Granted 637,880 1.23 — — Exercised — — — — Cancelled and forfeited (342,241) 16.90 — — Outstanding as of December 31, 2021 1,348,477 20.46 8.0 $ — Vested and exercisable as of December 31, 2021 533,564 45.05 6.7 $ — |
Summary of assumptions used for valuation of options | Input parameters 2021 2020 2019 Range of expected volatility 75.3% ‑ 77.3% 63.7% ‑ 74.4% 59.8% - 63.1% Expected term of options (in years) 5.5 - 6.1 5.5 - 6.1 6.0 - 6.1 Range of risk-free interest rate 0.8% ‑ 1.3% 0.8% ‑ 1.5% 1.9% - 3.0% Dividend yield — — – |
Schedule of allocation of share-based compensation expense | Year Ended December 31, (in thousands) 2021 2020 2019 Research and development expense $ 565 $ 1,280 $ 2,138 Selling, general and administrative expense 2,726 3,939 7,610 Total stock-based compensation expense $ 3,291 $ 5,219 $ 9,748 |
2017 Share Incentive Plan | |
Share-Based Payments | |
Summary of information regarding restricted stock awards | Weighted average grant date fair RSUs value in $ per share Outstanding as of January 1, 2019 137,210 33.34 Granted 47,900 19.00 Vested and issued (65,758) 31.80 Forfeited (14,183) 27.87 Outstanding as of December 31, 2019 105,169 28.50 Granted 244,832 10.99 Vested and issued (52,640) 31.15 Forfeited (57,977) 21.74 Outstanding as of December 31, 2020 239,384 11.60 Granted 769,132 2.02 Vested and issued (90,330) 12.04 Forfeited (128,448) 6.93 Outstanding as of December 31, 2021 789,738 2.92 |
Income Tax Expense (Tables)
Income Tax Expense (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Expense | |
Schedule of loss before income taxes attributable to domestic and international operations | Year ended December 31 (in thousands) 2021 2020 2019 Domestic $ (40,540) $ (71,344) $ (78,761) Foreign (8,420) 1,999 (3,902) Loss before income taxes $ (48,960) $ (69,345) $ (82,663) |
Schedule of income tax expense | Year ended December 31 (in thousands) 2021 2020 2019 Current tax Domestic $ — $ — $ — Foreign (490) (139) (101) Deferred tax Domestic — — — Foreign — — — Total income tax expense $ (490) $ (139) $ (101) |
Schedule of effective income tax rate reconciliation | Year ended December 31 (% of pre-tax income) 2021 2020 2019 Statutory income tax rate 12.5 % 12.5 % 12.5 % Non-deductible expenses — — (0.1) Income not subject to tax 0.4 0.2 0.3 Tax credits — 0.6 0.4 Foreign operations (7.3) 3.0 0.6 Tax audit assessments — — (11.8) Other (1.7) 2.3 0.8 Valuation allowance (4.9) (18.8) (2.8) Effective income tax rate (1.0) % (0.2) % (0.1) % |
Summary of the components of deferred income tax balances | As of December 31, (in thousands) 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 111,220 $ 108,095 Tax loss on liquidation of subsidiary 2,501 4,029 Equity compensation 4,067 4,449 Non-deductible reserves 905 447 Total deferred tax assets 118,693 117,020 Valuation allowance (118,583) (116,200) Net deferred tax assets 110 820 Deferred tax liabilities: Financial liabilities 100 757 Property, plant and equipment 10 63 Total deferred tax liability 110 820 Deferred tax, net $ — $ — |
Summary of changes in the deferred tax valuation allowance | Year ended December 31, (in thousands) 2021 2020 2019 Balance at beginning of year $ (116,200) $ (103,185) $ (100,832) Tax benefit (2,383) (13,015) (2,353) Balance at end of year $ (118,583) $ (116,200) $ (103,185) |
Summary of carryforwards of net operating losses | (in thousands) Amount Expiration Ireland $ 297,453 Indefinite Austria $ 239,510 Indefinite United States $ 10,403 Indefinite United States $ 35,516 2033 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings (Loss) per Share | |
Schedule of basic and diluted loss per share | Year ended December 31, (in thousands, except per share data) 2021 2020 2019 Net loss for the period $ (49,450) $ (69,484) $ (82,764) Weighted average number of shares outstanding 43,349,461 12,845,089 7,419,948 Basic and diluted loss per share $ (1.14) $ (5.41) $ (11.15) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Year ended December 31 2021 2020 2019 Stock option awards 1,348,477 1,052,838 816,891 Restricted share units 789,738 239,384 105,169 Warrants 10,619,347 5,438,842 1,379,310 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Schedule of future minimum contractual obligations and commitments | Year ending December 31, (in thousands) Total 2022 2023 2024 2025 2026 Thereafter Operating lease obligations $ 785 702 83 — — — $ — XENLETA API purchase 53,985 4,691 4,691 4,691 6,652 6,652 26,608 Other contractual commitments 10,913 5,072 3,983 929 929 — — Total contractual commitments and contingencies $ 65,683 $ 10,465 $ 8,757 $ 5,620 $ 7,581 $ 6,652 $ 26,608 |
Organization and Business Act_2
Organization and Business Activities (Details) | Jan. 01, 2022USD ($)shares | Jan. 31, 2022USD ($)shares | Sep. 30, 2021USD ($)$ / sharesshares | May 31, 2021USD ($)$ / sharesshares | Mar. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | May 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2021USD ($)employee$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($)shares |
Liquidity | |||||||||||
Cash, cash equivalents and short-term investments | $ 47,900,000 | ||||||||||
Number of sales representatives | employee | 60 | ||||||||||
Proceeds from at-the-market facility | $ 42,280,000 | $ 7,520,000 | $ 27,945,000 | ||||||||
Nominal value | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Shares issued | $ 70,138,000 | $ 61,060,000 | $ 48,082,000 | ||||||||
Regular purchase | $ 2,500,000 | ||||||||||
Public offering | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 6,000,000 | ||||||||||
Shares Issued, Price Per Share | $ / shares | $ 2.50 | $ 2.50 | |||||||||
Proceeds from at-the-market facility | $ 15,000,000 | ||||||||||
Net proceeds from sale of stock | $ 13,300,000 | ||||||||||
Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 4,144,537 | ||||||||||
Proceeds from at-the-market facility | $ 38,000,000 | ||||||||||
Net proceeds from sale of stock | $ 35,200,000 | ||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 4,144,537 | ||||||||||
Share and warrant price | $ / shares | $ 9.1686 | ||||||||||
Jefferies LLC | At-the-market offering | Maximum | |||||||||||
Liquidity | |||||||||||
Proceeds from at-the-market facility | $ 19,000,000 | ||||||||||
Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 9,761,010 | 1,379,310 | |||||||||
Proceeds from at-the-market facility | $ 20,000,000 | ||||||||||
Net proceeds from sale of stock | $ 23,400,000 | $ 18,300,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 25,400,000 | ||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 4,880,505 | 1,379,310 | 1,379,310 | ||||||||
Nominal value | $ / shares | $ 0.01 | ||||||||||
Share and warrant price | $ / shares | $ 14.50 | ||||||||||
Exercise price | $ / shares | $ 2.39 | ||||||||||
Term | 5 years | ||||||||||
Warrants outstanding | shares | 5,180,505 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Proceeds from at-the-market facility | 19,000,000 | ||||||||||
Net proceeds from sale of stock | $ 1,600,000 | $ 2,400,000 | |||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 3,600,000 | 3,600,000 | 2,400,000 | ||||||||
Proceeds from at-the-market facility | $ 1,600,000 | $ 2,400,000 | |||||||||
Commitment shares | shares | 632,474 | ||||||||||
Commitment share price | $ / shares | $ 0.01 | ||||||||||
Regular purchase | $ 2,500,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Maximum | |||||||||||
Liquidity | |||||||||||
Proceeds from at-the-market facility | $ 19,000,000 | ||||||||||
Shares issued | $ 23,000,000 | ||||||||||
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 | ||||||||||
Ordinary Share Warrants | Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 600,000 | ||||||||||
Share and warrant price | $ / shares | $ 2.4525 | ||||||||||
Exercise price | $ / shares | $ 2.39 | ||||||||||
Pre-Funded Warrants | Purchasers | Purchase agreement | |||||||||||
Liquidity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | shares | 300,000 | ||||||||||
Share and warrant price | $ / shares | $ 2.4425 | ||||||||||
Exercise price | $ / shares | $ 0.01 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | |||||||||||
Liquidity | |||||||||||
Number of shares issued | shares | 1,338,282 | 5,925,699 | 18,232,689 | ||||||||
Proceeds from at-the-market facility | $ 595,000 | $ 31,900,000 | $ 29,300,000 | ||||||||
Net proceeds from sale of stock | $ 580,000 | ||||||||||
Aggregate gross sale proceeds for ordinary shares | 33,700,000 | $ 30,500,000 | |||||||||
Ordinary shares remained unsold | $ 16,300,000 | ||||||||||
Nominal value | $ / shares | $ 0.01 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | Maximum | |||||||||||
Liquidity | |||||||||||
Proceeds from at-the-market facility | $ 50,000,000 | ||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 50,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Total inventory | $ 14,509 | $ 5,823 |
Obsolete inventory non-cash reserve | 1,000 | |
Inventory Valuation Reserves | 300 | 700 |
XENLETA | ||
Inventory [Line Items] | ||
Raw materials | 1,528 | 952 |
Work in process | 9,142 | 4,608 |
Finished goods | 18 | 263 |
Total inventory | 10,688 | $ 5,823 |
SIVEXTRO | ||
Inventory [Line Items] | ||
Finished goods | $ 3,821 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
IT equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 3 years |
IT equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 5 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 5 years |
Laboratory equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 10 years |
Other equipment | Minimum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 3 years |
Other equipment | Maximum | |
Property, Plant and Equipment | |
Estimated useful life of property, plant and equipment | 10 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Intangible Assets and Other Long-lived Assets and Segment Information (Details) | 12 Months Ended |
Dec. 31, 2021segment | |
Intangible assets | |
Number of operating segments | 1 |
Minimum | |
Intangible assets | |
Estimated useful life of intangible assets | 3 years |
Maximum | |
Intangible assets | |
Estimated useful life of intangible assets | 10 years |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Short-term investments: | ||
Transfer of assets from Level 1 to 2 | $ 0 | $ 0 |
Transfer of assets from Level 2 to 1 | 0 | 0 |
Transfer of liabilities from Level 1 to 2 | 0 | 0 |
Transfer of liabilities from Level 2 to 1 | 0 | 0 |
Recurring | ||
Cash equivalent: | ||
Money market funds | 8,050 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | 16 |
Total assets | 8,066 | 8,066 |
Level 1 | Recurring | ||
Cash equivalent: | ||
Money market funds | 8,050 | 8,050 |
Short-term investments: | ||
Term deposits | 16 | 16 |
Total assets | $ 8,066 | $ 8,066 |
Accounts Receivable, net and _3
Accounts Receivable, net and Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other receivables | ||
Receivables from customers, net | $ 8,778 | $ 56 |
Receivables from collaborative arrangements | 2,193 | 2,426 |
Research premium | 1,237 | 1,308 |
Other receivables | 543 | 119 |
Total accounts receivable, net and other receivables | $ 12,751 | $ 3,909 |
Accounts Receivable, net and _4
Accounts Receivable, net and Other Receivables - Product Revenue Allowances and Reserves (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable, net and Other Receivables | ||
Receivables from customers, gross | $ 10,149 | $ 75 |
Less: fee for service | (924) | |
Less: chargeback reserve | (249) | (17) |
Less: cash discount | (198) | (2) |
Receivables from customers, net | $ 8,778 | $ 56 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 4,588 | $ 4,899 |
Less: Accumulated depreciation | (4,355) | (4,131) |
Property, plant and equipment, net | 233 | 768 |
IT equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 1,083 | 1,077 |
Laboratory equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 3,404 | 3,392 |
ROU asset | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | 226 | |
Other equipment | ||
Property, Plant and Equipment | ||
Property, plant and equipment, gross | $ 101 | $ 204 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued expenses and other liabilities | |||
Research and development related costs | $ 789 | $ 1,055 | |
Payroll and related costs | 5,085 | 4,049 | |
Accounting, tax and audit services | 736 | 470 | |
Manufacturing and inventory | 592 | 4,779 | |
Product returns | 2,282 | 349 | $ 33 |
Government rebates | 1,751 | 135 | |
Other accrued gross to net | 1,090 | 178 | |
Other | 1,504 | 1,829 | |
Total other current liabilities | $ 13,829 | $ 12,844 |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Reserve for Product Returns (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accrued Expenses and Other Liabilities | ||
Balance at beginning | $ 349 | $ 33 |
Provision recorded during the period | 2,043 | 431 |
Credits issued during the period | (110) | (115) |
Balance at ending | $ 2,282 | $ 349 |
Debt - Summary (Details)
Debt - Summary (Details) - USD ($) | Jun. 02, 2021 | Mar. 11, 2020 | Feb. 29, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 |
Debt | |||||||
Loss on extinguishment of debt | $ (2,757,000) | ||||||
Term loan | |||||||
Debt | |||||||
End of term fee | $ 5,000,000 | $ 5,000,000 | |||||
Loan Agreement | Term loan | |||||||
Debt | |||||||
Maximum borrowing capacity | $ 75,000,000 | ||||||
Principal amount of advances outstanding | $ 35,000,000 | ||||||
Interest rate (as a percent) | 9.80% | ||||||
Fee due at maturity, as a percentage of aggregate advances | 6.95% | ||||||
The amount in excess of which prepayments may be made | $ 5,000,000 | ||||||
Repayment of debt | $ 30,000,000 | 30,000,000 | |||||
Minimum cash and cash equivalents in accounts to be maintained | $ 3,000,000 | ||||||
Net product revenue | $ 15,000,000 | ||||||
Trailing period | 3 months | 6 months | |||||
Percent of net product revenue sales target | 70.00% | 80.00% | |||||
Minimum liquidity requirement | $ 40,000,000 | ||||||
Minimum amount to be maintained in cash and cash equivalents | $ 3,000,000 | ||||||
Maximum value of lender option to purchase equity securities | 2,000,000 | ||||||
End of term loan charge payment | 2,100,000 | ||||||
End of term loan charge | $ 300,000 | $ 600,000 | |||||
Loan origination costs | 1,300,000 | ||||||
Initial fee paid to lender | 700,000 | ||||||
Loss on extinguishment of debt | $ 2,700,000 | ||||||
End of term fee | $ 5,000,000 | ||||||
Loan Agreement | Term loan | Prime rate | |||||||
Debt | |||||||
Variable rate basis | interest minus 5.50% | ||||||
Variable interest rate margin (as a percent) | 9.80% | ||||||
Variable rate adjustment (as a percent) | 5.50% | ||||||
Loan Agreement | Term loan | Initial Advance | |||||||
Debt | |||||||
Principal amount of advances outstanding | 25,000,000 | ||||||
Loan Agreement | Term loan | Tranche 7 Advance | |||||||
Debt | |||||||
Maximum borrowing capacity | $ 5,000,000 | ||||||
Additional tranches | $ 5,000,000 | ||||||
Loan Agreement | Term loan | Prepayment during the first 12 months following initial closing | |||||||
Debt | |||||||
Prepayment penalty as a percentage of the amount being repaid | 3.00% | ||||||
Loan Agreement | Term loan | Prepayment after the first 12 months following initial closing but before 24 months | |||||||
Debt | |||||||
Prepayment penalty as a percentage of the amount being repaid | 2.00% | ||||||
Loan Agreement | Term loan | Prepayment after the first 24 months following initial closing but before maturity | |||||||
Debt | |||||||
Prepayment penalty as a percentage of the amount being repaid | 1.00% |
Debt - Long-Term Debt (Details)
Debt - Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Long-term debt | ||
Less: Amounts due within one year | $ (3,765) | $ (2,041) |
Long-term debt | 4,265 | 5,686 |
Maturities of long-term debt | ||
2022 | 3,765 | |
2023 | 4,811 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 5,000 | 5,000 |
End of term fee | 2,331 | 2,048 |
Unamortized debt issuance costs | (145) | (206) |
Carrying value of term loan | 7,186 | 6,842 |
Other long-term debt | ||
Long-term debt | ||
Carrying value of term loan | $ 844 | $ 885 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Jan. 01, 2022 | Jan. 31, 2022 | Sep. 30, 2021 | May 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | May 31, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Stockholders' Equity | |||||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 42,280,000 | $ 7,520,000 | $ 27,945,000 | ||||||||
Shares issued | $ 70,138,000 | $ 61,060,000 | $ 48,082,000 | ||||||||
Nominal value | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Regular purchase | $ 2,500,000 | ||||||||||
Public offering | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 6,000,000 | ||||||||||
Shares issued, price per share | $ 2.50 | $ 2.50 | |||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 15,000,000 | ||||||||||
Net proceeds from sale of stock | $ 13,300,000 | ||||||||||
Purchase agreement | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 4,144,537 | ||||||||||
Number of ordinary shares that can be purchased by warrant holders | 4,144,537 | ||||||||||
Share and warrant price | $ 9.1686 | ||||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 38,000,000 | ||||||||||
Net proceeds from sale of stock | $ 35,200,000 | ||||||||||
Jefferies LLC | At-the-market offering | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 19,000,000 | ||||||||||
Purchasers | Warrants Issued In May 2020 | |||||||||||
Stockholders' Equity | |||||||||||
Warrants outstanding | 4,059,532 | ||||||||||
Purchasers | Purchase agreement | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 9,761,010 | 1,379,310 | |||||||||
Number of ordinary shares that can be purchased by warrant holders | 4,880,505 | 1,379,310 | 1,379,310 | ||||||||
Share and warrant price | $ 14.50 | ||||||||||
Per share exercise price of right | $ 2.39 | ||||||||||
Term | 5 years | ||||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 20,000,000 | ||||||||||
Net proceeds from sale of stock | $ 23,400,000 | $ 18,300,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 25,400,000 | ||||||||||
Nominal value | $ 0.01 | ||||||||||
Warrants outstanding | 5,180,505 | ||||||||||
Purchasers | Purchase agreement | Warrants Issued In December 2019 | |||||||||||
Stockholders' Equity | |||||||||||
Per share exercise price of right | $ 19 | ||||||||||
Term | 3 years 6 months | ||||||||||
Warrants outstanding | 1,379,310 | ||||||||||
Purchasers | Purchase agreement | Warrants Issued In May 2020 | |||||||||||
Stockholders' Equity | |||||||||||
Per share exercise price of right | $ 7.92 | ||||||||||
Term | 2 years | ||||||||||
Purchasers | Purchase agreement | Ordinary Share Warrants | |||||||||||
Stockholders' Equity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | 600,000 | ||||||||||
Share and warrant price | $ 2.4525 | ||||||||||
Per share exercise price of right | $ 2.39 | ||||||||||
Purchasers | Purchase agreement | Pre-Funded Warrants | |||||||||||
Stockholders' Equity | |||||||||||
Number of ordinary shares that can be purchased by warrant holders | 300,000 | ||||||||||
Share and warrant price | $ 2.4425 | ||||||||||
Per share exercise price of right | $ 0.01 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | |||||||||||
Stockholders' Equity | |||||||||||
Net proceeds for deducting commissions and offering expenses payable | 19,000,000 | ||||||||||
Net proceeds from sale of stock | $ 1,600,000 | $ 2,400,000 | |||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 3,600,000 | 3,600,000 | 2,400,000 | ||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 1,600,000 | $ 2,400,000 | |||||||||
Commitment shares | 632,474 | ||||||||||
Commitment share price | $ 0.01 | ||||||||||
Regular purchase | $ 2,500,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Ordinary shares | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 19,000,000 | ||||||||||
Shares issued | $ 23,000,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $0.25 Per Share | Ordinary shares | |||||||||||
Stockholders' Equity | |||||||||||
Share price | $ 0.25 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $0.25 Per Share | Ordinary shares | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 400,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $2.00 Per Share | Ordinary shares | |||||||||||
Stockholders' Equity | |||||||||||
Share price | $ 2 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $2.00 Per Share | Ordinary shares | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 600,000 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $3.00 Per Share | Ordinary shares | |||||||||||
Stockholders' Equity | |||||||||||
Share price | $ 3 | ||||||||||
Lincoln Park Capital Fund, LLC | Purchase agreement | Share Price Not Below $3.00 Per Share | Ordinary shares | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 800,000 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | |||||||||||
Stockholders' Equity | |||||||||||
Number of shares issued | 1,338,282 | 5,925,699 | 18,232,689 | ||||||||
Net proceeds for deducting commissions and offering expenses payable | $ 595,000 | $ 31,900,000 | $ 29,300,000 | ||||||||
Net proceeds from sale of stock | $ 580,000 | ||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 33,700,000 | $ 30,500,000 | |||||||||
Nominal value | $ 0.01 | ||||||||||
Ordinary shares remained unsold | $ 16,300,000 | ||||||||||
Open Market Sale Agreement | Jefferies LLC | Ordinary shares | Maximum | |||||||||||
Stockholders' Equity | |||||||||||
Net proceeds for deducting commissions and offering expenses payable | 50,000,000 | ||||||||||
Aggregate gross sale proceeds for ordinary shares | $ 50,000,000 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | ||||||
Revenue accounted for under Topic 606 | $ 28,895 | $ 5,027 | $ 9,481 | |||
Sinovant Sciences, LTD | License Agreement | ||||||
Revenue | ||||||
Regulatory milestone payment received | 500 | |||||
Merck & Co | License Agreement | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | 1,200 | |||||
Regulatory milestone payment received | 1,800 | |||||
Collaboration revenue | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | 3,830 | 2,756 | 6,210 | |||
Collaboration revenue | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | 2,600 | |||||
Collaboration revenue - Upfront payment | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | 23,386 | 108 | 1,538 | |||
Collaboration revenue - Upfront payment | Sinovant Sciences, LTD | License Agreement | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | 1,000 | |||||
Collaboration revenue - Upfront payment | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | $ 3,000 | $ 1,000 | $ 5,000 | |||
Collaboration revenue - Variable consideration | Sinovant Sciences, LTD | License Agreement | ||||||
Revenue | ||||||
Milestone payment received | 5,000 | |||||
Research premium and grant revenue | ||||||
Revenue | ||||||
Revenue accounted for under Topic 606 | $ 1,679 | $ 2,163 | $ 1,733 |
Revenue - Summary of Gross-To-N
Revenue - Summary of Gross-To-Net ("GTN") Adjustments (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenue, gross | $ 17,000 | |||
XENLETA | ||||
Disaggregation of Revenue [Line Items] | ||||
Returns reserve & GTN accrual adjustments | 1,300,000 | $ 400,000 | ||
GTN accrual adjustments | $ (400,000) | $ 100,000 | $ 1,500,000 | |
Percentage of inventory held | 50.00% | |||
SIVEXTRO | ||||
Disaggregation of Revenue [Line Items] | ||||
GTN accrual adjustments | $ 23,800,000 |
Share-Based Payments - Stock Pl
Share-Based Payments - Stock Plan Activity (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Jul. 31, 2018$ / sharesshares | Dec. 31, 2021$ / sharesshares | Dec. 31, 2020tranche$ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018tranche$ / shares | Sep. 30, 2021shares | Aug. 31, 2021shares | Mar. 04, 2021shares | Dec. 09, 2020shares | Mar. 12, 2019shares | |
Stock Options | ||||||||||
Share-Based Payments | ||||||||||
Options granted during the period | 637,880 | 465,055 | 316,645 | |||||||
Options exercise price (in dollars per share) | $ / shares | $ 20.46 | $ 35.08 | $ 47.82 | $ 65.17 | ||||||
Restricted Share Units ("RSUs") | ||||||||||
Share-Based Payments | ||||||||||
Restricted stock granted during the period | 769,132 | 244,832 | 47,900 | |||||||
Stock Option Plan 2015 | Stock Options | ||||||||||
Share-Based Payments | ||||||||||
Vesting period | 4 years | |||||||||
Stock Option Plan 2015 | Stock Options | Vesting period, year one | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 25.00% | |||||||||
Stock Option Plan 2015 | Stock Options | Vesting period, years 2-4 | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 75.00% | |||||||||
Monthly vesting percentage | 2.083% | |||||||||
Stock Option Plan 2015 | Maximum | Stock Options | ||||||||||
Share-Based Payments | ||||||||||
Exercise period | 10 years | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | ||||||||||
Share-Based Payments | ||||||||||
Vesting period | 4 years | |||||||||
Percentage that vests during the period | 25.00% | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | XENLETA | ||||||||||
Share-Based Payments | ||||||||||
Vesting period | 6 months | |||||||||
Number of vesting periods | tranche | 3 | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Immediate vesting upon regulatory approval | XENLETA | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Immediate vesting upon regulatory approval | CONTEPO | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | XENLETA | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
2017 Share Incentive Plan | Restricted Share Units ("RSUs") | Vesting upon the one-year-anniversary of FDA approval | CONTEPO | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
2019 Inducement Plan | Ordinary shares | ||||||||||
Share-Based Payments | ||||||||||
Shares reserved for future issuance | 200,000 | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year one | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 25.00% | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Vesting period, year two | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 75.00% | |||||||||
Monthly vesting period | 36 months | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Share Units ("RSUs") | Chief Executive Officer | ||||||||||
Share-Based Payments | ||||||||||
Options granted during the period | 15,000 | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Share Units ("RSUs") | Upon receipt of FDA approval | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Restricted Share Units ("RSUs") | First anniversary of FDA approval | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | ||||||||||
Share-Based Payments | ||||||||||
Vesting period | 4 years | |||||||||
Exercise period | 10 years | |||||||||
Options exercise price (in dollars per share) | $ / shares | $ 35.30 | |||||||||
Inducement Awards Outside of the 2019 Inducement Plan | Non-statutory option | Chief Executive Officer | ||||||||||
Share-Based Payments | ||||||||||
Options granted during the period | 85,000 | |||||||||
2020 Share Incentive Plan | Restricted Share Units ("RSUs") | Chief Executive Officer | ||||||||||
Share-Based Payments | ||||||||||
Percentage that vests during the period | 50.00% | |||||||||
Restricted stock granted during the period | 7,000 | |||||||||
2020 Share Incentive Plan | Restricted Share Units ("RSUs") | Employees | ||||||||||
Share-Based Payments | ||||||||||
Vesting period | 6 months | |||||||||
Number of vesting periods | tranche | 3 | |||||||||
2020 Share Incentive Plan | Ordinary shares | ||||||||||
Share-Based Payments | ||||||||||
Shares reserved for future issuance | 271,080 | |||||||||
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 | ten years | |||||||||
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 | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Assumptions | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Fair Value Assumptions | |||
Expected volatility | 75.30% | 63.70% | 59.80% |
Expected term of options (in years) | 5 years 6 months | 5 years 6 months | 6 years |
Range of risk-free interest rate | 0.80% | 0.80% | 1.90% |
Maximum | |||
Fair Value Assumptions | |||
Expected volatility | 77.30% | 74.40% | 63.10% |
Expected term of options (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Range of risk-free interest rate | 1.30% | 1.50% | 3.00% |
Stock Options | |||
Options | |||
Outstanding at beginning of year (in shares) | 1,052,838 | 816,891 | 609,133 |
Granted (in shares) | 637,880 | 465,055 | 316,645 |
Forfeited (in shares) | (342,241) | (229,108) | (108,887) |
Outstanding at end of year (in shares) | 1,348,477 | 1,052,838 | 816,891 |
Vested and exercisable at end of year (in shares) | 533,564 | ||
Weighted average exercise price in $ per share | |||
Outstanding balance at beginning of year (in dollars per share) | $ 35.08 | $ 47.82 | $ 65.17 |
Granted (in dollars per share) | 1.23 | 11.27 | 20.11 |
Forfeited (in dollars per share) | 16.90 | 31.92 | 64.33 |
Outstanding balance at end of year (in dollars per share) | 20.46 | 35.08 | 47.82 |
Vested and exercisable balance at end of year (in dollars per share) | $ 45.05 | ||
Weighted Average Remaining Contractual Term (in years) | |||
Weighted average remaining contractual term, outstanding | 8 years | ||
Weighted average remaining contractual term, vested and exercisable | 6 years 8 months 12 days | ||
Additional disclosures | |||
Total unrecognized compensation related to unvested options | $ 1.8 | ||
Recognition period | 10 months 24 days | ||
Weighted-average grant date fair value (in dollars per share) | $ 0.82 | $ 5.99 | $ 11.95 |
Stock Options | Exercise Price Range From 1.06 To 110.0 [Member] | |||
Additional disclosures | |||
Exercise price maximum range | 110 | ||
Exercise price minimum range | $ 1.06 | ||
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") - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted Stock Units | |||
Number of shares outstanding | 239,384 | 105,169 | 137,210 |
Granted | 769,132 | 244,832 | 47,900 |
Vested and issued | (90,330) | (52,640) | (65,758) |
Forfeited | (128,448) | (57,977) | (14,183) |
Number of shares outstanding | 789,738 | 239,384 | 105,169 |
Weighted average grant date fair value per share | |||
Weighted average grant date fair value per share at the beginning | $ 11.60 | $ 28.50 | $ 33.34 |
Granted | 2.02 | 10.99 | 19 |
Vested and issued | 12.04 | 31.15 | 31.80 |
Forfeited | 6.93 | 21.74 | 27.87 |
Weighted average grant date fair value per share at the end | $ 2.92 | $ 11.60 | $ 28.50 |
Additional disclosures | |||
Total unrecognized compensation related to unvested RSUs | $ 1.1 | ||
Recognition period | 1 year 8 months 12 days | ||
Fair Value | $ 0.2 | $ 0.4 | $ 1.5 |
Share-Based Payments - Share-Ba
Share-Based Payments - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-Based Payments | |||
Share-based compensation expense | $ 3,291 | $ 5,219 | $ 9,748 |
Research and development | |||
Share-Based Payments | |||
Share-based compensation expense | 565 | 1,280 | 2,138 |
Selling, general and administrative | |||
Share-Based Payments | |||
Share-based compensation expense | $ 2,726 | $ 3,939 | $ 7,610 |
Share-Based Payments - Employee
Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares | 1 Months Ended | 12 Months Ended |
Aug. 31, 2018 | Dec. 31, 2021 | |
Share-Based Payments | ||
Maximum number of shares authorized under plan (in shares) | 50,000 | |
Purchase discount as a percentage of current market price | 15.00% |
Post-employment Benefit Oblig_2
Post-employment Benefit Obligations (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Austria | |||
Post-employment Benefit Obligations | |||
Employer monthly contribution (as a percent) | 1.53% | 1.53% | 1.53% |
Contribution costs | $ 56,000 | $ 57,000 | $ 68,000 |
U.S. | |||
Post-employment Benefit Obligations | |||
Contribution costs | $ 360,000 | $ 396,000 | $ 710,000 |
Percent of match, first level | 100.00% | 100.00% | 100.00% |
Employee voluntary contribution, first level | 3.00% | 3.00% | 3.00% |
Percent match, second level | 50.00% | 50.00% | 50.00% |
Employee voluntary contribution, second level | 2.00% | 2.00% | 2.00% |
Income Tax Expense - Components
Income Tax Expense - Components (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Loss before income taxes attributable to domestic and international operations | |||
Domestic | $ (40,540) | $ (71,344) | $ (78,761) |
Foreign | (8,420) | 1,999 | (3,902) |
Loss before income taxes | (48,960) | (69,345) | (82,663) |
Current tax | |||
Foreign | (490) | (139) | (101) |
Total income tax expense | $ (490) | $ (139) | $ (101) |
Effective income tax reconciliation | |||
Statutory income tax rate | 12.50% | 12.50% | 12.50% |
Non-deductible expenses | (0.10%) | ||
Income not subject to tax | 0.40% | 0.20% | 0.30% |
Tax credits | 0.60% | 0.40% | |
Foreign operations | (7.30%) | 3.00% | 0.60% |
Tax audit assessments | (11.80%) | ||
Other | (1.70%) | 2.30% | 0.80% |
Valuation allowance | (4.90%) | (18.80%) | (2.80%) |
Effective income tax rate | (1.00%) | (0.20%) | (0.10%) |
Ireland | |||
Effective income tax reconciliation | |||
Statutory income tax rate | 12.50% | 12.50% | 12.50% |
Income Tax Expense - Deferred I
Income Tax Expense - Deferred Income Tax (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 111,220 | $ 108,095 | ||
Tax loss on liquidation of subsidiary | 2,501 | 4,029 | ||
Equity compensation | 4,067 | 4,449 | ||
Non-deductible reserves | 905 | 447 | ||
Total deferred tax assets | 118,693 | 117,020 | ||
Valuation allowance | (118,583) | (116,200) | $ (103,185) | $ (100,832) |
Net deferred tax assets | 110 | 820 | ||
Deferred tax liabilities: | ||||
Financial liabilities | 100 | 757 | ||
Property, plant and equipment | 10 | 63 | ||
Total deferred tax liability | 110 | 820 | ||
Deferred tax, net | $ 0 | $ 0 |
Income Tax Expense - Valuation
Income Tax Expense - Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income tax (expense) benefit | |||
Balance at beginning of year | $ (116,200) | $ (103,185) | $ (100,832) |
Balance at end of year | (118,583) | (116,200) | (103,185) |
Tax benefit | |||
Income tax (expense) benefit | |||
Change in valuation allowance | $ (2,383) | $ (13,015) | $ (2,353) |
Income Tax Expense - Net Operat
Income Tax Expense - Net Operating Losses (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net operating losses carryforwards | ||||
Period in which the company is in cumulative loss position. | 3 years | |||
Valuation allowance | $ 118,583 | $ 116,200 | $ 103,185 | $ 100,832 |
Uncertain tax positions disclosures | ||||
Uncertain tax positions | 0 | |||
Decrease in research tax credit | 100 | |||
Ireland | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | 297,453 | |||
Austria | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | 239,510 | |||
U.S. | ||||
Net operating losses carryforwards | ||||
Net operating losses carryforwards | 10,403 | |||
Net operating losses carryforwards | $ 35,516 |
Earnings (Loss) per Share - Bas
Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Basic and Diluted Loss per Share | |||
Net loss for the period | $ (49,450) | $ (69,484) | $ (82,764) |
Weighted average number of shares outstanding, Basic | 43,349,461 | 12,845,089 | 7,419,948 |
Weighted average number of shares outstanding, Diluted | 43,349,461 | 12,845,089 | 7,419,948 |
Basic ($ per share) | $ (1.14) | $ (5.41) | $ (11.15) |
Diluted ($ per share) | $ (1.14) | $ (5.41) | $ (11.15) |
Earnings (Loss) per Share - Ant
Earnings (Loss) per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Options | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 1,348,477 | 1,052,838 | 816,891 |
Restricted Share Units ("RSUs") | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 789,738 | 239,384 | 105,169 |
Warrants | |||
Anti-dilutive stock options | |||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 10,619,347 | 5,438,842 | 1,379,310 |
Significant Arrangements and _2
Significant Arrangements and License Agreements (Details) $ in Thousands | Apr. 12, 2021 | Jul. 10, 2020USD ($) | Dec. 31, 2020USD ($) | Mar. 31, 2018USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2021USD ($)employee | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | May 31, 2021USD ($) |
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 28,895 | $ 5,027 | $ 9,481 | |||||||||
Number of sales representatives | employee | 60 | |||||||||||
Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 23,386 | $ 108 | 1,538 | |||||||||
SIVEXTRO | ||||||||||||
License Agreement | ||||||||||||
Percentage of net product sales recognized | 100.00% | |||||||||||
Sunovion Pharmaceutics Canada, Inc. | Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 1,000 | |||||||||||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - Upfront payment | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | 1,000 | |||||||||||
License Agreement | Sinovant Sciences, LTD | Collaboration revenue - Variable consideration | ||||||||||||
License Agreement | ||||||||||||
Proceeds from license agreement, milestone | $ 5,000 | |||||||||||
License Agreement | Sunovion Pharmaceutics Canada, Inc. | NDS Approval | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 500 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | ||||||||||||
License Agreement | ||||||||||||
Upfront payment | $ 5,000 | |||||||||||
Notice period for termination of agreement | 180 days | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Achievement of certain regulatory and commercial milestones | ||||||||||||
License Agreement | ||||||||||||
Maximum contingent milestone payment | 91,500 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Subsequent regulatory approval | ||||||||||||
License Agreement | ||||||||||||
Maximum contingent milestone payment | $ 4,000 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Clinical trial application submission | ||||||||||||
License Agreement | ||||||||||||
Proceeds from license agreement, milestone | $ 1,500 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | FDA approval | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Approval of XENLETA | ||||||||||||
License Agreement | ||||||||||||
Revenue accounted for under Topic 606 | $ 5,000 | |||||||||||
Remaining probable of achieving | $ 1,000 | |||||||||||
Additional revenue recognized | 3,000 | |||||||||||
License Agreement | Sumitomo Pharmaceuticals (Suzhou) | Additional regulatory approvals and annual sales targets | ||||||||||||
License Agreement | ||||||||||||
Remaining milestone payments | 86,000 | |||||||||||
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 | $ 2,400 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) € in Millions, $ in Millions | Aug. 04, 2021EUR (€) | Dec. 31, 2021USD ($) | Jul. 31, 2018USD ($) |
Other Commitments and Contingencies | |||
Contingent liabilities | $ 0 | ||
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 | 0.00% | ||
Percentage of annual minimum purchase requirement reduction 2022 to 2024 | 50.00% | ||
Percentage of annual minimum purchase requirement reduction in 2025 | 25.00% | ||
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 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Lease Disclosures and Other Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Future payments of operating lease liabilities, ASC 842 | |
2022 | $ 702 |
2023 | 83 |
Total | 785 |
XENLETA API purchase | |
Total | 53,985 |
2022 | 4,691 |
2023 | 4,691 |
2024 | 4,691 |
2025 | 6,652 |
2026 | 6,652 |
Thereafter | 26,608 |
Other contractual commitments | |
Total | 10,913 |
2022 | 5,072 |
2023 | 3,983 |
2024 | 929 |
2025 | 929 |
Future minimum contractual obligations and commitments | |
Total contractual commitments and contingencies | 65,683 |
2022 | 10,465 |
2023 | 8,757 |
2024 | 5,620 |
2025 | 7,581 |
2026 | 6,652 |
Thereafter | 26,608 |
Other Commitments and Contingencies | |
Contingent liabilities | $ 0 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event | Jan. 04, 2022$ / shares |
Subsequent Event [Line Items] | |
Consecutive business days minimum bid price not complied | 30 days |
Period to regain compliance with bid price rule | 180 days |
Additional period to regain compliance with bid price rule | 180 days |
The minimum bid price requirement for continued listing | $ 1 |
Minimum | |
Subsequent Event [Line Items] | |
Consecutive business days in which the company has to maintain minimum closing bid price to regain compliance with bid price rule | 10 days |
The closing bid price to regain compliance with bid price rules | $ 1 |