Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Sep. 11, 2023 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-37558 | |
Entity Registrant Name | Nabriva Therapeutics plc | |
Entity Incorporation, State or Country Code | L2 | |
Entity Address, Address Line One | 25-28 North Wall Quay | |
Entity Address, Address Line Two | IFSC | |
Entity Address, City or Town | Dublin 1 | |
Entity Address, Country | IE | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Postal Zip Code | 00000 | |
City Area Code | 353 1 | |
Local Phone Number | 649 2000 | |
Title of 12(b) Security | Ordinary Shares, nominal value $0.01 per share | |
Trading Symbol | NBRV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Shares Outstanding | 3,230,837 | |
Entity Central Index Key | 0001641640 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 2,182 | $ 12,414 |
Restricted cash | 73 | 123 |
Accounts receivable, net and other receivables | 4,439 | 6,742 |
Inventory | 9,676 | |
Prepaid expenses | 3,258 | 2,149 |
Total current assets | 9,952 | 31,104 |
Property and equipment, net | 246 | 280 |
Intangible assets, net | 1 | 3 |
Other non-current assets | 379 | 378 |
Total assets | 10,578 | 31,765 |
Current liabilities: | ||
Current portion of long-term debt | 196 | 4,833 |
Accounts payable | 14,026 | 5,431 |
Accrued expense and other current liabilities | 11,981 | 17,341 |
Total current liabilities | 26,203 | 27,605 |
Non-current liabilities: | ||
Long-term debt | 344 | 388 |
Other non-current liabilities | 352 | 479 |
Total non-current liabilities | 696 | 867 |
Total liabilities | 26,899 | 28,472 |
Commitments and contingencies (Note 11) | ||
Stockholders' (deficit) equity: | ||
Ordinary shares, nominal value $0.01, 12,000,000 ordinary shares authorized at June 30, 2023 and December 31, 2022; 3,230,837 and 3,201,417 issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 32 | 32 |
Preferred shares, nominal value $0.01, 100,000,000 shares authorized at June 30, 2023 and December 31, 2022; None issued and outstanding | ||
Additional paid in capital | 657,243 | 656,095 |
Accumulated deficit | (673,623) | (652,861) |
Accumulated other comprehensive income | 27 | 27 |
Total stockholders' (deficit) equity | (16,321) | 3,293 |
Total liabilities and stockholders' (deficit) equity | $ 10,578 | $ 31,765 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Ordinary stock, nominal value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary stock, authorized shares | 12,000,000 | 12,000,000 |
Ordinary stock, issued shares | 3,230,837 | 3,201,417 |
Ordinary stock, outstanding shares | 3,230,837 | 3,201,417 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 100,000,000 | 100,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues: | ||||
Total revenues | $ 2,243 | $ 9,191 | $ 9,833 | $ 17,211 |
Operating expenses: | ||||
Cost of revenues | (9,074) | (4,455) | (13,512) | (7,816) |
Research and development expenses | (1,086) | (4,088) | (3,711) | (7,605) |
Selling, general and administrative expenses | (4,107) | (11,047) | (13,107) | (23,747) |
Total operating expenses | (14,267) | (19,590) | (30,330) | (39,168) |
Loss from operations | (12,024) | (10,399) | (20,497) | (21,957) |
Other (expense) income: | ||||
Other (expense) income, net | (39) | (92) | (70) | 216 |
Interest income (expense), net | 1 | (198) | (194) | (413) |
Loss before income taxes | (12,062) | (10,689) | (20,761) | (22,154) |
Income tax expense | 0 | (385) | (1) | (739) |
Net loss | $ (12,062) | $ (11,074) | $ (20,762) | $ (22,893) |
Loss per share | ||||
Basic loss ($ per share) | $ (3.73) | $ (4.38) | $ (6.43) | $ (9.38) |
Diluted loss ($ per share) | $ (3.73) | $ (4.38) | $ (6.43) | $ (9.38) |
Weighted average number of shares: | ||||
Basic (in shares) | 3,230,827 | 2,529,523 | 3,227,629 | 2,441,136 |
Diluted (in shares) | 3,230,827 | 2,529,523 | 3,227,629 | 2,441,136 |
Product revenue, net | ||||
Revenues: | ||||
Total revenues | $ 2,574 | $ 8,680 | $ 10,135 | $ 15,720 |
Collaboration revenue | ||||
Revenues: | ||||
Total revenues | 0 | 96 | 29 | 725 |
Research premium and grant revenue | ||||
Revenues: | ||||
Total revenues | $ (331) | $ 415 | $ (331) | $ 766 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Ordinary shares | Additional paid in capital | Accumulated other comprehensive income | Accumulated deficit | Total |
Stockholders' (deficit) equity, beginning balance at Dec. 31, 2021 | $ 23 | $ 648,976 | $ 27 | $ (595,676) | $ 53,350 |
Stockholders' (deficit) equity, beginning balance (in shares) at Dec. 31, 2021 | 2,269 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Issuance of ordinary shares | $ 2 | 2,219 | 2,221 | ||
Issuance of ordinary shares (in shares) | 198 | ||||
Shares issued in connection with the vesting of restricted stock units (in shares) | 3 | ||||
Equity transaction costs | (127) | (127) | |||
Stock-based compensation expense | 1,000 | 1,000 | |||
Net loss | (11,819) | (11,819) | |||
Stockholders' (deficit) equity, ending balance at Mar. 31, 2022 | $ 25 | 652,068 | 27 | (607,495) | 44,625 |
Stockholders' (deficit) equity, ending balance (in shares) at Mar. 31, 2022 | 2,470 | ||||
Stockholders' (deficit) equity, beginning balance at Dec. 31, 2021 | $ 23 | 648,976 | 27 | (595,676) | 53,350 |
Stockholders' (deficit) equity, beginning balance (in shares) at Dec. 31, 2021 | 2,269 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Net loss | (22,893) | ||||
Stockholders' (deficit) equity, ending balance at Jun. 30, 2022 | $ 26 | 653,121 | 27 | (618,569) | 34,605 |
Stockholders' (deficit) equity, ending balance (in shares) at Jun. 30, 2022 | 2,584 | ||||
Stockholders' (deficit) equity, beginning balance at Mar. 31, 2022 | $ 25 | 652,068 | 27 | (607,495) | 44,625 |
Stockholders' (deficit) equity, beginning balance (in shares) at Mar. 31, 2022 | 2,470 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Issuance of ordinary shares | $ 1 | 817 | 818 | ||
Issuance of ordinary shares (in shares) | 114 | ||||
Shares issued in connection with the vesting of restricted stock units | 1 | 1 | |||
Equity transaction costs | (82) | (82) | |||
Stock-based compensation expense | 317 | 317 | |||
Net loss | (11,074) | (11,074) | |||
Stockholders' (deficit) equity, ending balance at Jun. 30, 2022 | $ 26 | 653,121 | 27 | (618,569) | 34,605 |
Stockholders' (deficit) equity, ending balance (in shares) at Jun. 30, 2022 | 2,584 | ||||
Stockholders' (deficit) equity, beginning balance at Dec. 31, 2022 | $ 32 | 656,095 | 27 | (652,861) | 3,293 |
Stockholders' (deficit) equity, beginning balance (in shares) at Dec. 31, 2022 | 3,201 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Equity transaction costs | 1 | 1 | |||
Stock-based compensation expense | 1,049 | 1,049 | |||
Net loss | (8,700) | (8,700) | |||
Stockholders' (deficit) equity, ending balance at Mar. 31, 2023 | $ 32 | 657,145 | 27 | (661,561) | (4,357) |
Stockholders' (deficit) equity, ending balance (in shares) at Mar. 31, 2023 | 3,201 | ||||
Stockholders' (deficit) equity, beginning balance at Dec. 31, 2022 | $ 32 | 656,095 | 27 | (652,861) | 3,293 |
Stockholders' (deficit) equity, beginning balance (in shares) at Dec. 31, 2022 | 3,201 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Net loss | (20,762) | ||||
Stockholders' (deficit) equity, ending balance at Jun. 30, 2023 | $ 32 | 657,243 | 27 | (673,623) | (16,321) |
Stockholders' (deficit) equity, ending balance (in shares) at Jun. 30, 2023 | 3,231 | ||||
Stockholders' (deficit) equity, beginning balance at Mar. 31, 2023 | $ 32 | 657,145 | 27 | (661,561) | (4,357) |
Stockholders' (deficit) equity, beginning balance (in shares) at Mar. 31, 2023 | 3,201 | ||||
Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||||
Shares issued in connection with the vesting of restricted stock units (in shares) | 30 | ||||
Stock-based compensation expense | 98 | 98 | |||
Net loss | (12,062) | (12,062) | |||
Stockholders' (deficit) equity, ending balance at Jun. 30, 2023 | $ 32 | $ 657,243 | $ 27 | $ (673,623) | $ (16,321) |
Stockholders' (deficit) equity, ending balance (in shares) at Jun. 30, 2023 | 3,231 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (20,762) | $ (22,893) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash other income, net | 4 | 3 |
Non-cash interest income | (4) | |
Non-cash interest expense | 55 | 222 |
Impairment of inventory | 7,531 | |
Depreciation and amortization expense | 39 | 155 |
Stock-based compensation | 1,097 | 1,334 |
Other | 483 | (112) |
Changes in operating assets and liabilities: | ||
(Increase) decrease in other non-current assets | (1) | 2 |
Decrease (increase) in accounts receivable, net and other receivables and prepaid expenses | 1,194 | (692) |
Decrease (increase) in inventory | 2,145 | (1,026) |
Increase (decrease) in accounts payable | 8,595 | (3,265) |
Decrease in accrued expenses and other liabilities | (5,360) | (2,155) |
Decrease in deferred revenue | (374) | |
Decrease in other non-current liabilities | (127) | (104) |
Net cash used in operating activities | (5,107) | (28,909) |
Cash flows from investing activities | ||
Purchases of equipment | (3) | (99) |
Changes in restricted cash | (50) | (53) |
Net cash used in investing activities | (53) | (152) |
Cash flows from financing activities | ||
Proceeds from issuance of ordinary shares and warrants | 2,046 | |
Proceeds from at-the-market facility | 993 | |
Repayments of unexercised warrant nominal values | (406) | |
Repayments of long-term borrowings | (4,853) | (949) |
Other | 1 | (282) |
Net cash (used in) provided by financing activities | (4,852) | 1,402 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (270) | (12) |
Net decrease in cash, cash equivalents and restricted cash | (10,282) | (27,671) |
Cash, cash equivalents, and restricted cash at beginning of period | 12,537 | 47,834 |
Cash, cash equivalents and restricted cash at end of period | 2,255 | 20,163 |
Supplemental disclosure of cash flow information: | ||
Interest paid | $ 162 | 240 |
Taxes paid | $ 853 |
Organization and Business Activ
Organization and Business Activities | 6 Months Ended |
Jun. 30, 2023 | |
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 that historically engaged in the commercialization and research and development of novel anti-infective agents to treat serious infections. The Company has the commercial rights to an approved product, XENLETA, as well as a development product candidate, CONTEPO. The Company’s headquarters are located at Alexandra House, Office 225/227, The Sweepstakes, Dublin 4, Ireland. As part of a plan approved by its board of directors on January 4, 2023 to preserve its cash to adequately fund an orderly wind down of its operations, or the Cash Preservation Plan, the Company previously reduced its operations to those necessary to: (i) make SIVEXTRO and XENLETA commercially available to wholesale customers; (ii) identify and explore strategic options, including the sale, license or other disposition of one or more of its assets, technologies or products; and (iii) wind down its business. The Company has no intention of resuming any active sales promotion or research and development activities. As part of the Cash Preservation Plan, the Company terminated all of its employees . The total cost of severance associated with the wind down of our operations is approximately $5.4 million, of which $1.3 million was recorded in research and development expenses and $4.1 million was recorded in selling, general and administrative expenses in the statement of operations for the six months ended June 30, 2023. As of June 30, 2023, the remaining unpaid balance of severance costs is $2.7 million, which is recorded in accrued expenses and other current liabilities in the consolidated balance sheet and which is expected to be paid prior to the end of 2023. In January 2023, the Company settled all outstanding balances due to Hercules Capital, Inc., or Hercules, and removed all secured liens on all of its assets. The Company also terminated its agreement with Amplity Health, the contract sales organization responsible for promoting SIVEXTRO and XENLETA and, on January 31, 2023, entered into a letter agreement, or the Letter Agreement, relating to the Company’s Sales Promotion and Distribution Agreement, or the Distribution Agreement, with MSD International GmbH, or MSD, and Merck Sharp & Dohme Corp., or the Supplier, to begin transition responsibility for the promotion and distribution of SIVEXTRO back to Merck & Co. Inc., or Merck. The Company stopped selling SIVEXTRO when its Distribution Agreement with Merck expired on June 30, 2023. On July 30, 2023, the Company entered into an Asset Purchase Agreement with Sumitomo Pharma Co., Ltd., or Sumitomo, pursuant to which Sumitomo agreed to (i) purchase, among other things, the Company’s assets and rights related to the development, manufacture, marketing and commercialization of XENLETA in the People’s Republic of China, Hong Kong, Macau and Taiwan, or collectively the Territory, and (ii) assume certain liabilities related to the acquired assets. The transactions contemplated by the Asset Purchase Agreement closed on July 30, 2023. At the closing, Sumitomo made an upfront cash payment of million was paid to the Company in cash. The cash received by the Company is not reflected on the balance sheet at June 30, 2023. As part of the transactions contemplated by the Asset Purchase Agreement, the Company terminated its license agreement and certain related agreements with certain affiliates of Sumitomo, including Sumitomo Pharmaceuticals (Suzhou), pursuant to which the Company previously had granted an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin in the Territory. During a period of time that may extend to March 31, 2024, the Company has agreed to provide certain post-closing services to Sumitomo, including to continue and maintain the application for marketing approval for XENLETA filed by Nabriva Ireland with the National Medical Products Administration, or NMPA, of the People’s Republic of China, the import drug license for lefamulin filed with the NMPA and the existing market approval for lefamulin in the United States. In exchange for these obligations, Sumitomo has agreed to fully reimburse the Company for expenses incurred with respect to the post-closing activities. Following the closing of the transactions with Sumitomo, the Company is currently focused on the sale of its remaining assets, including CONTEPO. Liquidity Since adopting the Cash Preservation Plan in January 2023, the Company has significantly reduced its expenses. As of June 30, 2023, the Company had cash, cash equivalents and restricted cash of $2.3 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, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the consolidated financial statements are issued. As a result, the Company’s liquidity condition and its existing financial obligations raise substantial doubt about the Company’s ability to continue as a going concern one year from the date that these financial statements are filed. 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. 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. The financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern. The Company previously had sources of liquidity under an “at-the-market” equity financing facility with Jefferies LLC and an equity line of credit facility with Lincoln Park Capital Fund, LLC. The Company has not raised any proceeds under such facilities during 2023 and has no plans to raise any proceeds prior to the wind down of its business. Based on its current operating plans, the Company expects that its existing cash, cash equivalents and restricted cash as of the filing date of this Quarterly Report on Form 10-Q will be sufficient to enable the Company to fund its operating expenses and debt service obligations through the end of October 2023. 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 from the sale of its assets. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or US GAAP, for interim financial information, and US Securities and Exchange Commission, or SEC, regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 are unaudited. The December 31, 2022 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2023 and results of operations for the three and six months ended June 30, 2023 and 2022. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2023 and 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on April 17, 2023. The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023. Since the date of those financial statements, there have been no material changes to the Company’s significant accounting policies. Fair Value Measurement As of June 30, 2023 and December 31, 2022, 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. Reverse Stock Split On September 16, 2022, the Company filed an Amended and Restated Memorandum and Articles of Association of the Company with the Irish Companies Registration Office and effected a one twenty-five Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments—Credit Losses Derivatives and Hedging Financial Instruments |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2023 | |
Inventory | |
Inventory | 3. Inventory Inventory is stated at the lower of cost or net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, and related transportation costs along the Company’s supply chain. The Company capitalizes inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are recorded as research and development expense. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense and costs of sample inventory is recorded as selling, general and administrative expense. The Company reviews inventories for realization on a quarterly basis and records provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value when necessary. As a result of the Company’s intention to wind down operations, the Company made an assessment of the net realizable value of XENLETA inventory as of June 30, 2023 and December 31, 2022. As of June 30, 2023, the Company determined that the net realizable value of XENLETA inventory was not recoverable and recorded an impairment charge of Inventory reported at June 30, 2023 and December 31, 2022 consisted of the following: As of As of June 30, December 31, (in thousands) 2023 2022 XENLETA raw materials $ — $ 916 XENLETA work in process — 4,658 XENLETA finished goods — 640 Total XENLETA — 6,214 SIVEXTRO finished goods — 3,462 Total inventory $ — $ 9,676 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 4. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities included the following: As of June 30, As of December 31, (in thousands) 2023 2022 Research and development related costs $ 247 $ 707 Payroll and related costs 3,042 1,737 Accounting, tax and audit services 281 552 Manufacturing and inventory 2,566 8,113 Product returns 568 784 Government rebates 2,102 2,028 Other accrued gross to net 2,231 2,129 Other 944 1,291 Total accrued expenses and other current liabilities $ 11,981 $ 17,341 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2023 | |
Debt | |
Debt | 5. Debt In December 2018, the Company entered into a loan agreement, 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. The Loan Agreement initially provided for an initial term loan advance of $25.0 million, which was funded in December 2018, and, at the Company’s option and subject to the occurrence of certain funding conditions, several additional tranches of which $10.0 million became available upon the approval by the FDA of the NDA for XENLETA, which was drawn down in full. Prior to repayment as described below, the term loan bore interest at an annual rate equal to the greater of 9.80% or 9.80% plus the prime rate of interest minus 5.50%. Effective September 22, 2022 the prime rate increased to 6.25%, which increased the interest on the loan with Hercules to 10.55%. The Loan Agreement provided for interest-only payments through July 1, 2021, later extended to April 1, 2022, 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 was 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. In March 2020, the Company repaid $30.0 million of the $35.0 million in aggregate principal amount of debt outstanding under the Loan Agreement. 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 fee associated with the prepayment to $300,000 and to defer such fees until June 1, 2023 or such earlier date on which all loans under the Loan Agreement were repaid or become due and payable. The Company incurred a total of $1.3 million of costs in connection with the Loan Agreement, as amended, which along with the initial fee of $0.7 million paid to Hercules was recorded as debt issuance cost and was being amortized as interest expense using the effective interest method over the term of the loan. The End of Term Fee was being accrued as additional interest expense using the effective interest method over the term of the loan. On January 5, 2023, the Company repaid $4.5 million to Hercules, representing all principal, accrued and unpaid interest, fees and other expenses, due under the Loan Agreement. Effective at the time of repayment, the Loan Agreement was terminated, and Hercules released all security interests held on the assets of the Company and its subsidiaries. The Company previously obtained loans from the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft mbH Long-term debt as of June 30, 2023 and December 31, 2022 consisted of the following: As of As of June 30, December 31, (in thousands) 2023 2022 Term loan payable $ — $ 2,079 End of term fee — 2,615 Unamortized debt issuance costs — (55) Carrying value of term loan — 4,639 FFG loans 540 582 Less: Amounts due within one year (196) (4,833) Total long-term debt $ 344 $ 388 Maturities of long-term debt as of June 30, 2023 were as follows: (in thousands) Remaining six months of 2023 $ 148 2024 $ 196 2025 $ 196 |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2023 | |
Revenues | |
Revenues | 6. Revenues Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2023 2022 2023 2022 Product revenue, net $ 2,574 $ 8,680 $ 10,135 $ 15,720 Collaboration revenues — 96 29 725 Research premium and grant revenue (331) 415 (331) 766 Total revenues $ 2,243 $ 9,191 $ 9,833 $ 17,211 For the three months ended June 30, 2023 and 2022, product revenues, net of gross-to-net accruals and adjustments for returns, were $2.6 million and $8.7 million, respectively. For the six months ended June 30, 2023 and 2022, product revenues, net of gross-to-net accruals and adjustments for returns, were $10.1 million and $15.7 million, respectively. The Company´s gross-to-net 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. The Company sold its products to pharmaceutical wholesalers/distributors (i.e., the Company’s customers). The Company’s wholesalers/distributors in turn sold the Company’s products directly to clinics, hospitals, and private practices. Revenue from the Company’s product sales was recognized as physical delivery of product occurred (when the Company’s customer obtained control of the product), in return for agreed-upon consideration. Collaboration revenues for the three months ended June 30, 2022 were less than $0.1 million and no such revenues were recorded for the three months ended June 30, 2023. Collaboration revenues for the six months ended June 30, 2023 were less than $0.1 million. Collaboration revenues for the six months ended June 30, 2022 included $0.6 million related to the China Region License Agreement with an affiliate of Sumitomo (see Note 10). Research premium and grant revenue include government research premiums, non-refundable grants, collaboration revenues and the benefit of government loans at below-market rates. Research premium and grant revenue for the three and six months ended June 30, 2023 were a $0.3 million contra-revenue due to a partial reversal of a European research and development grant. Research premium and grant revenue for the three and six months ended June 30, 2022 were $0.4 million and $0.8 million, respectively. |
Share-Based Payments
Share-Based Payments | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payments | |
Share-Based Payments | 7. Share-Based Payments The Company has share-based compensation plans, which are more fully described in Note 10, Share Based Payments, to the consolidated financial statements in the Company’s Annual Report on Form 10-K filed with the SEC on April 17, 2023. During the six months ended June 30, 2023, the Company did not grant any share-based awards. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2023 2022 2023 2022 Research and development expense $ — $ 67 $ 164 $ 161 Selling, general and administrative expense 98 267 933 1,173 Total stock-based compensation expense $ 98 $ 334 $ 1,097 $ 1,334 |
Income Tax Expense
Income Tax Expense | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Expense | |
Income Tax Expense | 8. Income Tax Expense For the six months ended June 30, 2023, the Company recorded a tax expense of less than $0.1 million. For the three months ended June 30, 2023, the Company did not record a tax expense. For the three and six months ended June 30, 2022, the Company recorded a tax expense of $0.4 million and $0.7 million, respectively. Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of its deferred tax assets. On the basis of this evaluation the Company has recorded a valuation allowance against all of its deferred tax assets at June 30, 2023 and December 31, 2022. |
Loss per Share
Loss per Share | 6 Months Ended |
Jun. 30, 2023 | |
Loss per Share | |
Loss per Share | 9. Loss per Share Basic and Diluted Loss per Share For the three and six months ended June 30, 2023 and 2022, basic and diluted net loss per share was determined by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share is the same as basic net loss per share during the periods presented as the effects of the Company’s potential ordinary share equivalents are antidilutive since the Company had net losses for each period presented below. Three Months Ended Six Months Ended June 30, June 30, (in thousands, except share and per share data) 2023 2022 2023 2022 Net loss for the period $ (12,062) $ (11,074) $ (20,762) $ (22,893) Weighted average number of shares outstanding 3,230,827 2,529,523 3,227,629 2,441,136 Basic and diluted loss per share $ (3.73) $ (4.38) $ (6.43) $ (9.38) The following ordinary share equivalents were excluded from the calculations of diluted loss per share as their effect would be anti-dilutive since the Company had net losses for each period presented below: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock option awards 70,796 78,048 72,752 78,048 Restricted share units 36,705 46,901 37,199 46,901 Warrants 262,384 262,393 262,384 262,393 |
Significant Arrangements and Li
Significant Arrangements and License Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Significant Arrangements and License Agreements | |
Significant Arrangements and License Agreements | 10. Significant Arrangements and License Agreements Er-Kim License Agreement Sales Promotion and Distribution Agreement with Merck In July 2020, the Company entered into a Distribution Agreement with MSD and Supplier, each a subsidiary of Merck. 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 MSD and Supplier under the trademark SIVEXTRO® for injection, intravenous use and oral use. In April 2021, in accordance with the terms of the Distribution Agreement, the Company began exclusive distribution of SIVEXTRO under its own National Drug Code and the Company recognized 100% of net product sales of SIVEXTRO in its results of operations. On January 31, 2023, the Company converted its exclusive license to promote, distribute and commercialize SIVEXTRO to a non-exclusive license and provided for the termination of the Distribution Agreement, which became effective on June 30, 2023. 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 subsidiary of 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 agreed to guarantee all of the obligations of Sumitomo Pharmaceuticals (Suzhou) under the China Region License Agreement. In December 2020, the Company restructured its China Region License Agreement to provide for additional manufacturing collaboration and regulatory support to be provided to the contract counterparty by the Company that was expected to help expedite the delivery of XENLETA to patients in greater China. Except for the manufacturing collaboration and regulatory support discussed above, Sumitomo Pharmaceuticals (Suzhou) was solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing China Region Licensed Products in the Extended China Territory and was 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 was 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. The China Region License Agreement was terminated on July 30, 2023 in connection with the Asset Purchase Agreement being entered into with Sumitomo. Named Patient Program Agreement with WE Pharma Ltd. In June 2020, the Company and WE Pharma Ltd., or WEP Clinical, a specialist pharmaceutical services company, signed an exclusive agreement for the Company to supply XENLETA on a named patient or expanded access basis in certain countries outside of the US, China, Canada, Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia . |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 11. Commitments and Contingencies XENLETA API Supply In August 2021, the Company’s wholly-owned subsidiary, Nabriva Therapeutics Ireland DAC, entered into an amendment to its API Supply Agreement, or the Hovione Supply Agreement, with Hovione Limited, or Hovione, which provided for the long-term commercial supply of the active pharmaceutical ingredients, or API, for XENLETA. Hovione agreed to reduce the Company’s 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 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 were to be no greater than an aggregate of €10.0 million. If the aggregate amount of royalties payments received by Hovione was less than an aggregate of €4.0 million, the Company was obligated to pay Hovione the difference in a lump sum payment at the end of the Royalty Term. In addition, 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. In November 2022, Nabriva Therapeutics Ireland DAC, entered into an amendment to the Hovione Supply Agreement to reduce the Company’s annual minimum purchase requirements for XENLETA API for certain geographies. In consideration for the reduced minimum purchase requirements, the Company granted Hovione the right to a low single-digit royalty on total net sales of XENLETA by the Company’s licensees outside of the United States to the extent that the commercial product of XENLETA sold by such licensees is manufactured with API obtained from a third party (or any finished commercial product containing API obtained from a third party) other than Hovione during the terms of the agreement. On July 31, 2023, Nabriva Therapeutics Ireland DAC entered into an amendment to the Hovione Supply Agreement. Under the amendment, the Company is released from certain obligations arising under the agreement, including (i) the minimum annual commitment obligations and (ii) the royalty obligations. The Company has agreed to pay $6.3 million to satisfy its obligation in respect of the 2022 and 2023 minimal annual commitment and $1.0 million for settlement of 2024-2030 minimum annual commitments and royalties. As of June 30, 2023, the Company had $6.3 million accrued within accounts payable and $1.0 million accrued within accrued expenses and other current liabilities related to these obligations. For the six months ended June 30, 2023, the Company recognized $0.4 million of expense in cost of revenues relating to losses under the XENLETA purchase commitment. As of December 31, 2022, the Company had Inventory Purchase Commitments . Litigation Except as noted below, as of the date of the filing this Quarterly Report on Form 10-Q, there are no material outstanding legal proceedings against the Company or its current officers or directors. On September 29, 2023, a complaint was filed against the Company in the U.S. District Court for the Southern District of New York by Ladenburg, Thalmann & Co., Inc. (“LTCO”), alleging breach of contract by the Company relating to an engagement letter between the Company and LTCO for investment banking services. To date, the Company has yet to be formally served with the complaint. While the Company is unable to provide any assurances as to the ultimate outcome of the case, the Company intends to defend itself vigorously against the allegations. The Company is currently unable to estimate the costs and timing of any litigation, including any potential damages if LTCO were to prevail on its claims. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events As described in Note 1, on July 30, 2023, the Company sold certain assets and rights related to lefamulin in China, Hong Kong, Macau and Taiwan to Sumitomo for $15.0 million, which included full satisfaction of the settlement of purchase obligations with various contract manufacturing organizations. For additional information regarding the Company’s agreements with its contract manufacturing organizations, see the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Preparation | Basis of Preparation The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or US GAAP, for interim financial information, and US Securities and Exchange Commission, or SEC, regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 are unaudited. The December 31, 2022 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2023 and results of operations for the three and six months ended June 30, 2023 and 2022. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2023 and 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on April 17, 2023. The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023. Since the date of those financial statements, there have been no material changes to the Company’s significant accounting policies. |
Fair Value Measurement | Fair Value Measurement As of June 30, 2023 and December 31, 2022, 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. |
Reverse Stock Split | Reverse Stock Split On September 16, 2022, the Company filed an Amended and Restated Memorandum and Articles of Association of the Company with the Irish Companies Registration Office and effected a one twenty-five |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments—Credit Losses Derivatives and Hedging Financial Instruments |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory | |
Schedule of inventory | As of As of June 30, December 31, (in thousands) 2023 2022 XENLETA raw materials $ — $ 916 XENLETA work in process — 4,658 XENLETA finished goods — 640 Total XENLETA — 6,214 SIVEXTRO finished goods — 3,462 Total inventory $ — $ 9,676 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other liabilities | As of June 30, As of December 31, (in thousands) 2023 2022 Research and development related costs $ 247 $ 707 Payroll and related costs 3,042 1,737 Accounting, tax and audit services 281 552 Manufacturing and inventory 2,566 8,113 Product returns 568 784 Government rebates 2,102 2,028 Other accrued gross to net 2,231 2,129 Other 944 1,291 Total accrued expenses and other current liabilities $ 11,981 $ 17,341 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt | |
Schedule of long-term debt | As of As of June 30, December 31, (in thousands) 2023 2022 Term loan payable $ — $ 2,079 End of term fee — 2,615 Unamortized debt issuance costs — (55) Carrying value of term loan — 4,639 FFG loans 540 582 Less: Amounts due within one year (196) (4,833) Total long-term debt $ 344 $ 388 |
Schedule of maturities of long-term debt | (in thousands) Remaining six months of 2023 $ 148 2024 $ 196 2025 $ 196 |
Revenues (Tables)
Revenues (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenues | |
Summary of revenue by type | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2023 2022 2023 2022 Product revenue, net $ 2,574 $ 8,680 $ 10,135 $ 15,720 Collaboration revenues — 96 29 725 Research premium and grant revenue (331) 415 (331) 766 Total revenues $ 2,243 $ 9,191 $ 9,833 $ 17,211 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payments | |
Schedule of allocation of share-based compensation expense | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2023 2022 2023 2022 Research and development expense $ — $ 67 $ 164 $ 161 Selling, general and administrative expense 98 267 933 1,173 Total stock-based compensation expense $ 98 $ 334 $ 1,097 $ 1,334 |
Loss per Share (Tables)
Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Loss per Share | |
Schedule of basic and diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, (in thousands, except share and per share data) 2023 2022 2023 2022 Net loss for the period $ (12,062) $ (11,074) $ (20,762) $ (22,893) Weighted average number of shares outstanding 3,230,827 2,529,523 3,227,629 2,441,136 Basic and diluted loss per share $ (3.73) $ (4.38) $ (6.43) $ (9.38) |
Schedule of ordinary share equivalents excluded from the calculations of diluted loss per share | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock option awards 70,796 78,048 72,752 78,048 Restricted share units 36,705 46,901 37,199 46,901 Warrants 262,384 262,393 262,384 262,393 |
Organization and Business Act_2
Organization and Business Activities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jul. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Liquidity | ||||||||
Severance costs | $ 5,400 | $ 5,400 | ||||||
Remaining balance of severance costs | 2,700 | 2,700 | ||||||
Amount paid in cash | 3 | $ 99 | ||||||
Cash and cash equivalents and restricted cash | 2,255 | $ 20,163 | 2,255 | $ 20,163 | $ 12,537 | $ 47,834 | ||
Shares issued | $ 818 | $ 2,221 | ||||||
Research and development | ||||||||
Liquidity | ||||||||
Severance costs | 1,300 | 1,300 | ||||||
Selling, general and administrative | ||||||||
Liquidity | ||||||||
Severance costs | $ 4,100 | $ 4,100 | ||||||
Subsequent Event | Asset Purchase Agreement | Sumitomo Pharma Co. Ltd | ||||||||
Liquidity | ||||||||
Upfront cash payment | $ 15,000 | |||||||
Amount held back by purchaser | 1,800 | |||||||
Amount paid for remaining obligations | 10,400 | |||||||
Amount paid in cash | $ 2,800 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Reverse Stock Split (Details) | Sep. 16, 2022 shares |
Summary of Significant Accounting Policies | |
Conversion ratio of common stock to ordinary shares | 0.04% |
Fractional shares | 0 |
Inventory (Details)
Inventory (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Inventory | |||
Total inventory | $ 9,676,000 | ||
Impairment of inventory remaining balance | $ 7,531,000 | ||
XENLETA | |||
Inventory | |||
Raw materials | 916,000 | ||
Work in process | 4,658,000 | ||
Finished goods | 640,000 | ||
Total inventory | 6,214,000 | ||
Obsolete inventory non-cash reserve | 5,600,000 | ||
Impairment of inventory remaining balance | $ 7,500,000 | 7,500,000 | |
SIVEXTRO | |||
Inventory | |||
Finished goods | $ 3,462,000 | ||
Impairment of inventory remaining balance | $ 17,000 | $ 17,000 |
Inventory - Prepaid Inventory (
Inventory - Prepaid Inventory (Details) - USD ($) $ in Millions | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid expense | ||
Inventory [Line Items] | ||
Prepaid inventory | $ 0 | $ 0.9 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued expenses and other liabilities | ||
Research and development related costs | $ 247 | $ 707 |
Payroll and related costs | 3,042 | 1,737 |
Accounting, tax and audit services | 281 | 552 |
Manufacturing and inventory | 2,566 | 8,113 |
Product returns | 568 | 784 |
Government rebates | 2,102 | 2,028 |
Other accrued gross to net | 2,231 | 2,129 |
Other | 944 | 1,291 |
Total accrued expenses and other current liabilities | $ 11,981 | $ 17,341 |
Debt - Summary (Details)
Debt - Summary (Details) - Term loan - USD ($) | 6 Months Ended | |||||
Jan. 05, 2023 | Sep. 22, 2022 | Mar. 11, 2020 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2018 | |
Debt | ||||||
End of term fee | $ 2,079,000 | |||||
Loan Agreement | ||||||
Debt | ||||||
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% | |||||
Repayment of debt | $ 4,500,000 | 30,000,000 | ||||
End of term loan charge payment | 2,100,000 | |||||
End of term loan charge | $ 300,000 | |||||
Loan origination costs | $ 1,300,000 | |||||
Initial fee paid to lender | $ 700,000 | |||||
Loan Agreement | Prime rate | ||||||
Debt | ||||||
Variable interest rate margin (as a percent) | 9.80% | |||||
Variable rate adjustment (as a percent) | 5.50% | |||||
Reference rate for effective interest rate (as percent) | 6.25% | |||||
Loan Agreement | Initial Advance | ||||||
Debt | ||||||
Principal amount of advances outstanding | $ 25,000,000 | |||||
Loan Agreement | Tranche 7 Advance | ||||||
Debt | ||||||
Additional tranches | $ 10,000,000 | |||||
Hercules Capital Inc | Loan Agreement | ||||||
Debt | ||||||
Interest rate (as a percent) | 10.55% |
Debt - Long-Term Debt (Details)
Debt - Long-Term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Long-term debt | ||
Less: Amounts due within one year | $ (196) | $ (4,833) |
Long-term debt | 344 | 388 |
Maturities of long-term debt | ||
Remaining six months of 2023 | 148 | |
2024 | 196 | |
2025 | 196 | |
Term loan | ||
Long-term debt | ||
Term loan payable | 2,079 | |
End of term fee | 2,615 | |
Unamortized debt issuance costs | (55) | |
Carrying value of term loan | 4,639 | |
Other debt, FFG loans | ||
Long-term debt | ||
Carrying value of term loan | $ 540 | $ 582 |
Revenues (Details)
Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue | ||||
Revenue accounted for under Topic 606 | $ 2,243 | $ 9,191 | $ 9,833 | $ 17,211 |
Product revenue, net | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 2,574 | 8,680 | 10,135 | 15,720 |
Collaboration revenue | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 0 | 96 | 29 | 725 |
Collaboration revenue | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 600 | |||
Research premium and grant revenue | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | $ (331) | 415 | (331) | $ 766 |
Maximum | Collaboration revenue | Sumitomo Pharmaceuticals (Suzhou) | License Agreement | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | $ 100 | |||
Maximum | Research premium and grant revenue | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | 400 | |||
Maximum | Collaboration revenue - Upfront payment | ||||
Revenue | ||||
Revenue accounted for under Topic 606 | $ 100 |
Share-Based Payments - Stock-ba
Share-Based Payments - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payments | ||||
Share-based compensation expense | $ 98 | $ 334 | $ 1,097 | $ 1,334 |
Research and development | ||||
Share-Based Payments | ||||
Share-based compensation expense | 67 | 164 | 161 | |
Selling, general and administrative | ||||
Share-Based Payments | ||||
Share-based compensation expense | $ 98 | $ 267 | $ 933 | $ 1,173 |
Income Tax Expense (Details)
Income Tax Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income tax expense (benefit) | $ 0 | $ 385 | $ 1 | $ 739 |
Maximum | ||||
Income tax expense (benefit) | $ 100 |
Loss per Share - Basic and Dilu
Loss per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Basic and Diluted Loss per Share | ||||||
Net loss for the period | $ (12,062) | $ (8,700) | $ (11,074) | $ (11,819) | $ (20,762) | $ (22,893) |
Weighted average number of shares outstanding, Basic | 3,230,827 | 2,529,523 | 3,227,629 | 2,441,136 | ||
Weighted average number of shares outstanding, Diluted | 3,230,827 | 2,529,523 | 3,227,629 | 2,441,136 | ||
Basic loss ($ per share) | $ (3.73) | $ (4.38) | $ (6.43) | $ (9.38) | ||
Diluted loss ($ per share) | $ (3.73) | $ (4.38) | $ (6.43) | $ (9.38) |
Loss per Share - Anti-Dilutive
Loss per Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock Options | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 70,796 | 78,048 | 72,752 | 78,048 |
Restricted Share Units ("RSUs") | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 36,705 | 46,901 | 37,199 | 46,901 |
Warrants | ||||
Anti-dilutive stock options | ||||
Ordinary share equivalents excluded from the calculations of diluted earnings per share | 262,384 | 262,393 | 262,384 | 262,393 |
Significant Arrangements and _2
Significant Arrangements and License Agreements (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Apr. 30, 2021 | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jul. 13, 2022 country | |
License Agreement | ||||||
Number of countries, exclusive rights are distributed. | 9 | |||||
Number of additional countries rights are distributed | 5 | |||||
Revenue accounted for under Topic 606 | $ | $ 2,243 | $ 9,191 | $ 9,833 | $ 17,211 | ||
SIVEXTRO | ||||||
License Agreement | ||||||
Percentage of net product sales recognized | 100% |
Commitments and Contingencies (
Commitments and Contingencies (Details) € in Millions, $ in Millions | 1 Months Ended | 6 Months Ended | ||
Aug. 31, 2021 EUR (€) | Jun. 30, 2023 USD ($) | Jul. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Acquisition of Zavante | ||||
Losses under purchase commitment | $ 0.4 | |||
Accounts payable | ||||
Acquisition of Zavante | ||||
Minimum annual commitment and royalty obligation in the year of 2022 and 2023 | 6.3 | |||
Accrued expense and other current liabilities | ||||
Acquisition of Zavante | ||||
Minimum annual commitment and royalty obligation in the year of 2022 and 2023 | $ 1 | |||
2022 minimal annual commitment | $ 2.6 | |||
Purchase Obligation | $ 4.3 | |||
Hovione Supply Agreement | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Cash payments made for amendment of agreement | € | € 3.2 | |||
Threshold aggregate royalty payments | € | 4 | |||
Acquisition of Zavante | ||||
Percentage of annual minimum purchase requirement reduction in 2021 | 0% | |||
Percentage of annual minimum purchase requirement reduction 2022 to 2024 | 50% | |||
Percentage of annual minimum purchase requirement reduction in 2025 | 25% | |||
Hovione Supply Agreement | Maximum | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Royalty payment | € | € 10 | |||
Hovione Supply Agreement | Subsequent Event | ||||
Acquisition of Zavante | ||||
Minimum annual commitment and royalty obligation in the year of 2022 and 2023 | $ 6.3 | |||
Minimum annual commitment and royalty obligation in the year of 2024 to 2030 | $ 1 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | Jul. 30, 2023 USD ($) |
Subsequent Event | Asset Purchase Agreement with Sumitomo Pharma Co., Ltd | |
Subsequent Event [Line Items] | |
Proceeds from sale of assets and rights | $ 15 |