Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | APELLIS PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001492422 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 001-38276 | |
Entity Tax Identification Number | 27-1537290 | |
Entity Address, Address Line One | 100 Fifth Avenue | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 617 | |
Local Phone Number | 977-5700 | |
Entity Common Stock, Shares Outstanding | 109,865,305 | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Security 12b Title | Common Stock, $0.0001 par value per share | |
Trading Symbol | APLS | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 |
Current assets: | |||
Cash and cash equivalents | $ 604,489 | $ 640,192 | $ 270,764 |
Marketable securities | 248,307 | 60,358 | |
Accounts receivable | 7,518 | 10,103 | |
Inventory | 48,451 | 16,286 | |
Prepaid assets | 21,478 | 24,868 | |
Restricted cash | 1,266 | 1,563 | |
Other current assets | 28,460 | 70,677 | |
Total current assets | 959,969 | 824,047 | |
Non-current assets: | |||
Right-of-use assets | 20,755 | 19,901 | |
Property and equipment, net | 5,892 | 6,177 | |
Other assets | 15,882 | 31,640 | |
Total assets | 1,002,498 | 881,765 | |
Current liabilities: | |||
Accounts payable | 16,220 | 16,909 | |
Accrued expenses | 89,419 | 103,239 | |
Current portion of development liability | 15,842 | 7,584 | |
Current portion of right-of-use liabilities | 5,312 | 4,115 | |
Total current liabilities | 126,793 | 131,847 | |
Long-term liabilities: | |||
Long-term development liability | 333,729 | 345,151 | |
Convertible senior notes | 189,313 | 189,024 | |
Right-of-use liabilities | 16,676 | 17,081 | |
Other liabilities | 1,569 | ||
Total liabilities | 668,080 | 683,103 | |
Commitments and contingencies (Note 14) | |||
Stockholders' equity: | |||
Preferred stock, $0.0001 par value; 10,000 shares authorized, and zero shares issued and outstanding at June 30, 2022 and December 31, 2021 | 0 | 0 | |
Common stock, $0.0001 par value; 200,000 shares authorized at June 30, 2022 and December 31, 2021; 106,841 shares issued and outstanding at June 30, 2022, and 97,524 shares issued and outstanding at December 31, 2021 | 11 | 10 | |
Additional paid-in capital | 2,289,201 | 1,857,430 | |
Accumulated other comprehensive loss | (3,194) | (2,090) | |
Accumulated deficit | (1,951,600) | (1,656,688) | |
Total stockholders' equity | 334,418 | 198,662 | $ (141,493) |
Total liabilities and stockholders' equity | $ 1,002,498 | $ 881,765 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, issued | 106,841,000 | 97,524,000 |
Common stock, outstanding | 106,841,000 | 97,524,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income/(Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Revenue | $ 16,322 | $ 623 | $ 30,703 | $ 623 |
Operating expenses: | ||||
Cost of sales | 82 | 1,329 | ||
Research and development | 101,661 | 95,943 | 192,606 | 179,955 |
Cost of research collaboration | 50,000 | 50,000 | ||
General and administrative | 63,203 | 48,967 | 114,390 | 89,546 |
Total operating expenses: | 164,946 | 194,910 | 308,325 | 319,501 |
Net operating loss | (148,624) | (194,287) | (277,622) | (318,878) |
Loss on conversion of debt | (39,487) | |||
Loss from remeasurement of development derivative liability | (21,180) | (38,264) | ||
Interest income | 1,432 | 104 | 1,530 | 237 |
Interest expense | (8,448) | (3,767) | (16,986) | (7,941) |
Other income/(expense), net | 149 | (61) | (140) | 1,483 |
Net loss before taxes | (155,491) | (219,191) | (293,218) | (402,850) |
Income tax expense | 486 | 0 | 1,694 | 0 |
Net loss | (155,977) | (219,191) | (294,912) | (402,850) |
Other comprehensive (loss)/gain | ||||
Unrealized (loss)/gain on marketable securities | (766) | (35) | (818) | 44 |
Foreign currency loss | (369) | (174) | (286) | (1,756) |
Total other comprehensive income/(loss) | (1,135) | (209) | (1,104) | (1,712) |
Comprehensive loss, net of tax | $ (157,112) | $ (219,400) | $ (296,016) | $ (404,562) |
Net loss per common share, basic | $ (1.46) | $ (2.72) | $ (2.88) | $ (5.04) |
Net loss per common share, diluted | $ (1.46) | $ (2.72) | $ (2.88) | $ (5.04) |
Weighted-average number of common shares used in net loss per common share, basic | 106,630 | 80,654 | 102,349 | 79,938 |
Weighted-average number of common shares used in net loss per common share, diluted | 106,630 | 80,654 | 102,349 | 79,938 |
Product revenue, net [Member] | ||||
Revenue: | ||||
Revenue | $ 15,654 | $ 623 | $ 27,763 | $ 623 |
Licensing and other revenue [Member] | ||||
Revenue: | ||||
Revenue | $ 668 | $ 2,940 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholder's Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member] Cumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] Cumulative Effect, Period of Adoption, Adjustment [Member] |
Beginning balance at Dec. 31, 2020 | $ 204,557 | $ (149,734) | $ 8 | $ 1,131,013 | $ (165,747) | $ (117) | $ (926,347) | $ 16,013 |
Beginning balance, Shares at Dec. 31, 2020 | 76,130,000 | |||||||
Accounting Standards Update description | ASU 2020-06 | |||||||
Issuance of shares in exchange of 2019 Convertible Notes, including issuance costs | $ 162,258 | 162,258 | ||||||
Issuance of shares in exchange of 2019 Convertible Notes, including issuance costs, shares | 3,976,000 | |||||||
Forfeiture of accrued interest in exchange of 2019 Convertible Notes | 1,668 | 1,668 | ||||||
Issuance of common stock upon exercise of stock options | 2,588 | 2,588 | ||||||
Issuance of common stock upon exercise of stock options, shares | 285,000 | |||||||
Vesting of restricted stock units, net of shares withheld for taxes | (956) | (956) | ||||||
Vesting of restricted stock units, net of shares withheld for taxes. shares | 47,000 | |||||||
Share-based compensation expense | 16,439 | 16,439 | ||||||
Unrealized gain (loss) on available-for-sale investments | 79 | 79 | ||||||
Net loss | (183,659) | (183,659) | ||||||
Foreign currency gain (loss) | (1,582) | (1,582) | ||||||
Ending balance at Mar. 31, 2021 | 51,658 | $ 8 | 1,147,263 | (1,620) | (1,093,993) | |||
Ending balance, Shares at Mar. 31, 2021 | 80,438,000 | |||||||
Beginning balance at Dec. 31, 2020 | 204,557 | $ (149,734) | $ 8 | 1,131,013 | $ (165,747) | (117) | (926,347) | $ 16,013 |
Beginning balance, Shares at Dec. 31, 2020 | 76,130,000 | |||||||
Unrealized gain (loss) on available-for-sale investments | 44 | |||||||
Net loss | (402,850) | |||||||
Foreign currency gain (loss) | (1,756) | |||||||
Ending balance at Jun. 30, 2021 | (141,493) | $ 8 | 1,173,512 | (1,829) | (1,313,184) | |||
Ending balance, Shares at Jun. 30, 2021 | 80,956,000 | |||||||
Beginning balance at Mar. 31, 2021 | 51,658 | $ 8 | 1,147,263 | (1,620) | (1,093,993) | |||
Beginning balance, Shares at Mar. 31, 2021 | 80,438,000 | |||||||
Issuance of common stock upon exercise of stock options | 7,062 | 7,062 | ||||||
Issuance of common stock upon exercise of stock options, shares | 444,000 | |||||||
Vesting of restricted stock units, net of shares withheld for taxes | (233) | (233) | ||||||
Vesting of restricted stock units, net of shares withheld for taxes. shares | 11,000 | |||||||
Share-based compensation expense | 17,722 | 17,722 | ||||||
Issuance of common stock to employee stock purchase plan | 1,698 | 1,698 | ||||||
Issuance of common stock to employee stock purchase plan, shares | 63,000 | |||||||
Unrealized gain (loss) on available-for-sale investments | (35) | (35) | ||||||
Net loss | (219,191) | (219,191) | ||||||
Foreign currency gain (loss) | (174) | (174) | ||||||
Ending balance at Jun. 30, 2021 | (141,493) | $ 8 | 1,173,512 | (1,829) | (1,313,184) | |||
Ending balance, Shares at Jun. 30, 2021 | 80,956,000 | |||||||
Beginning balance at Dec. 31, 2021 | 198,662 | $ 10 | 1,857,430 | (2,090) | (1,656,688) | |||
Beginning balance, Shares at Dec. 31, 2021 | 97,524,000 | |||||||
Common Stock -follow-on-offering | 380,120 | $ 1 | 380,119 | |||||
Common Stock -follow-on-offering, shares | 8,564,000 | |||||||
Issuance of common stock upon exercise of stock options | 4,000 | 4,000 | ||||||
Issuance of common stock upon exercise of stock options, shares | 239,000 | |||||||
Vesting of restricted stock units, net of shares withheld for taxes | (2,416) | (2,416) | ||||||
Vesting of restricted stock units, net of shares withheld for taxes. shares | 113,000 | |||||||
Share-based compensation expense | 20,773 | 20,773 | ||||||
Unrealized gain (loss) on available-for-sale investments | (52) | (52) | ||||||
Net loss | (138,935) | (138,935) | ||||||
Foreign currency gain (loss) | 83 | 83 | ||||||
Ending balance at Mar. 31, 2022 | 462,235 | $ 11 | 2,259,906 | (2,059) | (1,795,623) | |||
Ending balance, Shares at Mar. 31, 2022 | 106,440,000 | |||||||
Beginning balance at Dec. 31, 2021 | 198,662 | $ 10 | 1,857,430 | (2,090) | (1,656,688) | |||
Beginning balance, Shares at Dec. 31, 2021 | 97,524,000 | |||||||
Unrealized gain (loss) on available-for-sale investments | (818) | |||||||
Net loss | (294,912) | |||||||
Foreign currency gain (loss) | (286) | |||||||
Ending balance at Jun. 30, 2022 | 334,418 | $ 11 | 2,289,201 | (3,194) | (1,951,600) | |||
Ending balance, Shares at Jun. 30, 2022 | 106,841,000 | |||||||
Beginning balance at Mar. 31, 2022 | 462,235 | $ 11 | 2,259,906 | (2,059) | (1,795,623) | |||
Beginning balance, Shares at Mar. 31, 2022 | 106,440,000 | |||||||
Issuance of common stock upon exercise of stock options | 4,770 | 4,770 | ||||||
Issuance of common stock upon exercise of stock options, shares | 283,000 | |||||||
Vesting of restricted stock units, net of shares withheld for taxes | (536) | (536) | ||||||
Vesting of restricted stock units, net of shares withheld for taxes. shares | 26,000 | |||||||
Share-based compensation expense | 22,530 | 22,530 | ||||||
Issuance of common stock to employee stock purchase plan | 2,531 | 2,531 | ||||||
Issuance of common stock to employee stock purchase plan, shares | 92,000 | |||||||
Unrealized gain (loss) on available-for-sale investments | (766) | (766) | ||||||
Net loss | (155,977) | (155,977) | ||||||
Foreign currency gain (loss) | (369) | (369) | ||||||
Ending balance at Jun. 30, 2022 | $ 334,418 | $ 11 | $ 2,289,201 | $ (3,194) | $ (1,951,600) | |||
Ending balance, Shares at Jun. 30, 2022 | 106,841,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating Activities | ||
Net loss | $ (294,912) | $ (402,850) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 43,303 | 34,161 |
Loss on conversion of debt | 39,487 | |
Loss from remeasurement of development derivative liability | 38,264 | |
Forfeiture of accrued interest in exchange of convertible notes | 1,668 | |
Amortization of right-of-use assets | (61) | 118 |
Depreciation expense | 763 | 724 |
Amortization of discounts for convertible notes, net of financing costs | 290 | 679 |
Accretion of discount to development liability | 13,336 | |
Other liabilities | 1,571 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 2,584 | (719) |
Inventory | (32,134) | (3,731) |
Prepaid assets | 3,390 | (7,473) |
Other current assets | 42,225 | (4,311) |
Other assets | 15,757 | 2,758 |
Accounts payable | 2,591 | (3,296) |
Accrued expenses | (17,287) | 22,519 |
Net cash used in operating activities | (218,584) | (282,002) |
Investing Activities | ||
Purchase of property and equipment | (477) | (732) |
Purchase of available-for-sale securities | (331,863) | (171,281) |
Proceeds from maturity of available-for-sale securities | 143,320 | 155,000 |
Net cash used in investing activities | (189,020) | (17,013) |
Financing Activities | ||
Proceeds from issuance of common stock, net of issuance costs | 380,120 | |
Payments for development derivative liability | (4,000) | |
Payments for development liability | (16,500) | |
Proceeds from exercise of stock options | 8,770 | 9,650 |
Proceeds from issuance of common stock under employee share purchase plan | 2,531 | 1,698 |
Payments of employee tax withholding related to equity-based compensation | (2,952) | (1,190) |
Net cash provided by financing activities | 371,969 | 6,158 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (365) | (1,852) |
Net decrease in cash, cash equivalents and restricted cash | (36,000) | (294,709) |
Cash, cash equivalents and restricted cash at beginning of period | 641,755 | 567,045 |
Cash, cash equivalents and restricted cash at end of period | 605,755 | 272,336 |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | ||
Cash and cash equivalents | 604,489 | 270,764 |
Restricted cash | 1,266 | 1,572 |
Total cash, cash equivalents, and restricted cash | 605,755 | 272,336 |
Supplemental Disclosure of Financing Activities | ||
Cash paid for interest | 3,360 | 6,893 |
Cash paid for income taxes | $ 156 | |
Convertible Notes exchanged for common stock | $ 126,129 |
Nature of Organization and Oper
Nature of Organization and Operations | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Organization and Operations | 1. Nature of Organization and Operations Apellis Pharmaceuticals, Inc. (the “Company”) is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic compounds to treat diseases with high unmet needs through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. The Company was incorporated in September 2009 under the laws of the State of Delaware. The Company’s principal executive offices are located in Waltham, Massachusetts. The Company’s operations since inception have been limited to organizing and staffing the Company, acquiring rights to product candidates, business planning, raising capital, developing its product candidates, and commercializing EMPAVELI (pegcetacoplan) for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”). The Company is subject to risks common in the biotechnology industry including, but not limited to, raising additional capital, development by its competitors of new technological innovations, its ability to successfully complete preclinical and clinical development of product candidates and receive timely regulatory approval of products, market acceptance of the Company’s products, protection of proprietary technology, healthcare cost containment initiatives, and compliance with governmental regulations, including those of the U.S. Food and Drug Administration (“FDA”). Additionally, the Company is subject to risks arising from the Coronavirus Disease 2019 (COVID-19) pandemic, which could have adverse effects upon its business and operations, including on its ability to initiate, conduct and complete clinical trials, and could disrupt regulatory activities. Liquidity and Going Concern The accompanying unaudited condensed consolidated financial statements have been prepared on the basis of the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of August 8, 2022, the date of issuance of these unaudited condensed consolidated financial statements, the Company believes that its cash and cash equivalents and marketable securities of $ 852.8 million as of June 30, 2022 will be sufficient to fund its operations and capital expenditures for at least the next twelve months. The Company’s future viability beyond that point is dependent on its ability to raise additional capital to finance its operations. There are uncertainties associated with the Company’s ability to (1) obtain additional debt or equity financing on terms that are favorable to the Company, (2) enter into collaborative agreements with strategic partners, and (3) succeed in its future operations. If the Company is not able to obtain the required funding for its operations or is not able to obtain funding on terms that are favorable to the Company, it could be forced to delay, reduce or eliminate its research and development programs or future commercialization efforts and its business could be materially harmed. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”), for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted and, accordingly, the consolidated balance sheet as of December 31, 2021 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of the Company’s financial information. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other interim period or for any other future year. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2022 (the “2021 Form 10-K” ). Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: development derivative liability, accrued expenses, prepaid expenses, convertible debt and taxes. Summary of Significant Accounting Policies Reference is made to Note 2 Summary of Significant Accounting Policies in our 2021 Form 10-K for a detailed description of significant accounting policies. There have been no significant changes to our accounting policies as disclosed in our 2021 Form 10-K. |
Product Revenues, Accounts Rece
Product Revenues, Accounts Receivable, and Reserves for Product Sales | 6 Months Ended |
Jun. 30, 2022 | |
Product Revenues Accounts Receivable And Reserves For Product Sales [Abstract] | |
Product Revenues, Accounts Receivable, and Reserves for Product Sales | 3. Product Revenues, Accounts Receivable, and Reserves for Product Sales The Company received FDA approval for the sale of EMPAVELI in the United States in May 2021. The Company’s product revenues, net of sales discounts and allowances and reserves, for the three months ended June 30, 2022 and 2021 were $ 15.7 million and $ 0.6 million, respectively. The Company’s product revenues, net of sales discounts and allowances and reserves, for the six months ended June 30, 2022 and 2021 were $ 27.8 million and $ 0.6 million, respectively. The Company’s accounts receivable balance of $ 7.5 million as of June 30, 2022 and $ 10.1 million as of December 31, 2021, consisted of EMPAVELI product sales receivable, net of discounts and allowances of $ 0.3 million and $ 0.2 million, respectively. The Company does not have a reserve against its receivable balance. The Company’s product sales reserves totaled $ 2.5 million and $ 1.0 million as of June 30, 2022 and December 31, 2021, respectively. These amounts are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheet. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory The Company’s inventory of EMPAVELI consisted of the following as of June 30, 2022, and December 31, 2021 (in thousands): June 30, December 31, 2022 2021 Raw materials $ 19,292 $ 5,749 Semi-finished goods 27,973 10,058 Finished goods 1,186 479 Total Inventories $ 48,451 $ 16,286 |
Prepaid Assets and Accrued Expe
Prepaid Assets and Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid Assets And Accrued Expenses [Abstract] | |
Prepaid Assets And Accrued Expenses | 5. Prepaid Assets and Accrued Expenses Prepaid assets include $ 13.8 million and $ 12.0 million of prepaid research and development costs as of June 30, 2022 and December 31, 2021, respectively. Accrued expenses are as follows (in thousands): June 30, December 31, 2022 2021 Accrued research and development $ 39,006 $ 35,217 Accrued cost of research collaboration — 25,000 Accrued license fee — 5,000 Accrued royalties 1,042 — Accrued payroll liabilities 22,182 25,212 Other 27,189 12,810 Total $ 89,419 $ 103,239 |
Development Liability and Devel
Development Liability and Development Derivative Liability | 6 Months Ended |
Jun. 30, 2022 | |
Research and Development [Abstract] | |
Development Liability and Development Derivative Liability | 6. Development Liability and Development Derivative Liability On February 28, 2019, the Company entered into a development funding agreement (the “SFJ agreement”), with SFJ Pharmaceuticals Group (“SFJ”), under which SFJ agreed to provide funding to the Company to support the development of pegcetacoplan for the treatment of patients with PNH. Pursuant to the SFJ agreement, SFJ paid the Company $ 60.0 million following the signing of the agreement and agreed to pay the Company up to an additional $ 60.0 million in the aggregate in three equal installments upon the achievement of specified development milestones with respect to the Company’s Phase 3 program for pegcetacoplan in PNH. On June 7, 2019, the Company and SFJ amended the development funding agreement, (the “SFJ amendment”). Under the SFJ amendment, SFJ agreed to make an additional $ 20.0 million funding payment to the Company to support the development of systemic pegcetacoplan for the treatment of patients with PNH. As of January 29, 2020, the Company had received a total of $ 140.0 million from SFJ as the Company met milestones as identified in the SFJ agreement. The Company did not receive any additional funds from SFJ after January 29, 2020. Under the SFJ agreement, following regulatory approval by the FDA for the use of systemic pegcetacoplan as a treatment for PNH, the Company is obligated to pay SFJ an initial payment of $ 4.0 million and then an additional $ 226.0 million in the aggregate in six additional annual payments with the majority of the payments being made from the third anniversary to the sixth anniversary of regulatory approval. The Company obtained regulatory approval by the FDA on May 14, 2021 and paid to SFJ the initial payment of $ 4.0 million in June 2021 and the first annual payment of $ 11.5 million in May 2022. The subsequent annual payments remaining are due and payable in May of each year from 2023 through 2027. Under the SFJ agreement, following regulatory approval by the European Medicines Agency (the “EMA”) for the use of systemic pegcetacoplan as a treatment for PNH, the Company is obligated to pay SFJ an initial payment of $ 5.0 million and then an additional $ 225.0 million in the aggregate in six additional annual payments with the majority of the payments being made from the third anniversary to the sixth anniversary of regulatory approval. The Company obtained regulatory approval by the EMA on December 15, 2021 and paid to SFJ the initial payment of $ 5.0 million in January 2022. The subsequent annual payments are due and payable in December of each year from 2022 through 2027. Additionally, the Company granted a security interest to SFJ in all of its assets, excluding intellectual property and license agreements to which it is a party. In connection with the grant of the security interest, the Company agreed to certain affirmative and negative covenants, including restrictions on its ability to pay dividends, incur additional debt or enter into licensing transactions with respect to its intellectual property, other than specified types of licenses. Prior to EMA approval on December 15, 2021, the SFJ agreement was presented as a derivative liability on the consolidated balance sheet and, as such, was recorded at fair value and remeasured each quarter. As the variability of the future payments derived from the underlying contingency (i.e., EMA approval and FDA approval) no longer exists, the Company remeasured the development derivative liability on December 15, 2021 and reclassified it from a development derivative liability to a development liability, with subsequent accounting to follow an effective interest accretion schedule to the fixed payment amounts. From December 15, 2021 to the final annual payment due in December 2027, the development liability will be accreted from its initial carrying amount to the total payment amount using the effective interest rate method under FASB ASC Topic 835, Interest, over the remaining life of the SFJ agreement. The difference between the carrying amount and the total payment amount is presented as a discount to the development liability. The accretion is recorded as interest expense in the unaudited condensed consolidated statement of operations. The following table summarizes the development liability (in thousands): June 30, 2022 December 31, 2021 Effective Development liability $ 439,500 $ 456,000 7.91 % Less: Unamortized discount to development liability ( 89,929 ) ( 103,265 ) Less: Current portion of development liability, net of discount ( 15,842 ) ( 7,584 ) Total long term development liability $ 333,729 $ 345,151 For the three and six months ended June 30, 2022 , interest expense of $ 6.6 million and $ 13.3 million, respectively, was recorded for the accretion of the development liability. The following table presents a rollforward of the development derivative liability for the six months ended June 30, 2021 (in thousands): Balance at fair market value, January 1, 2021 $ 257,868 Loss from remeasurement of development 17,084 Balance at fair market value, March 31, 2021 $ 274,952 Amount repaid under the SFJ agreement and SFJ amendment ( 4,000 ) Loss from remeasurement of development 21,180 Balance at fair market value, June 30, 2021 $ 292,132 For the six months ended June 30, 2021, the total change in fair value of $ 38.3 million was recorded in loss from remeasurement of development derivative liability in the unaudited condensed consolidated statement of operations. The derivative fair value as of June 30, 2021 was a Level 3 fair value measurement and was valued using a scenario-based discounted cash flow method, whereby each scenario made assumptions about the probability and timing of cash flows, and such cash flows are present valued using a risk-adjusted discount rate. The analysis is calibrated such that the value of the derivative as of the date of the SFJ agreement was consistent with an arm’s-length transaction. Key inputs to the Level 3 fair value model included (i) the probability and timing of achieving stated development milestones to receive the next tranches of funding, (ii) the probability and timing of achieving FDA and EMA approval, (iii) SFJ’s cost of borrowing ( 8.0 %), and (iv) the Company’s cost of borrowing ( 11.15 %). SFJ’s implied cost of borrowing was 8.0 % and the Company’s implied cost of borrowing was 11.15 % as of June 30, 2021. These implied costs of borrowing were determined assuming the SFJ agreement was initially executed with arm’s-length terms. If the SFJ agreement was instead not determined to be an arm’s-length transaction, then implied discount rates could differ. |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 7. Long-term Debt Convertible Senior Notes On September 16, 2019, the Company completed a private offering of convertible notes (the “2019 Convertible Notes”) with an aggregate principal amount of $ 220.0 million issued pursuant to an indenture (the “Indenture”) with U.S. Bank National Association, as trustee. The net proceeds from the sale of the 2019 Convertible Notes were approximately $ 212.9 million after deducting the initial purchasers’ discounts and commissions of $ 6.6 million and offering expenses of $ 0.5 million by the Company. The Company used $ 28.4 million of the net proceeds from the sale of the 2019 Convertible Notes to pay the cost of the capped call transactions in September 2019 described below. On May 12, 2020, the Company issued convertible notes (the “2020 Convertible Notes”) with an aggregate principal amount of $ 300.0 million. The net proceeds from the sale of the 2020 Convertible Notes were approximately $ 322.9 million after deducting the purchasers’ discounts and commission of $ 5.7 million and offering expenses of $ 0.3 million. The Company used $ 43.1 million of the net proceeds from the sale to pay the cost of the additional capped call transactions in May 2020 described below. The 2019 Convertible Notes and the 2020 Convertible Notes are referred to together as the Convertible Notes. The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.5 % per year payable semiannually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. The Convertible Notes will mature on September 15, 2026 , unless converted earlier, redeemed or repurchased in accordance with their terms. The Convertible Notes are convertible into shares of the Company’s common stock at an initial conversion rate of 25.3405 shares per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of approximately $ 39.4625 per share of common stock). The conversion rate is subject to customary anti-dilution adjustments. In addition, following certain events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will increase the conversion rate for a holder who elects to convert its Convertible Notes in connection with such corporate event or a notice of redemption, as the case may be, in certain circumstances as provided in the Indenture. Prior to March 15, 2026, the Convertible Notes are convertible only under the following circumstances: • during any calendar quarter, if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day; • during the five business day period after any five consecutive trading day period in which the trading price per $ 1,000 principal amount of the Convertible Notes for each such trading day was less than 98 % of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; • if the Company calls any or all of the Convertible Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date; or • upon the occurrence of corporate events specified in the Indenture. On or after March 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date of the Convertible Notes, holders may convert the Convertible Notes at any time regardless of the foregoing circumstances. Upon conversion of the Convertible Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock or a combination of cash and shares of common stock, at the Company’s election. Prior to September 20, 2023, the Company may not redeem the Convertible Notes. The Company may redeem for cash all or a portion of the Convertible Notes, at its option, on or after September 20, 2023 if the last reported sale price of the Company’s common stock has been at least 130 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides a notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. The redemption price will be equal to 100 % of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company undergoes a “fundamental change,” as defined in the Indenture, prior to maturity, subject to certain conditions, holders may require the Company to repurchase for cash all or any portion of their Convertible Notes at a fundamental change repurchase price equal to 100 % of the principal amount of the notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Company used an effective interest rate of 10.5 % to determine the liability component of the 2019 and 2020 Convertible Notes. This resulted in the recognition of $ 145.1 million and $ 204.5 million as the liability component of the 2019 and 2020 Convertible Notes, respectively, and the recognition of the residual amount of $ 74.9 million and $ 95.5 million as the debt discount with a corresponding increase to additional paid in capital for the equity component of the 2019 and 2020 Convertible Notes, respectively. The 2020 Convertible Notes aggregate debt issuance costs of $ 6.0 million were allocated to the liability and equity components in the amounts of $ 3.7 and $ 2.3 million, respectively. The 2019 Convertible Notes aggregate debt issuance costs of $ 7.1 million were allocated to the liability and equity components in the amounts of $ 4.7 million and $ 2.4 million, respectively. Effective January 1, 2021 , the Company adopted ASU 2020-06 using the modified retrospective method. Upon adoption, the Company increased net debt and reduced net equity by $ 149.7 million. The $ 149.7 million consisted of several items. The first item is the reclassification from equity to debt of the residual amounts originally identified as the equity components of the 2019 and 2020 Convertible Notes of $ 74.9 million and $ 95.5 million, respectively. The equity component reclassification was offset by the adjustment to retained earnings for the reversal of previous non-cash interest expense recorded for the amortization of the equity components of $ 17.1 million. The second item is the reclassification from equity to debt of the debt issuance costs originally allocated to equity for the 2019 and 2020 Convertible Notes of $ 2.4 million and $ 2.3 million, respectively. The debt issuance costs reclassification was offset by the adjustment to retained earnings for previous amortization of the debt issuance costs recorded of $ 1.1 million. In January 2021 and in July 2021, the Company entered into separate, privately negotiated exchange agreements to modify the conversion terms with certain holders of its 2019 Convertible Notes. Under the terms of these exchange agreements, in January 2021 and July 2021, the holders exchanged approximately $ 126.1 million of 2019 Convertible Notes and $ 201.1 million of 2019 and 2020 Convertible Notes, respectively, in aggregate principal amount held by them for an aggregate of 3,906,869 shares and 5,992,217 shares, respectively, of common stock issued by the Company. In accordance with FASB ASC Topic 470-20, “ Debt – Debt with Conversion and Other Options,” (“ASC 470-20”) the Company accounted for the exchange as an induced conversion based on the short period of time the conversion offer was open and the substantive conversion feature offer. The Company accounted for the conversion of the debt as an inducement by expensing the fair value of the shares that were issued in excess of the original terms of the Convertible Notes. For the January 2021 transaction, the Company reduced net debt outstanding and increased net equity on the consolidated balance sheet by $ 122.8 million, consisting of the par value of the 2019 Convertible Notes exchanged of $ 126.1 million less the $ 3.3 million of remaining debt issuance costs associated with the exchanged notes. The Company also increased shares outstanding by 3,906,869 shares consisting of 3,196,172 shares issued at the initial conversion rate in the Indenture of 25.3405 plus an additional 710,697 shares. Additionally, the Company issued 69,491 shares as settlement of debt issuance costs paid to the Company’s advisor in connection with the conversion transaction. For the three months ended March 31, 2021, the Company recorded a loss on conversion of debt of $ 39.5 million comprised of $ 36.4 million related to the value of the shares issued in excess of the original conversion terms at the fair market value and $ 3.1 million for the value of the 69,491 shares issued in payment of issuance costs. Upon exchange of the 2019 Convertible Notes, the holders forfeited accrued interest through the date of the exchange of $ 1.7 million, which the Company charged to interest expense and to equity. For the July 2021 transaction, the Company reduced net debt outstanding and increased net equity on the consolidated balance sheet by $ 197.0 million, consisting of the par value of the Convertible Notes exchanged of $ 201.1 million less the $ 4.1 million of remaining debt issuance costs associated with the exchanged notes. The Company also increased shares outstanding by 5,992,217 shares consisting of 5,097,166 shares issued at the initial conversion rate in the Indenture of 25.3405 plus an additional 895,051 shares. Additionally, the Company issued 78,419 shares as settlement of debt issuance costs paid to the Company’s advisor in connection with the conversion transaction. For the three months ended September 30, 2021, th e Company recorded a loss on conversion of debt of $ 61.1 million comprised of $ 55.9 million related to the value of the shares issued in excess of the original conversion terms at the fair market value and $ 5.2 million for the value of the 78,419 shares issued in payment of issuance costs. Upon exchange of the Convertible Notes, the holders forfeited accrued interest through the date of the exchange of $ 2.5 million, which the Company charged to interest expense and to equity. The conditional conversion feature of the Convertible Notes was triggered as of June 30, 2021, and so the Convertible Notes were convertible at the option of the holders. Certain holders of the Convertible Notes converted approximately $ 0.7 million of aggregate principal amount of Convertible Notes into an aggregate of 18,775 shares, which were issued in October 2021. As of June 30, 2022 , the Company held in treasury Convertible Notes in principal amount of $ 327.2 million which notes had not been cancelled. Interest expense for the Convertible Notes was $ 1.8 million and $ 3.6 million for the three and six months ended June 30, 2022, respectively. For the three months ended June 30, 2022 , interest expense included accrued semi-annual coupon payable of $ 1.7 million and amortization of debt issuance costs of $ 0.1 million. For the six months ended June 30, 2022 , interest expense included accrued semi-annual coupon payable of $ 3.4 million and amortization of debt issuance costs of $ 0.2 million. As of June 30, 2022 and December 31, 2021, $ 2.7 million and $ 3.0 million, respectively, of debt issuance costs was recorded in the unaudited condensed consolidated balance sheet as a reduction to the carrying amount of the Convertible Notes. Interest expense for the Convertible Notes was $ 3.8 million and $ 7.9 million for the three and six months ended June 30, 2021, respectively. For the three months ended June 30, 2021, interest expense included accrued semi-annual coupon payable of $ 3.4 million and amortization of debt issuance costs of $ 0.3 million. For the six-months ended June 30, 2021, interest expense included accrued semi-annual coupon payable of $ 7.3 million and amortization of debt issuance costs of $ 0.6 million. As of June 30, 2021, $ 7.4 million of debt issuance costs was recorded in the unaudited condensed consolidated balance sheet as a reduction to the carrying amount of the Convertible Notes. The aggregate principal balance of the Convertible Notes held by third parties, net of unamortized debt issuance costs, as of June 30, 2022 and December 31, 2021 was $ 189.3 million and $ 189.0 million respectively. Capped Call Transactions On September 11, 2019 and May 6, 2020, concurrently with the pricing of the Convertible Notes, the Company entered into capped call transactions with two counterparties. The capped call transactions are expected generally to reduce the potential dilution to the Company’s common stock upon any conversion of Convertible Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted Convertible Notes, as the case may be, in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which is initially $ 39.4625 (the conversion price of the Convertible Notes) and is subject to anti-dilution adjustments substantially similar to those applicable to the conversion rate of such Convertible Notes. If, however, the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, exceeds the cap price of the capped call transactions, which is initially $ 63.14 per share, representing a premium of 100% above the last reported sale price of $ 31.57 per share of its common stock on The Nasdaq Global Select Market on September 11, 2019, there would nevertheless be dilution and/or there would not be an offset of such potential cash payments, in each case, to the extent that such market price exceeds the cap price of the capped call transactions. Pursuant to FASB ASC Topic 815-40 Derivatives and Hedging , the Company determined that the capped call transactions should be classified as equity instruments and the capped call premium paid in the amount of $ 28.4 million and $ 43.1 million were recorded as reductions to additional paid-in capital at December 31, 2021 for the 2019 Convertible Notes and the 2020 Convertible Notes, respectively. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 8. Leases The underlying assets of the Company’s leases primarily relate to office space leases, but also include some equipment leases. The Company determines if an arrangement qualifies as a lease at its inception. As a practical expedient permitted under Topic 842, the Company elected to account for the lease and non-lease components as a single lease component for all leases of which it is the lessee. Lease payments, which may include lease and non-lease components, are included in the measurement of the Company’s lease liabilities to the extent that such payments are either fixed amounts or variable amounts that depend on a rate or index as stipulated in the lease contract. When the Company cannot readily determine the rate implicit in the lease, the Company determines its incremental borrowing rate by using the rate of interest that it would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. The Company enters into lease agreements with terms generally ranging from 2 - 7 years . Some of the Company’s lease agreements include Company options to extend the lease on a month-to-month basis or for set periods for up to five years . Many of these leases also include options to terminate the leases within one year or per other contractual terms. Renewal and termination options were generally not included in the lease term for the Company’s existing operating leases. As of June 30, 2022 and December 31, 2021 , all leases were classified as operating lease assets and liabilities. Additional information related to the operating lease assets and liabilities is as follows (in thousands): June 30, December 31, 2022 2021 Operating Lease Assets $ 20,755 $ 19,901 Operating Lease Liabilities $ 21,988 $ 21,196 Weighted Average Remaining Term in years 4.01 4.66 Weighted Average discount rate used to measure 7.30 % 7.71 % For the three months ended June 30, 2022 and 2021, the total lease cost for operating lease expense was $ 1.5 million and $ 1.4 million, respectively. For the six months ended June 30, 2022 and 2021, the total lease cost for operating lease expense was $ 2.9 million and $ 2.7 million, respectively. Supplemental cash flow information related to operating leases for the six months ended June 30 is as follows (in thousands): 2022 2021 Operating cash flows for operating leases $ 3,532 $ 2,945 Operating lease assets obtained in exchange for lease obligations $ — $ 5,675 The maturities of the Company’s operating lease liabilities as of June 30, 2022 are as follows (in thousands): 2022 3,313 2023 6,667 2024 5,905 2025 4,745 2026 and thereafter 4,839 Total future minimum lease payments less 25,469 Imputed interest ( 3,481 ) Total operating lease liabilities $ 21,988 |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 9. Marketable Securities The amortized cost, gross unrealized holding losses and fair value of available-for-sale debt securities by type of security as of June 30, 2022 and December 31, 2021 were as follows (in thousands): As of June 30, 2022 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. Government-related obligations $ 249,124 $ — $ ( 817 ) $ 248,307 As of December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. Government-related obligations $ 60,357 $ 3 $ ( 2 ) $ 60,358 All available-for-sale securities mature in one year or less. |
Other Comprehensive Income and
Other Comprehensive Income and Accumulated Other Comprehensive Income | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Other Comprehensive Income and Accumulated Other Comprehensive Income | 10. Other Comprehensive Income and Accumulated Other Comprehensive Income The following tables summarize the changes in accumulated other comprehensive income/(loss), by component for the six months ended June 30, 2022 and June 30, 2021 (in thousands): Unrealized Gains (Losses) from Marketable Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Income (Loss) Balances, December 31, 2021 $ 1 $ ( 2,091 ) $ ( 2,090 ) Net other comprehensive income (loss) ( 52 ) 83 31 Balances, March 31, 2022 ( 51 ) ( 2,008 ) ( 2,059 ) Net other comprehensive loss ( 766 ) ( 369 ) ( 1,135 ) Balances, June 30, 2022 $ ( 817 ) $ ( 2,377 ) $ ( 3,194 ) Unrealized Gains (Losses) from Marketable Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Income (Loss) Balances, December 31, 2020 $ ( 8 ) $ ( 109 ) $ ( 117 ) Net other comprehensive income (loss) 79 ( 1,582 ) ( 1,503 ) Balances, March 31, 2021 71 ( 1,691 ) ( 1,620 ) Net other comprehensive loss ( 35 ) ( 174 ) ( 209 ) Balances, June 30, 2021 $ 36 $ ( 1,865 ) $ ( 1,829 ) |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 11 . Fair Value Measurements The Company is required to disclose information on the fair value of financial instruments and inputs that enable an assessment of the fair value. The three levels of the fair value hierarchy prioritize valuation inputs based upon the observable nature of those inputs as follows: Level 1 – Quoted prices 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 or indirectly; Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. The following table presents the fair value of financial instruments recorded originally at amortized cost or fair value and not remeasured on a recurring basis (in thousands): June 30, 2022 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents: Money market funds $ 549,895 $ — $ — $ 549,895 Total Financial Assets $ 549,895 $ — $ — $ 549,895 December 31, 2021 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents Money market funds $ 598,833 $ — $ — $ 598,833 Total Financial Assets $ 598,833 $ — $ — $ 598,833 The following table presents the fair value of financial instruments recorded at fair value at inception and remeasured on a recurring basis (in thousands): June 30, 2022 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Marketable securities: US government obligations $ 248,307 — — $ 248,307 Total Financial Assets $ 248,307 $ — $ — $ 248,307 December 31, 2021 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Marketable securities: US government obligations $ 60,358 $ — $ — $ 60,358 Total Financial Assets $ 60,358 $ — $ — $ 60,358 The Company's Convertible Notes and development liability are financial instruments that are reported in the financial statements at historical cost. The Convertible Notes are Level 1 within the fair value level hierarchy as of June 30, 2022 and December 31, 2021. The fair value of the Convertible Notes was $ 287.3 million as of June 30, 2022 and $ 290.7 million as of December 31, 2021. The Convertible Notes accrue a semi-annual coupon at an annual rate of 3.5 %, which was included in accrued expenses in the consolidated balance sheets as of June 30, 2022 and December 31, 2021. The fair value of the development liability was $ 317.8 million and $ 352.7 million as of June 30, 2022 and December 31, 2021, respectively. The development liability is Level 2 within the fair value hierarchy based on the discounting of fixed cash flows using an observed bond yield for borrowers with similar credit rating. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes For the three and six months ended June 30, 2022, the Company recorded $ 0.5 million and $ 1.7 million of income tax expense, respectively, primarily pertaining to federal and state income taxes where the utilization of net operating losses and research and development tax credits are limited. There was no income tax provision for the three months and six months ended June 30, 2021. The income tax provision during interim periods is computed by applying an estimated annual effective tax rate to year-to-date pre-tax income, plus adjustments for significant unusual or infrequently occurring items, in accordance with FASB ASC Topic 740-270, Income Taxes – Interim Reporting . The income tax provision differs from the U.S. federal statutory rate of 21 % primarily due to the effect of valuation allowance against the Company’s net deferred tax assets, which reduces the Company’s net tax benefit. Deferred tax assets and deferred tax liabilities are determined based on temporary differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company has recorded a full valuation allowance against its net deferred tax assets for the period ended June 30, 2022. The Company does not recognize a tax benefit for uncertain tax positions unless it is more likely than not that the position will be sustained upon examination by tax authorities, including resolution of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit that is recorded for these positions is measured at the largest amount of cumulative benefit that has greater than a 50 percent likelihood of being realized upon ultimate settlement. Deferred tax assets that do not meet these recognition criteria are not recorded and the Company recognizes a liability for uncertain tax positions that may result in tax payments. The Company recorded $ 1.6 million of unrecognized tax benefits for the period ended June 30, 2022 . If such unrecognized tax benefits were realized, the entire amount would impact the tax provision. Our policy is to review and update unrecognized tax positions as facts and circumstances change. |
License and Collaboration Agree
License and Collaboration Agreements | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | 13. License and Collaboration Agreements Sobi License and Collaboration Agreement On October 27, 2020, the Company and its subsidiaries, Apellis Switzerland GmbH and APL DEL Holdings, LLC entered into a Collaboration and License Agreement (the “Sobi collaboration agreement”) with Swedish Orphan Biovitrum AB (Publ) (“Sobi”), concerning the development and commercialization of pegcetacoplan and specified other structurally and functionally similar compstatin analogues or derivatives for use systemically or for local non-ophthalmological administration (collectively referred to as the “Licensed Products”). Under the Sobi collaboration agreement, the Company granted Sobi an exclusive (subject to certain retained rights of the Company), sublicensable license of certain patent rights and know-how to develop and commercialize Licensed Products in all countries outside of the United States. The Company retains the right to commercialize Licensed Products in the United States, and, subject to specified limitations, to develop Licensed Products worldwide for commercialization in the United States. Under the Sobi collaboration agreement, the Company and Sobi have agreed to collaborate to develop Licensed Products for the treatment of PNH, cold agglutinin disease, hematopoietic stem cell transplantation-associated thrombotic microangiopathy, C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis, and amyotrophic lateral sclerosis (collectively the “Initial Indications”), and any other indications subsequently agreed upon by the parties, for commercialization by or on behalf of the Company in the United States and by or on behalf of Sobi outside of the United States. If the parties do not agree to jointly pursue any development activities for the Licensed Products (whether for an Initial Indication or otherwise), the party proposing to pursue such activities may conduct such activities at its sole expense (with the non-proposing party having the right to obtain rights to the data generated by such development activities by paying a specified percentage of that expense), subject to agreed-upon exceptions that limit each party’s unilateral development rights. The initial development plan sets forth the initial development activities to be conducted by each of the Company and Sobi, with the Company bearing all costs incurred in conducting the activities set forth in such initial development plan, as well as certain specified additional costs that are not included in the initial development plan that may be incurred by the parties in developing Licensed Products for PNH in the European Union and the United Kingdom. The Company and Sobi have formed several governance committees to oversee the development and manufacture, and to review and discuss the commercialization, of Licensed Products. The Company shall supply Licensed Products to Sobi for development and for commercialization outside of the United States in accordance with a supply agreement to be negotiated by the parties. The collaboration agreement grants Sobi the right to perform or have performed drug product manufacturing of Licensed Products for development and for commercialization outside the United States and to manufacture or have manufactured drug substance under certain circumstances. Sobi paid the Company an upfront payment of $ 250.0 million in November 2020, and has agreed to pay up to an aggregate of $ 915.0 million upon the achievement of specified one-time regulatory development and commercial milestone events, of which the Company received $ 50.0 million in April 2022 for the achievement of a regulatory development milestone in Europe. Sobi also agreed to reimburse the Company for up to $ 80.0 million in development costs, of which the Company received $ 25.0 million in January 2021 and $ 20.0 million in January 2022. The Company will also be entitled to receive tiered, double-digit royalties (ranging from high teens to high twenties) on sales of Licensed Products outside of the United States, subject to customary deductions and third-party payment obligations, until the latest to occur of: (i) expiration of the last-to-expire of specified licensed patent rights; (ii) expiration of regulatory exclusivity; and (iii) ten (10) years after the first commercial sale of the applicable Licensed Product, in each case on a Licensed Product-by-Licensed Product and country-by-country basis. Under the Sobi collaboration agreement, the Company remains responsible for its license fee obligations (including royalty obligations) to the University of Pennsylvania as a licensor of the Company and for its payment obligations to SFJ. Sobi Accounting Analysis The Company has determined that the Sobi collaboration agreement is within the scope of FASB ASC Topic 808, Collaborative Arrangement Guidance and Considerations, (“ASC 808”) as a contractual arrangement that involves a joint operating activity whereby both parties are (i) active participants in the activity and (ii) exposed to certain significant risks and rewards dependent on the commercial success of the activity. ASC 808 does not address measurement or recognition matters but allows for analogizing to FASB ASC Topic 606, Revenue from Contracts with Customers , (“ASC 606”). Pursuant to ASC 606, the Company performed the following five steps: (i) identified the contract(s) with a customer; (ii) identified the performance obligations in the contract; (iii) determined the transaction price; (iv) allocated the transaction price to the performance obligations in the contract; and (v) recognized revenue when (or as) the entity satisfies a performance obligation. The Company identified the following material distinct promises under the Sobi collaboration agreement: (1) licenses to develop and commercialize pegcetacoplan (“Licenses to IP”), and (2) performance of research and development services. The Company determined the promises to be distinct because Sobi can benefit from each of the license and the development services on their own or with readily available services. The Company could have provided the license without any development services and Sobi would have been able to benefit from it by obtaining development services from another provider as the Licensed Products are at a more mature stage in their life cycle. Under the Sobi collaboration agreement, Sobi agreed to pay the Company i) a fixed amount of $ 250.0 million in an upfront payment in November 2020; ii) a fixed amount of an additional $ 80.0 million in development reimbursements, payable yearly in four tranches in amounts determined based upon actual expenses incurred by the Company; iii) up to an aggregate of $ 915.0 million upon the achievement of specified one-time regulatory and commercial milestone events; and iv) tiered, double-digit royalties, ranging from high teens to high twenties, on sales of Licensed Products outside of the United States, subject to customary deductions and third-party payment obligations. At contract inception, the $ 250.0 million non-refundable payment and the $ 80.0 million reimbursements were fixed proceeds. The Company evaluated whether Sobi is a customer for either of the distinct promises in the Sobi collaboration agreement. Under the Licenses to IP, the Company determined that Sobi is a customer as the know-how provided and the right granted by the Company to Sobi are outputs of the Company’s business activities for which the Company will receive consideration. With respect to research and development activity, management determined that there is no vendor relationship as performing research and development activities for others is not a part of the Company’s ongoing central operations. Based upon the evaluation of the relative fair values, the Company allocated the purchase price of $ 250.0 million and the related milestones and royalties to the License to IP and $ 80.0 million to performance of research and development activities. The milestone and royalty payments are subject to activities outside the control of the Company. Per ASC 606, the Company considers this to be a customer/ vendor relationship, therefore, the Company will include the regulatory milestone payments in the total transaction price when it is probable that a significant reversal of revenue would not occur in a future period. The Company will recognize commercial milestone and royalty revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which the commercial milestone or royalty has been allocated has been satisfied. In case of commercial milestone or royalty payments, the Company will recognize revenue in the same period that the sales are completed for which the Company is contractually entitled to the milestone or percentage-based royalty payment. To date, the Company has not recognized any commercial milestone revenue resulting from any of its licensing arrangements. The Company has recognized $ 0.7 million and $ 0.8 million of royalty revenue for the three and six months ended June 30, 2022, respectively. Management periodically assesses the elements of the contract and re-evaluates revenue recognition as necessary. Pursuant to ASC 606, during the year ended December 31, 2020, the Company recognized the $ 250.0 million in revenue as this is the amount allocated to the license. The $ 80.0 million reimbursement for research and development activities does not constitute a customer/vendor relationship and thus is not in the scope of ASC 606. As ASC 808 does not include recognition guidance, the Company has established an accounting policy to recognize the payments under the reimbursement as a receivable on the balance sheet in an amount that is to be reimbursed based upon expense incurred by the Company, with a contra- research and development expense recognized in the consolidated statement of operations, over time as the expenses are incurred. Under the Sobi collaboration agreement, for the three and six months ended June 30, 2022 and 2021, the Company did no t recognize licensing revenue. For the three and six months ended June 30, 2022 , the Company recognized $ 0.7 million and $ 0.8 million, respectively, of royalty revenue. The Company did no t recognize any royalty revenue for the three and six months ended June 30, 2021. For the six months ended June 30, 2022 , the Company recognized $ 5.0 million for contra-research and development expense in the unaudited condensed consolidated statement of operations related to the $ 80.0 million reimbursement commitment from Sobi. The Company did no t recognize any contra-research and development expense for the three months ended June 30, 2022. For the three and six months ended June 30, 2021, the Company recognized $ 9.1 million and $ 17.2 million, respectively, for contra-research and development expense. As of June 30, 2022 , the Company recorded a receivable of $ 35.0 million, with $ 20.0 million in current assets and $ 15.0 million in long-term assets, on the unaudited condensed consolidated balance sheet. The total receivable balance as of June 30, 2022 is for contra-research and development reimbursement from Sobi. As of December 31, 2021, the Company recorded a receivable of $ 100.0 million, with $ 70.0 million in current assets and $ 30.0 million in long-term assets. Of the $ 100.0 million receivable as of December 31, 2021, $ 50.0 million is for contra-research and development reimbursement from Sobi, with $ 20.0 million and $ 30.0 million in current and long-term assets, respectively. The remaining $ 50.0 million receivable as of December 31, 2021 in current assets is for the achievement of the development milestone for first regulatory and reimbursement approval in Europe. University of Pennsylvania License Agreement The Company is a party to a license agreement with the Trustees of the University of Pennsylvania (“Penn”) for an exclusive, worldwide license to specified patent rights. The Company is required to pay annual maintenance fees of $ 0.1 million until the first sale of a licensed product. The Company is also required to make milestone payments aggregating up to $ 3.2 million based upon the achievement of specified development and regulatory milestones and up to $ 5.0 million based upon the achievement of specified annual sales milestones with respect to each licensed product, and to pay low single-digit royalties based on net sales of each licensed product and with minimum quarterly royalty thresholds. In addition, the Company is obligated to pay a specified portion of income it receives from sublicensees. In addition, the Company is also party to a license agreement with Penn for an exclusive, worldwide license to specified patent rights for the development and commercialization of products in fields of use, as defined therein. The Company is required to pay annual maintenance fees of $ 0.1 million until the first sale of a licensed product. The Company is required to make milestone payments aggregating up to $ 1.7 million, based upon the achievement of development and regulatory approval milestones, and up to $ 2.5 million, based upon the achievement of annual sales milestones with respect to each of the first two licensed products. The license agreement also requires the Company to pay low single digit royalties based on net sales of each licensed product, subject to minimum quarterly royalty thresholds. In addition, the Company is obligated to pay a specified portion of income it receives from sublicensees. In January 2021, the Company paid $ 25.0 million for sublicense fee owed to Penn related to the Sobi collaboration agreement and another licensing transaction. In August 2021 the Company paid $ 1.0 million to Penn upon the achievement of a development milestone. In June 2022 the Company paid an additional $ 5.0 million to Penn upon the achievement of a development milestone, which was accrued as of December 31, 2021, as it was considered probable at that time. The $ 5.0 million development milestone was recorded in accrued expenses on the unaudited condensed consolidated balance sheet as of December 31, 2021. Beam Research Collaboration In June 2021, the Company entered into an exclusive five-year research collaboration (the “Beam collaboration agreement”) with Beam Therapeutics, Inc. (“Beam”) focused on the use of Beam’s proprietary base editing technology to discover new treatments for complement-driven diseases. The Company and Beam agreed to collaborate on up to six research programs focused on C3 and other complement targets in the eye, liver and brain. Under the terms of the Beam collaboration agreement, Apellis is responsible for selecting specific genes within the complement system in various organs including the eye, liver and brain (the “Target List”) and providing analytical support while Beam will apply its base editing technology and conduct preclinical research on up to six base editing programs for the Target List. During the first five years of the Beam collaboration agreement, Beam is prohibited from developing on its own or with a third party any base editing therapies associated with the items on the Target List but does not prevent Beam from licensing its intellectual property to a third-party for another purpose outside of the Target List. The Company will have exclusive rights to license each of the six programs and will assume responsibility for subsequent development and commercialization. Beam may elect to enter a 50-50 co-development and U.S. co-commercialization agreement with the Company with respect to any one program licensed under the Beam collaboration agreement and upon such election any license agreement in place at that time, would be terminated. As part of the Beam collaboration agreement, the Company agreed to pay a $ 50.0 million up-front, non-refundable payment to Beam, which the Company paid in July 2021. In June 2022, the Company paid $ 25.0 million which was recorded as a cost of research collaboration expense for the year ended December 31, 2021, as it was considered probable of achievement. The Company and Beam are each responsible for their own costs during the research collaboration. If and after the opt-in license rights are exercised for each of the up to six programs, Beam will be eligible to receive development, regulatory and sales milestones from the Company, as well as royalty payments on sales. The Beam collaboration agreement has an initial term of five years and may be extended up to two years on a per year program-by-program basis. The Company analyzed the Beam research collaboration agreement pursuant to ASC 808 to assess whether the agreement involved joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. Since each party is actively participating in this activity and exposed to significant risks and rewards related to the activity through each party’s costs will be accounted for under ASC 808. Since ASC 808 does not provide recognition guidance, the Company referred to the guidance under FASB ASC Topic 730, Research and Development (“ASC 730”), to arrangements involving payments by the Company. ASC 730 requires the Company to recognize research and developments costs as expense as incurred since the payment was made for the use of Beam’s intellectual property and research and development services and there is no alternative use. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies The Company has certain non-cancelable purchase obligations related to the manufacturing of drug substance and drug product, with Bachem Americas, Inc. and Bachem AG (collectively, “Bachem”), agreeing to purchase a significant portion of our requirements for the pegcetacoplan drug substance over the next five years , and a commercial supply agreement with NOF Corporation (“NOF”), to purchase activated polyethylene glycol derivative, or PEG, which is a component of pegcetacoplan. Under these agreements, as of June 30, 2022 , we are obligated to pay up to $ 97.6 million to these vendors. In addition, we have other non-cancelable purchase agreements as of June 30, 2022 , where we are obligated to pay up to $ 3.3 million to these vendors. Following regulatory approval by the FDA and EMA for the use of pegcetacoplan as a treatment for PNH, the Company has certain payment and other obligations under the SFJ agreement, which are discussed above in Note 6 Development Liability and Development Derivative Liability. The Company is a party to a master lease agreement under which the Company leases vehicles with initial terms of 36 months from the date of delivery. If the Company were unable to take delivery of a previously ordered vehicle, the Company may incur nominal fees . Indemnifications —In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has no t incurred any cost to defend lawsuits or settle claims related to these indemnification provisions. Legal —During the normal course of business, the Company may be a party to legal claims that may not be covered by insurance. Management does not believe that any such claims would have a material impact on the Company’s consolidated financial statements. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 15. Net Loss per Share Since the Company was in a loss position for all periods presented, basic net loss per common share is the same as diluted net loss per common share for all periods presented as the inclusion of all potential common shares outstanding would have been anti-dilutive. Convertible notes and shares outstanding presented below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, as their effect is anti-dilutive (in thousands): As of June 30, 2022 2021 Convertible notes 4,865 9,981 Common stock options 13,072 12,981 Restricted stock units 3,254 1,012 Total 21,191 23,974 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events In July 2022, the Company entered into separate, privately negotiated exchange agreements with certain holders of its Convertible Notes. Under the terms of the exchange agreements, the holders exchanged approximately $ 98.1 million in aggregate principal amount of Convertible Notes held by them for an aggregate of 3,027,018 shares of common stock issued by the Company. These exchange transactions closed in August 2022 . The Company also issued 46,132 shares of common stock to our financial advisor for compensation for services performed in connection with the exchange transactions. Following closing of the exchange transactions, there was $ 93.9 million in aggregate principal amount of Convertible Notes outstanding and held by third parties. The Company held in treasury Convertible Notes in aggregate principal amount of $ 425.4 million, which notes had not been cancelled. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”), for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted and, accordingly, the consolidated balance sheet as of December 31, 2021 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of the Company’s financial information. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other interim period or for any other future year. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2022 (the “2021 Form 10-K” ). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: development derivative liability, accrued expenses, prepaid expenses, convertible debt and taxes. |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Reference is made to Note 2 Summary of Significant Accounting Policies in our 2021 Form 10-K for a detailed description of significant accounting policies. There have been no significant changes to our accounting policies as disclosed in our 2021 Form 10-K. |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule Of Inventory Current | The Company’s inventory of EMPAVELI consisted of the following as of June 30, 2022, and December 31, 2021 (in thousands): June 30, December 31, 2022 2021 Raw materials $ 19,292 $ 5,749 Semi-finished goods 27,973 10,058 Finished goods 1,186 479 Total Inventories $ 48,451 $ 16,286 |
Prepaid Assets and Accrued Ex_2
Prepaid Assets and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Prepaid Assets And Accrued Expenses [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are as follows (in thousands): June 30, December 31, 2022 2021 Accrued research and development $ 39,006 $ 35,217 Accrued cost of research collaboration — 25,000 Accrued license fee — 5,000 Accrued royalties 1,042 — Accrued payroll liabilities 22,182 25,212 Other 27,189 12,810 Total $ 89,419 $ 103,239 |
Development Liability and Dev_2
Development Liability and Development Derivative Liability (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Research and Development [Abstract] | |
Summary of Development Liability | The following table summarizes the development liability (in thousands): June 30, 2022 December 31, 2021 Effective Development liability $ 439,500 $ 456,000 7.91 % Less: Unamortized discount to development liability ( 89,929 ) ( 103,265 ) Less: Current portion of development liability, net of discount ( 15,842 ) ( 7,584 ) Total long term development liability $ 333,729 $ 345,151 |
Schedule of Development Derivative Liability | The following table presents a rollforward of the development derivative liability for the six months ended June 30, 2021 (in thousands): Balance at fair market value, January 1, 2021 $ 257,868 Loss from remeasurement of development 17,084 Balance at fair market value, March 31, 2021 $ 274,952 Amount repaid under the SFJ agreement and SFJ amendment ( 4,000 ) Loss from remeasurement of development 21,180 Balance at fair market value, June 30, 2021 $ 292,132 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Schedule of Additional Information Related to Operating Lease Assets and Liabilities | Additional information related to the operating lease assets and liabilities is as follows (in thousands): June 30, December 31, 2022 2021 Operating Lease Assets $ 20,755 $ 19,901 Operating Lease Liabilities $ 21,988 $ 21,196 Weighted Average Remaining Term in years 4.01 4.66 Weighted Average discount rate used to measure 7.30 % 7.71 % |
Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases for the six months ended June 30 is as follows (in thousands): 2022 2021 Operating cash flows for operating leases $ 3,532 $ 2,945 Operating lease assets obtained in exchange for lease obligations $ — $ 5,675 |
Maturities of Operating Lease Liabilities | The maturities of the Company’s operating lease liabilities as of June 30, 2022 are as follows (in thousands): 2022 3,313 2023 6,667 2024 5,905 2025 4,745 2026 and thereafter 4,839 Total future minimum lease payments less 25,469 Imputed interest ( 3,481 ) Total operating lease liabilities $ 21,988 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Amortized Cost, Gross Unrealized Holding Losses and Fair Value of Available-for-Sale Debt Securities by Type of Security | The amortized cost, gross unrealized holding losses and fair value of available-for-sale debt securities by type of security as of June 30, 2022 and December 31, 2021 were as follows (in thousands): As of June 30, 2022 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. Government-related obligations $ 249,124 $ — $ ( 817 ) $ 248,307 As of December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value U.S. Government-related obligations $ 60,357 $ 3 $ ( 2 ) $ 60,358 |
Other Comprehensive Income an_2
Other Comprehensive Income and Accumulated Other Comprehensive Income (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Changes in Accumulated Other Comprehensive Income/(Loss), by Component | The following tables summarize the changes in accumulated other comprehensive income/(loss), by component for the six months ended June 30, 2022 and June 30, 2021 (in thousands): Unrealized Gains (Losses) from Marketable Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Income (Loss) Balances, December 31, 2021 $ 1 $ ( 2,091 ) $ ( 2,090 ) Net other comprehensive income (loss) ( 52 ) 83 31 Balances, March 31, 2022 ( 51 ) ( 2,008 ) ( 2,059 ) Net other comprehensive loss ( 766 ) ( 369 ) ( 1,135 ) Balances, June 30, 2022 $ ( 817 ) $ ( 2,377 ) $ ( 3,194 ) Unrealized Gains (Losses) from Marketable Securities Foreign Currency Translation Adjustment Total Accumulated Other Comprehensive Income (Loss) Balances, December 31, 2020 $ ( 8 ) $ ( 109 ) $ ( 117 ) Net other comprehensive income (loss) 79 ( 1,582 ) ( 1,503 ) Balances, March 31, 2021 71 ( 1,691 ) ( 1,620 ) Net other comprehensive loss ( 35 ) ( 174 ) ( 209 ) Balances, June 30, 2021 $ 36 $ ( 1,865 ) $ ( 1,829 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value, Nonrecurring [Member] | |
Schedule of Financial Instruments and the Related Fair Value Hierarchy of the Valuation Techniques Utilized | The following table presents the fair value of financial instruments recorded originally at amortized cost or fair value and not remeasured on a recurring basis (in thousands): June 30, 2022 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents: Money market funds $ 549,895 $ — $ — $ 549,895 Total Financial Assets $ 549,895 $ — $ — $ 549,895 December 31, 2021 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Cash and cash equivalents Money market funds $ 598,833 $ — $ — $ 598,833 Total Financial Assets $ 598,833 $ — $ — $ 598,833 |
Fair Value, Recurring [Member] | |
Schedule of Financial Instruments and the Related Fair Value Hierarchy of the Valuation Techniques Utilized | The following table presents the fair value of financial instruments recorded at fair value at inception and remeasured on a recurring basis (in thousands): June 30, 2022 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Marketable securities: US government obligations $ 248,307 — — $ 248,307 Total Financial Assets $ 248,307 $ — $ — $ 248,307 December 31, 2021 Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total Financial Assets: Marketable securities: US government obligations $ 60,358 $ — $ — $ 60,358 Total Financial Assets $ 60,358 $ — $ — $ 60,358 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Shares Outstanding that were Excluded from Calculation of Diluted Net Loss Per Share | Convertible notes and shares outstanding presented below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, as their effect is anti-dilutive (in thousands): As of June 30, 2022 2021 Convertible notes 4,865 9,981 Common stock options 13,072 12,981 Restricted stock units 3,254 1,012 Total 21,191 23,974 |
Nature of Organization and Op_2
Nature of Organization and Operations - Additional Information (Detail) $ in Millions | Jun. 30, 2022 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash and cash equivalents and marketable securities | $ 852.8 |
Product Revenues, Accounts Re_2
Product Revenues, Accounts Receivable, and Reserves for Product Sales - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Product Revenues Accounts Receivable And Reserves For Product Sales [Line Items] | |||||
Revenue | $ 16,322 | $ 623 | $ 30,703 | $ 623 | |
Accounts receivable | 7,518 | 7,518 | $ 10,103 | ||
Accounts receivable, net of discount and allowance | 300 | 300 | 200 | ||
Accrued Expenses [Member] | |||||
Product Revenues Accounts Receivable And Reserves For Product Sales [Line Items] | |||||
Product sales reserves | 2,500 | 2,500 | $ 1,000 | ||
Product [Member] | |||||
Product Revenues Accounts Receivable And Reserves For Product Sales [Line Items] | |||||
Revenue | $ 15,654 | $ 623 | $ 27,763 | $ 623 |
Inventory - Schedule Of Invento
Inventory - Schedule Of Inventory Current (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 19,292 | $ 5,749 |
Semi-finished goods | 27,973 | 10,058 |
Finished goods | 1,186 | 479 |
Total Inventories | $ 48,451 | $ 16,286 |
Prepaid Assets and Accrued Ex_3
Prepaid Assets and Accrued Expenses - Additional Information (Detail) - USD ($) $ in Millions | Jun. 30, 2022 | Dec. 31, 2021 |
Prepaid Assets And Accrued Expenses [Abstract] | ||
Prepaid research and development | $ 13.8 | $ 12 |
Prepaid Assets and Accrued Ex_4
Prepaid Assets and Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Prepaid Assets And Accrued Expenses [Abstract] | ||
Accrued research and development | $ 39,006 | $ 35,217 |
Accrued cost of research collaboration | 25,000 | |
Accrued license fee | 5,000 | |
Accrued royalties | 1,042 | |
Accrued payroll liabilities | 22,182 | 25,212 |
Other | 27,189 | 12,810 |
Total | $ 89,419 | $ 103,239 |
Development Liability and Dev_3
Development Liability and Development Derivative Liability - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Jan. 29, 2020 USD ($) | Feb. 28, 2019 USD ($) Installment | May 31, 2022 USD ($) | Jan. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 07, 2019 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Interest expense | $ 8,448 | $ 3,767 | $ 16,986 | $ 7,941 | |||||||
Loss from remeasurement of development derivative liability | $ 21,180 | $ 17,084 | $ 38,264 | ||||||||
Level 3 [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Implied cost of borrowing discount rates | 11.15% | ||||||||||
SFJ Agreement [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Proceeds from SFJ agreement | $ 140,000 | $ 60,000 | |||||||||
Additional funding amount upon achievement of development milestones | $ 60,000 | ||||||||||
Number of milestone payments | Installment | 3 | ||||||||||
Increase in additional funding for development costs | $ 20,000 | ||||||||||
Payment made under agreement | $ 5,000 | $ 4,000 | |||||||||
First annual payment under agreement | $ 11,500 | ||||||||||
Interest expense | $ 6,600 | $ 13,300 | |||||||||
SFJ Agreement [Member] | Level 3 [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Implied cost of borrowing discount rates | 8% | ||||||||||
SFJ Agreement [Member] | Regulatory Approval Granted US Food and Drug Administration [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Obligated to pay initial payment | $ 4,000 | ||||||||||
Aggregate amount of additional annual payments | $ 226,000 | ||||||||||
Number of additional annual payments | Installment | 6 | ||||||||||
SFJ Agreement [Member] | Regulatory Approval Granted by EMA [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Obligated to pay initial payment | $ 5,000 | ||||||||||
Aggregate amount of additional annual payments | $ 225,000 | ||||||||||
Number of additional annual payments | Installment | 6 |
Development Liability and Dev_4
Development Liability and Development Derivative Liability - Summary of Development Liability (Detail) - SFJ Agreement [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Development liability | $ 439,500 | $ 456,000 |
Less: Unamortized discount to development liability | (89,929) | (103,265) |
Less: Current portion of development liability, net of discount | (15,842) | (7,584) |
Total long term development liability | $ 333,729 | $ 345,151 |
Effective Interest Rate | 7.91% | 7.91% |
Development Liability and Dev_5
Development Liability and Development Derivative Liability - Schedule of Development Derivative Liability (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Balance at fair market value | $ 274,952 | $ 257,868 | $ 257,868 |
Amount repaid under the SFJ agreement and SFJ amendment | (4,000) | ||
Loss from remeasurement of development derivative liability | 21,180 | 17,084 | 38,264 |
Balance at fair market value | $ 292,132 | $ 274,952 | $ 292,132 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Jan. 01, 2021 USD ($) | May 12, 2020 USD ($) | Sep. 16, 2019 USD ($) | Jul. 31, 2021 USD ($) shares | Jun. 30, 2021 USD ($) shares | Jan. 31, 2021 USD ($) shares | Jun. 30, 2022 USD ($) $ / shares | Sep. 30, 2021 USD ($) shares | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) shares | Jun. 30, 2022 USD ($) d $ / shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | May 06, 2020 CounterParty $ / shares | Sep. 11, 2019 USD ($) CounterParty $ / shares | |
Debt Instrument [Line Items] | |||||||||||||||
Aggregate principal amount converted | $ 126,129,000 | ||||||||||||||
Loss on conversion of debt | 39,487,000 | ||||||||||||||
Forfeiture of accrued interest in exchange of convertible notes | 1,668,000 | ||||||||||||||
ASU 2020-06 [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Change in accounting principle accounting standards update adopted | true | true | |||||||||||||
Change in accounting principle accounting standards update adoption date | Jan. 01, 2021 | Jan. 01, 2021 | |||||||||||||
Increase (decrease) in net debt | $ 149,700,000 | ||||||||||||||
Decrease in net equity | 149,700,000 | ||||||||||||||
Convertible notes | 149,700,000 | ||||||||||||||
Non-cash interest expense | 17,100,000 | ||||||||||||||
Amortization of debt issuance costs | 1,100,000 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Shares issued | shares | 3,976,000 | ||||||||||||||
2019 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Premium paid for capped call transactions | $ 28,400,000 | ||||||||||||||
2019 Convertible Notes [Member] | ASU 2020-06 [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | 2,400,000 | ||||||||||||||
Convertible notes | 74,900,000 | ||||||||||||||
2020 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Premium paid for capped call transactions | 43,100,000 | ||||||||||||||
2020 Convertible Notes [Member] | ASU 2020-06 [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | 2,300,000 | ||||||||||||||
Convertible notes | $ 95,500,000 | ||||||||||||||
Capped Call Transactions [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of counterparties | CounterParty | 2 | 2 | |||||||||||||
Initial conversion price | $ / shares | $ 39.4625 | $ 39.4625 | |||||||||||||
Initial cap price | $ / shares | 63.14 | ||||||||||||||
Sale price | $ / shares | $ 31.57 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument, stated percentage | 3.50% | ||||||||||||||
Debt instrument, due and payment description | The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.5% per year payable semiannually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. | ||||||||||||||
Debt instrument, frequency of periodic payment | semiannually | ||||||||||||||
Maturity date | Sep. 15, 2026 | ||||||||||||||
Threshold trading days | d | 20 | ||||||||||||||
Threshold consecutive trading days | d | 30 | ||||||||||||||
Threshold percentage of stock price trigger | 130% | ||||||||||||||
Redemption period, start date | Sep. 20, 2023 | ||||||||||||||
Redemption price, percentage | 100% | ||||||||||||||
Amortization of debt issuance costs | $ 100,000 | $ 300,000 | $ 200,000 | 600,000 | |||||||||||
Aggregate principal amount converted | $ 700,000 | ||||||||||||||
Aggregate principal amount converted into shares | shares | 18,775 | ||||||||||||||
Debt interest expense | 1,800,000 | 3,800,000 | 3,600,000 | 7,900,000 | |||||||||||
Accrued semi annual coupon payable | 1,700,000 | 3,400,000 | 3,400,000 | 7,300,000 | |||||||||||
Debt issuance costs gross | $ 7,400,000 | 2,700,000 | $ 7,400,000 | 2,700,000 | $ 7,400,000 | 3,000,000 | |||||||||
Long-term debt | $ 189,300,000 | $ 189,300,000 | $ 189,000,000 | ||||||||||||
Convertible Senior Notes Due 2026 [Member] | Prior to March 15, 2026 Convertible [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Threshold trading days | d | 20 | ||||||||||||||
Threshold consecutive trading days | d | 30 | ||||||||||||||
Threshold percentage of stock price trigger | 130% | ||||||||||||||
Trading price per principal amount | $ 1,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | Prior to March 15, 2026 Convertible [Member] | Maximum [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Threshold percentage of stock price trigger | 98% | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | Common Stock [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Terms of conversion | The Convertible Notes are convertible into shares of the Company’s common stock at an initial conversion rate of 25.3405 shares per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of approximately $39.4625 per share of common stock). | ||||||||||||||
Conversion ratio | 0.0253405 | ||||||||||||||
Conversion price | $ / shares | $ 39.4625 | $ 39.4625 | |||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Net proceeds from the sale of the notes | $ 212,900,000 | ||||||||||||||
Payment of convertible debt discounts and commissions | 6,600,000 | ||||||||||||||
Payment of convertible debt offering expenses | 500,000 | ||||||||||||||
Payments of transactions cost | 28,400,000 | ||||||||||||||
Debt instrument effective interest rate | 10.50% | ||||||||||||||
Debt instrument convertible carrying amount of liability component | $ 145,100,000 | ||||||||||||||
Debt discount | 74,900,000 | ||||||||||||||
Debt issuance costs | 7,100,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 Convertible Notes [Member] | Exchange Agreements [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Conversion ratio | 0.0253405 | 0.0253405 | |||||||||||||
Debt issuance costs | $ 4,100,000 | $ 3,300,000 | |||||||||||||
Increase (decrease) in net debt | $ (197,000,000) | (122,800,000) | |||||||||||||
Aggregate principal amount converted | $ 126,100,000 | ||||||||||||||
Increase in shares outstanding | shares | 5,992,217 | 3,906,869 | |||||||||||||
Shares issued | shares | 5,097,166 | 3,196,172 | |||||||||||||
Additional shares issued | shares | 895,051 | 710,697 | |||||||||||||
Additional shares issued for settlement of debt issuance cost paid | shares | 78,419 | 69,491 | 78,419 | ||||||||||||
Loss on conversion of debt | $ 61,100,000 | $ 39,500,000 | |||||||||||||
Loss on conversion of debt related to additional shares issued | 55,900,000 | 36,400,000 | |||||||||||||
Additional amount issued in payment of issuance costs | 5,200,000 | $ 3,100,000 | |||||||||||||
Forfeiture of accrued interest in exchange of convertible notes | $ 1,700,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 Convertible Notes [Member] | Common Stock [Member] | Exchange Agreements [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Aggregate principal amount converted into shares | shares | 3,906,869 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 Convertible Notes [Member] | Liability Component [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | 4,700,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 Convertible Notes [Member] | Equity Component [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | $ 2,400,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2020 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Net proceeds from the sale of the notes | $ 322,900,000 | ||||||||||||||
Payment of convertible debt discounts and commissions | 5,700,000 | ||||||||||||||
Payment of convertible debt offering expenses | 300,000 | ||||||||||||||
Payments of transactions cost | $ 43,100,000 | ||||||||||||||
Debt instrument effective interest rate | 10.50% | ||||||||||||||
Debt instrument convertible carrying amount of liability component | $ 204,500,000 | ||||||||||||||
Debt discount | 95,500,000 | ||||||||||||||
Debt issuance costs | 6,000,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2020 Convertible Notes [Member] | Exchange Agreements [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Convertible notes held in treasury | $ 327,200,000 | $ 327,200,000 | |||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2020 Convertible Notes [Member] | Common Stock [Member] | Exchange Agreements [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Aggregate principal amount converted into shares | shares | 5,992,217 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2020 Convertible Notes [Member] | Liability Component [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | 3,700,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2020 Convertible Notes [Member] | Equity Component [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt issuance costs | 2,300,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | 2019 and 2020 Convertible Notes [Member] | Exchange Agreements [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Aggregate principal amount converted | $ 201,100,000 | ||||||||||||||
Forfeiture of accrued interest in exchange of convertible notes | $ 2,500,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | Private Offering [Member] | 2019 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 220,000,000 | ||||||||||||||
Convertible Senior Notes Due 2026 [Member] | Private Offering [Member] | 2020 Convertible Notes [Member] | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 300,000,000 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Lessee Lease Description [Line Items] | ||||
Operating lease description | The Company enters into lease agreements with terms generally ranging from 2-7 years. Some of the Company’s lease agreements include Company options to extend the lease on a month-to-month basis or for set periods for up to five years. Many of these leases also include options to terminate the leases within one year or per other contractual terms. Renewal and termination options were generally not included in the lease term for the Company’s existing operating leases. | |||
Operating lease, existence of option to extend | true | |||
Operating lease maximum term of options to terminate lease | 1 year | |||
Operating lease expense | $ 1.5 | $ 1.4 | $ 2.9 | $ 2.7 |
Minimum [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, term of contract | 2 years | 2 years | ||
Maximum [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, term of contract | 7 years | 7 years | ||
Operating lease options to extend lease | 5 years | 5 years |
Leases - Schedule of Additional
Leases - Schedule of Additional Information Related to Operating Lease Assets and Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Operating Lease Assets | $ 20,755 | $ 19,901 |
Operating Lease Liabilities | $ 21,988 | $ 21,196 |
Weighted Average Remaining Term in years | 4 years 3 days | 4 years 7 months 28 days |
Weighted Average discount rate used to measure outstanding lease liabilities | 7.30% | 7.71% |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Operating Leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||
Operating cash flows for operating leases | $ 3,532 | $ 2,945 |
Operating lease assets obtained in exchange for lease obligations | $ 5,675 |
Leases - Maturities of Operatin
Leases - Maturities of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2022 | $ 3,313 | |
2023 | 6,667 | |
2024 | 5,905 | |
2025 | 4,745 | |
2026 and thereafter | 4,839 | |
Total future minimum lease payments less | 25,469 | |
Imputed interest | (3,481) | |
Total operating lease liabilities | $ 21,988 | $ 21,196 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Amortized Cost, Gross Unrealized Holding Losses and Fair Value of Available-for-Sale Debt Securities by Type of Security (Detail) - U.S. Government-Related Obligations [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Available for sale securities: | ||
Amortized Cost | $ 249,124 | $ 60,357 |
Gross Unrealized Holding Gains | 3 | |
Gross Unrealized Holding Losses | (817) | (2) |
Fair Value | $ 248,307 | $ 60,358 |
Other Comprehensive Income an_3
Other Comprehensive Income and Accumulated Other Comprehensive Income - Summary of Changes in Accumulated Other Comprehensive Income/(Loss), by Component (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning balance | $ 462,235 | $ 198,662 | $ 51,658 | $ 204,557 |
Ending balance | 334,418 | 462,235 | (141,493) | 51,658 |
Unrealized Gains (Losses) from Marketable Securities [Member] | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning balance | (51) | 1 | 71 | (8) |
Net other comprehensive income (loss) | (766) | (52) | (35) | 79 |
Ending balance | (817) | (51) | 36 | 71 |
Foreign Currency Translation Adjustment [Member] | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning balance | (2,008) | (2,091) | (1,691) | (109) |
Net other comprehensive income (loss) | (369) | 83 | (174) | (1,582) |
Ending balance | (2,377) | (2,008) | (1,865) | (1,691) |
Total Accumulated Other Comprehensive Income (Loss) [Member] | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning balance | (2,059) | (2,090) | (1,620) | (117) |
Net other comprehensive income (loss) | (1,135) | 31 | (209) | (1,503) |
Ending balance | $ (3,194) | $ (2,059) | $ (1,829) | $ (1,620) |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Instruments and the Related Fair Value Hierarchy of the Valuation Techniques Utilized (Detail) - Fair Value, Nonrecurring [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | $ 549,895 | $ 598,833 |
Money Market Funds [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | 549,895 | 598,833 |
Level 1 [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | 549,895 | 598,833 |
Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | $ 549,895 | $ 598,833 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Financial Instruments and the Related Fair Value Hierarchy of the Valuation Techniques Utilized (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | $ 248,307 | $ 60,358 |
Marketable Securities [Member] | US Government Obligations [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | 248,307 | 60,358 |
Level 1 [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | 248,307 | 60,358 |
Level 1 [Member] | Marketable Securities [Member] | US Government Obligations [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total Financial Assets | $ 248,307 | $ 60,358 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Jun. 30, 2022 | Dec. 31, 2021 |
Level 1 [Member] | Convertible Senior Notes [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Convertible notes | $ 287.3 | $ 290.7 |
Convertible notes, interest rate | 3.50% | 3.50% |
Level 2 [Member] | Development Liability [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair value | $ 317.8 | $ 352.7 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Tax Expense (Benefit), Continuing Operations [Abstract] | ||||
Income tax expense | $ 486 | $ 0 | $ 1,694 | $ 0 |
U.S. federal statutory rate | 21% | |||
Minimum percentage of tax position likelihood of being realized upon examination by taxing authorities | 50% | |||
Unrecognized income tax benefits | $ 1,600 | $ 1,600 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||
Nov. 30, 2020 USD ($) | Oct. 27, 2020 USD ($) | Apr. 30, 2022 USD ($) | Jan. 31, 2022 USD ($) | Aug. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) Program | Jan. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) License | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) License | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jul. 31, 2021 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | $ 16,322,000 | $ 623,000 | $ 30,703,000 | $ 623,000 | ||||||||||
Swedish Orphan Biovitrum AB (Publ) [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Development cost reimbursement | $ 80,000,000 | |||||||||||||
Non-refundable Upfront Payment | 250,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Development cost reimbursement | $ 80,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | License [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront payment | $ 250,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | Swedish Orphan Biovitrum AB (Publ) [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront payment | 250,000,000 | |||||||||||||
Milestone payment received for achievement of regulatory development milestone | $ 50,000,000 | |||||||||||||
Development cost reimbursement | 80,000,000 | |||||||||||||
Development cost reimbursement received | $ 20,000,000 | $ 25,000,000 | ||||||||||||
Royalty revenue | 700,000 | 0 | 800,000 | 0 | ||||||||||
Contract research and development reimbursement commitment | 80,000,000 | |||||||||||||
Contract research and development expense | 0 | 9,100,000 | 5,000,000 | 17,200,000 | ||||||||||
Contract research and development receivable | 35,000,000 | 35,000,000 | $ 100,000,000 | |||||||||||
Contract research and development current | 20,000,000 | 20,000,000 | 70,000,000 | |||||||||||
Contract research and development long-term assets | 15,000,000 | 15,000,000 | 30,000,000 | |||||||||||
Contra research and development reimbursement | 50,000,000 | |||||||||||||
Contra research and development reimbursement current | 20,000,000 | |||||||||||||
Contra research and development reimbursement long-term assets | 30,000,000 | |||||||||||||
Contra research and development reimbursement remaining | 50,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | Swedish Orphan Biovitrum AB (Publ) [Member] | License [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Revenue | 0 | 0 | 0 | 0 | ||||||||||
Collaboration and License Agreement [Member] | Swedish Orphan Biovitrum AB (Publ) [Member] | ASC Topic 808 | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront payment | $ 250,000,000 | |||||||||||||
Development cost reimbursement | 80,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | Swedish Orphan Biovitrum AB (Publ) [Member] | Maximum [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Aggregate milestone payments upon achievement of specified one time regulatory development and commercial milestone events | 915,000,000 | |||||||||||||
Collaboration and License Agreement [Member] | Swedish Orphan Biovitrum AB (Publ) [Member] | Maximum [Member] | ASC Topic 808 | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Aggregate milestone payments upon achievement of specified one-time regulatory and commercial milestone events | $ 915,000,000 | |||||||||||||
University of Pennsylvania [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Annual maintenance fees | 100,000 | |||||||||||||
Milestone payments based on annual sales milestones | $ 5,000,000 | |||||||||||||
Development milestone achievement | $ 1,000,000 | 5,000,000 | ||||||||||||
University of Pennsylvania [Member] | Maximum [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Aggregate milestones payments | $ 3,200,000 | 3,200,000 | ||||||||||||
Milestone payments based on annual sales milestones | 5,000,000 | |||||||||||||
2010 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Annual maintenance fees | $ 100,000 | |||||||||||||
Number of licensed products | License | 2 | 2 | ||||||||||||
2010 License Agreement [Member] | Maximum [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Aggregate milestones payments | $ 1,700,000 | $ 1,700,000 | ||||||||||||
Milestone payments based on annual sales milestones | $ 2,500,000 | |||||||||||||
Sobi Agreement and Another Licensing Transaction [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Sublicense fee owed | $ 25,000,000 | |||||||||||||
Research Collaboration Agreement [Member] | Beam [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration agreement term | 5 years | |||||||||||||
Number of research programs | Program | 6 | |||||||||||||
Up-front non-refundable payment | $ 50,000,000 | |||||||||||||
Up-front payment on first anniversary of agreement on June 30, 2022 | $ 25,000,000 | $ 25,000,000 | $ 25,000,000 | |||||||||||
Collaboration agreement maximum extendable term | 2 years |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Commitments And Contingencies [Line Items] | |
Incurred any cost to defend lawsuits or settle claims | $ 0 |
Vehicles [Member] | |
Commitments And Contingencies [Line Items] | |
Operating lease, term of contract | 36 months |
Bachem and NOF | |
Commitments And Contingencies [Line Items] | |
Non-cancellable purchase obligation substance over period | 5 years |
Non-cancellable purchase commitments | $ 97,600,000 |
Other Commitment | $ 3,300,000 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Shares Outstanding that were Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 21,191 | 23,974 |
Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,865 | 9,981 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 13,072 | 12,981 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,254 | 1,012 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | |
Aug. 08, 2022 | Jul. 31, 2022 | Jun. 30, 2021 | |
Subsequent Event [Line Items] | |||
Aggregate principal amount converted | $ 126,129 | ||
Exchange Agreements [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Common stock issued to Financial Advisor as compensation for services | 46,132 | ||
Convertible Notes [Member] | Exchange Agreements [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Principal amount | $ 98,100 | ||
Aggregate principal amount converted | $ 93,900 | ||
Aggregate principal amount converted into shares | 3,027,018 | ||
Convertible notes held in treasury | $ 425,400 | ||
Debt exchange transactions closing date | 2022-08 |