Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 000-26770 | |
Entity Registrant Name | NOVAVAX, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 22-2816046 | |
Entity Address, Address Line One | 21 Firstfield Road | |
Entity Address, City or Town | Gaithersburg | |
Entity Address, Country | MD | |
Entity Address, Postal Zip Code | 20878 | |
City Area Code | (240) | |
Local Phone Number | 268-2000 | |
Title of 12(b) Security | Common Stock, Par Value $0.01 per share | |
Trading Symbol | NVAX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 78,503,952 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001000694 | |
Current Fiscal Year End Date | --12-31 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Revenues | $ 734,577 | $ 178,844 | $ 1,624,473 | $ 924,090 |
Expenses: | ||||
Cost of sales | 434,593 | 0 | 720,874 | 0 |
Research and development | 304,297 | 408,195 | 977,428 | 1,571,551 |
Selling, general, and administrative | 122,876 | 77,793 | 327,028 | 214,144 |
Total expenses | 861,766 | 485,988 | 2,025,330 | 1,785,695 |
Loss from operations | (127,189) | (307,144) | (400,857) | (861,605) |
Other expense: | ||||
Interest expense | (4,169) | (5,182) | (15,279) | (15,989) |
Other expense | (34,783) | (4,064) | (53,002) | (7,267) |
Loss before income tax expense | (166,141) | (316,390) | (469,138) | (884,861) |
Income tax expense | 2,472 | 6,041 | 6,552 | 12,606 |
Net loss | $ (168,613) | $ (322,431) | $ (475,690) | $ (897,467) |
Earnings Per Share [Abstract] | ||||
Basic (in usd per share) | $ (2.15) | $ (4.31) | $ (6.13) | $ (12.13) |
Weighted average number of common shares outstanding | ||||
Basic (in shares) | 78,274 | 74,745 | 77,631 | 73,972 |
Product sales | ||||
Revenue: | ||||
Revenues | $ 626,091 | $ 0 | $ 1,267,174 | $ 0 |
Grants | ||||
Revenue: | ||||
Revenues | 106,273 | 135,007 | 313,348 | 854,390 |
Royalties and other | ||||
Revenue: | ||||
Revenues | $ 2,213 | $ 43,837 | $ 43,951 | $ 69,700 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (168,613) | $ (322,431) | $ (475,690) | $ (897,467) |
Other comprehensive loss: | ||||
Net unrealized losses on marketable securities available-for-sale, net of reclassifications | 0 | 0 | 0 | (9) |
Foreign currency translation adjustment | (12,924) | (3,309) | (22,441) | (6,154) |
Other comprehensive loss | (12,924) | (3,309) | (22,441) | (6,163) |
Comprehensive loss | $ (181,537) | $ (325,740) | $ (498,131) | $ (903,630) |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 1,280,581 | $ 1,515,116 |
Restricted cash | 10,785 | 11,490 |
Accounts receivable | 111,645 | 454,993 |
Inventory | 82,432 | 8,872 |
Prepaid expenses and other current assets | 274,522 | 164,648 |
Total current assets | 1,759,965 | 2,155,119 |
Property and equipment, net | 255,532 | 228,696 |
Right of use asset, net | 108,543 | 40,123 |
Intangible assets, net | 8,456 | 4,770 |
Goodwill | 117,535 | 131,479 |
Other non-current assets | 17,406 | 16,566 |
Total assets | 2,267,437 | 2,576,753 |
Current liabilities: | ||
Accounts payable | 144,997 | 127,050 |
Accrued expenses | 551,069 | 673,731 |
Deferred revenue | 404,776 | 1,422,944 |
Current portion of finance lease liabilities | 82,095 | 130,533 |
Convertible notes payable | 324,525 | 0 |
Other current liabilities | 160,499 | 36,061 |
Total current liabilities | 1,667,961 | 2,390,319 |
Deferred revenue | 1,035,418 | 172,528 |
Convertible notes payable | 0 | 323,458 |
Non-current finance lease liabilities | 31,474 | 0 |
Other non-current liabilities | 98,569 | 42,121 |
Total liabilities | 2,833,422 | 2,928,426 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.01 par value, 600,000,000 shares authorized at September 30, 2022 and December 31, 2021; and 79,204,509 shares issued and 78,476,814 shares outstanding at September 30, 2022 and 76,433,151 shares issued and 75,841,171 shares outstanding at December 31, 2021 | 792 | 764 |
Additional paid-in capital | 3,640,597 | 3,351,967 |
Accumulated deficit | (4,093,640) | (3,617,950) |
Treasury stock, cost basis, 727,695 shares at September 30, 2022 and 591,980 shares at December 31, 2021 | (89,940) | (85,101) |
Accumulated other comprehensive loss | (23,794) | (1,353) |
Total stockholders’ deficit | (565,985) | (351,673) |
Total liabilities and stockholders’ deficit | $ 2,267,437 | $ 2,576,753 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value per share (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 600,000,000 | 600,000,000 |
Common stock, shares issued (in shares) | 79,204,509 | 76,433,151 |
Common stock, shares outstanding (in shares) | 78,476,814 | 75,841,171 |
Treasury stock, shares (in shares) | 727,695 | 591,980 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Treasury Stock | Accumulated Other Comprehensive Income (Loss) |
Balance beginning (in shares) at Dec. 31, 2020 | 71,350,365 | |||||
Balance beginning at Dec. 31, 2020 | $ 627,209 | $ 714 | $ 2,535,476 | $ (1,874,199) | $ (41,806) | $ 7,024 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation | 151,457 | 151,457 | ||||
Stock issued under incentive programs (in shares) | 2,044,191 | |||||
Issuance of common stock, net of issuance costs | 21,441 | $ 20 | 58,747 | (37,326) | ||
Issuance of common stock, net of issuance costs (in shares) | 2,578,967 | |||||
Issuance of common stock, net of issuance costs | 564,859 | $ 26 | 564,833 | |||
Unrealized loss on marketable securities | (9) | (9) | ||||
Foreign currency translation adjustment | (6,154) | (6,154) | ||||
Net loss | (897,467) | (897,467) | ||||
Balance ending (in shares) at Sep. 30, 2021 | 75,973,523 | |||||
Balance ending at Sep. 30, 2021 | 461,336 | $ 760 | 3,310,513 | (2,771,666) | (79,132) | 861 |
Balance beginning (in shares) at Jun. 30, 2021 | 74,672,351 | |||||
Balance beginning at Jun. 30, 2021 | 745,562 | $ 747 | 3,237,085 | (2,449,235) | (47,205) | 4,170 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation | 45,274 | 45,274 | ||||
Stock issued under incentive programs (in shares) | 1,301,172 | |||||
Issuance of common stock, net of issuance costs | (3,760) | $ 13 | 28,154 | (31,927) | ||
Foreign currency translation adjustment | (3,309) | (3,309) | ||||
Net loss | (322,431) | (322,431) | ||||
Balance ending (in shares) at Sep. 30, 2021 | 75,973,523 | |||||
Balance ending at Sep. 30, 2021 | 461,336 | $ 760 | 3,310,513 | (2,771,666) | (79,132) | 861 |
Balance beginning (in shares) at Dec. 31, 2021 | 76,433,151 | |||||
Balance beginning at Dec. 31, 2021 | (351,673) | $ 764 | 3,351,967 | (3,617,950) | (85,101) | (1,353) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation | 104,367 | 104,367 | ||||
Stock issued under incentive programs (in shares) | 573,960 | |||||
Issuance of common stock, net of issuance costs | 67 | $ 6 | 4,900 | (4,839) | ||
Issuance of common stock, net of issuance costs (in shares) | 2,197,398 | |||||
Issuance of common stock, net of issuance costs | 179,385 | $ 22 | 179,363 | |||
Foreign currency translation adjustment | (22,441) | (22,441) | ||||
Net loss | (475,690) | (475,690) | ||||
Balance ending (in shares) at Sep. 30, 2022 | 79,204,509 | |||||
Balance ending at Sep. 30, 2022 | (565,985) | $ 792 | 3,640,597 | (4,093,640) | (89,940) | (23,794) |
Balance beginning (in shares) at Jun. 30, 2022 | 78,776,234 | |||||
Balance beginning at Jun. 30, 2022 | (416,950) | $ 788 | 3,604,614 | (3,925,027) | (86,455) | (10,870) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation | 33,386 | 33,386 | ||||
Stock issued under incentive programs (in shares) | 428,275 | |||||
Issuance of common stock, net of issuance costs | (884) | $ 4 | 2,597 | (3,485) | ||
Foreign currency translation adjustment | (12,924) | (12,924) | ||||
Net loss | (168,613) | (168,613) | ||||
Balance ending (in shares) at Sep. 30, 2022 | 79,204,509 | |||||
Balance ending at Sep. 30, 2022 | $ (565,985) | $ 792 | $ 3,640,597 | $ (4,093,640) | $ (89,940) | $ (23,794) |
CONSOLIDATED STATEMENTS OF CH_2
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Stockholders' Equity [Abstract] | ||
Issuance of common stock, issuance costs | $ 2,311 | $ 7,292 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Activities: | ||
Net loss | $ (475,690) | $ (897,467) |
Reconciliation of net loss to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 21,832 | 8,989 |
Non-cash stock-based compensation | 102,525 | 151,457 |
Provision for excess and obsolete inventory | 358,075 | 0 |
Right-of-use assets expensed, net of credits received | 40,187 | 17,117 |
Other items, net | (25,059) | 2,739 |
Changes in operating assets and liabilities: | ||
Inventory | (426,466) | 0 |
Accounts receivable, prepaid expenses, and other assets | 171,325 | 209,221 |
Accounts payable, accrued expenses, and other liabilities | 90,418 | 180,708 |
Deferred revenue | (155,268) | 992,590 |
Net cash provided by (used in) operating activities | (298,121) | 665,354 |
Investing Activities: | ||
Purchases of property and equipment | (66,033) | (41,122) |
Internal-use software development costs | (4,888) | 0 |
Purchases of marketable securities | 0 | (2,167) |
Proceeds from maturities and sale of marketable securities | 0 | 159,807 |
Net cash provided by (used in) investing activities | (70,921) | 116,518 |
Financing Activities: | ||
Net proceeds from sales of common stock | 179,385 | 564,859 |
Net proceeds from the exercise of stock-based awards | 67 | 21,441 |
Finance lease payments | (45,904) | (63,876) |
Net cash provided by financing activities | 133,548 | 522,424 |
Effect of exchange rate on cash, cash equivalents, and restricted cash | 257 | (6,208) |
Net increase (decrease) in cash, cash equivalents, and restricted cash | (235,237) | 1,298,088 |
Cash, cash equivalents, and restricted cash at beginning of period | 1,528,259 | 648,738 |
Cash, cash equivalents, and restricted cash at end of period | 1,293,022 | 1,946,826 |
Supplemental disclosure of non-cash activities: | ||
Right-of-use assets from new lease agreements | 118,262 | 34,914 |
Capital expenditures included in accounts payable and accrued expenses | 11,984 | 7,884 |
Supplemental disclosure of cash flow information: | ||
Cash interest payments | 17,260 | 17,768 |
Cash paid for income taxes | $ 17,843 | $ 6,041 |
Organization and Business
Organization and Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The Company’s COVID-19 vaccine (“NVX-CoV2373,” “Nuvaxovid™,” “Covovax™,” “Novavax COVID-19 Vaccine, Adjuvanted”); influenza vaccine candidate; COVID-19-Influenza Combination (“CIC”) vaccine candidate; and additional vaccine candidates, including for Omicron subvariants and bivalent formulations with prototype vaccine (“NVX-CoV2373”), are genetically engineered nanostructures of conformationally correct recombinant proteins critical to disease pathogenesis and may elicit differentiated immune responses, which may be more efficacious than naturally occurring immunity or other vaccine approaches. NVX-CoV2373 and the Company’s other vaccine candidates incorporate the Company's proprietary Matrix-M ™ adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response. The Company has announced data from its ongoing PREVENT-19 study supporting the use of NVX-CoV2373 for homologous boosting in adults and adolescents aged 12 through 17. Additional findings in Phase 3 COVID-19 Omicron (study 311) trial showed utility of the prototype vaccine as a heterologous booster, inducing broad immune responses against contemporary Omicron variants. As of September 30, 2022, the Company had received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for NVX-CoV2373 for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications. The Company commenced commercial shipments of NVX-CoV2373 doses under the name “Novavax COVID-19 Vaccine, Adjuvanted” and the brand name “Nuvaxovid™” in 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The consolidated financial statements are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, operating results, comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for the periods presented. Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The unaudited consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Accumulated other comprehensive loss included a foreign currency translation loss of $23.8 million and $1.4 million as of September 30, 2022 and December 31, 2021, respectively. The accompanying unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Results for this or any interim period are not necessarily indicative of results for any future interim period or for the entire year. The Company operates in one business segment. Reclassifications Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations. Use of Estimates The preparation of the consolidated 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 at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates. Revenue Recognition - Product Sales Product sales are associated with the Company’s NVX-CoV2373 supply agreements, sometimes referred to as advance purchase agreements (“APAs”), with various international governments. The Company recognizes revenue from product sales based on the transaction price per dose calculated in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (Topic 606) when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory. If an APA includes a term that may have the effect of decreasing the price per dose of previously delivered shipments, the Company constrains the price until it is probable that a significant reversal in revenue recognized will not occur. Cost of Sales Cost of sales includes cost of raw materials, production, and manufacturing overhead costs associated with the Company’s product sales during the period. Cost of sales also includes adjustments for excess, obsolete, or expired inventory; idle capacity; and losses on firm purchase commitments to the extent the cost cannot be recovered based on estimates about future demand. Cost of sales does not include certain expenses related to raw materials, production, and manufacturing overhead costs that were expensed prior to regulatory authorization as described under the caption “Inventory” below. Inventory Inventory is recorded at the lower of cost or net realizable value under the First In, First Out (“FIFO”) methodology, taking into consideration the expiration of the inventory item (see Note 7). The Company determines the cost of raw materials using moving average costs and the cost of semi-finished and finished goods using a standard cost method adjusted on a periodic basis to reflect the deviation in the actual cost from the standard cost estimate. Standard costs consist primarily of the cost of manufacturing goods, including direct materials, direct labor, and the services and products of third-party suppliers. Manufacturing overhead costs are applied to semi-finished and finished goods based on expected production levels. The Company utilizes third-party contract manufacturing organizations (“CMOs”), contract development and manufacturing organizations (“CDMOs”), and other suppliers and service organizations to support the procurement and processing of raw materials, management of inventory, packaging, and the delivery process. Adjustments to reduce the cost of inventory to its net realizable value, if required, are made for estimated excess, obsolete, or expired inventory through cost of sales. Prior to initial regulatory authorization for its product candidates, the Company expenses costs relating to raw materials, production, and manufacturing overhead costs as research and development expenses in the consolidated statements of operations, in the period incurred. Subsequent to initial regulatory authorization for a product candidate, the Company capitalizes the costs of production for a particular supply chain as inventory when the Company determines that it has a present right to the economic benefit associated with the product. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), with amendments in 2018, 2019, 2020, and 2022. The ASU sets forth a “current expected credit loss” (“CECL”) model that requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. ASU 2016-13 applies to financial instruments that are not measured at fair value, including receivables that result from revenue transactions. The ASU is effective for the Company beginning on January 1, 2023. Management is currently evaluating the effect of the guidance and does not expect it to have a material impact on the Company’s consolidated financial statements. Adopted In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplified the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts in an entity’s own equity. Specifically, the new standard removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It also removed certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplified the diluted earnings per share calculation for convertible instruments. The Company adopted ASU 2020-06 on January 1, 2022 using a modified retrospective approach, which did not have a material impact on the Company’s consolidated financial statements. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Grants, U.S. Government Contract and Joint Venture [Abstract] | |
Revenue | Revenue The Company's accounts receivable included $43.6 million and $419.7 million related to amounts that were billed to customers and $68.0 million and $35.3 million related to amounts which had not yet been billed to customers as of September 30, 2022 and December 31, 2021, respectively. During the nine months ended September 30, 2022, changes in the Company's accounts receivables and deferred revenue balances were as follows (in thousands): December 31, 2021 Additions Deductions September 30, 2022 Contract receivables: Accounts receivable $ 454,993 1,519,345 (1,862,693) $ 111,645 Contract liabilities: Deferred revenue (1) $ 1,595,472 96,298 (251,576) (2) $ 1,440,194 (1) Amount is comprised of $404.8 million and $1.4 billion of current Deferred revenue and $1.0 billion and $172.5 million of non-current Deferred revenue as of September 30, 2022 and December 31, 2021, respectively. (2) Deductions from Deferred revenue includes $202.5 million that was realized in Revenue and $49.1 million that was reclassified to Other liabilities. The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, was approximately $4 billion as of September 30, 2022. Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s APA agreements may require the Company to refund portions of upfront payments or result in reduced future payments, which could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations. The timing to fulfill performance obligations related to grant agreements will depend on the results of the Company's research and development activities, including clinical trials, and delivery of doses. The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype NVX-CoV2373 vaccine under certain of our APAs. The remaining unfilled performance obligations not related to grant agreements or APAs are expected to be fulfilled in less than 12 months. Grants The Company recognized grant revenue as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 U.S. government partnership (“OWS”) $ 104,348 $ 96,215 $ 311,423 $ 699,268 U.S. Department of Defense (“DoD”) 1,925 1,287 1,925 21,472 Coalition for Epidemic Preparedness Innovations (“CEPI”) — 37,505 — 131,022 Bill & Melinda Gates Foundation (“BMGF”) — — — 2,628 Total grant revenue $ 106,273 $ 135,007 $ 313,348 $ 854,390 U.S. Government The Company’s U.S. government partnership consists of an agreement (the “OWS Agreement”) with Advanced Technology International, the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (“OWS”). In July 2022, the Company entered into a modification to the OWS Agreement that amended the terms of such agreement to provide for (i) an initial delivery to the U.S. government of approximately 3 million doses of NVX-CoV2373 and (ii) any additional manufacture and delivery to the U.S. government up to an aggregate of 100 million doses of NVX-CoV2373 contemplated by the original OWS Agreement (inclusive of the initial batch of approximately 3 million doses) dependent on U.S. government demand, FDA guidance on strain selection, agreement between the parties on the price of such doses, and available funding. The 3 million initial doses were delivered in July 2022. Additionally, in July 2022, the Company modified its existing agreement with the DoD and delivered 0.2 million doses of NVX-CoV2373 after receipt of EUA approval from the FDA, with delivery of the remaining 9.8 million doses of NVX-CoV2373 contemplated by the original agreement subject to DoD demand and available funding. CEPI The Company’s funding agreement with CEPI, under which CEPI has agreed to provide funding of up to $399.5 million to the Company to support the development of NVX-CoV2373, provides up to $257.0 million in grant funding and up to $142.5 million in forgivable no-interest term loans. These loans are only repayable if NVX-CoV2373 manufactured by the CMO network funded by CEPI is sold under the Company’s APA with Gavi, the Vaccine Alliance (“Gavi”), and such sales cover the Company’s costs of manufacturing the vaccine, not including manufacturing costs funded by CEPI. The timing of any loan repayments is currently uncertain given the timing and quantities of future orders under the Company’s APA with Gavi are unclear, as discussed below. Royalties and Other During the three and nine months ended September 30, 2022, the Company recognized $1.3 million and $10.5 million, respectively, in revenue related to sales-based royalties. During the three months ended June 30, 2022, the Company recognized a $20.0 million milestone payment upon the sale of NVX-CoV2373 in Japan. During the three and nine months ended September 30, 2021, the Company recognized $39.9 million and $63.4 million, respectively, in revenue related to sales-based royalties. During the three and nine months ended September 30, 2021, the Company did not recognize any revenue related to milestone payments. Advance Purchase Agreements (APAs) Under the terms of the Company’s supply commitment with Gavi, which includes both Novavax’ APA with Gavi and the supply obligation of its licensed partner, Serum Institute of India Private Limited (“SIIPL”), 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Novavax APA contemplates that the Company will manufacture and distribute 350 million doses. Under that agreement with Gavi, the Company received an upfront payment of $350 million from Gavi in 2021 and an additional payment of $350 million in the first quarter of 2022 related to the Company’s achieving WHO Emergency Use Listing. Although Novavax continues to be prepared to deliver the quantities of NVX-CoV2373 doses to Gavi under the terms of the APA, the Company was notified by Gavi of its intent to seek to revise the number and timing of doses of NVX-CoV2373 supplied by Novavax under such agreement. Furthermore, Gavi may seek partial or full recovery of the prior nonrefundable payments it has made to Novavax. The Company’s position is that Gavi has no contractual right to recover prior nonrefundable payments if it fails to order the 350 million doses it committed to order. To date, except for an initial order of approximately 2 million doses, Novavax has not received an order from Gavi and the timing and quantities of future orders to deliver NVX-CoV2373 to the COVAX Facility are unclear. Under the terms of the Company’s SARS-CoV-2 Vaccine Supply Agreement, originally entered into in October 2020 (the “Original UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), the Authority agreed to purchase 60 million doses of NVX-CoV2373. In July 2022, the Company entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with the Authority, under which the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses of NVX-CoV2373, with the number of additional doses contingent on the Company’s timely achievement of supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”). In the event that the Company is unable to achieve the JCVI supportive recommendations, it may have to repay up to $225.0 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement. As of September 30, 2022, the Company will be required to repay a minimum of $40.0 million related to the upfront payment, which is reflected in Other current liabilities, with the remaining balance of $185.0 million reflected in Deferred revenue. Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024. The Company has an APA with the European Commission (“EC”) acting on behalf of various European Union member states to supply a minimum of 20 million and up to 100 million initial doses of NVX-CoV2373, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches, through 2023. In July and August 2022, the Company was notified by the EC that it was cancelling 5 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to 65 million doses. The Company is in the process of finalizing a revised delivery schedule for the remaining 23 million committed doses under the APA that were originally scheduled for delivery during the first and second quarters of 2022. Serum Institute The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373. SIIPL agreed to purchase the Company’s Matrix-M TM adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of NVX-CoV2373 in SIIPL’s licensed territory solely for use in the manufacture of NVX-CoV2373. The Company and SIIPL equally split the revenue from SIIPL’s sale of NVX-CoV2373 in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and Serum Life Sciences Limited (“SLS”) under which SIIPL and SLS supply the Company with NVX-CoV2373 for commercialization and sale in certain territories, as well as a contract development manufacture agreement with SLS, under which SLS manufactures and supplies finished vaccine product to the Company using antigen drug substance and Matrix-M™ adjuvant supplied by the Company. In May and August 2022, the Company expanded its license and supply arrangements with SIIPL to include its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, a quadrivalent influenza vaccine, and CIC vaccine, and supply such vaccines to the Company. In March 2020, the Company granted SIIPL a non-exclusive license for the use of Matrix-M™ adjuvant supplied by the Company to develop, manufacture, and commercialize R21, a malaria candidate developed by the Jenner Institute, University of Oxford. Takeda Pharmaceutical Company Limited The Company has a collaboration and license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) under which the Company granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in Japan. Under the agreement, Takeda purchases the Company’s Matrix-M™ adjuvant to manufacture NVX-CoV2373 and the Company is entitled to receive payments from Takeda based on the achievement of certain development and commercial milestones, as well as a portion of net profits from the sale of NVX-CoV2373 in the low to middle double-digit range. During the three months ended June 30, 2022, the Company recognized a milestone payment of $20.0 million upon the first sale in Japan. SK bioscience Co., Ltd. The Company has a collaboration and license agreement with SK bioscience Co., Ltd. (“SK bioscience”) to manufacture and commercialize NVX-CoV2373 for sale to the governments of South Korea, Thailand, and Vietnam. SK bioscience pays a royalty in the low to middle double-digit range. Additionally, the Company has a manufacturing supply arrangement with SK bioscience under which SK bioscience supplies the Company with the antigen component of NVX-CoV2373 for use in the final drug product globally, including product to be distributed by the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In July 2022, the Company signed an additional agreement with SK bioscience for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply the Novavax COVID-19 vaccine in a prefilled syringe. Other Supply Agreements On September 30, 2022, the Company, FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”), and FUJIFILM Diosynth Biotechnologies USA, Inc. (“FDBU” and together with FDBK and FDBT, “Fujifilm”) entered into a Confidential Settlement Agreement and Release (the “Fujifilm Settlement Agreement”) regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the Commercial Supply Agreement (the “CSA”) dated August 20, 2021 and Master Services Agreement dated June 30, 2020 and associated statements of work (the “MSA”) by and between the Company and Fujifilm. The MSA and CSA established the general terms and conditions applicable to Fujifilm’s manufacturing and supply activities related to NVX-CoV2373 under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company is responsible for payment of up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which (i) $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022 and (ii) the remaining balance is to be paid in four equal quarterly installments of $34.3 million each beginning March 31, 2023. As of September 30, 2022, $102.9 million of the remaining payment was reflected in Accrued expenses and $34.3 million was reflected in Other non-current liabilities. Under the Fujifilm Settlement Agreement, Fujifilm is required to use commercially reasonable efforts to mitigate the losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA, and the final two quarterly installments will be mitigated by any replacement revenue achieved by Fujifilm between July 1, 2023 and December 31, 2023. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three and nine months ended September 30, 2022, the Company recorded a benefit of $98.3 million as Research and development expense (see Note 9). Except with respect to certain limited activities agreed upon by the parties, the MSA terminated with respect to all activities in FDBU and FDBT on October 21, 2022 and the impact of the termination was determined in accordance with the provisions of the MSA. The terms and conditions of the MSA and CSA will remain in full force and effect with respect to the ongoing activities at FDBK. In addition, the Company and Fujifilm mutually released all claims relating to (i) the cancellation of batches to be manufactured at FDBT under the MSA or CSA, (ii) FDBT facility idle time in 2022, (iii) failure to complete product performance qualification testing of batches manufactured by Fujifilm by December 2021, and (iv) any obligation by Fujifilm to reserve capacity or manufacture batches at FDBT for the benefit of the Company under the MSA or CSA. The Company continues to assess its manufacturing needs and intends to modify its global manufacturing footprint consistent with its contractual obligations to supply, and anticipated demand for, NVX-CoV2373, and in doing so, recognizes that significant costs may be incurred. |
Collaboration, License, and Sup
Collaboration, License, and Supply Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Collaborative Arrangement [Abstract] | |
Collaboration, License, and Supply Agreements | Revenue The Company's accounts receivable included $43.6 million and $419.7 million related to amounts that were billed to customers and $68.0 million and $35.3 million related to amounts which had not yet been billed to customers as of September 30, 2022 and December 31, 2021, respectively. During the nine months ended September 30, 2022, changes in the Company's accounts receivables and deferred revenue balances were as follows (in thousands): December 31, 2021 Additions Deductions September 30, 2022 Contract receivables: Accounts receivable $ 454,993 1,519,345 (1,862,693) $ 111,645 Contract liabilities: Deferred revenue (1) $ 1,595,472 96,298 (251,576) (2) $ 1,440,194 (1) Amount is comprised of $404.8 million and $1.4 billion of current Deferred revenue and $1.0 billion and $172.5 million of non-current Deferred revenue as of September 30, 2022 and December 31, 2021, respectively. (2) Deductions from Deferred revenue includes $202.5 million that was realized in Revenue and $49.1 million that was reclassified to Other liabilities. The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, was approximately $4 billion as of September 30, 2022. Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under the Company’s APA agreements may require the Company to refund portions of upfront payments or result in reduced future payments, which could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations. The timing to fulfill performance obligations related to grant agreements will depend on the results of the Company's research and development activities, including clinical trials, and delivery of doses. The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype NVX-CoV2373 vaccine under certain of our APAs. The remaining unfilled performance obligations not related to grant agreements or APAs are expected to be fulfilled in less than 12 months. Grants The Company recognized grant revenue as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 U.S. government partnership (“OWS”) $ 104,348 $ 96,215 $ 311,423 $ 699,268 U.S. Department of Defense (“DoD”) 1,925 1,287 1,925 21,472 Coalition for Epidemic Preparedness Innovations (“CEPI”) — 37,505 — 131,022 Bill & Melinda Gates Foundation (“BMGF”) — — — 2,628 Total grant revenue $ 106,273 $ 135,007 $ 313,348 $ 854,390 U.S. Government The Company’s U.S. government partnership consists of an agreement (the “OWS Agreement”) with Advanced Technology International, the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (“OWS”). In July 2022, the Company entered into a modification to the OWS Agreement that amended the terms of such agreement to provide for (i) an initial delivery to the U.S. government of approximately 3 million doses of NVX-CoV2373 and (ii) any additional manufacture and delivery to the U.S. government up to an aggregate of 100 million doses of NVX-CoV2373 contemplated by the original OWS Agreement (inclusive of the initial batch of approximately 3 million doses) dependent on U.S. government demand, FDA guidance on strain selection, agreement between the parties on the price of such doses, and available funding. The 3 million initial doses were delivered in July 2022. Additionally, in July 2022, the Company modified its existing agreement with the DoD and delivered 0.2 million doses of NVX-CoV2373 after receipt of EUA approval from the FDA, with delivery of the remaining 9.8 million doses of NVX-CoV2373 contemplated by the original agreement subject to DoD demand and available funding. CEPI The Company’s funding agreement with CEPI, under which CEPI has agreed to provide funding of up to $399.5 million to the Company to support the development of NVX-CoV2373, provides up to $257.0 million in grant funding and up to $142.5 million in forgivable no-interest term loans. These loans are only repayable if NVX-CoV2373 manufactured by the CMO network funded by CEPI is sold under the Company’s APA with Gavi, the Vaccine Alliance (“Gavi”), and such sales cover the Company’s costs of manufacturing the vaccine, not including manufacturing costs funded by CEPI. The timing of any loan repayments is currently uncertain given the timing and quantities of future orders under the Company’s APA with Gavi are unclear, as discussed below. Royalties and Other During the three and nine months ended September 30, 2022, the Company recognized $1.3 million and $10.5 million, respectively, in revenue related to sales-based royalties. During the three months ended June 30, 2022, the Company recognized a $20.0 million milestone payment upon the sale of NVX-CoV2373 in Japan. During the three and nine months ended September 30, 2021, the Company recognized $39.9 million and $63.4 million, respectively, in revenue related to sales-based royalties. During the three and nine months ended September 30, 2021, the Company did not recognize any revenue related to milestone payments. Advance Purchase Agreements (APAs) Under the terms of the Company’s supply commitment with Gavi, which includes both Novavax’ APA with Gavi and the supply obligation of its licensed partner, Serum Institute of India Private Limited (“SIIPL”), 1.1 billion doses of NVX-CoV2373 are to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Novavax APA contemplates that the Company will manufacture and distribute 350 million doses. Under that agreement with Gavi, the Company received an upfront payment of $350 million from Gavi in 2021 and an additional payment of $350 million in the first quarter of 2022 related to the Company’s achieving WHO Emergency Use Listing. Although Novavax continues to be prepared to deliver the quantities of NVX-CoV2373 doses to Gavi under the terms of the APA, the Company was notified by Gavi of its intent to seek to revise the number and timing of doses of NVX-CoV2373 supplied by Novavax under such agreement. Furthermore, Gavi may seek partial or full recovery of the prior nonrefundable payments it has made to Novavax. The Company’s position is that Gavi has no contractual right to recover prior nonrefundable payments if it fails to order the 350 million doses it committed to order. To date, except for an initial order of approximately 2 million doses, Novavax has not received an order from Gavi and the timing and quantities of future orders to deliver NVX-CoV2373 to the COVAX Facility are unclear. Under the terms of the Company’s SARS-CoV-2 Vaccine Supply Agreement, originally entered into in October 2020 (the “Original UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), the Authority agreed to purchase 60 million doses of NVX-CoV2373. In July 2022, the Company entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with the Authority, under which the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses of NVX-CoV2373, with the number of additional doses contingent on the Company’s timely achievement of supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”). In the event that the Company is unable to achieve the JCVI supportive recommendations, it may have to repay up to $225.0 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement. As of September 30, 2022, the Company will be required to repay a minimum of $40.0 million related to the upfront payment, which is reflected in Other current liabilities, with the remaining balance of $185.0 million reflected in Deferred revenue. Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024. The Company has an APA with the European Commission (“EC”) acting on behalf of various European Union member states to supply a minimum of 20 million and up to 100 million initial doses of NVX-CoV2373, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches, through 2023. In July and August 2022, the Company was notified by the EC that it was cancelling 5 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to 65 million doses. The Company is in the process of finalizing a revised delivery schedule for the remaining 23 million committed doses under the APA that were originally scheduled for delivery during the first and second quarters of 2022. Serum Institute The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of NVX-CoV2373. SIIPL agreed to purchase the Company’s Matrix-M TM adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of NVX-CoV2373 in SIIPL’s licensed territory solely for use in the manufacture of NVX-CoV2373. The Company and SIIPL equally split the revenue from SIIPL’s sale of NVX-CoV2373 in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and Serum Life Sciences Limited (“SLS”) under which SIIPL and SLS supply the Company with NVX-CoV2373 for commercialization and sale in certain territories, as well as a contract development manufacture agreement with SLS, under which SLS manufactures and supplies finished vaccine product to the Company using antigen drug substance and Matrix-M™ adjuvant supplied by the Company. In May and August 2022, the Company expanded its license and supply arrangements with SIIPL to include its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, a quadrivalent influenza vaccine, and CIC vaccine, and supply such vaccines to the Company. In March 2020, the Company granted SIIPL a non-exclusive license for the use of Matrix-M™ adjuvant supplied by the Company to develop, manufacture, and commercialize R21, a malaria candidate developed by the Jenner Institute, University of Oxford. Takeda Pharmaceutical Company Limited The Company has a collaboration and license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) under which the Company granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373 in Japan. Under the agreement, Takeda purchases the Company’s Matrix-M™ adjuvant to manufacture NVX-CoV2373 and the Company is entitled to receive payments from Takeda based on the achievement of certain development and commercial milestones, as well as a portion of net profits from the sale of NVX-CoV2373 in the low to middle double-digit range. During the three months ended June 30, 2022, the Company recognized a milestone payment of $20.0 million upon the first sale in Japan. SK bioscience Co., Ltd. The Company has a collaboration and license agreement with SK bioscience Co., Ltd. (“SK bioscience”) to manufacture and commercialize NVX-CoV2373 for sale to the governments of South Korea, Thailand, and Vietnam. SK bioscience pays a royalty in the low to middle double-digit range. Additionally, the Company has a manufacturing supply arrangement with SK bioscience under which SK bioscience supplies the Company with the antigen component of NVX-CoV2373 for use in the final drug product globally, including product to be distributed by the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In July 2022, the Company signed an additional agreement with SK bioscience for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply the Novavax COVID-19 vaccine in a prefilled syringe. Other Supply Agreements On September 30, 2022, the Company, FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”), and FUJIFILM Diosynth Biotechnologies USA, Inc. (“FDBU” and together with FDBK and FDBT, “Fujifilm”) entered into a Confidential Settlement Agreement and Release (the “Fujifilm Settlement Agreement”) regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the Commercial Supply Agreement (the “CSA”) dated August 20, 2021 and Master Services Agreement dated June 30, 2020 and associated statements of work (the “MSA”) by and between the Company and Fujifilm. The MSA and CSA established the general terms and conditions applicable to Fujifilm’s manufacturing and supply activities related to NVX-CoV2373 under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company is responsible for payment of up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT under the CSA, of which (i) $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022 and (ii) the remaining balance is to be paid in four equal quarterly installments of $34.3 million each beginning March 31, 2023. As of September 30, 2022, $102.9 million of the remaining payment was reflected in Accrued expenses and $34.3 million was reflected in Other non-current liabilities. Under the Fujifilm Settlement Agreement, Fujifilm is required to use commercially reasonable efforts to mitigate the losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA, and the final two quarterly installments will be mitigated by any replacement revenue achieved by Fujifilm between July 1, 2023 and December 31, 2023. The Settlement Payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expense from FDBT manufacturing activity under the CSA prior to the Fujifilm Settlement Agreement and accordingly, during the three and nine months ended September 30, 2022, the Company recorded a benefit of $98.3 million as Research and development expense (see Note 9). Except with respect to certain limited activities agreed upon by the parties, the MSA terminated with respect to all activities in FDBU and FDBT on October 21, 2022 and the impact of the termination was determined in accordance with the provisions of the MSA. The terms and conditions of the MSA and CSA will remain in full force and effect with respect to the ongoing activities at FDBK. In addition, the Company and Fujifilm mutually released all claims relating to (i) the cancellation of batches to be manufactured at FDBT under the MSA or CSA, (ii) FDBT facility idle time in 2022, (iii) failure to complete product performance qualification testing of batches manufactured by Fujifilm by December 2021, and (iv) any obligation by Fujifilm to reserve capacity or manufacture batches at FDBT for the benefit of the Company under the MSA or CSA. The Company continues to assess its manufacturing needs and intends to modify its global manufacturing footprint consistent with its contractual obligations to supply, and anticipated demand for, NVX-CoV2373, and in doing so, recognizes that significant costs may be incurred. |
Cash, Cash Equivalents, and Res
Cash, Cash Equivalents, and Restricted Cash | 9 Months Ended |
Sep. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets that sums to the total of such amounts shown in the statements of cash flows (in thousands): September 30, 2022 December 31, 2021 Cash and cash equivalents $ 1,280,581 $ 1,515,116 Restricted cash, current 10,785 11,490 Restricted cash, non-current (1) 1,656 1,653 Cash, cash equivalents, and restricted cash $ 1,293,022 $ 1,528,259 (1) Classified as Other non-current assets as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following table represents the Company’s fair value hierarchy for its financial assets and liabilities (in thousands): Fair Value at September 30, 2022 Fair Value at December 31, 2021 Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Money market funds (1) $ 365,631 $ — $ — $ 361,822 $ — $ — Government-backed securities (1) — 261,000 — — 266,250 — Corporate debt securities (1) — 109,914 — — 790,672 — Agency securities (1) — 42,777 — — — — Total cash equivalents $ 365,631 $ 413,691 $ — $ 361,822 $ 1,056,922 $ — Liabilities Convertible notes payable $ — $ 317,044 $ — $ — $ 447,509 $ — (1) All investments are classified as Cash and cash equivalents as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets. Cash equivalents are recorded at cost, which approximate fair value due to their short-term nature. Pricing of the Company's Notes (see Note 10) has been estimated using other observable inputs, including the price of the Company's common stock, implied volatility, interest rates, and credit spreads. During the nine months ended September 30, 2022 and 2021, the Company did not have any transfers between levels . |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 17,557 $ 8,872 Semi-finished goods 33,030 — Finished goods 31,845 — Total inventory $ 82,432 $ 8,872 Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our consolidated statements of operations. For the three and nine months ended September 30, 2022, inventory write-downs were $202.4 million and $358.1 million, respectively. For the three and nine months ended September 30, 2022, losses on firm purchase commitments were $46.6 million and $146.2 million, respectively. There were no inventory write-downs or losses on firm purchase commitments during 2021. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Intangible Assets and Goodwill Identifiable Intangible Assets Purchased intangible assets consisted of the following (in thousands): September 30, 2022 December 31, 2021 Gross Accumulated Intangible Gross Accumulated Intangible Finite-lived intangible assets: Proprietary adjuvant technology $ 6,911 $ (3,069) $ 3,842 $ 8,239 $ (3,469) $ 4,770 Internal-use software (1) 4,888 (274) 4,614 — — — Total identifiable intangible assets $ 11,799 $ (3,343) $ 8,456 $ 8,239 $ (3,469) $ 4,770 (1) As of September 30, 2022, internal-use software included $3.6 million for assets under development. Amortization expense for the nine months ended September 30, 2022 and 2021 was $0.6 million and $0.3 million, respectively. Estimated amortization expense for existing in-use intangible assets for the remainder of 2022 and for each of the five succeeding years ending December 31 is estimated to be as follows (in thousands): Year Amount 2022 (remainder) $ 189 2023 756 2024 740 2025 392 2026 335 2027 335 Goodwill The change in the carrying amounts of goodwill for the nine months ended September 30, 2022 was as follows (in thousands): Amount Balance at December 31, 2021 $ 131,479 Currency translation adjustments (13,944) Balance at September 30, 2022 $ 117,535 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | LeasesDuring the nine months ended September 30, 2022, the Company concluded that changes in facts and circumstances on its CMO and CDMO agreements that had previously been determined to represent embedded lease arrangements resulted in the modification of existing leases and, in accordance with its policy, the Company remeasured and reallocated the remaining consideration in the contracts and reassessed the lease classification as of the effective date of the modification. As a result, during the nine months ended September 30, 2022, the Company recognized a Right-Of-Use (“ROU”) asset and a corresponding long-term operating lease liability of $44.0 million on the remeasurement of its long-term supply agreements using an average incremental borrowing rate of 5%. The Company expensed the ROU asset since it relates to research and development activities for the development of NVX-CoV2373 for which the Company does not have an alternative future use.During the three and nine months ended September 30, 2022, the Company recognized a short-term lease benefit of $46.6 million and expense of $37.3 million, respectively, related to its embedded leases, net of a benefit of $98.3 million related to the Fujifilm Settlement Agreement (see Note 4). During the three and nine months ended September 30, 2022, the Company expensed $24.2 million and $44.0 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2021, the Company recognized a short-term lease expense of $111.3 million and $325.5 million, respectively, related to its embedded leases and expensed $4.4 million and $17.1 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2022, the Company recognized $0.9 million and $4.3 million of interest expense, respectively, on its finance lease liabilities. During the three and nine months ended September 30, 2021, the Company recognized $1.6 million and $5.6 million of interest expense, respectively, on its finance lease liabilities.During 2020, the Company entered into a lease agreement for the premises located at 700 Quince Orchard Road, Gaithersburg, Maryland. The lease is for approximately 170,000 square feet of space that the Company intends to use for manufacturing, research and development, and corporate offices. The term of the lease is 15 years with options to extend the lease. The lease provides for an annual base rent of $5.8 million that is subject to future rent increases and obligates the Company to pay building operating costs. During the nine months ended September 30, 2022, the Company obtained the right to direct the use of, and obtain substantially all of the benefit from, certain floors located at the premises and recognized an ROU asset and related lease obligation of $73.2 million as the lease commencement dates for accounting purposes had occurred |
Leases | LeasesDuring the nine months ended September 30, 2022, the Company concluded that changes in facts and circumstances on its CMO and CDMO agreements that had previously been determined to represent embedded lease arrangements resulted in the modification of existing leases and, in accordance with its policy, the Company remeasured and reallocated the remaining consideration in the contracts and reassessed the lease classification as of the effective date of the modification. As a result, during the nine months ended September 30, 2022, the Company recognized a Right-Of-Use (“ROU”) asset and a corresponding long-term operating lease liability of $44.0 million on the remeasurement of its long-term supply agreements using an average incremental borrowing rate of 5%. The Company expensed the ROU asset since it relates to research and development activities for the development of NVX-CoV2373 for which the Company does not have an alternative future use.During the three and nine months ended September 30, 2022, the Company recognized a short-term lease benefit of $46.6 million and expense of $37.3 million, respectively, related to its embedded leases, net of a benefit of $98.3 million related to the Fujifilm Settlement Agreement (see Note 4). During the three and nine months ended September 30, 2022, the Company expensed $24.2 million and $44.0 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2021, the Company recognized a short-term lease expense of $111.3 million and $325.5 million, respectively, related to its embedded leases and expensed $4.4 million and $17.1 million, respectively, of ROU assets that represented assets acquired for research and development activities that did not have an alternative future use at the commencement or modification of the lease. During the three and nine months ended September 30, 2022, the Company recognized $0.9 million and $4.3 million of interest expense, respectively, on its finance lease liabilities. During the three and nine months ended September 30, 2021, the Company recognized $1.6 million and $5.6 million of interest expense, respectively, on its finance lease liabilities.During 2020, the Company entered into a lease agreement for the premises located at 700 Quince Orchard Road, Gaithersburg, Maryland. The lease is for approximately 170,000 square feet of space that the Company intends to use for manufacturing, research and development, and corporate offices. The term of the lease is 15 years with options to extend the lease. The lease provides for an annual base rent of $5.8 million that is subject to future rent increases and obligates the Company to pay building operating costs. During the nine months ended September 30, 2022, the Company obtained the right to direct the use of, and obtain substantially all of the benefit from, certain floors located at the premises and recognized an ROU asset and related lease obligation of $73.2 million as the lease commencement dates for accounting purposes had occurred |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Convertible Notes The Company incurred approximately $10.0 million of debt issuance costs during the first quarter of 2016 relating to the issuance of $325 million aggregate principal amount of convertible senior unsecured notes that will mature on February 1, 2023 (the “Notes”), which were recorded as a reduction to the Notes on the consolidated balance sheet. The $10.0 million of debt issuance costs is being amortized and recognized as additional interest expense over the seven-year contractual term of the Notes on a straight-line basis, which approximates the effective interest rate method. Total convertible notes payable consisted of the following (in thousands): September 30, 2022 December 31, 2021 Principal amount of Notes $ 325,000 $ 325,000 Unamortized debt issuance costs (475) (1,542) Total convertible notes payable (1) $ 324,525 $ 323,458 (1) Convertible notes are classified as current liabilities and as non-current liabilities in the consolidated balance sheets as of September 30, 2022 and December 31, 2021, respectively. The interest expense incurred in connection with the Notes consisted of the following (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Coupon interest at 3.75% $ 3,047 $ 3,047 $ 9,141 $ 9,141 Amortization of debt issuance costs 356 356 1,068 1,068 Total interest expense on Notes $ 3,403 $ 3,403 $ 10,209 $ 10,209 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders' Equity (Deficit)During the three months ended March 31, 2022, the Company sold 2.2 million of shares of its common stock resulting in net proceeds of approximately $179 million, under its most recent At Market Issuance Sales agreement entered in June 2021 (the “June 2021 Sales Agreement”), which allows it to issue and sell up to $500 million in gross proceeds of shares of its common stock. As of September 30, 2022, the remaining balance under the June 2021 Sales Agreement was approximately $318 million.During the nine months ended September 30, 2021, the Company sold 2.6 million shares of its common stock resulting in net proceeds of approximately $565 million, under its various At Market Issuance Sales agreements. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Equity Plans The 2015 Stock Incentive Plan, as amended (“2015 Plan”), was approved at the Company's annual meeting of stockholders in June 2015. Under the 2015 Plan, equity awards may be granted to officers, directors, employees, and consultants of and advisors to the Company and any present or future subsidiary. The 2015 Plan authorizes the issuance of up to 14.8 million shares of common stock under equity awards granted under the 2015 Plan, which includes an increase of 2.4 million shares approved for issuance under the 2015 Plan at the Company's 2022 annual meeting of stockholders. All such shares authorized for issuance under the 2015 Plan have been reserved. The 2015 Plan will expire on March 4, 2025. As of September 30, 2022, there were 4.6 million shares available for issuance under the 2015 Plan. The Amended and Restated 2005 Stock Incentive Plan (“2005 Plan”) expired in February 2015 and no new awards may be made under such plan, although awards will continue to be outstanding in accordance with their terms. The 2015 Plan permits and the 2005 Plan permitted the grant of stock options (including incentive stock options), restricted stock, stock appreciation rights (“SARs”), and restricted stock units (“RSUs”). In addition, under the 2015 Plan, unrestricted stock, stock units, and performance awards may be granted. Stock options and SARs generally have a maximum term of ten years and may be or were granted with an exercise price that is no less than 100% of the fair market value of the Company's common stock at the time of grant. Grants of stock options are generally subject to vesting over periods ranging from one The Company recorded all stock-based compensation expense in the consolidated statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Cost of sales $ 51 $ — $ 51 $ — Research and development 16,107 21,860 52,692 70,429 General and administrative 15,389 23,414 49,782 81,028 Total stock-based compensation expense $ 31,547 $ 45,274 $ 102,525 $ 151,457 Total stock-based compensation capitalized and included in inventory as of September 30, 2022 was $1.8 million. There was no stock-based compensation capitalized and included in inventory as of December 31, 2021. As of September 30, 2022, there was approximately $189 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan, as amended (“ESPP”). This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of approximately one year. This estimate does not include the impact of other possible stock-based awards that may be made during future periods. The aggregate intrinsic value represents the total intrinsic value (the difference between the Company’s closing stock price on the last trading day of the period and the exercise price, multiplied by the number of in-the-money stock options and SARs) that would have been received by the holders had all stock option and SAR holders exercised their stock options and SARs on September 30, 2022. This amount is subject to change based on changes to the closing price of the Company's common stock. The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the nine months ended September 30, 2022 and 2021 was approximately $19 million and $381 million, respectively. Stock Options and Stock Appreciation Rights The following is a summary of stock options and SARs activity under the 2015 Plan and 2005 Plan for the nine months ended September 30, 2022: 2015 Plan 2005 Plan Stock Weighted-Average Stock Weighted-Average Outstanding at December 31, 2021 3,635,837 $ 42.60 68,225 $ 109.52 Granted 558,181 71.21 — — Exercised (132,420) 15.75 (3,000) 31.10 Canceled (61,364) 88.58 (1,500) 121.00 Outstanding at September 30, 2022 4,000,234 $ 46.78 63,725 $ 112.94 Shares exercisable at September 30, 2022 2,739,565 $ 39.72 63,725 $ 112.94 The fair value of stock options granted under the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Weighted average Black-Scholes fair value of stock options granted $37.66 $203.51 $60.24 $156.86 Risk-free interest rate 3.0%-3.6% 0.6%-0.9% 1.4%-3.6% 0.5%-1.1% Dividend yield —% —% —% —% Volatility 122.2%-136.4% 126.4%-140.0% 120.5%-136.7% 124.7%-142.0% Expected term (in years) 4.0-5.3 4.1-6.1 4.0-6.3 4.1-6.1 The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2015 Plan and 2005 Plan as of September 30, 2022 was approximately $9 million and 7.4 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2015 Plan and 2005 Plan as of September 30, 2022 was approximately $5 million and 7.0 years, respectively. Restricted Stock Units The following is a summary of RSU activity for the nine months ended September 30, 2022: Number of Per Share Outstanding and unvested at December 31, 2021 819,828 $ 116.70 Granted 1,113,958 68.49 Vested (379,802) 78.17 Forfeited (114,976) 110.59 Outstanding and unvested at September 30, 2022 1,439,008 $ 90.03 Employee Stock Purchase Plan The ESPP was approved at the Company's annual meeting of stockholders in June 2013. The ESPP currently authorizes an aggregate of 1.1 million shares of common stock to be purchased, and the aggregate amount of shares will continue to increase 5% on each anniversary of its adoption up to a maximum of 1.65 million shares. The ESPP allows employees to purchase shares of common stock of the Company at each purchase date through payroll deductions of up to a maximum of 15% of their compensation, at 85% of the lesser of the market price of the shares at the time of purchase or the market price on the beginning date of an option period (or, if later, the date during the option period when the employee was first eligible to participate). As of September 30, 2022, there were 0.7 million shares available for issuance under the ESPP. The ESPP is considered compensatory for financial reporting purposes. As such, the fair value of ESPP shares was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Range of Black-Scholes fair values of ESPP shares granted $23.59-$39.73 $83.47-$152.11 $23.59-$79.74 $83.47-$238.85 Risk-free interest rate 3.2%-3.3% 0.1%-0.2% 0.6%-3.3% 0.1%-0.2% Dividend yield —% —% —% —% Volatility 103.0%-114.8% 114.9%-150.6% 103.0%-142.9% 114.9%-159.4% Expected term (in years) 0.5-2.0 0.5-2.0 0.5-2.0 0.5-2.0 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company evaluates the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets. A significant piece of objective evidence evaluated was the cumulative loss incurred over the three-year period ended September 30, 2022 and that the Company has historically generated pretax losses. Such objective evidence limits the ability to consider other subjective evidence, such as projections for future growth. On the basis of this evaluation, as of September 30, 2022, the Company continued to maintain a full valuation allowance against its deferred tax assets, except to the extent Net Operating Losses (“NOLs”) have been used to reduce taxable income. The Company’s remaining U.S. Federal NOLs are subject to limitation in accordance with the 2017 Tax Cuts and Jobs Act (“TCJA”), which limits allowable NOL deductions to 80% of federal taxable income. Effective January 1, 2022, a provision of the TCJA has taken effect creating a significant change to the treatment of research and experimental expenditures under Section 174 of the IRC (“Sec. 174 expenses”). Historically, businesses have had the option of deducting Sec. 174 expenses in the year incurred or capitalizing and amortizing the costs over five years. The new TCJA provision, however, eliminates this option and will require Sec. 174 expenses associated with research conducted in the U.S. to be capitalized and amortized over a five-year period. For expenses associated with research outside of the U.S., Sec. 174 expenses will be capitalized and amortized over a 15-year period. The Company recognized federal and state income tax expense of $2.4 million and $4.3 million, in total, for the three and nine months ended September 30, 2022, respectively, and did not recognize federal or state income tax expense for the three and nine months ended September 30, 2021. The Company recognized income tax expense related to foreign withholding tax on royalties of $0.1 million and $2.3 million, respectively, for the three and nine months ended September 30, 2022 and $6.0 million and $12.6 million for the three and nine months ended September 30, 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Legal Matters On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland against the Company and certain members of senior management, captioned Sothinathan Sinnathurai v. Novavax, Inc. , et al., No. 8:21-cv-02910-TDC (the “Sinnathurai Action”). On January 26, 2022, the court entered an order designating David Truong, Nuggehalli Balmukund Nandkumar, and Jeffrey Gabbert as co-lead plaintiffs in the Sinnathurai Action. The co-lead plaintiffs filed a consolidated amended complaint on March 11, 2022, alleging that the defendants made certain purportedly false and misleading statements concerning the Company’s ability to manufacture NVX-CoV2373 on a commercial scale and to secure the vaccine’s regulatory approval. The amended complaint defines the purported class as those stockholders who purchased the Company’s securities between February 24, 2021 and October 19, 2021. On April 25, 2022, defendants filed a motion to dismiss the consolidated amended complaint. On June 9, 2022, the co-lead plaintiffs filed an opposition to the motion to dismiss and on July 11, 2022, the Company filed a reply brief. The matter is now fully briefed. The Court has not indicated whether it intends to schedule any hearing on the motion before issuing a ruling. After the Sinnathurai Action was filed, six derivative lawsuits were filed: (i) Robert E. Meyer v. Stanley C. Erck, et al. , No. 8:21-cv-02996-TDC (the “Meyer Action”), (ii) Shui Shing Yung v. Stanley C. Erck, et al. , No. 8:21-cv-03248-TDC (the “Yung Action”), (iii) William Kirst, et al. v. Stanley C. Erck, et al. , No. 8:22-cv-00024-TDC (the “Kirst Action”), (iv) Amy Snyder v. Stanley C. Erck, et al. , No. 8:22-cv-01415-TDC (the “Snyder Action”), (v) Charles R. Blackburn, et al. v. Stanley C. Erck, et al. , No. 1:22-cv-01417-TDC (the “Blackburn Action”), and (vi) Diego J. Mesa v. Stanley C. Erck, et al . (the “Mesa Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the U.S. District Court for the District of Maryland. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the U.S. District Court for the District of Maryland by the defendants. The Mesa Action was filed in the Delaware Court of Chancery. The derivative lawsuits name members of the board of directors and certain members of senior management as defendants. The Company is deemed a nominal defendant. The plaintiffs assert derivative claims arising out of substantially the same alleged facts and circumstances as the Sinnathurai Action. Collectively, the derivative complaints assert claims for breach of fiduciary duty, insider selling, unjust enrichment, violation of federal securities law, abuse of control, waste, and mismanagement. Plaintiffs seek declaratory and injunctive relief, as well as an award of monetary damages and attorneys’ fees. On July 21, 2022, the Court issued a memorandum opinion and order remanding the Kirst Action to state court. On February 4, 2022, the Court entered an order consolidating the Meyer and Yung Actions (the “First Consolidated Derivative Action”). The plaintiffs in the First Consolidated Derivative Action filed their consolidated derivative complaint on April 25, 2022. On May 10, 2022, the Court entered an order in the First Consolidated Derivative Action granting the parties’ request to stay all proceedings and deadlines pending the earlier of dismissal or the filing of an answer in the Sinnathurai Action. On June 10, 2022, the Snyder and Blackburn Actions were filed. On October 5, 2022, the court entered an order granting a request by the plaintiffs in the First Consolidated Derivative Action and the Snyder and Blackburn Actions to consolidate all three actions and appoint co-lead plaintiffs and co-lead and liaison counsel (the “Second Consolidated Derivative Action”). The co-lead plaintiffs in the Second Consolidated Derivative Action will designate an operative complaint or file a consolidated amended complaint by November 21, 2022. On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the court entered an order granting the parties’ request to stay all proceedings and deadlines in the Mesa Action pending the earlier of dismissal of the Sinnathurai Action or the filing of an answer to the operative complaint in the Sinnathurai Action. The financial impact of the claims is not estimable. On February 26, 2021, a Novavax stockholder named Thomas Golubinski filed a derivative complaint against members of the Novavax board of directors and members of senior management in the Delaware Court of Chancery (the “Court”), captioned Thomas Golubinski v. Richard H. Douglas, et al. , No. 2021-0172-JRS. The Company is deemed a nominal defendant. Golubinski challenged equity awards made in April 2020 and in June 2020 on the ground that they were “spring-loaded,” that is, made at a time when such board members or members of senior management allegedly possessed undisclosed positive material information concerning the Company. The complaint asserted claims for breach of fiduciary duty, waste, and unjust enrichment. The plaintiff sought an award of damages to the Company, an order rescinding both awards or requiring disgorgement, and an award of attorneys’ fees incurred in connection with the litigation. On May 10, 2021, the defendants moved to dismiss the complaint in its entirety. On June 17, 2021, the Company’s stockholders voted FOR ratification of the April 2020 awards and ratification of the June 2020 awards. Details of the ratification proposals are set forth in the Company’s Definitive Proxy Statement filed with the SEC on May 3, 2021. The results of the vote were disclosed in the Company’s Current Report on Form 8-K filed with the SEC on June 24, 2021. Thereafter, the plaintiff stipulated that, as a result of the outcome of the June 17, 2021 vote, the plaintiff no longer intends to pursue the lawsuit or any claim arising from the April 2020 and June 2020 awards. On August 23, 2021, the plaintiff filed a motion seeking an award of attorneys’ fees and expenses, to which the defendants filed an opposition. The motion was argued before the Court on October 18, 2022. The same day, the Court issued a bench ruling denying the plaintiff’s fee application in its entirety and entered an order to that effect. Under a prior Court order, the case was automatically dismissed with prejudice upon denial of the plaintiff’s fee application. On March 29, 2022, Par Sterile Products, LLC (“Par”) submitted a demand for arbitration against the Company with the American Arbitration Association, alleging that the Company breached certain provisions of the Manufacturing and Services Agreement (“MSA”) that the Company entered into with Par in September 2020 to provide fill-finish manufacturing services for NVX-CoV2373. The matter is at a preliminary stage and therefore the potential loss is not reasonably estimable. The parties are engaged in discovery and arbitration is scheduled for July 2023. While the Company maintains that no breach of the MSA has occurred and intends to vigorously defend the matter, if the final resolution of the matter is adverse to the Company, it could have a material impact on the Company’s financial position, results of operations, or cash flows. The Company is also involved in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, management does not expect the resolution of these legal proceedings to have a material adverse effect on the Company’s financial position, results of operations, or cash flows. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events[Placeholder for Omicron data] |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The consolidated financial statements are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, operating results, comprehensive loss, changes in stockholders’ equity (deficit), and cash flows for the periods presented. Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The unaudited consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Accumulated other comprehensive loss included a foreign currency translation loss of $23.8 million and $1.4 million as of September 30, 2022 and December 31, 2021, respectively. The accompanying unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Results for this or any interim period are not necessarily indicative of results for any future interim period or for the entire year. The Company operates in one business segment. |
Reclassifications | Reclassifications Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations. |
Use of Estimates | Use of Estimates The preparation of the consolidated 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 at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates. |
Revenue Recognition - Product Sales | Revenue Recognition - Product Sales Product sales are associated with the Company’s NVX-CoV2373 supply agreements, sometimes referred to as advance purchase agreements (“APAs”), with various international governments. The Company recognizes revenue from product sales based on the transaction price per dose calculated in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (Topic 606) when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory. If an APA includes a term that may have the effect of decreasing the price per dose of previously delivered shipments, the Company constrains the price until it is probable that a significant reversal in revenue recognized will not occur. |
Cost of Sales | Cost of Sales Cost of sales includes cost of raw materials, production, and manufacturing overhead costs associated with the Company’s product sales during the period. Cost of sales also includes adjustments for excess, obsolete, or expired inventory; idle capacity; and losses on firm purchase commitments to the extent the cost cannot be recovered based on estimates about future demand. Cost of sales does not include certain expenses related to raw materials, production, and manufacturing overhead costs that were expensed prior to regulatory authorization as described under the caption “Inventory” below. |
Inventory | Inventory Inventory is recorded at the lower of cost or net realizable value under the First In, First Out (“FIFO”) methodology, taking into consideration the expiration of the inventory item (see Note 7). The Company determines the cost of raw materials using moving average costs and the cost of semi-finished and finished goods using a standard cost method adjusted on a periodic basis to reflect the deviation in the actual cost from the standard cost estimate. Standard costs consist primarily of the cost of manufacturing goods, including direct materials, direct labor, and the services and products of third-party suppliers. Manufacturing overhead costs are applied to semi-finished and finished goods based on expected production levels. The Company utilizes third-party contract manufacturing organizations (“CMOs”), contract development and manufacturing organizations (“CDMOs”), and other suppliers and service organizations to support the procurement and processing of raw materials, management of inventory, packaging, and the delivery process. Adjustments to reduce the cost of inventory to its net realizable value, if required, are made for estimated excess, obsolete, or expired inventory through cost of sales. Prior to initial regulatory authorization for its product candidates, the Company expenses costs relating to raw materials, production, and manufacturing overhead costs as research and development expenses in the consolidated statements of operations, in the period incurred. Subsequent to initial regulatory authorization for a product candidate, the Company capitalizes the costs of production for a particular supply chain as inventory when the Company determines that it has a present right to the economic benefit associated with the product. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), with amendments in 2018, 2019, 2020, and 2022. The ASU sets forth a “current expected credit loss” (“CECL”) model that requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. ASU 2016-13 applies to financial instruments that are not measured at fair value, including receivables that result from revenue transactions. The ASU is effective for the Company beginning on January 1, 2023. Management is currently evaluating the effect of the guidance and does not expect it to have a material impact on the Company’s consolidated financial statements. Adopted In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplified the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts in an entity’s own equity. Specifically, the new standard removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It also removed certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplified the diluted earnings per share calculation for convertible instruments. The Company adopted ASU 2020-06 on January 1, 2022 using a modified retrospective approach, which did not have a material impact on the Company’s consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Grants, U.S. Government Contract and Joint Venture [Abstract] | |
Schedule of increase (decrease) in accounts receivable, unbilled services, and deferred revenue | During the nine months ended September 30, 2022, changes in the Company's accounts receivables and deferred revenue balances were as follows (in thousands): December 31, 2021 Additions Deductions September 30, 2022 Contract receivables: Accounts receivable $ 454,993 1,519,345 (1,862,693) $ 111,645 Contract liabilities: Deferred revenue (1) $ 1,595,472 96,298 (251,576) (2) $ 1,440,194 (1) Amount is comprised of $404.8 million and $1.4 billion of current Deferred revenue and $1.0 billion and $172.5 million of non-current Deferred revenue as of September 30, 2022 and December 31, 2021, respectively. (2) Deductions from Deferred revenue includes $202.5 million that was realized in Revenue and $49.1 million that was reclassified to Other liabilities. |
Schedule of revenue by major customers by reporting segments | The Company recognized grant revenue as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 U.S. government partnership (“OWS”) $ 104,348 $ 96,215 $ 311,423 $ 699,268 U.S. Department of Defense (“DoD”) 1,925 1,287 1,925 21,472 Coalition for Epidemic Preparedness Innovations (“CEPI”) — 37,505 — 131,022 Bill & Melinda Gates Foundation (“BMGF”) — — — 2,628 Total grant revenue $ 106,273 $ 135,007 $ 313,348 $ 854,390 |
Cash, Cash Equivalents, and R_2
Cash, Cash Equivalents, and Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of reconciliation of cash, cash equivalents and restricted cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets that sums to the total of such amounts shown in the statements of cash flows (in thousands): September 30, 2022 December 31, 2021 Cash and cash equivalents $ 1,280,581 $ 1,515,116 Restricted cash, current 10,785 11,490 Restricted cash, non-current (1) 1,656 1,653 Cash, cash equivalents, and restricted cash $ 1,293,022 $ 1,528,259 (1) Classified as Other non-current assets as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value hierarchy | The following table represents the Company’s fair value hierarchy for its financial assets and liabilities (in thousands): Fair Value at September 30, 2022 Fair Value at December 31, 2021 Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Money market funds (1) $ 365,631 $ — $ — $ 361,822 $ — $ — Government-backed securities (1) — 261,000 — — 266,250 — Corporate debt securities (1) — 109,914 — — 790,672 — Agency securities (1) — 42,777 — — — — Total cash equivalents $ 365,631 $ 413,691 $ — $ 361,822 $ 1,056,922 $ — Liabilities Convertible notes payable $ — $ 317,044 $ — $ — $ 447,509 $ — (1) All investments are classified as Cash and cash equivalents as of September 30, 2022 and December 31, 2021, on the consolidated balance sheets. |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 17,557 $ 8,872 Semi-finished goods 33,030 — Finished goods 31,845 — Total inventory $ 82,432 $ 8,872 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of identifiable intangible assets | Purchased intangible assets consisted of the following (in thousands): September 30, 2022 December 31, 2021 Gross Accumulated Intangible Gross Accumulated Intangible Finite-lived intangible assets: Proprietary adjuvant technology $ 6,911 $ (3,069) $ 3,842 $ 8,239 $ (3,469) $ 4,770 Internal-use software (1) 4,888 (274) 4,614 — — — Total identifiable intangible assets $ 11,799 $ (3,343) $ 8,456 $ 8,239 $ (3,469) $ 4,770 |
Schedule of estimated amortization expense | Estimated amortization expense for existing in-use intangible assets for the remainder of 2022 and for each of the five succeeding years ending December 31 is estimated to be as follows (in thousands): Year Amount 2022 (remainder) $ 189 2023 756 2024 740 2025 392 2026 335 2027 335 |
Schedule of goodwill | The change in the carrying amounts of goodwill for the nine months ended September 30, 2022 was as follows (in thousands): Amount Balance at December 31, 2021 $ 131,479 Currency translation adjustments (13,944) Balance at September 30, 2022 $ 117,535 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of convertible notes payable | Total convertible notes payable consisted of the following (in thousands): September 30, 2022 December 31, 2021 Principal amount of Notes $ 325,000 $ 325,000 Unamortized debt issuance costs (475) (1,542) Total convertible notes payable (1) $ 324,525 $ 323,458 |
Schedule of interest expense | The interest expense incurred in connection with the Notes consisted of the following (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Coupon interest at 3.75% $ 3,047 $ 3,047 $ 9,141 $ 9,141 Amortization of debt issuance costs 356 356 1,068 1,068 Total interest expense on Notes $ 3,403 $ 3,403 $ 10,209 $ 10,209 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense | The Company recorded all stock-based compensation expense in the consolidated statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Cost of sales $ 51 $ — $ 51 $ — Research and development 16,107 21,860 52,692 70,429 General and administrative 15,389 23,414 49,782 81,028 Total stock-based compensation expense $ 31,547 $ 45,274 $ 102,525 $ 151,457 |
Schedule of option and appreciation rights activity | The following is a summary of stock options and SARs activity under the 2015 Plan and 2005 Plan for the nine months ended September 30, 2022: 2015 Plan 2005 Plan Stock Weighted-Average Stock Weighted-Average Outstanding at December 31, 2021 3,635,837 $ 42.60 68,225 $ 109.52 Granted 558,181 71.21 — — Exercised (132,420) 15.75 (3,000) 31.10 Canceled (61,364) 88.58 (1,500) 121.00 Outstanding at September 30, 2022 4,000,234 $ 46.78 63,725 $ 112.94 Shares exercisable at September 30, 2022 2,739,565 $ 39.72 63,725 $ 112.94 |
Schedule of assumptions used in estimation of fair value of stock | The fair value of stock options granted under the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Weighted average Black-Scholes fair value of stock options granted $37.66 $203.51 $60.24 $156.86 Risk-free interest rate 3.0%-3.6% 0.6%-0.9% 1.4%-3.6% 0.5%-1.1% Dividend yield —% —% —% —% Volatility 122.2%-136.4% 126.4%-140.0% 120.5%-136.7% 124.7%-142.0% Expected term (in years) 4.0-5.3 4.1-6.1 4.0-6.3 4.1-6.1 The ESPP is considered compensatory for financial reporting purposes. As such, the fair value of ESPP shares was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Range of Black-Scholes fair values of ESPP shares granted $23.59-$39.73 $83.47-$152.11 $23.59-$79.74 $83.47-$238.85 Risk-free interest rate 3.2%-3.3% 0.1%-0.2% 0.6%-3.3% 0.1%-0.2% Dividend yield —% —% —% —% Volatility 103.0%-114.8% 114.9%-150.6% 103.0%-142.9% 114.9%-159.4% Expected term (in years) 0.5-2.0 0.5-2.0 0.5-2.0 0.5-2.0 |
Schedule of share based compensation restricted stock awards activity | The following is a summary of RSU activity for the nine months ended September 30, 2022: Number of Per Share Outstanding and unvested at December 31, 2021 819,828 $ 116.70 Granted 1,113,958 68.49 Vested (379,802) 78.17 Forfeited (114,976) 110.59 Outstanding and unvested at September 30, 2022 1,439,008 $ 90.03 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Basis of Presentation (Details) $ in Millions | 9 Months Ended | |
Sep. 30, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Accounting Policies [Abstract] | ||
Foreign currency translation adjustment | $ | $ 23.8 | $ 1.4 |
Number of business segments | segment | 1 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) $ in Thousands, segment in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2022 USD ($) dose | Jun. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) dose | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) dose | Aug. 31, 2022 dose | Jul. 31, 2022 USD ($) dose segment | |
Revenue Recognition | |||||||||
Billed contracts receivable | $ | $ 43,600 | $ 43,600 | $ 419,700 | ||||||
Unbilled contracts receivable | $ | 68,000 | 68,000 | $ 35,300 | ||||||
Purchase agreement, number of vaccine doses | 60,000,000 | ||||||||
Revenues | $ | 734,577 | $ 178,844 | 1,624,473 | $ 924,090 | |||||
Milestone payment recognized | $ | $ 20,000 | ||||||||
Deferred revenue | $ | 202,500 | 202,500 | |||||||
Other Liabilities | |||||||||
Revenue Recognition | |||||||||
Deferred revenue | $ | $ 49,100 | 49,100 | |||||||
Amended and Restated UK Supply Agreement | Minimum | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 1,000,000 | ||||||||
Amended and Restated UK Supply Agreement | Maximum | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 15,000,000 | ||||||||
U.S. government partnership (“OWS”) | |||||||||
Revenue Recognition | |||||||||
Purchase agreement, number of vaccine doses | 3,000,000 | ||||||||
Number of doses of vaccine to be distributed | 200,000 | ||||||||
Additional purchase option, number of doses | segment | 9.8 | ||||||||
U.S. government partnership (“OWS”) | Maximum | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 100,000,000 | ||||||||
Coalition for Epidemic Preparedness Innovations (“CEPI”) | |||||||||
Revenue Recognition | |||||||||
Fund agreed by provider | $ | 399,500 | ||||||||
Granted funding | $ | 257,000 | ||||||||
Forgivable no-interest term loans | $ | $ 142,500 | ||||||||
Gavi Advance Purchase Agreement SIIPL | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 1,100,000,000 | ||||||||
Milestone payment recognized | $ | $ 350,000 | $ 350,000 | |||||||
Number of doses, initial order | 2,000,000 | 2,000,000 | |||||||
Gavi Advance Purchase Agreement- COVAX Facility | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 350,000,000 | ||||||||
Joint Committee on Vaccination and Immunization (JCVI) | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 44,000,000 | ||||||||
Collaboration agreement upfront payment amount | $ | $ 40,000 | $ 40,000 | $ 225,000 | ||||||
Deferred revenue | $ | $ 185,000 | $ 185,000 | |||||||
European Commissions ("EC") | |||||||||
Revenue Recognition | |||||||||
Purchase agreement, number of vaccine doses | 65,000,000 | 65,000,000 | |||||||
Number of doses of vaccine to be distributed | 100,000,000 | 100,000,000 | |||||||
Additional purchase option, number of doses | 100,000,000 | 100,000,000 | |||||||
Number of doses, cancelled | 5,000,000 | 5,000,000 | |||||||
Number of doses, remaining | 23,000,000 | 23,000,000 | |||||||
European Commissions ("EC") | Minimum | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 20,000,000 | 20,000,000 | |||||||
European Commissions ("EC") | Maximum | |||||||||
Revenue Recognition | |||||||||
Number of doses of vaccine to be distributed | 200,000,000 | 200,000,000 | |||||||
Sales-Based Royalties | |||||||||
Revenue Recognition | |||||||||
Revenues | $ | $ 1,300 | $ 39,900 | $ 10,500 | $ 63,400 | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-10-01 | |||||||||
Revenue Recognition | |||||||||
Amount of transaction price not yet satisfied | $ | $ 4,000,000 | $ 4,000,000 | |||||||
Remaining performance obligation, expected timing of satisfaction, period | 12 months | 12 months |
Revenue - Accounts Receivable,
Revenue - Accounts Receivable, Unbilled Services, and Deferred Revenue (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Accounts Receivable, Unbilled Services and Deferred Revenue [Roll Forward] | ||
Accounts receivable, beginning balance | $ 454,993 | |
Additions | 1,519,345 | |
Deductions | (1,862,693) | |
Accounts receivable, ending balance | 111,645 | |
Deferred Revenue Increase (Decrease) [Abstract] | ||
Deferred revenue, beginning balance | 1,595,472 | |
Additions | 96,298 | |
Deductions | (251,576) | |
Deferred revenue, ending balance | 1,440,194 | |
Current deferred revenue | 404,776 | $ 1,422,944 |
Noncurrent deferred revenue | 1,035,418 | $ 172,528 |
Revenue Recognition | ||
Deferred revenue | 202,500 | |
Other Liabilities | ||
Revenue Recognition | ||
Deferred revenue | $ 49,100 |
Revenue - Schedule of Revenue (
Revenue - Schedule of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue Recognition | ||||
Revenues | $ 734,577 | $ 178,844 | $ 1,624,473 | $ 924,090 |
Grants | ||||
Revenue Recognition | ||||
Revenues | 106,273 | 135,007 | 313,348 | 854,390 |
Grants | U.S. government partnership (“OWS”) | ||||
Revenue Recognition | ||||
Revenues | 104,348 | 96,215 | 311,423 | 699,268 |
Grants | U.S. Department of Defense (“DoD”) | ||||
Revenue Recognition | ||||
Revenues | 1,925 | 1,287 | 1,925 | 21,472 |
Grants | Coalition for Epidemic Preparedness Innovations (“CEPI”) | ||||
Revenue Recognition | ||||
Revenues | 0 | 37,505 | 0 | 131,022 |
Grants | Bill & Melinda Gates Foundation (“BMGF”) | ||||
Revenue Recognition | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 2,628 |
Collaboration, License, and S_2
Collaboration, License, and Supply Agreements (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) installment | Jun. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) installment | Sep. 30, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payment recognized | $ 20,000 | ||||
Research and development | $ 304,297 | $ 408,195 | $ 977,428 | $ 1,571,551 | |
Settlement Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Settlement payment | 185,000 | 185,000 | |||
Initial reservation fee | $ 47,800 | $ 47,800 | |||
Number of quarterly installment payments | installment | 4 | 4 | |||
Settlement agreement, quarterly installment amount | $ 34,300 | $ 34,300 | |||
Research and development | 98,300 | 98,300 | |||
Settlement Agreement | Accrued Liabilities | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Settlement payment | 102,900 | 102,900 | |||
Settlement Agreement | Other Noncurrent Liabilities | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Settlement agreement, quarterly installment amount | $ 34,300 | $ 34,300 |
Cash, Cash Equivalents, and R_3
Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 1,280,581 | $ 1,515,116 | ||
Restricted cash, current | 10,785 | 11,490 | ||
Restricted cash, non-current | 1,656 | 1,653 | ||
Cash, cash equivalents, and restricted cash | $ 1,293,022 | $ 1,528,259 | $ 1,946,826 | $ 648,738 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Level 1 | ||
Assets | ||
Total cash equivalents | $ 365,631 | $ 361,822 |
Liabilities | ||
Convertible notes payable | 0 | 0 |
Level 1 | Money market funds | ||
Assets | ||
Total cash equivalents | 365,631 | 361,822 |
Level 1 | Government-backed securities | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 1 | Corporate debt securities | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 1 | Agency securities | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 2 | ||
Assets | ||
Total cash equivalents | 413,691 | 1,056,922 |
Liabilities | ||
Convertible notes payable | 317,044 | 447,509 |
Level 2 | Money market funds | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 2 | Government-backed securities | ||
Assets | ||
Total cash equivalents | 261,000 | 266,250 |
Level 2 | Corporate debt securities | ||
Assets | ||
Total cash equivalents | 109,914 | 790,672 |
Level 2 | Agency securities | ||
Assets | ||
Total cash equivalents | 42,777 | 0 |
Level 3 | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Liabilities | ||
Convertible notes payable | 0 | 0 |
Level 3 | Money market funds | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 3 | Government-backed securities | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 3 | Corporate debt securities | ||
Assets | ||
Total cash equivalents | 0 | 0 |
Level 3 | Agency securities | ||
Assets | ||
Total cash equivalents | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 17,557,000 | $ 17,557,000 | $ 8,872,000 |
Semi-finished goods | 33,030,000 | 33,030,000 | 0 |
Finished goods | 31,845,000 | 31,845,000 | 0 |
Total inventory | 82,432,000 | 82,432,000 | 8,872,000 |
Provision for excess and obsolete inventory | 202,400,000 | 358,100,000 | 0 |
Firm purchase commitment loss | $ 46,600,000 | $ 146,200,000 | $ 0 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Identifiable Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | $ 11,799 | $ 8,239 |
Accumulated Amortization | (3,343) | (3,469) |
Intangible Assets, Net | 8,456 | 4,770 |
Proprietary adjuvant technology | ||
Finite-lived intangible assets: | ||
Gross Carrying Amount | 6,911 | 8,239 |
Accumulated Amortization | (3,069) | (3,469) |
Intangible Assets, Net | 3,842 | 4,770 |
Internal-use software | ||
Finite-lived intangible assets: | ||
Gross Carrying Amount | 4,888 | 0 |
Accumulated Amortization | (274) | 0 |
Intangible Assets, Net | 4,614 | $ 0 |
Assets Under Development | $ 3,600 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Identifiable Intangible Assets, estimated amortization (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 600 | $ 300 |
Amortization expense, fiscal year maturity | ||
2022 (remainder) | 189 | |
2023 | 756 | |
2024 | 740 | |
2025 | 392 | |
2026 | 335 | |
2027 | $ 335 |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill - Goodwill (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Goodwill [Roll Forward] | |
Beginning balance | $ 131,479 |
Currency translation adjustments | (13,944) |
Ending balance | $ 117,535 |
Leases (Details)
Leases (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2020 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Right of use assets and lease liabilities obtained, operating lease | $ 44,000 | |||||
Long-term supply agreement, incremental borrowing rate | 5% | 5% | ||||
Short-term lease (benefit) expense | $ (46,600) | $ 111,300 | $ 37,300 | $ 325,500 | ||
Research and development | 304,297 | 408,195 | 977,428 | 1,571,551 | ||
Lease expense | 24,200 | 4,400 | 17,100 | |||
Interest expense | 900 | $ 1,600 | 4,300 | $ 5,600 | ||
Right of use asset, net | 108,543 | 108,543 | $ 40,123 | |||
700 Quince Orchard Road Agreement | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Lease expense | $ 5,800 | |||||
Facility, number of square feet | ft² | 170,000 | |||||
Operating lease term | 15 years | |||||
Right of use asset, net | 73,200 | 73,200 | ||||
Lease obligation | 73,200 | 73,200 | ||||
Settlement Agreement | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Research and development | $ 98,300 | $ 98,300 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2016 | Sep. 30, 2022 | Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |||
Debt issuance costs | $ 10,000 | ||
Face amount | 325,000 | $ 325,000 | $ 325,000 |
Deferred issuance costs | $ 10,000 | ||
Term | 7 years |
Debt - Notes Payable (Details)
Debt - Notes Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Mar. 31, 2016 |
Debt Disclosure [Abstract] | |||
Principal amount of Notes | $ 325,000 | $ 325,000 | $ 325,000 |
Unamortized debt issuance costs | (475) | (1,542) | |
Total convertible notes payable | $ 324,525 | $ 323,458 |
Debt - Interest Expense (Detail
Debt - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Disclosure [Abstract] | ||||
Coupon interest at 3.75% | $ 3,047 | $ 3,047 | $ 9,141 | $ 9,141 |
Amortization of debt issuance costs | 356 | 356 | 1,068 | 1,068 |
Total interest expense on Notes | $ 3,403 | $ 3,403 | $ 10,209 | $ 10,209 |
Coupon interest rate | 3.75% | 3.75% |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stockholders' Equity | ||||
Proceeds from shares sold, net | $ 179,385 | $ 564,859 | ||
Remaining unissued capital | $ 318,000 | |||
Common Stock | ||||
Stockholders' Equity | ||||
Issued (in shares) | 2,200,000 | 2,197,398 | 2,578,967 | |
Proceeds from shares sold, net | $ 500,000 | $ 22 | $ 26 | |
Additional Paid-in Capital | ||||
Stockholders' Equity | ||||
Proceeds from shares sold, net | $ 179,000 | $ 179,363 | $ 564,833 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2015 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Stock-Based Compensation | ||||
Stock-based compensation capitalized | $ 1.8 | $ 0 | ||
Unrecognized compensation expense | $ 189 | |||
Unrecognized compensation expense, recognition period | 1 year | |||
Aggregate intrinsic value, stock options and vesting RSA's | $ 19 | $ 381 | ||
Aggregate intrinsic value, outstanding | $ 9 | |||
Remaining term, outstanding (in years) | 7 years 4 months 24 days | |||
Aggregate intrinsic value, exercisable | $ 5 | |||
Remaining term, exercisable (in years) | 7 years | |||
ESPP | ||||
Stock-Based Compensation | ||||
Authorized (in shares) | 1,650,000 | |||
Additional shares authorized (in shares) | 1,100,000 | |||
Shares available for grant (in shares) | 700,000 | |||
Percentage increase of shares each anniversary | 5% | |||
Subscription rate cap | 15% | |||
Maximum discount rate | 85% | |||
2015 Plan | ||||
Stock-Based Compensation | ||||
Authorized (in shares) | 14,800,000 | |||
Additional shares authorized (in shares) | 2,400,000 | |||
Shares available for grant (in shares) | 4,600,000 | |||
Term (in years) | 10 years | |||
Minimum grant price, percent of common stock fair value | 100% | |||
2015 Plan | Minimum | ||||
Stock-Based Compensation | ||||
Vesting period | 1 year | |||
2015 Plan | Maximum | ||||
Stock-Based Compensation | ||||
Vesting period | 4 years |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Compensation expense: | ||||
Total stock-based compensation expense | $ 31,547 | $ 45,274 | $ 102,525 | $ 151,457 |
Cost of sales | ||||
Compensation expense: | ||||
Total stock-based compensation expense | 51 | 0 | 51 | 0 |
Research and development | ||||
Compensation expense: | ||||
Total stock-based compensation expense | 16,107 | 21,860 | 52,692 | 70,429 |
General and administrative | ||||
Compensation expense: | ||||
Total stock-based compensation expense | $ 15,389 | $ 23,414 | $ 49,782 | $ 81,028 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options and Appreciation Rights (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
2015 Plan | |
Stock Options | |
Outstanding, beginning balance (in shares) | shares | 3,635,837 |
Granted (in shares) | shares | 558,181 |
Exercised (in shares) | shares | (132,420) |
Canceled (in shares) | shares | (61,364) |
Outstanding, ending balance (in shares) | shares | 4,000,234 |
Shares exercisable (in shares) | shares | 2,739,565 |
Weighted-Average Exercise Price | |
Outstanding, beginning balance (in usd per share) | $ / shares | $ 42.60 |
Granted (in usd per share) | $ / shares | 71.21 |
Exercised (in usd per share) | $ / shares | 15.75 |
Canceled (in usd per share) | $ / shares | 88.58 |
Outstanding, ending balance (in usd per share) | $ / shares | 46.78 |
Shares exercisable (in usd per share) | $ / shares | $ 39.72 |
2005 Plan | |
Stock Options | |
Outstanding, beginning balance (in shares) | shares | 68,225 |
Granted (in shares) | shares | 0 |
Exercised (in shares) | shares | (3,000) |
Canceled (in shares) | shares | (1,500) |
Outstanding, ending balance (in shares) | shares | 63,725 |
Shares exercisable (in shares) | shares | 63,725 |
Weighted-Average Exercise Price | |
Outstanding, beginning balance (in usd per share) | $ / shares | $ 109.52 |
Granted (in usd per share) | $ / shares | 0 |
Exercised (in usd per share) | $ / shares | 31.10 |
Canceled (in usd per share) | $ / shares | 121 |
Outstanding, ending balance (in usd per share) | $ / shares | 112.94 |
Shares exercisable (in usd per share) | $ / shares | $ 112.94 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Options and Appreciation Rights, Assumptions (Details) - Stock options - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value | ||||
Weighted average Black-Scholes fair value of stop options and SARs granted (in usd per share) | $ 37.66 | $ 203.51 | $ 60.24 | $ 156.86 |
Risk-free interest rate, minimum | 3% | 0.60% | 1.40% | 0.50% |
Risk-free interest rate, maximum | 3.60% | 0.90% | 3.60% | 1.10% |
Dividend yield | 0% | 0% | 0% | 0% |
Volatility, minimum | 122.20% | 126.40% | 120.50% | 124.70% |
Volatility, maximum | 136.40% | 140% | 136.70% | 142% |
Minimum | ||||
Fair Value | ||||
Expected term (in years) | 4 years | 4 years 1 month 6 days | 4 years | 4 years 1 month 6 days |
Maximum | ||||
Fair Value | ||||
Expected term (in years) | 5 years 3 months 18 days | 6 years 1 month 6 days | 6 years 3 months 18 days | 6 years 1 month 6 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units (Details) - Restricted stock units | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of Shares | |
Outstanding and Unvested, beginning balance (in shares) | shares | 819,828 |
Restricted stock units granted (in shares) | shares | 1,113,958 |
Restricted stock units vested (in shares) | shares | (379,802) |
Restricted stock units forfeited (in shares) | shares | (114,976) |
Outstanding and Unvested, ending balance (in shares) | shares | 1,439,008 |
Per Share Weighted- Average Fair Value | |
Outstanding and Unvested, beginning balance (in usd per share) | $ / shares | $ 116.70 |
Restricted stock units granted (in usd per share) | $ / shares | 68.49 |
Restricted stock units vested (in usd per share) | $ / shares | 78.17 |
Restricted stock units forfeited (in usd per share) | $ / shares | 110.59 |
Outstanding and Unvested, ending balance (in usd per share) | $ / shares | $ 90.03 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) - ESPP - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value | ||||
Risk-free interest rate, minimum | 3.20% | 0.10% | 0.60% | 0.10% |
Risk-free interest rate, maximum | 3.30% | 0.20% | 3.30% | 0.20% |
Dividend yield | 0% | 0% | 0% | 0% |
Volatility, minimum | 103% | 114.90% | 103% | 114.90% |
Volatility, maximum | 114.80% | 150.60% | 142.90% | 159.40% |
Minimum | ||||
Fair Value | ||||
Range of Black-Scholes fair values of ESPP shares granted (in usd per share) | $ 23.59 | $ 83.47 | $ 23.59 | $ 83.47 |
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
Maximum | ||||
Fair Value | ||||
Range of Black-Scholes fair values of ESPP shares granted (in usd per share) | $ 39.73 | $ 152.11 | $ 79.74 | $ 238.85 |
Expected term (in years) | 2 years | 2 years | 2 years | 2 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Federal, state and local, tax expense (benefit) | $ 2,400,000 | $ 0 | $ 4,300,000 | $ 0 |
Foreign income tax expense (benefit) | $ 100,000 | $ 6,000,000 | $ 2,300,000 | $ 12,600,000 |