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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2023
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to .
Commission File No. 000-26770
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | |
Delaware | 22-2816046 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
700 Quince Orchard Road, | Gaithersburg, | MD | 20878 |
(Address of principal executive offices) | (Zip code) |
(240) 268-2000
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, Par Value $0.01 per share | NVAX | The Nasdaq Global Select Market |
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | |
Large accelerated filer | x | Accelerated Filer | o |
| | | |
Non-accelerated filer | o | Smaller reporting company | o |
| | | |
Emerging growth company | o | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x
The number of shares outstanding of the Registrant's Common Stock, $0.01 par value, was 118,790,222 as of October 31, 2023.
NOVAVAX, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| For the Three Months Ended September 30, | | For the Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Revenue: | | | | | | | |
Product sales | $ | 2,231 | | | $ | 626,091 | | | $ | 279,937 | | | $ | 1,267,174 | |
Grants | 164,922 | | | 106,273 | | | 389,380 | | | 313,348 | |
Royalties and other | 19,833 | | | 2,213 | | | 23,046 | | | 43,951 | |
Total revenue | 186,986 | | | 734,577 | | | 692,363 | | | 1,624,473 | |
| | | | | | | |
Expenses: | | | | | | | |
Cost of sales | 98,929 | | | 434,593 | | | 188,792 | | | 720,874 | |
Research and development | 106,229 | | | 304,297 | | | 572,805 | | | 977,428 | |
Selling, general, and administrative | 107,460 | | | 122,876 | | | 313,709 | | | 327,028 | |
Total expenses | 312,618 | | | 861,766 | | | 1,075,306 | | | 2,025,330 | |
Loss from operations | (125,632) | | | (127,189) | | | (382,943) | | | (400,857) | |
Other income (expense): | | | | | | | |
| | | | | | | |
Interest expense | (2,859) | | | (4,169) | | | (10,299) | | | (15,279) | |
Other income (expense) | (2,982) | | | (34,783) | | | 26,912 | | | (53,002) | |
Loss before income taxes | (131,473) | | | (166,141) | | | (366,330) | | | (469,138) | |
Income tax expense (benefit) | (697) | | | 2,472 | | | 343 | | | 6,552 | |
Net loss | $ | (130,776) | | | $ | (168,613) | | | $ | (366,673) | | | $ | (475,690) | |
| | | | | | | |
Net loss per share: | | | | | | | |
Basic and diluted | $ | (1.26) | | | $ | (2.15) | | | $ | (3.94) | | | $ | (6.13) | |
| | | | | | | |
Weighted average number of common shares outstanding | | | | | | | |
Basic and diluted | 103,429 | | | 78,274 | | | 93,046 | | | 77,631 | |
| | | | | | | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| For the Three Months Ended September 30, | | For the Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Net loss | $ | (130,776) | | | $ | (168,613) | | | $ | (366,673) | | | $ | (475,690) | |
Other comprehensive loss: | | | | | | | |
Foreign currency translation adjustment | (3,686) | | | (12,924) | | | (5,486) | | | (22,441) | |
Other comprehensive loss | (3,686) | | | (12,924) | | | (5,486) | | | (22,441) | |
Comprehensive loss | $ | (134,462) | | | $ | (181,537) | | | $ | (372,159) | | | $ | (498,131) | |
The accompanying notes are an integral part of these financial statements.
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
| (unaudited) | | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 651,104 | | | $ | 1,336,883 | |
| | | |
Restricted cash | 10,393 | | | 10,303 | |
Accounts receivable | 123,657 | | | 82,375 | |
Inventory | 69,592 | | | 36,683 | |
Prepaid expenses and other current assets | 152,018 | | | 237,147 | |
Total current assets | 1,006,764 | | | 1,703,391 | |
Property and equipment, net | 300,982 | | | 294,247 | |
Right of use asset, net | 190,741 | | | 106,241 | |
| | | |
Goodwill | 123,780 | | | 126,331 | |
Other non-current assets | 34,890 | | | 28,469 | |
Total assets | $ | 1,657,157 | | | $ | 2,258,679 | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | | | |
Current liabilities: | | | |
Accounts payable | $ | 101,914 | | | $ | 216,517 | |
Accrued expenses | 311,201 | | | 591,158 | |
Deferred revenue | 192,187 | | | 370,137 | |
Current portion of finance lease liabilities | 1,332 | | | 27,196 | |
Convertible notes payable | — | | | 324,881 | |
Other current liabilities | 861,956 | | | 930,055 | |
Total current liabilities | 1,468,590 | | | 2,459,944 | |
Deferred revenue | 608,842 | | | 179,414 | |
Convertible notes payable | 167,621 | | | 166,466 | |
Non-current finance lease liabilities | 53,158 | | | 31,238 | |
Other non-current liabilities | 37,296 | | | 55,695 | |
Total liabilities | 2,335,507 | | | 2,892,757 | |
| | | |
Commitments and contingencies (Note 14) | | | |
| | | |
Preferred stock, $0.01 par value, 2,000,000 shares authorized at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | — | | | — | |
| | | |
Stockholders' deficit: | | | |
Common stock, $0.01 par value, 600,000,000 shares authorized at September 30, 2023 and December 31, 2022; 119,641,667 shares issued and 118,730,398 shares outstanding at September 30, 2023 and 86,806,554 shares issued and 86,039,923 shares outstanding at December 31, 2022 | 1,196 | | | 868 | |
Additional paid-in capital | 4,066,585 | | | 3,737,979 | |
Accumulated deficit | (4,642,562) | | | (4,275,889) | |
Treasury stock, cost basis, 911,269 shares at September 30, 2023 and 766,631 shares at December 31, 2022 | (91,706) | | | (90,659) | |
Accumulated other comprehensive loss | (11,863) | | | (6,377) | |
Total stockholders’ deficit | (678,350) | | | (634,078) | |
Total liabilities and stockholders’ deficit | $ | 1,657,157 | | | $ | 2,258,679 | |
The accompanying notes are an integral part of these financial statements.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT
Three and Nine Ended September 30, 2023 and 2022
(in thousands, except share information)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Deficit | | Treasury Stock | | Accumulated Other Comprehensive Loss | | Total Stockholders' Deficit |
| Shares | | Amount | | | | | |
Balance at June 30, 2023 | 95,183,750 | | | $ | 952 | | | $ | 3,855,916 | | | $ | (4,511,786) | | | $ | (91,424) | | | $ | (8,177) | | | $ | (754,519) | |
Stock-based compensation | — | | | — | | | 21,254 | | | — | | | — | | | — | | | 21,254 | |
Stock issued under incentive programs | 176,329 | | | 2 | | | 634 | | | — | | | (282) | | | — | | | 354 | |
Issuance of common stock, net of issuance costs $3,063 | 24,281,588 | | | 242 | | | 188,781 | | | — | | | — | | | — | | | 189,023 | |
Foreign currency translation adjustment | — | | | — | | | — | | | — | | | — | | | (3,686) | | | (3,686) | |
Net loss | — | | | — | | | — | | | (130,776) | | | — | | | — | | | (130,776) | |
Balance at September 30, 2023 | 119,641,667 | | | $ | 1,196 | | | $ | 4,066,585 | | | $ | (4,642,562) | | | $ | (91,706) | | | $ | (11,863) | | | $ | (678,350) | |
| | | | | | | | | | | | | |
Balance at June 30, 2022 | 78,776,234 | | | $ | 788 | | | $ | 3,604,614 | | | $ | (3,925,027) | | | $ | (86,455) | | | $ | (10,870) | | | $ | (416,950) | |
Stock-based compensation | — | | | — | | | 33,386 | | | — | | | — | | | — | | | 33,386 | |
Stock issued under incentive programs | 428,275 | | | 4 | | | 2,597 | | | — | | | (3,485) | | | — | | | (884) | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Foreign currency translation adjustment | — | | | — | | | — | | | — | | | — | | | (12,924) | | | (12,924) | |
Net loss | — | | | — | | | — | | | (168,613) | | | — | | | — | | | (168,613) | |
Balance at September 30, 2022 | 79,204,509 | | | $ | 792 | | | $ | 3,640,597 | | | $ | (4,093,640) | | | $ | (89,940) | | | $ | (23,794) | | | $ | (565,985) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Deficit | | Treasury Stock | | Accumulated Other Comprehensive Loss | | Total Stockholders' Deficit |
| Shares | | Amount | | | | | |
Balance at December 31, 2022 | 86,806,554 | | | $ | 868 | | | $ | 3,737,979 | | | $ | (4,275,889) | | | $ | (90,659) | | | $ | (6,377) | | | $ | (634,078) | |
Stock-based compensation | — | | | — | | | 70,193 | | | — | | | — | | | — | | | 70,193 | |
Stock issued under incentive programs | 605,571 | | | 6 | | | 1,740 | | | — | | | (1,047) | | | — | | | 699 | |
Issuance of common stock, net of issuance costs of $3,924 | 32,229,542 | | | 322 | | | 256,673 | | | — | | | — | | | — | | | 256,995 | |
Foreign currency translation adjustment | — | | | — | | | — | | | — | | | — | | | (5,486) | | | (5,486) | |
Net loss | — | | | — | | | — | | | (366,673) | | | — | | | — | | | (366,673) | |
Balance at September 30, 2023 | 119,641,667 | | | $ | 1,196 | | | $ | 4,066,585 | | | $ | (4,642,562) | | | $ | (91,706) | | | $ | (11,863) | | | $ | (678,350) | |
| | | | | | | | | | | | | |
Balance at December 31, 2021 | 76,433,151 | | | $ | 764 | | | $ | 3,351,967 | | | $ | (3,617,950) | | | $ | (85,101) | | | $ | (1,353) | | | $ | (351,673) | |
Stock-based compensation | — | | | — | | | 104,367 | | | — | | | — | | | — | | | 104,367 | |
Stock issued under incentive programs | 573,960 | | | 6 | | | 4,900 | | | — | | | (4,839) | | | — | | | 67 | |
Issuance of common stock, net of issuance costs of $2,311 | 2,197,398 | | | 22 | | | 179,363 | | | — | | | — | | | — | | | 179,385 | |
Foreign currency translation adjustment | — | | | — | | | — | | | — | | | — | | | (22,441) | | | (22,441) | |
Net loss | — | | | — | | | — | | | (475,690) | | | — | | | — | | | (475,690) | |
Balance at September 30, 2022 | 79,204,509 | | | $ | 792 | | | $ | 3,640,597 | | | $ | (4,093,640) | | | $ | (89,940) | | | $ | (23,794) | | | $ | (565,985) | |
The accompanying notes are an integral part of these financial statements.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Operating Activities: | | | |
Net loss | $ | (366,673) | | | $ | (475,690) | |
Reconciliation of net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 30,431 | | | 21,832 | |
| | | |
Non-cash stock-based compensation | 69,699 | | | 102,525 | |
Provision for excess and obsolete inventory | 49,533 | | | 358,075 | |
Impairment of long-lived assets | 10,081 | | | — | |
Right-of-use assets expensed, net of credits received | — | | | 40,187 | |
Other items, net | (3,015) | | | (25,059) | |
Changes in operating assets and liabilities: | | | |
Inventory | (82,542) | | | (426,466) | |
Accounts receivable, prepaid expenses, and other assets | (34,418) | | | 171,325 | |
Accounts payable, accrued expenses, and other liabilities | (349,261) | | | 90,418 | |
Deferred revenue | 138,979 | | | (155,268) | |
Net cash used in operating activities | (537,186) | | | (298,121) | |
| | | |
Investing Activities: | | | |
Capital expenditures | (44,932) | | | (66,033) | |
Internal-use software | (4,796) | | | (4,888) | |
Net cash used in investing activities | (49,728) | | | (70,921) | |
| | | |
Financing Activities: | | | |
Net proceeds from sales of common stock | 256,995 | | | 179,385 | |
Net proceeds from the exercise of stock-based awards | 699 | | | 67 | |
Finance lease payments | (25,026) | | | (45,904) | |
Repayment of 2023 Convertible notes | (325,000) | | | — | |
Payments of costs related to issuance of 2027 Convertible notes | (3,591) | | | — | |
Net cash provided by (used in) financing activities | (95,923) | | | 133,548 | |
Effect of exchange rate on cash, cash equivalents, and restricted cash | 355 | | | 257 | |
Net decrease in cash, cash equivalents, and restricted cash | (682,482) | | | (235,237) | |
Cash, cash equivalents, and restricted cash at beginning of period | 1,348,845 | | | 1,528,259 | |
Cash, cash equivalents, and restricted cash at end of period | $ | 666,363 | | | $ | 1,293,022 | |
| | | |
Supplemental disclosure of non-cash activities: | | | |
| | | |
| | | |
| | | |
Right-of-use assets from new lease agreements | $ | 96,492 | | | $ | 118,262 | |
Capital expenditures included in accounts payable and accrued expenses | $ | 2,394 | | | $ | 11,984 | |
Internal-use software included in accounts payable and accrued expenses | $ | 167 | | | $ | — | |
| | | |
Supplemental disclosure of cash flow information: | | | |
Cash interest payments, net of amounts capitalized | $ | 11,751 | | | $ | 17,260 | |
Cash paid for income taxes | $ | 128 | | | $ | 17,843 | |
The accompanying notes are an integral part of these financial statements.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2023
(unaudited)
Note 1 – Organization and Business
Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is a biotechnology company that promotes improved health by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and patented Matrix-M™ adjuvant to enhance the immune response. Novavax currently has one commercial program, for vaccines to prevent COVID-19, which includes Nuvaxovid prototype COVID-19 vaccine ("NVX-CoV2373,” or “prototype vaccine”) and Nuvaxovid updated COVID-19 vaccine (“NVX-CoV2601,” or “updated vaccine”) (collectively, “COVID-19 Program,” or “COVID-19 Vaccine”). Local authorities have also specified nomenclature for the prototype and updated vaccines within their labeling (“Novavax COVID-19 Vaccine, Adjuvanted” and “Novavax COVID-19, Adjuvanted (2023-2024 Formula), respectively, for the U.S.). The Company’s partner, Serum Institute of India Pvt. Ltd. (“SIIPL”), markets NVX-CoV2373 as “Covovax™.”
Beginning in 2022, the Company received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for its prototype vaccine for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications in select territories. In October 2023, the U.S. Food and Drug Administration (“U.S. FDA”) amended the EUA for its prototype vaccine to include its updated vaccine. The amended EUA authorizes use of the Company’s updated vaccine in individuals 12 years and older. In October 2023, the European Commission (“EC”) granted approval for the Company’s updated vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. The Company exclusively depends on its supply agreement with SIIPL and its subsidiary, Serum Life Sciences Limited (“SLS”), for co-formulation, filling and finishing (other than in Europe) and on its service agreement with PCI Pharma Services for finishing in Europe. The Company plans to rely on these arrangements to supply its updated vaccine during the 2023-2024 vaccination season and subsequently (see Note 4).
Novavax is advancing development of other vaccine candidates, including its influenza vaccine candidate, its COVID19-Influenza Combination (“CIC”) vaccine candidate and additional vaccine candidates. The Company’s COVID-19 Program and its 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.
Note 2 – 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’ 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 $11.9 million and $6.4 million at September 30, 2023 and December 31, 2022, respectively. The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $12.2 million loss and a $3.9 million gain, and a $38.6 million loss and $59.6 million loss for the three and nine months ended September 30, 2023 and 2022, respectively, which are reflected in Other income (expense).
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, 2022. 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.
Liquidity and Going Concern
The accompanying unaudited consolidated financial statements have been prepared assuming, subject to the disclosures herein, that the Company will continue as a going concern within one year after the date that the financial statements are issued. In addition, as of September 30, 2023, the Company had $666.4 million in cash and cash equivalents and restricted cash. Pursuant to the June 2023 Amendment to the advance purchase agreement between the Company and the Canadian government (the “Canada APA”), the Company expects to receive the second installment of $174.8 million from the Canadian government that is contingent and payable upon the Company’s delivery of vaccine doses in the fourth quarter of 2023 (see Note 3). During the nine months ended September 30, 2023, the Company incurred a net loss of $366.7 million and had net cash flows used in operating activities of $537.2 million.
In accordance with Accounting Standards Codification 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued. While the Company’s current cash flow forecast for the one-year going concern look forward period estimates that there will be sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to revenue for the next 12 months, the Company’s ability to execute on certain cost-cutting initiatives and a pending matter subject to arbitration proceedings. The Company’s revenue projections depend on its ability to successfully manufacture, distribute and market its updated vaccine for the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the Company’s ability to obtain regulatory authorizations, the incidence of COVID-19 during the 2023-2024 vaccination season, the Company’s ability to timely deliver doses and achieve commercial adoption and market acceptance of its updated vaccine.
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 advance purchase agreements (“APAs”) may require the Company to refund portions of upfront and other payments or result in reduced future payments which would adversely affect the Company’s ability to continue as a going concern. For example, if the Company fails to deliver its updated vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. In addition, the Canadian government may terminate the Canada APA if the Company fails to achieve regulatory approval for use of the Biologics Manufacturing Centre, Inc. (“BMC”) for COVID-19 Vaccine production on or before December 31, 2024. Also, if the Company does not timely achieve supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”) with respect to use of its COVID-19 Program for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom, then the Company would be required to repay up to $112.5 million related to the upfront payment previously received from the Authority under the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the Company and the Authority. On January 24, 2023, Gavi, the Vaccine Alliance (“Gavi”) filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by the Company of the Company’s APA with Gavi (the “Gavi APA”). The arbitration hearing is scheduled for July 2024, with a written decision to follow. The outcome of that arbitration is inherently uncertain, and it is possible the Company could be required to refund all or a portion of the remaining advance payments of $696.4 million as of September 30, 2023 (see Note 3 and Note 14).
Management believes that, given the significance of these uncertainties, substantial doubt exists regarding the Company’s ability to continue as a going concern through one year from the date that these financial statements are issued.
In May 2023, the Company announced a global restructuring and cost reduction plan (the “Restructuring Plan”), which includes a more focused investment in its COVID-19 Program, reduction to its pipeline spending, the continued rationalization of its manufacturing network, a reduction to the Company’s global workforce, as well as the consolidation of facilities, and infrastructure. The workforce reduction plan included an approximately 25% reduction in the Company’s global workforce, comprised of an approximately 20% reduction in full-time Novavax employees and the remainder comprised of contractors and consultants. The Company has decided to progress its CIC vaccine candidate toward late-stage development and, as such, is assessing the impact on its workforce requirements. The Company expects the full annual impact of the cost savings from the Restructuring Plan to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which the Company operates. During the nine months ended September 30, 2023, the Company recorded a charge of $4.5 million related to one-time employee severance and benefit costs and recorded an impairment charge of $10.1 million related to the consolidation of facilities and infrastructure (see Note 15).
The Company’s ability to fund Company operations is dependent upon revenue related to vaccine sales for its products and product candidates, if such product candidates receive marketing approval and are successfully commercialized, and in particular the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the incidence of COVID-19 during the 2023-2024 vaccination season, regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance of its updated vaccine, the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved, and management’s plans, which includes cost reductions associated with the Restructuring Plan. Management’s plans may also include raising additional capital through a combination of equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements. New financings may not be available to the Company on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of the Company’s COVID-19 Program and the Company’s other vaccine candidates, including an influenza vaccine candidate, and a CIC vaccine candidate, remains uncertain. Also, the impact of the Company’s more focused investment in its COVID-19 Program, reduction to its pipeline spending, continued rationalization of its manufacturing network, reduction to its global workforce, and consolidation of its facilities and infrastructure remain uncertain. If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, or further downsize its organization, any of which may have a material adverse effect on its business, financial condition, results of operations, and ability to operate as a going concern.
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 Constraints
The Company constrains the transaction price for customer arrangements until it is probable that a significant reversal in cumulative revenue recognized will not occur. Specifically, if a customer arrangement includes a provision whereby the customer may request a discount, return, or refund for a previously satisfied performance obligation or otherwise could have the effect of decreasing the transaction price, revenue is constrained based on an estimate of the impact to the transaction price recognized until it is probable that a significant reversal in cumulative revenue recognized will not occur.
Restructuring
The Company recognizes restructuring charges when such costs are incurred. The Company’s restructuring charges consist of employee severance and other termination benefits related to the reduction of its workforce, the consolidation of facilities, and infrastructure and other costs. Termination benefits are expensed on the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. Ongoing benefits are expensed when restructuring activities are probable and the benefit estimable.
See Note 15 for additional information on the severance and employee benefit costs for terminated employees and impairment of assets in connection with the Company’s Restructuring Plan.
Recent Accounting Pronouncements
Adopted
In June 2016, the Financial Accounting Standards Board 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” 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 Company adopted ASU 2020-06 on January 1, 2023, using a modified retrospective approach, and it did not have a material impact on the Company’s consolidated financial statements.
Note 3 – Revenue
The Company's accounts receivable included $71.1 million and $53.8 million related to amounts that were billed to customers and $52.6 million and $28.6 million related to amounts which had not yet been billed to customers as of September 30, 2023 and December 31, 2022, respectively. During the nine months ended September 30, 2023, and 2022, changes in the Company’s accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Balance, Beginning of Period | | Additions | | Deductions | | Balance, End of Period |
Accounts receivable: | | | | | | | |
Nine Months Ended September 30, 2023 | $ | 96,210 | | | $ | 981,305 | | | $ | (946,182) | | | $ | 131,333 | |
Nine Months Ended September 30, 2022 | 454,993 | | | 1,519,345 | | | (1,862,693) | | | 111,645 | |
Allowance for doubtful accounts(1): | | | | | | | |
Nine Months Ended September 30, 2023 | $ | (13,835) | | | $ | — | | | $ | 6,159 | | | $ | (7,676) | |
Nine Months Ended September 30, 2022 | — | | | — | | | — | | | — | |
Deferred revenue:(2) | | | | | | | |
Nine Months Ended September 30, 2023 | $ | 549,551 | | | $ | 422,766 | | | $ | (171,288) | | | $ | 801,029 | |
Nine Months Ended September 30, 2022 | 1,595,472 | | | 96,298 | | | (251,576) | | | 1,440,194 | |
(1) There was no bad debt expense recorded during the three and nine months ended September 30, 2023 or 2022. There was a $6.2 million reversal of a bad debt allowance during the nine months ended September 30, 2023 due to the collection of a previously recognized allowance for doubtful accounts. To estimate the allowance for doubtful accounts, the Company evaluates the credit risk related to its customers based on historical loss experience, economic conditions, the aging of receivables, and customer-specific risks.
(2) Deductions from Deferred revenue generally related to the recognition of revenue once performance obligations on a contract with a customer are met. During the three and nine months ended September 30, 2023, deductions included a $112.5 million reclassification of refundable upfront payments previously included in Deferred revenue to Other current liabilities. There were no such reclassifications during the three and nine months ended September 30, 2022.
As of September 30, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, the Gavi APA, and the reduction in doses related to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement, dated as of July 1, 2022 (as amended on September 26, 2022, the “Amended and Restated UK Supply Agreement”) between the Company and the Authority, which amended and restated the Original UK Supply Agreement, was approximately $2 billion of which $801.0 million was included in Deferred revenue. 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 advance purchase agreements may require the Company to refund portions of upfront and other 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. The timing to fulfill performance obligations related to APAs will depend on the 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 the Company’s updated vaccine in place of the prototype vaccine under certain of the Company’s APAs.
Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of the prototype vaccine were to be made available to countries participating in the COVAX Facility. The Company expected to manufacture and distribute 350 million doses of the prototype vaccine to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL was expected to manufacture and deliver the balance of the 1.1 billion doses of the prototype vaccine for low- and middle-income countries participating in the COVAX Facility. The Company expected to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with Coalition for Epidemic Preparedness Innovations (“CEPI”), with initial doses supplied by SIIPL and SLS under a supply agreement. The Company expected to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi could prioritize such doses to low- and middle- income countries, at lower prices. Additionally, the Company could provide additional doses of prototype vaccine, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL could not materially deliver expected vaccine doses to the COVAX Facility. Under the agreement, the Company received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to the Company’s achieving an emergency use license for the Company’s prototype vaccine by the World Health Organization (“WHO”) (the “Advance Payment Amount”). The Company maintains that its termination of the Advance Payment Amount was valid and denies that Gavi is entitled to a refund.
On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of the Company’s prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.
Product Sales
Product sales by the Company’s customer’s geographic location was as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | Nine Months Ended September 30, |
| 2023 | | 2022 | 2023 | | 2022 |
North America | $ | 2,231 | | | $ | 129,718 | | $ | 2,231 | | | $ | 194,480 | |
Europe | — | | | 347,005 | | 59,322 | | | 760,750 | |
Rest of the world | — | | | 149,368 | | 218,384 | | | 311,944 | |
Total product sales revenue | $ | 2,231 | | | $ | 626,091 | | $ | 279,937 | | | $ | 1,267,174 | |
In May 2023, the Company extended a credit for certain doses delivered in 2022 that qualified for replacement under the contract with the Australian government. This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market. The credit will be applied against the future sale of doses to the customer and, during the nine months ended September 30, 2023, the Company recorded a reduction of $64.7 million in product sales, with a corresponding increase to Deferred revenue, non-current.
In April 2023, the Company amended the Canada APA to forfeit certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million received in the second quarter of 2023. On June 30, 2023, the Company entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA. Pursuant to the June 2023 Amendment, the parties revised the Canadian government’s previous commitment by (i) forfeiting certain doses of COVID-19 Vaccine previously scheduled for delivery, (ii) reducing the amount of doses of COVID-19 Vaccine due for delivery, (iii) revising the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered, and (iv) requiring use of the Biologics Manufacturing Centre (“BMC”) Inc. to produce bulk antigen for doses in 2024 and 2025. In connection with the forfeiture of doses of COVID-19 Vaccine, the Canadian government agreed to pay a total amount of $349.6 million to the Company in two equal installments in 2023, which total amount equals the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses. The first installment was payable upon execution of the June 2023 Amendment and the second installment is contingent and payable upon the Company’s delivery of vaccine doses in the second half of 2023. The first installment of $174.8 million was received from the Canadian government in July 2023. If the Company fails to deliver COVID-19 Vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. The Canadian government may terminate the Canada APA, as amended, if the Company fails to achieve regulatory approval for use of BMC for COVID-19 Vaccine production on or before December 31, 2024. The June 2023 Amendment maintained the total contract value of the original Canada APA. Pursuant to the June 2023 Amendment, the Company and the Canadian government will endeavor to expand the Company’s previously agreed in-country commitment to Canada and to further partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses. Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate the Company’s ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by the Company. As of September 30, 2023, the Company is in the process of negotiating the MOU. The Company agreed to hold $20.0 million in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU.
Grants
The Company’s U.S. government agreement consists of a Project Agreement (the “Project Agreement”) and a Base 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 (the Base Agreement together with the Project Agreement the “USG Agreement”). In February 2023, in connection with the execution of Modification 17 to the Project Agreement (“Modification 17”), the U.S. government indicated to the Company that the award may not be extended past its current period of performance, which is December 31, 2023. Also, Modification 17 included provisions requiring that the payment of up to $60.0 million of consideration associated with manufacturing work now be contingent upon meeting certain milestones, including the delivery of up to 1.5 million doses of its prototype vaccine and
development and regulatory milestones related to commercial readiness, expansion of the EUA and development of multiple vial presentations. As of September 30, 2023, the Company now expects to be entitled to the full $1.8 billion-funding under the USG Agreement by December 31, 2023, and accordingly, the Company recognized a $43.8 million cumulative increase to grant revenue under the contract during the three months ended September 30, 2023.
Royalties and Other
Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales.
During the three and nine months ended September 30, 2023, the Company recognized $6.0 million revenue related to sales-based royalties, and $13.8 million and $17.0 million, respectively in revenue related to a Matrix-M™ adjuvant sales. During the three and nine months ended September 30, 2023, the Company did not recognize revenue related to milestone payments.
During the three and nine months ended September 30, 2022, the Company recognized no revenue and $20.0 million, respectively, related to milestone payments, $1.3 million and $10.5 million, respectively, related to sales-based royalties, and $1.0 million and $13.4 million, respectively, related to a Matrix-M™ adjuvant sales.
Note 4 – Collaboration, License, and Supply Agreements
SIIPL
The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of its prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate. SIIPL agreed to purchase the Company's Matrix-M™ adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of the Company’s COVID-19 Vaccine in SIIPL’s licensed territory solely for use in the manufacture of COVID-19 Vaccine. The Company and SIIPL equally split the revenue from SIIPL’s sale of COVID-19 Vaccine in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and SLS under which SIIPL and SLS supply the Company with prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate 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 March 2020, the Company entered into an agreement with SIIPL that 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 (“R21/Malaria”). Under the agreement, SIIPL purchases the Company's Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single-to low- double-digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.
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 the Company’s COVID-19 Vaccine in Japan. Under the agreement, Takeda purchases Matrix-M™ adjuvant from the Company to manufacture doses of COVID-19 Vaccine, and the Company is entitled to receive milestone and sales-based royalty 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 COVID-19 Vaccine. In September 2021, Takeda finalized an agreement with the Government of Japan’s Ministry of Health, Labour and Welfare ("MHLW") for the purchase of 150 million doses of its prototype vaccine. In February 2023, MHLW canceled the remainder of doses under its agreement with Takeda. As a result, it is uncertain whether the Company will receive future sales-based royalty payments from Takeda under the terms and conditions of their current collaboration and licensing agreement.
Bill & Melinda Gates Medical Research Institute
In May 2023, the Company entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute
to provide the Company’s Matrix-M™ adjuvant for use in preclinical vaccine research.
SK bioscience, Co., Ltd
In February 2021, the Company entered into a Collaboration and License Agreement (“CLA”) with SK bioscience, Co., Ltd. (“SK”) to manufacture and commercialize its prototype vaccine for sale to the government of South Korea. The CLA was amended in December 2021 and July 2022 to include the sale of its prototype vaccine to Thailand and Vietnam and to supply the Company with the antigen component of prototype vaccine for use in the final drug product globally, including product to be distributed by the COVAX Facility. Under the CLA, as amended, SK agreed to pay the Company a royalty on the sale of its prototype vaccine in the low to middle double-digit range. The CLA was in addition to the Company's existing manufacturing arrangement with SK under a Development and Supply Agreement (“DSA”) entered into in August 2020. In July 2022, the Company signed an additional agreement with SK for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply its prototype vaccine in a prefilled syringe.
In June 2023, the Company entered into a material transfer agreement with SK for the use by SK of the Company’s Matrix-M™ adjuvant in preclinical vaccine experiments for shingles, influenza, and pan-COVID-19.
In August 2023, the Company and SK entered into a Settlement Agreement and General Release (the “Settlement Agreement”) regarding mutual release by the parties of all claims arising from or in relation to statements of work (“SOWs”) canceled by the Company under the DSA and the CLA (collectively the “Business Agreements”), and other SOWs under the Business Agreements (collectively, the “Subject SOWs”), in each case, in connection with the cessation of all drug substance and drug product manufacturing activity at SK for supply to the Company. Subject SOWs canceled by the Company under the Settlement Agreement included (i) Statement of Work No. 1 dated as of December 23, 2021 as amended to date under the CLA; (ii) Statement of Work No. 5 dated as of July 18, 2022 under the DSA; and (iii) Statement of Work No. 6 dated as of July 18, 2022, and as amended as of December 28, 2022 under the DSA.
Pursuant to the Settlement Agreement, the Company is responsible for payment of $149.8 million to SK in connection with the cancellation of manufacturing activity for the SOWs under the Business Agreements, of which (i) $130.4 million was paid in August 2023 and (ii) the remaining balance is to be paid on or before November 15, 2023. Under the Settlement Agreement, the Company and SK agreed to a wind down plan with respect to the remaining products, materials and equipment under the SOWs.
Under the Settlement Agreement, the Company and SK agreed to remove certain restrictions under the CLA that have been triggered by the launch of SK’s competing vaccine SKYCovione™ in the Republic of Korea. In addition, the Company agreed to extend the term of an exclusive license to SK under the CLA for the exploitation of antigen and vaccine products utilizing Company’s proprietary coronavirus vaccine antigens and Matrix-M adjuvant in certain territories. The Company recorded $4.0 million to Deferred revenue related to the extended licenses granted to SK under the Settlement Agreement.
In August 2023, the Company also entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which the Company agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of the Company’s common stock, par value $0.01 per share (the “Shares”) at a price of $13.00 per share for aggregate gross proceeds to the Company of approximately $84.5 million. The closing of the Private Placement occurred on August 10, 2023. The fair value of the Company’s common stock on the date of closing, based on the quoted market price, was $46.5 million, which results in a premium paid by SK of approximately $38.0 million.
The Settlement Agreement and the Subscription Agreement were negotiated concurrently between the parties, and therefore were combined for accounting purposes and analyzed as a single arrangement. As a result, the Company recorded the $46.5 million fair value of common stock issued to SK, based on the quoted market price on the date of close, as an equity transaction. The remaining elements of the arrangement were deemed to relate to the settlement of the Company’s outstanding liabilities due to SK. These elements consist primarily of the cash payable to SK of $149.8 million, offset by the premium paid on the common stock purchase by SK of $38.0 million, which resulted in a net gain upon derecognition of the liabilities due to SK of $79.2 million in connection with the settlement. As a result, during the three and nine months ended September 30, 2023, the Company recorded this net gain of $79.2 million between research and development expense, for $57.7 million, and cost of sales, for $21.5 million, proportionally based on the where the underlying costs were originally recorded.
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 the Company’s prototype vaccine under the associated statements of work.
Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay 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, which began on March 31, 2023. As of September 30, 2023, the remaining payment of $68.6 million was reflected in Accrued expenses. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach. On October 30, 2023, FDBT filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the third quarter installment of the Settlement Payment.
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, its COVID-19 Program, and in doing so, recognizes that significant costs may be incurred.
Note 5 – 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 consolidated statements of cash flows (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Cash and cash equivalents | $ | 651,104 | | | $ | 1,336,883 | |
Restricted cash, current | 10,393 | | | 10,303 | |
Restricted cash, non-current(1) | 4,866 | | | 1,659 | |
Cash, cash equivalents, and restricted cash | $ | 666,363 | | | $ | 1,348,845 | |
(1)Classified as Other non-current assets as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets.
Note 6 – 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, 2023 | | Fair Value at December 31, 2022 |
Assets | Level 1 | | Level 2 | | Level 3 | | Level 1 | | Level 2 | | Level 3 |
Money market funds(1) | $ | 196,679 | | | $ | — | | | $ | — | | | $ | 398,834 | | | $ | — | | | $ | — | |
Government-backed securities(1) | — | | | 200,000 | | | — | | | — | | | 296,000 | | | — | |
Treasury securities(1) | — | | | 36,913 | | | — | | | — | | | — | | | — | |
Corporate debt securities(1) | — | | | 23,028 | | | — | | | — | | | — | | | — | |
Agency securities(1) | — | | | — | | | — | | | — | | | 104,536 | | | — | |
Total cash equivalents | $ | 196,679 | | | $ | 259,941 | | | $ | — | | | $ | 398,834 | | | $ | 400,536 | | | $ | — | |
Liabilities | | | | | | | | | | | |
5.00% Convertible notes due 2027 | $ | — | | $ | 131,292 | | | $ | — | | $ | — | | $ | 172,789 | | $ | — |
3.75% Convertible notes due 2023 | — | | | — | | | — | | | — | | | 322,111 | | | — | |
Total convertible notes payable | $ | — | | | $ | 131,292 | | | $ | — | | | $ | — | | | $ | 494,900 | | | $ | — | |
(1)All investments are classified as Cash and cash equivalents as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets.
Fixed-income investments categorized as Level 2 are valued at the custodian bank by a third-party pricing vendor’s valuation models that use verifiable observable market data, such as interest rates and yield curves observable at commonly quoted intervals and credit spreads, bids provided by brokers or dealers, or quoted prices of securities with similar characteristics. Pricing of the Company’s convertible notes has been estimated using 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, 2023 and 2022, the Company did not have any transfers between levels.
The amount in the Company’s consolidated balance sheets for accounts payable and accrued expenses approximates its fair value due to its short-term nature.
Note 7 – Inventory
Inventory consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Raw materials | $ | 10,385 | | | $ | 13,912 | |
Semi-finished goods | 10,405 | | | 21,410 | |
Finished goods | 48,802 | | | 1,361 | |
Total inventory | $ | 69,592 | | | $ | 36,683 | |
Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments, offset by recoveries of such commitments, are recorded as a component of cost of sales in the Company’s consolidated statements of operations. For the three and nine months ended September 30, 2023, inventory write-downs were $18.1 million and $49.6 million, respectively and losses on firm purchase commitments were $63.5 million and $71.9 million, respectively. In addition, for the three and nine months ended September 30, 2023 the Company recorded recoveries on firm purchase commitments of $21.5 million and $40.3 million, respectively, related primarily to negotiated reductions to previously recognized firm purchase commitments. 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.
Note 8 – Goodwill
The Company has one reporting unit, which has a negative equity balance as of September 30, 2023 and December 31,
2022. The change in the carrying amounts of goodwill for the nine months ended September 30, 2023 was as follows (in thousands):
| | | | | |
| Amount |
Balance at December 31, 2022 | $ | 126,331 | |
Currency translation adjustments | (2,551) | |
Balance at September 30, 2023 | $ | 123,780 | |
Note 9 – Leases
The Company has embedded leases related to supply agreements with contract manufacturing organizations (“CMOs”) and contract manufacturing and development organizations to manufacture its COVID-19 Vaccine, as well as leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment. During the nine months ended September 30, 2023, the Company continued to align its global manufacturing footprint as a result of its ongoing assessment of manufacturing needs consistent with its contractual obligations related to the supply, and anticipated demand for, its COVID-19 Program.
During the three and nine months ended September 30, 2023, the Company recognized a short-term lease benefit of $39.5 million and $48.0 million, respectively, related to the reversal of previously recognized embedded lease expense on the settlement of CMO contracts. 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 and expensed $24.2 million and $44.0 million respectively, for the write off of right of use (“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 ROU written off. There were no ROU assets written off during the three and nine months ended September 30, 2023, related to embedded leases.
During the three and nine months ended September 30, 2023, the Company recognized $0.5 million and $1.4 million of interest expense, respectively, on its finance lease liabilities. 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 nine months ended September 30, 2023, the Company recorded an impairment charge of $5.9 million related to ROU facility leases used for research and development, manufacturing and offices space that are impacted by the Restructuring Plan (see Note 15).
The Company has a lease agreement for approximately 170,000 square feet of space at 700 Quince Orchard Road, Gaithersburg, Maryland, which the Company uses for manufacturing, research and development, and corporate offices. The term of the lease expires in 2035 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 three months ended September 30, 2023, 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 a ROU asset and related lease obligation of $96.5 million as the lease commencement dates for accounting purposes had occurred. The lease obligation was reduced by $73.4 million for prepaid rent and prior costs incurred on behalf of the landlord.
Note 10 – Long-Term Debt
Total convertible notes payable consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Current portion: | | | |
3.75% Convertible notes due 2023 | $ | — | | | $ | 325,000 | |
Unamortized debt issuance costs | — | | | (119) | |
Total current convertible notes payable | $ | — | | | $ | 324,881 | |
Non-current portion: | | | |
5.00% Convertible notes due 2027 | $ | 175,250 | | | $ | 175,250 | |
| | | |
Unamortized debt issuance costs | (7,629) | | | (8,784) | |
Total non-current convertible notes payable | $ | 167,621 | | | $ | 166,466 | |
In February 2023, the Company repaid the outstanding principal amount of $325.0 million on its 3.75% Convertible notes due in 2023, together with accrued but unpaid interest on the maturity date. The repayment was funded by the issuance of the 5.00% Convertible notes due 2027 and the concurrent common stock offering in December 2022, as well as cash on hand. The effective interest rate of the 2027 Convertible notes is 6.2%.
The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Coupon interest | $ | 2,191 | | | $ | 3,047 | | | $ | 7,588 | | | $ | 9,141 | |
Amortization of debt issuance costs | 395 | | | 356 | | | 1,295 | | | 1,068 | |
Total interest expense on convertible notes payable | $ | 2,586 | | | $ | 3,403 | | | $ | 8,883 | | | $ | 10,209 | |
Note 11 – Stockholders' Deficit
In August 2023, the Company entered into an At Market Issuance Sales Agreement (the "August 2023 Sales Agreement"), which allows it to issue and sell up to $500 million in gross proceeds of shares of its common stock, and terminated its then-existing At Market Issuance Sales agreement entered in June 2021 (the “June 2021 Sales Agreement”). During the three months ended September 30, 2023, the Company sold 17.8 million shares of its common stock under its August 2023 Sales Agreement resulting in net proceeds of approximately $143 million. During the nine months ended September 30, 2023, the Company sold 25.7 million shares of its common stock under its June 2021 and August 2023 Sales Agreement resulting in net proceeds of approximately $211 million. As of September 30, 2023, the remaining balance available under the August 2023 Sales Agreement was approximately $354 million.
During the nine months ended September 30, 2022, the Company sold 2.2 million shares of its common stock resulting in net proceeds of approximately $179 million, under its June 2021 Sales Agreement. There was no sale of shares of common stock recorded during the three months ended September 30, 2022.
In August 2023, pursuant to the Securities Subscription Agreement with SK, the Company agreed to sell and issue to SK 6.5 million shares of the Company’s common stock, par value $0.01 per share at a price of $13.00 per share (the “Shares”) in a Private Placement for aggregate gross proceeds to the Company of approximately $84.5 million. The Company recognized the Shares at the settlement date fair value of $46.5 million (see Note 4 for additional discussion of the Securities Subscription Agreement with SK). The closing of the Private Placement occurred on August 10, 2023.
Note 12 – Stock-Based Compensation
Equity Plans
In January 2023, the Company established the 2023 Inducement Plan (the “2023 Inducement Plan”), which provides for the granting of share-based awards to individuals who were not previously employees, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with the Company. The Company reserved 1.0 million shares of common stock for grants under the 2023 Inducement Plan. As of September 30, 2023, there were 0.2 million shares available for issuance under the 2023 Inducement Plan.
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 21.0 million shares of common stock under equity awards granted under the 2015 Plan, which includes an increase of 6.2 million shares approved for issuance under the 2015 Plan at the Company's 2023 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, 2023, there were 7.1 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 2023 Inducement Plan and the 2015 Plan permit, 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 2023 Inducement Plan and 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 share-based awards are generally subject to vesting over periods ranging from one to four years.
The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Cost of sales | $ | 767 | | | $ | 51 | | | $ | 2,283 | | | $ | 51 | |
Research and development | 10,022 | | | 16,107 | | | 33,826 | | | 52,692 | |
Selling, general, and administrative | 9,971 | | | 15,389 | | | 33,590 | | | 49,782 | |
Total stock-based compensation expense | $ | 20,760 | | | $ | 31,547 | | | $ | 69,699 | | | $ | 102,525 | |
During the three and nine months ended September 30, 2023, total stock-based compensation capitalized in inventory was $0.5 million. During the three and nine months ended September 30, 2022, total stock-based compensation capitalized in inventory was $1.7 million.
As of September 30, 2023, there was approximately $102 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, 2023. 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, 2023 and 2022 was approximately $3 million and $19 million, respectively.
Stock Options and Stock Appreciation Rights
The following is a summary of stock options and SARs activity under the 2023 Inducement Plan, 2015 Plan, and 2005 Plan for the nine months ended September 30, 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2023 Inducement Plan | | 2015 Plan | | 2005 Plan |
| Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price |
Outstanding at December 31, 2022 | — | | | $ | — | | | 4,053,290 | | | $ | 46.07 | | | 63,725 | | | $ | 112.94 | |
Granted | 422,800 | | | 10.67 | | | 861,602 | | | 7.29 | | | — | | | — | |
Exercised | — | | | — | | | (5,374) | | | 6.71 | | | — | | | — | |
Canceled | — | | | — | | | (103,504) | | | 56.45 | | | (5,450) | | | 39.70 | |
Outstanding at September 30, 2023 | 422,800 | | | $ | 10.67 | | | 4,806,014 | | | $ | 38.94 | | | 58,275 | | | $ | 119.79 | |
Shares exercisable at September 30, 2023 | — | | | $ | — | | | 3,437,364 | | | $ | 40.58 | | | 58,275 | | | $ | 119.79 | |
The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Weighted average Black-Scholes fair value of stock options granted | $7.84 | | $37.66 | | $7.27 | | $60.24 |
Risk-free interest rate | 4.3%-4.4% | | 3.0%-3.6% | | 3.5%-4.4% | | 1.4%-3.6% |
Dividend yield | —% | | —% | | —% | | —% |
Volatility | 128.7%-130.3% | | 122.2%-136.4% | | 120.4%-140.3% | | 120.5%-136.7% |
Expected term (in years) | 3.9-5.1 | | 4.0-5.3 | | 3.9-6.3 | | 4.0-6.3 |
The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of September 30, 2023 was approximately $1.4 million and 7.1 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of September 30, 2023 was approximately $1.1 million and 6.1 years, respectively.
Restricted Stock Units
The following is a summary of RSU activity for the nine months ended September 30, 2023:
| | | | | | | | | | | | | | | | | | | | | | | |
| 2023 Inducement Plan | | 2015 Plan |
| Number of Shares | | Per Share Weighted- Average Fair Value | | Number of Shares | | Per Share Weighted- Average Fair Value |
Outstanding and unvested at December 31, 2022 | — | | | $ | — | | | 2,034,574 | | | $ | 61.65 | |
Granted | 363,990 | | | 10.66 | | | 2,888,793 | | | 7.25 | |
Vested | — | | | — | | | (403,672) | | | 87.17 | |
Forfeited | — | | | — | | | (780,810) | | | 27.77 | |
Outstanding and unvested at September 30, 2023 | 363,990 | | | $ | 10.66 | | | 3,738,885 | | | $ | 23.95 | |
Employee Stock Purchase Plan
The ESPP was approved at the Company’s annual meeting of stockholders in June 2013. The ESPP currently authorized an aggregate of 1.2 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, 2023, there were 0.5 million shares available for issuance under the ESPP.
Note 13 – 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, 2023 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, 2023, 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.
During the three months ended September 30, 2023, the Company recognized $0.7 million of federal, state, and foreign income tax benefit. During the three months ended September 30, 2022, the Company recognized $2.4 million of federal, state, and foreign income tax expense. During the nine months ended September 30, 2023 and 2022, the Company recognized income tax expense of $0.3 million and $4.3 million, respectively. 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. The Company did not recognize any foreign withholding tax expense on royalties for the three and nine months ended September 30, 2023.
Note 14 – Commitments and Contingencies
Legal Matters
Stockholder Litigation
On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland (the “Maryland Court”) 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 Maryland 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 prototype vaccine on a commercial scale and to secure the prototype 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, the defendants filed a motion to dismiss the consolidated amended complaint. On December 12, 2022, the Maryland Court issued a ruling granting in part and denying in part defendants’ motion to dismiss. The Maryland Court dismissed all claims against two individual defendants and claims based on certain public statements challenged in the consolidated amended complaint. The Maryland Court denied the motion to dismiss as to the remaining claims and defendants, and directed the Company and other remaining defendants to answer within fourteen days. On December 27, 2022, the Company filed its answer and affirmative defenses. On March 16, 2023, the plaintiffs filed a motion for class certification and to appoint class representatives and counsel. The Company filed its opposition to the plaintiffs’ motion on September 22, 2023.
After the Sinnathurai Action was filed, eight 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. C-15-CV-21-000618 (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”), (vi) Diego J. Mesa v. Stanley C. Erck, et al., No. 2022-0770-NAC (the “Mesa Action”), (vii) Sean Acosta v. Stanley C. Erck, et al., No. 2022-1133-NAC (the “Acosta Action”), and (viii) Jared Needelman v. Stanley C. Erck, et al., No. C-15-CV-23-001550 (the “Needelman Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the Maryland Court. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the Maryland Court by the defendants. The Needleman Action was also filed in the Circuit Court for Montgomery County, Maryland. The Mesa and Acosta Actions were filed in the Delaware Court of Chancery (the “Delaware Court”). The derivative lawsuits name members of the Company’s 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 February 7, 2022, the Maryland 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 Maryland Court entered an order 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 Maryland 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 filed a consolidated amended complaint on November 21, 2022. On February 10, 2023, defendants filed a motion to dismiss the Second Consolidated Derivative Action. The plaintiffs filed their opposition to the motion to dismiss on April 11, 2023. Defendants filed their reply brief in further support of their motion to dismiss on May 11, 2023. On August 21, 2023, the court entered an order granting in part and denying in part the motion to dismiss. On September 5, 2023, the Company filed an Answer to the consolidated amended complaint. On September 6, 2023, the court entered an order granting the individual defendants an extension of time to file their answer until November 6, 2023. On October 6, 2023, the Board of Directors of the Company formed a Special Litigation Committee (“SLC”) with full and exclusive power and authority of the Board to, among other things, investigate, review, and analyze the facts and circumstances surrounding the claims asserted in the pending derivative actions, including the claims that remain following the court’s order on the motion to dismiss in the Second Consolidated Derivative Action. On November 7, 2023, the court entered an order granting the parties’ request to stay the Second Consolidated Derivative Action for up to six months from the date of entry of the order. This includes staying the deadline for the individual defendants to respond to the consolidated amended complaint.
On July 21, 2022, the Maryland Court issued a memorandum opinion and order remanding the Kirst Action to state court. On December 6, 2022, the parties to the Kirst Action filed a stipulated schedule pursuant to which the plaintiffs were expected to file an amended complaint on December 22, 2022, and either (i) the parties would file a stipulated stay of the Kirst Action or (ii) the defendants would file a motion to stay the case by January 23, 2023. The plaintiffs filed an amended complaint on December 30, 2022. On January 23, 2023, defendants filed a motion to stay the Kirst action. On February 22, 2023, the parties in the Kirst Action filed for the Court’s approval of a stipulation staying the Kirst Action pending the resolution of defendants’ motion to dismiss in the Second Consolidated Derivative Action. On March 22, 2023, the Court entered an order staying the Kirst Action pending resolution of the motion to dismiss in the Second Consolidated Derivative Action. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action.
On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the Delaware 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. On January 9, 2023, following the ruling on the motion to dismiss the Sinnathurai Action, the Delaware Court entered an order granting the Mesa Action parties’ request to set a briefing schedule in connection with a motion to stay by defendants. On February 28, 2023, the court granted the defendants’ motion and stayed the Mesa Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On August 31, 2023, the Mesa plaintiffs filed a motion to lift the stay in the Mesa Action. On October 6, 2023, the Company filed an opposition to plaintiff’s motion to lift the stay. On October 17, 2023, the Mesa plaintiff filed his reply in further support of his motion to lift the stay.
On December 7, 2022, the Acosta Action was filed. On February 6, 2023, defendants accepted service of the complaint and summons in the Acosta Action. On March 9, 2023, the court entered an order granting the parties’ request to stay the Acosta Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On October 13, 2023, the parties filed, and the Delaware Court entered, a stipulated order providing that (i) if the Delaware Court declines to lift the stay in the Mesa Action, the Acosta Action will also remain stayed, and (ii) if the Delaware Court lifts the stay in the Mesa Action, the stay in the Acosta Action will also be lifted.
On April 17, 2023, the Needelman Action was filed. On July 12, 2023, the parties filed a stipulation and proposed order to stay the Needelman Action pending the Maryland Court’s decision on the motion to dismiss in the Second Consolidated Derivative Action. The court entered that order on July 17, 2023. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action. The financial impact of this claim, as well as the claims discussed above, is not estimable.
On October 6, 2023, the Company’s board of directors voted unanimously to form a Special Litigation Committee (“SLC”) vested with full power and authority with respect to, among other things, claims in the derivative lawsuits related to certain sales of Company stock by certain Company officers, directors, or employees. The SLC has retained its own independent counsel.
On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA based on Gavi’s failure to procure the purchase of 350 million doses of prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. On August 24, 2023, Gavi filed a Statement of Claim, and on September 21, 2023, the Company filed a Statement of Defense and Counterclaim. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.
On September 30, 2022, the Company and Fujifilm entered into the Fujifilm Settlement Agreement regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the CSA dated August 20, 2021 and 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 the Company’s prototype vaccine under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach (see Note 4). On October 30, 2023, FDBT filed a demand for arbitration with JAMS seeking payment of the withheld installment payment.
The Company is also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flows.
Note 15 – Restructuring
During the nine months ended September 30, 2023, the restructuring charge recorded by the Company comprised (in thousands):
| | | | | |
| Amount |
Severance and employee benefit costs | $ | 4,503 | |
| |
| |
Impairment of assets | 10,081 | |
| |
| |
Total Restructuring charge (1) | $ | 14,584 | |
(1) Restructuring charges of $0.5 million, $2.3 million and $11.5 million are included in Cost of sales, Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the nine months ended September 30, 2023. All impairment charges were taken in the three months ended June 30, 2023. These charges reflect substantially all expected restructuring charges under the Restructuring Plan.
Severance and employee benefit costs
Employees affected by the reduction in force under the Restructuring Plan are entitled to receive severance payments and certain termination benefits. The Company recorded a severance and termination benefit cost in full for employees who were notified of their termination in the three months ended June 30, 2023 and had no requirements for future service. The Company paid a total of $4.3 million for the severance and employee benefit costs during the nine months ended September 30, 2023 and the remaining liability of $0.2 million is included in Accrued expenses in the Company’s consolidated balance sheet as of September 30, 2023.
Impairment of assets
In connection with the Restructuring Plan, the Company evaluated its long-lived assets for impairment including certain leased laboratory and office spaces located in Gaithersburg, Maryland. The Company performed an impairment evaluation for the applicable long-lived assets which is subject to judgment and actual results may vary from the estimates, resulting in potential future adjustments to amounts recorded. During the three months ended June 30, 2023, the Company recorded an impairment charge of $10.1 million related to the impairment of long-lived assets, including $5.9 million related to ROU assets for facility leases.
Note 16 – Subsequent Events
On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of issues identified in the notice of breach (see Note 4). On October 30, 2023, FDBT filed a demand for arbitration with JAMS seeking payment of the third quarter installment of the Settlement Payment.
On October 2, 2023, the World Health Organization (“WHO”) announced its recommendation of the R21/Matrix-M™ malaria vaccine to prevent malaria in children following advice from its Strategic Advisory Group of Experts and Malaria Policy Advisory Group. The vaccine contains R21 antigen developed by University of Oxford, specific to the malaria parasite, and Novavax’s Matrix-M™ adjuvant. This recommendation is a required step on the pathway to the WHO’s prequalification (“PQ”) of the vaccine. PQ designation is necessary for United Nations agencies and partners, for example UNICEF and Gavi, to procure the vaccine for eligible countries. This is the first recommendation from WHO to support the use of a vaccine containing the Company’s Matrix-M™ adjuvant in children as young as five months of age and it is based on the results from the Phase 3 clinical trial. The R21/Matrix-M™ malaria vaccine is being developed and manufactured by SIIPL.
On October 3, 2023, the Company announced that the updated vaccine has received EUA from the U.S. FDA for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, the Company’s updated vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention on September 12, 2023.
On October 18, 2023, the Company announced that the Medicines and Healthcare products Regulatory Agency in the United Kingdom has granted full marketing authorization for its prototype vaccine for individuals aged 12 and older for active immunization to help prevent COVID-19.
On October 18, 2023, the Company announced that Singapore's Health Sciences Authority has granted full approval for Novavax's prototype vaccine for active immunization to prevent COVID-19 in individuals aged 12 and older. The Singapore Ministry of Health has included Novavax’s prototype vaccine in the National Vaccination Programme as a protein-based non-mRNA option for COVID-19 prevention.
On October 31, 2023, the Company announced that the EC has granted approval for the updated vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. This decision follows positive opinion for approval from the Committee for Medicinal Products for Human Use.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Any statements in the discussion below and elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) about expectations, beliefs, plans, objectives, assumptions, or future events or performance of Novavax, Inc. (“Novavax,” together with its wholly owned subsidiaries, the “Company,” “we,” or “us”) are not historical facts and are forward-looking statements. Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities; our operating plans and prospects, including our ability to continue as a going concern through one year from the date of our unaudited financial statements for the period ended September 30, 2023 are issued; our global restructuring and cost reduction plan (“Restructuring Plan”), which includes a more focused investment in our COVID-19 program (which currently includes Nuvaxovid prototype COVID-19 vaccine ("NVX-CoV2373” or “prototype vaccine”) and Nuvaxovid updated COVID-19 vaccine (“NVX-CoV2601” or “updated vaccine”) collectively referred to as our (“COVID-19 Program,” or COVID-19 Vaccine”)), reduction to our pipeline spending, the continued rationalization of our manufacturing network, a reduction to our global workforce, as well as the consolidation of facilities, and infrastructure; our new cost reduction plan focused on further reductions to spend on Research & development expenses, Selling, general, & administrative expenses and supply network costs; the amount and timing of the charges and cash expenditures resulting from the size and timing of our workforce reduction; the impact of our decision to progress our COVID-19-Influenza Combination (“CIC”) vaccine candidate toward late-stage development on our workforce requirements; potential market sizes and demand for our product candidates; the efficacy, safety, and intended utilization of our product candidates; the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies, including NVX-CoV2601; the conduct, timing, and potential results from clinical trials; plans for and potential timing of regulatory filings, including our submission to the U.S. Food and Drug Administration (“U.S. FDA”) for the Biologics License Application (“BLA”) for the full approval of the Novavax COVID-19 Vaccine, Adjuvanted; our expectation of manufacturing capacity, timing, production, distribution, and delivery for NVX-CoV2601 by us and our partners; our expectations with respect to the anticipated ongoing development and commercialization or licensure of our COVID-19 Program, ongoing development of our influenza vaccine candidate, CIC vaccine candidate, high-dose COVID-19 vaccine candidate, and COVID-19 variant strain-containing monovalent formulation, including the Phase 2b/3 Hummingbird™ trial, and the timing of anticipated results from and our efforts for the 2023-2024 vaccination season, efforts to expand the COVID-19 Program label worldwide as a booster, and to various age groups and geographic locations; the expected timing, content, and outcomes of regulatory actions; funding from the U.S. government partnership formerly known as Operation Warp Speed under the USG Agreement (as defined below); funding under our advance purchase agreements (“APAs”) and supply agreements and amendments to, termination of, or legal disputes relating to any such agreement; our available cash resources and usage and the availability of financing generally; plans regarding partnering activities and business development initiatives; and other matters referenced herein. Generally, forward-looking statements can be identified through the use of words or phrases such as “believe,” “may,” “could,” “will,” “would,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume,” the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such risks and uncertainties include, without limitation, our ability to successfully manufacture, distribute, or market NVX-CoV2601 for the 2023-2024 vaccination season, our ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of NVX-CoV2601, NVX-CoV2373 or any COVID-19 variant strain containing formulation; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities, such as the U.S. FDA, the World Health Organization (“WHO”), United Kingdom (“UK”) Medicines and Healthcare Products Regulatory Agency (“MHRA”), the European Medicines Agency (“EMA”), the Republic of Korea’s Ministry of Food and Drug Safety, or Japan’s Ministry of Health, Labour and Welfare; challenges or delays in conducting clinical trials; or obtaining regulatory authorization for our product candidates, including for NVX-CoV2601 in time for the 2023-2024 vaccination season, or for future COVID variant strain changes manufacturing distribution or export delays or challenges; our exclusive dependence on Serum Institute of India Pvt. Ltd. (“SIIPL”), that markets our prototype vaccine as (“Covovax™”), and Serum Life Sciences Limited (“SLS”) for co-formulation, filling and finishing (other than in Europe), and PCI Pharma Services for finishing our COVID-19 Vaccine in Europe and the impact of any delays or disruptions in these suppliers’ operations on the delivery of customer orders; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, constraints on the ability of Novavax to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggered regulatory filings, and potential regulatory actions; the loss of future funding from the U.S. government; the potential for an unfavorable outcome
in disputes, including the pending arbitration with Gavi; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities including requirements to deliver doses that may require us to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges in implementing our global restructuring and cost reduction plan; and other risks and uncertainties identified in Part II, Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, in Part II, Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, in Part II, Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022, which may be detailed and modified or updated in other documents filed with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com. You are encouraged to read these filings as they are made.
We cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it is made, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Information in this Quarterly Report includes a financial measure that was not prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), which we refer to as adjusted cost of sales. We are presenting this non-GAAP financial measure to assist an understanding of our business and its performance. Adjusted cost of sales includes an estimate of standard manufacturing costs that were previously expensed to research and development prior to regulatory approvals for our COVID-19 Program that would otherwise have been capitalized to inventory. Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by GAAP, have no standardized meaning prescribed by GAAP, and may not be comparable to the calculation of similar measures of other companies.
Overview
We are a biotechnology company that promotes improved health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Our proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address global health needs.
Our vaccine candidates are nanostructures of conformationally correct recombinant proteins that mimic those found on pathogens. This technology enables the immune system to recognize target proteins and develop protective immune responses. We believe that our vaccine technology may lead to the induction of a differentiated immune response that may be more efficacious than naturally occurring immunity or some other vaccine approaches. Our vaccine candidates also incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response, stimulate higher levels of functional antibodies, and induce a cellular immune response.
We have developed an updated COVID-19 vaccine for the 2023-2024 vaccination season. In October 2023, the U.S. FDA granted emergency use authorization (“EUA”) for our updated vaccine for active immunization to prevent COVID-19. The updated vaccine is authorized as (1) a single dose in individuals 12 years and older who have been vaccinated with any COVID-19 vaccine at least 2 months after receipt of the last previous dose of COVID-19 vaccine, and (2) a series of 2 doses administered 3 weeks apart to individuals 12 years and older who were not previously vaccinated with any COVID-19 vaccine. Our updated vaccine is available within the U.S. at many major pharmacy retailers. Outside the U.S., in October 2023, we were granted approval by the European Commission (“EC”) for our updated vaccine. We are committed to meeting the full supply of our key target markets through their advanced purchase agreements (“APAs”). We continue to work closely with regulatory authorities for authorization of our updated vaccine globally. We previously developed a prototype COVID-19 vaccine, which has received full marketing authorization (“MA”), marketing approval, interim authorization, provisional approval, conditional marketing authorization (“CMA”), from multiple regulatory authorities in over 40 countries globally. We continue to seek full regulatory authorizations for our prototype vaccine, which we believe will facilitate authorization for our updated strains in the future.
Additionally, we are also developing a stand-alone influenza vaccine candidate, high-dose COVID-19 vaccine candidate, and a CIC vaccine candidate. In addition to COVID-19 and seasonal influenza, our other areas of focus include providing Matrix-M™ adjuvant for collaborations, including in R21/Matrix-M™ adjuvant malaria vaccine, which recently
received authorization in several countries, as well as other preclinical vaccine research with our Matrix-M™ adjuvant, including a partnership with the Bill & Melinda Gates Medical Research Institute.
We intend to focus the organization to align our investments and activities with our top priority of delivering our updated vaccine for the 2023-2024 vaccination season. To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, we have progressed our cost restructuring measures to reduce spend, extend our cash runway, and operate efficiently to seek to best position the Company to deliver longer-term growth. We discuss these cost restructuring strategies in greater detail in Note 2 to our consolidated financial statements in this Quarterly Report.
Technology Overview
We believe our recombinant nanoparticle vaccine technology, together with our proprietary Matrix-M™ adjuvant, is well suited for the development and commercialization of vaccine candidates targeting a broad scope of respiratory and other endemic and emerging infectious diseases.
Recombinant Nanoparticle Vaccine Technology
Once a target of interest has been identified, the genetic sequence encoding an antigen is selected for developing the vaccine construct. The genetic sequence may be optimized to enhance protein stability or confer resistance to degradation. This genetic construct is inserted into the baculovirus Spodoptera frugiperda (“Sf-/BV”) insect cell-expression system, which enables efficient, large-scale expression of the optimized protein. The Sf-/BV system produces protein-based antigens that are properly folded and modified—which can be critical for functional, protective immunity. Protein antigens are purified and organized around a polysorbate-based nanoparticle core in a configuration that resembles their native presentation. This results in a highly immunogenic nanoparticle that is ready to be formulated with Matrix-M™ adjuvant.
Matrix-M™ Adjuvant
Our proprietary Matrix-M™ adjuvant is a key differentiator within our platform. This adjuvant has enabled potent, well tolerated, and durable efficacy by stimulating the entry of antigen presenting cells (“APCs”) into the injection site and enhancing antigen presentation in local lymph nodes. This in turn activates APCs, T-cell and B-cell populations, and plasma cells, which promote the production of high affinity antibodies, an immune boosting response. This potent mechanism of action enables a lower dose of antigen to achieve the desired immune response, thereby contributing to increased vaccine supply and manufacturing capacity. These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.
We continue to evaluate commercial opportunities for the use of our Matrix-M™ adjuvant alongside vaccine antigens produced by other manufacturers. Matrix-M™ adjuvant is being evaluated in combination with several partner-led malaria vaccine candidates, including for R21/Matrix-M™ adjuvant, a malaria vaccine candidate created by the Jenner Institute, University of Oxford. The R21/Matrix-M™ adjuvant vaccine has been licensed to SIIPL for commercialization. Additionally, in May 2023, we entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute to provide our Matrix-M™ adjuvant for use in preclinical vaccine research. In June 2023, we signed a material transfer agreement with SK bioscience Co., Ltd. (“SK”) for use of our Matrix-M™ adjuvant in preclinical vaccine experiments for shingles, influenza, and pan-COVID-19. Our adjuvant technology is also being used by commercial partners as a key component in veterinary vaccines against equine influenza and Strangles, as well as the manufacture of black-widow anti-venom.
COVID-19 Vaccine Regulatory and Licensure
In October 2023, we received EUA from the U.S. FDA for our updated vaccine, to prevent COVID-19 in individuals aged 12 and older. Our updated vaccine is marketed in the U.S. under the brand name Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). In September 2023, the U.S. Centers for Disease Control and Prevention (“CDC”) Advisory Committee on Immunization Practices (“ACIP”) voted in favor of a recommendation for the use of 2023-2024 monovalent XBB containing COVID-19 vaccines authorized under EUA or approved BLA in individuals 6 months and older, which was adopted by the CDC Director. The U.S. FDA’s grant of EUA and CDC’s September 2023 recommendation makes our updated vaccine the only protein-based non-mRNA COVID-19 vaccine available in the U.S. The formulation for our updated vaccine aligns with global harmonized guidance from the U.S. FDA, EMA, and WHO recommendations for the 2023-2024 vaccination season. We continue to progress regulatory authorizations for our updated vaccine globally. In October 2023, we were granted approval by the EC for our updated vaccine in individuals aged 12 and older, which followed the positive opinion for approval from the Committee for Medicinal Products for Human Use of the EMA. We expect to meet the full supply commitment for
doses to European countries that requested it through APAs.
We have received authorizations for our prototype COVID-19 vaccine in over 40 countries globally including from major regulatory agencies including the WHO, EMA, and MHRA. To date, we have received full MA, approval, interim authorization, provisional approval, CMA, and EUA for the adult population, aged 18 and older, the adolescent population, aged 12 to 17 years, and the pediatric population, aged 7 to 11 years in select territories. The regulatory authorizations for our prototype vaccine include primary series and both homologous and heterologous booster indications within specific countries. For the territories in which our vaccine has received regulatory authorizations, our prototype vaccine is marketed under the brand names (i) Nuvaxovid™ (SARS-CoV-2 rS Recombinant, adjuvanted), (ii) Covovax™ (manufacturing and commercialization by SIIPL), or (iii) Novavax COVID-19 Vaccine, Adjuvanted. In October 2023, for our prototype vaccine we received full marketing authorization in the UK from the MHRA in individuals aged 12 and older, full approval in Singapore from Singapore’s Health Sciences Authority in individuals aged 12 and older, full registration in Australia from Australia’s Therapeutic Goods Administration as a booster in individuals aged 12 and older, and authorization in the EU from EMA for use as a booster in adolescents aged 12 through 17 years. We believe these authorizations for our prototype vaccine enable a pathway for additional authorizations for our updated strains of our COVID-19 vaccine in the future.
We are working to continue to expand our label for heterologous boosting in adults and adolescents, for primary and re-vaccination in younger children, and to achieve supportive policy recommendations enabling broad market access. We continue to work closely with governments, regulatory authorities, and non-governmental organizations in our commitment to facilitate global access to our COVID-19 vaccine.
Clinical Pipeline
Our clinical pipeline is comprised of vaccine candidates for infectious diseases, with our COVID-19 vaccines, our prototype vaccine (NVX-CoV2373) and our updated vaccine (NVX-CoV2601), as our lead products. Our prototype has received authorizations for both adult and adolescent populations globally. We advanced our prototype vaccine, through two pivotal Phase 3 clinical trials that demonstrated high efficacy against both the original COVID-19 strain and commonly circulating COVID-19 variants during the conduct of the trials, while maintaining a favorable safety profile. Our updated vaccine has received authorization from the U.S. FDA, and the EC. We advanced our updated vaccine through a Phase 3 strain-change trial and the EUA was based on non-clinical data presented in June 2023, at the U.S. Vaccines and Related Biological Products Advisory Committee's meeting. Beyond COVID-19, our clinical pipeline includes seasonal influenza and CIC vaccines, in addition to our Matrix-M™ adjuvant being used for collaboration in R21/Matrix-M™ adjuvant malaria vaccine.
The pipeline chart below summarizes the core clinical development programs that we are focusing on in the near-term.
(1) Authorized in select geographies under trade names Novavax COVID-19 Vaccine, Adjuvanted; Covovax™; and Nuvaxovid™.
(2) Authorized in the U.S. under trade name, Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula); Ongoing post-authorization Phase 3 strain-change trial.
(3) Authorized in Ghana, Nigeria, and Burkina Faso; Commercialized by SIIPL; Recommended by the WHO.
Coronavirus Vaccine Clinical Development
We continue to evaluate vaccine effectiveness and safety through ongoing and planned booster studies, as well as
collect real-world evidence for our updated vaccine. While these studies were not required ahead of our EUA receipt from the U.S., they will generate data to support continued use of our vaccine in subsequent seasons. We expect to leverage these studies to pursue additional regulatory authorizations of our COVID-19 vaccine for primary, re-vaccination, and pediatric indications globally.
Phase 3 Strain-Change and Re-vaccination Studies
Study 311 Part 2: In August 2023, we announced topline results that achieved all three co-primary endpoints demonstrating immunologic superiority for the Omicron BA.5 variant of a bivalent prototype and Omicron BA.5 vaccine compared to our prototype vaccine (NVX-CoV2373). This study design was developed in consultation with regulatory agencies to support the strain-change request for our updated vaccine (NVX-CoV2601) and demonstrated that our protein-based vaccine can be successfully adapted to new variant strains.
Study 312: In May 2023, we completed enrollment of 147 adults aged 18 and older who received 2 or 3 doses of mRNA and boosted with our prototype vaccine (NVX-CoV2373). The trial compared the prototype vaccine (NVX-CoV2373) booster on top of mRNA primed individuals compared to those primed and boosted with our prototype vaccine (NVX-CoV2373). Topline results are expected in the fourth quarter of 2023. This trial is intended to support the use of our vaccine as a second or subsequent re-vaccination.
Study 313: In September 2023, we fully enrolled 332 adults aged 18 and older in Part 1 of the study to evaluate the immunogenicity and safety of our updated vaccine (NVX-CoV2601) in previously mRNA vaccinated individuals. Part 1 topline results are expected in the fourth quarter of 2023. Part 2 of the study is in the process of enrollment and will aim to evaluate the immunogenicity of our updated vaccine (NVX-CoV2601) in previously unvaccinated adults aged 18 and older. This study is intended to support sBLA for future variant vaccine products.
Study 314: In September 2023, we fully enrolled 401 adolescents aged 12 to 17 years who were previously vaccinated with mRNA vaccines to evaluate the immunogenicity of boosting with our updated vaccine (NVX-CoV2601) and with a bivalent format vaccine containing our updated vaccine (NVX-CoV2373 + NVX-CoV2601). This data is intended to support adolescent heterologous label expansion in some territories with topline results expected in the first quarter of 2024.
Phase 2b/3 Pediatric Hummingbird™ Study
In August 2023, we announced topline results from our Phase 2b/3 Hummingbird™ trial that met its primary endpoints in children aged 6 through 11 years demonstrating immunologic effectiveness. We remain on track to submit data for this cohort to the U.S. FDA in the first quarter of 2024. This ongoing trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of our prototype vaccine (NVX-CoV2373), followed by a booster 6 months after the primary vaccination series. The trial includes three age de-escalation cohorts of 1,200 children each. The next cohort aged 2 through 5 years is fully enrolled, with topline results expected in the fourth quarter of 2023. The last cohort aged 6 to 23 months is fully enrolled and topline results are expected in first quarter of 2024.
COVID-Influenza Combination and Stand-alone Influenza Program
We continue to make strategic investments to prepare our CIC vaccine for advanced development. We have selected the CIC dose formulation and we remain on track to initiate the next study in the second half of 2024. Pending regulatory concurrence, we have designed this study to evaluate immunogenicity endpoints for accelerated approval while simultaneously expanding our safety database. We have updated the study’s designation to a Phase 3 study.
While our focus remains on the combination product, our development plans will maintain optionality to advance our stand-alone influenza vaccine, creating a pathway to potentially seek licensure. For our stand-alone influenza vaccine we have generated positive data through our previous Phase 2 trial and continue to believe this asset may be attractive from a pandemic preparedness perspective. The neutralization responses were more than double seen with Fluzone® HD for the A strains and similar performance may be expected for A/H5N1 pandemic strains.
In May 2023, we announced preliminary topline data from our Phase 2 trial for CIC, stand-alone influenza and high-dose COVID-19 vaccine candidates. All three vaccine candidates contain our Matrix-M™ adjuvant, showed preliminary robust immune responses, reassuring safety profiles, and reactogenicity that was comparable to the licensed influenza vaccine comparator arms.
High-dose COVID-19 Vaccine Study
Study 205: In October 2023, we initiated a Phase 2 trial to evaluate our high-dose COVID-19 vaccine for annual vaccination in older adults. The trial will compare immunogenicity levels of 5 micrograms of our prototype vaccine (NVX-CoV2373) against 5 micrograms, 35 micrograms, and 50 micrograms of our updated vaccine (NVX-CoV2601) that are matched with different levels of adjuvant. Data from this trial is intended to potentially support further development of a higher dose formulation for older adults, similar to that of influenza vaccines.
R21/Matrix-M™ Adjuvant Malaria Vaccine
Our partner-led malaria candidates present strong opportunities for future development. An ongoing Phase 3 clinical trial is being conducted for R21/Matrix-M™ adjuvant malaria vaccine, developed by our partner, the Jenner Institute, University of Oxford and manufactured by SIIPL, which is formulated with our Matrix-M™ adjuvant. We have an agreement with SIIPL related to its manufacture of R21/Matrix-M™ adjuvant malaria vaccine under which SIIPL purchases our Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single- to low- double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.
In October 2023, the WHO announced its recommendation of R21/Matrix-M™ adjuvant malaria vaccine to prevent malaria in children following advice from its Strategic Advisory Group of Experts and Malaria Policy Advisory Group. The WHO recommended that the R21/Matrix-M™ adjuvant malaria vaccine be administered in a 4-dose schedule from five months of age. This recommendation is a required step on the pathway to the WHO’s prequalification (“PQ”) of the vaccine. PQ designation is necessary for United Nations agencies and partners, for example UNICEF and Gavi, to procure the vaccine for eligible countries. This is the first recommendation from WHO to support the use of a vaccine containing our Matrix-M™ adjuvant in children as young as five months of age and it is based on the results from the Phase 3 clinical trial.
In September 2023, results from the Phase 3 clinical trial conducted in four African countries with 4,800 children aged 36 months to five years were published in a preprint manuscript in The Lancet. The preprint manuscript reported that R21/Matrix-M™ adjuvant malaria vaccine is well-tolerated and offers high-level efficacy against clinical malaria in African children at sites of both seasonal and perennial transmission.
In July 2023, R21/Matrix-M™ adjuvant malaria vaccine received authorization in Burkina Faso and in April 2023, received authorizations in Ghana and Nigeria.
Business Highlights
Third Quarter 2023 and Recent Highlights
U.S. Market: Novavax received EUA from the U.S. FDA in October for its updated vaccine and is executing its commercial strategy to maximize access for consumers who want a protein-based non-mRNA vaccine option.
•Expect U.S. 2023-2024 season COVID-19 vaccine demand of between 30 and 50 million doses, with potential for significant November and December vaccinations given current trends and later start as compared to 2022
•Secured broad access to the Company’s updated vaccine through major pharmacies, clinics and government programs
◦Novavax’s vaccine is available at approximately 14,000 pharmacy locations, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid and Stop & Shop
Global Markets: Received approval in Europe for the Company’s updated vaccine in individuals aged 12 and older
•Advancing regulatory filings against existing APAs for Australia, New Zealand, Singapore and Taiwan
Clinical development and technology platform updates
•Expect to initiate a pivotal Phase 3 trial for CIC vaccine candidate in the second half of 2024, with potential for accelerated approval and launch as early as 2026
•Advanced partnerships with Matrix-M™ adjuvant technology
◦R21/Matrix-M™ adjuvant vaccine received recommendation from the WHO; launch expected in 2024
Novavax is prepared to initiate a new cost reduction program to reduce 2024 expenses by over $300 million. Intend to further reshape the size and scope of global business operations beyond previously announced 2024 targets to align with the COVID-19 market opportunity.
•Anticipate reducing 2024 Research & development expenses and Selling, general, & administrative expenses by over $200 million compared to prior targets to reflect $750 million or lower spend for 2024, representing a greater than 50% reduction compared to 2022
•In addition, anticipate reducing supply network costs by over $100 million as we continue to rationalize our manufacturing footprint
Sales of Common Stock
In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our then-existing At Market Issuance Sales agreement entered in June 2021 (the "June 2021 Sales Agreement"). During the three months ended September 30, 2023, we sold 17.8 million shares of our common stock under our August 2023 Sales Agreement resulting in net proceeds of approximately $143 million. During the nine months ended September 30, 2023, we sold 25.7 million shares of our common stock under our June 2021 and August 2023 Sales Agreement resulting in net proceeds of approximately $211 million. As of September 30, 2023, the remaining balance available under the August 2023 Sales Agreement was approximately $354 million.
During the nine months ended September 30, 2022, we sold 2.2 million shares of our common stock resulting in net proceeds of approximately $179 million, under our June 2021 Sales Agreement. There was no sale of shares of common stock recorded during the three months ended September 30, 2022.
In August 2023, we entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which we agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of the Company’s common stock, par value $0.01 per share (the “Shares”) at a price of $13.00 per share for aggregate gross proceeds to us of approximately $84.5 million. We recognized the Shares at the settlement date fair value of $46.5 million (see Note 4 to our consolidated financial statements in this Quarterly Report). The closing of the Private Placement occurred on August 10, 2023.
Critical Accounting Policies and Use of Estimates
The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements (unaudited) and the accompanying notes, which have been prepared in accordance with generally accepted accounting principles in the United States.
The preparation of our consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Our critical accounting policies and estimates are included under Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC.
Recent Accounting Pronouncements Not Yet Adopted
See “Note 2―Summary of Significant Accounting Policies” included in our Notes to Consolidated Financial Statements (under the caption “Recent Accounting Pronouncements”).
Results of Operations
The following is a discussion of the historical financial condition and results of our operations that should be read in conjunction with the unaudited consolidated financial statements and notes set forth in this Quarterly Report.
Three Months Ended September 30, 2023 and 2022
Revenue
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 | | Change |
Revenue (in thousands): | | | | | |
Product sales | $ | 2,231 | | | $ | 626,091 | | | $ | (623,860) | |
Grants | 164,922 | | | 106,273 | | | 58,649 | |
Royalties and other | 19,833 | | | 2,213 | | | 17,620 | |
Total revenue | $ | 186,986 | | | $ | 734,577 | | | $ | (547,591) | |
Revenue for the three months ended September 30, 2023 was $187.0 million as compared to $734.6 million for the same period in 2022, a decrease of $547.6 million. Revenue for the three months ended September 30, 2023 and 2022 was primarily comprised of revenue from product sales of COVID-19 Vaccine and services performed under our U.S. government agreement with Advanced Technology International (“USG Agreement”), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed. The decrease in revenue is primarily due to a decreased quantity of dose sales of COVID-19 Vaccine during the three months ended September 30, 2023 as compared to the same period in 2022, partially offset by increased support activities under the USG Agreement, a $43.8 million increase to cumulative revenue under the USG Agreement, and additional Royalties and other revenue related to sales-based royalties and sales of Matrix-M™ adjuvant.
Product sales
Product sales for the three months ended September 30, 2023 were $2.2 million as compared to $626.1 million during the three months ended September 30, 2022. Our product sales related to sales of COVID-19 Vaccine under our APA agreements. The geographic distribution of product sales was as follows:
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 | | Change |
North America | $ | 2,231 | | | $ | 129,718 | | | $ | (127,487) | |
Europe | — | | | 347,005 | | | (347,005) | |
Rest of the world | — | | | 149,368 | | | (149,368) | |
Total product sales | $ | 2,231 | | | $ | 626,091 | | | $ | (623,860) | |
Grants
Grant revenue during the three months ended September 30, 2023 was $164.9 million as compared to $106.3 million during the same period in 2022, an increase of $58.6 million. Grant revenue comprised revenue for services performed under our USG Agreement. The increase was primarily due to increased support activities and achievement of certain milestones under the USG Agreement during the three months ended September 30, 2023.
Royalties and other
Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales. Royalties and other revenue during the three months ended September 30, 2023 was $19.8 million as compared to $2.2 million during the same period in 2022, an increase of $17.6 million. The increase was primarily due to increased revenue related to a Matrix-M™ adjuvant sales and sales-based royalties.
Expenses
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 | | Change |
Expenses (in thousands): | | | | | |
Cost of sales | $ | 98,929 | | | $ | 434,593 | | | $ | (335,664) | |
Research and development | 106,229 | | | 304,297 | | | (198,068) | |
Selling, general, and administrative | 107,460 | | | 122,876 | | | (15,416) | |
Total expenses | $ | 312,618 | | | $ | 861,766 | | | $ | (549,148) | |
Cost of Sales
Cost of sales was $98.9 million for the three months ended September 30, 2023, including expenses of $81.6 million related to excess, obsolete, or expired inventory and losses on certain firm purchase commitments, $14.3 million related to unutilized manufacturing capacity, and a credit of $21.5 million related to certain negotiated reductions to previously recognized firm purchase commitments. Cost of sales was $434.6 million for the three months ended September 30, 2022, including expense of $249.0 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments. Prior to receiving regulatory approval, we expensed manufacturing costs as research and development expenses. After receiving regulatory approval, we capitalize the costs of production for a particular supply chain when we determine that we have a present right to the economic benefit associated with the product. While we tracked the quantities of our manufactured vaccine product and components, we did not track pre-approval manufacturing costs and therefore the manufacturing cost of our pre-launch inventory produced prior to approval is not reasonably determinable. However, based on our expectations for future manufacturing costs to produce our vaccine product and components inventory, we estimate at September 30, 2023, we had approximately $24.3 million of salable commercial inventory that was expensed prior to approval. We expect to utilize the majority of our reduced-cost inventory through 2024. If inventory sold for the three months ended September 30, 2023 was valued at expected standard cost, including expenses related to excess and obsolete inventory, adjusted cost of sales for the period would have been approximately $103.2 million, an adjustment of $4.3 million as compared to cost of sales recognized. If inventory sold for the three months ended September 30, 2022 was valued at expected standard cost, adjusted cost of sales for the period would have been approximately $444.0 million, an adjustment of $9.4 million. The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer pricing mix or standard costs.
Research and Development Expenses
Research and development expenses were $106.2 million for the three months ended September 30, 2023 as compared to $304.3 million for the three months ended September 30, 2022, a decrease of $198.1 million. The decrease was primarily due to a reduction in overall expenditures relating to development activities on coronavirus vaccines, including our COVID-19 Program, and CIC, as summarized in the table below (in thousands):
| | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 |
Coronavirus vaccines | $ | 41,263 | | | $ | 208,004 | |
Influenza vaccine | 662 | | | 3,011 | |
Other vaccine development programs | 91 | | | 843 | |
Total direct external research and development expense | 42,016 | | | 211,858 | |
Employee expenses | 33,957 | | | 45,150 | |
Stock-based compensation expense | 10,022 | | | 16,107 | |
Facility expenses | 12,360 | | | 16,770 | |
Other expenses | 7,874 | | | 14,412 | |
Total research and development expenses | $ | 106,229 | | | $ | 304,297 | |
Research and development expenses for coronavirus vaccines for the three months ended September 30, 2023 and 2022 decreased from $208.0 million to $41.3 million primarily as a result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, including embedded lease costs, under manufacturing supply agreements with
Contract Manufacturing Organizations (“CMOs”) and contract manufacturing and development organizations (“CDMOs”). The decrease was also due to a benefit of $57.7 million for the three months ended September 30, 2023 resulting from our settlement agreement and Private Placement with SK (see Note 4 to our consolidated financial statements in this Quarterly Report). The decrease was partially offset by a benefit $80.5 million for the three months ended September 30, 2022 related to previously accelerated manufacturing costs for leases that we determined were embedded in manufacturing supply agreements with CMOs and CDMOs.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses were $107.5 million for the three months ended September 30, 2023 as compared to $122.9 million for the same period in 2022, a decrease of $15.4 million. The decrease in selling, general, and administrative expenses is primarily due to certain cost containment measures to reduce our operating spend.
For the remainder of 2023, we expect a reduction in our annual combined research and development, and selling, general, and administrative spend as a result of our Restructuring Plan announced during the three months ended June 30, 2023.
Other Income (Expense)
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 | | Change |
Other income (expense): | | | | | |
Interest expense | $ | (2,859) | | | $ | (4,169) | | | $ | 1,310 | |
Other income (expense) | (2,982) | | | (34,783) | | | 31,801 | |
Total other income (expense), net | $ | (5,841) | | | $ | (38,952) | | | $ | 33,111 | |
Total other expense, net was $5.8 million for the three months ended September 30, 2023 as compared to a total other expense, net of $39.0 million for the same period in 2022. The decrease in other expense, net is due to the favorable impact in 2023 as compared to 2022 of exchange rates on foreign currency denominated balances, including an intercompany loan with Novavax CZ, and an increase in interest income due to higher interest rates.
Income Tax Expense
During the three months ended September 30, 2023, we recognized an income tax benefit of $0.7 million related to federal, state, and foreign income taxes. During the three months ended September 30, 2022, we recognized an income tax expense of $2.5 million related to federal, state, and foreign income taxes.
Net Income (Loss)
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | 2022 | | Change |
Net Loss (in thousands, except per share information): | | | | | |
Net loss | $ | (130,776) | | | $ | (168,613) | | | $ | 37,837 | |
Net loss per share, basic and diluted | $ | (1.26) | | | $ | (2.15) | | | $ | 0.89 | |
| | | | | |
Weighted average shares outstanding, basic and diluted | 103,429 | | | 78,274 | | | 25,155 | |
| | | | | |
Net loss for the three months ended September 30, 2023 was $130.8 million, or $1.26 per share, as compared to net loss of $168.6 million, or $2.15 per share, for the same period in 2022. The decrease in net loss during the three months ended September 30, 2023, was primarily due to a decrease in excess, obsolete, or expired inventory and losses on firm purchase commitments, research and development expenses, and selling, general and administrative expenses as a result of the implementation of our Restructuring Plan, partially offset by a decrease in product sales.
The increase in weighted average shares outstanding for the three months ended September 30, 2023 was primarily a result of sales of our common stock.
Nine Months Ended September 30, 2023 and 2022
Revenue
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
Revenue (in thousands): | | | | | |
Product sales | $ | 279,937 | | | $ | 1,267,174 | | | $ | (987,237) | |
Grants | 389,380 | | | 313,348 | | | 76,032 | |
Royalties and other | 23,046 | | | 43,951 | | | (20,905) | |
Total revenue | $ | 692,363 | | | $ | 1,624,473 | | | $ | (932,110) | |
Revenue for the nine months ended September 30, 2023 was $692.4 million as compared to $1.6 billion for the same period in 2022, a decrease of $932.1 million. Revenue for the nine months ended September 30, 2023 was primarily comprised of revenue from product sales of COVID-19 Vaccine and services performed under our USG Agreement. The decrease in revenue was primarily due to a decrease in quantity of doses sold of COVID-19 Vaccine during the nine months ended September 30, 2023 as compared to the same period in 2022.
Product sales
Product sales for the nine months ended September 30, 2023 were $279.9 million as compared to $1.3 billion during the nine months ended September 30, 2022. Our product sales related to sales of COVID-19 Vaccine under our APA agreements. The geographic distribution of product sales was as follows:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
North America | $ | 2,231 | | | $ | 194,480 | | | $ | (192,249) | |
Europe | 59,322 | | | 760,750 | | | (701,428) | |
Rest of the world | 218,384 | | | 311,944 | | | (93,560) | |
Total product sales | $ | 279,937 | | | $ | 1,267,174 | | | $ | (987,237) | |
Grants
Grant revenue during the nine months ended September 30, 2023 was $389.4 million as compared to $313.3 million during the same period in 2022, an increase of $76.0 million. Grant revenue comprised revenue for services performed under our USG Agreement. The increase was primarily due to increased support activities under the USG Agreement during the nine months ended September 30, 2023.
Royalties and other
Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales. Royalties and other revenue during the nine months ended September 30, 2023 was $23.0 million as compared to $44.0 million during the same period in 2022, a decrease of $20.9 million. The decrease was primarily due to decreased revenue related to milestone payments.
Expenses
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
Expenses (in thousands): | | | | | |
Cost of sales | $ | 188,792 | | | $ | 720,874 | | | $ | (532,082) | |
Research and development | 572,805 | | | 977,428 | | | (404,623) | |
Selling, general, and administrative | 313,709 | | | 327,028 | | | (13,319) | |
Total expenses | $ | 1,075,306 | | | $ | 2,025,330 | | | $ | (950,024) | |
Cost of Sales
Cost of sales was $188.8 million for the nine months ended September 30, 2023, including expense of $121.6 million related to excess, obsolete, or expired inventory and losses on certain firm purchase commitments, $30.1 million related to unutilized manufacturing capacity, and a credit of $40.3 million related to negotiated reductions to certain previously recognized firm purchase commitments. Cost of sales was $720.9 million for the nine months ended September 30, 2022, including expense of $504.3 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments. Prior to receiving approval, we expensed manufacturing costs as research and development expenses. After receiving approval, we capitalize the costs of production for a particular supply chain when we determine that we have a present right to the economic benefit associated with the product. While we tracked the quantities of our manufactured vaccine product and components, we did not track pre-approval manufacturing costs and therefore the manufacturing cost of our pre-launch inventory produced prior to approval is not reasonably determinable. However, based on our expectations for future manufacturing costs to produce our vaccine product and components inventory, we estimate at September 30, 2023 we had approximately $24.3 million of commercial inventory that was expensed prior to approval. We expect to utilize the majority of our reduced-cost inventory through 2024. If inventory sold for the nine months ended September 30, 2023 was valued at expected standard cost, including expenses related to excess and obsolete inventory, adjusted cost of sales for the period would have been approximately $224.0 million, an adjustment of $35.2 million as compared to cost of sales recognized. If inventory sold for the nine months ended September 30, 2022 was valued at expected standard cost, adjusted cost of sales for the period would have been approximately $883.5 million, an adjustment of $162.6 million. The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix or standard costs.
Research and Development Expenses
Research and development expenses decreased to $572.8 million for the nine months ended September 30, 2023 from $977.4 million for the same period in 2022, a decrease of $404.6 million. The decrease was primarily due to a reduction in overall expenditures relating to development activities on coronavirus vaccines, including our COVID-19 Program, and CIC, as summarized in the table below (in thousands):
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Coronavirus vaccines | $ | 321,132 | | | $ | 697,952 | |
Influenza vaccine | 1,929 | | | 6,581 | |
Other vaccine development programs | 857 | | | 1,156 | |
Total direct external research and development expense | 323,918 | | | 705,689 | |
Employee expenses | 133,502 | | | 132,069 | |
Stock-based compensation expense | 33,826 | | | 52,692 | |
Facility expenses | 45,920 | | | 40,842 | |
Other expenses | 35,639 | | | 46,136 | |
Total research and development expenses | $ | 572,805 | | | $ | 977,428 | |
Research and development expenses for coronavirus vaccines for the nine months ended September 30, 2023 and 2022 decreased from $698.0 million to $321.1 million primarily as a result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, including under manufacturing supply agreements with CMO and CDMO, and a reduction in clinical study costs and the commercialization of internal manufacturing capabilities. The decrease was also due to a benefit of $57.7 million for the nine months ended September 30, 2023 resulting from our settlement agreement and Private Placement with SK (see Note 4 to our consolidated financial statements in this Quarterly Report). The decrease was partially offset by a benefit of $31.8 million and $147.8 million for the nine months ended September 30, 2023 and 2022, respectively, related to previously accelerated manufacturing costs for leases that we determined were embedded in manufacturing supply agreements with CMOs and CDMOs.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses decreased to $313.7 million for the nine months ended September 30, 2023 from $327.0 million for the same period in 2022, an decrease of $13.3 million. The decrease in selling, general, and administrative expenses is primarily due to cost containment measures to reduce our operating spend including a decrease in professional fees and marketing costs in support of our COVID-19 Program, partially offset by restructuring expenses.
Other Income (Expense)
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
Other income (expense) (in thousands): | | | | | |
| | | | | |
Interest expense | $ | (10,299) | | | $ | (15,279) | | | $ | 4,980 | |
Other income (expense) | 26,912 | | | (53,002) | | | 79,914 | |
Total other income (expense), net | $ | 16,613 | | | $ | (68,281) | | | $ | 84,894 | |
We had total other income, net of $16.6 million for the nine months ended September 30, 2023 as compared to total other expense, net of $68.3 million for the same period in 2022, an increase of $84.9 million. During the nine months ended September 30, 2023, other income, net increased due to the favorable impact in 2023 as compared to 2022 of exchange rates on foreign currency denominated balances, including an intercompany loan with Novavax CZ, and an increase in investment income due to higher interest rates.
Income Tax Expense
During the nine months ended September 30, 2023 and 2022, we recognized $0.3 million and $6.6 million, respectively, of income tax expense related to federal, state and foreign income taxes and foreign withholding tax on royalties.
Net Loss
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
Net Loss (in thousands, except per share information): | | | | | |
Net loss | $ | (366,673) | | | $ | (475,690) | | | $ | 109,017 | |
Net loss per share, basic and diluted | $ | (3.94) | | | $ | (6.13) | | | $ | 2.19 | |
| | | | | |
Weighted average shares outstanding, basic and diluted | 93,046 | | | 77,631 | | | 15,415 | |
| | | | | |
Net loss for the nine months ended September 30, 2023 was $366.7 million, or $3.94 per share, as compared to $475.7 million, or $6.13 per share, for the same period in 2022. The decrease in net loss during the nine months ended September 30, 2023 was primarily due to the decline in cost of sales and research and development expenses associated with our COVID-19 Program, partially offset by a decrease in revenue from product sales.
The increase in weighted average shares outstanding for the nine months ended September 30, 2023 is primarily a result of sales of our common stock.
Liquidity Matters and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, revenue from our product sales and royalties under licensing arrangements with our strategic partners; funding and repayments under our grant agreements; our projected activities related to the manufacturing and commercial support of our COVID-19 Program, including significant commitments under various CMO, and CDMO agreements; the progress of preclinical studies and clinical trials; the time and costs involved in obtaining regulatory approvals; the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights; and other manufacturing, sales, and distribution costs. We plan to continue developing other vaccines and product candidates, such as our influenza vaccine candidate and potential combination vaccines candidates, which are in various stages of development.
We have entered into supply agreements, sometimes referred to as APAs, with Gavi, the Vaccine Alliance (“Gavi”); the EC; and various countries globally. We also have grant and license agreements. As of September 30, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties under the license agreements, our advance purchase agreement with Gavi (the “Gavi APA”) and the reduction in doses related to the Amended and Restated UK Supply Agreement (as defined below), was approximately $2 billion, of which $801.0 million is included in Deferred revenue in our consolidated balance sheet. Failure to meet regulatory milestones, timely obtain supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under our APAs may require us to refund portions of upfront or other payments or result in reduced future payments, which could adversely impact our ability to realize revenue from our unsatisfied performance obligations. The timing to fulfill performance obligations related to grant agreements will depend on the results of our research and development activities, including clinical trials. The timing to fulfill performance obligations related to supply agreements 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 supply agreements typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of COVID-19 Vaccine. Such upfront payments generally become non-refundable upon our achievement of certain development, regulatory, and commercial milestones.
On October 3, 2023, our updated vaccine received EUA from the U.S. FDA for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, our updated vaccine has also been included in the recommendations issued by the CDC on September 12, 2023. Doses became available within the U.S. at many major pharmacy retailers, following the Center for Biologics Evaluation and Research release of vaccine batches.
Pursuant to the Fujifilm Settlement Agreement (see Note 4 to our consolidated financial statements in this Quarterly Report), we agreed to pay up to $185 million (the “Settlement Payment”) to Fujifilm in connection with the cancellation of manufacturing activity at FDBT under the Fujifilm 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, which began on March 31, 2023. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, we sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. We withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach. We paid the first two installments of $68.6 million during the nine months ended September 30, 2023, and the remaining balance of $68.6 million is reflected in Accrued expenses in our consolidated balance sheet. On October 30, 2023, FDBT filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the third quarter installment of the Settlement Payment.
In August 2023, we entered into a Settlement Agreement and General Release (the “Settlement Agreement”) with SK regarding the mutual release by the parties of all claims arising from or in relation to certain statements of work (“SOWs”) under the Development and Supply Agreement entered into in August 2020 and the Collaboration and License Agreement, entered into in February 2021 as amended in December 2021 and July 2022 in connection with the cessation of all drug substance and drug product manufacturing activity at SK for supply to us. Pursuant to the Settlement Agreement, we agreed to pay $149.8 million, of which (i) $130.4 million was paid in August 2023 and (ii) the remaining balance is to be paid on or before November 15, 2023. Under the Settlement Agreement, we also agreed with SK to a wind down plan with respect to the
remaining products, materials and equipment under the SOWs (see Note 4 to our consolidated financial statements in this Quarterly Report).
In August 2023, we entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which we agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of our common stock, par value $0.01 per share at a price of $13.00 per share for aggregate gross proceeds to us of approximately $84.5 million. The closing of the Private Placement occurred on August 10, 2023 (see Note 4 to our consolidated financial statements in this Quarterly Report).
In addition, we continue to assess our manufacturing needs and modify our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, and in doing so recognize that significant costs may be incurred. We currently depend exclusively on SIIPL and SLS for co-formulation and filling (other than in Europe), and PCI Pharma Services for finishing COVID-19 Vaccine in Europe and any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders.
We have an APA with the Commonwealth of Australia for the purchase of doses of COVID-19 Vaccine (the “Australia APA”). In April 2023, we amended the Australia APA to reduce the number of doses to be delivered with a commensurate increase in the per-dose price, such that the total contract value of the Australia APA is maintained with doses to be delivered through 2024. In May 2023, we extended a credit for certain doses delivered in 2022 to Australia that qualified for replacement under the Australia APA. This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market. The credit will be applied against the future sale of doses to Australia. In July 2023, we amended the Australia APA to provide for replacement doses and to extend the delivery schedule through 2025.
We have an APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), for the purchase of doses of COVID-19 Vaccine (the “Canada APA”). In April 2023, we amended the Canada APA to forfeit certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million received in the second quarter of 2023. In June 2023, we entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA. Pursuant to the June 2023 Amendment, the parties revised the Canadian government’s previous commitment by (i) forfeiting certain doses of COVID-19 Vaccine previously scheduled for delivery, (ii) reducing the amount of doses of COVID-19 Vaccine due for delivery, (iii) revising the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered, and (iv) requiring use of the Biologics Manufacturing Centre (“BMC”) Inc. to produce bulk antigen for doses in 2024 and 2025. In connection with the forfeiture of doses of COVID-19 Vaccine, the Canadian government agreed to pay a total payment amount of $349.6 million to the Company in two equal installments in 2023, which total amount equals the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses. The first installment was payable upon execution of the June 2023 Amendment and the second installment is contingent and payable upon our delivery of vaccine doses in the second half of 2023. The first installment of $174.8 million was received from the Canadian government in July 2023. If the Company fails to deliver COVID-19 vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment of $174.8 million will be terminated and not be payable to the Company. The Canadian government may terminate the Canada APA, as amended, if we fail to achieve regulatory approval for use of BMC for COVID-19 Vaccine production on or before December 31, 2024. The June 2023 Amendment maintained the total contract value of the original Canada APA.
Pursuant to the June 2023 Amendment, we and the Canadian government will endeavor to expand our previously agreed in-country commitment to Canada and to partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses. Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate our ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by us. As of September 30, 2023, we are in the process of negotiating the MOU. We agreed to hold $20.0 million in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU.
In July 2022, we entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (as amended on September 26, 2022, the “Amended and Restated UK Supply Agreement”) with The Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”), which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the parties (the “Original UK Supply Agreement”). Under the Original UK Supply Agreement, the Authority agreed to purchase 60 million doses of prototype vaccine and made an upfront payment to us. Under the terms of the Amended and Restated UK Supply Agreement, the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses (the “Conditional Doses”) of prototype vaccine, with the number of Conditional Doses contingent on, and subject to reduction based on, our timely achievement of supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) that is approved by the UK Secretary of State for Health, with respect to use of the vaccine for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom. If the Authority does not purchase the Conditional Doses or the number of such Conditional Doses is reduced below 15 million doses of prototype vaccine, we would have to repay up to $225 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement. 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.
As of November 30, 2022, the JCVI had not yet made a supportive recommendation with respect to our prototype vaccine, thereby triggering, under the terms of the Amended and Restated UK Supply Agreement, (i) a reduction of the number of Conditional Doses from 15 million doses to 7.5 million doses, which reduced number of Conditional Doses are contingent on, and subject to further reduction based on, our timely achievement by November 30, 2023 of a supportive recommendation from JCVI that is approved by the UK Secretary of State for Health as described in the paragraph above, and (ii) an obligation for us to repay $112.5 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement. In April 2023, we repaid the $112.5 million related to the November 30, 2022 triggering event. If we are unable to timely achieve a supportive recommendation from the JCVI by November 30, 2023, a reduction in the number of Conditional Doses from 7.5 million doses to zero will be triggered and we may be required to repay an additional $112.5 million in 2024.
Under the terms of the Gavi APA, we received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to our achieving an emergency use license for our prototype vaccine by the WHO (the “Advance Payment Amount”). On November 18, 2022, we delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of prototype vaccine from us as required by the Gavi APA. As of November 18, 2022, we had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in our consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. We filed our Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to our Counterclaims. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while we believe that we are entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that we will be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.
In February 2023, the execution of Modification 17 to the USG Agreement included provisions requiring that the payment of $60.0 million of consideration associated with manufacturing work now be contingent upon meeting certain milestones, including the delivery of up to 1.5 million doses of prototype vaccine and development and regulatory milestones related to commercial readiness, expansion of the EUA and development of multiple vial presentations. We expect to substantially meet milestones and other performance requirements under the USG Agreement by December 31, 2023.
Our funding agreements currently include funding from the Coalition for Epidemic Preparedness Innovations (“CEPI”) in the form of one or more forgivable no interest term loans (“CEPI Forgivable Loan Funding”). Payments received under the CEPI Forgivable Loan Funding are only repayable if COVID-19 Vaccine manufactured by the CMO network funded by CEPI is sold to one or more third parties (which would have previously included, but is not limited to, any sales under our
Gavi APA prior to its termination), and such sales cover our costs of manufacturing such vaccine, not including manufacturing costs funded by CEPI. The timing and amount of any loan repayments is currently uncertain.
As of September 30, 2023, we had $666.4 million in cash and cash equivalents and restricted cash as compared to $1.3 billion as of December 31, 2022.
We funded our operations for the nine months ended September 30, 2023 primarily with cash and cash equivalents, revenue from product sales, together with revenue under the USG Agreement that support our COVID-19 Vaccine development activities and the sale of our common stock under our June 2021 and August 2023 Sales Agreements. In May 2023, we announced our plan to restructure our global footprint to reduce our planned expenditures. We anticipate our future operations to be funded primarily by revenue from product sales, revenue under our USG Agreement, our cash and cash equivalents, and other potential funding sources including equity financings, which may include at-the-market offerings under our August 2023 Sales Agreement, debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements.
The following table summarizes cash flows for the nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 | | Change |
Net cash provided by (used in): | | | | | |
Operating activities | $ | (537,186) | | | $ | (298,121) | | | $ | (239,065) | |
Investing activities | (49,728) | | | (70,921) | | | 21,193 | |
Financing activities | (95,923) | | | 133,548 | | | (229,471) | |
Effect on exchange rate on cash, cash equivalents, and restricted cash | 355 | | | 257 | | | 98 | |
Net decrease in cash, cash equivalents, and restricted cash | (682,482) | | | (235,237) | | | (447,245) | |
Cash, cash equivalents, and restricted cash at beginning of period | 1,348,845 | | | 1,528,259 | | | (179,414) | |
Cash, cash equivalents, and restricted cash at end of period | $ | 666,363 | | | $ | 1,293,022 | | | $ | (626,659) | |
Net cash used in operating activities was $537.2 million for the nine months ended September 30, 2023, as compared to $298.1 million for the same period in 2022. The increase in cash used in operating activities is primarily due to a decrease in upfront payments received under our APAs, partially offset by the timing of payments to vendors.
Net cash used in investing activities was $49.7 million for the nine months ended September 30, 2023, as compared to $70.9 million for the same period in 2022. The decrease in cash used in investing activities is primarily due to lower expenditures on equipment and leasehold improvements.
Net cash used in financing activities was $95.9 million for the nine months ended September 30, 2023, as compared to net cash provided by finance activities of $133.5 million for the same period in 2022. The increase in cash used in financing activities in 2023 as compared with 2022, is primarily due to the $325 million repayment of our 3.75% Convertible notes during 2023, partially offset by an increase in net proceeds from the sales of our common stock under our June 2021 and August 2023 Sales Agreements and the Private Placement with SK.
Going Concern
The accompanying unaudited consolidated financial statements in Part I, Item 1, “Consolidated Financial Statements” of this Quarterly Report have been prepared assuming that we will continue as a going concern within one year after the date that the financial statements are issued. At September 30, 2023, we had $666.4 million in cash and cash equivalents and restricted cash. During the nine months ended September 30, 2023, we incurred a net loss of $366.7 million and had net cash flows used in operating activities of $537.2 million.
In accordance with Accounting Standards Codification 205-40, Going Concern, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued. While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to revenue for the next twelve months, our ability to execute on certain cost-cutting initiatives and a pending matter subject to arbitration proceedings. Our revenue projections depend on our ability to successfully manufacture, distribute, or market our COVID-19 Vaccine for the 2023-2024
vaccination season, which is inherently uncertain and subject to a number of risks, including our ability to obtain regulatory authorization, the incidence of COVID-19 during the 2023-2024 vaccination season, our ability to timely deliver doses and commercial adoption and market acceptance of our updated vaccine.
Further, 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 advance purchase agreements may require the Company to refund portions of upfront and other payments or result in reduced future payments which could adversely affect our ability to continue as a going concern. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by us of the Gavi APA. The outcome of that arbitration is inherently uncertain, and it is possible we could be required to refund all or a portion of the remaining Advance Payment Amount of $696.4 million as of September 30, 2023. See Note 3 and Note 14 to our consolidated financial statements in this Quarterly Report for additional information related to the arbitration with Gavi. Management believes that, given the significance of these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued.
In May 2023, we announced our Restructuring Plan, which includes a more focused investment in our COVID-19 Program, reduction to our pipeline spending, the continued rationalization of our manufacturing network, a reduction to our global workforce, as well as the consolidation of facilities, and infrastructure. The workforce reduction plan included an approximately 25% reduction in the Company’s global workforce, comprised of an approximately 20% reduction in full-time Company employees and the remainder comprised of contractors and consultants. We have decided to progress CIC toward late-stage development and, as such, we are assessing the impact on our workforce requirements and ability to meet our future needs. We incurred one time restructuring expenses of $14.6 million during the nine months ended September 30, 2023. See Note 15 to our unaudited consolidated financial statements in Part I for more details on restructuring. We expect the full annual impact of the cost savings to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which we operate.
Our ability to fund our operations is dependent upon revenue related to vaccine sales for our products and product candidates, if such product candidates receive marketing authorization and are successfully commercialized, and in particular our 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the incidence of COVID-19 during the 2023-2024 vaccination season, regulatory authorization, ability to timely deliver doses and achieve commercial adoption and market acceptance of our updated vaccine; the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved; and management’s plans, which include completing cost reductions associated with our global restructuring and cost reduction plan. Our plans may include raising additional capital through a combination of equity and debt financings, collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements. New financings may not be available to us on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require us to give up some or all of our rights to a product or technology, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of our COVID-19 Program and our other vaccine candidates, including an influenza vaccine candidate and a CIC vaccine candidate, remains uncertain. Also, the impact of our more focused investment in our COVID-19 Program, reduction to our pipeline spending, continued rationalization of our manufacturing network, reduction to our global workforce, and consolidation of our facilities and infrastructure remain uncertain. If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or further downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations, and ability to operate as a going concern.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are subject to certain risks that may affect our results of operations, cash flows, and fair values of assets and liabilities, including volatility in foreign currency exchange rates and interest rate movements.
Foreign Currency Exchange Risk
Although we are headquartered in the U.S. our results of operations, including our foreign subsidiaries’ operations, are subject to foreign currency exchange rate fluctuations, primarily the U.S. dollar against the Euro, Pound Sterling, Swedish Krona, and Czech Koruna. This exchange exposure may have a material effect on our cash and cash equivalents, cash flows, and results of operations, particularly in cases of revenue generated under APAs that include provisions that impact our and our counterparty’s currency exchange exposure. To date, we have not entered into any foreign currency hedging contracts, although
we may do so in the future.
We also face foreign currency exchange exposure that arises from translating the results of our global operations to the U.S. dollar at exchange rates that have fluctuated from the beginning of the period. While the financial results of our global activities are reported in U.S. dollars, the functional currency for our foreign subsidiaries is generally their respective local currency. Fluctuations in the foreign currency exchange rates of the countries in which we do business will affect our operating results, often in ways that are difficult to predict. A 10% decline in the foreign exchange rates (primarily against the U.S. dollar) relating to our foreign subsidiaries would result in a decline of stockholders’ equity (deficit) of approximately $24 million as of September 30, 2023.
Market and Interest Rate Risk
The primary objective of our investment activities is preservation of capital, with the secondary objective of maximizing income.
Our exposure to interest rate risk is primarily confined to our investment portfolio. We do not believe that a change in the market rates of interest would have any significant impact on the realizable value of our investment portfolio. Changes in interest rates may affect the investment income we earn on our marketable securities when they mature and the proceeds are reinvested into new marketable securities and, therefore, could impact our cash flows and results of operations.
Interest and dividend income is recorded when earned and included in investment income. Premiums and discounts, if any, on marketable securities are amortized or accreted to maturity and included in investment income. The specific identification method is used in computing realized gains and losses on the sale of our securities.
Our convertible senior unsecured notes have a fixed interest rate, and we have no additional material debt. As such, we do not believe that we are exposed to any material interest rate risk as a result of our borrowing activities.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the assistance of our chief executive officer and chief financial officer, has reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of September 30, 2023. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving such control objectives. Based on the evaluation of our disclosure controls and procedures as of September 30, 2023, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
Our management, including our chief executive officer and chief financial officer, have evaluated changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2023, and have concluded that there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Stockholder Litigation
On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland (the “Maryland Court”) 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 Maryland 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 prototype vaccine on a commercial scale and to secure the prototype 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, the defendants filed a motion to dismiss the consolidated amended complaint. On December 12, 2022, the Maryland Court issued a ruling granting in part and denying in part defendants’ motion to dismiss. The Maryland Court dismissed all claims against two individual defendants and claims based on certain public statements challenged in the consolidated amended complaint. The Maryland Court denied the motion to dismiss as to the remaining claims and defendants, and directed the Company and other remaining defendants to answer within fourteen days. On December 27, 2022, the Company filed its answer and affirmative defenses. On March 16, 2023, the plaintiffs filed a motion for class certification and to appoint class representatives and counsel. The Company filed its opposition to the plaintiffs’ motion on September 22, 2023.
After the Sinnathurai Action was filed, eight 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. C-15-CV-21-000618 (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”), (vi) Diego J. Mesa v. Stanley C. Erck, et al., No. 2022-0770-NAC (the “Mesa Action”), (vii) Sean Acosta v. Stanley C. Erck, et al., No. 2022-1133-NAC (the “Acosta Action”), and (viii) Jared Needelman v. Stanley C. Erck, et al., No. C-15-CV-23-001550 (the “Needelman Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the Maryland Court. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the Maryland Court by the defendants. The Needleman Action was also filed in the Circuit Court for Montgomery County, Maryland. The Mesa and Acosta Actions were filed in the Delaware Court of Chancery (the “Delaware Court”). The derivative lawsuits name members of the Company’s 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 February 7, 2022, the Maryland 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 Maryland Court entered an order 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 Maryland 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 filed a consolidated amended complaint on November 21, 2022. On February 10, 2023, defendants filed a motion to dismiss the Second Consolidated Derivative Action. The plaintiffs filed their opposition to the motion to dismiss on April 11, 2023. Defendants filed their reply brief in further support of their motion to dismiss on May 11, 2023. On August 21, 2023, the court entered an order granting in part and denying in part the motion to dismiss. On September 5, 2023, the Company filed an Answer to the consolidated amended complaint. On September 6, 2023, the court entered an order granting the individual defendants an extension of time to file their answer until November 6, 2023. On October 6, 2023, the Board of Directors of the Company formed a Special Litigation Committee (“SLC”) with full and exclusive power and authority of the Board to, among other things, investigate, review, and analyze the facts and circumstances surrounding the claims asserted in the pending derivative actions, including the claims that remain following the court’s order on the motion to dismiss in the Second Consolidated Derivative Action. On November 7, 2023, the court entered an order granting the parties’ request to stay the Second Consolidated Derivative Action for up to six months from the date of entry of the order. This includes staying the deadline for the individual defendants to respond to the consolidated amended complaint.
On July 21, 2022, the Maryland Court issued a memorandum opinion and order remanding the Kirst Action to state court. On December 6, 2022, the parties to the Kirst Action filed a stipulated schedule pursuant to which the plaintiffs were expected to file an amended complaint on December 22, 2022, and either (i) the parties would file a stipulated stay of the Kirst Action or (ii) the defendants would file a motion to stay the case by January 23, 2023. The plaintiffs filed an amended complaint on December 30, 2022. On January 23, 2023, defendants filed a motion to stay the Kirst action. On February 22, 2023, the parties in the Kirst Action filed for the Court’s approval of a stipulation staying the Kirst Action pending the resolution of defendants’ motion to dismiss in the Second Consolidated Derivative Action. On March 22, 2023, the Court entered an order staying the Kirst Action pending resolution of the motion to dismiss in the Second Consolidated Derivative Action. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action.
On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the Delaware 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. On January 9, 2023, following the ruling on the motion to dismiss the Sinnathurai Action, the Delaware Court entered an order granting the Mesa Action parties’ request to set a briefing schedule in connection with a motion to stay by defendants. On February 28, 2023, the court granted the defendants’ motion and stayed the Mesa Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On August 31, 2023, the Mesa plaintiffs filed a motion to lift the stay in the Mesa Action. On October 6, 2023, the Company filed an opposition to plaintiff’s motion to lift the stay. On October 17, 2023, the Mesa plaintiff filed his reply in further support of his motion to lift the stay.
On December 7, 2022, the Acosta Action was filed. On February 6, 2023, defendants accepted service of the complaint and summons in the Acosta Action. On March 9, 2023, the court entered an order granting the parties’ request to stay the Acosta Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On October 13, 2023, the parties filed, and the Delaware Court entered, a stipulated order providing that (i) if the Delaware Court declines to lift the stay in the Mesa Action, the Acosta Action will also remain stayed, and (ii) if the Delaware Court lifts the stay in the Mesa Action, the stay in the Acosta Action will also be lifted.
On April 17, 2023, the Needelman Action was filed. On July 12, 2023, the parties filed a stipulation and proposed order to stay the Needelman Action pending the Maryland Court’s decision on the motion to dismiss in the Second Consolidated Derivative Action. The court entered that order on July 17, 2023. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action. The financial impact of this claim, as well as the claims discussed above, is not estimable.
On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA based on Gavi’s failure to procure the purchase of 350 million doses of prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while we believe that we are entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that we could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi.
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 the Company’s prototype vaccine under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach. On October 30, 2023, FDBT filed a demand for arbitration with JAMS seeking payment of the withheld installment payment.
We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.
Item 1A. Risk Factors
Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on February 28, 2023, and Part II, Item 1A. “Risk Factors” of our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023, which was filed with the SEC on May 9, 2023 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, which was filed with the SEC on August 8, 2023. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K, for the fiscal year ended December 31, 2022, the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023 other than as described below.
Risks Related to Employee Matters, Managing Growth and Information Technology
Given our current cash position and cash flow forecast, and significant uncertainties related to 2023 revenue, and our pending arbitration with Gavi, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that the financial statements included in this Quarterly Report were issued.
Our management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. At September 30, 2023, we had $666.4 million in cash and cash equivalents and restricted cash. During the nine months ended September 30, 2023, we incurred a net loss of $366.7 million and had net cash flows used in operating activities of $537.2 million.
While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to the following:
• Revenue: The Company’s revenue projections depend on its ability to successfully manufacture, distribute and market its COVID-19 Vaccine for the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance. Further, 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 advance purchase agreements may require the Company to refund portions of upfront and other payments or result in reduced future payments.
• Pending Arbitration: On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by us of the Gavi APA. The outcome of that arbitration is inherently uncertain, and it is possible we could be required to refund all or a portion of the remaining advance payments of $696.4 million. See Note 3 and Note 14 to our consolidated financial statements in this Quarterly Report for additional information related to the arbitration with Gavi.
Management believes that, given the significance of these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued.
Our ability to fund Company operations is dependent upon revenue related to vaccine sales for our products and product candidates, if such product candidates receive marketing authorization and are successfully commercialized, and in particular the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the incidence of COVID-19 during the 2023-2024 vaccination season, regulatory authorization, ability to timely deliver doses and achieve commercial adoption and market acceptance of its updated vaccine; the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved; and management’s plans, which include cost reductions associated with the restructuring of our global footprint. Management’s plans may also include raising additional capital through a combination of equity and debt financing, collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements. In May 2023, we announced a global restructuring and cost reduction plan. This plan includes a more focused investment in our COVID-19 Program, reduction to our pipeline spending, the continued rationalization of our manufacturing network, a reduction to our global workforce, as well as the consolidation of facilities and infrastructure. New financings may not be available to us on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require us to give up some or all of our rights to a product or technology, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of our COVID-19 Program and our other vaccine candidates, including an influenza vaccine candidate and CIC vaccine candidate, remains uncertain. Also, the impact of the Company’s more focused investment in its COVID-19 Program, reduction to its pipeline spending, continued rationalization of its manufacturing network, reduction to its global workforce, and consolidation of its facilities and infrastructure remain uncertain. If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations, and ability to operate as a going concern.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
On August 8, 2023, we entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which we agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of the Company’s common stock, par value $0.01 per share at a price of $13.00 per share for aggregate gross proceeds to us of approximately $84.5 million. The proceeds from the Private Placement will be used for general corporate purposes, including but not limited to, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, commercialization activities, acquisitions and other strategic purposes. We recognized the shares at the settlement date fair value of $46.5 million (see Note 4 to our consolidated financial statements in this Quarterly Report). The closing of the Private Placement occurred on August 10, 2023.
Item 5. Other Information
During the three months ended September 30, 2023, no director or “officer” (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Item 6. Exhibits
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101 | | The following financial information from our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, formatted in Inline Extensible Business Reporting Language (Inline XBRL): (i) the Consolidated Statements of Operations for the three- and nine-month periods ended September 30, 2023 and 2022, (ii) the Consolidated Statements of Comprehensive Income (Loss) for the three- and nine-month periods ended September 30, 2023 and 2022, (iii) the Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022, (iv) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three- and nine-month periods ended September 30, 2023 and 2022, (v) the Consolidated Statements of Cash Flows for the nine-month periods ended September 30, 2023 and 2022, and (vi) the Notes to Consolidated Financial Statements. |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
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*Filed or furnished herewith.
± Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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| NOVAVAX, INC. |
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Date: November 9, 2023 | By: | /s/ John C. Jacobs |
| | John C. Jacobs President and Chief Executive Officer (Principal Executive Officer) |
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Date: November 9, 2023 | By: | /s/ James P. Kelly |
| | James P. Kelly Executive Vice President, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) |
Exhibit 10.1
CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Settlement Agreement and General Release
This Settlement Agreement and General Release (“Agreement”) is made effective as of the 8th day of August, 2023 (“Effective Date”) by and between Novavax, Inc., a Delaware corporation having a place of business at 21 Firstfield Rd., Gaithersburg, MD 20878 (“Novavax”) and SK bioscience Co., Ltd., a company incorporated in the Republic of Korea having a place of business at 310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 13494, Republic of Korea (“SK”). Novavax and SK shall each be hereinafter referred to as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, the Parties entered into the Development and Supply Agreement dated August 11, 2020 (“DSA”) and the Collaboration and License Agreement, dated February 12, 2021 as amended on December 23, 2021 and July 1, 2022 (“CLA”), under which SK Manufactures and supplies Covid-19 antigen and vaccine products to Novavax. The DSA and CLA, are collectively referred to herein as the “Business Agreements”. Products (under the DSA) and Collaboration Antigen Products (under the CLA) are hereinafter collectively referred to as “Novavax Products”;
WHEREAS, pursuant to Novavax’s cancellation notice on [***], SK has ceased all drug substance and drug product Manufacturing activities for supply to Novavax under the following statement of works in relation to the Business Agreements: (i) Statement of Work No.1 dated December 23, 2021, under the CLA as amended to date (“SOW No.1”); (ii) Statement of Work No. 5 dated July 18, 2022, under the DSA (“SOW No.5”); and (iii) Statement of Work No. 6 dated July 18, 2022, as amended to date under the DSA (“SOW No. 6”). SOW No.1, SOW No.5 and SOW No.6 are hereinafter collectively referred to as “Subject SOWs”;
WHEREAS, Novavax and SK desire to wind down all drug substance and drug product Manufacturing activities for supply to Novavax under the Subject SOWs as of the Effective Date; and
WHEREAS, without conceding to any of the claims [***], or any rights Novavax or SK has in connection with other Party’s performance of the Business Agreements or under the Parties’ [***], and [***], the Parties enter into this Agreement in their respective best interests to resolve their disputes through settlement and to agree the wind-down of the Subject SOWs.
NOW, THEREFORE, in exchange for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1.Recitations and Definitions. The above Recitals are incorporated into the terms and conditions of this Agreement and made a part hereof. Capitalized terms used but not otherwise defined herein shall have the meanings provided in the Business Agreements.
2.Settlement Terms
2.1 As of the Effective Date, Novavax and SK agree to wind down all drug substance and drug product Manufacturing activities for supply to Novavax under the Subject SOWs. In connection with the cancellation and wind down of the Subject SOWs and as consideration for the final and full release of all Claims (as defined below), the Parties hereby agree that the amounts payable by Novavax to SK shall be USD One Hundred and
Forty Nine Million and Seven Hundred Fifty Thousand ($149.75 million) (“Settlement Cash”).
Novavax will pay to SK the Settlement Cash in accordance with the following payment schedule:
| | | | | | | | |
| Payment milestones | Amount (in USD) |
First Payment | Within two (2) business days upon the Effective Date hereof | $130.4 million |
Second Payment | On or before November 15, 2023 | $19.35 million |
2.2. The Parties will work collaboratively to agree on and execute a plan to wind down all activities at [***], and SK’s and its Subcontractors’ other facilities (collectively, “SK Facilities”) that have been used for the Manufacture and supply of Novavax Products (“Wind Down Plan”). Each Party will bear their respective costs associated with the preparation of the Wind Down Plan. The Wind Down Plan shall be developed collaboratively and fully implemented by the Parties no later than [***] from the Effective Date. In accordance with the Quality Agreement and the Business Agreements, [***] is responsible for the final disposition of all Novavax Products Manufactured by SK from SK Facilities under the Business Agreements (including Subject SOWs, and any other statement of works where there are remaining Batches under review and testing). With respect to Novavax owned unused Raw Materials acquired for the Manufacturing of Novavax Products (“Left Over Raw Materials”) and Equipment remaining at SK Facilities as of the Effective Date hereof, the Wind Down plan will include a [***]. For the avoidance of doubt, any Purchaser Supplied Items remaining at SK Facilities as of the Effective Date hereof, as specified in the Wind Down Plan, are Novavax property, which wind-down shall be handled in accordance with such Wind Down Plan. The Wind Down Plan will include the following cost sharing agreement between the Parties:
(a)For all Left Over Raw Materials, Equipment and Purchaser Supplied Items that are designated as “returned to Novavax”, any cost and expense arising from or in connection with the return and delivery of same will be [***].
(b)For all Left Over Raw Materials, Equipment and Purchaser Supplied Items that are designated as “repurposed or destroyed by SK”, Novavax will transfer to SK all such Leftover Raw Materials, Equipment and Purchaser Supplied Items in accordance with the Wind Down Plan on an as-is basis and without any warranty, representation, or covenant. SK may, at its sole discretion and expense, repurpose or destroy all such Leftover Raw Materials and Equipment, and SK shall be fully responsible for the use or destruction of same. For Adjuvant (Matrix-M™), SK may only purpose such material in the Manufacturing SK Vaccine Products under the CLA; or, destroy in accordance with the Quality Agreement.
(c)For all Novavax Products unreleased from and/or stored at SK Facilities under the Business Agreement as of the Effective Date hereof for supply to Novavax, which are
listed under the Wind Down Plan as “delivered to Novavax”, SK will deliver and Novavax shall receive [***] at the location as set forth in the Wind Down Plan. [***].
2.3 The Parties hereby agree to: (i) remove certain restrictions under the CLA that have been triggered by the launch of SK’s Competing Vaccine SKYCovione™ in the Republic of Korea; (ii) grant an exclusive license by Novavax to SK under the CLA for the Exploitation of SK Antigen Product and SK Vaccine Product in the Republic of Korea and extend the term of such license until February 12, 2029; and (iii) grant a non-exclusive license by Novavax to SK under the CLA for Exploitation of the SK Antigen Product and SK Vaccine Product in Thailand and Vietnam with a term until June 30, 2028. SK Antigen Product and SK Vaccine Product include those utilizing Variant Antigen developed by Novavax during the Term of the CLA. This Section 2.3 shall constitute a valid and binding amendment of CLA between the Parties and be a part of the CLA. The other terms and conditions that are not covered in this Section 2.3 shall be subject to the CLA. [***] following the Effective Date hereof, the Parties will negotiate in good faith other matters regarding the amendment of CLA that are not covered in this Section 2.3, and use reasonable efforts to enter into a mutually acceptable amendment to the CLA to reflect such agreement of the Parties. The Parties acknowledge and agree that the value of the licenses extension granted in this Section 2.3 equals $[***]. The Parties agree to irrevocably deduct such amount from the total settlement amount set forth in the Exhibit A attached hereto. The Settlement Cash (which is the balance between the total settlement amount under Exhibit A and such $[***]), among other promises, covenants, releases, and agreements contained in this Agreement, constitutes the consideration for the Release under this Agreement. For further clarity, under no circumstances will Novavax be responsible to pay to SK such $[***] or any other amount with respect to the licenses granted under and/or extended in accordance with this Section 2.3.
2.4 Each Party will execute all further and additional documents and take all further actions as may reasonably be necessary to effectuate and carry out the provisions in this Section 2 in a timely manner.
3.Release
3.1In consideration of the promises, covenants, releases, and agreements contained herein, without further action by any party, SK and Novavax do hereby now and forever release, remise, hold harmless, and forever discharge each other, and their respective past, present, and future directors, officers, employees, Subcontractors, agents, sublicensees, consultants, attorneys and accountants, Affiliates, assigns, successors, shareholders, beneficiaries, predecessors, insurers, administrators, and successors in interest (each a “Releasee”) of any and all cause of actions, suits, claims, rights, damages, liabilities, obligations, debts, agreements, losses, costs, expenses (including attorneys’ fees and costs actually incurred), or controversies of any nature whatsoever, known or unknown, liquidated or unliquidated, suspected or unsuspected, fixed or contingent in law or in equity arising from or in connection with the Business Agreements, the Subject SOWs, and other statement of works existing under the Business Agreements, in each case, in connection with the Manufacturing and supply of Novavax Products and the cancellation of Services, which have been brought or could have been brought as of the Effective Date (collectively, “Claims”), including without limitation:
a.SK’s obligation to Manufacture or supply any Novavax Product; and
b.Claims by SK that Novavax has breached (i) its obligations under the Subject SOWs arising from or in connection with the cancelation or termination of the Services and disposition of Novavax Products by Novavax as set forth under Section 2.2 hereof; or (ii) its other obligations under the Business Agreements or other SOWs.
3.2For the avoidance of doubt, nothing in this Agreement terminates the DSA or CLA, nor releases either Party’s claims or obligations with respect to Section 2.2 hereof, nor modifies or releases either Party’s rights or obligations in connection with SK Antigen Product and SK Vaccine Product under the CLA, nor terminates or releases either Party’s claims or obligations to maintain the confidentiality of the other Party’s Confidential Information under the Business Agreements and Subject SOWs.
3.3Each Releasee will be an express beneficiary of the rights and releases granted under this Section 3 (Release) and will be entitled to rely on the same as a defense to any suit brought against such Releasee in contravention of the provisions of this Section 3 (Release), without regard to the fact that such Releasee may not be a party to this Agreement.
4.Confidentiality
4.1Each Party acknowledges the confidential nature of the terms and conditions of this Agreement, as well as the confidential information disclosed between the Parties pursuant to the confidentiality terms of the Business Agreements (which remain in full force and effect) (such information, collectively, the “Confidential Information”) and, except as set forth below or in Section 5.1 of this Agreement, each Party agrees that it shall not (a) disclose any Confidential Information to any person or entity, except to such Party and its Affiliates or their respective employees, officers, directors, advisors and other representatives (“Representatives”) who need to know the Confidential Information to assist such Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement, or (b) use the Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement or the Business Agreements. Each Party shall be responsible for any breach of this Section 4 caused by any of its Representatives. Notwithstanding the foregoing, if any Confidential Information is permissibly disclosed under Section 5.1, such information will no longer be deemed Confidential Information for the purposes of this Section 4.
4.2In the event that either Party receives a request to produce Confidential Information of the other Party pursuant to an order of a court of competent jurisdiction or a facially valid administrative, congressional, state or local legislative or other subpoena or believes that such Party is otherwise required by law to disclose Confidential Information, then such Party shall [***] notify the other Party prior to making such disclosure, unless prior notification is precluded by applicable laws or regulations or where enforcement action by applicable authority precludes prior notification, in which case the Party will notify the other Party [***], and shall provide the other Party the opportunity to challenge or otherwise lawfully seek limits upon such disclosure of Confidential Information.
5.Publicity
5.1Neither Party shall, orally or in writing, publicly disclose or issue any press release, make any other public statement, or otherwise communicate with the media, concerning the Subject SOWs, the Business Agreements, the existence of this Agreement or the subject matter hereof, without the prior written approval of the other Party, except to the extent that such Party is required to make any public disclosure or filing regarding the subject matter of this Agreement by applicable laws or regulations, or in connection with enforcing its rights under this Agreement.
5.2Neither Party shall make, publish, or communicate to any person or entity or in any public forum any comments or statements, written or oral, that denigrate or disparage, or are detrimental to, the reputation or stature of the other Party or its businesses, or any of its employees, officers, directors, and existing and prospective customers, suppliers, investors, and other associated third parties.
6.Non-Admission of Liability
The Parties understand and agree that this Agreement is a compromise and settlement of disputed Claims. Each Party specifically denies any liability or wrongdoing whatsoever on their part, such liability including without limitation the Subject SOWs financial breakdown specified under Exhibit A hereto. Nothing in this Agreement shall constitute or be construed as an admission of liability on behalf of a Party, or an admission as to the validity of the Claims.
7.Non-Transfer of Claims
Each Party represents and warrants that it has not assigned or otherwise transferred any interest in any Claim which it may have against the other Party, and hereby agrees that any transfer of any of its interest in any Claim before or after the date of this Agreement, if any, shall be void and invalid. For further clarity, no Party shall assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, and any attempt of assignment or transfer without such consent shall be void.
8.Free and Voluntary Act of the Parties
Each Party acknowledges that it is entering into this Agreement with full knowledge and understanding that in exchange for the benefits to be received as described herein, it is giving up certain valuable rights that such Party may now have or may later acquire under the Business Agreements.
9.Attorney Representation
This Agreement is entered into voluntarily by the Parties who stipulate and agree that they are under no duress or undue influence. The Parties represent that in the execution of this Agreement, they had the opportunity to consult legal counsel of their own selection and that the said attorneys have reviewed this Agreement, made any desired changes, and advised their respective clients with respect to the advisability of making the settlement and releases provided herein and of executing this Agreement.
10.Due Authorization
Each Party represents and warrants to the other Party that it has full corporate power and authority to execute, deliver and perform under this Agreement and has taken all corporate action required by applicable laws, and its organizational documents to authorize the execution and delivery of this Agreement, and the consummation of the transactions contemplated by this Agreement, and this Agreement constitutes a valid and binding agreement against it in accordance with its terms.
11.Governing Laws and Dispute Resolution
This Agreement, and all claims arising under or in connection therewith, shall be governed by and interpreted in accordance with the substantive laws of [***], without regard to conflict of law principles thereof. The dispute resolution provisions in Business Agreements shall apply to any and all disputes arising under this Agreement.
12.Entire Agreement
This Agreement contains the entire agreement and understanding of the Parties concerning the subject matter hereof (including without limitation any Claims) and supersedes and replaces all prior negotiations, proposed agreements, and agreements (written or oral) between the Parties on same. Each Party acknowledges that neither the other Party, nor any agent or attorney of the other Party, has made any promise, representation, or warranty whatsoever, express or implied, not contained herein concerning the subject matter hereof to induce it to execute this Agreement and acknowledges that it is not executing this Agreement in reliance on any such promise, representation or warranty not contained herein.
13.Separation of Terms
In the event that any provision of this Agreement is held to be void, voidable, or unenforceable, it shall be severed from this Agreement and the remaining portions hereof shall remain in full force and effect.
14.No Waiver; Amendment
No provision of this Agreement may be waived or modified, except in writing executed by the Party entitled to enforcement of such provision. The failure of any Party to require strict performance with any provision of this Agreement shall not be construed as a waiver. No provision of this Agreement may be amended or modified other than by a written document executed by authorized representatives of each Party.
15.Costs
The Parties have agreed to bear their own attorneys' fees and costs with respect to the preparation of any and all documents necessary to enter into this Agreement.
16.Notices.
All notices, requests, consents, and other communications under this Agreement shall be in writing Any notices, requests, demands and other communications required or permitted in this Agreement shall be effective if in writing and (i) delivered personally, (ii) sent by e-mail or (iii) delivered by overnight courier, in each case, addressed as follows:
If to the Company to:
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD 20878
Attention: John Herrmann
Title: Executive Vice President, Chief Legal Officer & General Counsel, Corporate Secretary
E-mail: [***]
If to SK to:
SK bioscience Co., Ltd.
[***]
[***]
Attention: [***]
Title: [***]
E-mail: [***]
or at such other address as Novavax or SK each may specify by written notice to the other party hereto. Either party may change the address to which notices, requests, consents or other communications hereunder are to be delivered by giving the other Party notice in the manner set forth in this Section 16.
17.Counterparts
This Agreement may be signed and executed in one or more counterparts, each of which shall be deemed an original and all of which together shall constitute one Agreement.
Delivery of an executed counterpart of a signature page of this Agreement by facsimile or email shall be effective as delivery of an originally executed counterpart of this Agreement.
[INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the Parties have executed this Agreement through their duly authorized officers or representatives.
| | | | | |
Novavax, Inc. | SK bioscience Co., Ltd. |
| |
/s/ John A. Herrmann III | /s/ [***] |
Name: John A. Herrmann III | Name: [***] |
Title: Executive Vice President, Chief Legal Officer & General Counsel, Corporate Secretary Date: 08/08/2023 | Title: [***]
Date: 08/08/2023 |
Exhibit A
Subject SOWs Financial Breakdown
[Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the financial breakdown of the Settlement Cash among the Subject SOWs has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted exhibits to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]
[***]
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
I, John C. Jacobs, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Novavax, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| | | | | | | | | | | |
Date: November 9, 2023 | | By: | /s/ John C. Jacobs |
| | | John C. Jacobs |
| | | President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, James P. Kelly, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Novavax, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| | | | | | | | | | | |
Date: November 9, 2023 | | By: | /s/ James P. Kelly |
| | | James P. Kelly |
| | | Executive Vice President, Chief |
| | | Financial Officer and Treasurer |
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO 18 UNITED STATES CODE §1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the Quarterly Report of Novavax, Inc. (the “Company”) on Form 10-Q for the fiscal period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John C. Jacobs, President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by this Report.
| | | | | | | | | | | |
Date: November 9, 2023 | | By: | /s/ John C. Jacobs |
| | | John C. Jacobs |
| | | President and Chief Executive Officer |
This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Company specifically incorporates it by reference.
Exhibit 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 UNITED STATES CODE §1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the Quarterly Report of Novavax, Inc. (the “Company”) on Form 10-Q for the fiscal period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James P. Kelly, Executive Vice President and Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by this Report.
| | | | | | | | | | | |
Date: November 9, 2023 | | By: | /s/ James P. Kelly |
| | | James P. Kelly |
| | | Executive Vice President, Chief |
| | | Financial Officer and Treasurer |
This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Company specifically incorporates it by reference.
v3.23.3
Cover Page - shares
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9 Months Ended |
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Sep. 30, 2023 |
Oct. 31, 2023 |
Cover [Abstract] |
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10-Q
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Document Quarterly Report |
true
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Document Period End Date |
Sep. 30, 2023
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Document Transition Report |
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Entity File Number |
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Entity Registrant Name |
NOVAVAX, INC.
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Entity Incorporation, State or Country Code |
DE
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|
Entity Tax Identification Number |
22-2816046
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|
Entity Address, Address Line One |
700 Quince Orchard Road,
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Entity Address, City or Town |
Gaithersburg,
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Entity Address, Country |
MD
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Entity Address, Postal Zip Code |
20878
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City Area Code |
(240)
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Local Phone Number |
268-2000
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Title of 12(b) Security |
Common Stock, Par Value $0.01 per share
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Trading Symbol |
NVAX
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Security Exchange Name |
NASDAQ
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v3.23.3
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Revenue: |
|
|
|
|
Revenues |
$ 186,986
|
$ 734,577
|
$ 692,363
|
$ 1,624,473
|
Expenses: |
|
|
|
|
Cost of sales |
98,929
|
434,593
|
188,792
|
720,874
|
Research and development |
106,229
|
304,297
|
572,805
|
977,428
|
Selling, general, and administrative |
107,460
|
122,876
|
313,709
|
327,028
|
Total expenses |
312,618
|
861,766
|
1,075,306
|
2,025,330
|
Loss from operations |
(125,632)
|
(127,189)
|
(382,943)
|
(400,857)
|
Other income (expense): |
|
|
|
|
Interest expense |
(2,859)
|
(4,169)
|
(10,299)
|
(15,279)
|
Other income (expense) |
(2,982)
|
(34,783)
|
26,912
|
(53,002)
|
Loss before income taxes |
(131,473)
|
(166,141)
|
(366,330)
|
(469,138)
|
Income tax expense (benefit) |
(697)
|
2,472
|
343
|
6,552
|
Net loss |
$ (130,776)
|
$ (168,613)
|
$ (366,673)
|
$ (475,690)
|
Net loss per share: |
|
|
|
|
Basic (in usd per share) |
$ (1.26)
|
$ (2.15)
|
$ (3.94)
|
$ (6.13)
|
Diluted (in usd per share) |
$ (1.26)
|
$ (2.15)
|
$ (3.94)
|
$ (6.13)
|
Weighted average number of common shares outstanding |
|
|
|
|
Basic (in shares) |
103,429
|
78,274
|
93,046
|
77,631
|
Diluted (in shares) |
103,429
|
78,274
|
93,046
|
77,631
|
Product sales |
|
|
|
|
Revenue: |
|
|
|
|
Revenues |
$ 2,231
|
$ 626,091
|
$ 279,937
|
$ 1,267,174
|
Grants |
|
|
|
|
Revenue: |
|
|
|
|
Revenues |
164,922
|
106,273
|
389,380
|
313,348
|
Royalties and other |
|
|
|
|
Revenue: |
|
|
|
|
Revenues |
$ 19,833
|
$ 2,213
|
$ 23,046
|
$ 43,951
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.23.3
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Statement of Comprehensive Income [Abstract] |
|
|
|
|
Net loss |
$ (130,776)
|
$ (168,613)
|
$ (366,673)
|
$ (475,690)
|
Other comprehensive loss: |
|
|
|
|
Foreign currency translation adjustment |
(3,686)
|
(12,924)
|
(5,486)
|
(22,441)
|
Other comprehensive loss |
(3,686)
|
(12,924)
|
(5,486)
|
(22,441)
|
Comprehensive loss |
$ (134,462)
|
$ (181,537)
|
$ (372,159)
|
$ (498,131)
|
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v3.23.3
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 651,104
|
$ 1,336,883
|
Restricted cash |
10,393
|
10,303
|
Accounts receivable |
123,657
|
82,375
|
Inventory |
69,592
|
36,683
|
Prepaid expenses and other current assets |
152,018
|
237,147
|
Total current assets |
1,006,764
|
1,703,391
|
Property and equipment, net |
300,982
|
294,247
|
Right of use asset, net |
190,741
|
106,241
|
Goodwill |
123,780
|
126,331
|
Other non-current assets |
34,890
|
28,469
|
Total assets |
1,657,157
|
2,258,679
|
Current liabilities: |
|
|
Accounts payable |
101,914
|
216,517
|
Accrued expenses |
311,201
|
591,158
|
Deferred revenue |
192,187
|
370,137
|
Current portion of finance lease liabilities |
1,332
|
27,196
|
Convertible notes payable |
0
|
324,881
|
Other current liabilities |
861,956
|
930,055
|
Total current liabilities |
1,468,590
|
2,459,944
|
Deferred revenue |
608,842
|
179,414
|
Convertible notes payable |
167,621
|
166,466
|
Non-current finance lease liabilities |
53,158
|
31,238
|
Other non-current liabilities |
37,296
|
55,695
|
Total liabilities |
2,335,507
|
2,892,757
|
Commitments and contingencies (Note 14) |
|
|
Preferred stock, $0.01 par value, 2,000,000 shares authorized at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022 |
0
|
0
|
Stockholders' deficit: |
|
|
Common stock, $0.01 par value, 600,000,000 shares authorized at September 30, 2023 and December 31, 2022; 119,641,667 shares issued and 118,730,398 shares outstanding at September 30, 2023 and 86,806,554 shares issued and 86,039,923 shares outstanding at December 31, 2022 |
1,196
|
868
|
Additional paid-in capital |
4,066,585
|
3,737,979
|
Accumulated deficit |
(4,642,562)
|
(4,275,889)
|
Treasury stock, cost basis, 911,269 shares at September 30, 2023 and 766,631 shares at December 31, 2022 |
(91,706)
|
(90,659)
|
Accumulated other comprehensive loss |
(11,863)
|
(6,377)
|
Total stockholders’ deficit |
(678,350)
|
(634,078)
|
Total liabilities and stockholders’ deficit |
$ 1,657,157
|
$ 2,258,679
|
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v3.23.3
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value per share (in usd per share) |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized (in shares) |
2,000,000
|
2,000,000
|
Preferred stock, shares issued (in shares) |
0
|
0
|
Preferred stock, shares outstanding (in shares) |
0
|
0
|
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) |
119,641,667
|
86,806,554
|
Common stock, shares outstanding (in shares) |
118,730,398
|
86,039,923
|
Treasury stock (in shares) |
911,269
|
766,631
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands |
Total |
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Treasury Stock |
Accumulated Other Comprehensive Loss |
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
|
|
|
|
|
Stock issued under incentive programs |
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
|
|
|
|
|
Stock issued under incentive programs |
(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)
|
Balance beginning (in shares) at Dec. 31, 2022 |
86,039,923
|
86,806,554
|
|
|
|
|
Balance beginning at Dec. 31, 2022 |
$ (634,078)
|
$ 868
|
3,737,979
|
(4,275,889)
|
(90,659)
|
(6,377)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Stock-based compensation |
70,193
|
|
70,193
|
|
|
|
Stock issued under incentive programs (in shares) |
|
605,571
|
|
|
|
|
Stock issued under incentive programs |
699
|
$ 6
|
1,740
|
|
(1,047)
|
|
Issuance of common stock, net of issuance costs (in shares) |
|
32,229,542
|
|
|
|
|
Issuance of common stock, net of issuance costs |
256,995
|
$ 322
|
256,673
|
|
|
|
Foreign currency translation adjustment |
(5,486)
|
|
|
|
|
(5,486)
|
Net loss |
$ (366,673)
|
|
|
(366,673)
|
|
|
Balance ending (in shares) at Sep. 30, 2023 |
118,730,398
|
119,641,667
|
|
|
|
|
Balance ending at Sep. 30, 2023 |
$ (678,350)
|
$ 1,196
|
4,066,585
|
(4,642,562)
|
(91,706)
|
(11,863)
|
Balance beginning (in shares) at Jun. 30, 2023 |
|
95,183,750
|
|
|
|
|
Balance beginning at Jun. 30, 2023 |
(754,519)
|
$ 952
|
3,855,916
|
(4,511,786)
|
(91,424)
|
(8,177)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Stock-based compensation |
21,254
|
|
21,254
|
|
|
|
Stock issued under incentive programs (in shares) |
|
176,329
|
|
|
|
|
Stock issued under incentive programs |
354
|
$ 2
|
634
|
|
(282)
|
|
Issuance of common stock, net of issuance costs (in shares) |
|
24,281,588
|
|
|
|
|
Issuance of common stock, net of issuance costs |
189,023
|
$ 242
|
188,781
|
|
|
|
Foreign currency translation adjustment |
(3,686)
|
|
|
|
|
(3,686)
|
Net loss |
$ (130,776)
|
|
|
(130,776)
|
|
|
Balance ending (in shares) at Sep. 30, 2023 |
118,730,398
|
119,641,667
|
|
|
|
|
Balance ending at Sep. 30, 2023 |
$ (678,350)
|
$ 1,196
|
$ 4,066,585
|
$ (4,642,562)
|
$ (91,706)
|
$ (11,863)
|
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v3.23.3
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating Activities: |
|
|
Net loss |
$ (366,673)
|
$ (475,690)
|
Reconciliation of net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
30,431
|
21,832
|
Non-cash stock-based compensation |
69,699
|
102,525
|
Provision for excess and obsolete inventory |
49,533
|
358,075
|
Impairment of long-lived assets |
10,081
|
0
|
Right-of-use assets expensed, net of credits received |
0
|
40,187
|
Other items, net |
(3,015)
|
(25,059)
|
Changes in operating assets and liabilities: |
|
|
Inventory |
(82,542)
|
(426,466)
|
Accounts receivable, prepaid expenses, and other assets |
(34,418)
|
171,325
|
Accounts payable, accrued expenses, and other liabilities |
(349,261)
|
90,418
|
Deferred revenue |
138,979
|
(155,268)
|
Net cash used in operating activities |
(537,186)
|
(298,121)
|
Investing Activities: |
|
|
Capital expenditures |
(44,932)
|
(66,033)
|
Internal-use software |
(4,796)
|
(4,888)
|
Net cash used in investing activities |
(49,728)
|
(70,921)
|
Financing Activities: |
|
|
Net proceeds from sales of common stock |
256,995
|
179,385
|
Net proceeds from the exercise of stock-based awards |
699
|
67
|
Finance lease payments |
(25,026)
|
(45,904)
|
Repayment of 2023 Convertible notes |
(325,000)
|
0
|
Payments of costs related to issuance of 2027 Convertible notes |
(3,591)
|
0
|
Net cash provided by (used in) financing activities |
(95,923)
|
133,548
|
Effect of exchange rate on cash, cash equivalents, and restricted cash |
355
|
257
|
Net decrease in cash, cash equivalents, and restricted cash |
(682,482)
|
(235,237)
|
Cash, cash equivalents, and restricted cash at beginning of period |
1,348,845
|
1,528,259
|
Cash, cash equivalents, and restricted cash at end of period |
666,363
|
1,293,022
|
Supplemental disclosure of non-cash activities: |
|
|
Right-of-use assets from new lease agreements |
96,492
|
118,262
|
Capital expenditures included in accounts payable and accrued expenses |
2,394
|
11,984
|
Internal-use software included in accounts payable and accrued expenses |
167
|
0
|
Supplemental disclosure of cash flow information: |
|
|
Cash interest payments, net of amounts capitalized |
11,751
|
17,260
|
Cash paid for income taxes |
$ 128
|
$ 17,843
|
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v3.23.3
Organization and Business
|
9 Months Ended |
Sep. 30, 2023 |
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 by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and patented Matrix-M™ adjuvant to enhance the immune response. Novavax currently has one commercial program, for vaccines to prevent COVID-19, which includes Nuvaxovid prototype COVID-19 vaccine ("NVX-CoV2373,” or “prototype vaccine”) and Nuvaxovid updated COVID-19 vaccine (“NVX-CoV2601,” or “updated vaccine”) (collectively, “COVID-19 Program,” or “COVID-19 Vaccine”). Local authorities have also specified nomenclature for the prototype and updated vaccines within their labeling (“Novavax COVID-19 Vaccine, Adjuvanted” and “Novavax COVID-19, Adjuvanted (2023-2024 Formula), respectively, for the U.S.). The Company’s partner, Serum Institute of India Pvt. Ltd. (“SIIPL”), markets NVX-CoV2373 as “Covovax™.” Beginning in 2022, the Company received approval, interim authorization, provisional approval, conditional marketing authorization, and emergency use authorization (“EUA”) from multiple regulatory authorities globally for its prototype vaccine for both adult and adolescent populations as a primary series and for both homologous and heterologous booster indications in select territories. In October 2023, the U.S. Food and Drug Administration (“U.S. FDA”) amended the EUA for its prototype vaccine to include its updated vaccine. The amended EUA authorizes use of the Company’s updated vaccine in individuals 12 years and older. In October 2023, the European Commission (“EC”) granted approval for the Company’s updated vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. The Company exclusively depends on its supply agreement with SIIPL and its subsidiary, Serum Life Sciences Limited (“SLS”), for co-formulation, filling and finishing (other than in Europe) and on its service agreement with PCI Pharma Services for finishing in Europe. The Company plans to rely on these arrangements to supply its updated vaccine during the 2023-2024 vaccination season and subsequently (see Note 4). Novavax is advancing development of other vaccine candidates, including its influenza vaccine candidate, its COVID19-Influenza Combination (“CIC”) vaccine candidate and additional vaccine candidates. The Company’s COVID-19 Program and its 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.
|
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- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.3
Summary of Significant Accounting Policies
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9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
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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’ 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 $11.9 million and $6.4 million at September 30, 2023 and December 31, 2022, respectively. The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $12.2 million loss and a $3.9 million gain, and a $38.6 million loss and $59.6 million loss for the three and nine months ended September 30, 2023 and 2022, respectively, which are reflected in Other income (expense). 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, 2022. 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. Liquidity and Going Concern The accompanying unaudited consolidated financial statements have been prepared assuming, subject to the disclosures herein, that the Company will continue as a going concern within one year after the date that the financial statements are issued. In addition, as of September 30, 2023, the Company had $666.4 million in cash and cash equivalents and restricted cash. Pursuant to the June 2023 Amendment to the advance purchase agreement between the Company and the Canadian government (the “Canada APA”), the Company expects to receive the second installment of $174.8 million from the Canadian government that is contingent and payable upon the Company’s delivery of vaccine doses in the fourth quarter of 2023 (see Note 3). During the nine months ended September 30, 2023, the Company incurred a net loss of $366.7 million and had net cash flows used in operating activities of $537.2 million. In accordance with Accounting Standards Codification 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued. While the Company’s current cash flow forecast for the one-year going concern look forward period estimates that there will be sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to revenue for the next 12 months, the Company’s ability to execute on certain cost-cutting initiatives and a pending matter subject to arbitration proceedings. The Company’s revenue projections depend on its ability to successfully manufacture, distribute and market its updated vaccine for the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the Company’s ability to obtain regulatory authorizations, the incidence of COVID-19 during the 2023-2024 vaccination season, the Company’s ability to timely deliver doses and achieve commercial adoption and market acceptance of its updated vaccine. 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 advance purchase agreements (“APAs”) may require the Company to refund portions of upfront and other payments or result in reduced future payments which would adversely affect the Company’s ability to continue as a going concern. For example, if the Company fails to deliver its updated vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. In addition, the Canadian government may terminate the Canada APA if the Company fails to achieve regulatory approval for use of the Biologics Manufacturing Centre, Inc. (“BMC”) for COVID-19 Vaccine production on or before December 31, 2024. Also, if the Company does not timely achieve supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”) with respect to use of its COVID-19 Program for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom, then the Company would be required to repay up to $112.5 million related to the upfront payment previously received from the Authority under the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the Company and the Authority. On January 24, 2023, Gavi, the Vaccine Alliance (“Gavi”) filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by the Company of the Company’s APA with Gavi (the “Gavi APA”). The arbitration hearing is scheduled for July 2024, with a written decision to follow. The outcome of that arbitration is inherently uncertain, and it is possible the Company could be required to refund all or a portion of the remaining advance payments of $696.4 million as of September 30, 2023 (see Note 3 and Note 14). Management believes that, given the significance of these uncertainties, substantial doubt exists regarding the Company’s ability to continue as a going concern through one year from the date that these financial statements are issued. In May 2023, the Company announced a global restructuring and cost reduction plan (the “Restructuring Plan”), which includes a more focused investment in its COVID-19 Program, reduction to its pipeline spending, the continued rationalization of its manufacturing network, a reduction to the Company’s global workforce, as well as the consolidation of facilities, and infrastructure. The workforce reduction plan included an approximately 25% reduction in the Company’s global workforce, comprised of an approximately 20% reduction in full-time Novavax employees and the remainder comprised of contractors and consultants. The Company has decided to progress its CIC vaccine candidate toward late-stage development and, as such, is assessing the impact on its workforce requirements. The Company expects the full annual impact of the cost savings from the Restructuring Plan to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which the Company operates. During the nine months ended September 30, 2023, the Company recorded a charge of $4.5 million related to one-time employee severance and benefit costs and recorded an impairment charge of $10.1 million related to the consolidation of facilities and infrastructure (see Note 15). The Company’s ability to fund Company operations is dependent upon revenue related to vaccine sales for its products and product candidates, if such product candidates receive marketing approval and are successfully commercialized, and in particular the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the incidence of COVID-19 during the 2023-2024 vaccination season, regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance of its updated vaccine, the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved, and management’s plans, which includes cost reductions associated with the Restructuring Plan. Management’s plans may also include raising additional capital through a combination of equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements. New financings may not be available to the Company on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of the Company’s COVID-19 Program and the Company’s other vaccine candidates, including an influenza vaccine candidate, and a CIC vaccine candidate, remains uncertain. Also, the impact of the Company’s more focused investment in its COVID-19 Program, reduction to its pipeline spending, continued rationalization of its manufacturing network, reduction to its global workforce, and consolidation of its facilities and infrastructure remain uncertain. If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, or further downsize its organization, any of which may have a material adverse effect on its business, financial condition, results of operations, and ability to operate as a going concern. 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 Constraints The Company constrains the transaction price for customer arrangements until it is probable that a significant reversal in cumulative revenue recognized will not occur. Specifically, if a customer arrangement includes a provision whereby the customer may request a discount, return, or refund for a previously satisfied performance obligation or otherwise could have the effect of decreasing the transaction price, revenue is constrained based on an estimate of the impact to the transaction price recognized until it is probable that a significant reversal in cumulative revenue recognized will not occur. Restructuring The Company recognizes restructuring charges when such costs are incurred. The Company’s restructuring charges consist of employee severance and other termination benefits related to the reduction of its workforce, the consolidation of facilities, and infrastructure and other costs. Termination benefits are expensed on the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. Ongoing benefits are expensed when restructuring activities are probable and the benefit estimable. See Note 15 for additional information on the severance and employee benefit costs for terminated employees and impairment of assets in connection with the Company’s Restructuring Plan. Recent Accounting Pronouncements Adopted In June 2016, the Financial Accounting Standards Board 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” 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 Company adopted ASU 2020-06 on January 1, 2023, using a modified retrospective approach, and it did not have a material impact on the Company’s consolidated financial statements.
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- DefinitionThe entire disclosure for the basis of presentation and significant accounting policies concepts. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Accounting policies describe all significant accounting policies of the reporting entity.
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v3.23.3
Revenue
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9 Months Ended |
Sep. 30, 2023 |
Grants, U.S. Government Contract and Joint Venture [Abstract] |
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Revenue |
Revenue The Company's accounts receivable included $71.1 million and $53.8 million related to amounts that were billed to customers and $52.6 million and $28.6 million related to amounts which had not yet been billed to customers as of September 30, 2023 and December 31, 2022, respectively. During the nine months ended September 30, 2023, and 2022, changes in the Company’s accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Balance, Beginning of Period | | Additions | | Deductions | | Balance, End of Period | Accounts receivable: | | | | | | | | Nine Months Ended September 30, 2023 | $ | 96,210 | | | $ | 981,305 | | | $ | (946,182) | | | $ | 131,333 | | Nine Months Ended September 30, 2022 | 454,993 | | | 1,519,345 | | | (1,862,693) | | | 111,645 | | Allowance for doubtful accounts(1): | | | | | | | | Nine Months Ended September 30, 2023 | $ | (13,835) | | | $ | — | | | $ | 6,159 | | | $ | (7,676) | | Nine Months Ended September 30, 2022 | — | | | — | | | — | | | — | | Deferred revenue:(2) | | | | | | | | Nine Months Ended September 30, 2023 | $ | 549,551 | | | $ | 422,766 | | | $ | (171,288) | | | $ | 801,029 | | Nine Months Ended September 30, 2022 | 1,595,472 | | | 96,298 | | | (251,576) | | | 1,440,194 | |
(1) There was no bad debt expense recorded during the three and nine months ended September 30, 2023 or 2022. There was a $6.2 million reversal of a bad debt allowance during the nine months ended September 30, 2023 due to the collection of a previously recognized allowance for doubtful accounts. To estimate the allowance for doubtful accounts, the Company evaluates the credit risk related to its customers based on historical loss experience, economic conditions, the aging of receivables, and customer-specific risks. (2) Deductions from Deferred revenue generally related to the recognition of revenue once performance obligations on a contract with a customer are met. During the three and nine months ended September 30, 2023, deductions included a $112.5 million reclassification of refundable upfront payments previously included in Deferred revenue to Other current liabilities. There were no such reclassifications during the three and nine months ended September 30, 2022. As of September 30, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, the Gavi APA, and the reduction in doses related to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement, dated as of July 1, 2022 (as amended on September 26, 2022, the “Amended and Restated UK Supply Agreement”) between the Company and the Authority, which amended and restated the Original UK Supply Agreement, was approximately $2 billion of which $801.0 million was included in Deferred revenue. 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 advance purchase agreements may require the Company to refund portions of upfront and other 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. The timing to fulfill performance obligations related to APAs will depend on the 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 the Company’s updated vaccine in place of the prototype vaccine under certain of the Company’s APAs. Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of the prototype vaccine were to be made available to countries participating in the COVAX Facility. The Company expected to manufacture and distribute 350 million doses of the prototype vaccine to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL was expected to manufacture and deliver the balance of the 1.1 billion doses of the prototype vaccine for low- and middle-income countries participating in the COVAX Facility. The Company expected to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with Coalition for Epidemic Preparedness Innovations (“CEPI”), with initial doses supplied by SIIPL and SLS under a supply agreement. The Company expected to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi could prioritize such doses to low- and middle- income countries, at lower prices. Additionally, the Company could provide additional doses of prototype vaccine, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL could not materially deliver expected vaccine doses to the COVAX Facility. Under the agreement, the Company received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to the Company’s achieving an emergency use license for the Company’s prototype vaccine by the World Health Organization (“WHO”) (the “Advance Payment Amount”). The Company maintains that its termination of the Advance Payment Amount was valid and denies that Gavi is entitled to a refund. On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of the Company’s prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi. Product Sales Product sales by the Company’s customer’s geographic location was as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | Nine Months Ended September 30, | | 2023 | | 2022 | 2023 | | 2022 | North America | $ | 2,231 | | | $ | 129,718 | | $ | 2,231 | | | $ | 194,480 | | Europe | — | | | 347,005 | | 59,322 | | | 760,750 | | Rest of the world | — | | | 149,368 | | 218,384 | | | 311,944 | | Total product sales revenue | $ | 2,231 | | | $ | 626,091 | | $ | 279,937 | | | $ | 1,267,174 | |
In May 2023, the Company extended a credit for certain doses delivered in 2022 that qualified for replacement under the contract with the Australian government. This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market. The credit will be applied against the future sale of doses to the customer and, during the nine months ended September 30, 2023, the Company recorded a reduction of $64.7 million in product sales, with a corresponding increase to Deferred revenue, non-current. In April 2023, the Company amended the Canada APA to forfeit certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million received in the second quarter of 2023. On June 30, 2023, the Company entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA. Pursuant to the June 2023 Amendment, the parties revised the Canadian government’s previous commitment by (i) forfeiting certain doses of COVID-19 Vaccine previously scheduled for delivery, (ii) reducing the amount of doses of COVID-19 Vaccine due for delivery, (iii) revising the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered, and (iv) requiring use of the Biologics Manufacturing Centre (“BMC”) Inc. to produce bulk antigen for doses in 2024 and 2025. In connection with the forfeiture of doses of COVID-19 Vaccine, the Canadian government agreed to pay a total amount of $349.6 million to the Company in two equal installments in 2023, which total amount equals the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses. The first installment was payable upon execution of the June 2023 Amendment and the second installment is contingent and payable upon the Company’s delivery of vaccine doses in the second half of 2023. The first installment of $174.8 million was received from the Canadian government in July 2023. If the Company fails to deliver COVID-19 Vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. The Canadian government may terminate the Canada APA, as amended, if the Company fails to achieve regulatory approval for use of BMC for COVID-19 Vaccine production on or before December 31, 2024. The June 2023 Amendment maintained the total contract value of the original Canada APA. Pursuant to the June 2023 Amendment, the Company and the Canadian government will endeavor to expand the Company’s previously agreed in-country commitment to Canada and to further partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses. Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate the Company’s ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by the Company. As of September 30, 2023, the Company is in the process of negotiating the MOU. The Company agreed to hold $20.0 million in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU. Grants The Company’s U.S. government agreement consists of a Project Agreement (the “Project Agreement”) and a Base 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 (the Base Agreement together with the Project Agreement the “USG Agreement”). In February 2023, in connection with the execution of Modification 17 to the Project Agreement (“Modification 17”), the U.S. government indicated to the Company that the award may not be extended past its current period of performance, which is December 31, 2023. Also, Modification 17 included provisions requiring that the payment of up to $60.0 million of consideration associated with manufacturing work now be contingent upon meeting certain milestones, including the delivery of up to 1.5 million doses of its prototype vaccine and development and regulatory milestones related to commercial readiness, expansion of the EUA and development of multiple vial presentations. As of September 30, 2023, the Company now expects to be entitled to the full $1.8 billion-funding under the USG Agreement by December 31, 2023, and accordingly, the Company recognized a $43.8 million cumulative increase to grant revenue under the contract during the three months ended September 30, 2023. Royalties and Other Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales. During the three and nine months ended September 30, 2023, the Company recognized $6.0 million revenue related to sales-based royalties, and $13.8 million and $17.0 million, respectively in revenue related to a Matrix-M™ adjuvant sales. During the three and nine months ended September 30, 2023, the Company did not recognize revenue related to milestone payments. During the three and nine months ended September 30, 2022, the Company recognized no revenue and $20.0 million, respectively, related to milestone payments, $1.3 million and $10.5 million, respectively, related to sales-based royalties, and $1.0 million and $13.4 million, respectively, related to a Matrix-M™ adjuvant sales. Collaboration, License, and Supply Agreements SIIPL The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of its prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate. SIIPL agreed to purchase the Company's Matrix-M™ adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of the Company’s COVID-19 Vaccine in SIIPL’s licensed territory solely for use in the manufacture of COVID-19 Vaccine. The Company and SIIPL equally split the revenue from SIIPL’s sale of COVID-19 Vaccine in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and SLS under which SIIPL and SLS supply the Company with prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate 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 March 2020, the Company entered into an agreement with SIIPL that 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 (“R21/Malaria”). Under the agreement, SIIPL purchases the Company's Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single-to low- double-digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country. 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 the Company’s COVID-19 Vaccine in Japan. Under the agreement, Takeda purchases Matrix-M™ adjuvant from the Company to manufacture doses of COVID-19 Vaccine, and the Company is entitled to receive milestone and sales-based royalty 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 COVID-19 Vaccine. In September 2021, Takeda finalized an agreement with the Government of Japan’s Ministry of Health, Labour and Welfare ("MHLW") for the purchase of 150 million doses of its prototype vaccine. In February 2023, MHLW canceled the remainder of doses under its agreement with Takeda. As a result, it is uncertain whether the Company will receive future sales-based royalty payments from Takeda under the terms and conditions of their current collaboration and licensing agreement. Bill & Melinda Gates Medical Research Institute In May 2023, the Company entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute to provide the Company’s Matrix-M™ adjuvant for use in preclinical vaccine research. SK bioscience, Co., Ltd In February 2021, the Company entered into a Collaboration and License Agreement (“CLA”) with SK bioscience, Co., Ltd. (“SK”) to manufacture and commercialize its prototype vaccine for sale to the government of South Korea. The CLA was amended in December 2021 and July 2022 to include the sale of its prototype vaccine to Thailand and Vietnam and to supply the Company with the antigen component of prototype vaccine for use in the final drug product globally, including product to be distributed by the COVAX Facility. Under the CLA, as amended, SK agreed to pay the Company a royalty on the sale of its prototype vaccine in the low to middle double-digit range. The CLA was in addition to the Company's existing manufacturing arrangement with SK under a Development and Supply Agreement (“DSA”) entered into in August 2020. In July 2022, the Company signed an additional agreement with SK for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply its prototype vaccine in a prefilled syringe. In June 2023, the Company entered into a material transfer agreement with SK for the use by SK of the Company’s Matrix-M™ adjuvant in preclinical vaccine experiments for shingles, influenza, and pan-COVID-19. In August 2023, the Company and SK entered into a Settlement Agreement and General Release (the “Settlement Agreement”) regarding mutual release by the parties of all claims arising from or in relation to statements of work (“SOWs”) canceled by the Company under the DSA and the CLA (collectively the “Business Agreements”), and other SOWs under the Business Agreements (collectively, the “Subject SOWs”), in each case, in connection with the cessation of all drug substance and drug product manufacturing activity at SK for supply to the Company. Subject SOWs canceled by the Company under the Settlement Agreement included (i) Statement of Work No. 1 dated as of December 23, 2021 as amended to date under the CLA; (ii) Statement of Work No. 5 dated as of July 18, 2022 under the DSA; and (iii) Statement of Work No. 6 dated as of July 18, 2022, and as amended as of December 28, 2022 under the DSA. Pursuant to the Settlement Agreement, the Company is responsible for payment of $149.8 million to SK in connection with the cancellation of manufacturing activity for the SOWs under the Business Agreements, of which (i) $130.4 million was paid in August 2023 and (ii) the remaining balance is to be paid on or before November 15, 2023. Under the Settlement Agreement, the Company and SK agreed to a wind down plan with respect to the remaining products, materials and equipment under the SOWs. Under the Settlement Agreement, the Company and SK agreed to remove certain restrictions under the CLA that have been triggered by the launch of SK’s competing vaccine SKYCovione™ in the Republic of Korea. In addition, the Company agreed to extend the term of an exclusive license to SK under the CLA for the exploitation of antigen and vaccine products utilizing Company’s proprietary coronavirus vaccine antigens and Matrix-M adjuvant in certain territories. The Company recorded $4.0 million to Deferred revenue related to the extended licenses granted to SK under the Settlement Agreement. In August 2023, the Company also entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which the Company agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of the Company’s common stock, par value $0.01 per share (the “Shares”) at a price of $13.00 per share for aggregate gross proceeds to the Company of approximately $84.5 million. The closing of the Private Placement occurred on August 10, 2023. The fair value of the Company’s common stock on the date of closing, based on the quoted market price, was $46.5 million, which results in a premium paid by SK of approximately $38.0 million. The Settlement Agreement and the Subscription Agreement were negotiated concurrently between the parties, and therefore were combined for accounting purposes and analyzed as a single arrangement. As a result, the Company recorded the $46.5 million fair value of common stock issued to SK, based on the quoted market price on the date of close, as an equity transaction. The remaining elements of the arrangement were deemed to relate to the settlement of the Company’s outstanding liabilities due to SK. These elements consist primarily of the cash payable to SK of $149.8 million, offset by the premium paid on the common stock purchase by SK of $38.0 million, which resulted in a net gain upon derecognition of the liabilities due to SK of $79.2 million in connection with the settlement. As a result, during the three and nine months ended September 30, 2023, the Company recorded this net gain of $79.2 million between research and development expense, for $57.7 million, and cost of sales, for $21.5 million, proportionally based on the where the underlying costs were originally recorded. 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 the Company’s prototype vaccine under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay 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, which began on March 31, 2023. As of September 30, 2023, the remaining payment of $68.6 million was reflected in Accrued expenses. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach. On October 30, 2023, FDBT filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the third quarter installment of the Settlement Payment. 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, its COVID-19 Program, and in doing so, recognizes that significant costs may be incurred.
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v3.23.3
Collaboration, License, and Supply Agreements
|
9 Months Ended |
Sep. 30, 2023 |
Collaborative Arrangement [Abstract] |
|
Collaboration, License, and Supply Agreements |
Revenue The Company's accounts receivable included $71.1 million and $53.8 million related to amounts that were billed to customers and $52.6 million and $28.6 million related to amounts which had not yet been billed to customers as of September 30, 2023 and December 31, 2022, respectively. During the nine months ended September 30, 2023, and 2022, changes in the Company’s accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Balance, Beginning of Period | | Additions | | Deductions | | Balance, End of Period | Accounts receivable: | | | | | | | | Nine Months Ended September 30, 2023 | $ | 96,210 | | | $ | 981,305 | | | $ | (946,182) | | | $ | 131,333 | | Nine Months Ended September 30, 2022 | 454,993 | | | 1,519,345 | | | (1,862,693) | | | 111,645 | | Allowance for doubtful accounts(1): | | | | | | | | Nine Months Ended September 30, 2023 | $ | (13,835) | | | $ | — | | | $ | 6,159 | | | $ | (7,676) | | Nine Months Ended September 30, 2022 | — | | | — | | | — | | | — | | Deferred revenue:(2) | | | | | | | | Nine Months Ended September 30, 2023 | $ | 549,551 | | | $ | 422,766 | | | $ | (171,288) | | | $ | 801,029 | | Nine Months Ended September 30, 2022 | 1,595,472 | | | 96,298 | | | (251,576) | | | 1,440,194 | |
(1) There was no bad debt expense recorded during the three and nine months ended September 30, 2023 or 2022. There was a $6.2 million reversal of a bad debt allowance during the nine months ended September 30, 2023 due to the collection of a previously recognized allowance for doubtful accounts. To estimate the allowance for doubtful accounts, the Company evaluates the credit risk related to its customers based on historical loss experience, economic conditions, the aging of receivables, and customer-specific risks. (2) Deductions from Deferred revenue generally related to the recognition of revenue once performance obligations on a contract with a customer are met. During the three and nine months ended September 30, 2023, deductions included a $112.5 million reclassification of refundable upfront payments previously included in Deferred revenue to Other current liabilities. There were no such reclassifications during the three and nine months ended September 30, 2022. As of September 30, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, the Gavi APA, and the reduction in doses related to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement, dated as of July 1, 2022 (as amended on September 26, 2022, the “Amended and Restated UK Supply Agreement”) between the Company and the Authority, which amended and restated the Original UK Supply Agreement, was approximately $2 billion of which $801.0 million was included in Deferred revenue. 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 advance purchase agreements may require the Company to refund portions of upfront and other 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. The timing to fulfill performance obligations related to APAs will depend on the 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 the Company’s updated vaccine in place of the prototype vaccine under certain of the Company’s APAs. Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of the prototype vaccine were to be made available to countries participating in the COVAX Facility. The Company expected to manufacture and distribute 350 million doses of the prototype vaccine to countries participating under the COVAX Facility. Under a separate purchase agreement with Gavi, SIIPL was expected to manufacture and deliver the balance of the 1.1 billion doses of the prototype vaccine for low- and middle-income countries participating in the COVAX Facility. The Company expected to deliver doses with antigen and adjuvant manufactured at facilities directly funded under the Company's funding agreement with Coalition for Epidemic Preparedness Innovations (“CEPI”), with initial doses supplied by SIIPL and SLS under a supply agreement. The Company expected to supply significant doses that Gavi would allocate to low-, middle- and high-income countries, subject to certain limitations, utilizing a tiered pricing schedule and Gavi could prioritize such doses to low- and middle- income countries, at lower prices. Additionally, the Company could provide additional doses of prototype vaccine, to the extent available from CEPI-funded manufacturing facilities, in the event that SIIPL could not materially deliver expected vaccine doses to the COVAX Facility. Under the agreement, the Company received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to the Company’s achieving an emergency use license for the Company’s prototype vaccine by the World Health Organization (“WHO”) (the “Advance Payment Amount”). The Company maintains that its termination of the Advance Payment Amount was valid and denies that Gavi is entitled to a refund. On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of the Company’s prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi. Product Sales Product sales by the Company’s customer’s geographic location was as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | Nine Months Ended September 30, | | 2023 | | 2022 | 2023 | | 2022 | North America | $ | 2,231 | | | $ | 129,718 | | $ | 2,231 | | | $ | 194,480 | | Europe | — | | | 347,005 | | 59,322 | | | 760,750 | | Rest of the world | — | | | 149,368 | | 218,384 | | | 311,944 | | Total product sales revenue | $ | 2,231 | | | $ | 626,091 | | $ | 279,937 | | | $ | 1,267,174 | |
In May 2023, the Company extended a credit for certain doses delivered in 2022 that qualified for replacement under the contract with the Australian government. This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market. The credit will be applied against the future sale of doses to the customer and, during the nine months ended September 30, 2023, the Company recorded a reduction of $64.7 million in product sales, with a corresponding increase to Deferred revenue, non-current. In April 2023, the Company amended the Canada APA to forfeit certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million received in the second quarter of 2023. On June 30, 2023, the Company entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA. Pursuant to the June 2023 Amendment, the parties revised the Canadian government’s previous commitment by (i) forfeiting certain doses of COVID-19 Vaccine previously scheduled for delivery, (ii) reducing the amount of doses of COVID-19 Vaccine due for delivery, (iii) revising the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered, and (iv) requiring use of the Biologics Manufacturing Centre (“BMC”) Inc. to produce bulk antigen for doses in 2024 and 2025. In connection with the forfeiture of doses of COVID-19 Vaccine, the Canadian government agreed to pay a total amount of $349.6 million to the Company in two equal installments in 2023, which total amount equals the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses. The first installment was payable upon execution of the June 2023 Amendment and the second installment is contingent and payable upon the Company’s delivery of vaccine doses in the second half of 2023. The first installment of $174.8 million was received from the Canadian government in July 2023. If the Company fails to deliver COVID-19 Vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. The Canadian government may terminate the Canada APA, as amended, if the Company fails to achieve regulatory approval for use of BMC for COVID-19 Vaccine production on or before December 31, 2024. The June 2023 Amendment maintained the total contract value of the original Canada APA. Pursuant to the June 2023 Amendment, the Company and the Canadian government will endeavor to expand the Company’s previously agreed in-country commitment to Canada and to further partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses. Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate the Company’s ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by the Company. As of September 30, 2023, the Company is in the process of negotiating the MOU. The Company agreed to hold $20.0 million in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU. Grants The Company’s U.S. government agreement consists of a Project Agreement (the “Project Agreement”) and a Base 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 (the Base Agreement together with the Project Agreement the “USG Agreement”). In February 2023, in connection with the execution of Modification 17 to the Project Agreement (“Modification 17”), the U.S. government indicated to the Company that the award may not be extended past its current period of performance, which is December 31, 2023. Also, Modification 17 included provisions requiring that the payment of up to $60.0 million of consideration associated with manufacturing work now be contingent upon meeting certain milestones, including the delivery of up to 1.5 million doses of its prototype vaccine and development and regulatory milestones related to commercial readiness, expansion of the EUA and development of multiple vial presentations. As of September 30, 2023, the Company now expects to be entitled to the full $1.8 billion-funding under the USG Agreement by December 31, 2023, and accordingly, the Company recognized a $43.8 million cumulative increase to grant revenue under the contract during the three months ended September 30, 2023. Royalties and Other Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales. During the three and nine months ended September 30, 2023, the Company recognized $6.0 million revenue related to sales-based royalties, and $13.8 million and $17.0 million, respectively in revenue related to a Matrix-M™ adjuvant sales. During the three and nine months ended September 30, 2023, the Company did not recognize revenue related to milestone payments. During the three and nine months ended September 30, 2022, the Company recognized no revenue and $20.0 million, respectively, related to milestone payments, $1.3 million and $10.5 million, respectively, related to sales-based royalties, and $1.0 million and $13.4 million, respectively, related to a Matrix-M™ adjuvant sales. Collaboration, License, and Supply Agreements SIIPL The Company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of its prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate. SIIPL agreed to purchase the Company's Matrix-M™ adjuvant and the Company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of the Company’s COVID-19 Vaccine in SIIPL’s licensed territory solely for use in the manufacture of COVID-19 Vaccine. The Company and SIIPL equally split the revenue from SIIPL’s sale of COVID-19 Vaccine in its licensed territory, net of agreed costs. The Company also has a supply agreement with SIIPL and SLS under which SIIPL and SLS supply the Company with prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), its quadrivalent influenza vaccine candidate, and its CIC vaccine candidate 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 March 2020, the Company entered into an agreement with SIIPL that 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 (“R21/Malaria”). Under the agreement, SIIPL purchases the Company's Matrix-M™ adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single-to low- double-digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country. 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 the Company’s COVID-19 Vaccine in Japan. Under the agreement, Takeda purchases Matrix-M™ adjuvant from the Company to manufacture doses of COVID-19 Vaccine, and the Company is entitled to receive milestone and sales-based royalty 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 COVID-19 Vaccine. In September 2021, Takeda finalized an agreement with the Government of Japan’s Ministry of Health, Labour and Welfare ("MHLW") for the purchase of 150 million doses of its prototype vaccine. In February 2023, MHLW canceled the remainder of doses under its agreement with Takeda. As a result, it is uncertain whether the Company will receive future sales-based royalty payments from Takeda under the terms and conditions of their current collaboration and licensing agreement. Bill & Melinda Gates Medical Research Institute In May 2023, the Company entered into a 3-year agreement with the Bill & Melinda Gates Medical Research Institute to provide the Company’s Matrix-M™ adjuvant for use in preclinical vaccine research. SK bioscience, Co., Ltd In February 2021, the Company entered into a Collaboration and License Agreement (“CLA”) with SK bioscience, Co., Ltd. (“SK”) to manufacture and commercialize its prototype vaccine for sale to the government of South Korea. The CLA was amended in December 2021 and July 2022 to include the sale of its prototype vaccine to Thailand and Vietnam and to supply the Company with the antigen component of prototype vaccine for use in the final drug product globally, including product to be distributed by the COVAX Facility. Under the CLA, as amended, SK agreed to pay the Company a royalty on the sale of its prototype vaccine in the low to middle double-digit range. The CLA was in addition to the Company's existing manufacturing arrangement with SK under a Development and Supply Agreement (“DSA”) entered into in August 2020. In July 2022, the Company signed an additional agreement with SK for the technology transfer of the Company’s proprietary COVID-19 variant antigen materials so that SK can manufacture the drug substance targeting COVID-19 variants, including the Omicron subvariants. The companies also signed an agreement to manufacture and supply its prototype vaccine in a prefilled syringe. In June 2023, the Company entered into a material transfer agreement with SK for the use by SK of the Company’s Matrix-M™ adjuvant in preclinical vaccine experiments for shingles, influenza, and pan-COVID-19. In August 2023, the Company and SK entered into a Settlement Agreement and General Release (the “Settlement Agreement”) regarding mutual release by the parties of all claims arising from or in relation to statements of work (“SOWs”) canceled by the Company under the DSA and the CLA (collectively the “Business Agreements”), and other SOWs under the Business Agreements (collectively, the “Subject SOWs”), in each case, in connection with the cessation of all drug substance and drug product manufacturing activity at SK for supply to the Company. Subject SOWs canceled by the Company under the Settlement Agreement included (i) Statement of Work No. 1 dated as of December 23, 2021 as amended to date under the CLA; (ii) Statement of Work No. 5 dated as of July 18, 2022 under the DSA; and (iii) Statement of Work No. 6 dated as of July 18, 2022, and as amended as of December 28, 2022 under the DSA. Pursuant to the Settlement Agreement, the Company is responsible for payment of $149.8 million to SK in connection with the cancellation of manufacturing activity for the SOWs under the Business Agreements, of which (i) $130.4 million was paid in August 2023 and (ii) the remaining balance is to be paid on or before November 15, 2023. Under the Settlement Agreement, the Company and SK agreed to a wind down plan with respect to the remaining products, materials and equipment under the SOWs. Under the Settlement Agreement, the Company and SK agreed to remove certain restrictions under the CLA that have been triggered by the launch of SK’s competing vaccine SKYCovione™ in the Republic of Korea. In addition, the Company agreed to extend the term of an exclusive license to SK under the CLA for the exploitation of antigen and vaccine products utilizing Company’s proprietary coronavirus vaccine antigens and Matrix-M adjuvant in certain territories. The Company recorded $4.0 million to Deferred revenue related to the extended licenses granted to SK under the Settlement Agreement. In August 2023, the Company also entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which the Company agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of the Company’s common stock, par value $0.01 per share (the “Shares”) at a price of $13.00 per share for aggregate gross proceeds to the Company of approximately $84.5 million. The closing of the Private Placement occurred on August 10, 2023. The fair value of the Company’s common stock on the date of closing, based on the quoted market price, was $46.5 million, which results in a premium paid by SK of approximately $38.0 million. The Settlement Agreement and the Subscription Agreement were negotiated concurrently between the parties, and therefore were combined for accounting purposes and analyzed as a single arrangement. As a result, the Company recorded the $46.5 million fair value of common stock issued to SK, based on the quoted market price on the date of close, as an equity transaction. The remaining elements of the arrangement were deemed to relate to the settlement of the Company’s outstanding liabilities due to SK. These elements consist primarily of the cash payable to SK of $149.8 million, offset by the premium paid on the common stock purchase by SK of $38.0 million, which resulted in a net gain upon derecognition of the liabilities due to SK of $79.2 million in connection with the settlement. As a result, during the three and nine months ended September 30, 2023, the Company recorded this net gain of $79.2 million between research and development expense, for $57.7 million, and cost of sales, for $21.5 million, proportionally based on the where the underlying costs were originally recorded. 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 the Company’s prototype vaccine under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay 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, which began on March 31, 2023. As of September 30, 2023, the remaining payment of $68.6 million was reflected in Accrued expenses. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach. On October 30, 2023, FDBT filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the third quarter installment of the Settlement Payment. 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, its COVID-19 Program, and in doing so, recognizes that significant costs may be incurred.
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v3.23.3
Cash, Cash Equivalents, and Restricted Cash
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9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
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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 consolidated statements of cash flows (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Cash and cash equivalents | $ | 651,104 | | | $ | 1,336,883 | | Restricted cash, current | 10,393 | | | 10,303 | | Restricted cash, non-current(1) | 4,866 | | | 1,659 | | Cash, cash equivalents, and restricted cash | $ | 666,363 | | | $ | 1,348,845 | |
(1)Classified as Other non-current assets as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets.
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- DefinitionThe entire disclosure for cash and cash equivalent footnotes, which may include the types of deposits and money market instruments, applicable carrying amounts, restricted amounts and compensating balance arrangements. Cash and equivalents include: (1) currency on hand (2) demand deposits with banks or financial institutions (3) other kinds of accounts that have the general characteristics of demand deposits (4) short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments maturing within three months from the date of acquisition qualify.
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
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, 2023 | | Fair Value at December 31, 2022 | Assets | Level 1 | | Level 2 | | Level 3 | | Level 1 | | Level 2 | | Level 3 | Money market funds(1) | $ | 196,679 | | | $ | — | | | $ | — | | | $ | 398,834 | | | $ | — | | | $ | — | | Government-backed securities(1) | — | | | 200,000 | | | — | | | — | | | 296,000 | | | — | | Treasury securities(1) | — | | | 36,913 | | | — | | | — | | | — | | | — | | Corporate debt securities(1) | — | | | 23,028 | | | — | | | — | | | — | | | — | | Agency securities(1) | — | | | — | | | — | | | — | | | 104,536 | | | — | | Total cash equivalents | $ | 196,679 | | | $ | 259,941 | | | $ | — | | | $ | 398,834 | | | $ | 400,536 | | | $ | — | | Liabilities | | | | | | | | | | | | 5.00% Convertible notes due 2027 | $ | — | | $ | 131,292 | | | $ | — | | $ | — | | $ | 172,789 | | $ | — | 3.75% Convertible notes due 2023 | — | | | — | | | — | | | — | | | 322,111 | | | — | | Total convertible notes payable | $ | — | | | $ | 131,292 | | | $ | — | | | $ | — | | | $ | 494,900 | | | $ | — | |
(1)All investments are classified as Cash and cash equivalents as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets. Fixed-income investments categorized as Level 2 are valued at the custodian bank by a third-party pricing vendor’s valuation models that use verifiable observable market data, such as interest rates and yield curves observable at commonly quoted intervals and credit spreads, bids provided by brokers or dealers, or quoted prices of securities with similar characteristics. Pricing of the Company’s convertible notes has been estimated using 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, 2023 and 2022, the Company did not have any transfers between levels. The amount in the Company’s consolidated balance sheets for accounts payable and accrued expenses approximates its fair value due to its short-term nature.
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v3.23.3
Inventory
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Inventory |
Inventory Inventory consisted of the following (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Raw materials | $ | 10,385 | | | $ | 13,912 | | Semi-finished goods | 10,405 | | | 21,410 | | Finished goods | 48,802 | | | 1,361 | | Total inventory | $ | 69,592 | | | $ | 36,683 | |
Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments, offset by recoveries of such commitments, are recorded as a component of cost of sales in the Company’s consolidated statements of operations. For the three and nine months ended September 30, 2023, inventory write-downs were $18.1 million and $49.6 million, respectively and losses on firm purchase commitments were $63.5 million and $71.9 million, respectively. In addition, for the three and nine months ended September 30, 2023 the Company recorded recoveries on firm purchase commitments of $21.5 million and $40.3 million, respectively, related primarily to negotiated reductions to previously recognized firm purchase commitments. 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.
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v3.23.3
Goodwill
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Goodwill |
GoodwillThe Company has one reporting unit, which has a negative equity balance as of September 30, 2023 and December 31, 2022. The change in the carrying amounts of goodwill for the nine months ended September 30, 2023 was as follows (in thousands): | | | | | | | Amount | Balance at December 31, 2022 | $ | 126,331 | | Currency translation adjustments | (2,551) | | Balance at September 30, 2023 | $ | 123,780 | |
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v3.23.3
Leases
|
9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
|
Leases |
Leases The Company has embedded leases related to supply agreements with contract manufacturing organizations (“CMOs”) and contract manufacturing and development organizations to manufacture its COVID-19 Vaccine, as well as leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment. During the nine months ended September 30, 2023, the Company continued to align its global manufacturing footprint as a result of its ongoing assessment of manufacturing needs consistent with its contractual obligations related to the supply, and anticipated demand for, its COVID-19 Program. During the three and nine months ended September 30, 2023, the Company recognized a short-term lease benefit of $39.5 million and $48.0 million, respectively, related to the reversal of previously recognized embedded lease expense on the settlement of CMO contracts. 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 and expensed $24.2 million and $44.0 million respectively, for the write off of right of use (“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 ROU written off. There were no ROU assets written off during the three and nine months ended September 30, 2023, related to embedded leases. During the three and nine months ended September 30, 2023, the Company recognized $0.5 million and $1.4 million of interest expense, respectively, on its finance lease liabilities. 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 nine months ended September 30, 2023, the Company recorded an impairment charge of $5.9 million related to ROU facility leases used for research and development, manufacturing and offices space that are impacted by the Restructuring Plan (see Note 15). The Company has a lease agreement for approximately 170,000 square feet of space at 700 Quince Orchard Road, Gaithersburg, Maryland, which the Company uses for manufacturing, research and development, and corporate offices. The term of the lease expires in 2035 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 three months ended September 30, 2023, 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 a ROU asset and related lease obligation of $96.5 million as the lease commencement dates for accounting purposes had occurred. The lease obligation was reduced by $73.4 million for prepaid rent and prior costs incurred on behalf of the landlord.
|
Leases |
Leases The Company has embedded leases related to supply agreements with contract manufacturing organizations (“CMOs”) and contract manufacturing and development organizations to manufacture its COVID-19 Vaccine, as well as leases for its research and development and manufacturing facilities, corporate headquarters and offices, and certain equipment. During the nine months ended September 30, 2023, the Company continued to align its global manufacturing footprint as a result of its ongoing assessment of manufacturing needs consistent with its contractual obligations related to the supply, and anticipated demand for, its COVID-19 Program. During the three and nine months ended September 30, 2023, the Company recognized a short-term lease benefit of $39.5 million and $48.0 million, respectively, related to the reversal of previously recognized embedded lease expense on the settlement of CMO contracts. 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 and expensed $24.2 million and $44.0 million respectively, for the write off of right of use (“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 ROU written off. There were no ROU assets written off during the three and nine months ended September 30, 2023, related to embedded leases. During the three and nine months ended September 30, 2023, the Company recognized $0.5 million and $1.4 million of interest expense, respectively, on its finance lease liabilities. 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 nine months ended September 30, 2023, the Company recorded an impairment charge of $5.9 million related to ROU facility leases used for research and development, manufacturing and offices space that are impacted by the Restructuring Plan (see Note 15). The Company has a lease agreement for approximately 170,000 square feet of space at 700 Quince Orchard Road, Gaithersburg, Maryland, which the Company uses for manufacturing, research and development, and corporate offices. The term of the lease expires in 2035 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 three months ended September 30, 2023, 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 a ROU asset and related lease obligation of $96.5 million as the lease commencement dates for accounting purposes had occurred. The lease obligation was reduced by $73.4 million for prepaid rent and prior costs incurred on behalf of the landlord.
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v3.23.3
Long-Term Debt
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Long-Term Debt |
Long-Term Debt Total convertible notes payable consisted of the following (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Current portion: | | | | 3.75% Convertible notes due 2023 | $ | — | | | $ | 325,000 | | Unamortized debt issuance costs | — | | | (119) | | Total current convertible notes payable | $ | — | | | $ | 324,881 | | Non-current portion: | | | | 5.00% Convertible notes due 2027 | $ | 175,250 | | | $ | 175,250 | | | | | | Unamortized debt issuance costs | (7,629) | | | (8,784) | | Total non-current convertible notes payable | $ | 167,621 | | | $ | 166,466 | |
In February 2023, the Company repaid the outstanding principal amount of $325.0 million on its 3.75% Convertible notes due in 2023, together with accrued but unpaid interest on the maturity date. The repayment was funded by the issuance of the 5.00% Convertible notes due 2027 and the concurrent common stock offering in December 2022, as well as cash on hand. The effective interest rate of the 2027 Convertible notes is 6.2%. The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Coupon interest | $ | 2,191 | | | $ | 3,047 | | | $ | 7,588 | | | $ | 9,141 | | Amortization of debt issuance costs | 395 | | | 356 | | | 1,295 | | | 1,068 | | Total interest expense on convertible notes payable | $ | 2,586 | | | $ | 3,403 | | | $ | 8,883 | | | $ | 10,209 | |
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v3.23.3
Stockholders' Deficit
|
9 Months Ended |
Sep. 30, 2023 |
Stockholders' Equity Note [Abstract] |
|
Stockholders' Deficit |
Stockholders' Deficit In August 2023, the Company entered into an At Market Issuance Sales Agreement (the "August 2023 Sales Agreement"), which allows it to issue and sell up to $500 million in gross proceeds of shares of its common stock, and terminated its then-existing At Market Issuance Sales agreement entered in June 2021 (the “June 2021 Sales Agreement”). During the three months ended September 30, 2023, the Company sold 17.8 million shares of its common stock under its August 2023 Sales Agreement resulting in net proceeds of approximately $143 million. During the nine months ended September 30, 2023, the Company sold 25.7 million shares of its common stock under its June 2021 and August 2023 Sales Agreement resulting in net proceeds of approximately $211 million. As of September 30, 2023, the remaining balance available under the August 2023 Sales Agreement was approximately $354 million. During the nine months ended September 30, 2022, the Company sold 2.2 million shares of its common stock resulting in net proceeds of approximately $179 million, under its June 2021 Sales Agreement. There was no sale of shares of common stock recorded during the three months ended September 30, 2022. In August 2023, pursuant to the Securities Subscription Agreement with SK, the Company agreed to sell and issue to SK 6.5 million shares of the Company’s common stock, par value $0.01 per share at a price of $13.00 per share (the “Shares”) in a Private Placement for aggregate gross proceeds to the Company of approximately $84.5 million. The Company recognized the Shares at the settlement date fair value of $46.5 million (see Note 4 for additional discussion of the Securities Subscription Agreement with SK). The closing of the Private Placement occurred on August 10, 2023.
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v3.23.3
Stock-Based Compensation
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9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
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Stock-Based Compensation |
Stock-Based Compensation Equity Plans In January 2023, the Company established the 2023 Inducement Plan (the “2023 Inducement Plan”), which provides for the granting of share-based awards to individuals who were not previously employees, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with the Company. The Company reserved 1.0 million shares of common stock for grants under the 2023 Inducement Plan. As of September 30, 2023, there were 0.2 million shares available for issuance under the 2023 Inducement Plan. 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 21.0 million shares of common stock under equity awards granted under the 2015 Plan, which includes an increase of 6.2 million shares approved for issuance under the 2015 Plan at the Company's 2023 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, 2023, there were 7.1 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 2023 Inducement Plan and the 2015 Plan permit, 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 2023 Inducement Plan and 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 share-based awards are generally subject to vesting over periods ranging from one to four years. The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Cost of sales | $ | 767 | | | $ | 51 | | | $ | 2,283 | | | $ | 51 | | Research and development | 10,022 | | | 16,107 | | | 33,826 | | | 52,692 | | Selling, general, and administrative | 9,971 | | | 15,389 | | | 33,590 | | | 49,782 | | Total stock-based compensation expense | $ | 20,760 | | | $ | 31,547 | | | $ | 69,699 | | | $ | 102,525 | |
During the three and nine months ended September 30, 2023, total stock-based compensation capitalized in inventory was $0.5 million. During the three and nine months ended September 30, 2022, total stock-based compensation capitalized in inventory was $1.7 million. As of September 30, 2023, there was approximately $102 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, 2023. 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, 2023 and 2022 was approximately $3 million and $19 million, respectively. Stock Options and Stock Appreciation Rights The following is a summary of stock options and SARs activity under the 2023 Inducement Plan, 2015 Plan, and 2005 Plan for the nine months ended September 30, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2023 Inducement Plan | | 2015 Plan | | 2005 Plan | | Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price | Outstanding at December 31, 2022 | — | | | $ | — | | | 4,053,290 | | | $ | 46.07 | | | 63,725 | | | $ | 112.94 | | Granted | 422,800 | | | 10.67 | | | 861,602 | | | 7.29 | | | — | | | — | | Exercised | — | | | — | | | (5,374) | | | 6.71 | | | — | | | — | | Canceled | — | | | — | | | (103,504) | | | 56.45 | | | (5,450) | | | 39.70 | | Outstanding at September 30, 2023 | 422,800 | | | $ | 10.67 | | | 4,806,014 | | | $ | 38.94 | | | 58,275 | | | $ | 119.79 | | Shares exercisable at September 30, 2023 | — | | | $ | — | | | 3,437,364 | | | $ | 40.58 | | | 58,275 | | | $ | 119.79 | |
The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Weighted average Black-Scholes fair value of stock options granted | $7.84 | | $37.66 | | $7.27 | | $60.24 | Risk-free interest rate | 4.3%-4.4% | | 3.0%-3.6% | | 3.5%-4.4% | | 1.4%-3.6% | Dividend yield | —% | | —% | | —% | | —% | Volatility | 128.7%-130.3% | | 122.2%-136.4% | | 120.4%-140.3% | | 120.5%-136.7% | Expected term (in years) | 3.9-5.1 | | 4.0-5.3 | | 3.9-6.3 | | 4.0-6.3 |
The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of September 30, 2023 was approximately $1.4 million and 7.1 years, respectively. The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2023 Inducement Plan, 2015 Plan and 2005 Plan as of September 30, 2023 was approximately $1.1 million and 6.1 years, respectively. Restricted Stock Units The following is a summary of RSU activity for the nine months ended September 30, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | 2023 Inducement Plan | | 2015 Plan | | Number of Shares | | Per Share Weighted- Average Fair Value | | Number of Shares | | Per Share Weighted- Average Fair Value | Outstanding and unvested at December 31, 2022 | — | | | $ | — | | | 2,034,574 | | | $ | 61.65 | | Granted | 363,990 | | | 10.66 | | | 2,888,793 | | | 7.25 | | Vested | — | | | — | | | (403,672) | | | 87.17 | | Forfeited | — | | | — | | | (780,810) | | | 27.77 | | Outstanding and unvested at September 30, 2023 | 363,990 | | | $ | 10.66 | | | 3,738,885 | | | $ | 23.95 | |
Employee Stock Purchase Plan The ESPP was approved at the Company’s annual meeting of stockholders in June 2013. The ESPP currently authorized an aggregate of 1.2 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, 2023, there were 0.5 million shares available for issuance under the ESPP.
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
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, 2023 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, 2023, 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. During the three months ended September 30, 2023, the Company recognized $0.7 million of federal, state, and foreign income tax benefit. During the three months ended September 30, 2022, the Company recognized $2.4 million of federal, state, and foreign income tax expense. During the nine months ended September 30, 2023 and 2022, the Company recognized income tax expense of $0.3 million and $4.3 million, respectively. 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. The Company did not recognize any foreign withholding tax expense on royalties for the three and nine months ended September 30, 2023.
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- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Commitments and Contingencies Legal Matters Stockholder Litigation On November 12, 2021, Sothinathan Sinnathurai filed a purported securities class action in the U.S. District Court for the District of Maryland (the “Maryland Court”) 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 Maryland 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 prototype vaccine on a commercial scale and to secure the prototype 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, the defendants filed a motion to dismiss the consolidated amended complaint. On December 12, 2022, the Maryland Court issued a ruling granting in part and denying in part defendants’ motion to dismiss. The Maryland Court dismissed all claims against two individual defendants and claims based on certain public statements challenged in the consolidated amended complaint. The Maryland Court denied the motion to dismiss as to the remaining claims and defendants, and directed the Company and other remaining defendants to answer within fourteen days. On December 27, 2022, the Company filed its answer and affirmative defenses. On March 16, 2023, the plaintiffs filed a motion for class certification and to appoint class representatives and counsel. The Company filed its opposition to the plaintiffs’ motion on September 22, 2023. After the Sinnathurai Action was filed, eight 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. C-15-CV-21-000618 (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”), (vi) Diego J. Mesa v. Stanley C. Erck, et al., No. 2022-0770-NAC (the “Mesa Action”), (vii) Sean Acosta v. Stanley C. Erck, et al., No. 2022-1133-NAC (the “Acosta Action”), and (viii) Jared Needelman v. Stanley C. Erck, et al., No. C-15-CV-23-001550 (the “Needelman Action”). The Meyer, Yung, Snyder, and Blackburn Actions were filed in the Maryland Court. The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the Maryland Court by the defendants. The Needleman Action was also filed in the Circuit Court for Montgomery County, Maryland. The Mesa and Acosta Actions were filed in the Delaware Court of Chancery (the “Delaware Court”). The derivative lawsuits name members of the Company’s 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 February 7, 2022, the Maryland 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 Maryland Court entered an order 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 Maryland 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 filed a consolidated amended complaint on November 21, 2022. On February 10, 2023, defendants filed a motion to dismiss the Second Consolidated Derivative Action. The plaintiffs filed their opposition to the motion to dismiss on April 11, 2023. Defendants filed their reply brief in further support of their motion to dismiss on May 11, 2023. On August 21, 2023, the court entered an order granting in part and denying in part the motion to dismiss. On September 5, 2023, the Company filed an Answer to the consolidated amended complaint. On September 6, 2023, the court entered an order granting the individual defendants an extension of time to file their answer until November 6, 2023. On October 6, 2023, the Board of Directors of the Company formed a Special Litigation Committee (“SLC”) with full and exclusive power and authority of the Board to, among other things, investigate, review, and analyze the facts and circumstances surrounding the claims asserted in the pending derivative actions, including the claims that remain following the court’s order on the motion to dismiss in the Second Consolidated Derivative Action. On November 7, 2023, the court entered an order granting the parties’ request to stay the Second Consolidated Derivative Action for up to six months from the date of entry of the order. This includes staying the deadline for the individual defendants to respond to the consolidated amended complaint. On July 21, 2022, the Maryland Court issued a memorandum opinion and order remanding the Kirst Action to state court. On December 6, 2022, the parties to the Kirst Action filed a stipulated schedule pursuant to which the plaintiffs were expected to file an amended complaint on December 22, 2022, and either (i) the parties would file a stipulated stay of the Kirst Action or (ii) the defendants would file a motion to stay the case by January 23, 2023. The plaintiffs filed an amended complaint on December 30, 2022. On January 23, 2023, defendants filed a motion to stay the Kirst action. On February 22, 2023, the parties in the Kirst Action filed for the Court’s approval of a stipulation staying the Kirst Action pending the resolution of defendants’ motion to dismiss in the Second Consolidated Derivative Action. On March 22, 2023, the Court entered an order staying the Kirst Action pending resolution of the motion to dismiss in the Second Consolidated Derivative Action. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action. On August 30, 2022, the Mesa Action was filed. On October 3, 2022, the Delaware 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. On January 9, 2023, following the ruling on the motion to dismiss the Sinnathurai Action, the Delaware Court entered an order granting the Mesa Action parties’ request to set a briefing schedule in connection with a motion to stay by defendants. On February 28, 2023, the court granted the defendants’ motion and stayed the Mesa Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On August 31, 2023, the Mesa plaintiffs filed a motion to lift the stay in the Mesa Action. On October 6, 2023, the Company filed an opposition to plaintiff’s motion to lift the stay. On October 17, 2023, the Mesa plaintiff filed his reply in further support of his motion to lift the stay. On December 7, 2022, the Acosta Action was filed. On February 6, 2023, defendants accepted service of the complaint and summons in the Acosta Action. On March 9, 2023, the court entered an order granting the parties’ request to stay the Acosta Action pending the entry of a final, non-appealable judgment in the Second Consolidated Derivative Action. On October 13, 2023, the parties filed, and the Delaware Court entered, a stipulated order providing that (i) if the Delaware Court declines to lift the stay in the Mesa Action, the Acosta Action will also remain stayed, and (ii) if the Delaware Court lifts the stay in the Mesa Action, the stay in the Acosta Action will also be lifted. On April 17, 2023, the Needelman Action was filed. On July 12, 2023, the parties filed a stipulation and proposed order to stay the Needelman Action pending the Maryland Court’s decision on the motion to dismiss in the Second Consolidated Derivative Action. The court entered that order on July 17, 2023. The parties continue to discuss next steps in the litigation following the Maryland Court’s ruling on the motion to dismiss the Second Consolidated Derivative Action. The financial impact of this claim, as well as the claims discussed above, is not estimable. On October 6, 2023, the Company’s board of directors voted unanimously to form a Special Litigation Committee (“SLC”) vested with full power and authority with respect to, among other things, claims in the derivative lawsuits related to certain sales of Company stock by certain Company officers, directors, or employees. The SLC has retained its own independent counsel. On November 18, 2022, the Company delivered written notice to Gavi to terminate the Gavi APA based on Gavi’s failure to procure the purchase of 350 million doses of prototype vaccine from the Company as required by the Gavi APA. As of November 18, 2022, the Company had only received orders under the Gavi APA for approximately 2 million doses. On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA. Gavi also contends that, based on its purported termination of the Gavi APA, it is entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility. Since December 31, 2022, the remaining Gavi Advance Payment Amount, which is $696.4 million as of September 30, 2023, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, has been classified within Other current liabilities in the Company’s consolidated balance sheet. On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above. The Company filed its Answer and Counterclaims on March 2, 2023. On April 5, 2023, Gavi filed its Reply to the Company’s Counterclaims. On August 24, 2023, Gavi filed a Statement of Claim, and on September 21, 2023, the Company filed a Statement of Defense and Counterclaim. The arbitration hearing is scheduled for July 2024, with a written decision to follow. Arbitration is inherently uncertain, and while the Company believes that it is entitled to retain the remaining Advance Payment Amount received from Gavi, it is possible that it could be required to refund all or a portion of the remaining Advance Payment Amount from Gavi. On September 30, 2022, the Company and Fujifilm entered into the Fujifilm Settlement Agreement regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the CSA dated August 20, 2021 and 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 the Company’s prototype vaccine under the associated statements of work. Pursuant to the Fujifilm Settlement Agreement, the Company agreed to pay up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with cancellation of manufacturing activity at FDBT. Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA. Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company. On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of the issues identified in the notice of breach (see Note 4). On October 30, 2023, FDBT filed a demand for arbitration with JAMS seeking payment of the withheld installment payment. The Company is also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flows.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Restructuring
|
9 Months Ended |
Sep. 30, 2023 |
Restructuring and Related Activities [Abstract] |
|
Restructuring |
Restructuring During the nine months ended September 30, 2023, the restructuring charge recorded by the Company comprised (in thousands): | | | | | | | Amount | Severance and employee benefit costs | $ | 4,503 | | | | | | Impairment of assets | 10,081 | | | | | | Total Restructuring charge (1) | $ | 14,584 | |
(1) Restructuring charges of $0.5 million, $2.3 million and $11.5 million are included in Cost of sales, Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the nine months ended September 30, 2023. All impairment charges were taken in the three months ended June 30, 2023. These charges reflect substantially all expected restructuring charges under the Restructuring Plan. Severance and employee benefit costs Employees affected by the reduction in force under the Restructuring Plan are entitled to receive severance payments and certain termination benefits. The Company recorded a severance and termination benefit cost in full for employees who were notified of their termination in the three months ended June 30, 2023 and had no requirements for future service. The Company paid a total of $4.3 million for the severance and employee benefit costs during the nine months ended September 30, 2023 and the remaining liability of $0.2 million is included in Accrued expenses in the Company’s consolidated balance sheet as of September 30, 2023. Impairment of assets In connection with the Restructuring Plan, the Company evaluated its long-lived assets for impairment including certain leased laboratory and office spaces located in Gaithersburg, Maryland. The Company performed an impairment evaluation for the applicable long-lived assets which is subject to judgment and actual results may vary from the estimates, resulting in potential future adjustments to amounts recorded. During the three months ended June 30, 2023, the Company recorded an impairment charge of $10.1 million related to the impairment of long-lived assets, including $5.9 million related to ROU assets for facility leases.
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- DefinitionThe entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Subsequent Events On October 2, 2023, the Company sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses. The Company withheld the $34.3 million installment payment due to Fujifilm on September 30, 2023, pending resolution of issues identified in the notice of breach (see Note 4). On October 30, 2023, FDBT filed a demand for arbitration with JAMS seeking payment of the third quarter installment of the Settlement Payment. On October 2, 2023, the World Health Organization (“WHO”) announced its recommendation of the R21/Matrix-M™ malaria vaccine to prevent malaria in children following advice from its Strategic Advisory Group of Experts and Malaria Policy Advisory Group. The vaccine contains R21 antigen developed by University of Oxford, specific to the malaria parasite, and Novavax’s Matrix-M™ adjuvant. This recommendation is a required step on the pathway to the WHO’s prequalification (“PQ”) of the vaccine. PQ designation is necessary for United Nations agencies and partners, for example UNICEF and Gavi, to procure the vaccine for eligible countries. This is the first recommendation from WHO to support the use of a vaccine containing the Company’s Matrix-M™ adjuvant in children as young as five months of age and it is based on the results from the Phase 3 clinical trial. The R21/Matrix-M™ malaria vaccine is being developed and manufactured by SIIPL. On October 3, 2023, the Company announced that the updated vaccine has received EUA from the U.S. FDA for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, the Company’s updated vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention on September 12, 2023. On October 18, 2023, the Company announced that the Medicines and Healthcare products Regulatory Agency in the United Kingdom has granted full marketing authorization for its prototype vaccine for individuals aged 12 and older for active immunization to help prevent COVID-19. On October 18, 2023, the Company announced that Singapore's Health Sciences Authority has granted full approval for Novavax's prototype vaccine for active immunization to prevent COVID-19 in individuals aged 12 and older. The Singapore Ministry of Health has included Novavax’s prototype vaccine in the National Vaccination Programme as a protein-based non-mRNA option for COVID-19 prevention. On October 31, 2023, the Company announced that the EC has granted approval for the updated vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. This decision follows positive opinion for approval from the Committee for Medicinal Products for Human Use.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Pay vs Performance Disclosure |
|
|
|
|
Net loss |
$ (130,776)
|
$ (168,613)
|
$ (366,673)
|
$ (475,690)
|
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- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
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’ 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 $11.9 million and $6.4 million at September 30, 2023 and December 31, 2022, respectively. The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $12.2 million loss and a $3.9 million gain, and a $38.6 million loss and $59.6 million loss for the three and nine months ended September 30, 2023 and 2022, respectively, which are reflected in Other income (expense). 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, 2022. 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.
|
Liquidity and Going Concern |
Liquidity and Going Concern The accompanying unaudited consolidated financial statements have been prepared assuming, subject to the disclosures herein, that the Company will continue as a going concern within one year after the date that the financial statements are issued. In addition, as of September 30, 2023, the Company had $666.4 million in cash and cash equivalents and restricted cash. Pursuant to the June 2023 Amendment to the advance purchase agreement between the Company and the Canadian government (the “Canada APA”), the Company expects to receive the second installment of $174.8 million from the Canadian government that is contingent and payable upon the Company’s delivery of vaccine doses in the fourth quarter of 2023 (see Note 3). During the nine months ended September 30, 2023, the Company incurred a net loss of $366.7 million and had net cash flows used in operating activities of $537.2 million. In accordance with Accounting Standards Codification 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these unaudited consolidated financial statements are issued. While the Company’s current cash flow forecast for the one-year going concern look forward period estimates that there will be sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to revenue for the next 12 months, the Company’s ability to execute on certain cost-cutting initiatives and a pending matter subject to arbitration proceedings. The Company’s revenue projections depend on its ability to successfully manufacture, distribute and market its updated vaccine for the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the Company’s ability to obtain regulatory authorizations, the incidence of COVID-19 during the 2023-2024 vaccination season, the Company’s ability to timely deliver doses and achieve commercial adoption and market acceptance of its updated vaccine. 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 advance purchase agreements (“APAs”) may require the Company to refund portions of upfront and other payments or result in reduced future payments which would adversely affect the Company’s ability to continue as a going concern. For example, if the Company fails to deliver its updated vaccine doses to the Canadian government in the fourth quarter of 2023, the second installment payment of $174.8 million will be terminated and not be payable to the Company. In addition, the Canadian government may terminate the Canada APA if the Company fails to achieve regulatory approval for use of the Biologics Manufacturing Centre, Inc. (“BMC”) for COVID-19 Vaccine production on or before December 31, 2024. Also, if the Company does not timely achieve supportive recommendations from the Joint Committee on Vaccination and Immunisation (the “JCVI”) of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”) with respect to use of its COVID-19 Program for (a) the general adult population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or (b) the general adolescent population as part of a SARS-CoV-2 vaccine booster campaign in the United Kingdom or as a primary series SARS-CoV-2 vaccination, excluding where that recommendation relates only to one or more population groups comprising less than one million members in the United Kingdom, then the Company would be required to repay up to $112.5 million related to the upfront payment previously received from the Authority under the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the Company and the Authority. On January 24, 2023, Gavi, the Vaccine Alliance (“Gavi”) filed a demand for arbitration with the International Court of Arbitration regarding an alleged material breach by the Company of the Company’s APA with Gavi (the “Gavi APA”). The arbitration hearing is scheduled for July 2024, with a written decision to follow. The outcome of that arbitration is inherently uncertain, and it is possible the Company could be required to refund all or a portion of the remaining advance payments of $696.4 million as of September 30, 2023 (see Note 3 and Note 14). Management believes that, given the significance of these uncertainties, substantial doubt exists regarding the Company’s ability to continue as a going concern through one year from the date that these financial statements are issued. In May 2023, the Company announced a global restructuring and cost reduction plan (the “Restructuring Plan”), which includes a more focused investment in its COVID-19 Program, reduction to its pipeline spending, the continued rationalization of its manufacturing network, a reduction to the Company’s global workforce, as well as the consolidation of facilities, and infrastructure. The workforce reduction plan included an approximately 25% reduction in the Company’s global workforce, comprised of an approximately 20% reduction in full-time Novavax employees and the remainder comprised of contractors and consultants. The Company has decided to progress its CIC vaccine candidate toward late-stage development and, as such, is assessing the impact on its workforce requirements. The Company expects the full annual impact of the cost savings from the Restructuring Plan to be realized in 2024 and approximately half of the annual impact to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which the Company operates. During the nine months ended September 30, 2023, the Company recorded a charge of $4.5 million related to one-time employee severance and benefit costs and recorded an impairment charge of $10.1 million related to the consolidation of facilities and infrastructure (see Note 15). The Company’s ability to fund Company operations is dependent upon revenue related to vaccine sales for its products and product candidates, if such product candidates receive marketing approval and are successfully commercialized, and in particular the 2023-2024 vaccination season, which is inherently uncertain and subject to a number of risks, including the incidence of COVID-19 during the 2023-2024 vaccination season, regulatory authorization, ability to timely deliver doses and commercial adoption and market acceptance of its updated vaccine, the resolution of certain matters, including whether, when, and how the dispute with Gavi is resolved, and management’s plans, which includes cost reductions associated with the Restructuring Plan. Management’s plans may also include raising additional capital through a combination of equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements. New financings may not be available to the Company on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights. In addition, the regulatory and commercial success of the Company’s COVID-19 Program and the Company’s other vaccine candidates, including an influenza vaccine candidate, and a CIC vaccine candidate, remains uncertain. Also, the impact of the Company’s more focused investment in its COVID-19 Program, reduction to its pipeline spending, continued rationalization of its manufacturing network, reduction to its global workforce, and consolidation of its facilities and infrastructure remain uncertain. If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, or further downsize its organization, any of which may have a material adverse effect on its business, financial condition, results of operations, and ability to operate as a going concern.
|
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 Constraints |
Revenue Recognition Constraints The Company constrains the transaction price for customer arrangements until it is probable that a significant reversal in cumulative revenue recognized will not occur. Specifically, if a customer arrangement includes a provision whereby the customer may request a discount, return, or refund for a previously satisfied performance obligation or otherwise could have the effect of decreasing the transaction price, revenue is constrained based on an estimate of the impact to the transaction price recognized until it is probable that a significant reversal in cumulative revenue recognized will not occur.
|
Restructuring |
Restructuring The Company recognizes restructuring charges when such costs are incurred. The Company’s restructuring charges consist of employee severance and other termination benefits related to the reduction of its workforce, the consolidation of facilities, and infrastructure and other costs. Termination benefits are expensed on the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. Ongoing benefits are expensed when restructuring activities are probable and the benefit estimable. See Note 15 for additional information on the severance and employee benefit costs for terminated employees and impairment of assets in connection with the Company’s Restructuring Plan.
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements Adopted In June 2016, the Financial Accounting Standards Board 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” 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 Company adopted ASU 2020-06 on January 1, 2023, using a modified retrospective approach, and it did not have a material impact on the Company’s consolidated financial statements.
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v3.23.3
Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Grants, U.S. Government Contract and Joint Venture [Abstract] |
|
Schedule of Accounts Receivable, Unbilled Services, and Deferred Revenue |
During the nine months ended September 30, 2023, and 2022, changes in the Company’s accounts receivables, allowance for doubtful accounts, and deferred revenue balances were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Balance, Beginning of Period | | Additions | | Deductions | | Balance, End of Period | Accounts receivable: | | | | | | | | Nine Months Ended September 30, 2023 | $ | 96,210 | | | $ | 981,305 | | | $ | (946,182) | | | $ | 131,333 | | Nine Months Ended September 30, 2022 | 454,993 | | | 1,519,345 | | | (1,862,693) | | | 111,645 | | Allowance for doubtful accounts(1): | | | | | | | | Nine Months Ended September 30, 2023 | $ | (13,835) | | | $ | — | | | $ | 6,159 | | | $ | (7,676) | | Nine Months Ended September 30, 2022 | — | | | — | | | — | | | — | | Deferred revenue:(2) | | | | | | | | Nine Months Ended September 30, 2023 | $ | 549,551 | | | $ | 422,766 | | | $ | (171,288) | | | $ | 801,029 | | Nine Months Ended September 30, 2022 | 1,595,472 | | | 96,298 | | | (251,576) | | | 1,440,194 | |
(1) There was no bad debt expense recorded during the three and nine months ended September 30, 2023 or 2022. There was a $6.2 million reversal of a bad debt allowance during the nine months ended September 30, 2023 due to the collection of a previously recognized allowance for doubtful accounts. To estimate the allowance for doubtful accounts, the Company evaluates the credit risk related to its customers based on historical loss experience, economic conditions, the aging of receivables, and customer-specific risks. (2) Deductions from Deferred revenue generally related to the recognition of revenue once performance obligations on a contract with a customer are met. During the three and nine months ended September 30, 2023, deductions included a $112.5 million reclassification of refundable upfront payments previously included in Deferred revenue to Other current liabilities. There were no such reclassifications during the three and nine months ended September 30, 2022.
|
Schedule of Product Revenue |
Product sales by the Company’s customer’s geographic location was as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | Nine Months Ended September 30, | | 2023 | | 2022 | 2023 | | 2022 | North America | $ | 2,231 | | | $ | 129,718 | | $ | 2,231 | | | $ | 194,480 | | Europe | — | | | 347,005 | | 59,322 | | | 760,750 | | Rest of the world | — | | | 149,368 | | 218,384 | | | 311,944 | | Total product sales revenue | $ | 2,231 | | | $ | 626,091 | | $ | 279,937 | | | $ | 1,267,174 | |
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v3.23.3
Cash, Cash Equivalents, and Restricted Cash (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
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 consolidated statements of cash flows (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Cash and cash equivalents | $ | 651,104 | | | $ | 1,336,883 | | Restricted cash, current | 10,393 | | | 10,303 | | Restricted cash, non-current(1) | 4,866 | | | 1,659 | | Cash, cash equivalents, and restricted cash | $ | 666,363 | | | $ | 1,348,845 | |
(1)Classified as Other non-current assets as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets.
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
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, 2023 | | Fair Value at December 31, 2022 | Assets | Level 1 | | Level 2 | | Level 3 | | Level 1 | | Level 2 | | Level 3 | Money market funds(1) | $ | 196,679 | | | $ | — | | | $ | — | | | $ | 398,834 | | | $ | — | | | $ | — | | Government-backed securities(1) | — | | | 200,000 | | | — | | | — | | | 296,000 | | | — | | Treasury securities(1) | — | | | 36,913 | | | — | | | — | | | — | | | — | | Corporate debt securities(1) | — | | | 23,028 | | | — | | | — | | | — | | | — | | Agency securities(1) | — | | | — | | | — | | | — | | | 104,536 | | | — | | Total cash equivalents | $ | 196,679 | | | $ | 259,941 | | | $ | — | | | $ | 398,834 | | | $ | 400,536 | | | $ | — | | Liabilities | | | | | | | | | | | | 5.00% Convertible notes due 2027 | $ | — | | $ | 131,292 | | | $ | — | | $ | — | | $ | 172,789 | | $ | — | 3.75% Convertible notes due 2023 | — | | | — | | | — | | | — | | | 322,111 | | | — | | Total convertible notes payable | $ | — | | | $ | 131,292 | | | $ | — | | | $ | — | | | $ | 494,900 | | | $ | — | |
(1)All investments are classified as Cash and cash equivalents as of September 30, 2023 and December 31, 2022, on the consolidated balance sheets.
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v3.23.3
Inventory (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Inventory consisted of the following (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Raw materials | $ | 10,385 | | | $ | 13,912 | | Semi-finished goods | 10,405 | | | 21,410 | | Finished goods | 48,802 | | | 1,361 | | Total inventory | $ | 69,592 | | | $ | 36,683 | |
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v3.23.3
Goodwill (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Goodwill |
The change in the carrying amounts of goodwill for the nine months ended September 30, 2023 was as follows (in thousands): | | | | | | | Amount | Balance at December 31, 2022 | $ | 126,331 | | Currency translation adjustments | (2,551) | | Balance at September 30, 2023 | $ | 123,780 | |
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v3.23.3
Long-Term Debt (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Convertible Notes Payable |
Total convertible notes payable consisted of the following (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Current portion: | | | | 3.75% Convertible notes due 2023 | $ | — | | | $ | 325,000 | | Unamortized debt issuance costs | — | | | (119) | | Total current convertible notes payable | $ | — | | | $ | 324,881 | | Non-current portion: | | | | 5.00% Convertible notes due 2027 | $ | 175,250 | | | $ | 175,250 | | | | | | Unamortized debt issuance costs | (7,629) | | | (8,784) | | Total non-current convertible notes payable | $ | 167,621 | | | $ | 166,466 | |
|
Schedule of Interest Expense |
The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Coupon interest | $ | 2,191 | | | $ | 3,047 | | | $ | 7,588 | | | $ | 9,141 | | Amortization of debt issuance costs | 395 | | | 356 | | | 1,295 | | | 1,068 | | Total interest expense on convertible notes payable | $ | 2,586 | | | $ | 3,403 | | | $ | 8,883 | | | $ | 10,209 | |
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock-Based Compensation expense |
The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Cost of sales | $ | 767 | | | $ | 51 | | | $ | 2,283 | | | $ | 51 | | Research and development | 10,022 | | | 16,107 | | | 33,826 | | | 52,692 | | Selling, general, and administrative | 9,971 | | | 15,389 | | | 33,590 | | | 49,782 | | Total stock-based compensation expense | $ | 20,760 | | | $ | 31,547 | | | $ | 69,699 | | | $ | 102,525 | |
|
Schedule of Option and Appreciation Rights Activity |
The following is a summary of stock options and SARs activity under the 2023 Inducement Plan, 2015 Plan, and 2005 Plan for the nine months ended September 30, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2023 Inducement Plan | | 2015 Plan | | 2005 Plan | | Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price | | Stock Options | | Weighted-Average Exercise Price | Outstanding at December 31, 2022 | — | | | $ | — | | | 4,053,290 | | | $ | 46.07 | | | 63,725 | | | $ | 112.94 | | Granted | 422,800 | | | 10.67 | | | 861,602 | | | 7.29 | | | — | | | — | | Exercised | — | | | — | | | (5,374) | | | 6.71 | | | — | | | — | | Canceled | — | | | — | | | (103,504) | | | 56.45 | | | (5,450) | | | 39.70 | | Outstanding at September 30, 2023 | 422,800 | | | $ | 10.67 | | | 4,806,014 | | | $ | 38.94 | | | 58,275 | | | $ | 119.79 | | Shares exercisable at September 30, 2023 | — | | | $ | — | | | 3,437,364 | | | $ | 40.58 | | | 58,275 | | | $ | 119.79 | |
|
Schedule of Assumptions Used in Estimation of Fair Value of Stock |
The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Weighted average Black-Scholes fair value of stock options granted | $7.84 | | $37.66 | | $7.27 | | $60.24 | Risk-free interest rate | 4.3%-4.4% | | 3.0%-3.6% | | 3.5%-4.4% | | 1.4%-3.6% | Dividend yield | —% | | —% | | —% | | —% | Volatility | 128.7%-130.3% | | 122.2%-136.4% | | 120.4%-140.3% | | 120.5%-136.7% | Expected term (in years) | 3.9-5.1 | | 4.0-5.3 | | 3.9-6.3 | | 4.0-6.3 |
|
Schedule of Share Based Compensation Restricted Stock Awards Activity |
The following is a summary of RSU activity for the nine months ended September 30, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | 2023 Inducement Plan | | 2015 Plan | | Number of Shares | | Per Share Weighted- Average Fair Value | | Number of Shares | | Per Share Weighted- Average Fair Value | Outstanding and unvested at December 31, 2022 | — | | | $ | — | | | 2,034,574 | | | $ | 61.65 | | Granted | 363,990 | | | 10.66 | | | 2,888,793 | | | 7.25 | | Vested | — | | | — | | | (403,672) | | | 87.17 | | Forfeited | — | | | — | | | (780,810) | | | 27.77 | | Outstanding and unvested at September 30, 2023 | 363,990 | | | $ | 10.66 | | | 3,738,885 | | | $ | 23.95 | |
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v3.23.3
Restructuring (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Restructuring and Related Activities [Abstract] |
|
Schedule of Restructuring and Related Costs |
During the nine months ended September 30, 2023, the restructuring charge recorded by the Company comprised (in thousands): | | | | | | | Amount | Severance and employee benefit costs | $ | 4,503 | | | | | | Impairment of assets | 10,081 | | | | | | Total Restructuring charge (1) | $ | 14,584 | |
(1) Restructuring charges of $0.5 million, $2.3 million and $11.5 million are included in Cost of sales, Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the nine months ended September 30, 2023. All impairment charges were taken in the three months ended June 30, 2023. These charges reflect substantially all expected restructuring charges under the Restructuring Plan.
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v3.23.3
Summary of Significant Accounting Policies (Details) $ in Thousands, member in Millions |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
Jul. 31, 2023
USD ($)
|
May 31, 2023 |
Sep. 30, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
member
segment
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2021
USD ($)
|
Summary Of Significant Accounting Policies [Line Items] |
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
$ (11,900)
|
|
|
$ (11,900)
|
|
$ (6,400)
|
|
Foreign currency transaction gain (loss) |
|
|
(12,200)
|
|
$ (38,600)
|
$ 3,900
|
$ (59,600)
|
|
|
Number of business segments | segment |
|
|
|
|
|
1
|
|
|
|
Cash, cash equivalents, and restricted cash |
|
|
666,363
|
|
$ 1,293,022
|
$ 666,363
|
1,293,022
|
$ 1,348,845
|
$ 1,528,259
|
Net loss |
|
|
|
|
|
(366,700)
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
|
|
|
$ (537,186)
|
(298,121)
|
|
|
Number of population members (less than) | member |
|
|
|
|
|
1
|
|
|
|
Contract with customer, liability, deductions |
|
|
|
|
|
$ 171,288
|
251,576
|
|
|
Global workforce percent |
|
25.00%
|
|
|
|
|
|
|
|
Restructuring and related cost percent |
|
20.00%
|
|
|
|
|
|
|
|
Severance and employee benefit costs |
|
|
|
|
|
4,503
|
|
|
|
Impairment of assets |
|
|
|
$ 10,100
|
|
10,081
|
$ 0
|
|
|
Canada APA |
|
|
|
|
|
|
|
|
|
Summary Of Significant Accounting Policies [Line Items] |
|
|
|
|
|
|
|
|
|
Installment charges |
$ 174,800
|
|
|
|
|
174,800
|
|
|
|
Collaboration agreement upfront payment amount |
|
|
100,400
|
|
|
100,400
|
|
|
|
Joint Committee on Vaccination and Immunization (JCVI) |
|
|
|
|
|
|
|
|
|
Summary Of Significant Accounting Policies [Line Items] |
|
|
|
|
|
|
|
|
|
Contract with customer, liability, deductions |
|
|
112,500
|
|
|
112,500
|
|
|
|
Gavi Advance Purchase Agreement- COVAX Facility |
|
|
|
|
|
|
|
|
|
Summary Of Significant Accounting Policies [Line Items] |
|
|
|
|
|
|
|
|
|
Collaboration agreement upfront payment amount |
|
|
$ 696,400
|
|
|
$ 696,400
|
|
|
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v3.23.3
Revenue - Additional Information (Details) dose in Millions |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
Jul. 31, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
dose
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
dose
installment
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Nov. 18, 2022
dose
|
Dec. 31, 2021
USD ($)
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Billed contracts receivable |
|
$ 71,100,000
|
|
$ 71,100,000
|
|
$ 53,800,000
|
|
|
Unbilled contracts receivable |
|
52,600,000
|
|
52,600,000
|
|
28,600,000
|
|
|
Amount of transaction price not yet satisfied |
|
2,000,000,000
|
|
2,000,000,000
|
|
|
|
|
Deferred revenue |
|
801,029,000
|
$ 1,440,194,000
|
801,029,000
|
$ 1,440,194,000
|
549,551,000
|
|
$ 1,595,472,000
|
Reduction in product sales |
|
|
|
64,700,000
|
|
|
|
|
Revenues |
|
186,986,000
|
734,577,000
|
692,363,000
|
1,624,473,000
|
|
|
|
Milestone Payments |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Revenues |
|
0
|
0
|
0
|
20,000,000
|
|
|
|
Sales-Based Royalties |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Revenues |
|
6,000,000
|
1,300,000
|
6,000,000
|
10,500,000
|
|
|
|
Gavi Advance Purchase Agreement- COVAX Facility |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Number of doses to be distributed | dose |
|
|
|
|
|
|
350
|
|
Purchase agreement, number of vaccine doses | dose |
|
|
|
|
|
|
2
|
|
Collaboration agreement upfront payment amount |
|
696,400,000
|
|
696,400,000
|
|
|
|
|
Canada APA |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Collaboration agreement upfront payment amount |
|
$ 100,400,000
|
|
100,400,000
|
|
|
|
|
Total payment amount |
|
|
|
$ 349,600,000
|
|
|
|
|
Number of equal installments | installment |
|
|
|
2
|
|
|
|
|
Obligation to deliver, terms |
|
|
|
15 years
|
|
|
|
|
Installment charges |
$ 174,800,000
|
|
|
$ 174,800,000
|
|
|
|
|
Percent of remaining amount to be paid |
|
100.00%
|
|
100.00%
|
|
|
|
|
Escrow to sales hold |
|
|
|
$ 20,000,000.0
|
|
|
|
|
US Government Partnership |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Amount of transaction price not yet satisfied |
|
$ 1,800,000,000
|
|
1,800,000,000
|
|
|
|
|
Contingent upon meeting certain milestones amount |
|
60,000,000
|
|
60,000,000
|
|
|
|
|
Grant consideration, amount development and regulatory milestones |
|
1,500,000
|
|
$ 1,500,000
|
|
|
|
|
Grant revenue increase |
|
$ 43,800,000
|
|
|
|
|
|
|
Gavi Advance Purchase Agreement SIIPL |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
$ 350,000,000.0
|
Number of doses to be distributed | dose |
|
1,100
|
|
1,100
|
|
|
|
|
Remaining performance obligation, variable consideration amount |
|
|
|
|
|
$ 350,000,000.0
|
|
|
Matrix-M Adjuvant Sales |
|
|
|
|
|
|
|
|
Revenue Recognition |
|
|
|
|
|
|
|
|
Revenues |
|
$ 13,800,000
|
$ 1,000,000
|
$ 17,000,000
|
$ 13,400,000
|
|
|
|
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Revenue - Accounts Receivable, Unbilled Services, and Deferred Revenue (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Accounts receivable |
|
|
|
|
Accounts receivable, beginning balance |
|
|
$ 96,210,000
|
$ 454,993,000
|
Additions |
|
|
981,305,000
|
1,519,345,000
|
Deductions |
|
|
(946,182,000)
|
(1,862,693,000)
|
Accounts receivable, ending balance |
$ 131,333,000
|
$ 111,645,000
|
131,333,000
|
111,645,000
|
Allowance for doubtful accounts |
|
|
|
|
Allowance for doubtful accounts, beginning balance |
|
|
(13,835,000)
|
0
|
Additions |
0
|
0
|
0
|
0
|
Deductions |
|
|
6,159,000
|
0
|
Allowance for doubtful accounts, end balance |
(7,676,000)
|
0
|
(7,676,000)
|
0
|
Deferred revenue |
|
|
|
|
Deferred revenue, beginning balance |
|
|
549,551,000
|
1,595,472,000
|
Additions |
|
|
422,766,000
|
96,298,000
|
Deductions |
|
|
(171,288,000)
|
(251,576,000)
|
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$ 801,029,000
|
$ 1,440,194,000
|
$ 801,029,000
|
$ 1,440,194,000
|
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v3.23.3
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3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Revenue Recognition |
|
|
|
|
Revenues |
$ 186,986
|
$ 734,577
|
$ 692,363
|
$ 1,624,473
|
Product |
|
|
|
|
Revenue Recognition |
|
|
|
|
Revenues |
2,231
|
626,091
|
279,937
|
1,267,174
|
Product | North America |
|
|
|
|
Revenue Recognition |
|
|
|
|
Revenues |
2,231
|
129,718
|
2,231
|
194,480
|
Product | Europe |
|
|
|
|
Revenue Recognition |
|
|
|
|
Revenues |
0
|
347,005
|
59,322
|
760,750
|
Product | Rest of the world |
|
|
|
|
Revenue Recognition |
|
|
|
|
Revenues |
$ 0
|
$ 149,368
|
$ 218,384
|
$ 311,944
|
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v3.23.3
Collaboration, License, and Supply Agreements (Details) $ / shares in Units, $ in Thousands, shares in Millions, dose in Millions |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
Aug. 31, 2023
USD ($)
$ / shares
shares
|
Sep. 30, 2023
USD ($)
installment
$ / shares
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
installment
$ / shares
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
installment
$ / shares
|
Dec. 31, 2021
USD ($)
|
Sep. 30, 2021
dose
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Royalty period |
|
|
|
15 years
|
|
|
|
|
Deferred revenue |
|
$ 801,029
|
$ 1,440,194
|
$ 801,029
|
$ 1,440,194
|
$ 549,551
|
$ 1,595,472
|
|
Common stock, par value per share (in usd per share) | $ / shares |
|
$ 0.01
|
|
$ 0.01
|
|
$ 0.01
|
|
|
Net proceeds from sales of common stock |
|
|
|
$ 256,995
|
179,385
|
|
|
|
Research and development |
|
$ 106,229
|
304,297
|
572,805
|
977,428
|
|
|
|
Takeda Arrangement |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Number of doses to be distributed | dose |
|
|
|
|
|
|
|
150
|
Settlement Agreement |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Settlement payment |
$ 149,800
|
$ 185,000
|
185,000
|
$ 185,000
|
185,000
|
|
|
|
Initial reservation fee |
130,400
|
|
$ 47,800
|
|
$ 47,800
|
|
|
|
Deferred revenue |
4,000
|
|
|
|
|
|
|
|
Number of quarterly installment payments | installment |
|
2
|
|
2
|
|
4
|
|
|
Settlement agreement, quarterly installment amount |
|
$ 34,300
|
|
$ 34,300
|
|
|
|
|
Settlement Agreement | Accrued Liabilities |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Settlement payment |
|
68,600
|
|
68,600
|
|
|
|
|
Securities Subscription Arrangement |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Settlement agreement, benefit |
|
79,200
|
|
79,200
|
|
|
|
|
Research and development |
|
$ 57,700
|
|
$ 57,700
|
|
|
|
|
Loss on firm purchase commitments |
$ 21,500
|
|
|
|
|
|
|
|
Securities Subscription Arrangement | Private Placement |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Shares sell and issue | shares |
6.5
|
|
|
|
|
|
|
|
Common stock, par value per share (in usd per share) | $ / shares |
$ 0.01
|
|
|
|
|
|
|
|
Share, price per share (in usd per share) | $ / shares |
$ 13.00
|
|
|
|
|
|
|
|
Net proceeds from sales of common stock |
$ 84,500
|
|
|
|
|
|
|
|
Common stock, quoted market price |
46,500
|
|
|
|
|
|
|
|
Common stock, premium paid |
$ 38,000
|
|
|
|
|
|
|
|
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v3.23.3
Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] |
|
|
|
|
Cash and cash equivalents |
$ 651,104
|
$ 1,336,883
|
|
|
Restricted cash, current |
10,393
|
10,303
|
|
|
Restricted cash, non-current |
4,866
|
1,659
|
|
|
Cash, cash equivalents, and restricted cash |
$ 666,363
|
$ 1,348,845
|
$ 1,293,022
|
$ 1,528,259
|
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v3.23.3
Fair Value Measurements (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
5.00% Convertible notes due 2027 | Unsecured Debt |
|
|
Liabilities |
|
|
Debt instrument, interest rate, stated percentage |
5.00%
|
|
3.75% Convertible notes due 2023 | Unsecured Debt |
|
|
Liabilities |
|
|
Debt instrument, interest rate, stated percentage |
3.75%
|
|
Level 1 |
|
|
Assets |
|
|
Total cash equivalents |
$ 196,679
|
$ 398,834
|
Liabilities |
|
|
Total convertible notes payable |
0
|
0
|
Level 1 | 5.00% Convertible notes due 2027 |
|
|
Liabilities |
|
|
Total convertible notes payable |
0
|
0
|
Level 1 | 3.75% Convertible notes due 2023 |
|
|
Liabilities |
|
|
Total convertible notes payable |
0
|
0
|
Level 1 | Money market funds |
|
|
Assets |
|
|
Total cash equivalents |
196,679
|
398,834
|
Level 1 | Government-backed securities |
|
|
Assets |
|
|
Total cash equivalents |
0
|
0
|
Level 1 | Treasury 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 |
259,941
|
400,536
|
Liabilities |
|
|
Total convertible notes payable |
131,292
|
494,900
|
Level 2 | 5.00% Convertible notes due 2027 |
|
|
Liabilities |
|
|
Total convertible notes payable |
131,292
|
172,789
|
Level 2 | 3.75% Convertible notes due 2023 |
|
|
Liabilities |
|
|
Total convertible notes payable |
0
|
322,111
|
Level 2 | Money market funds |
|
|
Assets |
|
|
Total cash equivalents |
0
|
0
|
Level 2 | Government-backed securities |
|
|
Assets |
|
|
Total cash equivalents |
200,000
|
296,000
|
Level 2 | Treasury securities |
|
|
Assets |
|
|
Total cash equivalents |
36,913
|
0
|
Level 2 | Corporate debt securities |
|
|
Assets |
|
|
Total cash equivalents |
23,028
|
0
|
Level 2 | Agency securities |
|
|
Assets |
|
|
Total cash equivalents |
0
|
104,536
|
Level 3 |
|
|
Assets |
|
|
Total cash equivalents |
0
|
0
|
Liabilities |
|
|
Total convertible notes payable |
0
|
0
|
Level 3 | 5.00% Convertible notes due 2027 |
|
|
Liabilities |
|
|
Total convertible notes payable |
0
|
0
|
Level 3 | 3.75% Convertible notes due 2023 |
|
|
Liabilities |
|
|
Total 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 | Treasury securities |
|
|
Assets |
|
|
Total cash equivalents |
0
|
0
|
Level 3 | Corporate debt securities |
|
|
Assets |
|
|
Total cash equivalents |
0
|
0
|
Level 3 | Agency securities |
|
|
Assets |
|
|
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$ 0
|
$ 0
|
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v3.23.3
Inventory (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Inventory Disclosure [Abstract] |
|
|
|
|
|
Raw materials |
$ 10,385
|
|
$ 10,385
|
|
$ 13,912
|
Semi-finished goods |
10,405
|
|
10,405
|
|
21,410
|
Finished goods |
48,802
|
|
48,802
|
|
1,361
|
Total inventory |
69,592
|
|
69,592
|
|
$ 36,683
|
Provision for excess and obsolete inventory |
18,100
|
$ 202,400
|
49,600
|
$ 358,100
|
|
Firm purchase commitment loss |
63,500
|
$ 46,600
|
71,900
|
$ 146,200
|
|
Inventory, firm purchase commitment, recoveries |
$ 21,500
|
|
$ 40,300
|
|
|
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v3.23.3
Leases (Details) $ in Millions |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2020
USD ($)
ft²
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
Short-term lease expense (benefit) |
$ (39.5)
|
$ (46.6)
|
$ (48.0)
|
$ 37.3
|
|
|
Lease expense |
|
24.2
|
|
44.0
|
|
|
Interest expense |
0.5
|
$ 0.9
|
1.4
|
$ 4.3
|
|
|
Impairment of long-lived assets |
|
|
5.9
|
|
|
|
700 Quince Orchard Road Agreement |
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
Lease expense |
|
|
|
|
|
$ 5.8
|
Facility number of square feet | ft² |
|
|
|
|
|
170,000
|
Right of use asset, net |
96.5
|
|
96.5
|
|
|
|
Lease obligation |
$ 96.5
|
|
$ 96.5
|
|
|
|
Increase (decrease) in operating lease liability |
|
|
|
|
$ (73.4)
|
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v3.23.3
Long-Term Debt - Notes Payable (Details) - USD ($) $ in Thousands |
1 Months Ended |
|
|
Feb. 28, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Instrument [Line Items] |
|
|
|
Unamortized debt issuance costs |
|
$ 0
|
$ (119)
|
Convertible notes payable |
|
0
|
324,881
|
Unamortized debt issuance costs |
|
(7,629)
|
(8,784)
|
Total non-current convertible notes payable |
|
167,621
|
166,466
|
3.75% Convertible notes due 2023 | Unsecured Debt |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Debt instrument, face amount, current |
|
$ 0
|
325,000
|
Debt instrument, interest rate, stated percentage |
|
3.75%
|
|
Repayments of debt |
$ 325,000
|
|
|
5.00% Convertible notes due 2027 | Unsecured Debt |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Aggregate principal amount of notes issued |
|
$ 175,250
|
$ 175,250
|
Debt instrument, interest rate, stated percentage |
|
5.00%
|
|
Debt instrument, interest rate, effective percentage |
|
6.20%
|
|
X |
- DefinitionDebt Instrument, Face Amount, Current
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v3.23.3
Long-Term Debt - Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Debt Disclosure [Abstract] |
|
|
|
|
Coupon interest |
$ 2,191
|
$ 3,047
|
$ 7,588
|
$ 9,141
|
Amortization of debt issuance costs |
395
|
356
|
1,295
|
1,068
|
Total interest expense on convertible notes payable |
$ 2,586
|
$ 3,403
|
$ 8,883
|
$ 10,209
|
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- DefinitionAmount of amortization expense attributable to debt issuance costs.
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v3.23.3
Stockholders' Deficit (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Aug. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Stockholders' Equity |
|
|
|
|
|
Common stock, par value per share (in usd per share) |
|
$ 0.01
|
$ 0.01
|
|
$ 0.01
|
Net proceeds from sales of common stock |
|
|
$ 256,995
|
$ 179,385
|
|
Private Placement | Securities Subscription Arrangement |
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Shares sell and issue |
6.5
|
|
|
|
|
Common stock, par value per share (in usd per share) |
$ 0.01
|
|
|
|
|
Share, price per share (in usd per share) |
$ 13.00
|
|
|
|
|
Net proceeds from sales of common stock |
$ 84,500
|
|
|
|
|
Settlement fair value |
46,500
|
|
|
|
|
Common Stock | June 2021 and August 2023 Sales Agreement |
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Sale of stock, consideration received on transaction |
|
|
$ 211,000
|
|
|
Sale of stock, number of shares issued in transaction (in shares) |
|
|
25.7
|
|
|
Common Stock | August 2023 Sales Agreement |
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Authorized amount |
500,000
|
|
|
|
|
Sale of stock, consideration received on transaction |
$ 143,000
|
|
|
|
|
Remaining unissued capital |
|
$ 354,000
|
$ 354,000
|
|
|
Sale of stock, number of shares issued in transaction (in shares) |
|
17.8
|
|
|
|
Common Stock | June 2021 Sales Agreement |
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Sale of stock, consideration received on transaction |
|
|
|
$ 179,000
|
|
Sale of stock, number of shares issued in transaction (in shares) |
|
|
|
2.2
|
|
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v3.23.3
Stock-Based Compensation - Additional Information (Details) - USD ($) shares in Thousands, $ in Millions |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
Jun. 30, 2015 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jan. 31, 2023 |
Jun. 30, 2013 |
Stock-Based Compensation |
|
|
|
|
|
|
|
Stock-based compensation capitalized |
|
$ 0.5
|
$ 1.7
|
$ 0.5
|
$ 1.7
|
|
|
Unrecognized compensation expense |
|
102.0
|
|
$ 102.0
|
|
|
|
Unrecognized compensation expense, recognition period |
|
|
|
1 year
|
|
|
|
Aggregate intrinsic value, stock options and vesting RSA's |
|
|
|
$ 3.0
|
$ 19.0
|
|
|
Aggregate intrinsic value, outstanding |
|
$ 1.4
|
|
$ 1.4
|
|
|
|
Remaining term, outstanding (in years) |
|
|
|
7 years 1 month 6 days
|
|
|
|
ESPP |
|
|
|
|
|
|
|
Stock-Based Compensation |
|
|
|
|
|
|
|
Shares available for grant (in shares) |
|
500
|
|
500
|
|
|
|
Authorized (in shares) |
|
1,650
|
|
1,650
|
|
|
1,200
|
Percentage increase of shares each anniversary |
|
5.00%
|
|
5.00%
|
|
|
|
Subscription rate cap |
|
15.00%
|
|
15.00%
|
|
|
|
Maximum discount rate |
|
|
|
85.00%
|
|
|
|
2023 Inducement Plan |
|
|
|
|
|
|
|
Stock-Based Compensation |
|
|
|
|
|
|
|
Shares available for grant (in shares) |
|
|
|
|
|
1,000
|
|
Number of shares available for issuance (in shares) |
|
200
|
|
200
|
|
|
|
2015 Plan |
|
|
|
|
|
|
|
Stock-Based Compensation |
|
|
|
|
|
|
|
Number of shares available for issuance (in shares) |
|
7,100
|
|
7,100
|
|
|
|
Authorized (in shares) |
|
21,000
|
|
21,000
|
|
|
|
Additional shares authorized (in shares) |
|
|
|
6,200
|
|
|
|
Term (in years) |
10 years
|
|
|
|
|
|
|
Minimum grant price, percent of common stock fair value |
100.00%
|
|
|
|
|
|
|
Aggregate intrinsic value, exercisable |
|
$ 1.1
|
|
$ 1.1
|
|
|
|
Remaining term, exercisable (in years) |
|
|
|
6 years 1 month 6 days
|
|
|
|
2015 Plan | Minimum |
|
|
|
|
|
|
|
Stock-Based Compensation |
|
|
|
|
|
|
|
Vesting period |
1 year
|
|
|
|
|
|
|
2015 Plan | Maximum |
|
|
|
|
|
|
|
Stock-Based Compensation |
|
|
|
|
|
|
|
Vesting period |
4 years
|
|
|
|
|
|
|
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v3.23.3
Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Compensation expense: |
|
|
|
|
Total stock-based compensation expense |
$ 20,760
|
$ 31,547
|
$ 69,699
|
$ 102,525
|
Cost of sales |
|
|
|
|
Compensation expense: |
|
|
|
|
Total stock-based compensation expense |
767
|
51
|
2,283
|
51
|
Research and development |
|
|
|
|
Compensation expense: |
|
|
|
|
Total stock-based compensation expense |
10,022
|
16,107
|
33,826
|
52,692
|
Selling, general, and administrative |
|
|
|
|
Compensation expense: |
|
|
|
|
Total stock-based compensation expense |
$ 9,971
|
$ 15,389
|
$ 33,590
|
$ 49,782
|
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v3.23.3
Stock-Based Compensation - Stock Options and Appreciation Rights (Details)
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
2023 Inducement Plan |
|
Stock Options |
|
Outstanding, beginning balance (in shares) | shares |
0
|
Granted (in shares) | shares |
422,800
|
Exercised (in shares) | shares |
0
|
Canceled (in shares) | shares |
0
|
Outstanding, ending balance (in shares) | shares |
422,800
|
Shares exercisable (in shares) | shares |
0
|
Weighted-Average Exercise Price |
|
Outstanding, beginning balance (in usd per share) | $ / shares |
$ 0
|
Granted (in usd per share) | $ / shares |
10.67
|
Exercised (in usd per share) | $ / shares |
0
|
Canceled (in usd per share) | $ / shares |
0
|
Outstanding, ending balance (in usd per share) | $ / shares |
10.67
|
Shares exercisable (in usd per share) | $ / shares |
$ 0
|
2015 Plan |
|
Stock Options |
|
Outstanding, beginning balance (in shares) | shares |
4,053,290
|
Granted (in shares) | shares |
861,602
|
Exercised (in shares) | shares |
(5,374)
|
Canceled (in shares) | shares |
(103,504)
|
Outstanding, ending balance (in shares) | shares |
4,806,014
|
Shares exercisable (in shares) | shares |
3,437,364
|
Weighted-Average Exercise Price |
|
Outstanding, beginning balance (in usd per share) | $ / shares |
$ 46.07
|
Granted (in usd per share) | $ / shares |
7.29
|
Exercised (in usd per share) | $ / shares |
6.71
|
Canceled (in usd per share) | $ / shares |
56.45
|
Outstanding, ending balance (in usd per share) | $ / shares |
38.94
|
Shares exercisable (in usd per share) | $ / shares |
$ 40.58
|
2005 Plan |
|
Stock Options |
|
Outstanding, beginning balance (in shares) | shares |
63,725
|
Granted (in shares) | shares |
0
|
Exercised (in shares) | shares |
0
|
Canceled (in shares) | shares |
(5,450)
|
Outstanding, ending balance (in shares) | shares |
58,275
|
Shares exercisable (in shares) | shares |
58,275
|
Weighted-Average Exercise Price |
|
Outstanding, beginning balance (in usd per share) | $ / shares |
$ 112.94
|
Granted (in usd per share) | $ / shares |
0
|
Exercised (in usd per share) | $ / shares |
0
|
Canceled (in usd per share) | $ / shares |
39.70
|
Outstanding, ending balance (in usd per share) | $ / shares |
119.79
|
Shares exercisable (in usd per share) | $ / shares |
$ 119.79
|
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v3.23.3
Stock-Based Compensation - Restricted Stock Units (Details) - Restricted stock units
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
2023 Inducement Plan |
|
Number of Shares |
|
Outstanding and Unvested, beginning balance (in shares) | shares |
0
|
Restricted stock units granted (in shares) | shares |
363,990
|
Restricted stock units vested (in shares) | shares |
0
|
Restricted stock units forfeited (in shares) | shares |
0
|
Outstanding and Unvested, ending balance (in shares) | shares |
363,990
|
Per Share Weighted- Average Fair Value |
|
Outstanding and Unvested, beginning balance (in usd per share) | $ / shares |
$ 0
|
Restricted stock units granted (in usd per share) | $ / shares |
10.66
|
Restricted stock units vested (in usd per share) | $ / shares |
0
|
Restricted stock units forfeited (in usd per share) | $ / shares |
0
|
Outstanding and Unvested, ending balance (in usd per share) | $ / shares |
$ 10.66
|
2015 Plan |
|
Number of Shares |
|
Outstanding and Unvested, beginning balance (in shares) | shares |
2,034,574
|
Restricted stock units granted (in shares) | shares |
2,888,793
|
Restricted stock units vested (in shares) | shares |
(403,672)
|
Restricted stock units forfeited (in shares) | shares |
(780,810)
|
Outstanding and Unvested, ending balance (in shares) | shares |
3,738,885
|
Per Share Weighted- Average Fair Value |
|
Outstanding and Unvested, beginning balance (in usd per share) | $ / shares |
$ 61.65
|
Restricted stock units granted (in usd per share) | $ / shares |
7.25
|
Restricted stock units vested (in usd per share) | $ / shares |
87.17
|
Restricted stock units forfeited (in usd per share) | $ / shares |
27.77
|
Outstanding and Unvested, ending balance (in usd per share) | $ / shares |
$ 23.95
|
X |
- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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v3.23.3
Income Taxes (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jan. 01, 2022 |
Income Tax Disclosure [Abstract] |
|
|
|
|
|
Capitalized amortization period |
|
|
|
|
15 years
|
Federal, state and local, income tax expense (benefit) |
$ (700,000)
|
$ 2,400,000
|
$ 300,000
|
$ 4,300,000
|
|
Foreign income tax expense (benefit) |
$ 0
|
$ 100,000
|
$ 0
|
$ 2,300,000
|
|
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v3.23.3
Commitment and Contingencies (Details) dose in Millions, $ in Millions |
Dec. 28, 2022
lawsuit
|
Dec. 12, 2022
defendant
|
Sep. 30, 2023
USD ($)
installment
payment
|
Aug. 31, 2023
USD ($)
|
Dec. 31, 2022
installment
|
Nov. 18, 2022
dose
|
Sep. 30, 2022
USD ($)
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
Number of defendants | defendant |
|
2
|
|
|
|
|
|
Period to answer |
|
14 days
|
|
|
|
|
|
Number of lawsuits filed | lawsuit |
8
|
|
|
|
|
|
|
Gavi Advance Purchase Agreement- COVAX Facility |
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
Number of doses to be distributed | dose |
|
|
|
|
|
350
|
|
Purchase agreement, number of vaccine doses | dose |
|
|
|
|
|
2
|
|
Collaboration agreement upfront payment amount |
|
|
$ 696.4
|
|
|
|
|
Settlement Agreement |
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
Settlement payment |
|
|
$ 185.0
|
$ 149.8
|
|
|
$ 185.0
|
Number of quarterly installment payments | installment |
|
|
2
|
|
4
|
|
|
Number of settlement payments | payment |
|
|
2
|
|
|
|
|
Settlement agreement, installment payment |
|
|
$ 34.3
|
|
|
|
|
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v3.23.3
Restructuring - Schedule of Impairment Charges (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Jun. 30, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Restructuring Cost and Reserve [Line Items] |
|
|
|
Severance and employee benefit costs |
|
$ 4,503
|
|
Impairment of assets |
$ 10,100
|
10,081
|
$ 0
|
Total Restructuring charge |
|
14,584
|
|
Cost of sales |
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
Total Restructuring charge |
|
500
|
|
Research and development |
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
Total Restructuring charge |
|
2,300
|
|
Selling, general, and administrative |
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
Total Restructuring charge |
|
$ 11,500
|
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