4 unchanged sentences
For the Three Months Ended
−Removed: September 30, For the Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
Product sales $ 621,678 $ 89,836
Licensing, royalties, and other 44,977 4,019
−Removed: Grants — 164,922 — 389,380
Total revenue 666,655 93,855
3 unchanged sentences
Total expenses 151,142 238,686
−Removed: Loss from operations
−Removed: ( 134,018 ) ( 125,632 ) ( 117,851 ) ( 382,943 )
+Added: Income (loss) from operations 515,513 ( 144,831 )
Other income (expense):
Interest expense ( 5,723 ) ( 4,111 )
−Removed: Other income (expense), net
−Removed: 15,922 ( 2,982 ) 27,307 26,912
−Removed: Loss before income tax expense (benefit)
−Removed: ( 122,332 ) ( 131,473 ) ( 103,034 ) ( 366,330 )
−Removed: Income tax expense (benefit) ( 1,032 ) ( 697 ) 3,435 343
+Added: Other income, net
+Added: Income (loss) before income tax expense
519,846 ( 145,288 )
−Removed: Net loss per share:
−Removed: Basic and diluted $ ( 0.76 ) $ ( 1.26 ) $ ( 0.71 ) $ ( 3.94 )
+Added: Income tax expense
+Added: Net income (loss) $ 518,646 $ ( 147,550 )
+Added: Net income (loss) per share:
+Added: Basic $ 3.22 $ ( 1.05 )
+Added: Diluted $ 2.93 $ ( 1.05 )
Weighted average number of common shares outstanding:
−Removed: Basic and diluted 160,049 103,429 149,486 93,046
−Removed: CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
+Added: Basic 161,049 139,916
+Added: Diluted 177,625 139,916
+Added: CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
For the Three Months Ended
−Removed: September 30, For the Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
−Removed: $ ( 121,300 ) $ ( 130,776 ) $ ( 106,469 ) $ ( 366,673 )
+Added: Net income (loss) $ 518,646 $ ( 147,550 )
Other comprehensive income (loss):
3 unchanged sentences
24,167 ( 13,547 )
−Removed: Comprehensive loss
−Removed: $ ( 107,194 ) $ ( 134,462 ) $ ( 105,593 ) $ ( 372,159 )
+Added: Comprehensive income (loss) $ 542,813 $ ( 161,097 )
The accompanying notes are an integral part of these financial statements.
2 unchanged sentences
(in thousands, except share and per share information)
−Removed: September 30,
2025 December 31,
26 unchanged sentences
Commitments and contingencies (Note 15)
−Removed: Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at September 30, 2024 and December 31, 2023;
−Removed: no shares issued and outstanding at September 30, 2024 and December 31, 2023
+Added: Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at March 31, 2025 and December 31, 2024;
+Added: no shares issued and outstanding at March 31, 2025 and December 31, 2024
Stockholders' deficit:
−Removed: Common stock, $ 0.01 par value, 600,000,000 shares authorized at September 30, 2024 and December 31, 2023;
−Removed: 161,558,247 shares issued and 160,148,088 shares outstanding at September 30, 2024 and 140,506,093 shares issued and 139,505,770 shares outstanding at December 31, 2023
+Added: Common stock, $ 0.01 par value, 600,000,000 shares authorized at March 31, 2025 and December 31, 2024;
+Added: 164,206,386 shares issued and 161,957,868 shares outstanding at March 31, 2025 and 161,942,677 shares issued and 160,421,136 shares outstanding at December 31, 2024
Additional paid-in capital 4,512,849 4,501,403
Accumulated deficit ( 4,489,804 ) ( 5,008,450 )
−Removed: Treasury stock, cost basis, 1,410,159 shares at September 30, 2024 and 1,000,323 shares at December 31, 2023
+Added: Treasury stock, cost basis, 2,248,518 shares at March 31, 2025 and 1,521,541 shares at December 31, 2024
( 101,938 ) ( 95,854 )
Accumulated other comprehensive income
+Added: 1,608 ( 22,559 )
Total stockholders’ deficit ( 75,643 ) ( 623,841 )
3 unchanged sentences
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT
−Removed: Three and Nine Months Ended September 30, 2024 and 2023
+Added: Three Months Ended March 31, 2025 and 2024
(in thousands, except share information)
7 unchanged sentences
Shares Amount
−Removed: Balance at June 30, 2024 161,267,120 $ 1,613 $ 4,477,748 $ ( 4,806,120 ) $ ( 94,439 ) $ ( 10,508 ) $ ( 431,706 )
−Removed: Stock-based compensation — — 12,049 — — — 12,049
−Removed: Stock issued under incentive programs 291,127 3 833 — ( 421 ) — 415
−Removed: Unrealized gain on available-for-sale marketable securities
−Removed: — — — — — 393 393
−Removed: Foreign currency translation adjustment — — — — 13,713 13,713
−Removed: — — — ( 121,300 ) — — ( 121,300 )
−Removed: Balance at September 30, 2024 161,558,247 $ 1,616 $ 4,490,630 $ ( 4,927,420 ) $ ( 94,860 ) $ 3,598 $ ( 526,436 )
−Removed: Balance at June 30, 2023 95,183,750 $ 952 $ 3,855,916 $ ( 4,511,786 ) $ ( 91,424 ) $ ( 8,177 ) $ ( 754,519 )
−Removed: Stock-based compensation — — 21,254 — — — 21,254
−Removed: Stock issued under incentive programs 176,329 2 634 — ( 282 ) — 354
−Removed: Issuance of common stock, net of issuance costs of $ 3,063
−Removed: 24,281,588 242 188,781 — — — 189,023
−Removed: Foreign currency translation adjustment — — — — — ( 3,686 ) ( 3,686 )
−Removed: — — — ( 130,776 ) — — ( 130,776 )
−Removed: Balance at September 30, 2023 119,641,667 $ 1,196 $ 4,066,585 $ ( 4,642,562 ) $ ( 91,706 ) $ ( 11,863 ) $ ( 678,350 )
−Removed: Common Stock Additional
−Removed: Capital Accumulated
−Removed: Deficit Treasury
−Removed: Stock Accumulated Other
−Removed: Comprehensive
−Removed: Income (Loss) Total Stockholders'
−Removed: Shares Amount
Balance at December 31, 2024 161,942,677 $ 1,619 $ 4,501,403 $ ( 5,008,450 ) $ ( 95,854 ) $ ( 22,559 ) $ ( 623,841 )
1 unchanged sentence
Stock issued under incentive programs 2,263,709 23 1,161 — ( 6,084 ) — ( 4,900 )
−Removed: Issuance of common stock, net of issuance costs of $ 3,830
−Removed: 19,093,397 191 256,218 — — — 256,409
Unrealized gain on available-for-sale marketable securities
1 unchanged sentence
Foreign currency translation adjustment — — — — — 23,578 23,578
−Removed: — — — ( 106,469 ) — — ( 106,469 )
−Removed: Balance at September 30, 2024 161,558,247 $ 1,616 $ 4,490,630 $ ( 4,927,420 ) $ ( 94,860 ) $ 3,598 $ ( 526,436 )
+Added: Net income — — — 518,646 — — 518,646
+Added: Balance at March 31, 2025 164,206,386 $ 1,642 $ 4,512,849 $ ( 4,489,804 ) $ ( 101,938 ) $ 1,608 $ ( 75,643 )
Balance at December 31, 2023 140,506,093 $ 1,405 $ 4,192,164 $ ( 4,820,951 ) $ ( 92,267 ) $ 2,722 $ ( 716,927 )
1 unchanged sentence
Stock issued under incentive programs 1,194,879 12 1,055 — ( 1,683 ) — ( 616 )
−Removed: Issuance of common stock, net of issuance costs of $ 3,924
−Removed: 32,229,542 322 256,673 — — — 256,995
Foreign currency translation adjustment — — — — — ( 13,547 ) ( 13,547 )
−Removed: Net loss — — — ( 366,673 ) — — ( 366,673 )
−Removed: Balance at September 30, 2023 119,641,667 $ 1,196 $ 4,066,585 $ ( 4,642,562 ) $ ( 91,706 ) $ ( 11,863 ) $ ( 678,350 )
+Added: — — — ( 147,550 ) — — ( 147,550 )
+Added: Balance at March 31, 2024 141,700,972 $ 1,417 $ 4,204,775 $ ( 4,968,501 ) $ ( 93,950 ) $ ( 10,825 ) $ ( 867,084 )
The accompanying notes are an integral part of these financial statements.
1 unchanged sentence
CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: (in thousands)(unaudited)
−Removed: Nine Months Ended September 30,
+Added: (in thousands)
+Added: Three Months Ended March 31,
Operating Activities:
−Removed: $ ( 106,469 ) $ ( 366,673 )
+Added: Net income (loss) $ 518,646 $ ( 147,550 )
Reconciliation of net loss to net cash used in operating activities:
9 unchanged sentences
Deferred revenue ( 603,995 ) ( 6,147 )
−Removed: Net cash provided by (used in) operating activities
−Removed: 85,900 ( 537,186 )
+Added: Net cash used in operating activities ( 185,502 ) ( 83,555 )
Investing Activities:
9 unchanged sentences
Finance lease payments ( 2,201 ) ( 360 )
−Removed: Repayment of 2023 Convertible notes — ( 325,000 )
−Removed: Payments of costs related to issuance of 2027 Convertible notes — ( 3,591 )
Net cash provided by (used in) financing activities ( 7,061 ) 5,886
Effect of exchange rate on cash, cash equivalents, and restricted cash ( 930 ) ( 2,955 )
−Removed: Net increase (decrease) in cash, cash equivalents, and restricted cash 4,777 ( 682,482 )
+Added: Net decrease in cash, cash equivalents, and restricted cash ( 266,812 ) ( 87,874 )
Cash, cash equivalents, and restricted cash at beginning of period 545,292 583,810
1 unchanged sentence
Supplemental disclosure of non-cash activities:
−Removed: Right-of-use asset leases, net of tenant improvement allowance on facility leases
−Removed: $ ( 4,302 ) $ 96,492
Capital expenditures included in accounts payable and accrued expenses $ — $ 1,208
3 unchanged sentences
Cash paid for income taxes, net of refunds
+Added: $ 1,499 $ ( 71 )
The accompanying notes are an integral part of these financial statements.
1 unchanged sentence
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: September 30, 2024
+Added: March 31, 2025
Note 1 – Organization and Business
Novavax, Inc.
−Removed: (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is a global company focused on driving value via its proven technology platform, which includes a combination of a recombinant protein approach, innovative nanoparticle technology, and patented Matrix-M™ adjuvant, through partnerships and research and development.
−Removed: The Company continues to evolve its operating model to leverage four key drivers of value:
−Removed: a partnership with Sanofi Pasteur Inc.
−Removed: (“Sanofi”) announced in May 2024, a late-stage pipeline focuses on its COVID-19-Influenza Combination (“CIC”) and stand-alone influenza vaccine candidates, leveraging its proven technology platform to drive additional partnerships and deals, and its emerging early-stage pipeline.
−Removed: In May 2024, Novavax entered into a collaboration and licensing agreement (the “Sanofi CLA”) with Sanofi.
−Removed: The agreement includes a co-exclusive license to co-commercialize Novavax’s COVID-19 vaccine following the end of the 2024-2025 vaccination season, a sole license to Novavax’s COVID-19 vaccine for use in combination with Sanofi’s influenza vaccines, a non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include the Company's Matrix-M TM adjuvant in vaccine products (See Note 6).
−Removed: Novavax’s program includes the Company’s prototype COVID-19 vaccine (“NVX-CoV2373,” or “prototype vaccine”), the Company’s XBB COVID-19 vaccine (“NVX-CoV2601”), and the Company’s updated vaccine for the 2024-2025 vaccination season (“NVX-CoV2705” or “updated vaccine” and, collectively with NVX-CoV2373 and NVX-CoV2601, the Company’s “COVID-19 Vaccine” or “COVID-19 Program”).
−Removed: Local regulatory authorities have also specified nomenclature for the labeling of NVX-CoV2373 and NVX-CoV2601 within their territories (e.g., “Novavax COVID-19 Vaccine, Adjuvanted”, “Novavax COVID-19, Adjuvanted (2023-2024 Formula),” respectively, for the U.S., and “Nuvaxovid™” for ex-US territories).
−Removed: Currently, the Company significantly depends on its supply agreement with Serum Institute of India Pvt.
−Removed: (“SII”) and its subsidiary, Serum Life Sciences Limited (“SLS” and together with SII, “Serum”), for co-formulation, filling, and finishing.
+Added: (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is tackling global health challenges through scientific innovation that seeks to maximize its deep scientific expertise in vaccines and cutting-edge technology platform.
+Added: The differentiated platform features the Company’s recombinant protein-based nanoparticle technology and its unique Matrix-M ® adjuvant.
+Added: The Company’s corporate growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development (“R&D”) innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations .
+Added: The Company’s three strategic priorities are:
+Added: focusing on its partnership with Sanofi Pasteur Inc.
+Added: ("Sanofi”) announced in May 2024, leveraging its technology platform and pipeline to forge additional partnerships, and advancing its proven technology platform and early-stage pipeline.
+Added: The Company’s corporate growth strategy is supported by a lean and focused operating model.
+Added: Novavax’s prototype COVID-19 vaccine (“NVX-CoV2373,” or “prototype vaccine”), the Company’s XBB COVID-19 vaccine (“NVX-CoV2601”), and the Company’s Nuvaxovid™ JN.1 COVID-19 vaccine (“NVX-CoV2705” or “updated vaccine”) are collectively referred to as the Company’s “COVID-19 vaccine.” Local regulatory authorities have also specified nomenclature for the labeling of NVX-CoV2373, NVX-CoV2601 and NVX-CoV2705 within their territories (e.g., “Novavax COVID-19 Vaccine, Adjuvanted”, “Novavax COVID-19, Adjuvanted (2023-2024 or 2024-2025 Formula),” respectively, for the U.S., and “Nuvaxovid™” for ex-U.S.
+Added: territories).
+Added: The Company’s partner, Serum Institute of India Pvt.
+Added: (“SII”), markets Novavax’s COVID-19 vaccine as “Covovax™.”
+Added: Currently, the Company significantly depends on its supply agreement with SII and its subsidiary, Serum Life Sciences Limited (“SLS” and together with SII, “Serum”), for co-formulation, filling, and finishing.
Note 2 – Summary of Significant Accounting Policies
2 unchanged sentences
GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X.
−Removed: The accompanying unaudited consolidated financial statements 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.
+Added: The accompanying unaudited consolidated financial statements include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, operating results, comprehensive income (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.
3 unchanged sentences
All intercompany accounts and transactions have been eliminated in consolidation.
−Removed: The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $ 1.2 million loss and a $ 7.9 million loss, and a $ 12.2 million loss and $ 3.9 million gain for the three and nine months ended September 30, 2024 and 2023, respectively, which are reflected in Other income (expense), net.
+Added: The aggregate foreign currency transaction losses resulting from the conversion of the transaction currency to functional currency were $ 12.6 million and $ 5.1 million for the three months ended March 31, 2025 and 2024, respectively, which are reflected in Other income (expense), net.
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, 2024.
1 unchanged sentence
The Company operates in one business segment.
+Added: Reclassifications
+Added: Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation.
+Added: These reclassifications have no material effect on previously reported financial position and cash flows.
+Added: The Company reclassified $ 7.5 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the three months ended March 31, 2024 related to adjuvant supply sales and other supply sales.
+Added: This presentation aligns with the Company’s enhanced focus on supply sales to partners.
Liquidity and Going Concern
1 unchanged sentence
The accompanying unaudited consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainty described below.
−Removed: As of September 30, 2024, the Company had $ 573.6 million in cash and cash equivalents, $ 335.9 million in marketable securities, and negative working capital of $ 77.3 million.
−Removed: During the nine months ended September 30, 2024, the Company recognized net loss of $ 106.5 million, and had net cash flows provided by operating activities of $ 85.9 million.
+Added: As of March 31, 2025, the Company had $ 263.3 million in cash and cash equivalents, $ 468.1 million in marketable securities, and working capital of $ 445.9 million.
+Added: During the three months ended March 31, 2025, the Company recognized net income of $ 518.6 million, and had net cash flows used in operating activities of $ 185.5 million.
In accordance with Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern, the Company evaluated its ability to continue as a going concern within one year after the date that the accompanying unaudited consolidated financial statements are issued.
Based on the Company’s current cash, cash equivalents and marketable securities balances and the Company's current cash flow forecast for the one-year going concern look forward period, the Company has concluded that it expects to have sufficient capital available to fund its operations for the one-year period from the date that these financial statements are issued.
−Removed: As of December 31, 2023, the Company had concluded that there was substantial doubt about its ability to continue as a going concern primarily due to significant uncertainty related to its ability to successfully develop, manufacture, distribute, and market its updated vaccine and execute on certain cost-reduction initiatives as described in Note 15.
−Removed: The Sanofi CLA combined with cost reductions and the settlement of certain liabilities, has alleviated the substantial doubt.
−Removed: Revenue Recognition, Licensing and Transition Services
−Removed: The terms of the Company’s third-party licensing agreements may contain multiple performance obligations, including licenses and transition services.
−Removed: The Company evaluates licensing agreements under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) to determine the distinct performance obligations.
−Removed: Prior to recognizing revenue, the Company estimates the transaction price, including variable consideration that is subject to a constraint.
−Removed: Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: Total consideration may include nonrefundable upfront license fees, transition service fees, other payments based upon the achievement of specified milestones, and royalty payments based on product sales from licensed products.
−Removed: For multiple performance obligation arrangements, the Company allocates the transaction price to each distinct performance obligation based on its relative stand-alone selling price.
−Removed: The stand-alone selling price is generally determined for each performance obligation based on the prices charged to customers, discounted cash flows, or using expected cost-plus margin.
−Removed: For stand-alone selling prices determined using discounted cash flows, the Company considers discounted, probability-weighted cash flows related to the performance obligation transferred.
−Removed: In developing such estimates, the Company applies judgment in determining the forecasted revenue, expected margins, and the discount rate.
−Removed: These estimates are subjective and require the Company to make assumptions about future cash flows.
−Removed: Revenue related to performance obligations satisfied at a point in time is recognized when the customer obtains control of the promised asset.
−Removed: For performance obligations recognized over time, the Company recognizes revenue using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.
−Removed: Under this process, the Company considers the costs that have been incurred to-date, as well as projections to completion using various inputs and assumptions, including, but not limited to, progress towards completion, labor costs and level of effort, material and subcontractor costs, and indirect administrative costs.
−Removed: Estimating the total cost at completion of the Company’s performance obligation under a contract is subjective and requires the Company to make assumptions about future activity and cost drivers.
−Removed: Changes in these estimates can occur for a variety of reasons and may impact the timing of revenue recognition on the Company’s contracts.
−Removed: Changes in estimates related to the process are recognized in the period when such changes are made on a cumulative catch-up basis.
−Removed: The Company has not experienced any material adjustments as a result of changes in estimates arising from this process.
Use of Estimates
6 unchanged sentences
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.
−Removed: Ongoing benefits are expensed when restructuring activities are probable and the benefit estimable.
+Added: Ongoing benefits are expensed when restructuring activities are probable and the benefit is estimable.
See Note 16 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 as defined in Note 16.
1 unchanged sentence
Not Yet Adopted
−Removed: In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06, Disclosure Improvements (“ASU 2023-06”), to clarify or improve disclosure and presentation requirements of a variety of topics and align the requirements in the FASB ASC with the SEC's regulations.
−Removed: The ASU is effective for the Company’s annual period ended December 31, 2024 and interim periods thereafter.
−Removed: The Company is currently evaluating ASU 2023-06 to determine its impact on the Company’s consolidated financial statements and disclosures.
−Removed: In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures (“ASU 2023-07”) which expands disclosures for reportable segments made by public entities and requires more detailed information about expenses within each reportable segment.
−Removed: Entities with a single reportable segment are required to provide on both an interim and annual basis, all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07.
−Removed: The amendments do not change the existing guidance on how a public entity identifies and determines its reportable segments.
−Removed: The ASU is effective for the Company’s annual period ended December 31, 2024 and interim periods thereafter.
−Removed: The Company is currently evaluating ASU 2023-07 to determine its impact on the Company's disclosures.
+Added: In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”).
+Added: The ASU includes enhanced disclosure requirements, which mandate transparency in financial statements by requiring detailed disclosures of specific expenses like inventory purchases, employee compensation, depreciation, and intangible asset amortization.
+Added: In January 2025, the FASB issued ASU 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) An Amendment of the FASB Accounting Standards Codification, Clarifying the Effective Date, which clarifies that public business entities are required to adopt the ASU 2024-03 guidance in annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of adopting this pronouncement on the Company’s consolidated financial statements and disclosures.
+Added: In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements (“ASU 2023-06”), to clarify or improve disclosure and presentation requirements of a variety of topics and align the requirements in the FASB ASC with the SEC's
+Added: The effective date for each amendment in the ASU is the effective date that the SEC removes the disclosure requirement from its regulations.
+Added: The Company is currently evaluating ASU 2023-06, however, as the ASU codifies SEC regulations, the Company does not anticipate that its implementation will have a material effect on the Company's consolidated financial statements and disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”).
1 unchanged sentence
The ASU also requires disaggregated disclosure related to pre-tax income (or loss) and income tax expense (or benefit) and eliminates certain disclosures related to the balance of an entity’s unrecognized tax benefit and the cumulative amount of certain temporary differences.
−Removed: The ASU is effective for the Company beginning on January 1, 2025.
−Removed: The Company is currently evaluating ASU 2023-09 to determine its impact on the Company's disclosures.
+Added: ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024.
+Added: The Company is completing its evaluation of the impact of ASU 2023-09 on its disclosures.
Note 3 – Marketable Securities
−Removed: Marketable securities were classified as available-for-sale as of September 30, 2024 and comprised of (in thousands):
−Removed: September 30, 2024 December 31, 2023
+Added: Marketable securities were classified as available-for-sale as of March 31, 2025 and December 31, 2024, comprised of (in thousands):
+Added: March 31, 2025 December 31, 2024
Losses Fair Value Amortized
Losses Fair Value
+Added: Treasury securities $ 184,544 $ 581 $ — $ 185,125 $ 184,438 $ 116 $ — $ 184,554
Corporate debt securities 282,968 48 — 283,016 208,410 — ( 76 ) 208,334
Total marketable securities $ 467,512 $ 629 $ — $ 468,141 $ 392,848 $ 116 $ ( 76 ) $ 392,888
−Removed: As of September 30, 2024, investments in marketable securities, comprised of corporate debt securities, were due to mature within one year.
−Removed: Based on the Company’s policy under the expected credit loss model, including an assessment of the investment portfolio as of September 30, 2024, the Company concluded that its marketable securities were not attributable to credit and therefore an allowance for credit losses has not been recorded as of September 30, 2024.
−Removed: As of September 30, 2024, the Company held no securities that were in an unrealized loss position for more than 12 months.
+Added: As of March 31, 2025, investments in marketable securities were comprised of $ 185.1 million of treasury securities, of which $ 64.0 million mature in 2025 and $ 121.1 million mature in 2026, and $ 283.0 million of corporate debt securities, of which $ 273.6 million mature in 2025 and $ 9.4 million mature in 2026.
+Added: As of December 31, 2024, investments in marketable securities comprised of $ 184.6 million of treasury securities, of which $ 23.0 million mature in 2025 and $ 161.5 million mature in 2026, and $ 208.3 million of corporate debt securities, of which $ 195.2 million mature in 2025 and $ 13.1 million mature in 2026.
+Added: Marketable securities are classified as Current assets in the Consolidated balance sheet of the Company as of March 31, 2025, and December 31, 2024.
+Added: Based on the Company’s policy under the expected credit loss model, including an assessment of the investment portfolio as of March 31, 2025 and December 31, 2024, the Company concluded that any unrealized losses for its marketable securities were not attributable to credit and therefore an allowance for credit losses has not been recorded.
+Added: As of March 31, 2025 and December 31, 2024, the Company held no securities that were in an unrealized loss position for more than 12 months.
Note 4– Fair Value Measurements
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities (in thousands):
−Removed: Fair Value at September 30, 2024 Fair Value at December 31, 2023
+Added: Fair Value at March 31, 2025 Fair Value at December 31, 2024
Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
11 unchanged sentences
$ — $ 163,918 $ — $ — $ 174,386 $ —
−Removed: (1) Classified as cash and cash equivalents as of September 30, 2024 and December 31, 2023, respectively, on the consolidated balance sheets.
−Removed: (2) Includes $ 124.2 million classified as Cash and cash equivalents and $ 335.9 million classified as marketable securities as of September 30, 2024, on the consolidated balance sheets.
+Added: (1) Classified as cash and cash equivalents as of March 31, 2025 and December 31, 2024, respectively, on the consolidated balance sheets.
+Added: (2) Includes $ 34.8 million classified as Cash and cash equivalents as of December 31, 2024, 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.
−Removed: During the nine months ended September 30, 2024 and 2023, the Company did not have any transfers between levels.
+Added: During the three months ended March 31, 2025 and 2024, 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 5 – Revenue
−Removed: The Company's accounts receivable included $ 88.8 million and $ 286.4 million related to amounts that were billed to customers and $ 6.2 million and $ 10.8 million related to amounts which had not yet been billed to customers as of September 30, 2024 and December 31, 2023, respectively.
−Removed: During the nine months ended September 30, 2024 and 2023, changes in the Company’s accounts receivables, allowance for credit losses, and deferred revenue balances were as follows (in thousands):
+Added: The Company's accounts receivable included $ 38.4 million and $ 102.9 million related to amounts that were billed to customers and $ 6.1 million and $ 5.4 million related to amounts which had not yet been billed to customers as of March 31, 2025 and December 31, 2024, respectively.
+Added: During the three months ended March 31, 2025 and 2024, changes in the Company’s accounts receivables, allowance for credit losses, and deferred revenue balances were as follows (in thousands):
Balance, Beginning of Period Additions Deductions Balance, End of Period
Accounts receivable:
−Removed: Nine Months Ended September 30, 2024 $ 304,916 $ 882,979 $ ( 1,085,258 ) $ 102,637
−Removed: Nine Months Ended September 30, 2023 96,210 981,305 ( 946,182 ) 131,333
+Added: Three Months Ended March 31, 2025 $ 115,960 $ 123,785 $ ( 187,560 ) $ 52,185
+Added: Three Months Ended March 31, 2024 304,916 136,510 ( 412,370 ) 29,056
Allowance for credit losses (1) :
−Removed: Nine Months Ended September 30, 2024 $ ( 7,675 ) $ — $ — $ ( 7,675 )
−Removed: Nine Months Ended September 30, 2023 ( 13,835 ) — 6,160 ( 7,675 )
+Added: Three Months Ended March 31, 2025 ( 7,675 ) — — ( 7,675 )
+Added: Three Months Ended March 31, 2024 ( 7,675 ) — — ( 7,675 )
Deferred revenue:
−Removed: Nine Months Ended September 30, 2024 $ 863,520 $ 363,758 $ ( 98,490 ) $ 1,128,788
−Removed: Nine Months Ended September 30, 2023 549,551 422,766 ( 171,288 ) 801,029
−Removed: (1) There was no allowance for credit losses recorded during the nine months ended September 30, 2024 or 2023.
−Removed: During the nine months ended September 30, 2023, there was a $ 6.2 million reversal of a credit loss allowance due to the collection of a previously recognized allowance for credit losses.
+Added: Three Months Ended March 31, 2025 1,121,886 — ( 603,995 ) 517,891
+Added: Three Months Ended March 31, 2024 863,521 225,000 ( 6,148 ) 1,082,373
+Added: (1) There was no allowance for credit losses recorded during the three months ended March 31, 2025 or 2024.
To estimate the allowance for credit losses, 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.
−Removed: During the nine months ended September 30, 2024, deductions included a $ 33.5 million reclassification of refundable upfront payments previously included in Deferred revenue to Other current liabilities.
−Removed: During the nine months ended September 30, 2024, additions included a $ 225.0 million reclassification of an upfront payment from Other current liabilities to Deferred revenue related to the settlement with Gavi as discussed below.
−Removed: During the 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.
−Removed: As of September 30, 2024, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties and constrained variable consideration, was $ 1.3 billion, of which $ 1.1 billion was included in Deferred revenue.
+Added: During the three months ended March 31, 2025, deductions include $ 555.7 million related to the Canada APA termination, discussed below.
+Added: During the three months ended March 31, 2024, additions included a $ 225.0 million reclassification of an upfront payment from Other current liabilities to Deferred revenue related to the settlement with Gavi as discussed below.
+Added: As of March 31, 2025, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties and constrained variable consideration, was $ 0.6 billion, of which $ 0.5 billion was included in Deferred revenue.
Failure to meet regulatory milestones, obtain timely 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 could adversely impact the Company’s ability to realize revenue from its unsatisfied performance obligations.
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 under certain of the Company’s APAs.
+Added: In the first quarter of 2025, the Company received written notice of a $ 23.0 million claim related to certain performance obligations under an APA agreement with a customer.
+Added: The Company believes it has fulfilled the requirements related to this matter and is evaluating the merits of the claim.
The timing to fulfill performance obligations related to the Sanofi CLA will depend on the timing of delivery of Sanofi Transition Services and Sanofi Technology Transfer services and delivery of doses and other materials based on Sanofi demand.
−Removed: Under an APA with Gavi, the Vaccine Alliance (“Gavi”), entered into in May 2021 (the “Gavi APA”), the Company received upfront payments of $ 700 million from Gavi (the “Advance Payment Amount”) to be applied against purchases of the Company’s prototype vaccine by certain countries participating in the COVAX Facility.
−Removed: As of December 31, 2023, the remaining Gavi Advance Payment Amount was $ 696.4 million.
−Removed: In February 2024, the Company entered into a Termination and Settlement Agreement with Gavi (the “Gavi Settlement Agreement”) terminating the Gavi APA, settling the arbitration proceedings, and releasing both parties of all claims arising from, under, or otherwise in connection with the Gavi APA.
−Removed: In February 2024, the claims and counterclaims were dismissed with prejudice.
−Removed: Pursuant to the Gavi Settlement Agreement, the Company is responsible for payment to Gavi of (i) an initial settlement payment of $ 75 million, which the Company paid in February 2024, and (ii) deferred payments, in equal annual amounts of $ 80 million payable each calendar year through a
−Removed: deferred payment term ending December 31, 2028.
+Added: Under an APA with Gavi, the Vaccine Alliance (“Gavi”), entered into in May 2021 (the “Gavi APA”), and a Termination and Settlement Agreement with Gavi, entered into in February 2024, (the “Gavi Settlement Agreement”) terminating the Gavi APA, the Company is responsible for deferred payments, in equal annual amounts of $ 80 million payable each calendar year through a deferred payment term ending December 31, 2028.
The deferred payments are due in variable quarterly installments and total $ 400 million during the deferred payment term.
4 unchanged sentences
In total, the Gavi settlement agreement is comprised of $ 700 million of potential consideration, consisting of the $ 75 million initial settlement payment, deferred payments of up to $ 400 million that may be reduced through annual vaccine credits, and the additional credit of up to $ 225 million that may be applied for certain qualifying sales.
−Removed: The Company recorded the $ 3.6 million difference between the refund liability recorded as of December 31, 2023 of $ 696.4 million and the $ 700 million of total consideration under the arrangement as a reduction to revenue during the nine months ended September 30, 2024.
−Removed: As of September 30, 2024, the remaining amounts included on the Company’s consolidated balance sheet were $ 225 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $ 95.0 million in Other current liabilities, and $ 290.0 million in Other non-current liabilities.
+Added: As of March 31, 2025, the remaining amounts included on the Company’s consolidated balance sheet were $ 225 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $ 80.0 million in Other current liabilities, and $ 240.0 million in Other non-current liabilities.
In addition, the Company and Gavi entered into a security agreement pursuant to which Novavax granted Gavi a security interest in accounts receivable from SII under the SII R21 Agreement (see Note 6), which will continue for the deferred payment term of the Gavi Settlement Agreement.
Product Sales
−Removed: Product sales by the Company’s customer’s geographic location was as follows (in thousands):
+Added: During the three months ended March 31, 2025 and 2024, the categories of product sales were as follows (in thousands):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
+Added: Product sales
+Added: Nuvaxovid™ sales (1)
$ 608,025 $ 82,324
−Removed: North America
+Added: Supply sales (2)
+Added: Total product sales $ 621,678 $ 89,836
+Added: (1) Nuvaxovid™ sales are sales of our COVID-19 vaccine associated with APAs with governments and commercial markets, where we are the commercial lead for sales and distribution, made through pharmaceutical wholesale distributors.
+Added: (2) Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and other material sales to the Company’s partners.
+Added: As of March 31, 2025 and 2024, changes in the Company’s gross-to-net deductions balances were as follows (in thousands):
+Added: Wholesale Distributor Fees, Discounts, and Chargebacks
+Added: Product Returns
+Added: Balance as of December 31, 2024 $ 21,136 $ 116,697 $ 137,833
+Added: Amounts charged against product sales (1)
16,572 38,999 55,571
−Removed: Europe 1,167 — 91,753 59,322
−Removed: Rest of the world
+Added: Credits/deductions
( 30,131 ) ( 84,783 ) ( 114,914 )
−Removed: Total product sales revenue $ 38,210 $ 2,231 $ 140,438 $ 279,937
−Removed: Product sales in the U.S.
−Removed: are primarily made through large pharmaceutical wholesale distributors at the wholesale acquisition cost (“WAC”).
−Removed: Product sales in the U.S.
−Removed: are recorded net of gross-to-net deductions.
−Removed: As of September 30, 2024, changes in the Company’s gross-to-net deductions balances were as follows (in thousands):
+Added: Balance as of March 31, 2025 $ 7,577 $ 70,913 $ 78,490
Wholesale Distributor Fees, Discounts, and Chargebacks
1 unchanged sentence
Balance as of December 31, 2023 $ 21,072 $ 84,616 $ 105,688
−Removed: $ 21,072 $ 84,616 $ 105,688
Amounts charged against product sales (1)
2 unchanged sentences
( 26,979 ) ( 10,999 ) ( 37,978 )
−Removed: Balance as of September 30, 2024
−Removed: $ 24,581 $ 78,272 $ 102,853
−Removed: (1) Amounts charged against product sales include $ 4.2 million of net adjustments made to prior period product sales, due primarily to $ 8.1 million of previously estimated product returns, which are no longer eligible for customer credits and therefore were recognized in product revenue during the nine months ended September 30, 2024, offset by increases to other gross-to-net deductions.
−Removed: As of September 30, 2024 and December 31, 2023, $ 3.4 million and $ 2.6 million of gross-to-net deductions were
−Removed: included in Accounts receivable, respectively.
−Removed: As of September 30, 2024 and December 31, 2023, $ 99.5 million and $ 103.1 million of gross-to-net deductions were included in Accrued expenses, respectively.
+Added: Balance as of March 31, 2024 $ 10,169 $ 92,913 $ 103,082
+Added: (1) For the three months ended March 31, 2025 and 2024, amounts charged against product sales include $ 1.5 million and $ 3.4 million of adjustments made to prior period product sales due primarily to changes in the estimate of product returns.
+Added: As of March 31, 2025, $ 50.4 million of gross-to-net deductions were included in Accrued expenses, $ 4.9 million were included in Accounts payable, and $ 23.2 million were included in and reduced Accounts receivable on the consolidated balance sheet.
+Added: As of December 31, 2024, $ 77.1 million of gross-to-net deductions were included in Accrued expenses, $ 10.1 million were included Accounts payable, and $ 50.6 million were included in and reduced Accounts receivable on the consolidated balance sheet.
The Company has an APA with the Commonwealth of Australia (“Australia”) for the purchase of doses of COVID-19 Vaccine (the “Australia APA”).
−Removed: In March 2024, the Company and Australia agreed to cancel the COVID-19 Vaccine doses previously scheduled for delivery in the fourth quarter of 2023.
−Removed: As a result of the cancellation, the total contract value was reduced by $ 54.0 million, including $ 6.0 million of deferred revenue related to the cancelled doses that will be applied as a credit towards future deliveries of doses.
−Removed: Australia is not required to purchase updated vaccine doses until the Company receives authorization from Therapeutic Goods Administration (“TGA”).
−Removed: The Company does not expect approval in time for product delivery in 2024 which could result in a loss or deferral of approximately $ 240 million of contract value.
−Removed: The Company plans to seek an amendment to the Australia APA which may not be achievable on acceptable terms or at all.
−Removed: As of September 30, 2024, $ 119.1 million was classified as current Deferred revenue and $ 14.7 million was classified as non-current Deferred revenue with respect to the Australia APA in the Company’s consolidated balance sheet.
−Removed: If the Company is unable to satisfy its obligations under the amended Australia APA, $ 92.5 million of deferred revenue may become refundable and approximately $ 225 million of remaining funds under the contract may no longer be available.
−Removed: The Company has 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”).
−Removed: The Canadian government may terminate the Canada APA, as amended, if the Company fails to receive regulatory approval for its COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre (“BMC”) Inc.
−Removed: on or before December 31, 2024 .
−Removed: The Company does not expect to receive regulatory approval of its COVID-19 Vaccine using bulk antigen produced at BMC on or before December 31, 2024 .
−Removed: Therefore, the Company plans to seek an amendment to the Canada APA to address possible alternatives, which may not be achievable on acceptable terms or at all.
−Removed: As of September 30, 2024, $ 452.1 million was classified as current Deferred revenue and $ 136.1 million was classified as non-current Deferred revenue with respect to the Canadian APA in the Company’s consolidated balance sheet.
−Removed: If the Canadian government terminates the Canada APA, $ 28.0 million of the deferred revenue would become refundable and approximately $ 224 million of the contract value related to future deliverables would no longer be available.
−Removed: In July 2024, the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, provided notice of its termination of its APA (the “New Zealand APA”).
−Removed: Pharmac has requested a refund of certain advanced payments, and the Company is in discussion with Pharmac regarding whether a refund of the advanced payments is appropriate under the New Zealand APA.
−Removed: As of September 30, 2024, $ 31.3 million was reclassified from current Deferred revenue to Other current liabilities in the Company’s consolidated balance sheet.
−Removed: Approximately $ 125 million of the contract value related to future deliverables may no longer be available if the New Zealand APA is terminated.
−Removed: The Company responded to Pharmac in September 2024 indicating it does not believe Pharmac has the right to unilaterally terminate the contract or receive a refund of any part of the remaining upfront payment.
+Added: As of March 31, 2025, $ 31.2 million was classified as current Deferred revenue and $ 102.6 million was classified as non-current Deferred revenue with respect to the Australia APA in the Company’s consolidated
+Added: balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
+Added: In the event that the Company does not, on or before the relevant contractual deadlines, receive regulatory approval for, and deliver, the seasonally updated COVID-19 vaccine, up to $ 92.5 million of deferred revenue may become refundable.
+Added: Specifically, Australia may cancel doses that are due to be delivered in 2025 if the Company does not receive regulatory approval for, and deliver, the updated COVID-19 vaccine on or before December 31, 2025, and may terminate the Australian APA, as amended, if the Company does not receive regulatory approval for, and deliver, the updated COVID-19 vaccine on or before March 31, 2026.
+Added: The Company had 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”).
+Added: In March 2025, the Company received a communication (the “Notice”) terminating, with immediate effect, the Canada APA on the basis of the Company not receiving regulatory approval for its COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre Inc.
+Added: on or before December 31, 2024, pursuant to the terms of the Canada APA.
+Added: As a result of the Notice, the Company has no remaining obligations to the Canadian government under the Canada APA.
+Added: Therefore, during the three months ended March 31, 2025, t he Company recognized $ 575.7 million , previously recorded in deferred revenue and other current liabilities, as product sales.
+Added: As of December 31, 2024 , the Company had $ 555.7 million of current deferred revenue and $ 48.0 million of other current liabilities related to advanced payments, and other commitments previously made under the Canada APA.
+Added: Under the terms of the Canada APA, $ 28.0 million in advanced purchase payments previously received by the Company were refundable to the Canadian government within 30 days of receipt of the Notice.
+Added: The Company repaid the $ 28.0 million in March 2025.
+Added: The APA, as amended in 2023, also contemplated the Company and the Canadian government would endeavor to enter into a memorandum of understanding (the “MOU”) related to certain in-country commitments, including a $ 20.0 million escrow funding.
+Added: The Notice also acknowledged that such MOU is no longer feasible and that the related funds may be released to the Company.
+Added: In March 2025, the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, and the Company executed a Deed of Settlement and Release (“New Zealand Settlement Agreement”) of its APA (the “New Zealand APA”).
+Added: As part of the New Zealand Settlement Agreement, the Company agreed to pay Pharmac a refund of previously received upfront payments of $ 4.0 million .
+Added: Under the New Zealand Settlement Agreement, the Company has no remaining obligation to Pharmac under the New Zealand APA.
+Added: Therefore, in the three months ended March 31, 2025, t he Company recognized $ 27.3 million , previously in other current liabilities, as product sales.
+Added: As of December 31, 2024 , the Company had $ 31.3 million included in Other current liabilities in the Company’s consolidated balance sheet related to the New Zealand APA.
Licensing, Royalties, and Other
1 unchanged sentence
royalty milestone payments;
−Removed: sales-based royalties;
−Removed: and Matrix-M™ adjuvant sales.
−Removed: During the three and nine months ended September 30, 2024, respectively, the Company recognized $ 9.9 million and $ 400.1 million in revenue related to license fees and sales-based royalties and $ 2.3 million and $ 11.9 million in revenue related to Matrix-M™ adjuvant sales, respectively.
−Removed: During the three and nine months ended September 30, 2024, the Company recognized $ 32.7 million and $ 39.4 million of transition services revenue and technology transfer revenue, respectively.
−Removed: During the three and nine months ended September 30, 2023, the Company recognized $ 13.8 million and $ 17.0 million in revenue related to Matrix-M™ adjuvant sales.
−Removed: During the three and nine months ended September 30, 2023, the Company recognized $ 6.0 million in revenue related related to sales-based royalties.
−Removed: The Company’s U.S.
−Removed: government agreement consisted 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”).
−Removed: As of December 31, 2023, the Company recognized the full $ 1.8 billion funding in revenue.
+Added: and sales-based royalties.
+Added: Licensing, royalties, and other by license partner for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
+Added: Three Months Ended March 31,
+Added: Licensing, royalties, and other
+Added: Sanofi $ 40,321 $ —
+Added: Other partners (1)
+Added: Total licensing, royalties, and other revenue $ 44,977 $ 4,019
+Added: (1) Other partners revenue includes royalties and license fees associated with agreements with other partners such as Serum, Takeda Pharmaceutical Company Limited (“Takeda”), and SK bioscience, Co., Ltd.
+Added: Sanofi licensing, royalties, and other revenue were comprised of the following (in thousands):
+Added: Three Months Ended March 31,
+Added: Sanofi licensing, royalties, and other revenue
+Added: Transition services and technology transfer:
+Added: Upfront fee amortization (1)
+Added: Milestones amortization (1)
+Added: Cost reimbursements
+Added: Total Sanofi licensing, royalties, and other revenue
+Added: (1) Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to the $ 500 million upfront payment and the $ 50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 that were deferred upon achievement and are recognized in revenue over time.
Note 6 – Collaboration, License, and Supply Agreements
−Removed: As of September 30, 2024, the Company’s material collaborations, license and supply agreements were as follows:
−Removed: The Company previously granted SII exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of its prototype vaccine, NVX-CoV2601, its updated vaccine, and its CIC vaccine candidate.
+Added: As of March 31, 2025, the Company’s material collaborations, license and supply agreements were as follows:
+Added: The Company previously granted SII exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of its prototype vaccine, NVX-CoV2601, its updated vaccine, and its COVID-19-Influenza (“CIC”) vaccine candidate.
SII agreed to purchase the Company's Matrix-M ® adjuvant and the Company granted SII a non-exclusive license to manufacture the antigen drug substance component of the Company’s COVID-19 Vaccine in SII’s licensed territory solely for use in the manufacture of COVID-19 Vaccine.
4 unchanged sentences
The Company agreed to supply SLS with all Matrix-M ® adjuvant needed to manufacture finished COVID-19 Vaccine doses.
+Added: In August 2022, the Company and SII entered into an influenza license agreement under which the Company granted SII licenses to develop, manufacture, and commercialize certain vaccine products including influenza vaccine products and influenza and coronavirus combination vaccine products (“Flu/CIC”) and is obligated for the purchase of certain raw materials under related agreements with SII.
+Added: As of March 31, 2025, the Company is conducting a clinical study for its Flu/CIC vaccine candidates with the intent of partnering these programs.
In March 2020, the Company entered into an agreement with SII that granted SII a non-exclusive license for the use of Matrix-M ® adjuvant supplied by the Company to develop, manufacture, and commercialize R21/Matrix-M ® adjuvant (“SII R21 Agreement”), a malaria vaccine created by the Jenner Institute, University of Oxford (“R21/Matrix-M ® ”).
1 unchanged sentence
Under the SII R21 Agreement, SII 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.
−Removed: Takeda Pharmaceutical Company Limited
−Removed: 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.
+Added: The Company has a collaboration and license agreement with 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.
−Removed: 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.
−Removed: In February 2023, MHLW canceled the remainder of doses under its agreement with Takeda.
−Removed: 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.
−Removed: In May 2024, the Company entered into the Sanofi CLA under which the Company granted and Sanofi received the following:
−Removed: i) A co-exclusive license to commercialize the Company’s current stand-alone COVID-19 Vaccine, including the Company’s prototype vaccine and updated vaccines, that address seasonal variants throughout the world (the “COVID-19 Vaccine Products”);
−Removed: ii) A sole license to develop and commercialize combination products containing a potential combination of the Company’s COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine (“COVID-19 and influenza Combination Products” or “CIC Products”);
−Removed: iii) A non-exclusive license to develop and commercialize combination products containing both the Company’s COVID-19 Vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID-19 Vaccine Products, CIC Products, and Other Combination Products, “Licensed COVID-19 Products”);
−Removed: iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include the Company’s Matrix-M™ adjuvant (as described below, the “Adjuvant Products”).
+Added: In May 2024, Novavax entered into a Collaboration and License Agreement with Sanofi (the “Sanofi CLA”), to co-commercialize the Company’s COVID-19 vaccine, including future updated versions that address seasonal COVID-19 variants.
+Added: Under the terms of the agreement, the Company will continue to commercialize its updated COVID-19 vaccine through the end
+Added: of the 2024-2025 vaccination season.
+Added: Beginning in 2025 and continuing during the term of the Sanofi CLA, the Company and Sanofi will commercialize the COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by the parties, under which Novavax will continue to supply certain of its existing APA customers and strategic partners, including Takeda and SII.
+Added: Upon completion of the existing APAs, the Company and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
+Added: Additionally, Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing Novavax’s COVID-19 vaccine and Sanofi’s seasonal influenza vaccine, combination products containing Novavax’s COVID-19 vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing Novavax’s Matrix-M ® adjuvant.
The Company is also responsible for performing services related to the technology transfer of its manufacturing process for the COVID-19 Vaccine Products and Matrix-M ® components to Sanofi.
1 unchanged sentence
In addition, the Company is responsible for certain research and development and medical affairs services related to the COVID-19 Vaccine.
−Removed: Under the Sanofi CLA, the Company will continue to commercialize its updated vaccine.
−Removed: Beginning in 2025 and continuing during the term of the Sanofi CLA, Sanofi and the Company will commercialize the COVID-19 Vaccine Products worldwide in accordance with a commercialization plan agreed by the Company and Sanofi, under which the Company will continue to supply its existing APA customers and strategic partners, including Takeda and SII.
−Removed: Upon completion of the existing APAs, the Company and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
−Removed: Pursuant to the Sanofi CLA, the Company received a non-refundable upfront payment of $ 500 million in the second quarter of 2024.
−Removed: In addition, the Company is eligible to receive development, technology transfer, launch, and sales milestone payments totaling up to $ 700 million in the aggregate with respect to the COVID-19 Vaccine Products and royalty payments on Sanofi’s sales of such licensed products.
−Removed: Milestone payments are comprised of a payment of $ 175 million upon the approval of the marketing authorization for a COVID-19 Vaccine Product in a pre-filled syringe from the U.S.
+Added: Pursuant to the Sanofi CLA, the Company is eligible to receive development, technology transfer, launch, and sales milestone payments totaling up to $ 700 million in the aggregate with respect to the COVID-19 Vaccine Products, of which $ 650 million remains outstanding, and royalty payments on Sanofi’s sales of such licensed products.
+Added: The remaining milestone payments are comprised of $ 175 million upon the approval of the marketing authorization for a COVID-19 Vaccine Product in a pre-filled syringe from the U.S.
Food and Drug Administration (“U.S.
−Removed: FDA”), $ 25 million upon the transfer of such approval to Sanofi, $ 25 million upon the transfer of EMA approval of a COVID-19 Vaccine Product in a pre-filled syringe to Sanofi, $ 50 million upon database lock of an existing Phase 2/3 clinical trial (identifier 2019nCoV-503), $ 75 million upon the completion of the technology transfer of the Company’s manufacturing process for the COVID-19 Vaccine Products to Sanofi, and up to $ 350 million in CIC Product-related development and launch milestones.
+Added: FDA”), $ 25 million upon the transfer of such approval to Sanofi, $ 25 million upon the transfer of European Medicines Agency (“EMA”), approval of a COVID-19 Vaccine Product in a pre-filled syringe to Sanofi, $ 75 million upon the completion of the technology transfer of the Company’s manufacturing process for the COVID-19 Vaccine Products to Sanofi, $ 125.0 million upon achievement of certain CIC Product-related development milestones, and $ 225.0 million in CIC Product-related launch milestones.
+Added: The Company achieved the $ 50.0 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024, which was received from Sanofi during the three months ended March 31, 2025.
The Company is also eligible to receive development, launch, and sales milestone payments of up to $ 200 million for each of the first four Adjuvant Products and $ 210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products.
In addition, a portion of the technology transfer costs and research and development costs incurred by the Company will be reimbursed by Sanofi in accordance with agreed upon plans and budgets.
−Removed: The Company assessed whether the Sanofi CLA fell within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards.
−Removed: The Company determined that the Sanofi CLA did not fall within the scope of ASC 808, as the Company does not share in the significant financial risks of Sanofi's development or commercialization activities.
−Removed: The Company then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.
−Removed: The Company identified the following performance obligations in the Sanofi CLA and determined that they were within the scope of ASC 606:
−Removed: delivery of (i) the licenses described above (the COVID-19 Vaccine license, CIC Products license, Other Combination Product license, and Adjuvant Products license) (collectively the “Sanofi CLA Licenses’), (ii) research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine, referred to as the “Sanofi Transition Services”, and (iii) technology transfer of the existing manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ adjuvant, referred to as the “Sanofi Technology Transfer.”
−Removed: The Company also evaluated whether certain options outlined in the Sanofi Agreement represented material rights that would give rise to a performance obligation and concluded that none of the options convey a material right to Sanofi and therefore are not considered separate performance obligations within the Sanofi CLA.
−Removed: The Sanofi CLA Licenses performance obligations are considered functional intellectual property and distinct from other promises under the contract as Sanofi can benefit from the licenses on their own or together with other readily available resources.
−Removed: Also, the Sanofi Transition Services provide a distinct benefit to Sanofi within the context of the contract, separate from the licenses, as the services could be provided by Sanofi or another third party without the Company’s assistance.
−Removed: The Sanofi Technology Transfer obligation is distinct as Sanofi can benefit from the Sanofi CLA Licenses transferred by the Company at the inception of the agreement with other readily available resources.
−Removed: Therefore, each represents a separate performance obligation within the contract with a customer under the scope of ASC 606 at contract inception.
−Removed: The Company determined the initial transaction price at inception of the Sanofi CLA to be $ 620.2 million, consisting of (i) fixed consideration (the $ 500 million upfront nonrefundable fee), (ii) and $ 120.2 million of variable consideration attributed to a $ 50.0 million clinical milestone and $ 70.2 million of estimated cost reimbursement related to Sanofi Transition Services and Sanofi Technology Transfer.
−Removed: Since the clinical milestone allocated to Sanofi Transition Services is entirely within the Company’s control, and the cost reimbursement variable consideration allocated to Sanofi Transition Services and Sanofi Technology Transfer would be recognized as revenue only as the costs are incurred, the Company determined it is not probable that a significant reversal of cumulative revenue would occur.
−Removed: The Company utilized the expected value method to determine the amount of these payments.
−Removed: The Company excluded certain regulatory and technology transfer milestones from the transaction price that were determined to be inherently uncertain of achievement and are highly susceptible to factors outside of the Company’s control.
−Removed: Sales-based royalties and launch milestones are related to the license of the intellectual property rights and the Company will recognize revenue for these in the period when subsequent sales are made or sale-based milestones are achieved pursuant to the sales-based royalty exception under ASC 606.
−Removed: The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
−Removed: The Company allocated the fixed consideration (i.e., the $ 500 million nonrefundable upfront fee) to the performance obligations in the Sanofi CLA based on each performance obligation’s relative stand-alone selling price, or SSP, as follows:
−Removed: • $ 389.6 million for the upfront transfer of the licenses;
−Removed: • $ 106.9 million for Sanofi Transition Services;
−Removed: • $ 3.5 million for Sanofi Technology Transfer.
−Removed: The SSP for the licenses were determined using an approach that considered discounted, probability-weighted cash flows related to the license transferred.
−Removed: In developing such estimates, the Company applied judgment in determining the forecasted revenues expected margins, and the discount rate.
−Removed: The SSP for the ongoing Sanofi Transition Services and Sanofi Technology Transfer were based on estimates of the associated effort and cost of these services, adjusted for a reasonable gross profit margin that would be expected to be realized under similar contracts.
−Removed: The Company recognized revenue related to the licenses at a point in time upon transfer of the rights and control of the license to Sanofi during the second quarter 2024.
The Sanofi Transition Services and Sanofi Technology Transfer are recognized in revenue over time using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.
−Removed: Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for the three and nine month period ended September 30, 2024 was $ 32.7 million and $ 39.4 million, respectively.
−Removed: The Company’s consolidated balance sheet as of September 30, 2024 includes a deferred revenue balance of $ 70.0 million ($ 29.8 million included in Deferred revenue, current portion and $ 40.2 million included in Deferred revenue, non-current portion) related to Sanofi Transition Services and Sanofi Technology Transfer.
+Added: Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for three month period ended March 31, 2025 was $ 40.3 million.
+Added: The Company’s consolidated balance sheet as of March 31, 2025 includes a deferred revenue balance of $ 49.4 million ($ 28.4 million included in Deferred revenue, current portion and $ 21.0 million included in Deferred revenue, non-current portion) related to Sanofi Transition Services and Sanofi Technology Transfer.
+Added: During three months ended March 31, 2025, the Company recognized a cumulative catch-up adjustment, which resulted in an increase of $ 9.5 million during the period.
+Added: This adjustment resulted from a change in total expected costs, partially offset by changes to estimates of variable consideration for Sanofi Transition Services and Sanofi Technology Transfer.
+Added: Lower expected costs and therefore lower estimates of reimbursements for costs included in estimates of variable consideration were driven by cost reduction efforts described in Note 16.
The Company recognized an asset for $ 35.0 million of direct costs incurred to obtain the Sanofi CLA.
These costs are amortized to expense over the expected period of the benefit in a manner that is consistent with the transfer of the related goods and services in the Sanofi CLA.
−Removed: The Company recognized $ 0.9 million and $ 28.0 million of amortization expense related to the asset in Selling, general, and administrative expense for the three and nine months ended September 30, 2024, respectively.
−Removed: In May 2024, the Company also entered into the Subscription Agreement, pursuant to which the Company sold and issued to Sanofi, in a private placement, 6.9 million shares of the Company’s common stock, at a price of $ 10.00 per share for aggregate gross proceeds to the Company of $ 68.8 million.
−Removed: The opening price of the Company’s common stock on the date of the sale approximated $ 10.00 per share and therefore all gross proceeds were allocated to stockholders’ deficit.
−Removed: Bill & Melinda Gates Medical Research Institute
−Removed: In May 2023, the Company entered into a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide the Company’s Matrix-M™ adjuvant for use in preclinical vaccine research.
−Removed: Other Supply Agreements
−Removed: In March 2024, the Company, FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”) and FUJIFILM Diosynth Biotechnologies USA, Inc.
−Removed: (“FDBU” and together with FDBK and FDBT, “Fujifilm”) entered into a Confidential Settlement Agreement and Release (the “Settlement Agreement”) to resolve disputes regarding amounts that Fujifilm claimed were due under a prior Confidential Settlement Agreement and Release effective September 30, 2022 (the “CSAR”) by and between the Company and Fujifilm.
−Removed: Under the CSAR, the Company agreed to pay up to $ 185.0 million to Fujifilm in connection with the cancellation of manufacturing activity at FDBT.
−Removed: The final two quarterly installments due to Fujifilm in 2023 under the CSAR, totaling $ 68.6 million, 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.
−Removed: In October 2023, the Company sent Fujifilm a notice of breach and refused to pay the final two installments based on its contention that Fujifilm had not used commercially reasonable efforts to mitigate losses and should have offset some portion of the final two payments.
−Removed: In October 2023, Fujifilm filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the full amount (the “Fujifilm Arbitration”).
−Removed: Pursuant to the Settlement Agreement, in March 2024, the Company paid $ 42.0 million to Fujifilm, the parties agreed to a mutual release of claims arising from, under or otherwise in connection with the CSAR, and Fujifilm agreed to dismiss the Fujifilm Arbitration.
−Removed: This payment is less than amounts previously accrued for and reflected in Research and development expense, and accordingly, the Company recorded a benefit of $ 26.6 million as Research and development expense during the nine months ended September 30, 2024 upon the execution of the Settlement Agreement.
−Removed: 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.
+Added: The Company recognized $ 0.9 million of amortization expense related to the asset in Selling, general, and administrative expense for the three ended March 31, 2025, respectively.
+Added: Note 7 – Earnings (Loss) per Share
+Added: Basic and diluted net loss per share were calculated as follows (in thousands, except per share data):
+Added: Three Months Ended
+Added: Net income (loss), basic
+Added: $ 518,646 $ ( 147,550 )
+Added: Interest on convertible notes 2,634 —
+Added: Net income (loss), dilutive
+Added: 521,280 ( 147,550 )
+Added: Weighted average number of common shares outstanding, basic 161,049 139,916
+Added: Effect of dilutive securities 16,576 —
+Added: Weighted average number of common shares outstanding, dilutive 177,625 139,916
+Added: Net income (loss) per share:
+Added: Basic $ 3.22 $ ( 1.05 )
+Added: Diluted $ 2.93 $ ( 1.05 )
+Added: Anti-dilutive securities excluded from calculations of diluted net income (loss) per share 5,349 24,269
Note 8 – 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):
−Removed: September 30, 2024 December 31, 2023
+Added: March 31, 2025 December 31, 2024
Cash and cash equivalents $ 263,338 $ 530,230
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Cash, cash equivalents, and restricted cash $ 278,480 $ 545,292
−Removed: (1) Classified as Other non-current assets as of September 30, 2024 and December 31, 2023, on the consolidated balance sheets.
+Added: (1) Classified as Other non-current assets as of March 31, 2025 and December 31, 2024, on the consolidated balance sheets.
Note 9 – Inventory
Inventory consisted of the following (in thousands):
−Removed: September 30, 2024 December 31, 2023
+Added: March 31, 2025 December 31, 2024
Raw materials $ 2,600 $ 2,087
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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.
−Removed: For the three and nine months ended September 30, 2024, inventory write-downs were $ 1.4 million and $ 19.9 million, respectively, and losses on firm purchase commitments were $ 4.8 million and $ 6.5 million, respectively.
−Removed: For the three and nine months ended September 30, 2024, the Company recorded recoveries on firm purchase commitments of $ 0.7 million related primarily to negotiated reductions to previously recognized firm purchase commitments.
−Removed: Also, for the three and nine months ended September 30, 2024, the Company recorded an impairment charge of $ 3.8 million in Cost of sales related to an embedded lease agreement with a CMO for production capacity in excess of production needs.
−Removed: 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.
−Removed: 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 .
+Added: For the three months ended March 31, 2025, inventory write-downs were $ 0.3 million
+Added: and there were no losses or recoveries on firm purchase commitments.
+Added: For the three months ended March 31, 2024, inventory write-downs were $ 8.8 million and there were no losses or recoveries on firm purchase commitments.
Note 10 – Goodwill
−Removed: The Company has one reporting unit, which has a negative carrying amount as of September 30, 2024 and December 31, 2023.
−Removed: The change in the carrying amounts of goodwill for the nine months ended September 30, 2024 was as follows (in thousands):
+Added: The Company has one reporting unit, which has a negative carrying amount as of March 31, 2025 and December 31, 2024.
+Added: The change in the carrying amounts of goodwill for the three months ended March 31, 2025 was as follows (in thousands):
Balance at December 31, 2024 $ 107,478
Currency translation adjustments 4,549
−Removed: Balance at September 30, 2024 $ 126,766
+Added: Balance at March 31, 2025 $ 112,027
Note 11 – Long-Term Debt
Total convertible notes payable consisted of the following (in thousands):
−Removed: September 30, 2024 December 31, 2023
+Added: March 31, 2025 December 31, 2024
5.00 % Convertible notes due 2027
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The effective interest rate of the 2027 Convertible notes is 6.2 %.
−Removed: During the nine months ended September 30, 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 interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
Coupon interest $ 2,192 $ 2,192
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Note 12 – Stockholders’ Deficit
−Removed: 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”).
−Removed: During the nine months ended September 30, 2024, the Company sold 12.2 million shares of its common stock under its August 2023 Sales Agreement resulting in net proceeds of approximately $ 188 million.
−Removed: There were no sales recorded under the August 2023 Sales Agreement during the three months ended September 30, 2024.
−Removed: As of September 30, 2024, the remaining balance available under the August 2023 Sales Agreement was approximately $ 51 million.
−Removed: 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.
−Removed: 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 .
−Removed: In May 2024, the Company also entered into the Subscription Agreement, pursuant to which the Company sold and issued to Sanofi, in a private placement, 6.9 million shares of the Company’s common stock, par value $ 0.01 per share at a price of $ 10.00 per share, for aggregate gross proceeds to the Company of $ 68.8 million.
−Removed: In August 2023, the Company entered into a Securities Subscription Agreement with SK bioscience Co., Ltd.
−Removed: (“SK”), pursuant to which the Company agreed to sell and issue to SK 6.5 million shares of the Company’s common stock at a price of $ 13.00 per share (the “SK Shares”) in a private placement (the “Private Placement”) for aggregate gross proceeds to the Company of approximately $ 84.5 million .
−Removed: The Company recognized the SK Shares at the settlement date fair value of $ 46.5 million .
−Removed: The closing of the Private Placement occurred on August 10, 2023.
+Added: 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.
+Added: During the three months ended March 31, 2025, and 2024, no sales were recorded under the August 2023 Sales Agreement.
+Added: As of March 31, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $ 51 million.
Note 13 – Stock-Based Compensation
−Removed: 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.
+Added: In January 2023, the Company established the 2023 Inducement Plan (the “2023 Inducement Plan”), which provides for the grant 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.
−Removed: As of September 30, 2024, there were 0.2 million shares available for issuance under the 2023 Inducement Plan.
−Removed: The 2015 Stock Incentive Plan, as amended (“2015 Plan”), was approved at the Company’s annual meeting of stockholders in June 2015.
+Added: As of March 31, 2025, there were 0.1 million shares available for issuance under the 2023 Inducement Plan.
+Added: The Amended and Restated 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.
2 unchanged sentences
The 2015 Plan will expire on April 19, 2034.
−Removed: As of September 30, 2024, there were 10.7 million shares available for issuance under the 2015 Plan.
−Removed: 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.
−Removed: 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”).
+Added: As of March 31, 2025, there were 0.4 million shares available for issuance under the 2015 Plan.
+Added: The 2023 Inducement Plan and the 2015 Plan permit, 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.
3 unchanged sentences
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
Cost of sales $ 525 $ 594
2 unchanged sentences
Total stock-based compensation expense $ 10,285 $ 11,556
−Removed: During the three and nine months ended September 30, 2024 ther e was no stock-based compensation expense capitalized into inventory.
−Removed: During the three and nine months ended September 30, 2023, total stock-based compensation capitalized in inventory was $ 0.5 million.
−Removed: As of September 30, 2024, there was approximately $ 55 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan (“ESPP”).
+Added: During the three months ended March 31, 2025 and 2024 ther e were no stock-based compensation expense capitalized into inventory.
+Added: As of March 31, 2025, there was approximately $ 73 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan (“ESPP”).
This unrecognized non-cash compensation expense is expected to be recognized over a weighted-average period of approximately one year and will be allocated between cost of sales, research and development, and general and administrative expenses accordingly.
This estimate does not include the impact of other possible stock-based awards that may be made during future periods.
−Removed: 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, 2024.
+Added: 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 March 31, 2025.
This amount is subject to change based on changes to the closing price of the Company's common stock.
−Removed: The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the nine months ended September 30, 2024 and 2023 was approximately $ 10 million and $ 3 million, respectively.
+Added: The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the three months ended March 31, 2025 and 2024 was $ 16.2 million and $ 4.5 million, respectively.
Stock Options and Stock Appreciation Rights
−Removed: 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, 2024:
−Removed: 2023 Inducement Plan 2015 Plan 2005 Plan
−Removed: Options Weighted-Average
+Added: The following is a summary of stock options and SARs activity under the 2023 Inducement Plan and 2015 Plan for the three months ended March 31, 2025:
+Added: 2023 Inducement Plan 2015 Plan
Options Weighted-Average
4 unchanged sentences
Canceled — — ( 419,113 ) 58.31
−Removed: Outstanding at September 30, 2024 422,800 $ 10.67 3,723,387 $ 32.70 294 $ 118.40
−Removed: Shares exercisable at September 30, 2024 162,636 $ 10.84 2,304,516 $ 43.54 294 $ 118.40
−Removed: The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of
−Removed: grant using the Black-Scholes option-pricing model with the following assumptions:
+Added: Outstanding at March 31, 2025 486,950 $ 10.45 5,295,846 $ 20.31
+Added: Shares exercisable at March 31, 2025 215,485 $ 10.80 2,055,818 $ 37.53
+Added: 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
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
Weighted average Black-Scholes fair value of stock options granted $ 5.59 $ 4.34
3 unchanged sentences
114.3 %- 121.1 %
−Removed: 120.4 %- 140.3 %
Expected term (in years) 3.9 - 6.5
−Removed: 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, 2024 was $ 11.6 million and 7.1 years, respectively.
−Removed: 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, 2024 was $ 3.7 million and 6.0 years, respectively.
+Added: The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs outstanding under the 2023 Inducement Plan and 2015 Plan as of March 31, 2025 was $ 0.9 million and 8.1 years , respectively.
+Added: The total aggregate intrinsic value and weighted-average remaining contractual term of stock options and SARs exercisable under the 2023 Inducement Plan and 2015 Plan as of March 31, 2025 was $ 0.4 million and 6.2 years , respectively.
Restricted Stock Units
−Removed: The following is a summary of RSU activity for the nine months ended September 30, 2024:
+Added: The following is a summary of RSU activity for the three months ended March 31, 2025:
2023 Inducement Plan 2015 Plan
6 unchanged sentences
Forfeited — — ( 187,046 ) 9.00
−Removed: Outstanding and unvested at September 30, 2024 242,659 $ 10.66 6,085,709 $ 8.92
+Added: Outstanding and unvested at March 31, 2025 182,633 $ 10.11 7,070,487 $ 8.27
Employee Stock Purchase Plan
2 unchanged sentences
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).
−Removed: As of September 30, 2024, there were 1.0 million shares available for issuance under the ESPP.
+Added: As of March 31, 2025, there were 0.7 million shares available for issuance under the ESPP.
Note 14 – 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.
−Removed: Significant pieces of objective evidence evaluated by the Company were the cumulative loss incurred over the three-year period ended September 30, 2024 and that the Company has historically generated pretax losses.
+Added: Significant pieces of objective evidence evaluated by the Company were the cumulative loss incurred over the three-year period ended March 31, 2025 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.
−Removed: On the basis of this evaluation, as of September 30, 2024, 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.
−Removed: During the three months ended September 30, 2024 and 2023, the Company recognized $ 1.3 million and $ 0.7 million of federal, state, and foreign income tax benefit, respectively.
−Removed: During the nine months ended September 30, 2024 and 2023, the Company recognized $ 3.1 million and $ 0.3 million of federal, state, and foreign income tax expense, respectively.
−Removed: During the three and nine months ended September 30, 2024, the company recognized $ 0.3 million of foreign withholding tax expense.
−Removed: During the three and nine months ended September 30, 2023, the company did no t recognize any foreign withholding tax expense.
+Added: On the basis of this evaluation, as of March 31, 2025, 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.
+Added: During the three months ended March 31, 2025 and 2024, the Company recognized $ 0.7 million and $ 2.3 million of federal, state, and foreign income tax expense, respectively.
+Added: During the three months ended March 31, 2025, the company recognized $ 0.5 million of foreign withholding tax expense.
+Added: During the three months ended March 31, 2024, the company did no t recognize any foreign withholding tax expense.
Note 15 – Commitments and Contingencies
7 unchanged sentences
The Maryland Court closed the Sinnathurai Action on May 24, 2024.
−Removed: Upon the Maryland Court’s final approval, the Company relieved the $ 47 million estimated settlement liability within Accrued expenses and the $ 47 million estimated insurance recovery within Prepaid expenses and other current assets on the consolidated balance sheet.
After the Sinnathurai Action was filed, eight derivative lawsuits were filed:
19 unchanged sentences
The Kirst Action was filed in the Circuit Court for Montgomery County, Maryland, and shortly thereafter removed to the Maryland Court by the defendants.
−Removed: The Needleman Action was also filed in the Circuit Court for Montgomery County, Maryland.
+Added: The Needelman 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”).
20 unchanged sentences
On August 19, 2024, the court entered another order extending the stay until November 4, 2024, to allow the SLC and the parties to continue then-ongoing mediation efforts.
−Removed: On November 1, 2024, the parties notified the court that a settlement in principle had been reached and requested the stay to be extended until the definitive settlement agreement is filed.
−Removed: On November 4, 2024, the Maryland Court ordered the parties to file the settlement agreement or a joint status report by November 18, 2024.
+Added: On November 1, 2024, the parties notified the court that a settlement in principle had been reached and requested the stay to be extended until the definitive settlement agreement was filed.
+Added: On November 22, 2024, the SLC filed its Unopposed Motion for Preliminary Approval of Derivative Settlement, Approval of Form and Manner of Notice, and Setting Hearing Date on Final Approval of Settlement and supporting documents.
+Added: Under the terms of the proposed settlement, individual defendants Erck and Herrmann agreed to pay or cause their insurers to pay $ 6.8 million to Novavax in exchange for a release of claims.
+Added: In addition, Novavax and its Board of Directors agreed to adopt and implement certain governance provisions identified in the settlement stipulation.
+Added: On December 12, 2024, the court entered an order granting preliminary approval of the derivative settlement and setting a date for a hearing on the final approval of the settlement.
+Added: On March 7, 2025, the court held a hearing and entered a Final Judgment and Order Approving Derivative Settlement (the “Final Judgment and Order”).
+Added: As part of the Final Judgment and Order, the court granted the motion for attorneys’ fees and awarded plaintiffs’ counsel fees and expenses in the amount of $ 2.0 million to be paid by the Company following its receipt of the $ 6.8 million settlement funds.
+Added: During the three months ended, March 31, 2025, the Company recorded a net gain on the settlement of $ 4.8 million in Other income (expense), net.
The Kirst Action was filed on December 28, 2021, and the defendants immediately removed the case to the Maryland Court.
16 unchanged sentences
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.
+Added: On April 28, 2025, the parties filed a joint status report with the Delaware Court in which they indicated that plaintiffs intend to dismiss the Mesa Action and Acosta Action in light of the Derivative Settlement.
+Added: On May 2, 2025, the Delaware Court granted the stipulated order of voluntary dismissal, and the Mesa Action was dismissed with prejudice.
On April 17, 2023, the Needelman Action was filed.
8 unchanged sentences
On November 4, 2024, the parties filed a stipulation requesting a status conference with the court and further requesting that the action remain stayed until such status conference takes place.
−Removed: The financial impact of the above derivative claims is not reasonably estimable.
+Added: On April 15, 2025, the parties filed a Stipulated Notice of Dismissal dismissing the Kirst and Needelman Actions in light of the Derivative Action.
The Company is also involved in various other legal proceedings arising in the normal course of business.
1 unchanged sentence
Note 16 – Restructuring
−Removed: In May 2023, the Company announced a global restructuring and cost reduction plan (the “2023 Restructuring Plan”), which includes a more focused investment in its COVID-19 Vaccine, 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.
−Removed: In January 2024, the Company announced further reductions to its global workforce, which supplemented the 2023 Restructuring Plan, jointly referred to as the “Restructuring Plan.”
−Removed: The Company recorded the following restructuring charge related to the Restructuring Plan in the consolidated statements of operations (in thousands):
+Added: During the three months ended March 31, 2025, the Company continued its global restructuring and cost reduction efforts that were initially announced in May 2023 (the 2023 plan combined with subsequent period efforts is referred to as the “Restructuring Plan.”).
+Added: As of March 31, 2025, the Company is in the process of reviewing its real estate portfolio, including its leased headquarters in Gaithersburg, Maryland, to optimize its footprint, reduce costs, and align its physical spaces with business needs as part of an effort to improve operational efficiency and enhance long-term financial performance.
+Added: Changes in the planned usage of the Company’s facilities could potentially impact the recoverability of the underlying right of use assets and leasehold improvements.
+Added: While no triggering events have occurred as of March 31, 2025, the Company continues to evaluate options and will perform impairment tests if such indicators arise in future periods.
+Added: As of March 31, 2025, the Company’s net investment in assets related to its corporate headquarter leased laboratory and office space located in Gaithersburg, Maryland was approximately $ 119 million, comprised of approximately $ 134 million of right of use assets, approximately $ 37 million of leasehold improvements net of a finance lease obligation of approximately $ 52 million.
+Added: The restructuring charge recorded by the Company consisted of the following (in thousands):
Three Months Ended
−Removed: September 30,
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: 2024 2023 2024 2023
Severance and employee benefit costs $ 505 $ 4,401
2 unchanged sentences
$ 505 $ 6,070
−Removed: (1) Restructuring charges of $ 0.4 million and $ 3.8 million are included in Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the three months ended September 30, 2024.
−Removed: Restructuring charges of $ 0.5 million, $ 2.3 million and $ 8.6 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, 2024.
−Removed: 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 .
+Added: (1) Restructuring charges of $ 0.5 million is included in Selling, general, and administrative expenses in the Consolidated Statements of Operations for the three months ended March 31, 2025.
+Added: Restructuring charges of $ 1.6 million and $ 4.5 million are included in Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the three months ended March 31, 2024 .
Severance and employee benefit costs
−Removed: Employees affected by the reduction in force under the Restructuring Plan are entitled to receive severance payments and certain termination benefits.
+Added: Employees affected by reductions 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 during the reporting period and had no requirements for future service.
−Removed: The Company paid a total of $ 8.2 million and $ 4.3 million for the severance and employee benefit costs during the nine months ended September 30, 2024 and September 30, 2023, respectively, and had a remaining liability of $ 1.6 million as of September 30, 2024.
−Removed: The Company had no remaining liability as of December 31, 2023.
+Added: The Company paid a total of $ 2.7 million for the severance and employee benefit costs during the three months ended March 31, 2025 and the remaining liability of $ 0.9 million is included in Accrued expenses in the Company’s consolidated balance sheet as of March 31, 2025.
+Added: The Company had $ 3.1 million of remaining liability for the severance and employee benefit costs included in Accrued expenses in its consolidated balance sheet as of December 31, 2024.
Impairment of assets
1 unchanged sentence
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.
−Removed: During the nine months ended September 30, 2024, the Company recorded an impairment charge of $ 1.7 million related to the impairment of capitalized internal-use software.
−Removed: During the nine months ended September 30, 2023 , the Company recorded an impairment charge of $ 10.1 million related to the impairment of
−Removed: long-lived assets, including $ 5.9 million related to ROU assets for facility leases.
−Removed: The Company did not recognize any impairment of assets related restructuring charges during the three months ended September 30, 2024 and 2023.
+Added: During the three months ended March 31, 2024, the Company recorded an impairment charge of $ 1.7 million related to the impairment of capitalized internal-use software.
+Added: The Company did not recognize any impairment charge during the three months ended March 31, 2025.
+Added: Note 17 – Segment Reporting
+Added: The Company manages its business as one reportable operating segment, in-house early-stage R&D to build a pipeline of high-value assets using its proven technology along with seeking to enter into partnerships to drive value creation for its assets.
+Added: The Company has determined its reportable operating segment based on the management approach, which considers the internal organization and reporting used by the Company’s chief operating decision-maker (“CODM”) to make decisions about allocating resources and assessing the Company’s performance.
+Added: The Company’s CODM uses consolidated single-segment net income (loss) as reported in the Consolidated Statements of Operations to evaluate performance, forecast future period financial results, allocate resources, and set incentive targets.
+Added: The table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands):
+Added: Three Months Ended
+Added: $ 666,655 $ 93,855
+Added: Cost of sales
+Added: 14,115 59,209
+Added: Research and development expenses:
+Added: Direct coronavirus vaccines (1)
+Added: 18,059 26,061
+Added: Direct other vaccine development programs (1)
+Added: Employee and benefit expenses
+Added: 39,910 43,458
+Added: Facility and other research and development expenses (2)
+Added: 29,089 22,824
+Added: Selling, general, and administrative expense
+Added: 48,090 86,798
+Added: Other segment income (expense) (3)
+Added: 3,133 ( 2,719 )
+Added: Net income (loss) $ 518,646 $ ( 147,550 )
+Added: (1) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities.
+Added: Direct coronavirus vaccines expenses include costs associated with the Phase 3 trial for our CIC and influenza vaccine candidates.
+Added: (2) Facility and other research and development expenses consist of indirect costs incurred in support of overall research and development activities and non-specific programs, such as overhead costs, information technology and facility-based expenses not allocated to a specific program.
+Added: (3) Other segment income (expense) includes interest expense, income tax expense, and other income.
+Added: Total revenue by the Company’s customer’s or collaboration partner’s geographic location was as follows (in thousands):
+Added: Three Months Ended
+Added: United States
+Added: $ 39,410 $ ( 6,431 )
+Added: Europe 8,086 90,416
+Added: Rest of the world
+Added: Total revenue
+Added: $ 666,455 $ 93,855
+Added: Total long-lived assets of the Company by geographic location were as follows (in thousands):
+Added: March 31, 2025 December 31, 2024
+Added: United States $ 287,059 $ 295,879
+Added: Europe 3,974 4,119
+Added: Total long-lived assets
+Added: $ 291,033 $ 299,998
Note 18 – Subsequent Events
−Removed: On October 16, 2024, Novavax disclosed that the U.S.
−Removed: FDA had placed a clinical hold on Novavax’s Investigational New Drug Application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates.
−Removed: On November 11, 2024, Novavax announced that the U.S.
−Removed: FDA has lifted the previously disclosed clinical hold for Novavax’s COVID-19-Influenza Combination and stand-alone influenza vaccine candidates.
−Removed: In November 2024, the Company and The Secretary of State for Health and Social Care, acting as part of the Crown, through the UK Health Security Agency (the “Authority”), entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-COV-2 Vaccine Supply Agreement effective July 1, 2022 (the “Amended and Restated Supply Agreement”) by and between the Company and the UK Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the Crown, settling the disputes regarding the Amended and Restated Supply Agreement and releasing both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.
−Removed: Under the terms of the Settlement Agreement, the Authority and the Company agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payment of $ 112.5 million, which is reflected in Other current liabilities on the consolidated balance sheet, previously received by the Company from the Authority under the Amended and Restated Supply Agreement.
−Removed: Pursuant to the Settlement Agreement, the Company agreed to pay a refund of $ 123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of $ 10.3 million over a three year period, ending in June 2027.
−Removed: The Settlement Payment amount includes a $ 11.3 million provision for interest over the period and may be avoided if the Company chooses to accelerate payments.
−Removed: Under the terms of the Settlement Agreement Amendment, the Authority and the Company agreed to the date of payment for the first quarterly installment to be November 30, 2024.
+Added: In April 2025, the Company received a formal communication from the U.S.
+Added: FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data.
+Added: The Company has responded to the U.S.
+Added: FDA’s information request with a proposed study design and continues to engage with the U.S.
+Added: FDA to address the PMC request and move to approval as soon as possible.
+Added: On April 29, 2025, the Company entered into a collaboration and exclusive license agreement, as amended (“Amended Takeda APA”), with Takeda which amends and supersedes its collaboration and exclusive license agreement with Takeda, dated February 24, 2021.
+Added: The Amended Takeda APA improves financial terms for the Company.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.