4 unchanged sentences
For the Three Months Ended
+Added: June 30, For the Six Months Ended
+Added: 2025 2024 2025 2024
Product sales $ 10,724 $ 22,588 $ 632,402 $ 112,424
5 unchanged sentences
Total expenses 138,170 254,486 289,311 493,172
−Removed: Income (loss) from operations 515,513 ( 144,831 )
+Added: Income from operations 101,070 160,998 616,584 16,167
Other income (expense):
1 unchanged sentence
Other income, net
−Removed: Income (loss) before income tax expense
11,902 7,731 21,957 11,385
+Added: Income before income tax expense 107,454 164,586 627,300 19,298
Income tax expense
−Removed: Net income (loss) $ 518,646 $ ( 147,550 )
−Removed: Net income (loss) per share:
+Added: 946 2,205 2,146 4,467
+Added: Net income $ 106,508 $ 162,381 $ 625,154 $ 14,831
+Added: Net income per share:
Basic $ 0.66 $ 1.09 $ 3.87 $ 0.10
6 unchanged sentences
For the Three Months Ended
−Removed: Net income (loss) $ 518,646 $ ( 147,550 )
+Added: June 30, For the Six Months Ended
+Added: 2025 2024 2025 2024
+Added: Net income $ 106,508 $ 162,381 $ 625,154 $ 14,831
Other comprehensive income (loss):
−Removed: Net unrealized gain on available-for-sale marketable securities
+Added: Net unrealized gain (loss) on available-for-sale marketable securities ( 139 ) ( 150 ) 450 ( 150 )
Foreign currency translation adjustment ( 1,927 ) 467 21,651 ( 13,080 )
1 unchanged sentence
( 2,066 ) 317 22,101 ( 13,230 )
−Removed: Comprehensive income (loss) $ 542,813 $ ( 161,097 )
+Added: Comprehensive income $ 104,442 $ 162,698 $ 647,255 $ 1,601
The accompanying notes are an integral part of these financial statements.
16 unchanged sentences
Total assets $ 1,336,549 $ 1,560,418
−Removed: LIABILITIES AND STOCKHOLDERS’ DEFICIT
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
11 unchanged sentences
Commitments and contingencies (Note 15)
−Removed: Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at March 31, 2025 and December 31, 2024;
−Removed: no shares issued and outstanding at March 31, 2025 and December 31, 2024
−Removed: Stockholders' deficit:
−Removed: Common stock, $ 0.01 par value, 600,000,000 shares authorized at March 31, 2025 and December 31, 2024;
−Removed: 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
+Added: Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at June 30, 2025 and December 31, 2024;
+Added: no shares issued and outstanding at June 30, 2025 and December 31, 2024
+Added: Stockholders' equity (deficit):
+Added: Common stock, $ 0.01 par value, 600,000,000 shares authorized at June 30, 2025 and December 31, 2024;
+Added: 164,475,337 shares issued and 162,155,109 shares outstanding at June 30, 2025 and 161,942,677 shares issued and 160,421,136 shares outstanding at December 31, 2024
Additional paid-in capital 4,522,193 4,501,403
Accumulated deficit ( 4,383,296 ) ( 5,008,450 )
−Removed: Treasury stock, cost basis, 2,248,518 shares at March 31, 2025 and 1,521,541 shares at December 31, 2024
+Added: Treasury stock, cost basis, 2,320,228 shares at June 30, 2025 and 1,521,541 shares at December 31, 2024
( 102,459 ) ( 95,854 )
−Removed: Accumulated other comprehensive income
+Added: Accumulated other comprehensive income (loss) ( 458 ) ( 22,559 )
+Added: Total stockholders’ equity (deficit) 37,625 ( 623,841 )
+Added: Total liabilities and stockholders’ equity (deficit)
$ 1,336,549 $ 1,560,418
−Removed: Total stockholders’ deficit ( 75,643 ) ( 623,841 )
−Removed: Total liabilities and stockholders’ deficit $ 1,292,992 $ 1,560,418
The accompanying notes are an integral part of these financial statements.
NOVAVAX, INC.
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT
−Removed: Three Months Ended March 31, 2025 and 2024
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
+Added: Three and Six Months Ended June 30, 2025 and 2024
(in thousands, except share information)
6 unchanged sentences
Total Stockholders'
+Added: Equity (Deficit)
Shares Amount
−Removed: Balance at December 31, 2024 161,942,677 $ 1,619 $ 4,501,403 $ ( 5,008,450 ) $ ( 95,854 ) $ ( 22,559 ) $ ( 623,841 )
+Added: Balance at March 31, 2025 164,206,386 $ 1,642 $ 4,512,849 $ ( 4,489,804 ) $ ( 101,938 ) $ 1,608 $ ( 75,643 )
Stock-based compensation — — 9,214 — — — 9,214
4 unchanged sentences
Net income — — — 106,508 — — 106,508
+Added: Balance at June 30, 2025 164,475,337 $ 1,645 $ 4,522,193 $ ( 4,383,296 ) $ ( 102,459 ) $ ( 458 ) $ 37,625
Balance at March 31, 2024 141,700,972 $ 1,417 $ 4,204,775 $ ( 4,968,501 ) $ ( 93,950 ) $ ( 10,825 ) $ ( 867,084 )
+Added: Stock-based compensation — — 14,099 — — — 14,099
+Added: Stock issued under incentive programs 472,751 5 2,656 — ( 489 ) — 2,172
+Added: Issuance of common stock, net of issuance costs of $ 3,830
+Added: 19,093,397 191 256,218 — — — 256,409
+Added: Unrealized loss on marketable securities — — — — — ( 150 ) ( 150 )
+Added: Foreign currency translation adjustment — — — — 467 467
+Added: — — — 162,381 — — 162,381
+Added: Balance at June 30, 2024 161,267,120 $ 1,613 $ 4,477,748 $ ( 4,806,120 ) $ ( 94,439 ) $ ( 10,508 ) $ ( 431,706 )
+Added: Common Stock Additional
+Added: Capital Accumulated
+Added: Deficit Treasury
+Added: Stock Accumulated Other
+Added: Comprehensive
+Added: Income (Loss) Total Stockholders'
+Added: Equity (Deficit)
+Added: 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 2,532,660 26 1,291 — ( 6,605 ) — ( 5,288 )
+Added: Unrealized gain on available-for-sale marketable securities
+Added: — — — — — 450 450
Foreign currency translation adjustment — — — — — 21,651 21,651
— — — 625,154 — — 625,154
−Removed: Balance at March 31, 2024 141,700,972 $ 1,417 $ 4,204,775 $ ( 4,968,501 ) $ ( 93,950 ) $ ( 10,825 ) $ ( 867,084 )
+Added: Balance at June 30, 2025 164,475,337 $ 1,645 $ 4,522,193 $ ( 4,383,296 ) $ ( 102,459 ) $ ( 458 ) $ 37,625
+Added: Balance at December 31, 2023 140,506,093 $ 1,405 $ 4,192,164 $ ( 4,820,951 ) $ ( 92,267 ) $ 2,722 $ ( 716,927 )
+Added: Stock-based compensation — — 25,655 — — — 25,655
+Added: Stock issued under incentive programs 1,667,630 17 3,711 — ( 2,172 ) — 1,556
+Added: Issuance of common stock, net of issuance costs of $ 3,830
+Added: 19,093,397 191 256,218 — — — 256,409
+Added: Unrealized loss on marketable securities — — — — — ( 150 ) ( 150 )
+Added: Foreign currency translation adjustment — — — — — ( 13,080 ) ( 13,080 )
+Added: — — — 14,831 — — 14,831
+Added: Balance at June 30, 2024 161,267,120 $ 1,613 $ 4,477,748 $ ( 4,806,120 ) $ ( 94,439 ) $ ( 10,508 ) $ ( 431,706 )
The accompanying notes are an integral part of these financial statements.
2 unchanged sentences
(in thousands)
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
Operating Activities:
−Removed: Net income (loss) $ 518,646 $ ( 147,550 )
+Added: Net income $ 625,154 $ 14,831
Reconciliation of net loss to net cash used in operating activities:
9 unchanged sentences
Deferred revenue ( 608,860 ) 111,037
−Removed: Net cash used in operating activities ( 185,502 ) ( 83,555 )
+Added: Net cash provided by (used in) operating activities ( 312,964 ) 230,714
Investing Activities:
4 unchanged sentences
Internal-use software ( 655 ) ( 622 )
−Removed: Net cash used in investing activities ( 73,319 ) ( 7,250 )
+Added: Net cash provided by (used in) investing activities 37,779 ( 379,957 )
Financing Activities:
4 unchanged sentences
Effect of exchange rate on cash, cash equivalents, and restricted cash 6,976 ( 3,111 )
−Removed: Net decrease in cash, cash equivalents, and restricted cash ( 266,812 ) ( 87,874 )
+Added: Net increase (decrease) in cash, cash equivalents, and restricted cash
+Added: ( 276,310 ) 111,748
Cash, cash equivalents, and restricted cash at beginning of period 545,292 583,810
1 unchanged sentence
Supplemental disclosure of non-cash activities:
+Added: Right-of-use asset leases, net of tenant improvement allowance on facility leases
+Added: $ — $ ( 8,289 )
Capital expenditures included in accounts payable and accrued expenses $ 81 $ 2,137
−Removed: Internal-use software included in accounts payable and accrued expenses
Supplemental disclosure of cash flow information:
5 unchanged sentences
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: March 31, 2025
+Added: June 30, 2025
Note 1 – Organization and Business
2 unchanged sentences
The differentiated platform features the Company’s recombinant protein-based nanoparticle technology and its unique Matrix-M ® adjuvant.
−Removed: 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 corporate growth strategy seeks to expand access to its proven technology platform by advancing research and development (“R&D”) innovation and organically growing our portfolio and strengthening existing partnerships while working actively to forge new collaborations .
The Company’s three strategic priorities are:
focusing on its partnership with Sanofi Pasteur Inc.
−Removed: ("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: ("Sanofi”) announced in May 2024, enhancing existing partnerships and leveraging its technology platform and pipeline to forge additional partnerships, and advancing its proven technology platform and early-stage pipeline.
The Company’s corporate growth strategy is supported by a lean and focused operating model.
−Removed: 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.
−Removed: territories).
+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.
The Company’s partner, Serum Institute of India Pvt.
5 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 income (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, changes in stockholders’ equity (deficit), and cash flows for the periods presented.
Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S.
3 unchanged sentences
All intercompany accounts and transactions have been eliminated in consolidation.
−Removed: 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.
+Added: The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were $ 4.7 million gain and $ 1.6 million loss, and a $ 1.9 million and $ 0.2 million loss for the three and six months ended June 30, 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.
4 unchanged sentences
These reclassifications have no material effect on previously reported financial position and cash flows.
−Removed: 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: The Company reclassified $ 2.7 million and $ 10.2 million of revenue previously reported as License, royalties, and other revenue to Product sales revenue for the three and six months ended June 30, 2024 related to adjuvant supply sales and other supply sales.
This presentation aligns with the Company’s enhanced focus on supply sales to partners.
2 unchanged sentences
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 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.
−Removed: 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.
+Added: As of June 30, 2025, the Company had $ 253.7 million in cash and cash equivalents, $ 358.6 million in marketable securities, and working capital of $ 530.4 million.
+Added: During the six months ended June 30, 2025, the Company recognized net income of $ 625.2 million and had net cash flows used in operating activities of $ 313.0 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.
14 unchanged sentences
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.
−Removed: 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: 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 (“ASC”), 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.
Early adoption is permitted.
The Company is currently evaluating the impact of adopting this pronouncement on the Company’s consolidated financial statements and disclosures.
−Removed: 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
−Removed: The effective date for each amendment in the ASU is the effective date that the SEC removes the disclosure requirement from its regulations.
−Removed: 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.
+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 regulations.
+Added: The effective date for each amendment in the ASU is the effective date that the SEC removes the disclosure
+Added: requirement from its regulations.
+Added: The Company is currently evaluating ASU 2023-06;
+Added: 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”).
4 unchanged sentences
Note 3 – Marketable Securities
−Removed: Marketable securities were classified as available-for-sale as of March 31, 2025 and December 31, 2024, comprised of (in thousands):
−Removed: March 31, 2025 December 31, 2024
+Added: Marketable securities were classified as available-for-sale as of June 30, 2025 and December 31, 2024, comprised of (in thousands):
+Added: June 30, 2025 December 31, 2024
Losses Fair Value Amortized
3 unchanged sentences
Total marketable securities $ 358,070 $ 490 $ — $ 358,560 $ 392,848 $ 116 $ ( 76 ) $ 392,888
−Removed: 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 June 30, 2025, investments in marketable securities were comprised of $ 185.1 million of treasury securities, of which 23.0 million mature in 2025 and $ 162.1 million mature in 2026, and $ 173.4 million of corporate debt securities, of which $ 160.2 million mature in 2025 and $ 13.2 million mature in 2026.
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.
−Removed: Marketable securities are classified as Current assets in the Consolidated balance sheet of the Company as of March 31, 2025, and December 31, 2024.
−Removed: 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.
−Removed: 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.
+Added: Marketable securities are classified as Current assets in the Consolidated balance sheet of the Company as of June 30, 2025 and December 31, 2024.
+Added: During the three and six months ended June 30, 2025, the Company recognized interest income of $ 7.0 million and $ 15.1 million, respectively, from its investments in securities.
+Added: During the three and six months ended June 30, 2024, the Company recognized interest income of $ 9.0 million and $ 15.6 million, respectively, from its investments in securities.
+Added: This income is included within Other income on the consolidated statements of operations.
+Added: Based on the Company’s policy under the expected credit loss model, including an assessment of the investment portfolio as of June 30, 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 June 30, 2025, the Company does not have the intent to sell its available-for-sale investments with an unrealized loss position, and it is more likely than not that the Company will not be required to sell these investments before their anticipated recovery of amortized cost bases, which may be at maturity.
+Added: As of June 30, 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 March 31, 2025 Fair Value at December 31, 2024
+Added: Fair Value at June 30, 2025 Fair Value at December 31, 2024
Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
11 unchanged sentences
$ — $ 173,543 $ — $ — $ 174,386 $ —
−Removed: (1) Classified as cash and cash equivalents as of March 31, 2025 and December 31, 2024, respectively, on the consolidated balance sheets.
+Added: (1) Classified as cash and cash equivalents as of June 30, 2025 and December 31, 2024, respectively, on the consolidated balance sheets.
(2) Includes $ 34.8 million classified as Cash and cash equivalents as of December 31, 2024 on the consolidated balance sheets.
1 unchanged sentence
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 three months ended March 31, 2025 and 2024, the Company did not have any transfers between levels.
+Added: During the six months ended June 30, 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 $ 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.
−Removed: 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):
+Added: The Company's accounts receivable included $ 221.1 million and $ 102.9 million related to amounts that were billed to customers and $ 5.3 million and $ 5.4 million related to amounts which had not yet been billed to customers as of June 30, 2025 and December 31, 2024, respectively.
+Added: During the six months ended June 30, 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: Three Months Ended March 31, 2025 $ 115,960 $ 123,785 $ ( 187,560 ) $ 52,185
−Removed: Three Months Ended March 31, 2024 304,916 136,510 ( 412,370 ) 29,056
+Added: Six Months Ended June 30, 2025 $ 115,960 $ 408,315 $ ( 290,204 ) $ 234,071
+Added: Six Months Ended June 30, 2024 304,916 672,326 ( 937,462 ) 39,780
Allowance for credit losses (1) :
−Removed: Three Months Ended March 31, 2025 ( 7,675 ) — — ( 7,675 )
−Removed: Three Months Ended March 31, 2024 ( 7,675 ) — — ( 7,675 )
+Added: Six Months Ended June 30, 2025 ( 7,675 ) — — ( 7,675 )
+Added: Six Months Ended June 30, 2024 ( 7,675 ) — — ( 7,675 )
Deferred revenue:
−Removed: Three Months Ended March 31, 2025 1,121,886 — ( 603,995 ) 517,891
−Removed: Three Months Ended March 31, 2024 863,521 225,000 ( 6,148 ) 1,082,373
−Removed: (1) There was no allowance for credit losses recorded during the three months ended March 31, 2025 or 2024.
+Added: Six Months Ended June 30, 2025 1,121,886 — ( 608,860 ) 513,026
+Added: Six Months Ended June 30, 2024 863,520 365,150 ( 28,849 ) 1,199,821
+Added: (1) There was no allowance for credit losses recorded during the six months ended June 30, 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 three months ended March 31, 2025, deductions include $ 555.7 million related to the Canada APA termination, discussed below.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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: During the six months ended June 30, 2025, deductions include $ 555.7 million related to the Canada Advanced Purchase Agreement (“APA”) termination, discussed below.
+Added: During the six months ended June 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.
+Added: As of June 30, 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 as included in Deferred revenue.
+Added: Failure to meet regulatory milestones, obtain timely supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations 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.
+Added: The timing and our ability to fulfill performance obligations related to APAs will depend on the timing of product manufacturing, receipt of marketing authorizations for its updated COVID-19 Vaccine, 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.
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.
The Company believes it has fulfilled the requirements related to this matter and is evaluating the merits of the claim.
−Removed: 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.
+Added: The timing to fulfill performance obligations related to the Sanofi Collaboration and License Agreement (“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.
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.
5 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: 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.
+Added: As of June 30, 2025, the remaining amounts included on the Company’s consolidated balance sheet were $ 225.0 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 $ 225.0 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: During the three months ended March 31, 2025 and 2024, the categories of product sales were as follows (in thousands):
+Added: During the three months ended June 30, 2025 and 2024, the categories of Product sales were as follows (in thousands):
Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Product sales
2 unchanged sentences
Supply sales (2)
+Added: 12,817 2,684 26,471 10,196
Total Product sales
−Removed: (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: $ 10,724 $ 22,588 $ 632,402 $ 112,424
+Added: (1) Nuvaxovid sales are sales of the Company’s COVID-19 Vaccine associated with APAs with governments and commercial markets, where the Company is the commercial lead for sales and distribution, made through pharmaceutical wholesale distributors.
+Added: During the three months ended June 30, 2025, Nuvaxovid sales include excess gross-to-net deductions primarily due to updates to estimated product returns.
(2) Supply sales include commercial sales of COVID-19 Vaccine, adjuvant sales, and other material sales to the Company’s partners.
−Removed: As of March 31, 2025 and 2024, changes in the Company’s gross-to-net deductions balances were as follows (in thousands):
+Added: As of June 30, 2025 and 2024, changes in the Company’s gross-to-net deductions balances were as follows (in thousands):
Wholesale Distributor Fees, Discounts, and Chargebacks
5 unchanged sentences
( 34,921 ) ( 140,546 ) ( 175,467 )
−Removed: Balance as of March 31, 2025 $ 7,577 $ 70,913 $ 78,490
+Added: Balance as of June 30, 2025 $ 608 $ 13,299 $ 13,907
Wholesale Distributor Fees, Discounts, and Chargebacks
5 unchanged sentences
( 35,621 ) ( 51,331 ) ( 86,952 )
−Removed: Balance as of March 31, 2024 $ 10,169 $ 92,913 $ 103,082
−Removed: (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.
−Removed: 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: Balance as of June 30, 2024 $ 887 $ 54,587 $ 55,474
+Added: (1) For the six months ended June 30, 2025 and 2024, amounts charged against Product sales include $ 2.6 million and $ 4.0 million of adjustments made to prior period Product sales due primarily to changes in the estimate of product returns.
+Added: As of June 30, 2025, $ 3.9 million of gross-to-net deductions were included in Accrued expenses and $ 10.0 million were included in Accounts payable on the consolidated balance sheet.
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: 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
−Removed: balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
+Added: As of June 30, 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 balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
+Added: Australia may cancel doses that
+Added: 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: Following the withdrawal of the Company’s application for authorization of its updated COVID-19 Vaccine at the request of the Therapeutic Goods Administration (“TGA”), the Company is currently in discussions with the TGA, regarding potential regulatory paths for approval, including the submission of a new application.
+Added: The Company may seek to further amend the Australian APA in light of this development, which amendment may not be achievable on acceptable terms or at all.
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.
−Removed: 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.
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”).
9 unchanged sentences
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”).
−Removed: 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: As part of the New Zealand Settlement Agreement, the Company paid Pharmac a refund of previously received upfront payments of $ 4.0 million .
Under the New Zealand Settlement Agreement, the Company has no remaining obligation to Pharmac under the New Zealand APA.
−Removed: 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: Therefore, during the three months ended March 31, 2025, t he Company recognized $ 27.3 million , previously in other current liabilities, as Product sales.
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
−Removed: Licensing, royalties, and other includes licensing payments, transition services revenue, and technology transfer revenue from the Sanofi CLA;
+Added: Licensing, royalties, and other includes licensing payments, transition services revenue, and technology transfer revenue from the Sanofi CLA (defined below);
royalty milestone payments;
and sales-based royalties.
−Removed: Licensing, royalties, and other by license partner for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
−Removed: Three Months Ended March 31,
+Added: Licensing, royalties, and other by license partner for the three months ended June 30, 2025 and 2024 were as follows (in thousands):
+Added: Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Licensing, royalties, and other
Sanofi $ 199,412 $ 392,896 $ 239,733 $ 392,896
+Added: Takeda 27,212 — 27,212 —
Other partners (1)
+Added: 1,892 — 6,548 4,019
Total licensing, royalties, and other revenue $ 228,516 $ 392,896 $ 273,493 $ 396,915
−Removed: (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: (1) Other partners revenue includes royalties and license fees associated with agreements with other partners such as Serum and SK bioscience, Co., Ltd.
Sanofi licensing, royalties, and other revenue were comprised of the following (in thousands):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Sanofi licensing, royalties, and other revenue
+Added: Upfront fee $ — $ 386,250 $ — $ 386,250
+Added: Milestones 175,000 — 175,000 —
Transition services and technology transfer:
Upfront fee amortization (1)
+Added: 12,268 4,573 32,180 4,573
Milestones amortization (1)
+Added: 5,665 2,073 14,808 2,073
Cost reimbursements
+Added: 6,479 — 17,745 —
Total Sanofi licensing, royalties, and other revenue
−Removed: (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.
+Added: $ 199,412 $ 392,896 $ 239,733 $ 392,896
+Added: (1) Upfront fee amortization and Milestones amortization represent revenue recognized during the period related to a portion of 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.
+Added: Takeda licensing, royalties, and other revenue were comprised of the following (in thousands):
+Added: Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
+Added: Takeda licensing, royalties, and other revenue
+Added: Upfront fee (1)
+Added: $ 18,500 $ — $ 18,500 $ —
+Added: Milestones 3,434 — 3,434 $ —
+Added: Royalties 5,000 — 5,000 $ —
+Added: Support services 278 — 278 —
+Added: Tota Total Takeda licensing, royalties, and other revenue
+Added: $ 27,212 $ — $ 27,212 $ —
+Added: (1) Upfront fee includes $ 14.5 million of nonrefundable upfront payments associated with the Amended Takeda CLA as defined below and $ 4.0 million of previously unrecognized consideration from the Original Takeda CLA.
Note 6 – Collaboration, License, and Supply Agreements
−Removed: As of March 31, 2025, the Company’s material collaborations, license and supply agreements were as follows:
+Added: As of June 30, 2025, the Company’s material collaborations, license and supply agreements were as follows:
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.
6 unchanged sentences
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.
−Removed: 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.
+Added: In June 2025, the Company announced results of the initial cohort of its 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: 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.
−Removed: 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 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.
−Removed: Under the terms of the agreement, the Company will continue to commercialize its updated COVID-19 vaccine through the end
−Removed: of the 2024-2025 vaccination season.
+Added: On April 29, 2025, the Company entered into a collaboration and exclusive license agreement, as amended (“Amended Takeda CLA”), with Takeda which amended and superseded its collaboration and exclusive license agreement with Takeda, dated February 24, 2021 (“Original Takeda CLA”).
+Added: The Original Takeda CLA, which granted Takeda an exclusive license to develop, manufacture, and commercialize the COVID-19 Vaccine in Japan, has been amended so that Takeda may develop and commercialize a strain for the COVID-19 Vaccine that is different from the strain that the Company selects for the year, provided such Takeda selected strain must be procured from the Company.
+Added: Under the Amended Takeda CLA, Takeda will continue to purchase the Company’s Matrix-M™ adjuvant to manufacture doses of finished COVID-19 Vaccine with updated adjuvant forecast and other supply terms.
+Added: In connection with the Amended Takeda CLA, on April 29, 2025, the Company entered into a release agreement with Takeda under which the Company released Takeda and Takeda released the Company from all claims that were asserted or could have been asserted by either party against the other party that related to the Original Takeda CLA and the activities thereunder.
+Added: The Company has determined that the Amended Takeda CLA represents a new contract under ASC 606 - Revenue from Contracts with Customers (“ASC 606”) with the following performance obligations:
+Added: the (i) delivery of an updated license to develop, manufacture, and commercialize the Company’s COVID-19 Vaccine in Japan, including the ability for Takeda to develop and commercialize a strain for the COVID-19 Vaccine that is different from the strain that the Company selects for the year (“Updated Takeda License”), and (ii) annual support services for Takeda’s regulatory and commercialization activities (“Takeda Support Services”).
+Added: The Company will recognize revenue on optional purchases of Matrix-M adjuvant upon delivery to Takeda.
+Added: The Updated Takeda License performance obligation is considered functional intellectual property and distinct from other promises under the contract as Takeda can benefit from the license on its own or together with other readily available resources.
+Added: The Takeda Support Services provide a distinct benefit to Takeda within the context of the contract, separate from the license, as the services could be provided by Takeda or another third party without the Company’s assistance.
+Added: The Company determined the initial transaction price at inception of the Amended Takeda CLA to be $ 27.5 million, consisting of (i) $ 19.5 million of the non-refundable upfront payment and royalties, (ii) $ 4.0 million of non-cancelable annual support payments within the 18-month notice period for contract termination, and (iii) $ 4.0 million of previously unrecognized consideration from the Original Takeda CLA.
+Added: The transaction price excludes annual milestone payments and annual support payments that are not due in the event that the Amended Takeda CLA is terminated by Takeda after the 18-month notice period.
+Added: Sales-based royalties and annual milestones relate to the Updated Takeda License performance obligation for which the Company will recognize revenue in the period that sales are made or annual milestones are achieved pursuant to the sales-based royalty exception under ASC 606.
+Added: The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
+Added: The Company allocated $ 26.9 million of fixed consideration to the Updated Takeda License performance obligations and $ 0.6 million to Takeda Support Services.
+Added: The Company recognized revenue of $ 26.9 million related to the Updated Takeda License on the transfer of the rights and control of the license to Takeda during the three and six months ended June 30, 2025.
+Added: The Takeda Support Services are recognized in revenue over time using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.
+Added: Revenue recognized related to Takeda Support Services for the three and six months ended June 30, 2025 was $ 0.3 million.
+Added: Under the Amended Takeda CLA, the Company received a non-refundable upfront payment of $ 19.5 million of which $ 5.0 million is creditable against royalties owed by Takeda for its fiscal year 2024.
+Added: In addition, on an annual basis, the Company will receive $ 2.0 million to compensate it for services provided by the Company under the Amended Takeda CLA, and the Company will receive an additional $ 8.0 million annual milestone payment, of which $ 5.0 million is creditable against royalties owed by Takeda in its fiscal year 2025 or thereafter, if Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year.
+Added: The parties have also updated the financial terms to replace the share of operating profits and, instead, provide the Company with a tiered royalty as a percentage of Takeda’s, its affiliates’ and sublicensees’ total net sales in the mid to high-teen percentages (subject to certain capped royalty reductions), commencing on April 1, 2024 and will continue until the latest of (a) twenty years after April 29, 2025, (b) all our know-how licensed under the Amended Takeda CLA has become publicly available through no fault of Takeda, and (c) the expiration of the last valid claim in the intellectual property rights licensed by the Company to Takeda under the Amended Takeda CLA covering COVID-19 Vaccine in Japan.
+Added: In May 2024, Novavax entered into 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 of the 2024-2025 vaccination season.
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.
5 unchanged sentences
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 $ 475 million remains outstanding, and royalty payments on Sanofi’s sales of such licensed products.
−Removed: 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.
+Added: The remaining milestone payments are comprised of $ 25.0 million upon the transfer of such approval to Sanofi, $ 25.0 million upon the transfer of European Medicines Agency (“EMA”), approval of a COVID-19 Vaccine product in a pre-filled syringe to Sanofi, $ 75.0 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 first quarter of 2025.
+Added: In May 2025, 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 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.
−Removed: 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.
+Added: FDA”) approved the Biologics License Application (“BLA”) for the Company’s COVID-19 Vaccine product in a pre-filled syringe.
+Added: The BLA approval triggered a $ 175.0 million milestone payment under the Sanofi CLA, which was recognized in Licensing, royalties, and other revenue for the three month period ended June 30, 2025 and is included in Accounts receivable as of June 30, 2025 on the accompanying unaudited balance sheet.
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.
−Removed: 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.
+Added: In addition, a portion of the technology transfer costs and R&D costs incurred by the Company will be reimbursed by Sanofi in accordance with agreed upon plans and budgets.
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 three month period ended March 31, 2025 was $ 40.3 million.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for three and six month period ended June 30, 2025 was $ 24.4 million and $ 64.7 million, respectively.
+Added: Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for three and six month period ended June 30, 2024 was $ 6.6 million.
+Added: The Company’s consolidated balance sheet as of June 30, 2025 includes a deferred revenue balance of $ 42.7 million ($ 32.0 million included in Deferred revenue, current portion and $ 10.7 million included in Deferred revenue, non-current portion) related to Sanofi Transition Services and Sanofi Technology Transfer.
+Added: The Company recognized cumulative catch-up adjustments, which resulted in a decrease to revenue of $ 1.5 million and an increase to revenue of $ 8.7 million during three and six months ended June 30, 2025, respectively.
+Added: These adjustments resulted from a change in total expected costs and changes to estimates of variable consideration for Sanofi Transition Services and Sanofi Technology Transfer.
+Added: Lower expected costs for Sanofi Transition Services 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 of amortization expense related to the asset in Selling, general, and administrative expense for the three ended March 31, 2025, respectively.
−Removed: Note 7 – Earnings (Loss) per Share
+Added: The Company recognized $ 0.9 million and $ 1.8 million of amortization expense related to the asset in Selling, general, and administrative expense for the three and six months ended June 30, 2025, respectively.
+Added: The Company recognized $ 27.1 million of amortization expense related to the asset in Selling, general, and administrative expense in the second quarter of 2024.
+Added: Note 7 – Earnings per Share
Basic and diluted net loss per share were calculated as follows (in thousands, except per share data):
Three Months Ended
−Removed: Net income (loss), basic
+Added: June 30, Six Months Ended
2025 2024 2025 2024
+Added: Net income, basic $ 106,508 $ 162,381 $ 625,154 $ 14,831
Interest on convertible notes 2,634 2,608 5,268 —
−Removed: Net income (loss), dilutive
−Removed: 521,280 ( 147,550 )
+Added: Net income, dilutive 109,142 164,989 630,422 14,831
Weighted average number of common shares outstanding, basic 162,019 148,379 161,536 144,147
1 unchanged sentence
Weighted average number of common shares outstanding, dilutive 177,215 165,855 177,410 145,121
−Removed: Net income (loss) per share:
+Added: Net income per share:
Basic $ 0.66 $ 1.09 $ 3.87 $ 0.10
Diluted $ 0.62 $ 0.99 $ 3.55 $ 0.10
−Removed: Anti-dilutive securities excluded from calculations of diluted net income (loss) per share 5,349 24,269
+Added: Anti-dilutive securities excluded from calculations of diluted net income per share 8,065 4,544 7,210 21,654
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: March 31, 2025 December 31, 2024
+Added: June 30, 2025 December 31, 2024
Cash and cash equivalents $ 253,744 $ 530,230
2 unchanged sentences
Cash, cash equivalents, and restricted cash $ 268,982 $ 545,292
−Removed: (1) Classified as Other non-current assets as of March 31, 2025 and December 31, 2024, on the consolidated balance sheets.
+Added: (1) Classified as Other non-current assets as of June 30, 2025 and December 31, 2024, on the consolidated balance sheets.
Note 9 – Inventory
Inventory consisted of the following (in thousands):
−Removed: March 31, 2025 December 31, 2024
+Added: June 30, 2025 December 31, 2024
Raw materials $ 2,294 $ 2,087
3 unchanged sentences
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 months ended March 31, 2025, inventory write-downs were $ 0.3 million
−Removed: and there were no losses or recoveries on firm purchase commitments.
−Removed: 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.
+Added: For the three and six months ended June 30, 2025, inventory write-downs were $ 1.1 million and $ 1.4 million, respectively, and there were no losses on firm purchase commitments.
+Added: For the three and six
+Added: months ended June 30, 2024, inventory write-downs were $ 9.7 million and $ 18.5 million, respectively, and losses on firm purchase commitments were $ 1.7 million.
Note 10 – Goodwill
−Removed: The Company has one reporting unit, which has a negative carrying amount as of March 31, 2025 and December 31, 2024.
−Removed: The change in the carrying amounts of goodwill for the three months ended March 31, 2025 was as follows (in thousands):
+Added: The Company has one reporting unit.
+Added: No goodwill impairment was identified for the period ended June 30, 2025.
+Added: The Company had a negative carrying value as of December 31, 2024.
+Added: The change in the carrying amounts of goodwill for the six months ended June 30, 2025 was as follows (in thousands):
Balance at December 31, 2024 $ 107,478
Currency translation adjustments 5,480
−Removed: Balance at March 31, 2025 $ 112,027
+Added: Balance at June 30, 2025 $ 112,958
Note 11 – Long-Term Debt
Total convertible notes payable consisted of the following (in thousands):
−Removed: March 31, 2025 December 31, 2024
+Added: June 30, 2025 December 31, 2024
5.00 % Convertible notes due 2027
3 unchanged sentences
$ 170,568 $ 169,684
−Removed: The effective interest rate of the 2027 Convertible notes is 6.2 %.
+Added: As of June 30, 2025 and December 31, 2024, the effective interest rate of the 2027 Convertible notes is 6.2 %.
The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands):
Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Coupon interest $ 2,192 $ 2,192 $ 4,384 $ 4,384
3 unchanged sentences
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.
−Removed: During the three months ended March 31, 2025, and 2024, no sales were recorded under the August 2023 Sales Agreement.
−Removed: As of March 31, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $ 51 million.
+Added: During the three and six months ended June 30, 2025, no sales were recorded under the August 2023 Sales Agreement.
+Added: During the three and six months ended June 30, 2024, the Company sold 12.2 million shares of its common stock resulting in net proceeds of approximately $ 188 million, under the August 2023 Sales Agreement.
+Added: As of June 30, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $ 51 million.
+Added: 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, 6,880,481 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.
Note 13 – Stock-Based Compensation
−Removed: 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.
+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-
+Added: 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 March 31, 2025, there were 0.1 million shares available for issuance under the 2023 Inducement Plan.
+Added: As of June 30, 2025, there were 0.1 million shares available for issuance under the 2023 Inducement Plan.
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.
3 unchanged sentences
The 2015 Plan will expire on April 19, 2034.
−Removed: As of March 31, 2025, there were 0.4 million shares available for issuance under the 2015 Plan.
+Added: As of June 30, 2025, there were 6.2 million shares available for issuance under the 2015 Plan.
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”).
4 unchanged sentences
Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Cost of sales $ 382 $ 1,104 $ 907 $ 1,698
2 unchanged sentences
Total stock-based compensation expense $ 9,214 $ 14,099 $ 19,499 $ 25,655
−Removed: During the three months ended March 31, 2025 and 2024 ther e were no stock-based compensation expense capitalized into inventory.
−Removed: 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”).
−Removed: 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.
+Added: During the three and six months ended June 30, 2025 and 2024 ther e were no stock-based compensation expense capitalized into inventory.
+Added: As of June 30, 2025, there was approximately $ 61 million of total unrecognized compensation expense related to unvested stock options, SARs, RSUs, and the Company’s Employee Stock Purchase Plan (“ESPP”).
+Added: 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, R&D, 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 March 31, 2025.
+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 June 30, 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 three months ended March 31, 2025 and 2024 was $ 16.2 million and $ 4.5 million, respectively.
+Added: The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the six months ended June 30, 2025 and 2024 was approximately $ 18 million and $ 8 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 and 2015 Plan for the three months ended March 31, 2025:
+Added: The following is a summary of stock options activity under the 2023 Inducement Plan and 2015 Plan for the six months ended June 30, 2025:
2023 Inducement Plan 2015 Plan
5 unchanged sentences
Canceled — — ( 521,034 ) 51.79
−Removed: Outstanding at March 31, 2025 486,950 $ 10.45 5,295,846 $ 20.31
−Removed: Shares exercisable at March 31, 2025 215,485 $ 10.80 2,055,818 $ 37.53
+Added: Outstanding at June 30, 2025 486,950 $ 10.45 5,408,098 $ 19.67
+Added: Shares exercisable at June 30, 2025 241,911 $ 10.79 2,209,663 $ 35.81
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
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Weighted average Black-Scholes fair value of stock options granted $ 5.65 $ 14.13 $ 5.60
Risk-free interest rate 3.7 %- 4.1 %
+Added: 4.3 % 3.7 %- 4.1 %
Dividend yield — % — % — % — %
1 unchanged sentence
98.1 %- 121.7 %
+Added: 114.3 %- 121.8 %
Expected term (in years) 3.8 - 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 and 2015 Plan as of March 31, 2025 was $ 0.9 million and 8.1 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 and 2015 Plan as of March 31, 2025 was $ 0.4 million and 6.2 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 June 30, 2025 was $ 0.8 million and 8.0 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 June 30, 2025 was $ 0.4 million and 6.1 years , respectively.
Restricted Stock Units
−Removed: The following is a summary of RSU activity for the three months ended March 31, 2025:
+Added: The following is a summary of RSU activity for the six months ended June 30, 2025:
2023 Inducement Plan 2015 Plan
6 unchanged sentences
Forfeited — — ( 677,308 ) 7.80
−Removed: Outstanding and unvested at March 31, 2025 182,633 $ 10.11 7,070,487 $ 8.27
+Added: Outstanding and unvested at June 30, 2025 182,633 $ 10.11 6,489,499 $ 7.28
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 March 31, 2025, there were 0.7 million shares available for issuance under the ESPP.
+Added: As of June 30, 2025, there were 0.8 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 March 31, 2025 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 June 30, 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 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.
−Removed: 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.
−Removed: During the three months ended March 31, 2025, the company recognized $ 0.5 million of foreign withholding tax expense.
−Removed: During the three months ended March 31, 2024, the company did no t recognize any foreign withholding tax expense.
+Added: On the basis of this evaluation, as of June 30, 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 June 30, 2025 and 2024, the Company recognized $ 0.9 million and $ 2.2 million of federal, state, and foreign income tax expense and foreign withholding tax expense, respectively.
+Added: During the six months ended June 30, 2025 and 2024, the Company recognized $ 2.1 million and $ 4.5 million of federal, state, and foreign income tax expense, respectively.
+Added: On July 4, 2025, President Trump signed into federal law H.R.
+Added: 1 – One Big Beautiful Bill Act (the “Act”).
+Added: Included in the Act are several corporate federal income tax considerations that will be relevant to the Company, specifically with respect to tax depreciation for specified fixed asset additions, capitalization of R&D costs, the deductibility of interest expense and certain federal tax rules with respect to the taxation of international operations.
+Added: There is no impact of the Act considered in the calculation of the total income tax expense recorded for the three and six months ended June 30, 2025 given the enactment of the Act occurred after the end of the period.
+Added: The Company is currently evaluating the financial statement impact of the Act.
Note 15 – Commitments and Contingencies
78 unchanged sentences
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.
−Removed: On May 2, 2025, the Delaware Court granted the stipulated order of voluntary dismissal, and the Mesa Action was dismissed with prejudice.
+Added: On May 2, 2025, and July 9, 2025, the Delaware Court granted the stipulated order of voluntary dismissal of the Mesa Action and the Acosta Action respectively, and both were dismissed with prejudice.
On April 17, 2023, the Needelman Action was filed.
12 unchanged sentences
Note 16 – Restructuring
−Removed: 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.”).
−Removed: 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: During the three and six months ended June 30, 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 June 30, 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.
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.
−Removed: 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.
−Removed: 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: While no triggering events have occurred as of June 30, 2025, the Company continues to evaluate options and will perform impairment tests if such indicators arise in future periods.
+Added: As of June 30, 2025, the Company’s net investment in assets related to its corporate headquarters’ leased laboratory and office space located in Gaithersburg, Maryland was approximately $ 111 million, comprised of approximately $ 131 million of right of use assets, approximately $ 32 million of leasehold improvements net of a finance lease obligation of approximately $ 52 million.
The restructuring charge recorded by the Company consisted of the following (in thousands):
Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
Severance and employee benefit costs $ 4,218 $ 1,119 $ 4,723 $ 5,520
2 unchanged sentences
$ 4,566 $ 1,119 $ 5,071 $ 7,189
−Removed: (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.
−Removed: 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 .
+Added: (1) Restructuring charges of $ 1.6 million and $ 3.0 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 June 30, 2025.
+Added: Restructuring charges of $ 1.6 million and $ 3.5 million are included in Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the six months ended June 30, 2025.
+Added: Restructuring charges of $ 0.5 million, $ 0.3 million and $ 0.3 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 three months ended June 30, 2024.
+Added: Restructuring charges of $ 0.5 million, $ 1.9 million and $ 4.8 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 six months ended June 30, 2024.
Severance and employee benefit costs
Employees affected by reductions in force under the Restructuring Plan are entitled to receive severance payments and certain termination benefits.
−Removed: 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 $ 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 recorded a severance and termination benefit cost in full for employees who were notified of their termination during the six months ended June 30, 2025 and had no requirements for future service as of the end of the period.
+Added: The Company paid a total of $ 5.2 million for the severance and employee benefit costs during the six months ended June 30, 2025 and the remaining liability of $ 2.6 million is included in Accrued expenses in the Company’s consolidated balance sheet as of June 30, 2025.
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.
2 unchanged sentences
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 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.
−Removed: The Company did not recognize any impairment charge during the three months ended March 31, 2025.
+Added: During the three and six months ended June 30, 2025, the Company recorded an impairment charge of $ 0.3 million, related to the impairment of right of use asset for a facility lease.
+Added: During six months ended June 30, 2024, the Company recorded an impairment charge of $ 1.7 million related to the impairment of capitalized internal-use software.
Note 17 – Segment Reporting
1 unchanged sentence
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.
−Removed: 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 Company’s CODM uses consolidated single-segment net
+Added: income (loss) as reported in the Consolidated Statements of Operations to evaluate performance, forecast future period financial results, allocate resources, and set incentive targets.
The table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands):
Three Months Ended
+Added: June 30, Six Months Ended
2025 2024 2025 2024
+Added: $ 239,240 $ 415,484 $ 905,895 $ 509,339
Cost of sales
4 unchanged sentences
Direct other vaccine development programs (1)
+Added: 842 400 2,720 736
Employee and benefit expenses
6 unchanged sentences
5,438 1,383 8,570 ( 1,336 )
−Removed: Net income (loss) $ 518,646 $ ( 147,550 )
+Added: Net income $ 106,508 $ 162,381 $ 625,154 $ 14,831
(1) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities.
−Removed: Direct coronavirus vaccines expenses include costs associated with the Phase 3 trial for our CIC and influenza vaccine candidates.
+Added: Direct coronavirus vaccines expenses include costs associated with the Phase 3 trial for the Company’s CIC and stand-alone influenza vaccine candidates.
(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.
2 unchanged sentences
Three Months Ended
+Added: June 30, Six Months Ended
+Added: 2025 2024 2025 2024
United States
$ 198,183 $ 394,504 $ 237,593 $ 388,073
+Added: — — 575,670 —
Europe 3,627 705 11,712 91,121
Rest of the world
+Added: 37,430 20,275 80,920 30,145
Total revenue
1 unchanged sentence
Total long-lived assets of the Company by geographic location were as follows (in thousands):
−Removed: March 31, 2025 December 31, 2024
+Added: June 30, 2025 December 31, 2024
United States $ 278,921 $ 295,879
3 unchanged sentences
Note 18 – Subsequent Events
−Removed: In April 2025, the Company received a formal communication from the U.S.
−Removed: FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data.
−Removed: The Company has responded to the U.S.
−Removed: FDA’s information request with a proposed study design and continues to engage with the U.S.
−Removed: FDA to address the PMC request and move to approval as soon as possible.
−Removed: 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.
−Removed: The Amended Takeda APA improves financial terms for the Company.
+Added: On July 10, 2025, the Company entered into a letter agreement with Sanofi (“Letter Agreement”) to address the funding and execution of the postmarketing commitment (“PMC”) to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19 requested as part of the FDA’s BLA approval.
+Added: The Letter Agreement establishes that the Company will be responsible for conducting the PMC study and details the level of financial support to be provided by Sanofi for the trial’s costs.
+Added: Sanofi will reimburse the Company for 70 % of the PMC costs, capped at the currently agreed upon cost estimates.
+Added: The Company will recognize cost reimbursements from Sanofi related to the PMC in licensing, royalties, and other revenue over time using an input method, consistent with Sanofi Transition Services and Sanofi Technology Transfer.
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.