Item 1. Financial Statements
Item 1. Financial Statements
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Table of Contents
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
For the Three Months Ended
September 30, For the Nine Months Ended
September 30,
2025 2024 2025 2024
Revenue:
Product sales $ 13,442 $ 41,528 $ 645,844 $ 153,952
Licensing, royalties, and other 57,003 42,984 330,496 439,899
Total revenue 70,445 84,512 976,340 593,851
Expenses:
Cost of sales 21,496 60,619 50,936 166,070
Research and development 98,274 87,164 266,444 286,789
Selling, general, and administrative 31,655 70,747 123,357 258,843
Impairment of assets held for sale
97,038 — 97,038 —
Total expenses 248,463 218,530 537,775 711,702
Income (loss) from operations
( 178,018 ) ( 134,018 ) 438,565 ( 117,851 )
Other income (expense):
Interest expense ( 5,482 ) ( 4,236 ) ( 16,723 ) ( 12,490 )
Loss on debt extinguishment
( 28,714 ) — ( 28,714 ) —
Other income, net
9,178 15,922 31,136 27,307
Income (loss) before income tax expense
( 203,036 ) ( 122,332 ) 424,264 ( 103,034 )
Income tax expense (benefit) ( 657 ) ( 1,032 ) 1,489 3,435
Net income (loss)
$ ( 202,379 ) $ ( 121,300 ) $ 422,775 $ ( 106,469 )
Net income (loss) per share:
Basic $ ( 1.25 ) $ ( 0.76 ) $ 2.61 $ ( 0.71 )
Diluted $ ( 1.25 ) $ ( 0.76 ) $ 2.53 $ ( 0.71 )
Weighted average number of common shares outstanding:
Basic 162,353 160,049 161,811 149,486
Diluted 162,353 160,049 168,195 149,486
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
(unaudited)
For the Three Months Ended
September 30, For the Nine Months Ended
September 30,
2025 2024 2025 2024
Net income (loss) $ ( 202,379 ) $ ( 121,300 ) $ 422,775 $ ( 106,469 )
Other comprehensive income (loss):
Net unrealized gain on available-for-sale marketable securities
95 393 545 243
Foreign currency translation adjustment ( 1,382 ) 13,713 20,269 633
Other comprehensive income (loss)
( 1,287 ) 14,106 20,814 876
Comprehensive income (loss) $ ( 203,666 ) $ ( 107,194 ) $ 443,589 $ ( 105,593 )
The accompanying notes are an integral part of these financial statements.
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Table of Contents
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
September 30,
2025 December 31,
2024
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 268,023 $ 530,230
Marketable securities 494,871 392,888
Restricted cash 10,816 10,626
Accounts receivable 34,174 108,285
Inventory 13,511 8,749
Prepaid expenses and other current assets 45,532 78,164
Assets held for sale 107,663 —
Total current assets 974,590 1,128,942
Property and equipment, net 49,120 138,413
Right of use asset, net 23,873 161,585
Goodwill 113,080 107,478
Other non-current assets 19,226 24,000
Total assets $ 1,179,889 $ 1,560,418
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 15,227 $ 41,579
Accrued expenses 115,586 211,165
Deferred revenue 104,251 675,067
Current portion of finance lease liabilities 5,036 7,009
Other current liabilities 138,334 219,596
Liabilities held for sale 51,435 —
Total current liabilities 429,869 1,154,416
Deferred revenue 397,105 446,819
Convertible notes payable 243,835 169,684
Non-current finance lease liabilities 2,269 53,726
Other non-current liabilities 263,483 359,614
Total liabilities 1,336,561 2,184,259
Commitments and contingencies (Note 15)
Preferred stock, $ 0.01 par value, 2,000,000 shares authorized at September 30, 2025 and December 31, 2024; no shares issued and outstanding at September 30, 2025 and December 31, 2024
— —
Stockholders' deficit:
Common stock, $ 0.01 par value, 600,000,000 shares authorized at September 30, 2025 and December 31, 2024; 164,817,266 shares issued and 162,470,138 shares outstanding at September 30, 2025 and 161,942,677 shares issued and 160,421,136 shares outstanding at December 31, 2024
1,648 1,619
Additional paid-in capital 4,531,763 4,501,403
Accumulated deficit ( 4,585,675 ) ( 5,008,450 )
Treasury stock, cost basis, 2,347,128 shares at September 30, 2025 and 1,521,541 shares at December 31, 2024
( 102,663 ) ( 95,854 )
Accumulated other comprehensive loss
( 1,745 ) ( 22,559 )
Total stockholders’ deficit
( 156,672 ) ( 623,841 )
Total liabilities and stockholders’ deficit
$ 1,179,889 $ 1,560,418
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
Three and Nine Months Ended September 30, 2025 and 2024
(in thousands, except share information)
(unaudited)
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Treasury
Stock Accumulated Other
Comprehensive
Income (Loss)
Total Stockholders'
Equity (Deficit)
Shares Amount
Balance at June 30, 2025 164,475,337 $ 1,645 $ 4,522,193 $ ( 4,383,296 ) $ ( 102,459 ) $ ( 458 ) $ 37,625
Stock-based compensation — — 8,549 — — — 8,549
Stock issued under incentive programs 341,929 3 1,021 — ( 204 ) — 820
Unrealized gain on available-for-sale marketable securities
— — — — — 95 95
Foreign currency translation adjustment — — — — — ( 1,382 ) ( 1,382 )
Net loss
— — — ( 202,379 ) — — ( 202,379 )
Balance at September 30, 2025 164,817,266 $ 1,648 $ 4,531,763 $ ( 4,585,675 ) $ ( 102,663 ) $ ( 1,745 ) $ ( 156,672 )
Balance at June 30, 2024 161,267,120 $ 1,613 $ 4,477,748 $ ( 4,806,120 ) $ ( 94,439 ) $ ( 10,508 ) $ ( 431,706 )
Stock-based compensation — — 12,049 — — — 12,049
Stock issued under incentive programs 291,127 3 833 — ( 421 ) — 415
Unrealized gain on marketable securities
— — — — — 393 393
Foreign currency translation adjustment — — — — 13,713 13,713
Net loss — — — ( 121,300 ) — — ( 121,300 )
Balance at September 30, 2024 161,558,247 $ 1,616 $ 4,490,630 $ ( 4,927,420 ) $ ( 94,860 ) $ 3,598 $ ( 526,436 )
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Treasury
Stock Accumulated Other
Comprehensive
Income (Loss) Total Stockholders'
Equity (Deficit)
Shares Amount
Balance at December 31, 2024 161,942,677 $ 1,619 $ 4,501,403 $ ( 5,008,450 ) $ ( 95,854 ) $ ( 22,559 ) $ ( 623,841 )
Stock-based compensation — — 28,048 — — — 28,048
Stock issued under incentive programs 2,874,589 29 2,312 — ( 6,809 ) — ( 4,468 )
Unrealized gain on available-for-sale marketable securities
— — — — — 545 545
Foreign currency translation adjustment — — — — — 20,269 20,269
Net income
— — — 422,775 — — 422,775
Balance at September 30, 2025 164,817,266 $ 1,648 $ 4,531,763 $ ( 4,585,675 ) $ ( 102,663 ) $ ( 1,745 ) $ ( 156,672 )
Balance at December 31, 2023 140,506,093 $ 1,405 $ 4,192,164 $ ( 4,820,951 ) $ ( 92,267 ) $ 2,722 $ ( 716,927 )
Stock-based compensation — — 37,704 — — — 37,704
Stock issued under incentive programs 1,958,757 20 4,544 — ( 2,593 ) — 1,971
Issuance of common stock, net of issuance costs of $ 3,830
19,093,397 191 256,218 — — — 256,409
Unrealized gain on marketable securities — — — — — 243 243
Foreign currency translation adjustment — — — — — 633 633
Net loss — — — ( 106,469 ) — — ( 106,469 )
Balance at September 30, 2024 161,558,247 $ 1,616 $ 4,490,630 $ ( 4,927,420 ) $ ( 94,860 ) $ 3,598 $ ( 526,436 )
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Nine Months Ended September 30,
2025 2024
Operating Activities:
Net income (loss) $ 422,775 $ ( 106,469 )
Reconciliation of net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization 22,488 35,979
Non-cash stock-based compensation 28,048 37,704
Provision for excess and obsolete inventory 1,945 19,913
Impairment of assets held for sale
97,038 —
Impairment of long-lived assets 3,382 5,431
Loss on debt extinguishment
28,714 —
Other items, net 4,453 ( 3,786 )
Changes in operating assets and liabilities:
Inventory ( 5,388 ) 13,103
Accounts receivable, prepaid expenses, and other assets 112,980 353,176
Accounts payable, accrued expenses, and other liabilities ( 301,023 ) ( 343,158 )
Deferred revenue ( 620,572 ) 74,007
Net cash provided by (used in) operating activities ( 205,160 ) 85,900
Investing Activities:
Capital expenditures ( 3,484 ) ( 11,125 )
Purchases of available-for-sale marketable securities
( 349,736 ) ( 441,265 )
Proceeds from maturities of available-for-sale marketable securities
255,125 105,607
Internal-use software ( 655 ) ( 1,262 )
Net cash provided used in investing activities
( 98,750 ) ( 348,045 )
Financing Activities:
Net proceeds from sales of common stock — 263,272
Proceeds on the issuance of Convertible Senior Notes due 2031, net of issuance costs
42,606 —
Net proceeds from the exercise of stock-based awards ( 4,468 ) 1,971
Finance lease payments ( 3,797 ) ( 1,238 )
Net cash provided by financing activities
34,341 264,005
Effect of exchange rate on cash, cash equivalents, and restricted cash 7,634 2,917
Net increase (decrease) in cash, cash equivalents, and restricted cash
( 261,935 ) 4,777
Cash, cash equivalents, and restricted cash at beginning of period 545,292 583,810
Cash, cash equivalents, and restricted cash at end of period $ 283,357 $ 588,587
Supplemental disclosure of non-cash activities:
Issuance of Convertible Senior Notes due 2031 in exchange for Convertible Senior Notes due 2027
$ 175,305 $ —
Right-of-use assets from new lease agreements $ 1,803 $ ( 4,302 )
Capital expenditures included in accounts payable and accrued expenses $ 250 $ 1,607
Internal-use software included in accounts payable and accrued expenses
$ — $ 320
Supplemental disclosure of cash flow information:
Cash interest payments, net of amounts capitalized $ 12,113 $ 8,500
Cash paid for income taxes, net of refunds
$ 8,800 $ 641
The accompanying notes are an integral part of these financial statements.
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NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2025
(unaudited)
Note 1 – Organization and Business
Novavax, Inc. (“Novavax,” and together with its wholly owned subsidiaries, the “Company”) is tackling global health challenges through scientific innovation by leveraging its deep scientific expertise in vaccines and cutting-edge technology platform. The differentiated platform features the Company’s recombinant protein-based nanoparticle technology and its unique Matrix-M ® adjuvant.
The Company’s corporate growth strategy seeks to create value from its proven technology platform by advancing research and development (“R&D”) innovation, organically growing its 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. ("Sanofi”) announced in May 2024, enhancing existing partnerships while 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, agile, and focused operating model.
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. Ltd. (“SII”), markets Novavax’s COVID-19 Vaccine as “Covovax™.”
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
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. The 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’ equity (deficit), and cash flows for the periods presented. Although the Company believes that the disclosures in these unaudited consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”).
The accompanying unaudited consolidated financial statements include the accounts of Novavax, Inc. and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The aggregate foreign currency transaction gains and losses resulting from the conversion of the transaction currency to functional currency were a $ 1.8 million and $ 0.2 million gain, and a $ 1.2 million and $ 7.9 million loss for the three and nine months ended September 30, 2025 and 2024, respectively, which are reflected in Other income, 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. Results for this or any interim period are not necessarily indicative of results for any future interim period or for the entire year. The Company operates in one business segment.
Reclassifications
Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position and cash flows.
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The Company reclassified $ 3.3 million and $ 13.5 million of revenue previously reported as License, royalties, and other revenue to Product sales for the three and nine ended September 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.
Liquidity and Going Concern
The accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued and contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. 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.
As of September 30, 2025, the Company had $ 268.0 million in cash and cash equivalents, $ 494.9 million in marketable securities, and working capital of $ 544.7 million. During the nine months ended September 30, 2025, the Company recognized net income of $ 422.8 million and had net cash flows used in operating activities of $ 205.2 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.
Use of Estimates
The preparation of the accompanying unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the accompanying unaudited consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.
Restructuring
The Company recognizes restructuring charges when such costs are incurred. The Company’s restructuring charges consist of employee severance and other termination benefits related to the reduction of its workforce, the consolidation of facilities, and infrastructure and other costs. Termination benefits are expensed on the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. Ongoing benefits are expensed when restructuring activities are probable and the benefit is estimable. When the Company commits to a plan to sell a disposal group and meets the criteria for classification as held for sale under ASC 360, Property, Plant, and Equipment (“ASC 360”), the disposal group is classified as held for sale. It is subsequently measured at the lower of its carrying amount or fair value less cost to sell. Upon reclassification, depreciation and amortization cease, and any resulting impairment loss is recognized immediately within Impairment of assets held for sale in the Consolidated Statements of Operations. The assets and any associated liabilities are presented separately as current assets and current liabilities on the Consolidated Balance Sheets, as the Company expects to divest the disposal group within 12 months.
See Note 16 for additional information on the impairment of assets and on the severance and employee benefit costs for terminated employees in connection with the Company's Restructuring Plan, as defined in Note 16.
Recent Accounting Pronouncements
Not Yet Adopted
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”). 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. 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
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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.
In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”). This standard is intended to improve the operability and application of guidance related to capitalized software development costs and becomes effective January 1, 2028. The Company is assessing the potential impact this ASU may have on the Company’s consolidated financial statements and disclosures upon adoption.
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. The effective date for each amendment in the ASU is the effective date that the SEC removes the disclosure requirement from its regulations. 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”). The standard enhances transparency in income tax disclosures by requiring, on an annual basis, certain disaggregated information about a reporting entity’s effective tax rate reconciliation and income taxes paid. 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. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024. The Company is completing its evaluation of the impact of ASU 2023-09 on its disclosures.
Note 3 – Marketable Securities
Marketable securities were classified as available-for-sale as of September 30, 2025 and December 31, 2024, comprised of (in thousands):
September 30, 2025 December 31, 2024
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
Treasury securities $ 171,765 $ 607 $ — $ 172,372 $ 184,438 $ 116 $ — $ 184,554
Corporate debt securities 322,521 — ( 22 ) 322,499 208,410 — ( 76 ) 208,334
Total marketable securities $ 494,286 $ 607 $ ( 22 ) $ 494,871 $ 392,848 $ 116 $ ( 76 ) $ 392,888
As of September 30, 2025, investments in marketable securities were comprised of $ 172.4 million of treasury securities, of which $ 10.0 million mature in 2025 and $ 162.4 million mature in 2026, and $ 322.5 million of corporate debt securities, of which $ 88.4 million mature in 2025 and $ 234.1 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. Marketable securities are classified as Current assets in the Consolidated balance sheet of the Company as of September 30, 2025 and December 31, 2024. During the three and nine months ended September 30, 2025, the Company recognized interest income of $ 7.2 million and $ 22.2 million, respectively, from its investments in securities. During the three and nine months ended September 30, 2024, the Company recognized interest income of $ 12.3 million and $ 28.0 million, respectively, from its investments in securities. This income is included within Other income, net on the consolidated statements of operations. Based on the Company’s policy under the expected credit loss model, including an assessment of the investment portfolio as of September 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. As of September 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. As of September 30, 2025 and December 31, 2024, the Company held no securities that were in an unrealized loss position for more than 12 months.
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Note 4– Fair Value Measurements
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities (in thousands):
Fair Value at September 30, 2025 Fair Value at December 31, 2024
Assets Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
Money market funds (1)
$ 106,160 $ — $ — $ 287,393 $ — $ —
Government-backed securities (1)
— 150,000 — — 130,000 —
Treasury securities
— 172,372 — — 184,554 —
Corporate debt securities (2)
— 322,499 — — 243,158 —
Total cash equivalents and marketable securities
$ 106,160 $ 644,871 $ — $ 287,393 $ 557,712 $ —
Liabilities
5.00 % Convertible notes due 2027
$ — $ 30,269 $ — $ — $ 174,386 $ —
4.625 % Convertible notes due 2031
$ — $ 252,241 $ — $ — $ — $ —
(1) Classified as cash and cash equivalents as of September 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.
Fixed-income investments categorized as Level 2 are valued at the custodian bank by a third-party pricing vendor’s valuation models that use verifiable observable market data, such as interest rates and yield curves observable at commonly quoted intervals and credit spreads, bids provided by brokers or dealers, or quoted prices of securities with similar characteristics. Pricing of the Company’s convertible notes has been estimated using observable inputs, including the price of the Company’s common stock, implied volatility, interest rates, and credit spreads.
During the nine months ended September 30, 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
The Company's accounts receivable included $ 28.9 million and $ 102.9 million related to amounts that were billed to customers and $ 5.2 million and $ 5.4 million related to amounts which had not yet been billed to customers as of September 30, 2025 and December 31, 2024, respectively. During the nine months ended September 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:
Nine Months Ended September 30, 2025 $ 115,960 $ 481,143 $ ( 555,254 ) $ 41,849
Nine Months Ended September 30, 2024 304,916 882,979 ( 1,085,258 ) 102,637
Allowance for credit losses (1) :
Nine Months Ended September 30, 2025 ( 7,675 ) — — ( 7,675 )
Nine Months Ended September 30, 2024 ( 7,675 ) — — ( 7,675 )
Deferred revenue (2) :
Nine Months Ended September 30, 2025 1,121,886 25,595 ( 646,125 ) 501,356
Nine Months Ended September 30, 2024 863,520 363,758 ( 98,490 ) 1,128,788
(1) There was no allowance for credit losses recorded during the nine months ended September 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.
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(2) Deductions from Deferred revenue generally relate to the recognition of revenue once performance obligations on a contract with a customer are met. During the nine months ended September 30, 2025, deductions include $ 555.7 million related to the Canada Advanced Purchase Agreement (“APA”) termination, discussed below. 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.
As of September 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. 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. The timing and the Company’s 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. The timing to fulfill performance obligations related to the Sanofi Collaboration and License Agreement (“Sanofi CLA”) will depend on the timing of research and development transition services that support further regulatory approval and development of the COVID-19 Vaccine (“Sanofi Transition Services”) and services related to the technology transfer of the existing manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ adjuvant (the “Sanofi Technology Transfer”) 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. The deferred payments are due in variable quarterly installments and total $ 400 million during the deferred payment term. Such deferred payments may be reduced through Gavi’s use of an annual vaccine credit equivalent to the unpaid balance of such deferred payments each year, which may be applied to qualifying sales of any of the Company’s vaccines for supply to certain low-income and lower-middle income countries. The Company has the right to price the vaccines offered to such low-income and lower-middle income countries in its discretion, and, when utilized by Gavi, the Company will credit the actual price per vaccine paid against the applicable credit. The Company intends to price vaccines offered via the tender process, consistent with its shared goal with Gavi to provide equitable access to those countries. Also, pursuant to the Gavi Settlement Agreement, the Company granted Gavi an additional credit of up to $ 225 million that may be applied against qualifying sales of any of the Company’s vaccines for supply to such low-income and lower-middle income countries that exceed the $ 80 million deferred payment amount in any calendar year during the deferred payment term. 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.
As of September 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 $ 210.0 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.
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Product Sales
During the three and nine months ended September 30, 2025 and 2024, the categories of Product sales were as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Product sales
Nuvaxovid sales (1)
$ ( 332 ) $ 38,210 $ 605,599 $ 140,438
Supply sales (2)
13,774 3,318 40,245 13,514
Total Product sales
$ 13,442 $ 41,528 $ 645,844 $ 153,952
(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. During the three months ended September 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.
As of September 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
Product Returns
Total
Balance as of December 31, 2024 $ 21,136 $ 116,697 $ 137,833
Amounts charged against Product sales (1)
14,718 37,141 51,859
Credits/deductions
( 35,137 ) ( 152,405 ) ( 187,542 )
Balance as of September 30, 2025 $ 717 $ 1,433 $ 2,150
Wholesale Distributor Fees, Discounts, and Chargebacks
Product Returns
Total
Balance as of December 31, 2023 $ 21,072 $ 84,616 $ 105,688
Amounts charged against Product sales (1)
60,092 80,593 140,685
Credits/deductions
( 56,583 ) ( 86,937 ) ( 143,520 )
Balance as of September 30, 2024 $ 24,581 $ 78,272 $ 102,853
(1) For the nine months ended September 30, 2025 and 2024, amounts charged against Product sales include $ 2.2 million and $ 4.2 million of adjustments made to prior period Product sales due primarily to changes in the estimate of product returns.
As of September 30, 2025, $ 0.1 million of gross-to-net deductions were included in and reduced Accounts receivable and $ 2.1 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 in 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”). As of September 30, 2025, $ 31.3 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 sales as doses are delivered to Australia. Australia may cancel doses that are
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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. Following the withdrawal of the Company’s application for authorization of its updated COVID-19 Vaccine in July 2025 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. The Company may seek to further amend the Australian APA in light of this development, which 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 if the Australian APA were to be terminated, of which $ 10.8 million may become refundable if 2025 dose deliveries were cancelled.
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”). 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. on or before December 31, 2024, pursuant to the terms of the Canada APA. As a result of the Notice, the Company has no remaining obligations to the Canadian government under the Canada APA. 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. 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. 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. The Company repaid the $ 28.0 million in March 2025. 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. The Notice also acknowledged that such MOU is no longer feasible and that the related funds may be released to the Company.
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”). 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. 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
Licensing, royalties, and other includes licensing payments, transition services revenue, and technology transfer revenue from the Sanofi CLA; royalty milestone payments; and sales-based royalties.
Licensing, royalties, and other by license partner for the three and nine months ended September 30, 2025 and 2024 were as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Licensing, royalties, and other
Sanofi $ 48,294 $ 36,115 $ 288,027 $ 429,012
Takeda 6,445 4,918 33,657 4,918
Other partners (1)
2,264 1,951 8,812 5,969
Total licensing, royalties, and other revenue $ 57,003 $ 42,984 $ 330,496 $ 439,899
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(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):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Sanofi licensing, royalties, and other revenue
Licensing:
Upfront fee $ — $ 3,392 $ — $ 389,642
Milestones — — 175,000 —
Royalties
4,196 — 4,196 —
Transition services and technology transfer:
Upfront fee amortization (1)
( 1,083 ) 14,973 31,097 19,546
Milestones amortization (1)
( 645 ) 7,032 14,163 9,105
Cost reimbursements
45,826 10,718 63,571 10,719
Total Sanofi licensing, royalties, and other revenue
$ 48,294 $ 36,115 $ 288,027 $ 429,012
(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. During the three months ended September 30, 2025, the Company recognized a change in estimate to cumulative revenue recognized for the Sanofi Transition Services performance obligation of $ 12.5 million as further described in Note 6, which also resulted in a reduction in upfront fee and milestone amortization revenue during the third quarter of 2025, and an increase in cost reimbursement revenue.
Takeda licensing, royalties, and other revenue were comprised of the following (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Takeda licensing, royalties, and other revenue
Licensing:
Upfront fee (1)
$ — $ — $ 18,500 $ —
Milestones 4,717 — 8,151 $ —
Royalties
1,456 4,564 6,456 $ 4,564
Support services 272 354 550 354
Tota Total Takeda licensing, royalties, and other revenue
$ 6,445 $ 4,918 $ 33,657 $ 4,918
(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.
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Note 6 – Collaboration, License, and Supply Agreements
As of September 30, 2025, the Company’s material collaborations, license and supply agreements were as follows:
Serum
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. The Company and SII equally split the revenue from SII’s sale of COVID-19 Vaccine in its licensed territory, net of agreed costs. In May 2024, the Company and SLS entered into a supply agreement (the “SLS Supply Agreement”) under which SLS agreed to supply the Company with antigen drug substance and finished COVID-19 Vaccine doses. The SLS Supply Agreement includes the general terms and conditions of supply orders between the Company and SLS. The Company and SLS execute firm purchase orders, which include specific quantities to be delivered under the SLS Supply Agreement. The Company agreed to supply SLS with all Matrix-M adjuvant needed to manufacture finished COVID-19 Vaccine doses. 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 up to approximately $ 36 million of certain raw materials under related agreements with SII. 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”). In December 2023, R21/Matrix-M received prequalification by the World Health Organization (“WHO”). 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.
Takeda
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”). 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. 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.
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.
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: 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”). The Company will recognize revenue on optional purchases of Matrix-M adjuvant upon delivery to Takeda.
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. 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.
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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. 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. 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. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur. The Company allocated $ 26.9 million of fixed consideration to the Updated Takeda License performance obligations and $ 0.6 million to Takeda Support Services.
The Company recognized revenue of $ 6.2 million and $ 33.1 million related to the Updated Takeda License during the three and nine months ended September 30, 2025, respectively. 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. Revenue recognized related to Takeda Support Services for the three and nine months ended September 30, 2025 was $ 0.3 million and $ 0.6 million, respectively.
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. 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. If Takeda receives marketing approval of the COVID-19 Vaccine in that year or such approval is not necessary for such year, 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. 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 later of (a) twenty years after April 29, 2025, (b) all the Company’s 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. During the three months ended September 30, 2025, the Company recognized $ 4.7 million of milestone revenue for additional milestones earned under the Takeda CLA.
Sanofi
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. Under the terms of the agreement, the Company continued 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. Upon completion of the existing APAs, the Company and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction. Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing the Company’s COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine, combination products containing the Company’s COVID-19 Vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing the Company’s Matrix-M adjuvant. The Company is also responsible for performing services related to Sanofi Technology Transfer. Until the successful completion of such transfer, the Company will supply Sanofi with both COVID-19 Vaccine products and Matrix-M intermediary components for Sanofi’s use and is eligible for reimbursement of such costs from Sanofi. In addition, the Company is responsible for Sanofi Transition Services and, in certain cases, is eligible for reimbursement of such costs from Sanofi.
Pursuant to the Sanofi CLA, the Company is eligible to receive development, technology transfer, launch, and sales milestone payments for COVID-19 Vaccine products, CIC products, and Adjuvant products. The Company is also eligible to receive royalty payments on Sanofi’s sales of such licensed products.
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The Company is eligible to receive milestone payments totaling up to $ 350 million in the aggregate with respect to the COVID-19 Vaccine products, of which $ 125 million remains outstanding, and royalty payments in the high teens to low twenties percent on Sanofi’s sales of such licensed products. As of September 30, 2025, the remaining milestone payments are comprised of $ 25 million upon the transfer of the U.S. marketing authorization 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, and $ 75 million upon the completion of the technology transfer of the Company’s manufacturing process for the COVID-19 Vaccine products to Sanofi. During the three and nine month period ended September 30, 2025, the Company recognized $ 4.2 million of royalties on Sanofi sales of COVID-19 Vaccine products. The Company achieved the $ 50 million milestone for database lock of an existing Phase 2/3 clinical trial in 2024 and the $ 175 million milestone for the U.S. Food and Drug Administration (“U.S. FDA”) approval of the Biologics License Application (“BLA”) for the Company’s COVID-19 Vaccine product in a pre-filled syringe in the second quarter of 2025, both of which have been received from Sanofi. Of the $ 125 million of milestones remaining outstanding as of September 30, 2025, the Company achieved the $ 25 million milestone for the transfer of the EMA approval to Sanofi and the $ 25 million milestone for the transfer of the transfer of the U.S. marketing authorization to Sanofi in October and November 2025, respectively.
The Company is eligible to receive milestone payments totaling up to $ 125 million with respect to CIC products upon achievement of certain CIC Product-related development milestones and $ 225 million in CIC Product-related launch milestones. The Company is eligible to receive royalty payments in the high teens to low twenties percent on Sanofi’s sales of such licensed products.
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 mid-single digit sales royalties for 20 years on Sanofi’s sales of all such licensed products. 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. Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for three and nine month period ended September 30, 2025 was $ 44.1 million and $ 108.8 million, respectively. Revenue recognized related to Sanofi Transition Services and Sanofi Technology Transfer for three and nine month period ended September 30, 2024 was $ 32.7 million and $ 39.4 million, respectively. The Company’s consolidated balance sheet as of September 30, 2025 includes a deferred revenue balance of $ 32.9 million ($ 24.3 million included in Deferred revenue, current portion and $ 8.6 million included in Deferred revenue, non-current portion) related to Sanofi Transition Services and Sanofi Technology Transfer. The Company recognized cumulative catch-up adjustments related to changes in estimates, which resulted in an increase to revenue of $ 12.5 million and $ 14.8 million during three and nine months ended September 30, 2025, respectively. These changes in estimates resulted primarily from a change in both the total expected costs and the amount of variable consideration for Sanofi Transition Services, driven by a letter agreement with Sanofi executed in the third quarter of 2025 related to the postmarking commitment 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. The Company also updated its estimates of expected costs and total variable consideration for additional manufacturing development activities performed by SII in support of Sanofi Transition Services during the third quarter of 2025.
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. The Company recognized $ 0.9 million and $ 2.7 million of amortization expense related to the asset in Selling, general, and administrative expense for the three and nine months ended September 30, 2025, respectively. 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. As of September 30, 2025, $ 3.4 million of these costs remain to be amortized.
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Note 7 – Earnings per Share
Basic and diluted net income (loss) per share were calculated as follows (in thousands, except per share data):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Numerator:
Net income (loss), basic $ ( 202,379 ) $ ( 121,300 ) $ 422,775 $ ( 106,469 )
Interest on convertible notes — — 2,252 —
Net income (loss), dilutive ( 202,379 ) ( 121,300 ) 425,027 ( 106,469 )
Denominator:
Weighted average number of common shares outstanding, basic 162,353 160,049 161,811 149,486
Effect of dilutive securities — — 6,384 —
Weighted average number of common shares outstanding, dilutive 162,353 160,049 168,195 149,486
Net income (loss) per share:
Basic $ ( 1.25 ) $ ( 0.76 ) $ 2.61 $ ( 0.71 )
Diluted $ ( 1.25 ) $ ( 0.76 ) $ 2.53 $ ( 0.71 )
Anti-dilutive securities excluded from calculations of diluted net income per share 29,519 25,234 17,386 25,311
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):
September 30, 2025 December 31, 2024
Cash and cash equivalents $ 268,023 $ 530,230
Restricted cash, current 10,816 10,626
Restricted cash, non-current (1)
4,518 4,436
Cash, cash equivalents, and restricted cash $ 283,357 $ 545,292
(1) Classified as Other non-current assets as of September 30, 2025 and December 31, 2024, on the consolidated balance sheets.
Note 9 – Inventory
Inventory consisted of the following (in thousands):
September 30, 2025 December 31, 2024
Raw materials $ 1,783 $ 2,087
Semi-finished goods 7,291 4,899
Finished goods 4,437 1,763
Total inventory $ 13,511 $ 8,749
Inventory write-downs as a result of excess, obsolescence, expiry, or other reasons, and losses on firm purchase commitments, offset by recoveries of such commitments, are recorded as a component of cost of sales in the Company’s consolidated statements of operations. For the three and nine months ended September 30, 2025, inventory write-downs were
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$ 0.2 million and $ 1.9 million, respectively, and losses on firm purchase commitments were $ 0.3 million for both periods. 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 net of recoveries were $ 4.1 million and $ 5.8 million, respectively.
Note 10 – Goodwill
The Company has one reporting unit. No goodwill impairment was identified for the period ended September 30, 2025. The Company had a negative carrying value as of September 30, 2025 and December 31, 2024. The change in the carrying amounts of goodwill for the nine months ended September 30, 2025 was as follows (in thousands):
Amount
Balance at December 31, 2024 $ 107,478
Currency translation adjustments 5,602
Balance at September 30, 2025 $ 113,080
Note 11 – Long-Term Debt
Total convertible notes payable consisted of the following (in thousands):
September 30, 2025 December 31, 2024
5.00 % Convertible Senior Notes due 2027
$ 26,485 $ 175,250
4.625 % Convertible Senior Notes due 2031
225,000 —
Unamortized debt issuance costs ( 7,650 ) ( 5,566 )
Total convertible notes payable
$ 243,835 $ 169,684
As of September 30, 2025 and December 31, 2024, the effective interest rate of the Convertible Senior Notes due 2027 is 6.2 %. As of September 30, 2025, the effective interest rate of the Convertible Senior Notes due 2031 is 5.3 %.
The interest expense incurred in connection with the convertible notes payable consisted of the following (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Coupon interest $ 2,554 $ 2,192 $ 6,937 $ 6,576
Amortization of debt issuance costs 402 416 1,287 1,248
Total interest expense on convertible notes payable $ 2,956 $ 2,608 $ 8,224 $ 7,824
Convertible Senior Notes Due 2031
In August 2025, the Company issued $ 225.0 million aggregate principal amount of its 4.625 % Convertible Senior Notes due 2031 (the “2031 Notes”) consisting of (a) $ 175.3 million principal amount of 2031 Notes issued in exchange for $ 148.8 million principal amount of the Company’s 5.00 % Convertible Senior Notes due 2027 (the “2027 Notes”), and (b) approximately $ 49.7 million principal amount of 2031 Notes issued for cash, in each case, pursuant to exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”), and the rules and regulations thereunder.
The 2031 Notes were issued pursuant to, and are governed by, an indenture (the “2031 Indenture”), dated as of August 27, 2025, between the Company and The Bank of New York Mellon Trust Company, N.A. as trustee.
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The 2031 Notes are senior, unsecured obligations of the Company and accrue interest at a rate of 4.625 % per annum, payable semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2026. The 2031 Notes will mature on September 1, 2031, unless earlier repurchased, redeemed or converted. Before June 1, 2031, noteholders have the right to convert their 2031 Notes only upon the occurrence of certain events. From and including June 1, 2031, noteholders may convert their 2031 Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. The Company will settle conversions by paying cash, shares of its common stock or a combination of cash and shares of its common stock, at its election, based on the applicable conversion rate. The initial conversion rate is 89.7384 shares of common stock per $1,000 principal amount of 2031 Notes, which represents an initial conversion price of approximately $ 11.14 per share of common stock. The initial conversion price represents a premium of approximately 28 % over the last reported sale price of the Company’s common stock on August 20, 2025. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the 2031 Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time. The initial maximum conversion rate is 114.4164 shares of common stock per $1,000 principal amount of 2031 Notes.
The 2031 Notes are redeemable, in whole or in part (subject to certain limitations), for cash at the Company’s option at any time, and from time to time, on or after September 5, 2028 and before the 41st scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of the Company’s common stock exceeds 130 % of the conversion price for a specified period of time. However, the Company may not redeem less than all of the outstanding 2031 Notes unless at least $ 50.0 million aggregate principal amount of 2031 Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. The redemption price is equal to the principal amount of the 2031 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the relevant redemption date.
Holders of the 2031 Notes will have the right to require the Company to repurchase all or part of their 2031 Notes for cash in the event of certain Fundamental Changes (as defined in the 2031 Indenture), at a repurchase price equal to 100% of the principal amount of the 2031 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the relevant repurchase date.
In accordance with ASC 470-50 Modification and Extinguishments , the Company determined that the modified terms of the $ 175.3 million principal amount of the 2031 Notes were substantially different than the terms of $ 148.8 million principal amount of the 2027 Notes they were exchanged for, and therefore, the exchange was accounted for as an extinguishment of the 2027 Notes and Issuance of 2031 Notes. The Company recorded a loss on debt extinguishment of $ 28.7 million related to the exchange.
The initial purchasers’ fees and the Company’s issuance costs related to the issuance of the 2031 Notes totaled $ 7.1 million, which were recorded as a reduction to the 2031 Notes on the consolidated balance sheet and is being amortized and recognized as additional interest expense over the six-year contractual term of the 2031 Notes using the effective interest rate of 5.3 %.
Note 12 – Stockholders’ Deficit
In August 2023, the Company entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows it to issue and sell up to $ 500 million in gross proceeds of shares of its common stock, and terminated its then-existing At Market Issuance Sales agreement entered in June 2021. During the three and nine months ended September 30, 2025, no sales were recorded under the August 2023 Sales Agreement. During the three and nine months ended September 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. As of September 30, 2025, the remaining balance available under the August 2023 Sales Agreement was approximately $ 51 million.
In May 2024, the Company also entered into the securities 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.
Note 13 – Stock-Based Compensation
Equity Plans
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-
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employment, as an inducement material to such individuals entering into employment with the Company. The Company reserved 1.0 million shares of common stock for grants under the 2023 Inducement Plan. As of September 30, 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. Under the 2015 Plan, equity awards may be granted to officers, directors, employees, and consultants of and advisors to the Company and any present or future subsidiary.
The 2015 Plan authorizes the issuance of up to 27.5 million shares of common stock under equity awards granted under the 2015 Plan. All such shares authorized for issuance under the 2015 Plan have been reserved. The 2015 Plan will expire on April 19, 2034. As of September 30, 2025, there were 6.4 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”). In addition, under the 2023 Inducement Plan and the 2015 Plan, unrestricted stock, stock units, and performance awards may be granted. Stock options and SARs generally have a maximum term of ten years and may be or were granted with an exercise price that is no less than 100 % of the fair market value of the Company’s common stock at the time of grant. Grants of share-based awards are generally subject to vesting over periods ranging from one to four years .
The Company recorded stock-based compensation expense in the consolidated statements of operations as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Cost of sales $ 367 $ 942 $ 1,274 $ 2,640
Research and development 3,491 5,166 11,281 16,848
Selling, general, and administrative 4,691 5,941 15,493 18,216
Total stock-based compensation expense $ 8,549 $ 12,049 $ 28,048 $ 37,704
During the three and nine months ended September 30, 2025 and 2024 ther e were no stock-based compensation expense capitalized into inventory.
As of September 30, 2025, there was approximately $ 51 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, 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.
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, 2025. This amount is subject to change based on changes to the closing price of the Company's common stock. The aggregate intrinsic value of stock options and SARs exercises and vesting of RSUs for the nine months ended September 30, 2025 and 2024 was approximately $ 19 million and $ 10 million, respectively.
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Stock Options and Stock Appreciation Rights
The following is a summary of stock options activity under the 2023 Inducement Plan and 2015 Plan for the nine months ended September 30, 2025:
2023 Inducement Plan 2015 Plan
Stock
Options Weighted-Average
Exercise
Price Stock
Options Weighted-Average
Exercise
Price
Outstanding at December 31, 2024 486,950 $ 10.45 3,496,052 $ 32.75
Granted — — 2,461,163 7.74
Exercised — — ( 41,147 ) 6.65
Canceled — — ( 640,899 ) 51.03
Outstanding at September 30, 2025 486,950 $ 10.45 5,275,169 $ 19.67
Shares exercisable at September 30, 2025 268,335 $ 10.78 2,184,071 $ 34.56
The fair value of stock options granted under the 2023 Inducement Plan and the 2015 Plan was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Weighted average Black-Scholes fair value of stock options granted $ 4.90 $ — $ 5.60
$ 5.86
Risk-free interest rate 3.7 %
— % 3.7 %- 4.1 %
4.3 %
Dividend yield — % — % — % — %
Volatility 94.6 %
—% 94.6 %- 121.7 %
114.3 %- 121.8 %
Expected term (in years) 3.5
— 3.5 - 6.5
3.9 - 6.3
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 September 30, 2025 was $ 6.1 million and 7.7 years , respectively. 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 September 30, 2025 was $ 2.1 million and 5.9 years , respectively.
Restricted Stock Units
The following is a summary of RSU activity for the nine months ended September 30, 2025:
2023 Inducement Plan 2015 Plan
Number of
Shares Per Share
Weighted-
Average
Fair Value Number of
Shares Per Share
Weighted-
Average
Fair Value
Outstanding and unvested at December 31, 2024 285,429 $ 10.42 5,558,642 $ 8.27
Granted — — 3,705,898 7.81
Vested ( 121,329 ) 10.66 ( 2,135,288 ) 11.22
Forfeited — — ( 857,875 ) 7.66
Outstanding and unvested at September 30, 2025 164,100 $ 10.23 6,271,377 $ 7.08
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Employee Stock Purchase Plan
The ESPP was approved at the Company’s annual meeting of stockholders in June 2013. The ESPP currently authorizes an aggregate of 2.3 million shares of common stock to be purchased, and the aggregate number of shares will continue to increase 5 % on January 1 of each year up to a maximum of 3.5 million shares. The ESPP allows employees to purchase shares of common stock of the Company at each purchase date through payroll deductions of up to a maximum of 15 % of their compensation, at 85 % of the lesser of the market price of the shares at the time of purchase or the market price on the beginning date of an option period (or, if later, the date during the option period when the employee was first eligible to participate). As of September 30, 2025, there were 0.5 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. Significant pieces of objective evidence evaluated by the Company were the cumulative loss incurred over the three-year period ended September 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. On the basis of this evaluation, as of September 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.
During the three months ended September 30, 2025 and 2024, the Company recognized $ 0.7 million and $ 1.0 million of income tax benefit related to federal, state, and foreign income tax expense and foreign withholding tax expense, respectively. During the nine months ended September 30, 2025 and 2024, the Company recognized $ 1.5 million and $ 3.4 million of income tax expense related to federal, state, and foreign income tax expense and foreign withholding tax expense, respectively.
On July 4, 2025, President Trump signed into federal law H.R. 1 – One Big Beautiful Bill Act (the “Act”). 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. The Act has not had a material impact on the Company’s effective income tax rate and its net deferred federal income tax assets as the Company maintains a full valuation allowance.
Note 15 – Commitments and Contingencies
Legal Matters
The Company had been involved in a number of legal proceedings around stockholder litigation. The Company has previously disclosed the resolution of these matters, and all financial impact was reflected in the Company’s results as of March 31, 2025. The Company is also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these other legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flows.
Note 16 – Restructuring
During the three and nine months ended September 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”). During the three months ended September 30, 2025, the Company classified its corporate headquarters facility at 700 Quince Orchard, Gaithersburg, Maryland (“700QO”), together with its related finance lease obligation, certain related property and equipment and land parcel adjacent to the facility (collectively referred to as the "Disposal Group"), as held for sale, in accordance with its accounting policy defined in Note 2. As of September 30, 2025, the assets and liabilities of the Disposal Group were classified as held for sale and were presented separately in Current assets and Current liabilities on the consolidated balance sheet. The carrying value of the Disposal Group was determined to be greater than its fair value less costs to sell and, consequently, the Company recorded an impairment of assets held for sale of $ 97 million during the three months ended September 30, 2025. The fair value less cost to sell of the Disposal Group was estimated at $ 56.5 M, comprised of $ 59.8 million as supported by a binding offer from a third party, less $ 3.3 M of costs to sell. In October 2025, the Company entered into a definitive agreement to sell the Disposal Group with an expected completion of the transaction by the end of the first quarter of 2026 (see Note 18).
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As of September 30, 2025, the net carrying amounts of the major classes of assets and liabilities of the Disposal Group were as follows (in thousands):
Amount
Right of use asset, net $ 127,914
Property and equipment, net 76,787
Less: Impairment of assets held for sale ( 97,038 )
Assets held for sale $ 107,663
Current portion of finance lease liabilities $ 2,036
Non-current finance lease liabilities 49,399
Liabilities held for sale $ 51,435
Other restructuring charges under the Restructuring Plan recorded by the Company consisted of the following (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Severance and employee benefit costs $ 347 4,245 5,070 9,765
Impairment of long-lived assets 1,230 — 1,578 1,669
Total other restructuring charges (1)
$ 1,577 $ 4,245 $ 6,648 $ 11,434
(1) Restructuring charges of $ 1.5 million and $ 0.1 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, 2025. Restructuring charges of $ 3.1 million and $ 3.6 million are included in Research and development and Selling, general, and administrative expenses, respectively, in the Consolidated Statements of Operations for the nine months ended September 30, 2025. 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. 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.
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. The Company recorded a severance and termination benefit cost in full for employees who were notified of their termination during the nine months ended September 30, 2025 and had no requirements for future service as of the end of the period. The Company paid a total of $ 8.0 million for the severance and employee benefit costs during the nine months ended September 30, 2025 and the remaining liability of $ 0.2 million is included in Accrued expenses in the Company’s consolidated balance sheet as of September 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.
Impairment of long-lived assets
In connection with the Restructuring Plan, the Company also evaluated its long-lived assets, other than the Disposal Group classified as held for sale, for impairment. The Company performed an impairment evaluation for the applicable long-lived assets, which is subject to judgment and actual results may vary from the estimates, resulting in potential future adjustments to amounts recorded. During the three and nine months ended September 30, 2025, the Company recorded an impairment charge of $ 1.2 million and $ 1.6 million, respectively, related to the impairment of right of use asset for a facility lease and some laboratory equipment. During 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.
Note 17 – Segment Reporting
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
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assets. 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. 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.
The table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
Revenue
$ 70,445 $ 84,512 $ 976,340 $ 593,851
Cost of sales
21,496 60,619 50,936 166,070
Research and development expenses:
Direct coronavirus vaccines (1)
39,439 21,798 86,161 87,759
Direct other vaccine development programs (1)
1,296 2,660 4,017 3,395
Employee and benefit expenses
35,270 38,670 111,330 124,544
Facility and other research and development expenses (2)
22,269 24,036 64,936 71,091
Selling, general, and administrative expense
31,655 70,747 123,357 258,843
Other segment income (expense) (3)
( 121,399 ) 12,718 ( 112,828 ) 11,382
Net income (loss)
$ ( 202,379 ) $ ( 121,300 ) $ 422,775 $ ( 106,469 )
(1) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities. 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.
(3) Other segment income (expense) includes interest expense, impairment of assets held for sale, loss on debt extinguishment, income tax expense (benefit), and other income, net.
Total revenue by the Company’s customer’s or collaboration partner’s geographic location was as follows (in thousands):
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 2025 2024
United States
$ 56,776 $ 71,091 $ 294,369 $ 459,232
Canada
— — 575,670 —
Europe 655 1,814 12,367 94,033
Rest of the world
13,014 11,607 93,934 40,586
Total revenue
$ 70,445 $ 84,512 $ 976,340 $ 593,851
Total long-lived assets of the Company by geographic location were as follows (in thousands):
September 30, 2025 December 31, 2024
United States $ 69,328 $ 295,879
Europe 3,665 4,119
Total long-lived assets
$ 72,993 $ 299,998
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Note 18 – Subsequent Events
On October 1, 2025, the European Commission approved the transfer application to change the holder of the MAH for Nuvaxovid™ from the Company to Sanofi. On November 3, 2025, the U.S. FDA approved the transfer application to change the holder of the MAH for Nuvaxovid™ from the Company to Sanofi. Completion of each of these transfer authorizations has triggered $ 25 million milestone payments from Sanofi under the Sanofi CLA. The Company anticipates receipt of these payments in the first quarter of 2026.
On October 16, 2025, the Company entered into an assignment of the lease with respect to the Company’s Gaithersburg, MD headquarters facility with AstraZeneca Pharmaceuticals LP (“AstraZeneca”). The effect of the agreement is to assign the lease agreement for the Company’s corporate headquarters, which together with a parcel purchase agreement for the sale of a parcel of land adjacent to the facility and an asset purchase agreement for the sale of certain personal property and equipment, will result in an aggregate of $ 59.8 million payable by AstraZeneca to the Company. An initial payment of $ 20.0 million, associated with the parcel purchase, is scheduled to occur in the fourth quarter of 2025 and the remaining approximately $ 39.8 million payment is scheduled to occur in the first quarter of 2026.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.