Moderna, Inc.
A biotechnology company that uses messenger RNA (mRNA) to build medicines and vaccines, best known for Spikevax, its COVID-19 vaccine. Founded in 2010 in Cambridge, Massachusetts, it grew out of the venture-building firm Flagship Pioneering with help from scientists including MIT's Robert Langer. Its name blends "modified" and "RNA"—and conveniently hides the word "modern."
10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗
The original filing sections are available below.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financi…
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the SEC) on February 20, 2026 (the 2025 Form 10-K). Overview We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics. Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We currently have four approved products—Spikevax® and mNEXSPIKE®, our COVID vaccines; mRESVIA®, our vaccine against respiratory syncytial virus (RSV); and mCOMBRIAX®, our flu plus COVID combination vaccine, which was approved in Europe for individuals 50 years of age and older. We also have a diverse development pipeline of 26 development candidates across our 36 development programs currently in clinical studies. Business Highlights European Commission Marketing Authorization for mCOMBRIAX In April 2026, we received marketing authorization from the European Commission (EC) for mCOMBRIAX (mRNA-1083), our mRNA combination vaccine for the prevention of influenza disease and COVID-19 in individuals 50 years of age and older. The marketing authorization follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is our fourth authorized product and further strengthens our respiratory portfolio and commitment to the EU. The vaccine builds on advances from the clinical development of mNEXSPIKE and mRNA-1010, our investigational seasonal influenza vaccine. mCOMBRIAX will be made available across the EU, subject to national regulatory and access procedures, and we are working with national authorities to support local access and implementation. FDA Advisory Committee Positive Recommendation for mRNA-1010 In June 2026, the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously that the benefits of mRNA-1010 outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and in adults 65 years of age and older. The recommendation was based on data from our Phase 3 clinical development program and supports the FDA's ongoing review of our Biologics License Application (BLA) for mRNA-1010. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Expanded Strategic Collaboration with CEPI In June 2026, we expanded our strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a potential vaccine against Bundibugyo ebolavirus (BDBV), a cause of Ebola virus disease for which there are currently no licensed vaccines indicated. Under the agreement, CEPI has committed up to $50 million to support preclinical development and Phase 1 clinical evaluation of our investigational BDBV vaccine candidate, as well as parallel manufacturing activities to enable doses to be produced while clinical evaluation is underway and support rapid advancement into Phase 2/3 clinical trials, if warranted. The program builds on our existing research and development efforts in filoviruses, including Ebola-related viruses, and expands our longstanding strategic collaboration with CEPI to accelerate the development of vaccines and other countermeasures against epidemic and pandemic threats. Total Revenue and Net Loss Per Share For the second quarter of 2026, we recognized total revenue of $145 million, compared to $142 million for the second quarter of 2025. Net loss per share was $(1.97) for the second quarter of 2026, compared to net loss per share of $(2.13) for the second quarter of 2025. 29 Table of Contents Recent Program Developments Infectious Disease Vaccines •Seasonal flu + COVID vaccine: We received EC marketing authorization for mCOMBRIAX in the EU and our mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. We are awaiting further guidance from the FDA on refiling the submission for our flu plus COVID combination vaccine. •Seasonal flu vaccine: Our mRNA-1010 regulatory filings are under review in Europe, Canada and Australia, and potential approvals are expected to begin in 2026. The FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026. •Norovirus vaccine: Our Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. The trial is ongoing and remains blinded as we work toward enrolling an additional cohort. Oncology Therapeutics •Intismeran autogene: We are advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC. Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. We expect Phase 3 adjuvant melanoma data potentially in 2026. We recently presented positive five-year Phase 2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone. •mRNA-4359. Our Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC. Rare Disease Therapeutics •Propionic acidemia (PA) therapeutic: Our investigational therapeutic for PA (mRNA-3927) is in a registrational study and target enrollment has been reached. We expect potential data in 2026. •Methylmalonic acidemia (MMA) therapeutic: We deferred our decision on a pivotal trial for mRNA-3705 until PA registrational data readout. 30 Table of Contents Our Pipeline The following chart shows our current pipeline of 36 development programs across our several modalities. Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; MIBC, muscle invasive bladder cancer; NMIBC, non-muscle invasive bladder cancer; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus. 31 Table of Contents Results of operations The following table summarizes our condensed consolidated statements of operations for the periods presented (in millions): Three Months Ended June 30, Change 2026 vs. 2025 2026 2025 $ % Revenue: Net product sales $ 94 $ 114 $ (20) (18)% Other revenue 51 28 23 82% Total revenue 145 142 3 2% Operating expenses: Cost of sales 93 119 (26) (22)% Research and development 651 700 (49) (7)% Selling, general and administrative 216 230 (14) (6)% Total operating expenses 960 1,049 (89) (8)% Loss from operations (815) (907) 92 (10)% Interest income 67 81 (14) (17)% Other (expense) income, net (19) 8 (27) (338)% Loss before income taxes (767) (818) 51 (6)% Provision for income taxes 15 7 8 114% Net loss $ (782) $ (825) $ 43 (5)% Six Months Ended June 30, Change 2026 vs. 2025 2026 2025 $ % Revenue: Net product sales $ 446 $ 200 $ 246 123% Other revenue 88 50 38 76% Total revenue 534 250 284 114% Operating expenses: Cost of sales 1,048 209 839 401% Research and development 1,300 1,556 (256) (16)% Selling, general and administrative 389 442 (53) (12)% Total operating expenses 2,737 2,207 530 24% Loss from operations (2,203) (1,957) (246) 13% Interest income 139 171 (32) (19)% Other (expense) income, net (37) 4 (41) (1,025)% Loss before income taxes (2,101) (1,782) (319) 18% Provision for income taxes 24 14 10 71% Net loss $ (2,125) $ (1,796) $ (329) 18% Revenue Net product sales Net product sales by customer geographic location were as follows (in millions): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 United States $ 70 $ 88 $ 143 $ 119 Europe 16 — 255 — Rest of world 8 26 48 81 Total $ 94 $ 114 $ 446 $ 200 32 Table of Contents Net product sales by product were as follows (in millions): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 COVID (1) $ 91 $ 114 $ 436 $ 198 RSV 3 — 10 2 Total $ 94 $ 114 $ 446 $ 200 _______ (1) Includes sales of Spikevax and mNEXSPIKE. As of June 30, 2026, we have four approved products, our COVID vaccines, Spikevax and mNEXSPIKE, our RSV vaccine, mRESVIA, and our flu and COVID combination vaccine, mCOMBRIAX, which has received EC marketing authorization in the EU. We launched commercial sales of mNEXSPIKE in the third quarter of 2025. As of June 30, 2026, mCOMBRIAX had not been commercialized. We sell our COVID vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to governments and international organizations. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions. The following table summarizes product sales provision adjustments for the periods presented (in millions): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Gross product sales $ 122 $ 176 $ 472 $ 281 Product sales provision: Wholesaler chargebacks, discounts and fees (50) (62) (39) (84) Returns, rebates and other fees 22 — 13 3 Total product sales provision adjustments $ (28) $ (62) $ (26) $ (81) Net product sales $ 94 $ 114 $ 446 $ 200 Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of June 30, 2026, we had deferred revenue of $265 million related to product sales, of which $207 million is expected to be realized in less than one year. Other revenue Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and stand-ready manufacturing revenue. For the three months ended June 30, 2026, total revenue increased by $3 million, or 2%, compared to the same period in 2025. Net product sales decreased by $20 million, or 18%, primarily due to lower COVID vaccine sales in the United States and South America, partially offset by product deliveries in the United Kingdom. The decrease in net product sales was offset by higher stand-ready manufacturing revenue from related facilities and higher collaboration revenue, primarily related to our collaboration with Recordati for our investigational propionic acidemia therapeutic, mRNA-3927. For the six months ended June 30, 2026, total revenue increased by $284 million, or 114%, compared to the same period in 2025. Net product sales increased by $246 million, or 123%, primarily due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Other revenue also increased, primarily reflecting higher stand-ready manufacturing revenue, including from facilities that became operational during the second half of 2025, and higher collaboration revenue. Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities. 33 Table of Contents Operating expenses Cost of sales Cost of sales for the three months ended June 30, 2026 was $93 million, which included inventory write-downs of $41 million, unutilized manufacturing capacity costs of $23 million, and third-party royalties of $11 million. Cost of sales for the six months ended June 30, 2026 was $1.0 billion, which included third-party royalties of $906 million, inventory write-downs of $79 million, and unutilized manufacturing capacity costs of $25 million. Third-party royalties included $6 million and $884 million for the three and six months ended June 30, 2026, respectively, related to the litigation settlement with Arbutus and Genevant and amortization of the associated intangible asset. Please refer to Note 12, Commitments and Contingencies, to our condensed consolidated financial statements for additional information. Inventory write-downs in 2026 primarily related to our finished and semi-finished vaccine inventory and raw materials relative to updated demand forecasts, shelf-life expiration and other adjustments. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges. Cost of sales for the three months ended June 30, 2026 decreased by $26 million, or 22%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the three months ended June 30, 2026 was 74%, compared to 91% for the same period in 2025. The decreases were primarily due to lower unutilized manufacturing capacity costs. Cost of sales for the six months ended June 30, 2026 increased by $839 million, or 401%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the six months ended June 30, 2026 was 206%, compared to 91% for the same period in 2025. The increase was primarily driven by litigation settlement-related expenses. Excluding these expenses, cost of sales and cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the six months ended June 30, 2026 decreased by 59% and 65 percentage points, respectively, compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs and losses on firm purchase commitments, partially offset by higher sales volume. In 2026, we anticipate a modest decrease in cost of sales compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies. This expectation excludes the impact of the settlement with Arbutus and Genevant, for which we recorded $884 million in cost of sales during the first half of 2026 and expect additional amortization expense in the remainder of the year. Excluding this impact, to the extent net product sales increase, cost of sales as a percentage of net product sales and stand-ready revenue will decrease moderately. Research and development expenses Research and development expenses decreased by $49 million, or 7%, for the three months ended June 30, 2026, compared to the same period in 2025. This reduction was primarily due to lower clinical trial expenses of $76 million, personnel-related costs and stock-based compensation of $27 million, and outside services of $18 million, partially offset by a $62 million benefit recognized in the second quarter of 2025 under the Blackstone research and development funding arrangement, due to revisions of prior period estimates. For the six months ended June 30, 2026, research and development expenses decreased by $256 million, or 16%, compared to the same period in 2025. This decrease primarily reflected lower clinical trial expenses of $119 million, personnel-related costs and stock-based compensation of $77 million, and outside services of $49 million. The lower clinical trial expenses for both periods were primarily driven by the wind-down of several late-stage programs, including the Company's flu plus COVID combination vaccine, as well as its congenital CMV and norovirus programs. The decrease in personnel-related costs and stock-based compensation for both periods primarily reflected portfolio reprioritization and associated resource realignment. We anticipate a modest reduction in research and development expenses in 2026 compared to 2025, primarily driven by the wind-down of several late-stage programs, continued disciplined cost management, and a focused approach to pipeline execution. We remain committed to advancing our pipeline and late-stage programs, including our oncology and rare disease programs, while continuing to manage research and development investment levels in line with our long-term objectives. Selling, general and administrative expenses Selling, general and administrative expenses decreased by $14 million, or 6%, for the three months ended June 30, 2026, compared to the same period in 2025. The decrease was primarily driven by continued cost discipline across the organization, including reduced commercial and marketing-related spending, lower employee-related costs and other operating expenses. For the six months ended June 30, 2026, selling, general and administrative expenses decreased by $53 million, or 12%, compared to the same period in 2025. This decrease for the six-month period primarily reflected lower employee-related costs and stock-based compensation of $25 million, reduced commercial and marketing-related spending of $15 million, and lower other operating expenses. The decreases in both periods reflected continued cost discipline and efficiencies across the organization. 34 Table of Contents We expect selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025, reflecting an efficient and scalable operating structure. While we will continue to make selective investments to support our key priorities, including our global commercial and regulatory activities, we expect these investments to be largely offset by ongoing efficiency initiatives and disciplined resource allocation. Interest income For the three months ended June 30, 2026, interest income decreased by $14 million, or 17%, compared to the same period in 2025. For the six months ended June 30, 2026, interest income decreased by $32 million, or 19%, compared to the same period in 2025. The decrease in each period was primarily due to lower average investment balances and interest rates. Other expense, net The following tables summarize other expense, net for the periods presented (in millions): Three Months Ended June 30, Change 2026 vs. 2025 2026 2025 $ % Interest expense $ (17) $ (1) $ (16) 1,600% Other (expense) income, net (2) 9 (11) (122)% Total other (expense) income, net $ (19) $ 8 $ (27) (338)% Six Months Ended June 30, Change 2026 vs. 2025 2026 2025 $ % Loss on investments $ (1) $ (7) $ 6 (86)% Interest expense (34) (2) (32) 1,600% Other (expense) income, net (2) 13 (15) (115)% Total other (expense) income, net $ (37) $ 4 $ (41) (1,025)% For the three and six months ended June 30, 2026, we recorded total other expense, net of $19 million and $37 million, respectively, compared to total other income, net of $8 million and $4 million for the same periods in 2025. The increase in other expense, net for the three and six months ended June 30, 2026, was largely driven by higher interest expense and lower net gains on foreign currency transactions. Interest expense is primarily related to our long-term debt issued in November 2025 and finance leases related to certain contract manufacturing service agreements. Please refer to Note 10 and Note 11 to our condensed consolidated financial statements for additional information. Income taxes Provision for income taxes increased by $8 million and $10 million, or 114% and 71%, for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily because certain of our foreign subsidiaries generated higher taxable income while we incurred a consolidated pre-tax loss. The effective tax rate continues to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the losses. Please refer to Note 14 to our condensed consolidated financial statements for additional details. 35 Table of Contents Liquidity and capital resources The following table summarizes our cash, cash equivalents, investments and working capital as of June 30, 2026 and December 31, 2025 (in millions): June 30, December 31, 2026 2025 Financial assets: Cash and cash equivalents $ 1,723 $ 2,595 Investments 3,415 3,204 Investments, non-current 1,772 2,336 Total $ 6,910 $ 8,135 Working capital: Current assets $ 5,815 $ 6,544 Current liabilities 2,534 1,987 Total $ 3,281 $ 4,557 Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of June 30, 2026 decreased by $1.2 billion, or 15%, compared to December 31, 2025. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $1.2 billion and purchases of property and equipment of $99 million during the six months ended June 30, 2026. Working capital, defined as current assets less current liabilities, decreased by $1.3 billion, or 28%, as of June 30, 2026, compared to December 31, 2025. This was primarily driven by a decrease in cash, cash equivalents and current investments of $661 million to fund operations, an increase in accrued liabilities of $523 million, largely driven by the $950 million litigation settlement accrual partially offset by lower spend in the period, and a $196 million increase in deferred revenue primarily associated with advance payments for products, partially offset by a decrease in accounts payable of $150 million. As of June 30, 2026, we did not have any off-balance sheet arrangements. For a discussion of our contractual obligations and commitments, refer to our 2025 Form 10-K. Cash flow The following table summarizes the primary sources and uses of cash for each period presented (in millions): Six Months Ended June 30, 2026 2025 Net cash (used in) provided by: Operating activities $ (1,156) $ (1,956) Investing activities 253 1,294 Financing activities 31 13 Operating activities We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements. Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our COVID and RSV vaccines to the commercial market as well as to governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. In addition, we receive customer advance payments related to certain other revenue arrangements. As of June 30, 2026, we had $442 million in deferred revenue related to customer advance payments received or billable. 36 Table of Contents Net cash used in operating activities for the six months ended June 30, 2026 was $1.2 billion and consisted of net loss of $2.1 billion, non-cash adjustments of $337 million, and a net change in assets and liabilities of $632 million. Non-cash items primarily included stock-based compensation of $224 million and depreciation and amortization of $122 million. The net change in assets and liabilities was mainly due to an increase in accrued liabilities and accounts payable of $347 million, driven by the $950 million litigation settlement accrual, partially offset by lower spend during the period, an increase in deferred revenue of $195 million driven by customer advance payments, and a decrease in accounts receivable, net of $167 million due to timing of collections, partially offset by an increase in inventory of $126 million driven by increased production for the upcoming season. Net cash used in operating activities decreased by $800 million, or 41%, during the six months ended June 30, 2026, compared to the same period in 2025, primarily attributable to a change in accrued liabilities and accounts payable of $945 million, largely driven by the $950 million litigation settlement accrual, partially offset by an increase in net loss of $329 million. Investing activities Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for facilities, manufacturing and laboratory equipment, and computer equipment and software, as well as business development activities. Net cash provided by investing activities for the six months ended June 30, 2026 was $253 million, driven primarily by proceeds from maturities and sales of marketable securities of $2.3 billion, partially offset by purchases of marketable securities of $1.9 billion, and purchases of property and equipment of $99 million. Net investing cash flows decreased by $1.0 billion, or 80%, during the six months ended June 30, 2026, compared to the same period in 2025, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $2.2 billion, partially offset by a decrease in purchases of marketable securities of $1.2 billion, and a decrease in purchases of plant, property and equipment of $21 million. Financing activities Net cash provided by financing activities for the six months ended June 30, 2026 was $31 million, primarily related to proceeds from issuance of common stock through equity plans. Net cash provided by financing activities increased by $18 million, or 138%, during the six months ended June 30, 2026, compared to the same period in 2025, mainly due to an increase in proceeds from issuance of common stock through equity plans of $25 million. Operation and funding requirements Our principal sources of funding as of June 30, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $2.1 billion for the six months ended June 30, 2026 and net losses of $2.8 billion and $3.6 billion for the years 2025 and 2024, respectively. Historically, from our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following the authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We have retained earnings of $5.1 billion as of June 30, 2026. We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs. We anticipate maintaining substantial expenses across all areas of our ongoing activities, particularly as we continue research and development of our development candidates and clinical activities for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our supply and manufacturing partners. Our ongoing work on our intismeran autogene, norovirus, and flu plus COVID combination vaccine candidates, our other oncology programs, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which will not be reimbursed or otherwise paid for by our collaborators or alliances. We may also incur additional costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. In addition, we have substantial facility, lease and purchase obligations, as well as the $950 million litigation settlement obligation accrued as of June 30, 2026, which was paid in July 2026. We have entered into various collaboration and licensing agreements, as well as research and development funding arrangements with third parties. These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangement, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments. 37 Table of Contents In November 2025, we entered into a Credit and Guaranty Agreement (Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent, providing for a term loan facility with aggregate commitments of $1.5 billion. As of June 30, 2026, we had drawn $600 million under the initial term loan. The Credit Agreement also provides for $900 million of delayed draw term loan commitments, consisting of $400 million available, subject to applicable conditions, through November 2027 and $500 million available, subject to applicable conditions and specified regulatory approval milestones, through November 2028. Borrowings under the Credit Agreement bear interest at a variable rate based on Term SOFR or a base rate, at our option, plus an applicable margin, with interest payable periodically and the principal amount due in full at maturity in November 2030. The Credit Agreement includes customary affirmative and negative covenants, with which we were in compliance as of June 30, 2026. See Note 11 to our condensed consolidated financial statements for additional information. We believe that our cash, cash equivalents, and investments as of June 30, 2026, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of these financial statements included in this Form 10-Q. In July 2026, we paid the $950 million litigation settlement that was accrued as of June 30, 2026. We are subject to all the risks related to the development and commercialization of novel medicines, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business. For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend continued in 2025 as the market transitions to a more competitive and commercially driven environment, with broader external factors continuing to affect market dynamics. We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Critical accounting policies and significant judgments and estimates There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the three months ended June 30, 2026 compared to those disclosed in our 2025 Form 10-K. Contractual Obligations As of June 30, 2026, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2025 Form 10-K.
Our market risks, and the way we manage them, are summarized in Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our 2025 Form 10-K. There have been no material changes to our market risk or to our management of such risks for the three and six…
Our market risks, and the way we manage them, are summarized in Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our 2025 Form 10-K. There have been no material changes to our market risk or to our management of such risks for the three and six months ended June 30, 2026.
Read original filing text →We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described under the heading “Legal Proceedings” in our 2025 Form 10-K and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 20…
We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described under the heading “Legal Proceedings” in our 2025 Form 10-K and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026. Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2025 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment. Sanofi Patent Litigation In July 2026, Translate Bio, Inc., Translate Bio MA, Inc., Sanofi Vaccines US, Inc., and VaxServe, Inc. (all subsidiaries of Sanofi SA), filed a complaint against us in the U.S. District Court for the District of New Jersey asserting that our manufacture and sale of our COVID and RSV vaccines infringe U.S. patents related to compositions and methods for mRNA delivery. The complaint seeks a judgment of infringement of the asserted patents and unspecified damages.
Read original filing text →Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our 2025 Form 10-K. There have been no material changes from the risk factors previously disclosed in the 2025 Form 10-K.
Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our 2025 Form 10-K. There have been no material changes from the risk factors previously disclosed in the 2025 Form 10-K.
Read original filing text →