Moderna, Inc.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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 five approved products—Spikevax® and mNEXSPIKE®, our COVID vaccines; mRESVIA®, our vaccine against respiratory syncytial virus (RSV); our flu plus COVID combination vaccine, which was authorized for individuals 50 years of age and older in Europe (marketed as mCOMBRIAX®) and in Canada (marketed as mCOFLU®); and mFLUSIVA®, our influenza vaccine, which was approved in the United States and Canada for individuals 50 years of age and older.

Previous wording

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.

Current wording

For the third quarter of 2026, we recognized total revenue of $1.3 billion, compared to $1.0 billion for the third quarter of 2025. Diluted earnings per share was $0.38 for the third quarter of 2026, compared to loss per share of $(0.51) for the third quarter of 2025.

Previous wording

•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.

Current wording

•Intismeran autogene: We are advancing mRNA-4157 in collaboration with Merck evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types and stages of disease, including three ongoing Phase 3 trials in non-small cell lung cancer (NSCLC). Additional studies include a Phase 2b trial in adjuvant melanoma and Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC.

Previous wording

The following chart shows our current pipeline of 36 development programs across our several modalities.

Current wording

The following chart shows our current pipeline of development programs across our several modalities.

Previous wording

European Commission Marketing Authorization for mCOMBRIAX

Current wording

As of September 30, 2026, we have five approved products, our COVID vaccines, Spikevax and mNEXSPIKE, our RSV vaccine, mRESVIA, our flu and COVID combination vaccine, mCOMBRIAX, which has received European Commission marketing authorization in the EU, and our influenza vaccine, mFLUSIVA, which has been approved in the United States. We launched commercial sales of mNEXSPIKE in the third quarter of 2025. As of September 30, 2026, mCOMBRIAX had not been commercialized. In August 2026, mFLUSIVA was approved by the FDA for the prevention of influenza disease in adults 50 years of age and older, and we launched commercial sales of mFLUSIVA in September 2026. Net product sales of mFLUSIVA were immaterial for the quarter, reflecting the timing of the approval and launch relative to the 2026–2027 influenza contracting season, as well as uncertainty regarding uptake of mFLUSIVA during the season.

Previous wording

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.

Current wording

We sell our vaccines to the commercial market as well as to governments and international organizations. In the U.S., our vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers, healthcare providers and government entities. Net product sales are recognized net of estimated chargebacks, fulfillment fees, prompt-pay discounts, provisions for sales returns and government rebates, and other related deductions.

Previous wording

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.

Current wording

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2026, we had deferred revenue of $218 million related to product sales, of which $160 million is expected to be realized in less than one year.

Previous wording

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.

Current wording

For the three months ended September 30, 2026, total revenue increased by $297 million, or 29%, compared to the same period in 2025, primarily driven by a $300 million, or 31%, increase in net product sales. For the nine months ended September 30, 2026, total revenue increased by $581 million, or 46%, compared to the same period in 2025, primarily driven by a $547 million, or 47%, increase in net product sales. The increase in net product sales in both periods was mainly due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Net product sales in the U.S. were generally consistent with the corresponding periods in 2025. Other revenue remained relatively consistent for the three months ended September 30, 2026 compared to the same period in 2025. For the nine months ended September 30, 2026, other revenue increased by $34 million, or 36%, compared to the same period, primarily due to higher stand-ready manufacturing revenue, including from facilities that became operational during the second half of 2025, and higher collaboration revenue, mainly related to our collaboration with Recordati for our investigational propionic acidemia therapeutic, mRNA-3927.

Previous wording

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.

Current wording

Cost of sales for the three months ended September 30, 2026 was $318 million, which included third-party royalties of $65 million, inventory write-downs of $54 million, and unutilized manufacturing capacity costs of $29 million. Cost of sales for the nine months ended September 30, 2026 was $1.4 billion, which included third-party royalties of $971 million, inventory write-downs of $133 million, and unutilized manufacturing capacity costs of $54 million. Third-party royalties included $6 million and $890 million for the three and nine months ended September 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.

Previous wording

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.

Current wording

Cost of sales for the three months ended September 30, 2026 increased by $111 million, or 54%, 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 September 30, 2026 was 24%, compared to 21% for the same period in 2025. The increases were primarily due to higher product sales volume and higher unutilized manufacturing costs. Cost of sales for the nine months ended September 30, 2026 increased by $950 million, or 228%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the nine months ended September 30, 2026 was 75%, compared to 34% for the same period in 2025. The increase was primarily driven by litigation settlement-related expenses. Excluding these expenses, cost of sales increased by 14%, while cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the nine months ended September 30, 2026 decreased by eight percentage points compared to the same period in 2025. The increase in cost of sales was primarily due to higher product sales volume, partially offset by lower inventory write-downs and the absence of losses on firm purchase commitments recorded in the prior year. The decrease in cost of sales as a percentage of net product sales and stand-ready manufacturing revenue primarily reflected sales growth outpacing the increase in underlying cost of sales.

Previous wording

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.

Current wording

Research and development expenses decreased by $218 million, or 27%, for the three months ended September 30, 2026, compared to the same period in 2025. This reduction was primarily due to lower clinical trial expenses of $127 million, including a $33 million benefit recognized under the Blackstone research and development funding arrangement resulting from a revision to prior-period estimates, and lower personnel-related costs and stock-based compensation of $75 million. For the nine months ended September 30, 2026, research and development expenses decreased by $474 million, or 20%, compared to the same period in 2025. This decrease primarily reflected lower clinical trial expenses of $246 million, personnel-related costs and stock-based compensation of $152 million, and outside services of $58 million. The lower clinical trial expenses for both periods were primarily driven by reduced spending on several late-stage studies, including those related to our flu plus COVID combination vaccine, congenital CMV, RSV and norovirus programs. For the nine-month period, these reductions were partially offset by higher spending on oncology programs and COVID postmarketing commitments. The decrease in personnel-related costs and stock-based compensation for both periods primarily reflected portfolio reprioritization and associated resource realignment.

Previous wording

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.

Current wording

We anticipate a 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.

Previous wording

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.

Current wording

Selling, general and administrative expenses increased by $14 million, or 5%, for the three months ended September 30, 2026, compared to the same period in 2025. The increase was primarily due to higher legal expenses, partially offset by reduced commercial and marketing-related spending, lower employee-related costs and other operating expenses. For the nine months ended September 30, 2026, selling, general and administrative expenses decreased by $39 million, or 5%, compared to the same period in 2025. This decrease for the nine-month period primarily driven by lower employee-related costs of $27 million, reduced commercial and marketing-related spending of $24 million, and lower other operating expenses, partially offset by higher legal expense. The reduction in commercial and marketing-related spending and other operating expenses reflected continued cost discipline and efficiencies across the organization.

Previous wording

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.

Current wording

For the three months ended September 30, 2026, interest income decreased by $11 million, or 15%, compared to the same period in 2025. For the nine months ended September 30, 2026, interest income decreased by $43 million, or 18%, compared to the same period in 2025. The decrease in each period was primarily due to lower average investment balances and interest rates.

Previous wording

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.

Current wording

For the three and nine months ended September 30, 2026, we recorded total other expense, net of $21 million and $58 million, respectively, compared to total other income, net of an immaterial amount and $4 million for the same periods in 2025. The increase in other expense, net for the three and nine months ended September 30, 2026, was largely driven by higher interest expense. Interest expense is primarily related to our term loan issued in November 2025, our convertible notes issued in September 2026, 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.

Previous wording

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.

Current wording

Provision for income taxes was $9 million and $33 million for the three and nine months ended September 30, 2026, respectively, compared to $13 million and $27 million for the same periods in 2025. The provision primarily resulted from taxable income generated by certain of our foreign subsidiaries. The effective tax rate continues to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits associated with our expected full-year loss. Please refer to Note 14 to our condensed consolidated financial statements for additional details.

Previous wording

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.

Current wording

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 September 30, 2026 decreased by $159 million, or 2%, 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 $2.7 billion, partly offset by net proceeds of $2.6 billion from the issuance of convertible notes, after payments for the related capped call transactions, during the nine months ended September 30, 2026.

Previous wording

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.

Current wording

Working capital, defined as current assets less current liabilities, increased by $759 million, or 17%, as of September 30, 2026, compared to December 31, 2025. This was primarily driven by an increase in accounts receivable, net of $1.2 billion, driven by product sales in the quarter, partly offset by a decrease in cash, cash equivalents and current investments of $628 million to fund operations.

Previous wording

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.

Current wording

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 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 vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers, healthcare providers and government entities. 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 September 30, 2026, we had $407 million in deferred revenue related to customer advance payments received or billable.

Previous wording

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.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $2.7 billion and consisted of net loss of $2.0 billion, non-cash adjustments of $527 million, and a net change in assets and liabilities of $1.3 billion. Non-cash items primarily included stock-based compensation of $351 million and depreciation and amortization of $190 million. The net change in assets and liabilities was mainly due to an increase in accounts receivable, net of $1.2 billion, driven by sales in the quarter and timing of collections, and an increase in inventory of $159 million driven by increased production for the 2026/2027 respiratory season, partially offset by an increase in deferred revenue of $160 million driven by customer advance payments.

Previous wording

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.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026 was $1.5 billion, driven primarily by purchases of marketable securities of $5.1 billion, and purchases of property and equipment of $146 million, partially offset by proceeds from maturities and sales of marketable securities of $3.9 billion.

Previous wording

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.

Current wording

Net investing cash flows decreased by $3.5 billion, or 173%, during the nine months ended September 30, 2026, compared to the same period in 2025, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $2.5 billion and an increase in purchases of marketable securities of $928 million.

Previous wording

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.

Current wording

Net cash provided by financing activities increased by $2.8 billion, during the nine months ended September 30, 2026, compared to the same period in 2025, mainly due to net proceeds of $2.6 billion from the issuance of convertible notes, after payments for the related capped call transactions, and an increase in proceeds from issuance of common stock through equity plans of $153 million.

Previous wording

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.

Current wording

Our principal sources of funding as of September 30, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $2.0 billion for the nine months ended September 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 $5.3 billion as of September 30, 2026.

Previous wording

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.

Current wording

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 intismeran autogene, our other oncology programs, norovirus, 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 are also incurring, and expect to continue to incur, costs related to postmarketing requirements and commitments for certain approved products, including ongoing clinical and safety studies. The scope, timing and duration of these activities remain subject to regulatory requirements and may evolve over time. In addition, we have substantial facility, lease and purchase obligations. 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.

Previous wording

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.

Current wording

We believe that our cash, cash equivalents, and investments as of September 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. 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.