REGENERON PHARMACEUTICALS, INC.

Previous wording

•competing drugs and product candidates that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") (including biosimilar versions of Regeneron's Products);

Current wording

•competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates");

Previous wording

•changes to drug pricing regulations and requirements and our drug pricing strategy;

Current wording

•changes to drug pricing regulations and requirements and our drug pricing strategy, including in connection with our April 2026 agreements with the U.S. government discussed in this report;

Previous wording

•our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;

Current wording

•our ability to meet any of our financial projections or guidance and changes to the assumptions underlying those projections or guidance;

Previous wording

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.

Current wording

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below. A program is classified in Phase 2 or 3 clinical development after enrollment for the corresponding study or studies has commenced.

Previous wording

(f) Sanofi is entitled to receive royalties on sales of the product, if any

Current wording

(f) Sanofi is entitled to receive royalties on sales of the product

Previous wording

(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation

Current wording

(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for one or more indications

Previous wording

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of September 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $905 million.

Current wording

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab. Under the terms of the collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development expenses as incurred. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi (i.e., "development balance") based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of March 31, 2026, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $278 million.

Previous wording

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits. The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

Current wording

We are obligated to reimburse Bayer for 50% of the development expenses that it has incurred under the agreement from our share of the collaboration profits. The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

Previous wording

Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization agreement or a license agreement. The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain milestones (the "Research Term"). In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.

Current wording

For each target nominated, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation. Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") or a license agreement. The target nomination period of the collaboration agreement ends in May 2026.

Previous wording

We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

Current wording

We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab. Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the product under such program. The licensee will be responsible for its own expenses incurred. The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as tiered royalty payments to the licensor based on the aggregate annual sales of the product.

Previous wording

We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology forin vivo therapeutic development, including therapies focused on neurological and muscular diseases. We have the right to select targets under the license and collaboration agreement until April 2026.

Current wording

We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development, including therapies focused on neurological and muscular diseases. We had the right to select targets under the license and collaboration agreement until April 2026.

Previous wording

Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us). If nex-z is commercialized, Intellia will lead commercialization activities and we will be entitled to 25% of any profits.

Current wording

Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us). If nex-z is commercialized, Intellia will lead commercialization activities and we will share in 25% of any profits or losses.

Previous wording

In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP-1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.

Current wording

We have licensed from Hansoh Pharmaceuticals Group Company Limited the development and commercial rights for olatorepatide (a dual GLP-1/GIP receptor agonist) outside of mainland China, Hong Kong, and Macau. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.

Previous wording

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.

Current wording

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.

Previous wording

Net product sales of EYLEA HD increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, due to higher sales volumes, partly offset by a lower net selling price.

Current wording

Net product sales of EYLEA HD increased for the three months ended March 31, 2026, compared to the same period in 2025, due to higher sales volumes, partly offset by a lower net selling price. In addition, EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2026 compared to the end of the fourth quarter of 2025.

Previous wording

Net product sales of EYLEA for the three and nine months ended September 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Current wording

Net product sales of EYLEA decreased for the three months ended March 31, 2026, compared to the same period in 2025, due to (i) lower sales volumes as a result of continued competitive pressures (as described below) and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Previous wording

EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part II, Item 1A. "Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products -We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition -Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.

Current wording

EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part II, Item 1A. "Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products -We are substantially dependent on revenues derived from net product sales of EYLEA HD, EYLEA, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition -Marketed Products."

Previous wording

The increase in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by higher profits associated with an increase in Dupixent sales.

Current wording

The increase in our share of profits for the three months ended March 31, 2026, compared to the same period in 2025, was driven by higher profits primarily associated with an increase in Dupixent sales.

Previous wording

The decrease in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by lower profits associated with a decrease in EYLEA sales outside the United States.

Current wording

The decrease in our share of profits for the three months ended March 31, 2026, compared to the same period in 2025, was driven by lower profits primarily associated with a decrease in EYLEA sales outside the United States.

Previous wording

The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

Current wording

The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

Previous wording

Selling, general, and administrative expenses decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $92.0 million and $83.1 million for the three months ended September 30, 2025 and 2024, respectively, and $279.0 million and $251.9 million for the nine months ended September 30, 2025 and 2024, respectively.

Current wording

Selling, general, and administrative expenses increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to an increase in commercialization-related expenses for EYLEA HD and Libtayo and higher headcount and headcount-related costs, partly offset by lower charitable contributions to an independent non-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $89.2 million and $95.2 million for the three months ended March 31, 2026 and 2025, respectively.

Previous wording

Our effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law. In addition, our effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced our effective tax rate for the nine months ended September 30, 2025 by 1.4%.

Current wording

Our effective tax rate for the three months ended March 31, 2026 and 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and, to a lesser extent, federal tax credits for research activities, partly offset by changes in unrecognized tax benefits. In addition, our effective tax rate increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower tax benefits from cross-border tax laws and federal tax credits for research activities.

Previous wording

Capital expenditures for the nine months ended September 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters. We expect to incur capital expenditures of $850 million to $890 million for the full year of 2025.

Current wording

Capital expenditures for the three months ended March 31, 2026 included costs incurred in connection with the expansion of our research and support facilities at our Tarrytown, New York corporate headquarters, as well as costs associated with the expansion of our manufacturing facilities. We expect to incur capital expenditures of $1.100 billion to $1.200 billion for the full year of 2026, including in connection with the continued expansion of our facilities in Tarrytown, New York, and the continued expansion of our manufacturing facilities, including in connection with developing our property in Saratoga Springs, New York for production support activities and additional manufacturing capacity.

Previous wording

In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. As of September 30, 2025, $2.156 billion remained available for share repurchases under the programs.

Current wording

Our board of directors has authorized share repurchase programs, including a share repurchase program for up to $3.0 billion of our Common Stock which was authorized in February 2025. The programs have no time limit and can be discontinued at any time. As of March 31, 2026, $688.2 million remained available for share repurchases under the programs.

Previous wording

In each of the first, second, and third quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock. Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.

Current wording

In January 2026, our board of directors declared a quarterly cash dividend of $0.94 per share on our Common Stock and Class A Stock, which was paid to our shareholders in March 2026.

Previous wording

Additionally, in October 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock. The dividend will be payable on December 5, 2025 to our shareholders of record as of November 20, 2025.

Current wording

Additionally, in April 2026, our board of directors declared a cash dividend of $0.94 per share on our Common Stock and Class A Stock. The dividend will be payable on June 4, 2026 to our shareholders of record as of May 20, 2026.

Previous wording

A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.

Current wording

A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (filed February 4, 2026). There have been no material changes to critical accounting estimates during the three months ended March 31, 2026.