REGENERON PHARMACEUTICALS, INC.

Previous wording

In April 2026, we announced agreements with the U.S. government (the "U.S. Government Agreements") pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program at or below prices benchmarked against a defined group of other developed countries ("Most-Favored-Nation Pricing"). We have also agreed to price certain future medicines in the United States at or below Most-Favored-Nation Pricing; to participate in a direct purchasing platform, TrumpRx.gov, that will allow eligible patients to purchase Praluent directly; and to provide our recently FDA-approved gene therapy Otarmeni™ for free in the United States. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the U.S. Department of Commerce's recent investigation under Section 232 of the Trade Expansion Act of 1962, as amended, through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States.

Current wording

In April 2026, we announced agreements with the U.S. government (the "U.S. Government Agreements") pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program at prices no greater than prices determined based on benchmarking against a defined group of other developed countries ("Most-Favored-Nation Pricing"). We have also agreed to price certain future medicines in the United States at prices no greater than Most-Favored-Nation Pricing; to participate in a direct purchasing platform, TrumpRx.gov, that will allow eligible patients to purchase Praluent directly; and to provide our recently FDA-approved gene therapy Otarmeni™ for free in the United States. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the U.S. Department of Commerce's recent investigation under Section 232 of the Trade Expansion Act of 1962, as amended, through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States.

Previous wording

Under our collaboration agreement, Sanofi records product sales for commercialized products, and we have the right to co-commercialize such products on a country-by-country basis. We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).

Current wording

Agreed-upon development expenses incurred by the parties are generally shared equally. Under our collaboration agreement, Sanofi records product sales for commercialized products, and we have the right to co-commercialize such products on a country-by-country basis. We co-commercialize Dupixent in the United States and in certain countries outside the United States. We also supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).

Previous wording

We and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA 8 mg and EYLEA outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

Current wording

We and Bayer are parties to a license and collaboration agreement for the development and commercialization of EYLEA 8 mg and EYLEA. Agreed-upon development expenses incurred by the parties are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

Previous 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.

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 ended in May 2026.

Previous 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.

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 pay 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 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 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 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.

Current wording

Net product sales of EYLEA HD increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes, partly offset by a lower net selling price.

Previous 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.

Current wording

Net product sales of EYLEA decreased for the three and six months ended June 30, 2026, compared to the same periods 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

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.

Current wording

The increase in our share of profits for the three and six months ended June 30, 2026, compared to the same periods in 2025, was driven by higher profits primarily associated with an increase in Dupixent net product sales.

Previous 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.

Current wording

The decrease in our share of profits for the three and six months ended June 30, 2026, compared to the same periods in 2025, was driven by lower profits primarily associated with a decrease in EYLEA sales outside the United States.

Previous wording

Acquired IPR&D expenses for the three months ended March 31, 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements.

Current wording

Acquired IPR&D expenses for the three and six months ended June 30, 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements. In addition, Acquired IPR&D expenses for the six months ended June 30, 2026 included the premium on equity securities purchased and development milestone payments in connection with collaboration and licensing agreements.

Previous 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.

Current wording

Selling, general, and administrative expenses increased for the six months ended June 30, 2026, compared to the same period in 2025, partly due to an increase in commercialization-related expenses and higher headcount and headcount-related costs, offset in part by lower charitable contributions to an independent non-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $85.5 million and $91.8 million for the three months ended June 30, 2026 and 2025, respectively, and $174.7 million and $187.0 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

Gross margin on net product sales decreased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to unabsorbed manufacturing costs and higher inventory write-offs and reserves as a result of a temporary interruption of bulk manufacturing production at our facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. We resumed initial production at the facility in the second quarter of 2026; however, gross margin will continue to be negatively impacted until production returns to normal levels, which is expected by the end of the second quarter of 2026. The interruption has not impacted, nor is it expected to impact, the availability of any of our products. See Part II, Item 1A. "Risk Factors - Risks Related to Manufacturing and Supply -Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators or contract manufacturers, or the facilities of any other party participating in the supply chain, could adversely affect our ability to supply our products."

Current wording

Gross margin on net product sales decreased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to unabsorbed manufacturing costs as a result of a temporary interruption of bulk manufacturing production at our facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. As of June 30, 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of our products. See Part II, Item 1A. "Risk Factors - Risks Related to Manufacturing and Supply -Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators or contract manufacturers, or the facilities of any other party participating in the supply chain, could adversely affect our ability to supply our products."

Previous 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.

Current wording

Our effective tax rate for the three and six months ended June 30, 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, tax benefits from cross-border tax laws and federal tax credits for research activities, partly offset by changes in unrecognized tax benefits. In addition, our effective tax rate increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to the release of liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit.

Previous 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.

Current wording

Capital expenditures for the six months ended June 30, 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 $1.030 billion to $1.100 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

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.

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 April 2026. The programs have no time limit and can be discontinued at any time. As of June 30, 2026, $2.534 billion remained available for share repurchases under the program.

Previous 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.

Current wording

In each of the first and second quarters of 2026, our board of directors declared a quarterly cash dividend of $0.94 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.

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, 2025 (filed February 4, 2026). There have been no material changes to critical accounting estimates during the three months ended March 31, 2026.

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 six months ended June 30, 2026.