REGENERON PHARMACEUTICALS, INC.
For the period ended Sep 30, 2026. Filed Oct 30, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Oct 30, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-07-30.
0000872589-26-000025
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-10-30.
0000872589-26-000034
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 136 previous paragraphs and 138 current paragraphs.
106 unchanged; 23 reworded; 8 added; 6 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 24 previous and 25 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
(r) In collaboration with Alnylam
Current report
U.S. Government Agreements
Current report
In October 2026, the parties amended the collaboration agreement to include four additional long-acting, Regeneron-invented antibodies: (i) an antibody targeting IL-13, (ii) an antibody targeting IL-4, (iii) an antibody targeting IL-4 receptor alpha, and (iv) a bispecific antibody targeting IL-4xIL-13 (collectively, the "New Licensed Products"). As described above, REGN20423, an antibody targeting IL-13, is currently in Phase 1 clinical development, and the other three product candidates are expected to enter clinical studies in 2027. We will also have the option, on an asset-by-asset basis after completion of certain ongoing clinical trials, to include in the collaboration Sanofi's Phase 2/3 asset lunsekimig, an investigational bispecific Nanobody® VHH therapy targeting thymic stromal lymphopoietin ("TSLP") and IL-13, and another Sanofi early development product candidate. In the event we exercise our option for any such product, we will reimburse Sanofi for certain development costs related to such product.
Current report
Under the terms of the amendment, we received an up-front payment of $1.0 billion from Sanofi, and we are entitled to receive up to an additional $7.0 billion in the aggregate upon the achievement of certain development, regulatory, and sales-based milestones.
Current report
As described in the "Collaboration, License, and Other Agreements – Sanofi" section above, in October 2026, the parties amended the collaboration agreement. Under the terms of the agreement, we received an up-front payment of $1.0 billion from Sanofi, which will be recorded to Collaboration revenue in the fourth quarter of 2026.
Current report
Operating expenses included stock-based compensation expense of $255.8 million and $237.0 million for the three months ended September 30, 2026 and 2025, respectively, and $756.2 million and $744.4 million for the nine months ended September 30, 2026 and 2025, respectively.
Current report
Research and development expenses included stock-based compensation expense of $140.3 million and $125.1 million for the three months ended September 30, 2026 and 2025, respectively, and $406.2 million and $405.1 million for the nine months ended September 30, 2026 and 2025, respectively.
Current report
Acquired IPR&D expenses for the nine months ended September 30, 2025 included an $80.0 million up-front payment in connection with our license agreement with Hansoh Pharmaceuticals Group Company Limited.
Removed paragraphs (6)
Previous report
(s) In collaboration with Alnylam. Study on clinical hold in the U.S. by the FDA; continuing to enroll ex-U.S.
Previous report
Recent Developments – U.S. Government Agreements
Previous report
Operating expenses included stock-based compensation expense of $243.0 million and $251.7 million for the three months ended June 30, 2026 and 2025, respectively, and $500.4 million and $507.4 million for the six months ended June 30, 2026 and 2025, respectively.
Previous report
Research and development expenses included stock-based compensation expense of $130.8 million and $139.0 million for the three months ended June 30, 2026 and 2025, respectively, and $265.9 million and $280.0 million for the six months ended June 30, 2026 and 2025, respectively.
Previous report
Selling, General, and Administrative Expenses
Previous report
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.
Reworded paragraphs (23)
Previous wording
•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
Current wording
•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), risks associated with intellectual property of the Company or other parties and pending or future litigation or patent office proceedings relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 12 to our Condensed Consolidated Financial
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. A program is classified in Phase 2 or 3 clinical development after enrollment for the corresponding study or studies has commenced.
Current wording
Product candidates in Phase 2 and Phase 3 clinical development that 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
Note: We and Sanofi have discontinued further clinical development of itepekimab, an antibody to IL-33, in COPD, CRSwNP, and chronic rhinosinusitis without nasal polyposis ("CRSsNP"). In addition, we have discontinued further clinical development of REGN7999, an antibody to TMPRSS6, which was previously being studied in iron overload in beta-thalassemia.
Current wording
Note: During 2026, we and Sanofi discontinued further clinical development of itepekimab, an antibody to IL-33, in COPD, CRSwNP, and chronic rhinosinusitis without nasal polyposis ("CRSsNP"). In addition, we discontinued further clinical development of bremzalerbart-atisnolerbart (REGN5713-5715), a multi-antibody therapy to Bet v 1, in birch allergy and REGN7999, an antibody to TMPRSS6, in iron overload in beta-thalassemia.
Previous wording
(n) Studied in combination with semaglutide with and without garetosmab
Current wording
(n) Studied in combination with semaglutide with and without Pasatru (garetosmab)
Previous wording
We are party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent, Kevzara, and itepekimab. As described above, during 2026 we and Sanofi discontinued further clinical development of itepekimab.
Current wording
We are party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which, as of September 30, 2026, consisted of Dupixent, Kevzara, and itepekimab. As described above, during 2026 we and Sanofi discontinued further clinical development of itepekimab.
Previous 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).
Current wording
Agreed-upon development expenses incurred by the parties are shared equally. Sanofi leads commercialization activities for products under the collaboration agreement, 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. For Dupixent and Kevzara, 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). Global profits from sales of New Licensed Products will be shared equally between the parties.
Previous 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.
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. We also supply commercial bulk product to Bayer. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.
Previous wording
For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.
Current wording
For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will share profits and costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.
Previous wording
In January 2026, our collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 (Tessera's investigational program for the treatment of alpha-1 antitrypsin deficiency ("AATD")) became effective. Tessera will lead the initial first-in-human trial, while we will lead subsequent global development and commercialization. The parties will share worldwide development expenses and, if commercialized, any future profits or losses equally. Under the terms of the agreement, the Company made aggregate payments of $150.0 million in the first quarter of 2026, consisting of an up-front payment and the purchase of Tessera preferred stock. In addition, we are obligated to make additional payments upon achievement of certain development milestones.
Current wording
In January 2026, our collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 (Tessera's investigational program for the treatment of alpha-1 antitrypsin deficiency ("AATD")) became effective. Tessera will lead the initial first-in-human trial, while we will lead subsequent global development and commercialization. The parties will share global development expenses and, if commercialized, any future profits or losses equally. Under the terms of the agreement, the Company made aggregate payments of $150.0 million in the first quarter of 2026, consisting of an up-front payment and the purchase of Tessera preferred stock. In addition, we are obligated to make additional payments upon achievement of certain development milestones.
Previous wording
In May 2026, we entered into a collaboration agreement with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon™ peptide platform. Under the terms of the agreement, we made a $50.0 million up-front payment and purchased $75.0 million of Parabilis common stock. We will lead development and commercialization, and Parabilis will be eligible to receive milestone payments for development, regulatory and commercial milestones, as well as tiered royalties up to low double-digits on sales. Under the terms of the agreement, additional targets may be pursued upon additional option payments made by us.
Current wording
In May 2026, we entered into a collaboration agreement with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis' Helicon™ peptide platform. Under the terms of the agreement, we made a $50.0 million up-front payment and purchased $75.0 million of Parabilis common stock. We will lead development and commercialization, and Parabilis will be entitled to receive milestone payments for development, regulatory, and sales milestones, as well as tiered royalties up to low double-digits on sales. Under the terms of the agreement, additional targets may be pursued upon additional option payments made by us.
Previous 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.
Current wording
EYLEA HD U.S. net product sales increased for the three and nine months ended September 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 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.
Current wording
EYLEA U.S. net product sales decreased for the three and nine months ended September 30, 2026, compared to the same periods in 2025, primarily due to lower sales volumes as a result of continued competitive pressures (as described below) and the continued transition of patients to EYLEA HD.
Previous wording
Global net product sales of Libtayo increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes.
Current wording
Libtayo U.S. net product sales increased for the three and nine months ended September 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes.
Previous 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.
Current wording
The increase in our share of profits for the three and nine months ended September 30, 2026, compared to the same periods in 2025, was driven by higher profits primarily associated with an increase in Dupixent net product sales, as well as higher Sanofi collaboration revenue resulting from the full repayment of the Sanofi development balance as of the second quarter of 2026.
Previous 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.
Current wording
The decrease in our share of profits for the three and nine months ended September 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 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.
Current wording
Acquired IPR&D expenses for the nine months ended September 30, 2026 included the premium on equity securities purchased and up-front, opt-in, and development milestone payments in connection with various collaboration and licensing agreements.
Previous 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."
Current wording
Gross margin on net product sales decreased for the nine months ended September 30, 2026, compared to the same period 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. The interruption did not impact the availability of any of our products; and, as of June 30, 2026, bulk manufacturing production had returned to normal levels.
Previous 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.
Current wording
Our effective tax rate for the three and nine months ended September 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 (which, for the nine months ended September 30, 2025, included the release of liabilities upon the settlement of an IRS audit). In addition, our effective tax rate for the three and nine months ended September 30, 2025 was negatively impacted by the enactment of the "One Big Beautiful Bill Act," including the re-measurement of our U.S. net deferred tax assets.
Previous 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.
Current wording
Capital expenditures for the nine months ended September 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 $1.050 billion to $1.100 billion for the full year of 2026.
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 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.
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 September 30, 2026, $2.157 billion remained available for share repurchases under the program.
Previous 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.
Current wording
In each of the first, second, and third quarters of 2026, we 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
Additionally, in July 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 August 31, 2026 to our shareholders of record as of August 18, 2026.
Current wording
Additionally, in October 2026, we declared a cash dividend of $0.94 per share on our Common Stock and Class A Stock. The dividend will be payable on December 3, 2026 to our shareholders of record as of November 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, 2025 (filed February 4, 2026). There have been no material changes to critical accounting estimates during the six months ended June 30, 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 nine months ended September 30, 2026.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
(r) Studied as monotherapy and in combination with Evkeeza (evinacumab)