Regeneron Pharmaceuticals REGN
Regeneron Pharmaceuticals reported $5.12 billion in revenue for Q3 2026.
- Form
- 10-Q
- Filed
- Importance
- Major
- Accession
- 0000872589-26-000034
- Revenue: $5.12 billion for the three months ended Sep 30, 2026
- Net income: $1.95 billion for the three months ended Sep 30, 2026
- Diluted EPS: $18.45 for the three months ended Sep 30, 2026
- Cash and equivalents: $3.66 billion at Sep 30, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed
26 changes since the June 2026 10-Q
Compared with the 10-Q 0000872589-26-000025, filed Jul 30, 2026.
New legal mention
On August 19, 2026, the U.S. Court of Appeals for the Ninth Circuit (the "Ninth Circuit") reversed the District Court's decision to dismiss the amended complaint with respect to Regeneron in part, affirmed the decision…
From the filings
Now
On August 19, 2026, the U.S. Court of Appeals for the Ninth Circuit (the "Ninth Circuit") reversed the District Court's decision to dismiss the amended complaint with respect to Regeneron in part, affirmed the decision in part, and remanded the lawsuit to the District Court for further proceedings.New legal mention
On August 19, 2026, the court dismissed the amended complaint; and, on September 9, 2026, the plaintiff filed a second amended complaint.
From the filings
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On August 19, 2026, the court dismissed the amended complaint; and, on September 9, 2026, the plaintiff filed a second amended complaint.New legal mention
On October 19, 2026, the court dismissed the action as to all defendants without prejudice for failure to timely serve the complaint and ordered the case closed.
From the filings
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On October 19, 2026, the court dismissed the action as to all defendants without prejudice for failure to timely serve the complaint and ordered the case closed.New legal mention
On September 23, 2026, an alleged shareholder filed a shareholder derivative complaint in the SDNY, naming members of the Company's board of directors and certain executive officers and employees of the Company as…
From the filings
Now
On September 23, 2026, an alleged shareholder filed a shareholder derivative complaint in the SDNY, naming members of the Company's board of directors and certain executive officers and employees of the Company as defendants and Regeneron as a nominal defendant.New legal mention
The complaint alleges, among other things, that the individual defendants violated securities laws, breached their fiduciary duties, and wasted corporate assets by failing to properly manage and oversee the Company in…
From the filings
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The complaint alleges, among other things, that the individual defendants violated securities laws, breached their fiduciary duties, and wasted corporate assets by failing to properly manage and oversee the Company in connection with the conduct alleged in the July 2026 Class Action Complaint discussed under "k.New legal mention
On October 9, 2026, the court denied the Company's motion to dismiss as to the plaintiff's breach of fiduciary duty claim, but granted it as to the unjust enrichment and corporate waste claims.
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On October 9, 2026, the court denied the Company's motion to dismiss as to the plaintiff's breach of fiduciary duty claim, but granted it as to the unjust enrichment and corporate waste claims.New legal mention
The court also granted the plaintiff's motion to substitute the named plaintiff.
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The court also granted the plaintiff's motion to substitute the named plaintiff.New legal mention
On September 18, 2026, the court granted the Company's motion to dismiss; and, on October 15, 2026, the purported shareholder filed a notice of appeal.
From the filings
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On September 18, 2026, the court granted the Company's motion to dismiss; and, on October 15, 2026, the purported shareholder filed a notice of appeal.New legal mention
On October 1, 2026, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.
From the filings
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On October 1, 2026, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.New legal mention
On September 15, 2026, the parties filed a joint request seeking to consolidate the state lawsuits in New Jersey for coordinated pretrial proceedings.
From the filings
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On September 15, 2026, the parties filed a joint request seeking to consolidate the state lawsuits in New Jersey for coordinated pretrial proceedings.U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions…
Since March 11, 2026, the Office of the U.S. Trade Representative ("USTR") has initiated four new investigations under Section 301 of the Trade Act of 1974 ("Section 301") covering forced labor in supply chains…
From the filings
Before
U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions. Since March 11, 2026, the Office of the U.S. Trade Representative ("USTR") has initiated four new investigations under Section 301 of the Trade Act of 1974 ("Section 301") covering forced labor in supply chains; industrial overcapacity; intellectual property protection and enforcement concerns; and underpayment for certain pharmaceutical products. These investigations collectively target nearly 80 countries. As described below, the forced labor investigation has already resulted in new tariffs, effective July 24, 2026, and the remaining investigations could result in additional new tariffs impacting our business. On July 23, 2026, USTR issued a notice of action in the Section 301 investigation into forced labor. As a result of this notice, tariffs of either 10% or 12.5%, effective July 24, 2026, apply to imports from 60 countries, including locations where we have operations, such as Canada, the European Union, India, Japan, and the United Kingdom. These tariffs essentially replace the 10% Section 122 surcharge that expired on July 24, 2026. USTR has provided a number of exemptions to the new tariffs, including exemptions for 700 specific articles used in pharmaceutical applications. While these exemptions limit the direct impact of the forced labor Section 301 tariffs on our import activities, some of our imports may not qualify for the exemptions and may be subject to the new tariffs. Additionally, because the scope, timing, and applicability of any tariffs resulting from the other ongoing Section 301 investigations remain uncertain, it is unclear what impact they may have on our supply chain and operations. We face significant risks from the existing tariffs imposed by the United States (such as those discussed above) and potential new tariffs as well as their secondary…EPS up 51% from Jun 30
$18.45, was $12.23.
From the filings
Before
$12.23Now
$18.45Net income up 50% from Jun 30
$1.9B, was $1.3B.
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Before
$1.3BNow
$1.9BCash up 49% from Jun 30
$3.7B, was $2.5B.
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$2.5BNow
$3.7BRevenue up 19% from Jun 30
$5.1B, was $4.3B.
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$4.3BNow
$5.1BThe commercial success of our products and product candidates is subject to significant competition.
Adds "and Biocon's Yesafili (aflibercept-jbvf)"; drops "antibodies".
From the filings
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The commercial success of our products and product candidates is subject to significant competition. We face substantial competition from pharmaceutical and biotechnology companies. Many of our competitors have substantially greater research, preclinical and clinical product development, and manufacturing capabilities, as well as financial, marketing, and human resources, than we do. Our competitors, regardless of their size, may also enhance their competitive position if they acquire or discover patentable inventions, form collaborative arrangements, or merge with other pharmaceutical or biotechnology companies. There is significant actual and potential future competition for each of our marketed products. EYLEA HD and EYLEA. EYLEA HD and EYLEA face significant competition in the marketplace. For example, each of EYLEA HD and EYLEA competes in one or more of its approved indications with other VEGF inhibitors. These include Genentech/Roche's Vabysmo (faricimab-svoa) and Susvimo (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis (ranibizumab); Novartis' Beovu (brolucizumab); and a biosimilar version of Lucentis commercialized in the United States by Harrow, Inc. In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu (aflibercept-ayyh) in the United States. We are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments. We expect that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings (including those described in Note 12 to our Condensed Consolidated Financial Statements included in this report) and the…Now
The commercial success of our products and product candidates is subject to significant competition. We face substantial competition from pharmaceutical and biotechnology companies. Many of our competitors have substantially greater research, preclinical and clinical product development, and manufacturing capabilities, as well as financial, marketing, and human resources, than we do. Our competitors, regardless of their size, may also enhance their competitive position if they acquire or discover patentable inventions, form collaborative arrangements, or merge with other pharmaceutical or biotechnology companies. There is significant actual and potential future competition for each of our marketed products. EYLEA HD and EYLEA. EYLEA HD and EYLEA face significant competition in the marketplace. For example, each of EYLEA HD and EYLEA competes in one or more of its approved indications with other VEGF inhibitors. These include Genentech/Roche's Vabysmo (faricimab-svoa) and Susvimo (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis (ranibizumab); Novartis' Beovu (brolucizumab); and a biosimilar version of Lucentis commercialized in the United States by Harrow, Inc. In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu (aflibercept-ayyh) and Biocon's Yesafili (aflibercept-jbvf) in the United States. We are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments. We expect that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings (including those described in Note 12 to our Condensed Consolidated Financial…We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact…
Adds "IEEPA"; drops "Such".
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Before
We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition. Our Company faces risks associated with tariffs and other trade protection measures (including tariffs that have been or may in the future be imposed by the United States or other countries), import or export licensing requirements, trade embargoes, sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade), and protectionist or retaliatory measures taken by the United States or other countries. In 2025, the U.S. administration imposed an array of tariffs under the International Emergency Economic Powers Act ("IEEPA"). In July 2025, the United States and the EU announced the framework of a trade agreement that generally imposes a 15% tariff on imports from the EU. Under this agreement, pharmaceutical products would not be subject to any future duties under Section 232 in excess of this 15% rate. Such tariffs have prompted retaliatory measures from several countries, which may further escalate. On February 20, 2026, the U.S. Supreme Court ruled that IEEPA does not confer the authority to impose tariffs. In response, the U.S. administration ceased collecting these duties and, on February 24, 2026, imposed a temporary 10% surcharge on imports from all trading partners under Section 122 of the Trade Act of 1974 ("Section 122"). This surcharge expired on July 24, 2026. In addition, in April 2026, the United States imposed new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which are set to become effective for certain companies on July 31, 2026, and for others on September 29, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending…Now
We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition. Our Company faces risks associated with tariffs and other trade protection measures (including tariffs that have been or may in the future be imposed by the United States or other countries), import or export licensing requirements, trade embargoes, sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade), and protectionist or retaliatory measures taken by the United States or other countries. In 2025, the U.S. administration imposed an array of tariffs under the International Emergency Economic Powers Act ("IEEPA"). In July 2025, the United States and the EU announced the framework of a trade agreement that generally imposes a 15% tariff on imports from the EU. Under this agreement, pharmaceutical products would not be subject to any future duties under Section 232 in excess of this 15% rate. IEEPA tariffs prompted retaliatory measures from several countries. On February 20, 2026, the U.S. Supreme Court ruled that IEEPA does not confer the authority to impose tariffs. In response, the U.S. administration ceased collecting these duties and, on February 24, 2026, imposed a temporary 10% surcharge on imports from all trading partners under Section 122 of the Trade Act of 1974 ("Section 122"). This surcharge expired on July 24, 2026. In addition, in April 2026, the United States announced new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which became effective for those companies that had not entered into a qualifying agreement with the U.S. government by September 29, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending on…If our Antibody Collaboration with Sanofi is terminated, or Sanofi materially breaches its obligations…
Adds "under the Antibody Collaboration. We expect this reliance"; drops "With respect".
From the filings
Before
If our Antibody Collaboration with Sanofi is terminated, or Sanofi materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed. We rely on support from Sanofi to develop, manufacture, and commercialize certain of our products and product candidates. With respect to the products and product candidates that we are co-developing with Sanofi under our Antibody Collaboration, Sanofi initially funds a portion of development expenses incurred in connection with the development of these products and product candidates. In addition, we rely on Sanofi to lead much of the clinical development efforts, assist with or lead efforts to obtain and maintain regulatory approvals, and lead the commercialization efforts for these products and product candidates. If Sanofi terminates the Antibody Collaboration or fails to comply with its obligations thereunder, our business, prospects, operating results, and financial condition may be materially harmed. We would be required to either expend substantially more resources than we have anticipated to support our development efforts or cut back on such activities. If Sanofi does not perform its obligations with respect to the products and product candidates it is co-developing and/or co-commercializing with us, our ability to develop, manufacture, and commercialize these products and product candidates may be adversely affected. As described in Note 12 to our Condensed Consolidated Financial Statements included in this report, we have commenced the Antibody Collaboration Litigation against Sanofi and certain of its affiliated entities. It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we…Now
If our Antibody Collaboration with Sanofi is terminated, or Sanofi materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed. We rely on support from Sanofi to develop, manufacture, and commercialize certain of our products and product candidates under the Antibody Collaboration. We expect this reliance to continue for the foreseeable future following the recent amendment to the Antibody Collaboration to add four new product candidates to the Antibody Collaboration, as discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Collaboration, License, and Other Agreements Sanofi." Under the Antibody Collaboration, agreed-upon development costs incurred with respect to the products and product candidates covered thereby are shared equally. In addition, we rely on Sanofi to assist with or lead clinical development efforts, assist with or lead efforts to obtain and maintain regulatory approvals, and lead the commercialization efforts for these products and product candidates. If Sanofi terminates the Antibody Collaboration or fails to comply with its obligations thereunder, our business, prospects, operating results, and financial condition may be materially harmed. We would be required to either expend substantially more resources than we have anticipated to support our development efforts or cut back on such activities. If Sanofi does not perform its obligations with respect to the products and product candidates subject to the Antibody Collaboration, our ability to develop, manufacture, and commercialize these products and product candidates may be adversely affected. While we have some commercial presence outside the United States, our commercial capabilities outside the United States…European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive…
New paragraph in MD&A.
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European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for every 6-week dosing regimen for approved indicationsPresented longer-term data from Phase 3 study in adjuvant CSCC at European Society for Medical Oncology…
New paragraph in MD&A.
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Presented longer-term data from Phase 3 study in adjuvant CSCC at European Society for Medical Oncology ("ESMO") 2026 MeetingPresented additional data from Phase 2 study in obesity at European Association for the Study of Diabetes…
New paragraph in MD&A.
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Presented additional data from Phase 2 study in obesity at European Association for the Study of Diabetes ("EASD") Annual MeetingInitiate Phase 3 study in MASH/metabolic dysfunction-associated steatotic liver disease ("MASLD") (fourth…
New paragraph in MD&A.
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Initiate Phase 3 study in MASH/metabolic dysfunction-associated steatotic liver disease ("MASLD") (fourth quarter 2026)In October 2026, the parties amended the collaboration agreement to include four additional long-acting…
New paragraph in MD&A.
From the filings
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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.Under the terms of the amendment, we received an up-front payment of $1.0 billion from Sanofi, and we are…
New paragraph in MD&A.
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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.As described in the "Collaboration, License, and Other Agreements Sanofi" section above, in October 2026…
New paragraph in MD&A.
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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.Share of profits and royalties in connection with license and other agreements (a)
New paragraph in MD&A.
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Share of profits and royalties in connection with license and other agreements (a)
Show the redline
Section by section. Added words and removed words against the earlier filing.
Cover page 4 changes
3 unchanged paragraphs
For the quarterly period ended June September 30, 2026
10 unchanged paragraphs
Common Stock - par value $.001 per share REGN The Nasdaq Global Select Market
6 unchanged paragraphs
The number of shares outstanding of each of the registrant's classes of common stock as of July 23, October 22, 2026:
2 unchanged paragraphs
Common Stock, $.001 par value 101,137,842 101,630,713
3 unchanged paragraphs
Financial statements 124 changes
3 unchanged paragraphs
Inventories 3,084.3 3,200.8
Total assets $ 41,730.6 $ 40,558.7
June September 30, December 31,
Cash and cash equivalents $ 2,455.8 3,659.1 $ 3,118.1
Marketable securities 5,538.8 5,642.0 5,487.1
Accounts receivable, net 6,565.4 7,578.6 5,741.1
Inventories 2,894.6 3,200.8
Prepaid expenses and other current assets 801.7 1,020.8 474.8
Total current assets 18,446.0 20,795.1 18,021.9
Marketable securities 9,828.3 9,557.4 10,260.6
Property, plant, and equipment, net 5,458.9 5,727.5 5,120.4
Intangible assets, net 1,309.8 1,315.5 1,257.4
Deferred tax assets 4,381.4 4,535.6 4,077.2
Other noncurrent assets 2,306.2 2,474.1 1,821.2
Total assets $ 44,405.2 $ 40,558.7
2 unchanged paragraphs
Accounts payable $ 1,159.3 1,140.3 $ 939.0
Accrued expenses and other current liabilities 2,966.5 3,592.0 2,876.4
1 unchanged paragraph
Deferred revenue 684.8 749.8 553.0
Total current liabilities 5,530.6 6,202.1 4,368.4
Long-term debt 1,986.6 1,987.0 1,985.9
1 unchanged paragraph
Deferred revenue 220.4 220.2 208.7
Other noncurrent liabilities 2,281.6 2,497.4 2,018.8
Total liabilities 10,019.2 10,906.7 9,301.8
3 unchanged paragraphs
Retained earnings 37,621.4 35,797.1
Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 138.0 138.5 in 2026 and 137.6 in 2025
Additional paid-in capital 14,700.6 15,172.7 13,995.0
Retained earnings 39,471.8 35,797.1
Accumulated other comprehensive (loss) income ( 35.8 197.5 ) 77.5
Treasury Stock, at cost; 36.4 36.9 shares in 2026 and 33.7 shares in 2025 ( 20,574.9 20,948.6 ) ( 18,612.8 )
Total stockholders' equity 31,711.4 33,498.5 31,256.9
Total liabilities and stockholders' equity $ 41,730.6 44,405.2 $ 40,558.7
4 unchanged paragraphs
June 30, Six Months Ended
September 30, Nine Months Ended
1 unchanged paragraph
Net product sales $ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6
Collaboration revenue 2,455.0 1,860.7 4,354.7 3,391.9
Other revenue 193.3 183.9 364.5 265.8
Research and development 1,631.6 1,421.7 3,175.1 2,749.1
Acquired in-process research and development 127.0 10.0 228.9 22.3
Selling, general, and administrative 662.1 634.2 1,309.8 1,267.2
Cost of goods sold 360.7 275.6 734.1 541.1
Cost of collaboration and contract manufacturing 215.8 254.6 511.8 453.4
Income from operations 1,293.5 1,079.5 1,936.4 1,671.2
Net product sales $ 1,805.3 $ 1,587.7 $ 4,982.2 $ 4,634.3
Collaboration revenue 3,000.5 1,968.4 7,355.2 5,360.3
Other revenue 310.0 198.2 674.5 464.0
Research and development 1,794.7 1,475.0 4,969.8 4,224.1
Acquired in-process research and development 21.5 83.1 250.4 105.4
Selling, general, and administrative 677.8 657.8 1,987.6 1,925.0
Cost of goods sold 321.7 281.0 1,055.8 822.1
Cost of collaboration and contract manufacturing 251.9 240.6 763.7 694.0
Other operating (income) expense, net ( 10.0 ) ( 10.0 )
Income from operations 2,048.2 1,026.8 3,984.6 2,698.0
2 unchanged paragraphs
Interest expense ( 11.0 ) ( 3.6 ) ( 23.9 ) ( 12.3 )
Income before income taxes 1,527.8 1,518.7 2,359.0 2,423.7
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income per share - basic $ 12.62 $ 13.24 $ 19.58 $ 20.78
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Weighted average shares outstanding - diluted 106.0 108.6 106.8 109.9
Interest expense ( 10.6 ) ( 19.3 ) ( 34.5 ) ( 31.6 )
Income before income taxes 2,284.1 1,763.3 4,643.1 4,187.0
Net income $ 1,948.7 $ 1,460.0 $ 3,972.8 $ 3,660.3
Net income per share - basic $ 19.16 $ 14.09 $ 38.65 $ 34.83
Net income per share - diluted $ 18.45 $ 13.62 $ 37.37 $ 33.61
Weighted average shares outstanding - basic 101.7 103.6 102.8 105.1 103.4 105.9
Weighted average shares outstanding - diluted 105.6 107.2 106.3 108.9
1 unchanged paragraph
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income $ 1,948.7 $ 1,460.0 $ 3,972.8 $ 3,660.3
1 unchanged paragraph
Unrealized (loss) gain on debt securities ( 48.0 ) 22.1 ( 113.8 ) 60.2
Gain on foreign currency translation 0.3 1.3 0.5 0.2
Comprehensive income $ 1,249.2 $ 1,415.0 $ 1,910.8 $ 2,260.7
Unrealized (loss) gain on debt securities ( 160.8 ) 15.7 ( 274.6 ) 75.9 (Loss) gain on foreign currency translation ( 0.9 ) 0.8 ( 0.4 ) 1.0
Comprehensive income $ 1,787.0 $ 1,476.5 $ 3,697.8 $ 3,737.2
24 unchanged paragraphs
Issuance of Common Stock for equity awards granted under long-term incentive plans 0.6 301.2 301.2
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations ( 0.1 ) ( 95.7 ) ( 95.7 )
Issuance/distribution of Common Stock for 401(k) Savings Plan 19.4 2.8 22.2
Repurchases of Common Stock ( 0.5 ) ( 376.5 ) ( 376.5 )
Dividends declared ( 98.3 ) ( 98.3 )
Stock-based compensation charges 247.2 247.2
Net income 1,948.7 1,948.7
Other comprehensive loss, net of tax ( 161.7 ) ( 161.7 )
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and 44 more changes in the filing
Note 2: Product Sales 9 changes
1 unchanged paragraph
June 30, Six Months Ended
September 30, Nine Months Ended
1 unchanged paragraph
Total EYLEA HD and EYLEA U.S. 1,008.5 1,147.5 1,950.0 2,190.3
June 30, Six Months Ended
Total EYLEA HD and EYLEA U.S. 1,098.5 1,111.2 3,048.5 3,301.5
Other products Global
As of June September 30, 2026 and December 31, 2025, the Company had $ 3.784 4.132 billion and $ 3.458 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.
The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and six nine months ended June September 30, 2026 and 2025. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:
September 30, Nine Months Ended
Note A: Sanofi 13 changes
The Company is 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 (dupilumab), Kevzara (sarilumab), and itepekimab.
In October 2026, the parties amended the collaboration agreement to include four additional long-acting, Regeneron-invented antibodies (the "New Licensed Products"). Under the terms of the amendment, the Company received an up-front payment of $ 1.0 billion from Sanofi (which will be recorded to Collaboration revenue in the fourth quarter of 2026), and the Company is entitled to receive up to an additional $ 7.0 billion in the aggregate upon the achievement of certain development, regulatory, and sales-based milestones. In addition, the Company will have the option, on an asset-by-asset basis after the completion of certain ongoing clinical trials, to include additional Sanofi-developed product candidates in the collaboration. In the event the Company exercises its option for any such product, the Company will reimburse Sanofi for certain development costs related to such product.
The Company is party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent (dupilumab), Kevzara (sarilumab), and itepekimab . Agreed-upon development expenses incurred by the Company and Sanofi are generally shared equally. Sanofi leads commercialization activities for products under the collaboration subject to agreement, and the Company's Company has the right to co-commercialize such products on a country-by-country basis. The Company co-commercializes Dupixent in the United States and in certain countries outside the United States. The Company also supplies certain commercial bulk product to Sanofi. For Dupixent and Kevzara, the parties 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 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron). Global profits from sales of New Licensed Products will be shared equally between the parties.
2 unchanged paragraphs
June 30, Six Months Ended
September 30, Nine Months Ended
2 unchanged paragraphs
Collaboration revenue $ 2,032.6 $ 1,282.1 $ 3,483.4 $ 2,300.2
Collaboration revenue $ 2,574.9 $ 1,455.5 $ 6,058.3 $ 3,755.7
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 141.7 149.1 $ 161.5 $ 296.0 445.1 $ 326.6 488.1
2 unchanged paragraphs
Reduction of SG&A expense $ 188.8 $ 194.0 $ 372.9 $ 353.2
Reduction of SG&A expense $ 196.1 $ 182.6 $ 569.0 $ 535.8
As of June 30, 2026, the "development balance," which represented the Company's obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid. and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
1 unchanged paragraph
June September 30, December 31,
Accounts receivable, net $ 2,272.4 2,839.9 $ 1,610.6
Note B: Bayer 10 changes
The Company is party to a license and collaboration agreement with Bayer for the development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept). Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. The Company is also obligated to use commercially reasonable efforts to supply clinical and supplies commercial bulk product to Bayer.
3 unchanged paragraphs
June 30, Six Months Ended
September 30, Nine Months Ended
2 unchanged paragraphs
Collaboration revenue $ 227.3 $ 383.4 $ 467.3 $ 700.7
Collaboration revenue $ 211.5 $ 311.9 $ 678.8 $ 1,012.6
1 unchanged paragraph
Collaboration revenue $ 48.9 $ 31.6 $ 96.2 $ 58.2
Collaboration revenue $ 55.3 $ 32.9 $ 151.5 $ 91.1
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 0.6 0.3 ) $ ( 5.6 3.9 ) $ 0.4 0.1 $ ( 15.0 18.9 )
1 unchanged paragraph
June September 30, December 31,
Accounts receivable, net $ 223.4 234.5 $ 287.6
Note C: Other 2 changes
2 unchanged paragraphs
Acquired IPR&D expenses for the three and six months ended June 30, 2026 were $ 127.0 million and $ 228.9 million, respectively, and included up-front and opt-in payments in connection with collaboration and licensing agreements. In addition, Acquired IPR&D expenses for the six nine months ended June 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.
Acquired IPR&D expenses for the nine months ended September 30, 2025 included an $ 80.0 million up-front payment in connection with the Company's license agreement with Hansoh Pharmaceuticals Group Company Limited.
Note 4: Net Income Per Share 17 changes
1 unchanged paragraph
June 30, Six Months Ended
September 30, Nine Months Ended
1 unchanged paragraph
Net income - basic and diluted $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income - basic and diluted $ 1,948.7 $ 1,460.0 $ 3,972.8 $ 3,660.3
Weighted average shares - basic 101.7 103.6 102.8 105.1 103.4 105.9
1 unchanged paragraph
Weighted average shares - diluted 106.0 108.6 106.8 109.9
Net income per share - basic $ 12.62 $ 13.24 $ 19.58 $ 20.78
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Stock options 2.1 2.4 1.5 2.3 2.0 1.8
Restricted stock awards and restricted stock units 1.1 2.0 1.1 1.5 2.1 1.2 2.0
Weighted average shares - diluted 105.6 107.2 106.3 108.9
Net income per share - basic $ 19.16 $ 14.09 $ 38.65 $ 34.83
Net income per share - diluted $ 18.45 $ 13.62 $ 37.37 $ 33.61
1 unchanged paragraph
June 30, Six Months Ended
September 30, Nine Months Ended
1 unchanged paragraph
Stock options 4.9 6.3 4.9 6.2
Stock options 3.5 6.3 4.8 6.3
1 unchanged paragraph
Note 5: Marketable Securities 19 changes
Marketable securities as of June September 30, 2026 and December 31, 2025 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).
2 unchanged paragraphs
As of September 30, 2026
1 unchanged paragraph
Corporate bonds $ 10,768.4 $ 19.7 $ ( 36.2 ) $ 10,751.9
U.S. government and government agency obligations 3,317.6 1.0 ( 15.1 ) 3,303.5
Commercial paper 558.6 ( 0.3 ) 558.3
Certificates of deposit 304.4 ( 0.3 ) 304.1
Asset-backed securities 193.2 0.2 ( 0.3 ) 193.1
Sovereign bonds 78.5 0.1 ( 0.3 ) 78.3
Corporate bonds $ 10,707.4 $ 3.9 $ ( 126.6 ) $ 10,584.7
U.S. government and government agency obligations 3,477.4 0.1 ( 38.2 ) 3,439.3
Commercial paper 402.7 ( 0.6 ) 402.1
Certificates of deposit 345.1 ( 0.4 ) 344.7
Asset-backed securities 159.6 ( 0.9 ) 158.7
Sovereign bonds 90.6 ( 1.2 ) 89.4
7 unchanged paragraphs
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of June September 30, 2026 mature at various dates through December 2032. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
June September 30, December 31,
Maturities within one year $ 5,538.8 5,642.0 $ 5,487.1
Maturities after one year through five years 9,643.1 9,375.5 10,224.8
Maturities after five years 7.3 1.4 1.5
Note 6: Fair Value Measurements 24 changes
6 unchanged paragraphs
Cash equivalents $ 1,336.0 $ 1,205.3 $ 130.7
As of September 30, 2026
Cash equivalents $ 2,644.8 $ 678.9 $ 1,965.9
1 unchanged paragraph
Corporate bonds 10,751.9 10,751.9
Commercial paper 558.3 558.3
Certificates of deposit 304.1 304.1
Asset-backed securities 193.1 193.1
Sovereign bonds 78.3 78.3
Corporate bonds 10,584.7 10,584.7
U.S. government and government agency obligations 3,303.5 3,303.5 3,439.3 3,439.3
Commercial paper 402.1 402.1
Certificates of deposit 344.7 344.7
Asset-backed securities 158.7 158.7
Sovereign bonds 89.4 89.4
11 unchanged paragraphs
(a) Includes equity securities of $ 114.0 134.5 million as of June September 30, 2026 which were subject to transfer restrictions that expire in December 2026
1 unchanged paragraph
Other income (expense), net included net unrealized gains related to investments in equity securities that were still held as of the period end date of $ 61.4 million and $ 85.4 million for the three and six months ended June 30, 2026, respectively, and $ 249.8 million and $ 389.5 million for the three and six months ended June 30, 2025, respectively.
As of June September 30, 2026 and December 31, 2025, $ 597.3 607.6 million and $ 334.0 million, respectively, of equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was primarily the result of additional purchases.
As of June September 30, 2026 and December 31, 2025, equity and other securities held through ownership interest in an investment fund of $ 203.9 207.0 million and $ 147.5 million, respectively, which are primarily measured at fair value based on Level 3 inputs. The change in carrying value was primarily the result of additional purchases by the fund.
Amounts recognized in Other income (expense), net, related to the Company's investments in equity securities consist of the following:
September 30, Nine Months Ended
Net gains recognized during the period $ 57.7 $ 577.0 $ 143.2 $ 966.6
Less: Net gains recognized on investments sold during the period 76.6 370.9 76.6 650.4
Net unrealized (losses)/gains recognized on investments still held as of period end date $ ( 18.9 ) $ 206.1 $ 66.6 $ 316.2
1 unchanged paragraph
The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.561 1.494 billion and $ 1.576 billion as of June September 30, 2026 and December 31, 2025, respectively. The carrying value was $ 1.987 billion as of June September 30, 2026 and $ 1.986 billion as of December 31, 2025.
Note 7: Inventories 8 changes
1 unchanged paragraph
Raw materials $ 610.9 $ 641.5
Finished goods 142.0 190.2
Deferred costs 820.9 727.5
June September 30, December 31,
Raw materials $ 548.0 $ 641.5
Work-in-process 1,510.5 1,345.0 1,641.6
Finished goods 101.1 190.2
Deferred costs 900.5 727.5
1 unchanged paragraph
Note 8: Income Taxes 2 changes
The Company's effective tax rate was 15.1 14.7 % and 8.4 17.2 % for the three months ended June September 30, 2026 and 2025, respectively, and 14.2 14.4 % and 9.2 12.6 % for the six nine months ended June September 30, 2026 and 2025, respectively.
The Company's effective tax rate for the three and six nine months ended June 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, the Company's effective tax rate for the three and six nine months ended June September 30, 2025 was positively negatively impacted by the release enactment of liabilities associated with unrecognized tax benefits upon the settlement of "One Big Beautiful Bill Act," including the IRS audit re-measurement of the Company's 2017 and 2018 federal income U.S. net deferred tax returns. assets.
Note A: Share Repurchase Programs 7 changes
2 unchanged paragraphs
June 30, Six Months Ended
September 30, Nine Months Ended
1 unchanged paragraph
Number of shares 1.7 1.9 2.7 3.4
Total cost of shares $ 1,164.5 $ 1,069.9 $ 1,967.7 $ 2,122.3
Number of shares 0.5 1.1 3.2 4.5
Total cost of shares $ 376.5 $ 663.0 $ 2,344.2 $ 2,785.3
As of June September 30, 2026, $ 2.534 2.157 billion remained available for share repurchases under the Company's share repurchase programs. program.
Note B: Dividends 2 changes
In each of the first, and second, and third quarters of 2026, the Company's board of directors Company declared a quarterly cash dividend of $ 0.94 per share on its Common Stock and Class A Stock. Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared.
Additionally, in July October 2026, the Company's board of directors Company declared a cash dividend of $ 0.94 per share on its Common Stock and Class A Stock. The dividend will be payable to the Company's shareholders in August December 2026.
Note 10: Statement of Cash Flows 5 changes
1 unchanged paragraph
Cash and cash equivalents $ 2,455.8 $ 1,995.8
Cash and cash equivalents $ 3,659.1 $ 2,506.4
4 unchanged paragraphs
Accrued capital expenditures $ 182.4 $ 178.8 $ 126.1 $ 151.6
June September 30, December 31, June September 30, December 31,
Accrued capital expenditures $ 224.0 $ 178.8 $ 176.9 $ 151.6
1 unchanged paragraph
Note 11: Segment Information 7 changes
2 unchanged paragraphs
June 30, Six Months Ended
September 30, Nine Months Ended
3 unchanged paragraphs
Payroll and benefits 460.4 449.4 944.5 901.1
Payroll and benefits 471.9 438.3 1,416.4 1,339.5
1 unchanged paragraph
Occupancy and other operating costs 182.0 158.6 352.9 313.0
Occupancy and other operating costs 175.7 166.3 528.6 479.2
2 unchanged paragraphs
Reimbursement of research and development expenses by collaborators ( 26.2 26.5 ) ( 42.3 32.8 ) ( 59.8 86.4 ) ( 79.7 112.5 )
2 unchanged paragraphs
Note 12: Legal Matters 1 change
1 unchanged paragraph
The Company recognizes gain contingencies associated with such proceedings when the award or recovery is realized or realizable and loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of June September 30, 2026 and December 31, 2025, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time. Costs associated with the Company's involvement in legal proceedings are expensed as incurred.
Note A: Proceedings Relating to EYLEA (aflibercept) Injection 14 changes
In addition to the patent infringement proceedings in the United States alleging infringement of certain Company patents pertaining to EYLEA discussed below, certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office (the "USPTO").
On January 10, 2024, the Company filed a patent infringement lawsuit (as amended on January 7, 2026) against Amgen Inc. ("Amgen") in the United States District Court for the Central District of California (subsequently transferred to the United States District Court for the Northern District of West Virginia) alleging that Amgen's filing for U.S. Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringed certain Company patents (as amended, the "2024 lawsuit"). On September 23, 2024, the court denied the Company's motion for a preliminary injunction, which decision was affirmed by the Federal Circuit on March 14, 2025. On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California (subsequently transferred to the United States District Court for the Northern District of West Virginia) alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S. Patent No. 12,331,099 (the "2025 lawsuit"). On September 12, 2025, Amgen filed its answer and counterclaims in the 2025 lawsuit alleging, among other things, that the Company obtained numerous patents fraudulently, rendering them unenforceable, and that obtaining and enforcing certain Company patents violated Section 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). On November 12, 2025, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2025 lawsuit, and an oral hearing on the motion was held on April 7, 2026. On March 9, 2026, Amgen filed its answer and counterclaims in the 2024 lawsuit; and, on April 20, 2026, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2024 lawsuit. On July 7, 2026, the court granted the Company's motion to dismiss Amgen's affirmative defenses and counterclaims challenged in the 2025 lawsuit with the exception of Amgen's prosecution delay affirmative defense and counterclaim. A claim construction hearing has been scheduled for December 1, 2026.
2 unchanged paragraphs
Various parties, including Amgen and other, anonymous parties, are seeking revocation of the Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO. On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent. An oral hearing concerning the Company's appeal of this decision has been scheduled for October 2026. On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form, which decision has been appealed by Amgen. On April 21, 2026, following an oral hearing, the OD invalidated the '049 Patent.
(II) Country-Specific Proceedings
The Company is also party to proceedings against various parties, including Sandoz Inc. ("Sandoz"), Sam Chun Dang Pharm. Co., Ltd ("Sam Chun Dang"), and/or their affiliated entities, before several European national courts. In Germany, in a January 2026 preliminary injunction proceeding, the Munich Regional Court issued a decision that found that Sandoz's aflibercept 2 mg biosimilar product infringes the Company's European Patent No. 2,364,691 (the "'691 Patent") and granted the Company's motion for a preliminary injunction, enjoining Sandoz from selling its aflibercept 2 mg biosimilar in Germany until the expiration of the '691 Patent. Following an appeal by Sandoz, in February 2026 the Munich Higher Regional Court suspended enforcement of, and the Company subsequently withdrew its request for, the preliminary injunction. In March June 2026, the Company initiated patent infringement lawsuits in the Munich Regional Court against each of Sandoz and Sam Chun Dang alleging that their respective aflibercept 2 mg biosimilars infringe the '691 Patent and seeking damages for past infringement and injunctions to enjoin such parties and their commercialization partners from continuing to sell their respective aflibercept 2 mg biosimilars in Germany and several other countries in the European Union.
The Company and Bayer Consumer Care AG have filed patent infringement lawsuits in the Seoul Central District Court against Sam Chun Dang and OPTUS Pharmaceutical Co., Ltd. These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendants would infringe one or more claims of the Company's Korean Patent Nos. 1406811, 659477, and 2519234.
(i) Multijurisdictional Settlements
Sam Chun Dang. On August 12, 2026, the Company and Bayer Consumer Care AG ("Bayer") entered into a settlement agreement with Sam Chun Dang Pharm. Co., Ltd ("Sam Chun Dang") in respect of Europe, South Korea, and certain other markets in the Asia-Pacific region. Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Sam Chun Dang's aflibercept 2 mg biosimilar product have been dismissed.
Sandoz . On October 9, 2026, the Company and Bayer entered into a settlement agreement with Sandoz AG and its affiliated entities (collectively, "Sandoz") in respect of all jurisdictions other than the United States, Australia, and Canada (each of which was separately settled in 2025, as previously disclosed). Pursuant to the settlement agreement, all remaining pending judicial and administrative proceedings related to Sandoz's aflibercept 2 mg biosimilar product, including the previously disclosed litigation in Germany, have been or will be dismissed.
(I) (ii) Europe EPO Post-Grant Proceedings
The Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") have been subject to post-grant proceedings before the Opposition Division ("OD") of the EPO:
On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent, which decision has been appealed by Regeneron.
On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form, which decision has been appealed by Amgen.
On April 21, 2026, following an oral hearing, the OD invalidated the '049 Patent. The Company did not appeal the OD's decision and, as a result, the '049 Patent has been revoked.
Note E: Department of Justice Matters 2 changes
1 unchanged paragraph
On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint (as amended on October 29, 2021) filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"). The amended complaint alleges violations of the federal Anti-Kickback Statute and asserts causes of action under the federal False Claims Act and state law relating to allegedly unlawful remuneration and assistance provided to prescribers. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. Oral argument on the appeal was held on November 18, 2025. On August 19, 2026, the U.S. Court of Appeals for the Ninth Circuit (the "Ninth Circuit") reversed the District Court's decision to dismiss the amended complaint with respect to Regeneron in part, affirmed the decision in part, and remanded the lawsuit to the District Court for further proceedings.
1 unchanged paragraph
On January 20, 2026, a qui tam plaintiff filed a complaint under seal against the Company and other pharmaceutical companies purportedly on behalf of the United States and various states. The complaint alleges violations of the federal Anti-Kickback Statute and other laws and asserts causes of action under the federal False Claims Act and various state laws relating to allegedly unlawful remuneration and assistance provided to prescribers. On May 22, 2026 and June 17, 2026, respectively, the United States and the applicable states notified the court of their decisions to decline to intervene in the case. On June 18, 2026, the United States District Court for the Central District of California unsealed the qui tam complaint. On July 20, 2026, the plaintiff filed an amended complaint. On August 19, 2026, the court dismissed the amended complaint; and, on September 9, 2026, the plaintiff filed a second amended complaint. On October 19, 2026, the court dismissed the action as to all defendants without prejudice for failure to timely serve the complaint and ordered the case closed.
Note F: Proceedings Initiated by Other Payors 2 changes
The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "d. "e. Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the SDNY on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the SDNY pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.
On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S. District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors. The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "d. "e. Department of Justice Matters" above. The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief. On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S. District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings. On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S. District Court for the District of Massachusetts. On February 1, 2025, the parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.
Note G: Shareholder Derivative Complaint Department of Justice June 2020 Civil Complaint Matters 1 change
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the Supreme Court of the State of New York (the "NY Supreme Court"), naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "d. "e. Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the NY Supreme Court to the SDNY. On September 23, 2021, the plaintiff moved to remand the case to the NY Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the SDNY denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay.
Note H: Shareholder Derivative Complaints Department of Justice March 2024 Civil Complaint Matters 1 change
In 2025, various purported shareholders of the Company filed several shareholder derivative complaints in the SDNY or the NY Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "d. "e. Department of Justice Matters" above, and one lawsuit also alleges a breach of fiduciary duty relating to the conduct alleged in the second amended putative January 2025 Class Action civil Complaint discussed under "i. "k. Class Action Civil Complaint" Complaints" below. The complaints also allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company. The complaints seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants; an order requiring the individual defendants to take all necessary actions to reform and improve the Company's corporate governance and internal procedures; and costs and disbursements of the applicable action, including attorneys' fees. The cases filed in the SDNY were consolidated and stayed pending resolution of the motion to dismiss, including any appeal of the decision on the motion to dismiss, filed in the putative January 2025 Class Action Complaint discussed under "i. "k. Class Action Civil Complaint" Complaints" below. The shareholder derivative complaints filed in the NY Supreme Court were removed to the SDNY, and the purported shareholders filed motions to remand. On March 16, 2026, the SDNY denied the motions to remand and consolidated the cases with the other shareholder derivative lawsuits pending in the SDNY (which, as noted above, are subject to a stay).
Note J: Shareholder Derivative Complaint Director Compensation 1 change
On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the NY Supreme Court, naming the current non-employee members of the Company's board of directors, and the co-Chairs of the Company's board of directors (who also serve as Regeneron's President and Chief Executive Officer and Regeneron's President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and/or were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets. The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets; improvements to Regeneron's corporate governance and internal procedures; equitable relief, including restitution from the individual defendants; and award of the costs of the action, including attorneys' fees. An oral hearing on the Company's motion to dismiss the complaint was held on April 17, 2026. On June 22, 2026, plaintiff's counsel filed a motion to substitute the named plaintiff. On October 9, 2026, the court denied the Company's motion to dismiss as to the plaintiff's breach of fiduciary duty claim, but granted it as to the unjust enrichment and corporate waste claims. The court also granted the plaintiff's motion to substitute the named plaintiff.
Note K: Class Action Civil Complaints 2 changes
On January 7, 2025 (as amended on September 8, 2025 and October 30, 2025), a purported shareholder filed a putative class action civil complaint (the "January 2025 Class Action Complaint"), on behalf of himself and all others similarly situated, in the SDNY against the Company and certain current and former executive officers of the Company. The second amended complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "d. "e. Department of Justice Matters" above as well as allegations relating to the launch of EYLEA HD. On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action. On November 17, 2025, the Company filed a motion to dismiss the second amended complaint. An oral hearing on the Company's motion to dismiss was held on June 25, 2026. On September 18, 2026, the court granted the Company's motion to dismiss; and, on October 15, 2026, the purported shareholder filed a notice of appeal.
On July 16, 2026, a purported shareholder filed a putative class action civil complaint (the "July 2026 Class Action Complaint"), on behalf of herself and all others similarly situated, in the SDNY against the Company and certain employees of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the Company's fianlimab clinical development program.
Note L: Sanofi Litigation 1 change
On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the SDNY against Sanofi and certain of its affiliated entities (collectively, "Sanofi"). The lawsuit alleges alleged that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks sought a declaratory judgment, injunctive relief, damages, and other relief. On March 17, 2026, the court denied Sanofi's motion to dismiss the complaint. On October 1, 2026, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.
Note M: Dupixent Product Liability Litigation 2 changes
Since 2025, a number of product liability lawsuits have been filed in various U.S. district and state courts against the Company and certain of Sanofi's affiliated entities claiming that Dupixent either caused or exacerbated the patients' T-cell lymphoma, and asserting causes of action under various state laws. On February 13, 2026, several of the plaintiffs filed a motion with the United States Judicial Panel on Multidistrict Litigation (the "JPML") seeking to consolidate the federal lawsuits for coordinated pretrial proceedings. On June 4, 2026, the JPML issued an order transferring the federal lawsuits to the District of New Jersey for coordinated pretrial proceedings. On September 15, 2026, the parties filed a joint request seeking to consolidate the state lawsuits in New Jersey for coordinated pretrial proceedings.
On July 17, 2026, two plaintiffs filed a putative class action lawsuit in the United States District Court for the District of Maryland, alleging that the Company failed to warn that Dupixent allegedly causes or is linked to the development of cutaneous T-cell lymphoma. The complaint asserts causes of action under various state laws and seeks damages and equitable relief, including the creation of a fund to finance Dupixent medical monitoring and treatment services. On August 25, 2026, this action was transferred to the federal multidistrict litigation pending in the District of New Jersey.
MD&A 258 changes
19 unchanged paragraphs
the impact of public health outbreaks, epidemics, or pandemics on our business; and 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 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.
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.
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June 30, Six Months Ended
September 30, Nine Months Ended
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Revenues $ 4,290.7 $ 3,675.6 $ 7,896.1 $ 6,704.3
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Revenues $ 5,115.8 $ 3,754.3 $ 13,011.9 $ 10,458.6
Net income $ 1,948.7 $ 1,460.0 $ 3,972.8 $ 3,660.3
Net income per share - diluted $ 18.45 $ 13.62 $ 37.37 $ 33.61
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Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a a a a a
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Pasatru (garetosmab)
Fibrodysplasia ossificans progressiva ("FOP")
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CD55-deficient protein-losing enteropathy ("CHAPLE") (in patients aged 1 year and older) a
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Recurrent pericarditis (in adults and adolescents) a
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Lynozyfic $ 16.2 $ 0.3 $ 16.5 $ $ $ *
Lynozyfic $ 18.6 $ 0.4 $ 19.0 $ 0.8 $ $ 0.8 *
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Lynozyfic $ 26.9 $ 0.8 $ 27.7 $ $ $ *
Lynozyfic $ 45.5 $ 1.2 $ 46.7 $ 0.8 $ $ 0.8 *
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Product candidates in Phase 2 and Phase 3 clinical development which 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.
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Pre-filled syringe (U.S.)
Approved by European Commission ("EC") for RVO
FDA decisions for pre-filled syringe
Pre-filled syringe (U.S.) Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for RVO
Approved by U.S. Food and Drug Administration ("FDA") for extension of dosing intervals up to 20 weeks in wAMD and DME FDA decision for pre-filled syringe
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Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (fourth (first quarter 2026) 2027)
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Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for bullous pemphigoid
Approved by MHLW for bullous pemphigoid
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Bremzalerbart-atisnolerbart (REGN5713-5715)
Multi-antibody therapy to Bet v 1
Clinical Program (continued)
Phase 2 Phase 3 Regulatory
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Initiate Initiated second Phase 3 study trial in cat allergy (second half 2026)
Clinical Program (continued)
Phase 2 Phase 3 Regulatory
2026 Events to Date Select Upcoming
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Fianlimab (f) (REGN3767)
(antibody to LAG-3) + Libtayo (cemiplimab) (f)
Every 6-week dosing regimen for approved indications (U.S. and EU)
Approved by MHLW for adjuvant and advanced CSCC (Japan)
European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for every 6-week dosing regimen for approved indications
Presented longer-term data from Phase 3 study in adjuvant CSCC at European Society for Medical Oncology ("ESMO") 2026 Meeting
FDA decision on supplemental Biologics License Application ("sBLA") (March 2027) and EC decision on regulatory submission (fourth quarter 2026) for every 6-week dosing regimen for approved indications (antibody to LAG-3) + Libtayo (cemiplimab) (f)
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Report results from Phase 3 study versus pembrolizumab in adjuvant melanoma (fourth quarter 2026) (first half 2027)
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Clinical Program ( continued)
Phase 2 Phase 3 Regulatory
2026 Events to Date Select Upcoming
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High-grade serous ovarian cancer
Low-grade serous ovarian cancer (potentially pivotal study)
Reported data from Phase 1/2 trial in patients with low-grade serous ovarian cancer
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
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Antibody-targeted cytokine PD1-IL2R -IL2
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Relapsed/refractory DLBCL (U.S.)
FDA decision on BLA for relapsed/refractory DLBCL (February 2027)
Report potentially pivotal data in low-grade lymphoma (fourth quarter 2026)
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Clinical Program ( continued)
Phase 2 Phase 3 Regulatory
2026 Events to Date Select Upcoming
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Initiate additional Phase 3 studies in anticoagulation (second half 2026)
Peripherally inserted central
catheter ("PICC")-associated
Initiate additional Phase 3 study in anticoagulation (fourth quarter 2026)
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Initiate additional Phase 3 studies in anticoagulation (second half 2026)
Clinical Program (continued)
Phase 2 Phase 3 Regulatory
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Report Presented additional data from Phase 2 study in obesity (second half 2026) at European Association for the Study of Diabetes ("EASD") Annual Meeting
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Initiate Phase 3 program in obesity in patients with and without Type 2 diabetes (second half (fourth quarter 2026) and with Type 2 diabetes (first half 2027)
Clinical Program ( continued)
Phase 2 Phase 3 Regulatory
2026 Events to Date Select Upcoming
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Postural orthostatic tachycardia syndrome ("POTS")
Sepsis-induced hypotension
Postural orthostatic tachycardia syndrome ("POTS") Phase 2 study in sepsis-induced hypotension did not meet primary endpoint Report results from Phase 2 study in POTS (fourth quarter 2026)
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Present results from Phase 1/2 study (fourth quarter 2026)
Initiate Phase 3 study in MASH/metabolic dysfunction-associated steatotic liver disease ("MASLD") (fourth quarter 2026)
Pivicasiran (ALN-PNP) (k)
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Pasatru (garetosmab) (f) (REGN2477)
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Fibrodysplasia ossificans progressiva
Clinical Program (continued)
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and 178 more changes in the filing
Market risk 1 change
Our market risks, and the way we manage them, are summarized in Part II, Item 7A, "Quantitative and Qualitative Disclosures About Market Risk" of our 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 our market risks or to our management of such risks as of June September 30, 2026.
Controls and procedures 1 change
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There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act) during the quarter ended June September 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Risk factors 34 changes
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Analysis of Financial Condition and Results of Operations - Overview - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that these enhancements (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product sales. The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain.
We are substantially dependent on revenues derived from net product sales of EYLEA HD and EYLEA. Net product sales of these products have historically represented a substantial portion of our revenues, and we expect net sales of these products to continue to be a significant contributor to our revenues and operating results, with an increasing dependence on EYLEA HD relative to our historical dependence on EYLEA. For the six nine months ended June September 30, 2026 and 2025, our aggregate EYLEA HD and EYLEA net product sales in the United States represented 25% 23% and 33% 32% of our total revenues, respectively. For the six nine months ended June September 30, 2026, EYLEA HD U.S. net product sales represented 55% 58% of our aggregate EYLEA HD and EYLEA U.S. net product sales. If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the commercialization of EYLEA HD or EYLEA outside the United States beyond what has been experienced to date as described below, if EYLEA HD net product sales do not sufficiently offset any sustained decline of EYLEA net product sales in or outside the United States, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
Commercialization of EYLEA HD and EYLEA in the United States and elsewhere is subject to significant competition (as described further below under " The commercial success of our products and product candidates is subject to significant competition "), which we expect to continue to increase in the future. For each of the three and six nine months ended June September 30, 2026, EYLEA U.S. net product sales declined by 45% and 41% respectively, compared to the corresponding periods in 2025 as a result of competitive pressures and other factors described under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations." Following the expiration of the U.S. regulatory exclusivity period for EYLEA in May 2024, several biosimilar versions of EYLEA have been approved by the FDA, and one such product has some of these products have launched in the United States. EYLEA and/or EYLEA HD net product sales recorded by us are likely to continue to be negatively impacted by biosimilar competition in the United States, including competition from additional biosimilar versions of EYLEA expected to launch in the United States in the near future, which may have a material adverse impact on our results of operations. In addition, we expect that competition for EYLEA and/or EYLEA HD outside the United States will continue to increase as biosimilar versions of EYLEA (including those already approved but not yet launched) are brought to market in additional countries and if biosimilar versions of EYLEA HD are approved and launched, which may continue to negatively impact the amount of collaboration revenue we earn from Bayer. Payor preferences for biosimilar products outside the United States may exacerbate this risk. While the FDA recently approved EYLEA HD for the treatment of RVO and for additional dosing regimens and we continue to work toward FDA approval of the EYLEA HD pre-filled syringe as discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Overview - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that these enhancements (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product sales. The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain.
We also are substantially dependent on our share of profits from the commercialization of Dupixent under our collaboration with Sanofi (the "Antibody Collaboration"). For the six nine months ended June September 30, 2026 and 2025, Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented 48% 50% and 39% 41% of our total revenues, respectively. If we or Sanofi were to experience any difficulty with the commercialization of Dupixent or if we or Sanofi are unable to maintain current marketing approvals of Dupixent, we may experience a reduction in revenue and our business, prospects, operating results, and financial condition may be materially harmed.
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the outcome of the pending proceedings relating to EYLEA our products (described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below);
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In April 2026, in response to the May 2025 executive order described above and a related letter that we and certain other pharmaceutical companies received from President Trump, we entered into 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, and to price certain future medicines in the United States, at prices no greater than Most-Favored-Nation Pricing. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the investigation under Section 232 of the Trade Expansion Act of 1962, as amended ("Section 232"), through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States. The U.S. Government Agreements will likely result, and any potential future agreements with government entities could also result, in reduced prices and reimbursement for certain of our current and future marketed products and may impact our results of operations. See Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Overview Recent Developments Agreement with the U.S. Government ." We also remain subject to any current or future pricing mandates implemented outside the United States, and it is possible that current or future pricing regulations may have a material impact on our business and results of operations. Agreements."
At the state level, legislatures are becoming increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, price and marketing cost disclosure and transparency measures, and measures that could expand the applicability of the ceiling price under the federal government's 340B program (see also "Other Regulatory and Litigation Risks - If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects ."). In some cases, these measures are designed to encourage importation from other countries and bulk purchasing. A reduction in the availability or extent of reimbursement from U.S. government programs (including as a result of the legislation, proposals, initiatives, and developments described above) could have a material adverse effect on the sales of our marketed products. Economic pressure on state budgets may also have a similar impact. We also remain subject to any current or future pricing mandates implemented outside the United States, and it is possible that current or future pricing regulations may have a material impact on our business and results of operations.
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EYLEA HD and EYLEA. EYLEA HD and EYLEA face significant competition in the marketplace. For example, each of EYLEA HD and EYLEA competes in one or more of its approved indications with other VEGF inhibitors. These include Genentech/Roche's Vabysmo (faricimab-svoa) and Susvimo (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis (ranibizumab); Novartis' Beovu (brolucizumab); and a biosimilar version of Lucentis commercialized in the United States by Harrow, Inc. In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu (aflibercept-ayyh) and Biocon's Yesafili (aflibercept-jbvf) in the United States. We are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments. We expect that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings (including those described in Note 12 to our Condensed Consolidated Financial Statements included in this report) and the expiration of the patents protecting EYLEA (including those set forth under Part I - Item 1. "Business - Patents, Trademarks, and Trade Secrets" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (filed February 4, 2026)). Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA HD's and EYLEA's respective indications, and we are aware of another company with an ophthalmic formulation of such product that has been approved in the United States and the EU. In DME and RVO, EYLEA HD and EYLEA also compete with intravitreal implants of corticosteroids. We are also aware of a number of companies working on the development of product candidates and extended delivery devices for the potential treatment of one or more of EYLEA HD's and EYLEA's respective indications, including those that act by blocking VEGF and VEGF receptors (including therapies designed to extend the treatment interval) and/or other targets. Other potentially competitive products in development include products for use in combination with EYLEA and/or other anti-VEGF treatments, small-molecule tyrosine kinase inhibitors, gene therapies, conjugated antibodies, and other eye-drop formulations, devices, and oral therapies. There also is a risk that third parties repackage ZALTRAP for off-label use and sale for the treatment of diseases of the eye, even though ZALTRAP has not been manufactured and formulated for use in intravitreal injections. We are aware of claims by third parties, including those based on published clinical data, alleging that ZALTRAP may be safely administered to the eye.
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Dupixent . The market for Dupixent's current and potential future indications is also increasingly competitive. There are systemic JAK inhibitors and antibodies against IL-13 and IL-4Ra approved or in development for atopic dermatitis. There is also an antibody against IL-31R approved for atopic dermatitis and prurigo nodularis. In addition, a number of companies are developing antibodies therapeutics against other targets, including OX40(L), IL-2 receptor agonists, that may compete with Dupixent in atopic dermatitis. In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin TSLP; and some of these antibodies are either approved or in development for indications that also compete or may compete in the future with Dupixent in CRSwNP, EoE, COPD, and CSU where approved. There are several other potentially competitive products in development that may compete with Dupixent in atopic dermatitis, asthma, COPD, and potential future indications, including an antibody against IL-33, half-life extended antibodies against IL-13 and TSLP, STAT6 oral small molecules, and multispecific antibodies against IL-13 and TSLP, with and without IL-4. Dupixent also faces competition from a Bruton tyrosine kinase inhibitor in CSU and may in the future face competition from inhaled products in asthma, COPD, and potential future indications.
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Other marketed products. There is significant actual and potential future competition for other products marketed or otherwise commercialized by us and/or our collaborators or licensees under our collaboration or license agreements with them. For example, Lynozyfic faces significant actual and potential future competition from other bispecific antibodies and CAR-T cell therapies targeting BCMA, GPRC5D, and/or other targets that are currently approved or in development for the treatment of relapsed/refractory multiple myeloma. In addition, there are several companies that are marketing and/or developing antibodies or other molecules (such as small interfering RNA molecules, or siRNAs, and oral small molecules) against PCSK9, ANGPTL3 and IL-6 and/or IL-6R, which currently (or, for product candidates in development, may in the future if approved) treat the same conditions as Praluent, Evkeeza, and Kevzara, respectively. In addition, our products or product candidates, including our collaborated or licensed products or product candidates, may face additional competition from products or product candidates of our collaborators or licensees, depending on the terms of the applicable agreements.
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In addition, under the terms of our Antibody Collaboration, we and Sanofi co-commercialize Dupixent in the United States and, as further discussed below, certain jurisdictions outside the United States. As a result, we rely in part on Sanofi's sales and marketing organization for Dupixent. If we and Sanofi fail to coordinate our sales and marketing efforts effectively, sales of Dupixent may be materially adversely affected. Sanofi also maintains other important responsibilities relating to Dupixent. For example, Sanofi records product sales for Dupixent in the United States and leads negotiations with payors relating to this product. We also rely on Sanofi for sales, marketing, and distribution of Dupixent in many countries outside the United States. While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we continue to rely in considerable part on Sanofi's sales and marketing organization in such jurisdictions. As described in Note 12 to our Condensed Consolidated Financial Statements included in this report, we have sued Sanofi and certain of its affiliated entities (the "Antibody Collaboration Litigation") alleging that the defendants breached certain provisions of the agreement governing the Antibody Collaboration (the "Collaboration Agreement"). These provisions concern Sanofi's obligation to provide Regeneron with full access to material information relating to also leads or will lead the commercialization of Dupixent or efforts for the other products commercialized pursuant and product candidates subject to the Antibody Collaboration, Agreement and Regeneron's audit rights under which now includes four new product candidates pursuant to the Collaboration Agreement. It is not possible recent amendment to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Collaboration, License, and our business relationship with Other Agreements Sanofi." or whether we will be successful in the Antibody Collaboration Litigation.
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We sell our marketed products for which we record net product sales in the United States to several distributors and specialty pharmacies, as applicable (collectively, "distributor customers"), which generally sell the product directly to healthcare providers or other pharmacies (as applicable). For each of the six nine months ended June September 30, 2026 and 2025, our product sales to two distributor customers accounted on a combined basis for 76% 77% of our total gross product revenue. We expect significant distributor customer concentration to continue for the foreseeable future. Our ability to generate and grow sales of our products will depend, in part, on the extent to which our distributor customers are able to provide adequate distribution of our products to healthcare providers. Although we believe we can find additional distributors, if necessary, our revenue during any period of disruption could suffer and we might incur additional costs. In addition, these distributor customers are responsible for a significant portion of our net trade accounts receivable balances. The loss of any large distributor customer, a significant reduction in sales we make to them, any cancellation of orders they have made with us, or any failure to pay for the products we have shipped to them could adversely affect our results of operations. Commercialization of any of our marketed products may also be adversely impacted by vertical integration of private payor healthcare and insurance programs, health maintenance organizations, and PBMs, or further consolidation among the healthcare providers served or operated by our distributor customers if, for example, one or more consolidated groups of healthcare providers determines not to use (or decides to switch from) such marketed product in favor of a competing product. See also " The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above.
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In some jurisdictions such as the EU, initiating Phase 3 clinical trials and clinical trials in the pediatric population is subject to a requirement to obtain approval or a waiver from the competent authorities of the EU Member States and/or the European Medicines Agency. ("EMA"). If we do not obtain such approval, our ability to conduct clinical trials and obtain marketing authorizations or approvals may be severely impaired and our business may be adversely impacted.
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In the United States, each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a drug, biologic, or device. The determination of whether a product is a combination product or two separately regulated products is made by the FDA on a case-by-case basis. Although a single marketing application is generally sufficient for the approval, clearance, or licensure of a combination product, the FDA may determine that separate marketing applications are necessary. In addition, submitting separate marketing applications may be necessary to receive some benefit that accrues only from approval under a particular type of application. This could significantly increase the resources and time required to bring a particular combination product to market.
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Our business requires using sensitive and proprietary technology and other information that we protect as trade secrets. We seek to prevent improper disclosure of these trade secrets through confidentiality agreements and other means. If our trade secrets are improperly disclosed, by our current or former employees, our collaborators, or otherwise, it could help our competitors and adversely affect our business. Our ability to protect our trade secrets may be impaired by a number of risks and uncertainties, including those discussed under "Other Regulatory and Litigation Risks - The use of social media platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage ," "Other Regulatory and Litigation Risks - There are inherent risks related to our increasing use of artificial intelligence-based solutions ," and "Other Risks Related to Our Business - Significant disruptions of information technology systems or breaches of data security could adversely affect our business " below. We will be able to protect our proprietary rights only to the extent that our proprietary technologies and other information are covered by valid and enforceable patents or are effectively maintained as trade secrets. The patent position of biotechnology companies, including our Company, involves complex legal and factual questions and, therefore, enforceability cannot be predicted with certainty. Our patents may be challenged, invalidated, held to be unenforceable, or circumvented. Certain of our U.S. patents (including those pertaining to our key products, such as EYLEA HD and EYLEA) have been and may in the future be challenged by parties who file a request for post-grant review or inter partes review under the America Invents Act of 2011 or ex parte reexamination. For example, in March 2026, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the "USPTO") instituted a post-grant review of U.S. Patent No. 12,168,036 relating to EYLEA HD (see Note 12 to our Condensed Consolidated Financial Statements included in this report for additional information). Post-grant proceedings are increasingly common in the United States and are costly to defend. In addition, patent applications filed outside the United States may be challenged by other parties, for example, by filing pre-grant third-party observations that argue against patentability or a post-grant opposition. Similarly, such opposition proceedings are increasingly common in Europe and are costly to defend. For example, certain of our European patents, including those pertaining to EYLEA HD, EYLEA, and Dupixent, are subject to opposition proceedings before the European Patent Office (the "EPO") and/or patent offices of various European countries (see Note 12 to our Condensed Consolidated Financial Statements included in this report for additional information). We have pending patent applications in the USPTO, the EPO, and the patent offices of other foreign jurisdictions, and it is likely that we will need to defend patents from challenges by others from time to time in the future. Our patent rights may not provide us with a proprietary position or competitive advantages against competitors.
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We have been in the past, are currently, and may in the future be involved in patent litigation and other proceedings involving patents and other intellectual property. For example, we are currently party to patent infringement and other proceedings relating to EYLEA and EYLEA HD, as described in Note 12 to our Condensed Consolidated Financial Statements included in this report.
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The increased likelihood of generic and biosimilar competition has exacerbated the risk of loss of innovators' market exclusivity. It is also not possible to predict changes in United States U.S. regulatory law that might reduce drug or biological product regulatory exclusivity and/or requirements to demonstrate biosimilarity. Due to this risk, and uncertainties regarding patent protection, the length of market exclusivity for any particular product we currently or may in the future commercialize is inherently uncertain. Biosimilar versions of EYLEA have been recently approved and/or launched in the United States, EU, and other jurisdictions, with additional biosimilar versions of EYLEA and/or EYLEA HD in development, as discussed further under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above. As an EYLEA biosimilar has biosimilars have been launched in the United States following the expiration of the U.S. regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product could be approved by the FDA) in May 2024, EYLEA no longer has U.S. market exclusivity. Similarly, as EYLEA biosimilars have also been recently launched in certain jurisdictions outside the United States, EYLEA no longer has market exclusivity in those jurisdictions. In addition, as EYLEA HD does not benefit from regulatory exclusivity in the United States, market exclusivity for EYLEA HD in the United States is based solely on our patent rights pertaining to this product (which are subject to the risks and uncertainties discussed above under " If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed. "). Any future loss of market exclusivity for a product would likely negatively affect revenues from product sales of that product and thus our financial results and condition and could have a material negative impact on our business.
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We have large-scale manufacturing operations in Rensselaer, New York and Limerick, Ireland. Manufacturing facilities operated by us and by third-party contract manufacturers engaged by us would be inadequate to produce the active pharmaceutical ingredients of our current marketed products and our product candidates in sufficient clinical quantities if our clinical pipeline advances as planned or if there is greater demand than currently expected for our marketed products. In addition to expanding our internal capacity, we intend to continue to rely on our collaborators and/or contract manufacturers to produce commercial quantities of drug material needed for commercialization of our products. As we increase our production in anticipation of potential regulatory approval for our product candidates, our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes. The COVID-19 pandemic exacerbated, and this or other public health outbreaks, epidemics, or pandemics may in the future further exacerbate, certain of these risks. For example, the impact of having to prioritize certain manufacturing-related resources for our COVID-19 monoclonal antibodies included, among other things, drawing down inventory safety stock levels for certain of our other products. (including Dupixent and EYLEA). Depending on the demand for our products and other relevant factors, we may not be able to replenish our inventory safety stock to the levels we deem prudent or supply our products and product candidates in sufficient quantities to satisfy our commercial and development needs. We also currently rely entirely on other parties (such as contract manufacturers) and our collaborators for filling and finishing services, and expect to increase our reliance on other parties and/or our collaborators for bulk product manufacturing in the future. Generally, in order for other parties to perform any step in the manufacturing and supply chain, we must transfer technology to the other party, which can be time consuming and may not be successfully accomplished without considerable cost and expense, or at all. We depend on the parties we have engaged for these purposes to perform effectively on a timely basis and to comply with regulatory requirements. If for any reason they are unable to do so, and as a result we are unable to directly or through other parties manufacture and supply sufficient commercial and clinical quantities of our products on acceptable terms, or if we should encounter delays or other difficulties with our collaborators, contract manufacturers, warehouses, shipping, testing laboratories, or other parties involved in our supply chain which adversely affect the timely manufacture and supply of our products or product candidates, our business, prospects, operating results, and financial condition may be materially harmed.
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Certain raw materials or other products necessary for the manufacture and formulation of our marketed products and product candidates, some of which are difficult to source, are provided by single-source unaffiliated third-party suppliers. In addition, we rely on certain third parties or our collaborators to perform filling, finishing, distribution, laboratory testing, and other services related to the manufacture of our marketed products and product candidates, and to supply various raw materials and other products. We would be unable to obtain these raw materials, other products, or services for an indeterminate period of time if any of these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contaminations, business interruptions, or labor shortages or disputes (in each case, including as a result of public health outbreaks, epidemics, or pandemics or other geopolitical developments, such as the armed conflicts between Russia and Ukraine and in the Middle East). Regional or single-source dependencies may in some cases accentuate these risks. For example, the pharmaceutical industry generally, and in some instances our Company or our collaborators or other third parties on which we rely, depend on China-based suppliers or service providers for certain raw materials, products and services, or other activities. Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or the BIOSECURE Act that was enacted into law in late 2025. See also "Other Regulatory and Litigation Risks - We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition " below. In any such circumstances, we may not be able to engage a backup or alternative supplier or service provider in a timely manner or at all. This, in turn, could materially and adversely affect our or our collaborators' ability to manufacture or supply marketed products and product candidates or advance our or our collaborators' preclinical research or clinical development programs, which could materially and adversely affect our business and future prospects.
2 unchanged paragraphs
We and our collaborators, contract manufacturers, and other third-party providers are required to maintain compliance with cGMPs, and are subject to inspections by the FDA or comparable agencies in other jurisdictions to confirm such compliance. Changes of suppliers or modifications of methods of manufacturing may require amending the relevant application(s) relating to our products or product candidates to the FDA or such comparable foreign agencies and acceptance of the change by the FDA or such comparable foreign agencies prior to release of product(s). Because we produce multiple products and product candidates at our facilities in Rensselaer, New York and Limerick, Ireland, there are increased risks associated with cGMP compliance. In recent years, the FDA issued CRLs to multiple companies (including us, as further discussed in this report or previously disclosed) citing unresolved inspection findings at third-party manufacturers, which prevented the timely approval of such companies' marketing applications. Our inability, or the inability of our collaborators, contract manufacturers, and third-party fill/finish or other service providers, to demonstrate ongoing cGMP compliance has in the past required us, and could in the future require us, to engage in lengthy and expensive remediation efforts, identify and onboard new service providers, withdraw or recall product, halt or interrupt clinical trials, and/or interrupt commercial supply of any marketed products, and could also delay or prevent our obtaining regulatory approval for our product candidates or new indications for our marketed products. Any delay, interruption, or other issue that arises in the manufacture, fill/finish, packaging, or storage of any drug product or product candidate as a result of a failure of our facilities or the facilities or operations of our collaborators, contract manufacturers, or other third parties to pass any regulatory agency inspection or maintain cGMP compliance could significantly impair our ability to develop, obtain approval for, and successfully commercialize our products, which would substantially harm our business, prospects, operating results, and financial condition. Any finding of non-compliance could also increase our costs, cause us to delay the development of our product candidates, result in delay in our obtaining, or our not obtaining, regulatory approval of product candidates or new indications for our marketed products, and cause us to lose revenue from any marketed products, which could be seriously detrimental to our business, prospects, operating results, and financial condition. In recent years, we recently have received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product, as discussed above under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain. If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them; and if we do not obtain approvals for new indications for our marketed products, we may not be able to realize the full commercial potential of such products. Any of the foregoing may materially and negatively impact our business, prospects, operating results, and financial condition. " Significant noncompliance with the requirements discussed in this paragraph could also result in the imposition of monetary penalties or other civil or criminal sanctions and damage our reputation.
19 unchanged paragraphs
In particular, our business activities outside the United States (which have recently expanded and continue to expand due to, in part, our efforts to establish further commercialization and co-commercialization capabilities in certain jurisdictions outside the United States) are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K. Bribery Act. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA. There is no certainty that all of our employees, agents, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our ability to expand internationally, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.
14 unchanged paragraphs
We have large-scale manufacturing operations in Limerick, Ireland and have also established offices in the United Kingdom, Germany, Japan, and other countries outside the United States. Changes impacting our ability to conduct business in the those countries, or changes to the regulatory regime applicable to our operations in those countries (such as with respect to the approval of our product candidates), may materially and adversely impact our business, prospects, operating results, and financial condition.
2 unchanged paragraphs
In 2025, the U.S. administration imposed an array of tariffs under the International Emergency Economic Powers Act ("IEEPA"). In July 2025, the United States and the EU announced the framework of a trade agreement that generally imposes a 15% tariff on imports from the EU. Under this agreement, pharmaceutical products would not be subject to any future duties under Section 232 in excess of this 15% rate. Such IEEPA tariffs have prompted retaliatory measures from several countries. which may further escalate.
1 unchanged paragraph
U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions.
In addition, in April 2026, the United States imposed announced new tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients under Section 232, which are set to become became effective for certain those companies on July 31, 2026, and for others on that had not entered into a qualifying agreement with the U.S. government by September 29, 2026. The Section 232 tariffs create a tiered structure with multiple rates depending on the country of origin, the importing company's status concerning onshoring and pricing agreements, and the nature of the product. The Section 232 tariffs implement all pharmaceutical-related commitments in existing U.S. trade deals. As discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Recent Developments U.S. Government Agreements," we have entered into the U.S. Government Agreements and thus have exemptions from the Section 232 tariffs through January 2029, subject to certain conditions.
8 unchanged paragraphs
Outside the United States, we have operations and conduct business in several countries and have been significantly expanding the scope of these activities in those and/or additional countries, as discussed above under " Risks associated with our operations outside the United States could adversely affect our business ." We also conduct clinical trials in these and many other countries around the world. These activities subject us to additional data protection authority oversight and require us to comply with stringent local and regional data privacy laws. Such laws include the EU's General Data Protection Regulations Regulation ("GDPR"), which has a wide range of compliance obligations relating to the processing and protection of personal data. Violations of the GDPR carry significant financial penalties for noncompliance. The GDPR also confers a private right of action on data subjects and consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. Many other jurisdictions outside the United States have adopted and continue to adopt varying privacy and data protection legislation, the continued emergence of which has increased the costs and complexity of compliance.
8 unchanged paragraphs
We rely on support from Sanofi to develop, manufacture, and commercialize certain of our products and product candidates With respect under the Antibody Collaboration. We expect this reliance to continue for the products and foreseeable future following the recent amendment to the Antibody Collaboration to add four new product candidates that we are co-developing with to the Antibody Collaboration, as discussed under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Collaboration, License, and Other Agreements Sanofi." Under our the Antibody Collaboration, Sanofi initially funds a portion of agreed-upon development expenses costs incurred in connection with respect to the development of these products and product candidates covered thereby are shared equally. In addition, we rely on Sanofi to assist with or lead much of the clinical development efforts, assist with or lead efforts to obtain and maintain regulatory approvals, and lead the commercialization efforts for these products and product candidates.
If Sanofi terminates the Antibody Collaboration or fails to comply with its obligations thereunder, our business, prospects, operating results, and financial condition may be materially harmed. We would be required to either expend substantially more resources than we have anticipated to support our development efforts or cut back on such activities. If Sanofi does not perform its obligations with respect to the products and product candidates it is co-developing and/or co-commercializing with us, subject to the Antibody Collaboration, our ability to develop, manufacture, and commercialize these products and product candidates may be adversely affected. As described in Note 12 to our Condensed Consolidated Financial Statements included in this report, we have commenced the Antibody Collaboration Litigation against Sanofi and certain of its affiliated entities. It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we will be successful in the Antibody Collaboration Litigation. While we have some commercial presence outside the United States, our commercial capabilities outside the United States are still limited and would need to be further developed or outsourced for products commercialized under our Antibody Collaboration (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above). Termination of the Antibody Collaboration may create substantial new and additional risks to the successful development and commercialization of the products and product candidates subject to such collaborations, the Antibody Collaboration, particularly outside the United States.
23 unchanged paragraphs
We have certain indebtedness and contingent liabilities, including milestone and royalty payment obligations. As of June September 30, 2026, we had an aggregate of $2.707 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility. We may also incur additional debt in the future. Any such indebtedness could:
5 unchanged paragraphs
As of June September 30, 2026, we had $2.456 $3.659 billion in cash and cash equivalents and $16.168 $16.014 billion in marketable and other securities, as further described in Note 5 and Note 6 to our Condensed Consolidated Financial Statements included in this report. Our investments consist primarily of debt securities, including investment-grade corporate bonds. These fixed-income investments are subject to external factors that may adversely affect their market value or liquidity, such as interest rate, liquidity, market, and issuer credit risks, including actual or anticipated changes in credit ratings. The equity securities we hold may experience significant volatility and may decline in value or become worthless if the issuer experiences an adverse development. Furthermore, our equity investments could be subject to dilution (and decline in value) as a result of the issuance of additional equity interests by the applicable issuer. If any of our investments suffer market price declines, such declines may have an adverse effect on our financial condition and operating results.
30 unchanged paragraphs
A small number of our shareholders beneficially own a substantial amount of our Common Stock. As of June September 30, 2026, our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 31.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of June September 30, 2026. If our significant shareholders or we sell substantial amounts of our Common Stock in the public market, or there is a perception that such sales may occur, the market price of our Common Stock could fall. Sales of Common Stock by our significant shareholders also might make it more difficult for us to raise funds by selling equity or equity-related securities in the future at a time and price that we deem appropriate.
1 unchanged paragraph
In April 2026, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock (of which $2.534 $2.157 billion remained available as of June September 30, 2026). In 2025, our board of directors also initiated a quarterly cash dividend program. Any future share repurchases, share repurchase program authorizations, or dividend declarations will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial condition, the price of our Common Stock on the Nasdaq Global Select Market, and other factors that we may deem relevant. Our share repurchases and dividend payments may change from time to time, and we can provide no assurance that we will repurchase shares of our Common Stock at favorable prices, in particular amounts, or at all, or that we will maintain or increase our quarterly cash dividend payments or declare future cash dividends. A reduction in our share repurchases or reduction in, or elimination of, our quarterly cash dividend payments could have an adverse effect on our stock price.
1 unchanged paragraph
Holders of Class A Stock, who are generally the shareholders who purchased their stock from us before our initial public offering, are entitled to ten votes per share, while holders of Common Stock are entitled to one vote per share. As of June September 30, 2026, holders of Class A Stock held 15.2% of the combined voting power of all shares of Common Stock and Class A Stock then outstanding. These shareholders, if acting together, would be in a position to substantially influence the election of our directors and the vote on certain corporate transactions that require majority or supermajority approval of the combined classes, including mergers and other business combinations. This may result in our taking corporate actions that other shareholders may not consider to be in their best interest and may affect the price of our Common Stock. As of June September 30, 2026:
our current executive officers and directors beneficially owned 5.3% 5.2% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of June September 30, 2026, and 17.7% 17.6% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options and release of all restricted stock units held by such persons which are exercisable or releasable within 60 days of June September 30, 2026; and our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 31.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of June September 30, 2026. In addition, these five shareholders plus our Chief Executive Officer held approximately 39.9% 40.0% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of June September 30, 2026.
9 unchanged paragraphs
Unregistered sales of stock 1 change
1 unchanged paragraph
The table below reflects shares of Common Stock we repurchased under our share repurchase programs, as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans, during the three months ended June September 30, 2026. Refer to Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources" for further details of our share repurchase programs.
2 unchanged paragraphs
Other information 17 changes
Name Position Date of Plan Adoption Scheduled End Date of Trading Arrangement (a)
Total Number of Securities to Be Sold Under the Plan
Andrew J. Murphy, Ph.D Executive Vice President, Co-Chief Scientific Officer 5/7/2026 12/31/2027 84,000 (a) The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are completed (a) Exhibits
Exhibit Number Description
31.1 Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
31.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
32 Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
101 Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the registrant's Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025; (ii) the registrant's Condensed Consolidated Statements of Operations and Comprehensive Income for the three and six months ended June 30, 2026 and 2025; (iii) the registrant's Condensed Consolidated Statements of Stockholders Equity for the three and six months ended June 30, 2026 and 2025; (iv) the registrant's Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025; and (v) the notes to the registrant's Condensed Consolidated Financial Statements.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
REGENERON PHARMACEUTICALS, INC.
Date: July 30, 2026 By: /s/ Christopher Fenimore
Christopher Fenimore
Executive Vice President, Finance and
Chief Financial Officer
(Duly Authorized Officer)
As disclosed in the table below, During the three months ended June September 30, 2026, certain of our directors and/or no director or executive officers officer adopted plans for , modified, or terminated any trading arrangements arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
Exhibits 22 changes
"Altibodies ," "ARCALYST ," "Evkeeza ," "EYLEA ," "EYLEA HD ," "Inmazeb ," "Libtayo ," "Lynozyfic ," "Ordspono ," "Otarmeni ," "Praluent " (in the United States), "REGEN-COV ," "Regeneron ," "Regeneron Genetics Center ," "RGC ," "STEM-Fueled ," " Veloci-Bi ," " VelociGene ," " VelociHum ," " VelociMab ," " VelocImmune ," " VelociMouse ," " VelociSuite ," " VelociT ," "Veopoz ," and "ZALTRAP " are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products.
PART I. FINANCIAL INFORMATION
Exhibit Number Description
10.1 A ward agreement and related notice of grant in connection with the 2026 grant of performance restricted stock units ( the "2026 PS Us") to Leonard S. Schleifer, M.D., Ph.D. (Incorporated by reference from the Form 8-K for Regeneron Pha rmaceuticals, Inc. (the "Registrant") , filed September 30, 2026 .)
10.2 Award agreement and related notice of grant in connection with the grant of the 2026 PSUs to George D. Yancopoulos, M.D., Ph.D. (Incorporated by reference from the Form 8-K for the Registrant , filed September 30, 2026.)
10.3* Form of restricted stock purchase agreement in connection with the grant of equity in Three Sevens Holding Corp. to each of Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D.
10.4** Sixth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 1, 2026, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.
19.1 Insider Trading Policy.
31.1 Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
31.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
32 Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
101 Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025; (ii) the Registrant's Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2026 and 2025; (iii) the Registrant's Condensed Consolidated Statements of Stockholders Equity for the three and nine months ended September 30, 2026 and 2025; (iv) the Registrant's Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025; and (v) the notes to the Registrant's Condensed Consolidated Financial Statements.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* Certain of the exhibits and/or schedules to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules of this Exhibit to the SEC upon its request.
** Certain confidential portions of this Exhibit were omitted in accordance with Item 601(b)(10) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of all confidential portions of this Exhibit that were omitted to the SEC upon its request.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
REGENERON PHARMACEUTICALS, INC.
Date: October 30, 2026 By: /s/ Christopher Fenimore
Christopher Fenimore
Executive Vice President, Finance and
Chief Financial Officer
(Duly Authorized Officer)
Unchanged: Financial Statements (unaudited), Notes to the financial statements, Note 1: Interim Financial Statements, Note C: Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe, Note D: Proceedings Relating to Praluent (alirocumab) Injection, Legal proceedings
Only in this filing: Note B: Proceedings Relating to EYLEA HD (aflibercept 8 mg) Injection, Note I: Shareholder Derivative Complaint July 2026 Securities Class Action
Compared by code from the two filings' text and XBRL. Not advice.
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