Core Insights - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported strong second quarter results, surpassing both EPS and revenue expectations [2] - The Eylea franchise continues to show weakness, which is expected to persist in the future [2] Financial Performance - The company achieved better-than-expected earnings per share (EPS) and revenue for the second quarter [2] - Specific financial figures were not disclosed in the provided content, but the performance indicates a positive trend in overall financial health [2] Product Analysis - The Eylea franchise is facing ongoing challenges, which may impact future revenue [2] - Dupixent remains a key product for the company, although specific performance metrics were not detailed in the content [2]

Core Insights - Regeneron Pharmaceuticals reported second-quarter 2025 adjusted earnings per share (EPS) of $12.89, significantly surpassing the Zacks Consensus Estimate of $8.03, marking a 12% increase from $11.56 in the same quarter last year [1][7] - Total revenues grew by 4% year over year to $3.7 billion, driven by higher sales of Eylea HD and increased profits from Dupixent, exceeding the Zacks Consensus Estimate of $3.3 billion [2][7] Revenue Breakdown - Eylea's sales in the U.S. decreased by 39% year over year to $754 million, primarily due to increased competition and market share loss, although it still beat the Zacks Consensus Estimate of $686 million [3][5] - Eylea HD generated revenues of $393 million in the U.S., up 29% year over year, driven by higher sales volumes, surpassing the Zacks Consensus Estimate of $320 million [5][7] - Dupixent sales rose by 22% year over year to $4.3 billion globally, contributing significantly to collaboration revenues of $1.9 billion, which increased by 22.1% from the previous year [8][9] Collaboration Revenues - Sanofi's collaboration revenues increased by 26% to $1.44 billion, driven by higher Dupixent sales, exceeding the Zacks Consensus Estimate of $1.36 billion [9] - Bayer's collaboration revenues totaled $415 million, reflecting an 11% year-over-year increase [9] Product Performance - Total Libtayo sales reached $376.5 million, up 27% year over year, beating the Zacks Consensus Estimate of $322 million [10] - Praluent's net sales in the U.S. were $65.8 million, while Kevzara recorded global sales of $152.2 million, up 39% from the previous year [11] Expense Management - Adjusted R&D expenses increased by 20% year over year to $1.3 billion, reflecting advancements in the company's pipeline, while adjusted SG&A expenses decreased by 19% to $542 million [12] Regulatory Updates - The FDA approved a label expansion of Dupixent for treating adults with bullous pemphigoid, with additional applications under review in the EU and Japan [13] - The FDA granted accelerated approval to Lynozyfic for treating adults with relapsed or refractory multiple myeloma [15] - A complete response letter was issued for the BLA for odronextamab due to site inspection issues [16] Strategic Developments - Regeneron entered into an in-licensing agreement with Hansoh Pharmaceuticals for an obesity drug, HS-20094, expanding its clinical-stage obesity portfolio [17] - The company has initiated a share repurchase program, repurchasing shares worth $1.07 billion in Q2 2025 [12]

Regeneron (REGN) reported $3.68 billion in revenue for the quarter ended June 2025, representing a year-over-year increase of 3.6%. EPS of $12.89 for the same period compares to $11.56 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $3.34 billion, representing a surprise of +9.91%. The company delivered an EPS surprise of +60.52%, with the consensus EPS estimate being $8.03.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how ...

Financial Data and Key Metrics Changes - Regeneron's total revenues for Q2 2025 were $3.7 billion, reflecting a 4% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of EYLEA HD and Libtayo [50][51] - Diluted net income per share grew 12% year-over-year to $12.89, with net income reaching $1.4 billion [51] - The gross margin on net product sales was 86%, with a decrease attributed to ongoing investments in manufacturing operations and higher inventory write-offs [54] Business Line Data and Key Metrics Changes - Worldwide net product sales for Dupixent increased by 21% to $4.3 billion, while Libtayo's sales grew by 25% on a constant currency basis [9][13] - EYLEA's U.S. net product sales were $754 million, down 39% year-over-year, but EYLEA HD's sales reached an all-time high of $393 million, driven by a 16% increase in unit demand [10][11][39] - Libtayo's global net sales were $377 million, with a 36% increase in the U.S. driven by growth in non-melanoma skin and lung cancer indications [43][44] Market Data and Key Metrics Changes - Dupixent continues to lead in new-to-brand and total prescriptions across seven of its eight FDA-approved indications, with a total addressable population in the U.S. exceeding four million patients [13][41] - EYLEA's branded share in the anti-VEGF category was just over 60%, with a decline in overall branded anti-VEGF category volume attributed to increased use of Avastin due to affordability issues [75] Company Strategy and Development Direction - The company plans to invest over $7 billion in the U.S. to expand R&D capabilities and manufacturing networks, including a new fill-finish manufacturing facility [16] - Regeneron is focused on internal R&D investments while also considering opportunities for business development that can enhance existing capabilities [17] - The pipeline includes approximately 45 product candidates in various stages of clinical development, with significant investments in R&D yielding notable progress [14][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of Dupixent and EYLEA HD, despite competitive pressures and pricing challenges [9][10] - The company anticipates a resolution of manufacturing issues related to EYLEA HD and expects favorable FDA actions once these issues are addressed [73] - Management highlighted the importance of maintaining innovation and addressing affordability issues to ensure continued growth and market leadership [60][92] Other Important Information - The FDA issued a Complete Response Letter (CRL) for the BLA of ogeneximab due to the Catalent site inspection, impacting timelines for regulatory approvals [12] - The company is exploring opportunities in the obesity market with a recently licensed GLP-1 GIP receptor agonist [31] Q&A Session Summary Question: Insights on potential policy impacts related to EYLEA - Management noted no unique insights into policy impacts but emphasized the need for fair pricing across markets to support innovation [60] Question: Factors driving the rebound in EYLEA HD sales - The increase in EYLEA HD sales was attributed to physician appreciation for its product profile, including clinical efficacy and safety [68] Question: Updates on PDUFAs and share erosion dynamics - Management expressed confidence in receiving favorable FDA actions post-resolution of manufacturing issues and noted that branded share erosion is primarily due to affordability issues with Avastin [73][75] Question: ROI on prioritizing R&D assets - Management acknowledged the broad pipeline and indicated a willingness to consider out-licensing non-core assets if it makes strategic sense [78] Question: Early results from the matching program with Good Days - Management indicated it is still early to assess the impact of the matching program on commercial performance [85] Question: Competitive landscape regarding OX40 Ligand data - Management highlighted Dupixent's unique safety profile and efficacy, suggesting that competing products may take time to match its established comfort level [90][92]

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.7 billion for Q2 2025, a 4% increase compared to the prior year, driven by higher collaboration revenue from Sanofi, particularly from Dupixent [49] - Diluted net income per share grew 12% year-over-year to $12.89, with net income reaching $1.4 billion [49] - Gross margin on net product sales was 86%, reflecting ongoing investments in manufacturing operations and higher inventory write-offs [54] Business Line Data and Key Metrics Changes - Worldwide net product sales for Dupixent increased by 21% on a constant currency basis, reaching $4.3 billion, with U.S. sales growing 23% [10][39] - EYLEA U.S. net product sales were $754 million, down 39% year-over-year, while EYLEA HD reached an all-time high of $393 million in U.S. sales, driven by a 16% increase in unit demand [8][37] - Libtayo's global net sales grew 25% on a constant currency basis, totaling $377 million, with U.S. sales increasing 36% [43] Market Data and Key Metrics Changes - The branded anti-VEGF category volume decreased by 1.2%, primarily due to increased competition from Avastin [73] - EYLEA HD's market share in the anti-VEGF category is over 60%, but the overall branded share is under pressure from affordability issues [73] Company Strategy and Development Direction - Regeneron plans to invest over $7 billion in the U.S. to expand R&D capabilities and manufacturing networks, including a new fill-finish facility [14] - The company is focused on internal R&D investments while also considering share repurchases and dividends to return capital to shareholders [14][56] - Regeneron aims to maintain its leadership in the market by maximizing growth from existing brands and launching new products [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of Dupixent, with potential to treat over 4 million patients in the U.S. [11] - The company anticipates challenges for EYLEA due to competitive pressures and patient affordability issues, but expects EYLEA HD to continue its strong performance [8][38] - Management remains optimistic about the pipeline, with several key programs expected to deliver significant advancements in the coming months [34] Other Important Information - The FDA's site inspection at Catalent, which impacted EYLEA HD and ogeneximab, is expected to be resolved expeditiously, with no major structural changes required [10][65] - Regeneron has approximately $2.8 billion available for share repurchases as of June 30, 2025 [55] Q&A Session Summary Question: Insights on the relationship with Trump and potential policy impacts - Management indicated no frequent visits to Mar A Lago and emphasized the need for equitable pricing across markets to support innovation [59][60] Question: Factors behind EYLEA HD's quarter-over-quarter rebound - Management attributed the growth to physician appreciation for EYLEA HD's product profile and expected further growth with upcoming label enhancements [64][67] Question: Updates on PDUFAs and branded share erosion - Management expressed confidence in receiving favorable FDA actions once manufacturing issues are resolved and noted that branded share erosion is primarily due to Avastin's affordability issues [71][73] Question: ROI on prioritizing R&D assets - Management acknowledged the broad pipeline and indicated a willingness to consider out-licensing non-core assets if it aligns with strategic goals [77][79] Question: Impact of the matching program with Good Days - Management stated it is too early to assess the impact of the matching program on commercial performance [82] Question: Competitive landscape regarding OX40 Ligand data - Management noted that current data does not suggest advantages over Dupixent, emphasizing Dupixent's unique safety profile [87][89]

Regeneron (REGN) came out with quarterly earnings of $12.89 per share, beating the Zacks Consensus Estimate of $8.03 per share. This compares to earnings of $11.56 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +60.52%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $8.43 per share when it actually produced earnings of $8.22, delivering a surprise of -2.49%.Over the last four quarter ...

Financial Performance - Regeneron reported total revenues of $3.68 billion for Q2 2025[8] - Non-GAAP EPS for Q2 2025 was $12.89[8] - Dupixent global net sales reached $4.3 billion in Q2 2025, representing a 21% year-over-year increase[9] - EYLEA HD and EYLEA together held approximately 61% of the U S branded anti-VEGF category share in Q2 2025[22] - Libtayo global net sales for Q2 2025 were $377 million, a 25% year-over-year increase[30] Dupixent Expansion - Dupixent is approved for eight indications globally and has reached approximately 12 million patients worldwide[9] - The U S FDA approved Dupixent for chronic spontaneous urticaria (CSU) in April 2025 and bullous pemphigoid (BP) in June 2025[9, 19] - Dupixent was approved by the FDA in late September 2024 for COPD[11] Pipeline Developments - Lynozyfic received approval in the U S and Europe for relapsed/refractory multiple myeloma and was added to NCCN treatment guidelines[8] - The company initiated the first Phase 3 study for Factor XI (REGN7508) in VTE prevention after total knee replacement surgery[8] - Regeneron in-licensed olatorepatide/HS-20094 (dual GLP-1/GIP receptor agonist) to evaluate as a monotherapy and study combinations to address muscle loss and other comorbidities of obesity[8] Reimbursement and Development Balance - Reimbursement of Sanofi's antibody development balance is expected to average approximately $800 million per year in 2025 and 2026[15] - As of June 30, 2025, the antibody development balance stood at approximately $1.2 billion[17]

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section provides unaudited financial statements and management's analysis of financial condition and operations [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Regeneron Pharmaceuticals' unaudited condensed consolidated financial statements for Q2 and H1 2025, including balance sheets, statements of operations, stockholders' equity, and cash flows, with accompanying notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and marketable securities | $17,527.8 | $17,912.6 | | Accounts receivable, net | $5,610.0 | $6,211.9 | | Total current assets | $16,859.5 | $18,660.9 | | Total assets | $38,219.2 | $37,759.4 | | **Liabilities & Equity** | | | | Total current liabilities | $3,667.0 | $3,944.3 | | Long-term debt | $1,985.1 | $1,984.4 | | Total liabilities | $8,280.3 | $8,405.8 | | Total stockholders' equity | $29,938.9 | $29,353.6 | [Condensed Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) This section details the company's financial performance, including revenues, expenses, and net income for the three and six-month periods ended June 30, 2025 and 2024 Q2 2025 Statement of Operations Highlights (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $3,675.6 | $3,547.1 | +3.6% | | Net Product Sales | $1,631.0 | $1,918.6 | -15.0% | | Collaboration Revenue | $1,860.7 | $1,524.0 | +22.1% | | R&D Expenses | $1,421.7 | $1,200.0 | +18.5% | | Income from Operations | $1,079.5 | $1,069.6 | +0.9% | | Net Income | $1,391.6 | $1,432.3 | -2.8% | | Diluted EPS | $12.81 | $12.41 | +3.2% | H1 2025 Statement of Operations Highlights (in millions, except per share data) | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $6,704.3 | $6,692.1 | +0.2% | | Net Product Sales | $3,046.6 | $3,679.9 | -17.2% | | Collaboration Revenue | $3,391.9 | $2,790.8 | +21.5% | | R&D Expenses | $2,749.1 | $2,448.4 | +12.3% | | Income from Operations | $1,671.2 | $1,821.0 | -8.2% | | Net Income | $2,200.3 | $2,154.3 | +2.1% | | Diluted EPS | $20.02 | $18.68 | +7.2% | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, reflecting net income, share repurchases, and dividends for the period - Total stockholders' equity increased from **$29.35 billion** at year-end 2024 to **$29.94 billion** as of June 30, 2025, primarily driven by net income of **$2.20 billion**[13](index=13&type=chunk)[12](index=12&type=chunk) - During the first six months of 2025, the company repurchased **3.4 million shares** of common stock for a total cost of **$2.12 billion**[13](index=13&type=chunk)[45](index=45&type=chunk) - The company declared and paid dividends totaling **$192.0 million** in the first six months of 2025[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash inflows and outflows from operating, investing, and financing activities for the six-month periods ended June 30, 2025 and 2024 Cash Flow Summary for Six Months Ended June 30 (in millions) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $2,189.5 | $1,866.5 | | Net cash used in investing activities | ($446.5) | ($2,244.3) | | Net cash used in financing activities | ($2,217.4) | ($431.0) | | **Net decrease in cash** | **($473.4)** | **($809.6)** | - The significant decrease in cash used in investing activities in H1 2025 compared to H1 2024 was mainly due to lower net purchases of marketable securities[16](index=16&type=chunk) - The increase in cash used in financing activities in H1 2025 was driven by higher common stock repurchases (**$2.1 billion** vs. **$895.2 million** in H1 2024) and the payment of dividends (**$186.4 million**)[16](index=16&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and breakdowns of significant accounting policies, product sales, collaboration revenues, and legal proceedings Net Product Sales for Three Months Ended June 30 (in millions) | Product | 2025 | 2024 | | :--- | :--- | :--- | | EYLEA HD (U.S.) | $393.2 | $304.2 | | EYLEA (U.S.) | $754.3 | $1,230.5 | | **Total EYLEA & EYLEA HD (U.S.)** | **$1,147.5** | **$1,534.7** | | Libtayo (Global) | $376.5 | $297.4 | - Regeneron's share of profits from the significant collaboration with Sanofi for Dupixent, Kevzara, and itepekimab was **$1.28 billion** in Q2 2025, up from **$988.3 million** in Q2 2024[21](index=21&type=chunk)[23](index=23&type=chunk) - The collaboration with Bayer for EYLEA outside the U.S. generated **$383.4 million** in profit share for Regeneron in Q2 2025, compared to **$353.0 million** in Q2 2024[24](index=24&type=chunk)[25](index=25&type=chunk) - The company is involved in numerous legal proceedings, primarily related to patent litigation for its key product EYLEA against several companies developing biosimilars, including Mylan, Celltrion, Samsung Bioepis, and Amgen[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - The company is also involved in matters with the Department of Justice concerning allegations of violations of the federal Anti-Kickback Statute and False Claims Act related to EYLEA[75](index=75&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Q2 and H1 2025 financial performance, highlighting strong collaboration revenue growth offsetting declining U.S. EYLEA sales, alongside updates on product performance, clinical pipeline, and liquidity [Overview and Products](index=28&type=section&id=MD%26A%20-%20Overview%20and%20Products) This section provides an overview of Regeneron's business model and presents global net product sales for its key discovered products - Regeneron is a fully integrated biotechnology company focused on inventing, developing, manufacturing, and commercializing medicines for serious diseases across multiple therapeutic areas[91](index=91&type=chunk) Global Net Product Sales of Regeneron-Discovered Products (in millions) | Product | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Total EYLEA HD and EYLEA | $2,125.2 | $2,442.5 | (13%) | | Dupixent | $4,344.6 | $3,556.4 | 22% | | Libtayo | $376.5 | $297.4 | 27% | | Praluent | $222.0 | $191.9 | 16% | [Clinical Development](index=32&type=section&id=MD%26A%20-%20Clinical%20Development) This section details regulatory updates, clinical trial results, and upcoming milestones for the company's pipeline products - Regulatory approvals for pending EYLEA HD applications are expected to be delayed due to FDA inspection observations at a third-party filler, Catalent[116](index=116&type=chunk) - The FDA issued a Complete Response Letter (CRL) for the BLA for Ordspono (odronextamab) in relapsed/refractory follicular lymphoma, also impacted by the Catalent site inspection[119](index=119&type=chunk) - A Phase 3 trial (AERIFY-1) for Itepekimab in COPD met its primary endpoint, but a second trial (AERIFY-2) did not, with the company discussing next steps with regulators[117](index=117&type=chunk) - Key upcoming milestones include an FDA decision on the sBLA for Libtayo in adjuvant CSCC in **October 2025** and results from a Phase 3 study of Fianlimab in first-line metastatic melanoma in **Q4 2025/Q1 2026**[108](index=108&type=chunk)[109](index=109&type=chunk) [Results of Operations](index=42&type=section&id=MD%26A%20-%20Results%20of%20Operations) This section analyzes the drivers behind changes in revenue, research and development expenses, selling, general and administrative expenses, and the effective tax rate - U.S. net product sales of EYLEA decreased significantly in Q2 and H1 2025 due to competitive pressures, loss of market share to compounded bevacizumab, and patient transition to EYLEA HD[136](index=136&type=chunk)[137](index=137&type=chunk) - Sanofi collaboration revenue increased by **$298.0 million** in Q2 2025, driven by higher profits from Dupixent sales[134](index=134&type=chunk)[139](index=139&type=chunk) - R&D expenses increased by **$221.7 million** in Q2 2025, primarily due to higher clinical manufacturing costs and increased spending on various clinical programs like Lynozyfic and Trevogrumab[142](index=142&type=chunk)[145](index=145&type=chunk) - SG&A expenses decreased by **$124.6 million** in Q2 2025, mainly due to lower charitable contributions to an independent patient assistance organization[142](index=142&type=chunk)[148](index=148&type=chunk) - The effective tax rate for Q2 2025 was **8.4%**, down from **12.0%** in Q2 2024, partly due to the release of liabilities for uncertain tax positions following an IRS audit settlement[152](index=152&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=MD%26A%20-%20Liquidity%20and%20Capital%20Resources) This section assesses the company's financial position, including cash, marketable securities, working capital, and capital allocation plans Financial Position (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,995.8 | $2,488.2 | | Marketable securities | $15,532.0 | $15,424.4 | | Working capital | $13,192.5 | $14,716.6 | - The company expects to incur capital expenditures of **$880 million to $950 million** for the full year 2025[157](index=157&type=chunk) - As of June 30, 2025, **$2.814 billion** remained available for share repurchases under the authorized programs[159](index=159&type=chunk) - The company initiated and paid quarterly cash dividends of **$0.88 per share** in Q1 and Q2 2025[160](index=160&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risks or its management of such risks as of June 30, 2025, compared to what was disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - There have been no material changes to the company's market risks or its management of such risks as of June 30, 2025[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[165](index=165&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[166](index=166&type=chunk) [PART II OTHER INFORMATION](index=49&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers other important disclosures, including legal proceedings, risk factors, equity security sales, and exhibits [Item 1. Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates detailed legal proceedings from Note 12, primarily concerning EYLEA patent litigation against biosimilar developers and Department of Justice investigations - Information regarding legal proceedings is incorporated by reference from Note 12 to the Condensed Consolidated Financial Statements[167](index=167&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including dependence on key products, intense competition, pricing pressures, development uncertainties, intellectual property litigation, and reliance on third-party collaborators - The company is substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent, with U.S. EYLEA sales declining due to competition and patient transition, and future sales likely impacted by biosimilar competition[179](index=179&type=chunk)[180](index=180&type=chunk) - Sales are dependent on coverage and reimbursement from third-party payors, and the Inflation Reduction Act (IRA) and other drug price control measures pose a significant risk to future profitability[187](index=187&type=chunk)[197](index=197&type=chunk)[199](index=199&type=chunk) - Drug development is costly and uncertain, with serious side effects or efficacy failures potentially leading to program delays or discontinuation, and regulatory approval is not guaranteed, as evidenced by recent CRLs due to third-party manufacturing issues[218](index=218&type=chunk)[241](index=241&type=chunk)[228](index=228&type=chunk) - The company faces significant intellectual property risks, including ongoing patent litigation for EYLEA and the potential for biosimilar competition to erode market exclusivity[252](index=252&type=chunk)[258](index=258&type=chunk)[264](index=264&type=chunk) - The company relies on limited internal and contracted manufacturing capacity, where failures at its own facilities or those of third-party suppliers could disrupt product supply[270](index=270&type=chunk)[275](index=275&type=chunk) - The company is subject to government investigations and legal challenges under healthcare laws like the Anti-Kickback Statute and False Claims Act, which could result in significant penalties[283](index=283&type=chunk)[287](index=287&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2025, Regeneron repurchased approximately 1.93 million shares, with $2.81 billion remaining available under authorized share repurchase programs as of June 30, 2025 Issuer Purchases of Equity Securities (Q2 2025) | Period | Total Shares Purchased | Average Price Paid per Share | Shares Purchased as Part of Program | | :--- | :--- | :--- | :--- | | April 2025 | 615,505 | $577.66 | 609,388 | | May 2025 | 552,495 | $574.98 | 552,495 | | June 2025 | 767,705 | $510.97 | 763,732 | | **Total** | **1,935,705** | | **1,925,615** | - As of the end of June 2025, approximately **$2.814 billion** remained available for purchase under the company's share repurchase programs[351](index=351&type=chunk) [Item 5. Other Information](index=87&type=section&id=Item%205.%20Other%20Information) This section discloses that during the second quarter of 2025, Director Bonnie L. Bassler, Ph.D., adopted a Rule 10b5-1 trading plan for the potential sale of 5,121 securities, scheduled to end on May 1, 2026 - On May 2, 2025, Director Bonnie L. Bassler, Ph.D., adopted a Rule 10b5-1 trading plan for the sale of **5,121 securities**[352](index=352&type=chunk)[353](index=353&type=chunk) [Item 6. Exhibits](index=88&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Restated Certificate of Incorporation, an amendment to the collaboration agreement with Sanofi, officer certifications, and Interactive Data Files (Inline XBRL) - Exhibits filed include officer certifications (31.1, 31.2, 32), an amendment to the Sanofi collaboration agreement (10.1), and Inline XBRL data files (101, 104)[354](index=354&type=chunk)

Exhibit 99.1 Press Release Regeneron Reports Second Quarter 2025 Financial and Operating Results Tarrytown, New York (August 1, 2025) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2025 and provided a business update. "Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, Pre ...

Core Insights - Regeneron Pharmaceuticals reported strong financial results for Q2 2025, with notable growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo, alongside multiple regulatory approvals [2][3][5] Financial Highlights - Total revenues for Q2 2025 reached $3.68 billion, a 4% increase from $3.55 billion in Q2 2024 [3][12] - GAAP net income was $1.39 billion, down 3% from $1.43 billion in the same quarter last year, while non-GAAP net income increased by 5% to $1.42 billion [3][12] - Non-GAAP net income per share rose 12% to $12.89, compared to $11.56 in Q2 2024 [3][12] Business Highlights - Dupixent global net sales increased by 22% to $4.34 billion, while EYLEA HD U.S. net sales grew by 29% to $393 million [5][12] - The FDA approved Lynozyfic for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria [5][10] - The company has approximately 45 product candidates in clinical development, with significant progress in its oncology portfolio [4][5] Regulatory and Pipeline Updates - The FDA accepted for priority review Libtayo's supplemental Biologics License Application for adjuvant cutaneous squamous cell carcinoma, with a target action date in October 2025 [10][11] - The company reported interim results from the Phase 2 COURAGE trial, showing promising data for obesity treatment [10][11] Capital Allocation - Regeneron returned over $2.3 billion to shareholders through share repurchases and dividends, while committing over $7 billion to U.S. manufacturing investments and business development since the start of 2025 [3][23] - A cash dividend of $0.88 per share was declared, payable on September 3, 2025 [24]