On Tuesday, Regeneron Pharmaceuticals Inc REGN  reported first-quarter adjusted earnings per share of $8.22, down 14% year-over-year, missing the consensus of $8.82.The company reported sales of $3.03 billion, down 4%, missing the consensus of $3.29 billion.In the first quarter, U.S. net sales for Eylea HD and Eylea decreased 26% year-over-year to $1.04 billion, including $307 million from Eylea HD.Also Read: FDA Sets The Countdown: Regeneron’s Eylea HD Could Be Headed For Major ExpansionNet product sales o ...

Regeneron Pharmaceuticals, Inc. (REGN) reported first-quarter 2025 adjusted earnings per share (EPS) of $8.22, which missed the Zacks Consensus Estimate of $8.43. The reported figure was down 14% from $9.55 reported in the year-ago quarter. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The decline in the bottom line can be attributed to lower revenues and higher operating expenses.Total revenues decreased 4% year over year to $3 billion due to lower sales of lead drug Eylea. Reven ...

Regeneron Pharmaceuticals (REGN) Q1 2025 Earnings Call April 29, 2025 01:50 PM ET Speaker0 Welcome to the Regeneron Pharmaceuticals First Quarter twenty twenty five Earnings Conference Call. My name is Josh, and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now turn the call over to Ryan Crow, Senior Vice President, Investor Relations. Yo ...

Financial Data and Key Metrics Changes - Regeneron's Q1 2025 total revenues were $3 billion, driven by higher collaboration revenue from Sanofi and increased U.S. net sales of EYLEA HD compared to the prior year [41] - The diluted net income per share for Q1 2025 was $8.22, with net income of $928 million [42] - Gross margin on net product sales was 85%, reflecting a decrease due to higher inventory write-offs and a change in product mix [45] - Free cash flow generated in Q1 2025 was $816 million, with cash and marketable securities totaling $17.6 billion and debt of approximately $2.7 billion [46] Business Line Data and Key Metrics Changes - EYLEA U.S. net sales were $736 million, down 39% year-over-year and down 38% sequentially, primarily due to lower physician demand and increased competition [7][29] - EYLEA HD U.S. sales were $307 million, up 54% year-over-year and flat sequentially, with physician unit demand growing by 5% [8][30] - DUPIXENT achieved global net sales of $3.7 billion, representing a 20% year-over-year increase on a constant currency basis, with U.S. net sales growing 19% to $2.6 billion [32][33] - Libtayo's global net sales grew 8% year-over-year to $285 million, with U.S. net sales reaching $193 million, up 21% [38] Market Data and Key Metrics Changes - The branded anti-VEGF category contracted due to increased usage of low-cost off-label repackaged Avastin, which gained approximately 6 percentage points in market share to 32% [28] - EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite competitive pressures [28] Company Strategy and Development Direction - Regeneron aims to capitalize on multiple near-term opportunities across its portfolio, including product enhancements and launches of new medicines and indications [27] - The company is focused on promoting the ongoing adoption of EYLEA HD, which has the potential to become the new standard of care [29] - Significant investments in R&D are planned, with approximately 45 product candidates in clinical development and expectations for multiple regulatory approvals in 2025 [12][41] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a mixed performance in Q1 2025, with challenges in the retinal franchise but positive developments in other commercial areas and pipeline advancements [6] - The company remains committed to investing heavily in R&D and delivering scientific breakthroughs while maximizing growth opportunities from in-line brands [13] - Management expressed confidence in the potential for EYLEA HD and DUPIXENT to continue delivering significant growth [12][34] Other Important Information - Regeneron plans to return capital to shareholders through share repurchases and dividends, having repurchased approximately $1.1 billion worth of shares in Q1 2025 [48] - The company has updated its 2025 gross margin guidance to be in the range of 86% to 87% due to higher than expected inventory write-offs [49] Q&A Session Summary Question: Can you elaborate on the EYLEA HD CRL for the prefilled syringe? - Management explained that the FDA's questions pertained to a third-party component supplier, and they believe the key issue is being addressed. They expect a resolution could be quick but acknowledged uncertainty [52][56] Question: How does the company prioritize indications for Factor XI antibodies? - Management indicated that they are focusing on indications that demonstrate both anticoagulation benefits and lower bleeding risks, with plans to enroll patients in pivotal studies this year [61][63] Question: What are the updated thoughts on foundation funding for EYLEA? - Management discussed the complexities of patient assistance funding and the potential for a matching program to stimulate contributions from others, emphasizing the need for broader support [66][71] Question: Can you confirm if the component in the prefilled syringe is used in other approved products? - Management confirmed that the component is the same as that used in the prefilled syringe approved in Europe, which provides confidence in resolving the FDA's concerns [75][77] Question: What steps are being taken to improve regulatory performance? - Management acknowledged the challenges faced with CRLs and attributed them to increased scrutiny by the FDA on contract manufacturers, while expressing confidence in their regulatory team's capabilities [88][90]

Financial Performance - Regeneron reported revenues of $3,028.7 million for the three months ended March 31, 2025, a decrease of 3.7% compared to $3,145.0 million in the same period of 2024[82]. - Net income for the same period was $808.7 million, representing an increase of 12.0% from $722.0 million in the prior year[82]. - Diluted net income per share increased to $7.27, up 16.0% from $6.27 in the previous year[82]. - Total revenues decreased to $3,028.7 million in Q1 2025 from $3,145.0 million in Q1 2024, representing a decline of 3.7%[116]. - Net income for the three months ended March 31, 2025, was $808.7 million, an increase of 11.9% compared to $722.0 million in the same period of 2024[115]. - Total operating expenses rose to $2,437.0 million in Q1 2025, a slight increase of 1.8% from $2,393.6 million in Q1 2024[127]. - Cash flows provided by operating activities decreased by $467.4 million, totaling $1,045.1 million for the three months ended March 31, 2025, compared to $1,512.5 million in 2024[142]. - Cash flows provided by investing activities increased by $2,334.6 million, totaling $647.5 million for the three months ended March 31, 2025, compared to $(1,687.1) million in 2024[142]. - As of March 31, 2025, cash and cash equivalents increased to $3,090.2 million, up by $602.0 million from $2,488.2 million at the end of 2024[141]. - The effective tax rate for the three months ended March 31, 2025, was 10.6%, compared to (3.0%) in 2024, influenced by income earned in foreign jurisdictions[138][139]. Product Sales and Revenue - EYLEA HD and EYLEA total net product sales reached $1,900.6 million, a decrease of 16% compared to $2,251.0 million in the previous year[90]. - Dupixent generated net product sales of $3,665.6 million, reflecting a 19% increase from $3,076.8 million in the prior year[90]. - Libtayo reported net product sales of $285.1 million, an 8% increase from $263.9 million year-over-year[90]. - Kevzara's net product sales increased by 24% to $116.4 million, compared to $94.1 million in the previous year[90]. - Other products saw a 24% increase in net sales, totaling $54.6 million, up from $44.2 million[90]. - Net product sales of EYLEA HD in the U.S. increased to $306.8 million, up 53.4% from $200.0 million in Q1 2024[116]. - Collaboration revenue from Sanofi increased to $1,183.2 million in Q1 2025, up 30.0% from $909.8 million in Q1 2024[121]. - Regeneron's share of profits from Dupixent and Kevzara increased to $1,018.2 million, up 26.7% from $804.0 million in Q1 2024[122]. Research and Development - The company continues to focus on developing treatments for serious diseases, including eye diseases, cancer, and rare diseases, leveraging proprietary technologies[80][81]. - The company is actively engaged in research and clinical programs, with a focus on achieving anticipated development milestones[82]. - Research and development expenses increased to $1,327.4 million in Q1 2025, up 6.3% from $1,248.4 million in Q1 2024[127]. - Total direct research and development expenses for the three months ended March 31, 2025, were $1,327.4 million, an increase of $79.0 million compared to $1,248.4 million in 2024[130]. - Indirect research and development expenses increased to $666.0 million for the three months ended March 31, 2025, up from $609.4 million in 2024, reflecting a $56.6 million increase[130]. - The company expects to continue incurring substantial expenses related to research and development and commercialization of products[114]. Regulatory and Clinical Developments - The company is advancing EYLEA HD in clinical development with a target FDA decision date for the pre-filled syringe on August 19, 2025[94]. - Dupixent is undergoing regulatory review for multiple indications, with a target FDA decision date of June 20, 2025, for chronic spontaneous urticaria (CSU) in adults and adolescents[95]. - The company plans to report results from Phase 3 trials for Itepekimab in COPD by mid-2025[95]. - Libtayo is in Phase 3 studies for various oncology indications, with positive interim data reported for adjuvant CSCC[95]. - The company is initiating a Phase 2 study for Fianlimab in combination with Libtayo for first-line metastatic head and neck squamous cell carcinoma in 2025[95]. - An interim analysis of two ongoing Phase 2/3 studies for fianlimab in first-line advanced NSCLC showed no new safety signals, with further analyses expected in Q1 2026[103]. - The FDA issued a Complete Response Letter (CRL) regarding the sBLA for EYLEA HD, indicating that data did not support extended dosing intervals greater than every 16 weeks[101]. - The FDA also issued a CRL for the EYLEA HD pre-filled syringe, with no issues identified regarding safety, efficacy, or usability[102]. Collaborations and Partnerships - Regeneron collaborates with Bayer and Sanofi for the development and commercialization of certain products, impacting revenue sharing and market reach[88]. - The collaboration with Sanofi involves the company reimbursing 30% to 50% of development expenses, with a contingent reimbursement obligation of approximately $1.453 billion as of March 31, 2025[104]. - The company co-commercializes Dupixent in the U.S. and shares profits on a sliding scale with Sanofi, starting at 65% (Sanofi) and ending at 55% (Sanofi)[105]. - The collaboration with Bayer for EYLEA involves shared development expenses and equal profit sharing from sales outside the U.S.[106]. - The company is obligated to reimburse Bayer for 50% of development costs incurred under their agreement, with reimbursement payments capped at 5% of the outstanding obligation[107]. - The collaboration with Alnylam focuses on discovering and developing RNAi therapeutics for various diseases, with an initial discovery period extended to seven years[108]. Manufacturing and Supply Chain - The company is committed to maintaining strong manufacturing and supply chain capabilities to support its product portfolio[79].

Financial Performance - Total revenues for Q1 2025 were $3.029 billion, a decrease of 4% compared to $3.145 billion in Q1 2024[4] - GAAP net income for Q1 2025 was $809 million, representing a 12% increase from $722 million in Q1 2024[4] - Non-GAAP net income for Q1 2025 was $928 million, a decrease of 17% from $1.116 billion in Q1 2024[4] - Total revenues for the quarter were $3,028.7 million, a decline of 3.7% from $3,145.0 million in the prior year[39] - Net income for the quarter was $808.7 million, representing an increase of 12.0% compared to $722.0 million in the same quarter of 2024[39] - Non-GAAP net income was $928.4 million, down from $1,115.9 million year-over-year[40] - Free cash flow for the quarter was $815.8 million, a decrease from $1,378.6 million in the same period last year[41] Sales Performance - Dupixent global net sales increased by 19% to $3.67 billion in Q1 2025 compared to Q1 2024[5] - EYLEA HD U.S. net sales increased by 54% to $307 million in Q1 2025, while total EYLEA HD and EYLEA U.S. net sales decreased by 26% to $1.04 billion[5] - Total net product sales for EYLEA HD and EYLEA reached $1,900.6 million, a decrease of 16% compared to $2,251.0 million in the previous year[44] - Dupixent generated net product sales of $3,665.6 million, reflecting a 19% increase from $3,076.8 million in the prior year[44] - Libtayo's net product sales amounted to $285.1 million, an 8% increase from $263.9 million year-over-year[44] - Kevzara saw net product sales of $116.4 million, representing a 24% increase compared to $94.1 million in the previous year[44] - Other products generated net sales of $54.6 million, also a 24% increase from $44.2 million year-over-year[44] - EYLEA HD sales in the U.S. were $306.8 million, a significant increase of 111% from $215.2 million in the previous year[44] - Total EYLEA sales in the U.S. were $1,042.8 million, down from $1,401.6 million, indicating a 16% decline[44] Collaboration and Revenue Streams - Sanofi collaboration revenue increased by 30% to $1.183 billion in Q1 2025, driven by higher profits from Dupixent sales[20] - The company records its share of profits from global sales of Dupixent and Kevzara within Collaboration revenue, reflecting strong international performance[45] - The company pays royalties on global sales of Libtayo and Praluent, contributing to its revenue streams[45] - The company does not include net product sales of ARCALYST in its reported figures, as those are recorded by Kiniksa[45] Expenses and Margins - In Q1 2025, GAAP R&D expenses increased to $1,327 million, a 6% rise from $1,248 million in Q1 2024[21] - GAAP SG&A expenses decreased to $633 million, an 8% decline from $689 million in Q1 2024[21] - GAAP gross margin on net product sales was 81%, down from 86% in Q1 2024[21] - Regeneron's gross margin on net product sales was 81%, down from 86% in the same quarter of 2024[41] Tax and Shareholder Returns - The GAAP effective tax rate (ETR) for Q1 2025 was 10.6%, up from (3.0%) in Q1 2024[23] - The effective tax rate (ETR) for GAAP was 10.6%, compared to a negative 3.0% in the prior year[41] - A new share repurchase program was authorized for up to $3.0 billion, with $1.052 billion repurchased in Q1 2025[24] - The company declared a cash dividend of $0.88 per share, payable on June 6, 2025[25] Future Outlook and Investments - The company announced ongoing investments in infrastructure and manufacturing in New York and North Carolina expected to exceed $7 billion[5] - The FDA accepted priority review for EYLEA HD sBLA for retinal vein occlusion and monthly dosing, with a target action date of August 19, 2025[5] - The company has approximately 45 product candidates in clinical development, with several pivotal data readouts expected later this year[6] - A 10-year agreement with FUJIFILM Diosynth Biotechnologies was announced to nearly double the company's large-scale manufacturing capacity in the U.S.[15] - Full year 2025 GAAP R&D guidance remains unchanged at $5.560–$5.795 billion[26] - The updated GAAP gross margin on net product sales guidance is now 83%–84%, down from the previous 84%–85%[26] - The company utilizes non-GAAP measures for better evaluation of operating performance, excluding certain non-cash items[28] Investments and Securities - The company recognized net unrealized gains on equity securities of $140 million in Q1 2025, compared to net unrealized losses of $196 million in Q1 2024[22] - Cash and marketable securities totaled $17,625.7 million as of March 31, 2025, a slight decrease from $17,912.6 million at the end of 2024[38] - Total assets decreased to $37,545.2 million from $37,759.4 million at the end of the previous year[38]

First quarter 2025 revenues of $3.0 billion; GAAP diluted EPS of $7.27 and non-GAAP diluted EPS(a) of $8.22First quarter 2025 Dupixent® global net sales (recorded by Sanofi) increased 19% to $3.67 billion versus first quarter 2024First quarter 2025 EYLEA HD® U.S. net sales increased 54% to $307 million versus first quarter 2024; total EYLEA HD and EYLEA® U.S. net sales decreased 26% to $1.04 billion Dupixent approved for chronic spontaneous urticaria (CSU) in U.S.; approved for chronic obstructive pulmonary ...

Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory ...

Wall Street analysts expect Regeneron (REGN) to post quarterly earnings of $8.76 per share in its upcoming report, which indicates a year-over-year decline of 8.3%. Revenues are expected to be $3.25 billion, up 3.3% from the year-ago quarter.The consensus EPS estimate for the quarter has been revised 6.1% lower over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimates during this timeframe.Ahead of a company's earnings ...

Biotech giant Regeneron Pharmaceuticals, Inc. (REGN) is slated to report first-quarter 2025 results on April 29, 2025.The Zacks Consensus Estimate for revenues is pegged at $3.25 billion, while the same for earnings is pinned at $8.76 per share. (Find the latest earnings estimates and surprises on Zacks Earnings Calendar.)REGN’s Earnings Surprise HistoryThe company’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 3.23%. In the las ...