Core Insights - Regeneron Pharmaceuticals reported a decline in first-quarter adjusted earnings per share to $8.22, down 14% year-over-year, missing the consensus estimate of $8.82 [1] - The company's sales for the first quarter were $3.03 billion, a 4% decrease from the previous year, also falling short of the consensus of $3.29 billion [1] - U.S. net sales for Eylea HD and Eylea decreased by 26% year-over-year to $1.04 billion, which included $307 million from Eylea HD [1] Sales Performance - Net product sales of Eylea HD increased in the first quarter of 2025 compared to the first quarter of 2024, primarily due to higher sales volumes [2] - However, Eylea's net product sales were negatively impacted by increased competition from other anti-VEGF products and the transition of patients to Eylea HD [2][7] Collaboration Revenue - Sanofi collaboration revenue increased in the first quarter of 2025, driven by higher profits from the commercialization of antibodies, amounting to $1.018 billion compared to $804 million in the first quarter of 2024 [3] Manufacturing Expansion - Regeneron announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies to produce bulk drug products at their North Carolina campus [4] - The company revised its 2025 GAAP gross margin guidance to 83%-84%, down from 84%-85%, and adjusted gross margin guidance to 86%-87%, down from 87%-88% [4] Regulatory Developments - The European Commission granted conditional marketing approval to Regeneron's Lynozyfic (linvoseltamab) for treating adults with relapsed and refractory multiple myeloma [5] - The FDA accepted the Biologics License Application for linvoseltamab in the U.S., with a target action date of July 10, 2025 [5] Stock Performance - Following the announcements, Regeneron stock experienced a decline of 6.38%, trading at $571.90 [5]

Core Viewpoint - Regeneron Pharmaceuticals reported disappointing first-quarter 2025 results, with adjusted EPS of $8.22, missing estimates and down 14% year-over-year, primarily due to lower revenues and higher operating expenses [1][2][17] Financial Performance - Total revenues decreased 4% year-over-year to $3 billion, missing the Zacks Consensus Estimate of $3.27 billion, driven by lower sales of Eylea and Libtayo [2][17] - Eylea sales in the U.S. plummeted 39% year-over-year to $736 million, impacted by increased competition and market share loss [4][17] - Total Eylea and Eylea HD sales in the U.S. were $1 billion, down 26% year-over-year, also missing estimates [7][17] - Collaboration revenues from Sanofi and Bayer totaled $1.53 billion, up 20.9% year-over-year, exceeding estimates [8][9] Product Performance - Sanofi's collaboration revenues increased 30% to $1.2 billion, driven by higher Dupixent sales, which rose 19% year-over-year to $3.7 billion [9] - Libtayo sales were $285.1 million, up 8% year-over-year, but missed estimates [10] - Eylea HD generated $307 million in revenues, a 54% increase year-over-year, but total Eylea and Eylea HD sales were still down significantly [6][7] Cost and Expenses - Gross margin decreased to 85% from 89% due to higher inventory write-offs and reserves [11] - Adjusted R&D expenses rose 6% year-over-year to $1.2 billion, while adjusted SG&A expenses decreased 8% to $537 million [11] Shareholder Actions - The board authorized a new share repurchase program for up to $3 billion, with $1.052 billion repurchased in Q1 2025 [12] - A cash dividend of $0.88 per share was declared in April 2025 [12] Regulatory Updates - The FDA approved a label expansion for Dupixent and accepted applications for Eylea HD and other drugs, but also issued complete response letters for some applications [13][14][15][16] Strategic Developments - Regeneron entered a 10-year agreement with Fujifilm Diosynth Biotechnologies to enhance manufacturing capacity in the U.S. [19]

Financial Data and Key Metrics Changes - In 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] - Diluted net income per share was $8.22, with net income of $928 million [42] - Gross margin on net product sales was 85%, reflecting higher inventory write-offs and a change in product mix [45] - Free cash flow generated in Q1 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, primarily due to lower physician demand and increased competition [7][29] - EYLEA HD U.S. sales were $307 million, up 54% year-over-year, 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, with U.S. sales growing 19% [32] - Libtayo's global net sales grew 8% year-over-year to $285 million, with U.S. 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 [7][28] - EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite competitive pressures [28] - DUPIXENT continues to lead in new-to-brand prescription share across all approved indications, except for chronic spontaneous urticaria [11][34] Company Strategy and Development Direction - The company aims to capitalize on multiple near-term opportunities across its portfolio, including product enhancements and new medicine launches [27] - Significant investments in R&D are planned, with approximately 45 product candidates in clinical development [12][41] - The company is focused on maintaining leadership in the anti-VEGF category while promoting the adoption of EYLEA HD as the new standard of care [30] 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][7] - The company remains committed to investing heavily in R&D and delivering scientific breakthroughs while maximizing growth opportunities from existing brands [13] - Management expressed confidence in the potential for EYLEA HD and DUPIXENT to continue delivering significant growth [12][34] Other Important Information - The company plans to return capital to shareholders through share repurchases and dividends, with $1.1 billion worth of shares repurchased in Q1 [48] - A new agreement with Fujifilm Diosynth Biotechnologies will invest over $3 billion to nearly double U.S. large-scale manufacturing capacity [46][47] - The company 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 relate to a third-party component supplier, and they believe the key issue is being addressed. They expect a resolution could be quick, similar to previous CRLs [52][56] Question: How does the company prioritize indications for Factor XI antibodies? - The company prioritizes indications based on the potential to demonstrate benefits in anticoagulation and bleeding risk profiles, with plans to enroll in phase three 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: Is there acknowledgment of unsatisfactory regulatory performance? - Management took responsibility for the CRLs, attributing them to increased scrutiny by the FDA on contract manufacturers and expressing confidence in their regulatory team's capabilities [87][90]

Company Performance - Regeneron reported quarterly earnings of $8.22 per share, missing the Zacks Consensus Estimate of $8.43 per share, and down from $9.55 per share a year ago, representing an earnings surprise of -2.49% [1] - The company posted revenues of $3.03 billion for the quarter, missing the Zacks Consensus Estimate by 7.53%, and down from $3.15 billion year-over-year [2] - Over the last four quarters, Regeneron has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Outlook - Regeneron shares have declined approximately 14.3% since the beginning of the year, compared to a 6% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $10.12 on revenues of $3.52 billion, and for the current fiscal year, it is $38.75 on revenues of $14.32 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Regeneron belongs, is currently in the top 31% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that the industry outlook can significantly impact stock performance [5][8]

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]

Core Viewpoint - Regeneron Pharmaceuticals reported its Q1 2025 financial results, highlighting a diverse pipeline and significant progress in clinical programs, alongside a slight decline in total revenues compared to the previous year [1][3]. Financial Highlights - Total revenues for Q1 2025 were $3,029 million, a decrease of 4% from $3,145 million in Q1 2024 [3][13]. - GAAP net income increased by 12% to $809 million, with diluted earnings per share (EPS) rising 16% to $7.27 [3][37]. - Non-GAAP net income fell by 17% to $928 million, with non-GAAP diluted EPS decreasing by 14% to $8.22 [3][39]. - The company reported a gross margin on net product sales of 81% for Q1 2025, down from 86% in Q1 2024 [19][40]. Business Highlights - Regeneron has approximately 45 product candidates in clinical development, with notable advancements in its pipeline [4]. - 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 rose by 54% to $307 million, while total EYLEA HD and EYLEA U.S. net sales decreased by 26% to $1.04 billion [5][13]. - Regulatory approvals were achieved for Dupixent in chronic spontaneous urticaria (CSU) in the U.S. and chronic obstructive pulmonary disease (COPD) in Japan [5][6]. Pipeline Progress - The FDA accepted a priority review for Dupixent in bullous pemphigoid, with a target action date of June 20, 2025 [7]. - Ongoing and planned investments in infrastructure and manufacturing in New York and North Carolina are expected to exceed $7 billion [5]. Collaboration Revenue - Collaboration revenue from Sanofi increased by 30% to $1,183 million in Q1 2025, driven by higher profits from Dupixent sales [18][42]. - Total collaboration revenue for Q1 2025 was $1,531 million, compared to $1,266 million in Q1 2024 [42]. Capital Allocation - The board of directors authorized a new share repurchase program of up to $3 billion, with $1.052 billion spent on repurchases in Q1 2025 [22][23]. - A cash dividend of $0.88 per share was declared, payable on June 6, 2025 [23].

Industry Overview - The first-quarter earnings season for the drug and biotech sector is underway, with major companies like Pfizer, Eli Lilly, Amgen, Biogen, and Regeneron set to announce results [1] - Johnson & Johnson and Merck have reported results, both exceeding first-quarter estimates for earnings and sales, while Sanofi had mixed results, beating earnings estimates but missing sales [1] Earnings Trends - As of April 23, 15% of companies in the Medical sector, representing 33.8% of the sector's market capitalization, reported quarterly earnings, with 77.8% surpassing estimates for both earnings and revenues [3] - Year-over-year earnings increased by 4.7%, and revenues rose by 9.4% [3] - Overall, first-quarter earnings for the Medical sector are expected to increase by 35%, while sales are projected to rise by 7.8% compared to the previous year [3] Company Performance Pfizer (PFE) - Pfizer has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 44.16% [5] - The Zacks Consensus Estimate for first-quarter sales and earnings is $13.88 billion and 64 cents per share, respectively [6] - Non-COVID operational revenues are driving growth, supported by products like Vyndaqel, Padcev, and Eliquis, despite a decline in sales of COVID products [7] Eli Lilly (LLY) - Eli Lilly has had mixed performance, exceeding earnings expectations in three of the last four quarters, with an average earnings surprise of 8.47% [8] - The Zacks Consensus Estimate for sales and earnings is $12.62 billion and $3.52 per share, respectively [8] - Growth is expected to be driven by demand for FDA-approved tirzepatide medicines, although sales of Mounjaro and Zepbound were below expectations [9][10] Amgen (AMGN) - Amgen has shown strong performance, beating earnings estimates in each of the last four quarters, with an average earnings surprise of 5.23% [11] - The Zacks Consensus Estimate for first-quarter sales and earnings is $7.96 billion and $4.15 per share, respectively [11] - Product sales are expected to be driven by strong volume growth, although prices may decline due to higher rebates [12] Biogen (BIIB) - Biogen has consistently beaten earnings estimates in the last four quarters, with an average earnings surprise of 11.80% [13] - The Zacks Consensus Estimate for sales and earnings is $2.23 billion and $3.52 per share, respectively [13] - Lower sales of multiple sclerosis drugs are likely to be offset by revenues from new drugs [14] Regeneron (REGN) - Regeneron has had mixed results, surpassing earnings expectations in three of the last four quarters, with an average earnings surprise of 3.23% [16] - The Zacks Consensus Estimate for first-quarter sales and earnings is $3.28 billion and $8.43 per share, respectively [17] - Sales of Eylea are expected to have declined due to competition, but sales of Eylea HD and Dupixent are likely to have surged [18][19]

Core Insights - The European Commission has granted conditional marketing approval for Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory multiple myeloma, specifically for those who have undergone at least three prior therapies [1][3][5] - Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing [1][3] - The approval is based on the LINKER-MM1 trial, which showed a 71% objective response rate and a 50% complete response rate among patients treated with Lynozyfic [3][4] Company Overview - Regeneron Pharmaceuticals is a leading biotechnology company focused on developing innovative medicines for serious diseases, including blood cancers [17][18] - The company has a strong commitment to transforming cancer care, as evidenced by the approval of Lynozyfic as its second bispecific antibody [5][12] - Regeneron utilizes proprietary technologies, such as VelociSuite, to develop optimized fully human antibodies and bispecific antibodies [15][18] Clinical Development - Lynozyfic is currently being investigated in a broad clinical development program, including monotherapy and combination regimens across different lines of therapy for multiple myeloma [11][12] - The ongoing LINKER-MM1 trial has enrolled over 300 patients, assessing safety, tolerability, and anti-tumor activity [9][10] - The regimen for Lynozyfic includes an initial step-up dosing followed by a response-adapted schedule, allowing for convenient administration every four weeks for eligible patients [2][10] Market Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [6][7] - Despite treatment advances, multiple myeloma remains incurable, and patients often experience relapses and require new therapies [7][8] - The introduction of Lynozyfic provides a new treatment option with a different mechanism of action, addressing the need for innovative therapies in this patient population [3][5]