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Regeneron Stock Rises on Q2 Earnings and Sales Beat, Eylea HD Sales Up
ZACKS· 2025-08-01 16:11
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 Initial Data on Multiple Myeloma Drug Encouraging
ZACKS· 2025-05-23 21:11
Core Insights - Regeneron Pharmaceuticals, Inc. announced promising initial results from the early-stage study of oncology drug linvoseltamab, particularly in patients with relapsed/refractory multiple myeloma [1][2] Group 1: Study Results - The LINKER-MM2 trial showed linvoseltamab combined with carfilzomib or bortezomib yielded high response rates in earlier treatment lines for relapsed/refractory multiple myeloma [2] - Efficacy results indicated a 90% objective response rate (ORR) and a 76% complete response (CR) at a median follow-up of 15 months [6] - Among patients treated with linvoseltamab and bortezomib, an 85% ORR was observed with 50% achieving CR [7] Group 2: Patient Demographics - The study included patients who had progressed after at least two lines of therapy, with many being double-class refractory or triple-class exposed [4] - 48% of enrolled patients had baseline soft tissue plasmacytomas, and 39% were over 75 years old, indicating a high-risk patient population [5] Group 3: Regulatory Developments - The European Commission granted conditional marketing approval for linvoseltamab under the brand name Lynozyfic for adults with relapsed/refractory multiple myeloma [8] - The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025 [9] Group 4: Oncology Portfolio Expansion - Regeneron is focused on strengthening its oncology portfolio, which includes Libtayo for various cancers [10] - The approval of odronextamab for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has also contributed to the oncology franchise [11] Group 5: Market Competition - The decline in sales of Regeneron's lead drug Eylea is a concern, attributed to competition from Roche's Vabysmo, which has significantly impacted Eylea's market share [12][13]