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Regeneron Reports Eylea Sales, Provides Other Pipeline Updates
REGNRegeneron(REGN) ZACKS·2025-01-14 19:50

Business and Pipeline Updates - Enrollment for a confirmatory study to support resubmission of the BLA for FL to the FDA is underway, targeting the first quarter of 2025 [1] - Two Factor XI antibodies, REGN7508 and REGN9933, will advance to pivotal trials in 2025 based on positive proof-of-concept data [1] - Shares of REGN have declined 33.7% in the past six months, compared to the industry's decline of 12.3% [3] Eylea Franchise Updates - Eylea and Eylea HD recorded 6billioninsalesin2024intheUnitedStates,withQ4salesof6 billion in sales in 2024 in the United States, with Q4 sales of 1.5 billion [5] - Eylea sales were 1.19billioninQ42024,whileEyleaHD′snetproductsaleswere1.19 billion in Q4 2024, while Eylea HD's net product sales were 305 million in the same period [5] - Eylea franchise sales in Q4 were favorably impacted by 85millionduetohigherwholesalerinventorylevelsforEylea,partiallyoffsetbylowerlevelsforEyleaHD[6]−EyleasaleshavebeenunderpressureduetocompetitionfromRoche′sVabysmo[6]−REGNfiledanapplicationwiththeFDAfortheuseoftheEyleaHDpre−filledsyringe,withpotentialapprovalandlaunchexpectedbymid−2025[7]−Longer−termdataforEyleaHDinwetAMDanddiabeticmacularedemaareunderFDAreview,withatargetactiondateofApril20,2025[9]−REGNplanstosubmitasupplementalBLAforEyleaHDforeveryfour−weekdosingandretinalveinocclusioninQ12025[9]−REGNhasacollaborationagreementwithBayerforEylea,withREGNrecordingnetproductsalesintheUnitedStatesandBayerhandlingsalesoutsidethecountry[10]DupixentUpdates−REGN′stoplineincludesitsshareofprofits/lossesfromglobalsalesofDupixent,withSanofirecordingglobalnetproductsales[11]−Dupixentsaleshavebeenstrong,withencouraginginitialuptakefortherecentlyapprovedindicationofCOPD[12]−AnapplicationforexpandingDupixent′slabelforchronicspontaneousurticariaisunderreviewintheUnitedStates,withatargetactiondateofApril18,2025[13]−AsupplementalBLAseekinglabelexpansionforbullouspemphigoidwassubmittedinQ42024[13]OncologyFranchiseUpdates−REGN′soncologyfranchiseincludesLibtayo,whichexceeded85 million due to higher wholesaler inventory levels for Eylea, partially offset by lower levels for Eylea HD [6] - Eylea sales have been under pressure due to competition from Roche's Vabysmo [6] - REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe, with potential approval and launch expected by mid-2025 [7] - Longer-term data for Eylea HD in wet AMD and diabetic macular edema are under FDA review, with a target action date of April 20, 2025 [9] - REGN plans to submit a supplemental BLA for Eylea HD for every four-week dosing and retinal vein occlusion in Q1 2025 [9] - REGN has a collaboration agreement with Bayer for Eylea, with REGN recording net product sales in the United States and Bayer handling sales outside the country [10] Dupixent Updates - REGN's top line includes its share of profits/losses from global sales of Dupixent, with Sanofi recording global net product sales [11] - Dupixent sales have been strong, with encouraging initial uptake for the recently approved indication of COPD [12] - An application for expanding Dupixent's label for chronic spontaneous urticaria is under review in the United States, with a target action date of April 18, 2025 [13] - A supplemental BLA seeking label expansion for bullous pemphigoid was submitted in Q4 2024 [13] Oncology Franchise Updates - REGN's oncology franchise includes Libtayo, which exceeded 1 billion in sales for 2024 [14] - Positive results from the late-stage C-POST study showed that adjuvant treatment with Libtayo improved disease-free survival in high-risk cutaneous squamous cell carcinoma patients [15] - The European Commission approved odronextamab (brand name Ordspono) for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma [17] - REGN's efforts to get odronextamab approved in the United States faced a setback with the issuance of complete response letters for its BLA [19] Pipeline and Collaborations - REGN has a deep pipeline with promising candidates, including itepekimab for COPD, fianlimab for melanoma, and linvoseltamab for multiple myeloma [16] - The BLA for linvoseltamab was resubmitted after resolving third-party manufacturing issues, with a launch anticipated in mid-2025 [16] - REGN is evaluating combinations with GLP-based therapies for obesity, with phase II studies fully enrolled and initial data expected in the second half of 2025 [18] - REGN announced a strategic collaboration with Truveta to advance innovation and data-driven discovery across life sciences and healthcare [20]