Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Day (November 2025)
36 slides from Regeneron Pharmaceuticals's investor day presentation, Nov 10, 2025
Slide 1: Roundtable: Factor XI
ROUNDTABLE Factor XI NOVEMBER 10, 2025
Slide 2: Speakers
Speakers Regeneron Roundtable – Factor XI George Yancopoulos Andres Sirulnik David Gutstein Ryan Crowe Board co-Chair Senior Vice President Vice President Senior Vice President President Clinical Development Unit Head Global Program Head Investor Relations & Chief Scientific Officer Hematology Hemat
Slide 3: Note regarding forward-looking statements
Note regarding forward-looking statements This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materia
Slide 4: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 4
Slide 5: Hematology and Heme-Onc Development Pipeline
Hematology and Heme-Onc Development Pipeline Phase 1 Phase 2 Phase 3 Approved CD22xCD28 (REGN5837) Factor XI (REGN9933A2) Factor XI (REGN7508Cat) Costimulatory Bispecific Ab SPAF Post-Op VTE Lymphoma TMPRSS6 (REGN7999) odronextamab (CD20xCD3) BCMAxCD3 (REGN5459) Beta Thalassemia Lymphoma anti-HLA de
Slide 6: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 6
Slide 7: Why target Factor XI for anticoagulation therapy?
Why target Factor XI for anticoagulation therapy? Anticoagulants available today are effective, but use is limited by bleeding concerns OVERVIEW What is the unmet need in anticoagulation treatment? • The current $20Bn global market, driven primarily by stroke prevention in atrial fibrillation, remai
Slide 8: What is the unmet need?
What is the unmet need? Currently >$15B market in the U.S. alone, with room for growth in areas where bleeding risk has restricted standard-of-care usage OVERVIEW Venous Cardioembolic Contact-mediated Arterial Thromboembolism Stroke Thrombosis Thrombosis SoC: DOACs, LMWH SoC: DOACs SoC: warfarin, he
Slide 9: Genetics supports targeting Factor XI for anticoagulation therapy
Genetics supports targeting Factor XI for anticoagulation therapy People with genetically lower FXI levels show reduced risk of VTE and cardioembolic stroke OVERVIEW • Epidemiological studies also show that FXI deficiency conveys protection from VTE and MACE1, with a mild bleeding phenotype2,3 • Our
Slide 10: Why continued development of two Factor XI antibodies?
Why continued development of two Factor XI antibodies? Patient-centric approach tailored to different risk-benefit profiles: REGN9933A2 for indications with low tolerance for bleeding risk, REGN7508Cat broadly across Factor XI program indications OVERVIEW Anticipated therapeutic profile Decreased av
Slide 11: Preclinical data support differentiated profile for REGN's FXI antibodies
Preclinical data support differentiated profile for REGN’s FXI antibodies In preclinical assays, REGN7508Cat and REGN9933A2 demonstrate more robust aPTT prolongation and stronger inhibition of thrombin generation compared to other FXI inhibitors, suggesting Regeneron’s antibodies may be more complet
Slide 12: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 12
Slide 13: AHA 2025: ROXI-VTE-I and -II Study Design
AHA 2025: ROXI-VTE-I and -II Study Design Randomized, Open-Label, Active-Control, Phase 2 studies in patients undergoing Total Knee Replacement All treatment started 12–24 hours post-surgery ROXI-VTE-I REGN9933A2 300 mg single IV dose (N=123) Primary efficacy outcome: (1:1:1) • Incidence of adjudica
Slide 14: AHA 2025: VTE prevention post-knee replacement data
AHA 2025: data in VTE prevention post-knee replacement surgery support broad Phase 3 development REGN7508Cat demonstrated numerically lowest VTE rate while REGN9933A2 demonstrated numerically lower VTE rate vs. enoxaparin Risk difference in VTE incidence, % (95% CI) Cross-study pooled analyses of th
Slide 15: AHA 2025: Safety Outcomes of ROXI-VTE-I and ROXI-VTE-II
AHA 2025: Safety Outcomes of ROXI-VTE-I and ROXI-VTE-II There were no major or clinically relevant nonmajor bleeds in any arm in either study; none of the serious adverse events were related to any of the study drugs ROXI-VTE-I ROXI-VTE-II REGN9933A2 Enoxaparin Apixaban REGN7508Cat Enoxaparin 300 m
Slide 16: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 16
Slide 17: ROXI-CATH in catheter-associated thrombosis: interim results
Phase 2 ROXI-CATH in catheter-associated thrombosis: promising interim results for Regeneron’s Factor XI inhibitors beyond VTE Results support Phase 3 development for Cancer-Associated VTE prevention and PICC-associated thrombosis Avoiding replacement of long-term indwelling catheters (e.g., PICC li
Slide 18: Phase 1 GI bleed study: favorable bleeding profile
Phase 1 GI bleed study: Factor XI antibodies demonstrate a favorable bleeding profile in a healthy volunteer provoked bleeding model These results support antibodies’ safety profile (bleeding risk) for all planned Phase 3 indications Proof-of-mechanism study schema Preliminary results Study tested h
Slide 19: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 19
Slide 20: Factor XI Development Program
Factor XI Development Program Genetics, preclinical, and clinical data support broad Factor XI development Target Treatment Est. Est. Primary Patient Segment Study Enrollment Period Study Start Completion ROXI-APEX Post-Total Knee Replacement (Cat vs. apixaban vs. ~2,000 Single dose enrolling 1Q 202
Slide 21: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 21
Slide 22: Factor XI Program targeting several indications
Regeneron’s Factor XI Program, which consists of two antibody candidates, is targeting several indications REGN7508Cat pursued in all listed indications, REGN9933A2 in indications with lowest bleeding risk tolerance Post-TKR Cancer Stroke Prevention Peripheral Artery VTE VTE in AF Disease COMMERCIAL
Slide 23: Commercial Opportunity: Post-TKR and Cancer VTE
Commercial Opportunity: Post-TKR and Cancer VTE Differentiated Factor XI inhibitors designed to potentially reduce bleeding risk, deliver strong efficacy, and simplify treatment with convenient SC Q2W dosing for chronic disease management Post-TKR VTE Cancer VTE Vision: Single dose VTE prevention op
Slide 24: Commercial Opportunity: SPAF and PAD
Commercial Opportunity: SPAF and PAD Differentiated Factor XI inhibitors designed to potentially reduce bleeding risk, deliver strong efficacy, and simplify treatment with convenient SC Q2W dosing for chronic disease management Stroke Prevention in AF Peripheral Artery Disease Vision: Prevent major
Slide 25: Regeneron Roundtable – Factor XI Agenda
REGENERON ROUNDTABLE – Factor XI Regeneron’s Hematology Pipeline Overview of Factor XI Program Clinical Data: AHA 2025 ROXI-VTE-I and ROXI-VTE-II Results Clinical Data: ROXI-CATH & GI Bleed Preliminary Results Factor XI Development Plan Commercial Opportunity Closing Remarks and Q&A 25
Slide 26: Tailored approach to anticoagulation to meet patient-specific needs
Regeneron’s Factor XI antibodies to provide tailored approach to anticoagulation to meet patient-specific needs Unique Factor XI development approach at Regeneron aims to address unmet need and build future market Expand into Expedited Compete underutilized segments path to market with SoC 2027: Piv
Slide 27: Q&A Session
Q&A Session Regeneron Roundtable – Factor XI George Yancopoulos Andres Sirulnik David Gutstein Ryan Crowe Board co-Chair Senior Vice President Vice President Senior Vice President President Clinical Development Unit Head Global Program Head Investor Relations & Chief Scientific Officer Hematology He
Slide 28: Appendix Slides
Appendix Slides REGENERON’
Slide 29: Post-Total Knee Replacement (TKR) VTE Background
Post-Total Knee Replacement (TKR) VTE Background Post-TKR VTE Condition Current Management U.S. Patient Share* (2024) • Patients undergoing total hip and total knee replacement (TKR) are at an • In the U.S., nearly all patients are given drug prophylaxis for VTE prevention 8% 2% increased risk of ve
Slide 30: Post-Total Knee Replacement (TKR) VTE
Post-Total Knee Replacement (TKR) VTE U.S. Opportunity (mid-2030s) Differentiation and Positioning Vision: Single dose VTE prevention option for standard and high-risk patients following knee replacement U.S. treated post-knee • Only agent in Phase 3 development for this ~2M replacement patients pat
Slide 31: Cancer-Associated VTE Prevention Background
Cancer-Associated VTE Prevention Background Cancer VTE Condition Current Management • Cancer-associated thrombosis is the second leading cause of • Guidelines recommend use of LMWH or DOAC death in patients with malignant disease, behind only cancer for treatment and secondary prevention; primary So
Slide 32: Cancer-Associated VTE Prevention
Cancer-Associated VTE Prevention Opportunity for Factor XI to address ~1M patients (estimated $1.4Bn future U.S. market) U.S. Opportunity (mid-2030s) Differentiation and Positioning Vision: Prevent and treat cancer-associated thrombosis with convenient Q2W dosing and low U.S. eligible patients bleed
Slide 33: Stroke Prevention in Atrial Fibrillation (SPAF) Background
Stroke Prevention in Atrial Fibrillation (SPAF) Background Stroke Prevention in Atrial Fibrillation Current Management G7 Atrial Fibrillation Condition & Development Market (2032) = $20.7B • Atrial fibrillation (AF) is a type of irregular heartbeat that can lead to • Current standard of care is a di
Slide 34: Stroke Prevention in Atrial Fibrillation (SPAF)
Stroke Prevention in Atrial Fibrillation (SPAF) Large market opportunity for Factor XI if less bleeding vs. DOACs and similar efficacy on stroke prevention is demonstrated (estimated $12.6Bn future U.S. market) SPAF Patient Segmentation Differentiation and Positioning DOAC-Non- DOAC-Candidates (80%)
Slide 35: Peripheral Artery Disease (PAD) Post-Revascularization Background
Peripheral Artery Disease (PAD) Post-Revascularization Background Peripheral Artery Disease Condition Current Management • Peripheral Artery Disease (PAD) is caused by a buildup of plaque in the • Most patients are on anti-platelet therapy only arteries (atherosclerosis), reducing circulation to the
Slide 36: Peripheral Artery Disease (PAD) Post-Revascularization
Peripheral Artery Disease (PAD) Post-Revascularization Estimated $1-1.5Bn future U.S. market U.S. Opportunity (mid-2030s) Differentiation and Positioning Vision: Prevent major limb complications after lower- extremity revascularization in PAD patients with safer US patients receiving first alternati
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