Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (June 2019)
25 slides from Regeneron Pharmaceuticals's investor presentation, June 2019
Slide 1: Corporate Presentation June 2019
C O R PO RAT E PR ESEN TAT ION JUNE 2019 Not for use in promotion. For approved corporate use only.
Slide 2: Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND NON-GAAP FINANCIAL MEASURES 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 even
Slide 3: EYLEA: Strengthening Market Leadership Position
EYLEA®: STRENGTHENING MARKET LEADERSHIP POSITION $4.1 Net Sales: 1Q19 FY18 $3.7 $3.3 U.S. $1,074.1MM $4,076.7MM $2.7 Global $1,743.5MM $6,745.6MM Building on leadership position in wAMD and diabetic $1.7 $1.4 eye disease, both of which are increasing in prevalence $0.8 ▪ We believe there are no near
Slide 4: EYLEA: Leading Ophthalmology Innovation
EYLEA®: LEADING OPHTHALMOLOGY INNOVATION Opportunities in Diabetic Eye Diseases Diabetic Macular Edema (DME) ▪ Targeted commercial strategy to increase anti-VEGF penetration Diabetic Retinopathy (DR) ▪ EYLEA is now approved to treat all stages of diabetic retinopathy, and thereby reduce the risk of
Slide 5: DUPIXENT: Building Leadership in Atopic Dermatitis and Launching in Asthma
DUPIXENT ®: BUILDING LEADERSHIP IN ATOPIC DERMATITIS AND LAUNCHING IN ASTHMA 1,400 Asthma Adolescent AD Launch Launch Atopic Dermatitis: Practice-Changing Moderate-to-Severe Asthma: 1,200 Branded DTC Advance in Management High Unmet Need TV Starts Only asthma biologic approved for: 1,000 In the U.S.
Slide 6: DUPIXENT: Delivering on the Pipeline in a Product Promise
DUPIXENT ®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE APPROVED Atopic Dermatitis Approved in Adults and Adolescents INDICATIONS Moderate-to-Severe Asthma Approved in Adults and Adolescents Atopic Dermatitis in Pediatrics (6–11 years) Ph3 results expected in 2019 Chronic Rhinosinusitis with N
Slide 7: DUPIXENT: Adolescent and Pediatric Atopic Dermatitis
DUPIXENT ®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE ADOLESCENT AND PEDIATRIC ATOPIC DERMATITIS – HIGH DISEASE BURDEN WITH LIMITED TREATMENT OPTIONS Adolescent Atopic Dermatitis (Ages 12–17 years) Before DUPIXENT Now FDA approved Prior treatments included 50% cycles of prednisone, oral 41.5
Slide 8: LIBTAYO: New Hope for Patients with Advanced CSCC
LIBTAYO®: NEW HOPE FOR PATIENTS WITH ADVANCED CSCC Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer (after Basal Cell Carcinoma) and is responsible for an estimated 7,000 deaths per year in the U.S. LIBTAYO is the only FDA approved treatment option for advanced
Slide 9: LIBTAYO: The Foundation of Our IO Strategy
LIBTAYO®: THE FOUNDATION OF OUR IO STRATEGY DEVELOPMENT STRATEGY 2L Basal Cell Carcinoma (BCC) – Ph2 (potentially pivotal) ongoing; locally Maximize Skin advanced BCC cohort fully enrolled in 1Q19 Cancer CSCC – Ph3 adjuvant trial to start in 2Q19; neo-adjuvant study to start in 3Q19 CSCC: THE FIRST
Slide 10: Regeneron's IO Strategy Is Built on a Deep Foundation of Science and Technology
REGENERON’S IO STRATEGY IS BUILT ON A DEEP FOUNDATION OF SCIENCE AND TECHNOLOGY 619 manuscripts published, 9,351 patent applications filed and 500,000 exomes sequenced by 4,945 patents issued over the last 10 years Regeneron Genetics Center (RGC) TM VELOCI-Bi TM ® ® Fully human T-cell Proprietary me
Slide 11: Regeneron's IO Strategy Connects Multiple Individual Pieces…
REGENERON’S IO STRATEGY CONNECTS MULTIPLE INDIVIDUAL PIECES… LIBTAYO 11
Slide 12: …Logically and Rationally into a Cohesive Whole
…LOGICALLY AND RATIONALLY INTO A COHESIVE WHOLE ...like pieces in a puzzle, bringing order to chaos Regeneron’s IO puzzle is evolving and not yet complete; based on science and experimental data, the shape, components and LIBTAYO configuration may change 12
Slide 13: REGN1979, CD20xCD3 Bispecific Antibody, Demonstrates High ORR/CR
REGN1979, OUR EXCLUSIVELY-OWNED CD20xCD3 BISPECIFIC ANTIBODY, DEMONSTRATES HIGH ORR/CR Data presented at the 2018 American Society of Hematology (ASH) Annual Meeting In our dose escalation Ph1 study, Relapsed/ REGN1979 dose groups treatment with ≥5 mg of REGN1979 Refractory <5 mg (n=7) ≥5-≤12 mg (n=
Slide 14: Regeneron's IO Strategy Is Based on Rational Combinations
REGENERON’S IO STRATEGY IS BASED ON RATIONAL COMBINATIONS Anti-PD-1 Unresponsive Tumors Anti-PD-1 Responsive Tumors TCR does not recognize tumor Additional Strategic Opportunities TCR binds tumor MHC/peptide MHC/peptide Anti-PD-1 mAb CD3 bispecific CAR-T monotherapy alone, or in therapies or combina
Slide 15: CD3 & Costimulatory Bispecifics Are Off-the-Shelf Drugs
REGENERON’S CD3 & COSTIMULATORY BISPECIFICS ARE OFF-THE-SHELF DRUGS WITH POTENTIAL TO TURN PATIENTS’ T CELLS INTO CAR-T-LIKE CANCER KILLERS CAR-T Mechanism Bispecific/Costimulatory Mechanism Tumor Tumor Tumor Target Target Target CD3ζ TCRβ CD3ζ TCRα scFv CD3 bispecific Costimulatory bispecific CD3δ
Slide 16: CD3 & Costimulatory Bispecifics with LIBTAYO
REGENERON’S CD3 & COSTIMULATORY BISPECIFICS ARE OFF-THE-SHELF DRUGS WITH POTENTIAL TO TURN PATIENTS’ T CELLS INTO CAR-T-LIKE CANCER KILLERS CAR-T Mechanism Bispecific/Costimulatory Mechanism Tumor Tumor Tumor Target Target Target CD3ζ TCRβ CD3ζ TCRα scFv CD3 bispecific Costimulatory bispecific CD3δ
Slide 17: Costimulatory Bispecifics Show Synergy in Preclinical Tumor Models
ADDING COSTIMULATORY BISPECIFICS TO CD3 BISPECIFICS OR TO ANTI-PD-1 SHOWS SYNERGY IN PRECLINICAL TUMOR MODELS TSA1xCD3 + TSA1xCD28 anti-PD-1 + PSMAxCD28 in vivo xenogeneic humanized TSA1 mouse model in vivo syngeneic humanized PSMA mouse model 2000 Control xCD3 Control xCD3 Tumor Volume (mm3) TSA1xC
Slide 18: Broadening Our Immuno-Oncology Pipeline
BROADENING OUR IMMUNO-ONCOLOGY PIPELINE Clinical Development LIBTAYO Pre-IND Approved (Active IND) Potential Indications LIBTAYO TSAxCD28 REGN1979 (CD20xCD3) LIBTAYO NSCLC, Cervical, BCC, B cell malignancy B-Cell NHL CSCC Pediatric, Adjuvant CSCC REGN5458 (BCMAxCD3) LIBTAYO + REGN1979 GITR (CD20xCD3
Slide 19: Many Companies Can Do One Thing...
MANY COMPANIES CAN DO ONE THING... CTLA-4, LAG-3, GITR… CD3 bispecifics PD-1/L1 Costimulatory bispecifics 19
Slide 20: …Few Can Do Many Things
…FEW CAN DO MANY THINGS PD-1/L1 Costimulatory PD-1/L1 bispecifics CTLA-4, LAG-3, GITR… is one of the few CD3 bispecifics 20
Slide 21: Fasinumab: High Risk/High Reward
FASINUMAB: HIGH RISK/HIGH REWARD OSTEOARTHRITIS IS A COMMON CONDITION ASSOCIATED WITH WEAR AND TEAR ON THE JOINTS, AND IS THE MOST COMMON INDICATION FOR Fasinumab* is a human KNEE AND HIP REPLACEMENT monoclonal antibody that treats osteoarthritis Pain is a protective mechanism pain by blocking nerve
Slide 22: Portfolio & Pipeline
PORTFOLIO & PIPELINE PHASE 1 PHASE 2 PHASE 3 REGN4461 (LEPR) REGN3767 (LAG-3) Garetosmab (Activin-A) Evinacumab (ANGPTL3) Pozelimab (C5) REGN5069 (GFRα3) Evinacumab (ANGPTL3) Alirocumab* (PCSK9) REGN3048-3051 (MERS virus) Cemiplimab* (PD-1) Cemiplimab* (PD-1) Cemiplimab* (PD-1) REGN1979 (CD20xCD3 bi
Slide 23: Select Next 12 Months Goals and Milestones
SELECT NEXT 12 MONTHS GOALS AND MILESTONES KEY EYLEA FDA decision on Prior-Approval Supplement (PAS) for pre-filled syringe REGULATORY DUPIXENT FDA (PDUFA date Jun 26, 2019) decision on Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); EU APPROVALS decision on adolescent AD & SUBMISSIONS LIBTAYO EC
Slide 24: 2019 Financial Guidance
2019 FINANCIAL GUIDANCE* GAAP Sanofi Collaboration Revenue: $500 – $535MM Reimbursement of Regeneron Commercialization-Related Expenses GAAP Unreimbursed R&D $2.280 – $2.400B Non-GAAP Unreimbursed R&D† $1.610 – $1.710B GAAP SG&A $1.695 – $1.800B Non-GAAP SG&A† $1.500 – $1.580B GAAP Effective Tax Rat
Slide 25: Reconciliation of Full Year 2019 Non-GAAP to GAAP Financial Guidance
RECONCILIATION OF FULL YEAR 2019 NON-GAAP TO GAAP FINANCIAL GUIDANCE Projected Range (in millions) Low High GAAP unreimbursed R&D* $ 2,280 $ 2,400 R&D: Non-cash share-based compensation (270) (290) expense R&D: Up-front payment related to license and (400) (400) collaboration agreements Non-GAAP unr
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