Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (March 2019)
26 slides from Regeneron Pharmaceuticals's investor presentation, March 2019
Slide 1: Corporate Presentation March 2019
C O R PO RAT E PR ESEN TAT ION MARCH 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: Key 2018 Milestones and Achievements
KEY 2018 MILESTONES AND ACHIEVEMENTS Key Regulatory Key Regulatory Clinical Trial Ph2 and Ph3 Trial INDs & Ph1 Approvals* Filings Readouts Initiations Trial Initiations LIBTAYO Advanced EYLEA Diabetic DUPIXENT Ph3 Chronic DUPIXENT REGN4018 CSCC Retinopathy Rhinosinusitis with Nasal Ph2/3 Eosinophili
Slide 4: EYLEA: Strengthening Market Leadership Position
EYLEA®: STRENGTHENING MARKET LEADERSHIP POSITION $4.1 Net Sales: 4Q18 FY18 $3.7 $3.3 U.S. $1,078.9MM $4,076.7MM $2.7 Global $1,803.3MM $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 5: 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) without DME – PDUFA date May 13, 2019 ▪ Phase 3 PANORAMA study shows potential to change clinical pr
Slide 6: DUPIXENT: Building Leadership in Atopic Dermatitis and Launching in Asthma
DUPIXENT ®: BUILDING LEADERSHIP IN ATOPIC DERMATITIS AND LAUNCHING IN ASTHMA 1,200 Asthma Launch Atopic Dermatitis: Practice-Changing Moderate-to-Severe Asthma: 1,000 Advance in Management High Unmet Need Branded DTC TV Starts Only asthma biologic approved for: In the U.S., less than 15% of adult AD
Slide 7: DUPIXENT: Delivering on the Pipeline in a Product Promise
DUPIXENT ®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE APPROVED Atopic Dermatitis Approved in Adults INDICATIONS Moderate-to-Severe Asthma Approved in Adults and Adolescents Atopic Dermatitis in Adolescents (12–17 years) PDUFA date March 11, 2019 Atopic Dermatitis in Pediatrics (6–11 years) P
Slide 8: 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 Positive Ph3 data reported; PDUFA date March 11, 2019 Prior treatments include
Slide 9: 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 10: 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 Maximize Skin CSCC – Ph3 adjuvant trial to start in 1H19; neo-adjuvant studies to follow Cancer CSCC: THE FIRST OF MANY Opportunity Melanoma – regulatory discussions ant
Slide 11: 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 12: Regeneron's IO Strategy Connects Multiple Individual Pieces
REGENERON’S IO STRATEGY CONNECTS MULTIPLE INDIVIDUAL PIECES… LIBTAYO 12
Slide 13: …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 13
Slide 14: REGN1979 CD20xCD3 Bispecific 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 15: 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 16: 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 17: 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 18: 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 + TSA2xCD28 in vivo xenogeneic humanized TSA1 mouse model in vivo syngeneic humanized TSA2 mouse model 2000 Control xCD3 Control xCD3 Tumor Volume (mm3) TSA1xC
Slide 19: Broadening Our Immuno-Oncology Pipeline
BROADENING OUR IMMUNO-ONCOLOGY PIPELINE LIBTAYO Pre-IND Clinical Development Approved Potential Indications TSAxCD28 REGN1979 (CD20xCD3) LIBTAYO LIBTAYO Solid Tumor B-Cell NHL NSCLC, Cervical, BCC, Pediatric CSCC LIBTAYO + REGN1979 TSAxCD28 REGN5458 (BCMAxCD3) (CD20xCD3) B cell malignancy Multiple M
Slide 20: Many Companies Can Do One Thing...
MANY COMPANIES CAN DO ONE THING... CTLA-4, LAG-3, GITR… CD3 bispecifics PD-1/L1 Costimulatory bispecifics 20
Slide 21: …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 21
Slide 22: 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 23: Portfolio & Pipeline
PORTFOLIO & PIPELINE PHASE 1 PHASE 2 PHASE 3 REGN4461 (LEPR) REGN1979 (CD20xCD3 bispecific) Garetosmab (Activin-A) Evinacumab (ANGPTL3) Pozelimab (C5) REGN5458* (BCMAxCD3 bispecific) Evinacumab (ANGPTL3) Alirocumab* (PCSK9) Trevogrumab (GDF8) REGN4018* (MUC16xCD3 bispecific) Cemiplimab* (PD-1) Cemip
Slide 24: 2019 Goals and Milestones
2019 GOALS AND MILESTONES EYLEA FDA decision on sBLA for the treatment of Diabetic Retinopathy (PDUFA date May 13, 2019); re-submission of Prior-Approval Supplement (PAS) for pre-filled syringe KEY DUPIXENT FDA decision on sBLA for expanded Atopic Dermatitis indication in adolescent patients 12–17 y
Slide 25: 2019 Financial Guidance
2019 FINANCIAL GUIDANCE* GAAP Sanofi Collaboration Revenue: $510 – 560MM Reimbursement of Regeneron Commercialization-Related Expenses GAAP unreimbursed R&D $1.855 – $2.000B Non-GAAP unreimbursed R&D† $1.590 – $1.710B GAAP SG&A $1.700 – $1.830B Non-GAAP SG&A† $1.500 – $1.600B GAAP Effective Tax Rate
Slide 26: 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* $ 1,855 $ 2,000 R&D: Non-cash share-based compensation (265) (290) expense Non-GAAP unreimbursed R&D $ 1,590 $ 1,710 GAAP SG&A $ 1,700 $ 1,830 SG&A: Non-cash share-based
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