Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (September 2018)
35 slides from Regeneron Pharmaceuticals's investor presentation, September 2018
Slide 1: Corporate Presentation
CORPORATE PRESENTATION September 2018
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 eve
Slide 3: Combining Science and Technology to Improve Patients' Lives
COMBINING SCIENCE AND TECHNOLOGY TO IMPROVE PATIENTS’ LIVES Use biology Inventing tools and Invent scalable, 7 out of 12 members of and genetics technologies (e.g. cutting-edge Board of Directors are VelociSuite, RGC) to to identify & technology members of the National overcome bottlenecks in valida
Slide 4: Robust Pipeline Across Many Therapeutic Areas
ROBUST PIPELINE ACROSS MANY THERAPEUTIC AREAS REGN5069 (undisclosed target)) REGN4461 (LEPR agonist antibody) REGN1908-1909 (Fel d 1 antibody) Trevogrumab (GDF8 antibody)† Garetosmab (Activin-A antibody) Skeletal Diseases Oncology/IO REGN4659* (CTLA antibody) Immunology & Inflammation Infectious Dis
Slide 5: YTD 2018 Highlights
YTD 2018 HIGHLIGHTS EYLEA® - Positive topline data reported from Phase 3 PANORAMA study in non-proliferative diabetic retinopathy, sBLA submitted EYLEA® - Approved for use in a modified 12-week dosing schedule after one year of effective therapy EYLEA® - sBLA submitted for EYLEA in a pre-fille
Slide 6: EYLEA (Aflibercept) Injection
EYLEA® (AFLIBERCEPT) INJECTION U.S. Net Sales, $Bn • 2Q’18 Sales: $3.7 • U.S. EYLEA® net sales of $992MM $3.3 • Ex-U.S. EYLEA® net sales of $666MM† $2.7 • Clinical Updates: • Positive topline data from Phase 3 PANORAMA study in diabetic $1.7 retinopathy reported in 1Q’18, sBLA submitted $1.4 • sBLA
Slide 7: Dupixent (Dupilumab): Launch in Atopic Dermatitis Progressing Well
DUPIXENT® (DUPILUMAB): LAUNCH IN ATOPIC DERMATITIS PROGRESSING WELL Weekly TRx since launch 6,000 • Underlying demand for Dupixent remains 5,000 strong 4,000 • Total prescriptions up ~27% sequentially from Q1’18 to Q2’18* 3,000 • On average, ~550 new patients/week are 2,000 dispensed drug* 1,000 • P
Slide 8: Important Pipeline Advances
IMPORTANT PIPELINE ADVANCES Regulatory submissions and new/expanded indications* 11 Programs in late-stage clinical development† 22 2018 Product candidates in clinical development, all discovered at Regeneron 20 Product candidates expected to enter clinical development 4-6 * Regulatory application s
Slide 9: 2018 Select Milestones
2018 SELECT MILESTONES Report one-year data from Phase 3 PANORAMA study for the treatment of non-proliferative diabetic retinopathy in patients without diabetic macular EYLEA edema (DME) FDA decision on sBLA for asthma in adult/adolescent patients (target action date of October 20, 2018) Addit
Slide 10: Diabetic Eye Diseases Present Important Opportunities for EYLEA
DIABETIC EYE DISEASES PRESENT IMPORTANT OPPORTUNITIES FOR EYLEA Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Characterized by visual loss due to Characterized by vascular abnormalities edema or swelling in the most important that can lead to profound vision loss, by part of the retina caus
Slide 11: Diabetic Macular Edema (DME) Is an Important Opportunity for EYLEA
DIABETIC MACULAR EDEMA (DME) IS AN IMPORTANT OPPORTUNITY FOR EYLEA 1.5 million adults diagnosed with DME ~750,000 patients have clinically significant macular edema ~200,000 patients are treated ~125,000 (8% of diagnosed) patients receive an anti-VEGF therapy Patients with DME continue to be under-d
Slide 12: Diabetic Retinopathy Without DME Is an Important Related Potential Opportunity for EYLEA
DIABETIC RETINOPATHY WITHOUT DME IS AN IMPORTANT RELATED POTENTIAL OPPORTUNITY FOR EYLEA 3.5 million people in the U.S. are diagnosed with diabetic retinopathy without DME1,2 • Severe, non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) may result in profound v
Slide 13: Praluent: ODYSSEY OUTCOMES Provides Strong Clinical Evidence
PRALUENT® (ALIROCUMAB): ODYSSEY OUTCOMES PROVIDES STRONG CLINICAL EVIDENCE OF PATIENT BENEFIT FROM LONG-TERM THERAPY1 Transformational Study Positive Results Potential Patient Impact ● High risk patients with ACS event ● Primary endpoint met: ● Greatest clinical benefit was seen between 1 and 12 mon
Slide 14: Praluent ODYSSEY OUTCOMES Post Hoc Analysis: All-Cause Death by Baseline LDL-C
PRALUENT® ODYSSEY OUTCOMES POST HOC ANALYSIS: ALL-CAUSE DEATH BY BASELINE LDL-C SUBGROUPS ARR* 1.7% Pinteraction=0.12 <80 mg/dL 80 to <100 mg/dL ≥100 mg/dL HR 0.89 HR 1.03 HR 0.71 (95% CI 0.69, 1.14) (95% CI 0.78, 1.36) (95% CI 0.56, 0.90) *Based on cumulative incidence 14
Slide 15: Praluent ODYSSEY OUTCOMES Efficacy: Subgroup With Baseline LDL-C 100 mg/dL
PRALUENT® ODYSSEY OUTCOMES EFFICACY: SUBGROUP WITH BASELINE LDL-C 100 MG/DL (MEDIAN BASELINE LDL-C 118 MG/DL) Alirocumab Placebo Absolute Endpoint, n (%) HR (95% CI) (N=2814) (N=2815) risk reduction (%) MACE 324 (11.5) 420 (14.9) 3.4 0.76 (0.65, 0.87) CHD death 69 (2.5) 96 (3.4) 1.0 0.72 (0.53, 0.9
Slide 16: Praluent ODYSSEY OUTCOMES Safety (1)
PRALUENT® ODYSSEY OUTCOMES SAFETY (1) Treatment-emergent adverse events, Alirocumab Placebo n (%) (N=9451) (N=9443) Any 7165 (75.8) 7282 (77.1) Serious 2202 (23.3) 2350 (24.9) Laboratory value Alirocumab Placebo ALT >3 ULN, n/N (%) 212/9369 (2.3) 228/9341 (2.4) Creatine kinase >10 ULN, n/N (%) 4
Slide 17: Praluent ODYSSEY OUTCOMES Safety (2)
PRALUENT® ODYSSEY OUTCOMES SAFETY (2) Alirocumab Placebo Event (N=9451) (N=9443) Diabetes worsening or diabetic complications: pts 506/2688 (18.8) 583/2747 (21.2) w/DM at baseline, n/N (%) New onset diabetes; pts w/o DM at baseline, n/N (%) 648/6763 (9.6) 676/6696 (10.1) General allergic reaction, n
Slide 18: Praluent: Committed to Make Praluent Accessible for Patients With Greatest Risk
PRALUENT®: COMMITTED TO MAKE PRALUENT ACCESSIBLE FOR PATIENTS WITH GREATEST HEALTH RISK AND UNMET NEED ● Regeneron and Sanofi High-Risk ● For payers willing to reduce Patients lowered the net price of access barriers for high-risk Praluent in exchange for, patients, companies will straightforward, m
Slide 19: Kevzara (Sarilumab): Launched in Rheumatoid Arthritis; Planning Additional Studies
KEVZARA® (SARILUMAB): LAUNCHED IN RHEUMATOID ARTHRITIS; PLANNING PIVOTAL STUDIES IN ADDITIONAL INDICATIONS • Launch ongoing in rheumatoid arthritis in U.S., EU and Japan • Increased formulary coverage started in January 2018 • FDA approved single-dose pre-filled pen, the only IL-6 inhibitor with an
Slide 20: Regeneron and Sanofi Accelerate and Expand Investment for Cemiplimab and Dupilumab
REGENERON AND SANOFI ACCELERATE AND EXPAND INVESTMENT FOR CEMIPLIMAB AND DUPILUMAB DEVELOPMENT PROGRAMS • Investment in cemiplimab to be increased by ~$1 billion • Companies will continue to equally fund cemiplimab development • The companies will also continue their additional investment in other i
Slide 21: 2018 Financial Guidance
2018 FINANCIAL GUIDANCE1 Non-GAAP Unreimbursed R&D $1,210MM - $1,260MM Non-GAAP SG&A $1,340MM - $1,390MM Sanofi Collaboration Revenue: Reimbursement of Regeneron $455MM - $485MM Commercialization-Related Expenses Effective Tax Rate 13%-16% Capital Expenditures $410MM - $450MM 1) As of August 2nd, 20
Slide 22: Dupilumab: IL-4/IL-13 Blocker With Positive Data in Many Allergic Diseases
DUPILUMAB: AN IL-4/IL-13 BLOCKER WITH POSITIVE DATA IN MANY ALLERGIC DISEASES Atopic Dermatitis Asthma • Approved in U.S., EU and Japan • Efficacy demonstrated in 3 pivotal studies; • Positive data reported in adolescent (ages Oct 20, 2018 FDA target action date 12-17) Phase 3 study; U.S. regulatory
Slide 23: Pediatric Atopic Dermatitis Represents a High Disease Burden
PEDIATRIC ATOPIC DERMATITIS REPRESENTS A HIGH DISEASE BURDEN WITH LIMITED TREATMENT OPTIONS ADOLESCENTS (AGES 12-17 YEARS) PEDIATRICS (AGES 6 MONTHS -11 YEARS) • Positive data reported in Phase 3 AD study; U.S. regulatory • Prevalence of AD is ~10% of U.S. pediatric submission planned for Q3 2018 po
Slide 24: Dupilumab in Asthma: Comprehensive Clinical Program
DUPILUMAB IN ASTHMA: COMPREHENSIVE CLINICAL PROGRAM DEMONSTRATES EFFICACY IN BROAD PATIENT POPULATION • In three pivotal studies (DRI, QUEST, VENTURE) dupilumab reduced exacerbations in both the overall patient population and in patients with eosinophilic phenotype – 46%-70% reductions in overall pa
Slide 25: REGN3500 (IL-33) Clinical Development Underway
REGN3500 (IL-33) CLINICAL DEVELOPMENT UNDERWAY • Role of IL-33 in respiratory disease has been validated by genetic associations (Regeneron Genetics Center®) – Genetic link established to asthma: • Common “gain-of-function” (GOF) variants in IL-33 and its receptor increase the risk of asthma • Rare
Slide 26: Fasinumab: Opportunity for a Novel Class of Non-Opioid Pain Therapies
FASINUMAB: OPPORTUNITY EXISTS FOR A NOVEL CLASS OF NON- OPIOID PAIN THERAPIES • Fasinumab (NGF) presents a novel, non-opioid approach to addressing chronic pain – Partnered with Teva and Mitsubishi Tanabe Pharma (MTPC) outside of the U.S. • Approximately 50 million U.S. adults suffer from significan
Slide 27: Trevogrumab + Garetosmab Demonstrated Significant Increase in Muscle Mass
TREVOGRUMAB (ANTI-GDF8) + GARETOSMAB (ANTI ACTIVIN-A) DEMONSTRATED SIGNIFICANT INCREASE IN MUSCLE MASS AT 8 WEEKS Thigh Muscle Volume, cm3 Trevogrumab + Trevogrumab+ Trevogrumab+ Pbo Trevogrumab Garetosmab Garetosmab Garetosmab Garetosmab Dose ‐ High High Low Mid High N 12 6 6 6 6 12 Week 8 LS Mean
Slide 28: A Multi-Pronged Approach to Immuno-Oncology
A MULTI-PRONGED APPROACH TO IMMUNO-ONCOLOGY CHECKPOINT INHIBITORS BISPECIFIC ANTIBODIES OTHER MODALITIES that block targets such as PD-1 and that can bind two different molecular targets, LAG-3, helping T-cells to recognize and allowing for diverse approaches to targeting and attack cancer cells kil
Slide 29: Pivotal Study in Advanced CSCC Demonstrated High Response Rate
PIVOTAL STUDY IN ADVANCED CSCC DEMONSTRATED HIGH RESPONSE RATE AND DURABLE RESPONSES • ~1M cases of Cutaneous Squamous Cell Carcinoma (CSCC) annually in the U.S. • While most are well-treated with surgery, CSCC results in 3,900 to 8,800 deaths/year in US1 (compared to 9,700 deaths from melanoma) • T
Slide 30: CD20xCD3 Bispecific Antibody (REGN1979): Positive Data in B-Cell Malignancies
CD20XCD3 BISPECIFIC ANTIBODY (REGN1979): POSITIVE DATA OBSERVED IN B-CELL MALIGNANCIES Cancer cell T-cell • REGN1979 monotherapy demonstrated response rates of 50% at highest tested doses in heavily pre-treated/Rituxan- CD20 CD3 refractory NHL1,2 Antibody • Dose escalation ongoing • Manageable safet
Slide 31: Broad Development Program With a Focus on NSCLC
BROAD DEVELOPMENT PROGRAM WITH A FOCUS ON NON-SMALL CELL LUNG CANCER (NSCLC) TARGET CONDITION/DISEASE STUDY STATUS Chemo naïve or experienced, monotherapy Target FDA action date Advanced CSCC cemiplimab of Oct 28, 2018 Monotherapy: cemiplimab vs platinum 1st Line NSCLC ≥ 50% PD-L1 Ongoing doublet Ch
Slide 32: Additional Indications and Combinations Being Studied
ADDITIONAL INDICATIONS AND COMBINATIONS BEING STUDIED TARGET CONDITION/DISEASE STUDY STATUS Cemiplimab combinations with candidates from collaborators Glioblastoma Phase 1/2 (DNA vaccines + cemiplimab; Inovio) Ongoing Renal Cell Carcinoma Phase 1/2 (Oncolytic virus + cemiplimab; SillaJen) Ongoing Sq
Slide 33: Regeneron Genetics Center: Large Scale Integration of Human Genetics
REGENERON GENETICS CENTER (RGC): LARGE SCALE INTEGRATION OF HUMAN GENETICS INTO DRUG DISCOVERY AND DEVELOPMENT CREATING WORLD’S LARGEST SEQUENCING >300,000 + HEALTH INFORMATION >250,000 EXOMES RESOURCES ADDITIONAL SEQUENCED EXOMES TO BE TO DATE SEQUENCED IN 2018 >50 NEW TARGET BIOLOGY PROGRAMS 60+ R
Slide 34: Leading a New Life Sciences Consortium to Build a 'Big Data' Resource
LEADING A NEW LIFE SCIENCES CONSORTIUM TO BUILD AN UNPRECEDENTED, ACCESSIBLE ‘BIG DATA’ RESOURCE • RGC to sequence exomes from 500,000 people by end of 2019; data will be paired with detailed, de-identified health information • All data will be openly available to the global research community • Lar
Slide 35: Inventing Technologies That Address Bottlenecks and Complement Biology
velociHUM INVENTING TECHNOLOGIES A suite of THAT ADDRESS broadly enabling BOTTLENECKS & technologies COMPLEMENT BIOLOGY 35
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