Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (January 2018)
35 slides from Regeneron Pharmaceuticals's investor presentation, Jan 8, 2018
Slide 1: Safe Harbor Statement circa 1988
Safe Harbor Statement circa 1988 2 Regeneron is a risky investment. That we hope will pay off handsomely!
Slide 2: Note regarding forward-looking statements and non-GAAP financial measures
Note regarding FORWARD-LOOKING STATEMENTs and non-gaap financial measures 3 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 ev
Slide 3: The early days
The early days ATING NEURONS Founded by physician-scientists 30 years ago, our science-driven approach has resulted in six FDA-approved medicines and numerous product candidates in a range of diseases, including asthma, pain, cancer and infectious diseases. 0 products in development Focused on genet
Slide 4: Then & now
THEN & now 1988 2018 5 Still innovating, still focused on genetics ~6,000 people 6 approved medicines, 15 candidates in clinical development, all from our own labs Just getting started
Slide 5: Combining science and technology to improve patients' lives
Combining Science and technology to improve patients’ lives 6 Use biology and genetics to identify & validate targets Invent scalable, cutting-edge technology to empower biology Improve patients’ lives Follow the science and unmet need to create a dynamic pipeline Inventing tools and technologies (e
Slide 6: Fostering a culture of scientific excellence
Fostering a culture of scientific excellence 7 Named #1 top global biopharmaceutical employer FOR THE FIFTH TIME TOP 10 SINCE 2013 2017 300 top Scholars to be announced tomorrow! Over 50% of senior scientists have been with the company for more than a decade
Slide 7: Robust pipeline across many therapeutic areas
Robust pipeline across many therapeutic areas 8 This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described her
Slide 8: Strong pipeline and operational execution in 2017
Strong pipeline and operational execution in 2017 9 CLINICAL & REGULATORY PROGRESS EYLEA® superior to laser in proliferative diabetic retinopathy study (CLARITY) KEVZARA® approved for rheumatoid arthritis in U.S., EU and Japan DUPIXENT® approved for moderate-to-severe atopic dermatitis in U.S. and E
Slide 9: 2017: EYLEA highlights
2017: EYLEA® (aflibercept) Injection highlights 10 2017 U.S. EYLEA net sales were ~$3.7Bn* 2017 ex-U.S. EYLEA net sales expected to be in excess of $2Bn*† EYLEA continued to be the market-leading product among FDA-approved anti-VEGF agents for its approved indications EYLEA superior to laser in prol
Slide 10: Dupixent: Launch in atopic dermatitis progressing well
Dupixent®: Launch in atopic dermatitis progressing well 11 Strong prescription trajectory with >8,000 healthcare providers having written a prescription for DUPIXENT On average, ~750 prescriptions/week written On average, ~500 new patients/week are dispensed drug High patient and physician satisfact
Slide 11: Anticipated clinical and regulatory highlights for 2018
Anticipated CLINICAL & REGULATORY highlights for 2018 12 EYLEA Phase 3 data from diabetic retinopathy study (PANORAMA) EYLEA FDA submission of sBLAs for diabetic retinopathy and pre-filled syringe EYLEA FDA regulatory decision for Q12W dosing in wet-AMD Dupilumab FDA regulatory decision in asthma in
Slide 12: Important pipeline advances expected in 2018
Important pipeline advances expected in 2018 13 Product candidates in clinical development, all discovered at Regeneron Product candidates expected to enter clinical development Regulatory submissions and new/expanded indications Programs in late-stage clinical development 2018 15 4-6 5 17
Slide 13: Diabetic eye diseases present important opportunities for EYLEA
Diabetic eye diseases present important opportunities for eylea 14 Diabetic Retinopathy Diabetic Macular Edema Characterized by vascular abnormalities that can lead to profound vision loss, by causing edema, hemorrhage, or vascular proliferation Characterized by visual loss due to edema or swelling
Slide 14: Diabetic macular edema is an important opportunity for EYLEA
Diabetic macular edema (DME) is an important opportunity for EYLEA 15 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 Takeaway text Patients with DME conti
Slide 15: Diabetic retinopathy without DME is an important related opportunity
Diabetic retinopathy without dme is an important related opportunity for EYLEA 16 Severe, non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) may result in profound vision loss and represent a potential opportunity for EYLEA The majority of people with PDR are
Slide 16: Praluent: topline data from ODYSSEY Outcomes expected 1Q18
Topline data from 18,000 patient cardiovascular outcomes study expected 1Q18 Regulatory U.S. and EU submissions expected 3Q18 Committed to helping patients receive access to PRALUENT® Praluent®: topline Data from odyssey outcomes expected in 1Q18 17
Slide 17: Kevzara: launched in rheumatoid arthritis; planning pivotal studies
Launch ongoing in rheumatoid arthritis in U.S. and EU Increased formulary coverage starting January 2018 Studies planned in additional indications Giant Cell Arteritis (U.S. prevalence >228,000)1 Polymyalgia Rheumatica (U.S. prevalence ~711,000)1 Kevzara®: launched in rheumatoid arthritis; Planning
Slide 18: Regeneron and Sanofi accelerate and expand investment for cemiplimab and dupilumab
Regeneron and Sanofi Accelerate and Expand Investment for Cemiplimab and Dupilumab Development Programs 19 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 immu
Slide 19: 2018 Financial guidance
Non-GAAP Unreimbursed R&D Non-GAAP SG&A Sanofi Collaboration Revenue: Reimbursement of Regeneron Commercialization-Related Expenses Effective Tax Rate Capital Expenditures 2018 Financial guidance1 20 As of January 8, 2018. The guidance does not assume the completion of any significant business devel
Slide 20: 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 21 Eosinophilic Esophagitis Positive Phase 2 proof-of-concept data reported Phase 3 studies to be initiated in 2018 Approved in U.S. and Europe for atopic dermatitis Studies ongoing in pediatric populations Asthma: Efficac
Slide 21: Pediatric atopic dermatitis represents a high disease burden with limited treatment options
Dupixent is approved for adult patients with moderate-to-severe atopic dermatitis (AD), with average improvement in EASI score of ~70%-80% Prevalence of AD is ~10% of U.S. pediatric population1 1%–2% of these pediatric AD patients have severe disease2,3,4, with up to more than 50% of their skin surf
Slide 22: Dupilumab in asthma: comprehensive clinical program demonstrates efficacy
Dupilumab in asthma: comprehensive clinical program demonstrates efficacy in broad patient population 23 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 pat
Slide 23: Dupilumab: potential in indications beyond atopic dermatitis and asthma
Dupilumab: Potential in indications beyond atopic dermatitis and asthma 24 Nasal Polyps Positive Phase 2 proof-of-concept data reported Both Phase 3 studies fully enrolled COPD Planning on initiating Phase 3 program in 2018 Eosinophilic Esophagitis Positive Phase 2 proof-of-concept data reported Pla
Slide 24: 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 “loss-of-function” (LOF) variants in IL-33 decrease risk
Slide 25: Anti-Activin-A + trevogrumab demonstrated significant increase in muscle mass
Regeneron scientists identified Activin-A as a second “myostatin” that appears to be a more important regulator of muscle mass in primates The addition of anti-Activin-A (REGN2477) to anti-GDF8 (REGN1033, trevogrumab) in healthy volunteers, resulted in: Dose-dependent increase in thigh muscle volume
Slide 26: A multi-pronged approach to immuno-oncology
A multi-pronged approach to immuno-oncology 27 Cemiplimab and REGN3767 antibodies in clinical development Cemiplimab in development as backbone for mono- and combination therapy Additional targets in development, including CTLA-4 OTHER MODALITIES BISPECIFIC ANTIBODIES that can bind two different mol
Slide 27: Pivotal study in advanced cSCC demonstrated high response rate
Phase 2 study results in 82 patients with metastatic and locally advanced disease demonstrated Primary endpoint: 46.3% ORR by independent review 32 of 38 responses ongoing (with ³ 6 months follow-up) Safety profile generally consistent with approved anti-PD-1 drugs pivotal study in advanced cscc dem
Slide 28: Pivotal study in advanced cSCC demonstrated high response rate
pivotal study in advanced cscc demonstrated high response rate and durable responses 29 U.S. and EU regulatory submissions expected 1Q18 Phase 2 study results in 82 patients with metastatic and locally advanced disease demonstrated Primary endpoint: 46.3% ORR by independent review 32 of 38 responses
Slide 29: CD20xCD3 bispecific (REGN1979): positive data in B-cell malignancies
CD20XCD3 Bi-specific (REGN1979): positive data observed in b-cell malignancies 30 FULLY HUMAN, WITH MINIMAL ENGINEERING1 REGN1979 resembles a full-length human antibody, engineered to minimize risk of undesired immune activity and to enhance its stability in the body. DESIGNED FOR SCALE A small chan
Slide 30: Multiple registration studies underway with cemiplimab
Developing a portfolio of immuno-oncology therapies: Multiple Registration studies underway with cemiplimab 31 All therapies are investigational. Safety and efficacy of these investigational products have not been evaluated by any regulatory authority. TARGET CONDITION/DISEASE STUDY STATUS Advanced
Slide 31: Multiple studies of cemiplimab combinations with novel agents
Developing a portfolio of immuno-oncology therapies: Multiple studies OF cemiplimab Combinations with novel agents 32 All therapies are investigational. Safety and efficacy of these investigational products have not been evaluated by any regulatory authority. TARGET CONDITION/DISEASE STUDY STATUS Ce
Slide 32: Regeneron Genetics Center: speed, scale and integration of human genetics
Regeneron genetics center (RGC): WORLD-CLASS speed, scale & integration of Human Genetics into Drug development PROCESS CREATING WORLD’S LARGEST SEQUENCING + HEALTH INFORMATION RESOURCES 60 RESEARCH PARTNERS 250,000+ EXOMES SEQUENCED TO DATE >250,000 ADDITIONAL EXOMES TO BE SEQUENCED IN 2018 MULTIPL
Slide 33: RGC to sequence exomes from 500,000 people by end of 2019
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 Largest database of its kind may have profound impact on human health Additional collaborators expected LE
Slide 34: VelociHum: inventing technologies that address bottlenecks
35 velociHUM Inventing technologies that address bottlenecks & complement biology A suite of broadly enabling technologies
Slide 35: Inventing technologies that address bottlenecks & complement biology
INVENTING TECHNOLOGIES A suite THAT ADDRESS faa BOTTLENECKS & teehneogis COMPLEMENT BIOLOGY REGENERON
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