Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — J.P. Morgan 34th Annual Healthcare Conference January 2016
31 slides from Regeneron Pharmaceuticals's conference presentation, Jan 12, 2016
Slide 1: 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 2: Dr. Alfred G. Gilman: 1941-2015
Dr. Alfred G. Gilman: 1941--2015 3
Slide 3: Regeneron is committed to consistently bringing new medicines to patients
RegenEron is committed to consistently and repeatedly bringing new medicines to patients with serious diseases LEADING TECHNOLOGY VELOCI-SUITE BISPECIFICS GENOMICS INNOVATIVE CULTURE TOP BIOPHARMA EMPLOYER BROAD PIPELINE 5 LATE-STAGE Programs DRIVEN BY DISCOVERY DIVERSE EARLY R&D SCIENCE AT THE CORE
Slide 4: A broad and compelling pipeline
A broad and compelling pipeline 5 Program partnered with Sanofi Program partnered with Bayer ex-U.S. ANTIBODY CANDIDATES PRALUENT® (ALIROCUMAB) Hypercholesterolemia SARILUMAB Rheumatoid arthritis DUPILUMAB Atopic dermatitis, asthma FASINUMAB (NGF) Pain REGN2222 (RSV) RSV DUPILUMAB Nasal polyps w. as
Slide 5: EYLEA: leadership in the retinal franchise
EYLEA is the market-leading product among FDA-approved anti-VEGF agents EYLEA full year U.S. net sales of $2.68 billion* EYLEA global sales of over $4 billion* Phase 3 study of EYLEA in Diabetic Retinopathy to begin in 1Q16 Diabetic Retinopathy Clinical Research Network’s Protocol-W study in DR expe
Slide 6: Praluent: Approved in the U.S. and EU
Praluent®: Approved in the U.S. and EU in high cardiovascular risk hypercholesterolemic patients* 7 Approved in EU on September 25, 2015 Indicated in adults with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidaemia, as an adjunct to diet in patients unable to reach their LDL-C
Slide 7: Praluent Launch underway: education
Praluent® Launch underway 8 Physician and patient education ongoing through field force efforts, medical conferences, publications, advertising Two approved doses—75 mg and 150 mg—resonating well with physicians Education Access Outcomes Study Global launch Building awareness and education 75 mg dos
Slide 8: Praluent Launch underway: access
Praluent® Launch underway 9 Sampling, bridging, and patient assistance programs through launch period Praluent coverage for ~150 MM lives in the U.S. Stringent utilization management criteria Contract rebating occurring Parity access with Express Scripts, Prime Therapeutics* Exclusive status with Un
Slide 9: Praluent Launch underway: global launch
Praluent® Launch underway 10 Drug is available in Germany, UK, and Nordic Countries* Expect Italy, Spain, France, Canada, and Japan to launch in 2016 Pricing negotiations are ongoing in many EU countries Education Access Outcomes Study Global launch Global launch ongoing *Not yet on national formula
Slide 10: Praluent Launch underway: ODYSSEY OUTCOMES study
Praluent® Launch underway 11 ODYSSEY OUTCOMES study fully enrolled In 2016, expect interim futility analysis when approximately 50% of events have occurred and potentially also when 75% (for futility and overwhelming efficacy) of the targeted number of primary events have occurred Additional details
Slide 11: Sarilumab for Rheumatoid Arthritis
Sarilumab For Rheumatoid Arthritis FDA action date of October 30, 2016 Positive Phase 3 data demonstrated efficacy in methotrexate-inadequate responder (IR) and difficult-to-treat TNF-IR populations Phase 3 MONARCH study data of sarilumab vs. adalimumab expected in 2H16 Launch preparation underway –
Slide 12: Dupilumab: A Pipeline in a Product
Dupilumab: A Pipeline in a Product DUPILUMAB Nasal polyps (Phase 2) Eosinophilic esophagitis (Phase 2) Other allergic, IL4/13 mediated diseases Asthma Phase 3 Atopic dermatitis Phase 3 Additional Indications 13
Slide 13: Dupilumab: major unmet medical need in Atopic Dermatitis
Dupilumab: major unmet medical need in Atopic Dermatitis (AD) Approximately 1 million adults estimated to have uncontrolled, moderate-to-severe atopic dermatitis in the U.S. Only topical therapies approved by FDA (topical glucocorticoids, calcineurin inhibitors) Systemic immuno-suppressants (e.g. cy
Slide 14: Dupilumab AD: Phase 2b Efficacy
Parameter Placebo 300mg Q2W 300mg QW % EASI-501 (50% improvement) 29.5% 78.1% 82.5% % EASI-751 (75% improvement) 11.5% 53.1% 60.3% % EASI-901 (90% improvement) 3.3% 29.7% 36.5% % IGA Responders2 1.6% 29.7% 33.3% Phase 2b Study in AD – Responder Analyses at 16 Weeks p < 0.0001 vs placebo for all para
Slide 15: Dupilumab AD: Illustrative example of an IGA responder
Dupilumab AD: ILLUSTRATIVE EXAMPLE OF AN IGA RESPONDER FROM P2B TRIAL Images of patient before and after receiving dupilumab therapy for atopic dermatitis Images from actual patient who received dupilumab in a Phase 2 clinical study. Results may vary. In this clinical study, all doses of dupilumab s
Slide 16: Dupilumab AD: Illustrative example of an IGA responder (post-treatment)
POST-TREATMENT Dupilumab AD: ILLUSTRATIVE EXAMPLE OF AN IGA RESPONDER FROM P2B TRIAL Images of patient before and after receiving dupilumab therapy for atopic dermatitis Images from actual patient who received dupilumab in a Phase 2 clinical study. Results may vary. In this clinical study, all doses
Slide 17: Dupilumab AD: Safety Findings
Nasopharyngitis, the most common adverse event, balanced across dupilumab treatment groups vs. placebo Headache and injection site reactions more frequent with dupilumab Ongoing follow-up period of 16 weeks after treatment 18 Phase 2b Study in Moderate-to-Severe Atopic Dermatitis (Safety Data, N=380
Slide 18: Dupilumab AD: LIBERTY SOLO and CHRONOS Study Design
Dupilumab AD: LIBERTY SOLO and CHRONOS Study Design 19 Primary endpoint: Percentage of patients with both IGA 0 to 1 and reduction from baseline of >2 points at week 16 SOLO 1 and SOLO 2 Study Design CHRONOS Study Design Primary endpoint: Percentage of patients with both IGA 0 to 1 and reduction fro
Slide 19: Dupilumab Asthma: Unmet need despite existing therapies
DUPILUMAB ASTHMA: UNMET NEED DESPITE EXISTING THERAPIES Estimated that approximately 26 million people are affected by asthma in the U.S. Despite therapy with ICS/LABA, asthma is not adequately controlled in 5% to 10% of the patients1 Approximately 1.7 million patients have have moderate-to-severe,
Slide 20: Dupilumab Asthma: Efficacy seen in all patient subsets
The annualized rate of asthma exacerbation events (e.g. LOAC, severe exacerbation) was analyzed using a negative binomial regression model. The model included the total number of events occurring during the double-blind treatment period as the response variable, with treatment group, pooled countrie
Slide 21: Dupilumab: Safety profile in uncontrolled persistent asthma
Injection Site Reactions Upper Respiratory Tract Infections Headache Nasopharyngitis Bronchitis Phase 2b Study in Uncontrolled Persistent Asthma – Common AEs* *More than 5% of patients in any treatment group by Preferred Term (included also: back pain, cough, influenza, sinusitis, and oropharyngeal
Slide 22: Dupilumab: Phase 3 in Asthma
DUPILUMAB: PHASE 3 IN ASTHMA 23 Primary endpoints: Absolute change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at 12 weeks and annualized rate of severe exacerbation events at 52 weeks Dupilumab 300 mg Q2W Placebo N=1638 Dupilumab 200 mg Q2W Primary endpoints at
Slide 23: Fasinumab: Phase 3 study in osteoarthritis pain
Fasinumab (NGF mAb) presents a novel, non-opioid approach to addressing chronic pain Osteoarthritis (OA) estimated to affect about 25 million adults in the U.S., with many inadequately served by current therapies* Based on discussions with the FDA, Phase 3 trials (>16 weeks) expected to begin in 1H1
Slide 24: REGN2222: Phase 3 in Respiratory Syncytial Virus
REGN2222: PHASE 3 IN RESPIRATORY SYNCYTIAL VIRUS (RSV) 25 1 in 5 infants <6 months will require medical attention for RSV infection Hospitalization, emergency room or clinic visits Current guidelines restrict use of only approved prophylactic to infants born before 29 weeks gestation, infants with b
Slide 25: Building a strong immuno-oncology pipeline
BUILDING A STRONG IMMUNO-ONCOLOGY PIPELINE Bispecific platform has potential to have significant impact CD20XCD3* enrollment continues with preliminary evidence of activity at very low doses (<1/100 dose of approved CD20 antibody), initial data expected in 2016 Multiple additional bispecific antibod
Slide 26: Regeneron Rapid Response: leveraging VelociSuite technologies
REGENERON RAPID RESPONSE: LEVERAGING CORE VELOCISUITE® TECHNOLOGIES Rapid Response enables Regeneron to compress time for discovery and preclinical validation from years to months 27 MERS Identification and validation of Spike-protein blocking antibodies Phase 1 studies planned for 2H16 EBOLA Identi
Slide 27: Regeneron Genetics Center
Regeneron genetics center: unprecedented speed, scale & integration 28 100,000 ~100,000 DOZEN >95% EXOMES SEQUENCED TO DATE ADDITIONAL EXOMES TO BE SEQUENCED IN 2016 POTENTIAL NEW DRUG TARGETS IDENTIFIED RESEARCH PARTNERS OF GENES WITH IDENTIFIED LOF CARRIER(S) MULTIPLE EXISTING TARGETS VALIDATED NU
Slide 28: 2016 Financial guidance
2016 Financial guidance1 29 ACTIVITY GUIDANCE Non-GAAP Unreimbursed R&D $875MM - $950MM Non-GAAP SG&A This includes REGN incurred commercial-related expenses for Sanofi collaboration antibodies $925MM - $1000MM Cash Tax2 as a % of Non-GAAP Pre-tax Income Includes one-time ~$222 million tax payment r
Slide 29: Upcoming Milestones in 2016
Upcoming Milestones in 2016 30 EYLEA + PDGF: Readout from Phase 2 study EYLEA + ANG2: Initiation of Phase 2 study EYLEA: Initiation of Phase 3 study in diabetic retinopathy Praluent®: Ongoing launches worldwide Praluent®: Interim analyses from ODYSSEY OUTCOMES study Sarilumab: Regulatory review and
Slide 30: J.P. Morgan 34th Annual Healthcare Conference January 2016
J.P. MORGAN 34TH ANNUAL HEALTHCARE CONFERENCE JANUARY 2016
Slide 31: Regeneron
REGENERON J.P. MORGAN 3474 ANNUAL HEALTHCARE CONFERENCE JANUARY 2016
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