Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — JP Morgan Healthcare Conference 2015
36 slides from Regeneron Pharmaceuticals's conference presentation, Jan 13, 2015
Slide 1: JP Morgan Healthcare Conference
JP Morgan Healthcare Conference January 13, Leonard S. Schleifer, M.D., Ph.D. President and Chief Executive Officer
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: Regeneron's vision to bring new medicines to patients
For over 25 years, Regeneron’s vision has been to build an innovative company that consistently brings new medicines to patients with serious diseases.
Slide 4: Now Is Our Time and It's Just Beginning
NOW IS OUR TIME AND IT’S JUST BEGINNING
Slide 5: A Clear Path Forward
A CLEAR PATH FORWARD GENERATE MAJOR SUBMISSIONS AND/OR APPROVALS YEAR AFTER YEAR TRANSFORM THE MANAGEMENT OF SERIOUS DISEASES: HEART DISEASE, RA, ATOPIC DERMATITIS, ASTHMA AND OTHERS SUPPORT EYLEA AS THE RETINAL THERAPY OF CHOICE & MAINTAIN LEADERSHIP IN RETINAL DISEASE INVEST IN THE NEXT WAVES OF I
Slide 6: And the Engine to Make It a Reality
AND THE ENGINE TO MAKE IT A REALITY… UNMATCHED PIPELINE CULTURE OF INNOVATION PEOPLE SCIENCE & TECH PROWESS
Slide 7: And the Engine to Make It a Reality
AND THE ENGINE TO MAKE IT A REALITY… PIPELINE 17 antibodies across multiple therapeutic areas in late stage CULTURE OF INNOVATION PEOPLE SCIENCE & TECH PROWESS
Slide 8: And the Engine to Make It a Reality
AND THE ENGINE TO MAKE IT A REALITY… PIPELINE 17 antibodies across multiple therapeutic areas in late stage PEOPLE SCIENCE Top Employer for 3 years #5 Most Innovative Company (Forbes) Rapidly growing Commercial team SCIENCE & TECH PROWESS
Slide 9: And the Engine to Make It a Reality
AND THE ENGINE TO MAKE IT A REALITY… PIPELINE 17 antibodies across multiple therapeutic areas 3 in late stage PEOPLE SCIENCE Top Employer for 3 years #5 Most Innovative Company (Forbes) Rapidly growing Commercial team PROWESS VelocImmune® Industrial Regeneron Operations Genetics Center & Supply Bi-s
Slide 10: Late Stage Pipeline: Multiple Potential Regulatory Submissions/Approvals
LATE STAGE PIPELINE: MULTIPLE POTENTIAL REGULATORY SUBMISSIONS/APPROVALS ADDRESSING SERIOUS DISEASES PRALUENT™ (alirocumab) SARILUMAB DUPILUMAB PRALUENT, sarilumab and dupilumab are being developed in collaboration with Sanofi
Slide 11: Unmet Need Remains High in CV Disease
UNMET NEED REMAINS HIGH IN CV DISEASE CV disease causes 17.3M deaths per year1 17.3M Significant driver of U.S. economic costs2 $315B LDL-C contributes to 60% of coronary heart 60% disease and 40% of all ischemic stroke3 24M high-risk patients fail to reach LDL-C goals4 24M (1) WHO. http://who.int/m
Slide 12: Praluent: Significant and Consistent LDL-C Reduction Across All 10 Pivotal Trials
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS LDL-C Change from Baseline at 24 Weeks Dosing Mean Baseline Study Q2W LDL-C (mg/dL) alirocumab Comparator HIGH FH 150 mg 198 46% 7% placebo FH I 75/150 mg(1) 145 49% 9% placebo HeFH FH II 75/150 mg(1) 134 49% 3% place
Slide 13: Praluent: Significant and Consistent LDL-C Reduction Across All 10 Pivotal Trials
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS alirocumab 46% 49% 49% 61% 48% 51% 44-54% 36-51% 45% 48% (1) Per protocol dose increase to 150 mg possible based on pre-specified LDL-C levels.
Slide 14: Praluent: Significant and Consistent LDL-C Reduction Across All 10 Pivotal Trials
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS alirocumab 46% 49% Largest registration program to date Evaluation 49% of 75mg and 150mg Q2W as well 14 trials with ³ 23,500 patients as monthly 61% options Primary endpoint evaluated at 24 weeks Post-hoc data on lowe
Slide 15: Praluent: Safety Profile from ODYSSEY LONG TERM
PRALUENT™: SAFETY PROFILE FROM ODYSSEY LONG TERM % of Patients with Treatment Emergent Adverse Events of Interest alirocumab Placebo (n=1550) (n=788) General allergic reaction events 9.0 9.0 Treatment emergent local injection site reactions 5.8 4.3 Myalgia 4.9 3.0 Neurological events2 4.2 3.9 All ca
Slide 16: Praluent: Critical Launch Preparedness Underway
PRALUENT™: CRITICAL LAUNCH PREPAREDNESS UNDERWAY 2015 PRIORITIES U.S. & EU Regulatory Review FDA Priority Review expected Invest for Successful Launch in 2H15 Manufacturing scale-up; commercial/ field force expansion Present Monthly Dosing Results CHOICE I and CHOICE II data
Slide 17: Sarilumab in Rheumatoid Arthritis: Growing Opportunity; Broad Development Program
SARILUMAB IN RHEUMATOID ARTHRITIS: GROWING OPPORTUNITY; BROAD DEVELOPMENT PROGRAM RA affects up to 70M people worldwide1 Unmet need exists as patients cycle through multiple treatments Biologic monotherapy is an important and growing market segment2 ~2,500 RA patients targeted in SARIL-RA program ST
Slide 18: Sarilumab: Phase 3 Results Show Strong Efficacy at Both Doses
SARILUMAB: PHASE 3 RESULTS SHOW STRONG EFFICACY AT BOTH DOSES ACR RESPONSE AT ACR RESPONSE AT WEEK 24 WEEK 52 ACR ACHIEVING (n=398) % (n=400) (n=399) * p<0.0001 vs. placebo SARIL-RA-MOBILITY Change from Baseline in mTSS Placebo + MTX mTSS 3 IN 2.5 mTSS: Sarilumab Modified 2 70% Total Sharp 150 mg +
Slide 19: Sarilumab: Critical Year with Major Phase 3 Readouts
SARILUMAB: CRITICAL YEAR WITH MAJOR PHASE 3 READOUTS 2015 PRIORITIES Report Results from 3 Phase 3 Trials TNF-IR and monotherapy populations Complete U.S. Submission by Year End
Slide 20: Dupilumab: First-in-Class IL4/IL13 Inhibitor for Allergic Diseases
DUPILUMAB: A FIRST-IN-CLASS IL4/IL13 INHIBITOR WITH POTENTIAL FOR IMPORTANT ALLERGIC DISEASES Moderate-to-Severe Asthma Up to 300M WW affected1 10-20% uncontrolled despite existing therapies2 Moderate-to-Severe Atopic Dermatitis (AD) >5M affected in U.S. & EU3 Widespread lesions; intense itching Sle
Slide 21: Dupilumab: First-in-Class IL4/IL13 Inhibitor for Allergic Diseases
DUPILUMAB: A FIRST-IN-CLASS IL4/IL13 INHIBITOR WITH POTENTIAL FOR IMPORTANT ALLERGIC DISEASES Moderate-to-Severe Asthma Up to 300M WW affected1 10-20% uncontrolled despite existing therapies2 Moderate-to-Severe Atopic Dermatitis (AD) Breakthrough Therapy Designation Chronic Sinusitis with Nasal Poly
Slide 22: Dupilumab: Positive Phase 2 Results Across Key Diseases
DUPILUMAB: POSITIVE PHASE 2 RESULTS ACROSS 3 KEY DISEASES ATOPIC DERMATITIS PHASE 2B (n=380): MEAN PERCENT CHANGE IN EASI/ITCHING EASI SCORE OVER 16 WEEKS REDUCTION IN ITCHING AT 16 WEEKS 0 2 4 6 8 10 12 14 16 0 Pbo 300m 300mg Placebo g QW -25 Q2W (n=61) (n=64) (n=63) -50 300mg Q2W Pruritus 11% 53%
Slide 23: Dupilumab: Balanced Adverse Event Profile in Phase 2 Studies
DUPILUMAB: BALANCED ADVERSE EVENT PROFILE IN PHASE 2 STUDIES TO DATE ATOPIC DERMATITIS PHASE 2B: ASTHMA PHASE 2B: PHASE 2A CSwNP: MOST COMMON AEs MOST COMMON AEs TOP-LINE COMMON AEs Nasopharyngitis: Injection site reaction: Injection site reactions, 18-23% vs. 21% placebo 13-25% vs. 12% placebo naso
Slide 24: Dupilumab: Advance Broad Development Program
DUPILUMAB: ADVANCE BROAD DEVELOPMENT PROGRAM PRIORITIES Execute Phase 3 Adult AD Program; Initiate Pediatric AD Program Launch Phase 3 in Asthma Plan Phase 3 in Chronic Sinusitis with Nasal Polyps Launch Eosinophilic Esophagitis Development Program
Slide 25: Support EYLEA as the Retinal Therapy of Choice
SUPPORT EYLEA® AS THE RETINAL THERAPY OF CHOICE; MAINTAIN LEADERSHIP IN RETINAL DISEASE ® EYLEA will continue to drive top-line growth, supported by a growing body of clinical evidence
Slide 26: EYLEA: Positioned for Continued Growth
EYLEA®: POSITIONED FOR CONTINUED GROWTH EYLEA® CONTINUED GROWTH U.S. NET SALES Now approved for major retinal diseases in U.S. & EU NIH-sponsored PROTOCOL T study should support DME growth Granted Breakthrough Therapy designation by U.S. FDA for treatment of diabetic retinopathy in patients with DME
Slide 27: Advancing Next-Generation Retinal Therapies
ADVANCING NEXT-GENERATION RETINAL THERAPIES PDGFR-B inhibitor/EYLEA co-formulation moving to Phase 2 in 2015 Regeneron owns 100% U.S. commercial rights ANG2 inhibitor/EYLEA co-formulation in Phase 1 AVALANCHE Biotech collaboration
Slide 28: Invest in Next Waves of Innovation
INVEST IN NEXT WAVES OF INNOVATION To realize our vision, we must continually refuel the pipeline and advance science and technology innovation
Slide 29: A Broad and Sustainable Pipeline
A BROAD AND SUSTAINABLE PIPELINE ANTIBODY CANDIDATES PHASE 1 PHASE 2 PHASE 3 PRALUENT™ (alirocumab) Hypercholesterolemia Sarilumab (REGN88) Rheumatoid arthritis, non-infectious uveitis Dupilumab (REGN668) Atopic dermatitis, asthma, chronic sinusitis with nasal polyps REGN1033 (GDF8) Skeletal muscle
Slide 30: Accelerating Clinical Programs: RSV, NGF
ACCELERATING CLINICAL PROGRAMS: RSV, NGF RSV ANTIBODY (PHASE 1) MOST COMMON CAUSE OF BRONCHIOLITIS AND PNEUMONIA IN U.S. CHILDREN <11 Leading cause of infant hospitalization Phase 1 results expected in 2015 Potential for less frequent dosing EXPECT TO MOVE TO PHASE 3 in 2015 FASINUMAB, NGF ANTIBODY
Slide 31: Advancing Multiple Approaches in Immuno-Oncology
ADVANCING MULTIPLE APPROACHES IN IMMUNO-ONCOLOGY IMMUNO-ONCOLOGY Deep research and early development focus: bi-specifics, checkpoint inhibitors and ADCs Phase 1: CD20/CD3 bi-specific antibody for blood cancers IND Filed in Q414: anti-PD1 for cancer BI-SPECIFICS CHECKPOINT INHIBITORS KILLING Tumor T-
Slide 32: Rapid Progress with Regeneron Genetics Center
RAPID PROGRESS WITH REGENERON GENETICS CENTER Unprecedented Speed, Scale and Integration in Genetic Research
Slide 33: 2015 Financial Guidance
2015 FINANCIAL GUIDANCE1 Non-GAAP Unreimbursed R&D: $525MM—$575MM Non-GAAP SG&A: $650MM—$725MM This includes REGN incurred commercial-related expenses for Sanofi collaboration antibodies Cash Tax2 as a % of Non-GAAP Pre-tax Income: 10%—20% Capital Expenditures: $650MM—$800MM 1) The 2015 guidance doe
Slide 34: Important Data, Regulatory and Operational Milestones Throughout 2015
IMPORTANT DATA, REGULATORY AND OPERATIONAL MILESTONES THROUGHOUT 2015 PRALUENT™ U.S. & EU regulatory review & launch Sarilumab Phase 3 readouts & U.S. submission Expansion of dupilumab Phase 3 program RSV, NGF, GDF8 antibodies clinical progress Protocol T DME publication; EYLEA® WW growth Continued
Slide 35: Now Is Our Time
NOW IS OUR TIME AND IT’S JUST BEGNNING
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