Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Corporate Update (January 2019)
28 slides from Regeneron Pharmaceuticals's corporate update, Jan 7, 2019
Slide 1: Note regarding Forward-Looking Statements and Non-GAAP Financial Measures
2 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 ev
Slide 2: Proven Innovation: Where We Are
Proven Innovation WHERE WE ARE
Slide 3: Key Milestones and Achievements
4 KEY milestones and achievements RESEARCH & DEVELOPMENT COMMERCIAL Key Regulatory Approvals* LIBTAYO Advanced CSCC DUPIXENT Moderate-to-severe Asthma EYLEA Q12 week dosing in wAMD after one year of effective therapy Key Regulatory Filings EYLEA Diabetic Retinopathy DUPIXENT Atopic Dermatitis in ado
Slide 4: EYLEA: Strengthening Market Leadership Position
EYLEA®: Strengthening market leadership position U.S. Net Sales†, $Billion Building on leadership position in wAMD and diabetic eye disease, both of which are increasing in prevalence Label expansions and line extensions Innovating next generation therapeutics Our strategy is to maximize EYLEA growt
Slide 5: EYLEA: Leading Ophthalmology Innovation
EYLEA®: Leading ophthalmology innovation 6 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 prac
Slide 6: Dupixent: Building Leadership in Atopic Dermatitis and Launching in Asthma
Dupixent ®: Building leadership in ATOPIC DERMATITIS and Launching in Asthma 7 2018 Weekly New to Brand (NBRx)* Atopic Dermatitis: Practice-Changing Advance in Management In the U.S., less than 15% of adult AD patients with the greatest need have used DUPIXENT High persistence and compliance indicat
Slide 7: DUPIXENT: Delivering on the Pipeline in a Product Promise
DUPIXENT ®: DELIVERING on The “pipeline in a product” promise 8 Atopic Dermatitis Approved in Adults Moderate-to-Severe Asthma Approved in Adults and Adolescents Pediatric Asthma (6-11 years) Ph3 ongoing Food Allergies Ph2 in Peanut Allergy initiated; more planned Airborne Allergies Ph2 in Grass All
Slide 8: LIBTAYO: New Hope for Patients with Advanced CSCC
9 LIBTAYO®: new hope for patients with advanced CScc LIBTAYO is now the only approved treatment option for advanced CSCC, a life-threatening condition June 2018 NEJM publication details pivotal Phase 2 study results in 59 metastatic CSCC patients: Primary endpoint: 47.5% Overall Response Rate by ind
Slide 9: 2019 Goals and Milestones
2019 Goals and milestones KEY REGULATORY APPROVALS & SUBMISSIONS 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 DUPIXENT FDA decision on sBLA for expanded Atopic Dermatitis indica
Slide 10: 2019 Financial Guidance
11 2019 financial Guidance* * As of January 7, 2019. The guidance does not assume the completion of any significant business development transaction that had not been completed as of the date of the guidance. Regeneron does not undertake any obligation to update publicly any financial projection or
Slide 11: Reconciliation of Full Year 2019 Non-GAAP to GAAP Financial Guidance
12 Reconciliation of full year 2019 Non-GAAP to GAAP Financial guidance * Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers Projected Range (in millions) Low High GAAP unreimbursed R&D* $ 1,855 $ 2,000 R&D: Non-cash share
Slide 12: Portfolio & Pipeline
PORTFOLIO & pipeline PHASE 1 PHASE 2 REGN-EB3 (Ebola virus) REGN3767 (LAG-3) REGN1908-1909 (Feld1) Cemiplimab* (PD-1) Sarilumab* (IL-6R) Dupilumab* (IL-4R) Cemiplimab* (PD-1) Fasinumab† (NGF) Aflibercept (VEGF Trap) Dupilumab* (IL-4R) Alirocumab* (PCSK9) Pozelimab (C5) Cemiplimab* (PD-1) REGN4461 (L
Slide 13: Adolescent and Pediatric Atopic Dermatitis: High Disease Burden
Adolescent and pediatric atopic dermatitis – high disease burden with limited treatment options 14 Patient had significantly improved overall disease severity, skin clearing and reduced itching IGA: Investigator’s Global Assessment, EASI: Eczema Area and Severity Index Overall rate of treatment-emer
Slide 14: Driven by Discovery: Regeneron's IO Strategy
Driven by discovery Regeneron’s IO Strategy
Slide 15: IO Strategy Built on 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 4,945 patents issued over the last 10 years Rapid, automated and high-scale manipulation of mouse DNA to identify and validate therapeutic targets Geneticall
Slide 16: LIBTAYO: The Foundation of Our IO Strategy
LIBTAYO®: the Foundation of Our IO strategy 17 Combinations DEVELOPMENT STRATEGY CSCC: THE FIRST OF MANY POTENTIAL APPROVALS Additional Solid & Liquid Tumor Indications Pediatric Glioblastoma (GBM) – Ph1/2 initiated 1L Classical Hodgkin Lymphoma – Ph1 anticipated in 2019 HPV Positive Cancers 2L Cerv
Slide 17: Regeneron's IO Strategy Connects Multiple Individual Pieces
LIBTAYO 18 Regeneron’s IO strategy connects multiple individual pieces Kinase Inhibitors CD3 bispecifics Costimulatory bispecifics Chemo Vaccines Tcell Rx GITR LAG-3 CTLA-4
Slide 18: Logically and Rationally into a Cohesive Whole
GITR LIBTAYO 19 Logically and rationally into a cohesive whole ...like pieces in a puzzle, bringing order to chaos Kinase Inhibitors CD3 bispecifics Costimulatory bispecifics Chemo Vaccines Tcell Rx LAG-3 Regeneron’s IO puzzle is evolving and not yet complete; based on science and experimental data,
Slide 19: CD3 and Costimulatory Bispecifics: Off-the-Shelf CAR-T-like Cancer Killers
20 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 CD3ζ PD-1 scFv Costim Signal 2 Signal 1 + Costimulatory bispecific CD3 bispecific PD-L1/2 Signal 1 Signal 2 + Costim Tumor Target CD3γ CD3ε CD3ε CD3δ T
Slide 20: LIBTAYO Blocks the Stop Signal
21 CAR-T CD3ζ PD-1 scFv Costim Signal 2 Signal 1 + Costimulatory bispecific CD3 bispecific PD-L1/2 Signal 1 Signal 2 + Costim CD3γ CD3ε CD3ε CD3δ TCRα TCRβ CD3ζ CD3ζ CAR-T Mechanism Bispecific/Costimulatory Mechanism PD-1 PD-L1/2 Tumor Target Tumor Target Tumor Target LIBTAYO LIBTAYO blocks the stop
Slide 21: Adding Costims Shows Synergy in Preclinical Tumor Models
anti-PD-1 22 Adding COSTIMs to cd3 BISPECIFICs or to ANTI-PD-1 shows synergy in preclinical tumor models Unlike superagonist CD28 mAbs, our CD28 bispecifics have no toxicity, and little or no activity on their own, but when clustered on cells expressing their target, activate signal 2 and synergize
Slide 22: Additional Strategic Opportunities
Anti-PD-1 Responsive Tumors TCR binds tumor MHC/peptide Anti-PD-1 Unresponsive Tumors TCR does not recognize tumor MHC/peptide Additional Strategic Opportunities Block T cell inhibition with LIBTAYO (anti-PD-1) monotherapy Enhance with combinations: chemotherapy, other immune modulators (e.g., CTLA-
Slide 23: REGN1979 CD20xCD3 Bispecific Demonstrates High ORR/CR
Putting theory into practice: REGN1979, Our exclusively-owned cd20xcd3 bispecific antibody, demonstrates high orr/cr In our dose escalation Ph1 study, treatment with >5 mg of REGN1979 demonstrated 100% ORR and 80% CR in 10 pts with R/R FL At higher doses in R/R DLBCL we are seeing response rates tha
Slide 24: Broadening Our Immuno-Oncology Pipeline
BROADENING OUR IMMUNO-ONCOLOGY PIPELINE Approved LIBTAYO CSCC LIBTAYO Potential Indications LIBTAYO NSCLC, Cervical, BCC, Pediatric LIBTAYO + REGN1979 (CD20xCD3) B-Cell NHL Clinical Development REGN1979 (CD20xCD3) B-Cell NHL REGN5458 (BCMAxCD3) Multiple Myeloma REGN4018 (MUC16xCD3) Ovarian Cancer RE
Slide 25: Many Companies Can Do One Thing...
PD-1/L1 PD-1/L1 MANY COMPANIES CAN DO ONE THING... CD3 bispecifics Costimulatory bispecifics CTLA-4, LAG-3, GITR 26
Slide 26: Few Can Do Many Things
PD-1/L1 PD-1/L1 few can do many things is one of the few CD3 bispecifics Costimulatory bispecifics CTLA-4, LAG-3, GITR 27
Slide 27: Few Can Do Many Things
..-FEW CAN DO MANY THINGS PD-1/L1 REGENERON is one of the few CD3 bispecifics REGENERON
Slide 28: Thank You
THANK YOU
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