Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (June 2020)
27 slides from Regeneron Pharmaceuticals's investor presentation, June 2020
Slide 1: Corporate Presentation June 2020
® C O R PO RAT E PR ESEN TAT ION JUNE 2020 ®
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: Solid Execution Despite Initial Impact from COVID-19
SOLID EXECUTION DESPITE INITIAL IMPACT FROM COVID-19 1Q20 Top- and Bottom-line Growth Revenues of $1.83Bn, +33% y/y Non-GAAP EPS** of $6.60, +48% y/y EYLEA® U.S. net product sales of $1.17Bn, +9% y/y Dupixent® global net product sales* of $855MM, +129% y/y Significant Pipeline Advancements / COVID-1
Slide 4: Regeneron's Near-Term Growth Drivers
REGENERON’S NEAR-TERM GROWTH DRIVERS Specialized growth EYLEA Dupixent* Oncology opportunities: • Execute in wet AMD and • Transform the treatment • Realize potential Fasinumab^ (NGF) diabetic eye diseases of Type 2 inflammatory for best-in-class Osteoarthritis pain • Maximize DR and pre- diseases i
Slide 5: EYLEA: Strengthening Market Leadership Position
EYLEA®: STRENGTHENING MARKET LEADERSHIP POSITION Net Product Y/Y EYLEA $1.22 Sales Change $1.19 $1.17 U.S. $1.17Bn +9% $1.16 1Q20 Global* $1.85Bn +6% $1.08 $1.07 $1.02 • COVID-19 impact on EYLEA sales $0.98 $0.99 o Greater impact on patients with diabetic eye disease than on patients with wet AMD o
Slide 6: Dupixent: Strong Execution Across Multiple Indications
DUPIXENT®: STRONG EXECUTION ACROSS MULTIPLE INDICATIONS 2,500 Adolescent AD Launch $176 2,000 Asthma US ROW Launch $146 Branded AD $125 1,500 DTC TV $103 1,000 $71 $679 $60 $605 $43 $508 $455 $28 500 $303 $15 $259 $181 $220 CRSwNP $117 Launch 0 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20 Net Produc
Slide 7: Dupixent: Delivering on the Pipeline in a Product Promise
DUPIXENT ®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE Moderate-to-Severe Atopic Dermatitis ✓ Approved (6+ years) US APPROVED Moderate-to-Severe Asthma ✓ Approved in Adults and Adolescents (12+ years) INDICATIONS* Chronic Rhinosinusitis with Nasal Polyposis ✓ Approved in Adults Atopic Dermati
Slide 8: Libtayo: Leading Treatment for Advanced CSCC in U.S.
LIBTAYO®: LEADING TREATMENT FOR ADVANCED CSCC IN U.S. Advanced CSCC – Total U.S. Patient Share by Products† 3% 7% 9% 11% 14% 13% 19% 22% 13% 27% 31% 31% 34% 14% 37% 40% 13% 41% 43% 44% 45% 11% 47% 48% 11% 12% US ROW 15% 25% 22% 20% 19% 10% 9% 9% $14 $13 8% 19% 7% 18% 8% 16% 7% 6% 6% 14% 13% 13% 11%
Slide 9: Oncology Strategy: Aspire to Compete, Enhance, Extend
ONCOLOGY STRATEGY: ASPIRE TO COMPETE, ENHANCE, EXTEND Oncology Opportunity COMPETE: LIBTAYO in tumors “responsive” to PD-1 monotherapy (e.g., skin & NCSLC) • PD-(L)1 market: >$21Bn, +42% YoY growth* Patient Benefit COMPETE Tumor Types *Based on annual sales data for approved PD-(L)1 agents in 2019 a
Slide 10: Oncology Strategy: Aspire to Compete, Enhance, Extend
ONCOLOGY STRATEGY: ASPIRE TO COMPETE, ENHANCE, EXTEND Oncology Opportunity COMPETE: LIBTAYO in tumors “responsive” to PD-1 monotherapy (e.g., skin & NCSLC) • PD-(L)1 market: >$21Bn, +42% YoY growth* Patient Benefit ENHANCE ENHANCE: Even for “responsive” tumors, more than half of patients do not resp
Slide 11: Oncology Strategy: Aspire to Compete, Enhance, Extend
ONCOLOGY STRATEGY: ASPIRE TO COMPETE, ENHANCE, EXTEND Oncology Opportunity COMPETE: LIBTAYO in tumors “responsive” to PD-1 monotherapy (e.g., skin & NCSLC) • PD-(L)1 market: >$21Bn, +42% YoY growth* Patient Benefit ENHANCE ENHANCE: Even for “responsive” tumors, more than half of patients do not resp
Slide 12: Regeneron Oncology Toolkit Leverages Multiple Platforms
REGENERON ONCOLOGY TOOLKIT LEVERAGES MULTIPLE PLATFORMS TO CREATE COMBINATORIAL FLEXIBILITY BiSpecifics VelocImmune® CD3 BiSpecifics CoStimulatory New Classes of Collaborations Antibodies (to link Killer T Cell to BiSpecifics BiSpecifics (CAR-Ts; Vaccines) (e.g. checkpoint tumor: Signal 1) (to provi
Slide 13: Establish Libtayo as a Foundation in Oncology
ESTABLISH LIBTAYO AS A FOUNDATION IN ONCOLOGY COMPETE, ENHANCE, and EXTEND treatment benefits in monotherapy and in combination settings LEAD in dermato-oncology COMPETE ENHANCE & EXTEND CSCC: FIRST-IN-CLASS BCC: FIRST-IN-CLASS NSCLC Investigational • First PD-(L)1 approval for Combinations • Advanc
Slide 14: 1L NSCLC: Libtayo Monotherapy Survival Benefit Over Chemotherapy
1L NSCLC: LIBTAYO MONOTHERAPY DEMONSTRATED A CLINICALLY MEANINGFUL AND SIGNIFICANT SURVIVAL BENEFIT OVER CHEMOTHERAPY Goal: become competitive in the major anti-PD-1 Overall ITT analysis opportunity – Lung Cancer N=710 LIBTAYO LIBTAYO in combination OS HR: 0.676 (p=0.002) monotherapy in PD- with che
Slide 15: CD3 Bispecifics Show Significant Anti-Tumor Activity
CD3 BISPECIFICS SHOW SIGNIFICANT ANTI-TUMOR ACTIVITY American Society of Hematology (ASH) – December 2019 Data REGN1979 Anti- Anti- CD3 CD20 R/R Follicular Lymphoma R/R DLBCL (CAR-T naïve) R/R DLBCL (post-CAR-T) • ORR=95%, CR=77% • ORR=71%, CR=71% • ORR=50%, CR=25% • N=22, doses 5-320 mg • N=7, dose
Slide 16: Powerful Pipeline for Rational Combinations
POWERFUL PIPELINE FOR RATIONAL COMBINATIONS BiSpecifics Costims New Classes VelocImmune® Antibodies CD3 BiSpecifics BiSpecifics Collaborations EARLY REGN3767 (LAG-3) REGN5458* (BCMAxCD3) REGN5678 (PSMAxCD28) ISA101b + LIBTAYO (ISA) DEVELOPMENT Solid/hematologic cancers Multiple myeloma Prostate canc
Slide 17: Summary of Combinations in the Clinic, and Ones to Come
SUMMARY OF COMBINATIONS IN THE CLINIC, AND ONES TO COME COMBINATIONS INDICATIONS STATUS Resubmit modified study design to ONGOING REGN1979 (CD20xCD3) + LIBTAYO* Lymphoma FDA in 2H20^ REGN4018* (MUC16xCD3) + LIBTAYO* Ovarian cancer Dose escalation ongoing REGN5678 (PSMAxCD28) + LIBTAYO* Prostate canc
Slide 18: Broad Range of Activity and Assets in the Pipeline Beyond Oncology
BROAD RANGE OF ACTIVITY AND ASSETS IN THE PIPELINE BEYOND ONCOLOGY PHASE 1 PHASE 2 PHASE 3 Cemiplimab* (PD-1) REGN3767 (LAG-3) REGN4461 (LEPR) Sarilumab* (IL-6R) Evinacumab (ANGPTL3) REGN1979 (CD20xCD3) REGN5713-5714-5715 Pozelimab (C5) REGN1908-1909 (Feld1) Alirocumab (PCSK9) (Betv1) REGN5458* (BCM
Slide 19: Multiple Potential Regulatory Submissions: 2020-2022+
MULTIPLE POTENTIAL REGULATORY SUBMISSIONS: 2020-2022+ 2020 2021 2022+ Evinacumab Fasinumab† REGN1979 (CD20xCD3) DUPIXENT* Homozygous Familial Hypercholesterolemia Osteoarthritis Pain B Cell NHL Pediatric Atopic Dermatitis (6 mo-5 yr) Eosinophilic Esophagitis REGN-EB3 LIBTAYO* REGN5458 (BCMAxCD3)* Bu
Slide 20: Leveraging Proprietary Technologies to Respond to SARS-CoV-2/COVID-19
LEVERAGING REGENERON’S PROPRIETARY TECHNOLOGIES AND EXPERTISE TO RESPOND TO THE SARS-COV-2/COVID-19 THREAT VELOCIGENE®️ • Over the past 3 decades of investment, Regeneron has built a suite of proprietary technologies for drug discovery, development, and VELOCIMOUSE®️ Rubine / Marigold / White (Late
Slide 21: Regeneron Rapid Response for Global Good
REGENERON RAPID RESPONSE FOR GLOBAL GOOD Using VelociSuite technologies, discovery and preclinical validation has been compressed to 3-6 MONTHS vs. years with a standard process OUTBREAK CLINICAL Isolation of fully human antibodies Creation of and preclinical testing Creation of manufacturing-ready
Slide 22: Moving Rapidly with SARS-CoV-2/COVID-19 Response
MOVING RAPIDLY WITH SARS-COV-2/COVID-19 RESPONSE ANTICIPATED TIMELINE OF REGENERON DRUG DISCOVERY, DEVELOPMENT & MANUFACTURING EFFORT: March: Screening for most August: Scale-up production to have Jan: Began coronavirus discovery potent antibody candidates June: Small quantities available hundreds o
Slide 23: Regeneron's Balance Sheet Enables Opportunity
REGENERON’S BALANCE SHEET ENABLES OPPORTUNITY CASH & MARKETABLE SECURITIES ($Billion) $8.0 $7.2 $7.0 $6.5 $6.0 $5.0 $4.6 $4.0 $2.9 $3.0 $1.7 $1.9 $2.0 $1.0 $0.0 12/31/2015 12/31/2016 12/31/2017 12/31/2018 12/31/2019 3/31/2020 ® 23
Slide 24: Capital Allocation Framework and Priorities
CAPITAL ALLOCATION FRAMEWORK AND PRIORITIES FUND INTERNAL • Consistently high return on R&D Investments R&D • Broad preclinical and early/late-stage clinical pipeline BUSINESS • > $950MM in upfront and equity investments in last ~24 months DEVELOPMENT • Restructured Sanofi Agreements (IO, Praluent)
Slide 25: $5B Share Repurchase / Successful Secondary Offering
$5B SHARE REPURCHASE / SUCCESSFUL SECONDARY OFFERING Regeneron Strategic Rationale Transaction Details ✓ Repurchased 9.8 million shares from ✓ Conviction in business fundamentals, Sanofi at $509.85 per share future prospects, and valuation ✓ Funded share repurchase with $3.5 billion ✓ Participation
Slide 26: 2020 Key Upcoming Milestones
2020 KEY UPCOMING MILESTONES Dupixent (IL-4/IL-13) Ph3 study readout in pediatric Asthma (ages 6-11 years) Fasinumab (NGF) Ph3 long-term safety and efficacy studies readout Pozelimab (C5) Interim results from Ph2 study in Paroxysmal Nocturnal Hemoglobinuria (PNH) REGN1979 (CD20xCD3) and BCMAxCD3 Upd
Slide 27: Reconciliation of GAAP Net Income to Non-GAAP Net Income
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) (In millions, except per share data) ® 27 * See slide 2 for additional important information regarding non-GAAP financial measures included in
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