Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (November 2020)
26 slides from Regeneron Pharmaceuticals's investor presentation, November 2020
Slide 1: Corporate Presentation November 2020
® C O R PO RAT E PR ESEN TAT ION NOVEMBER 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: Regeneron: A Diversified and Exciting Growth Story
REGENERON: A DIVERSIFIED AND EXCITING GROWTH STORY Strong and Growing Core Entering a Period of Planned A Broad and Diverse Pipeline Brands Launches REGN-COV2 for COVID-19 Non-Small Cell Lung Cancer and EUA* under FDA review $1.32Bn U.S. sales in 3Q20 Basal Cell Carcinoma Dupixent in pivotal trials
Slide 4: Results Reflect Solid Execution and Diversification Across Business Despite COVID-19
RESULTS REFLECT SOLID EXECUTION AND DIVERSIFICATION ACROSS BUSINESS DESPITE COVID-19 3Q20 Double-Digit Top- Significant Pipeline Progress / COVID-19 Program Advancing and Bottom-line Growth Dupixent® Libtayo® • FDA accepted for priority review sBLA in • Ph3 trial in pediatric asthma met primary Reve
Slide 5: EYLEA, Dupixent, and Libtayo Are Core to Diversified Growth Strategy
EYLEA, DUPIXENT, AND LIBTAYO ARE CORE TO DIVERSIFIED GROWTH STRATEGY; NEAR-TERM SPECIALIZED PROGRAMS OFFER ADDITIONAL GROWTH POTENTIAL Specialized growth EYLEA Dupixent* Oncology opportunities: • Execute in wet AMD and • Transform treatment of • Realize potential diabetic eye diseases Type 2 inflamm
Slide 6: EYLEA: Solidifying Market Leadership Position
EYLEA®: SOLIDIFYING MARKET LEADERSHIP POSITION Net Product YoY EYLEA $1.32 Sales Change $1.22 $1.16 $1.19 $1.17 U.S. $1.32Bn +11% $1.11 $1.07 3Q20 Global* $2.10Bn +9% ▪ EYLEA outperformed overall market o Demand normalizing with volumes at or above prior year levels ▪ High-dose EYLEA Phase 3 program
Slide 7: Dupixent: Strong Execution Across Multiple Indications
DUPIXENT®: STRONG EXECUTION ACROSS MULTIPLE INDICATIONS • Total Dupixent Rx remain resilient $221 U.S. ROW • New initiations recovering, nearing pre- $175 $176 $851 COVID-19 levels $770 $146 $679 • Approved in late May in pediatric AD (6y+): $125 $103 $605 launch progressing well $508 $455 $71 • 300
Slide 8: Dupixent: Driving Leverage in Collaboration Profitability
DUPIXENT®: DRIVING LEVERAGE IN COLLABORATION PROFITABILITY Antibody Collaboration Share of Profits / (Losses)* (in Millions) $250 $200 $150 $100 $50 $0 ($50) ($100) 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 ® * Share of profits/losses are derived from global sales of Praluent (up until
Slide 9: Dupixent: Delivering on the Pipeline in a Product Promise
DUPIXENT®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE Moderate-to-Severe Atopic Dermatitis Approved in Adults, Adolescents, Peds (6+ years) U.S. APPROVED Moderate-to-Severe Asthma Approved in Adults and Adolescents (12+ years) INDICATIONS* Chronic Rhinosinusitis with Nasal Polyposis Approved
Slide 10: Substantial Patient Opportunity in Type 2 Inflammatory Diseases for Dupixent
SUBSTANTIAL PATIENT OPPORTUNITY IN TYPE 2 INFLAMMATORY DISEASES FOR DUPIXENT® Up to 4MM+ Atopic Asthma 2023+e Eligible CRSwNP 2021e 2022e Dermatitis Patients by 2023 Eosinophilic Type 2 Esophagitis COPD 48k 300k Prurigo Nodularis Chronic CSsNP 2.3MM* 975k* 90k 74k Spontaneous Urticaria 130k 308k Bul
Slide 11: 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† 9% 11% 22% 14% 31% 13% 39% 43% U.S. ROW 47% 49% 51% 15% 12% $25 21% 10% 18% 8% $17 6% $14 $13 15% 12% 6% 5% 5% 10% 14% 12% 9% 12% 11% 12% 8% 7% 61% 7% 8% 6% $72 41% $61 $62 $63 37% 35% 29% 30%
Slide 12: 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 EXTEND than half of patients do n
Slide 13: 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 prov
Slide 14: 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 DATA NSCLC Investigational • First PD-(L)1 approval for Combinations •
Slide 15: ESMO 2020: Libtayo in PD-L1+ NSCLC Improves Overall Survival vs. Chemotherapy
ESMO 2020: LIBTAYO IN PD-L1+ NSCLC – IMPROVES OVERALL SURVIVAL VS. CHEMOTHERAPY DESPITE HIGH CROSSOVER RATE OS Overall population: 32% reduced risk of death Confirmed PD-L1 ≥50%: 43% reduced risk of death (HR=0.68; p=0.0022) (HR=0.57; p=0.0002) N=710 N mOS, mo (95% CI) N=563 N mOS, mo (95% CI) Cemip
Slide 16: ESMO 2020: Libtayo in Advanced BCC
ESMO 2020: LIBTAYO IN ADVANCED BCC – FIRST SYSTEMIC THERAPY TO SHOW BENEFIT AFTER HHI THERAPY FAILURE 31% overall response rate and estimated 85% of Survival Estimates: median overall survival not responses ongoing at one year reached Est. mPFS: 19.3 months (95% CI, 8.6, NE) PFS Est. 1-year PFS: 56.
Slide 17: Powerful and Diverse Oncology Portfolio for Rational Combinations
POWERFUL AND DIVERSE ONCOLOGY PORTFOLIO FOR RATIONAL COMBINATIONS BiSpecifics Costims New Classes Collaborations VelocImmune® Antibodies CD3 BiSpecifics BiSpecifics Other EARLY REGN3767 (LAG-3) REGN5458* (BCMAxCD3) REGN5678 (PSMAxCD28) REGN5093 (METxMET) DEVELOPMENT Solid/hematologic cancers Multipl
Slide 18: Broad Combinations Pipeline Continues to Advance and Grow
BROAD COMBINATIONS PIPELINE CONTINUES TO ADVANCE AND GROW COMBINATIONS INDICATIONS STATUS Resubmit modified study design to ONGOING REGN1979 (CD20xCD3) + LIBTAYO* Lymphoma FDA^ REGN4018* (MUC16xCD3) + LIBTAYO* Ovarian cancer Dose escalation ongoing REGN5678 (PSMAxCD28) + LIBTAYO* Prostate cancer Dos
Slide 19: Regeneron-Discovered, Approved and Investigational Medicines
REGENERON-DISCOVERED, APPROVED AND INVESTIGATIONAL MEDICINES ACROSS A WIDE AND DIVERSE SET OF DISEASES PHASE 1 PHASE 2 PHASE 3 REGN-COV2 (SARS-CoV-2) REGN5381 (NPR1) REGN-COV2 (SARS-CoV-2) Dupilumab* (IL-4R) REGN-COV2 (SARS-CoV-2) Cemiplimab* (PD-1) REGN5713-5714-5715 REGN4461 (LEPR) Aflibercept (VE
Slide 20: How Antibodies Work Against SARS-CoV-2
HOW ANTIBODIES WORK AGAINST SARS-COV-2 SARS-CoV-2 Binding Mechanism With Antibodies… ACE 2 receptor Virus binds to healthy cell receptor in order to infect Spike protein REGN-COV2 Antibodies block the virus’s Spike protein, antibody “cocktail” neutralizing its ability to bind and infect • Regeneron
Slide 21: REGN-COV2 Has a Broad Ongoing Development Program
REGN-COV2 HAS A BROAD ONGOING DEVELOPMENT PROGRAM In ongoing Ph2/3, REGN-COV2 significantly reduced viral STUDY 2067 Outpatient (IV): Seamless Ph1/2/3 load and patient medical visits Symptomatic | Asymptomatic Emergency Use Authorization (EUA) being evaluated in mild-to-moderate outpatients at high
Slide 22: Consistent REGN-COV2 Antiviral Effects in Outpatient Study
CONSISTENT REGN-COV2 ANTIVIRAL EFFECTS ACROSS OVERALL POPULATIONS IN BOTH ANALYSIS GROUPS IN OUTPATIENT STUDY Significant REGN-COV2 antiviral effect seen with both doses in the larger data set (Analysis 2) Viral load reduction results driven by patients who did not mount their own immune response at
Slide 23: REGN-COV2 Significantly Reduced Patient Medical Visits
REGN-COV2 SIGNIFICANT REDUCED PATIENT MEDICAL VISITS, KEY CLINICAL ENDPOINT IN OUTPATIENT STUDY REGN-COV2 reduced medical visits by 57% vs. placebo Overall medical visits PBO Low Dose High Dose (n=27) (n=231) (n=215) (n=219) Hospitalization 5 (2.2%) 2 (0.9%) 1 (0.5%) ER Visit 5 (2.2%) 2 (0.9%) 3 (1.
Slide 24: Multiple Potential Regulatory Submissions: 2020-2022+
MULTIPLE POTENTIAL REGULATORY SUBMISSIONS: 2020-2022+ 2020 2021 2022+ REGN-COV2 Fasinumab† Odronextemab (CD20xCD3) Itepekimab (IL-33)* COVID-19 (EUA submitted) Osteoarthritis Pain^ B Cell NHL Chronic Obstructive Pulmonary Disease Evinacumab Garetosmab REGN5458 (BCMAxCD3)* DUPIXENT* HoFH (PDUFA 2/11/
Slide 25: Key Upcoming Milestones
KEY UPCOMING MILESTONES DUPIXENT Regulatory submissions in pediatric asthma (6-11 years) LIBTAYO Regulatory decisions for BCC and 1L NSCLC REGN-COV2 Regulatory decision on EUA for COVID-19 ambulatory patients EYLEA Continue to enroll high-dose formulation Ph3 studies Odronextamab (CD20xCD3) and BCMA
Slide 26: 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) ® 26 * See slide 2 for additional important information regarding non-GAAP financial measures included in
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