Vertex Pharmaceuticals Incorporated · NASDAQ:VRTX
Vertex Pharmaceuticals — Q1 2024 Earnings Presentation
22 slides from Vertex Pharmaceuticals's earnings presentation, May 6, 2024
Slide 1: First Quarter 2024 Financial Results
FIRST QUARTER 2024 FINANCIAL RESULTS MAY 6, 2024 ©2024 Vertex Pharmaceuticals Incorporated
Slide 2: Agenda
AGENDA Introduction Susie Lisa, CFA, Senior Vice President, Investor Relations CEO Perspective and Pipeline Update Reshma Kewalramani, M.D., Chief Executive Officer and President Commercial Update Stuart Arbuckle, Executive Vice President and Chief Operating Officer Financial Results Charlie Wagner,
Slide 3: Safe Harbor Statement & Non-GAAP Financial Measures
SAFE HARBOR STATEMENT & NON-GAAP FINANCIAL MEASURES This presentation contains forward-looking statements that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all
Slide 4: Vertex's Strong Momentum Continues, Kicking Off 2024 with Excellent Q1 Performance
Expand our leadership and raise the bar in CF • Continue to reach more people living with cystic fibrosis • Vanzacaftor triple: Completed regulatory filings ages 6+ U.S./EU; initiating trial ages 2-5 VERTEX’S STRONG • VX-522: Enrolling/dosing MAD portion of study; for >5K pts who can’t benefit from
Slide 5: Acquisition of Alpine Immune Sciences: $65/Share, ~$4.9B Cash
ACQUISITON OF • Compelling fit with the Vertex strategy of investing in ALPINE IMMUNE SCIENCES: serial innovation to create transformative medicines that $65/SHARE, ~$4.9B CASH target serious diseases with high unmet need in specialty markets • Alpine’s lead asset, povetacicept (“pove”), is a Phase
Slide 6: CF: Expanding Leadership & Raising the Bar with Serial Innovation
CF: EXPANDING LEADERSHIP & RAISING THE BAR WITH SERIAL INNOVATION SUBMITTED VANZACAFTOR TRIPLE COMBO REGULATORY SUBMISSIONS IN U.S. AND EU FOR PATIENTS AGES 6+, AHEAD OF MID-YEAR FILING GOAL Vanzacaftor Triple VX-522 • Positive Phase 3 results met high expectations: • CFTR mRNA therapy in developmen
Slide 7: Novel, Effective, Non-Opioid Therapies for Moderate to Severe Acute Pain
NOVEL, EFFECTIVE, NON-OPIOID THERAPIES FOR MODERATE TO SEVERE ACUTE PAIN First novel mechanism for acute pain in over 20 years Suzetrigine (VX-548) is an oral Nav1.8, pain signal inhibitor that holds the potential to treat acute pain types across multiple settings of care Origin of pain Compelling
Slide 8: Suzetrigine End-of-Phase 2 Meeting with FDA Completed; Phase 3 DPN Trial
SUZETRIGINE END-OF-PHASE 2 MEETING WITH FDA COMPLETED; PHASE 3 DIABETIC PERIPHERAL NEUROPATHY (DPN) TRIAL TO BEGIN H2:2024 Two Identical Randomized, Double-Blind, Placebo Controlled Trials Efficacy Endpoints n = ~1,100 • Based upon change from baseline to week 12: • Primary: SUZ vs placebo on weekly
Slide 9: Next Steps for Our Pain Programs
NEXT STEPS FOR OUR PAIN PROGRAMS • Suzetrigine: • Complete rolling NDA submission in U.S. in Q2:24 • Seek broad moderate-to-severe acute pain label Acute Pain • VX-993: • Enroll Phase 1 study for intravenous formulation • Advance oral formulation into Phase 2 study later this year • Suzetrigine: • D
Slide 10: Type 1 Diabetes: Advancing Potentially Curative Treatments
TYPE 1 DIABETES: ADVANCING POTENTIALLY CURATIVE TREATMENTS FOR ~3.8M PATIENTS IN NORTH AMERICA & EUROPE VX-880 PHASE 1/2 TRIAL RESUMED; GLOBAL 17-PATIENT STUDY IS FULLY ENROLLED EDITED, FULLY DIFFERENTIATED, • Same cells as VX-880, edited to eliminate need for immunosuppressants HYPOIMMUNE ISLET CEL
Slide 11: Alpine Immune Sciences Acquisition: Povetacicept Best-in-Class Potential
ALPINE IMMUNE SCIENCES ACQUISITION: POVETACICEPT HAS SHOWN BEST-IN-CLASS POTENTIAL WITH IMPORTANT MILESTONES IN H2:2024 Best-in-class • High affinity and potency against both BAFF and APRIL pathways in pre-clinical assays potential • Differentiated efficacy in both human B-cell depletion assays and
Slide 12: Clinical Portfolio Is Broad, Diverse and Rapidly Advancing
CLINICAL PORTFOLIO IS BROAD, DIVERSE AND RAPIDLY ADVANCING EXCLUDES ALPINE IMMUNE SCIENCES PIPELINE* STRONG PROGRESS TOWARDS OUR GOAL OF FIVE LAUNCHES OVER FIVE YEARS (2028) Select, Next Wave Phase 1 Phase (1)/2 Pivotal Development Regulatory Submissions Approved Research-stage Programs in Healthy V
Slide 13: Expanding Leadership in CF and Raising the Bar with Serial Innovation
EXPANDING LEADERSHIP IN CF AND RAISING THE BAR WITH SERIAL INNOVATION ~92,000 GROWTH DRIVERS Treating younger patients Patients living longer Best-in-class patients with CF* Goal: carrier levels Serial CFTRm innovation medicines of CFTR function mRNA for last >5,000 patients ~20,000 eligible
Slide 14: CASGEVY Represents a Potential Multi-$B Opportunity for Vertex
CASGEVY REPRESENTS A POTENTIAL MULTI-$B OPPORTUNITY FOR VERTEX 2024 A FOUNDATIONAL YEAR: ATCS ACTIVATED, AND PATIENTS’ CELLS COLLECTED IN ALL REGIONS WHERE APPROVED STRONG PROGRESS ACROSS ALL REGIONS WITH PAYERS, PATIENTS AND PHYSICIANS COMMERCIAL Bahrain Kingdom of Saudi Arabia • Commercial: under
Slide 15: Acute Pain Is a Multi-Billion Dollar Market, with Significant Unmet Need
ACUTE PAIN IS A MULTI-BILLION DOLLAR MARKET, WITH SIGNIFICANT UNMET NEED Anti-Inflammatory/ TODAY Opioids Analgesics Pain signal inhibitors, FUTURE starting with suzetrigine • 80M patients are prescribed a medicine for moderate to severe • Build-out of commercial team is well underway: field leaders
Slide 16: Q1 2024 Financial Highlights
Q1 2024 FINANCIAL HIGHLIGHTS ($ in millions except where noted or per share data and percentages) Q1 23 FY 23 Q1 24 Total CF product revenues $2.37B $9.87B $2.69B TRIKAFTA/KAFTRIO 2.10B 8.94B 2.48B Other CF products 278 925 207 Combined non-GAAP R&D, acquired IPR&D and SG&A expenses 1.21B 4.24B 1.02
Slide 17: Reiterate Full Year 2024 Financial Guidance
REITERATE FULL YEAR 2024 FINANCIAL GUIDANCE Current FY 2024 FY 2024 Guidance Commentary Includes expectations for continued growth in CF as Total Product Revenue $10.55 - $10.75B well as contribution in the second half from the launch of CASGEVY in approved indications and geographies Combined GAAP
Slide 18: Multiple Catalysts Throughout 2024 and Beyond
MULTIPLE CATALYSTS THROUGHOUT 2024 AND BEYOND RECENT HIGHLIGHTS ANTICIPATED KEY MILESTONES • KALYDECO received European Commission approval in infants with CF ages 1 mo to <4 mo • Continue to reach more eligible patients; expand into younger age groups • Vanza triple combo therapy: Completed NDA sub
Slide 19: 2023 Corporate Responsibility Report: Priorities and Progress
2023 CORPORATE RESPONSIBILITY REPORT: PRIORITIES AND PROGRESS Improve the Lives of Foster a Culture Carefully Manage Make a Positive Impact People With Serious of Innovation, Integrity Our Operations and in the Communities Diseases and Inclusion Environmental Footprint Where We Are Located 3 out of
Slide 20: First Quarter 2024 Financial Results: Appendices
FIRST QUARTER 2024 FINANCIAL RESULTS: APPENDICES MAY 6, 2024 ©2024 Vertex Pharmaceuticals Incorporated
Slide 21: Appendix A: GAAP to Non-GAAP Financial Information
APPENDIX A GAAP TO NON-GAAP FINANCIAL INFORMATION ($ in millions except as noted, per share data and percentages) Q1 23 FY 23 Q1 24 Combined R&D, Acquired IPR&D and SG&A GAAP 1.33B 4.83B 1.21B Non-GAAP 1.21B 4.24B 1.02B Operating income GAAP 779 3.83B 1.14B Non-GAAP 902 4.37B 1.34B Operating Margin
Slide 22: Additional Information About the Acquisition and Where to Find It
ADDITIONAL INFORMATION ABOUT THE ACQUISITION AND WHERE TO FIND IT The tender offer for the outstanding shares of common stock of Alpine Immune Sciences, Inc. referenced in this presentation commenced on April 22, 2024. This presentation is for informational purposes only and is neither an offer to p
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