Alnylam Pharmaceuticals, Inc. · NASDAQ:ALNY
Alnylam Pharmaceuticals — Q2 2022 Earnings Presentation
29 slides from Alnylam Pharmaceuticals's earnings presentation, Jul 28, 2022
Slide 1: Second Quarter 2022 Financial Results
Nathan (USA) Diagnosed with AHP Second Quarter 2022 Financial Results July 28, 2022 1 © 2022 Alnylam Pharmaceuticals, Inc.
Slide 2: Agenda
Agenda Welcome • Christine Lindenboom Senior Vice President, Investor Relations & Corporate Communications Overview • Yvonne Greenstreet, MBChB, MBA Chief Executive Officer Commercial Highlights • Tolga Tanguler Chief Commercial Officer Alnylam Pipeline • Akshay Vaishnaw, M.D., Ph.D. President Finan
Slide 3: Forward Looking Statements & Non-GAAP Financial Measures
Alnylam Forward Looking Statements & Non-GAAP Financial Measures This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including expectations regarding our aspiration to become a l
Slide 4: Overview
Yvonne Greenstreet, MBChB, MBA Chief Executive Officer Overview 4
Slide 5: The fifth RNAi therapeutic is now approved
The fifth RNAi therapeutic is NOW APPROVED 5
Slide 6: 2022 Expected to Deliver Multiple Catalysts with Value-Creation Potential
2022 Expected to Deliver Multiple Catalysts with Value-Creation Potential Full 18-Month HELIOS-A Phase 3 Results with Vutrisiran January 21, 2022 Société Francophone du Nerf Périphérique Cemdisiran Phase 2 Data in IgA Nephropathy Early 2022 FDA Approval of Vutrisiran Mid-2022 APOLLO-B Phase 3 Result
Slide 7: Multiple Drivers of Future Growth
Multiple Drivers of Future Growth TTR Franchise Leadership Expansion into Prevalent Diseases Engine for Sustainable Innovation Andreas (Sweden) 7 Diagnosed with hATTR amyloidosis
Slide 8: P5x25 Goals: Performance, Patients, Products, Pipeline
Patients: Over 0.5 million on Alnylam RNAi therapeutics globally Products: 6+ marketed products in rare and prevalent diseases Pipeline: Over 20 clinical programs, with 10+ in late stages and 4+ INDs per year Performance: ≥40% revenue CAGR through YE 2025 Profitability: Achieve sustainable non-GAAP
Slide 9: Commercial Highlights
Tolga Tanguler Chief Commercial Officer Commercial Highlights 9
Slide 10: ONPATTRO (patisiran) Update: Q2 2022
ONPATTRO® (patisiran) Update: Q2 2022 Q2 Highlights $153M >2,400 U.S. YoY % Growth 36% QoQ % Growth 14% ONPATTRO Global Q2 2022 Patients Worldwide on Commercial ROW 34% 10% Net Product Revenues ONPATTRO at end of Q2 2022 Global 35% 12% $153.4M • Steady patient growth continues across key markets ROW
Slide 11: AMVUTTRA (vutrisiran) Update: Initial Launch Progress
AMVUTTRA™ (vutrisiran) Update: Initial Launch Progress Promising Early Indicators Following U.S. Approval on June 13 PERFORMANCE HCP & PATIENT OUTREACH HEALTH SYSTEMS & PAYERS EARLY HIGHLIGHTS Encouraging early demand signal Initial promotion / education efforts Positive payer interactions • 133 Sta
Slide 12: GIVLAARI (givosiran) Update: Q2 2022
GIVLAARI® (givosiran) Update: Q2 2022 Q2 Highlights $45M >420 U.S. YoY % Growth 33% QoQ % Growth 25% GIVLAARI Global Q2 2022 Patients Worldwide on Commercial ROW 87% 34% Net Product Revenues GIVLAARI at end of Q2 2022 Global 47% 28% $45.2M • U.S. QoQ growth of 25% impacted by: ROW $40.7M 15.5 – Dema
Slide 13: OXLUMO (lumasiran) Update: Q2 2022
OXLUMO® (lumasiran) Update: Q2 2022 Q2 Highlights $15M >200 U.S. YoY % Growth 9% QoQ % Growth 32% OXLUMO Global Q2 2022 Patients Worldwide on Commercial ROW -20% -15% Net Product Revenues OXLUMO at end of Q2 2022 Global -9% 2% • U.S. QoQ growth of 32% primarily due to increase in patient ROW demand,
Slide 14: Alnylam Pipeline
Akshay Vaishnaw, M.D., Ph.D. President Alnylam Pipeline 14
Slide 15: Patisiran APOLLO-B Phase 3 Study
Patisiran Phase 3 Study Randomized, Double-Blind, Placebo-Controlled Study in ATTR Amyloidosis Patients with Cardiomyopathy N ~ 300 Primary Endpoint Patient Population Patisiran • Change in 6-MWT at 12 months IV q3w† 1:1 RANDOMIZATION • ATTR amyloidosis; wild-type or 0.3 mg/kg any TTR mutation Key S
Slide 16: Vutrisiran HELIOS-A Phase 3 Study
Vutrisiran Phase 3 Study Randomized, Open-Label Study in Patients with Hereditary ATTR Amyloidosis with Polyneuropathy • As previously reported, the primary endpoint of change from baseline in mNIS+7 at Month 9 was met1 Efficacy Assessments Vutrisiran vs APOLLO Placebo n=122 Primary Endpoint (at Mon
Slide 17: Vutrisiran HELIOS-B Phase 3 Study
Vutrisiran Phase 3 Study Randomized, Double-Blind Outcomes Study in ATTR Amyloidosis Patients with Cardiomyopathy Primary Endpoint N = 655 • Composite outcome of all-cause mortality and recurrent CV events (when Vutrisiran last patient reaches Month 30) Patient Population SC q3M 1:1 RANDOMIZATION •
Slide 18: Alnylam Clinical Development Pipeline
Alnylam Clinical Development Pipeline Focused in 4 Strategic Therapeutic Areas (STArs): EARLY/MID-STAGE LATE STAGE REGISTRATION/ COMMERCIAL Genetic Medicines Cardio-Metabolic Diseases (IND/CTA Filed-Phase 2) (Phase 2-Phase 3) COMMERCIAL1 RIGHTS Infectious Diseases CNS/Ocular Diseases (OLE/Phase 4/II
Slide 19: Alnylam Clinical Development Pipeline
Alnylam Clinical Development Pipeline Focused in 4 Strategic Therapeutic Areas (STArs): EARLY/MID-STAGE LATE STAGE REGISTRATION/ COMMERCIAL Genetic Medicines Cardio-Metabolic Diseases (IND/CTA Filed-Phase 2) (Phase 2-Phase 3) COMMERCIAL1 RIGHTS Infectious Diseases CNS/Ocular Diseases (OLE/Phase 4/II
Slide 20: Progress with Platform Innovation
Progress with Platform Innovation Alnylam Proprietary Advances in Delivery and Target Discovery • Leveraging Alnylam’s decades long investment in the siRNA delivery platform, this paper describes lipid conjugates suitable for clinical development for targets in CNS, eye, lung • Potential for lipid c
Slide 21: Financial Summary and Upcoming Milestones
Jeff Poulton Chief Financial Officer Financial Summary and Upcoming Milestones 21
Slide 22: Q2 2022 Financial Summary
Q2 2022 Financial Summary Financial Results ($ millions) Q2 2022 Q2 2021 Reported Growth % CER Growth %3 Net Product Revenues $214 $161 33% 40% Net Revenues from Collaborations $9 $59 (85%) Royalty Revenues $2 $0 Total Revenues $225 $221 2% 7% Cost of Goods Sold and Collaborations $41 $39 5% Gross M
Slide 23: 2022 Financial Guidance Reiterated
2022 Financial Guidance Reiterated FY 2022 Guidance1,2 Net Product Revenue $870M – $930M (ONPATTRO, GIVLAARI, OXLUMO, AMVUTTRA) Net Revenues from Collaborations & Royalties $175M – $225M Non-GAAP Combined R&D and SG&A Expenses3 $1,390M – $1,450M 1 As of April 28, 2022 2 Our FY 2022 Guidance utilizes
Slide 24: Alnylam 2022 Goals
Alnylam 2022 Goals Early Mid Late Combined Net Product Revenue Guidance $870 million – $930 million APOLLO-B Phase 3 Topline Results PATISIRAN hATTR/ATTR Amyloidosis File sNDA for ATTR with cardiomyopathy FDA Approval U.S. Launch hATTR/ATTR Amyloidosis VUTRISIRAN* EMA Approval Biannual Dose Regimen
Slide 25: Q&A Session
Q2 2022 Financial Results Q&A Session 25
Slide 26: Challenge Accepted
To those who say “impossible, impractical, unrealistic,” we say: CHALLENGE ACCEPTED © 2022 Alnylam Pharmaceuticals, Inc. 26
Slide 27: Appendix
Q2 2022 Financial Results Appendix 27
Slide 28: Reconciliation of Selected GAAP Measures to Non-GAAP Measures
Alnylam Pharmaceuticals, Inc. Reconciliation of Selected GAAP Measures to Non-GAAP Measures (In thousands) 28 Please note that the figures presented may not sum exactly due to rounding
Slide 29: Reconciliation of Revenue and Operating Expense Growth at CER
Alnylam Pharmaceuticals, Inc. Reconciliation of Revenue and Operating Expense Growth at Constant Exchange Rate (CER)* Please note that the figures presented may not sum exactly due to rounding 29 * Constant Exchange Rate (CER) representing growth calculated as if the exchange rates had remained unch
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