Product & Clinical Data - RELYVRIO™ and ALBRIOZA™ are approved in the United States and Canada as treatments for ALS [4] - The CENTAUR trial showed a 232-point difference (p=003) in ALSFRS-R scores, indicating a statistically significant functional benefit with RELYVRIO [10] - Participants on RELYVRIO in the CENTAUR trial had a median survival of 235 months compared to 187 months for placebo, a 48-month difference (HR=064, 95% CI=0416-0995) [11] - Common adverse events with RELYVRIO (at least 15% and at least 5% greater than placebo) included diarrhea (25% vs 19%), abdominal pain (21% vs 13%), nausea (18% vs 13%), and upper respiratory tract infection (18% vs 10%) [15] - The PHOENIX Phase 3 trial, with 664 participants, completed enrollment in February 2023, with topline data anticipated in mid-2024 [38] Market & Commercial Strategy - ALS affects at least 200000 people worldwide [20] - In the United States, approximately 29000 people are living with ALS; in Canada, approximately 3000 people; and in Europe (EU and UK), over 30000 people [20] - The company is focused on driving awareness and education of RELYVRIO, engaging payors on access, and ensuring positive interactions for people living with ALS and ALS clinics [21] - Approximately 500 ALS physicians represent approximately two-thirds of prescriptions in the U S market [30] Financials - As of December 31, 2022, the company had $3469 million in cash, cash equivalents, and short-term investments [68] - Net product revenue for Q4 2022 was $219 million, and expenses for the same period were $665 million [68]
Amylyx Pharmaceuticals (AMLX) Investor Presentation - Slideshow
