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Sep 30, 2023
Amylyx Q3 2023 Earnings Report
Reported strong Q3 2023 financial results with significant product revenue and net income.
Key Takeaways
Amylyx Pharmaceuticals reported a successful third quarter in 2023, marked by $102.7 million in product revenue and a net income of $20.9 million. The company's financial position remains strong, supported by cash, cash equivalents, and short-term investments totaling $355.0 million.
Third quarter product revenue reached $102.7 million, contributing to $272.3 million in the first three full quarters of U.S. launch.
Net income for the third quarter stood at $20.9 million.
Cash, cash equivalents, and short-term investments totaled $355.0 million as of September 30, 2023.
Continued progress of commercial launches of RELYVRIO® in the U.S. and ALBRIOZA™ in Canada
Forward Guidance
Amylyx anticipates topline data from the Phase 3 PHOENIX trial in the second quarter of 2024 and is working on a new taste-masked formulation of RELYVRIO for Phase 1 testing in 2024.
Positive Outlook
- Company plans to seek approval in the EU as quickly as possible if PHOENIX is supportive.
- The Company continues to expect data from the Phase 2 clinical trial of AMX0035 in Wolfram syndrome in 2024.
- The Company is planning to file an IND and conduct Phase 1 testing for this innovative formulation in 2024.
- The goal of this program is to create a tool that allows for earlier diagnosis of ALS which may result in earlier treatment and better outcomes.
- ORION study initiation anticipated by the end of 2023 starting in the United States.
Challenges Ahead
- The CHMP opinion will be forwarded to the European Commission, who will adopt the final decision on this application anticipated by the end of 2023.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its initial negative opinion adopted in June 2023 on the Marketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS in the European Union (EU).
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