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Jun 30, 2023
Amylyx Q2 2023 Earnings Report
Reported strong financial results driven by commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada.
Key Takeaways
Amylyx Pharmaceuticals reported strong financial results for the second quarter of 2023, with product revenue of $98.2 million and net income of $22.1 million. The company's commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada continued to progress.
Second quarter product revenue reached $98.2 million, driven by demand and insurance coverage for RELYVRIO in the U.S. and ALBRIOZA in Canada.
Net income for the second quarter was $22.1 million.
Cash, cash equivalents, and short-term investments totaled $357.3 million as of June 30, 2023.
Plans are underway to initiate a global, pivotal Phase 3 trial of AMX0035 for the treatment of progressive supranuclear palsy (PSP).
Amylyx
Amylyx
Forward Guidance
Amylyx is focused on the commercialization of RELYVRIO and ALBRIOZA, as well as the development of AMX0035 for other neurodegenerative diseases.
Positive Outlook
- Continued progress in commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada.
- Expected ALBRIOZA coverage to be in place for the vast majority of publicly insured lives in Canada by the end of August.
- Plans to initiate a global Phase 3 ORION trial of AMX0035 for the treatment of progressive supranuclear palsy later this year.
- Phase 2 HELIOS study of AMX0035 for the treatment of Wolfram syndrome is enrolling participants, with topline results expected next year.
- Marketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS under review with the European Medicines Agency’s (EMA).
Challenges Ahead
- Received a negative opinion from the CHMP in June regarding the MAA and requested a formal re-examination.
- Re-examination procedure is an approximately four-month process, with a final opinion expected in fall 2023.
- Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders
- RELYVRIO has a high salt content.
- The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection.