Loading...
•
Dec 31, 2022
Amicus Therapeutics Q4 2022 Earnings Report
Amicus Therapeutics reported full-year financial results, highlighting revenue growth and progress towards AT-GAA approval.
Key Takeaways
Amicus Therapeutics announced its full-year 2022 financial results, showcasing a 16% revenue growth at CER to $329 million. The company is projecting Galafold revenue growth of 12-17% at CER in 2023 and anticipates non-GAAP profitability in the second half of 2023. The U.S. FDA pre-approval inspection for AT-GAA is now scheduled, with approval expected in Q3 2023.
Delivered strong growth in Galafold, with over 2,000 people now on treatment globally.
Established a strong foundation for the anticipated global launch of its second product, AT-GAA.
Streamlined pipeline while maintaining judicious management of resources.
Focused on growing Galafold globally at double-digit rates and preparing for the expected approvals and launches of AT-GAA for Pompe disease.
Amicus Therapeutics
Amicus Therapeutics
Forward Guidance
Amicus Therapeutics projects Galafold revenue growth and is preparing for AT-GAA approvals and launches, aiming for non-GAAP profitability in the second half of 2023.
Positive Outlook
- Continuing to grow Galafold globally at double-digit rates.
- Preparing for the expected approvals and launches of AT-GAA for Pompe disease in multiple major markets.
- Maintaining financial discipline.
- Achieving non-GAAP profitability in the second half of this year.
- FDA pre-approval inspection for AT-GAA now scheduled
Challenges Ahead
- Potential impact on operations from the COVID-19 pandemic.
- Risk of clinical or preclinical studies indicating product candidates are unsafe or ineffective.
- Potential difficulties in enrolling patients in clinical trials.
- Regulatory authorities may delay or not grant approval for product candidates.
- Potential delays or failures in required regulatory inspections.