Amicus Therapeutics Q4 2020 Earnings Report
Key Takeaways
Amicus Therapeutics announced its full-year 2020 financial results, highlighting the company's resilience and strategic advancements despite the challenges of COVID-19. Galafold revenue increased, and the company is committed to advancing AT-GAA for Pompe disease.
Total Galafold Revenue of $260.9M; Increased 43 Percent Year-on-Year
Continued Strong Global Growth of Galafold Expected in 2021 with Revenue of $300M-$315M
AT-GAA Rolling BLA Submission in Pompe Disease Planned for Completion in 2Q21 and Other Global Submissions Expected Throughout 2021
CLN6 Batten Disease Gene Therapy Granted Fast Track Designation by U.S. FDA
Amicus Therapeutics
Amicus Therapeutics
Amicus Therapeutics Revenue by Segment
Forward Guidance
Amicus Therapeutics anticipates continued growth for Galafold in 2021, with projected revenue between $300M and $315M. The company plans to complete the AT-GAA rolling BLA submission for Pompe disease in 2Q21 and pursue other global submissions throughout the year.
Positive Outlook
- Continued Strong Global Growth of Galafold Expected in 2021 with Revenue of $300M-$315M
- AT-GAA Rolling BLA Submission in Pompe Disease Planned for Completion in 2Q21 and Other Global Submissions Expected Throughout 2021
- CLN6 Batten Disease Gene Therapy Granted Fast Track Designation by U.S. FDA
- Cash Position Sufficient to Achieve Self-Sustainability
- Galafold continues its path to becoming the worldwide standard of care for Fabry patients with amenable variants.
Challenges Ahead
- Potential impact on operations and/or revenue from the COVID-19 pandemic
- Risk that clinical or preclinical studies indicate that the product candidates are unsafe or ineffective
- Potential that it may be difficult to enroll patients in our clinical trials
- Risk that regulatory authorities may not grant or may delay approval for our product candidates
- Potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues