Amicus Therapeutics Q3 2022 Earnings Report
Key Takeaways
Amicus Therapeutics reported strong commercial uptake of Galafold globally and is on track to deliver double-digit operational growth in 2022. The company is making progress towards gaining regulatory approvals of AT-GAA for people living with Pompe disease.
On-Track to Deliver Full-Year 2022 Double-Digit Revenue Growth of 15-20% at CER
Advancing Launch Preparation for AT-GAA in Pompe Disease
Updating Full-Year 2022 Non-GAAP Operating Expense Guidance from $470M-$485M to $430M-$440M
Strong commercial uptake of Galafold globally is on track to deliver double-digit operational growth in 2022
Amicus Therapeutics
Amicus Therapeutics
Forward Guidance
Amicus Therapeutics is on track to deliver full-year 2022 double-digit revenue growth of 15-20% at CER and is updating full-year 2022 non-GAAP operating expense guidance from $470M-$485M to $430M-$440M.
Positive Outlook
- On-Track to Deliver Full-Year 2022 Double-Digit Revenue Growth of 15-20% at CER
- Advancing Launch Preparation for AT-GAA in Pompe Disease
- Updating Full-Year 2022 Non-GAAP Operating Expense Guidance from $470M-$485M to $430M-$440M
- The strong commercial uptake of GalafoldĀ® globally is on track to deliver double-digit operational growth in 2022.
- Amicus is well positioned to drive significant value for shareholders and further our mission to bring innovative new medicines to people living with rare diseases.
Challenges Ahead
- The potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective
- The potential that it may be difficult to enroll patients in our clinical trials
- The potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates
- The potential that we may not be successful in commercializing Galafold in Europe, Japan, the US and other geographies or our other product candidates if and when approved
- The potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues