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Sep 30, 2022
Amicus Therapeutics Q3 2022 Earnings Report
Announced financial results for the quarter ended September 30, 2022 and corporate updates.
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 Galafold® 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