Amicus Therapeutics Q4 2019 Earnings Report
Key Takeaways
Amicus Therapeutics reported full-year 2019 revenue of $182.2 million, driven by Galafold sales, and anticipates Galafold revenue between $250 million and $260 million for 2020. The company is advancing its Pompe program and gene therapy pipeline, with a cash position expected to fund operations into 2022.
Galafold revenue grew to $182.2 million in 2019, exceeding guidance.
Phase 3 PROPEL trial for AT-GAA in Pompe disease exceeded enrollment.
Plans to apply for and initiate a rolling BLA for AT-GAA, completing final submission in the first half of 2021.
Cash, cash equivalents, and marketable securities totaled $452.7 million at the end of 2019.
Amicus Therapeutics
Amicus Therapeutics
Amicus Therapeutics Revenue by Segment
Forward Guidance
Amicus expects Galafold revenue between $250 million and $260 million for 2020 and non-GAAP operating expenses between $410 million and $420 million.
Positive Outlook
- On track to meet full-year 2020 revenue guidance range of $250 million to $260 million for Galafold
- Plans to apply for and initiate a Rolling Biologics License Application (BLA) for AT-GAA in 2020
- Initiate long-term follow-up of initial participants in the CLN6 Phase 1/2 study in 1H2020
- Plan to advance regulatory discussions to finalize clinical and regulatory path in CLN3
- Manufacturing advancements across portfolio
Challenges Ahead
- A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure.
- Potential that results of 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
- Potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates
- 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