Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Amicus Therapeutics Inc (FOLD, Financial) reported a strong revenue growth of 37% year-over-year, reaching $142 million in Q3 2024.
- The company increased its full-year revenue guidance for 2024 to 30-32%, up from the previous 26-31%.
- Galafold achieved $120 million in global revenue for the quarter, marking a 19% growth from the previous year on a constant currency basis.
- Pompe disease therapy, Pombility, reported $21 million in revenue for Q3 2024, a 33% increase from Q2 2024.
- Amicus Therapeutics Inc (FOLD) achieved non-GAAP profitability for the full year, with a non-GAAP net income of $31 million in Q3 2024.
Negative Points
- The company faces ongoing litigation with two remaining litigants, Aurobindo and Lupin, regarding the intellectual property of Galafold.
- There is a potential impact on gross margins in 2025 due to the transition from previously expensed inventory to new inventory costs.
- The market for Pompe disease in Japan is smaller and more fragmented compared to other regions, limiting growth potential.
- The company is still in the early stages of developing next-generation therapies for Fabry and Pompe diseases, with significant progress expected only in the coming years.
- Amicus Therapeutics Inc (FOLD) has not yet achieved GAAP profitability, focusing instead on non-GAAP profitability.
Q & A Highlights
Q: Can you elaborate on the prescribing trends for Pombil AODA and the decision-making process for switching patients? Also, what is the market opportunity in Japan for Pompe disease?
A: Bradley L. Campbell, CEO, explained that the breadth and depth of prescribing are increasing, with more new prescribers and repeat prescriptions. Physicians typically wait 12 to 24 months before switching treatments, assessing patient stability and improvement. Regarding Japan, Sébastien Martel, Chief Business Officer, noted that the Pompe disease market is smaller, with about 100 treated patients, unlike the larger Fabry disease market.
Q: What are you seeing with previously untreated patients now on Galafold, especially in core versus emerging markets?
A: Bradley L. Campbell, CEO, stated that in key markets like the US, Europe, and Japan, there is significant diagnosis of new patients and penetration into the diagnosed untreated market. In newer regions like Latin America and Southeast Asia, there is still a significant switch opportunity, contributing to market growth.
Q: Are there any remaining IP filers for Galafold, and can you comment on dropout rates?
A: Bradley L. Campbell, CEO, confirmed that there are two remaining litigants, Aurobindo and Lupin, but Amicus is confident in its IP strength. The dropout rates for Galafold have decreased, with patients tending to stay on the treatment, contributing to sustained patient growth.
Q: What is the focus for building out the clinical pipeline, and are you considering business development opportunities?
A: Bradley L. Campbell, CEO, mentioned that Amicus is focusing on later-stage or commercial assets for business development. Internally, they are working on next-generation therapies for Fabry and Pompe diseases, with a focus on novel delivery methods. Jeffrey P. Castelli, Chief Development Officer, added that they are refining constructs for Fabry and Pompe with new technologies.
Q: How should we think about the trajectory of the Pompe launch and expectations for 2025?
A: Bradley L. Campbell, CEO, noted that the trajectory depends on new patient starts and the launch of new countries. The US market has a sizable number of patients moving into the 1-2 year treatment zone, which could drive switches. Reimbursement and regulatory processes will also impact the launch sequence and momentum.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
