Release Date: August 08, 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 34% year-over-year, reaching $127 million in Q2 2024.
- Galafold achieved $111 million in global revenue, marking a 19% growth from the previous year on a constant currency basis.
- The company increased its full-year 2024 revenue growth guidance for Galafold to 14% to 18%, reflecting strong market demand.
- Pombiliti and Opfolda, the novel therapy for late-onset Pompe disease, reported $16 million in revenue, a 44% increase from Q1 2024.
- Amicus Therapeutics Inc (FOLD) achieved non-GAAP profitability in the second quarter and the first half of 2024, indicating strong financial management.
Negative Points
- Despite the strong revenue growth, Amicus Therapeutics Inc (FOLD) reported a GAAP net loss of $16 million for Q2 2024.
- The time from prescription to infusion for Pombiliti and Opfolda remains at 65 days, which the company aims to reduce.
- There are ongoing challenges with insurance coverage for Pombiliti and Opfolda, although improvements have been noted.
- The company faces competitive dynamics in the market, particularly from Genzyme's Nexviazyme, which is impacting physician preferences.
- Amicus Therapeutics Inc (FOLD) is still in the process of securing reimbursement and launching Pombiliti and Opfolda in additional European countries, which may affect short-term revenue growth.
Q & A Highlights
Q: How should we think about the cadence of the Europe launch versus the US launch, given the differences in label languages?
A: Bradley Campbell, President and CEO, explained that both markets are progressing well, with the US being the largest single market. The rate of new patients in the US will remain strong, while Europe will see growth as new countries are added. The label differences mean that in Europe, patients are switching from both Myozyme and Nexviazyme, while in the US, switches are predominantly from Nexviazyme.
Q: What are the trends in the US regarding patients switching from Nexviazyme to PomOp, particularly concerning the average length of time on Nexviazyme before switching?
A: Bradley Campbell noted that most patients switching from Nexviazyme have been on treatment for one to two years. This aligns with expectations and reflects a large pool of patients available for targeting. Some patients switch earlier due to positive experiences shared within the community.
Q: Regarding the Galafold guidance increase, is there any regional variation in growth?
A: Bradley Campbell and Sébastien Martel, Chief Business Officer, highlighted strong growth across key markets, particularly in the US, where there is a high demand for Galafold among newly diagnosed patients. The US has seen the highest number of new patients in five years, and similar growth patterns are observed in Europe and Japan.
Q: Is there a preference among physicians to switch patients from Myozyme to Nexviazyme before considering PomOp?
A: Bradley Campbell clarified that there is no preference for switching to Nexviazyme first. The observed dynamics are due to Nexviazyme's earlier approval. In Europe, switches occur equally from both Myozyme and Nexviazyme, reflecting good progress with the PomOp launch.
Q: Can you comment on the prescriber mix for Pombiliti and Opfolda, particularly between larger academic centers and community settings?
A: Bradley Campbell noted a 50% increase in global prescribers, indicating strong uptake. In concentrated markets like the UK, all key centers are prescribing. In larger markets like Germany and the US, there is significant penetration among top prescribers, with increasing prescriptions from more distal physicians as well.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
