Amicus Therapeutics (FOLD) 6 Nov 24 2024 Q3 Earnings call transcript

Amicus Therapeutics reported a robust financial performance and significant milestones in the third quarter of 2024, highlighting a promising outlook for the company. The earnings call, led by CEO Bradley Campbell and key executives, provided insights into the company's strategic initiatives and financial health.

Strong Commercial Execution and Financial Performance

Amicus Therapeutics achieved a total revenue of $142 million in the third quarter, representing a 37% year-over-year growth. This strong performance is attributed to the excellent commercial execution of its flagship product, Galafold, which generated $120 million in global revenue. The company is now projecting total revenue growth of 30% to 32% for the full year, with Galafold revenue growth expected to be 16% to 18%. These figures underscore Amicus's commitment to delivering transformative therapies and its focus on enhancing patient outcomes.

Galafold's Outstanding Performance and Market Share

Galafold's performance continues to be a standout, with global revenue growth of 19% at constant currency and a 60% market share of treated Fabry patients with amenable mutations. The company's focus on both switch and naive populations across key markets has resulted in sustained demand and compliance rates above 90%. This strong market positioning sets the stage for Galafold to serve as the foundation of Amicus's business for the next decade and beyond.

Commercial Launch of Pombiliti and Opfolda

The commercial launch of Pombiliti and Opfolda, Amicus's novel therapy for late-onset Pompe disease, is a significant driver of growth. The therapy has shown exceptional progress, with a rate of new commercial patients coming on to the therapy increasing exceptionally well. The company is focused on maximizing patient access, and the launch has been successful in the U.S., Europe, and the U.K., with strong switch dynamics and uptake in naive patients outside the U.S. This launch represents a major milestone for Amicus, further solidifying its position in the market.

Regulatory and Intellectual Property Milestones

Amicus also achieved key regulatory and intellectual property milestones. The license agreement with Teva for the marketing of a generic version of Galafold in the U.S. starting in 2037 reinforces the strength of Amicus's IP estate and underscores the company's commitment to supporting the Fabry community with Galafold for years to come. Additionally, the recent submission of a Japan New Drug Application for Pombiliti and Opfolda highlights Amicus's dedication to expanding commercial access through regulatory submissions.

Looking Ahead

Amicus Therapeutics is poised for continued growth, with a focus on sustaining double-digit Galafold revenue growth, successfully executing multiple commercial launches, and advancing ongoing studies to support medical and scientific leadership in Fabry and Pompe diseases. The company's strong financial position and strategic initiatives position it well for future success.

In conclusion, Amicus Therapeutics' third-quarter 2024 financial results and strategic milestones underscore the company's commitment to delivering transformative therapies and enhancing patient outcomes. The strong performance of Galafold and the successful commercial launch of Pombiliti and Opfolda, coupled with strategic regulatory and intellectual property achievements, set the stage for Amicus to continue making a meaningful impact in the rare disease landscape.