AMICUS THERAPEUTICS, INC. Q2 FY2024 earnings call

Management Statement and Operational Highlights

• Commercial Execution: Total revenue in Q2 was $127 million, a 34% year-over-year growth (36% constant currency). Full-year total revenue guidance is raised to 26%-31% from 25%-30%. Galafold's strong performance led to raising its full-year growth guidance to 14%-18%.
• Product Launches: Pombiliti and Opfolda's global launch is progressing well. In Q2, there were the largest number of new commercial patients. Switzerland approved the therapy, Germany finalized negotiations, and Spain saw patient additions. The goal is to maximize patients on therapy by year-end.
• Financial Position: Amicus was non-GAAP profitable in Q2 and the first half of 2024. Full-year non-GAAP operating expense guidance is narrowed to $345 million to $360 million. Continues to invest in registry studies, Pompe Phase 3 study, and next-generation manufacturing.

Segment Performance

• Galafold: In the second quarter of 2024, Galafold generated global revenue of $111 million, representing 19% growth year-over-year on a constant currency basis. Operational growth was 19% at constant exchange rates. It holds over 60% global market share for treated Fabry patients with amenable mutations. Revenue contribution from Galafold is substantial, with strong performance in leading markets like the U.S., U.K., top EU countries, and Japan. The global mix for Galafold is about 42% switch and 58% naïve, with increasing uptake in naïve populations.
• Pombiliti and Opfolda: Q2 revenue was $16 million, a 44% increase from Q1 2024. In the U.S., it saw patients transitioning from clinical trials and switching from other therapies (e.g., ~68% from Nexviazyme). Outside the U.S., it has patients from switch (Myozyme, Nexviazyme) and naïve populations. Switzerland approved the therapy, Germany finalized key negotiations, and Spain added significant patients. Full-year guidance for Pombiliti and Opfolda is $62 million to $67 million.

Guidance

• Raised full-year total revenue guidance to 26%-31% from the previous 25%-30% range.
• Galafold's full-year revenue growth guidance is increased to 14%-18% from prior ranges.
• Pombiliti and Opfolda's full-year guidance remains $62 million to $67 million.
• Narrowed full-year non-GAAP operating expense guidance to $345 million to $360 million, with operating expense growth in low-single digits year-over-year at the midpoint.

Risks

• No specific detailed risks discussed, but general forward-looking statement risks and market uncertainties are mentioned in the opening, referencing the need to not unduly rely on forward-looking statements as they can be affected by various risks and uncertainties.

Question and Answer

Q: How should we be thinking about the cadence of the Europe launch versus how the U.S. launch is going?

A: The U.S. is the largest single market with strong new patient rates continuing, while Europe is adding new countries (e.g., Spain, Switzerland approval). Both markets are progressing well with key performance indicators going well.

Q: What are the patient switching trends in the U.S. for Pombiliti and Opfolda?

A: Majority switching from Nexviazyme, some from earlier in their journey, with word of mouth and positive experiences driving some earlier switches.

Q: Any regional variation in Galafold growth?

A: Strong growth in all key markets. U.S. has strong naïve patient growth, Japan has potential for growth as it's a large underpenetrated market.

Q: Inflection point for Pom-Opf patient addition in the back half of the year?

A: Building momentum, focusing on maximizing patients on therapy by year-end, with new countries in Europe contributing to growth.

Q: Competitive messaging for Pom-Opf?

A: Efficacy shown in Phase 3 with improvement in 6-minute walk and force vital capacity versus active comparator; educating on data showing improvements across multiple aspects.

Q: Galafold new patients and naïve uptake reasons?

A: Market growing due to better diagnosis through newborn screening, family screening, and medical education; increasing identification of diagnosed, untreated, and newly diagnosed patients.

Q: Prescriber mix for Pom-Opf?

A: Global number of prescribers increased by 50%, with breadth (new prescribers) and depth (existing prescribers adding more prescriptions) in prescribing, seen in various markets including U.K., U.S., and Germany.