AMICUS THERAPEUTICS, INC. Q1 FY2024 earnings call

Management Statement and Operational Highlights:

• Commercial Execution: Delivered strong total revenue of $110 million, a 28% year-over-year growth. Galafold continued strong performance with 16% Y/Y growth on a constant currency basis, within the high end of initial guidance.
• Pombiliti and Opfolda Launch: Strong global commercial launch with revenue of $11 million in Q1 2024. Rate of new commercial patients in 2024 is double that of 2023. Launched in Germany, Austria, U.K., U.S., and Spain. Reimbursed and launched in Spain ahead of expectations.
• Guidance Updates: Raised full-year 2024 Galafold revenue growth guidance to 13%-17%. Provided full-year guidance of $62M-$67M for Pombiliti and Opfolda sales. Confident in achieving full-year non-GAAP profitability in 2024.

Segment Performance:

• Galafold: In the first quarter of 2024, Galafold generated revenue of $99 million globally, representing 16% year-over-year growth on a constant currency basis. It contributed 90% of the total revenue of $110 million for the quarter. Galafold's revenue growth guidance for the full year 2024 was raised from 11%-16% to 13%-17%.
• Pombiliti and Opfolda: For the first quarter of 2024, revenue from Pombiliti and Opfolda was $11 million. The full-year guidance for Pombiliti and Opfolda sales is $62 million to $67 million.

Guidance:

• Full year 2024 total revenue growth is guided to 25% to 30%.
• Galafold's full-year revenue growth guidance raised from 11%-16% to 13%-17% at constant exchange rates.
• Pombiliti and Opfolda sales guidance for the full year is $62 million to $67 million.
• Full year 2024 non-GAAP operating expense guidance remains at $345 million to $365 million.

Risks:

• BIOSECURE Act: Uncertainty regarding the impact of the BIOSECURE bill on supply chain, including potential changes in manufacturing sources and raw material sourcing.
• Supply Chain: Need to mitigate risks related to supply chain, including ensuring sufficient supply and managing transition periods for manufacturing.

Question and Answer: Q: As you guys were constructing sort of the guidance for Pombiliti and Opfolda and you started looking at Street models, where did you see the biggest disconnect between your guidance and Street models, given that almost $30 million divergence there?

A: The biggest disconnect was in timing to get new patients through the insurance process in the U.S., rate of new commercial starts, and timing of launches in Europe. Now have the information needed to provide accurate guidance.

Q: In terms of your guidance, can you help us understand the assumptions that go into it for [indiscernible], specifically the mix between U.S. and ex U.S. revenues as patients start. What markets ex U.S. does this include sales force? And I guess just can you remind us what proportion of the EAP and clinical trial patients are now reimbursed versus the proportion of that are not yet reimbursed?

A: For Pombiliti and Opfolda, distribution of revenue between U.S. and Europe is weighted more towards Europe initially, but expected to move towards 40% from U.S. and balance from ex U.S. over time. Remaining EAP and clinical trial patients in Europe, with about 40 in Europe and 20 in countries expecting reimbursement later in the year.

Q: Can you talk more to what your goals are here? And any expectations that you have on how many patients you might be able to enroll on an annual basis? Especially when it comes to your goal of maximizing Pombiliti and Opfolda patients on treatment by year-end?

A: The registry serves to generate real-world evidence. It has purposes of post-marketing commitments and collecting real-world data on patient response. Plan is to have the registry in countries where commercial, with hundreds of patients, capturing data on safety and long-term real-world outcomes.