Amicus Therapeutics (FOLD) investor relations material

Business performance and growth outlook

• Achieved over $150 million in Q2 sales, with strong momentum in both Galafold and Pompe therapies.

• Galafold guided for 10–15% growth in 2025; Pompe therapies expected to grow 50–65%.

• Anticipates reaching GAAP profitability for the first time in 2025, marking a key inflection point.

• Operating leverage expected to increase as OpEx grows at low to mid-single digits, supporting margin expansion.

• Focus remains on late-stage assets and accretive business development to accelerate growth.

Product updates and market dynamics

• Galafold maintains double-digit growth, driven by new patient identification, especially among women and late-onset Fabry cases.

• Pompe therapy expanding rapidly, with launches in multiple new countries and strong uptake in concentrated markets like the Netherlands.

• US Pompe market acceleration expected as more patients reach two years on competing therapy and consider switching.

• No significant payer or logistical barriers for Pompe therapy; focus is on physician and patient education to shift expectations toward improvement.

• Real-world and clinical data continue to support the differentiated profile and durability of Pompe therapy.

Regulatory, intellectual property, and reimbursement

• Ongoing engagement with FDA for pediatric studies and potential label expansion for Pompe therapy.

• Galafold patent settlement with Teva supports protection through January 2037; additional patents extend into the 2040s.

• UK rebate rate for 2025 set at 22.9%, with limited expected year-over-year impact; future rates assumed stable.

• Tariffs and US government pricing reforms considered manageable, with rare disease carve-outs likely.