Amicus Therapeutics Stock Earnings Reports

Amicus reported a strong Q3 2025: total revenue was $169.1M (up 19% YoY, +17% at CER), driven by continued double‑digit growth in core product Galafold and rapid launch momentum for Pompe products Pombiliti/Opfolda. Galafold: $138.3M, +12% at CER, with 13% YoY patient growth and ~69% share of treated Fabry patients with amenable mutations; management expects continued runway from undiagnosed/untreated populations. Pombiliti/Opfolda: $30.7M, +42% at CER, strong U.S. and ex‑U.S. uptake, reimbursement in 15 countries (Japan, Belgium, Ireland, Luxembourg added), and management reiterates full‑year product growth guidance of 50–65% (CER). Clinical and real‑world evidence supporting PomOp differentiation continues to accumulate (4‑year PROPEL extension data, independent switch data). DMX‑200 (licensed from Dimerix) is a late‑stage Phase III FSGS asset with ACTION3 >90% enrolled and on track for year‑end enrollment; FDA alignment on proteinuria as primary endpoint. Financials: GAAP net income of $17.3M in Q3 (first profitable quarter in 2025), non‑GAAP net income $54.2M, cash and marketable securities $263.8M (Sep 30, 2025). Company reiterated 2025 guidance: total revenue growth 15–22% (CER), Galafold 10–15%, PomOp 50–65%; gross margin mid‑80s; non‑GAAP operating expenses $380–400M (likely at high end); and positive GAAP net income expected for H2 2025. Key investor takeaways: strong commercial execution with durable growth drivers for both franchises, improving profitability and cash generation, clear path to $1B combined product sales by 2028, and near‑term value potential from DMX‑200 Phase III. Risks include execution on continued launches/reimbursements, label expansions (pediatrics/IOPD), manufacturing/regulatory considerations, and typical clinical and market risks.