Amicus (FOLD) Q2 Revenue Jumps 22%

Core Insights - Amicus Therapeutics reported strong quarterly results for Q2 2025, exceeding expectations in both GAAP revenue and non-GAAP earnings, with GAAP revenue of $154.7 million, a 22.1% increase year-over-year, and non-GAAP EPS of $0.01, significantly better than the estimated –$0.12 [1][2] Financial Performance - GAAP revenue reached $154.7 million, up from $126.7 million a year earlier, surpassing the analyst target of $146.7 million [1][2] - Non-GAAP EPS was $0.01, compared to an estimate of –$0.12 and a previous year EPS of $0.06, reflecting an 83.3% decline year-over-year [2] - Galafold revenue was $128.9 million, a 16.3% increase from $110.8 million in Q2 2024 [2][5] - Pombiliti + Opfolda revenue increased by 62.8% to $25.8 million, up from $15.9 million a year earlier [2][6] - Non-GAAP operating expenses rose to $127.8 million, a 55.7% increase from $82.1 million in the previous year [2][8] Business Focus and Strategy - Amicus Therapeutics specializes in treatments for rare diseases, particularly genetic disorders, with key products being Galafold for Fabry disease and Pombiliti + Opfolda for Pompe disease [3] - The company is focused on broadening patient access, securing regulatory approvals, and expanding into related rare disease therapies [4] - The majority of sales are driven by Galafold, which is now approved in over 40 countries, with high global patient demand [5] Recent Developments - The company licensed U.S. rights for DMX-200, a late-stage drug for focal segmental glomerulosclerosis, paying a $30 million upfront fee [7] - Operating expenses increased due to the licensing payment and ongoing investments in research and development [8] Financial Outlook - Amicus reaffirmed its 2025 revenue growth outlook of 15–22% at constant exchange rates, with Galafold projected to grow 10–15% and Pombiliti + Opfolda expected to increase 50–65% [9] - The company anticipates gross margin to normalize in the mid-80% range for 2025 and aims for positive GAAP net income in the second half of 2025 [9] Key Monitoring Points - Investors should watch for progress in new country launches for Pombiliti + Opfolda, patient onboarding, and any changes in operating expenses or regulatory landscapes that could impact growth [10]