Amicus Therapeutics(US:FOLD)2024-08-09 13:57Financial Data and Key Metrics Changes - Total revenue for Q2 2024 reached $127 million, representing a 34% year-over-year growth or 36% on a constant currency basis [6][30] - The company has increased its total revenue guidance for the full year to 26% to 31%, up from the previous range of 25% to 30% [6][32] - Non-GAAP net income for Q2 was $18 million or $0.06 per share, compared to a loss of $20 million or $0.07 per share in the same period last year [32] Business Line Data and Key Metrics Changes - Galafold generated $111 million in global revenue for the quarter, reflecting a 19% growth year-over-year on a constant currency basis [7][14] - Pombiliti and Opfolda reported revenue of $16 million for Q2 2024, marking a 44% increase compared to Q1 2024 [20][21] Market Data and Key Metrics Changes - The U.S. market saw the highest number of net new patients for Galafold in over five years, indicating strong demand [14][19] - The company holds over 60% of the global market share for treated Fabry patients with amenable mutations [13][14] Company Strategy and Development Direction - The company aims to sustain double-digit revenue growth for Galafold and maximize the number of patients on therapy for Pombiliti and Opfolda by year-end [13][24] - Amicus is focused on expanding into new markets and enhancing patient access through reimbursement efforts [10][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year non-GAAP profitability in 2024, supported by strong commercial execution and revenue growth [12][33] - The company anticipates continued growth driven by increased patient identification and improved diagnosis in the Fabry market [18][63] Other Important Information - The Swissmedic approved Pombiliti and Opfolda for adults with late-onset Pompe disease in July 2024 [11][22] - The company has narrowed its full-year 2024 non-GAAP operating expense guidance to $345 million to $360 million [33] Q&A Session Summary Question: How should the cadence of the Europe launch be compared to the U.S. launch? - Management noted that both markets are progressing well, with the U.S. expected to see a stronger rate of new patients due to its size, while Europe is adding new countries and gaining traction [36] Question: What trends are seen in patients switching from Nexviazyme? - The majority of patients switching from Nexviazyme have been on treatment for one to two years, with some switching earlier due to positive word-of-mouth [42] Question: Are there regional variations in Galafold growth? - Strong growth is observed in all key markets, particularly in the U.S. and Japan, with a growing proportion of newly diagnosed patients being treated with Galafold [46][49] Question: What is the current status of the Pom-Opf launch? - The rate of new patients is expected to build momentum as new countries are opened, with a focus on maximizing the number of patients on therapy by year-end [52] Question: How is the competitive landscape with Genzyme's Nexviazyme? - Management emphasized the unique efficacy of Pombiliti and Opfolda, highlighting improvements shown in clinical trials compared to competitors [55][56] Question: What is the status of insurance coverage for Opfolda? - There have been no reported denials for coverage of either component, with improvements in the time from prescription to infusion [59]