Key Takeaways Galafold raked in $371.5M in the first nine months of 2025, accounting for over 80% of FOLD's product sales.Galafold benefits from broad global approvals and U.S. patent protection extending through 2038.FOLD's Pombiliti Opfolda delivered $77.5M sales in the first nine months of 2025, up 61% Y/Y.Amicus Therapeutics (FOLD) has made solid progress with its lead marketed product, Galafold (migalastat), which generates the majority of the company’s revenues.Galafold is approved for treating Fabry ...

Key Takeaways FOLD touched a 52-week high as shares rally 87.6% in six months, beating the industry, sector and S&P 500.Galafold is the key revenue driver, generating $371.5M in the first nine months of 2025, up 12% Y/Y.Pombiliti Opfolda sales reached $77.5M in the first nine months of 2025, reflecting 61.5% y/y growth.Shares of Amicus Therapeutics (FOLD) touched a 52-week high of $11.14 on Dec. 15. The stock is currently trading at $10.88.Shares of Amicus have surged 87.6% in the past six months compared w ...

Key Takeaways FOLD's Galafold delivered $371.5M in the first nine months of 2025, up 12% year over year.Patent settlement with Teva blocks Galafold generics in the United States until January 2037.FOLD's Pombiliti Opfolda earned $77.5M in nine-month 2025 sales, rising 61.5% year over year.Amicus Therapeutics (FOLD) has been making meaningful progress with its lead product, Galafold (migalastat), which has been driving the majority of the company’s revenues. The drug has remained a key top-line driver for Am ...

Core Insights - Amicus Therapeutics' lead product, Galafold, is the primary revenue driver for the company, being the first oral precision medicine approved for Fabry disease treatment [1][2] - Galafold sales reached $233.1 million in the first half of 2025, reflecting an 11% year-over-year increase, with a projected CAGR of 11.7% over the next three years [2][9] - The company has secured strong patent protection for Galafold in the U.S. until 2038, following a licensing agreement with Teva Pharmaceuticals that prevents generic competition until January 2037 [3][4][9] Product Performance - Galafold has shown consistent sales growth since its launch, with label expansions and approvals in new regions contributing to its revenue increase [2][3] - The combination therapy Pombiliti + Opfolda for late-onset Pompe disease generated $46.8 million in sales during the first half of 2025, marking a 74% year-over-year increase [5] Market Dynamics - Amicus is heavily reliant on Galafold for revenue, which poses risks if regulatory challenges arise [6] - The company faces significant competition from established players in the lysosomal storage disorder market, including Sanofi and Takeda Pharmaceuticals, which market products for Fabry and Pompe diseases [7][8]

Summary of Amicus Therapeutics Conference Call Company Overview - **Company**: Amicus Therapeutics - **Industry**: Biotechnology, specifically focusing on rare diseases and therapies Key Points and Arguments Macro Environment and Regulatory Impact - Recent executive orders, particularly the most favored nation (MFN) pricing, could impact Amicus's revenue structure, with approximately 60% of Galafold's revenue coming from outside the US and 40% from within, including Medicare and Medicaid exposure [4][5][6] - Tariffs are not expected to significantly affect Amicus in 2025 due to existing inventory and a transition from China to Ireland for manufacturing [7][8][10] Product Performance and Market Dynamics - **Galafold**: Expected to surpass $500 million in sales this year, driven by growth in the US, Germany, and the UK, with a focus on diagnosing underdiagnosed Fabry disease [15][16][20] - The company is leveraging AI to identify potential Fabry patients through medical records, which could enhance patient diagnosis and treatment [17][18] - The amenability rate for Galafold is projected to increase to over 50% in new patient diagnoses, enhancing market share [20][21] Growth Strategy - Future growth will primarily come from diagnosing new patients rather than switching existing patients from other treatments [19][24] - There is a significant pool of diagnosed but untreated patients, estimated at 6,000 to 7,000, which presents an opportunity for growth [24][25] Pompe Disease Treatment - **Pompe Disease**: The company anticipates a revenue growth guidance of 50% to 65%, with April showing the strongest demand since launch [31][32] - The company is expanding into new reimbursed markets like Italy and the Netherlands, with a focus on existing markets for growth [33][34] - Transitioning patients from existing therapies to Amicus's products is expected to accelerate as more data becomes available [38][39] Acquisition Strategy - Amicus is pursuing a cautious acquisition strategy, focusing on in-licensing products that align with its existing portfolio, such as DMX 200, which targets FSGS [53][54][58] - The acquisition of DMX 200 is seen as a strategic move to leverage existing infrastructure and address a significant unmet medical need in the US market [58][59] Financial Outlook - The company aims to achieve GAAP profitability while managing risks associated with new acquisitions and product launches [60] Additional Important Insights - The company is focused on balancing shareholder interests with growth opportunities, avoiding over-dilution while pursuing strategic investments [55][56] - There is a strong emphasis on educating physicians about the benefits of switching to Amicus's therapies, particularly in the context of progressive diseases like Pompe [47][48] This summary encapsulates the key discussions and insights from the Amicus Therapeutics conference call, highlighting the company's strategic direction, product performance, and market opportunities.