Amicus Therapeutics' Galafold Drives Strong Revenue Growth Amid Pending $4.8B BioMarin Acquisition
Key Insights
Galafold (migalastat) generated $371.5 million in sales during the first nine months of 2025, representing a 12% year-over-year increase and contributing over 80% of Amicus Therapeutics' net product revenues.
The company secured patent protection for Galafold through 2038 and reached a settlement with Teva Pharmaceuticals preventing generic competition until January 2037.
Amicus' combination therapy Pombiliti + Opfolda for late-onset Pompe disease (search) showed robust growth with $77.5 million in sales, up 61% year-over-year.
Amicus Therapeutics has demonstrated strong commercial momentum with its lead product Galafold (migalastat), which continues to drive the majority of the company's revenues as it prepares for a $4.8 billion acquisition by BioMarin expected to close in the second quarter of 2026.
Galafold Maintains Strong Commercial Performance
Galafold, approved for treating Fabry disease (search) in patients with amenable genetic variants, generated $371.5 million in sales during the first nine months of 2025, representing approximately 12% year-over-year growth. The drug contributed more than 80% of Amicus' net product sales during this period and is approved in multiple markets including the United States, European Union, United Kingdom, and Japan.
The company's financial models project a compound annual growth rate (CAGR) of 10.4% for Galafold sales over the next three years, driven by strong commercial execution across all markets and robust patient compliance. The drug benefits from a strong intellectual property portfolio in the United States, providing patent protection through 2038.
Patent Settlement Secures Market Position
In October 2024, Amicus resolved a significant patent litigation with Teva Pharmaceuticals through a licensing agreement. The settlement prevents Teva from selling its generic version of Galafold 123 mg capsules in the United States until January 2037, providing substantial protection for the company's primary revenue driver.
The litigation had arisen after Teva submitted an abbreviated new drug application seeking approval to market a generic version of Galafold before the related patents expired.
Pompe Disease Portfolio Shows Rapid Growth
Beyond Galafold, Amicus has achieved notable success with its two-component therapy Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for treating adults with late-onset Pompe disease (search). During the first nine months of 2025, this combination therapy generated $77.5 million in sales, representing approximately 61.5% year-over-year growth.
The approval of Pombiliti + Opfolda has enabled Amicus to access a market with significant commercial opportunity, providing an additional revenue stream beyond its Fabry disease (search) franchise.
Competitive Landscape Challenges
Despite its commercial success, Amicus faces increasing competition in the lysosomal storage disorder market. Sanofi markets Fabrazyme for Fabry disease (search) treatment, while Takeda Pharmaceuticals (search) offers Replagal for long-term enzyme replacement therapy in confirmed Fabry disease patients.
In the Pompe disease (search) market, Sanofi competes directly with its established products Myozyme/Lumizyme and Nexviazyme. The competition from these larger pharmaceutical companies with greater resources remains a concern for Amicus' market position.
Financial Performance and Market Valuation
Amicus shares have gained 5.7% year-to-date, underperforming the industry's 20% growth. However, over the past six months, the stock has rallied 135.6% compared to the industry's 21.5% increase, likely reflecting investor optimism around the pending BioMarin acquisition.
From a valuation perspective, Amicus trades at a premium to the industry with a price-to-sales ratio of 5.16-7.39, compared to the industry average of approximately 2.43-2.49. The stock currently trades below its five-year mean valuation range.
Analyst estimates for 2025 earnings per share have increased from 31 cents to 35-36 cents over the past 60 days, while 2026 estimates have declined slightly from approximately 70 cents to 65-67 cents.