Can FOLD's Product Pipeline Drive Revenue Growth Before Year-End Earnings?

Amicus Therapeutics FOLD continues to demonstrate solid commercial execution, with its flagship treatment portfolio becoming increasingly central to investor expectations ahead of fourth-quarter results. The company operates in a competitive landscape focused on rare genetic disorders, including conditions like Fabry disease and other lysosomal storage disorders that require specialized therapeutic solutions like cipa disorder treatments.

Market Competitive Pressures Shape FOLD’s Growth Narrative

The pharmaceutical market for rare lysosomal storage disorders has become increasingly crowded. Sanofi SNY maintains a strong position with Fabrazyme approved for Fabry disease treatment, while Takeda Pharmaceuticals markets Replagal for the same indication. Sanofi also controls significant market share in Pompe disease therapy through Myozyme/Lumizyme and Nexviazyme. This competitive environment underscores Amicus’ challenge: the company must maximize its commercial footprint while competing against well-established players with substantially larger resources.

Galafold Remains the Revenue Powerhouse

Galafold (migalastat) continues to be the cornerstone of Amicus’ financial performance. The drug is indicated for Fabry disease patients with amenable genetic variants and maintains regulatory approvals across the United States, European Union, United Kingdom, and Japan. Through the first nine months of 2025, Galafold generated $371.5 million in sales, representing 12% year-over-year growth and accounting for over 80% of total net product revenues.

A critical catalyst for sustained growth came with the October 2024 licensing settlement with Teva Pharmaceuticals TEVA. The agreement blocks Teva’s generic entry into the U.S. market through January 2037, providing substantial patent protection alongside Galafold’s existing U.S. patent coverage extending to 2038. This regulatory moat positions Galafold to benefit from ongoing commercial expansion across all geographic markets.

Emerging Product Contributions Signal Diversification

Beyond Galafold, Amicus is gaining traction with Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), a dual-component therapy for late-onset Pompe disease. During the first nine months of 2025, this combination generated $77.5 million in sales, demonstrating impressive 61% year-over-year momentum. As Amicus expands awareness and adoption of this therapy in the Pompe disease market—a space with substantial commercial opportunity—incremental revenue contributions are anticipated to bolster fourth-quarter performance.

Valuation Metrics and Stock Performance Context

Amicus’ equity has surged 135.6% over the past six months, substantially outpacing the broader industry’s 21.5% advance. From a valuation lens, the stock trades at a premium to peers, with a price-to-sales ratio of 7.39 versus 2.43 for the industry average, though this remains below its five-year mean of 8.89.

Analyst consensus has shown mixed directional movement: 2025 earnings per share (EPS) estimates have improved from 31 cents to 35 cents over the past 60 days, while 2026 EPS projections have declined from 70 cents to 65 cents. The stock currently maintains a Zacks Rank #1 (Strong Buy) designation.

Strategic Acquisition Adds Perspective

The announced acquisition by BioMarin for $4.8 billion, expected to close in Q2 2026, contextualizes the near-term investment thesis. Until the transaction completes, Galafold and the Pombiliti + Opfolda portfolio will continue driving quarterly results, making fourth-quarter revenue execution a critical data point for shareholders monitoring the company’s trajectory through the close.