Will Galafold Be Able to Aid FOLD's Top Line Heading Into Q4 Earnings?

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 disease in patients who have amenable genetic variants. The drug is approved in several countries across the world, including the United States, the European Union, the United Kingdom and Japan. Galafold has been a key top-line driver for the company in recent quarters.

In the first nine months of 2025, Galafold generated sales worth $371.5 million, which increased around 12% on a year-over-year basis. The drug contributed more than 80% of Amicus’ net product sales during the same time. As Amicus is gearing up to report its fourth-quarter results, investors will be closely watching the sales performance of Galafold.

Galafold sales are likely to have been driven by strong commercial execution in all markets as well as strong compliance. The drug also has a strong IP portfolio in the United States, providing patent protection through 2038.

Meanwhile, the recent settlement of the Galafold patent litigation with Teva Pharmaceuticals TEVA marks a significant step forward in Amicus' efforts to support Galafold.

In October 2024, Amicus signed a licensing agreement with Teva, resolving the patent lawsuit that it had filed earlier. Per the settlement terms, TEVA will not be able to sell its generic version of Galafold in the United States until January 2037.

Sales are expected to grow steadily as Amicus is looking to expand its commercial footprint, driving continued momentum for Galafold.

Besides Galafold, Amicus is also making good progress with Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), a two-component therapy, which is approved for treating adults with late-onset Pompe disease.

In the first nine months of 2025, the combo drug generated sales worth $77.5 million, up around 61% on a year-over-year basis. The approval of Pombiliti + Opfolda helped FOLD tap into a market with a significant commercial opportunity. Incremental contributions from Pombiliti + Opfolda should also aid Amicus’ top line in the fourth quarter.

Amicus is set to be acquired by BioMarin for $4.8 billion. The transaction is expected to be closed in the second quarter of 2026.

FOLD’s Competition in the Target Market

Though Amicus is riding on the success of Galafold, the company’s heavy reliance on the drug for revenues remains a concern. Rising competition in the target market also remains a headwind, as several companies currently market and sell products for treating lysosomal storage disorders, including Fabry disease.

Sanofi SNY markets Fabrazyme, which is approved for treating Fabry disease. Japan-based Takeda Pharmaceuticals’ Replagal is also indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.

Sanofi also markets its Pompe disease drugs, Myozyme/Lumizyme, as well as Nexviazyme. Stiff competition from established players in the target market also remains a concern for Amicus, whose resources are limited compared with a large drugmaker like SNY.

FOLD’s Price Performance, Valuation and Estimates

In the past six months, shares of Amicus have rallied 135.6% compared with the industry’s growth of 21.5%.

From a valuation standpoint, Amicus is trading at a premium to the industry. Going by the price-to-sales (P/S) ratio, the company’s shares currently trade at 7.39, higher than 2.43 for the industry. The stock is trading below its five-year mean of 8.89.

The Zacks Consensus Estimate for 2025 earnings per share (EPS) has increased from 31 cents to 35 cents over the past 60 days. During the same time frame, EPS estimates for 2026 have declined from 70 cents to 65 cents.

FOLD’s Zacks Rank

Amicus currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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