Amicus Therapeutics FOLD announced preliminary total revenues for the fourth quarter and full-year 2024. The company’s top line currently comprises sales of the lead product, Galafold (migalastat), which is approved for treating Fabry disease and Pombiliti + Opfolda.

The FDA approved Pombiliti + Opfolda, a two-component therapy for treating late-onset Pompe disease, in September 2023.

Along with the preliminary results, Amicus also outlined key strategic priorities and outlook for 2025.

In the past year, shares of Amicus have plunged 31.6% compared with the industry’s decline of 16%.

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FOLD's Strategic Goals and Outlook 2025

For full-year 2025, management expects total revenues to grow in the range of 17%-24% on a constant exchange rate (CER).

Revenues from Galafold are expected to grow in the range of 10%-15% at CER in 2025.

The company expects Pombiliti + Opfolda revenue growth of 65%-85% at CER for full-year 2025.

Both Fabry disease and Pompe disease are rare diseases. Amicus is currently advancing ongoing studies to broaden labels in Fabry and Pompe diseases.

Amicus expects to achieve positive GAAP net income in the second half of 2025. The company expects to exceed $1 billion in total sales in 2028.

FOLD Settles Galafold Patent Litigation

In October 2024, Amicus signed a licensing agreement with Teva Pharmaceuticals TEVA, resolving the patent lawsuit FOLD filed earlier.

The litigation arose after Teva submitted an abbreviated new drug application seeking approval to sell a generic version of Amicus' Galafold 123 mg capsules before the related patents expired.

Per the settlement terms, TEVA will not be able to sell its generic version of Galafold in the United States until January 2037.

The agreement also ended all ongoing litigation between Amicus and Teva concerning Galafold patents in the U.S. District Court for Delaware.

FOLD's Preliminary Results for 2024

Preliminary total revenues were $528.5 million in 2024, reflecting an increase of 32% year over year at CER. Total revenues were $149.9 million in the fourth quarter of 2024.

Preliminary Galafold net revenues were $458.2 million in 2024, reflecting an increase of 18% year over year at CER. Net Galafold revenues were $127.7 million in the fourth quarter of 2024.

Preliminary net product sales from Pombiliti + Opfolda were $70.3 million in 2024. Pombiliti + Opfolda net sales were $22.2 million in the fourth quarter of 2024.

Per management, several pricing and reimbursement agreements related to Pombiliti + Opfolda were achieved in late 2024 and early 2025.

FOLD's Zacks Rank & Stocks to Consider

Amicus currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are CytomX Therapeutics, Inc. CTMX and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CytomX Therapeutics’ loss per share have narrowed from 46 cents to 35 cents for 2025. In the past year, shares of CTMX have plunged 49.7%.

CTMX’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 115.70%.

In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 36%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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