Amicus Therapeutics FOLD reported first-quarter 2025 adjusted earnings of 3 cents per share, which missed the Zacks Consensus Estimate of 8 cents. The company had reported a loss of 2 cents per share in the year-ago quarter.(Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)

Revenues totaled $125.2 million, up 13% year over year on a reported basis and 15% on a constant-currency (cc) basis. The figure missed the Zacks Consensus Estimate of $136 million. The top line comprised sales of Galafold (migalastat), which is approved for Fabry disease, and the newly approved combo drug, Pombiliti + Opfolda.

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

The top line increased year over year owing to higher revenues from Galafold and incremental revenues from the sale of Pombiliti + Opfolda. Both Fabry and Pompe are rare diseases. Amicus is currently advancing ongoing studies to broaden labels in Fabry and Pompe diseases.

Shares of Amicus were down 13% on May 1 following the earnings release.

In the past year, shares of Amicus have plunged 29% compared with the industry’s decline of 2.7%.Zacks Investment Research

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More on FOLD's Q1 Results

Galafold sales totaled $104.2 million, up 6% year over year at cc. Strong patient demand of 14% in the quarter was partially offset by order timing and the ongoing impact of the higher-than-anticipated VPAG (Voluntary Scheme for Branded Medicines Pricing and Access) rebate in the U.K.

The top line missed the Zacks Consensus Estimate of $113 million and also our model estimate of $114.3 million.

Net product sales of Pombiliti + Opfolda were $21 million. The figure missed the Zacks Consensus Estimate of $23 million and our model estimate of $25.1 million.

Sales reflected the timing of patient starts in new launch countries and the ongoing impact of the higher-than-anticipated VPAG rebate in the U.K.

Operating expenses rose 10.4% to $94.5 million in the first quarter of 2025.

As of March 31, 2025, Amicus had cash, cash equivalents and marketable securities worth $250.6 million compared with $249.9 million as of Dec. 31, 2024.

FOLD’s 2025 Guidance Updated

For full-year 2025, management now expects total revenues to grow in the range of 15-22% on a constant exchange rate (CER) (previous guidance: 17% to 24%).

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

However, the company now expects Pombiliti + Opfolda revenue growth of 50-65% at CER (previous guidance: 65-85%). FOLD expects the benefit of patient starts in new launch markets to be more weighted toward the second half of the year.

Story Continues

Total adjusted operating expenses are expected to be in the band of $380-$400 million (previous guidance: $350-$370 million).

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

Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise

Amicus Therapeutics, Inc. price-consensus-eps-surprise-chart | Amicus Therapeutics, Inc. Quote

FOLD’s Other Updates

Amicus has licensed exclusive rights for the commercialization of Dimerix’s phase III program, DMX-200, in the United States. The candidate is a first-in-class treatment for FSGS, a rare and fatal kidney disease with no approved therapies and significant market potential.

FOLD will make an upfront payment of $30 million to Dimerix. The latter is also entitled to receive up to $560 million for success-based milestone payments, in addition to tiered royalties on DMX-200 net sales in the United States.

In October 2024, Amicus signed a licensing agreement with Teva Pharmaceuticals TEVA, resolving the patent lawsuit that it had 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.

FOLD’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are ADMA Biologics Inc ADMA and Beam Therapeutics Inc BEAM, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025.

During the same period, EPS estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 39.7%.

ADMA’s earnings beat estimates in three of the trailing four quarters and missed the same in the remaining one, the average surprise being 32.80%.

In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.45 to $4.27 for 2025. During the same period, loss per share estimates for 2026 have narrowed from $4.94 to $4.80. BEAM’s earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 3.92%.

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