FOLD Q2 Earnings Miss Mark, Revenues Beat on Higher Product Sales

Amicus Therapeutics FOLD reported adjusted earnings of 1 cent per share for the second quarter of 2025, which missed the Zacks Consensus Estimate of 2 cents. The company had incurred a loss of 6 cents per share in the year-ago quarter.

Revenues in the second quarter totaled $154.7 million, up 22% year over year on a reported basis and 18% at constant exchange rates (CER). The figure beat the Zacks Consensus Estimate of $148 million. The top line comprised sales of Galafold (migalastat), which is approved for Fabry disease, and the newly approved combo drug, Pombiliti + Opfolda.

Pombiliti + Opfolda, a two-component therapy, is approved for treating late-onset Pompe disease.

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.

Year to date, shares of Amicus have declined 36.4% against the industry’s 1.5% rise.

FOLD's Q2 Earnings in Detail

Galafold sales totaled $128.9 million, up 12% year over year at CER. The sale of the drug was driven by new patient starts, continued commercial execution in all markets and strong compliance.

Galafold sales missed the Zacks Consensus Estimate of $133 million but beat our model estimate of $123.4 million.

Net product sales of Pombiliti + Opfolda were $25.8 million. The reported figure beat the Zacks Consensus Estimate of $24 million as well as our model estimate of $25 million.

Adjusted operating expenses rose 56% to $127.8 million in the second quarter of 2025. The uptick was due to an upfront payment of $30 million made to Dimerix for licensing exclusive rights to DMX-200 in the United States.

As of June 30, 2025, Amicus had cash, cash equivalents and marketable securities worth $231 million compared with $250.6 million as of March 31, 2025.

FOLD's 2025 Guidance

Amicus maintained its financial guidance for 2025, which it had provided earlier this year.

The company continues to expect total revenues to grow in the range of 15-22% at CER for full-year 2025.

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

Pombiliti + Opfolda revenue is still expected to grow in the range of 50-65% at CER.

Total adjusted operating expenses are expected to be in the band of $380-$400 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.

FOLD's Recent Developments

In May 2025, Amicus 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 blockbuster potential. Currently, there are no FDA-approved treatments for FSGS.

The pivotal phase III ACTION3 study (funded and executed by Dimerix) is progressing well and remains on track for full enrollment by 2025-end.

Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise

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

FOLD's Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Arvinas ARVN, CorMedix CRMD and Immunocore IMCR, 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 Arvinas’ 2025 loss per share have narrowed from $1.60 to $1.50. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 61.2% year to date.

Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.

In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 43.3%.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%.

In the past 60 days, estimates for Immunocore’s 2025 loss per share have narrowed from 86 cents to 68 cents. Loss per share estimates for 2026 have narrowed from $1.34 to $1.10 during the same period. IMCR stock has increased 11.1% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%.

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

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