Amicus' Q3 Earnings Beat, Higher Product Sales Drive Y/Y Revenues

Amicus Therapeutics FOLD reported adjusted earnings of 17 cents per share for the third quarter of 2025, which beat the Zacks Consensus Estimate of 12 cents. The company had reported adjusted earnings of 10 cents per share in the year-ago quarter.

Revenues in the third quarter totaled $169.1 million, up 19% year over year on a reported basis and 17% at constant exchange rates (CER). The figure beat the Zacks Consensus Estimate of $165 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.

Amicus achieved positive GAAP net income in the third quarter of 2025.

Year to date, shares of Amicus have declined 4.5% against the industry’s 10.9% rise.

FOLD's Q3 Earnings in Detail

Galafold sales totaled $138.3 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 $150 million but beat our model estimate of $134.9 million.

Net product sales of Pombiliti + Opfolda were $30.7 million. The reported figure beat the Zacks Consensus Estimate of $29.7 million as well as our model estimate of $29.4 million.

Adjusted operating expenses rose 15% to $95.4 million in the third quarter of 2025.

As of Sept. 30, 2025, Amicus had cash, cash equivalents and marketable securities worth $263.8 million compared with $231 million as of June 30, 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 revenues are 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 continues to expect 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

Amicus licensed exclusive rights for the commercialization of Dimerix’s phase III program, DMX-200, in the United States in May 2025. 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 & Other Stocks to Consider

Amicus currently carries a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the biotech sector are Alkermes ALKS, CorMedix CRMD and Exact Sciences EXAS, each carrying a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Alkermes’ earnings per share have increased from $1.78 to $1.96 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.69 to $1.77. Year to date, shares of ALKS have risen 5.7%.

Alkermes’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 4.58%.

In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.24 to $1.85 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.09 to $2.49. Year to date, shares of CRMD have rallied 40.9%.

CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 34.85%.

In the past 60 days, estimates for Exact Sciences’ earnings per share have increased from 33 cents to 40 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.29 to $1.34. Year to date, shares of EXAS have gained 23.8%.

Exact Sciences’ earnings beat estimates in each of the trailing four quarters, the average surprise being 352.28%.

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