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We expect investors to focus on the sales performance of Amicus Therapeutics’ FOLD lead marketed drug, Galafold (migalastat), which is approved for Fabry disease, when the company reports first-quarter 2025 results on May 1, before market open.
The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $135.6 million, while the same for earnings is pegged at 8 cents per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar)
Year to date, shares of Amicus have plunged 26.6% compared with the industry’s decline of 8.7%.
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Factors Shaping FOLD's Upcoming Results
Amicus’ top line comprises sales of Galafold and the relatively new combo drug, Pombiliti + Opfolda. The FDA approved Pombiliti + Opfolda, a two-component therapy for treating late-onset Pompe disease, in September 2023.
In the last reported quarter, revenues increased year over year owing to higher revenues from Galafold sales and incremental revenues from the sale of Pombiliti + Opfolda. This is likely to have continued in the to-be-reported quarter.
Galafold sales increased year over year in the last reported quarter, driven by continued strong demand, a trend most likely to have continued in the first quarter.
The Zacks Consensus Estimate for Galafold’s first-quarter sales is pegged at $113 million.
Net product sales of Pombiliti + Opfolda also increased sequentially in the last reported quarter, a trend most likely to have continued in the to-be-reported quarter.
Both Fabry disease and Pompe disease are rare diseases. Amicus has been advancing ongoing studies to broaden labels in Fabry and Pompe diseases. Investors will be keen to get more updates on the same during the upcoming earnings call.
Activities related to label expansion studies and other development activities might have escalated operating expenses in the to-be-reported quarter.
Earnings Surprise History
Amicus has a mixed history of earnings surprises. The company beat on earnings in three of the trailing four quarters while missing the same on the remaining occasion, delivering an average surprise of 45.42%. In the last reported quarter, FOLD delivered a negative earnings surprise of 10.00%.
Amicus Therapeutics, Inc. Price and EPS Surprise
Amicus Therapeutics, Inc. price-eps-surprise | Amicus Therapeutics, Inc. Quote
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Amicus this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.