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Amicus Therapeutics (FOLD - Free Report) reported fourth-quarter 2024 adjusted earnings of 9 cents per share, which missed the Zacks Consensus Estimate of 10 cents. The company had reported earnings of 1 cent per share in the year-ago quarter.
Revenues in the fourth quarter totaled $149.7 million, up 30% year over year on a reported basis and a constant-currency (cc) basis. The figure marginally beat the Zacks Consensus Estimate of $149 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 sales and incremental revenues from the sale of Pombiliti + Opfolda. Both Fabry disease and Pompe disease are rare diseases. Amicus is currently advancing ongoing studies to broaden labels in Fabry and Pompe diseases.
In the past year, shares of Amicus have plunged 29.5% compared with the industry’s decline of 8.1%.
Image Source: Zacks Investment Research
More on FOLD's Q4 Results
In the fourth quarter, Galafold sales were $127.5 million, up 20% year over year at cc, driven by continued strong demand. However, Galafold sales missed the Zacks Consensus Estimate of $141 million and also our model estimate of $127.7 million.
Weaker-than-expected Galafold sales could be the reason for the stock price to decline 2.9% on Feb. 19.
Net product sales of Pombiliti + Opfolda were $22.2 million, reflecting sequential growth of 5.2%. The figure narrowly missed the Zacks Consensus Estimate of $22.3 million and was in-line with our model estimate.
Per Amicus, as of the end of 2024, almost 220 patients were treated or are scheduled to be treated with the combo drug in five markets (the United States, Germany, the United Kingdom, Spain and Austria).
As of Dec. 31, 2024, Amicus had cash, cash equivalents and marketable securities worth $249.9 million compared with $249.8 million as of Sept. 30, 2024.
FOLD's Full-Year Results
For 2024, Amicus generated revenues of $528.3 million, reflecting a 33% increase year over year at cc.
For the same period, the company reported adjusted earnings of 24 cents per share against a loss of 13 cents per share reported in the year-ago period.
FOLD's 2025 Guidance
The company reiterated its total revenue guidance for 2025, which it had provided last month.
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.
Total adjusted operating expenses are expected in the band of $350-$370 million.
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.
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.
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $3.01 to $3.16 for 2025. In the past year, shares of HRMY have risen 6.9%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Pacira BioSciences’ earnings per share have increased from $2.79 to $3.46 for 2025. In the past year, shares of PCRX have decreased 12.8%.
PCRX’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 7.13%.
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FOLD's Q4 Earnings Miss, Higher Product Sales Drive Revenue Growth
Amicus Therapeutics (FOLD - Free Report) reported fourth-quarter 2024 adjusted earnings of 9 cents per share, which missed the Zacks Consensus Estimate of 10 cents. The company had reported earnings of 1 cent per share in the year-ago quarter.
See the Zacks Earnings Calendar to stay ahead of market-making news.
Revenues in the fourth quarter totaled $149.7 million, up 30% year over year on a reported basis and a constant-currency (cc) basis. The figure marginally beat the Zacks Consensus Estimate of $149 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 sales and incremental revenues from the sale of Pombiliti + Opfolda. Both Fabry disease and Pompe disease are rare diseases. Amicus is currently advancing ongoing studies to broaden labels in Fabry and Pompe diseases.
In the past year, shares of Amicus have plunged 29.5% compared with the industry’s decline of 8.1%.
Image Source: Zacks Investment Research
More on FOLD's Q4 Results
In the fourth quarter, Galafold sales were $127.5 million, up 20% year over year at cc, driven by continued strong demand. However, Galafold sales missed the Zacks Consensus Estimate of $141 million and also our model estimate of $127.7 million.
Weaker-than-expected Galafold sales could be the reason for the stock price to decline 2.9% on Feb. 19.
Net product sales of Pombiliti + Opfolda were $22.2 million, reflecting sequential growth of 5.2%. The figure narrowly missed the Zacks Consensus Estimate of $22.3 million and was in-line with our model estimate.
Per Amicus, as of the end of 2024, almost 220 patients were treated or are scheduled to be treated with the combo drug in five markets (the United States, Germany, the United Kingdom, Spain and Austria).
As of Dec. 31, 2024, Amicus had cash, cash equivalents and marketable securities worth $249.9 million compared with $249.8 million as of Sept. 30, 2024.
FOLD's Full-Year Results
For 2024, Amicus generated revenues of $528.3 million, reflecting a 33% increase year over year at cc.
For the same period, the company reported adjusted earnings of 24 cents per share against a loss of 13 cents per share reported in the year-ago period.
FOLD's 2025 Guidance
The company reiterated its total revenue guidance for 2025, which it had provided last month.
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.
Total adjusted operating expenses are expected in the band of $350-$370 million.
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 - Free Report) , 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.
The agreement also ended all ongoing litigation between Amicus and Teva concerning Galafold patents in the U.S. District Court for Delaware.
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 #2 (Buy).
Some other top-ranked stocks in the biotech sector are Harmony Biosciences Holdings, Inc. (HRMY - Free Report) and Pacira BioSciences, Inc. (PCRX - Free Report) , 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 Harmony Biosciences’ earnings per share have increased from $3.01 to $3.16 for 2025. In the past year, shares of HRMY have risen 6.9%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Pacira BioSciences’ earnings per share have increased from $2.79 to $3.46 for 2025. In the past year, shares of PCRX have decreased 12.8%.
PCRX’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 7.13%.