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Amicus (FOLD) Banks on Galafold, High Dependence a Concern
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Amicus Therapeutics, Inc.’s (FOLD - Free Report) lead marketed drug, Galafold (migalastat), is the first and only approved oral medicine for patients living with Fabry disease, having amenable genetic variants. The drug has witnessed a strong sales uptake driven by continued demand.
Sales of Galafold have been rising consistently over the past years. In the first six months of 2024, the drug generated sales worth $210.2 million, which increased 17% year over year at a constant currency basis. Galafold is currently approved in several countries, including the United States, European Union (EU), United Kingdom and Japan.
Owing to continued global uptake and sustained patient demand, FOLD increased Galafold revenues guidance for 2024. The company now anticipates its total Galafold revenues to grow in the range of 14-18% compared with the previous guidance of 13-17%.
The drug also has a strong IP portfolio in the United States, providing patent protection through 2038. Label expansion, along with approvals in additional geographies, is likely to drive sales of the drug further in the days ahead.
Shares of Amicus have plunged 16% in the year so far against the industry’s growth of 0.2%.
Image Source: Zacks Investment Research
In September 2023, the FDA approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) 65mg capsules, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh more than 40 kg and are not improving on their current enzyme replacement therapy.
The approval for Pombiliti + Opfolda in the United States is a huge boost and provides a significant commercial opportunity for Amicus in the long run.
Pombiliti + Opfolda is also approved in Europe, including the United Kingdom, for treating LOPD in adults.The drugs are witnessing a strong launch so far, which continues to build momentum with an increasing rate of commercial patient starts.
Though Amicus is riding on the success of Galafold, which drives the majority of the company’s top line, heavy dependence on the product for revenues remains a concern. Though Pombiliti + Opfolda has just been approved, it is still in the initial stage of launch and is yet to generate incremental sales. Any regulatory setback for the drugs will hurt the company’s growth prospects in the days ahead.
Also, several large pharmaceutical and biotechnology companies currently market and sell products for treating Fabry disease and Pompe disease. This acute competition remains a headwind for Amicus.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 4.8%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 39.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have moved up from 27 cents to 40 cents. Earnings per share estimates for 2025 have improved from 43 cents to 45 cents. Year to date, shares of BVS have rallied 55.6%.
BVS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 102.86%.
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Amicus (FOLD) Banks on Galafold, High Dependence a Concern
Amicus Therapeutics, Inc.’s (FOLD - Free Report) lead marketed drug, Galafold (migalastat), is the first and only approved oral medicine for patients living with Fabry disease, having amenable genetic variants. The drug has witnessed a strong sales uptake driven by continued demand.
Sales of Galafold have been rising consistently over the past years. In the first six months of 2024, the drug generated sales worth $210.2 million, which increased 17% year over year at a constant currency basis. Galafold is currently approved in several countries, including the United States, European Union (EU), United Kingdom and Japan.
Owing to continued global uptake and sustained patient demand, FOLD increased Galafold revenues guidance for 2024. The company now anticipates its total Galafold revenues to grow in the range of 14-18% compared with the previous guidance of 13-17%.
The drug also has a strong IP portfolio in the United States, providing patent protection through 2038. Label expansion, along with approvals in additional geographies, is likely to drive sales of the drug further in the days ahead.
Shares of Amicus have plunged 16% in the year so far against the industry’s growth of 0.2%.
Image Source: Zacks Investment Research
In September 2023, the FDA approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) 65mg capsules, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh more than 40 kg and are not improving on their current enzyme replacement therapy.
The approval for Pombiliti + Opfolda in the United States is a huge boost and provides a significant commercial opportunity for Amicus in the long run.
Pombiliti + Opfolda is also approved in Europe, including the United Kingdom, for treating LOPD in adults.The drugs are witnessing a strong launch so far, which continues to build momentum with an increasing rate of commercial patient starts.
Though Amicus is riding on the success of Galafold, which drives the majority of the company’s top line, heavy dependence on the product for revenues remains a concern. Though Pombiliti + Opfolda has just been approved, it is still in the initial stage of launch and is yet to generate incremental sales. Any regulatory setback for the drugs will hurt the company’s growth prospects in the days ahead.
Also, several large pharmaceutical and biotechnology companies currently market and sell products for treating Fabry disease and Pompe disease. This acute competition remains a headwind for Amicus.
Amicus Therapeutics, Inc. Price and Consensus
Amicus Therapeutics, Inc. price-consensus-chart | Amicus Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Amicus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Illumina, Inc. (ILMN - Free Report) , Fulcrum Therapeutics, Inc. (FULC - Free Report) and Bioventus Inc. (BVS - 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 Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 4.8%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 39.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have moved up from 27 cents to 40 cents. Earnings per share estimates for 2025 have improved from 43 cents to 45 cents. Year to date, shares of BVS have rallied 55.6%.
BVS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 102.86%.