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Amicus Therapeutics (FOLD - Free Report) reported a loss of 18 cents per share in first-quarter 2023, wider than the Zacks Consensus Estimate of a loss of 13 cents and our model estimates of a loss of 16 cents. The company reported a loss of 30 cents per share in the year-ago quarter.
Revenues in the quarter totaled $86.3 million, up 10% year over year. The figure beat both the Zacks Consensus Estimate and our model estimates of $82 million. The top line comprised sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 14%.
Shares of Amicus were up almost 2% on May 10, soon after the company reported its earnings. The stock lost 5.1% in the year-to-date period compared with the industry’s 5.4% decline.
Image Source: Zacks Investment Research
Quarter in Details
Research and development expenses were down 51% year over year to $41 million.
Selling, general and administrative expenses totaled $74 million, up 27% from the year-ago quarter’s level.
As of Mar 30, 2023, Amicus had cash, cash equivalents and marketable securities worth $267.1 million compared with $293.6 million as of Dec 31, 2022.
2023 Guidance
The company reiterated its previously issued guidance for 2023.
FOLD expects total Galafold revenue growth of 12-17% at cc. This was driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including EU, Japan, the U.K. and the United States.
Adjusted operating expenses are estimated between $340 million and $360 million.
Other Updates
The lead pipeline candidate in Amicus’ portfolio is AT-GAA, developed as a potential treatment for Pompe disease. The biologics license application (BLA) and new drug application (NDA) for the two components of AT-GAA were accepted by the FDA in September 2021.The FDA has deferred the dates of the NDA and BLA. It has also recently completed the required pre-approval inspection of the WuXi Biologics manufacturing site in China.
Management expects regulatory approval and the launch of AT-GAA in the United States in the third quarter of 2023.
In April, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion regarding the marketing authorization of Opfolda (miglustat) — the enzyme stabilizer component used in combination with cipaglucosidase alfa for adults with late-onset Pompe disease.
The full approval of Pombiliti + Opfolda is anticipated in the third quarter of 2023.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days.
The company’s shares have surged 76.8% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.31 for 2023 and from $2.53 to $2.20 for 2024, in the past 60 days. Shares of ALLO have surged 1.1% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.
Loss per share estimates for Arcus Biosciences have narrowed from $4.52 to $4.42 for 2023 and from $3.51 to $3.33 for 2024, in the past 60 days. Shares of RCUS have plunged 9% in the year-to-date period.
Arcus Biosciences’ earnings outpaced estimates in two of the last four quarters, met the mark in one and missed in another, the average negative surprise being 48.83%.
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Amicus (FOLD) Q1 Earnings Miss, Galafold Sales Grow
Amicus Therapeutics (FOLD - Free Report) reported a loss of 18 cents per share in first-quarter 2023, wider than the Zacks Consensus Estimate of a loss of 13 cents and our model estimates of a loss of 16 cents. The company reported a loss of 30 cents per share in the year-ago quarter.
Revenues in the quarter totaled $86.3 million, up 10% year over year. The figure beat both the Zacks Consensus Estimate and our model estimates of $82 million. The top line comprised sales of Galafold (migalastat), approved for Fabry disease. On a constant-currency (cc) basis, total year-over-year revenue growth was 14%.
Shares of Amicus were up almost 2% on May 10, soon after the company reported its earnings. The stock lost 5.1% in the year-to-date period compared with the industry’s 5.4% decline.
Image Source: Zacks Investment Research
Quarter in Details
Research and development expenses were down 51% year over year to $41 million.
Selling, general and administrative expenses totaled $74 million, up 27% from the year-ago quarter’s level.
As of Mar 30, 2023, Amicus had cash, cash equivalents and marketable securities worth $267.1 million compared with $293.6 million as of Dec 31, 2022.
2023 Guidance
The company reiterated its previously issued guidance for 2023.
FOLD expects total Galafold revenue growth of 12-17% at cc. This was driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including EU, Japan, the U.K. and the United States.
Adjusted operating expenses are estimated between $340 million and $360 million.
Other Updates
The lead pipeline candidate in Amicus’ portfolio is AT-GAA, developed as a potential treatment for Pompe disease. The biologics license application (BLA) and new drug application (NDA) for the two components of AT-GAA were accepted by the FDA in September 2021.The FDA has deferred the dates of the NDA and BLA. It has also recently completed the required pre-approval inspection of the WuXi Biologics manufacturing site in China.
Management expects regulatory approval and the launch of AT-GAA in the United States in the third quarter of 2023.
In April, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion regarding the marketing authorization of Opfolda (miglustat) — the enzyme stabilizer component used in combination with cipaglucosidase alfa for adults with late-onset Pompe disease.
The full approval of Pombiliti + Opfolda is anticipated in the third quarter of 2023.
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 same sector are Ocuphire Pharma (OCUP - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Arcus Biosciences (RCUS - Free Report) . While Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy), Allogene Therapeutics and Arcus Biosciences, both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days.
The company’s shares have surged 76.8% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.31 for 2023 and from $2.53 to $2.20 for 2024, in the past 60 days. Shares of ALLO have surged 1.1% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.
Loss per share estimates for Arcus Biosciences have narrowed from $4.52 to $4.42 for 2023 and from $3.51 to $3.33 for 2024, in the past 60 days. Shares of RCUS have plunged 9% in the year-to-date period.
Arcus Biosciences’ earnings outpaced estimates in two of the last four quarters, met the mark in one and missed in another, the average negative surprise being 48.83%.