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Amicus (FOLD) Up as Q2 Earnings & Sales Top, '24 View Updated

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Amicus Therapeutics (FOLD - Free Report) reported second-quarter 2024 adjusted earnings of 6 cents per share, beating the Zacks Consensus Estimate of 3 cents. The company had incurred a loss of 7 cents per share in the year-ago quarter.

Please note that the company achieved non-GAAP profitability for the first time in the reported quarter. The year-over-year improvement can be attributed to higher revenues from Galafold (migalastat) sales and incremental revenues from the sale of the newly approved combo drug, Pombiliti + Opfolda.

Revenues in the reported quarter totaled $126.7 million, up 34% year over year on a reported basis and 36% on constant-currency (cc) basis. The figure beat the Zacks Consensus Estimate of $121 million. The top line comprised sales of Galafold, which is approved for Fabry disease and Pombiliti + Opfolda.

The FDA approved Pombiliti + Opfolda, a two-component therapy for treating late-onset Pompe disease, in September 2023.

Shares of Amicus gained 13.2% on Aug 8, as investors cheered the better-than-expected second-quarter results. Year to date, shares of FOLD have plunged 20.2% compared with the industry’s 5.9% decline.

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Quarter in Detail

In the second quarter, Galafold net product sales were $110.8 million, up 19% year over year at cc, driven by continued strong demand. The drug’s sales beat the Zacks Consensus Estimate of $109 million as well as our model estimate of $106.1 million.

Net product sales of Pombiliti + Opfolda were $15.9 million, reflecting sequential growth of 44%. The figure beat the Zacks Consensus Estimate of $14.1 million and our model estimate of $15 million. Per Amicus, as of the end of July, 186 patients have been treated or are scheduled to be treated with the combo drug in five markets (the United States, Germany, United Kingdom, Spain and Austria).

Total adjusted operating expenses of $82.1 million declined 2% from the year-ago quarter’s figure.

As of Jun 30, 2024, Amicus had cash, cash equivalents and marketable securities worth $260.1 million compared with $239.6 million as of Mar 31, 2024.

Updated 2024 Guidance

Amicus updated its previously provided guidance for the full year. The company now expects its total revenues to grow in the range of 26-31% in 2024 compared with the previously guided range of 25-30%.

The company now anticipates its total Galafold revenues to grow in the range of 14-18% compared with the previous guidance of 13-17%.

This guidance reflects continued patient demand from both switch and treatment-naïve patients, expansion into other geographies, label extensions, continued diagnosis of new Fabry patients and commercial execution across all major markets, including the EU, Japan, the United States and U.K.

For 2024, the company maintained its total Pombiliti + Opfolda revenue guidance in the range of $62-$67 million.

The company now anticipates its total adjusted operating expenses in the band of $345-$360 million compared with the previous guidance of $345-$365 million.

Amicus expects non-GAAP profitability to accelerate in the second half of 2024. The company expects to achieve its first full year of non-GAAP profitability in 2024. Its profits are anticipated to grow in the remainder of the current year.

Zacks Rank & Stocks to Consider

Amicus currently carries a Zacks Rank #3 (Hold). 

Some better-ranked stocks in the biotech sector are Annovis Bio (ANVS - Free Report) , Anixa Biosciences (ANIX - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 55.9%.

ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.

In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2025 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 20.1%.

ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%. 

In the past 60 days, estimates for Akero Therapeutics’ 2024 loss per share have narrowed from $3.87 to $3.82. During the same period, loss per share estimates for 2025 have remained constant at $4.29. Year to date, shares of AKRO have gained 6.8%.

Akero’s earnings beat estimates in one of the trailing four quarters, missed twice and matched once, delivering an average negative surprise of 5.10%.

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