Amicus Therapeutics FOLD reported third-quarter 2024 adjusted earnings of 10 cents per share, beating the Zacks Consensus Estimate of 8 cents. The company had incurred a loss of 1 cent per share in the year-ago 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 third quarter totaled $141.5 million, up 37% year over year on a reported basis and 36% on constant-currency (cc) basis. The figure beat the Zacks Consensus Estimate of $134 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.

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Despite the better-than-expected results, shares of Amicus were down 4.3% on Nov. 6 following the announcement of the news. The stock has plunged 20.8% so far this year compared with the industry’s decline of 2.5%.

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More on FOLD's Q3 Results

In the third quarter, Galafold net product sales were $120.4 million, up 19% year over year at cc, driven by continued strong demand. Galafold sales beat the Zacks Consensus Estimate of $119 million as well as our model estimate of $114.7 million.

Net product sales of Pombiliti + Opfolda were $21.1 million, reflecting sequential growth of 33%. The figure beat the Zacks Consensus Estimate of $18.04 million and our model estimate of $18 million.

Per Amicus, as of the end of October, 203 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).

Total adjusted operating expenses of $82.6 million declined 8% from the year-ago quarter’s figure.

As of Sept 30, 2024, Amicus had cash, cash equivalents and marketable securities worth $249.8 million compared with $260.1 million as of June 30, 2024.

2024 Guidance

Given the strong business performance and continued financial discipline so far, Amicus updated its previously provided guidance for full-year 2024.

The company now expects its total revenues to grow in the range of 30%-32% in 2024 compared with the previously guided range of 26%-31%.

Total Galafold revenues are now expected to grow in the range of 16%-18% compared with the previous guidance of 14%-18%.

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 expects total Pombiliti + Opfolda revenue to be in the range of $69-$71 million compared with the earlier projection of $62-$67 million.

The company now anticipates its total adjusted operating expenses in the band of $340-$350 million compared with the previous guidance of $345-$360 million.

The company remains committed to achieving its first full year of non-GAAP profitability in 2024.

FOLD's Recent Updates

Last month, Amicus signed a licensing agreement with Teva Pharmaceuticals TEVA, resolving the patent lawsuit FOLD filed earlier.

The litigation arose after Teva submitted an abbreviated new drug application seeking approval to sell a generic version of Amicus' Galafold (migalastat) 123 mg capsules before the related patents expired.

Per the agreement, Amicus will grant Teva a license to sell its generic version of Galafold in the United States starting Jan. 30, 2037, pending FDA approval and subject to the fulfillment of certain customary conditions.

The agreement ends all ongoing litigation between Amicus and Teva concerning Galafold patents in the U.S. District Court for Delaware.

However, a similar patent litigation will continue against Aurobindo Pharma as the remaining active party, and the litigation stay remains in place for Lupin.

FOLD's Zacks Rank & Other Key Picks

Amicus currently carries a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks from the biotech space are CRISPR Therapeutics AG CRSP and Lisata Therapeutics, Inc. LSTA, each carrying a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CRISPR Therapeutics’ 2024 loss per share have narrowed from $5.58 to $5.55. Loss per share estimates for 2025 have narrowed from $4.98 to $4.94 during the same time. Year to date, shares of CRSP have decreased 19%.

CRSP’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 100.64%.

In the past 60 days, estimates for Lisata Therapeutics’ 2024 loss per share have narrowed from $2.97 to $2.90. Loss per share estimates for 2025 have narrowed from $2.61 to $2.53 during the same time. Year to date, shares of LSTA have increased 6.9%.

LSTA’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.75%.

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