Amicus Therapeutics, Inc. FOLD reported fourth-quarter 2023 adjusted earnings of 1 cent per share against the Zacks Consensus Estimate of a loss of 6 cents. The company had reported a loss of 17 cents per share in the year-ago quarter.

The year-over-year improvement can be attributed to higher revenues of Galafold (migalastat) and the successful ongoing commercial launch of the newly approved Pombiliti + Opfolda.

Revenues in the fourth quarter totaled $115.1 million, up 31% year over year on a reported basis. The figure matched the Zacks Consensus Estimate. The top line comprised sales of Galafold, approved for Fabry disease and Pombiliti + Opfolda. On a constant-currency (cc) basis, total revenue growth was 27% year over year.

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

Shares of Amicus were down 6.5% on Feb 28 following the announcement of the earnings result. The stock has lost 4.3% in the past year compared with the industry’s decrease of 6.1%.

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Quarter in Detail

Galafold net product sales were $106.6 million in the fourth quarter, reflecting an increase of 18% year over year at cc. The drug’s sales were almost in line with our model estimate of $106.5 million.

Net product sales of Pombiliti + Opfolda were $8.5 million in the fourth quarter. The figure matched our model estimate. The commercial launch of the drug is currently underway in various markets, including Europe and the U.K.

As of Dec 31, 2023, Amicus had cash, cash equivalents and marketable securities worth $286.2 million compared with $280.3 million as of Sep 30, 2023.

Full-Year Results

In 2023, Amicus generated revenues of $399.4 million, increasing 20% year over year at cc.

In the same period, the company recorded an adjusted loss of 13 cents per share compared with a loss of 53 cents in 2022.

2024 Guidance

Amicus maintained the guidance it provided earlier in January 2024. The company continues to expect total Galafold revenue to grow in the range of 11-16% at cc.

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 U.K. and the United States.

Amicus shares were down, probably because investors were not too impressed with the sales outlook.

Adjusted operating expenses are estimated in the band of $345-$365 million.

The company targets to achieve profitability on a non-GAAP basis for the full year of 2024. Also, FOLD is looking to generate over $0.5 billion in total revenues in 2024.