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Amicus' (FOLD) Q4 Earnings Miss Estimates, Sales Beat on Galafold

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Amicus Therapeutics (FOLD - Free Report) reported a loss of 27 cents per share in the fourth quarter of 2020, wider than the Zacks Consensus Estimate of a loss of 24 cents but narrower than the loss of 35 cents per share in the year-ago quarter.

Revenues of $71 million in the fourth quarter easily beat the Zacks Consensus Estimate of $70 million and increased from $55.3 million in the year-ago quarter.

Shares of the company have slumped 48.9% against the industry’s growth of 3.2%.

Full-Year Results

Revenues of $260.9 million in 2020 grew from $182.2 million in 2019 and beat the Zacks Consensus Estimate of $260.8 million. Revenues were entirely derived from sales of the company's drug Galafold (migalastat), approved for Fabry disease. The performance was driven largely by strong patient demand. Global compliance and adherence rates continued to exceed 90%.

Loss per share came in $1.07, narrower than the loss of $1.48 in the year-ago quarter.

As of Dec 31, 2020, the company had cash, cash equivalents and marketable securities of $483.3 million, compared to $452.7 million on Dec 31, 2019.

2021 Guidance

For 2021, the company expects total Galafold revenues of at least $300-$315 million, driven by continued operational growth and commercial execution across all major markets, including the United States, the EU, the U.K. and Japan.

Other Updates

The lead pipeline candidate in Amicus’ portfolio is AT-GAA, being evaluated for Pompe disease. The company plans to complete the BLA submission in the second quarter of this year and anticipates additional regulatory submissions in the European Union and other geographies throughout 2021.

The FDA has granted a Fast Track Designation to the CLN6 Batten disease gene therapy, AT-GTX-501.

Our Take

The uptake of Galafold has been pretty good in 2020.  The pipeline progress has been encouraging too.

However, competition is stiff from bigwigs like Sanofi’s (SNY - Free Report) Fabrazyme and Takeda’s (TAK - Free Report) Replagal. Roche (RHHBY - Free Report) is also developing a gene therapy for Pompe disease.

Zacks Rank

Amicus currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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