Amicus Therapeutics ( FOLD Quick Quote FOLD - Free Report) reported a loss of 25 cents per share in the first quarter of 2021, wider than the Zacks Consensus Estimate of a loss of 23 cents but narrower than the loss of 35 cents reported in the year-ago quarter.
Revenues of $66.4 million in the first quarter missed the Zacks Consensus Estimate of $72 million but increased from $60.5 million in the year-ago quarter. Revenues were entirely derived from sales of Galafold (migalastat), approved for Fabry disease.
Shares of the company have slumped 59.3% against the
industry’s growth of 5.2%. Quarter in Detail
Revenues in the first quarter reflected increased patient demand, offset by the timing of orders in ex-U.S. geographies, reauthorizations in the United States and irregular ordering patterns due to COVID-19. Global compliance and adherence rates continue to exceed 90%.
Amicus continues to expect the number of new patients starting on Galafold treatment in 2021 to be greater than that in 2020.
Operating expenses (adjusted basis) came in at $90.5 million, down from $116.7 million in the year-ago quarter.
As of Mar 31, 2020, the company had cash, cash equivalents and marketable securities of $417.4 million compared to $483.3 million on Dec 31, 2020.
For 2021, the company expects total Galafold revenues of $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.
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 company continues to follow the first 13 CLN6 patients and the 4 CLN3 patients in their respective phase I/II studies.
Revenues in the quarter were being negatively impacted by the typical uneven ordering patterns on a sequential basis along with COVID-19 impacts. The number of Galafold patients at the end of the quarter was ahead of management’s expectations. The company anticipates a recovery from COVID-related impacts in the second half of the year.
However, competition is stiff from
Sanofi’s ( SNY Quick Quote SNY - Free Report) Fabrazyme and Takeda’s ( TAK Quick Quote TAK - Free Report) Replagal. Roche ( RHHBY Quick Quote RHHBY - Free Report) is also developing a gene therapy for Pompe disease. Zacks Rank
Amicus currently carries a Zacks Rank #4 (Sell).
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