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Amicus Therapeutics FOLD reported a loss of 19 cents per share for second-quarter 2021, slightly narrower than the Zacks Consensus Estimate of a loss of 21 cents and the year-ago loss of 20 cents.
Revenues increased 24% year over year to $77.4 million for the second quarter, surpassing the Zacks Consensus Estimate of $71.4 million. Revenues were entirely derived from sales of Galafold (migalastat), approved for Fabry disease.
Shares of the company were up 3.9% on Aug 5, following encouraging pipeline updates and second-quarter results. Yet, the stock has slumped 56.4% in the year so far against the industry’s growth of 4.2%.
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Quarter in Detail
Revenues for the second quarter reflected increased patient demand and partly benefited from the timing of orders in ex U.S. geographies and a continuing FX tailwind.
Operating expenses (adjusted basis) were $93.5 million, down 2.4% year over year.
As of Jun 30, 2021, the company had cash, cash equivalents and marketable securities of $383.1 million compared with $417.4 million on Mar 31, 2021.
Amicus expects cash resources and revenues to be enough to support operations and the ongoing research programs through self-sustainability without the need for any future dilutive financings.
2021 Guidance Maintained
The company expects total Galafold revenues within $300-$315 million, driven by persistent operational growth and commercial execution across all major markets, including the United States, the EU, U.K. and Japan.
It anticipates operating expense (adjusted basis) within $410-$420 million, driven by continued investment in its pipeline.
Following label expansion by the European Commission, Galafold is the first and only oral therapy approved in the EU for use in adolescents with Fabry disease aged 12 to less than 16 years weighing at least 45 kg who have an amenable mutation.
The lead pipeline candidate in Amicus’ portfolio is AT-GAA, which is being evaluated for Pompe disease. In the United States, the company has completed rolling biologics license application and new drug application for AT-GAA. In the EU, Amicus anticipates its approval in second-half 2021, following positive EMA rapporteur and co-rapporteur meeting support the marketing authorization application submissions for AT-GAA.
The company continues to follow the first 13 CLN6 patients and four CLN3 patients in their respective phase I/II studies.
Amicus Therapeutics, Inc. Price
Amicus Therapeutics, Inc. price | Amicus Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Amicus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Horizon Therapeutics HZNP, Repligen RGEN and Vertex Pharmaceuticals VRTX. While Vertex sports a Zacks Rank #1 (Strong Buy), both Horizon and Repligen currently carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s shares have rallied 45.4% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.69 in the past 30 days. The same for 2022 has risen from $2.56 to $2.94 over the same period. The stock has rallied 32.9% in the year so far.
Vertex’s earnings per share estimates for 2021 have been raised from $11.20 to $12.28 in the past 30 days. The same for 2022 has been revised upward from $12.25 to $13.02 over the same period.
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