We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amicus' (FOLD) Q1 Loss Wider Than Expected, Sales Up Y/Y
Read MoreHide Full Article
Amicus Therapeutics (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.
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
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.
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 company continues to follow the first 13 CLN6 patients and the 4 CLN3 patients in their respective phase I/II studies.
Our Take
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 - Free Report) Fabrazyme and Takeda’s (TAK - Free Report) Replagal. Roche (RHHBY - Free Report) is also developing a gene therapy for Pompe disease.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
Image: Bigstock
Amicus' (FOLD) Q1 Loss Wider Than Expected, Sales Up Y/Y
Amicus Therapeutics (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.
Amicus Therapeutics, Inc. Price, Consensus and EPS Surprise
Amicus Therapeutics, Inc. price-consensus-eps-surprise-chart | Amicus Therapeutics, Inc. Quote
2021 Guidance
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.
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 company continues to follow the first 13 CLN6 patients and the 4 CLN3 patients in their respective phase I/II studies.
Our Take
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 - 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.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>