Amicus Therapeutics, Inc. (FOLD - Free Report) reported loss of $1.88 per share for full-year 2018, wider than the year-ago loss of $1.85 and the Zacks Consensus Estimate of a loss of $1.74.
Total revenues in 2018 were $91.2 million, reflecting 147.2% increase from $36.9 million in 2017. The figure exceeded the Zacks Consensus Estimate of $89.9 million. The company realized revenues from commercial sales and reimbursed expanded access programs for the company’s only marketed drug Galafold (migalastat).Growth in 2018 was largely driven by EU, and other countries outside the United States and Japan. Revenues exceeded the full-year 2018 guidance range of $80-$90 million.
Share price of the company has decreased 14.8% in the past year.
Amicus received Breakthrough Therapy designation for AT-GAA in late onset Pompe disease. The company expects to complete enrollment in pivotal PROPEL study in Pompe disease and report additional phase II data in 2019.
The company has two gene-therapy programs in pipeline for two different types of Batten disease. It expectsto release results from the phase I/II study in the middle of 2019 from the CLN6 Batten program in additional patients at two years following a one-time administration of its gene therapy. Amicus also expects to complete enrollment in the ongoing CLN3 Batten disease phase I/IIstudy.
The company plans to establish preclinical proof of concept for Fabry and Pompe gene therapies in 2019.
For full-year 2019, the company expects total Galafold revenues of $160-$180 million. The upside is expected to be driven by continued growth in EU markets, further geographic expansion and success from the first full year of launch in the United States and Japan.
The company expects to end 2019 with approximately $300-million cash in hand. The current cash position is anticipated to fund ongoing operations till at least mid-2021.
Zacks Rank & Stocks to Consider
Amicus currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks are Celgene Corp. (CELG - Free Report) , BieGene Ltd. (BGNE - Free Report) and BioDelivery Sciences International, Inc. (BDSI - Free Report) . all of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings per share estimates have increased from $10.21 to $10.75 for 2019 and from $11.63 to $12.70 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.
BieGene’s loss per share estimates have narrowed from $10.09 to $9.90 for 2019 and from $10.57 to $10.24 for 2010 in the past 60 days.
BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 22 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 8.57%.
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