Amicus Therapeutics, Inc. (FOLD - Free Report) reported loss of 39 cents per share in the first quarter of 2019 (excluding loss on exchange of convertible notes), wider than the year-ago loss of 28 cents and the Zacks Consensus Estimate of a loss of 31 cents.
Total revenues in the first quarter were $34 million, reflecting 104% surge from $16.7 million in the year-ago quarter. The figure missed the Zacks Consensus Estimate of $38 million. The company realized revenues from commercial sales of its only marketed drug, Galafold (migalastat).
The growth was largely driven by net new patients added in the first quarter along with higher-than-anticipated prescriptions in the EU, Japan and the United States, and continued global compliance and adherence rates exceeding 90%. Revenues were in line with management’s expectations. The company expects the drug to generate revenues of $160 million-$180 million, with more than 1,000 Fabry patients by the end of the year.
Share price of the company has rallied 36.8% year to date compared with the industry’s growth of 3.4%.
Amicus expects to complete enrollment in pivotal PROPEL study for AT-GAA in Pompe disease by 2019 end.
The company has two gene-therapy programs in pipeline for two different types of Batten disease. It expects to release top-line results from the phase I/II study of the CLN6 Batten program in additional patients at two years following a one-time administration of its gene therapy in the third quarter of 2019, with more detail at a scientific congress later in the year. Amicus also expects to complete enrollment in the ongoing CLN3 Batten disease phase I/II study.
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 the drug’s launch in the United States and Japan. Consistent with Galafold’s adoption trends and ordering patterns seen in previous years, Amicus expects higher revenues in the second and fourth quarters of 2019.
The company expects to end 2019 with approximately $300 million of cash in hand. The current cash position is anticipated to be enough to fund ongoing operations til at least mid-2021.
Zacks Rank & Stocks to Consider
Amicus currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks are Gilead Sciences Inc. (GILD - Free Report) , Fibrocell Science Inc. (FCSC - Free Report) and Genmab A/S (GNMSF - Free Report) . All the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.65 to $6.72 for 2019 and from $7.00 to $7.03 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average being 6.86%.
Fibrocell’s loss per share estimates has narrowed from $2.68 to $1.15 for 2019 and from $2.55 to 97 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters, the average being 28.30%.
Genmab’s earnings per share estimates have increased from $2.69 to $2.79 for 2019 and from $4.91 to $5.08 for 2020 in the past 60 days.
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