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Amicus Therapeutics, Inc. (NASDAQ:FOLD) just announced financial results for the third quarter ended September 30, 2018. The Company also summarized recent program updates, reiterated its full-year 2018 revenue guidance and reduced its net cash spend guidance for the year.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. stated, “The third quarter marked a major transformation for Amicus that brings us several steps closer toward our 2023 vision to treat at least 5,000 patients and to achieve $1 billion in annual global revenue. In the last three months, we received our first U.S. drug approval for Galafold, expanded our pipeline to include 14 new gene therapy programs for rare metabolic diseases, and presented positive 18-month data for our differentiated Pompe treatment paradigm. With a strong revenue base and $500M+ peak sales opportunity for Galafold, as well as $564 million in cash, we have never been in a stronger position to advance our robust portfolio to drive significant value for shareholders and the patient communities that we serve.”

Amicus Therapeutics, Inc. (NASDAQ:FOLD) trumpets itself as a biotechnology company that engages in the discovery, development, and commercialization of medicines for various rare and orphan diseases.

The company offers migalastat HCl, an orally administered small molecule pharmacological chaperone for the treatment of Fabry disease. It is also conducting a Phase 1/2 clinical study of ATB200-02 to investigate in patients with pompe disease.

The company has a strategic alliance with GlaxoSmithKline plc to develop and commercialize migalastat as a monotherapy and in combination with ERT for Fabry disease, as well as a research and development collaboration with the University of Pennsylvania to develop AAV gene therapies.

Amicus Therapeutics, Inc. was founded in 2002 and is headquartered in Cranbury, New Jersey.

According to company materials, “Amicus Therapeutics (FOLD) is a global, patient-centric biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases.  With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases.”

 

Past, Present, and Future

As noted above, FOLD just announced financial results for the third quarter ended September 30, 2018. The Company also summarized recent program updates, reiterated its full-year 2018 revenue guidance, and reduced its net cash spend guidance for the year.

This announcement has popped the stock higher, which certainly isn’t surprising. FOLD shareholders are now sitting on about 2% in gains over the past week.

“We are very pleased with the momentum of the global Galafold launch,” said Bradley L. Campbell, President and Chief Operating Officer of Amicus Therapeutics. “We see continued strong uptake and growth, along with very high compliance and adherence to this new oral Fabry treatment option, in both patients who are ERT-experienced and an increasing number who are ERT-treatment naïve in Europe. As anticipated, quarter-over-quarter revenues reflect some uneven ordering patterns as well as a rising number of extended, 90-day prescriptions as we headed into the summer months, which have normalized since the start of the fourth quarter. These adoption trends may reflect the emerging Fabry treatment paradigm with a stable oral medication that can be taken during summer travels and on holidays. Japan is also off to a solid start, now with a double-digit number of patient prescriptions. Importantly, the first 12 weeks of the U.S. launch have significantly exceeded our expectations. With more than 100 individual prescriptions for Galafold in the U.S., we are seeing robust patient demand from a broad prescriber base of more than 40 Fabry physicians. Given this global momentum, we are confident in meeting the higher end of our full-year 2018 guidance and setting a solid foundation for 2019.”

Amicus Therapeutics, Inc. (NASDAQ:FOLD) managed to rope in revenues totaling $21.3M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top-line growth of 197.7%, as compared to year-ago data in comparable terms.

In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($539M against $53M).