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Amicus Therapeutics Announces Full-Year 2020 Financial Results and Corporate Updates
2020 Total Galafold Revenue of $260.9M; Increased 43 Percent Year-on-Year
Continued Strong Global Growth of Galafold Expected in 2021 with Revenue of $300M-$315M
AT-GAA Rolling BLA Submission in Pompe Disease Planned for Completion in 2Q21 and Other Global Submissions Expected Throughout 2021
CLN6 Batten Disease Gene Therapy Granted Fast Track Designation by U.S. FDA
Cash Position Sufficient to Achieve Self-Sustainability
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PHILADELPHIA, PA, Mar. 1, 2021 – Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced financial results for the full year ended December 31, 2020.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “During 2020, Amicus remained resilient on our journey to becoming a leading global rare disease biotechnology company. Despite the challenges of COVID, Amicus emerged from 2020 a better and stronger company organizationally, strategically, scientifically and financially. Galafold continues its path to becoming the worldwide standard of care for Fabry patients with amenable variants. And we are steadfast and passionate in our commitment to advancing AT-GAA to global regulatory submissions as fast as possible for the benefit of all people living with Pompe disease. The data from the Phase 3 PROPEL study we believe continue to show the overwhelmingly positive benefits of AT-GAA compared to the only approved medicine in this devastating disease. And the unmet need in Pompe is so great. We have the team, the resources and the programs that strongly position us to achieve our vision of delivering groundbreaking new medicines and hopefully, one day, cures for people living with rare diseases.”
|·||Global revenue for Galafold® (migalastat) in the full year of 2020 was $260.9 million. Full year revenue represented a year-over-year increase of 43% from total revenue of $182.2 million in the full year of 2019. On a constant currency basis, full year 2020 total revenue was $258.6 million, representing operational revenue growth measured at constant currency exchange rates of 42%, which was further benefited by a positive currency impact of $2.3 million, or 1%. Galafold performance was driven largely by strong patient demand. Global compliance and adherence rates continue to exceed 90%.|
|·||Results from the global Phase 3 PROPEL clinical study of AT-GAA in late-onset Pompe disease (LOPD) were presented at the 17th Annual WORLDSymposium™ 2021. 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 in other geographies throughout 2021.|
|·||The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the CLN6 Batten disease gene therapy, AT-GTX-501. The Fast Track program facilitates the development and accelerates the review of new drugs for serious conditions, which have the potential to address unmet medical needs. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.|
The following information was filed by Amicus Therapeutics Inc (FOLD) on Monday, March 1, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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