Amicus Therapeutics Reports Preliminary 2020 Revenue and Provides 2021 Outlook

Full-Year 2020 Galafold Revenue of ~$261M Exceeds Guidance

Strengthened Galafold IP Portfolio Now Includes 24 Issued Patents Including 13 Patents through 2038

Pompe Phase 3 PROPEL Study Last Patient, Last Visit Complete with Data Expected in 1Q2021

AT-GAA Pompe Clinical and CMC Milestones On-Track to Support 2021 BLA and MAA

Multiple Data and Manufacturing Updates and Advancements Planned Across Industry-Leading Rare Disease Gene Therapy Portfolio

Cash Position Sufficient to Achieve Self-Sustainability

CRANBURY, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today provided preliminary, unaudited Galafold revenue for the full-year 2020 and introduced its full-year 2021 strategic outlook and financial guidance.

Over the previous year, Amicus substantially met or exceeded its strategic priorities, highlighted by:

• $261 million of global product revenue for Galafold driven by strong adoption and patient adherence
• Completed last patient, last visit of the AT-GAA Phase 3 PROPEL clinical study, advanced manufacturing activities, and initiated the rolling Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)
• Advanced clinical development and manufacturing for CLN6 and CLN3 Batten programs
• Progressed Pompe gene therapy and disclosed Fabry as the next gene therapy IND candidate
• Maintained strong financial position
  

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “During 2020, Amicus remained steadfast on our journey to becoming a leading global rare disease biotechnology company. Despite the extraordinary challenges of COVID, Amicus emerged from 2020 a better and stronger company organizationally, strategically, scientifically and financially. Following continued momentum and strong adoption across the globe for our Fabry precision medicine Galafold, we have again for 2020 exceeded our annual revenue guidance.   We are eagerly looking ahead to our Phase 3 readout of AT-GAA in Pompe disease this quarter with high expectations that this novel medicine has the potential to become the new standard of care in Pompe disease treatment. And finally, our world leading gene therapy pipeline gives us tremendous promise in the ability to develop next-generation gene therapies to treat many devastating rare diseases. Amicus is in a stronger position than ever and remains focused on transforming the lives of people living with these rare, life-threatening conditions and creating significant value for our shareholders.”