Amicus Therapeutics Reports Preliminary 2020 Revenue and Provides 2021 Outlook - Seite 2

Amicus is focused on the following five key strategic priorities in 2021:

• Achieve continued double-digit growth and Galafold revenue of at least $300 million+¹
• Report data from the AT-GAA Phase 3 PROPEL study and complete BLA and MAA filings for regulatory approvals
• Advance clinical studies, regulatory discussions and scientific data across industry leading gene therapy pipeline
• Further manufacturing capabilities and capacity to build world-class technical operations to support all gene therapy programs
• Maintain strong financial position

¹ Guidance range to be provided on full-year earnings call.

Mr. Crowley will discuss Amicus' corporate objectives and key milestones in a presentation at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 8:20 a.m. ET. A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.

Full-Year 2020 Galafold Summary and 2021 Guidance

Global revenue for Galafold in full-year 2020 was approximately $261 million, preliminary and unaudited, representing a year-over-year increase of 43% from total revenue of $182 million in 2019, and exceeded the Company’s 2020 guidance of $250 million to $260 million despite worsening of the COVID-19 pandemic towards the end of the year. Full-year revenue benefited from a positive currency impact of approximately $2 million. Fourth quarter Galafold revenue was approximately $70 million, preliminary and unaudited. While we observed increased lag times between patient identification and Galafold initiation due to the resurgence of COVID in the fourth quarter, demand for Galafold for Fabry patients with amenable variants worldwide remained strong with queues of potential new Galafold patients in multiple geographies. We also continue to see 90%+ compliance rates among already treated Galafold patients.

For the full-year 2021, the Company anticipates total Galafold of revenue at least $300 million+. Double-digit revenue growth in 2021 is expected to be driven by continued operational growth and commercial execution across all major markets, including the U.S., EU, U.K. and Japan. Non-GAAP operating expense guidance in 2021 is expected to remain flat at $410 million to $420 million, driven by continued investment in the global Galafold launch, AT-GAA clinical studies and advancing the gene therapy pipeline. The current cash position is sufficient to achieve self-sustainability without the need for future dilutive financing.