3Q 2023 Total Revenue of $103.5M, a 27% Increase Year-Over-Year and 22% at CER
Galafold® Quarterly Revenue Surpasses $100M for the First Time
Increasing FY 2023 Galafold® Revenue Growth Guidance to 16%-18% at CER
Pombiliti™ + Opfolda™ Approved and Launched in the U.S., EU, and U.K.
Non-GAAP Profitability Projected in Q4 2023
Conference Call and Webcast Today at 8:30 a.m. ET
2023 Financial Guidance
- For the full-year 2023, the Company is increasing the Galafold revenue growth guidance to between 16 and 18% at CER1 driven by several factors including continued strong underlying demand from both switch and treatment-naïve patients, further geographic expansion and label extensions, the continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
- Non-GAAP operating expense guidance for the full-year 2023 is $330 million to $350 million, driven by prudent expense management offset by continued investment in Galafold, AT-GAA clinical studies, non-recurring costs for manufacturing as well as global launch activities4.
- The Company is on-track to achieve non-GAAP profitability2 in the fourth quarter of 2023.
Amicus is focused on the following five key strategic priorities in 2023:
- Sustain double-digit Galafold revenue growth (16-18% at CER1)
- Secure EMA, MHRA, and FDA approvals for Pombiliti + Opfolda
- Initiate successful global launches of Pombiliti + Opfolda
- Advance next-generation pipeline programs (Fabry GTx, Fabry Next-Generation Chaperone, Pompe GTx)
- Maintain strong financial position on path to profitability
Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, November 8, 2023, at 8:30 a.m. ET to discuss the third quarter 2023 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal PIN to access the event.
A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.
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