Amicus Therapeutics Reports Preliminary 2022 Revenue and Provides 2023 Strategic Outlook

Amicus Therapeutics

PHILADELPHIA, PAAmicus Therapeutics (Nasdaq: FOLD) this week provided its preliminary and unaudited 2022 revenue, corporate updates, and full-year 2023 outlook.

Corporate Highlights:

  • Global revenue in 2022 reached $329 million (preliminary and unaudited) driven by strong new patient accruals and sustained patient adherence, representing a year-over-year operational revenue growth measured at constant exchange rates (CER)1 of 16%. Full-year revenue growth measured at actual exchange rates was 8% reflecting a negative currency impact of approximately $26 million, or 8%, in 2022. Fourth quarter revenue was approximately $88 million (preliminary and unaudited).
  • For the full-year 2023, the Company anticipates double-digit Galafold revenue growth of 12-17% at CER. Growth is expected to be driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
  • Multiple approvals and launches expected in 2023 for AT-GAA in Late-onset Pompe disease. In Europe, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Pombiliti™, also known as cipaglucosidase alfa. A CHMP opinion for miglustat, the enzyme stabilizer component of AT-GAA is expected in the second quarter 2023. The regulatory submission process for AT-GAA in the U.K. was initiated in December 2022, with final approval expected in the second half of 2023. As previously announced, in the U.S., the Food and Drug Administration (FDA) deferred action on AT-GAA. Amicus remains actively engaged with the Agency on developing a plan and logistics for the pre-approval inspection and once there is more clarity, will provide expected approval timing.
  • Expanded access programs continue to meet the growing demand for AT-GAA across multiple countries. In the U.K., under the Early Access to Medicines Scheme (EAMS), multiple physicians have requested access from each of the leading Pompe centers in the country. Many patients with Pompe disease are participating in additional expanded access programs in the U.S., France, Germany, and Japan.
  • Galafold U.S. intellectual property estate strengthened following the issuance of 19 new patents in 2022. Galafold is protected by orphan drug regulatory exclusivities and a broad U.S. intellectual property portfolio of 46 orange book-listed patents, including 5 composition of matter patents, 30 of which provide protection through at least 2038.
  • Based on the current operating plan, the timing of AT-GAA approvals, and through careful management of expenses, the Company is on track to achieve non-GAAP profitability2 in the second half of 2023.
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Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “In 2022, Amicus remained steadfast in our mission to transform the lives of people living with rare diseases with excellent progress made across our strategic priorities. The Galafold business remained very strong last year, delivering double-digit operational revenue growth and finishing the year with over 2,000 patients on Galafold. We continue to expect robust growth again for 2023 driven by patient demand across the globe for this precision medicine for Fabry disease. In Pompe disease, we eagerly anticipate multiple AT-GAA regulatory approvals in key geographies including the EU, U.K., and U.S. following completion of the FDA inspection, and look forward to launching our second commercial product. We remain excited for the opportunity to offer a new and innovative treatment option, one that we believe has the potential to be the new standard of care, to people living with Pompe disease around the world. We believe we have the opportunity to deliver significant value for our shareholders as Amicus transforms into a leading global rare disease biotechnology company with two innovative therapies that can make a significant impact on the lives of people living with Fabry disease and Pompe disease.”

Amicus is focused on the following five key strategic priorities in 2023:

  • Sustain double-digit Galafold revenue growth (12-17% at CER)
  • Secure FDA, EMA, and MHRA approvals for AT-GAA
  • Initiate successful global launches of AT-GAA
  • Advance next generation pipeline programs (Fabry GTx, Fabry Next-Generation Chaperone, Pompe GTx)
  • Maintain strong financial position on path to profitability
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Mr. Campbell will discuss the Amicus corporate objectives and key milestones in a presentation at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023, at 2:15 p.m. PT. A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.

In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period. Full-year 2023 Galafold revenue guidance utilizes actual exchange rate at December 31, 2022.
Based on projections of Amicus non-GAAP Net Income under current operating plans, which includes successful AT-GAA regulatory approvals and continued Galafold growth. We define non-GAAP Net Income as GAAP Net Income excluding the impact of share-based compensation expense, changes in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense), loss on extinguishment of debt, loss on impairment of assets, restructuring charges, and income taxes.

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