PHILADELPHIA, PA — Amicus Therapeutics (Nasdaq: FOLD) this week announced financial results for the first quarter ended March 31, 2023.
Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “We had an outstanding start to 2023 across our global business. In Q1, Galafold saw strong operational growth primarily driven by robust patient demand in our major markets. We are pleased with the outcome of the U.S. FDA inspection of the WuXi Biologics manufacturing facility and remain highly confident in the anticipated global approvals of AT-GAA as we move towards launch in the three largest Pompe markets this year. Our strategic focus remains on continuing to grow Galafold, securing regulatory approvals and launching of AT-GAA, and achieving non-GAAP profitability in the second half of 2023. Together, we see these driving value for our stakeholders and advancing our mission of delivering high quality medicines for people living with rare diseases.”
- Global revenue in the first quarter 2023 was $86.3 million. First quarter revenue represented a year-over-year increase of 10% from total revenue of $78.7 million in the first quarter of 2022. First quarter operational revenue growth measured at constant exchange rates (CER)1 was 14%.
|(in thousands)||Three Months Ended
|Year over Year
|Net Product Revenues||$86,270||$78,715||10%||14%|
- For the full-year 2023, the Company anticipates double-digit Galafold revenue growth of 12-17% at CER1. Growth is expected to be driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
- The U.S. Food and Drug Administration (FDA) has very recently completed the required pre-approval inspection of the WuXi Biologics manufacturing site in China. The Company believes the comments and observations received at the close of the FDA inspection are all addressable and continues to expect regulatory approval of AT-GAA in the U.S. in the third quarter of 2023.
- The EU and U.K. AT-GAA regulatory reviews remain on-track with marketing authorization expected in 3Q 2023. In the European Union (EU), the European Commission (EC) granted approval for Pombiliti® (cipaglucosidase alfa), used in combination with miglustat for adults with late-onset Pompe disease. In April, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Opfolda® (miglustat), the enzyme stabilizer component. Full approval of Pombiliti + Opfolda is anticipated in the third quarter of 2023. In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.
- Strategic expansion of Supply and Manufacturing Services Agreement with WuXi Biologics. The long-term agreement further strengthens relationship with WuXi and secures long-term capacity at the new state-of-the-art manufacturing facility of WuXi in Dundalk, Ireland.
- 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., Germany, France, and Japan.
- Galafold U.S. intellectual property estate strengthened following the issuance of multiple new patents in 2023. Galafold is protected by orphan drug regulatory exclusivities and a broad U.S. intellectual property portfolio of 49 orange book-listed patents, including 8 composition of matter patents, 33 of which provide protection through at least 2038.
- Full-year 2023 non-GAAP operating expense guidance of $340 million to $360 million, driven by prudent expense management while investing in AT-GAA manufacturing and pre-launch activities.
- Based on the current operating plan, the timing of AT-GAA approvals, and through prudent management of expenses, the Company is on-track to achieve non-GAAP profitability2 in the second half of 2023.
First Quarter 2023 Financial Results
- Total revenue in the first quarter 2023 was $86.3 million, a year-over-year increase of 10% from total revenue of $78.7 million in the first quarter 2022. On a constant currency basis, first quarter 2023 total revenue growth was 14%. Compared to the first quarter 2022, reported revenue was offset by a negative currency impact of $3.8 million, or 4%.
- Cash, cash equivalents, and marketable securities totaled $267.1 million at March 31, 2023, compared to $293.6 million at December 31, 2022.
- Total GAAP operating expenses of $117.0 million for the first quarter 2023 decreased as compared to $146.5 million for the first quarter 2022.
- Total non-GAAP operating expenses of $80.6 million for the first quarter 2023 decreased as compared to $109.0 million for the first quarter 2022, primarily reflecting decreased program spend.3
- Net loss was $52.9 million, or $0.18 per share in the first quarter 2023, and was reduced compared to a net loss of $85.3 million, or $0.30 per share, for the first quarter 2022.
2023 Financial Guidance
- For the full-year 2023, the Company anticipates total Galafold revenue growth between 12 and 17% at CER1 driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, 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 $340 million to $360 million, driven by prudent expense management offset by continued investment in Galafold, AT-GAA clinical studies and pre-launch activities, in addition to certain non-recurring costs for manufacturing to support the global launch of AT-GAA4.
- The Company is on-track to achieve non-GAAP profitability2 in the second half of 2023.
Amicus is focused on the following five key strategic priorities in 2023:
- Sustain double-digit Galafold revenue growth (12-17% at CER1)
- 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
1 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 the actual exchange rates at December 31, 2022.
2 Based on projections of Amicus’ non-GAAP Net Income under current operating plans, which includes successful AT-GAA regulatory approvals and continued Galafold growth. Amicus defines 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, restructuring charges and income taxes.
3 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables within the Company’s original release.
4 A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to high variability, complexity, and low visibility as to the items that would be excluded from the GAAP measure.
For more information visit the company’s website at www.amicusrx.com.
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