Amicus Therapeutics Reports Q1 2024 Financial Results and Corporate Updates

Amicus Therapeutics, a global biotechnology firm dedicated to treating rare diseases, has reported its financial results for the first quarter of 2024. The company, listed on Nasdaq under the symbol FOLD, has shown strong performance and growth across its product lines.

The total revenue for the first quarter of 2024 reached $110.4 million, marking a significant 28% increase compared to the $86.3 million recorded in the same period in 2023. On a constant currency basis, this growth also stands at 28%. This impressive performance is attributed primarily to the sales of two key product lines: Galafold® and the newly launched Pombiliti® + Opfolda®.

Galafold, an oral treatment for Fabry disease, generated $99.4 million in net product sales in the first quarter of 2024, reflecting a 15% year-over-year increase. When accounting for constant exchange rates, this growth slightly improves to 16%. The continuing demand for Galafold has led Amicus to revise its annual guidance for the product upwards.

Pombiliti + Opfolda, a two-component therapy for late-onset Pompe disease, achieved $11.0 million in net sales during the first quarter of 2024. This represents a notable increase from the prior quarter and indicates a successful commercial launch, with over 155 patients either receiving treatment or scheduled to begin treatment by the end of April 2024.

Despite these revenue increases, Amicus reported total GAAP operating expenses of $124.6 million for Q1 2024, a 6% rise from $117.0 million in the same period of 2023. Similarly, non-GAAP operating expenses also rose by 6%, from $80.6 million to $85.6 million. However, the company managed to reduce its GAAP net loss to $48.4 million, or $0.16 per share, down from a net loss of $52.9 million or $0.18 per share in Q1 2023. On a non-GAAP basis, the net loss was $4.6 million, or $0.02 per share, compared to a net loss of $16.8 million, or $0.06 per share, in the previous year.

Amicus ended the first quarter with cash, cash equivalents, and marketable securities totaling $239.6 million, a decrease from $286.2 million at the end of 2023. This reduction in cash reserves is notable but is balanced by the company's strong revenue growth and controlled operating expenses.

Looking ahead, Amicus has updated its financial guidance for the full year 2024. The company now expects total revenue growth to be between 25% and 30%, with Galafold revenue growth projected at 13% to 17%. Additionally, the revenue from Pombiliti + Opfolda is anticipated to fall within the range of $62 million to $67 million. Non-GAAP operating expenses are expected to remain between $345 million and $365 million for the year.

The company's strategic priorities for 2024 include delivering double-digit revenue growth for Galafold, executing successful launches of Pombiliti + Opfolda, advancing studies to support its leadership in Fabry and Pompe diseases, and achieving full-year non-GAAP profitability.

Amicus's success in the first quarter of 2024 sets a promising tone for the remainder of the year. With its continued focus on the needs of patients with rare diseases and a strong pipeline of innovative therapies, the company is well-positioned to achieve its ambitious goals.