Amicus Therapeutics Reports Q2 2024 Financial Results and Corporate Updates

Amicus Therapeutics, a biotechnology company focused on developing treatments for rare diseases, has reported strong financial performance for the second quarter ending June 30, 2024. The company's total revenue for Q2 2024 was $126.7 million, representing a 34% increase from the same period last year.

Galafold® (migalastat) led the revenue charge, with Q2 sales of $110.8 million, reflecting a 17% year-over-year increase. Additionally, Pombiliti® (cipaglucosidase alfa-atga) and Opfolda® (miglustat) contributed $15.9 million in Q2, a 44% increase from the previous quarter, signaling robust market uptake.

Given the strong performance, Amicus has updated its 2024 revenue growth guidance. The company now expects total revenue growth between 26% and 31% at constant exchange rates (CER), and Galafold's growth is projected to be between 14% and 18% at CER. Amicus also forecasts Pombiliti + Opfolda revenue to be in the range of $62 million to $67 million for the full year.

Amicus achieved non-GAAP profitability in Q2 2024, with a net income of $18.5 million, or $0.06 per share, compared to a non-GAAP net loss of $20.3 million, or $0.07 per share, in the same period of the previous year. The company aims to accelerate this profitability in the second half of 2024.

In terms of expenses, Amicus reported a decrease in GAAP operating expenses to $100.4 million in Q2 2024, down 4% from the previous year. Non-GAAP operating expenses also saw a reduction, coming in at $82.1 million, down 2% year-over-year. The company has revised its non-GAAP operating expense guidance to a range of $345 million to $360 million for 2024.

At the end of June 2024, Amicus held cash, cash equivalents, and marketable securities totaling $260.1 million, compared to $286.2 million at the end of December 2023.

Recent regulatory approvals have bolstered Amicus's market position. Notably, Swissmedic approved Pombiliti + Opfolda on July 4th for long-term enzyme replacement therapy and enzyme stabilization for adults with late-onset Pompe disease. Additional regulatory reviews are ongoing in Australia and Canada.

Galafold's continued demand is notable, with net sales reaching $110.8 million in Q2, a 17% increase from the previous year. Given this strong performance, Amicus has raised its revenue growth expectations for Galafold. The company has also seen significant momentum with Pombiliti + Opfolda, treating 186 patients in markets including the USA, Germany, UK, Spain, and Austria by the end of July.

Amicus plans to execute several strategic priorities in 2024, including delivering double-digit revenue growth for Galafold, successful launches of Pombiliti + Opfolda, advancing studies in Fabry and Pompe diseases, and achieving full-year non-GAAP profitability.

In summary, Amicus Therapeutics has demonstrated strong financial and operational performance in the first half of 2024, driven by the commercial success of Galafold and the promising launch of Pombiliti + Opfolda. The company is well-positioned to continue its growth trajectory and achieve its strategic objectives for the year.