Amicus Therapeutics Reports Q3 2024 Financials and Corporate News

Amicus Therapeutics, a global biotechnology company dedicated to creating innovative treatments for rare diseases, has released its financial results for the third quarter ending September 30, 2024. The company reported a total revenue of $141.5 million for Q3 2024, marking a 37% increase compared to the same period last year. Galafold® generated $120.4 million in revenue for the quarter, reflecting a 20% year-over-year growth. Additionally, Pombiliti® + Opfolda® contributed $21.1 million, showing a 33% rise from Q2 2024.

Bradley Campbell, President and CEO of Amicus, highlighted the strong performance of these therapies and the company's commitment to financial discipline. He emphasized that the increased demand for Galafold and the successful launch of Pombiliti and Opfolda have driven the company's revenue growth. Campbell also mentioned the recent settlement of the Galafold patent litigation with Teva, ensuring continued support for the Fabry community. Amicus has exceeded expectations throughout the year, achieving non-GAAP profitability for the full year 2024 by the end of Q3.

The company's financial highlights for Q3 2024 include a total revenue increase of 37% year-over-year, with Galafold and Pombiliti + Opfolda contributing significantly to this growth. In the first nine months of 2024, Galafold achieved sales of $330.6 million, an 18% rise from the previous year, and Pombiliti + Opfolda reached $48.0 million, a substantial improvement compared to last year’s $3.1 million.

Amicus has raised its total revenue growth guidance for 2024 to 30-32% at constant exchange rates (CER) and updated its Galafold revenue growth guidance to 16-18% at CER. The company has also revised its guidance for Pombiliti + Opfolda revenue to $69-71 million for the year.

In terms of operating expenses, Amicus reported a 4% decrease in GAAP operating expenses to $106.6 million for Q3 2024 compared to Q3 2023. Non-GAAP operating expenses also decreased by 8% to $82.6 million. The company has adjusted its non-GAAP operating expense guidance to $340-350 million for 2024.

For Q3 2024, Amicus recorded a GAAP net loss of $6.7 million, or $0.02 per share, which is an improvement from the $21.6 million net loss, or $0.07 per share, reported in Q3 2023. On a non-GAAP basis, the company achieved a net income of $30.8 million, or $0.10 per share, compared to a non-GAAP net loss of $4.0 million, or $0.01 per share, in Q3 2023. Additionally, the company’s cash, cash equivalents, and marketable securities totaled $249.8 million as of September 30, 2024.

Amicus also announced a licensing agreement with Teva Pharmaceuticals USA, Inc., allowing Teva to market a generic version of Galafold in the United States starting January 30, 2037, pending FDA approval.

Moving forward, Amicus remains focused on key strategic priorities, including driving double-digit revenue growth for Galafold, executing successful launches of Pombiliti + Opfolda, advancing studies to support medical leadership in Fabry and Pompe diseases, and achieving full-year non-GAAP profitability.

In summary, Amicus Therapeutics has demonstrated strong financial performance and strategic progress in Q3 2024, highlighted by significant revenue growth, improved profitability, and effective cost management, while continuing to support the needs of patients with rare diseases.