Amicus Therapeutics (FOLD) Q3 2024 earnings summary

Executive summary

• Q3 2024 revenue reached $142 million, up 37% year-over-year, driven by strong Galafold and Pombiliti + Opfolda sales and commercial execution.

• Achieved non-GAAP profitability for the first nine months of 2024, with Q3 non-GAAP net income of $31 million ($0.10 per share), ahead of expectations.

• Net loss for Q3 2024 was $6.7 million, a significant improvement from $21.6 million loss in Q3 2023.

• Cash, cash equivalents, and marketable securities totaled $250 million as of September 30, 2024.

• Continued global launches and strong uptake for Pombiliti and Opfolda in Pompe disease, with 203 patients treated or scheduled as of late October.

Financial highlights

• Q3 2024 Galafold revenue: $120.4 million (+19% year-over-year at constant currency); Pombiliti + Opfolda Q3 revenue: $21.1 million (+33% sequentially from Q2).

• Gross profit for Q3 was $128.2 million on $141.5 million in net product sales; cost of goods sold was 9.4% of net sales.

• Non-GAAP operating expenses for Q3 were $82.6 million, down 8% year-over-year.

• Cash, cash equivalents, and marketable securities: $250 million as of September 30, 2024.

• Long-term debt stood at $389.5 million as of September 30, 2024.

Outlook and guidance

• Full-year 2024 total revenue growth guidance raised to 30%-32% at constant exchange rates.

• Galafold full-year revenue growth guidance increased to 16%-18%.

• Pombiliti and Opfolda full-year sales guidance raised to $69-$71 million.

• Non-GAAP operating expense guidance lowered to $340-$350 million for 2024.

• Company expects to achieve full-year non-GAAP profitability and positive cash flow.