Amicus Therapeutics Q1 2025 Earnings Preview: Can Strong Biotech Momentum Overcome Legal Headwinds?

Amicus Therapeutics (NASDAQ: FOLD) is set to report its first-quarter 2025 financial results on May 1, 2025, following a year of mixed performance that highlights both its promise as a rare-disease specialist and its vulnerabilities as a debt-laden biotech. The company’s upcoming earnings call will offer critical insights into whether it can sustain its growth trajectory while navigating legal and financial risks that have weighed on its stock.

The Growth Engine: Galafold and Pombiliti + Opfolda

Amicus’s 2024 results underscore its reliance on two key therapies: Galafold (for Fabry disease) and the Pombiliti + Opfolda combination (for Pompe disease). Combined, these products drove $528.5 million in 2024 revenue, a 32% year-over-year increase. For 2025, the company projects 17-24% revenue growth at constant exchange rates, with Galafold targeting 10-15% growth and Pombiliti + Opfolda aiming for a 65-85% surge. The latter’s rapid expansion reflects new reimbursement deals in markets like Italy and Sweden, as well as its potential to treat an expanding patient base.

The Q1 2025 results, which the company reported in February, already hinted at this momentum: revenue hit $150 million, a 30.1% YoY jump, though the stock dipped 5.1% post-earnings due to lingering concerns about execution risks and debt. Analysts will be watching closely for clues about whether Amicus is on track to achieve its $1 billion revenue target by 2028 and its goal of GAAP profitability in H2 2025.

Legal and Financial Risks Looming Over Q1 Results

Amicus’s path to profitability is not without hurdles. A notable headwind is the ongoing legal investigation launched by Kaskela Law LLC in early April 2025. The suit, prompted by a nearly 45% decline in Amicus’s stock price since December 2023 (from $14.50 to below $8.00), alleges potential securities law violations or fiduciary duty breaches by company leadership. This adds pressure to the May 1 earnings call, as investors will scrutinize whether management addresses the probe and its implications for governance.

Equally pressing is Amicus’s debt burden. With a debt-to-equity ratio exceeding 2.0, the company’s financial flexibility is constrained. While the settlement with Teva Pharmaceuticals delayed generic competition for Galafold until 2037—a win for long-term stability—near-term cash needs remain. As of late 2024, Amicus had $250 million in cash, cash equivalents, and marketable securities, which may need to stretch further as it invests in clinical trials and commercialization.

The Bottom Line: Growth vs. Execution

Amicus’s Q1 results will serve as a litmus test for whether its strategic priorities—expanding global market access, controlling costs, and delivering on regulatory milestones—are paying off. Analysts project the company could achieve a $8.5 million GAAP net profit in 2025, a stark reversal from its $56 million loss in 2024. However, this hinges on executing on its guidance, managing debt, and resolving the legal investigation.

The Pombiliti + Opfolda pipeline remains a wildcard. With just over 220 patients treated as of end-2024, securing additional reimbursement agreements in markets like Japan and Canada will be critical to hitting its 65-85% growth target. Meanwhile, the delayed generic threat for Galafold provides breathing room, but Amicus must continue to demonstrate strong commercial traction to offset its financial fragility.

Conclusion: A High-Reward, High-Risk Play

Amicus Therapeutics sits at a pivotal juncture. Its rare-disease therapies are driving robust revenue growth, and its strategic moves—like the Teva settlement—suggest long-term viability. Yet, its high debt load, stock volatility, and the unresolved legal probe amplify risks. Investors will parse Q1 results for signs of progress on profitability and regulatory wins, while weighing whether management can navigate these challenges.

If Amicus delivers on its 2025 targets—$500 million to $550 million in revenue and GAAP profitability—it could finally stabilize its stock and position itself for the $1 billion revenue milestone. However, any misstep could reignite investor skepticism. For now, the May 1 earnings call is the critical event that could tip the scales for this biotech’s future.

Final Note: Amicus’s story is a microcosm of the biotech sector—innovation meets operational uncertainty. Investors should monitor both its financial metrics and regulatory updates closely.