• Total Revenue: $528 million for the full year 2024, a 32% increase year over year.
• Galafold Revenue: $458 million, representing 18% growth year over year.
• POMBILITI and OPFOLDA Revenue: Over $70 million globally for the full year 2024.
• Cost of Goods Sold: 10% of net sales for the full year 2024.
• GAAP Operating Expenses: $450 million in 2024, a 3% increase from 2023.
• Non-GAAP Operating Expenses: $348 million in 2024, a 2% increase from 2023.
• GAAP Net Loss: $56 million or $0.18 per share in 2024.
• Non-GAAP Net Income: $74 million or $0.24 per share in 2024.
• Cash, Cash Equivalents, and Marketable Securities: $250 million as of December 31, 2024.
• Projected Revenue Growth for 2025: 17% to 24% at constant exchange rates.
• Galafold Projected Revenue Growth for 2025: 10% to 15% at constant exchange rates.
• POMBILITI and OPFOLDA Projected Revenue Growth for 2025: 65% to 85% at constant exchange rates.
• Gross Margin: Expected to be in the mid-80s percent range for 2025.

• Warning! GuruFocus has detected 3 Warning Signs with FOLD.

Release Date: February 19, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Amicus Therapeutics Inc (NASDAQ:FOLD) reported a significant revenue growth of 32% year-over-year, reaching $528 million for the full year 2024.
• Galafold, a key product for Amicus, achieved $458 million in revenue, marking an 18% growth year-over-year, driven by strong patient demand and market penetration.
• The company successfully launched POMBILITI and OPFOLDA for late-onset Pompe disease, generating over $70 million in revenue globally in their first year.
• Amicus achieved non-GAAP profitability for the full year 2024, demonstrating strong financial management and operational efficiency.
• The company is on track to surpass $1 billion in total sales by 2028, with a clear path to continued revenue growth and profitability in the coming years.

Negative Points

• Amicus Therapeutics Inc (NASDAQ:FOLD) reported a GAAP net loss of $56 million for 2024, although this was an improvement from the previous year.
• The company faces significant foreign exchange exposure, with 60% of its revenue generated outside the United States, which could impact reported revenues.
• There is a risk of non-linear revenue growth within the year due to factors like uneven ordering patterns and FX fluctuations, particularly affecting Galafold sales.
• The launch of POMBILITI and OPFOLDA in new markets is subject to regulatory and reimbursement processes, which could delay revenue recognition in certain regions.
• Amicus is still working on establishing second-source manufacturing for PomOp, which could pose supply chain risks if not completed as planned.

Q & A Highlights

Q: How long are doctors keeping patients on first or second-generation ERTs before switching to Amicus' PomOp? A: Bradley Campbell, President and CEO, explained that while some physicians prefer to see a year or two of experience before switching, there is excitement for POMBILITI and OPFOLDA. He noted that about 40% of patients who switched to NEXVIAZYME will soon reach the two-year mark, making them potential candidates for switching. Physicians often switch sooner if they observe patient decline.

Q: Can you elaborate on the prevalence of Pompe in the Netherlands and the timing for revenue recognition from that region? A: Bradley Campbell, President and CEO, highlighted the Netherlands as a significant market due to its high diagnosed population. He expects first patients to start treatment by the end of Q1 or early Q2. SAbastien Martel, Chief Business Officer, added that the Netherlands has about 125 adult LOPD patients and is one of the largest markets in Europe.

Q: How does Amicus plan to mitigate FX volatility, and do you have any hedging programs? A: Simon Harford, CFO, stated that Amicus does not traditionally hedge FX exposure due to unpredictability. With 60% of revenues outside the US, they are exposed to FX fluctuations. A 1% change in the US dollar could impact revenues by approximately $4 million. They monitor geopolitical and economic factors but do not predict FX movements.

Q: What is the progress on establishing second-source manufacturing for PomOp, and are there any tariff risks? A: Bradley Campbell, President and CEO, reported successful progress with Wuxi in Dundalk, Ireland, with commercial product expected in Europe later this year and in the US next year. He noted minimal tariff exposure this year and next, with guidance accounting for potential tariffs.

Q: How has the commercial competitive dynamic evolved for PomOp, and what are the plans for LOPD label expansion? A: Bradley Campbell, President and CEO, observed a slightly lesser presence from Sanofi at the World Congress but emphasized strong engagement for Amicus. Jeff Castelli, Chief Development Officer, outlined progress in enrolling pediatric LOPD patients and anticipated label expansions in the coming years. SAbastien Martel, Chief Business Officer, discussed leveraging Amicus' infrastructure for potential business development opportunities.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.