Amicus Therapeutics ((FOLD)) has held its Q1 earnings call. Read on for the main highlights of the call.
Amicus Therapeutics’ recent earnings call conveyed a strong positive sentiment, highlighting significant growth in revenue and strategic collaborations. Despite challenges such as higher than expected rebates and revised revenue guidance, the overall outlook remains optimistic, driven by robust growth and strategic partnerships.
Strong Double-Digit Revenue Growth
Amicus Therapeutics reported its eleventh consecutive quarter of double-digit sales growth in its core business areas of Pompe and Fabry. This consistent growth is expected to continue for years, showcasing the company’s strong market position and effective business strategies.
Strategic Collaboration with Dimerix
The company announced a strategic collaboration with Dimerix, acquiring U.S. commercialization rights to DMX-200. This first-in-class compound, currently in late Phase III development for a rare fatal kidney disease, holds blockbuster market potential, further strengthening Amicus’ portfolio.
Onshoring Manufacturing to Strengthen Supply Chain
Amicus is onshoring a portion of its drug product manufacturing, enhancing its supply chain diversification strategy. This move is expected to bolster the company’s operational resilience and ensure a steady supply of its products.
Galafold Revenue Growth and Market Share
Galafold’s revenue reached $104.2 million, marking a 6% increase at constant exchange rates. The product also saw a 14% rise in new patient starts and holds a 69% global market share among treated Fabry patients with amenable mutations.
Pombiliti and Opfolda Revenue Growth
Revenues from Pombiliti and Opfolda surged to $21 million, up 92% at constant exchange rates. This growth was primarily driven by significant market expansion in the U.S., Germany, and Spain.
Positive Outlook for DMX-200
The Phase III ACTION study for DMX-200 is progressing well, with FDA alignment on proteinuria as the primary endpoint for approval. This promising development underscores the potential success of this strategic collaboration.
Unexpected Rebate Impact in the UK
The UK’s VPAG rebate was higher than anticipated, affecting revenue projections for both Galafold and Pombiliti and Opfolda. This unforeseen challenge has prompted a reassessment of revenue expectations.
Revised Revenue Guidance for Pombiliti and Opfolda
Amicus revised its full-year 2025 revenue growth guidance for Pombiliti and Opfolda from 65%-85% to 50%-65% at constant exchange rates, reflecting adjustments due to market conditions and rebate impacts.
Delayed Patient Starts in New Markets
The company experienced delays in expected patient starts in newly reimbursed countries, shifting from Q1 to Q2. This delay has impacted immediate revenue projections but is expected to stabilize in the coming quarters.
Challenges with Nonlinear Order Patterns
Nonlinear order patterns outside the U.S. and unexpected factors have impacted quarterly revenues for Galafold and Pom-Op, presenting challenges that the company is actively addressing.
Forward-Looking Guidance
Amicus Therapeutics provided a forward-looking guidance that emphasizes continued growth. The company reported a total revenue growth of 13% year-over-year, with a constant exchange rate growth of 15%. Despite rebate challenges, Amicus remains confident in achieving its full-year 2025 growth guidance for Galafold and projects combined sales of $1 billion by the end of 2028 for its key products. The company also anticipates reaching GAAP profitability in the second half of 2025, supported by strategic collaborations and supply chain expansion.
In conclusion, Amicus Therapeutics’ earnings call reflects a positive sentiment with strong growth and strategic initiatives. While challenges such as unexpected rebates and revised guidance pose hurdles, the company’s robust revenue growth and strategic collaborations position it well for future success.