Galafold (migalastat)

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FOLD Q1 Earnings and Sales Miss Estimates, Stock Falls
ZACKSยท 2025-05-02 18:20
Core Viewpoint - Amicus Therapeutics reported disappointing first-quarter 2025 earnings, with adjusted earnings per share of 3 cents, missing the consensus estimate of 8 cents, and revenues of $125.2 million, which also fell short of expectations [1][2]. Financial Performance - Adjusted earnings per share for Q1 2025 were 3 cents, compared to a loss of 2 cents per share in the same quarter last year [1]. - Revenues reached $125.2 million, reflecting a 13% year-over-year increase on a reported basis and a 15% increase on a constant-currency basis, but missed the consensus estimate of $136 million [1][4]. - Galafold sales amounted to $104.2 million, up 6% year-over-year at constant currency, but also missed the estimate of $113 million [4]. - Net product sales of Pombiliti + Opfolda were $21 million, below the consensus estimate of $23 million [5]. Market Reaction - Following the earnings release, Amicus shares declined by 13% on May 1, 2025 [2]. Guidance and Future Outlook - For full-year 2025, management revised revenue growth expectations to 15-22% on a constant exchange rate, down from the previous guidance of 17-24% [9]. - Galafold revenue growth is still expected to be in the range of 10-15% at constant exchange rates [9]. - Pombiliti + Opfolda revenue growth is now projected at 50-65% at constant exchange rates, reduced from 65-85% [9]. - Total adjusted operating expenses are anticipated to be between $380-$400 million, up from the previous guidance of $350-$370 million [10]. - The company aims to achieve positive GAAP net income in the second half of 2025 and targets over $1 billion in total sales by 2028 [10]. Strategic Developments - Amicus has licensed exclusive rights for Dimerix's phase III program, DMX-200, for FSGS treatment, with an upfront payment of $30 million and potential milestone payments of up to $560 million [11][12]. - A licensing agreement with Teva Pharmaceuticals was signed to resolve a patent lawsuit, preventing Teva from selling a generic version of Galafold in the U.S. until January 2037 [13].
Amicus Therapeutics(FOLD) - 2025 Q1 - Earnings Call Presentation
2025-05-01 11:15
AT THE FOREFRONT OF THERAPIES FOR RARE DISEASES 1Q25 Results Conference Call & Webcast May 1, 2025 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the prospects and timing of the potential regulatory and pricing approval of our products, commercialization plans, manufacturing and supply plans, financing plans, the collaboration with Dimerix, and the projected revenues and cash position f ...