Core Insights - Amicus Therapeutics reported adjusted earnings of 1 cent per share for Q2 2025, missing the Zacks Consensus Estimate of 2 cents, compared to a loss of 6 cents per share in the same quarter last year [1][6] Financial Performance - Revenues for Q2 2025 totaled $154.7 million, representing a 22% year-over-year increase on a reported basis and an 18% increase at constant exchange rates, surpassing the Zacks Consensus Estimate of $148 million [2][6] - Galafold sales reached $128.9 million, up 12% year-over-year at constant exchange rates, although it fell short of the Zacks Consensus Estimate of $133 million [4][6] - Sales of the newly approved combination drug Pombiliti + Opfolda amounted to $25.8 million, exceeding both the Zacks Consensus Estimate of $24 million and the internal model estimate of $25 million [4][6] Growth Drivers - The revenue increase was attributed to higher sales from Galafold and additional revenues from Pombiliti + Opfolda, with ongoing studies aimed at expanding treatment labels for both Fabry and Pompe diseases [3][6] - The company maintained its 2025 revenue growth guidance of 15-22% at constant exchange rates, with Galafold expected to grow by 10-15% and Pombiliti + Opfolda by 50-65% [8] Operating Expenses and Cash Position - Adjusted operating expenses rose 56% to $127.8 million in Q2 2025, primarily due to a $30 million upfront payment for licensing rights to DMX-200 [7] - As of June 30, 2025, Amicus had cash, cash equivalents, and marketable securities totaling $231 million, down from $250.6 million as of March 31, 2025 [7] Future Outlook - The company expects to achieve positive GAAP net income in the second half of 2025 and aims to exceed $1 billion in total sales by 2028 [9] - Amicus has licensed exclusive rights for the commercialization of DMX-200, a potential first-in-class treatment for FSGS, with the pivotal phase III study on track for full enrollment by the end of 2025 [10]

Financial Performance - Q2 2025 total revenue reached $154.7 million, an 18% increase at CER (Constant Exchange Rates)[61] - Non-GAAP net income for Q2 2025 was $1.9 million[61] - The company expects to surpass $1 billion in total revenue in FY 2028[6] - The company reiterates FY 2025 total revenue growth guidance of 15% to 22% at CER[65,67] Product Performance - Galafold Q2 2025 revenue was $128.9 million, a 16% increase in reported sales growth[10] - The company anticipates Galafold revenue growth of 10% to 15% for FY 2025 at CER[4,65,67] - Pombiliti + Opfolda Q2 2025 revenue was $25.8 million, a 58% increase at CER[22] - The company anticipates Pombiliti + Opfolda revenue growth of 50% to 65% for FY 2025 at CER[5,25,65,67] Strategic Initiatives - The company acquired U S licensing of DMX-200 Phase 3 Program[4] - The company aims to deliver positive GAAP net income during H2 2025[65,67]

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].

Financial Performance - Total revenue for Q1 2025 was $125 million, a 15% increase at CER (constant exchange rates)[4,56] - Galafold revenue for Q1 2025 reached $104.2 million, representing a 14% increase[10,12] - Pombiliti + Opfolda revenue for Q1 2025 was $21 million, a 92% increase at CER[18] - The company expects total revenue to surpass $1 billion in FY 2028[5] - The company is guiding for total revenue growth of 15% to 22% for FY 2025[60] Product Performance and Growth - Galafold is the only approved oral treatment for Fabry disease, holding a 69% share of treated amenable patients[9,10] - The company anticipates Galafold revenue growth of 10% to 15% for FY 2025[4,15,60] - Pombiliti + Opfolda revenue growth guidance is updated to 50% to 65% for FY 2025[5,20,60] - Approximately 2,730 individuals have been treated with Galafold as of the end of 2024[10] DMX-200 and Strategic Initiatives - The company has an exclusive U S license agreement with Dimerix for DMX-200, a Phase 3 program for FSGS (Focal Segmental Glomerulosclerosis)[4,34,76] - The upfront investment for DMX-200 is $30 million, with potential success-based milestone payments up to $560 million and tiered royalties[38] - DMX-200 targets a market of over 40,000 people in the U S with FSGS, a rare and fatal kidney disease[37]