Key Takeaways Amicus' Galafold recorded $233.1M in H1 2025 sales, up 11% year over year.Label expansion and global approvals have boosted Galafold's revenue growth in recent times.Teva settlement blocks Galafold generics in the United States until January 2037.Amicus Therapeutics’ (FOLD) lead product, Galafold (migalastat), has been driving the majority of the company’s revenues. The drug remains a key top-line driver for the company.Galafold is the first oral precision medicine approved for treating patien ...

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]