Revenue Performance - For the nine months ended September 30, 2025, Galafold revenue was $371.5 million, an increase of $40.9 million compared to the same period in the prior year[85]. - For the same period, Pombiliti + Opfolda revenue was $77.5 million, with approvals in multiple countries including the U.S., E.U., and Japan[85]. - Net product sales for the three months ended September 30, 2025, were $169.1 million, an increase of $27.5 million from $141.5 million in the same period of 2024[94]. - Net product sales increased by $70.4 million to $448.998 million for the nine months ended September 30, 2025, compared to $378.589 million in the same period of 2024[98]. - Gross profit rose to $402.616 million, reflecting a $62.13 million increase from $340.482 million in the prior year[98]. Expenses - The cost of goods sold increased by $6.2 million to $19.5 million, primarily due to the increase in net product sales[95]. - Research and development expenses for the three months ended September 30, 2025, were $23.4 million, a decrease of $2.7 million from $26.2 million in 2024[95]. - Research and development expenses increased by $32.9 million to $112.102 million, primarily due to a $30.0 million upfront license payment to Dimerix[98]. - Selling, general, and administrative expenses increased by $14.9 million to $90.0 million, driven by higher professional fees and increased personnel costs[96]. - Selling, general, and administrative expenses rose by $29.7 million to $266.406 million, driven by higher personnel costs and professional fees[99]. Cash and Investments - Total cash, cash equivalents, and marketable securities as of September 30, 2025, was $263.8 million[90]. - Cash, cash equivalents, and marketable securities totaled $263.8 million as of September 30, 2025[104]. - Net cash provided by operations was $16.9 million for the nine months ended September 30, 2025, compared to a net cash used of $30.0 million in the same period of 2024[105][106]. - Net cash used in investing activities was $39.9 million, primarily for the purchase of marketable securities[107]. - The company has $164.2 million available under its at-the-market equity program as of September 30, 2025[103]. Future Outlook - An exclusive license agreement was entered into with Dimerix for the U.S. commercialization rights of DMX-200, with an upfront payment of $30 million and potential milestone payments totaling up to $590 million[83]. - DMX-200 is currently in a pivotal Phase 3 study for the treatment of Focal Segmental Glomerulosclerosis, with positive interim results reported[88]. - The company is committed to developing next-generation genetic medicines for Fabry and Pompe diseases[92]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory approvals for drug candidates[111]. Net Loss - Net loss attributable to common stockholders decreased by 42.04% to $28.800 million from $70.845 million in the previous year[98].

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Core Insights - Amicus Therapeutics reported quarterly earnings of $0.17 per share, exceeding the Zacks Consensus Estimate of $0.12 per share, and showing an increase from $0.10 per share a year ago, resulting in an earnings surprise of +41.67% [1] - The company achieved revenues of $169.06 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 2.61% and up from $141.52 million year-over-year [2] - The stock has underperformed the market, losing about 5.9% year-to-date compared to the S&P 500's gain of 16.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.16 on revenues of $179.38 million, and for the current fiscal year, it is $0.31 on revenues of $624.06 million [7] - The estimate revisions trend for Amicus Therapeutics was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Amicus Therapeutics belongs, is currently ranked in the top 39% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $169.1 million, a 19% increase compared to Q3 2024, with a 17% growth at constant exchange rates [23] - GAAP net income for Q3 2025 was $17.3 million, or $0.06 per share, compared to a net loss of $6.7 million, or $0.02 per share, in Q3 2024, marking the first quarter of positive GAAP net income in 2025 [24][25] - Non-GAAP net income for Q3 2025 was $54.2 million, or $0.18 per share, compared to $30.8 million, or $0.10 per share, in the same quarter last year [25] Business Line Data and Key Metrics Changes - Galafold revenue reached $138.3 million, up 12% at constant exchange rates and 15% in reported terms, with a year-over-year patient demand increase of 13% [10] - Pombiliti and Opfolda generated $30.7 million in revenue for Q3, a 42% increase at constant exchange rates and 45% in reported terms, with year-to-date growth of 59% at CER [14] Market Data and Key Metrics Changes - Approximately 69% of the global market share of treated Fabry patients with amenable mutations is held by Galafold [10] - The U.S. represented approximately 43% of Pombiliti and Opfolda revenue, while ex-U.S. accounted for 57% [15] Company Strategy and Development Direction - The company aims to achieve combined sales of $1 billion for its two commercial products by 2028, supported by growing diagnostic rates and patient access [7] - The company is advancing the development of DMX-200, a therapy for FSGS, with over 90% enrollment in the ACTION3 pivotal study expected to complete by year-end [8][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth in the Fabry and Pompe core business, driven by record demand and robust new patient starts [5] - The company anticipates positive GAAP net income for the second half of 2025 and reiterated full-year financial guidance for 2025, projecting total revenue growth of 15%-22% [26][27] Other Important Information - The company highlighted the significant unmet need in Fabry disease, with over 6,000 diagnosed patients remaining untreated, indicating a larger market opportunity for Galafold [12] - The company is focused on expanding its market presence and increasing patient compliance and adherence rates above 90% [16] Q&A Session Summary Question: Reception of Pombiliti in the U.S. and real-world evidence impact - Management noted that the label for Pombiliti has been well received, with ongoing studies expected to support label expansion for pediatric patients [32] - Real-world evidence is increasingly important in discussions with physicians, and the company plans to continue supporting publications and presentations [33][34] Question: U.S. new patient starts and revenue trajectory for 2026 - Management reported significant increases in new patient starts in Q3 and expressed confidence in continued momentum into 2025 [42] - The company is focused on expanding its sales force and enhancing real-world evidence to drive revenue growth [43] Question: Galafold patient adds from core vs. emerging countries - The growth in patient adds is primarily driven by core countries, with a significant number of naive patients being diagnosed [48][49] Question: DMX-200 candidate selection based on MCP-1 levels - Management indicated that higher MCP-1 levels correlate with more robust responses to DMX-200, and they are measuring MCP-1 throughout the phase three study [54][55] Question: Impact of Biosecure 2.0 on Pombiliti usability in the U.S. - Management expressed confidence in maintaining a stable supply from the Ireland facility and highlighted the importance of providing evidence to physicians regarding Pombiliti [59][60] Question: Timing for infantile onset Pompe disease label expansion - Management anticipates a submission for adolescent patients mid-next year, with further progress expected for infantile onset patients thereafter [66][68] Question: Commercial trajectory of Pombiliti and market share expectations - Management is confident in continued growth and aims for over 50% market share at peak for Pombiliti, with a target of exceeding $1 billion in revenue [71][72]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $169.1 million, a 19% increase compared to Q3 2024, with a 17% growth at constant exchange rates [23] - GAAP net income for Q3 2025 was $17.3 million, or $0.06 per share, compared to a net loss of $6.7 million, or $0.02 per share, in Q3 2024, marking the first quarter of positive GAAP net income in 2025 [24][25] - Non-GAAP net income for Q3 2025 was $54.2 million, or $0.18 per share, compared to $30.8 million, or $0.10 per share, in the same quarter last year [25] Business Line Data and Key Metrics Changes - Galafold revenue reached $138.3 million, up 12% at constant exchange rates and 15% in reported terms, with a year-over-year patient demand increase of 13% [10][11] - Pombiliti and Opfolda generated $30.7 million in revenue for Q3 2025, reflecting a 42% increase at constant exchange rates and 45% in reported terms, with year-to-date growth of 59% at CER [14][15] Market Data and Key Metrics Changes - The U.S. represented approximately 43% of Pombiliti and Opfolda revenue, while ex-U.S. accounted for 57% [15] - Galafold holds approximately 69% of the global market share of treated Fabry patients with amenable mutations [10] Company Strategy and Development Direction - The company aims to achieve combined sales of $1 billion for its two commercial products by 2028, supported by strong growth in patient demand and market penetration [7][8] - The company is advancing the development of DMX-200, a first-in-class therapy for FSGS, with over 90% enrollment in the ACTION3 pivotal study expected to complete by year-end [8][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth in the Fabry and Pompe core business, driven by record demand and new patient starts [5][6] - The company anticipates positive GAAP net income for the second half of 2025, reinforcing its financial discipline and growth trajectory [24][26] Other Important Information - The company is focused on expanding its market presence and improving patient access, particularly in underdiagnosed populations [12][13] - The company is working on enhancing awareness and diagnosis of Fabry disease through initiatives like the Finding Fabry campaign [13] Q&A Session Summary Question: Reception of Pombiliti label and real-world evidence impact - Management noted that the label for Pombiliti has been well received, with ongoing studies expected to support label expansion for pediatric patients [32] - Real-world evidence is increasingly important in discussions with physicians, with positive feedback on durability and effectiveness from clinical trials [34] Question: U.S. new patient starts and revenue trajectory for 2026 - Management confirmed that Q3 saw the largest net commercial demand for Pombiliti and Opfolda, with significant increases in prescriptions and improved reimbursement times [42] - The company is optimistic about continued momentum into 2025, with plans to expand into new markets and enhance real-world evidence [43] Question: Galafold patient additions from core vs. emerging countries - The growth in Galafold patient additions is primarily driven by core countries, with a significant number of naive patients being diagnosed [48] Question: DMX-200 candidate selection based on MCP-1 levels - Management indicated that while there is no defined threshold for MCP-1 levels for DMX-200 candidates, higher levels may correlate with better responses [54] Question: Impact of Biosecure 2.0 on Pombiliti usability - Management expressed confidence in maintaining a stable supply from the Ireland facility, which is expected to enhance the usability of Pombiliti in the U.S. [59] Question: Timing for infantile onset Pompe disease label expansion - Management anticipates a submission for adolescent patients by mid-next year, with further expansions for younger patients and infantile onset following [66][68] Question: Commercial trajectory of Pombiliti in 2026 - Management is confident in strong growth for Pombiliti, aiming for over 50% market share at peak, with a trajectory towards $1 billion in revenue [71][72]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $169.1 million, a 19% increase year-over-year, with a 17% growth at constant exchange rates [22] - GAAP net income was $17.3 million, or $0.06 per share, compared to a net loss of $6.7 million, or $0.02 per share, in Q3 2024, marking the first quarter of positive GAAP net income in 2025 [24] - Non-GAAP net income was $54.2 million, or $0.18 per share, compared to $30.8 million, or $0.10 per share, in the same quarter last year [24] Business Line Data and Key Metrics Changes - Galafold revenue reached $138.3 million, up 12% at constant exchange rates and 15% in reported terms, with a 13% year-over-year increase in patient demand [8][22] - Pombiliti and Opfolda generated $30.7 million in revenue for Q3, a 42% increase at constant exchange rates and 45% in reported terms, with year-to-date growth of 59% at CER [12][22] Market Data and Key Metrics Changes - Approximately 69% of the global market share of treated Fabry patients with amenable mutations is held by Galafold, with a significant opportunity for further market penetration [8] - The U.S. represented approximately 43% of Pombiliti and Opfolda revenue, while ex-U.S. accounted for 57% [13] Company Strategy and Development Direction - The company aims to achieve combined sales of $1 billion for its two commercial products by 2028, supported by strong growth in Galafold and Pombiliti and Opfolda [5][6] - The company is advancing the development of DMX-200, a late-stage therapy for FSGS, with over 90% enrollment in the ACTION3 pivotal study [6][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth in the Fabry and Pompe core business, driven by record demand and new patient starts [4][5] - The company anticipates positive GAAP net income for the second half of 2025 and reiterated full-year financial guidance for total revenue growth of 15%-22% [25][24] Other Important Information - The company is focused on expanding its market presence and improving patient access, with ongoing efforts to enhance awareness and diagnosis of Fabry disease [10][11] - The company has secured reimbursement in 15 countries for Pombiliti and Opfolda, with plans to launch in up to 10 new countries in 2024 [16] Q&A Session Summary Question: Can you discuss the reception of Pombiliti's label and real-world evidence? - Management noted that the label has been well received, with ongoing studies expected to support label expansion, particularly for pediatric patients [30] Question: What is the status of new patient starts in the U.S. for Pompe? - Management reported significant increases in new patient starts and improved time to reimbursement, contributing to strong growth [38] Question: How should we think about the commercial trajectory of Pombiliti in 2026? - Management expressed confidence in continued momentum and expects strong growth, aiming for over 50% market share at peak [64]

Financial Performance - Q3 2025 total revenue reached $169 million, a 17% increase[4,59] - Galafold revenue in Q3 2025 was $138.3 million[9,13] - Pombiliti + Opfolda revenue in Q3 2025 was $30.7 million, representing a 42% increase[26] - The company anticipates surpassing $1 billion in total revenue in FY 2028[5] - Non-GAAP net income for Q3 2025 was $54.2 million[59] Galafold Performance - Galafold revenue grew 15% in Q3 2025[11] - Approximately 2,730 individuals are currently being treated with Galafold[9] - Galafold holds a 69% share of treated amenable patients[9] Pombiliti + Opfolda Performance - Pombiliti + Opfolda revenue is expected to grow 50-65% in FY 2025[4,28] - The number of naïve starts for Pombiliti + Opfolda doubled in the first 9 months of 2025 compared to FY 2024[31]

Financial Performance - Q3 2025 total revenue reached $169.1 million, reflecting a 17% increase at constant exchange rates (CER) and a currency tailwind of approximately $4 million[3] - GAAP net income for Q3 2025 was $17.3 million, compared to a net loss of $6.7 million in Q3 2024, marking a significant turnaround[4] - Galafold net product sales were $138.3 million in Q3 2025, a 15% year-over-year increase, while Pombiliti + Opfolda sales reached $30.7 million, up 45% year-over-year[4] - Net product sales for Q3 2025 reached $169.1 million, a 19.5% increase from $141.5 million in Q3 2024[26] - Gross profit for Q3 2025 was $149.6 million, compared to $128.2 million in Q3 2024, reflecting a gross margin improvement[26] - Non-GAAP net income for Q3 2025 was $54.2 million, significantly higher than $30.8 million in Q3 2024[32] Expenses and Liabilities - Total GAAP operating expenses for Q3 2025 were $115.3 million, an 8% increase from $106.6 million in Q3 2024[4] - Research and development expenses decreased to $23.4 million in Q3 2025 from $26.2 million in Q3 2024, indicating a 10.6% reduction[26] - Selling, general, and administrative expenses increased to $90.0 million in Q3 2025, up from $75.1 million in Q3 2024, representing a 19.9% rise[26] - The company’s total liabilities rose to $638.4 million as of September 30, 2025, compared to $591.0 million at the end of 2024[28] Cash Position and Assets - Cash position increased to $263.8 million as of September 30, 2025, up from $249.9 million at the end of 2024[4] - Cash and cash equivalents decreased to $190.6 million from $213.8 million at the end of 2024[28] - Total assets increased to $868.8 million as of September 30, 2025, up from $785.0 million at the end of 2024[28] - The weighted-average common shares outstanding for Q3 2025 were 308.5 million, slightly up from 304.7 million in Q3 2024[32] Future Projections - Amicus anticipates total revenue growth of 15% to 22% for 2025, with Galafold revenue growth projected at 10% to 15% and Pombiliti + Opfolda revenue growth expected between 50% to 65%[6] - The company aims to achieve positive GAAP net income during the second half of 2025[6] - Amicus is focused on surpassing $1 billion in total sales by 2028, driven by growth in Galafold and Pombiliti + Opfolda[12] - Enrollment in the Phase 3 study of DMX-200 is on track for completion by year-end 2025, targeting a rare kidney disease with significant market potential[12] Market Expansion - New pricing and reimbursement agreements for Pombiliti + Opfolda were completed in four countries, including Japan and Belgium, with plans for up to 10 new launch countries in 2025[12]

Core Insights - Amicus Therapeutics reported a total revenue of $169.1 million for Q3 2025, reflecting a 17% increase at constant exchange rates (CER) [4][3] - The company achieved a positive GAAP net income of $17.3 million, compared to a net loss of $6.7 million in Q3 2024 [7][27] - Cash position increased to $264 million, marking a $33 million rise in Q3 2025 [4][7] Financial Performance - Total revenues for Q3 2025 were $169.1 million, with a year-over-year growth of 19% reported and 17% at CER [4][5] - Galafold sales reached $138.3 million, a 15% increase year-over-year, while Pombiliti + Opfolda sales were $30.7 million, up 45% year-over-year [7][5] - Total GAAP operating expenses were $115.3 million, an 8% increase from $106.6 million in Q3 2024 [7][27] Product Performance - Galafold's net product sales for Q3 2025 were $138.3 million, with a 12% growth at CER [7][5] - Pombiliti + Opfolda saw a significant increase in sales, driven by high demand and new market entries, achieving a 42% growth at CER [7][5] - The company is on track for full enrollment in the Phase 3 study of DMX-200 by year-end 2025 [3][14] Strategic Outlook - Amicus anticipates total revenue growth of 15% to 22% for 2025, with Galafold revenue growth projected at 10% to 15% and Pombiliti + Opfolda at 50% to 65% [8][4] - The company aims to achieve sustainable double-digit growth in the coming years, with a target of surpassing $1 billion in total sales by 2028 [14][3] - Amicus continues to focus on expanding its commercial business and enhancing its product pipeline for rare diseases [22][3]

Core Viewpoint - Amicus Therapeutics is actively participating in several investor conferences in November 2025, highlighting its commitment to engaging with investors and stakeholders in the biotechnology sector [1][5]. Company Overview - Amicus Therapeutics (Nasdaq: FOLD) is a biotechnology company dedicated to developing innovative medicines for rare diseases, emphasizing a patient-centric approach [3]. - The company aims to advance a pipeline of first- or best-in-class therapies, showcasing its focus on high-quality medicine development [3]. Upcoming Events - The company will present at the 2025 UBS Global Healthcare Conference in Palm Beach Gardens, FL on November 10, 2025, at 2:45 p.m. ET [5]. - Additionally, Amicus Therapeutics will participate in the Jefferies Global Healthcare Conference 2025 in London, U.K. on November 18, 2025, at 4:30 p.m. GMT [5].