Amicus Therapeutics(FOLD)
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15 Stocks Set to Explode in 2026
Insider Monkey· 2025-11-09 14:03
Core Insights - The article discusses 15 stocks anticipated to experience significant growth by 2026, amidst a capital rotation towards growth leaders outside of Big Tech as AI spending is projected to reach $500 billion by 2026 [2][4]. Industry Trends - AI spending is expected to reach $500 billion by 2026, with traditional industries such as power infrastructure and construction gaining investor interest due to their role in supporting AI expansion [2]. - Investment in AI encompasses not only technology like GPUs and chips but also infrastructure such as HVAC, IT, and power grids, indicating a broad impact across various sectors including industrials, materials, and financials [2]. Market Outlook - A cautious outlook for 2026 has been expressed, predicting "sticky yields" and a potential shift in Federal Reserve policy towards rate cuts, which may lead to subdued equity momentum [3]. - The sentiment around an AI bubble persists, with industry leaders acknowledging its presence and potential longevity [4]. Stock Selection Methodology - The list of 15 stocks was curated by screening U.S.-listed companies with a market capitalization over $2 billion and a potential upside exceeding 50% as of November 4, 2025, ensuring significant analyst coverage and hedge fund interest [6]. - The strategy of selecting stocks favored by hedge funds is based on research indicating that mimicking top hedge fund picks can lead to market outperformance [7]. Company Highlights - **Amicus Therapeutics, Inc. (NASDAQ:FOLD)**: - Hedge fund interest: 40 holders - Upside potential: 73.53% - Reported a 17% revenue increase to $169.1 million in Q3 2025, achieving GAAP net income of $17.3 million, marking a transition to profitability [9][11][12]. - **Summit Therapeutics Inc. (NASDAQ:SMMT)**: - Hedge fund interest: 30 holders - Upside potential: 78.62% - Announced positive results from the Phase III HARMONi trial, showing significant improvement in overall survival for lung cancer patients [13][15][16]. - **Chime Financial, Inc. (NASDAQ:CHYM)**: - Hedge fund interest: 46 holders - Upside potential: 83.37% - Reported a 29% year-over-year revenue increase to $544 million in Q3 2025, with significant growth in platform-related revenue and active members [18][20][22].
Bet on These 4 Top-Performing Liquid Stocks to Maximize Returns
ZACKS· 2025-11-07 16:41
Core Insights - Investors should consider adding stocks with strong liquidity to their portfolios, as liquidity indicates a company's ability to meet short-term obligations and supports business expansion [1][2] - Four top-ranked stocks recommended for investment include EverQuote, Inc. (EVER), Amicus Therapeutics, Inc. (FOLD), Lam Research Corporation (LRCX), and Cboe Global Markets, Inc. (CBOE) [2][9] Liquidity Measures - Current Ratio: Measures current assets against current liabilities; a ratio below 1 indicates more liabilities than assets, while a range of 1-3 is ideal [4] - Quick Ratio: Indicates a company's ability to pay short-term obligations, with a desirable ratio of more than 1 [5] - Cash Ratio: The most conservative measure, focusing on cash and equivalents relative to current liabilities; a ratio greater than 1 is desirable but may indicate inefficiency [6] Screening Parameters - Asset Utilization: A measure of efficiency, calculated as total sales over the last 12 months divided by the average total assets; companies with a ratio higher than their industry average are considered efficient [7][8] - Growth Score: A proprietary score added to ensure that liquid and efficient stocks also have solid growth potential [8] Company-Specific Insights - **EverQuote, Inc. (EVER)**: Reported revenues of $173.9 million, a 20% year-over-year increase; projected fourth-quarter revenues between $174-$180 million [12][13] - **Amicus Therapeutics, Inc. (FOLD)**: Revenues of $169.1 million, a 19% year-over-year increase; expects total revenues to grow by 15-22% in 2025 [14][15] - **Lam Research Corporation (LRCX)**: Reported revenues of $5.32 billion, a 28% increase year-over-year; projects second-quarter revenues of $5.2 billion [16][17] - **Cboe Global Markets, Inc. (CBOE)**: Achieved record revenues of $605.5 million, a 14% year-over-year increase; raised 2025 organic revenue growth target to low double-digit to mid-teens [18][19]
Amicus' Q3 Earnings Beat, Higher Product Sales Drive Y/Y Revenues
ZACKS· 2025-11-05 16:11
Core Insights - Amicus Therapeutics (FOLD) reported adjusted earnings of 17 cents per share for Q3 2025, surpassing the Zacks Consensus Estimate of 12 cents and up from 10 cents in the same quarter last year [1][6] - Revenues for Q3 totaled $169.1 million, reflecting a 19% year-over-year increase and exceeding the Zacks Consensus Estimate of $165 million [2][6] - The revenue growth was driven by sales of Galafold and the newly approved combination therapy Pombiliti + Opfolda, which is aimed at treating late-onset Pompe disease [2][3] Financial Performance - Galafold sales reached $138.3 million, a 12% increase year-over-year at constant exchange rates, although it fell short of the Zacks Consensus Estimate of $150 million [4][6] - Sales of Pombiliti + Opfolda amounted to $30.7 million, surpassing both the Zacks Consensus Estimate of $29.7 million and the internal estimate of $29.4 million [7] - Adjusted operating expenses rose by 15% to $95.4 million in Q3 2025, while cash and marketable securities increased to $263.8 million from $231 million as of June 30, 2025 [7] Guidance and Future Outlook - Amicus reaffirmed its 2025 guidance, projecting total revenue growth of 15-22% at constant exchange rates, with Galafold expected to grow by 10-15% and Pombiliti + Opfolda by 50-65% [8] - The company anticipates achieving positive GAAP net income in the second half of 2025 and aims to exceed $1 billion in total sales by 2028 [9] Recent Developments - Amicus licensed exclusive rights for Dimerix's phase III program, DMX-200, in the U.S., targeting FSGS, a rare kidney disease, with the pivotal ACTION3 study on track for full enrollment by the end of 2025 [10]
Compared to Estimates, Amicus Therapeutics (FOLD) Q3 Earnings: A Look at Key Metrics
Yahoo Finance· 2025-11-05 14:30
Core Insights - Amicus Therapeutics reported revenue of $169.06 million for the quarter ended September 2025, marking a year-over-year increase of 19.5% and an EPS of $0.17 compared to $0.10 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $164.76 million by 2.61%, and the EPS surpassed the consensus estimate of $0.12 by 41.67% [1] Financial Performance - Geographic net product sales outside the U.S. were $98.79 million, slightly below the estimated $100.21 million, reflecting a year-over-year increase of 15.8% [4] - U.S. geographic net product sales reached $70.27 million, exceeding the average estimate of $64.47 million, with a year-over-year growth of 25.1% [4] - Net product sales for Pombiliti and Opfolda totaled $30.71 million, surpassing the estimated $29.77 million, representing a significant year-over-year increase of 45.3% [4] - Net product sales for Galafold were reported at $138.35 million, below the average estimate of $150.1 million, but still showing a year-over-year growth of 14.9% [4] Stock Performance - Shares of Amicus Therapeutics have returned +10.2% over the past month, outperforming the Zacks S&P 500 composite's +1% change [3] - The stock currently holds a Zacks Rank 1 (Strong Buy), indicating potential for outperformance in the near term [3]
Amicus Therapeutics(FOLD) - 2025 Q3 - Quarterly Report
2025-11-04 21:03
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].
Amicus Therapeutics, Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:FOLD) 2025-11-04
Seeking Alpha· 2025-11-04 18:31
Group 1 - The article does not provide any specific content related to a company or industry [1]
Amicus Therapeutics (FOLD) Beats Q3 Earnings and Revenue Estimates
ZACKS· 2025-11-04 14:37
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]
Amicus Therapeutics(FOLD) - 2025 Q3 - Earnings Call Transcript
2025-11-04 14:32
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]
Amicus Therapeutics(FOLD) - 2025 Q3 - Earnings Call Transcript
2025-11-04 14:32
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]
Amicus Therapeutics(FOLD) - 2025 Q3 - Earnings Call Transcript
2025-11-04 14:30
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]