Core Insights - AngioDynamics (ANGO) is experiencing growth driven by its NanoKnife product and a focus on cancer treatment markets, supported by a strong fourth-quarter fiscal 2025 performance and ongoing studies [1][6][10] - The company's shares have seen a slight decline of 0.3% year-to-date, contrasting with a 7% decline in the industry and an 8.8% increase in the S&P 500 [1][2] Company Performance - AngioDynamics has a market capitalization of $358.8 million and projects a 50% growth over the next year, with earnings surpassing the Zacks Consensus Estimate in the last four quarters, averaging a surprise of 72.58% [2][3] - The fourth-quarter fiscal 2025 results showed a narrower adjusted loss per share and revenues exceeding expectations, indicating strong execution across both operating segments [11] Product and Market Dynamics - The NanoKnife product, which received FDA clearance and Breakthrough Device Designation, generated total revenues of $24.5 million in fiscal 2025, with fourth-quarter revenues of $7.2 million reflecting growth in disposable sales despite softer capital placements [3][4] - Recurring disposable sales grew by 9.6% for the year, providing a reliable revenue stream to offset variability in system placements [3] Clinical and Product Development - AngioDynamics is advancing a broad pipeline of clinical studies, including the AMBITION trial for Auryon and the RECOVER-AV trial for AlphaVac, aimed at enhancing its market position [7][8] - The NanoKnife's PRESERVE prostate trial has met primary endpoints, paving the way for reimbursement catalysts starting in 2026 [8] Financial Outlook - The company anticipates gross margins in the range of 53.5% to 55.5% for fiscal 2026, with adjusted EBITDA projected between $3.0 million and $8.0 million [13] - However, there has been a negative estimate revision trend for fiscal 2026, with the consensus estimate for loss per share expanding from 6 cents to 30 cents [14]

Summary of AngioDynamics Conference Call Company Overview - AngioDynamics is undergoing a transformation to enhance its value by focusing on high-margin, high-growth areas, specifically targeting cardiovascular disease and cancer treatment [3][4] - The company has shifted its portfolio into two reportable segments: med device and med tech, with the latter being the future growth driver [4][25] Financial Performance - The med tech segment has achieved a 25% compound annual growth rate (CAGR) over the last five years [5][25] - For fiscal year 2025, AngioDynamics reported over 8% overall growth, with the med tech segment growing at 20% [26] - Guidance for fiscal year 2026 includes projected revenue between $300 million to $310 million, with med tech expected to grow 12% to 15% year-over-year [30][31] Market Opportunities - The total addressable market (TAM) for the med tech segment in the U.S. is approximately $7 billion, with a global TAM of about $10 billion [7][8] - The company is focusing on venous thromboembolism (VTE) and peripheral arterial disease (PAD) as key growth areas [10][14] Product Segments Med Tech Segment - **Mechanical Thrombectomy**: Products include AlphaVac and AngioVac, with AlphaVac expected to grow significantly due to its advantages over competitors [10][12][60] - **Peripheral Arterial Disease (PAD)**: The AURYON product has grown from zero revenue to over $50 million, with expectations for continued double-digit growth [33][34] - **NanoKnife**: A unique ablation product for treating solid tumors, particularly prostate cancer, with a CPT code expected to enhance market penetration starting January 1 [20][22][24] Growth Strategies - Expansion of the U.S. sales force from 40 to 50 representatives to support growth in the mechanical thrombectomy market [12] - Focus on educating the urology community about NanoKnife's benefits, particularly for patients with intermediate-risk prostate cancer [68][69] Cash Flow and Financial Guidance - The company anticipates a cash burn of $20 million in Q1 of fiscal year 2026 but expects to generate positive cash flow for the remainder of the year [42][44] - The company aims to avoid using its revolver and maintain a safety net for financial stability [43] Risks and Considerations - The company acknowledges the potential impact of tariffs on its operations but believes it can mitigate these effects [46][47] - The competitive landscape includes established players, but AngioDynamics is confident in its product advantages and market strategies [62][65] Conclusion - AngioDynamics is positioned for growth through strategic focus on high-potential markets, innovative products, and a commitment to improving patient outcomes while maintaining financial discipline [28][25]

Core Viewpoint - AngioDynamics reported stronger-than-expected Q4 2025 sales and earnings, but the overall market reaction was negative due to ongoing losses and cautious guidance for the upcoming fiscal year [1][2][4]. Financial Performance - Q4 sales increased by 13% year-over-year, reaching $80.2 million, while gross profit margins declined by 160 basis points to 52.7% [4]. - Adjusted loss per share was $0.03, better than the forecasted loss of $0.12, and GAAP loss per share improved from $0.33 a year ago to $0.15 [4][5]. - For the full fiscal year 2025, AngioDynamics reported a loss of $0.83 per share under GAAP, with sales growth of only 8.1% [5]. Future Guidance - The company expects fiscal 2026 sales to be between $305 million and $310 million, which exceeds Wall Street forecasts [6]. - However, management warned of expected losses ranging from $0.25 to $0.35 per share, adjusted for one-time items, which is worse than the $0.23 per-share loss anticipated by analysts [6][7].

Core Insights - AngioDynamics Inc. reported a fourth-quarter 2025 adjusted loss of 3 cents per share, outperforming the consensus loss of 12 cents per share [1] - The company achieved sales of $80.2 million, reflecting a year-over-year increase of 12.7%, surpassing the consensus estimate of $74.26 million [1] - CEO Jim Clemmer stated that the company is "profitable" and its portfolio addresses approximately $10 billion in annual global market opportunities, up from $3 billion in 2021 [1] Financial Guidance - For fiscal year 2026, AngioDynamics expects net sales between $305 million and $310 million, slightly above the consensus of $304.9 million [2] - The company anticipates an adjusted loss between 35 and 25 cents per share, compared to the consensus loss of 23 cents per share [2] Tariff Impact and Financial Metrics - The company expects a $4 million to $6 million impact from tariffs for the full fiscal year 2026 [3] - The gross margin was reported at 52.7%, down 161 basis points from the fourth quarter of fiscal 2024; without the $1.6 million tariff impact, the gross margin would have been 54.7% [4] - Adjusted EBITDA for the quarter was $3.4 million, an increase from $1.5 million a year ago [4] Sales Performance - Med Tech net sales reached $35.8 million, a 22% increase from $29.3 million in the prior-year period, driven by Auryon sales of $15.6 million, which increased 19.7% [4] - Mechanical Thrombectomy revenue, including AngioVac and AlphaVac, was $11.3 million, marking a 44.7% increase [4] - Med Device net sales were $44.4 million, representing a 6.2% increase from $41.8 million in the prior-year period [4]

Core Insights - AngioDynamics reported a strong performance in Q4 FY2025, with total revenue of $80.2 million, reflecting a year-over-year increase of 12.7% driven by growth in both MedTech and med device segments [4][25][45] - The company emphasized the transformational impact of regulatory approvals and market expansion on future revenue potential, despite facing tariff-related headwinds [12][50][63] Financial Performance - Total revenue for FY2025 reached $292.7 million, up 8.1% from the previous year, with MedTech segment revenue growing 19.5% to $126.7 million [9][57] - Adjusted EBITDA for Q4 FY2025 was $3.4 million, an improvement from $1.5 million in Q4 FY2024, indicating margin improvement despite tariff impacts [8][54] - Gross margin for Q4 FY2025 was 52.7%, negatively impacted by tariffs, which reduced margins by 204 basis points [7][51] Segment Performance - MedTech revenue in Q4 FY2025 was $35.8 million, a 22% increase, while med device revenue was $44.4 million, up 6.2% [4][45] - The Auryon platform generated $15.6 million in revenue, growing 19.7% year-over-year, and has shown consistent double-digit growth since its launch [5][45][57] - Mechanical thrombectomy revenue, including AngioVac and AlphaVac, increased by 44.7% year-over-year, with AlphaVac revenue growing 60.8% [6][46][57] Guidance and Future Outlook - For FY2026, the company expects net sales between $305 million and $310 million, representing 4%-6% growth, with MedTech sales projected to increase by 12%-15% [10][60] - The company anticipates $15 million in annualized savings by FY2027 through manufacturing transitions, which will enhance operational efficiency [10][42] - Regulatory milestones, including a CPT Category I code for NanoKnife, are expected to drive growth and reimbursement access starting January 2026 [11][37][72] Strategic Initiatives - The company is focused on driving adoption and market share gains across its MedTech platforms while maintaining operational discipline [63][64] - Continued investments in clinical trials and evidence generation are planned to support product adoption and market penetration [11][29][38] - Management has indicated no plans for major acquisitions or divestitures in the near term, focusing instead on executing their current strategy [12][16]

Financial Data and Key Metrics Changes - Total revenue for the fourth quarter was $80.2 million, representing a year-over-year growth of over 12% [5][23] - MedTech revenue was $35.8 million, a 22% increase, while Med Device revenue was $44.4 million, an increase of 6.2% [23] - For the full fiscal year, total revenue increased by 8.1% to $292.7 million, primarily driven by growth in the MedTech segment [34][35] - Gross margin for the fourth quarter was 52.7%, with MedTech gross margin at 59% and Med Device gross margin at 47.6% [30][36] Business Line Data and Key Metrics Changes - AURYON platform generated $15.6 million in revenue, growing 19.7% year-over-year [23] - Mechanical thrombectomy revenue, including AngioVac and AlphaVac, increased by 44.7% year-over-year, with AngioVac revenue at $8.2 million (39.5% increase) and AlphaVac revenue at $3.1 million (60.8% increase) [24] - NanoKnife revenue totaled $7.2 million, a decrease of 2.5%, attributed to lower capital sales, while disposable sales grew by 5.5% [25] Market Data and Key Metrics Changes - Hospital customers represented approximately 36% of total AURYON revenue, up from 28% at the beginning of fiscal 2025 [7] - In Europe, over $1 million in revenue was generated from AURYON, indicating successful market entry following CE Mark approval [8] Company Strategy and Development Direction - The company is focused on a long-term strategic transformation to simplify its business and enter high-growth, high-margin MedTech markets [5][20] - Continued investment in R&D is planned, targeting approximately 10% of sales to support long-term growth in the MedTech segment [31] - The company aims to drive adoption and market share gains across its MedTech platforms while maintaining operational discipline [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate tariff impacts and maintain profitability, expecting to be cash flow positive in fiscal 2026 [20][39] - The company anticipates net sales for fiscal 2026 to be in the range of $305 million to $310 million, representing growth of 46% over fiscal 2025 [38] Other Important Information - The company achieved significant regulatory approvals and reimbursement wins, which are expected to drive future growth [5][15] - The company incurred $1.6 million in tariff expenses during the fourth quarter, impacting gross margins [28] Q&A Session Summary Question: Details on the blood return product for the VTE business - Management confirmed that the blood return product is designed as an ancillary add-on and is undergoing the 510(k) regulatory process, with confidence in its market potential [46][50] Question: Expectations for NanoKnife growth with upcoming reimbursement - Management indicated that reimbursement starting in January 2026 is expected to drive growth, although immediate acceleration may not be seen [52][56] Question: Major product growth expectations for FY 2026 - Management expects AURYON to grow in the mid-teens, while mechanical thrombectomy products are anticipated to show the strongest growth [60][63] Question: Impact of tariffs on gross margin and outsourcing benefits - Management acknowledged the complexity of tariff impacts and indicated that benefits from the manufacturing transfer plan will be seen in FY 2026 [64][66] Question: Plans for acquiring new MedTech products or divesting existing ones - Management expressed satisfaction with the current portfolio and indicated no immediate plans for acquisitions or divestitures, focusing instead on maximizing existing assets [70][74]

Core Insights - The Medical Instruments industry is experiencing significant advancements due to artificial intelligence (AI) and predictive analytics, which are driving innovation in diagnostics, patient monitoring, and personalized treatment [2][4] - The global AI in healthcare market is projected to grow at a CAGR of 38.5% from 2024 to 2030, despite facing challenges such as geopolitical tensions and supply chain issues [4][8] - The industry is currently underperforming compared to the S&P 500 but has shown resilience against sector declines [17] Industry Overview - The Zacks Medical - Instruments industry is highly fragmented, involving extensive research and development across various therapeutic areas, regulated by the FDA [5] - Recent trends include the integration of AI in diagnostics, the rise of telemedicine, robotic-assisted surgeries, and advancements in 3D printing and gene editing [6][9] - The ongoing merger and acquisition trend is notable, with 305 M&A transactions in 2024 totaling over $63.1 billion, indicating a competitive landscape [10][11] Company Highlights Integer Holdings - Integer Holdings focuses on portfolio optimization and has divested its Non-Medical business to support long-term growth [20] - The consensus estimate for 2025 sales is $1.87 billion, reflecting a 7.7% increase from 2024, with EPS expected to rise by 19.4% to $6.33 [21] AngioDynamics - AngioDynamics is focusing on cancer treatment markets and has a strong product pipeline, with sales for fiscal 2026 estimated at $305 million, a 6.3% increase from fiscal 2025 [22][23] Penumbra - Penumbra is experiencing consistent revenue growth driven by strong patient outcomes and growth in its vascular and neuro businesses [24] - The consensus estimate for Penumbra's 2025 sales is $1.35 billion, indicating a 13.4% rise from 2024, with EPS expected to improve by 67.6% to $3.72 [25]

Financial Performance - AngioDynamics reported pro forma adjusted EBITDA of $1.3 million, improving from a loss of $3.6 million in Q3 FY24[6] - The company achieved 9% year-over-year pro forma total revenue growth[8] - MedTech segment pro forma revenue grew by 22% year-over-year[8] - For Q3 2025, MedTech net sales were $31.341 million, compared to $25.844 million in Q3 2024[38] - For YTD 2025, MedTech net sales were $90.863 million, compared to $77.068 million in YTD 2024[40] - AngioDynamics increased full-year 2025 guidance for revenue, MedTech growth, gross margin, adjusted EBITDA, and adjusted EPS[7] Product Performance - Auryon sales reached $13.9 million, representing a 17% year-over-year growth[8] - AngioVac sales were $6.8 million, with a 23% year-over-year increase[8] - AlphaVac sales amounted to $3.0 million, demonstrating a 161% year-over-year growth[8] - NanoKnife probe sales totaled $4.9 million, showing a 16% year-over-year growth[8] Strategic & Regulatory Milestones - AngioDynamics received FDA clearance for NanoKnife for prostate tissue ablation[5]