Core Insights - AngioDynamics, Inc. reported stronger-than-expected first-quarter results and raised its fiscal 2026 guidance, indicating growth across its Med-Tech businesses [1][3] Financial Performance - First-quarter revenue increased by 12.1% to $75.7 million, exceeding consensus estimates, driven by a 26.2% rise in Med-Tech sales [2] - Gross margin improved to 55.3%, surpassing the expected 52.5% [2] - Adjusted EPS showed a loss of 10 cents, slightly below forecasts, while adjusted EBITDA reached $2.2 million, exceeding estimates [2] Fiscal Guidance - Fiscal year 2026 revenue guidance was raised to between $308 million and $313 million, reflecting a projected Med-Tech growth of 14% to 16% [3] - Adjusted EBITDA is now expected to range from $6 million to $10 million, with positive cash flow anticipated for the year [3] - Gross margin guidance remains steady at 53.5%-55.5%, despite challenges from manufacturing transitions and raw material costs [3] Product Performance - Mechanical Thrombectomy revenue grew by 41.2% year-over-year to $11.3 million, with strong performance from AngioVac and AlphaVac [4] - Auryon generated $16.5 million in revenue, up 20.1% year-over-year, benefiting from expansion in outpatient labs and hospitals [5] - NanoKnife revenue reached $6.4 million, a 26.7% year-over-year increase, with disposables sales exceeding forecasts [5] Financial Position - AngioDynamics ended the quarter with $38.8 million in cash, no debt, and full access to a $25 million revolving credit facility [6] - Management anticipates approximately $3 million in cash burn in the second quarter before achieving positive cash flow in the second half [6] - Canaccord projects revenue of $310.9 million for fiscal year 2026 and $325.1 million for fiscal year 2027, slightly adjusted from previous estimates [6]

Financial Data and Key Metrics Changes - Revenue increased by 12.2% to $75.7 million, driven by growth across both med-tech and med-device segments [12][21] - Gross margin for Q1 FY26 was 55.3%, a 90 basis point increase from the previous year [16] - Adjusted net loss for Q1 FY26 was $4.2 million, an improvement from a loss of $4.4 million in the same quarter last year [18] Business Line Data and Key Metrics Changes - Med-tech revenue was $35.3 million, a 26.1% increase, while med-device revenue was $40.4 million, an increase of 2.3% [13] - Auryon platform contributed $16.5 million in revenue, growing 20.1% year-over-year [14] - Mechanical thrombectomy revenue increased by 41.2% year-over-year, with AngioVac revenue at $8 million (37.1% increase) and AlphaVac revenue at $3.3 million (52.3% increase) [15] Market Data and Key Metrics Changes - Med-tech platforms comprised 47% of total revenue, up from 41% a year ago, illustrating the strategic shift towards med-tech [13] - International adoption of Auryon following CE mark approval contributed approximately $500,000 in revenue during the quarter [14] Company Strategy and Development Direction - The company is focused on expanding its product portfolio to compete in large, fast-growing markets, particularly in med-tech [5] - Continued investment in Auryon and plans to enter the coronary market are part of the long-term growth strategy [6] - The company aims to increase its market share in the hospital segment, driving both top-line growth and higher margins [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of the med-tech segment, particularly in mechanical thrombectomy and NanoKnife [26] - The company expects to be cash flow positive for the current fiscal year, with significant cash generation anticipated in Q4 [20] - Guidance for FY26 was raised, expecting net sales in the range of $308 to $313 million, reflecting growth of 5% to 7% over the previous year [21] Other Important Information - The company continues to face tariff expenses, with an estimated impact of $4 to $6 million for the full fiscal year [17] - R&D expenses were $6.4 million, or 8.5% of sales, as the company remains committed to investing in long-term growth initiatives [18] Q&A Session Summary Question: Guidance on growth drivers - The increase in guidance is primarily driven by mechanical thrombectomy and NanoKnife segments, with expectations for continued solid contributions from Auryon [26] Question: NanoKnife disposable revenue specifics - The growth in NanoKnife disposable revenue is largely driven by prostate initiatives, with no significant one-time stocking effects noted [30] Question: Update on mechanical thrombectomy hospital penetration - There has been good uptake in hospitals, with ongoing efforts to convert accounts into value analysis committee approvals [33] Question: Sales force updates in mechanical thrombectomy - The sales force for mechanical thrombectomy has increased to 50 dedicated reps, with plans for further investments in the NanoKnife urology sales force [38] Question: Revenue growth attribution to price increases - Revenue growth in mechanical thrombectomy is attributed to a combination of price increases, new customer acquisitions, and increased utilization [42] Question: Update on ongoing clinical trials - The Ambition BTK study is progressing well, with positive expectations for Auryon's role in atherectomy treatments [44]

Financial Data and Key Metrics Changes - Revenue increased by 12.2% to $75.7 million, driven by growth across both med-tech and med-device segments [12][21] - Gross margin for Q1 FY26 was 55.3%, a 90 basis point increase from the previous year [16] - Adjusted net loss for Q1 FY26 was $4.2 million, improving from a loss of $4.4 million in the same quarter last year [18] Business Line Data and Key Metrics Changes - Med-tech revenue was $35.3 million, a 26.1% increase, while med-device revenue was $40.4 million, an increase of 2.3% [13] - Auryon platform contributed $16.5 million in revenue, growing 20.1% year-over-year [14] - Mechanical thrombectomy revenue increased by 41.2% year-over-year, with AngioVac revenue at $8 million (37.1% increase) and AlphaVac revenue at $3.3 million (52.3% increase) [15] Market Data and Key Metrics Changes - Med-tech platforms comprised 47% of total revenue, up from 41% a year ago, illustrating the strategic shift towards med-tech [13] - International adoption of Auryon following CE mark approval contributed approximately $500,000 in revenue [14] Company Strategy and Development Direction - The company is focused on expanding its product portfolio into large, fast-growing markets, particularly in med-tech [5] - Continued investment in Auryon and mechanical thrombectomy products is expected to drive long-term growth [6][10] - The company aims to increase its market share and expand access to new opportunities, particularly in the hospital market [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of the med-tech segment, particularly Auryon and NanoKnife, as key drivers for future revenue [21][27] - The company anticipates continued strong performance in mechanical thrombectomy and NanoKnife, with expectations for growth in the urology market [27][28] Other Important Information - The company expects to incur between $4 million and $6 million in tariff expenses for the full fiscal year 2026 [17] - Cash utilization was better than expected, with a cash balance of $38.8 million at the end of Q1 FY26 [20] Q&A Session Summary Question: Guidance on growth drivers - The increase in guidance is primarily driven by mechanical thrombectomy and NanoKnife segments, with expectations for continued solid contributions from Auryon [25][26] Question: NanoKnife disposable revenue specifics - The strong growth in NanoKnife disposable revenue is largely driven by prostate initiatives, with no significant one-time stocking effects noted [29][30] Question: Update on mechanical thrombectomy hospital penetration - There has been good uptake in hospitals, with ongoing efforts to convert interest into approvals for product usage [32][33] Question: Sales force updates - The company has increased its sales force for mechanical thrombectomy by 25%, now totaling 50 dedicated sales reps [37][38] Question: Revenue growth attribution - Revenue growth in mechanical thrombectomy is attributed to a combination of price increases, new customer acquisitions, and increased utilization [41][42] Question: Clinical trials update - The Ambition BTK study is progressing well, with positive expectations for its impact on the Auryon business [43][44]

Financial Data and Key Metrics Changes - Revenue increased by 12.2% to $75.7 million, driven by growth across both med-tech and med-device segments [12][21] - Gross margin for Q1 FY26 was 55.3%, a 90 basis point increase from the previous year [17] - Adjusted net loss for Q1 FY26 was $4.2 million, improving from a loss of $4.4 million in the same quarter last year [19] Business Line Data and Key Metrics Changes - Med-tech revenue was $35.3 million, a 26.1% increase, while med-device revenue was $40.4 million, an increase of 2.3% [13] - Auryon platform contributed $16.5 million in revenue, growing 20.1% year-over-year [15] - Mechanical thrombectomy revenue increased by 41.2% year-over-year, with AngioVac revenue at $8 million (37.1% increase) and AlphaVac revenue at $3.3 million (52.3% increase) [16] Market Data and Key Metrics Changes - Med-tech platforms comprised 47% of total revenue, up from 41% a year ago, illustrating the strategy to increase revenue from this segment [14] - The annual revenue of the med-tech segment grew from $41 million in 2020 to $127 million in 2025, representing a compound annual growth rate of 25% [15] Company Strategy and Development Direction - The company is focused on growing its med-tech segment, particularly through innovative products like Auryon and NanoKnife, which are expected to drive future growth [5][7] - Continued investment in R&D initiatives is planned to support long-term growth, targeting approximately 10% of sales [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of the med-tech segment, particularly in mechanical thrombectomy and NanoKnife, with expectations for continued strong performance [26][27] - The company anticipates being cash flow positive for the current fiscal year, with significant cash generation expected in Q4 [20] Other Important Information - The company expects net sales for FY26 to be in the range of $308 to $313 million, an increase from previous guidance [21] - Tariff expenses for FY26 are estimated to be between $4 and $6 million [18] Q&A Session Summary Question: Guidance on growth drivers - The increase in guidance is primarily driven by mechanical thrombectomy and NanoKnife segments, with expectations for continued growth in these areas [25][26] Question: Update on mechanical thrombectomy hospital penetration - There has been good uptake in hospitals, with ongoing efforts to convert accounts into value analysis committee approvals [31][32] Question: Revenue growth attributable to price increases - Revenue growth is driven by a combination of price increases, new customer acquisitions, and increased utilization [38][39] Question: Update on clinical trials for Ambition BTK - The Ambition BTK study is progressing well, with enrollment in both RCT and registry segments, expected to significantly impact the Auryon business [40][41]

Financial Performance - Net sales reached $75.7 million, a 12.2% year-over-year increase[5] - Med Tech segment sales grew by 26.1% year-over-year, reaching $35.3 million[5] - Med Device segment sales increased by 2.3% year-over-year, totaling $40.4 million[5] - Pro forma adjusted EBITDA was $2.2 million, a $2.3 million improvement from Q1 FY25[5] Med Tech Growth Drivers - Auryon sales reached $16.5 million, with a year-over-year growth of 20.1%[16] - Total Mech Thrombectomy sales, including AngioVac and AlphaVac, reached $11.3 million, a 41.2% year-over-year increase[20] - NanoKnife disposables sales were $5.4 million, a 31.3% year-over-year increase[25] - Total NanoKnife sales were $6.4 million, a 26.7% year-over-year increase[25] Financial Outlook - The company increased its net sales guidance for FY2026 to $308 - $313 million[26] - Med Tech net sales growth guidance increased to +14% – 16%[26] - Adjusted EBITDA guidance increased to +$6.0 - $10.0 million[26]

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]

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]

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]