Core Viewpoint - AngioDynamics, Inc. (ANGO) is positioned for growth due to the potential of its NanoKnife System, despite facing pricing pressure and macroeconomic challenges [1] Company Overview - AngioDynamics designs, manufactures, and sells a variety of medical, surgical, and diagnostic devices, focusing on minimally invasive procedures, with a market capitalization of $310.85 million [1] - The company projects a 7.6% earnings growth for fiscal 2026 and has surpassed earnings estimates in three of the last four quarters, with an average beat of 28.61% [1] Factors Favoring ANGO Stock - **Broad Product Line**: AngioDynamics specializes in minimally invasive medical devices, with a product portfolio that includes Microwave Ablation, Radiofrequency Ablation (RFA), and the NanoKnife system, which is in high demand for tumor treatments [3] - **R&D Investments**: The company is increasing its R&D expenses at a projected CAGR of 1.3% from fiscal 2024 to 2027 to enhance core technologies [3] - **Regulatory Achievements**: Recent regulatory successes, including CE Mark approval and FDA clearance for the AlphaVac F18 System, support commercial launches [3] Potential in NanoKnife System - The NanoKnife product has received FDA clearance for soft tissue surgical ablation and is designated as a Breakthrough Device, contributing to an 11.3% year-over-year increase in Med Tech segment sales [4] - Capital sales surged by 247.8%, indicating strong demand for disposables, with expectations for FDA clearance for prostate ablation by the end of 2024 [4] - Revenue projections indicate a 5.9% CAGR from fiscal 2024 to 2027, driven by a 10.3% CAGR in the Med Tech segment [4] Strong Geographic Expansion - In fiscal 2024, 85.6% of net sales came from the U.S., up from 83.5% in 2023, with international sales growing by 14% [5] - U.S. revenues increased by 4.3% in the fourth quarter of 2024, with anticipated steady growth at a CAGR of 2.2% in the U.S. and 0.5% internationally through 2027 [5] Estimate Trend - The earnings estimate for 2024 has improved, with the Zacks Consensus Estimate for loss narrowing from 47 cents to 41 cents per share [7] - The third-quarter 2024 revenue estimate is $68.49 million, reflecting a 13% decline from the previous year [7]

Core Viewpoint - AngioDynamics experienced a significant decline in share price following its fiscal Q1 2025 update, which revealed mixed financial results and a net loss, despite maintaining its full-year guidance [1][2]. Financial Performance - AngioDynamics reported fiscal Q1 net sales of $67.5 million, reflecting a year-over-year increase of 1.1%, but falling short of analysts' expectations of $67.93 million [1]. - The company posted a net loss of $12.8 million, equating to $0.31 per share under GAAP, while the adjusted net loss was $4.4 million, or $0.11 per share, which was better than the consensus estimate of an adjusted loss of $0.15 per share [1]. Regulatory Developments - AngioDynamics submitted results from a pivotal study of the NanoKnife system to the FDA, aiming for 510(k) clearance for prostate tissue ablation in intermediate-risk patients [2]. - The company received European CE Mark approval for its Auryon Atherectomy System, which is used for treating peripheral artery disease, having previously been cleared by the FDA in 2020 [2]. Future Guidance - Despite the mixed fiscal Q1 results, AngioDynamics maintained its full-year guidance, expecting net sales between $282 million and $288 million, indicating year-over-year growth of 4.2% to 6.4% [2]. - The company projects an adjusted net loss per share between $0.38 and $0.42, an improvement compared to a pro forma adjusted loss per share of $0.45 in fiscal 2024 [2].

Financial Data and Key Metrics Changes - Total worldwide revenue for Q1 FY 2025 was $67.5 million, representing a year-over-year growth of just over 1% [8][20] - Adjusted EBITDA loss was $200,000, an improvement from a loss of $1.1 million in Q1 FY 2024 [9][25] - Adjusted net loss for Q1 FY 2025 was $4.4 million, or $0.11 per share, compared to a loss of $6.2 million or $0.16 per share in the prior year [24][25] Business Line Data and Key Metrics Changes - MedTech segment revenue was $28 million, an increase of 8.7% year-over-year, while Med Device revenue was $39.5 million, a 3.6% increase [20] - Auryon revenue grew 24.9% to $13.7 million, while AlphaVac revenue increased by over 21% [20][21] - NanoKnife revenue declined by 6.9% to approximately $5.1 million due to a tough year-over-year comparison [13][22] Market Data and Key Metrics Changes - The U.S. Med Device business increased by 2.1% year-over-year, while international business faced challenges due to timing of orders [16][20] - The MedTech segment now comprises 41.4% of total revenue, up from 38.5% a year ago [20] Company Strategy and Development Direction - The company is focused on increasing penetration in the hospital market for Auryon and expanding its geographic reach in Europe [28][29] - Continued investment in clinical data and product enhancements for AlphaVac is planned to drive adoption [30] - The transition to outsourced manufacturing is expected to generate approximately $15 million in annualized savings by FY 2027 [17][40] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth opportunities within the MedTech segment, with a total addressable market now estimated at $10 billion [28] - The company remains on track to achieve previously issued guidance for FY 2025, expecting revenue growth of 4.2% to 6.4% [26][27] Other Important Information - The company has zero debt and had $55 million in cash and cash equivalents as of August 31, 2024 [25] - A stock repurchase program was approved, allowing for purchases of up to $15 million of outstanding common shares [25][26] Q&A Session Summary Question: Can you provide further details on the AlphaVac PE launch ramp? - Management reported positive feedback from physicians regarding AlphaVac's design and efficiency, with ongoing measurement of new customer interactions [32][33] Question: What initiatives are being targeted for the Auryon hospital market? - The company is shifting focus to hospital customers, leveraging existing familiarity with Auryon from outpatient settings [36][38] Question: What are the expected savings from the manufacturing transition? - The transition is on track, with significant savings anticipated at the end of the program, expected to total $15 million [39][40] Question: What is the timeline for NanoKnife's CPT pathway? - The reimbursement process is complex, and while timelines are uncertain, the company is parallel-pathing the FDA and reimbursement processes [44][46] Question: What is the outlook for cash flow breakeven? - Management expects to reach cash flow positivity by the end of FY 2026, with Q1 being the highest cash utilization quarter [49][50]

Group 1: AngioDynamics, Inc. - AngioDynamics reported a first-quarter adjusted loss of 11 cents per share, better than market estimates of a loss of 15 cents per share [1] - The company's quarterly sales were $67.491 million, slightly below expectations of $67.933 million [1] - Following the earnings report, AngioDynamics shares fell 15.6% to $6.45 [1] Group 2: Other Notable Stock Movements - Youdao, Inc. shares decreased by 14.6% to $5.08 [2] - Ingevity Corporation shares declined 12.6% to $32.74 after the departure of CEO John Fortson [2] - Hims & Hers Health, Inc. fell 11.1% to $16.85, possibly influenced by Eli Lilly's announcement regarding a weight-loss drug shortage [2] - Levi Strauss & Co. reported worse-than-expected third-quarter sales and its FY24 adjusted EPS guidance, leading to a 9.1% decline in shares to $19.14 [2] - Joby Aviation, Inc. shares dipped 8.8% to $5.59 despite Toyota's announcement of a $500 million investment [2] - Bilibili Inc. shares fell 8.2% to $27.23 as US-listed Chinese stocks pulled back [2] - Wolfspeed, Inc. shares decreased by 7.5% to $8.45 after a downgrade from Mizuho [2] - GDS Holdings Limited shares fell 6.4% to $21.51 [2] - Weibo Corporation shares dipped 5% to $10.65, reflecting a broader decline in US-listed Chinese stocks [2] - Baidu, Inc. shares fell 4% to $110.49, also part of the sector's pullback [2]

Company Performance - AngioDynamics reported a quarterly loss of $0.11 per share, better than the Zacks Consensus Estimate of a loss of $0.15, and compared to a loss of $0.12 per share a year ago, indicating an earnings surprise of 26.67% [1] - The company posted revenues of $67.49 million for the quarter ended August 2024, missing the Zacks Consensus Estimate by 1.46%, and down from $78.68 million in the same quarter last year [1] - Over the last four quarters, AngioDynamics has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [1] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.10 on revenues of $71.22 million, and for the current fiscal year, it is -$0.41 on revenues of $284.81 million [4] - The estimate revisions trend for AngioDynamics is currently favorable, resulting in a Zacks Rank 1 (Strong Buy), suggesting that the shares are expected to outperform the market in the near future [4] Industry Context - The Medical - Instruments industry, to which AngioDynamics belongs, is currently in the top 24% of over 250 Zacks industries, indicating a strong performance potential [5] - Another company in the same industry, Integer, is expected to report quarterly earnings of $1.36 per share, reflecting a year-over-year change of +7.1%, with revenues anticipated to be $444.59 million, up 9.9% from the previous year [5][6]

Financial Performance - AngioDynamics achieved pro forma revenue growth of 1.1% year-over-year[3] - MedTech segment pro forma revenue grew by 8.7% year-over-year[3] - Auryon sales reached $13.7 million, a 24.9% increase year-over-year[3] - AlphaVac sales amounted to $2.2 million, reflecting a 21.1% year-over-year growth[3] - The company reported a pro forma Adjusted EBITDA loss of ($0.2) million, an improvement from ($1.1) million in Q1 FY24[3] - Full Year Net Sales guidance is $282 - $288 million[28] Product & Regulatory Milestones - The Auryon System received CE Mark approval in Europe[3] - An FDA submission was filed for NanoKnife prostate indication[3] - The RECOVER-AV clinical trial was initiated[3] - Cumulative sales of Auryon are over $140 million since its launch in September 2020[5] - FDA 510(k) & CE Mark for PE was received for AlphaVac in Q4 FY24[13]

[Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) AngioDynamics reported 1.1% pro forma net sales growth in Q1 FY2025, driven by Med Tech, while achieving key regulatory and clinical milestones Q1 FY2025 Pro Forma Net Sales Overview | Metric | August 31, 2024 | Pro Forma YoY Growth | | :--- | :--- | :--- | | Net Sales | $67.5 million | 1.1% | | Med Tech Net Sales | $28.0 million | 8.7% | | Med Device Net Sales | $39.5 million | (3.6)% | Q1 FY2025 Key Profitability Metrics | Metric | Value | | :--- | :--- | | GAAP Gross Margin | 54.4% | | GAAP Loss Per Share | $0.31 | | Adjusted Loss Per Share | $0.11 | - Key operational milestones include submitting the NanoKnife System for FDA 510(k) clearance for prostate tissue, receiving CE Mark approval for the Auryon System in Europe, and initiating the RECOVER-AV clinical trial[2](index=2&type=chunk) - The CEO highlighted a strong start to FY2025, driven by **over 20% growth in both Auryon and AlphaVac**, viewing the fiscal year as an inflection point for the business[3](index=3&type=chunk) [Detailed Financial Performance (Q1 FY2025)](index=1&type=section&id=Detailed%20Financial%20Performance%20%28Q1%20FY2025%29) AngioDynamics reported Q1 FY2025 pro forma net sales of $67.5 million, driven by Med Tech growth, alongside a GAAP net loss of $12.8 million and an adjusted net loss of $4.4 million [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Med Tech sales grew 8.7% to $28.0 million, driven by Auryon and AlphaVac, while Med Device sales declined 3.6% and international sales decreased significantly Q1 FY2025 Net Sales by Segment and Product | Segment / Product | Q1 FY2025 Sales | YoY Growth | | :--- | :--- | :--- | | **Med Tech** | **$28.0 million** | **8.7%** | | - Auryon | $13.7 million | 24.9% | | - AlphaVac | $2.2 million | 21.1% | | - NanoKnife | $5.1 million | (6.9)% | | **Med Device** | **$39.5 million** | **(3.6)%** | Q1 FY2025 Net Sales by Geography | Geography | Q1 FY2025 Sales | YoY Growth | | :--- | :--- | :--- | | U.S. Net Sales | $59.5 million | 6.2% | | International Net Sales | $8.0 million | (25.4)% | [Profitability Analysis](index=2&type=section&id=Profitability%20Analysis) Overall gross margin for Q1 FY2025 was 54.4%, a 40 basis point decrease, leading to a GAAP net loss of $12.8 million and an adjusted net loss of $4.4 million, despite an improved adjusted EBITDA Q1 FY2025 Gross Margin by Segment | Margin Metric | Q1 FY2025 | YoY Change | | :--- | :--- | :--- | | Overall Gross Margin | 54.4% | -40 bps | | Med Tech Gross Margin | 63.3% | -160 bps | | Med Device Gross Margin | 48.2% | -40 bps | Q1 FY2025 Profitability Summary | Profitability Metric | Q1 FY2025 | Q1 FY2024 | | :--- | :--- | :--- | | GAAP Net Loss | $(12.8) million | - | | GAAP Loss Per Share | $(0.31) | - | | Adjusted Net Loss | $(4.4) million | $(6.2) million | | Adjusted Loss Per Share | $(0.11) | $(0.16) | | Adjusted EBITDA | $(0.2) million | $(1.1) million | [Cash Flow and Balance Sheet](index=2&type=section&id=Cash%20Flow%20and%20Balance%20Sheet) AngioDynamics used $18.3 million in operating cash during Q1 FY2025, consistent with historical trends, resulting in $55.0 million in cash and cash equivalents as of August 31, 2024 - Used **$18.3 million** in operating cash during Q1 FY2025, consistent with historical trends for the first fiscal quarter[8](index=8&type=chunk) Cash and Cash Equivalents | Date | Cash and Cash Equivalents | | :--- | :--- | | August 31, 2024 | $55.0 million | | May 31, 2024 | $76.1 million | [Business & Clinical Updates](index=3&type=section&id=Business%20%26%20Clinical%20Updates) AngioDynamics achieved significant regulatory and clinical progress, including FDA submission for NanoKnife, European CE Mark for Auryon, and initiation of the RECOVER-AV clinical trial for AlphaVac - **NanoKnife System:** Submitted results from the PRESERVE pivotal study to the FDA for 510(k) clearance for the ablation of prostate tissue in intermediate-risk patients[10](index=10&type=chunk) - **Auryon System:** Received European CE Mark approval, allowing marketing in Europe for treating Peripheral Artery Disease (PAD) and expanding reach into a **$1.1 billion** global PAD market[11](index=11&type=chunk) - **AlphaVac System:** Initiated the RECOVER-AV clinical trial in Europe to evaluate the AlphaVac F18⁸⁵ System for treating acute, intermediate-risk pulmonary embolism (PE), enrolling patients across up to 20 hospital sites[12](index=12&type=chunk) [Fiscal Year 2025 Financial Guidance](index=3&type=section&id=Fiscal%20Year%202025%20Financial%20Guidance) AngioDynamics reaffirmed its FY2025 financial guidance, projecting net sales between $282 to $288 million, driven by Med Tech growth, and an adjusted EBITDA loss between $0 and $2.5 million FY2025 Financial Guidance | Metric | FY2025 Guidance | | :--- | :--- | | Net Sales | $282 - $288 million | | Pro Forma Net Sales Growth | 4.2% - 6.4% | | Med Tech Net Sales Growth | 10% - 12% | | Med Device Net Sales Growth | 1% - 3% | | Gross Margin | 52% - 53% | | Adjusted EBITDA | $(2.5) million - $0 | | Adjusted Loss Per Share | $(0.38) - $(0.42) | [Financial Statements & Reconciliations](index=6&type=section&id=Financial%20Statements%20%26%20Reconciliations) Unaudited Q1 FY2025 financial statements, including Consolidated Income Statements, Balance Sheets, and Cash Flows, are presented with comprehensive GAAP to non-GAAP reconciliations [Consolidated Income Statements](index=6&type=section&id=Consolidated%20Income%20Statements) For Q1 FY2025, AngioDynamics reported net sales of $67.5 million, a gross profit of $36.7 million, an operating loss of $13.1 million, and a GAAP net loss of $12.8 million Q1 FY2025 Consolidated Income Statement Highlights | Income Statement (Q1 FY2025) | Amount (in thousands) | | :--- | :--- | | Net Sales | $67,491 | | Gross Profit | $36,724 | | Total Operating Expenses | $49,822 | | Operating Loss | $(13,098) | | Net Loss | $(12,798) | | Loss Per Share (Basic & Diluted) | $(0.31) | [Consolidated Balance Sheets](index=13&type=section&id=Consolidated%20Balance%20Sheets) As of August 31, 2024, total assets were $293.6 million, primarily due to a reduction in cash to $55.0 million, with total liabilities at $97.0 million and stockholders' equity at $196.6 million Consolidated Balance Sheet Highlights | Balance Sheet Item | Aug 31, 2024 (in thousands) | May 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $55,005 | $76,056 | | Total Current Assets | $172,594 | $193,253 | | Total Assets | $293,628 | $317,671 | | Total Liabilities | $97,046 | $112,085 | | Total Stockholders' Equity | $196,582 | $205,586 | [Consolidated Statements of Cash Flows](index=14&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For Q1 FY2025, net cash used in operating activities was $18.3 million, investing activities $2.4 million, and financing activities $0.5 million, resulting in a total cash decrease of $21.1 million Q1 FY2025 Consolidated Cash Flow Summary | Cash Flow Item (Q1 FY2025) | Amount (in thousands) | | :--- | :--- | | Net cash used in operating activities | $(18,253) | | Net cash used in investing activities | $(2,405) | | Net cash used in financing activities | $(509) | | **Increase (decrease) in cash** | **$(21,051)** | [Non-GAAP Reconciliations](index=7&type=section&id=Non-GAAP%20Reconciliations) Detailed reconciliations from GAAP to non-GAAP and pro forma figures are provided, showing an adjusted net loss of $4.4 million and an adjusted EBITDA loss of $163 thousand for Q1 FY2025 - Adjusted net loss for Q1 FY2025 was **$(4.4) million**, reconciled from a GAAP net loss of **$(12.8) million** by excluding items such as amortization of intangibles (**$2.6 million**) and acquisition/restructuring costs (**$4.3 million**)[22](index=22&type=chunk) - Pro forma adjusted diluted loss per share for Q1 FY2025 was **$(0.11)**, an improvement from **$(0.16)** in the prior-year period[28](index=28&type=chunk) - Pro forma adjusted EBITDA for Q1 FY2025 was **$(152) thousand**, compared to **$(1,072) thousand** in Q1 FY2024[30](index=30&type=chunk)

Core Insights - AngioDynamics, Inc. is expected to report a quarterly loss of 15 cents per share for its first quarter, compared to a loss of 12 cents per share in the same period last year [1] - Projected quarterly revenue for AngioDynamics is $67.93 million [1] - The company received CE Mark approval for its Auryon System in Europe on September 3 [1] - AngioDynamics shares closed at $7.65, reflecting a gain of 0.3% [1] Analyst Ratings - HC Wainwright analyst Yi Chen has a Buy rating with a price target of $14, with an accuracy rate of 63% [2] - Oppenheimer analyst Steven Lichtman upgraded the stock to Outperform with a price target of $12, having an accuracy rate of 74% [2] - Raymond James analyst Jayson Bedford maintained an Outperform rating but reduced the price target from $12 to $10, with an accuracy rate of 71% [2] Consensus Price Target - The consensus price target for AngioDynamics is $12.25 based on ratings from four analysts [3] - The highest price target is $14 from HC Wainwright & Co., while the lowest is $10 from Raymond James [3] - Recent analyst ratings suggest an implied upside of 75.21% for AngioDynamics based on an average price target of $13.67 [3]

Core Insights - Five stocks have been added to the Zacks Rank 1 (Strong Buy) List, indicating strong potential for investment based on earnings estimates [1] Company Summaries - **Marex Group plc (MRX)**: This financial services platform provider has seen a 22.3% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **AngioDynamics, Inc. (ANGO)**: This medical technology company has experienced a 12.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **Opera Limited (OPRA)**: This internet technology company has also seen a 12.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **Atour Lifestyle Holdings Limited (ATAT)**: This lifestyle hospitality company has had a 9.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **Pampa Energía (PAM)**: This integrated power company has seen a 10.7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1]

AngioDynamics, Inc.(ANGO) has initiated the RECOVER-AV clinical trial, a prospective, multinational, single-arm study aimed at assessing the efficacy, safety and long-term outcomes of the AlphaVac Multipurpose Mechanical Aspiration F1885 System for treating acute intermediate-risk pulmonary embolism (PE).Following the success of the U.S.-based APEX-AV trial, which demonstrated significant improvements in right ventricular function and clot burden reduction, RECOVER-AV will enroll patients across 20 European ...