Fiscal Year 2026 First Quarter Overview [Executive Summary and Key Highlights](index=1&type=section&id=1.1.%20Executive%20Summary%20and%20Key%20Highlights) AngioDynamics reported strong Q1 FY26 results with significant Med Tech growth, improved Adjusted EBITDA, and raised full-year guidance, while expecting positive cash flow Quarter Ended August 31, 2025 | Metric | Quarter Ended August 31, 2025 | Pro Forma* YoY Growth | | :--- | :--- | :--- | | Net Sales | $75.7 million | 12.2% | | Med Tech Net Sales | $35.3 million | 26.1% | | Med Device Net Sales | $40.4 million | 2.3% | - Med Tech segment delivered its **fourth consecutive quarter of over 20% revenue growth**[4](index=4&type=chunk) Metric | Metric | Value | | :--- | :--- | | Reported Adjusted EBITDA | $2.2 million (compared to ($0.2) million in prior year) | | GAAP loss per share | $0.26 | | Adjusted loss per share | $0.10 | | Cash and cash equivalents (end of Q1 FY26) | $38.8 million | - **Raised full year FY 2026 guidance** for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS[4](index=4&type=chunk) - Continues to expect to be **cash flow positive** for the full fiscal year 2026[4](index=4&type=chunk)[5](index=5&type=chunk) [CEO Commentary](index=1&type=section&id=1.2.%20CEO%20Commentary) CEO Jim Clemmer attributed Q1 success to strategic platform technologies and operational excellence, driving consistent profitable growth - Strategy to bring unique platform technologies to large, fast-growing global markets has paid off, resulting in **four consecutive quarters of MedTech growth over 20%**[3](index=3&type=chunk) - Continued performance combined with disciplined focus on operational excellence is driving **sustained profitable growth**[3](index=3&type=chunk) - Company is well-positioned to drive **consistent, profitable growth and deliver sustained value creation** during the balance of 2026 and beyond, supported by superior technologies, clinical investments, and balance sheet strength[6](index=6&type=chunk) Detailed Fiscal Year 2026 First Quarter Financial Results [Net Sales Performance](index=2&type=section&id=2.1.%20Net%20Sales%20Performance) Q1 FY26 net sales grew **12.2%** to **$75.7 million**, driven by **26.1% Med Tech** growth, with Med Device sales up **2.3%** Net Sales Performance (Pro Forma YoY Growth) | Category | Q1 FY26 Net Sales | YoY Growth | | :--- | :--- | :--- | | Total Net Sales | $75.7 million | 12.2% | | Med Tech Net Sales | $35.3 million | 26.1% | | Med Device Net Sales | $40.4 million | 2.3% | Med Tech Segment Sales Performance | Med Tech Platform | Q1 FY26 Sales | Increase | | :--- | :--- | :--- | | Auryon | $16.5 million | 20.1% | | Mechanical Thrombectomy (AngioVac, AlphaVac) | $11.3 million | 41.2% | | NanoKnife | $6.4 million | 26.7% (including 31.3% growth in probes) | [Gross Margin Analysis](index=2&type=section&id=2.2.%20Gross%20Margin%20Analysis) Q1 FY26 GAAP gross margin improved to **55.3%**, up **90 basis points** year-over-year, due to Med Tech revenue and efficiency Gross Margin Performance | Metric | Q1 FY26 | Q1 FY25 | | :--- | :--- | :--- | | GAAP Gross Margin | 55.3% | 54.4% | | Sequential Gross Margin (Q4 FY25) | 55.3% | 52.7% | | Tariff Expense | $1.7 million | N/A | - Gross margin improvement primarily due to **increased Med Tech revenue and operational efficiencies**[9](index=9&type=chunk) [Net Loss and Adjusted Net Loss](index=2&type=section&id=2.3.%20Net%20Loss%20and%20Adjusted%20Net%20Loss) Q1 FY26 GAAP net loss was **$10.9 million** (**$0.26 per share**), adjusted net loss improved to **$4.2 million** Net Loss and Adjusted Net Loss (Q1 FY26 vs. Q1 FY25) | Metric | Q1 FY26 | Q1 FY25 (Pro Forma) | | :--- | :--- | :--- | | GAAP Net Loss | $(10.9) million | $(12.9) million | | GAAP Loss per share | $(0.26) | $(0.32) | | Adjusted Net Loss | $(4.2) million | $(4.4) million | | Adjusted Loss per share | $(0.10) | $(0.11) | [Adjusted EBITDA](index=3&type=section&id=2.4.%20Adjusted%20EBITDA) Q1 FY26 Adjusted EBITDA significantly improved to **$2.2 million**, a positive shift from **$(0.2) million** in Q1 FY25 Adjusted EBITDA Performance | Metric | Q1 FY26 | Q1 FY25 (Pro Forma) | | :--- | :--- | :--- | | Adjusted EBITDA | $2.2 million | $(0.2) million | [Cash Flow and Balance Sheet](index=3&type=section&id=2.5.%20Cash%20Flow%20and%20Balance%20Sheet) Q1 FY26 cash utilization was **$17.1 million**, ending with **$38.8 million** cash and a debt-free balance sheet, expecting positive full-year cash flow - Company used **$17.1 million of cash** in Q1 FY26, which was **better than expectations** for the historically highest cash utilization quarter[13](index=13&type=chunk) Cash and Cash Equivalents | Date | Cash and Cash Equivalents | | :--- | :--- | | August 31, 2025 | $38.8 million | | May 31, 2025 | $55.9 million | - The Company maintains a **debt-free balance sheet**[14](index=14&type=chunk) - Continues to expect to be **cash flow positive** for the full year fiscal 2026[13](index=13&type=chunk) Clinical and Research Achievements [AMBITION BTK Trial Enrollment](index=3&type=section&id=3.1.%20AMBITION%20BTK%20Trial%20Enrollment) First patient enrolled in AMBITION BTK trial, assessing Auryon Atherectomy System for critical limb ischemia - **First patient enrolled** in the AMBITION BTK trial, a prospective, multicenter, randomized controlled trial[15](index=15&type=chunk) - Trial investigates the **Auryon Atherectomy System** for treating challenging below-the-knee lesions in patients with Critical Limb Ischemia[15](index=15&type=chunk) - The trial will include up to **224 patients** at up to **30 sites**, with a companion registry enrolling up to **1,500 additional patients**[15](index=15&type=chunk) [RECOVER-AV Clinical Trial Enrollment](index=3&type=section&id=3.2.%20RECOVER-AV%20Clinical%20Trial%20Enrollment) First patient enrolled in RECOVER-AV trial, evaluating AlphaVac F1885 System for acute pulmonary embolism - **First patient enrolled** in the RECOVER-AV clinical trial[16](index=16&type=chunk) - The study evaluates the **AlphaVac F1885 System** for the treatment of acute, intermediate-risk pulmonary embolism[16](index=16&type=chunk) - Multi-center, multi-national study across Europe, Canada, and Hong Kong, following patients for **12 months** to assess functional and quality-of-life outcomes[16](index=16&type=chunk) [NanoKnife PRESERVE Study Publication](index=4&type=section&id=3.3.%20NanoKnife%20PRESERVE%20Study%20Publication) PRESERVE study results published, showing NanoKnife System's effectiveness for prostate cancer with **84.0%** disease-free rate and preserved quality of life - Results from the **PRESERVE study published in European Urology**, a leading journal in urologic research[18](index=18&type=chunk) - The study assessed the safety and effectiveness of irreversible electroporation with the **NanoKnife System** to ablate prostate tissue in patients with intermediate-risk prostate cancer[18](index=18&type=chunk) - Met primary effectiveness endpoint with **84.0% of men free from in-field, clinically significant disease at 12 months** post-procedure, and demonstrated strong quality-of-life outcomes (**96% urinary continence, 84% good sexual function**)[18](index=18&type=chunk) Fiscal Year 2026 Financial Guidance [Updated Guidance Metrics](index=4&type=section&id=4.1.%20Updated%20Guidance%20Metrics) AngioDynamics raised its full-year FY26 guidance for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS, reflecting increased confidence Fiscal Year 2026 Financial Guidance Update | Guidance Metric | Guidance Action | Current Guidance (as of Oct 2, 2025) | Previous Guidance (as of July 15, 2025) | | :--- | :--- | :--- | :--- | | Net Sales | Increased | $308 - $313 million | $305 - $310 million | | Med Tech Net Sales Growth | Increased | 14% - 16% | 12% - 15% | | Med Device Net Sales Growth | Unchanged | Flat | Flat | | Gross Margin | Unchanged | 53.5% - 55.5% | 53.5% - 55.5% | | Adjusted EBITDA | Increased | $6.0 - $10.0 million | $3.0 - $8.0 million | | Adjusted EPS | Increased | ($0.33) – ($0.23

Core Insights - AngioDynamics reported a strong first quarter for fiscal year 2026, with net sales reaching $75.7 million, reflecting a year-over-year growth of 12.2% [2][7] - The Med Tech segment experienced significant growth, with net sales of $35.3 million, marking a 26.1% increase compared to the previous year [2][8] - The company continues to focus on operational excellence and innovative technologies to drive profitable growth and enhance patient care [4][5] Financial Performance - Net sales for the first quarter of fiscal year 2026 were $75.7 million, an increase of 12.2% from the prior year [2][7] - Med Tech net sales were $35.3 million, a 26.1% increase from $28.0 million in the prior-year period [2][8] - Med Device net sales were $40.4 million, a 2.3% increase compared to $39.5 million in the prior-year period [9] Profitability Metrics - The company reported a GAAP gross margin of 55.3%, which is 90 basis points higher than the first quarter of fiscal 2025 [10] - Adjusted EBITDA for the first quarter was $2.2 million, compared to a loss of $0.2 million in the prior year [12] - The company recorded a GAAP net loss of $10.9 million, or a loss per share of $0.26, while the adjusted net loss was $4.2 million, or a loss per share of $0.10 [11][12] Cash Flow and Guidance - The company ended the first quarter with $38.8 million in cash and cash equivalents, down from $55.9 million at the end of the previous quarter [14] - AngioDynamics expects to be cash flow positive for the full fiscal year 2026 [5][13] - The company raised its full-year guidance for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS [5][19] Clinical Developments - The first patients were enrolled in the AMBITION BTK and RECOVER-AV clinical trials, demonstrating the company's commitment to advancing clinical evidence [15][16] - Results from the NanoKnife PRESERVE study were published, showing promising outcomes for prostate cancer treatment [18]

Group 1 - AngioDynamics, Inc. (NASDAQ:ANGO) is expected to report a quarterly loss of 12 cents per share on revenue of $72.72 million [2] - Grindr Inc (NYSE:GRND) appointed John North as chief financial officer, effective immediately [2] - Entero Therapeutics (NASDAQ:ENTO) acquired 100% of GRID AI Corp [2] - Gulf Island Fabrication Inc (NASDAQ:GIFI) received a $35 million fabrication contract for the Francis Scott Key Bridge project in Baltimore, Maryland [2] - Globant SA (NYSE:GLOB) approved a share repurchase program of up to $125 million [2]

Economic Indicators - US MBA mortgage applications fell by -12.7% in the week ended September 26, with the purchase mortgage sub-index down -1.0% and the refinancing sub-index down -20.6% [1] - The September ISM manufacturing index rose +0.4 to a 7-month high of 49.1, exceeding expectations of 49.0 [6] - The September ADP employment change unexpectedly fell by -32,000, marking the largest decline in 2.5 years, while August was revised lower to -3,000 from +54,000 [5] Market Reactions - Stocks initially moved lower due to the US government shutdown, but later recovered, with the S&P 500 and Nasdaq 100 reaching new all-time highs [2][4] - The dollar index fell to a one-week low, while gold prices climbed to a record high amid risk-off sentiment [2] - Rising corporate earnings expectations are a bullish backdrop for stocks, with over 22% of S&P 500 companies providing guidance for Q3 earnings that are expected to beat analysts' expectations [8] Sector Performance - Pharmaceutical stocks rallied, with AstraZeneca closing up more than +9% and Eli Lilly up more than +8%, driven by hopes from Pfizer's deal with the US government [15] - Chipmakers and AI-infrastructure stocks also saw gains, with Super Micro Computer closing up more than +9% and Micron Technology up more than +8% [16] - Grocery retailers declined after Amazon announced a new private-label food brand, leading to Dollar Tree and Dollar General closing down more than -4% and -3% respectively [22] Upcoming Economic Data - Weekly initial unemployment claims are expected to increase by +7,000 to 225,000, and August factory orders are expected to rise by +1.4% month-over-month [9] - September nonfarm payrolls are anticipated to increase by +51,000, with the unemployment rate expected to remain unchanged at 4.3% [9]

AngioDynamics, Inc. (NASDAQ:ANGO) will release earnings results for the first quarter, before the opening bell on Thursday, Oct. 2.Analysts expect the Latham, New York-based company to report a quarterly loss at 12 cents per share, versus a year-ago loss of 11 cents per share in the year-ago period. AngioDynamics projects to report quarterly revenue at $72.69 million, compared to $67.49 million a year earlier, according to data from Benzinga Pro.On July 15, AngioDynamics reported better-than-expected fourth ...

AngioDynamics, Inc. (NASDAQ:ANGO) will release earnings results for the first quarter, before the opening bell on Thursday, Oct. 2.Analysts expect the Latham, New York-based company to report a quarterly loss at 12 cents per share, versus a year-ago loss of 11 cents per share in the year-ago period. AngioDynamics projects to report quarterly revenue at $72.69 million, compared to $67.49 million a year earlier, according to data from Benzinga Pro.On July 15, AngioDynamics reported better-than-expected fourth ...

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 (ANGO) is undergoing a multi-year transformation and is nearing an inflection point in its business strategy [1] - The company has divested its legacy assets and resolved litigation issues, allowing it to focus on sales growth [1] Company Developments - AngioDynamics has successfully divested from legacy assets, which is a significant step in its transformation process [1] - The resolution of litigation has cleared obstacles for the company, enabling a more concentrated effort on expanding its sales [1] Growth Potential - With the divestiture and litigation resolved, AngioDynamics is positioned to capitalize on growth opportunities in the market [1]

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]

Part I [Business](index=5&type=section&id=Item%201.%20Business) AngioDynamics is a diversified medical technology company focusing on cardiovascular and cancer treatments, with products in Med Tech and Med Device segments - The company operates through two segments: **Med Tech** (Auryon, Thrombectomy, NanoKnife) and **Med Device** (peripheral products, ports, venous insufficiency treatments)[21](index=21&type=chunk) - Recent strategic moves include the sale of **dialysis, BioSentry, PICC, and Midline businesses** in June 2023 and February 2024 to focus on higher-growth areas[19](index=19&type=chunk) - Products are sold primarily through a **direct sales force in the U.S.** and a combination of direct sales and distributors internationally[58](index=58&type=chunk) - A manufacturing restructuring plan, announced in January 2024, aims to optimize efficiency by shifting production to **third-party manufacturers**, with completion expected in Q3 fiscal 2026[62](index=62&type=chunk) [Products](index=6&type=section&id=Products) The company's product portfolio spans Med Tech, featuring high-growth platforms like Auryon and NanoKnife, and Med Device, offering a broad range of interventional products - The **Med Tech segment** includes the **Auryon Atherectomy System** for peripheral artery disease, **Thrombectomy systems** (AlphaVac, AngioVac) for thrombi removal, and the **NanoKnife IRE Ablation System** for soft tissue ablation, with recent expanded FDA clearance for prostate tissue[22](index=22&type=chunk)[23](index=23&type=chunk)[31](index=31&type=chunk) - The **Med Device segment** offers a broad portfolio including angiographic catheters, guidewires, drainage products, implantable ports (**SmartPort, BioFlo**), the **VenaCure EVLT laser system** for varicose veins, and the **Solero Microwave Ablation System**[32](index=32&type=chunk)[38](index=38&type=chunk)[43](index=43&type=chunk) [Competition](index=11&type=section&id=Competition) The company faces intense competition from large, well-resourced manufacturers and specialized companies, primarily based on product quality, clinical outcomes, and price - The company faces significant competition from **large, well-resourced manufacturers** and smaller, specialized companies[55](index=55&type=chunk) - Primary competitors include **Boston Scientific, Medtronic, Johnson & Johnson, Cook Medical, and Becton Dickinson**[56](index=56&type=chunk) - Competition is based on **product quality, clinical outcomes, ease of use**, and increasingly on **price** due to healthcare provider consolidation and declining reimbursement rates[57](index=57&type=chunk) [Government Regulation](index=13&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA in the U.S. and require CE Mark for sales in the European Union - Products are regulated by the **FDA in the U.S.**, typically requiring **510(k) clearance** before marketing, a process historically used for the company's products[69](index=69&type=chunk)[72](index=72&type=chunk) - Manufacturing facilities are subject to **FDA's Quality System Regulation (QSR)** and periodic inspections to ensure compliance[74](index=74&type=chunk) - For sales in the **European Union**, a **CE Mark** is required, with new products subject to the more stringent **Medical Device Regulation (MDR)** and transition periods for existing products ending in 2027 or 2028[77](index=77&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant business, regulatory, and intellectual property risks, including intense competition, supply chain dependence, and cybersecurity threats - The company faces **intense competition** from larger competitors and increasing pressure to compete on **price** due to the purchasing power of GPOs and IDNs[102](index=102&type=chunk)[104](index=104&type=chunk) - Dependence on **single-source suppliers** and a strategic shift to **third-party manufacturing** in Costa Rica, Israel, and China expose the company to supply chain interruptions, quality control issues, and geopolitical risks[116](index=116&type=chunk)[119](index=119&type=chunk) - The business is subject to extensive government regulation, including **FDA's Quality System Regulation (QSR)** and the **EU's new Medical Device Regulation (MDR)**, requiring significant compliance resources[169](index=169&type=chunk)[173](index=173&type=chunk) - Product liability is an inherent risk, with the company currently defending numerous claims related to its **port products** consolidated into a multidistrict litigation[132](index=132&type=chunk) - Cybersecurity threats to the company's or partners' IT systems could result in **unauthorized data access, intellectual property theft**, and operational disruptions[156](index=156&type=chunk)[157](index=157&type=chunk) [Cyber Security](index=33&type=section&id=Item%201C.%20Cyber%20Security) AngioDynamics implements a cybersecurity risk management program based on NIST Cyber Security Framework 2.0, with oversight from the Board and Audit Committee - The company's cybersecurity program is based on the **NIST Cyber Security Framework 2.0** and integrated into its enterprise risk management (ERM) program[192](index=192&type=chunk) - Governance is led by the **Senior Vice President of Information Technology**, with oversight from the CEO, Board of Directors, and Audit Committee[194](index=194&type=chunk)[195](index=195&type=chunk) [Properties](index=34&type=section&id=Item%202.%20Properties) The company leases all primary facilities, including corporate headquarters, manufacturing sites, and R&D centers across multiple locations | Location | Purpose | Approx. Sq. Ft. | Property Type | | :--- | :--- | :--- | :--- | | Latham, NY | Corporate headquarters | 39,000 | Lease | | Glens Falls, NY | Manufacturing | 21,000 | Lease | | Queensbury, NY | Manufacturing | 135,000 | Lease | | Queensbury, NY | Distribution | 58,000 | Lease | | Marlborough, MA | Research and development | 8,400 | Lease | | Rehovot, IL | Research and development | 4,300 | Lease | [Legal Proceedings](index=34&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in various legal proceedings, including settled patent litigation and ongoing product liability claims related to its port products - Information regarding legal proceedings is included in **Note 17** to the consolidated financial statements[198](index=198&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=35&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) AngioDynamics' common stock trades on NASDAQ under "ANGO", with no cash dividends paid in the last three fiscal years or anticipated in the foreseeable future - The company's common stock trades on the **NASDAQ Global Select Market** under the symbol **"ANGO"**[201](index=201&type=chunk) - No cash dividends were declared in the last three fiscal years, and none are anticipated for the **foreseeable future**[203](index=203&type=chunk) Common Stock Sale Prices (Fiscal Year 2025) | Fiscal Year 2025 | High Sale Price | Low Sale Price | | :--- | :--- | :--- | | Fourth Quarter | $10.86 | $8.37 | | Third Quarter | $12.94 | $7.00 | | Second Quarter | $7.78 | $5.88 | | First Quarter | $7.84 | $5.51 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) FY2025 revenue decreased 3.8% to **$292.5 million** due to divestitures, while Med Tech grew 19.0% and gross margin improved to 53.9% Financial Highlights | Metric | FY 2025 | Change from FY 2024 | | :--- | :--- | :--- | | Revenue | $292.5 million | -3.8% | | Med Tech Revenue Growth | 19.0% | N/A | | Med Device Revenue Decline | -16.0% | N/A | | Gross Margin | 53.9% | +300 bps | | Net Loss | $34.0 million | Decreased by $150.4 million | | Loss per Share | ($0.83) | Decreased by $3.76 | | Cash Flow from Operations | ($10.1 million) | Improved by $18.0 million | - The decrease in total revenue was primarily due to the divestiture of **PICC, Midline, dialysis, and BioSentry businesses**, impacting sales by **$33.4 million** compared to the prior year[219](index=219&type=chunk) - A manufacturing restructuring plan is expected to generate **$15.0 million in annual cost savings** starting in fiscal year 2027[214](index=214&type=chunk) - On July 16, 2024, the Board approved a **$15.0 million share repurchase program**, with **243,847 shares repurchased for $1.7 million** during FY2025[215](index=215&type=chunk) [Results of Operations (FY2025 vs. FY2024)](index=40&type=section&id=Results%20of%20Operations%20%28FY2025%20vs.%20FY2024%29) In FY2025, total net sales decreased to $292.5 million, driven by a 19.0% growth in Med Tech sales offset by a 16.0% decline in Med Device sales due to divestitures Net Sales by Segment (in thousands) | (in thousands) | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | **Net Sales** | | | | | Med Tech | $126,653 | $106,403 | $20,250 | | Med Device | $165,845 | $197,511 | ($31,666) | | **Total** | **$292,498** | **$303,914** | **($11,416)** | - **Med Tech sales growth** was driven by a **$9.8 million increase in Auryon sales** and a **$10.9 million increase** in the thrombus management platform[241](index=241&type=chunk) - **Med Device sales decrease** was primarily due to the divestiture of **PICCs and Midline products** (**$30.1 million decrease**)[241](index=241&type=chunk) - Total gross margin increased to **53.9% from 50.9%**, driven by favorable sales volume, price, and product mix, positively impacting gross margin by **$19.9 million**, offsetting a **$9.2 million negative impact** from divestitures[242](index=242&type=chunk)[243](index=243&type=chunk) - Operating expenses decreased significantly, primarily due to a **$159.5 million non-cash goodwill impairment charge** in FY2024 not present in FY2025[246](index=246&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents decreased to $55.9 million in FY2025, with an improved operating cash flow and a new $25.0 million revolving credit facility Liquidity Highlights (in thousands) | (in thousands) | May 31, 2025 | May 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $55,893 | $76,056 | | Working Capital (Current Assets - Current Liabilities) | $92,127 | $102,098 | - Cash used in operating activities was **$10.1 million** in FY2025, an improvement from **$28.2 million** used in FY2024[255](index=255&type=chunk)[256](index=256&type=chunk) - On May 28, 2025, the company entered into a new **two-year, $25.0 million secured revolving credit facility**, with no outstanding balance as of May 31, 2025[218](index=218&type=chunk)[257](index=257&type=chunk) - Total contractual obligations as of May 31, 2025, are **$41.7 million**, including operating leases, finance leases, and royalties[259](index=259&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from foreign currency exchange rates, interest rates, and credit concentration, with foreign currency sales at 3.4% in FY2025 - The company is exposed to **foreign currency exchange rate risk**, with approximately **3.4% of fiscal year 2025 sales** denominated in foreign currencies like the Euro, British pound, and Canadian dollar[263](index=263&type=chunk) - Interest rate risk is limited with **no outstanding debt** as of May 31, 2025, though the new revolving facility carries a **variable interest rate based on SOFR**[264](index=264&type=chunk)[265](index=265&type=chunk) - Concentration of credit risk is limited due to a **large and diverse customer base**, with no single customer representing more than **10% of total sales**[267](index=267&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of May 31, 2025, management and independent auditors concluded that the company's disclosure controls and internal control over financial reporting were effective - Management, including the CEO and CFO, concluded that the company's **disclosure controls and procedures were effective** as of May 31, 2025[271](index=271&type=chunk) - Based on the **COSO framework**, management concluded that **internal control over financial reporting was effective** as of May 31, 2025[274](index=274&type=chunk) - The independent auditor, **Deloitte & Touche LLP**, issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of May 31, 2025[275](index=275&type=chunk)[279](index=279&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, and Other Matters](index=51&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information for Part III of the Form 10-K, including directors, executive compensation, and corporate governance, is incorporated by reference from the upcoming proxy statement - Information for **Items 10 through 14** is incorporated by reference from the registrant's Proxy Statement for its 2025 Annual Meeting of Stockholders[7](index=7&type=chunk)[290](index=290&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=52&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section includes the company's consolidated financial statements, the independent auditor's report, financial schedules, and a list of all exhibits filed with the Form 10-K [Report of Independent Registered Public Accounting Firm](index=53&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP issued an unqualified opinion on the financial statements, identifying the reserve for excess and obsolete inventory as a critical audit matter - Auditor **Deloitte & Touche LLP** issued an **unqualified opinion**, stating financial statements are presented fairly in all material respects in conformity with U.S. GAAP[299](index=299&type=chunk) - The audit identified the **reserve for excess quantities and obsolete inventory** as a critical audit matter due to significant management estimates and judgments in determining expected demand[303](index=303&type=chunk)[305](index=305&type=chunk) [Consolidated Financial Statements](index=55&type=section&id=Consolidated%20Financial%20Statements) This section presents the company's consolidated statements of operations, balance sheets, and cash flows for the fiscal years ended May 31, 2025, 2024, and 2023 Consolidated Statement of Operations Highlights (in thousands) | | 2025 | 2024 | 2023 | | :--- | :--- | :--- | :--- | | Net sales | $292,498 | $303,914 | $338,752 | | Gross margin | $157,705 | $154,698 | $174,246 | | Operating loss | ($39,954) | ($192,435) | ($51,181) | | Net loss | ($33,993) | ($184,349) | ($52,442) | | Loss per share (diluted) | ($0.83) | ($4.59) | ($1.33) | Consolidated Balance Sheet Highlights (in thousands) | | May 31, 2025 | May 31, 2024 | | :--- | :--- | :--- | | Total current assets | $168,324 | $193,253 | | Total Assets | $280,144 | $317,671 | | Total current liabilities | $76,197 | $91,155 | | Total Liabilities | $97,174 | $112,085 | | Total Stockholders' Equity | $182,970 | $205,586 | Consolidated Statement of Cash Flows Highlights (in thousands) | | 2025 | 2024 | 2023 | | :--- | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($10,128) | ($28,158) | $78 | | Net cash (used in) provided by investing activities | ($10,178) | $123,717 | ($9,746) | | Net cash (used in) provided by financing activities | ($255) | ($64,248) | $25,420 | [Notes to Consolidated Financial Statements](index=61&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed notes to the consolidated financial statements, covering significant accounting policies, divestitures, commitments, contingencies, and restructuring plans - **Note 2 (Divestitures)**: The company completed the sale of its **PICC and Midline businesses for $34.5 million** in cash in Feb 2024, and its **Dialysis and BioSentry businesses for $100 million** in cash in June 2023[352](index=352&type=chunk)[355](index=355&type=chunk) - **Note 17 (Commitments and Contingencies)**: The company settled patent litigation with BD for a **$7.0 million one-time payment**, six minimum annual payments of **$2.5 million**, and potential future royalties, while defending approximately **162 product liability claims** related to its port products[448](index=448&type=chunk)[449](index=449&type=chunk) - **Note 19 (Restructuring)**: A manufacturing restructuring plan announced in Jan 2024 is estimated to cost between **$33.4 million and $38.4 million**, with **$23.2 million in total charges** recorded as of May 31, 2025[459](index=459&type=chunk)[461](index=461&type=chunk)[462](index=462&type=chunk)