AngioDynamics(ANGO) - 2024 Q4 - Annual Report

Part I Business AngioDynamics is a medical technology company focused on vascular health and cancer treatment, operating through Med Tech and Med Device segments with a strategic shift to outsourced manufacturing - The company is transforming into a focused medical technology company by investing in high-growth platforms and divesting mature, lower-growth product lines[208] - A significant strategic initiative is the restructuring of its manufacturing footprint to a fully outsourced model, expected to be completed by the third quarter of fiscal year 2026[50][203] - The business is organized into two segments: Med Tech (Auryon, Thrombectomy, NanoKnife) and Med Device (Peripheral Products, Ports, Venous Insufficiency, etc)[17] - Recent divestitures include the sale of the BioSentry and dialysis businesses to Merit Medical in June 2023, and the PICC and Midline businesses to Spectrum Vascular in February 2024[117][118][202] Products The product portfolio spans Med Tech, featuring Auryon, AlphaVac/AngioVac, and NanoKnife, and Med Device, including vascular access and ablation systems - Med Tech Products: - Auryon Atherectomy System: Treats infrainguinal stenoses and occlusions in peripheral arteries[18] - Thrombectomy Portfolio: Includes AlphaVac and AngioVac systems for mechanical thrombectomy and various thrombolytic catheters[19] - NanoKnife System: Utilizes Irreversible Electroporation (IRE) for surgical ablation of soft tissue without thermal energy[23] - Med Device Products: - Peripheral Products: Angiographic catheters (Soft-Vu, Accu-Vu), guidewires, and drainage catheters[26] - Vascular Access Ports: SmartPort, BioFlo, and Xcela Plus ports for central venous access, featuring technologies like Vortex and BioFlo with Endexo[34] - Venous Insufficiency: VenaCure EVLT laser system for treating varicose veins[38] - Microwave Ablation: Solero MTA System for soft tissue ablation[38] Competition, Sales, and Manufacturing The company competes with major medical device firms, uses direct and distributor sales, and is transitioning to a fully outsourced manufacturing model by fiscal 2026 - Primary competitors include Boston Scientific, Cook Medical, Medtronic, Johnson & Johnson, and Inari Medical[44] - The company sells products through a direct sales force in the U.S. and a mix of direct sales and distributor relationships internationally[46] - The company is transitioning to a fully outsourced manufacturing model by Q3 FY2026 to improve its cost structure[50] - At the end of fiscal year 2024, the company had a product backlog of $1.3 million, a decrease from $2.7 million in the prior year[51][232] Government Regulation Products are subject to extensive FDA and international regulations, including 510(k) clearance, QSR compliance, and EU MDR, alongside healthcare fraud and abuse laws - Products require marketing clearance from the FDA, primarily through the 510(k) process, which demonstrates substantial equivalence to a predicate device[56][57] - Manufacturing operations must comply with the FDA's Quality System Regulation (QSR) and are subject to periodic inspections[60] - For sales in the European Union, products must comply with the new Medical Device Regulation (MDR), which has stricter requirements and longer certification timeframes (12-18 months or more) than previous directives[63] - The company is subject to federal and state anti-fraud laws, including the Anti-kickback Statute and the False Claims Act, which govern relationships with healthcare providers[67] Risk Factors The company faces significant business, regulatory, intellectual property, and market risks, including intense competition, product development reliance, and manufacturing transition challenges - The company faces intense competition from larger, better-resourced competitors and increasing price pressure from group purchasing organizations (GPOs)[83][84][86] - Future growth heavily relies on the successful completion of clinical trials and market adoption of key products like the NanoKnife, AngioVac, AlphaVac, and Auryon systems[89][93] - The strategic shift to a fully outsourced manufacturing model by FY2026 introduces risks related to execution, quality control, and reliance on third-party manufacturers, some of whom are located in China[101][102][105] - The business is subject to extensive government regulation, and failure to obtain or maintain marketing clearances (e.g., FDA 510(k), EU MDR) could prevent product sales[160][164] - Recent divestitures of product lines (PICC, Midline, Dialysis, BioSentry) may impact revenue, and there is a risk the company will be unable to replace the lost earnings and cash flow with higher-margin growth[117][118][119] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the Securities and Exchange Commission - None[182] Cyber Security AngioDynamics has implemented a cybersecurity risk management program based on the NIST Cyber Security Framework 2.0, overseen by the Board and Audit Committee - The company's cybersecurity program is based on the NIST Cyber Security Framework 2.0 and is integrated into its enterprise risk management (ERM) program[182][183] - Governance is led by the SVP of IT, with oversight from the CEO, the Board of Directors, and the Audit Committee[184][185] - The company is not aware of any cybersecurity incidents to date that have had or are reasonably likely to have a material impact on the business[183] Properties AngioDynamics operates from its Latham, NY headquarters, owns two manufacturing facilities, and leases several other facilities for various functions Property Locations and Types | Location | Purpose | Approx. Sq. Ft. | Property Type | | :--- | :--- | :--- | :--- | | Latham, NY | Corporate headquarters | 39,000 | Lease | | Glens Falls, NY | Manufacturing | 21,000 | Owned | | Queensbury, NY | Manufacturing | 135,000 | Owned | | Queensbury, NY | Distribution | 58,000 | Lease | | Marlborough, MA | Research and development | 8,400 | Lease | | Amsterdam, NL | Selling, marketing and administrative | 8,100 | Lease | | Rehovot, IL | Research and development | 4,300 | Lease | Legal Proceedings The company is involved in various legal proceedings, notably a patent litigation settlement with Becton, Dickinson and Company (BD) in March 2024 - On March 31, 2024, the company settled ongoing patent litigation with Becton, Dickinson and Company (BD) concerning implantable port products[450] - The settlement terms include a $7.0 million lump-sum payment, six minimum annual payments of $2.5 million, and potential future payments contingent on sales and an ongoing appeal[450] Mine Safety Disclosures This item is not applicable to the company - Not applicable[190] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities AngioDynamics' common stock trades on NASDAQ under ANGO, with no cash dividends paid or anticipated in the foreseeable future - The company's common stock trades on the NASDAQ under the symbol ANGO[191] - No cash dividends were paid in the last three fiscal years, and none are anticipated in the foreseeable future[193] Common Stock High and Low Sale Prices | Fiscal Year 2024 | High Sale Price | Low Sale Price | | :--- | :--- | :--- | | Fourth Quarter | $7.03 | $5.27 | | Third Quarter | $8.04 | $5.49 | | Second Quarter | $7.73 | $6.17 | | First Quarter | $11.16 | $8.00 | | Fiscal Year 2023 | High Sale Price | Low Sale Price | | :--- | :--- | :--- | | Fourth Quarter | $12.65 | $8.29 | | Third Quarter | $15.48 | $12.06 | | Second Quarter | $22.81 | $12.51 | | First Quarter | $24.30 | $17.83 | Reserved This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations For FY2024, AngioDynamics reported a 10.3% revenue decrease to $303.9 million, a $184.3 million net loss due to goodwill impairment, and increased cash to $76.1 million from divestitures Key Financial Metrics | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $303.9M | $338.8M | -10.3% | | Gross Profit % | 50.9% | 51.4% | -50 bps | | Net Loss | ($184.3M) | ($52.4M) | ($131.9M) | | Loss per Share | ($4.59) | ($1.33) | ($3.26) | | Cash from Operations | ($28.2M) | $0.1M | ($28.3M) | - The Med Tech business grew 10.0%, driven by Auryon and NanoKnife sales, while the Med Device business decreased 18.4%, primarily due to divestitures of non-core product lines[207] - A non-cash goodwill impairment charge of $159.5 million was recorded for the Med Tech reporting unit due to a sustained decline in the company's stock price[205][243] - The company extinguished all outstanding debt in June 2023 after completing the sale of the dialysis and BioSentry businesses[203][250] Results of Operations In FY2024, net sales decreased to $303.9 million, gross margin contracted to 50.9%, and a $159.5 million goodwill impairment led to a $192.4 million operating loss Net Sales (in thousands) | Net Sales (in thousands) | FY 2024 | FY 2023 | $ Change | | :--- | :--- | :--- | :--- | | Med Tech | $106,403 | $96,687 | $9,716 | | Med Device | $197,511 | $242,065 | ($44,554) | | Total | $303,914 | $338,752 | ($34,838) | Gross Profit (in thousands) | Gross Profit (in thousands) | FY 2024 | FY 2023 | $ Change | | :--- | :--- | :--- | :--- | | Med Tech | $67,198 (63.2%) | $61,966 (64.1%) | $5,232 | | Med Device | $87,500 (44.3%) | $112,280 (46.4%) | ($24,780) | | Total | $154,698 (50.9%) | $174,246 (51.4%) | ($19,548) | - A goodwill impairment charge of $159.5 million was recorded in FY2024, compared to $14.5 million in FY2023[242][243] - Acquisition, restructuring and other items increased by $37.5 million, driven by a $19.3 million legal settlement with BD and $9.5 million in plant closure expenses[245] Liquidity and Capital Resources As of May 31, 2024, the company held $76.1 million in cash with no debt, primarily due to $134.5 million from asset sales offsetting operating and financing cash uses Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | FY 2024 | FY 2023 | | :--- | :--- | :--- | | Cash from Operating Activities | ($28,158) | $78 | | Cash from Investing Activities | $123,717 | ($9,746) | | Cash from Financing Activities | ($64,248) | $25,420 | | Net Change in Cash | $31,436 | $15,795 | - Cash and cash equivalents increased to $76.1 million at year-end, up from $44.6 million in the prior year[250] - All outstanding debt under the Credit Agreement was repaid and the agreement was extinguished in June 2023[254] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is foreign currency fluctuations, with minimal interest rate risk due to no outstanding debt and low credit risk from a diverse customer base - The primary market risk is foreign currency exchange rate fluctuation, as about 3.6% of FY2024 sales were in foreign currencies[260] - Interest rate risk is not significant as the company has no outstanding debt as of May 31, 2024[261] - Credit risk is considered low, with no single customer representing more than 10% of total sales[263] Financial Statements and Supplementary Data This section incorporates the company's audited consolidated financial statements and supplementary data by reference from Part IV of the Form 10-K - The financial statements and supplementary data required by this item are included in Part IV of the report[264] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[264] Controls and Procedures Management concluded disclosure controls and internal control over financial reporting were effective as of May 31, 2024, with an unqualified audit opinion from Deloitte & Touche LLP - Management concluded that disclosure controls and procedures were effective as of May 31, 2024[266] - Management assessed internal control over financial reporting as effective based on the 2013 COSO framework[268] - Deloitte & Touche LLP issued an unqualified audit opinion on the effectiveness of the company's internal control over financial reporting as of May 31, 2024[269][273] Other Information The company reports no other information for this item - None[279] Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable[279] Part III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the registrant's Proxy Statement for its 2024 Annual Meeting of Stockholders[5][282] Executive Compensation Executive compensation information is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the registrant's Proxy Statement for its 2024 Annual Meeting of Stockholders[5][283] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the registrant's Proxy Statement for its 2024 Annual Meeting of Stockholders[5][284] Certain Relationships and Related Transactions, and Director Independence Information on related transactions and director independence is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the registrant's Proxy Statement for its 2024 Annual Meeting of Stockholders[5][285] Principal Accounting Fees and Services Principal accounting fees and services information is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the registrant's Proxy Statement for its 2024 Annual Meeting of Stockholders[5][286] Part IV Exhibits, Financial Statement Schedules This section includes the company's consolidated financial statements, the independent auditor's report, schedules, and a list of exhibits Report of Independent Registered Public Accounting Firm Deloitte & Touche LLP issued unqualified opinions on AngioDynamics' financial statements and internal controls, highlighting inventory valuation and goodwill impairment as Critical Audit Matters - The auditor, Deloitte & Touche LLP, issued an unqualified opinion on both the financial statements and the effectiveness of internal control over financial reporting[293] - Critical Audit Matters (CAMs) identified were: 1. Inventories – Excess Quantities and Obsolescence: Due to significant management estimates and assumptions regarding expected demand[296] 2. Goodwill - Valuation of Goodwill for the Med Tech Reporting Unit: Due to judgmental assumptions in the fair value estimate, including revenue growth rates and discount rates[298] Consolidated Financial Statements The consolidated financial statements detail AngioDynamics' FY2024 net sales of $303.9 million, a $184.3 million net loss, and a balance sheet with $317.7 million in total assets Consolidated Balance Sheets (in thousands) | (in thousands) | May 31, 2024 | May 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $76,056 | $44,620 | | Total current assets | $193,253 | $163,542 | | Goodwill | $0 | $159,238 | | Total Assets | $317,671 | $532,637 | | Liabilities & Equity | | | | Total current liabilities | $91,155 | $83,825 | | Long-term debt | $0 | $49,818 | | Total Liabilities | $112,085 | $154,341 | | Total Stockholders' Equity | $205,586 | $378,296 | Consolidated Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | FY 2024 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | | Net sales | $303,914 | $338,752 | $316,219 | | Gross profit | $154,698 | $174,246 | $165,732 | | Goodwill impairment | $159,476 | $14,549 | $0 | | Operating loss | ($192,435) | ($51,181) | ($28,471) | | Net loss | ($184,349) | ($52,442) | ($26,547) | | Diluted loss per share | ($4.59) | ($1.33) | ($0.68) |