8-K: AngioDynamics Reports Strong Q2 FY26, Raises Guidance

AngioDynamics announced robust fiscal Q2 2026 results driven by double-digit Med Tech growth, increased profitability, and raised full-year guidance.

Summary

• Net sales for the fiscal second quarter ended November 30, 2025, were $79.4 million, an increase of 8.8% year-over-year on a pro forma basis.
• Med Tech net sales grew by 13.0% to $35.7 million, marking the fifth consecutive quarter of double-digit growth for the segment.
• Med Device net sales increased by 5.6% to $43.8 million.
• GAAP gross margin improved to 56.4% from 54.7% in the prior-year quarter.
• Adjusted EBITDA for the quarter was $5.9 million, significantly up from $3.1 million in Q2 FY25.
• The company reported an adjusted loss per share of $0.00, an improvement from a $0.04 loss per share in Q2 FY25.
• AngioDynamics generated $4.7 million in cash during the quarter, ending with $41.6 million in cash and cash equivalents and a debt-free balance sheet.
• Received FDA IDE approvals for the APEX-Return study (AlphaReturn Blood Management System) and the PAVE clinical study (AngioVac System for right-sided infective endocarditis).
• Obtained FDA 510(k) clearance for a modified AlphaVac F1885 System with expanded indications for use.
• Successfully concluded patent litigation with C.R. Bard, affirming the invalidation of Bard's patents and eliminating a $3 million contingent payment obligation.
• Raised full-year FY 2026 guidance for net sales to $312 $314 million and Adjusted EBITDA to $8.0 $10.0 million.
• President and CEO Jim Clemmer announced his intention to retire during fiscal year 2027 upon the appointment of a successor, with a comprehensive search initiated by the Board.

Sentiment

Score: 8

Explanation: The filing indicates strong operational execution, significant financial improvements, positive regulatory milestones, and increased future guidance, all contributing to a very positive outlook despite a GAAP loss.

Positives

• Med Tech segment achieved its fifth consecutive quarter of double-digit growth, increasing 13.0% year-over-year.
• Overall net sales increased by 8.8% year-over-year on a pro forma basis, reaching $79.4 million.
• GAAP gross margin improved by 170 basis points to 56.4% due to product mix shift, manufacturing transfer benefits, and a transition to a distributor model in France.
• Adjusted EBITDA significantly increased to $5.9 million from $3.1 million in the prior-year quarter.
• Achieved adjusted loss per share of $0.00, an improvement from a $0.04 loss per share in Q2 FY25.
• Generated $4.7 million in cash during the quarter, exceeding expectations, and maintains a debt-free balance sheet with $41.6 million in cash.
• Received three significant regulatory milestones: FDA IDE approvals for APEX-Return and PAVE studies, and 510(k) clearance for modified AlphaVac F1885 System.
• Successfully concluded long-standing patent litigation with C.R. Bard, eliminating a $3 million contingent payment.
• Raised full-year FY 2026 guidance for net sales and Adjusted EBITDA, indicating confidence in continued performance.

Negatives

• Reported a GAAP net loss of $6.4 million, or $0.15 per share, for the quarter.
• AngioVac sales decreased by 7.5% to $7.5 million in Q2 FY26.
• Unifuse sales decreased by 15.2% to $1.1 million in Q2 FY26.

Risks

• The scale and scope of the COVID-19 global pandemic.
• Ability to develop existing and new products.
• Technological advances and patents attained by competitors.
• Infringement of AngioDynamics' technology or assertions that AngioDynamics' technology infringes the technology of third parties.
• Ability to effectively compete against competitors that have substantially greater resources.
• Future actions by the FDA or other regulatory agencies.
• Domestic and foreign health care reforms and government regulations.
• Results of pending or future clinical trials.
• Overall economic conditions, including inflation, tariffs, labor shortages, and supply chain challenges (cost and availability of raw materials).
• Results of ongoing litigation.
• Challenges with respect to third-party distributors or joint venture partners or collaborators.
• Results of sales efforts.
• Effects of product recalls and product liability claims.
• Changes in key personnel.
• Ability to execute on strategic initiatives.
• Effects of economic, credit, and capital market conditions.
• General market conditions and market acceptance.
• Foreign currency exchange rate fluctuations.
• Effects on pricing from group purchasing organizations and competition.
• Ability to obtain regulatory clearances or approval of products, or to integrate acquired businesses.

Future Outlook

AngioDynamics has raised its full-year fiscal 2026 guidance for net sales to $312 $314 million and Adjusted EBITDA to $8.0 $10.0 million, reflecting confidence in continued strong performance, particularly from its Med Tech segment. The company reaffirms its expectation to be cash flow positive for the full fiscal year 2026 and anticipates continued growth in Med Tech net sales between 14% and 16%.

Management Comments

• "We delivered an excellent second quarter, with continued strong Med Tech growth driving our overall performance." Jim Clemmer, President and Chief Executive Officer.
• "Across our Med Tech portfolio, we're seeing the benefits of our strategic transformation as our innovative platform technologies, from Auryon to Mechanical Thrombectomy to NanoKnife, continue taking share in large, attractive markets." Jim Clemmer, President and Chief Executive Officer.
• "The momentum across our technology platforms demonstrates the strength of our diversified Med Tech portfolio. We will continue to invest in the long-term growth of our Med Tech portfolio." Jim Clemmer, President and Chief Executive Officer.
• "Importantly, our strong top-line growth, combined with disciplined execution of our operating initiatives, translated into another quarter of positive adjusted EBITDA and cash generation. With our differentiated technology portfolio, proven commercial execution, and strong balance sheet, we remain confident in delivering sustained, profitable growth throughout the year." Jim Clemmer, President and Chief Executive Officer.
• "Jim has spearheaded our multi-year strategic transformation that reshaped our product portfolio, captured significant opportunities in the large, global MedTech market, and delivered a substantially enhanced top-line growth profile for shareholders." Howard Donnelly, AngioDynamics Chairman of the Board.
• "Jims dedication to mentoring our people and cultivating a standard of excellence ensures we have a strong foundation to pursue growth opportunities across the MedTech market through clinical development, and new products and indications that will enable us to help treat substantially more patients." Howard Donnelly, AngioDynamics Chairman of the Board.
• "After ten years at AngioDynamics, I feel ready to move on to the next chapter of my life." Jim Clemmer.
• "Together, we have completed a meaningful strategic transformation and built a strong foundation, developed an industry-leading product portfolio, and expanded operating capabilities. These strengths position the Company well to continue serving our customers while driving profitable growth and long-term value creation." Jim Clemmer.

Industry Context

AngioDynamics' strong Med Tech growth, particularly in Auryon, AlphaVac, and NanoKnife, aligns with broader trends in the medical technology industry favoring innovative, minimally invasive solutions for vascular and oncology treatments. The focus on high-growth platforms and strategic divestitures positions the company to capitalize on expanding markets for advanced medical devices. The FDA approvals for new clinical studies and expanded indications demonstrate continued innovation, which is crucial for maintaining competitiveness in the rapidly evolving MedTech landscape. The successful patent litigation outcome also strengthens its intellectual property position against competitors.

Comparison to Industry Standards

• The filing does not provide specific comparisons to comparable companies, projects, or industry benchmarks beyond general statements about taking market share and strong growth in Med Tech.

Management Changes

Legal Proceedings

• Successful conclusion of patent litigation with C.R. Bard, where the U.S. Court of Appeals for the Federal Circuit affirmed the district court's judgment invalidating Bard's patents related to power injectable port products. This eliminates any obligation for AngioDynamics to make a $3 million contingent payment.

Stakeholder Impact

• **Shareholders:** Positive impact due to strong financial performance, raised guidance, and strategic execution, potentially leading to increased share value. The elimination of a $3 million contingent payment from litigation is also beneficial.
• **Employees:** Potential impact from the CEO transition, though Jim Clemmer's commitment to a seamless transition aims to minimize disruption. Continued investment in Med Tech suggests stability and growth opportunities.
• **Customers (Physicians/Healthcare Providers):** Positive impact from new FDA approvals and expanded indications for products like AlphaVac and AngioVac, offering more treatment options and potentially improved patient outcomes. The new CPT code for NanoKnife prostate procedures is expected to streamline reimbursement.
• **Suppliers:** Continued demand for Med Tech products may lead to stable or increased business for suppliers.
• **Creditors:** Positive impact from a debt-free balance sheet and positive cash flow generation, indicating strong financial health and reduced credit risk.

Next Steps

• Continue to invest in the long-term growth of the Med Tech portfolio.
• Enroll up to 40 patients across multiple sites for the APEX-Return study to evaluate the AlphaReturn Blood Management System.
• Enroll up to 30 patients with right-sided infective endocarditis at up to six U.S. centers for the PAVE clinical study.
• The Board of Directors will conduct a comprehensive search for a successor CEO, assisted by a leading executive search firm.
• Jim Clemmer will continue as President and CEO until his successor is appointed, focusing on revenue growth and profitability.

Key Dates

Recommendation

AngioDynamics delivered a strong fiscal second quarter, exceeding expectations with robust Med Tech growth and significant improvements in profitability, as evidenced by the positive adjusted EBITDA and cash generation. The company's strategic transformation is yielding results, with key product platforms gaining market share and receiving important regulatory approvals that expand their addressable markets. The raised full-year guidance for both net sales and Adjusted EBITDA, coupled with a debt-free balance sheet, signals strong operational momentum and financial health. The successful conclusion of patent litigation further de-risks the business. While a CEO transition is on the horizon, the planned, structured search and Jim Clemmer's commitment to a smooth handover mitigate immediate concerns. These factors collectively suggest a positive trajectory for the company, making it an attractive investment.

Keywords

Medical Technology, MedTech, Financial Results, Earnings, FDA Approval, Thrombectomy, Atherectomy, NanoKnife, AngioVac, AlphaVac, Oncology, Vascular, Interventional Radiology, CEO Retirement, Guidance Update