8-K: AngioDynamics Q1 FY26: Med Tech Soars, Guidance Raised

AngioDynamics reports strong fiscal Q1 2026 results driven by 26.1% Med Tech growth, raising full-year guidance across key metrics.

Summary

• Net sales for Q1 FY2026 were $75.7 million, a 12.2% increase year-over-year on a pro forma basis.
• Med Tech net sales grew 26.1% to $35.3 million, marking the fourth consecutive quarter of over 20% growth for this segment.
• Adjusted EBITDA improved significantly to $2.2 million, compared to a loss of $0.2 million in the prior-year quarter.
• The company raised its full-year FY2026 guidance for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS.
• Key clinical milestones include the enrollment of the first patients in the AMBITION BTK and RECOVER-AV trials, and the publication of positive NanoKnife PRESERVE study results.

Sentiment

Score: 9

Explanation: The company demonstrated strong operational and commercial execution, particularly in its high-growth Med Tech segment, which achieved its fourth consecutive quarter of over 20% revenue growth. The significant improvement in Adjusted EBITDA, better-than-expected cash utilization, and the decision to raise full-year guidance across key financial metrics indicate robust performance and positive momentum. Furthermore, progress in clinical trials and the publication of positive study results, along with securing favorable CPT codes for NanoKnife, strengthen the company's market position and future revenue potential.

Positives

• Med Tech segment achieved 26.1% year-over-year revenue growth, reaching $35.3 million.
• This marks the fourth consecutive quarter of over 20% revenue growth for the Med Tech segment.
• Adjusted EBITDA significantly improved to $2.2 million in Q1 FY2026, compared to a loss of $0.2 million in Q1 FY2025.
• Full-year FY2026 guidance was raised for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS.
• Net sales increased by 12.2% year-over-year to $75.7 million on a pro forma basis.
• Auryon sales grew 20.1% to $16.5 million.
• Mechanical Thrombectomy sales (AngioVac and AlphaVac) increased 41.2% to $11.3 million.
• NanoKnife sales rose 26.7% to $6.4 million, with probes growing 31.3%.
• GAAP gross margin improved by 90 basis points year-over-year to 55.3%.
• Adjusted loss per share improved to $0.10 from $0.11 in the prior-year quarter.
• Ended the quarter with $38.8 million in cash and cash equivalents and maintains a debt-free balance sheet.
• Cash utilization of $17.1 million in Q1 FY2026 was better than expectations.
• First patients enrolled in the AMBITION BTK trial for the Auryon Atherectomy System and the RECOVER-AV trial for the AlphaVac F1885 System.
• NanoKnife PRESERVE study results, demonstrating 84.0% effectiveness in treating prostate cancer while preserving quality of life, were published in European Urology.
• Received Prostate Tissue CPT Category 1 Code (effective January 1, 2026) and Pancreas procedures CPT level I code (effective January 1, 2027) for NanoKnife, expected to streamline reimbursement.

Negatives

• Reported a GAAP net loss of $10.9 million, or $0.26 per share, for the quarter.
• Reported an adjusted net loss of $4.2 million, or $0.10 per share, for the quarter.
• Used $17.1 million of cash in operating activities during the quarter, although this was better than expected.

Risks

• 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 third-party technology.
• Ability to effectively compete against competitors with 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.
• Risk factors listed in the Annual Report on Form 10-K for the year ended May 31, 2025.

Future Outlook

The company raised its full-year fiscal year 2026 guidance, now expecting net sales between $308 million and $313 million, Med Tech net sales growth of 14% to 16%, and Adjusted EBITDA between $6.0 million and $10.0 million. Adjusted EPS guidance was also improved to a loss between $0.33 and $0.23. The company continues to expect to be cash flow positive for the full fiscal year 2026, despite an anticipated $4.0 million to $6.0 million impact from tariffs.

Management Comments

• "We had an outstanding first quarter as we continued to build off of the strong momentum created in fiscal 2025."
• "Our strategy to bring unique platform technologies to large, fast growing global markets has paid off as we reported our fourth quarter in a row of MedTech growth of over 20%. This continued performance, combined with our disciplined focus on operational excellence, is driving sustained profitable growth."
• "Our exceptional team is executing our vision to deliver transformative technologies that expand treatment options and help patients live healthier, happier lives. With our superior technologies supported by our clinical investments and the strength of our balance sheet, we remain well-positioned to drive consistent, profitable growth, and deliver sustained value creation during the balance of 2026 and beyond."

Industry Context

The medical technology sector continues to see strong demand for innovative solutions, particularly in vascular and cancer treatment. AngioDynamics' focus on unique platform technologies like Auryon, AlphaVac, and NanoKnife positions it well within fast-growing global markets. The consistent Med Tech growth, coupled with clinical advancements and favorable reimbursement codes, indicates a positive trend for specialized medical device companies addressing unmet patient needs.

Stakeholder Impact

• Shareholders: Positive impact due to strong financial performance, raised guidance, and strategic execution, potentially leading to increased shareholder value.
• Patients: Improved quality of life and expanded treatment options through innovative medical technologies like Auryon, AlphaVac, and NanoKnife, supported by ongoing clinical trials and positive study results.
• Employees: Positive impact from continued growth and operational excellence, reinforcing the company's vision and potentially leading to stability and growth opportunities.
• Healthcare Providers: Enhanced treatment capabilities and streamlined reimbursement processes for advanced procedures, particularly with the new CPT codes for NanoKnife.

Next Steps

• Continue enrollment and progress in the AMBITION BTK trial for the Auryon Atherectomy System.
• Continue enrollment and progress in the RECOVER-AV clinical trial for the AlphaVac F1885 System.
• Leverage the effective Prostate Tissue CPT Category 1 Code for NanoKnife procedures starting January 1, 2026.
• Prepare for the effective Pancreas procedures CPT level I code for NanoKnife procedures starting January 1, 2027.
• Host a conference call on October 2, 2025, at 8:00 a.m. ET to discuss the results.

Key Dates

Recommendation

The company delivered exceptional Q1 FY2026 results, significantly outperforming expectations with robust Med Tech segment growth (26.1% YoY) and a substantial improvement in Adjusted EBITDA. The decision to raise full-year guidance for net sales, Med Tech growth, Adjusted EBITDA, and Adjusted EPS signals strong confidence in sustained momentum. Key clinical milestones, including new trial enrollments and positive study publications for NanoKnife, coupled with the securing of critical CPT reimbursement codes, de-risk future revenue streams and expand market access. With a debt-free balance sheet and a clear strategy for profitable growth in high-demand medical markets, AngioDynamics presents a compelling investment opportunity.

Keywords

Medical Technology, AngioDynamics, Med Tech, Auryon, NanoKnife, Thrombectomy, Financial Results, Q1 2026, Earnings, Guidance, Clinical Trials, FDA, CPT Codes