AngioDynamics Reports Fiscal Year 2025 Second Quarter Financial Results

AngioDynamics, Inc. (NASDAQ:ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced financial results for the second quarter of fiscal year 2025, which ended November 30, 2024.

Fiscal Year 2025 Second Quarter Highlights

• GAAP Gross margin of 54.8%
• GAAP loss per share of $(0.26)
• Adjusted loss per share of $(0.04)
• Adjusted EBITDA of $3.1 million
• Received CPT Category I Codes for Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, for the treatment of lesions in the prostate and liver, effective January 1, 2026
• Received FDA 510(k) clearance for NanoKnife Prostate Tissue Ablation in December 2024
• Announced NanoKnife hit all primary endpoints of PRESERVE clinical trial for use in Prostate Tissue Ablation in December 2024
• Raising fiscal year 2025 guidance for Adjusted EBITDA and Adjusted EPS

*Pro forma results exclude the Dialysis and BioSentry businesses divested in June 2023 and the PICC and Midline product portfolios divested in February 2024, as well as the discontinued Radiofrequency and Syntrax products in February 2024. Pro forma revenue for Q2 FY25 excludes approximately $0.2 million of returns of divested products during the quarter.

"We are very excited about our strong performance during the second quarter, and in particular the continued strength of our Med Tech segment, which grew 25% over the prior year. We also hit a number of key milestones for our NanoKnife System, with the receipt of CPT Category I Codes and FDA 510(k) clearance for prostate tissue ablation. These achievements put us in a fantastic position to drive accelerated growth for NanoKnife in coming quarters," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Through a combination of strong sales results, increasing contribution from our Med Tech segment, and operating efficiency efforts, we delivered positive Adjusted EBITDA and operating cash flow in the quarter. As a result of the tremendous progress made towards our goal of achieving profitability, we now expect to be Adjusted EBITDA positive for the fiscal year."

Second Quarter 2025 Financial Results

Unless otherwise noted, all financial metrics and growth rates presented below are on a pro forma basis.

Net sales for the second quarter of fiscal year 2025 were $73.0 million, an increase of 9.2% compared to the prior-year quarter.

Med Tech net sales were $31.5 million, a 25.0% increase from $25.2 million in the prior-year period. Med Tech includes the Auryon peripheral atherectomy platform, the thrombus management platform, which includes the AlphaVac and AngioVac mechanical thrombectomy systems, and the NanoKnife irreversible electroporation platform.

Growth in the quarter was driven by strength across all product lines, including Auryon sales of $13.7 million, which increased 21.8%, AngioVac sales of $8.1 million, which increased 50.7%, AlphaVac sales of $2.5 million, which increased 33.3%, and NanoKnife disposable sales of $5.0 million, which increased 23.1%. Total NanoKnife sales, including capital, of $6.0 million, increased 4.9%.

Med Device net sales were $41.5 million, a decrease of 0.4% compared to $41.6 million in the prior-year period. U.S. net sales of Med Device products grew 1.6% during the second quarter compared to last year.

U.S. net sales in the second quarter of fiscal 2025 were $62.7 million, an increase of 12.3% from $55.8 million a year ago. International net sales were $10.3 million, a decrease of 6.6%, compared to $11.1 million a year ago.

Gross margin for the second quarter of fiscal 2025 was 54.7%, which was 10 basis points down compared to the second quarter of fiscal 2024, and 30 basis points sequentially up from 54.4% in the first quarter of fiscal 2025.

Gross margin for the Med Tech business was 63.7%, an increase of 120 basis points from the second quarter of fiscal 2024 driven by growth in AngioVac. Gross margin for the Med Device business was 47.8%, a decrease of 240 basis points compared to the second quarter of fiscal 2024 due to inflationary pressures and costs associated with the transition to outsourced manufacturing.

The Company recorded a GAAP net loss of $10.7 million, or a loss per share of $0.26, in the second quarter of fiscal 2025. Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the second quarter of fiscal 2025 was $1.7 million, or a loss per share of $0.04. This compares to an adjusted net loss during the fiscal second quarter of 2024 of $3.4 million, or a loss per share of $0.08.

Adjusted EBITDA in the second quarter of fiscal 2025, excluding the items shown in the non-GAAP reconciliation table below, was $3.1 million, compared to $(0.0) million in the second quarter of fiscal 2024.

In the second quarter of fiscal 2025, the Company generated $2.5 million in operating cash.

At November 30, 2024, the Company had $54.1 million in cash and cash equivalents compared to $55.0 million in cash and cash equivalents at August 31, 2024. During the second quarter, the Company utilized $1.1 million on share repurchases.

In accordance with the Company's previously announced expectations regarding cash usage for the fiscal year ended May 31, 2025, the Company expects to utilize cash in the third fiscal quarter and generate cash in the fourth fiscal quarter.

Received CPT Category I Codes for IRE for the Treatment of Lesions in the Prostate and Liver

In October, the Company announced that Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, has received CPT® Category I codes for the treatment of lesions in the prostate and liver. The decision by the American Medical Association's ("AMA") CPT® Editorial Panel will facilitate reimbursement for healthcare providers performing IRE ablation procedures and enables broader access to the NanoKnife System for patients. The new codes will be effective, with physician Relative Value Units (RVUs) attached, on January 1, 2026.

With these new CPT® Category I codes, healthcare providers will be able to bill more precisely for the treatments provided and should achieve broader insurance coverage and defined reimbursement rates for NanoKnife procedures, increasing market access to this minimally invasive IRE technology.

NanoKnife System Receives FDA 510(k) Clearance for Prostate Tissue Ablation

In December, subsequent to the end of the quarter, the Company received FDA 510(k) clearance for the NanoKnife System for prostate tissue ablation.

Prostate cancer is the second most common cancer in men worldwide, with approximately 1.5 million new cases diagnosed annually.¹ Many of these patients seek alternatives to radical procedures that can lead to significant, long-term urological side effects.² The NanoKnife System is the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment.

The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions. As the Company expands its global footprint and increases access to the technology, the Company is launching comprehensive education and awareness campaigns to empower physicians with hands-on training and clinical support while engaging patients through innovative outreach initiatives.

NanoKnife System Hit All Primary Endpoints in PRESERVE Study

The NanoKnife System's clearance followed the completion of the pivotal PRESERVE clinical study and submission of results in September of 2024.

The PRESERVE clinical study met its primary effectiveness endpoint demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12-months post-procedure, 84.0% of men were free from in-field, clinically significant disease. In addition, the study demonstrated strong quality of life outcomes with respect to short-term urinary continence and sexual function preservation. ³

The study's results validated the robust safety and clinical efficacy profile of the NanoKnife System, reinforcing findings from more than 32 clinical studies performed around the world involving over 2,600 patients.³

Fiscal Year 2025 Financial Guidance

For fiscal year 2025:

• The Company continues to expect net sales to be in the range of $282 to $288 million, representing growth of between 4.2% – 6.4% over fiscal 2024 pro forma revenue of $270.7 million
• The Company now expects Med Tech net sales to grow in the range of 12% to 15%, an increase from 10% to 12%
• The Company now expects Med Device net sales to be flat, a decrease from 1% to 3%
• The Company continues to expect Gross margin to be approximately 52% to 53%
• The Company now expects Adjusted EBITDA in the range of $1.0 to $3.0 million, an increase from the previous guidance of a loss of $2.5 million to $0. The updated guidance compares to a pro forma Adjusted EBITDA loss of $3.2 million in fiscal 2024
• The Company now expects Adjusted loss per share in the range of $0.34 to $0.38, an improvement from the previous guidance of a loss per share of $0.38 to $0.42. The updated guidance compares to a pro forma Adjusted loss per share of $0.45 in fiscal 2024

Conference Call

The Company's management will host a conference call at 8:00 a.m. ET the same day to discuss the results. To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international).

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available, until Wednesday, January 15, 2025 at 11:59 PM ET. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13750571.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics' business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported pro forma results, adjusted EBITDA, adjusted net income and adjusted earnings per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics' performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics' underlying business. Management encourages investors to review AngioDynamics' financial results prepared in accordance with GAAP to understand AngioDynamics' performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics' financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

About AngioDynamics, Inc.

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients.

The Company's innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.

Safe Harbor

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics' expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as "expects," "reaffirms," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "projects," "optimistic," or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics' expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its 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, the ability of AngioDynamics 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, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics' SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

¹ https://www.wcrf.org/cancer-trends/prostate-cancer-statistics/

² Cheng JY. The Prostate Cancer Intervention Versus Observation Trial (PIVOT) in Perspective. J Clin Med Res. 2013;5(4):266-268. doi:10.4021/jocmr1395w

³ Data on file.