AngioDynamics Reports Fiscal Year 2025 Second Quarter Financial Results

LATHAM, N.Y.--(BUSINESS WIRE)--January 08, 2025-- 

AngioDynamics, Inc. $(ANGO)$, 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

 
                             Quarter Ended 
                            November 30, 2024  Pro Forma* YoY Growth 
-------------------------  ------------------  --------------------- 
Pro Forma* Net Sales         $73.0 million             9.2% 
-------------------------  ------------------  --------------------- 
    Med Tech Net Sales       $31.5 million             25.0% 
    Med Device Net Sales     $41.5 million            (0.4)% 
-------------------------  ------------------  --------------------- 
 
   -- 
 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 $(IRE.AU)$, 
      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$(R)$ Category I codes for the treatment of lesions in the prostate and liver. The decision by the American Medical Association's ("AMA") CPT(R) 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(R) 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

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