LATHAM, N.Y.--(BUSINESS WIRE)--Apr. 4, 2024-- AngioDynamics, Inc. (NASDAQ: ANGO):

Fiscal Year 2024 Third Quarter Highlights

• Completed the sale of its PICC and Midline product portfolios to Spectrum Vascular on February 15, 2024
  • Discontinued its Uniblate and Starburst RadioFrequency products, as well as its Syntrax support catheter products, to further streamline its product portfolio

• Pro forma Med Tech net sales of $25.7 million increased 12.6%
• Pro forma Med Device net sales of $40.3 million increased 5.2%
• Subsequent to quarter end, the Company entered into a settlement agreement with Becton, Dickinson and Company (“BD”) to resolve all patent litigation with C.R. Bard, Inc., an affiliate of BD
• Subsequent to quarter end, the Company received 510(k) clearance for the use of AlphaVac to treat pulmonary embolism

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 third quarter of fiscal year 2024, which ended February 29, 2024.

“During our fiscal third quarter, we took another significant step in our transformation with the divestiture of our PICC and Midline product portfolios, further strengthening our balance sheet and providing us with an opportunity to enhance our focus on the growth of our Med Tech portfolio,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “We saw a strong pick up in growth from both our Med Tech and Med Device portfolios during the quarter and continue to drive toward meaningful margin expansion and profitability.”

Mr. Clemmer continued, “Subsequent to the end of our fiscal third quarter, we reached a settlement agreement with BD/Bard that provides us with clarity and certainty going forward. This allows us to avoid continued litigation and keep the team focused on further developing our key growth platforms. I am also very pleased to announce that earlier this week we received FDA 510(k) clearance for AlphaVac in the treatment of pulmonary embolism. This approval came in ahead of even our expectations and is a testament to the strong submission compiled by our team and the compelling data generated by our APEX trial. This expanded indication is a significant piece of our long-term strategy and validates the effectiveness of the product, opening up another large, fast-growing market for us to serve with this innovative platform.”

Third Quarter 2024 Financial Results

Unless otherwise noted, all financial results below are presented on a pro forma basis excluding the Dialysis and BioSentry businesses divested in June 2023, the PICC and Midline product portfolios divested in February 2024, and the recently discontinued Uniblate and Starburst RadioFrequency products and Syntrax support catheter products.

Net sales for the third quarter of fiscal year 2024 were $66.0 million, an increase of 8.0% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company’s net sales in the quarter.

Med Tech net sales were $25.7 million, a 12.6% increase from $22.8 million in the prior-year period. Med Tech includes the Auryon peripheral atherectomy platform, the thrombus management platform and the NanoKnife irreversible electroporation platform. Year-over-year growth was driven by Auryon sales during the quarter of $11.8 million, which increased 14.7%, and NanoKnife sales of $6.0 million, which increased 46.7% compared to the third quarter of fiscal 2023. NanoKnife disposable sales were $4.2 million, which increased 19.8% compared to the third quarter of fiscal 2023. AngioVac sales were $5.5 million, similar to the prior-year quarter, while AlphaVac sales were $1.1 million, down from $2.0 million in the third quarter of fiscal 2023.

Med Device net sales were $40.3 million, an increase of 5.2% compared to the prior-year period.

U.S. net sales in the third quarter of fiscal 2024 were $55.8 million, an increase of 5.9% from sales of $52.7 million a year ago. International net sales were $10.1 million, an increase of 20.8% from sales of $8.4 million in the prior-year period.

GAAP reported gross margin was 47.7%, a decrease of 250 basis points compared to the third quarter of fiscal 2023. On a pro forma basis, gross margin for the third quarter of fiscal 2024 was 51.1%, a decline of 290 basis points from the third quarter of fiscal 2023. Gross margin for the Med Tech business was 61.5%, a decline of 300 basis points from the third quarter of fiscal 2023. The year-over-year decline in gross margin for the Med Tech business was driven primarily by product and geographic mix. Gross margin for the Med Device business was 44.4%, a decrease of 330 basis points compared to the third quarter of fiscal 2023. The year-over-year decline in gross margin for the Med Device business was driven primarily by a supplier recall as well as costs associated with the Company’s ongoing transition to outsourced manufacturing.

The Company recorded a GAAP net loss of $190.4 million, or a loss per share of $4.73, in the third quarter of fiscal 2024. The GAAP net loss includes a goodwill impairment charge of $159.5 million, settlement charge of $22.0 million and asset impairment charges totaling $6.7 million related to the transition to outsourced manufacturing and discontinuation of Syntrax. The amount of the goodwill impairment is preliminary, is undergoing further evaluation and will be adjusted, if necessary, prior to the filing of the Company’s quarterly report on Form 10-Q. Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the third quarter of fiscal 2024 was $6.5 million, and adjusted loss per share was $0.16.

Adjusted EBITDA in the third quarter of fiscal 2024, excluding the items shown in the reconciliation table below, was negative $3.6 million, compared to adjusted EBITDA of negative $1.5 million in the third quarter of fiscal 2023.

On February 29, 2024, the Company had $78.5 million in cash and cash equivalents and no debt compared to $44.6 million in cash and cash equivalents and $50.0 million of debt on May 31, 2023.

In the third quarter of fiscal 2024, the Company used $12.5 million in operating cash, had capital expenditures of $0.6 million and had additions to Auryon placement and evaluation units of $1.2 million. Cash flow during the third quarter was significantly impacted by a combination of timing and extraordinary items related to both the divestiture transaction and manufacturing restructuring as well as approximately $1.0 million related to a supplier recall.

Nine Months Financial Results

Unless otherwise noted, all financial results below are presented on a pro forma basis excluding the Dialysis and BioSentry businesses divested in June 2023, the PICC and Midline product portfolios divested in February 2024, and the recently discontinued Uniblate and Starburst RadioFrequency products and Syntrax support catheter products.

For the nine months ended February 29, 2024:

Net sales were $199.6 million, an increase of 6.5% compared to $187.4 million for the same period a year ago.

Med Tech net sales were $76.6 million, a 9.6% increase from the prior-year period. Med Device net sales were $123.0 million, an increase of 4.6% from the prior-year period.

U.S. net sales were $167.6 million, a 3.6% increase from the prior-year period. International net sales were $32.0 million, an increase of 24.6% from the prior-year period.

GAAP reported gross margin was 49.9%, a decrease of 170 basis points compared to the prior-year period. On a pro forma basis, gross margin was 53.6%, a decline of 150 basis points from the prior-year period. The year-over-year decline in gross margin was driven primarily by a supplier recall as well as costs associated with the Company’s ongoing transition to outsourced manufacturing.

The Company’s GAAP net loss was $173.6 million, or a loss of $4.33 per share, compared to a net loss of $31.0 million, or a loss of $0.79 per share, a year ago. The GAAP net loss includes a goodwill impairment charge of $159.5 million, settlement charge of $22.0 million and asset impairment charges totaling $6.8 million related to the transition to outsourced manufacturing and discontinuation of Syntrax. The amount of the goodwill impairment is preliminary, is undergoing further evaluation and will be adjusted, if necessary, prior to the filing of the Company’s quarterly report on Form 10-Q. Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss was $16.1 million, with adjusted loss per share of $0.40, compared to adjusted net loss and adjusted loss per share of $17.5 million and $0.44, respectively, a year ago.

Adjusted EBITDA, excluding the items shown in the reconciliation table below, was negative $4.7 million, compared to negative $4.3 million for the same period a year ago.

Fiscal Year 2024 Financial Guidance

The Company now expects its fiscal year 2024 net sales to be in the range of $270 to $275 million, which reflects the recent divestiture of the PICC and Midline businesses and discontinuance of the RadioFrequency ablation and Syntrax businesses, which accounted for approximately $50 million of the prior revenue guidance of $320 to $325 million. The Company expects gross margin to be approximately 52.0% to 54.0% and adjusted loss per share in the range of $0.54 to $0.58.

For comparison, pro forma revenue, gross margin, and adjusted loss per share for FY23 when excluding the discontinued assets and the assets divested to Spectrum Vascular and Merit Medical were $257.2 million, 54.9%, and $0.55, respectively.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its third quarter 2024 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13745239.

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 from 10:00 a.m. ET on Thursday, April 4, 2024, until 11:59 p.m. ET on Thursday, April 11, 2024. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13745239.

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, 2023. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.