ANGO AngioDynamics Inc

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  December 29, 2023

AngioDynamics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

(518) 795-1400

 

(Registrant’s telephone number, including area code)

 

 

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 5.02 – Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On December 29, 2023, David D. Helsel, Senior Vice President of Global Operations and R&D, notified the Company of his intention to leave the Company, effective January 12, 2024, in order to pursue other opportunities. Mr. Helsel’s decision to resign was not the result of any disagreement between Mr. Helsel and the Company on any matter relating to the Company’s operations, policies or practices.

Item 7.01 – Regulation FD Disclosure.

Presentation slides discussing AngioDynamics and its fiscal second quarter ended November 30, 2023 are furnished herewith as Exhibit 99.2.

The presentation slides furnished pursuant to Item 7.01 of this Form 8-K (including Exhibit 99.2) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section. Furthermore, the presentation slides shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act.

Forward-Looking Statements

This document and its attachments contain 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.

Item 9.01 – Financial Statements and Exhibits.

(d)

Exhibits.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Exhibit 99.1

 

 

PRESS RELEASE

 

Investor Contact:

AngioDynamics, Inc.

Stephen Trowbridge, Executive Vice President & CFO

(518) 795-1408

 

AngioDynamics Reports Fiscal Year 2024 Second Quarter

Financial Results;

Revises Fiscal Year 2024 Guidance

 

Fiscal Year 2024 Second Quarter Highlights

•	Net sales of $79.1 million increased 2.7% on a pro-forma basis compared to the prior-year quarter

o

Med Tech net sales of $25.4 million increased 3.5%

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Med Device net sales of $53.7 million increased 2.3% on a pro-forma basis

•	Gross margin of 50.9% declined 80 basis points on a pro-forma basis year over year

•	GAAP loss per share of $0.72 and adjusted loss per share of $0.05

•	Cash and cash equivalents at November 30, 2023 were $60.9 million

•	Subsequent to quarter end, completed enrollment in APEX-AV trial for the treatment of acute intermediate-risk pulmonary embolism using AlphaVac F18

•	Initiated restructuring of manufacturing footprint and transition to outsourced manufacturing and continues portfolio optimization initiatives

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Expects to achieve full-year adjusted EPS profitability in FY27

“Today, we are announcing meaningful steps in our strategic transformation. We have initiated a restructuring of our manufacturing footprint and are shifting to an outsourced model. Currently, more than 80% of our Med Tech revenue utilizes third-party manufacturing. Fully shifting both Med Device and Med Tech to this model will allow us to more effectively compete in our chosen markets, fundamentally changing our corporate gross margin profile and driving us to profitability in two years,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “Additionally, we continue our efforts to further optimize our portfolio following the divestiture of our BioSentry and Dialysis businesses in June, making us a more focused med-tech company. While our second quarter revenue was softer than we would have liked, particularly in our Thrombus business, we were pleased to complete enrollment of our APEX-AV trial and believe our sales training and education efforts along with new product launches and the anticipated PE indication will solidify this business as a growth driver. With all of these initiatives, we believe we are taking the right steps to generate meaningful long-term growth and profitability while improving patient outcomes in the markets we serve.”

Second Quarter 2024 Financial Results

Unless otherwise noted, all financial results below are presented on a pro forma basis when excluding the divested Dialysis and BioSentry businesses.

On November 30, 2023, the Company had $60.9 million in cash and cash equivalents compared to $44.6 million in cash and cash equivalents on May 31, 2023.

Six Months Financial Results

Unless otherwise noted, all financial results below are presented on a pro forma basis when excluding the divested Dialysis and BioSentry businesses.

For the six months ended November 30, 2023:

Manufacturing Restructuring

The Company announced today that it is committed to shifting its manufacturing operations from a company-owned facility in upstate New York to a fully outsourced model over the next two years. This shift is expected to result in an approximate $15 million annualized reduction in expenses by fiscal year 2027. The Company expects to achieve full-year adjusted EPS profitability in FY27.

Fiscal Year 2024 Financial Guidance

The Company now expects its fiscal year 2024 net sales to be in the range of $320 to $325 million, accounting for the softer Thrombectomy sales during the fiscal second quarter, which it now expects will continue throughout the back half of the year, as well as certain SKU rationalization and other impacts associated with the manufacturing restructuring. The Company expects gross margin to be approximately 49% to 51% and adjusted loss per share in the range of $0.35 to $0.42.

Conference Call

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1- 201-689-8560 (international) and refer to the passcode 13743023.

A recording of the call will also be available from 11:00 a.m. ET on Friday, January 5, 2024, until 11:59 p.m. ET on Friday, January 12, 2024. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13743023.

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.

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.

ANGIODYNAMICS, INC. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENTS

(in thousands, except per share data)

 

(1)  Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended November 30, 2023 and 2022.

(2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENTS

(in thousands, except per share data)

 

(1)  Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the six months ended November 30, 2023 and 2022.

(2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

(in thousands, except per share data)

(1)  Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

(2) Adjustment to reflect the income tax provision on a non-GAAP basis has been calculated assuming no valuation allowance on the Company's U.S. deferred tax assets and an effective tax rate of 23% for the periods ended November 30, 2023 and 2022.

(3) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP loss.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION (Continued)

(in thousands, except per share data)

 

 

(1)  Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

(in thousands, except per share data)

(1)  Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

(2) Adjustment to reflect the income tax provision on a non-GAAP basis has been calculated assuming no valuation allowance on the Company's U.S. deferred tax assets and an effective tax rate of 23% for the periods ended November 30, 2023 and 2022.

(3) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP loss.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION (Continued)

(in thousands, except per share data)

 

(1)  Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

NET SALES BY PRODUCT CATEGORY AND BY GEOGRAPHY

(in thousands)

 

(1)  Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended November 30, 2023 and 2022.

(2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses.

 

GROSS PROFIT BY PRODUCT CATEGORY

(in thousands)

(1)  Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended November 30, 2023 and 2022.

(2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

NET SALES BY PRODUCT CATEGORY AND BY GEOGRAPHY

(in thousands)

 

(1)  Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the six months ended November 30, 2023 and 2022.

(2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses.

 

GROSS PROFIT BY PRODUCT CATEGORY

(in thousands)