8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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):  January 11, 2024

AngioDynamics, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	000-50761	11-3146460
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

14 Plaza Drive Latham, New York	12110
(Address of Principal Executive Offices)	(Zip Code)

(518) 795-1400

(Registrant’s telephone number, including area code)

 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.01 per share	ANGO	NASDAQ Global Select Market

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. ☐

Item 7.01 – Regulation FD Disclosure.

On January 11, 2024, James Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics”), will present at the J.P. Morgan 42nd Annual Healthcare Conference. The presentation slides are furnished herewith as Exhibit 99.1.

The presentation slides furnished pursuant to Item 7.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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 of 1933, as amended, 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.

Exhibit No.	Description
99.1	Presentation slides for the J.P. Morgan 42nd Annual Healthcare Conference, dated January 11, 2024

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.

	ANGIODYNAMICS, INC.
	(Registrant)
Date:  January 11, 2024	By:	/s/ Stephen A. Trowbridge
		Name:	Stephen A. Trowbridge
		Title:	Executive Vice President and Chief Financial Officer

EX-99.1

Exhibit 99.1

 J.P. Morgan  Healthcare Conference January 11, 2024  Jim Clemmer, President & CEO 

 A medical technology platform company focused on a select group of large, high growth markets where meaningful treatment gaps exist in current standard of care.  We are transforming our portfolio to be a company focused on investing our resources on innovative technologies backed by science and clinical data. Our technologies positively impact treatment options and patients' quality of life.  AngioDynamics 

 AngioDynamics  Cardiovascular disease and cancer have the highest morbidity and mortality worldwide  Global Cardiovascular Disease Burden1  523M diagnosed in 2020  ~19 million deaths  Cardiovascular Disease causes 1 in 3 deaths globally  Global Cancer Burden2  Cancer causes 1 in 6 deaths globally  19.3M diagnosed in 2020  ~10 million deaths  3  https://professional.heart.org/-/media/PHD-Files-2/Science-News/2/2022-Heart-and-Stroke-Stat-Update/2022-Stat-Update-factsheet-GIobal-Burden-of-Disease.pdf; https://www.cdc.gov/pcd/issues/2022/22_0347.htm  https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660#:~:text=Worldwide%2C%20an%20estimated%2019.3%20million,skin%20cancer)%20occurred%20in%202020. 

 MedTech Markets  4  Targeted segments have attractive underpenetrated addressable markets  Cardiac Thrombus & Emboli  $825M TAM  Pulmonary Embolism  $2.9B TAM  Prostate Cancer  $2B TAM  Deep Vein Thrombosis  $3B TAM  Peripheral Arterial Disease  $1.1B TAM  *AlphaVac PE, Auryon Venous Thrombectomy/DVT, AngioVac Left Heart and Infective Endocarditis are not cleared by the US Food and Drug Administration (FDA) for these indications 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  The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition. 

 5  AngioDynamics  Investments in our Med Tech platforms are funded by operating cash flows from our Med Device portfolio  Med Tech: Invest for Growth  Disease State  Latest Investment Updates  Peripheral Arterial Disease  Radial length catheter launch Jan 2024  Pathfinder 12 month & 24 month publications Feb & July 2024  Below the knee study publication March 2024  CE Mark expected May 2024  6 additional new product extensions/upgrades scheduled throughout 2024  Coronary Atherectomy pre-submission (PMA) & pilot trial planned to begin in 2024  Venous Thromboembolism  APEX complete, PE indication expected by June 2024  CE Mark for PE expected by June 2024  2 additional new product extensions/upgrades scheduled throughout 2024  IDE clinical trial for Auryon DVT to begin in late 2024  Cardiac Thrombus & Emboli  Begin study for Infective Endocarditis indication in 2024  Prostate  PRESERVE Study enrolled, expected Prostate indication by December 2024  Med Device: Maintain Positioning  PICCs, Midlines &  Accessories  Microwave &  Radiofrequency Ablation  Diagnostic Catheters, Guidewires & Kits  Implantable Ports  Endovenous Laser Treatment  Radiation Treatment Stabilization Balloons  *AlphaVac PE, Auryon Venous Thrombectomy/DVT, Auryon Coronary Atherectomy, AngioVac Left Heart and Infective Endocarditis are not cleared by the US Food and Drug Administration (FDA) for these indications 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.  The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.  The planned portfolio additions and new indications are based on management estimates and industry sources as of July 2022 and are not guarantees of future performance and are subject to risks and uncertainties including FDA clearance. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. 

 PAD  As of November 2023, the Auryon Atherectomy System has treated over 50,000 patients and reached $100M cumulative sales since its September 2020 launch  6  T H E M A R K E T  O U R S O L U T I O N  Peripheral Atherectomy  Protective of vessel wall c-e  Targeted biological reactions to address risk of perforations  Built-in aspiration to address risk of embolization†  †Built-in aspiration available with the 2.0-and 2.35-mm catheters.  W H Y I T M A T T E R S  Treat all levels of calcification a-c  Indicated for in-stent restenosis*  Treats above and below the knee (inc. below the ankle)  *2.0mm and 2.35mm catheters are indicated for ISR.  Designed for hospital and lab a-c, f  Portable, 110V outlet, low noise, touch screen  Debulk in fewer passes  2022 TAM  $1.1B  a-f See reference page  “We’ve always known that Auryon’s technology is one-of-a-kind and unmatched. With the new [hydrophilic  coating], we should be able to prove this – case after case after case”  – Dr. Curtis Anderson, Vascular & Interventional Radiologist  Europe APAC US  $760M  $210M  $100M  Source: Management estimate & industry sources as of July 2022. 

 Thrombus Management  Our differentiated technology platforms offer potential treatment solutions across multiple disease states  T H E M A R K E T O U R S O L U T I O N  W H Y I T M A T T E R S  Only solution on the market with continuous aspiration and simultaneous reinfusion of filtered blood  Aspirates large clot burden  Controlled aspiration  Aspirates large clot burden  APEX-AV study for PE  Right Heart and Left Heart* removal of cardiac thrombus  Large Vessel Venous Thrombectomy/DVT  Pulmonary Embolism*  Small Vessel Venous Thrombectomy/DVT*  7  2022 TAM  $6.7B  M  $3.9  $  1B  $210M  $1B  Auryon’s low profile + laser + aspiration, make it a compelling and simple technology to effectively ablate & remove thrombus with the legs  VTE  PE  Pulmonary Embolism  DVT  Deep Vein Thrombosis  Cardiac  TVIE  Tricuspid Valve Infective Endocarditis  LV  Lead Vegetation  RA  Right Atrial Thrombus  +  Europe APAC US  Europe US  Cardiac  $3.9B  $1B  VTE  $1B  $535M  $290M  Source: Management estimate & industry sources as of July 2022.  *AlphaVac PE, Auryon Venous Thrombectomy/DVT, and AngioVac Left Heart and Infective Endocarditis are not cleared by the US FDA for these indications. 

 Thrombus Management  All-purpose technology platforms targeted at peripheral and cardiovascular thrombolytic events, including small and large vessels  POWERFUL  355 nm laser is designed to deliver an optimized wavelength, pulse width, and amplitude to restore flow in occluded vesselsc, d, g  Small Vessel  The AngioVac System allows for the continuous aspiration of embolic material such as thrombi and emboli from the venous system while simultaneously reinfusing the patient’s own filtered blood to limit procedural blood loss  MULTIPLE TIP ANGLES  200, 850, 1800  PROPRIETARY FUNNEL DESIGN  Allows for Significant Clot Removal  RADIOPAQUE MARKERS  Better Tip Visibility  LARGE END HOLE ASPIRATION  42FR & 30FR Opening  The AlphaVac System allows for the controlled aspiration of embolic material such as thrombi and emboli from the venous system  Large Vessel  PRECISE  Protective of vessel wallc-e  ADAPTABLE  Potential to treat all types of small vessel DVT*  c-g See reference page  *Auryon Venous Thrombectomy/DVT is not cleared by the US FDA for this indication. 

 NanoKnife Prostate Initiative*  Over 505,000 men with prostate cancer could be treated with this technology  9  USA EMEA APAC LAM CAN  *IDE Study in progress; enrollment completed  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.  The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.  Market Source: Management estimate & industry sources as of July 2022.  Focal Therapy  O U R S O L U T I O N  W H Y I T M A T T E R S  T H E M A R K E T  2023 Global TAM  $2B  Targeted: Short electric pulses destroy cells without relying on extreme heat or cold and spare vital structures within the ablation zone  Quality of Life: Better preserves urinary control and erectile function  Versatile: Can be used in all segments of the  prostate for primary and recurrent disease  Fast: Minimally invasive treatment that is delivered in a single session  Preserves future treatment options  $702M  $728M  $521M  $30M  $60M 

 International Expansion Plan  Expanding our business reach in targeted regions, markets & countries  10  Aligning our Go-to-Market strategy to the different regions, markets & countries, utilizing new partnerships where appropriate to maximize growth  Preparing for CE Mark and other selected international launches of both the Auryon System and the AlphaVac F1885 System  Auryon CE Mark expected 1H of calendar 2024  AlphaVac F1885 System CE Mark expected 1H of calendar 2024  Continue to increase our global presence through our series of life symposiums which has attracted interest from global key opinion leaders who are gaining more access to our technologies 

 IDE  Clinical Studies and Pathway Expansion  Corporate Developments – Q2 and YTD FY24  Initiated restructuring of manufacturing footprint to a fully outsourced model  Continued portfolio optimization initiatives  Full-year adjusted EPS profitability expected in FY27 Cumulative Auryon sales of over $100.0 million  achieved in November  Q2  Highlights and Operational Developments  PRESERVE study for the treatment of prostate cancer with NanoKnife completed enrollment in July 2023  APEX AV study for the treatment of pulmonary embolism with AlphaVac F1885 System  Completed enrollment in December 2023  Submission to the FDA planned in early calendar 2024  Continued focused investment in our 3 key Med Tech platforms: Auryon, Thrombus Management & NanoKnife  NanoKnife disposables down 3.6% YOY  Q2 FY24  Revenue  $79.1 mil  Pro Forma Revenue Growth*  2.7%  Med Tech up 3.5%  Med Device up 2.3%*  $11.4 million in Auryon sales; growth of 12.9% YOY  Mechanical Thrombectomy  down 4.7% YOY  $1.9 million in AlphaVac sales AngioVac sales declined 10.8% YOY  * On a pro forma basis, excluding the sale of Dialysis and BioSentry  11 AngioDynamics Second Quarter FY2024 Earnings  12.9% YOY growth in  NanoKnife disposables  YTD FY24  Pro Forma Revenue*  $157.1 mil  Pro Forma Revenue Growth*  4.2%  Med Tech up 8.3%  Med Device up 2.3%*  $22.5 million in Auryon sales; growth of 18.9% YOY  Mechanical Thrombectomy  down 5.3% YOY  $3.7 million in AlphaVac sales AngioVac sales declined 9.2% YOY 

 FY24 Revised Guidance  * FY23 pro forma results excluding the divested assets were $306.3 million for revenue, 50.5% for gross margin and adjusted loss per share of $0.43.  12 AngioDynamics Second Quarter FY2024 Earnings  Guidance*  Revised Guidance*  Revenue  $328 - $333 million  $320 - $325 million  Gross Margin  Med Tech Med Device  50.0% - 52.0%  63.0% – 65.0%  43.0% - 45.0%  49.0% - 51.0%  61.0% – 63.0%  43.0% - 45.0%  Adjusted EPS  ($0.28) – ($0.34)  ($0.35) – ($0.42) 

 J.P. Morgan  Healthcare Conference January 11, 2024  Jim Clemmer, President & CEO 

 Auryon References  Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study. Catheter Cardiovasc Interv. 2019;1-8.  Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-Laser™, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92.  Auryon. Instructions for use. AngioDynamics; 2019.  Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary  report. Lasers Surg Med. 2016;48(3):281-287.  Herzog A, Steinberg I, Gaisenberg E, Nomberg R, Ishaaya AA. A route to laser angioplasty in the presence of fluoroscopy contrast media, using a nanosecond-pulsed 355- nm laser. IEEE J Sel Top Quantum Electron. 2016;22(3):342-347.  Kuczmik W, Kruszyna L, Stanisic MG, Dzieciuchowicz L, Ziaja K, Zelawski W, et al. Laser atherectomy using the novel B-Laser™ catheter, for the treatment of femoropopliteal lesions: twelve-month results from the EX-PAD-01 study. Not yet published.  Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644.  14 

XML

Document and Entity Information	Jan. 11, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 11, 2024
Entity File Number	000-50761
Entity Registrant Name	AngioDynamics, Inc.
Entity Central Index Key	0001275187
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	11-3146460
Entity Address, Address Line One	14 Plaza Drive
Entity Address, City or Town	Latham
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	12110
City Area Code	518
Local Phone Number	795-1400
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	ANGO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false