8-K
Angiodynamics Inc (ANGO)
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): April 17, 2023
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 April 17, 2023, James Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics”), and Stephen Trowbridge, Executive Vice President and Chief Financial Officer of AngioDynamics, will present at the 22nd Annual Needham Virtual 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, 2022. 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 22nd Annual Needham Virtual Healthcare Conference, dated April 17, 2023 |
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: April 17, 2023 | By: | /s/ Stephen A. Trowbridge | |
| Name: | Stephen A. Trowbridge | ||
| Title: | Executive Vice President and<br><br> <br>Chief Financial Officer |
Exhibit 99.1
Needham & Company 22nd Annual Virtual Healthcare Conference April 17, 2023 Jim Clemmer, President & CEO Stephen Trowbridge, Executive Vice President & CFO
2 Notice Regarding Forward-Looking Statements This presentation 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,” “projects,” “believes,” “seeks,” “estimates,” “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, 2022. 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. Notice Regarding Non-GAAP Financial 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 presentation, AngioDynamics has reported adjusted EBITDA (income before interest, taxes, depreciation and amortization and stock-based compensation); 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.
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. Our technologies positively impact treatment options and patients' quality of life. AngioDynamics
Cardiovascular disease and cancer have the highest morbidity and mortality worldwide AngiodynamicsA medical technology platform company focused on a select group of large, high growth markets where meaningful treatment gaps exist in current standard of care. Our technologies positively impact treatment options and patients' quality of life. 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 4 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.
5 AngioDynamicsInvestments in our Med Tech platforms are funded by operating cash flows from our Med Device portfolio 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. FOCUSED TRANSFORMATION PURSUING ATTRACTIVE MARKETS U.S. Total Addressable Markets FY2021 - $3.0B Launch of the Auryon System gives us access to the peripheral atherectomy market FY2023 - $6.0B Planned Thrombectomy & NanoKnife System portfolio additions & new indications increase market access FY2025 - $8.0B Planned Thrombectomy & PE portfolio additions & new indications increase market access FY2018 - $1.3B Began our strategic initiative to become a growth company Med Tech: Invest for Growth Peripheral Arterial Disease Venous Thromboembolism Cardiac Thrombus & Emboli Solid Tumor Med Device: Maintain Positioning Vascular Access Catheters & Accessories Microwave & Radiofrequency Ablation Diagnostic Catheters, Guidewires & Kits Lung Biopsy Safety Endovenous Laser Treatment Radiation Treatment Stabilization Balloons
6 DVT Deep Vein Thrombosis Small Bore* Large Bore PAD Peripheral Arterial Disease Atherectomy PE* Pulmonary Embolism Solid Tumor* Prostate, Liver & Pancreas Cardiovascular Disease Cancer $1.1B TAM $2.4B TAM $600M TAM $2.9B TAM $160M TAM $2.0B TAM AngioDynamics Cardiac Thrombus & Emboli Left Heart* Right Heart $665M TAM *AlphaVac PE, Auryon Venous Thrombectomy/DVT, AngioVac Left Heart 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.
7 AngioDynamicsFocused technology platforms targeting attractive markets with meaningful treatment gaps, where our differentiated technologies can address unmet needs Disease State Platform Treatment Status PAD Peripheral Arterial Disease Atherectomy Launched Thrombus Venous Thromboembolism & Cardiac Thrombus & Emboli Pulmonary Embolism* APEX study currently enrolling Targeted launch 2H calendar 2024 Large Vessel Thrombectomy Launched Small Vessel Thrombectomy* Targeted 510K approval end of calendar 2024 Right Heart Launched Left Heart* In Development Solid Tumor Prostate Tissue* PRESERVE study >70% enrolled Launch targeted end of calendar 2024 *AlphaVac PE, Auryon Venous Thrombectomy/DVT, AngioVac Left Heart & NanoKnife Prostate are not cleared by the US Food and Drug Administration (FDA) for these indications.
PADWith over 35,000 cases performed, the Auryon Atherectomy System is the only atherectomy solution with the safety profile and versatility to treat every lesion location and morphology 8 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 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. 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 $760M $210M $100M Source: Management estimate & industry sources as of July 2022.
Thrombus ManagementOur 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* 9 2022 TAM $6.7B $210M $3.9M $1B $1B Auryon’s low profile + laser + aspiration, make it a compelling and simple technology to effectively ablate& remove thrombus with the legs. VTE Cardiac PE Pulmonary Embolism DVT Deep Vein Thrombosis TVIE Tricuspid Valve Endocarditis LV Lead Vegetation RA Right Atrial Thrombus + Cardiac VTE $3.9B $1B $1B $535M $290M Source: Management estimate & industry sources as of July 2022. *AlphaVac PE, Auryon Venous Thrombectomy/DVT, and AngioVac Left Heart are not cleared by the US FDA for these indications.
Thrombus ManagementTechnology portfolio targeted at peripheral and cardiovascular thrombolytic events, including small and large vessels c-g See reference page *AlphaVac PE, Auryon Venous Thrombectomy/DVT, and AngioVac Left Heart are not cleared by the US FDA for these indications. Small Vessel Large Vessel PE Pulmonary Embolism IVC/SVC Inferior & Superior Vena Cava DVT Ilio-Fem Larger vessels can accommodate large devices (>18FR) Larger the vessel the larger the clot Bigger is better (inner lumen) Funnel matters – dehydrate clot Smaller devices needed for smaller vessels and access sites (<14FR) Laser will “break-up” thrombus while the aspiration pump will remove Laser safety profile is effective in arteries and veins Simple, intuitive and safe for DVT CARDIAC RH/LH Thrombus 355 nm laser is designed to deliver an optimized wavelength, pulse width, and amplitude to restore flow in occluded vessels c, d, g
Prostate Initiative*Over 505,000 men with prostate cancer could be treated with this technology 11 *IDE Study in progress Market Source: Management estimate & industry sources as of July 2022. Focal Therapy 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 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 PlanExpanding our business reach in targeted regions & countries 12 Aligning our Go-to-Market strategy to the different regions and markets, utilizing new partnerships where appropriate to maximize growth Preparing for EU and selected OUS launches of both the Auryon Atherectomy Product line, and the AlphaVac large bore Thrombectomy product Line Targeted launch date Auryon: 1H of calendar 2024 Targeted launch date AlphaVac: 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 of our technologies
Medical Device 13 Med Device: Maintain Positioning Vascular Access Catheters & Accessories Microwave & Radiofrequency Ablation Diagnostic Catheters, Guidewires & Kits Lung Biopsy Safety Endovenous Laser Treatment Radiation Treatment Stabilization Balloons Optimizing our commercial approach by re-aligning Core portfolio into new VA - Device centric commercial team Broader Med Device bag allows deeper customer engagement Maximize clinical differentiation & secure committed customers through targeted GPO/IDN contracting Maintain a strong culture of execution and collaboration through disciplined sales & marketing plans Develop & export key talent throughout the organization P O R T F O L I O M A R K E T A C C E S S P E R F O R M A N C E
Q3 and YTD FY23 Results (unaudited) 14 $ in thousands (except per share data) Q3 FY23 Q3 FY22 Change YTD FY23 YTD FY22 Change Revenue $80,712 $73,970 9.1% $247,678 $229,221 8.1% Med Tech Med Device $22,874 $57,838 $19,612 $54,358 16.6% 6.4% $70,193 $177,485 $56,106 $173,115 25.1% 2.5% United States International $67,620 $13,092 $62,445 $11,525 8.3% 13.6% $208,274 $39,404 $192,259 $36,962 8.3% 6.6% Gross Margin Med Tech Med Device 50.2% 64.6% 44.5% 52.2% 66.1% 47.1% (200 bps) (150 bps) (260 bps) 51.6% 63.8% 46.8% 52.0% 66.1% 47.5% (40 bps) (230 bps) (70 bps) Net Loss Non-GAAP Adjusted Net Income (Loss) ($9,485) ($1,023) ($4,958) $1,307 ($4,527) ($2,330) ($30,975) ($3,153) ($20,281) ($436) ($10,694) ($2,717) GAAP EPS Non-GAAP Adjusted EPS ($0.24) ($0.03) ($0.13) $0.03 ($0.11) ($0.06) ($0.79) ($0.08) ($0.52) ($0.01) ($0.27) ($0.07) Adjusted EBITDA $4,258 $6,695 ($2,437) $14,674 $14,687 ($13) $ in thousands Q3 FY23 Q4 FY22 Change Cash $30,111 $28,825 $1,286 Debt Revolving Facility Delayed-Draw Term Loan $50,000 $25,000 $25,000 $25,000 $25,000 $0 $25,000 $0 $25,000 Net (Debt) Cash ($19,889) $3,825 ($23,714)
Q3 and YTD FY23 Results 15 Med Device Med Tech 25.1% growth 2.5% growth YTD Revenue Growth YTD FY22 YTD FY23 YTD Revenue Contribution YTD FY22 YTD FY23 Med Device Med Tech 16.6% growth 6.4% growth Q3 Revenue Growth Q3 FY22 Q3 FY23 Q3 Revenue Contribution Q3 FY22 Q3 FY23
Needham & Company 22nd Annual Virtual Healthcare Conference April 17, 2023 Jim Clemmer, President & CEO Stephen Trowbridge, Executive Vice President & CFO
Auryon References a. 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. b. 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. c. Auryon. Instructions for use. AngioDynamics; 2019. d. 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. e. 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. f. 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. g. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644. 17