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): July 13, 2021
AngioDynamics, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-50761 | 11-3146460 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File<br><br> Number) | (IRS Employer<br><br> Identification No.) |
| 14 Plaza Drive Latham, New York <br> 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<br><br> 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 July 13, 2021, AngioDynamics, Inc. (“AngioDynamics”) will host the AngioDynamics’ Investor & Technology Day. 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,” “project”, “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, express 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, 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 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, 2020 and its Quarterly Reports on Form 10-Q for the fiscal periods ended August 31, 2020, November 30, 2020 and February 28, 2021. 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<br> for the AngioDynamics Investor & Technology Day, dated July 13, 2021 |
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.<br><br> <br>(Registrant) | |||
|---|---|---|---|
| Date: July 13, 2021 | By: | /s/ Richard C. Rosenzweig | |
| Name: | Richard C. Rosenzweig | ||
| Title: | Senior Vice President,<br><br> <br>General Counsel and Secretary |
Exhibit 99.1
1 Investor & technology day JULY 2021
AGENDA 9:30 – 10:50 AM ET | BUSINESS PRESENTATIONS ANGIODYNAMICS OVERVIEW GROWTH STRATEGY & TECHNOLOGY OVERVIEW KEY TECHNOLOGY PLATFORM OVERVIEW Thrombus management – ANGIOVAC & ALPHAVAC PERIPHERAL ATHERECTOMY – AURYON IRREVERSIBLE ELECTROPORATION – NANOKNIFE VASCULAR ACCESS AND MED DEVICES GLOBAL HEALTHCARE ECONOMICS10:50 – 11:00 AM ET | FINANCIAL GOALS & CAPITAL ALLOCATION11:00 – 11:30 AM ET | Q&A
3 Notice Regarding Forward-Looking StatementsThis 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, 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 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, 2020. 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 MeasuresManagement 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 included 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.
4 Disclaimers:This presentation includes videos of key opinion leaders, who are paid consultants of AngioDynamics. The views and opinions expressed by these key opinion leaders are their own and do not necessarily reflect the views and opinions of AngioDynamics.The FDA-approved/cleared labeling for all products may not be consistent with all uses described herein. These videos are in no way intended to promote the off-label use of medical devices. AngioDynamics only markets its products in accordance with their cleared or approved labeling.
AngioDynamics has a rich history that is deeply rooted in upstate New York’s region known as “Catheter Valley.” The Company has grown through its many phases to become a global, industry-leading provider of high-quality medical technology used by physicians for the treatment of cancer and peripheral vascular disease. 33 YEARS
PURSUE LARGER, FASTER GROWING MARKETSActive portfolio management enables us to compete in larger, faster growing markets relying on technology & innovation to produce measurable patient outcomes DEPLOY FOCUSED RESOURCE DEVELOPMENTResource deployment focused in areas that offer better opportunities for success DRIVE PORTFOLIO TRANSFORMATIONPortfolio transformation & strength driven by R&D, M&A, and Clinical & Regulatory ATTRACT AND RETAIN TOP TALENT Strong and innovative portfolio combined with top talent drives value STRATEGIC TRANSFORMATION
Diagnostic Catheters, Guidewires and Kits Vascular Access Catheters and Accessories Microwave & Radiofrequency Tumor Ablation Endovenous Laser Treatment Lung Biopsy Safety Radiation Treatment Stabilization Balloons MED TECHInvest for Growth MED DEVICEMaintain Positioning Thrombus Management Irreversible Electroporation Peripheral Atherectomy AlphaVac commercial launch planned for 4th quarter calendar year 2021.
Focus on Innovative Medical Technologies Leveraging three main drivers to carve out our space in large, growing markets through innovative, disruptive technologies that treat patients with cancer, promote healthy blood flow and deliver critical therapies. M & A R & D Clinical & Regulatory Pathway Expansion Advancing Our Transformation
FOCUSED TRANSFORMATIONU.S. Total Addressable Markets FY2021 Launch of the Auryon System gives us access to the peripheral atherectomy market Planned Thrombectomy & NanoKnife System portfolio additions & new indications increase market access $3.0B 2-5% Mkt CAGR $5.5B 3-7%Mkt CAGR $8.0B 3-7%Mkt CAGR FY2023 FY2025 The planned portfolio additions and new indications 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. Planned Thrombectomy & PE portfolio additions & new indications increase market access Began our strategic initiative to become a growth company FY2018 $1.3B 0-3% Mkt CAGR
TECHNOLOGY PIPELINE FY22 FY23 FY24 Thrombus Management Peripheral Atherectomy AlphaVac F2220, F22180 AlphaVac F1885 AngioVac F1885 AlphaVac F1885 PE, IDE Approval AlphaVac Lower Extremity (DVT), Smaller Cannula Auryon 2.0 Catheter Enhancements Prostate PRESERVE Study Irreversible Electroporation Pancreas DIRECT Study Auryon Expanded Indication PAD Line Extensions PRODUCT LAUNCHES REGULATORY CLEARANCES REIMBURSEMENT SUPPORT The planned portfolio additions and new indications 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. IDE Study
THROMBUS MANAGEMENT MED TECH
Deep Vein ThrombosisDVT + Pulmonary EmbolismPE = Venous ThromboembolismVTE A blood clot that forms in a deep vein, usually the leg, groin or arm A DVT breaks free from a vein wall and travels to the lungs blocking some or all of the blood supply DVT and PE are collectively referred to as VTE 208,000 Iliofemoral Cases1 171,000 High-risk & intermediate-risk PE Cases1 VTE Affects up to 900k Americans each year100,000 VTE-Related Deaths in the USA Annually2Roughly 30% of Americans who get a blood clot will have a reoccurrence in less than 10 yearsVTE Costs our US Healthcare system $10 Billion a year Stages of Clot Clot in Transit (traveling through the heart) Clot in Pulmonary Arteries (PE) 1. Plovanic, W. J., & Furlong, C. (2020, June). Inari Medical Biomedical Devices and Services. Canaccord Genuity Capital Markets.2. “Venous Thromboembolism (VTE).” World Thrombosis Day, www.worldthrombosisday.org/issue/vte. Illustrations and Images not Produced by AngioDynamics Include:https://www.vascularmedcure.com/disease-backgroundDVT (Blood Clot In the Leg): 7 Warning Signs and Symptoms (emedicinehealth.com) VTE Represents 390k Cases Annually https://www.cdc.gov/ncbddd/dvt/data.html
13 DVT & PE TREATMENT OPTIONSPercutaneous Thrombectomy CDT & US-CDTCatheter-Directed Thrombolysis (with or without the assistance of ultrasound) PCMTPharmacomechanical Thrombectomy Continuous Aspiration Suction Thrombectomy MTMechanical Retrieval Thrombectomy MAMechanical Aspiration(Small & Large) Lytic Based Non-Lytic Based Rx AnticoagulationPrescription Medication SIMPLE COMPLEX MODERATE Treatment “Type” Spectrum Illustrations and Images not Produced by AngioDynamics Include:https://youtu.be/0QUUBZ6BxSo https://www.penumbrainc.com/indigo-lightning/ https://www.vascularmedcure.com/ourproducts Active Portfolio Development
The Difference The AngioVac System allows for the continuous aspiration of embolic material such as fresh, soft thrombi or vegetation from the venous systemUtilizing a self-expanding, nitinol reinforced funnel tipSimultaneously reinfusing the patient’s own filtered blood to limit procedural blood loss Centrifugal Pump Console Waste Collection System Filter Saline AngioVac Cannula Reinfusion Cannula AngioVac Circuit Individual experience may not be indicative of all procedure results.
THE NEXT GENERATION OF ANGIOVACPhysician requests for use in DVT drive new product development $1.6B Controlled Powerful Versatile THE NEXT PORTFOLIO INNOVATION A purpose-built, innovative product leveraging the strengths of the AngioVac cannula technology with off-circuit manual aspiration control Proven funnel tip design allows efficient aspiration and compression of large clot burden Designed to allow the end-user command and control of the mechanical aspiration Broadens Thrombus Management portfolio and is designed to provide an intuitive, first-line treatment option without the need for lytics and advanced procedural support AlphaVac commercial launch planned for 4th quarter calendar year 2021.
Handle | Control Features DIRECTIONAL LABELSCannula | Waste Bag SYRINGE BARREL DURABLE LABELSVisible in low light environments VOLUME LIMITING SWITCHIntuitive location | Multiple glove sizes VACUUM LOCKControlled, single-hand design ANGLED HILTEasy access to vacuum lock TEXTURED GRIPEnhances grip control ROBUST DESIGNEnables smooth pulls with contemporary design ANGLED EXIT Prevents large thrombus clog MALE AND FEMALE CONNECTION Ensures correct connection SPACERAllows sterile blood path and confirms plunger passes shelf-life constraints
F1885° Cannula | Simple Design. Powerful Features. Tapered Distal TipEnhanced navigation and safety Lubricious Shaft MaterialEasy delivery through tortuous anatomy Hemostasis ValvePrevents blood loss during device exchange Quarter Turn ValveLocks tip angle in place Side Arm Flush PortRemove air between sheath and cannula Radiopaque Tapered Soft TipEnhanced visibility Atraumatic transition to obturator Funnel Shaped HandleGuided device insertion Quick Connect Handle Alignment RibIndicates cannula curve Triple Durometer Braided ShaftStiffness for powerful push, terminates with a more flexible atraumatic distal end with 1:1 torque Nitinol Reinforced Funnel TipReliable clot entrapment and removal 85° Cannula BendEnhanced direct-ability OBTURATOR SHEATH CANNULA AlphaVac F1885 is not cleared by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the FDA. The device is not currently being marketed, nor is it available for sale in any country.
Purpose-Built Portfolio to Address the Removal of Clot & Thrombus from Neck to Knee F22180° Represents the French Size of our cannula Represents the Angle/Degree of our cannula tip Example AngioVac & AlphaVac Nomenclature F2220° F22180° F1885° F1310° F1885 ° PE NA AlphaVac commercial launch planned for 4th quarter calendar year 2021. AlphaVac F1885 and F1310 are not cleared by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the FDA. The device is not currently being marketed, nor is it available for sale in any country.
ADDRESSABLE MARKETThrombus Procedures by Location Right Heart/Atrium97K Patients$77M TAM IVC/SVC – Caval DVT20K Patients$360M TAM PE167K Patients$1.6B TAM Popliteal – DVT95K Patients$300M TAM Ilio-Femoral – DVT246K Patients$700M TAM RESTORATIVE FLOW THERAPIES Funnel TipOpening FR Size Cannula AngleDegree Cannula FR Size ModalityType F2220 F22180 F1885 F1310 F1885 PE 42FR 42FR 33FR ~16FR 33FR 20º 180º 85º 10º 85º 22FR Cannula25FR Sheath 22FR Cannula25FR Sheath 18FR Cannula22FR Sheath ~13FR Cannula~16FR Sheath 18FR Cannula22FR Sheath Deliberate Attention to Key Technology Elements Shapes, Sizes and Angles will be available in both on/off circuit options (AlphaVac/AngioVac) Availability FY22 Q2/3 FY22 Q2/3 FY22 Q3* FY23 Q4* FY24 Q4* AlphaVac F1885 and F1310 are not cleared by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the FDA. The device is not currently being marketed, nor is it available for sale in any country. AlphaVac and AngioVac are not indicated for PE. AlphaVac commercial launch planned for 4th quarter calendar year 2021.
RAPID Registry
Objective: To evaluate the patterns of use, safety and effectiveness data of the AngioVac device in bulk removal of endovascular material. Principal Investigator: Dr. John Moriarty, UCLANumber of patients enrolled: 234Number of sites: 21Recruitment goal: 200Timeline: 2016 - 2019 REGISTRY OF ANGIOVAC PROCEDURES IN DETAIL
Right Heart Mass: 123Caval thromboembolism*: 91Catheter related thrombus: 25Pulmonary embolism*: 7Combination of above = 5.6 % 5.6% 1.7% 8.5% 35.9% 48.3% Right Heart Mass Caval thromboembolism Catheter related thrombus Pulmonary embolism Combination * The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli. Use of the AngioVac cannula in the Pulmonary Arteries is off-label. All procedures performed in the registry using the Generation 2 cannula. Moriarty et al, Endovascular removal of thrombus and right heart masses using the AngioVac system. Results of 234 patients from the prospective multicenter registry of AngioVac procedures in detail (RAPID). JVIR. Accepted * Rounding decimals to the nearest whole number RAPID – TARGET ANATOMY
First large scale prospective multicenter assessment of the AngioVac system. RAPID – KEY TAKEAWAYS Effective: Majority of patients have > 70% clot/mass removed. Safe: 75% of all cases no RBC transfusion with 6 (2%) major hemorrhage, 1 procedure-related death.
PE IDE study
Seek FDA clearance for Pulmonary Embolism Indication: Determine the safety and effectiveness of the AlphaVac F1885° in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE)Patient Enrollment Target: 122Timeline: 2022-2024, Currently in study design discussions with FDA PE IDE Study: A Prospective, Multicenter, Single-arm Study
THROMBUS
MANAGEMENTPurpose Built Portfolio & Technology 26 Right Atrium AngioVac’s use is currently focused on the Right Atrium, which is a $77M addressable market. Pulmonary Embolism Deep Vein Thrombosis AlphaVac, a multi-purpose mechanical
aspiration device, will allow us to compete in the broader DVT & PE addressable markets \($2.9B\) with a first-line treatment option without the need for perfusion. C U R R E N T P O R T F O L I O EXPANDED P O R T F O L I O DVT &
PE Uni-Fuse+ catheter directed thrombolysis now has the additional indication for placement in the pulmonary artery. C U R R E N T P O R T F O L I O SIMPLE COMPLEX MODERATE $3B $77M2 $1.3B1 $1.6B1 PULMONARY EMBOLISM RIGHT
ATRIUM DEEP VEIN THROMBOSIS Plovanic, W. J., & Furlong, C. \(2020, June\). Inari Medical Biomedical Devices and Services. Canaccord Genuity Capital Markets. Fletcher Spaght, Inc. AngioVac market assessment March 2018, AngioDynamics
funded AlphaVac commercial launch planned for 4th quarter calendar year 2021.
THROMBUS MANAGEMENTPlanned Portfolio Additions & U.S. Addressable Markets Expansion $1.3B FY 2021 FY 2022 FY 2023 FY 2025 FY 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 $140M $700M $3.6B $1.5B 1 2 The planned portfolio additions are not guarantees of future performance and are subject to risks and uncertainties, including clearance by the FDA. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. (F2220, F22180)Right Atrium, Illio-caval DVT (F2220 - F22180 - F1885Entry into Ilio-femoral DVT (F1310)Access to full Ilio-femoral DVT market (F1885) Smaller size should drive further adoption in addressable market PE Indication (F1885 PE) Purpose Built, Comprehensive, Thrombus Portfolio F2220 F22180 F1885 1885 PE F1310 Continuous Aspiration with Simultaneous Reinfusion Multi-purpose Mechanical/Manual Aspiration Catheter Directed Thrombolysis with PE Indication F2220 F22180 F1885 1885 PE F1310
PERIPHERAL ATHERECTOMY MED TECH
MECHANICAL LASER $600M 23%1 1.
Peripheral Vascular Devices Medtech 360 Market Analysis US 2017. \(2016, December\). Millennium Research Group, Inc. 77%1 2021 Served Market Over 8 Million2 Americans Suffer from PADOver 150,000 Limbs2 are Lost Every Year because of PAD50%
Mortality Rate2 Associated with PAD after Limb Loss 2. https://www.cookmedical.com/peripheral-intervention/10-facts-about-peripheral-arterial-disease/ PERIPHERAL ATHERECTOMYUS Addressable Markets & Competitive Landscape
The Auryon System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR)1. 1. 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-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8. 2. 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-LaserTM, 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. 3. Auryon. Instructions for use. AngioDynamics; 2019. 4. 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. 5. 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. 6. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644. 7. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl). 2015;8:1-10. 8. Cross FW, Bowker TJ. The physical properties of tissue ablation with Excimer lasers. Med Instrum. 1987;21(4):226-230. 9. Kuczmik W, Kruszyna L, Stanisic MG, 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
2.35 mmAspiration and Off-Center capabilities and indicated for Peripheral Atherectomy and In-Stent Restenosis (ISR) 2.0 mmAspiration capability and indicated for Peripheral Atherectomy and ISR 1.5 mmIndicated for Peripheral Atherectomy Why wavelength mattersEach type of tissue interacts differently with a given wavelength Why pulse width and amplitude matterGreater amplitude is achieved with shorter pulses, which can deposit energy before thermal diffusion occurs The Auryon System produces a photon energy of 3.5 eV, which is low enough to be nonreactive to vessel endothelium, but high enough to vaporize calcium. b, c The Auryon System has a pulse width of 10 to 25 ns, ensuring enough power to target the lesion and spare the vessel. a 0.9 mmIndicated for Peripheral Atherectomy a. Auryon. Instructions for use. AngioDynamics; 2019. b. 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. c. Spectranetics Corporation. CVX-300 Excimer Laser System: Operator’s Manual. Version 28. 2019:1-56.
The Science of the Auryon System – Solid State Technology The Auryon System is designed to deliver an optimized wavelength, pulse width, and amplitude to remove lesions while preserving vessel wall endothelium.1,6 Competitive 308nm Laser 1. 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-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8. 6. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644.
The Science of the Auryon SystemWavelength & Pulse Width Competitive 308nm Laser 1. 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-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8. . Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644. 7. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl). 2015;8:1-10.
- 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-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8. 2. 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-LaserTM, 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. 3. Auryon. Instructions for use. AngioDynamics; 2019. 4. 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.
FY21Procedures† 507945462469 ATKAbove the Knee BTKBelow the Knee 2,61752% 2,38348% 1,850767 Tibio-peroneal TrunkAnterior Tibial Peroneal TibialPosterior Tibial Common/Superficial Femoral ArteryPopliteal >5,000 Resiliency in the Face of ALL Lesions The Auryon System can handle it † Data on file ISR* ATK/BTK SEVERECALCIUM *Only the 2.0 and 2.35mm catheters are cleared for in-stent restenosis (ISR).
Post market, prospective, multicenter, single-arm, all-comers registry PATHFINDER-I Study Design 1at 30 days visit only MAEs are reported 104 Patients de novo, re-stenotic, and ISR lesions High procedural success with challenging lesions, including long occlusions, severely calcified lesions, and ISR Treatment +/-Adjunctive Therapy Primary endpoints:1) Acute Success: ≤ 30% final RDS (by corelab) 2) Freedom from peri-procedural MAEs/ complications by discharge Complete six-month results are expected by the end of 2021
Collaborations with our Physician Partners Retrospective Chart Reviews Prospective Investigator Initiated Trials Single Center Experience 70 Patients3-year follow up OBL Single Center Experience 55 Patients iDissection ATK 29 Patients iDissection BTK Procedural safety analyzed by IVUS post-laserFollow up of 1 year Procedural safety analyzed by IVUS post-lasercompleted and data to be published soon Multi-site prospective registry 60 Patients
38 A revolutionary experience is exactly what AngioDynamics is delivering in the world of interventional devices used to perform peripheral atherectomy for peripheral arterial disease (PAD). The introduction of Auryon may seem like it’s another in a series of options for performing this procedure, but the experience physicians will have with it will be unlike any other. 0 1 November 1, 2019 ZERO REVENUECUSTOMERSINVENTORYSALES REPRESENTATIVES AMAZING TECHNOLOGY Giving Physicians a device that is finally adaptable as they are and as diverse as their patients. CLINICALLY PROVEN SAFE CONVENIENT
A Compelling Technology Being Endorsed Through Experienced Users and Convincing Patient Outcomes 132 Auryon Commercial Representatives 5K Auryon Procedures FY21 47 Customers $11M
IRREVERSIBLE ELECTROPORATION MED TECH
INNOVATION DOCTORS NEEDExpands treatment options and help preserve patient's quality of life DECELLULARIZATIONDestroys targeted tissue with precise treatment margins.1,2 PROBE PLACEMENTNanoKnife can be confidently used in all segments of an organ.1,2 NON-THERMALSpares vital structures by retaining the structural integrity of tissue.3,4 REVASCULARIZATIONFacilitates functional tissue regeneration post-ablation.3,4 1 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. (2010);4(SUPPL. 1):99–104. doi: 10.5009/gnl.2010.4.S1.S99 2 Guidance for Selection of NanoKnife Probe Array Configuration and Ablation parameters for the Treatment of Stage III Pancreatic Cancer. 3 Scheltema MJ, Chang JI, van den Bos W, Gielchinsky I, Nguyen TV, Reijke TM, Siriwardana AR, Böhm M, de la Rosette JJ, Stricker PD. Impact on genitourinary function and quality of life following focal irreversible electroporation of different prostate segments. Diagn Interv Radiol. 2018 Sep;24(5):268-275. doi: 10.5152/dir.2018.17374. PMID: 30211680; PMCID: PMC6135060. 4 Li W, Fan Q, Ji Z, Qiu X, Li Z. The effects of irreversible electroporation (IRE) on nerves. PLoS One. 2011 Apr 14;6(4):e18831. doi: 10.1371/journal.pone.0018831. PMID: 21533143; PMCID: PMC3077412.
$1.6B Interventional
Oncology Devices Medtech 360 Market Analysis US 2016. \(2016, December\). Millennium Research Group, Inc.“Cancer Facts & Figures 2021.” American Cancer Society,
www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2021.html. 2021 Total Addressable Market \(TAM\) 22%1,2 8%1,2 LIVER PROSTATE 70%1,2 PANCREAS THE NANOKNIFE SYSTEMEstimated # of U.S. Patients
Diagnosed in 20212 Liver 42,230 Pancreas60,430 Prostate248,530
Can be confidently used in all segments of an organ. 4,5 RADICAL RADIATION In 2021 248,530 men are estimated to be diagnosed with prostate cancerin the US.1 RADICAL SURGERY 27% undergo 31% undergo 35% report erectile dysfunction 79% report erectile dysfunction PROSTATE CANCERTreatments 1 “Cancer Facts & Figures 2021.” American Cancer Society, www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2021.html.2 Mahal BA, Butler S, Franco I, et al. Use of Active Surveillance or Watchful Waiting for Low-Risk Prostate Cancer and Management Trends Across Risk Groups in the United States, 2010-2015. Jama. 2019;321(7):704. doi:10.1001/jama.2018.199413 Widmark A, Gunnlaugsson A, Beckman L, et al. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019;394(10196):385-395. doi:10.1016/S0140-6736(19)31131-64 Hamdy FC, Donovan JL, Lane JA, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016;375(15):1415-1424. doi:10.1056/NEJMoa1606220 2 2 3 4
44 FOCAL THERAPYBridges the gap between whole gland treatments and active surveillance1 Tareen B, Godoy G, Taneja SS. Focal therapy: a new paradigm for the treatment of prostate cancer. Reviews in urology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2809988/. Published 2009. Accessed January 7, 2021.]Lee, Byron H., et al. “Changing Landscape of Prostate Cancer Favoring Low-Risk Prostate Cancer: Implications for Active Surveillance Versus Focal Therapy.” Imaging and Focal Therapy of Early Prostate Cancer, 2012, pp. 17–36., doi:10.1007/978-1-62703-182-0_2.Klotz, MD, FRCSC, CM, Laurence Klotz. “Active Surveillance for Prostate Cancer: How to Do It Right.” Oncology, 2017.Cedars-Sinai Medical Center. Hormone Therapy Can Make Prostate Cancer Worse, Study Finds, Cedars-Sinai Medical Center, 31 Mar. 2021, www.cedars-sinai.org/newsroom/hormone-therapy-can-make-prostate-cancer-worse-study-finds/. https://koelis.com/koelis-announces-first-procedures-in-3d-fusion-imaging-guided-focal-ablation-of-prostate-cancer-in-its-clinical-study-violette PSA adoption has led to a shift towards less aggressive prostate cancer being diagnosed.2 Genetic, molecular, and clinical evidence supports the dominant lesion paradigm.2 Improvements in prostate cancer diagnostic tools.2 3 4 5
45 FOCAL THERAPYU.S. Served and Target Markets Qualified Patients Focal Procedures 0 25,000 50,000 75,000 100,000 1 Definitive Healthcare All-Payor Hospital Outpatient Volume by CPT Code, 02/05/20212 “Cancer Facts & Figures 2021.” American Cancer Society, www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2021.html.3 Parry MG, Cowling TE, Sujenthiran A, et al. Risk stratification for prostate cancer management: value of the Cambridge Prognostic Group classification for assessing treatment allocation. BMC Medicine. 2020;18(1). doi:10.1186/s12916-020-01588-9 Target Market2,3 $500M Served Market1 $25M
46 Existing thermal technology has less than ideal outcomes1,2 1. Worrell Design. Next Gen Voice of Customer, 2020.2. Sivaraman A, Barret E. Focal Therapy for Prostate Cancer: An "À la Carte" Approach. Eur Urol. 2016;69(6):973-975. doi:10.1016/j.eururo.2015.12.0153. Klotz, MD, FRCSC, CM, Laurence Klotz. “Active Surveillance for Prostate Cancer: How to Do It Right.” Oncology, 2017. FOCAL THERAPY ADOPTIONRemains low despite patient and physician interest Current data includes low-risk disease within the study cohorts1,3
47 To evaluate the effectiveness and safety of the NanoKnife System for the ablation of Stage 3 pancreatic cancer 1 “The Anatomy of the Pancreas.” Verywell Health, 6 June 2020, www.verywellhealth.com/pancreas-anatomy-4800990.
Up to 20 Sites in the U.S. Pivotal study of the NanoKnife System for ablation of prostate tissue in an intermediate-risk patient population IDE Approved July 2nd, 2021 1 1. “The Future of Prostate Cancer Screening Is Here.” Https://Health.Clevelandclinic.Org/, 14 July 2020, health.clevelandclinic.org/the-future-of-prostate-cancer-screening-is-here.
PRESERVE Prostate IDE 37 SUO-CTC US sites responded to Call for Sites Up to 20 Sites to be selected, focused on geographic and demographic diversity, high-volume focal therapy institutions 100 Intermediate-risk patients enrolled through 1-year follow up SUO-CTC is a clinical research investigator network of 500+ members from more than 250 clinical sites in the US and Canada. Primary endpoint: Rate of negative in-field biopsy at 1 year
50 RIGHT TREATMENT RIGHT PATIENT RIGHT TIME 1 https://www.gaurology.com/dr-gonzalez-draws-upon-his-familys-own-prostate-cancer-experience-to-help-others/2 https://koelis.com/koelis-announces-first-procedures-in-3d-fusion-imaging-guided-focal-ablation-of-prostate-cancer-in-its-clinical-study-violette/ The NanoKnife System Intermediate-Risk Patients Advancements in focal therapy(Imaging, Staging, Technique) 1 2
VASCULAR ACCESS & DEVICES MED DEVICE
52 VASCULAR ACCESSSafely delivering medication to patients PORTFOLIO MARKET ACCESS PERFORMANCE PICCs Midlines Tip Location Ports Dialysis Point of Care Ultrasound Delivering on our product road map through a mix of R&D, clinical & regulatory pathway expansion and M&A will enable us to serve more patients with a differentiated portfolio that includes our BioFlo family of catheters Maximize clinical differentiation by reducing thrombus accumulation through the utilization of our BioFlo family of catheters Maintain a strong culture of execution and collaboration through disciplined sales & marketing plans CONNECT / CAPTURE / CONFIRM
Pediatric PICCs Acute Patient Chronic Patient Midlines Ports Dialysis PICCs Vascular Access Product Portfolio – Today and Beyond FY’19 FY’21 “PICCs for Patients of All Sizes” FY’22 FY’23 AST Midline/EDC Next Gen C3 Wave FY’20
Healthcare Economics and Market Access Wins - IRE CY2019 SIR Includes IRE in their universal training curriculumMedicare reviews new CPT for placement in APCs CPTs active/Outpatient IRE reimbursement assigned Outpatient Reimbursement active/Private Payers reported to pay OP CY2020 CY2021 Outpatient IRE assigned to APC equivalent to or higher than other ablation therapiesPRESERVE approved Outpatient IRE Market Access Model Medicare Implementation of ICD-10 codes specific to Irreversible Electroporation in Liver and Pancreas in the inpatient setting CY2018 Medicare Implementation of ICD-10 codes specific to Irreversible Electroporation in Liver and Pancreas in the inpatient setting SIR and ACOS Application for CPT codes specific to Irreversible Electroporation for physician billing Inpatient Codes mapped to complex DRGs CPT codes specific to IRE approved
Advancing Market Access: Physician & Patient Society Engagement
Financial Goals & Capital Allocation Strategy
57 57 FY22 FY22 RevenueGrowth $305M – $310M5% - 7% Gross Margin ~55% Adjusted EPS $0.00 - $0.05 FY23 FY22 RevenueGrowth $330M – $336M7% - 9% FY24 FY22 RevenueGrowth $360M – $375M10% - 12% FY21 FY24 Tech CAGR30% - 35% Device CAGR1% - 3% Med Tech Med Device <20% ~35% Revenue Contribution Revenue Growth CAGR Transformation Toward Double Digit Revenue GrowthAngioDynamics in investment mode throughout the planning horizon Planned significant investment in Med Tech platforms drives top line growth Bottom line leverage will ramp slower than top line growth The projections and growth rates depicted on this slide are forward-looking statements. These forward-looking statements are not guarantees of future performance and subject to risks and uncertainties.
Gross MarginShifting to high margin portfolio expected to drive margin expansion Headwinds Tight labor marketDrives increasing costsImpacts absorptionRaw Materials Inflationary PressureIncreasing Freight CostsAuryon Impacts – will abate over timeOBL vs Hospital MixHardware placements Operational Focus Mix increase from Med Tech growth contributionGrowth from >70% margin productsMake vs buy analysisMaintain service levelsContinued focus on cost reduction opportunitiesPrioritization on service efficiency
Focused on leveraging current operations to fund future investments in R&D and S&M Revolver capacity available for future opportunities if neededStrong banking group relationshipOpportunistic and disciplined approach to tuck-in M&A prospects that support our Med Tech platformsStrategic plan to continue meaningful investment while being good stewards of the bottom line Capital Allocation
PURSUE LARGER, FASTER GROWING MARKETSActive portfolio management enables us to compete in larger, faster growing markets relying on technology & innovation to produce measurable patient outcomes DEPLOY FOCUSED RESOURCE DEVELOPMENTResource deployment focused in areas that offer better opportunities for success DRIVE PORTFOLIO TRANSFORMATIONPortfolio transformation & strength driven by R&D, M&A, and Clinical & Regulatory ATTRACT AND RETAIN TOP TALENT Strong and innovative portfolio combined with top talent drives value STRATEGIC TRANSFORMATION