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): November 19, 2020
(Exact Name of Registrant as Specified in Charter)
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Identification No.)
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(Registrant’s telephone number, including area code)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))
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Securities registered pursuant to Section 12(b) of the Act:
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Name of each exchange on which
registered |
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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 November 19, 2020, James C. Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics”), will present at
the Canaccord Genuity 2020 Medical Technologies & Diagnostics Forum. 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,” “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 from AngioDynamics’
expectations. 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 purchased 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 Report on Form 10-Q for the fiscal period ended August 31, 2020. 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.
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Exhibit No.
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Description
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Presentation slides for the Canaccord Genuity 2020 Medical Technologies & Diagnostics Forum, dated November 19, 2020.
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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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Date: November 19, 2020
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By:
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/s/ Stephen A. Trowbridge | ||
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Stephen A. Trowbridge |
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Executive Vice President, General Counsel |
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and Chief Financial Officer |
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Exhibit 99.1
11 | 19 | 2020 ANGIODYNAMICS Canaccord Genuity2020 Medical Technologies & Diagnostics Forum
2 Forward-Looking Statement 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,” “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 from AngioDynamics’ expectations. 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. 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 reported adjusted EBITDA (income before interest, taxes, depreciation and
amortization and stock-based compensation); adjusted net income; adjusted earnings per share and free cash flow. 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.
PURSUIT OF LARGER MARKETSActive portfolio management enables us to compete in larger, growing markets
relying on technology & innovation to produce measurable patient outcomes FOCUSED RESOURCE DEVELOPMENTResource deployment is focused in areas that offer best opportunities for success PORTFOLIO TRANSFORMATIONPortfolio
transformation & strength is driven by R&D, M&A, and Clinical & Regulatory TOP TALENT Portfolio combined with talent supports our value more closely to MedTech growth companies DRIVE VALUEProduct & talent investments
generate increased profit and our continuance as a financially solid company ANGIODYNAMICSStrategic Transformation 3
4 FOCUSED TRANSFORMATIONU.S. Total Addressable Markets Our strategic initiative to become a growth
company begins 2018 Launch of the Auryon System gives us access to the peripheral atherectomy market New Thrombectomy & NanoKnife System portfolio additions & indications increase market access $1.3B 0-3%
CAGR $3.2B 2-5%CAGR $7.8B 3-7%CAGR 2021 2025 The planned portfolio additions are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ
from AngioDynamics’ expectations.
5 Diagnostic Catheters, Guidewires and Kits Vascular Access Catheters and Accessories Microwave
& Radiofrequency Tumor Ablation Endovenous Laser Treatment Lung Biopsy Safety Radiation Treatment Stabilization Balloons INVEST FOR GROWTH MAINTAIN POSITIONING Thrombus Management Irreversible Electroporation Peripheral
Atherectomy
PERIPHERAL ATHERECTOMY 11 | 19 | 2020 6
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.d, g The Auryon System has a pulse width of 10 to 25 ns, ensuring enough power to target the lesion and spare the vessel.c c, d, g See appendix for references 0.9 mmIndicated for Peripheral
Atherectomy 7
PERIPHERAL
ATHERECTOMYUS Addressable Markets MECHANICAL LASER $555M 23%1 1. Peripheral Vascular Devices Medtech 360 Market Analysis US 2017. (2016, December). Millennium Research Group, Inc. 77%1 ADAPTABLETreat all levels of
calcificationa-cIndicated for in-stent restenosis*Treats above and below the knee (including below the ankle)Treat eccentric lesions with 2.35mm*Only the 2.0- and 2.35-mm catheters are indicated for ISR. PRECISEProtective of vessel
wallc-eTargeted biological reactions to address risk of perforationsNonreactive to contrast mediaBuilt-in aspiration to address risk of embolization††Built-in aspiration available with only the 2.0-and 2.35-mm catheters. EFFICIENTDesigned for
hospital and laba-c, fPortable, 110V outlet, low noise, touch screenDebulk in fewer passesSmall footprint, easy storage a-f See appendix for references 2020 Total Addressable Market (TAM) 8
THROMBUS MANAGEMENT 11 | 19 | 2020 9
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. 10
THROMBUS
MANAGEMENTPlanned Portfolio Additions & U.S. Addressable Markets Expansion 11 PULMONARYEMBOLISM RIGHT HEART $3B DEEP VEIN THROMBOSIS $77M $1.3B $1.6B 2020 TAM 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 Multipurpose Mechanical Aspiration AngioVac Gen 4 Multipurpose Mechanical Aspiration Gen 2 PE Indication AngioVac
$3.6B $1.5B 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 1 1 2 The
planned portfolio additions are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations.
IRREVERSIBLE ELECTROPORATION 11 | 19 | 2020 12
13 Probe placement Placement of probes around a target area provides
effective treatment coverage a-d Electrical pulses cause pores to form within the cellular membrane leading to non-thermal cell death a-d Electrical field Decellularization Non-thermal Revascularization The NanoKnife System’s unique
technology enables physicians to provide localized treatments in locations and at times previously unavailable to them a-d By preserving those underlying structures the potential for revascularization of treated tissue is maintained
a-d Target tissue undergoes complete decellularization while preserving the underlying structure of blood vessels, nerves, ducts, and tissue a-d IRREVERSIBLE ELECTROPORATIONNanoKnife a. Maor E. et al., The effect of irreversible
electroporation on blood vessels, Technol. Cancer Res. Treat. 6(4), 307–312 (2007).10.1177/153303460700600407.b. Rubinsky, B., Onik, G., and Mikus, P., Irreversible electroporation: a new ablation modality–clinical implications. Technol. Cancer
Res. Treat. 6, 37–48. (2007). doi:10.1177/153303460700600106.c. Onik G., Mikus P., and Rubinsky B., Irreversible electroporation: implications for prostate ablation, Technol. Cancer Res. Treat. 6(4), 295–300(2007).10.1177/153303460700600405.d.
Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST., Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology 255:426–433. (2010). doi: e.1148/radiol.10090337
14 PANCREAS DIRECT IDETechnology & Treatment FDA Breakthrough DesignationFDA
granted the NanoKnife System breakthrough therapy designation and AngioDynamics launched the DIRECT IDE. NanoKnife TechnologyThe NanoKnife System delivers a non-thermal ablation that preserves critical structures while terminating the cells
of targeted tissue. Stage III Pancreatic CancerThe pancreas is surrounded by several blood vessels and other critical structures. In stage III pancreatic cancer, most tumors are considered unresectable, or unable to be removed by surgery.
DIRECT IDE ApprovalA comprehensive study to provide meaningful clinical information to healthcare professionals and patients and support expanded indications.
15 540,400 Liver
Cancer63,780 Patients Prostate Cancer 174,650 Patients Lung Cancer 228,150 Patients Kidney Cancer 73,820 Patients IRREVERSIBLE ELECTROPORATIONMarket Expansion Opportunities 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.1-SEER Cancer Stat Facts. SEER. https://seer.cancer.gov/statfacts/. Accessed November 9, 2020. 1 1 1 1 The NanoKnife System’s unique mechanism of action may expand opportunities to
provide localized treatment options 2020 U.S. Patients
First Quarter FY2021 Results (unaudited) $ in thousands (except per share data) Q1 FY2021 Q1
FY2020 YOY Change Revenue Vascular Interventions and Therapies Vascular Access Oncology United States International $70,21629,85728,10512,25454,10816,108 $66,04228,91323,15913,97052,93713,105 6.3%3.3%21.4%(12.3%)2.2%22.9% Net LossAdjusted
Net Income ($4,268)$618 ($1,275)$3,174 ($2,993)($2,556) GAAP EPSNon-GAAP Adjusted EPS ($0.11)$0.02 ($0.03)$0.08 ($0.08)($0.06) Gross Margin 50.9% 57.9% 700 bps Adjusted EBITDA $4,466 $7,280 ($2,814) Free Cash
Flow ($7,249) ($7,925) $676 Q1 FY2021 Q4 FY2020 Change Cash $47,929 $54,435 ($6,506) Debt $40,000 $40,000 - 16
PURSUIT OF LARGER MARKETSActive portfolio management enables us to compete in larger, growing markets
relying on technology & innovation to produce measurable patient outcomes FOCUSED RESOURCE DEVELOPMENTResource deployment is focused in areas that offer best opportunities for success PORTFOLIO TRANSFORMATIONPortfolio
transformation & strength is driven by R&D, M&A, and Clinical & Regulatory TOP TALENT Portfolio combined with talent supports our value more closely to MedTech growth companies DRIVE VALUEProduct & talent investments
generate increased profit and our continuance as a financially solid company ANGIODYNAMICSStrategic Transformation 17
18 **Peripheral Atherectomy 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. Spectranetics Corporation. CVX-300 Excimer Laser System: Operator’s Manual. Version 28. 2019:1-56.
AngioVac Cannula Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage
cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. | Contraindications: Contraindicated for patients with severe arterial or venous vascular disease, contraindicated for removal of chronic
firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism) and for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation. | Refer to Directions for Use and/or User
Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. | AngioVac Circuit Indications for Use: The AngioVac Circuit is indicated for use
in procedure requiring extracorporeal circulatory support for period of up to six hours. | Contraindications: Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications. Refer to Directions for Use and/or
User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. | CAUTION: Federal law (USA) restricts this device to sale by or on the order
of a physician. | Auryon System Indications for Use and Important Risk Information: The AURYON Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent
restenosis (ISR). | Caution: Federal (USA) law restricts the use of the system by or on the order of a physician. | Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions,
Possible Adverse Effects and Contraindications prior to use of the product. | NanoKnife System Indications For Use and Important Risk Information US: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue. |
CE: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as
a physical stimulus, bringing about alterations in cell membranes that result in increased permeability. | Contraindications: Ablation procedures using the NanoKnife System are contraindicated in the following cases: • Ablation of lesions in
the thoracic area in the presence of implanted cardiac pacemakers or defibrillators • Ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts • Ablation of lesions of the eyes, including the
eyelids • Patient history of Epilepsy or Cardiac Arrhythmia • Recent history of Myocardial Infarction | Potential Adverse Effects: Adverse effects that may be associated with the use of the NanoKnife System include, but are not limited to,
the following: • Arrhythmia • Atrial fibrillation or flutter • Bigeminy • Bradycardia • Heart block or atrioventricular block • Paroxysmal supraventricular tachycardia • Tachycardia o Reflex tachycardia o Ventricular tachycardia • Ventricular
fibrillation • Damage to critical anatomical structure (nerve, vessel, and/or duct) • Fistula formation • Hematoma • Hemorrhage • Hemothorax • Infection • Pneumothorax • Reflex Hypertension • Unintended mechanical perforation • Vagal
Stimulation, asystole • Venous Thrombosis | Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for
use prior to use. Failure to do so may result in patient complications. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. | Uni-Fuse+ Infusion System Indication for Use and Important Risk Information:
Indications for Use: The Uni-Fuse+ Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature. Contraindications: The Uni-Fuse+ Infusion
System is contraindicated for use in the coronary and cerebral vasculature. The Uni-Fuse+ Infusion System is not intended for the infusion of blood or blood products. Refer to the product insert of the therapeutic solution for indications,
contraindications, side effects, cautions and warnings. Refer to Directions for Use provided with the product for complete instructions, warnings, precautions, possible adverse effects, and contraindications. CAUTION: Federal (USA) law
restricts this device to sale by or on the order of a physician. *AngioDynamics, the AngioDynamics logo, AngioVac, the AngioVac logo, Auryon, the Auryon logo, NanoKnife, the NanoKnife logo, UniFuse+, and the UniFuse+ logo are trademarks and/or
registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. ©2020 AngioDynamics, Inc. US/NA/PR/540 Rev 01 11/2020 19