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): January 16, 2020
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> <br>Number) | (IRS Employer<br><br> <br>Identification No.) | |
| 14 Plaza Drive Latham, New York 12110 | |||
| (Address of Principal Executive Offices) (Zip Code) | |||
| (518) 795-1400 | |||
| (Registrant’s telephone number, including area code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| □ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| □ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| □ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b)) |
| --- | --- |
| □ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.01 per share | ANGO | NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 – Regulation FD Disclosure.
On January 16, 2020, James C. Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics”), will present to certain investors at the J.P. Morgan 38th Annual Healthcare Conference. The conference 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 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, 2019. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Presentation slides for the J.P. Morgan 38th Annual Healthcare Conference on January 16, 2020. |
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: January 16, 2020 | By: | /s/ Stephen A. Trowbridge |
| Stephen A. Trowbridge | ||
| Senior Vice President, General Counsel and | ||
| Interim Chief Financial Officer |
Exhibit 99.1
J.P. MORGAN HEALTHCARE CONFERENCEAngioDynamicsJim Clemmer, President and CEOJanuary 16, 2020
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 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, 2019. 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 net sales excluding acquired assets and Asclera. 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. Forward-Looking Statements 2
VALUE CREATION AngioDynamics Transformation Evolving Total Addressable Markets Hi-Tech Platforms Supplies 0-3% Growth Rate 2-5% Growth Rate 3-7% Growth Rate 2018$ 1.3B 2020$ 1.9B 2024$ 3.2B 3
Focus on Innovative Medical Technologies Healthy Blood Flow to the Heart Expanded Treatment Options in Oncology Leveraging 3 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. Healthy Blood Flow from the Heart M & A R & D Clinical and Regulatory Pathway Expansion 4
ANY lesion type, ANY lesion length, ANY lesion location The first peripheral atherectomy technology that efficiently and repeatedly treats: Eximo is now Visit Auryon-PAD.com for more information. CONVENIENT SAFE EFFICIENT 5
Targeted, disciplined M&A The Auryon Laser system uses a revolutionary, proprietary method of delivering a 355 nm wavelength combined with a short-pulse (10-25ns) providing a design to achieve superior clinical results. 6
The Auryon system is the first peripheral atherectomy technology that efficiently and repeatedly treats any lesion type, any lesion length, at any lesion location.1 References: 1. Rundback J, Chandra P, Brodmann M, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study. Catheter Cardiovasc Interv. 2019;94(7):1010-1017. 2. 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. 3. Herzog A, Steinberg I, Ishaaya AA. Shaping photomechanical effects in tissue ablation using 355 nm laser pulses. J Biophotonics. 2017;10(10):1262-1270. 4. Herzog A, Malka D, Zalevsky Z, Ishaaya AA. Effect of spatial coherence on damage occurrence in multimode optical fibers. Optics Letters. 2015;40(3):415. doi:10.1364/ol.40.000415. 5. Herzog A, Oszkinis G, Planer D, et al. Atherectomy using a solid-state laser at 355 nm wavelength. J Biophotonics. 2017;10(10):1271-1278. A longer wavelength and shorter pulse enable effective treatment of calcified lesions.3,4 Targeted biological reactions address the risk of perforation and vaporize lesions without thermal ablation.2 Solid state delivery offers stability, no toxic gases, no calibration burden on staff, and minimal warm-up time.5 355 nm Protects Vessel Wall From Perforation Small, Stable Footprint 7
Auryon Atherectomy System is the first and only system capable of treating lesions in any location, whether highly calcified or thromboticOptimized laser parameters provide the power to treat calcified lesions above- (ATK) and below-the-knee (BTK), including below-the-ankleFDA 510(k) with ISR labeling (second in US) and CE MarkUnique combination of 355nm short pulse laser and blunt blade enables:Better accuracyIncreased safetyTissue selectivityMore efficient procedure with fewer passed Clinical Benefits Excellent long-term results:2.1% TLRs (Target Lesion Revascularization) in 141 subjects at 6 months (IDE)4.3% TLRs (Target Lesion Revascularization) in 46 subjects at 12 months (CE) Compelling Data Illustrates Clinical Benefits ZERO Distal emboli events (with minimal use of filters, 2 used)Device-related flow-limiting dissectionsPerforationsDevice-related complications 8
2019 REVENUE 6.0% 5Yr CAGR 2019 PROCEDURES 157,400 47,600 $400M $120M AURYON ADDRESSABLE MARKETS 4.5% 5Yr CAGR *Millennium Research Group, Peripheral Vascular Devices 2017, 2019 market size estimates Laser Mechanical COMMERCIALIZATION FY20 FY21 Sales Headcount 12-18 26-32 Marketing Branding Implementation of full-scale brand strategy Clinical Affairs Pathfinder Registry Registry established Registry continued Advisory Board 1st Advisory Board Meeting Identification of scientific advisory board members and first meeting held Additional medical advisory board established with cadence of quarterly to semi annual meetings Case Studies Study(s) endpoints determined and case studies to begin Additional sites selected for future case and clinical studies Supply Chain Operations New Suppliers Scaled Production Ongoing Improvement 9
The AngioVac System allows physicians to remove unparalleled levels of clot burden through a minimally invasive procedure. Execution of internal R&D 10
Centrifugal Pump Console Waste Collection System Filter Saline AngioVac Cannula Reinfusion Cannula The AngioVac System The AngioVac System allows for the aspiration of embolic material such as fresh, soft thrombi or vegetation from the venous system. Utilizing a self-expanding, nitinol-reinforced funnel tipAs blood and embolic material are aspirated, the blood is filtered and simultaneously reinfusing the patients own filtered blood to limit procedural blood loss 11 The AngioVac Equation Circuit Funnel Pump Filter Minimal blood loss Large bore clot burden removedMinimal blood loss
AngioVac provides a platform to move into Larger Market Segments S I M P L E C O M P L E X M O D E R A T E HIGH VOLUMELOW ASP C a t h e t e r D I r e c t e d T h r o m b o l y s I s P E R C U T A N E O U S T H R O M B E C T O M Y L a r g e M a t e r I a l A s p I r a t I o n Catheter Directed Thrombolysis Aspiration & Reinfusion $13.5M LOW VOLUMEHIGH ASP Aspiration & Reinfusion Today, AngioVac procedures are focused in the Right Heart (RH). Future product development and clinical and regulatory pathway expansion will unlock the much larger Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) markets. 76KDVTInterventions* 84KPEInterventions* 5KRH Interventions* Total Addressable Market$500M7-8% 5Yr CAGR 12 RH = Right heartDVT = Deep Vein ThrombosisPE = Pulmonary Embolism* = Annually
AngioVac Gen 1One shape – no directionalityNo Radio Opaque (RO) markersNo Over The Wire (OTW)Cutting and adapters AngioVac Gen 3Two shapesImproved flow ratesImproved flexibilityImproved navigation180-degree pre-curve is built for the RH AngioVac Gen 2Two shapesImproved RO markersOTW capabilityQuick connects FY2020 FY2021 AngioVac Gen 3 is the first product to move through our revamped internal R&D process Customer feedback led to improved design AngioVac Gen 4More flexible, steerable, smaller diameter, longer cannulaPotential to address PE Multi-purpose MechanicalAspirator 13 Future
Clinical & Regulatory Pathway Expansion A cancer therapy that increases a physician's options for patient treatment. 14
NanoKnife Irreversible Electroporation (IRE) The NanoKnife System uses 2 – 6 electrode probes to create a high-voltage electric field Cells within the electric field develop irreversible, nano-size pores, causing the cells to dieThis ablation is less traumatic than death caused by extreme heat or cold and the cellular debris is removed by the body’s normal processes Critical structures, such as blood vessels, bile ducts and nerves, within the ablation zone remain patent. 15 Immediate Hours Days Apoptosis & PyroptosisDestruction of cell membrane PhagocytosisCellular clearance of debris Irreversible Electroporation E
NanoKnife provides a platform to address unmet needs in a number of large markets $32MANGO REV $162MCURRENT MARKET ~$590MTOTAL ADDRESSABLE MARKET LIVER, LUNG, KIDNEY, PANCREAS, PROSTATE Cancer Facts & Figures 2020American Cancer Society Cancer New Cases Annually Pancreas 57,600 Prostate 191,930 Liver 42,810 Lung 228,820 Kidney 73,750 16
Jan 2018 Oct 2018 Mar 2019 May 2019 Jun 2019 Oct 2019 Breakthrough Designation First Patient Enrolled FDA Nano 3.0 Clearance CPT Code Submission by SIR & ACS ICD 10 Codes (IRE Specific)Inpatient Payment Amounts (MS-DRG) IDE Approval ANTICIPATED FIRST 15 SITES 17
FY2020First Half Results FY2020Full Year Guidance (Unchanged) Revenue $136.0M $280M – $286M GAAP Earnings Per ShareNon-GAAP Adjusted EPS $(0.11)$0.14 $(0.35) – $(0.40)$0.10 – $0.15 Gross Margin 58.6% 58% - 59% Adjusted EBITDA $13.7M $15M-20M Debt $0.0M $15.0M FY 2020 Six-Month Actuals and Full-Year Expectations 18
SUMMARY Growth Potential Powered by Three Key Drivers M&A R&D Expansion of Clinical and Regulatory Pathways Meaningful transformation into larger, faster-growing markets with higher value medical technologies. 5 DEALS MONTHS 18 Innovative, proprietary portfolio of Medical Technologies that address unmet needs of healthcare professionals and patients. 19
Amounts in thousands Reconciliation Tables Includes costs related to merger and acquisition activities, restructurings, and unusual items, including asset impairments and write-offs, certain litigation, and other items.Deferred financing fees related to the old credit agreement were written off during the first quarter of fiscal year 2020.Adjustment to reflect the income tax provision on a non-GAAP basis has been calculated assuming no valuation allowance on the Company's U.S. deferred tax assets and an effective tax rate of 23% for November 30, 2019 and 2018. GAAP to Non-GAAP Net Income & EPS Net Income to Adjusted EBITDA