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): September 6, 2018
AngioDynamics, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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000-50761
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11-3146460
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(State or Other Jurisdiction
of Incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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14 Plaza Drive Latham, New York 12110
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(Address of Principal Executive Offices) (Zip Code)
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(518) 795-1400
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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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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 September 6, 2018, James C. Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics” or the “Company”), will present to certain investors at the Wells Fargo Securities Healthcare Conference. The conference slides are furnished herewith as Exhibit 99.1.
The slides are being furnished pursuant to Item 7.01 and the information contained therein shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section. Furthermore, the information in Exhibit 99.1 shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended.
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, 2018. 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 Wells Fargo Securities Healthcare Conference on September 6, 2018.
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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: September 6, 2018
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By:
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/s/ Stephen A. Trowbridge | |
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Stephen A. Trowbridge
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Senior Vice President and General Counsel
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Exhibit 99.1
Wells Fargo Securities Healthcare Conference September 6, 2018
Forward-Looking Statement Notice Regarding Forward-Looking StatementsThis release 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 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, 2018. 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 EBITDAS (income before interest, taxes, depreciation and amortization and stock-based compensation); free cash flow 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.TrademarksAngioDynamics, the AngioDynamics logo, BioFlo, the BioFlo logo, NanoKnife, the NanoKnife logo, VenaCureEVLT, the VenaCureEVLT logo, AngioVac, the AngioVac logo, Solero, the Solero logo, Uni-Fuse, the Uni-Fuse logo, NAMIC, and the NAMIC logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. Endexo is a trademark and/or registered trademark of Interface Biologics. Habib is a trademark and/or registered trademark of Emcision. ASCLERA is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. All other marks are property of their respective owner.
AngioDynamics Today 3 Focus on serving undertreated patient populations, improving patient outcomes and offering economic value to healthcare providers Operating franchises in growing, strategic markets Growth strategy to optimize product portfolio, focus on operational efficiencies and expand internationally Growth Strategy Patient Focus Leading provider of innovative medical devices used by physicians for treatment of cancer and peripheral vascular disease Industry Leader
Three Global Business Units with Unique Growth Opportunities CategoriesFluid ManagementVenous InsufficiencyThrombus ManagementDrainageAngiographic CathetersKey Growth Drivers Vascular Interventions and Therapies Vascular Access Oncology CategoriesPICCsPortsDialysisKey Growth Drivers CategoriesNon-Thermal AblationMicrowave AblationRadiofrequency AblationSurgical ResectionKey Growth Drivers Invest where we can win
Providing a continuum of care Unique, commercialized product (U.S., 2013) immediately enhances Oncology business.Adds clinically proven product to portfolio that minimizes occurrence of pneumothorax or PTX; the most common complication of CT-guided percutaneous lung biopsyProprietary hydrogel plug that prevents air leakage from the lung, a condition known as PTXFirst biopsy sealant system designed specifically to address the issues of biopsy-related PTXFDA approved in December 2012 CE Mark approved in Europe BioSentry Delivery Device BioSentry Co-Axial Adapter Clinical NeedPTX: Significant cost burdenIncidence rates 15-42%; higher for smokers or those with lung conditionsUp to 17% of pneumothoraces are large enough to require chest tube placementPTX can lead to additional radiographs, chest tube placements, ER or inpatient admission, and delayed time to ambulation and hospital discharge
2018 Scorecard Driving transformation Gross Margin Expansion Strategic Capital Allocation Simplified Footprint Portfolio Optimization Commercial Discipline
2019 Framework for Growth Operational Excellence Delivering sustainable and improved marginsFocused investments on growth and innovationCommitment to quality and complianceStrong cash flow generation Value Creation Practice dispassionate portfolio optimization Focus on areas of compelling unmet needs - patient-centric/evidence-basedIncrease focus on high- growth markets Target global expansion opportunities
Financial Update
Revised FY2019 Guidance RevenueAdjusted EPS Free Cash Flow* Previous Guidance$344-$349m$0.82-$0.86$38m - $43m Revised Guidance$348-$353m$0.82-$0.86$38m-$43m * Original and current guidance excludes the cash payment related to the DOJ legal matters disclosed previously, which was paid in 1Q FY’2019; Including this payment, Free Cash Flow is expected to be in the range of $25m-$30m.
Significant Liquidity Drives Capital Allocation Strategy Uses of Cash Priorities Invest internallyOpportunistically evaluate M&AExecute share buyback program authorized up to $25 million Significant cash generation and available debt capital support range of allocation options to capitalize on growth opportunities $ in millions $200-$215m $240-$260m $225m
Our Vision for AngioDynamics 3 1 2 Increase our value to each of our stakeholders Partner with providers and caregivers to deliver superior care to patients Be recognized as a consistent, high-performing MedTech company