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 10, 2017

AngioDynamics, Inc.
(Exact Name of Registrant as Specified in Charter)

Delaware
000-50761
11-3146460
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(IRS Employer
Identification No.)
 
14 Plaza Drive Latham, New York
12110
(Address of Principal Executive Offices)
(Zip Code)
 
(518) 795-1400
(Registrant’s telephone number, including area code)
 
 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))
 

Item 7.01 – Regulation FD Disclosure.
 
On January 10, 2017, James C. Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. (“AngioDynamics” or the “Company”), and Michael C. Greiner, Executive Vice President and Chief Financial Officer of the Company, will present to certain investors at the JP Morgan 35th Annual 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, 2016 and its quarterly reports on Form 10-Q for the fiscal periods ended August 31, 2016 and November 30, 2016. 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 JP Morgan Healthcare Conference on January 10, 2017




SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  ANGIODYNAMICS, INC.  
  (Registrant)  
       
Date:  January 10, 2017
By:
/s/ Stephen A. Trowbridge  
    Stephen A. Trowbridge  
    Senior Vice President and General Counsel  
       

 




EXHIBIT INDEX

 Exhibit No.
 
Description
99.1
 
Presentation slides for the JP Morgan Healthcare Conference on January 10, 2017





 


Exhibit 99.1
 
 J.P. Morgan Healthcare ConferenceJim Clemmer, CEOMichael Greiner, CFOJanuary 10, 2017 
 

 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, 2016 and its quarterly reports on Form 10-Q for the fiscal periods ended August 31, 2016 and November 30, 2016. 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. EmboMedics microsphere products have not been reviewed by the U.S. Food and Drug Administration or any other international regulatory body at this time; as such they are currently not available for sale by AngioDynamics.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 news release, AngioDynamics has reported net sales excluding a supply agreement; adjusted sales growth; EBITDA (income before interest, taxes, depreciation and amortization); adjusted EBITDA; adjusted gross profit; adjusted net income and adjusted earnings per share. Additionally, this press release evaluates results on a constant currency basis. As a non-GAAP measure, constant currency excludes the impact of foreign currency exchange rate fluctuations. 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. 
 

 AngioDynamics Today    3    Leading provider of innovative medical devices used by physicians for treatment of cancer and peripheral vascular disease    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  $354FY’16 Revenue  MILLION  $53FY’16 Adjusted EBITDA  MILLION  $43FY’16 Free Cash Flow        Growth Strategy  Industry Leader  Patient Focus  $0.60FY’16 Adjusted EPS  MILLION 
 

 Three Operating FranchisesEach with Unique Growth Opportunities  CategoriesFluid ManagementVenous InsufficiencyThrombus ManagementDrainageAngiographic CathetersKey Products  Peripheral Vascular  Vascular Access  Oncology/Surgery  CategoriesPICCsPortsDialysisKey Product  CategoriesNon-Thermal AblationMicrowave AblationRadiofrequency AblationSurgical ResectionKey Products    Sample Competitors  Source: US MRG Data, all market values and growth rates are US. In process of securing global market data 
 

 Positioned to Innovate in Changing Marketplace  Global Cancer Incidence To Nearly Double By 2030  $436B Global Med Tech Market by 2020  Industry growth products focus on improved patient and economic outcomes  Sources: U.S. Department of Commerce International Trade Administration “2016 Top Markets Report: Medical Devices”; EvaluateMedTech “World Preview 2015, Outlook for 2020”; Johns Hopkins Bloomberg School of Public Health “Chronic Conditions: Making the Case for Ongoing Care”; American Cancer Society “Global Cancer Facts & Figures 2nd Edition  Evolving industry conditions offer favorable market dynamics  Between 2000 and 2030 the number of Americans with chronic conditions will increase by 37 percent to 171 million people 
 

 Market Opportunity  Discipline  Prioritize areas where we have a competitive advantage  Improve Operationally   Lessen the burden on caregivers and the healthcare system  Product Portfolio  Strategic Approach 
 

 MARKET OPPORTUNITY AND PRODUCT PORTFOLIO 
 

 Building a Venous Disease Business  Clinical Data  Focused Marketing  Patient Advocacy  Pillars for Strategic Execution  $300 Million US Varicose Vein Treatment Device Market Value (2014)  3.4 Million Annual Procedures (2015)568,500 Endovenous Ablation2,967,900 Standard Sclerotherapy  Source: Millennium Research Group Medtech 360 Report. Varicose Vein Treatment Devices, US Market Analysis, 2015  <2% Receive Treatment  80 Million People in U.S. w/ varicose veins or spider veins  Global Expansion  Capitalize on AngioDynamics’ legacy and reputation in the Venous business to expand the existing market to the 78.4 million patients not being treated  Aprpox. 
 

 $107M  Treating the Chronic Vascular Access Patient  For Patients: The BioFlo PICC demonstrated on average 87% less thrombus accumulation on its surface compared to commonly used PICCs (based on platelet count).*  * Based on platelet count from in-vitro blood loop model test which may not be indicative of in-vivo clinical results .  † DVT cost was calculated on a mean DVT rate of 3.5%Assumption is single-dose efficacyEvans S. et al. Chest (2013);143(3)Deitcher SR, Fesen MR, Kiproff PM, et al. J Clin Oncol. 2002;20(1):317-324Centers for Disease Control and Prevention (CDC). MMWR Morb Martal Wkly Rep. 2011;60(8):243-248Chopra V et al. The American Journal of Medicine. 2012; 125(8)Maki, D. et al. Mayo Clinic Proceedings. 2006;81(9)  BioFlo offers clinical benefits to patients and financial improvements for providers, especially for patients with chronic conditions.  2.7M PICCs Placed Annually  $1.07B  $1.5B*  $450M  6x  $2.65B  AVG. RATE  AVG. TREATMENT COST  Upper Extremity –Deep Vein Thrombosis: 2.0-7.8%4  $15,9731  Occlusions 25%2**  $123.77  Catheter-Related Bloodstream Infections: 0.4-0.8 per 1,000 catheter days4 OR 2.4%5  $16,5503  For Providers: Treating the complications caused by PICCs is 6X greater than the acquisition cost of the device† 
 

 Deploying Disruptive Oncology Therapies  Clinical Data  Priority Int’l Registrations  New Technology  Pillars for Strategic Execution  $350 Million US Interventional Oncology Device Market Value (2015)  Sources: World Health Organization Cancer Fact Sheet; Millennium Research Group Medtech 360 Report. Interventional Oncology Devices, US Market Analysis, 2015  Customer-first, disease state strategic approach based on innovative technology, international expansion and clinical evidence can unlock significant revenue opportunities.    Colorectal  Stomach  Liver        Breast    Esophageal    Lung 
 

 Deploying Disruptive Oncology Therapies  Clinical Data  Priority Int’l Registrations  New Technology  Pillars for Strategic  $350 Million US Interventional Oncology Device Market Value (2015)  Sources: World Health Organization Cancer Fact Sheet; Millennium Research Group Medtech 360 Report. Interventional Oncology vices, US Market Analysis, 2015  Customer-first, disease state strategic approach based on innovative technology, international expansion and clinical evidence can unlock significant revenue opportunities.    Colorectal  Stomach  Liver        Breast    Esophageal    Lung 
 
 DISCIPLINE 
 

 Operational ImprovementsA Near-Term Focus to Position Company Towards Growth  Capital Allocation  R&D   New credit facility offers enhanced flexibility for future investmentsInvestment in company through recent share repurchase  Smarter product development process to unlock strategic opportunities and enable better go-to-market strategiesR&D focus toward disruptive innovations  Infrastructure Improvements  Operational improvements via SKU rationalization, disciplined SG&A and supply chain optimizationStrengthened executive team and added Board Members 
 

 A Smarter Product Development Process   New products currently represent ~5% of all AngioDynamics revenues, a disciplined stage gate process will unlock strategic R&D Pipeline opportunities  Proposal  Feasibility  Development  Qualification  Launch                                                                                                          Review  Review  Review  Review  Review       
 

 FINANCIALS 
 

   Historical Past Performance      Adjusted EBITDA*  Sales  $0.58  50.7%  $0.60  50.9%  Adjusted EPS*  Gross Margin**  * Adjusted results exclude costs relating to acquisitions, debt financing, business restructuring, litigation, credit card fees, facility consolidations, amortization of basis step-up of acquired inventory, revaluation of contingent earn outs related to acquisitions, recalls, product discontinuations and amortization of intangible assets. ** Adjusted Results exclude one time inventory charges related to Recall, Inventory Step Up and One Time Write offs.  $0.71  50.6%      Capital Expenses  Free Cash Flow  $ in millions  $ in millions 
 

 Strong Balance Sheet Drives Capital Allocation Strategy  Uses of Cash Priorities  Invest internallyOpportunistically evaluate M&AExecute recently announced share buyback program authorized up to $25 million  Significant cash generation, low debt and new credit facility provides flexibility to capitalize on growth opportunities  $ in millions    Available      Revolver  Term Loan A  Figures as of Dec. 31, 2016 
 

 Q2’17 Financial Highlights  Q2 FY2017  Net Sales $89.0M-0.3% yoyAdjusted EBITDA$16.1M+19% yoyAdjusted EPS$0.19+36% yoyFree Cash Flow$13.6M  Key Points  Improved operational performance and profitability in the quarterRaised Adjusted EPS and Cash Flow guidanceContinued to capitalize on demand driven by Cook Medical angiographic catheter recallFocusing on long-term improved performance by strengthening foundation  Adjusted EPS  Free Cash Flow  Fiscal 2017 Financial Guidance  Net Sales $177.1M+2% yoyAdjusted EBITDA$31.0M +23% yoyAdjusted EPS$0.36+44% yoyFree Cash Flow$20.5M  1H FY2017  Revenue  $355  $360  Million  $0.62  $0.65  $0.67  $30+  $35+  Million  Orig.  Orig.  Adj.  Adj. 
 

 The Strategic Framework to Drive Growth  Targeted, High-Growth Portfolio  Expanded International Reach  HIGH ROI INVESTMENTSMore focused R&D Program and Opportunistic M&A strategy  OPERATIONAL EFFICIENCYOperational excellence across entire organization  A WINNING CULTUREA culture of Accountability, Focus and Execution  Drivers  A Strategic Balance Sheet  DISRUPTIVE TECHNOLOGIESCreative product innovation to enable growth  Execution of fundamentals will drive stakeholder value  Outcomes   
 

 J.P. Morgan Healthcare ConferenceJim Clemmer, CEOMichael Greiner, CFOJanuary 10, 2017