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8-K - CURRENT REPORT - ANGIODYNAMICS INC | an33247826-8k.htm |
Exhibit 99.1
UBS 2015 SMID Cap One-on-One Conference Mark Frost, Executive Vice President & CFOAugust 5, 2015
Forward-Looking Statements 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, 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, 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, 2014; its Annual Report on Form 10-K/A for the fiscal year ended May 31, 2014; its quarterly reports on form 10-Q for the fiscal quarters ended August 31, 2014, and November 30, 2014; and the current report on Form 8-K, filed with the SEC on March 2, 2015. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the treatment or therapy of a specific disease or condition. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.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 presentation, AngioDynamics has reported non-GAAP sales growth, non-GAAP gross margin, non-GAAP operating income, adjusted EBITDA (income before interest, taxes, depreciation and amortization), non-GAAP net income and non-GAAP 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. *
Performance Update Next generation AngioVac launched510(k) clearance of a BioFlo Midline catheters Dr. Robert Martin, Director of Surgical Oncology, published NanoKnife abstract in the Annals of Surgery510(k) clearance of NanoKnife System generator and FDA issued Certificates to Foreign Governments (CFGs)BioFlo DuraMax chronic hemodialysis catheter CE MarkFirst patient treated in CROES NanoKnife prostate cancer trialUCLA has initiated RAPID, a multicenter, prospective registry of real world AngioVac use. Awarded two contracts by Novation in the quarter, for BioFlo PICCs & PortsEmboMedics AgreementCelerity “no chest x-ray” claim received Recent Events * Adjusted results exclude costs relating to acquisitions, debt financing, business restructuring, litigation, 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.On a constant currency basis. Q4 FY15 Results Q4 FY15 Reported $90.9M $0.14 Sales AdjustedEPS(a) Q4 FY15b $92.2M $0.15
Profile of AngioDynamics Global, leading provider of innovative, image guided, minimally invasive solutions. Three Franchises – Peripheral Vascular, Vascular Access and Oncology/SurgeryFounded 1988 | IPO May 2004—ANGO (NASDAQ)Worldwide presence with 1,300 employees and 7 operating locations, as well as a 210+ global sales team in U.S., Australia, Canada, France, Germany, Netherlands and UK Present in 50+ markets through 110+ distributors Innovative TechnologyDevelop innovative technology that improves patient outcomes while reducing overall healthcare costs Operational ExcellenceEnhancing profitability by driving operation excellence across the entire organization Above Market GrowthFocusing investments in categories and geographic markets that offer sustainable, profitable growth *
Leadership Joseph M. DeVivoPresident & CEO Mark FrostEVP & CFO John SotoEVP & CCO Stephen TrowbridgeSVP & General Counsel Barbara KucharczykSVP, Operations Mark StephensSVP, Administration Gary BarrettSVP, RA/QA * Benjamin DavisSVP, Business Development
AngioDynamics in FY14 * RFA Resection NanoKnife Microwave Venous Ports Dialysis PICCs Other Access Core PV FluidMgmt Sales Growth StdGrossMargin // 100% AngioVac Harvest Fix/Divest Invest Scale FY14 4% Sales Growth; 51% GM Sales by FranchisePeripheral Vascular: $193MVascular Access: $106MOncology/Surgery: $49MTotal: $348M* 75% *Excludes BSC supply agreement. With supply agreement FY14 net sales were $354.5M. High Low
Growth Driver Performance Our strategy is working * 65% FY15 over FY14 BioFlo GROWTH 21% FY15 over FY14 MicrowaveAblation GROWTH 23% FY15 over FY14 AngioVac GROWTH • • • 25% FY15 over FY14 NanoKnife GROWTH
Implement near term product family consolidation / elimination opportunitiesTarget Indirect procurement supplier consolidation and processesCompress Queensbury shift structure through deployment of Operational Excellence and CapexRe-align manufacturing organizational leadership Site consolidation:Queensbury repurposed as Distribution Center for NY regionProducts moved from Queensbury to Glens Falls Manchester as center of excellence for Hardware, Disposables and PortsComprehensive product family consolidationDirect procurement consolidation Phase 3 - PLANNING Global distribution strategyAssess Global manufacturing global footprint:Selective off shoring – e.g. Costa Rica, Malaysia, Singapore Phase 2 – EXECUTING Phase 1 - COMPLETE OpEx Net Savings Per Year $ in millions INPROCESS INPROCESS INPROCESS INPROCESS INPROCESS INPROCESS INPROCESS Operational Improvements Plan and Impact *
Resection Core PV Dialysis NanoKnife AngioVac PICCs FluidMgmt Ports Other Access Microwave RFA Venous Sales Growth StdGrossMargin High Low AngioDynamics in FY20 FY209% 5YR Sales CAGR; 59% GM Sales by FranchisePeripheral Vascular: ̴$300MVascular Access: ̴$200MOncology/Surgery: ̴$100MTotal: ̴$553M Embolics *
Strong Product Development Pipeline* PV VA O/S Celerity X-Ray FY15 BioFlo New Product Launch FY16 Celerity Navigation FY16 BioFlo Port Line Extension FY16 BioFlo PICC Line Extension FY16 Next Generation Radio Frequency Ablation System FY17 Next Generation Microwave Ablation FY16 Next Generation NanoKnife System FY18 AngioVac Enhancements FY15 PV Line Extension FY16 Drainage Line Extension FY16 Fluid Management Line Extension FY16 Pain-Free Laser Procedure FY17 AngioVac Line Extension FY16 Next Generation Laser FY17 Automated Fluid Management FY17 New Thrombus Management Product FY17 *Timelines are estimated and subject to change. * Next Generation BioFlo Port FY18 Next Generation BioFlo PICC FY18
Clinical Studies* PV O/S SeCure IDE for Expanded EVLT Indication FY18 Pancreas NanoKnife Pre-Clinical FY16 Next Generation Microwave Ablation Pre-Clinical FY15 CROES II NanoKnife Prostate Study FY17 Prostate NanoKnife IDE FY18 O/SLEIDEN – NanoKnife Pancreas CROES Registry NEAT – NanoKnife Prostate CROES II – NanoKnife Prostate AHPBA Registry Investigator Initiated Trials PVEVLT RegistryAngioVac Registry VABioFlo Dialysis BioFlo PICCsBioFlo Ports *Timelines are estimated and subject to change. *
Peripheral Vascular Franchise * FY15 Fluid Mgmt. Venous $80 $52 $ in millions $1.6B Market 12% Share Thrombus Mgmt. $15 Other Core Products $45 Total PV $193 YoYGrowth 1% -4% 5% 0% 0% FY14Growth -4% 18% 109% 7% 7%
Source:Heit JA, et al. Blood. 2005;106:267A.Murphy SL, et al. Deaths: Preliminary Data for 2010. National Vital Statistics Reports; 2012 Thrombus Management Market Summary Additional:Annual Incidence Catheter/Lead RA200,000 RA Mass47,000 IVCF Thrombosis14,000 TV Endocarditis2,500 Surgical Embolectomy Mechanical / PharmacoMechanical Oral Anticoagulation Systemic and Catheter Directed Thrombolysis CurrentTreatmentOptions Venous Thromboembolism (VTE) Incidence Overall ̴̴1 Million VTE Events per Year in U.S.Overall 300,000 VTE Deaths per Year in U.S. – #3 cause *
Solution: AngioVac FDA cleared & CE Mark approved Attractive pricing & higher margins Scalable platform for next generation devices Newly expanded U.S. indication *
Solution: AngioVac FDA cleared & CE Mark approved Attractive pricing & higher margins Scalable platform for next generation devices Newly expanded U.S. indication *
Vascular Access Franchise * FY15 PICCs Ports $48 $35 $ in millions Dialysis $20 Total VA $108 $1.0B Market 11% Share YoY Growth -6% 7% 8% 1% FY14Growth 0% 3% -2% 0%
BioFlo Technology The BioFlo family of products, including PICCs, ports and dialysis catheters, are the only vascular access products manufactured with Endexo Technology, a permanent and non-eluting integral polymer. Less Thrombus Accumulation BioFlo PICCs BioFlo Ports Vs. common PICC Vs. non-coated conventional port catheters Vs. non-coated conventionaldialysis catheters Vs. heparin-coated dialysis catheters 87%1 – BioFlo Dialysis – 96%2 – – – – – – 90%3 83%4 1. Based on benchtop test results which may not be indicative of clinical results. Data on file. 2. Based on benchtop testing performed up to two hours using bovine blood, which may not be indicative of clinical results. Data on file. 3. The reduction in thrombus accumulation (based on platelet count) is supported by acute in-vitro testing. Pre-clinical in-vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation. 4. Based on benchtop testing performed up to two hours using bovine blood which may not be indicative of clinical results. Data on file. *
Reducing Healthcare Costs Facility 1 1,251 BioFlo PICCs placed85% reduction in symptomatic UEDVT 7 UEDVTs reported from 1251 PICCsUEDVT rate of .45% versus prior 3.1% Facility 2272 BioFlo PICCs placed42% reduction in Occlusions19.7% reduction in baseline occlusion rate Facility 3776 BioFlo PICCs placed65% reduction in tPA use47% reduction in occlusionsFacility 41,212 BioFlo PICCs placed65% reduction in declots36% reduction in DVTs Clinical Results* *Clinical results were publicly reported by independent facilities based upon their individual clinical experience. These results do not reflect data gathered by AngioDynamics pursuant to a clinical trial. Individual results may vary from those set forth above. Facility 5533 BioFlo PICCs placed66% reduction on occlusions75% reduction in tPA25% reduction in DVTs *
Celerity Tip Location Tip location, coupled with our innovative BioFlo Technology, will improve our competitive position in the PICC market. Ease of use Use with existing ultrasound Three lead EKG-based platformPredictable and reliable confirmation 50% less cost vs. competitors Clinical efficacy Cost effective Fall 2013 – Canadian Launch March 6, 2014 – Acquired regulatory control over Celerity platform and rights to next generation technology Mid-summer 2014 – U.S. Clearance Fall 2014 – File for no x-ray Winter 2014/15 – No x-ray clearance Winter Q3 - Navigation *
Leveraging BioFlo to Win Contracted Business The Market ̴30% of ANGO Sales are Contracted AngioDynamics 2 0 1 2 2 0 1 3 2 0 1 4 2 0 1 5 Novation Awards ANGO New Technology Award for BioFlo PICCs8/1/2014 Premier Awards ANGO PICC Contract 7/1/2013 HealthTrust Awards ANGO PICC Contract 1/1/20158/1/2014 FDA Approves BioFlo PICCs8/1/2012 4,872Hospitals Purchasing PICCs under a GPO Agreement 90% 5,686Registered Acute Care Hospitals 5,441Acute Care Hospitals Purchasing PICCs GPO Contract History 3,688 # of Hospitals that ANGO could officially sell PICCs through a GPO Contract 0
Oncology/Surgery Franchise * FY15 Thermal Ablation NanoKnife $29 $17 $ in millions Resection/Other $6 Total O/S $52 $225M Market 22% Share YoY Growth -3% 25% 4% 6% FY14Growth 10% 7% -18% 5%
Expanding Leadership in Tissue Ablation THERMAL NON-THERMAL AngioDynamics offers a full complement of tissue ablation products that provide clinicians maximum choice in treating patients. *
Re-Entering the Embolization Market On April 9, 2015, AngioDynamics entered an agreement with EmboMedics Inc., which develops injectable & resorbable microspheres and expects to file for U.S. FDA 510(k) clearance for the embolization of hypervascular tumors by January 2016. Novel Technology Highly margin accretive Worldwide rights for direct and distributor sales Pathway to own technology * Investment Strategy Terms Initial $2M equity investmentMay make $9M additional investments based on milestones $150M WorldwideAddressable Market
International Growth Strategy Market Led, Efficient & Aligned Region-based business model improves competitivenessIncreased direct market expansionNew product introductions and full registration of product portfolioDelivering operating margin improvementAlign talent and organization to ensure consistent execution of Company’s strategy Q1 FY14 Q2 FY14 Q3 FY14 Q4 FY14 Q1 FY15 International Quarterly Growth Rates * Q2 FY15 Q3 FY15a FY159%Growtha On a constant currency basis. Q4 FY15a
Fiscal Fourth Quarter and Full Year Results There is no difference in the number of sales days between the fiscal 2015 and fiscal 2014 periods.Adjusted results exclude costs relating to acquisitions, debt financing, business restructuring, litigation, 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.Excludes impact of our supply agreement.Constant-currency basis. Sales $ in millions, except per share amounts Q4 2015 (a) YOY Growth WW WW(c)(d) PV VA O/S U.S.(c) Int’l $90.9 $91.2 $49.8 $27.1 $13.0 $72.0 $17.9 -3% -2% -2% -4% -5% -2% -6% Adjusted EBITDA Adjusted EPS $13.4 $0.14 -14% -22% Q4 2015 (b) YOY Growth FY15 Growth 1% 2% 0% 1% 6% 0% 5% 4% 3% FY15 Growth Int’l(d) $19.2 0% 9% Adjusted EPS(d) $0.15 -17% 10% Fiscal Guidance* $ in millions, except per share amounts Q1 Full-Year Sales(d) Adjusted EPS(b) $83-$87 $0.10-$0.12 $364-$370 $0.62-$0.66 *Guidance is as of July 2015. No updates have been providedsince this date.
AngioDynamics Transformation FY11 FY12 FY13 FY14 Net Sales $216M $222M $342M $354M Pro Forma 0% 3% -1%a 4% Exc. BSC/FX – 5% On a pro forma basis prior year sales for AngioDynamics and Navilyst Medical were $344.6 million. Investor Profile – – Major acquisitions – Navilyst (2012), Vortex Medical (2012), Microsulis (2013)Disruptive technology in PV, VA & O/S markets with strong product pipelineSignificant International opportunityOperational Excellence Program in place to drive margin expansionEmerging GPO presence Reported Growth 0% 3% 54% 4% Net Sales FY20 Net Sales$553M59%Gross Margin * FY15 $357M 1% 1% 2%
UBS 2015 SMID Cap One-on-One Conference Mark Frost, Executive Vice President & CFOAugust 5, 2015
Balance Sheet & Cash Flow $ in millions May 31, 2015 May 31, 2014 Cash & investments $20.1 $17.9 Net working capital $94.7 $85.0 Total assets $773.6 $798.9 Total debt $137.7 $142.7 Total stockholder’s equity $545.0 $536.8 $ in millions, except per share amounts Year ended May 31, 2015 Year ended May 31, 2014 Cash flow from operations $26.2 $24.7 CFFO/share $0.72 $0.70 Free cash flow $14.3 $13.5 *
Adjusted Income Statement(a) $ in millions, except per share amounts Year ended May 31, 2015 Year ended May 31, 2014 Sales $357.0 $354.4 Gross margins 50.9% 50.7% Operating expenses $141.6 $141.2 Operating income $40.1 $38.7 Operating margin 11.2% 10.9% Net income $21.2 $20.0 EPS $0.58 $0.56 EBITDA $57.2 $55.0 Adjusted results exclude costs relating to acquisitions, debt financing, business restructuring, litigation, 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. *