BVX investorpresentation 11-27-17 - Bovie Medical...2017/11/27 · -Vipul R. Patel, MD, FACS...
Transcript of BVX investorpresentation 11-27-17 - Bovie Medical...2017/11/27 · -Vipul R. Patel, MD, FACS...
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November2017
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SafeHarborStatement
CertainmattersdiscussedinthispresentationandoralstatementsmadefromtimetotimebyrepresentativesoftheCompanymayconstituteforward-lookingstatementswithinthemeaningofthePrivateSecuritiesLitigationReformActof1995andtheFederalsecuritieslaws. AlthoughtheCompanybelievesthattheexpectationsreflectedinsuchforward-lookingstatementsarebaseduponreasonableassumptions,itcangivenoassurancethatitsexpectationswillbeachieved.
Forward-lookinginformationissubjecttocertainrisks,trendsanduncertaintiesthatcouldcauseactualresultstodiffermateriallyfromthoseprojected. ManyofthesefactorsarebeyondtheCompany’sabilitytocontrolorpredict. ImportantfactorsthatmaycauseactualresultstodiffermateriallyandthatcouldimpacttheCompanyandthestatementscontainedinthispresentationcanbefoundintheCompany’sfilingswiththeSecuritiesandExchangeCommissionincludingourmostrecentreportsonForm10-KandForm10-Q.CopiesofthesefilingsareavailableonlinefromtheSEC. Forforward-lookingstatementsinthispresentation,theCompanyclaimstheprotectionofthesafeharborforforward-lookingstatementscontainedinthePrivateSecuritiesLitigationReformActof1995. TheCompanyassumesnoobligationtoupdateorsupplementanyforward-lookingstatementsasaresultofnewinformation,futureevents,orotherwise.
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InvestmentHighlights
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Establishedcommercialbusinesssegmentsin“Core”and“OEM”withstrongprofitabilityandcashflowprofiles
AdvancedEnergysegmentis‘engineofgrowth’forBovieMedical
AdvancedEnergysegmentgrowthfueledbycommercializationofJ-Plasma®
J-Plasma®:transformationaltechnology;growthprofileenhancedbyfocusedsellingefforts,growingclinicalsupportandpendingnewproductlaunchesinQ4’17
ExperiencedManagementTeam
Improvinggrowthandprofitabilityprofilesupportedbysolidbalancesheetcondition
AdvancedEnergysegmentsupportedbystrong,andgrowing,IPportfolio
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ExperiencedManagementTeam
Executive JoinedBovie RepresentativePreviousExperience
RobGershonChiefExecutiveOfficer December2013
JayEwersChiefFinancialOfficer June2014
ToddHornsbyVicePresident&General
ManagerofAdvancedEnergyAugust2014
ShawnRomanVicePresidentof
R&D,RegulatoryandQualityOctober2014
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RobSaronPresidentandDirector January1978
MosheCitronowiczSeniorVicePresident October1993
YearsofRelevantExperience
28
34
15
15
35
30 KCRTechnologies SequentialInformationSystems
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CompanySnapshot
Core
Advanced energy-based medical device company specializing in developing,manufacturing and marketing a range of electrosurgical products andtechnologies, as well as related medical products used in doctor’s offices, surgerycenters and hospitals worldwide.
Founded: 1978
Locations:• Purchase,NY• Clearwater,FL• Sofia,Bulgaria
Full-Time Employees: ~217**
CommercialProfile: >300 products soldin>150countries
LTMSales(9/30/17): $37.0M
OperatingSegments:• Core• OEM• AdvancedEnergy
Yearof IPO: 1982NYSEMKT: BVXMarketCap: ~$127M*
Avg.DailyVol(LTM): ~114,000*
*Shareprice:$3.88asofmarketcloseon10/30/2017;Sharesoutstanding:32.8Masof10/30/2017**Asof12/31/2016LTM=“LastTwelveMonths”
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OperatingSegment:“Core”
• Legacybusinessfocusedonthedesignandmanufactureofproductsusedindoctor’sofficesandambulatorysurgerycenters
• Productsprimarilyconsistofelectrosurgicalgenerators&accessories(43%FY’16“core”sales)andbattery-operatedcauteries(26%ofFY’16“core”sales)
• MarketedandsoldbydistributorsworldwideunderprivatelabelandBovie’swell-respectedbrands(Bovie®,IDS™,ICON™&DERM™)
• CoresegmentFY’16EBITmargin:~27%
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Long-standingrelationshipswith“Big7”distributors: SampleProducts:
“Core”segmentprofile:mid-singledigitrevenuegrowthwithattractiveprofitability
Core:76%ofFY’16Revenue
$24.3M$26.1M
$27.8M~$28.8M
FY'14 FY'15 FY'16 FY'17GuidanceMidPt.
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• Manufacturingelectrosurgerytechnologiestomeetdesign-specificneedsoflarge,well-knownmedicaldevicecompanies
• LeveragingBovie’s establishedR&D/innovationcapabilities
• Compellingoperatingprofitability
- OEMsegmentFY’16EBITmargin:~57%
• Segmentrevenuegrowthfluctuatesbasedontimingoforders/demandfrommedicaldevicecustomers
OperatingSegment:“OEM”
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“OEM”segmentprofile:leveragesR&D/innovationcapabilities;generatesstrongprofitability/cashflows
OEM:15%ofFY’16Revenue
$3.2M$2.1M
$5.3M
FY'14 FY'15 FY'16 FY'17GuidanceMidPt.
$2.5M
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• Advancedelectrosurgicalandplasmatechnologysurgicalproducts(generatorsandhandpieces)
• PrimarydriverofBovie’slong-termrevenuegrowth
• Commercializedproductsmarketedthroughdirectselling()andsaleschannelpartnerships()
• Targetedmedicalspecialties:
- PlasticSurgery- SurgicalOncology
- Orthopedicarthroscopy/sportsmedicine
OperatingSegment:“AdvancedEnergy”
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“AdvancedEnergy”segmentisthegrowthengineofBovieMedical
AdvancedEnergy:10%ofFY’16
Revenue
$0.2M$1.3M
$3.5M
FY'14 FY'15 FY'16 FY'17GuidanceMidPt.
J-Plasm
aPlazXa
ct
~$6.8M
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AdvancedEnergy:J-Plasma®
• Revolutionarytechnologyionizesheliumtocreatestreamofplasmaforcutting,coagulatingandablatingsofttissue
• Superiorprecision,withlimitedthermalspread
- Stable,thin,focusedstreamofionizedheliumgas
- Widerangeofcontrol
- Noconductivecurrentsthroughthepatientduringsurgery
• Allowssurgeonstosafelyperformproceduresonorarounddelicatestructures
• Commercialfocusonplasticsurgeryandsurgicaloncologyprocedurecategories;~2.7millionU.S.proceduresannually
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Transformationaltechnology;potentialtoreplace‘standardofcare’inavarietyofsurgicalprocedures
UniqueRetractableBlade
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J-Plasma®:LimitedThermalDamagevs.Energy-basedSurgicalTools*
• Prospectivestudycomparedlevelsofunintendedthermaldamagetoperitonealtissue(membraneliningtheabdominalcavity)amongotherenergy-basedsurgicaltoolsvs.J-Plasma®
• Redareasrepresentthedepthofthermalorenergydamageeachtoolleftbelowthetissuesurface;blueareasrepresentunaffectedtissue
• J-Plasma®demonstratedfarlowestamountofcollateralthermalinjurytohealthytissuesurroundingtheoperativesite
*Reference:PedrosoJ,GutierrezM,VolkerW.J-Plasma,monopolarpencil,argonbeamandCO2laserelectrosurgery:comparativeevaluationofthermalspreadinaporcinetissuemodel(whitepaper).BovieMedicalCorporation.June2014 10
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J-Plasma®:DemonstrationVideo
11VideoURL:http://www.boviemedical.com/downloads/J-Plasma_Demonstration_Video.mp4
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J-Plasma®:SampleClinicianFeedback
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“J-Plasmaisoneofthemostsignificantinnovationsinenergyinmorethanadecade,andithasthepotentialtobeoftremendousbenefittopatientsundergoingsurgeryforprostatecancer.”
-VipulR.Patel,MD,FACSUrologistandRoboticSurgeon
“J-PlasmadeliversthemostprecisionIhaveeverseeninanenergy-baseddevice.Thisallowsthephysiciantotreatsmallandlargeareaswithease.TheamountofenergycanbetailoredtogetoutcomesIhavenotyetseenwithanycompetitivelaserdevice.”
-JasonEmer,M.D.,FAAD,FAACSDermatologicSurgeon
“J-PlasmaisatrulyinnovativetechnologythatwillbeinvaluabletoFacialandPlasticSurgeonsandDermatologists.Thethermalcharacteristicsofthisenergy-baseddeviceareunlikeanydevicescurrentlyavailable.”
-RichardGentile,M.D.,MBAPlasticSurgeon
“Thereisanincredibleamountofcontrolintermsofdepth-of-penetrationbecauseitissosafe;becauseit’snotdeliveringaburningenergy”“It’sachancetobeartistic,becauseyouareusingadevicemorelikeapaintbrushthananatombomb.”
-JosephB.DeLozier III,MD,FACSPlasticSurgeon
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J-Plasma®:ExpandingProductPortfolio
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ContinuedinnovationinJ-Plasmatechnologieswithrecenthandpiece andgeneratorclearances
Precise360®HandpiecePrecise®Handpiece
Ultimate®Generator(Gen.2)
FDA510(k):May2017CEMark:March2017
CommercialLaunch:June2017
ExistingProductPortfolio:
PreciseFlexRoboticHandpieceFDA510(k):May2017CEMark:May2017
ExpectedCommercialLaunch:Q4’17
OpenHandpieceRedesignFDA510(k):March2017CEMark:March2017
ExpectedCommercialLaunch:Q4’17
2017NewProductClearances:
Ultimate®Generator(Gen.1)OpenHandpiece
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J-Plasma®:ClinicalValidation
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• PeerReviewedLiterature:- Publications:2- Presentations:3
• WhitePapers:- Published:10
• PreclinicalandClinicalStudies:
Procedure Area Design IRB/IACUCSubmission
EnrollmentInitiated Completed Published
Preclinical BowelStudy P P P 2H’17
LymphoceleReduction P P P 2H’17
GynecologicOncology P P P P 2H’18
DermalResurfacing(IDE) P P
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• Sterile,single-usedeviceforcutting,coagulatingandablatingsofttissue
• Efficienttipdesigntranslatesintothefollowingadvantages:
- Lowpowerrequirementtoinitiateablation- Lowerpower=lowerheat:saferforthepatient- Compatiblewithanygenerator
• Distributionpartner:
- GlobalsaleschannelpartnershipagreementforPlazXact™tobemarketedastheUltrAblatorBipolar®series
• Compellingaddressablemarket:- >1.2Mestimatedknee,shoulder,elbow&ankle
arthroscopyproceduresinU.S.alone
AdvancedEnergy:Ablator
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PlazXact™
InitialFDA510(k): January2016
CEMark: January 2016
CommercialLaunch: March 2017
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• EstablishedIPportfolio;pendingapprovalsfocusedonAdvancedEnergysegment:
IP&NewProductDevelopment
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GrowingIPportfolioandcontinuedprogressinnewproductdevelopment
PatentsIssued PatentsPending
UnitedStates 41 12
International 23 9
Total 64 21
AdvancedEnergyproductscomprise:42%ofissuedpatentsand100%ofpendingpatents
Progress(2010– 2013):
- 4510(k)clearances- 2CEMarkclearances- 4Productscommercialized
ProgresssinceJanuary,2014:
- 9510(k)clearances- 9CEMarkclearances- 8Productscommercialized
• Productdevelopmentpipelinereinvigoratedin2014:
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MedicalAdvisoryBoard• Sixsurgeonthought-leadersrepresentingavarietyofmedical
specialties
• Focusedonidentifying,andmaximizing,theclinicalapplicationsofourinnovativesurgicaltechnology,J-Plasma®
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Dr.HusamBalkhy,Director,MinimallyInvasive&RobotCardiacSurgery,DuhossoisCenterforAdvancedMedicine
Dr.RobertJ.Cerfolio,ChiefofClinicalThoracicSurgery,NYULangone
DirectoroftheLungCancerCenter,NYULangonePerlmutter CancerCenter
Foundingmember:Dr.VipulPatel,worldrenownedroboticsurgeon,MedicalDirectorofGlobalRoboticsInstitute,Florida
Dr.CraigMcCoy,Women’sWellnessCenter,ColumbiaMO.Obstetrics&GynecologySpecialistAdjunctAssistantProfessorofObstetricsandGynecologyattheUniversityofMissouri-Columbia
Dr.DennisChi,DeputyChiefandHeadofOvarianCancerSurgery,GynecologyServiceatMemorialSloanKetteringCancerCenter
Dr.JackZamora,Oculo-facialplasticsurgeonspecializinginminimallyinvasivecosmeticprocedures.
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State-of-the-ArtManufacturingFootprint
Clearwater, FL Sofia, Bulgaria China
Size: 60,000sq.ft. 16,000sq. ft. • 70,000sq.ft.
Owned/Contracted:
Owned Owned Contracted
Capabilities:
• Assembly• Integration• FinalTesting• Packaging• SterilizationManagement
• Manufacturing• ComplexComponent
Assembly• InitialTesting
• ComponentManufacturing• Sub-Assemblies• Finished MedicalDevices
(Electrodes)
Thecompanyalsorentsofficespaceof3,650sq.ft.inPurchase,NY
Capacitytoincreaseoutputfromexistingfacilities
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HistoricalFinancialSummary
($in000's)2016 2017 2015 2016
Revenue $10,063 $9,347 $29,520 $36,627RevenueGrowth(Y/Y) 28.6% -7.1% 6.6% 24.1%
CostofGoodsSold 5,002 4,753 16,963 18,712
GrossProfit $5,061 $4,594 $12,557 $17,915GrossMargin 50.3% 49.1% 42.5% 48.9%
OperatingExpenses 5,306 5,728 19,543 21,707
LossfromOperations ($245) ($1,134) ($6,986) ($3,792)
CashonhandasofSeptember30,2017 $9,411
Q3 FY
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FY’17GuidanceSummary
• FormalFinancialGuidance:
• TotalGAAPrevenueintherangeof$37.9millionto$38.4million,comparedto$36.6millioninfiscalyear2016.
• AdjustedEBITDAlossinarangeof$3.3millionto$3.5million,comparedtoalossof$2.2millioninfiscalyear2016.
• FY’17totalCompanyrevenueguidanceassumes:• LargestdriveroftotalCompanyrevenuegrowthistheAdvanced
Energysegment,whichisexpectedtogrowsales93%- 98%y/yin2017• SecondlargestdriveroftotalCompanyrevenuegrowthistheCore
segmentwhichisexpectedtogrowsales3%- 4%y/yin2017
Together,salesinourAdvancedEnergyandCoresegmentsrepresentapproximately93%oftotalCompanysalesinFY’17;
guidanceimpliesthesesegmentsgrow~14%y/yin2017
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FinancialAppendix
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BalanceSheet
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(Unaudited)(Inthousands)September30,
2017December31,
2016
ASSETSCurrentassets:Cashandcashequivalents 9,411$ 14,456$Restrictedcash 779 779Tradeaccountsreceivable,netofallowanceof$154and$118 4,077 4,733Inventories,net 7,335 6,158Prepaidexpensesandothercurrentassets 634 413Totalcurrentassets 22,236 26,539
Propertyandequipment,net 6,376 6,449Brandnameandtrademark 1,510 1,510Purchasedtechnologyandlicenserights,net 189 215Goodwill 185 185Deposits 84 109Otherassets 119 103
Totalassets 30,699$ 35,110$
LIABILITIESANDSTOCKHOLDERS'EQUITYCurrentliabilities:Accountspayable 1,387$ 1,606$Accruedpayroll 193 419Accruedvacation 330 404Currentportionofmortgagenotepayable 239 239Accruedandotherl iabil ities 2,657 2,604Totalcurrentliabilities 4,806 5,272
Mortgagenotepayable,netofcurrentportion 2,515 2,694Notepayable 140 140Deferredrents 11 14Deferredtaxl iabil ity 564 564Derivativel iabil ities 146 203Totalliabilities 8,182 8,887
STOCKHOLDERS'EQUITY
SeriesBconvertiblepreferredstock,$0.001parvalue;3,588,139authorizedandzeroissuedandoutstandingasofSeptember30,2017and3,588,139authorizedand975,639issuedandoutstandingasofDecember31,2016,respectively — 1
Commonstock,$0.001parvalue;75,000,000sharesauthorized;32,975,174issuedand32,832,095outstandingasofSeptember30,2017and40,000,000sharesauthorized;31,002,832issuedand30,859,753outstandingasofDecember31,2016,respectively 33 31Additionalpaid-incapital 50,156 49,625Accumulateddeficit (27,672) (23,434)Totalstockholders'equity 22,517 26,223Totalliabilitiesandstockholders'equity 30,699$ 35,110$
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IncomeStatement
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(Unaudited)(Inthousands,exceptpersharedata)
2017 2016 2017 2016Sales 9,347$ 10,063$ 27,535$ 27,133$Costofsales 4,753 5,002 13,673 14,049Grossprofit 4,594 5,061 13,862 13,084Othercostsandexpenses:Researchanddevelopment 610 681 2,015 1,941Professionalservices 421 292 1,291 1,045Salariesandrelatedcosts 2,080 2,192 6,783 6,492Selling,generalandadministrative 2,617 2,141 7,950 6,354Totalothercostsandexpenses 5,728 5,306 18,039 15,832Lossfromoperations (1,134) (245) (4,177) (2,748)Interestexpense,net (36) (37) (103) (125)Changeinfairvalueofderivativel iabil ities (69) (683) 57 (555)Totalotherloss,net (105) (720) (46) (680)Lossbeforeincometaxes (1,239) (965) (4,223) (3,428)Incometaxexpense 6 — 15 —Netloss (1,245)$ (965)$ (4,238)$ (3,428)$
LosspershareBasic (0.04)$ (0.04)$ (0.14)$ (0.13)$Diluted (0.04)$ (0.04)$ (0.14)$ (0.13)$
Weightedaveragenumberofsharesoutstanding-basic 31,078 27,075 30,932 27,059Weightedaveragenumberofsharesoutstanding-dilutive 31,078 27,075 30,932 27,059
ThreeMonthsEndedSeptember30,
NineMonthsEndedSeptember30,
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ReconciliationBetweenGAAPandNon-GAAP
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(Unaudited)(Inthousands)
2017 2016 2017 2016NetlossGAAPBasis (1,245)$ (965)$ (4,238)$ (3,428)$Interestexpense,net 36 37 103 125Incometaxexpense 6 — 15 —Depreciationandamortization 171 201 527 556Stockbasedcompensation 191 173 532 533Changeinfairvalueofderivativeliabilities 69 683 (57) 555AdjustedEBITDA (772) 129 (2,748) (1,659)
ThreeMonthsEndedSeptember30,
NineMonthsEndedSeptember30,
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FY’17GuidanceDetail
• TheCompanynowexpectstotalrevenueintherangeof$37.9millionto$38.4million,representinggrowthof4%to5%year-over-year,comparedtopriorguidancewhichassumedgrowthintherangeofapproximately5%to11%year-over-year.
• TheCompanyexpectstotalrevenuegrowthtobedrivenby:
• AdvancedEnergysalesgrowthintherangeofapproximately93%to98%year-over-yearascomparedtogrowthintherangeofapproximately90%to95%year-over-yearpreviously,
• OEMsalesdeclineintherangeofapproximately50%to55%year-over-year,unchangedfrompriorguidanceexpectations.
• Coresalesgrowthintherangeofapproximately3%to4%year-over-year,ascomparedtogrowthintherangeofapproximately5%to11%year-over-yearpreviously.
• TheCompanynowexpectsadjustedEBITDAlossinarangeof$3.3millionto$3.5million,comparedtoadjustedEBITDAlossinarangeof$2.8to$3.0millioninourpriorguidancerange.
• TheCompanywillrecognizeapproximately$525,000ofseparationrelatedexpenseinthefourthquarterof2017relatedtothedepartureofamemberofitsmanagementteam.TheupdatedadjustedEBITDArangereflectstheimpactofthisexpense.
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