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FORWARDLOOKINGSTATEMENT
Thispresentationincludesforwardlookingstatements,includingstatementsregardingtheCompanysabilitytoachievethemilestonesandfinancial
projectionsinthe3and1in20plan,including2020revenuesof$560million,AdjustedEPSof$1.00,and$110millioninrevenuesfromnewpain
managementproducts;theCompanysabilitytosustain20%+revenuegrowthoverthelongterm;theCompanysabilitytodeliverP&Lleveragein2017
andbeyond;theCompanysabilitytotransitiontoabiopharmaceuticalcompanyatanacceleratedpace;theCompanyscontinuedabilitytosellexisting
productsunderSection361ofthePHSApriortotheissuanceofaBLA;theCompanysabilitytoexpanditssalesforce;thetiming,results,andpublication
ofclinicalstudies,andthepotentialsafetyandefficacy,andthetimingandresultsofINDs/BLAs;theabilitytoobtain,andpotentialincrementalrevenues
from,incrementalcommercialreimbursementcoverage,includingcoverageforDFUsandVLUs;theabilitytoobtainincrementalbenefitsfromGPOand
IDNcontracts,andthetimingofsuchbenefits;theCompanysabilitysuccessfullytodevelopnewproductsandthetimingand receiptofpendingand
anticipatedregulatoryclearancesandapprovals,thetimingofproductlaunches,thesizeofthemarketsfortheCompanyscurrentandfutureproducts,
andtheshareofsuchmarketsthattheCompanywillbeabletogarner;theCompanysabilitytocontinuetoincreasemarketshare,expandthemarkets
foritsproducts,toexpandinternationally,andthetimingofsuchactions;theCompanysabilitytogrowoperatingroomrevenues,tohireadditionalsales
representatives,tolaunchadditionalproducts,toacquiresynergisticcompaniesorproducts,andtoincreasedemand;andestimated2017revenues.
Forwardlookingstatementsalsomaybeidentifiedbywordssuchas"believe,""except,""may,""plan,""potential,""will,"goal,target,market
opportunityandsimilarexpressions,andarebasedonourcurrentbeliefsandexpectations.
Forwardlookingstatementsaresubjecttosignificantrisksanduncertainties,andwecautioninvestorsagainstplacingunduerelianceonsuchstatements.
Actualresultsmaydiffermateriallyfromthosesetforthintheforwardlookingstatements.Amongtherisksanduncertaintiesthatcouldcauseactual
resultstodiffermateriallyfromthoseindicatedbysuchforwardlookingstatementsincludetherisksthattheCompanymaybeunabletotransitiontoa
biopharmaceuticalcompanyatanacceleratedpace;theCompanymaybeunablesuccessfullytodevelopanticipatednewproducts; thetimingof
anticipatedregulatoryclearancesandapprovalsmaybedelayedordenied;adverseregulatoryactionsagainsttheCompany;the marketsforthe
CompanyscurrentandfutureproductsmaynotbeaslargeastheCompanyprojectsorgrowasanticipated;theCompanymaynot be abletoachievethe
marketshareitanticipates;theCompanymayfacemoreandmoreeffectivecompetition,theCompanymaynotcontinuetoachievesignificantprocess
improvementsandefficiencies;theCompanymaybeunabletoachievethemilestonesandfinancialprojectionsinthe3and1in20plan;market
demandfortheCompanysproductsmaynotgroworcoulddecline;unexpectedconcernsmayarisefromadditionaldataoranalysisfromourclinical
trials;regulatorysubmissionsmaytakelongerorbemoredifficulttocompletethanexpected;andthatregulatoryauthoritiesmayrequireadditional
informationorfurtherstudiesormayfailtoapproveormaydelayapprovalorgrantmarketingapprovalthatisdifferentthananticipated;andwemaybe
unabletohiretheexpectednumberofsalesrepresentativesonatimelybasis.ForadditionalrisksthatmightaffecttheCompany,pleasereviewtheRisk
FactorssectionofourmostrecentannualreportorquarterlyreportfiledwiththeSecuritiesandExchangeCommission.Anyforwardlookingstatements
speakonlyasofthedateofthispressreleaseandweassumenoobligationtoupdateanyforwardlookingstatement.
2
INVESTMENTHIGHLIGHTS
GlobalCompanyDeliveringInnovativePlacentalTissueBasedRegenerative
TherapiesandTherapeuticBiologicsthatRestoreFunctionandImproveQuality
ofLife
OpportunitytouseaProductUnderthe361RegulationsbeforeConductinga
BLATrialProvidesUniqueClinicalTrialandRevenueBenefits
3and1in20StrategicPlanTriples2015Revenuesto$560MandDelivers
$1.00ofAdjustedEarningsin2020
Sustain20%+RevenueGrowthOvertheLongTerm
>85%GrossMarginsandStrongBalanceSheet
DeliverP&LLeveragein2017andBeyond
FromInceptiontoSeptember30,2017,Executed$100MofShareRepurchases
ProgramSizehasbeenIncreasedto$120M
3
COMPANYHIGHLIGHTS
5InnovativeTechnologyPlatforms
Over100*IssuedandAllowedPatents
ProprietaryPurionProcessedPlacentalTissueAllograftContainsaMilieu
of220Proteins(GrowthFactors,ChemokinesandCytokines)
IndustryLeaderintheAmnioticandPlacentalTissueMarket
EmergingLeaderintheSurgicalandOrthoBiologicsMarket
In2020CompleteTransitiontoaBiopharmaceuticalCompany
ExistingProductsRemainRegulatedthroughSection361ofPHSA
NewProductsRegulatedthroughSection351ofPHSAunderIND/BLA
PainManagement,RespiratoryDiseaseandCardiovascularDiseaseareLarge
BiopharmaceuticalOpportunities
*ownedandlicensed
4
EXPERIENCEDMANAGEMENTTEAM
ParkerH.PetePetit WilliamC.Taylor MichaelJ.Senken AlexandraO.Haden
Chairman&CEO President&COO ChiefFinancialOfficer GeneralCounsel
ThorntonA.Kuntz DeborahL.Dean ChristopherM.Cashman MarkE.Diaz
SeniorVicePresident, ExecutiveVicePresident ExecutiveVicePresident & SeniorVicePresident,
HR&Administration Chief CommercializationOfficer CommercialOperations
ScottM.Turner MichaelW.Carlton KevinD.Lilly MarleneM.DeSimone
SeniorVicePresident, SeniorVicePresident, SeniorVicePresident, Senior VicePresident,
Operations&Procurement Global Sales Sales Marketing
Dr.Rebeccah Brown Dr. DonaldE.Fetterolf Dr. ThomasJ.Koob Dr.I.MarkLandy
VicePresident, ChiefMedicalOfficer ChiefScientificOfficer SeniorVicePresident,
GlobalRegulatoryAffairs StrategicInitiatives
Dr.GloriaMatthews
SeniorVicePresident,
ResearchandDevelopment
5
DELIVERINGCONSISTENTSUSTAINABLEGROWTH
27ConsecutiveQuartersofSequentialRevenueGrowth
MetorExceededRevenueGuidancein26ofLast27Quarters
90
80
70
60
$s Millions
50
40
30
20
10
6
2017GROWTHDRIVERS
2016NewProductLaunches:EpiCord,AmnioFill,OrthoFloLyo
ContinuedSalesForceExpansion
ClinicalTrialResultsandPublications
IncrementalCommercialReimbursementCoverageforDFUandVLU
InternationalExpansion
ContinuedLeverageofGPO/IDNContracts
5GroupPurchasingOrganizations(GPO)contractsinplace
4have80%orsolecommitmenttiersforAmnioticTissue/SkinSubstitute
Coversapproximately4,000hospitals
40IntegratedDeliveryNetworks(IDN)Contracts
Coversapproximately1,300hospitals
ManyhavecommittedAmnioticTissueContracts
7
5YEARSTRATEGICPLAN:3AND1IN20
In2020:Triple2015Revenue,Deliver$1.00 ofAdjustedEPS
andCompleteTransitiontoa BiopharmaceuticalCompany
2020Assumptions
OrganicRevGrowth
*EBITDA30%
Tax36%
$187M $560M**
**NumberCommunicatedtothe
Street.InternalPlanisMuchHigher
*Adjusted
8
U.S.WOUNDBIOLOGICSMARKETIN2020
2020Skin/DermalSubstitute(SDS)SegmentSalesEstimate$1.1B
2020AmnioticTissueShareEstimate58%vs.29%in2014
2016SDSSalesEstimate$681Mup16%vs.2015
2016MiMedxAmnioticTissueShare63%
10%
21% 18%
39%
2015SDSSegment 2016SDSSegment 45% 2020SDSSegment
27%
32%
34% 5%
6%
6%
WoundCareGrowthDrivers
1. ContinueToTakeMarketShare
LeverageSafetyAdvantageofTerminalSterilization
ExpandScientificandClinicalBodyofEvidence
IncreaseLivesUnderCoverage
BroadenReachInIDN/GPOContracts
NewProducts
NewSettings,LongtermCare(LTAC)
2. ExpandTheMarket
SecondaryCityExpansion
ConvertPhysiciansthatdonot
useAWCProducts
InfluenceandImproveReferral
Patterns
WoundCare OperatingRoom PainManagement
3. InternationalExpansion
10
CHRONICWOUNDMARKETISUNDERPENETRATED
1.4MChronicDFU/VLUWounds $3BMktOpportunityAlone
2015
2016U.S.MarketFacts 6.5MUSPatientshave
ChronicWounds
AnnualCostofTreatingChronicWounds
intheU.S.is$25Billion
Skin/DermalSubstitutesistheLargest
Segmentat$681Million 3Marenon
MiMedxistheMarketLeaderat31%
healingwounds
SalesofPlacentaDerived/AmnioticTissue
ProductsGrew33%to$305M
MiMedxistheMarketShareLeaderat63%
Under200KareTreatedwith
a SkinorDermalSubstitute
SmartTRAKBusinessIntelligence
11
EPIFIXVLUMULTICENTERTRIAL
FINALANALYSIS
VLU:EpiFixvs.Control%SubjectsCompleteWound VLU:Apligraf vs.Control%SubjectsComplete
Closure WoundClosure
100% 100%
EpiFixvs.ApligrafVLUStudyResults
Note:TheMiMedx 100%
ControlwasMore
80% 71%
Efficaciousthanthe 60% 57%
60%
ApligrafControl
35% 37%
40% 29%
Pleasenote:Apligraf andEpiFix studiesare 17%
20% 9%
independentofoneanother
Controls:MultiLayerCompression
Apligraf Reference:PMASupplement
0% TherapywithEpiFix NuDerm Alginate
(P950032)approvaldated05/22/1998
Week4 Week8 Week12 Week16 Week24 Apligraf MoistGauzewithZincPaste
EpiFixReference:PublishedFinalData
Report,ReportedPressRelease08/31/2017
EpiFix(N=52) Apligraf(N=130)
12
VLUCOMMERCIALINSURANCE
COVERAGEIMPACTMODEL
ONLY33%ofCommercialPayersCoverEpiFix ForBothDFUandVLU
*Under65Truven Data
13
SDSCOMPETITIVEPRODUCTCOMPARISON
ApligrafandDermagraftareregisteredtrademarksofOrganogenesis,Inc.
OmnigraftandPriMatrixareregisteredtrademarksofIntegraLifeSciencesCorporation.AMNIOEXCELisregisteredtrademarkofBioD,LLC,anIntegraLifeSciencescompany.
BIOVANCEisaregisteredtrademarkofAlliquaBiomedical,Inc.
GrafixisregisteredtrademarkofOsirisTherapeutics,Inc.
Referencesprovidedatendofpresentation.
14
OPERATINGROOMGROWTHTARGET:5YR20%CAGR
OperatingRoomGrowthDrivers
1. IncreaseFootprint
ContinuetoHireDirectSurgicalReps,
Currentlyat30
DeeperPenetrationofGPOandIDN
Contracts
2. ExpandProductLine
NewProductLaunches:
AmnioFill,OrthoFloLYO
SynergisticAcquisitions
3. GrowDemand
PublishClinicalTrialsShowing
ImprovedSurgicalOutcomesand WoundCare OperatingRoom PainManagement
ReducedComplications
IncreaseNumberofVACApprovals
15
TARGETHIGHVALUESURGICALPROCEDURES
NumberofProcedures(000) AddressableMarketValue($M)
4.3M $5.7B
Orthopedics
Spine,Trauma,Extremities, 2,821
1,528 SportsMedicine
GYN
Hysterectomy,Endometriosis,
$2.9B
1,154 Myomectomy,CSection,Episiotomy 1,000
PLASTICS
HandTendonandNerves,Mohs,
652 ScarRevision,SkinGrafting,Surgical 990
Dehiscence,BreastRecon,Burn
GENERALCOLORECTAL
Bariatric,FistulaRepair,
GIAnastomosis
714 714
UROLOGY
Prostatectomy,PartialNephrectomy,
237 Cystectomy 200
Source:MilleniumResearchGroup,MRGLap2014,ASPSStatistics,MiMedx2015AnnualPlan,MiMedxinternalcodingdata,ManagementEstimates
16
MUSCULOSKELETALPAINISALARGEOPPORTUNITY
EverydayuseUnder361RegulationsProvidestheOpportunity
toGenerateRevenuewhiletheBLAProcessisOngoing
WoundCare
OperatingRoom
PainManagement
17
2015U.S.JOINTPAININJECTIONMARKET
NumberofProcedures
SmartTRAKBusinessIntelligence
andCompanyEstimates
18
TRANSITIONTOABIOPHARMACEUTICALCOMPANY
AmnioFixInjectable(AI)isourLeadProductCandidate
MicronizedversionofdHACM
CoveredbyourExtensivePlacentalTissueTechnologyPatentFamily
ContainsaMilieuof220+Proteins
IncludesFactorsRequiredforSoftTissueHomeostasisandRepair
AddressMultipleTargetswithaUnifiedMechanismofAction
ProvenSafetyProfile
First3BLAsTargetMusculoskeletalPain
PlantarFasciitis
AchillesTendonitis
OsteoarthriticKneePain
PositiveInterimPhase2BDataValidatesAITherapeuticEffectinTreatingSoft
TissuePain,RestoringFunctionandImprovingQualityofLife
Exiting2020BiopharmaceuticalSalesApproximately20%ofTotalRevenue
19
PLANTARFASCIITIS:
REPORTEDINTERIMPHASE2BDATA
PrimaryEfficacyEndpoint,PainReliefat3Months:AmnioFixInjectableDemonstrated
ClinicallyMeaningfulandStatisticallySignificantSeparationfromPlacebo(pvalue=0.0001)
StatisticallySignificantResultsWereSeenat6Months(pvalue=0.0005)
AverageReductioninPainfromBaselineat3Monthswas77.5%vs.45.7%forPlacebo
AverageReductioninPainfromBaselineat6Monthswas85.9%vs.57.1%forPlacebo
0%
At3MonthsSubjectsinthePlacebo
10% GroupWereAllowedtoUndergo
AlternativeTherapy
PercentReductionfromBaseline
20%
30%
40%
50%
60%
70%
80%
90%
100%
Baseline 1Month 2Months 3Months 6Months
AmnioFix Saline
20
OSTEOARTHRITIS(OA)ISABOOMINGEPIDEMIC
OAAffectsanEstimated31MAmericans
ItistheMostCommonformofArthritisandtheLeadingCauseof
DisabilityinAmericanAdults
PrevalenceIncreaseswithAge,Rangingfromabout2%Among
Personsunder45toMoreThan80%AmongThoseOver75
14MAmericansSufferSymptomaticKneeOA
AffectsMoreThan2MPeopleUndertheAgeof45andMore
Than6MPeopleBetweentheAgesof45and64
KneeOAContributesMoreThan$27BillioninU.SHealthCare
ExpendituresAnnually
AstheWorldsPopulationAges,itisEstimatedthatDegenerative
JointDiseasewillImpactOver130MIndividualsGloballyby2050
Source:ArthritisFoundation
21
ASAFERMOREEFFECTIVEPRODUCTISNEEDED
*
*
* **
*
*
*
**
*Toxicsideeffectsandlimitedefficacy **Limitedefficacy
22
AMNIOFIXINJECTABLEADDRESSESALLSTAGESOFKNEEOA
23
PAINMANAGEMENTCLINICALTRIALMILESTONES
20182021:ManagementsEstimation
24
RESPIRATORYANDCARDIOVASCULARUPDATE
ScanningElectronMicroscope
RespiratorySystem SlidesofRespirableParticles
CompletingDrugDiscoveryand
DesignProcess
InitiatingPreClinicalDevelopment
Program
CurrentGoalistoBeginHuman
Testingin4Q2018
CardiovascularSystem
PublishedSmallAnimalStudy Particlesize
distribution
RefiningDevelopmentProgram
OptimizingDeliverySystem
25
FINANCIALHIGHLIGHTS
*ReconciliationofnonGAAPfinancialmeasuresincludedinsupplementalslidessectionoftheslidedeck
26
FINANCIALHIGHLIGHTS
Revenue
350
300
250
200
150
100
50
0
2014 2015 2016 2017(Est.)
Wound SSO
2017RevenueGuidance=$320.6M $321.6M
27
KEY2017MILESTONES
PositiveAetnaCoverageDecision
PositiveKaiserCoverageDecision
PresentedGIAnastomosisData
ReleasedPlantarFasciitisPhase2BInterimData
SecondHalf2017
InitiatePivotalBLAPhase3PlantarFasciitisTrial
InitiatePivotalBLAPhase3AchillesTendonitisTrial
InitiateBLAPhase2BOsteoarthritisKneePainTrial
ReportVLUMulticenterData
ReportDFUMulticenterData
PublishGIAnastomosisData
FirstPatentInfringementTrialPossible
AdditionalReimbursementWins
28
REFERENCES
1. http://www.apligraf.com/professional/pdf/FDAApprovalLetter.pdf
2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p000036
3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm
4. http://www.prnewswire.com/newsreleases/dermasciencesexpandsaccessofitsamniotictissueproductlinewithnewpremierincagreement
300024252.html
5. http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083440.pdf
6. http://ir.alliqua.com/pressreleases/detail/544/alliquatolaunchbiovancerhumanamnioticmembrane
7. http://investor.osiris.com/annualsproxies.cfm;2011.
8. www.clinicaltrials.gov.Accessed03/01/17.
9. ZelenCM,SerenaTE,DenozireG,FetterolfDE. Aprospectiverandomizedcomparativeparallelstudyofamnioticmembranewoundgraftinthemanagementof
diabeticfootulcers.IntWoundJ.2013Oct;10(5):5027.
10. ZelenCM,SerenaTE,SnyderRJ. Aprospective,randomisedcomparativestudyofweeklyversusbiweeklyapplicationofdehydratedhumanamnion/chorion
membraneallograftinthemanagementofdiabeticfootulcers.IntWoundJ.2014Apr;11(2):1228.
11. ZelenCM,GouldL,SerenaTE,CarterMJ,KellerJ,LiWW. Aprospective,randomised,controlled,multicentrecomparativeeffectivenessstudyofhealingusing
dehydratedhumanamnion/chorionmembraneallograft,bioengineeredskinsubstituteorstandardofcarefortreatmentofchroniclowerextremitydiabetic
ulcers.IntWoundJ.2015Dec;12(6):72432.
12. ZelenCM,SerenaTE,GouldL,LeL,CarterMJ,KellerJ,LiWW. Treatmentofchronicdiabeticlowerextremityulcerswithadvancedtherapies:aprospective,
randomised,controlled,multicentrecomparativestudyexaminingclinicalefficacyandcost.IntWoundJ.2016Apr;13(2):27282.
13. VevesA,FalangaV,ArmstrongDG,SabolinskiML.Graftskin,ahumanskinequivalent,iseffectiveinthemanagementofnoninfectedneuropathicdiabeticfoot
ulcers:aprospectiverandomizedmulticenterclinicaltrial.DiabetesCare.(24)2.2001.pp2905.
14. MarstonW,HanftJ,NorwoodP,Pollak R.TheEfficacyandSafetyofDermagraftinImprovingtheHealingofChronicDiabeticFootUlcers.DiabetesCare,Vol26
#6,June2000.
15. Driver,V.R.,Lavery,L.A.,Reyzelman,A.M.,Dutra,T.G.,Dove,C.R.,Kotsis,S.V.,Kim,H.M.andChung,K.C.(2015),AclinicaltrialofIntegraTemplatefor
diabeticfootulcertreatment.WoundRepandReg,23:891900.doi:10.1111/wrr.12357.
16. SnyderRJ,Shimozaki K,Tallis A,Kerzner M,Reyzelman A,Lintzeris D,BellD,Rutan RL,RosenblumBAProspective,Randomized,Multicenter,Controlled
EvaluationoftheUseofDehydratedAmnioticMembraneAllograftComparedtoStandardofCarefortheClosureofChronicDiabetic FootUlcer.Wounds.2016
Mar;28(3):707.
17. Kavros,S;Dutra,T;GonzalezCruz,R;Liden,B;Marcus,B;McGuire,J;NazarioGuirau,L.TheUseofPriMatrix,aFetalBovineAcellularDermalMatrix,inHealing
ChronicDiabeticFootUlcers:AProspectiveMulticenterStudy.AdvancesinSkin&WoundCare:August2014 Volume27 Issue8 p356362.doi:
10.1097/01.ASW.0000451891.87020.69.
18. Lavery A,etal.TheefficacyandsafetyofGrafix fortreatmentofchronicdiabetesfootulcers:resultsofamulticentre,controlled,randomized,blinded,clinical
trial.IntWoundJ2014;doi:10.1111/iwj.12329.
19. Publicdomain
30
PLANTARFASCIITISPHASE2BSTUDYOUTLINE
AProspective,SingleBlinded,RandomizedControlledTrialofMicronized
dHACM Injection ComparedtoSalinePlacebo Injection intheTreatmentofPF
Randomized,MultiCenter,SingleBlind(Patient)
DESIGN
147PatientswithRecalcitrantPF(ConfirmedDiagnosis>1Monthand<18Months,
VAS>45,ConservativeUsualCare>1Month*)
2ArmUnilateralTreatmentwith:
n=73:Placebo(1mlNormalSaline)
n=74:AmnioFixInjectable(1mlof40mgAI)
PRIMARY MeanChangeinVASScoreBetweenBaselineand3Months
IncidenceofAdverseEventsat12Months
SECONDARY MeanChangeinFunctionalScoreasMeasuredbyFFIRat3Months
ImmunoCompatibilityofFirst20PatientsFollowedinEachArmat3and12Months
LongTermFFIR,VASat6and12 Months
31
*Includinganyofthefollowingmodalities:RICE,SteroidInjection,Stretching,NSAID,Orthotics
PLANTARFASCIITISPHASE3STUDYOUTLINE
AProspective,DoubleBlinded,RandomizedControlledTrialofMicronized
dHACM Injection ComparedtoSalinePlacebo Injection intheTreatmentofPF
Randomized,MultiCenter,DoubleBlinded(PatientandReviewer)
DESIGN
164PatientswithRecalcitrantPF(ConfirmedDiagnosis>1Monthand
<18Months,VAS>45,ConservativeUsualCare>1Month*)
2ArmUnilateralTreatmentwith:
n=82:Placebo(1mlNormalSaline)
n=82:AmnioFixInjectable(1mlof40mgAI)
PRIMARY MeanChangeinVASScoreBetweenBaselineand3Months
IncidenceofAdverseEventsat6 Months
SECONDARY MeanChangeinFunctionalScoreasMeasuredbyFFIRat3Months
LongTermFFIRandVASat6Months
*Includinganyofthefollowingmodalities:RICE,SteroidInjection,Stretching,NSAID,Orthotics
32
ACHILLESTENDONITISPHASE3STUDYOUTLINE
AProspective,DoubleBlinded,RandomizedControlledTrialofMicronized
dHACM Injection ComparedtoSalinePlacebo Injection intheTreatmentofAchillesTendonitis
Randomized,MultiCenter,DoubleBlinded(PatientandReviewer)
DESIGN 158patientswithAchillesTendonitis(ConfirmedDiagnosis>1Monthand<18
Months,VAS>45,ConservativeUsualCare>1Month*)
2ArmUnilateralTreatmentwith:
n=79:Placebo(1mlNormalSaline)
n=79:AmnioFixInjectable(1mlof40mgAI)
PRIMARY MeanChangeinVASScoreBetweenBaselineand3Months
IncidenceofAdverseEventsat6 Months
SECONDARY MeanChangeinFunctionalScoreasMeasuredbyFFIRat3Months
LongTermFFIRandVASat6Months
*Includinganyofthefollowingmodalities:RICE,SteroidInjection,Stretching,NSAID,Orthotics
33
OSTEOARTHRITISPHASE2BSTUDYOUTLINE
AProspective,DoubleBlinded,RandomizedControlledTrialofMicronized
dHACM Injection ComparedtoSalinePlacebo Injection intheTreatmentofOsteoarthritis
DESIGN Randomized,MultiCenter,DoubleBlinded(PatientandReviewer)
318PatientswithOsteoarthritis(DiagnosisofOsteoarthritis(OA)Definedas
Grade1to3ontheKellgrenLawrenceGradingScale,VAS>45)
2ArmUnilateralTreatmentwith:
n=159:Placebo(1mlNormalSaline)
n=159:AmnioFixInjectable(1mlof40mgAI)
MeanChangeinVASScoreBetweenBaselineand3Months
PRIMARY MeanChangeinWOMAC3.1Score(Pain,StiffnessandPhysicalFunction)
IncidenceofAdverseEventsat12Months
SECONDARY MeanChangeinFunctionalScoreasMeasuredbyKOOSat3Months
LongTermKOOSandVASat12Months
*Includinganyofthefollowingmodalities:RICE,SteroidInjection,Stretching,NSAID,Orthotics
34
SUPPLEMENTALSLIDE
RECONCILIATIONOFNONGAAP FINANCIALMEASURES
GROSSMARGIN
NonGAAP Adjustments:
35
SUPPLEMENTALSLIDE
RECONCILIATIONOFNONGAAP FINANCIALMEASURES
NETINCOME
Three MonthsEnded NineMonthsEnded
September30,2017 September30,2017
2017 2016 2017 2016
Net Income(PerGAAP) $17.5M $3.3M $29.9M $6.5M
NonGAAP Adjustments:
TaxRateNormalization* (7.4M) (.5M) (11.4M) (0.9M)
Gain onDivestiture (4.3M) (4.3M)
OneTimeCostsIncurredinConnection 0.2M 1.1M
with Acquisition
OneTimeInventoryCostsIncurredin 0.3M 0.2M 1.6M
ConnectionwithAcquisition
AmortizationofIntangibleAssets 0.4M 0.6M 1.5M 1.9M
SharebasedCompensation 5.3M 4.7M 15.2M 13.8M
EstimatedIncomeTaxImpactfrom (2.0M) (2.4M) (5.9M) (7.7M)
Adjustments
AdjustedNetIncome $9.5M $6.2M $25.2M $16.3M
*Assumesanormalizedtaxrateof42% for2016and35%for2017.
36
SUPPLEMENTALSLIDE
RECONCILIATIONOFNONGAAP FINANCIALMEASURES
EBITDA
Three MonthsEnded NineMonthsEnded
September30,2017 September30,2017
2017 2016 2017 2016
Net Income(PerGAAP) $17.5M $3.3M $29.9M $6.5M
AddBack:
GainonDivestiture (4.2M) (4.3M)