UNITED STATESSECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-KCURRENT REPORT

Pursuant to Section 13 or 15(d) ofThe Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2019

Glaukos Corporation(Exact name of registrant as specified in its charter)

         

Delaware   001-37463   33-0945406(State or other jurisdiction   (Commission   (I.R.S. Employer

of incorporation)   File Number)   Identification No.)      

229 Avenida Fabricante San Clemente, California

 92672

(Address of principal executive offices)   (Zip Code) 

Registrant’s telephone number, including area code: (949) 367-9600

Not Applicable(Former name or former address, if changed since last report.)

 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of theregistrant 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of theSecurities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of thischapter).  Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the ExchangeAct.   ☐   

  

 

Item 7.01. Regulation FD Disclosure.

Glaukos Corporation (the “Company”) intends to present the materials attached as Exhibit 99.1 to this Current Report onForm 8-K (the “Investor Presentation”) from time to time in presentations to investors and other stakeholders. The InvestorPresentation will also be available on the investor page of the Company’s website at http://investors.glaukos.com.

The information contained in this Item 7.01 (excluding Exhibit 99.1) shall not be deemed “filed” for purposes of theExchange Act, or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing of theCompany whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits .     

Exhibit No.   Description99.1   Investor Presentation, dated January 2019 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to besigned on its behalf by the undersigned hereunto duly authorized.

  GLAUKOS CORPORATION (Registrant)

       By: /s/ Joseph E. Gilliam    Name: Joseph E. Gilliam    Title: Chief Financial Officer and Senior Vice

President, Corporate Development Date: January 8, 2019 

Exhibit 99.1

1©2019GlaukosCorporation1January2019

2©2019GlaukosCorporationAllstatementsotherthanstatementsofhistoricalfactsincludedinthispresentationthataddressactivities,eventsordevelopmentsthatweexpect,believeoranticipatewillormayoccurinthefutureareforward-lookingstatements.Althoughwebelievethatwehaveareasonablebasisforforward-lookingstatementscontainedherein,wecautionyouthattheyarebasedoncurrentexpectationsaboutfutureeventsaffectingusandaresubjecttorisks,uncertaintiesandfactorsrelatingtoouroperationsandbusinessenvironment,allofwhicharedifficulttopredictandmanyofwhicharebeyondourcontrol,thatmaycauseouractualresultstodiffermateriallyfromthoseexpressedorimpliedbyforward-lookingstatementsinthispresentation.Thesepotentialrisksanduncertaintiesinclude,withoutlimitation,uncertaintiesaboutourabilitytomaintainprofitability;ourdependenceonthesuccessandmarketacceptanceoftheiStent®;ourabilitytoleverageoursalesandmarketinginfrastructuretoincreasemarketpenetrationandacceptancebothintheUnitedStatesandinternationallyofourproducts;ourdependenceonalimitednumberofthird-partysuppliers,someofwhicharesingle-source,forcomponentsofourproducts;theoccurrenceofacripplingaccident,naturaldisasterorotherdisruptionatourprimaryfacility,whichmaymateriallyaffectourmanufacturingcapacityandoperations;maintainingadequatecoverageorreimbursementbythird-partypayorsforproceduresusingtheiStentorotherproductsindevelopment;ourabilitytoproperlytrain,andgainacceptanceandtrustfrom,ophthalmicsurgeonsintheuseofourproducts;ourabilitytosuccessfullydevelopandcommercializeadditionalproducts;ourabilitytocompeteeffectivelyinthehighlycompetitiveandrapidlychangingmedicaldeviceindustryandagainstcurrentandfuturecompetitors(includingMIGScompetitors)thatarelargepubliccompaniesordivisionsofpubliclytradedcompaniesthathavecompetitiveadvantages;thetiming,effectandexpenseofnavigatingdifferentregulatoryapprovalprocessesaswedevelopadditionalproductsandpenetrateforeignmarkets;theimpactofanyproductliabilityclaimsagainstusandanyrelatedlitigation;theeffectoftheextensiveandincreasingfederalandstateregulationinthehealthcareindustryonusandoursuppliers;thelengthyandexpensiveclinicaltrialprocessandtheuncertaintyofoutcomesfromanyparticularclinicaltrial;ourabilitytoprotect,andtheexpenseandtime-consumingnatureofprotecting,ourintellectualpropertyagainstthirdpartiesandcompetitorsthatcoulddevelopandcommercializesimilaroridenticalproducts;theimpactofanyclaimsagainstusofinfringementormisappropriationofthirdpartyintellectualpropertyrightsandanyrelatedlitigation;andthemarket’sperceptionofourlimitedoperatinghistoryasapubliccompany.Theseandotherknownrisks,uncertaintiesandfactorsaredescribedindetailunderthecaption“RiskFactors”andelsewhereinourfilingswiththeSecuritiesandExchangeCommission,includingourAnnualReportonForm10-Kfor2017andQuarterlyReportonForm10-QforthequarterendedSeptember30,2018.OurfilingswiththeSecuritiesandExchangeCommissionareavailableintheInvestorSectionofourwebsiteatwww.glaukos.comoratwww.sec.gov.Inaddition,informationabouttherisksandbenefitsofourproductsisavailableonourwebsiteatwww.glaukos.gov.Allforward-lookingstatementsincludedinthispressreleaseareexpresslyqualifiedintheirentiretybytheforegoingcautionarystatements.Youarecautionednottoplaceunduerelianceontheforward-lookingstatementsinthispressrelease,whichspeakonlyasofthedatehereof.Wedonotundertakeanyobligationtoupdate,amendorclarifytheseforward-lookingstatementswhetherasaresultofnewinformation,futureeventsorotherwise,exceptasmayberequiredunderapplicablesecuritieslaw.Disclaimer

3©2019GlaukosCorporationWearetransformingglaucomatherapy…OURMISSIONTODAYTopioneerandleadtheglobalglaucomamarketwithmicro-scaleinjectabletherapiesthatadvancethestandard-of-careandenrichthelivesandtreatmentalternativesforglaucomapatientsworldwide.OURLONG-TERMSTRATEGICGOALToleadtheglobalophthalmicmarketforwardbybuildingrobustsustainedpharmaceutical,surgicalanddiagnosticplatformsthatprovidedrop-lessapproachesforeffectivelymanagingglaucomaandotheroculardiseases.…andtransitioningGlaukosintoanophthalmicpharma/deviceleader.OurMissionandLong-termGoal

4©2019GlaukosCorporation2013201420152016TotalNetSales(inmillions)$175-177M2018RevenueGuidance,Provided11/7/2018$138MCash&Short-TermEquivalents11Asof9/30/2018$21.0$45.6$71.7$114.4$159.320174-YrCAGR:66%86%Q32018GrossMarginWe’veMadeTremendousProgressThusFar…

5©2019GlaukosCorporationWe’veMadeTremendousProgressThusFar…KeyMetrics6/30/159/30/18%GrowthCommercialsalespersonnelworldwide65183Employeesworldwide139410195%182%iStents,iStentinjectsimplantedgloballyIssued,licensedorpendingpatents+500K+200Articlesinpeer-reviewedpublications9717CountrieswithdirectGlaukossalesoperations

6©2019GlaukosCorporation…ButWeAreJustBeginningOurLong-TermGrowthStoryNewproductsbeingevaluatedbyFDA2018revenueinvestedinR&D1429%Scientists,engineersfocusedonpipelinedevelopment30+•OptimizingworldwideClinical&Regulatorystructure•Upgradingglobalsystemsandtechnologyinfrastructure•EstablishingnewHQfacilities•Growingglobalsalesforceandmarketaccessteams•Evaluatingnewinternationalmarkets•ExpandingsizeanddepthofR&Dteams•FocusingR&Donearly-stagenewproductdevelopment,noveldrugformulationsthatleverageiDoseTMplatform•Investinginstate-of-the-arttechnicalequipment•EnhancingmanufacturingefficienciesSizeofglobalglaucomamarketserved$5B+8.2MEst.USOHT/POAGdiagnosedandtreatedeyesStrategicInvestmentstoStimulateandSupportOurGrowth1Asof9/30/2018

7©2019GlaukosCorporationMajor2018AccomplishmentsbyObjectiveObtainFDAapprovalandcommenceUScommerciallaunchofiStentinject®BeginpatientenrollmentofkeypivotalstudiesReceivediStentinjectapprovalinJune,approximatelysixmonthsfollowingPMAsubmissionExecutedpremieriStentinjectlaunchinSeptember,focusedonfacileprocedure,predictableperformanceandfavorablesafetyprofile;strongreal-worldclinicalperformancereportedInitiatedPhaseIIIstudiesforiDoseTravoprostSecuredearlyFDA510(k)IDEandinitiatedstudyforiStentinfiniteTMDriveincreasedpenetrationinourinternationalmarketsAchieved60%YoYinternationalrevenuegrowth1SecurednewregulatoryapprovalsandreimbursementinkeyinternationalmarketsExpandpharmaceuticalcapabilitiesthroughcontinuedinvestmentImplementedsignificantGlaukosPharmateamexpansionInitiatedpharmaceuticaldevelopmentagreementwithD.WesterntoexploreRho-kinase(ROCK)inhibitorsforiDosedeliverysystem1Forninemonthsended9/30/2018vs.sameperiodin2017

8©2019GlaukosCorporationNovelSurgical&PharmaceuticalGlaucomaTherapy

9©2019GlaukosCorporationOcularHypertensionIOPof21-30mmHgTargetIOP20%↓frombaseline;≤18mmHgTreatment0-1medMildOAGIOPof25-30mmHgwithminoropticnervedamageandvisualfieldlossModerateOAGIOPof>30mmHgwithmoderateopticnervedamageandvisualfieldlossAdvancedOAGUncontrolledIOPwithsignificantopticnervedamageandvisualfieldlossRefractoryOAGUncontrolledIOPwithsevereopticnervedamageandvisualfieldlossIOPismeasuredinmillimetersofmercury(mmHg).NormalIOPinhealthyeyesrangesfrom10-21mmHg.CurrentOAGTreatmentAlgorithm12345Open-AngleGlaucomaProgressionTargetIOP25%↓frombaseline;≤18mmHgTreatment~1med,laser,MIGSTargetIOP30%↓frombaseline;≤15mmHgTreatment~2meds,laser,MIGSTargetIOP35%↓frombaseline;<15mmHgTreatment~3meds,filteringsurgery,tubeshuntTargetIOP35%↓frombaseline;<15mmHg(ideally~12mmHg)Treatment3+meds,filteringsurgery,tubeshunt

10©2019GlaukosCorporationOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORYAddressingfullrangeofglaucomadiseasestatesandprogressionInjectabledrugdeliveryimplant;sustaineddrugtherapyforextendedperiodsEnvisionusealoneorincombinationwithotherMIGSdevicesInjectable2-stenttherapyforstandaloneproceduresInjectable2-stenttherapyforcombo-cataractproceduresAccessessecondaryoutflowpathway;envisionuseprimarilyincombinationwithotherMIGSdevicesInjectable3-stenttherapyforstandaloneproceduresPortfolioofMicro-ScaleInjectableTherapyREFRACTORYADVANCEDMODERATEMILDOCULARHYPERTENSIONSinglestenttherapyforcombo-cataractproceduresTMTM®iStentSA,iStentSupra,iStentinfiniteandiDosearenotapprovedbytheFDA.

11©2019GlaukosCorporationOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORY2021-22201820202020-215in5:EstimatedCadenceofMajorNewUSProductIntroductionsREFRACTORYADVANCEDMODERATEMILDOCULARHYPERTENSION2023iStentSA,iStentSupra,iStentinfiniteandiDosearenotapprovedbytheFDA.AddressingfullrangeofglaucomadiseasestatesandprogressionTMTM2012®

12©2019GlaukosCorporationiStentinject:First-of-a-KindMulti-StentSystemOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORYTwomulti-directional,titaniumstentspreloadedintoautoinjectionsystemDesignedtodeliveraccesstomultiplecollectorchannelsandrestorenaturaloutflowthroughtheconventionalpathwaySignificantIOPreductionacrossawiderangeofclinicalstudiesElegantandpreciseabinternoprocedure;leavesnaturalanatomyintactandsparesconjunctivaltissuePostoperativecareprofilesimilartocataractsurgery

13©2019GlaukosCorporation29Peer-ReviewedPublicationsoniStentinjectorMultipleiStent®TherapyConsecutivecaseseriesstudyinprimarilyOAGeyes;81implantedwithiStentinjectincombinationwithcataractsurgeryHengererF.Ophthalmology&TherapyDecember2018MeanIOPmmHg22.614.814.514.31216202428Preop(n=81)Year1(n=71)Year2(n=52)Year3(n=41)Reductioninmean#ofmeds68%Retrospective,single-sitecaseseriesof179eyeswithvaryingglaucomaseverityandconcomitantcataractsurgeryHarasymowycz,P.ASCRS2018MeanIOPmmHg16.213.8101418Preop6months-1yearReductioninmean#ofmeds43%7450204060PreopPostop%MedicationFreeiStentinject+CataractSurgeryiStentinject+CataractSurgery

14©2019GlaukosCorporationiStentinject:SuccessfulLaunchContinuesAmericanAcademyofOphthalmology–October2018CommerciallyavailableinUS,EU,Australia,Brazil,Canada0191Tconsistentlyreimbursed;0376add-oncoderepresentsprofessionalfeeupside

15©2019GlaukosCorporationiStentinject:RecentSurgeonObservations

16©2019GlaukosCorporationiStentinjectIvantisHydrusiStentinjectvs.CompetitionSmallestdeviceknowntobeimplantedinthehumanbody,measuring360µmx230µmPartofmarket-expandingportfoliofromMIGSpioneer

17©2019GlaukosCorporationMIGSStandaloneSolutionforAdvancedandRefractoryOAGThreeheparin-coatedtrabecularbypassstents,preloadedintoautoinjectionsystemEnhancedinsertionsystemprovidesunlimitedactivationsandsmoothimplantationofeachstentacross5-6clockhoursofSchlemm’scanalLessinvasive,fasterrecoveryandfewercomplicationsthanconventionallate-stageprocedures;noblebformationCurrentlyenrollingpatientsinclinicaltrialtosupport510(k)submissionOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORYiStentinfiniteisnotapprovedbytheFDATitratableStentTherapyMeanIOPmmHg17.415.814.21014182226MeanpreopmedicatedIOPMeanpreopIOPafterwashoutMonth36-37post-washoutIOP1Stent2Stent3StentInternationalstudyofOAGpatients(n=119)withunmedicatedIOPof22-38mmHg;randomizedtoreceive1,2or3stentsinstandaloneprocedure;follow-uptocontinuefor5yearsKatzLJetalClinicalOphthalmology2018TM

18©2019GlaukosCorporationTwoheparin-coatedtitaniumstents,preloadedintoautoinjectionsystemAbilitytoentertheeyeoncetoimplantbothstentsinstraightforwardclick-and-releasemotionStandalone2-StentTherapyforMildtoModerateOAGOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORYiStentSAisnotapprovedbytheFDA2StandaloneStents19.524.414.314.214.113.113.21014182226PreopBaseline(Washout)Month1Month12Month24Month36Month42International,prospectivestudy;allpatients(n=57)on1preoperativeglaucomamedication;at42months,95%ofeyesremainedmedicationfreeLindstromRASCRS2018mmHg®

19©2019GlaukosCorporationDrugReservoirScleralAnchorRetainingCapElutionMembraneTitaniumimplant(1.8mmx0.5mm)designedforcontinuousdrugdeliverydirectlyintoanteriorchamberFilledwithproprietary,novelanduber-potentformulationoftravoprost;membrane-controlledFickianelution;zero-orderratesdemonstratedinvitroandinvivoElegantandfacileinjectableprocedure;bypassingcorneaallowsformicro-elutionratestoachievetherapeuticindexAnchorkeepsdeviceinplaceandfacilitatesstraightforwardexchangeupondrugdepletionCurrentlyenrollingOHT–moderateOAGpatientsinPhaseIIIclinicaltrialsOAGProgressionOCULARHYPERTENSIONMILDMODERATEADVANCEDREFRACTORYiDoseTravoprost:First-of-a-KindIntraocularDrugDeliveryDeviceTMiDoseTravoprostisanunapproveddrugandlimitedbyUSlawtoinvestigationaluse

20©2019GlaukosCorporationiDoseTravoprostUSPhaseII:PreliminaryEfficacyResultsAverageIOPreductionsthroughMonth12rangingfrom7.9to8.5mmHgintheimplantarmsRepresents32-33%reductionintheimplantarmsAverageIOPReductionsfromBaselinethroughMonth12*FastElutionSlowElution*CalculatedusingallIOPobservationsthrougheachdatapointweightedequallymmHgTimolol0.5%8.58.48.48.28.08.07.97.97.67.67.67.66.06.57.07.58.08.59.0Week12Month6Month9Month1233%30%n=51544950534935424025242532%33%33%32%32%32%32%30%30%30%iDoseTravoprostisanunapproveddrugandlimitedbyUSlawtoinvestigationaluseTimololgrouprequired31%moremedicationsonaverage,comparedtoiDosecohorts

21©2019GlaukosCorporation53%iDoseTravoprost:UnderstandingNeedforAlternativetoTopicalMedicationsKeyNon-AdherenceStatistics11QuigleyHAGlaucoma:WhatEveryPatientShouldKnow2011;FriedmanDSetalInvestOphthalmolVisSci.2007;GlaucomaResearchFoundation;MarketScope2AGISInvestigatorsAmJOphthalmol.2000;LeskeMCetalArchOphthalmol.2003;BlalockSetalOphthalmology2011;OlthhoffetalOphthalmology2005KeyReasonforNon-Adherence1ComplexdosingregimensCostandforgetfulnessDifficultyinstillingdrops,especiallyforelderlypatientsAdversesideeffects(hyperemia,etc.)and/orintolerancewithtopicalmedicationsInconvenienceand/ormisunderstandingabouttheneedValueofAdherencetoTherapy2LoweringIOPisonlyprovenglaucomatreatmentLowIOPisassociatedwithreducedprogressionofopticnervedamageandvisualfielddefect,permultiplestudiesStudiesshowthatpatientswithpoormedicationadherencehaveworsevisualfielddefectseverity10-25%ofnewlyprescribedpatientsdon’trefill2ndprescription40-60%ofnewlyprescribedpatientsarestilltakingtheirmedsatendofYear170-75%rateofcompliancereportedfor“compliant”patientsPatientnon-adherencetotopicalglaucomamedicationsisubiquitous

22©2019GlaukosCorporationProstaglandinsBetaBlockersAlphaAgonistsCombinationDrugsOther53%TopicalPharmaceuticalsDominatetheMarketiDoseTravoprost:UnderstandingtheUSGlaucomaPharmaceuticalMarket201720228.2M9.8MPrimaryOAGOcularHypertensionDiagnosedandTreatedPopulationProjections(eyes)3.6%AnnualGrowth83%Surgical,includingMIGSDiagnosticsTopicalMedicationsProstaglandinAnalogsAreMostCommonFirst-LineTherapySource:MarketScopeSource:CompanyEstimates50%1Med2Meds≥3MedPatientsFrequentlyRequireMultipleMedications53%37MEst.Rxunitssold$2.2BEst.annualrevenue=

23©2019GlaukosCorporationiDoseTravoprostProcedureiDoseTravoprostisanunapproveddrugandlimitedbyUSlawtoinvestigationaluse

24©2019GlaukosCorporationiDoseTravoprostExchange(Removal)ProcedureiDoseTravoprostisanunapproveddrugandlimitedbyUSlawtoinvestigationaluse

25©2019GlaukosCorporationLeverageCoreCompetenciesLeveraginguniqueexpertiseinmicro-mechanicaldesign,assemblyandfillingprocessesBuildSeasonedTeamBuildingseasonedoculardrugdeliveryteamofchemists,scientists,engineersFocusedonearly-stageproductdevelopment,novelsustainedpharmaceuticalsystems,platformoptimizationUnderstandingdrugcharacteristicsandpredictabilityfordeliveryviaiDosesystem•Small-moleculeAPIs,highpotency,lowaqueoussolubility•Receptordoesnotlosesensitivityduringlong-termdosing•Potentialforreducedsideeffectsvs.topicaldelivery•MolecularstructurechemicallystableovertimeImplementROCKInhibitorCollaborationPreeminentROCKinhibitorresearchorganizationAbilitytoaccessDWTI’sROCKinhibitorcompoundlibraryandpotentialnewcompoundsCertainexclusiverightstodevelopnovelproductsusingcompoundsStrategyforExpandingOurMicro-ScaleRxInjectableTherapyPotential

26©2019GlaukosCorporationPotentiallyExpandingOurAnnualMarketOpportunity7x+OHT/POAGprevalence:~18Meyes8.2MeyesdiagnosedandtreatedGrowing3.5%annually33%ofstandaloneOHT/POAGpopulationispseudophakicCombinationtherapydrivesmoreopportunityforGlaukosportfolio*2017marketopportunity;basedonGlaukosalgorithmofphysicianpreferenceandcombinationtherapyutilization;assumesfullproductportfolioavailabilityforphysician2xTotalglobalopportunityUSAnnualOpportunity*(eyes)Mild-ModPOAG/Combo-cataractAdv-RefractoryPOAG/StandaloneMild-ModPOAG/StandaloneOHT-RefractoryPOAG/Standalone~0.6M~0.8M~3.8M~4.3MTotalDx&TreatedPrevalence(eyes)2.4M8.4M11.1MTotalPrevalence(eyes)2.8M17.3M21.7M

27©2019GlaukosCorporationGlaukos:TransitioningintoOphthalmicPharma/DeviceLeader•Deliveringnovelsolutionsthataddressimportantunmetclinicalneedsinlargeandgrowingmarkets•StrengtheningpositionasglobalMIGSleaderwithsuccessfulUSlaunchofiStentinject•Advancingsolidcadenceofmarket-expandingpharmaandsurgicalproductintroductionsovernext5+years•Investingstrategicallyacrossallaspectsofbusinesstostimulateandsupportlong-termgrowth•BuildingthreedistinctandcomplementarytechnologyplatformstotransformglaucomatherapySurgicalPharmaDiagnosticsDeliveringnovelglaucomatherapyacrossmultipletechnologyplatforms

28©2019GlaukosCorporation28