DrivingInnovationAndStrategicExcellenceintheLifeSciences

CarlosNVelez,Ph.D.ManagingPartnerLacertaBioInc.

carlosnvelez@lacertabio.comOffice+18452933343

OurPracticeAreasAreDedicatedToServingTheBusinessDevelopmentCommunity

Weruncompletein-licensingandout-licensingprocesses,utilizingasuiteofapproachestomaximizetheprobabilityoflicensingsuccess.

WeconsulttoBD&Lteamsbyprovidingduediligencesupport,valuation,secondopinions,andprocessaudits.

OutsourcedLicensing Consulting

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OurPractice

OurConsultingPractice

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• ProductDevelopment• IntellectualProperty• MarketOpportunityAssessments

• ProductIn- andOut-Licensing• ProductandCompanyFundRaising• Duediligencesupportforinvestors

• InterimandFullTimeManagement• TurnAroundSituations• TemporaryManagementSupport

Weadviseonproductdevelopmentandcommercialopportunities.

Wesource andassessnoveltechnologies,orfindpartnersforourclients’innovations.

WeFocusOnWhatMattersMostToSeniorManagementAndTheirInvestors

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Weexecutecompanyturnarounds,orprovideinterimmanagementservices.

OurOutreachFramework

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WhetherIn- orOut-Licensing,WeUtilizeMultipleChannelsForMaximizingCommunication

• PassiveMarketing– IndividualpagesonLacertaBio.commarketedviaLinkedInandotherdigitalchannels

• Databases – Pastconferences,MedTrack…

• ActiveOutreach– Callstocompanieswithexpressedinterestintherapeuticareaorasset,plusnewsletterwith3000+recipients

• Conferences – RepresentationatBiotechShowcase,BIO,andBIOEuropeFallincludedinfees

• Client/LacertaBioIdeas– PriorcontactsandrelationshipsandVCs

WeIncreasethePaceofBDThroughaCompletelyOutsourcedApproach

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ExecutivesWantFasterBDWithoutMajorIncreasesinExpenses.WeProvideThisSolution.

Situation

• Managementneedstoefficiently increasein- andout-licensingcapabilitiesanddealflow

• AmplesupplyofexperiencedBDprofessionalsavailable

• Demandforqualityassetswithattractivecommercialpotentialandaclearly-definedriskprofilehasneverbeengreater

Challenges

• InvestorsdemandfasterBD&L,distractingmanagementfromkeyoperationaltasks

• HiringBDtalentisexpensive,risky,andtime-consuming

• Needtoemphasizecommercialbenefitsandriskstoprospectivepartners

OurSolution

• WeprovidetheBDservicesneeded,enablingmanagementtofocusonotherareasofthebusiness

• OutsourcedBDledbyindependent,seasonedprofessionals

• Materialsandprocessesemphasizecommercialbenefitstoprospectivepartner,unclutteredbytechnicaldetails

ConsultingCaseStudy:ValuationForLicensing

Situation

• CanadianpharmaceuticalcompanywithaPreclinicallicensingopportunity

• NegotiatingalicensingdealwithaChinesepharmaceuticalcompany

• NeedforChina-specificmarketassessment,valuation,anddealanalysis

Challenges

• Reformulationofexistingdruginahighlycompetitive,price-sensitivemarket

• ChinesecompanypreferringtransactionbasedonSales,notUpfronts &Milestones

• ChinesehealthcaresystemamysterytomanyNorthAmericansandEuropeans

OurSolution

• Emphasisofclinicalbenefitstonewproduct,andresultingcost-savings

• On-the-groundanalystsinChinawhounderstandlocalsystem

• BlendofUSandChinesedatasourcestoarriveatreasonablevaluationanddealterms

OurGlobalReachEnablesLacertaBioToConductMultinationalValuationExercises

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DrugDeliveryLicensingPresentsSpecialChallenges

Situation

• Drugdeliverytechnologycompaniesfrequentlyhavealargeportfolioofprojects

• Rangefromideastofullclinicalprograms

• Productlicenseorapprovaloftennecessarytovalidateunderlyingtechnology

Challenges

• Difficulttoextractmeaningfulbenefitsorperformancefromolddrugs

• BigPharmacompaniesusuallyeschewnon-NCEproductcandidates

• Reimbursement canbeatremendouschallengewithoutdemonstratedhead-to-headclinicalbenefits

OurSolution

• Prioritizationbasedonlocalcompetitiveenvironments&superioritytogenerics

• Seekpartnersoutside“BigPharma”landscape, suchasAsiaandLatAm

• Focus onclinicalbenefits,nottechnicalperformance

OurExperienceatPenwestRemainsQuiteRelevant

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Consulting:AnalysesHelpFocusBDEffortsOurApproachHelpsFocusOut-LicensingEffortsOnAssetsWithGreatestChanceofSuccess

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AssetAnalysis• Indications•Datainhand•CommercialOpportunity•Developmentplan• IP•Competition

PartnerPerspective•Searchforpotentialpartners•Examinetheirrequirements•Assessgapsintheirpipelineorrevenueforecasts

Decision•YES- Assetislicensableandseveralpotentialpartnersidentified

•NO- Noobviousmarketforasset;deprioritize

•MAYBE- Assethaspotential,butgapsexist,i.e.,datagaps &furtheranalysis

Deliverableisareportwhich:• Prioritizesassetstofocusout-licensingefforts• Identifiesprospectivepartnerstotarget• Providesinformationtohelpcustomizemessagetotargetcompany

CaseStudy:License-AbilityandPrioritizationWeHelpFocusLicensingEffortsToMaximizeChancesForATransaction

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Situation

• Asiangovernmentresearchinstitutewith12drugdiscoveryprograms

• Eachwithalibraryofnoveldrugcandidatesandinitialpreclinicaldata

• Instituteinitiatedout-licensingefforttofindcorporatepartners

Challenges

• Onlyonepersonresponsibleforout-licensing12programs

• SomeNCEswereagainstestablishedtargets,somewithonmarketproducts

• Lackofcleardetailedcommunicationinpresentationmaterials

OurSolution

• Were-prioritized andfocusedeffortson6ofthe12programs

• Repositionedassetstogeographiesoutsideestablishedmarkets

• Workedtoreviseallnon-confidentialandconfidentialdatapackages

BDAudits:WhatHappensWhenBDIsNotSuccessful?

CommercialAssessments– WhatCanGoWrong?• ExaggerationsorincorrectassumptionscanquicklyleadtoBDfailure• Overestimationofreimbursementenvironmentanotherproblem•Wecanidentifyareasthatrequirerevisionofexistingdata

OutreachProcess• Areyouattendingtherightconferences?• Areyoutalkingtotherightpeople?• Areyourmaterialscustomizedforyouraudiences?

BDPersonnel&SkillSet• Doyouneedleadgeneratorswhenyouonlyhaveclosers?• Isthereamismatchbetweenyoursalesfunnelandyourorganization?• Aretherightpeoplewiththerightskillsinplace?

WeCanAuditExistingEfforts,ProvidingReal-WorldAdviceWhichMayLeadToSuperiorResults

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DatabaseSearchesIdentifyProductsandCompaniesMedTrackIsButOneToolInTheOverallSearchProcess

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• MedTrack canbeusedtoidentifyindividualtecjnologies,productsandcompanies

• Otherdatabasesusedincludethosefrompastpartneringconferences,partnering360,data.com,andothers

SearchforEarly-StageAssetsandTechnologiesinGastroenterology

ExamplesofPast&CurrentConsultingClientsProjectsInvolvedLicensing,MarketResearch,DueDiligence,&OtherTopics

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TeamandPartners

LacertaBioLeadership– CarlosN.Velez

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Nearly20YearsExperienceinConsultingandBusinessDevelopment

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• FounderandManagingPartnerofLacertaBio (2010)• CurrentandpastclientsincludeTzamal(Israel),Panion(Sweden),Nevakar

(USA),CombiGene(Sweden),Troikaa(India),KRICT(Korea),Cornerstone(USA),Almac(UK),UniversityofBath(UK),APJLabs(India),Pfizer(USA)…

• Co-founderofConnexinTherapeutics,anophthalmologydrugdevelopmentcompanycurrentlyraisingaSeed/SeriesAroundoffinancing.

• PreviouslytheChiefBusinessOfficerofLanticTherapeutics(UK)untilthepassingofthescientificco-founderin2012.

• FormerDirectorofBusinessDevelopmentatPenwestPharmaceuticals,wherehewasresponsiblefortheout-licensingof505(b)(2)programsdevelopedinternally,aswellasthescoutingandanalysisofneurologyin-licensingopportunities.

• OtherpreviousemployersincludeForestLabs,FrankelGroup(nowHuronConsulting)andGenencor(nowownedbyDanisco).

• B.S.inPharmacyfromtheAlbanyCollegeofPharmacy,aPh.D.inPharmacyfromtheUniversityofNorthCarolinaatChapelHill,andanMBAinFinancefromtheRochesterInstituteofTechnology.

OurPartnershipsWePartnerWithExpertsGlobally,OnAPer-ProjectBasis,ImprovingGlobalReachandEfficiency

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Since2010,London-basedEgamidhasfacilitatedvarioustransactionsacrossEurope,Asia,andNorthAmerica

WithofficesinShanghai,HongKong,andBeijing,LingmedoffersavarietyofpartneringservicesandtoolsfortheAsianmarkets

OperatesdualbusinessmodelofconsultingandcompanyformationfromofficesintheUS,Europe,andChina

DrivingInnovationAndStrategicExcellenceintheLifeSciences

CarlosNVelez,Ph.D.ManagingPartnerLacertaBioInc.

carlosnvelez@lacertabio.comOffice+18452933343