Company Overview March 2020€¦ · 13/03/2020 · which will aid market uptake. Marketing...
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Company Overview March 2020
Transcript of Company Overview March 2020€¦ · 13/03/2020 · which will aid market uptake. Marketing...
CompanyOverviewMarch2020
Forward-LookingStatements
Thispresentationincludes,andourresponsetovariousquestionsmayinclude,forward-lookingstatements.Allstatementscontainedinthispresentationotherthanstatementsofhistoricalfacts,includingstatementsregardingourfutureresultsofoperationsandfinancialposition,ourbusinessstrategyandplansandourobjectivesforfutureoperations,areforward-lookingstatements.Thewords“anticipate,”“believe,”“continue,”“estimate,”“expect,”“intend,”“may,”“will”andsimilarexpressionsareintendedtoidentifyforward-lookingstatements.Wehavebasedtheseforward-lookingstatementslargelyonourcurrentexpectationsandprojectionsaboutfutureeventsandfinancialtrendsthatwebelievemayaffectourfinancialcondition,resultsofoperations,businessstrategy,short-termandlong-termbusinessoperationsandobjectivesandfinancialneeds.Theseforward-lookingstatements,includingregulatoryandcommercialtimelinesandmarketsizeestimates,amongothers, aresubjecttoanumberofrisks,uncertaintiesandassumptions.Moreover,weoperateinaverycompetitiveandrapidlychangingenvironmentandourindustryhasinherentrisks.Newrisksemergefromtimetotime.Itisnotpossibleforourmanagementtopredictallrisks,norcanweassesstheimpactofallfactorsonourbusinessortheextenttowhichanyfactor,orcombination offactors,maycauseactualresultstodiffermateriallyfromthosecontainedinanyforward-lookingstatementswemaymake.Inlightoftheserisks,uncertaintiesandassumptions,thefutureeventsandtrendsdiscussedinthispresentationmaynotoccurandactualresultscoulddiffermateriallyandadverselyfromthoseanticipatedorimpliedintheforward-lookingstatements.Althoughwebelievethattheexpectationsreflectedintheforward-lookingstatementsarereasonable,wecannotguaranteefutureresults,levelsofactivity,performance,achievementsoreventsandcircumstancesreflectedintheforward-lookingstatementswilloccur.Weareundernodutytoupdateanyoftheseforward-lookingstatementsafterthedateofthispresentationtoconformthesestatementstoactualresultsorrevisedexpectations,exceptasrequiredbylaw.Thispresentationalsocontainsestimatesandotherstatisticaldatamadebyindependentpartiesandbyusrelatingtomarketsizeandgrowthandotherdataaboutourindustry.Thisdatainvolvesanumberofassumptionsandlimitations,andyou arecautionednottogiveundueweighttosuchestimates.Inaddition,projections,assumptionsandestimatesofourfutureperformanceandthefutureperformanceofthemarketsinwhichweoperatearenecessarilysubjecttoahighdegreeofuncertaintyandrisk.Thispresentationincludeslong-termgoalsthatareforward-looking,aresubjecttosignificantbusiness,economic,regulatoryandcompetitiveuncertaintiesandcontingencies,manyofwhicharebeyondourcontrolandourmanagement’scontrol,andarebaseduponassumptionswithrespect to futuredecisions,whicharesubjecttochange.Actualresultswillvaryandthosevariationsmaybematerial.Nothinginthispresentationshouldberegardedasarepresentationbyanypersonthatthesegoalswillbeachievedandweundertakenodutytoupdateourgoals.
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NeumentumisPoisedtoBecomeALeaderinNon-OpioidPainProducts
• Neumentum iswellpositionedtotakeadvantageofmajorshiftsawayfromopioidsandincreasedinvestorinterestinPainspace.
• Developingsixnovelnon-opioid productcandidates
• Toradol PMB(Pre-MixedBag)couldbethe firstevercontinuously-infused,long-actingnon-opioidanalgesic,offeringalowornoopioidpost-operativeanalgesicprotocol
• Potentialapprovalin2021underthe505(B)(2)process
• Phase3firstpatientdosingexpectedQ2/Q3,2020
• Patentprotectionthrough2032
• Globalin-licenseagreementwithJ&JforJNJ-232,anoralnon-opioid/non-NSAIDanalgesicwithnovelMOA – AdenosineA3ReceptorModulator,or“ARM”
• Twicedaily,oraldose,targetingbroadindicationformoderatetomoderatelysevereacutepain
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Companyisnowseekingto
raiseit’sSeriesB/Crossover
Round,
withIPObeingcontemplated
in2020-21
ExecutiveOfficers:WorldClassLeadershipIntheAnalgesicSpace
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R.ScottShivelyChiefExecutiveOfficer
• Instrumentalin$1BacquisitionfromJ&JandrelaunchofNucynta
• LedGlobalCommercialforPfizer’s$7BPainPortfolio
• DevelopedLyricafranchise,exceeding$4Binsales
JosephPergolizzi,Jr.,M.D.ExecutiveChairman
• InternationallyrecognizedkeyopinionleaderinPainMedicine
• Co-FounderNEMAResearchInc.,aspecialtyCRO
• ChairmanPAINWEEKandConsultanttoNationalPainFoundationBOD
IlonaSteigerwald,M.D.ChiefMedicalOfficer
• Morethan20yearsofinternationalpharmaceuticalexperience
• Ledresearchanddevelopmentstrategiesforalate-stageportfoliofocusedinanalgesiaatGrünenthal GmbH
SarahHowlettFaustChiefCommercialOfficer
• SeniorcommercialleaderinthepharmaceuticalindustrywithU.S.andglobalexperience
• Ledhighperformingsalesand/ormarketingteamsatPharmaDerm,KingPharmaceuticalsandSanofi.
• Deepcommercialexperiencelaunchingandgrowingbigbrands.
RobertRaffa,Ph.D.ChiefScientificOfficer
• Experiencedindustryleaderinpharmacologyandtherapeuticutility
• Teamco-leaderforanalgesicsdrugdiscoveryatJohnson&Johnson.
• Internationallyrenownedscientistandkeyopinionleader
SalmaLemtouni,MD,MPHVP– RegulatoryAffairs• 14yearsattheFoodand
DrugAdministration(FDA),
• DeepinsightintoFDA’sstructuredapproachtoBenefit-Riskassessment
• Guidedpharmaceuticalindustrysponsorsintodevelopingsoundregulatoryplans,furtheringdevelopment.
NTM-001Toradol PMB
(Ketorolacpre-mixedbag)
Novel,Non-OpioidTreatmentforPost-OperativePainRelief
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KetorolacHistory MarketOpportunityin2017(#ofinjections,annually)
NovelFormulationofToradol (ketorolac)ProvidesSignificantOpportunityinLargeandHighlyDisruptedPost-SurgicalPainMarket
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• Toradol (ketorolac)wasdevelopedbySyntexCorporationandwasfirstapprovedforintramuscular(IM)andintravenousIVinjectioninNovember1989
• Ketorolaciswell-knownbyphysicians,nurses,andsurgeons
• Widelyusedinthepost-operativepainmanagementsetting
• In2017,ketorolacrepresented21%ofthe~218mmdosesoftheUSinjectableanalgesicmarketin2017,+18%YOY.
• Dr.Joe Pergolizzi developedToradolPMB,thefirstcontinuouslyinfusedNSAID,andNeumentumsubsequentlyacquiredrightstotheproduct
Source:SHAPHASTUSIVanalgesicnon-retailpackunitdata,MATNov2017
Ketorolac,45.,7MM
21% Ofirmev,9.8MM5%
Opioids,161.4MM
74%
Hydromorphone 59MM,27%Morphine62MM,27%Fentanyl26MM,12%
MallinckrodtacquiredOfirmevfromCadencePharmaceuticalsin2014
for $1.3B
OurSolution:ToradolPMB(NTM-001)
• NovelketorolacPremixedbagwhichallowsforupto24hrs ofcontinuousinfusion ofketorolac,apotentNSAIDforcontinuouspainrelief• Reducesanalgesicgaps(improvespainmanagement)• Eliminatesneedformultipledoses(patientscannotexceed
doseceiling)• Indicatedformoderately-severepost-surgicalpain,where
opioidtherapymaybe required• OpioidandNSAIDsparing.Potentialopioid-replacement• Reducesinstitutionalliabilityandadministrativeburdens• Alcohol-freeformulationavoidspainuponinjectionand
venousdamage• Convenientandfitsdesired24-hrhospitallength-of-stay• Reduceslengthofstay,loweringhospitalizationcosts
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NTM-001(ToradolPMB)AimstoAddressShortfallsinCurrentPainManagementPractices
Source:IndependentAcutePainResearch,Nov2010.N=24(12anesthesiologists,12clinicalpharmacists)
Opioids:• An abuse anddiversionliability• Dangeroussideeffect profiles• Increasedhospitalization expenses• Administrativelyburdensome
CurrentKetorolacProducts:• Onlyavailableasshort-actingbolusinjections(shots)
• Oftenrequiremultipledoses1 totreatpain,resultinginanalgesicgaps
• Mayexceeddailydoseceiling• Inconvenientw/potentialdosingerrors• Painfulinjectionduetoalcoholformulation
ChallengeswithPainMedicationOptions: ChallengeswiththePainManagementRegimen:
• Opioidsarestillfoundationaltreatment• Needformultipledosesandanalgesicgapswithnon-opioidoptions
• Useofopioidsinsettingswheremoreefficaciouspainreliefisneeded• RaisestheriskofaddictionandopioidinducedAEs
• Increasedlengthofhospitalstayandcosts• Institutionalliabilityandadministrativeburdens
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Phase1ClinicalDataPredictiveof24-hourContinuousEfficacy,LeadingtoPhase3
Open-Label,randomized,controlledtrialofNTM-001vs.IVbolusQ6Hfor24hoursforatotalof4doses
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PKStudyDemonstratedPlasmaLevelsofKetorolacasPredicted,withLowInterpatient
Variability
MedianactualNTM-001exposureisapproximately13%lowerthanpredicted
InitialconcentrationsassociatedwithI.V.loadingdoseofNTM-001somewhathigherthanpredicted
Initialpainreliefscoreshigherthanpredicted
(rapidonset)
PainreliefscoresforNTM-001consistentlyover70%.Boluscanbeaslowas35%
0 4 8 12 16 20 24 28 32 36 40 44 480102030405060708090100
Effect
Time
0 4 8 12 16 20 24 28 32 36 40 44 48
0
1
2
3
4
5
6
7
Co
nc
mg
/L
Hour0 4 8 12 16 20 24 28 32 36 40 44 48
0
1
2
3
4
5
6
7
Co
nc
mg
/L
Hour
PlasmaCo
ncentration
Efficacy
96.5mg/24h
120mg/24h
0 4 8 12 16 20 24 28 32 36 40 44 480102030405060708090100
Effect
Hour
BlackLines/greyshading:Median+/- 95%populationpredictionintervalfromoriginalmodelingRedLines/redshading:Median+/- 95%populationpredictionintervalfromPhase1study
Source:Steigerwald etal.,abstract/poster#40,PAINWeek,LasVegas,Sep.2019
2019 2020 20211Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
NTM-001Phase3ProgramRequiresOnly1PivotalStudy,withFDAApprovalPossiblein2021
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Approval
HEORTrial
End-of-Ph2 meetingPotentialLaunchQ1/2022
PotentialPriorityReviewApproval
Preclinical
PIIIEfficacy
PIIISafety/Effectiveness
NDAPrep
Chemistry,ManufacturingandControls
Phase3:NTM-001-CT001Efficacy Phase3:NTM-001-CT002Safety/Effectiveness
Post-Bunionectomy patients(n=390)PrimaryEndpoint:SuperiorefficacyofNTM-001vsplacebo(SPID24)KeySecondaryEndpoint: Non-inferiorityofNTM-001vsIVmorphine(SPID24)/opioidreplacementSecondaryEndpoints:Opioid-sparingand/oropioid-freecontinuation
ElectiveSurgerypatients(n=616)PrimaryStatistics:IncidenceofmajorGISAEsofinterest(non-comparative)SecondaryStatistics: Non-inferiority(effectiveness)vsIVmorphine
ToradolPMBPotentialPeakUSSalesExceed$700M*
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Note:NeumentumhasregisteredtheToradoltrademark.Webelievethetrademarkhassubstantialbrandequitywhichwillaidmarketuptake.Marketingresearchsupportshighpreferencesharesandrapidformularyuptake
*Neumentum revenueforecastmodel,onfile
BasedPrimarilyUponPenetrationofExistingMultiple-DoseKetorolacMarket.GreaterOpioidReplacementPresentsUpsidePotential
$10
$65
$192
$387
$494
$568$609
$639$671
$704$740
$-
$100
$200
$300
$400
$500
$600
$700
$800
2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031
GrossS
ales($
MM)
ToradolPMBRevenueForecast
JNJ-10450232
ANovel,OralNon-opioidAnalgesic
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GlobalLicensingAgreementwithJ&JforJNJ-10450232–aPhase2Oral,Non-opioidAnalgesic
• NTM-006(JNJ-10450232)hasdemonstratedefficacyvs.placeboinPhase2Adentalpainstudy
• Non-opioid/non-NSAIDanalgesicwithnovelMOA – AdenosineA3ReceptorModulator,or“ARM”
• Dealincludes8backupmolecules
• BIDoraldose,targetingbroadindicationformoderatetomoderatelysevereacute pain
• Potentiallyexcellentreplacementoptionfororalopioidsforpost-surgicalpainupon
dischargefrominstitutionandotheroutpatientnon-opioidanalgesicregimens
• J&JConsumerProductsdivisionhasfirstoptiontofutureOTCswitchrights
• Fulllife-cycleprogram,includingex-US,isplannedtomaximizefranchise
• Firststageofdevelopmentintendedtomitigatemild,transientrashAEseeninsomePh1andPh2
patients(10%)
• FDAapprovalpossiblein2023,potentiallaunchin2024
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JNJ-10450232PostulatedMechanismofAction:AdenosineA3ReceptorModulator– “ARM”
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AdenosineA3 receptor-mediatedanalgesiaandinhibitionofinflammation
to
Brain:inhibitsN-typeCa2+channelsandexcesscellexcitationSpinalcord:inhibitsexcessmicrogliaandanomalousconvergenceofneurons
Inhibitsincomingpainsignalinbrain
Activatesdescendingsystemsthatattenuatepainsignalatspinalcord
NTM-006PhaseIIProofofConceptStudyDemonstratesUniqueEfficacy
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• DentalSurgeryStudy
• Single-dose,randomized,
double-blind,placebo-
andactive-controlled
study– 269patients
• Moderatetoseverepain
• Objectivetoevaluate
overallefficacy(and
safety/PK)
• Painassessmentsover24
hours
Time(hours)
LSMeanofSPID(+S.E.)
0
10
20
30
40
50
60
70
80
90
0 - 4 0 - 6 0 - 8 0 - 12 0 - 24
Placebo JNJ-10450232250mg JNJ-104502321000mg
SumofPainIntensityDifference(SPID)OverVariousTimeIntervalsx
Note:DataonfileJohnson&JohnsonCorporation
NeumentumDevelopmentPipelineandMilestones
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NTM-001(KetorolacPMB)
NTM-002(KetorolacPCA)
NTM-004(APAP Analogue)RarediseaseIV
NTM-003(Ketorolac
Intrathecal)
NTM-005(APAPAnalogue)BroadPainOral
NTM-006
2019 2020 2021 2022 2023 2024
Phase3 NDA
hase2 NDAPhase3
Phase1 Phase2/Phase3 NDA
Phase2 Phase3
P1 PC
Pre-Phase3 Phase3 NDACMC
Preparation&Planning
Phase1
Combination/LifecycleStrategy
Ongoingassessmentofassetcombinationsorcontinuityofcarelifecycles
Preclinical
Preclinical
Phase1 Phase2 Phase3 NDA
NeumentumMajorCatalysts:2019– 2021
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Catalyst ExpectedTiming
Closing&AnnouncementofJNJ-10450232Deal Oct2019
PreclinicalInjectionSiteStudyResolution March2020
Potential NTM-001partnering– Japan&China Q22020
StartofNTM-001Phase3EfficacyTrial Q2/Q32020
ToplineData – Phase3EfficacyTrial Q4 2020
CompletionofJNJ-10450232 “Pre-Phase 3”Stageof development Dec2020
PotentialNTM-001Approval 2021
StartJNJ-10450232Phase3Studies Q3 2021
ü
NeumentumInvestmentHighlights
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• Neumentum iswellpositionedtotakeadvantageofmajorshiftsawayfromopioidsinboththehospitalandout-patient/retailmarkets,andincreasedinvestorinterestinPainspace.
• Developingsixnovelnon-opioid productcandidates• LeadassetToradol Pre-MixedBag(PMB)isaPhase3-readyIVproductforpost-surgicalpain
• Recentlyin-licensedaPhase2oralproductwithanovelmechanismforacutepain• Toradol PMBcouldbethe firstevercontinuously-infused,long-actingnon-opioidanalgesic,offeringalowornoopioidpost-operativeanalgesicprotocol
• Potentialapprovalin2021underthe505(B)(2)process
• Phase3firstpatientdosingexpectedlateQ1/earlyQ22020• Patentprotectionthrough2032
• Globalin-licenseagreementwithJ&JforJNJ-10450232,anon-opioid/non-NSAIDanalgesicwithnovelMOA – AdenosineA3ReceptorModulator,or“ARM”
• Twicedaily,oraldose,targetingbroadindicationformoderatetomoderatelysevereacutepain
ExecutiveBios
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Dr.JosephV.Pergolizzi,Jr.,M.D.- ExecutiveChairman
Dr.JosephPergolizzi isaninternationallyrecognizedthoughtleaderinInternalMedicine,PerioperativeMedicine,PainMedicine,CriticalCare,PalliativeCare,Pharmacology,DrugDevelopment,andRegulatoryAffairs.
HeisanexperiencedexecutivewithC-levelpositionsheldinPharmaceutical,MedicalDevice,ConsumersHealth,ContractResearchOrganization,LifeScienceIndustry,andHealthcareInformationTechnologyCompanies.HehasservedastheChiefMedicalOfficerofKirax CorporationandTigrisPharmaceuticals;ChiefExecutiveOfficerofUmbriaPharmaceuticals;ChiefExecutiveOfficerofNativeCardiovascularInc;andaGeneralPartneratLifeScienceEquityPartners.
Dr.Pergolizzi istheformerDirectorofBusinessDevelopmentandFinancialAffairsfortheJohnsHopkinsUniversitySchoolofMedicine’sClinicalTrialsUnit.
HehasdemonstratedexperienceofselectinginvestmentsinlifesciencecompaniesbyBigPharmaandVCs,andisakeyconsultanttovariouspharmaceuticalandhealthcare-relatedcompanies.
Dr.Pergolizzi activelycontributedtoatleast5blockbusterdrugs,3NCEsandnumerous505(b)(2)compounds,medicaldevices,andconsumerhealthproductsresultinginexcessof$15billioninglobalsales.
HeformerlyservedonthesteeringcommitteememberoftheFoodandDrugAdministration’sSafeUseInitiativeandasGrantReviewerforVAH.Heco-foundedNEMAResearchInc.,aspecialtyCRO.
Healsoformerlyservedasapart-timeadjunctfacultymemberinthedepartmentofmedicineattheJohnsHopkinsUniversitySchoolofMedicine.
Experiencedinglobalhealthcarewithanextensiveprofessionalnetwork.
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R.ScottShively- ChiefExecutiveOfficer
ScottShivelyisanexperiencedseniorleaderintheUSandinternationalpharmaceuticalmarketswithextensiveCOOandCCO,experience. Hehasdeepexpertiseinmarketing,sales,managedmarketsandbusinessdevelopment/M&As,withdemonstratedabilitytolead,rapidlycreateandgroworganizations,developstrategyandexecutetodeliverresultsanddriverapidgrowthinsalesandvalueforshareholders.
CareerExperienceScotthasmostrecentlyservedasChiefCommercialOfficerandSeniorVicePresidentforDepomed,whereheledthe400-person,six-brandcommercialbusinessforthedynamicallygrowingPain&CNSSpecialtyPharmaceuticalcompany.DuringhistimeatDepomed,thecompany’snetsalesincreasedby199%annually,andheledcommercialandallfunctionaleffortsina$1.05billionacquisitionandre-launchoftheNucyntaproductsfromJohnson&Johnson.PriortoDepomed,ScottservedasExecutiveVicePresidentandChiefCommercialOfficerofZogenix,wherehedirectedallcommercialeffortsofthecompany,builtthecommercialorganizationandlaunchedanewpainproductinrecordtime.From2009to2012,hewasVicePresident- GlobalCommercialDiseaseAreaLeadforPainforPfizer,Inc.,wherehehadglobalcommercialleadershipresponsibilityforallofPfizer’smarketedanddevelopmentstagepainproducts,includingLyrica andCelebrex,withaccountabilityfor
over$6.5billioninrevenues.From2007to2009,ScottwasSeniorVicePresidentforCommercialOperationsatAlpharma Pharmaceuticals,aspecialtypharmaceuticalcompanyfocusedonpainmanagement,whereheledtheexpansionofthecommercialorganizationandnewproductlaunches,triplingbrandsaleswithintwoyears.HewasamemberoftheseniortransactionteamwhichcompletedthesaleofthecompanytoKingPharmaceuticalsin2009.
Earlierinhiscareer,ScottheldavarietyofdomesticandinternationalcommercialleadershiprolesatEndoandSanofi-Aventis.
In2015,ScottreceivedtheprestigiousPM360TransformationalLeaderAward,forhisachievementswithspecialtypharma companies,transformingcommercialteamstoexcelatacquiringnewassets,launchingnewbrands,andachievingrapidbusinessgrowth.
ScottreceivedaB.S.inZoologyfromDukeUniversitywithapre-medicalfocus.
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IlonaSteigerwald,M.D.– ChiefMedicalOfficer
Dr.IlonaSteigerwaldbringstoNeumentum 20yearsofinternationalandcross-culturalpharmaceuticalexperience,withafocusoninnovativetreatmentsforacuteandchronicpain.Mostrecently,shewasBusinessLeadoflateresearchanddevelopmentatGrünenthal GmbH.There,sheledresearchanddevelopmentstrategiesforalate-stageportfoliofocusedinanalgesia,centralnervoussystemandorphandrugs.
Dr.Steigerwaldhasworkedonavarietyofopioidandnon-opioidpainproductsandproductcandidatesincludingtramadol,tramadol-acetaminophen,transdermalbuprenorphine,topicallidocainepatch,tapentadol foracuteandchronicpain,asufentanil-relateddeviceforacutepostoperativepainandvariouslicensingopportunitiesinthefield.
Dr.Steigerwaldhaswrittenover30fulltextarticlesasacorrespondingorcontributingauthorandcontributedtoover70congressabstractsorposters.SheisamemberoforganizationsincludingtheAmericanPainSociety,InternationalAssociationfortheStudyofPainandNeuropathicPainSpecialInterestGroup.
Dr.SteigerwaldreceivedhermedicaldegreefromJulius-Maximilians UniversityinWürzburg,Germany.
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RobertB.Raffa,Ph.D.– ChiefScientificOfficer
Dr.RobertB.Raffahasdevotedhisprofessionalcareertopharmacologyandunderstandingthebalancebetweentherapeuticutilityandabusepotentialofdrugs.Hewasteamco-leaderforanalgesicsdrugdiscoveryatJohnson&Johnson,wherehewasinvolvedintheelucidationofthemechanism-of-actionoftramadolandthediscoveryoftramadolcombinations.Duringhis10-yearcareeratJohnson&Johnson,hewaspromotedtopositionsofincreasingresponsibilityandattainedthetitleofResearchFellow.
Dr.Raffahaspublishedover300peer-reviewedpapers,isco-authororeditorofseveralbooksonpharmacologyandisaco-editoroftheJournalofClinicalPharmacyandTherapeutics.Hehasreceivedmorethan$3millioninresearchfundingfromNIH(NationalInstitutesofHealth)andothersourcesforinvestigationofdrugactionanddrugabuseissues.
Dr.RaffataughtatTempleUniversitySchoolofPharmacyandisadjunctprofessorattheUniversityofArizona.
HeisapastpresidentoftheMid-AtlanticPharmacologySociety,andhelecturesandconsultsworldwideonanalgesicsandanalgesiccombinations.
Dr.Raffaearnedbachelor’sdegreesinChemicalEngineeringandinPhysiologicalPsychology(bothfromUniversityofDelaware),master’sdegreesinBiomedicalEngineering(DrexelUniversity,Philadelphia)andToxicology(ThomasJeffersonUniversity,Philadelphia),andadoctorateinPharmacology(TempleUniversitySchoolofMedicine,Philadelphia).
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SarahFaust– ChiefCommercialOfficer
SarahFaustisaseniorcommercialleaderinthepharmaceuticalindustrywithU.S.andglobalexperience.Shehasaproventrackrecordoflaunchingandgrowingrobust,multi-milliontomulti-billiondollarbrandsspanningthespecialty,retailandinstitutionalsettings.Sheisaresults-orientedbusinessexecutiveandanaccomplishedstrategistandmarketerwhoishighlyeffectiveatleadingsalesforcesandmobilizingcross-functionalteams.
Sarah’srecentrolesincludeleadingallaspectsofmarketingatDepomed fortherelaunchofNucyntaandNucyntaERfromacquisition,throughrepositioning,strategydevelopmentandoversightoftacticalexecutionforlaunch.Priortothis,SarahwasVicePresidentofSalesandMarketing,forthespecialtydermatologycompany,PharmaDerm.HereshemanagedthestrategicrefocusingoftheCompany’sportfolioandresourceoptimizationtodriveprofitability,launchedcompetitiveactionplanstodefendtheCompany’sleadingbrandandled
growthstrategiestodoublerevenuesofanother.BeforePharmaDerm,Sarahledahigh-performingmarketingorganizationforthespecialtypharmaceuticalcompanyKingPharmaceuticals,wheresheoversawthelaunchofthefirstabusedeterrentopioidandpreparedlaunchesforaportfolioofothers,whiledrivingrevenuesoftheCompany’sexistingpainandhospitalbasedproducts.SarahplayedapivotalroleinthetransitionofthePharmaDerm andKingbusinessesfollowingtheiracquisitionbySandozandPfizerrespectively.
Sarah’spreviousrolesincludeavarietyofcommercial,communicationsandmedicalpositionsatSanofi- notablyleadingglobalmarketingforLovenox,theworld’sleadinglowmolecularweightheparin,providingdeepexperienceinthesurgicalandinstitutionalsettings.
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PedroGranadillo - Director
Mr.Granadillo isahighly-respectedpharmaceuticalbusinessleaderwithover40yearsofexperienceintheindustryandaproventrackrecordinhumanresources,manufacturing,qualityandcorporategovernance.Hehasexpertiseinmultipleareas,includingdesigningandoperatingcomplexglobalmanufacturingnetworks,seniorleadershipdevelopmentandsuccessionplanning,executiveandnon-executivecompensation,organizationaltransformation,andportfoliomanagement.Hepossessesover2decadesofinternationalexperience,withdirectglobalresponsibilityforManufacturing,QualityandHumanResourcesand13yearsinleadershiprolesinEurope.
HeservedasSeniorVicePresidentforEliLillyandCompanyuntilhisretirementin2004after34yearsofservice.AsamemberofLilly’sExecutiveCommitteeandasLilly’sheadofhumanresources,manufacturingandquality,hewasresponsibleforpoliciesaffectingaglobalworkforceofmorethan45,000employees,aswellasabroadnetworkofmanufacturingfacilitiesforitsextensivelineofproducts.Healsooversawmorethan20sitesand13,000employeesinvolvedinthemanufacturingofLilly’sconventional“small-molecule”pharmaceuticalsand“large-molecule”biotechtherapies.
Pedrohasreceivedanumberofawardsoverthecourseofhiscareer,includingthePurdueUniversityDistinguishedAlumniAward.WhileatLilly,heledtheireffortsinaffirmativeaction,diversity,andprogressiveemployment,resultinginLilly’sreceiptoftheOpportunity2000AwardfromtheUSDept.ofLabor,andLilly’snamingtothe“BestCompaniestoWorkFor”byWorkingMotherMagazineforeveryyearduringhistenure.
SincehisretirementfromLilly,Pedrohasbeeninvolvedinanumberofpublicandprivatecompaniesinthebiotechnologyandmedicaldevicefields.HecurrentlyservesontheBoardofDirectorsofHaemonetics Corporation,inBraintree,MA.HepreviouslyservedontheBoardsofDirectorsofDendreon Corporation,Noven Pharmaceuticals,FirstIndianaBankandmostrecentlyontheBoardofDirectorsofNPSPharmaceuticals,whichsoldtoShirefor$5.2Billionin2015.
PedroearnedhisB.S.degreeinIndustrialEngineeringfromPurdueUniversity.
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ChristineMikail - Director
Christinehasspent15yearsinthebiopharmaindustryservinginavarietyofrolesspanningcorporatestrategyandbusinessdevelopment,managingandbuildingoperationsatstart-upcompaniesandconstructingandexecutingoncomplexfinancingsandlifesciencestransactions.
ChristineservedasCAO,headofexternalbusinessdevelopmentandgeneralcounselofAxovantSciences,Inc.,whichisdevelopingsolutionsforpatientswithdementia.ChristinewaspartofthesmallleadershipteamoffivethattookAxovant publicin2015witha$362millionIPO,thelargestbiotechIPOinhistoryatthetime.Christinebuiltoperationsfromthegroundupandledbusinessdevelopmentatthisfast-growingcompany.
Priortothat,shewasseniorvicepresidentforlegalaffairs,generalcounselandboardsecretaryatNPSPharmaceuticals,Inc.,whereshewasanintegralpartofitssaletoShirePharmaceuticalsfor$5.2billion.ChristinealsowasexecutivevicepresidentforcorporatedevelopmentattheDendreonCorporation,wheresheledthecompany’srestructuringsthatculminatedinitssaletoValeant.ShealsoheldseveralrolesatImClone SystemsandEliLilly,includinganinstrumentalroleinthesaleofImClone toLillyfor$6.5billion.
Shereceivedherbachelor’sdegreefromRutgersUniversityandherJDfromFordhamUniversitySchoolofLaw.
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AugustMoretti- Director
AugustMorettijoinedourBoardinApril2019.HeiscurrentlytheCFOof4DMolecularTechnologies,aprivatelyheldgenetherapycompany. Augiehasextensiveoperatingandfinancialexecutiveexperienceinallphasesofcompanygrowthandfunding,fromearlystagedevelopmenttoproductapprovalandcommercialization. From2012to2018hewasCFOofAssertio Therapeutics,apubliclyheldspecialtypharmaceuticalscompanyfocusedinpainandneurology,andfrom2004to2011CFOofAlexzaPharmaceuticals,apubliclyheldpharmaceuticalcompanydevelopingdrugdevicecombinationproductsforpulmonarydeliveryofCNSdrugs. From2001to2004hewasCFOandGeneralCounselofSurromed,aprivatelyheldbiotechnologycompanyfocusedonproteomics.Priorto2001hewasapartnerofHellerEhrman,aninternationallawfirm,wherehispracticeincludedrepresentationoflifesciencecompaniesonissuesrelatingtopublicandprivatefinancings,mergersandacquisitions,corporategovernance,disclosureandpublicreporting.
AsCFOofAssertio,Alexza andSurromed hehasraisedover$1.5billioninfunding,includingpublicandprivateissuanceofequity,convertibledebtandsecureddebtandmonetizationofroyaltyinterests,hasoverseenseveralproductacquisitionsandhasbeenresponsiblefor50consecutivequartersofpubliccompanyreporting.
AugieholdsaB.A.inEconomicsfromPrincetonUniversityandaJ.D.fromHarvardLawSchoolandhastaughtFinanceatUCBerkeleySchoolofBusinessAdministration.
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SalmaLemtouni,MD,MPH– VP– RegulatoryAffairs
Dr.Lemtouni,inher14yearsattheFoodandDrugAdministration(FDA),acquireddeepinsightintoFDA’sstructuredapproachtoBenefit-Riskassessmentindrugregulatorydecision-making,FDA’sapproachtopost-marketingsafetyevaluationandtheimpetusbehindFDA’spoliciesandregulations.
AtFDA’sDivisionofCardiovascularandRenalProducts,asaSeniorreviewer,Dr.Lemtouni guidedpharmaceuticalindustrysponsorsintodevelopingsoundregulatoryplansthatfurthereddrugdevelopmentprogramsandachievedapprovalandmarketingofmuchneedednewtherapies.AtFDA’sSafeUseInitiative,sheidentifiedandinvestigatedmultiplepost-marketingsafetysignalsthatledtoregulatoryaction.Dr.Lemtouni wasgivenmultipleawardsforexcellenceinreviewandcommunication,forhercontributiontoredesigningNewDrugApplicationreviewtoolsandforinitiatinginternalandexternalcollaborationsthatfocusedonthesafetyofFDAapprovedproducts.
PrevioustoherFDAtenure,asamedicalofficeratMedtronic,Dr.Lemtouni initiatedandestablishedtheclinicalprogramforthepremarketapprovalofSYNCRATMCRT-P(CardiacResynchronizationTherapyinheartfailure);andasaco-primaryinvestigator,shemanaged64clinicaltrialcentersinoneofNIH’slargeststudies,ALLHAT(Anti-hypertensiveandLipidLoweringtopreventHeartAttackTrial),thefindingsofwhichshapedtheguidelinesandchangedthepracticeofmedicineinthemanagementofhypertension.
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RiskFactors
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RisksAssociatedwithOurBusiness:
Thesuccessfulexecutionofourbusinessstrategyinvolvessignificantrisksanduncertainties,including,amongothers,theriskof:• Incurringsubstantialandincreasingnetlossesforatleastthenext24-36monthsbecausewehavenoproductsapprovedfor
commercialsaleandwehavenotgeneratedanyproductrevenuetodate.• Beingunabletoobtainsufficientadditionalfundingwhenneededforanyadditionallyrequiredclinicalprogramsand/ortopreparefor
potentialcommerciallaunchofourlatestageassets.• TheFDAmayrequireadditionalstudiesorsafetydatatobegeneratedandmaynotgranttheclaimsthatweseekforourproduct
labelling.AtourJanuary29,2019pre-Ph3meetingonourproduct(NTM-001),wesoughttheFDA’sagreementwithourproposedphase3program,andthevariousstudieswithinit.TheFDAguidedthatanactive-comparatoropioidarmbeaddedasaco-primaryendpointtoourpivotalbunionectomy study.TheFDAalsoaskedthatwecompleteapreclinicalstudypriortoinitiationofdosingofpatientsinourPhase3studiestoassesspotentiallocaltolerabilityandsecondaryeffectsoftwoexposurelevelsofcontinuousinfusionofNTM-001inminipigs.TheFDArespondedonJune25,2019toourproposedprotocolfortheminipigstudyand,basedonsuchresponse,wemayneedtoexpandonthestudy,whichweanticipatewilldelaythePhase3clinicaltrialstartdatetoQ12020 or later,andmayaddcosttoNeumentum's NTM-001program.
• UntiltheFDAreviewsourfinalPhase3studyprotocolsandtheresultsofthepreclinicalstudy,thereisariskthattherecouldbeadditionalcostordelaytothe NTM-001program,orboth.
• Beingunabletosuccessfullycompletetheclinicaldevelopmentandregulatoryapprovalprocessofourleadproductcandidates;• Potentialadversesideeffectsorlackofefficacyofourproductcandidatesthatcoulddelayorpreventcommercializationor causean
approveddrugtobetakenoffthemarket.• Ourinabilitytosuccessfullyobtainandmaintainintellectualpropertyrightsrelatedtoourproducts,preventmisappropriation or
infringementofourintellectualpropertyrights,andconductoperationswithoutviolatingorinfringingontheintellectualpropertyrightsofthirdparties.
• Ourpatentedandpatentpendingtechnologiesnotprovidinguswithacompetitiveadvantage,usbeingunabletodeveloporacquireadditionaltechnologythatispatentable,orthirdpartiesdevelopingandofferingtechnologiesthataresimilartoours.
• Failingtoobtainformularyuptakeandmarketacceptanceofourfutureproductsorachievesalesforecastandprofitprojections.• Competitionfromexistingproductsornewproductsthatmayemerge,ourfromcompanieswithlongeroperatinghistoriesandgreater
financialresources.• Ourabilitytosuccessfullycompleteanypotentialbusinessdevelopmentdealsonterms
acceptabletousifatall.30
RisksAssociatedwithOurBusiness(cont’d):
• Amild,transientrashAEwasseeninsomePh1andPh2patientsforJNJ-10450232.ThefirststageofNeumentum’s pre-Phase3developmentprogramisintendedtomitigatethisAE,howeveroureffortsmaynotbesuccessfulorcompletelysuccessful.
• Genericpricingcouldaffectcertainpricingassumptionsmadebyusandourabilitytosuccessfullycommercializeourproducts.• Anyearlystagetherapeuticcandidateswemaydevelopwillbesubjecttoextensivepreclinicalandclinicaltestingand
regulatoryapprovalandanysuchtherapeuticcandidatemayfailtosatisfactorilyprovidetherapeuticresultsormaydemonstratesafetyconcernsatanystageofdevelopment,whichmayadverselyaffectourabilitytocontinuetodeveloporcommercializeanyprospectivetherapeuticcandidates;theresultsof,anddatafrom,earlystageclinicaltrialsmaynotbepredictiveofresultsinfutureclinicaltrials.
• Wemaynotrealizeallofthebenefitscurrentlyanticipatedfromcertainlicenseagreementsandothercommercialarrangements,thatwehaveenteredintotodate,orthatwemayenterintointhefuture,includingthelicenseagreementreferencedonslide15.Inaddition,certaincommercialarrangementsandpartnerships,includingthelicenseagreementreferencedonslide15,thatwecurrentlyanticipateenteringintomaynotultimatelybeconsummated.
• Inadditiontothecapitalraisedinthisfinancing,wewillhaveasubstantialneedtoraisecapitalinthefutureinordertocommercializeourlatestageproductsandtocompleteclinicaldevelopmentandmonetizeourearlystageportfolio.Anyadditionalequityfinancingswillresultindilutiontoexistingstockholders.
• Nopublicmarketnowexistsforthesecuritiestobesoldinthisfinancing(orthesharesofcapitalstockintowhichtheyareconvertible),andtherecanbenoassurancethatapublicmarketwilleverexistforsuchsecurities.
• CertainmembersofourseniormanagementandBoardofDirectorshaverelationshipsandagreementsamongthemselvesaswellaswithus(suchagreementsincludeourlicenseoftheformulationsforNTM-001fromRTUPharmaceuticals,LLC),thatcreatethepotentialforbothreal,aswellasperceived,conflictsofinterest.
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RisksAssociatedwithOurBusiness(cont’d):
• Wemaynotsuccessfullyestablishandmaintaincollaborativeandlicensingarrangements,whichcouldadverselyaffectourabilitytodevelopandcommercializecertainofourproductcandidates.Anyofourcollaborationpartnersmaynotadequatelyperformtheirresponsibilitiesunderouragreements,whichcouldadverselyaffectourdevelopmentandcommercializationprogram.
• Wefacesubstantialcompetitioninthebiotechnologyindustryandmaynotbeabletocompetesuccessfullyagainstoneormoreofourcompetitors.
• Wedependonthirdpartiesforclinicalandcommercialsupplies,includingsinglesuppliersforNMT-001.• Ifwefailtocomplywithenvironmental,healthandsafetylawsandregulations,wecouldbecomesubjecttofinesorpenalties
orincurcoststhatcouldhaveamaterialadverseeffectonourbusiness.• Wemaybeexposedtoclaimsandmaynotbeabletoobtainormaintainadequateproductliabilityinsurance.
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