163.2012_AGM_Presentation_05-07-2013_EV_FINAL

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 2012 Annual & Special ee ng o  are o ers Ma y 8, 2013

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Transcript of 163.2012_AGM_Presentation_05-07-2013_EV_FINAL

  • 2012Annual &SpecialM ti f Sh h ldMeetingofShareholders

    May8,2013

  • 1. OpeningoftheMeetingAgenda

    2. ChairmanandSecretary3. Scrutineers4. NoticeofMeeting5. ReportoftheScrutineers6. MinutesofthelastMeeting7. ConsolidatedFinancialStatementsandAuditorsReport

    R ifi i f h f h Di8. RatificationoftheactsoftheDirectors9. ElectionofDirectors10 Appointment of Auditors and Fixing of their Remuneration10. AppointmentofAuditorsandFixingoftheirRemuneration

    11.Increaseofmaximumofcommonsharesreservedforissuanceundertheamendedandrestatedstockoptionplanp p

    12. RenewaloftheamendedandrestatedProMetic loanagreement13. Varia 2

  • Corporate Presentationp

  • ForwardLookingStatement/Copyrightnotice/ Disclaimer/Disclaimer

    ForwardLookingStatementThis presentation contains forwardlooking statements about ProMetics objectives, strategies and businessesthat involve risks and uncertainties. These statements are forwardlooking because they are based on ourcurrent expectations about the markets we operate in and on various estimates and assumptions. Actual eventsor results may differ materially from those anticipated in these forwardlooking statements if known or unknowni k ff t b i if ti t ti t t t b i t S h i k drisks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks andassumptions include, but are not limited to, ProMetics ability to develop, manufacture, and successfullycommercialize valueadded pharmaceutical products, the availability of funds and resources to pursue R&Dprojects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage ofbusiness opportunities in the pharmaceutical industry, uncertainties related to the regulatory process andgeneral changes in economic conditions. You will find a more detailed assessment of the risks that could causeactual events or results to materially differ from our current expectations in the Annual Information Form for theyear ended December 31, 2012, under the heading Risk Factors. As a result, we cannot guarantee that anyforwardlooking statement will materialize. We assume no obligation to update any forwardlooking statementeven if new information becomes available, as a result of future events or for any other reason, unless requiredby applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

    Copyright noticeThe information contained in this presentation (including names, images, logos and descriptions portrayingProMetic's products and/or services) is the property of ProMetic Life Sciences Inc., of its divisions and / or of itssubsidiaries (ProMetic) and is protected by copyright, patent and trademark law and / or other intellectualproperty rights. Neither this presentation nor any part may be reproduced or transmitted in any form or by anyproperty rights. Neither this presentation nor any part may be reproduced or transmitted in any form or by anymeans, electronic or mechanical, including printing and photocopying, or by any information storage or retrievalsystem without prior permission in writing from ProMetic.

    DisclaimerProMetic reserves the right to make improvements, corrections and/or changes to this presentation at any time.

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    ProMetic reserves the right to make improvements, corrections and/or changes to this presentation at any time.

  • ProMeticLifeSciencesInc.d i Introduction

    2012FinancialResultsB i S t BusinessSegments: Smallmoleculetherapeutics

    Protein Technologies:ProteinTechnologies: Bioseparation /filters

    Plasmaderivedproteins

    Q12013 2013Business:BaseCase

    l k Outlook 2013Objectives

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    QuestionandAnswerPeriod

  • 2012FinancialResults

  • The following information is derived from the auditedSourceofFinancialInformation

    The following information is derived from the auditedconsolidated December 31, 2012 financial informationand on the statutory financial statements for 2011,and on the statutory financial statements for 2011,both of which were prepared in accordance withInternational Financial Reporting Standards (IFRS).

    Further financial information, including the ProMetics, gAnnual Information Form, is available on SEDAR(www.sedar.com).

    All tabulated sums are in CAD 000s except for pershare amounts or where indicated.

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  • FinancialPerformancefor2012

    Significantly improved financialperformance in 2012 with recordrevenues of $23.3 million exceedinganticipated base case of $21.0million.

    P d t l f $11 6 illi Product sales of $11.6 million,Services revenues of $5.3 million andLicensing revenues totalling $6.4million.

    Stronger total revenues and costgcontainment positively impactedEBITDA.

    First EBITDA positive year in corporate$

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    history at $2.5 million.

  • ComparisonofKeyFinancials:P&LYearendedDecember31

    2012CAD 000s

    2011CAD 000sCAD000s CAD000s

    Revenues 23,321 17,589

    CostofGoods 5,326 1,854

    Total Research & Development Costs 10 310 11 230TotalResearch&DevelopmentCosts 10,310 11,230

    Administration&Marketing 5,966 5,789

    FinanceCosts 1,483 1,363

    NetLoss (424) (3,267)

    NetLosspershare(basicanddiluted) (0.00) (0.01)

    EBITDA* 2,498 (526)

    *EBITDA is a nonGAAP measure, employed by the corporation to monitor its performance. Therefore it is unlikely to becomparable to similar measures presented by other companies. The corporation calculates its EBITDA by subtracting fromR it C t f G d S ld it R h d D l t E R h bl d N R h bl ll itRevenues, its Cost of Goods Sold, its Research and Development Expenses Rechargeable and NonRechargeable as well as itsAdministration and Marketing Expenses and excluding amortization of capital assets and licenses and patents.

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  • ComparisonofKeyFinancials:B l Sh tBalanceSheet

    YearendedDecember31

    2012CAD000s

    2011CAD000s

    Cash 1,205 275

    Accounts Receivable 4,750 1,438AccountsReceivable 4,750 1,438

    ShareSubscriptionReceivable 9,822

    BankandOtherLoans (1,636) (752)

    Trade&OtherPayables (5,094) (7,091)

    DeferredRevenues (2,355) (447)

    LongtermDebtProvidedbyShareholders (4,017) (4,161)

    AdvanceonRevenuesfromaSupplyAgreement (3,030) (3,063)

    NetEquity(Deficiency) 5,819 (8,568)

    BalanceSheetTotalAssets 22,991 8,692

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  • BusinessSegment:SmallMolecule Therapeutics

  • USRDS2012AnnualDataReport

    Medicare Population 2010 Medicare Costs 2010

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  • RegulatoryStrategyKeyRegulatoryFilingMilestones&Timing:IVIGPBI4050 NewDatatobepresentedat

    l fInternationalConferences

    ERAEDTA(EuropeanRenalAssociation EuropeanDialysisandTransplantAssociation):Istanbul,1821May,2013.

    W ld C f N h l H K 31 M 4 J 2013 WorldCongress ofNephrology:HongKong,31May 4June,2013.

    Americanassociationforthestudyofliverdiseases:Washington15November , 2013November,2013

    AmericanSocietyofNephrology:Atlanta,November11,2013

    A i A i ti R i l C ti A h i N b 16 AmericanAssociationRespirology Convention:Anaheim,November162013

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  • Value Probability

    PhasesinDrugDevelopment&Relativevalue/ProbabilityofregulatoryApproval

    100%$5000M

    y

    RegulatoryFiling

    75%PhIII

    50%

    Ph Ib / II

    $500MPh II

    GLPTOXGMPAPI

    fili

    PhI

    PhIb /II

    +$250M

    10%R&DDiscovery

    PreclinicalProofofconcept

    INDfilings

    $50M$1.5M

    2013

  • DevelopmentMilestoneTimelinesCTAHealthCanada

    PreINDMeetingFDA/EMA/Health Canada

    IND FDACTA

    p

    Tech transfer chemical synthesis

    2013 2014Q1 Q2 Q3 Q4 Q1

    CanadaHealthCanada

    TechtransferchemicalsynthesisChemicalsynthesisscaleupGMPManufacturinginFDAplant

    Pharmaco kineticsGLP T i l PGLPToxicologyProgramFinaldosageformulation

    PhaseIHealthyl t

    PhaseIb IIPatients

    volunteers

  • BusinessSegment:gProtein Technologies

  • Bioseparation Enables the capture of multiple targeted proteins directly fromEnablesthecaptureofmultipletargetedproteinsdirectlyfrom

    varioussourceproducts

    Providesforahighlyefficientandcosteffectiveseparationprocessfromotherproteinsandimpuritiesdeliveringhighyieldsofpurifiedproduct

    Results in significant reductions in clients cost of goods andResultsinsignificantreductionsinclient scostofgoodsandcostsassociatedtodrugpurification.

  • Protein PowerHouse

    InitiationofacollaborativeagreementinJanuary2003tocodevelopanovelprocesstorecovertherapeutic proteins in a sequential manner from plasmatherapeuticproteinsinasequentialmannerfromplasma.

    CollaborationrelyingonProMetic's MimeticLigandstechnologiesandAmericanRedCross'suniquecompetenciesinplasmaandbloodproducts,processandanalyticaldevelopment.

    Resultedinthedevelopmentofaprocess(PPPS)capableofextractingsomeofthemostvaluableproteinsfromplasmaatmuchhigheryieldsthanotherprocesses.

  • PlasmaProteins

    75%ofrevenuesaregeneratedwith4proteins:Albumin,IgG,FactorVIIIandAAT

    74%ofrevenuesareusedby16%ofpopulation(NA,EU)

  • What is PPPSTM? Multiproductsequentialpurificationprocessoriginallydevelopedwith ARC. Proprietary platformderivedfromtheuseofPBLaffinitytechnology. DevelopedandcommercializedbyProMetics USbasedsubsidiary,PBT Using powerful affinity separation materials to extract and purify commerciallyUsingpowerfulaffinityseparationmaterialstoextractandpurifycommercially

    valuableplasmaproteinsinhighyield.

    Highlyefficientinextractingandpurifyingtherapeuticproteinsfromhumanplasma to develop best in class biotherapeutic productsplasmatodevelopbestinclassbio therapeuticproducts.

  • PPPSTM: The BenefitsPPPS :TheBenefits

    Improvedeconomicsoverindustryaverages,through: improvedrecoveryyield, smallerfootprintforsamemanufacturingoutput, more product from less plasmamoreproductfromlessplasma

    Improvedpurity

    Improvedsafety pathogenremovalandviralinactivation

    Recoveryofvaluableproteinstargetingrarediseases,potentiallyresultinginproductswithOrphanDrugDesignation

  • PPPSTM: The ProcessPPPS :TheProcess

  • TurnKeyProcess

  • PPPSTM:TheProducts&MarketOpportunitiesOpportunities

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  • Orphan Drug DesignationOrphan DrugDesignation

    Noveldrugsorbiologicsg g Treatmentofararediseaseorcondition Affectingfewerthan200,000patientsintheUS.g p SevenyearperiodofU.S.marketingexclusivityuponmarketingapproval

    Taxcreditsforclinicalresearchcosts Abilitytoapplyforannualgrantfunding

    l l h l d Clinicalresearchtrialdesignassistance Waiverofprescriptiondruguserfees.

  • TYPE1Plasminogen Deficiency Plasminogen: Plasminogen is a naturally occurring protein synthesized by Plasminogen: Plasminogen is a naturally occurring protein synthesized by

    the liver and circulates in the blood. Plasmin is involved in wound healing,cell migration, tissue remodeling, angiogenesis and embryogenesis.

    Type 1 Plasminogen Deficiency: One of the most welldefined conditionsassociated with plasminogen deficiency is ligneous conjunctivitis, which ischaracterized by thick, woody (ligneous) growths on the conjunctiva of the

    d if l ft t t d l d t bli d M t ff t deye, and if left untreated, can lead to blindness. Most affected cases areinfants and children

    Hypoplasminogenemia: multisystem disease that can also affect the earsHypoplasminogenemia: multisystem disease that can also affect the ears,sinuses, tracheobronchial tree, genitourinary tract, and gingiva.

  • OrphanDrugDiseasesTakingFrontStage

    TheNationalInstitutesofHealthestimatesthatthereareapproximately7,0008,000rarediseasesaffecting25millionAmericans.Ararediseaseisdefinedasaconditionaffectingfewerthan200,000peopleintheUnitedStatesStates.

    TheOrphanDrugAct(ODA)enactedin1983hasincreasedfrom10drugsin1983to382 in2011

    UndertheODA,>2,500medicineshavebeendesignatedorphandrugsandareinallstagesofdevelopment

    Orphandrugscurrentlymakeup22% oftotaldrugsales

    Inthelast3years,35% ofFDAapproveddrugswereforOrphandiseases

    In2011,35newmedicineswereapprovedbytheFDA:24NCEs,6

    therapeuticbiologics,andfiveotherbiologics.11 ofthenewmedicinesh dareorphandrugs.

  • WeBelieve:InbuildingShareholderValue

    Sales of Biopharmaceuticals

    Sales of Bulk Active Ingredients

    Royalties on Licencees' sales of Biopharmaceuticals

    Sales of Affinity Resins to Licensees

    0 10 20 30 40 50 60 70 80 90 100

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  • Q12013FinancialResultsQ

  • ComparisonofKeyFinancials:P&LQ12013

    Q12013CAD 000s

    Q12012CAD 000sCAD000s CAD000s

    Revenues 4,445 1,059

    CostofGoods 1,347 916

    Total Research & Development Costs 3 098 2 535TotalResearch&DevelopmentCosts 3,098 2,535

    Administration&Marketing 1,519 1,397

    FinanceCosts 354 352

    NetLoss (2,093) (4,571)

    NetLosspershare(basicanddiluted) (0.00) (0.01)

    EBITDA* (1,321) (3,581)

    *EBITDA is a nonGAAP measure, employed by the corporation to monitor its performance. Therefore it is unlikely to becomparable to similar measures presented by other companies. The corporation calculates its EBITDA by subtracting fromR it C t f G d S ld it R h d D l t E R h bl d N R h bl ll itRevenues, its Cost of Goods Sold, its Research and Development Expenses Rechargeable and NonRechargeable as well as itsAdministration and Marketing Expenses and excluding amortization of capital assets and licenses and patents.

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  • ComparisonofKeyFinancials:B l Sh tBalanceSheet

    Mar312013CAD000s

    Dec312012CAD000s

    Cash 7,549 1,205

    Accounts Receivable 3,695 4,750AccountsReceivable 3,695 4,750

    ShareSubscriptionReceivable 9,822

    Inventories 2,498 1,238

    BankandOtherLoans 700 1,636

    Trade&OtherPayables 5,041 5,094

    DeferredRevenues 1,212 2,355

    LongtermDebtProvidedbyShareholders 3,135 4,017

    AdvanceonRevenuesfromaSupplyAgreement 2,919 3,030

    NetEquity 6,258 5,819

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  • Estimated 2013 Revenue vs. 2012

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    Estimated2013Revenuevs.2012

    n

    20

    25

    $

    M

    i

    l

    l

    i

    o

    n

    15

    20

    2012

    E. 2013

    5

    10

    E.2013

    0

    5

    H1 H2 YEARH1 H2 YEAR

    E.2013aheadof2012by~$3,3MinQ1

  • PotentialRevenueMix

    120

    l

    l

    i

    o

    n

    80

    100

    $

    M

    i

    40

    60

    0

    20

    2013 2014 2015 2016 2017

    Salesofaffinity filters /bioseparation products

    Productdevelopment servicerevenues

    Plasmaderived proteins /biopharmaceuticals

  • $250M

    $200M

    $150M

    ProMetics totalrevenuesfromtheProteinTechnologiessegmentwillbeinfluencedbytheexactmixof:

    $100MProductsmanufacturedforlicenseesandMarketedbylicenseesRoyaltiesfromlicenseesProducts manufactured and marketed by $50MProductsmanufacturedandmarketedbyProMetic &marketingpartners

    200820092010201120122013201420152016 201720182019

  • Key2013Objectives

    Plasmaderived Therapeutics: Plasmaderived Therapeutics: OperationallaunchofProMeticBioProductionInc. Secureorphan drug designations

    SmallMolecule Therapeutics:Ad l d d t li i l t i l t Advanceleadcompoundtoclinicaltrialstage

    Developandenterintonewprograms/strategicalliances

  • QUESTIONANDQANSWERPERIOD