163.2012_AGM_Presentation_05-07-2013_EV_FINAL
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Transcript of 163.2012_AGM_Presentation_05-07-2013_EV_FINAL
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2012Annual &SpecialM ti f Sh h ldMeetingofShareholders
May8,2013
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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
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Corporate Presentationp
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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.
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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
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2012FinancialResults
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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 $6.4million.
Stronger total revenues and costgcontainment positively impactedEBITDA.
First EBITDA positive year in corporate$
8
history at $2.5 million.
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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
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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
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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
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BusinessSegment:gProtein Technologies
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Bioseparation Enables the capture of multiple targeted proteins directly fromEnablesthecaptureofmultipletargetedproteinsdirectlyfrom
varioussourceproducts
Providesforahighlyefficientandcosteffectiveseparationprocessfromotherproteinsandimpuritiesdeliveringhighyieldsofpurifiedproduct
Results in significant reductions in clients cost of goods andResultsinsignificantreductionsinclient scostofgoodsandcostsassociatedtodrugpurification.
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Protein PowerHouse
InitiationofacollaborativeagreementinJanuary2003tocodevelopanovelprocesstorecovertherapeutic proteins in a sequential manner from plasmatherapeuticproteinsinasequentialmannerfromplasma.
CollaborationrelyingonProMetic's MimeticLigandstechnologiesandAmericanRedCross'suniquecompetenciesinplasmaandbloodproducts,processandanalyticaldevelopment.
Resultedinthedevelopmentofaprocess(PPPS)capableofextractingsomeofthemostvaluableproteinsfromplasmaatmuchhigheryieldsthanotherprocesses.
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PlasmaProteins
75%ofrevenuesaregeneratedwith4proteins:Albumin,IgG,FactorVIIIandAAT
74%ofrevenuesareusedby16%ofpopulation(NA,EU)
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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.
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PPPSTM: The BenefitsPPPS :TheBenefits
Improvedeconomicsoverindustryaverages,through: improvedrecoveryyield, smallerfootprintforsamemanufacturingoutput, more product from less plasmamoreproductfromlessplasma
Improvedpurity
Improvedsafety pathogenremovalandviralinactivation
Recoveryofvaluableproteinstargetingrarediseases,potentiallyresultinginproductswithOrphanDrugDesignation
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PPPSTM: The ProcessPPPS :TheProcess
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TurnKeyProcess
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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.
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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.
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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.
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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
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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
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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
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$250M
$200M
$150M
ProMetics totalrevenuesfromtheProteinTechnologiessegmentwillbeinfluencedbytheexactmixof:
$100MProductsmanufacturedforlicenseesandMarketedbylicenseesRoyaltiesfromlicenseesProducts manufactured and marketed by $50MProductsmanufacturedandmarketedbyProMetic &marketingpartners
200820092010201120122013201420152016 201720182019
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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
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QUESTIONANDQANSWERPERIOD