Beruflich Dokumente
Kultur Dokumente
M ti
MeetingofShareholders
f Sh h ld
May8,2013
Agenda
1.
2.
3.
4.
5.
6.
7.
8.
9.
10
10.
11.
12.
13.
OpeningoftheMeeting
ChairmanandSecretary
Scrutineers
NoticeofMeeting
ReportoftheScrutineers
MinutesofthelastMeeting
ConsolidatedFinancialStatementsandAuditorsReport
R ifi i
RatificationoftheactsoftheDirectors
f h
f h Di
ElectionofDirectors
Appointment of Auditors and Fixing of their Remuneration
AppointmentofAuditorsandFixingoftheirRemuneration
Increaseofmaximumofcommonsharesreservedforissuance
undertheamendedandrestatedstockoptionplan
p
p
RenewaloftheamendedandrestatedProMetic loanagreement
2
Varia
Corporate
p
Presentation
ForwardLookingStatement/Copyrightnotice
/ Disclaimer
/Disclaimer
ForwardLookingStatement
This presentation contains forwardlooking statements about ProMetics objectives, strategies and businesses
that involve risks and uncertainties. These statements are forwardlooking because they are based on our
current expectations about the markets we operate in and on various estimates and assumptions. Actual events
or results may differ materially from those anticipated in these forwardlooking statements if known or unknown
risks
i k affect
ff t our business,
b i
or if our estimates
ti t or assumptions
ti
t
turn
outt to
t be
b inaccurate.
i
t Such
S h risks
i k and
d
assumptions include, but are not limited to, ProMetics ability to develop, manufacture, and successfully
commercialize valueadded pharmaceutical products, the availability of funds and resources to pursue R&D
projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of
business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and
general changes in economic conditions. You will find a more detailed assessment of the risks that could cause
actual events or results to materially differ from our current expectations in the Annual Information Form for the
year ended December 31, 2012, under the heading Risk Factors. As a result, we cannot guarantee that any
forwardlooking statement will materialize. We assume no obligation to update any forwardlooking statement
even if new information becomes available, as a result of future events or for any other reason, unless required
by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.
Copyright notice
The information contained in this presentation (including names, images, logos and descriptions portraying
ProMetic's products and/or services) is the property of ProMetic Life Sciences Inc., of its divisions and / or of its
subsidiaries (ProMetic) and is protected by copyright, patent and trademark law and / or other intellectual
property rights. Neither this presentation nor any part may be reproduced or transmitted in any form or by any
means, electronic or mechanical, including printing and photocopying, or by any information storage or retrieval
system without prior permission in writing from ProMetic.
Disclaimer
ProMetic reserves the right to make improvements, corrections and/or changes to this presentation at any time.
ProMeticLifeSciencesInc.
Introduction
d i
2012FinancialResults
B i
BusinessSegments:
S
t
Smallmoleculetherapeutics
Protein Technologies:
ProteinTechnologies:
Bioseparation /filters
Plasmaderivedproteins
Q12013
2013Business:BaseCase
Outlook
l k
2013Objectives
QuestionandAnswerPeriod
2012FinancialResults
SourceofFinancialInformation
The following information is derived from the audited
consolidated December 31, 2012 financial information
and on the statutory financial statements for 2011,
both of which were prepared in accordance with
International Financial Reporting Standards (IFRS).
Further financial information,, includingg the ProMetics
Annual Information Form, is available on SEDAR
(www.sedar.com).
All tabulated sums are in CAD 000s except for per
share amounts or where indicated.
7
FinancialPerformancefor2012
Significantly
improved
financial
performance in 2012 with record
revenues of $23.3 million exceeding
anticipated base case of $21.0
million.
Product
P d t sales
l
off $11.6
$11 6 million,
illi
Services revenues of $5.3 million and
Licensing revenues totalling $6.4
million.
Stronger
g
total revenues and cost
containment positively impacted
EBITDA.
First EBITDA positive year in corporate
history at $2.5
$ million.
8
ComparisonofKeyFinancials:P&L
YearendedDecember31
2012
CAD 000s
CAD000s
23,321
2011
CAD 000s
CAD000s
17,589
5,326
1,854
10 310
10,310
11 230
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)
Revenues
CostofGoods
Total Research & Development Costs
TotalResearch&DevelopmentCosts
*EBITDA is a nonGAAP measure, employed by the corporation to monitor its performance. Therefore it is unlikely to be
comparable to similar measures presented by other companies. The corporation calculates its EBITDA by subtracting from
R
Revenues,
it Cost
its
C t off Goods
G d Sold,
S ld its
it Research
R
h and
d Development
D l
t Expenses
E
R h
Rechargeable
bl and
d NonRechargeable
N R h
bl as wellll as its
it
Administration and Marketing Expenses and excluding amortization of capital assets and licenses and patents.
9
ComparisonofKeyFinancials:
B l
BalanceSheet
Sh t
YearendedDecember31
2012
CAD000s
1,205
2011
CAD000s
275
Accounts Receivable
AccountsReceivable
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)
5,819
(8,568)
22,991
8,692
Cash
NetEquity(Deficiency)
BalanceSheetTotalAssets
10
BusinessSegment:
SmallMolecule Therapeutics
USRDS2012AnnualDataReport
Medicare Population 2010
12
RegulatoryStrategy
PBI4050
NewDatatobepresentedat
KeyRegulatoryFilingMilestones&Timing:IVIG
InternationalConferences
l
f
ERAEDTA(EuropeanRenalAssociation EuropeanDialysisand
TransplantAssociation):Istanbul,1821May,2013.
WorldCongress
W ld C
ofNephrology:HongKong,31May
fN h l
H
K
31 M
4J
4June,2013.
2013
Americanassociationforthestudyofliverdiseases:Washington15
November , 2013
November,2013
AmericanSocietyofNephrology:Atlanta,November11,2013
A
AmericanAssociationRespirology
i
A
i ti R i l
C
Convention:Anaheim,November16
ti
A h i N
b 16
2013
14
PhasesinDrugDevelopment&
Relativevalue/ProbabilityofregulatoryApproval
Probabilityy
Value
$5000M
Regulatory
Filing
PhIII
100%
75%
Ph II
$500M
50%
Ph Ib /II
PhIb
/ II
PhI
$50M
R&D
Discovery
Preclinical
Proofofconcept
GLPTOX
GMPAPI
INDfilings
fili
+$250M
10%
$1.5M
2013
DevelopmentMilestoneTimelines
p
PreINDMeeting
FDA/EMA/
Health
Canada
HealthCanada
2013
Q1
Q2
Q3
CTA
Health
Canada
Q4
IND FDA
CTA
2014
Q1
Techtransferchemicalsynthesis
Tech transfer chemical synthesis
Chemicalsynthesisscaleup
GMPManufacturinginFDAplant
Pharmaco kinetics
GLP T i l
GLPToxicologyProgram
P
Finaldosageformulation
PhaseI
Healthy
volunteers
l t
PhaseIb II
Patients
BusinessSegment:
g
Protein Technologies
Bioseparation
Enables
Enablesthecaptureofmultipletargetedproteinsdirectlyfrom
the capture of multiple targeted proteins directly from
varioussourceproducts
Providesforahighlyefficientandcosteffectiveseparation
processfromotherproteinsandimpuritiesdeliveringhighyields
ofpurifiedproduct
Resultsinsignificantreductionsinclient
Results in significant reductions in clientsscostofgoodsand
cost of goods and
costsassociatedtodrugpurification.
Protein PowerHouse
InitiationofacollaborativeagreementinJanuary2003tocodevelopanovelprocesstorecover
therapeutic proteins in a sequential manner from plasma
therapeuticproteinsinasequentialmannerfromplasma.
CollaborationrelyingonProMetic's MimeticLigandstechnologiesandAmericanRedCross's
uniquecompetenciesinplasmaandbloodproducts,processandanalyticaldevelopment.
Resultedinthedevelopmentofaprocess(PPPS)capableofextractingsomeofthemost
valuableproteinsfromplasmaatmuchhigheryieldsthanotherprocesses.
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 commercially
Usingpowerfulaffinityseparationmaterialstoextractandpurifycommercially
valuableplasmaproteinsinhighyield.
Highlyefficientinextractingandpurifyingtherapeuticproteinsfromhuman
plasma to develop best in class biotherapeutic
plasmatodevelopbestinclassbio
therapeuticproducts.
products
PPPSTM:TheBenefits
: The Benefits
Improvedeconomicsoverindustryaverages,through:
improvedrecoveryyield,
smallerfootprintforsamemanufacturingoutput,
moreproductfromlessplasma
more product from less plasma
Improvedpurity
Improvedsafety pathogenremovalandviralinactivation
Recoveryofvaluableproteinstargetingrarediseases,potentially
resultinginproductswithOrphanDrugDesignation
PPPSTM:TheProcess
: The Process
TurnKeyProcess
PPPSTM:TheProducts&Market
Opportunities
25
Orphan DrugDesignation
Drug Designation
Noveldrugsorbiologics
g
g
Treatmentofararediseaseorcondition
g
p
Affectingfewerthan200,000patientsintheUS.
SevenyearperiodofU.S.marketingexclusivityupon
marketingapproval
Taxcreditsforclinicalresearchcosts
Abilitytoapplyforannualgrantfunding
Clinicalresearchtrialdesignassistance
l
l
h
ld
Waiverofprescriptiondruguserfees.
TYPE1Plasminogen Deficiency
OrphanDrugDiseasesTakingFrontStage
TheNationalInstitutesofHealthestimatesthatthereareapproximately
7,0008,000rarediseasesaffecting25millionAmericans.Ararediseaseis
definedasaconditionaffectingfewerthan200,000peopleintheUnited
States.
States
10drugs
TheOrphanDrugAct(ODA)enactedin1983hasincreasedfrom
in1983to
382 in2011
>2,500
UndertheODA,
medicineshavebeendesignatedorphan
drugsandareinallstagesofdevelopment
Orphandrugscurrentlymakeup
Inthelast3years,
diseases
22% oftotaldrugsales
35% ofFDAapproveddrugswereforOrphan
In2011,35newmedicineswereapprovedbytheFDA:24NCEs,6
11 ofthenewmedicines
therapeuticbiologics,andfiveotherbiologics.
areorphandrugs.
h d
WeBelieve:InbuildingShareholderValue
Sales of Biopharmaceuticals
10
20
30
40
50
60
70
80
90 100
29
Q
Q12013FinancialResults
ComparisonofKeyFinancials:P&L
Q12013
Q12013
CAD 000s
CAD000s
4,445
Q12012
CAD 000s
CAD000s
1,059
CostofGoods
1,347
916
3 098
3,098
2 535
2,535
Administration&Marketing
1,519
1,397
354
352
(2,093)
(4,571)
(0.00)
(0.01)
(1,321)
(3,581)
Revenues
FinanceCosts
NetLoss
NetLosspershare(basicanddiluted)
EBITDA*
*EBITDA is a nonGAAP measure, employed by the corporation to monitor its performance. Therefore it is unlikely to be
comparable to similar measures presented by other companies. The corporation calculates its EBITDA by subtracting from
R
Revenues,
it Cost
its
C t off Goods
G d Sold,
S ld its
it Research
R
h and
d Development
D l
t Expenses
E
R h
Rechargeable
bl and
d NonRechargeable
N R h
bl as wellll as its
it
Administration and Marketing Expenses and excluding amortization of capital assets and licenses and patents.
31
ComparisonofKeyFinancials:
B l
BalanceSheet
Sh t
Mar312013
CAD000s
7,549
Dec312012
CAD000s
1,205
3,695
4,750
9,822
2,498
1,238
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
Cash
Accounts Receivable
AccountsReceivable
ShareSubscriptionReceivable
Inventories
BankandOtherLoans
32
Estimated
2013 Revenue vs. 2012
Estimated2013Revenuevs.2012
$Million
n
30
25
20
2012
15
E. 2013
E.2013
10
5
0
H1
H2
YEAR
E.2013aheadof2012by~$3,3MinQ1
$Million
PotentialRevenueMix
120
100
80
60
40
20
0
2013
2014
2015
2016
2017
$250M
$200M
ProMetics totalrevenuesfromthe
ProteinTechnologiessegmentwillbe
influencedbytheexactmixof:
$150M
Productsmanufacturedforlicenseesand
Marketedbylicensees
Royaltiesfromlicensees
Products manufactured and marketed by
Productsmanufacturedandmarketedby
ProMetic &marketingpartners
200820092010201120122013201420152016
$100M
$50M
201720182019
Key2013Objectives
Plasmaderived Therapeutics:
OperationallaunchofProMeticBioProductionInc.
Secureorphan drug designations
SmallMolecule Therapeutics:
Advanceleadcompoundtoclinicaltrialstage
Ad
l d
d t li i l t i l t
Developandenterintonewprograms/strategicalliances
QUESTIONAND
Q
ANSWERPERIOD