Transcript Slide 1

ProMetic Life Sciences Inc.
Financial Results Q1-2011
June 15, 2011
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TSX:PLI
ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Therapeutics Business Review & Outlook
Protein Technologies Business Review & Outlook
Summary
Q&A
2
ProMetic - 4 Opportunities : 1 Company
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Forward Looking Statement / Copyright notice / Disclaimer
Forward Looking Statement
This presentation contains forward-looking statements about ProMetic’s objectives, strategies and businesses
that involve risks and uncertainties. These statements are “forward-looking” 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 forward-looking statements if known or
unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and
assumptions include, but are not limited to, ProMetic’s ability to develop, manufacture, and successfully
commercialize value-added 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 on page 24 of ProMetic’s Annual
Information Form for the year ended December 31, 2010, under the heading “Risk Factors”. As a result, we
cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any
forward-looking 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.
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ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Therapeutics Business Review & Outlook
Protein Technologies Business Review & Outlook
Summary
Q&A
5
Source of Financial Information
The following information is derived from the financial
information of the Company for each of the two most
recently completed financial years.
The financial
statements are, for the first time, prepared in accordance
with International Financial Reporting Standards (IFRS).
More financial information, including the Company’s
Annual Information Form, is available on SEDAR
(www.sedar.com). All tabulated sums in CAD 000’s except
for “per share” amounts.
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International Financial Reporting Standards (IFRS)
Transition to and initial adoption of IFRS
•
Starting January 1, 2011, the Corporation has applied IFRS as issued by the International Accounting Standards Board
[“IASB”].
•
The preparation of the condensed unaudited interim consolidated financial statements for the three-month period ending
March 31, 2011 includes the initial adoption of accounting policies under IFRS which are different than the accounting
policies used to prepare the most recent annual consolidated financial statements prepared under Canadian generally
accepted accounting principles [“GAAP”].
•
The accounting policies as set out in note 2 to the condensed unaudited interim consolidated financial statements for the
three-month period ended March 31, 2011 have been applied consistently to all periods beginning on or after January 1,
2010 presented in these financial statements. Comparative information for the three-month period ended March 31, 2010
and financial statements for the year ended December 31, 2010, have thus been adjusted from amounts previously
reported under Canadian GAAP. They also have been applied in preparing an opening IFRS balance sheet at January 1,
2010 for the purpose of the transition to IFRS, as required by IFRS 1, First-time Adoption of International Financial
Reporting Standards.
•
A reconciliation of previously reported periods in accordance with Canadian GAAP to IFRS, as well as an explanation of
how the transition from Canadian GAAP to IFRS has affected our financial position, financial performance and cash flows
are provided in note 19 to the condensed unaudited interim consolidated financial statements.
Impact of IFRS on our Corporation
•
The conversion to IFRS impacts the way we present our financial results. The impact of the conversion to IFRS on our
accounting systems has been minimal due to limited changes in accounting policies. Our internal and disclosure control
processes, as currently designed, have not required significant modifications as a result of conversion to IFRS. We have
assessed the impact of adopting IFRS on our contractual arrangements, and have not identified any material compliance
issues. We have also considered the impact that the transition will have on our internal planning process and
compensation arrangements and have not identified any significant issues.
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Revenue Analysis – Q1
Quarter ended
31 March *
Service & Licence Fees
Product Sales
Total
2011
2010
CAD 000s
CAD 000s
2,411
367
+ 556.9 %
407
2,636
- 84.5 %
2,818
3,002
- 6.1 %
Change
*2010 as restated for IFRS
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Cost Analysis – Q1
Quarter ended
31 March *
2011
2010
CAD 000s
CAD 000s
415
998
- 58.4 %
Total R&D
2,997
3,074
- 2.5 %
Admin & Marketing
1,574
1,515
+ 3.9 %
Exchange Movement
(261)
147
- 277.6%
Cost of Goods Sold
Change
*2010 as restated for IFRS
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Business Segment Performance for Q1
Quarter ended
31 March *
2011
2010
CAD 000s
CAD 000s
Therapeutics
(563)
(163)**
+ 245.4 %
Protein Technologies
(395)
(901)
- 56.16%
Corporate
(1,720)
(2,064)
- 16.7 %
Total Profit / (Loss)
(2,678)
(3,128)
- 14.4%
Profit / (Loss)
*2010 as restated for IFRS
** 2010 includes a one-off gain of $251 in relation to an
insurance claim
Change
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Performance Comparison
Quarter ended
31 March *
Revenues
Net Loss
Net Loss per share (basic and diluted)
Issued and Fully Paid Common Shares
EBITDA**
2011
2010
CAD 000s
CAD 000s
2,818
3,002
- 6.1 %
(2,678)
(3,128)
- 14.4 %
0.01
0.01
0%
357,672,838
349,593,400
+ 2.3 %
(1,725)
(2,560)
- 32.6 %
Change
*2010 as restated for IFRS
**EBITDA is a non-GAAP measure, employed by the company to monitor its performance. Therefore it is unlikely to be
comparable to similar measures presented by other companies. The company calculates its EBITDA by subtracting from
Revenues, its Cost of Goods Sold, excluding amortization of capital assets, its Research and Development Expenses
Rechargeable and Non-Rechargeable as well as its Administration and Marketing Expenses.
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Balance Sheet
•
Quarter-end cash balance augmented by post balance-sheet funding initiatives
•
Advances from Shareholders of $2,240k represents sums received by way of
equity investment for which the associated shares were not issued at quarter-end.
These sums are not repayable.
–
–
$1,500k relates to investments in Newco
$740k relates to a PIPE in PLI closed in April, and for which shares were issued in April
•
Deferred Revenues includes USD 8,000k in relation to the extinguishment of the
Celgene debt. USD 2,000k will be released in Q2, with the remaining USD 6,000k
anticipated to be released in H2 as the associated milestones are met.
•
As a result, Long-term debt, at fair value, reduced from $13,762k at 31 December
2010 to $ 2,952k at quarter-end.
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Post-Balance Sheet Events
•
During April 2011, the Company closed a series of equity issuances by way of
private placements totalling $2,750, of which $2,010 was received in April, 2011.
These issuances were done at an average approximate share price of $0.16 per
share for a total issuance of 17,686,274 common shares of ProMetic which are
subject to a four month hold period.
•
During May 2011, ProMetic Biosciences Limited, a subsidiary of the Company,
secured an interest free, repayable working capital grant from the Isle of Man
Government department of Economic Development for the sum of GBP 300,000
($474). This sum is repayable in six equal instalments starting 6 months from the
date of the draw down of the grant. The funds have been granted for working
capital purposes in ProMetic Biosciences Ltd.
•
The Company also granted a total of 3,200,000 restricted share units (“RSUs”) to
certain executive officers of the Company, as part of an incentive program design
to align the interests of its executives with those of its shareholders, and in
accordance with its Long Term Incentive Plan (“LTIP”). The RSUs only vest upon
achievement of various important corporate and commercial objectives that would
create significant shareholder value.
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ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Protein Technologies Business Review & Outlook
Therapeutics Business Review & Outlook
Summary
Q&A
14
Lead Drug Candidates
Multiple Opportunities
PBI-1402
PBI-4050
Cancer Indications
e.g. pancreas
leukemia
Anemia in cancer
patients
(CIA, CRA)
PBI-4419
Fibrosis Indications
(CKD, ESRD, AKI)
Anemia in renal
patients
(CKD, ESRD)
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PBI-1402 inhibits pancreatic tumor growth in a dose dependant manner
And synergizes with gemcitabine
PBI-1402
Control
410
Tumor Growth (%)
370
Cancer Indications
e.g. pancreas
leukemia
PBI-1402 (100 mg/kg)
330
PBI-1402 (200 mg/kg)
290
PBI-1402 (400 mg/kg)
(p<0.05 Day 25 to 37)
(p<0.05 Day 23 to 37)
250
Gemcitabine
210
(p<0.05 Day 23 to 37, T/C<40 Day 23, 25 and 37)
PBI-1402 (400 mg/kg) + Gemcitabine
170
(p<0.05 Day 23 to 37, T/C<40 Day 23 to 37)
130
injection of Gemcitabine
90
22
26
30
34
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Anemia in cancer
patients
(CIA, CRA)
% mice with liver metastasis
Days
100
90
80
70
60
50
40
30
20
10
0
*
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*
Control
Aspirin
EPO
(200U)
EPO
(2000U)
PBI-1402
(40 mg/kg)
PBI-1402
(200 mg/kg)
Mastocytoma P815 cells express both EPO and PBI-1402 receptors. EPO increases the
percentage of mice bearing liver metastasis while PBI-1402 reduces it (dose dependent).
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Facts About Chronic Kidney Disease (CKD)
26 million Americans have CKD and
millions of others are at increased risk
Heart disease is the major cause
of death for all people with CKD
Hypertension causes CKD
CKD causes hypertension
Anemia
Cardiovascular
Complications
Hypertension
End Stage Renal Disease
Risk Factors
Diabetes
nephropathy
Diabetes
CKD
Dialysis
Fibrosis = progression of CKD to kidney failure
CONFIDENTIAL
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Risk factors
PBI-4050
Anemia
Cardiovascular
Complications
Hypertension
End Stage Renal Disease
Risk Factors
Diabetes
nephropathy
CKD
Dialysis
Diabetes
PBI-4419
CONFIDENTIAL
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ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Protein Technologies Business Review & Outlook
Therapeutics Business Review & Outlook
Summary
Q&A
19
Blue Chip Clients
Celgene Deal
Worldwide exclusive agreement for
Protein Technologies for restricted
fields
On-going supply of affinity resin
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Late 1970’s
Changes to
preparation of
meat and bone
meal used in
animal feed
1986
1990
1995
First cases of
BSE identified;
feed ban
introduced
1988
Government
assures the
public British
beef safe for
human
consumption
First case of
vCJD
identified
1996
Link between
BSE and vCJD
made; 30
month cull
initiated
2003
First vCJD
transfusion
transmission
case identified
June 13, 2011 – House of Commons, UK
Written questions from Sir Paul Beresford answered:
Sir Paul Beresford: To ask the Secretary of State for Health (1) pursuant to the answer of 24 March 2011, Official
Report, column 1273W, on blood transfusions, whether the dates for the timetabling of the prion filtered red blood
cells in surgery and multi-tansfused patients (PRISM) study have changed; and when he expects the final report to
be completed; (2) whether the eight-week antibody tests of the prion filtered red blood cells in surgery and multitransfused patients (PRISM) study have been concluded.
Anne Milton: The timetable remains as set out in my reply of 24 March 2011, Official Report, column 1273W. The
final report will be completed by the end of December 2011, for consideration by the Advisory Committee on the
Safety of Blood, Tissue and Organs in early 2012. I understand that the study in multi-transfused patients will no
longer go ahead due to difficulties in recruiting sufficient patients to the study.
As of 3 June 2011, eight-week antibody samples continue to be received from surgical patients, as part of the prion
filtered red cells in surgery and multi-transfused patients study. The samples are taken eight weeks after the patients
receive the red cell units, and follow-up samples taken at six months.
Sir Paul Beresford: To ask the Secretary of State for Health what estimate he has made of the costs of the (a)
development and (b) implementation of (i) prion filtration and (ii) a blood test for vCJD.
Anne Milton: With regard to prion filtration I refer the hon. Member to the written answer I gave the hon. Member
for Ogmore (Huw Irranca-Davies) on 23 May 2011, Official Report , column 423W. Costs of development are borne
by manufacturers.
With regard to blood tests no estimates have been made of the costs of the development and implementation of a
blood test for variant Creutzfeldt-Jakob disease (vGD) as there is currently no test proven to identify
asymptomatic vCJD infection.
SaBTO November 09
recommendations for
Red Blood Cell
concentrates:
PRISM study: transfusion of P-Capt filtered red
cells (Target 270 patients + 270 controls).
To use P-Capt®
for transfusion in
children < 14 years
Red Blood Cells
concentrate
March 2011:
329 patients transfused with 942 units
of prion-filtered RCC;
273 control patients transfused with
normal red cells.
No Serious Adverse Events reported.
Distribution of TSE infectivity in blood
Industrial applications
• Commercial use for manufacture of prionreduced SD Plasma (Octaplas LG®; Uniplas®).
• Octaplas LG now approved in 4 countries
(Germany, Switzerland, Portugal & Australia)
with several more approvals pending.
• ProMetic is currently working with >10
companies on industrial applications of PRDT
technology.
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Chart illustrating how PPPS™ yield advantage impact on
overall output value per L of plasma processed
Products
Concentration/
L plasma
commercial value
per gram of protein
Yield
Cohn
Yield
PPPS
Orphan Rx
µg
$ 000 000 / g
N/A
>70%
Coagulation
Factors
µg
$ 000 000 / g
20%
~50%
Plasminogen /
Plasmin
mg
$ 000 / g
35%
90%
Alpha 1 antiTrypsin
g
$300 / g
23%
86%
Fibrinogen
g
40%
91%
IgG
~8 g
$70/g
70%
93%
Albumin
~35 g
$3/g
82%
79%
ProMetic’s Laval facility
•
•
•
•
•
•
•
•
•
•
•
•
Recovery of therapeutic proteins from plasma
150,000 litre annual plasma capacity
cGMP facility
cGMP clinical trial supplies
Conformance lots post BLA
Initial commercial requirements
Supply bulk active proteins to partners
Provide validated blue print for partners’ future
plants
Technology showroom and training of partners’
staff
Technology transfer at scale
Functional H1 2012
First IND filings 2012
ProMetic’s new facility in Laval, Quebec, 2011
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Wuhan Institute of Biological Products
WIBP located in Wuhan
60 years experience in the fields of biomedical research and product development;
1,200 employees
>24 vaccines and plasma derivatives currently marketed throughout the China.
China National Biotech Group
Headquartered in Beijing, state-owned enterprise
the largest biopharmaceutical company in China.
CNBG is the largest producer of vaccines and blood derivatives in China, enjoying
more than 80% and 30% market share respectively.
The company consists of 6 Institute of Biological Products.
>9,000 employees,
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WIBP - newly built plasma production facility where PPPS™ is implemented
Production area in WIBP new plasma facility
Increased investment in China for the advancement of the PPPS™
manufacturing platform which will significantly expand the resources
deployed for the benefit of both CNBG/WIBP and ProMetic;
Intensification of the development program so that more plasma-derived
products can be developed simultaneously and at an accelerated pace;
ProMetic's new manufacturing facility in Laval, Quebec becoming a
strategic platform for WIBP/CNBG;
Reciprocal technology transfer between WIBP/CNBG and NewCo
regarding new manufacturing processes and products being scaled up in
China and Canada.
The original scientific collaboration between the two companies expanded
to also include engineering and manufacturing involving the new facilities
in Laval (Canada) and in Wuhan (China);
Turn-key process for Best-in-class Therapeutics
derived from plasma
Human plasma pooled for batch
process
cGMP
Manufacturing
process
Protein
extraction
Pure Bulk
Active
Ingredient
Finished
Dosage
form
Prionremoval
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ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Therapeutics Business Review & Outlook
Protein Technologies Business Review & Outlook
Summary
Q&A
33
ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Therapeutics Business Review & Outlook
Protein Technologies Business Review & Outlook
Summary
Q&A
34
ProMetic Life Sciences Inc.
Introduction – Forward Looking Statement
Financials Q1 2011
Therapeutics Business Review & Outlook
Protein Technologies Business Review & Outlook
Summary
Q&A
35