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PPT Development
1.
2. Forward Looking Statements
Statements made in this presentation may pertain to information that is not historical; these statements are essentially forward-looking. The audience should be aware that
the Company’s businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, future results may differ materially from past results
and those that may have been expressed or implied by any forward-looking statements. The audience should refer to a more detailed discussion of risks and uncertainties in
the most recently filed MD&A, found on the company website at www.cangene.com or on the SEDAR site at www.sedar.com. The Company undertakes no obligation to
publicly make or update any forward-looking statements except as required by applicable law.
Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the difficulty of predicting the timing of regulatory approvals or outcome
of regulatory actions or the Company’s ability to obtain required regulatory approvals on a timely basis; changes in the value of the Canadian dollar; the number and size of
new contract manufacturing activities; the quantities of products or services purchased by government organizations; dependence on revenues from a small number of
significant customers and products as a significant source of net revenue and net income; market and customer acceptance, and demand for new pharmaceutical products;
ability to market products; the impact of competitive products, services or pricing; timing or success of product development or launch including the Company’s ability to
successfully develop, license or otherwise acquire and introduce new products on a timely basis in relation to competing product introductions; availability and cost of raw
materials, especially the cost and antibody concentration of plasma used; the regulatory environment including the high cost and uncertainty associated with compliance
with extensive regulation of the pharmaceutical industry; fluctuations in operating results; progress of clinical trials; dependence on corporate relationships; the loss of
business from the Company’s concentrated customer base; government policies or actions; the significant research and development expenditures the Company makes to
develop products, the commercial success of which is uncertain; the costs and product introduction delays that may result from use of legal, regulatory and legislative
strategies by the Company’s competitors; uncertainties regarding patent, intellectual and other proprietary property protections; the expending of substantial resources
associated with litigation involving patent and other intellectual property protection of products; the Company’s exposure to lawsuits and contingencies associated with its
business; uncertainties and matters beyond the control of management, which could affect the Company’s earnings, as well as the subjectivity inherent in any probability
weighted analysis underlying the Company’s assumptions and estimates with respect to the future; inherent uncertainties involved in the estimates and judgments used in
the preparation of financial statements in accordance with GAAP and related standards; the effects of consolidation of the Company’s customer base. Scientific information
that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy
of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed
to refer to approved labelling for products and not rely on information contained in oral or written presentations.
The cautionary statements referred to above should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by
the Company or by persons acting on its behalf and in conjunction with its periodic filings with the Ontario Securities Commission, including those contained in the Company’s
news releases and most recently filed Annual Information Form. Forward-looking statements can be identified by the use of words such as “expects”, “plans”, “will”,
“believes”, “estimates”, “intends”, “may”, “bodes”, and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should
management’s assumptions prove inaccurate, actual results could vary materially from those anticipated.
3. Cangene – Strength in Numbers
22 year operating history
4 approved products
producing stable
revenue
12 products in development
supporting growth
and managing risk
$750 million (incl. optional orders)
awarded in recent
biodefense
contracts
4. Cangene is fully integrated
Develop
from concept to commercialization
Manufacture
process sensitive biopharmaceuticals
Sell
niche marketing team for biodefense
products and commercial partnerships
8. Hyperimmunes
What are
hyperimmunes?
– Natural antibodies
concentrated from
purified plasma
– Confer passive immunity
– Immediate clinical benefit
Why
hyperimmunes?
– Shorter development
timelines
– Economical development
and manufacture
– Broad applicability to
infectious disease
9. WinRho SDF – Cangene’s First Product
Two approved indications
Hemolytic disease of the newborn (HDN)
• Used in millions of at-risk pregnancies
Immune thrombocytopenic purpura (ITP)
• Includes ITP associated with HIV
Expanding the Franchise – Targeting 10% annual growth through:
Entering new markets
• Under MRP in Europe
• ROW
Aggressively marketing FDA-approved liquid formulation in U.S.
Long-term growth through:
New patient populations with thrombocytopenia (low platelet count)
• Dengue Hemorrhagic Fever (DHF)
• Side effects associated with Hepatitis C therapy
• Potential in other viral, bacterial, protazoal infections
10. WinRho®
SDF Sold/Licensed in 47 Countries
Awaiting licensure
HDN and ITP
HDN only
MRP approval, awaiting launch
Marketed by Baxter in U.S., Europe and Australia
11. HepaGam B™
Hepatitis B immune globulin
Health Canada approved for prevention of
reinfection following liver transplant
FDA approved for treatment of acute
exposure to Hepatitis B
– Birth to Hep B positive mothers
(90% of infants develop chronic infection)
– Healthcare worker exposure
Marketed in the U.S. by Apotex
Worldwide market for Hepatitis B immune globulin products
is approximately $115 million
12. VariZIG™
Varicella zoster (the virus that causes chickenpox)
immune globulin
Approved in Canada for treating exposure to
chickenpox during pregnancy
Expanded access IND protocol approved in U.S.
Granted orphan drug designation in U.S.
13. $1 billion
Cangene has attracted almost
in potential funding awarded by
the U.S. government under
BioShield I legislation
14. BioDefense:
A Core Market for Infectious Disease Products
Paid R&D costs through licensure
Sales prior to licensure (U.S.)
Ongoing replacement of stockpiled product
Opportunity to sell to foreign governments globally
Manufacturing synergies across multiple
products improves margins
15. BioDefense Pipeline
Ricin immune globulin
Botulinum toxin immune globulin
Anthrax immune globulin
Burkholderia antibodies
Ebola/Marburg antibodies
PRODUCT STATUS
Research/Preclinical Phase I Phase II Phase III
Approved
Vaccinia immune globulin
16. Vaccinia Immune Globulin
First Cangene hyperimmune added to U.S.
Strategic National Stockpile
Indicated for certain adverse reactions to smallpox vaccine
Initial contract up to 100,000 doses
FDA approved in May 2005, 32 months
following contract award
$16 million sold to U.K. in fiscal 2006
Sales to other governments internationally
Significant ongoing global potential
17. Botulinum Toxin Immune Globulin
Botulism toxin a Category A bioterrorism threat
Sole sourced for 5-year, 200,000 dose supply
agreement by U.S. HHS
Initial value US$362 million
Further US$234 million in optional task orders
Revenue following “usable product” delivery
targeted for end of fiscal 2007
Seeking FDA approval
Potential sales to foreign governments globally
18. Anthrax Immune Globulin
Anthrax a Category A bioterrorism threat
Awarded 10,000 dose, US$143 million contract expansion
of previous development and supply agreement
Supply through end of 2009
Revenue following “usable product” delivery
targeted for end of fiscal 2007
Seeking FDA approval
Potential sales to foreign governments globally
19. Other Biodefense
Hyperimmunes in Development
Ebola/Marburg virus immune globulins
– Developing therapy for hemorrhagic fever viruses
– Funding from Canadian CRTI program
– Ongoing parallel monoclonal antibody program
Ricin immune globulin
– Potent plant-derived toxin
– Often fatal, even in small doses
– No antidote
– Funding from Canadian CRTI program
– Ongoing parallel monoclonal antibody program
21. Cangene’s Innovative
Infectious Disease Treatment
S. aureus most common cause
of surgical wound infections in
humans
Antibiotic resistance in S.
aureus has increased
alarmingly in last 30 years
Hyaluronic-acid-binding
peptides
May reduce numbers of
Staphylococcus aureus and
associated inflammation at
surgical wound sites
May have similar activity
against other bacteria
Development next steps
– Toxicology testing
– Determine mechanism of
action
0
10
20
30
40
50
60
70
1974 1995 2004
Year
MRSAinfectionsas%ofstaphinfections
Source: CDC
25. Follow-on proteins in development
Leucotropin®
– Branded biosimilar version of GM-CSF
– Stimulates production of certain white blood cells
– Filed in Canada to enhance recovery in patients with Hodgkin’s
disease and non-Hodgkin’s lymphoma following stem cell
transplantation
– Currently only one GM-CSF product available in the U.S. market
– Marketing agreement with Apotex for U.S. and Canada
– Developing pegylated version with CRTI funding for acute
radiation exposure
26. Follow-on proteins in development
Accretropin™
– Human Growth Hormone
– GH deficiency and Turner Syndrome
– Existing hGH worldwide sales in excess of $1.3 billion
– Accepted for review by FDA
– Marketing agreement with Apotex for U.S. and Canada
27. Broad Pipeline
WinRho®
SDF (licensed indications)
WinRho®
SDF (new patient populations)
VariZIG™
HepaGam B™
Vaccinia immune globulin
Ricin immune globulin
Botulinum toxin immune globulin
Anthrax immune globulin
Burkholderia antibodies
Ebola/Marburg antibodies
Leucotropin®
(cancer)
Accretropin™
West Nile virus immune globulin
SARS immune globulin
PEG-Leucotropin®
(radiation)
PRODUCT STATUS
Research/Preclinical Phase I Phase II Phase III Approved
Developing for new patient populations
28. Contract Manufacturing
Broad capabilities
– Liposome manufacturing
– Growing expertise in mammalian cell manufacturing
– Live viral vaccine fill/finishing facility
Focus on process-sensitive biopharmaceuticals
International regulatory compliance
Revenue stream independent of Cangene’s own product
development initiatives
31. Five-Year Financial Review
Revenue Net Income
RevenueinmillionsCanadian$
200
180
160
140
120
100
80
60
40
20
0 -20
-10
0
10
20
30
40
50
NetIncomeinmillionsCanadian$
Contract R&D and manufacturing
2002 2003 2004 2005 2006 2002 2003 2004 2005 2006
Biopharmaceutical operations
• 2003 and 2004 VIG contract drove
extraordinary sales and profits
• 2005 impairment loss on
Chesapeake facility
32. Five-Year Financial Review (in $CDN thousands except per share data)
Year ended
July 31, 2006
Year ended
July 31, 2005
Year ended
July 31, 2004
Year ended
July 31, 2003
Year ended
July 31, 2002
Revenues $ 109,336 $ 102,725 $ 156,903 $ 186,213 $ 88,314
R&D expenses
(net of investment
Tax credits)
24,952 34,212 25,611 18,070 13,157
Income taxes 9,505 5,606 18,703 22,066 10,214
Net Income (loss)
for the year
13,143 (15,463) 2
32,542 40,090 10,4341
Basic earnings (loss)
per share
0.20 (0.24)2
0.52 0.67 0.181
Weighted -average
number of common
shares outstanding
65,746,366 64,563,797 63,016,496 60,186,293 59,580,372
At July 31, 2006 At July 31, 2005 At July 31, 2004 At July 31, 2003 At July 31, 2002
Cash $ 7,691 $ — $ 3,999 $ 6,273 $ 783
Debt 32,528 23,279 8,902 36,715 73,252
Total shareholders’
equity
165,937 149,690 160,132 119,397 78,673
1
In 2002, net income reflects an expense of $5.0 million, or $0.08 per share, related to a charge against goodwill
2
In 2005, net income (loss) and earnings (loss) per share reflect an $18.0-million non-cash impairment loss related to the Chesapeake facility
33. Q1–07 Selected Financials (in $CDN thousands except per share data)
Unaudited
Quarter ended
October 31, 2006
Quarter ended
October 31, 2005
Revenues $ 24,784 $ 24,127
R&D expenses 5,670 6,617
Income taxes 3,117 822
Net Income for the period 4,448 591
Basic earnings per s hare 0.07 0.01
Weighted -average number of
outs tanding s hares
65,845,753 65,022,637
At October 31, 2006 At J uly 31, 200 6
Cas h $ 8,556 $ 7,691
Debt
1
31,869 32,528
Total s hareholders’equity 170,65 1 165,937
1
$24 million subsequently repaid using proceeds of recent offering
36. Investment Summary
Fully integrated biopharmaceutical company
Stable and growing revenue base from existing
approved products and contract manufacturing
Broad pipeline focused on mitigating risk and driving
long-term revenue growth
Ability to leverage upside from:
– Leadership positions in biodefense and
infectious disease hyperimmunes
– Recombinant proteins, including follow-on
and 2nd
generation products
– Contract manufacturing of process-sensitive
biopharmaceuticals