PPT Development

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Transcript of PPT Development

Page 1: PPT Development
Page 2: PPT Development

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.

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Cangene – Strength in Numbers

22 year operating history

4 approved productsproducing stable revenue

12 products in development

supporting growth and managing risk

$750

million (incl. optional orders)

awarded in recent biodefense contracts

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Cangene is fully integrated

Develop from concept to commercialization Manufacture process sensitive biopharmaceuticals Sellniche marketing team for biodefense products and commercial partnerships

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Hyperimmunes

Peptides Monoclonalantibodies

Recombinant proteins

Viruses

Toxins

Bacteria

Autoimmune / immune modulation

Products Applications

Developing Niche Biopharmaceuticals

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Supporting a focus on the treatment of infectious disease

Approved Hyperimmunes

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Approved Hyperimmunes

PRODUCT STATUS

Research/Preclinical Phase I Phase II Phase III Approved

WinRho® SDF (licensed indications)

VariZIG™

HepaGam B™

Vaccinia immune globulin

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Hyperimmunes

What are hyperimmunes?

– Natural antibodies concentrated from purified plasma

– Confer passive immunity

– Immediate clinical benefit

Why hyperimmunes?

– Shorter developmenttimelines

– Economical developmentand manufacture

– Broad applicability to infectious disease

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WinRho SDF – Cangene’s First ProductTwo 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

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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

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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

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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.

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$1 billionCangene has attracted almost

in potential funding awarded by the U.S. government under BioShield I legislation

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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 multipleproducts improves margins

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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

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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

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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” deliverytargeted for end of fiscal 2007

Seeking FDA approval

Potential sales to foreign governments globally

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Anthrax Immune Globulin

Anthrax a Category A bioterrorism threat

Awarded 10,000 dose, US$143 million contract expansionof previous development and supply agreement

Supply through end of 2009

Revenue following “usable product” deliverytargeted for end of fiscal 2007

Seeking FDA approval

Potential sales to foreign governments globally

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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

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$30 billion

MRSA costs the U.S. healthcare system up to

each year.

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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

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billions in salesBiologics with

are coming off patent in the next few years

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Recombinant Proteins

Greater focus on managing drug costs, especially biologics

Cangene leveraging proprietary expertise, technology and state-of-the-art manufacturing facilities

Focus on developing commercially successful versions of approved protein therapeutics

Additional focus on developing second-generation biotech products

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Recombinant Protein Pipeline

Leucotropin® (cancer)

Accretropin™

PRODUCT STATUS

Research/Preclinical Phase I Phase II Phase III Approved

PEG-Leucotropin® (radiation)

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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

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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

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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

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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

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State-Of-The-Art Facilities

Recent facility expansion approximately $35 million

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State-Of-The-Art Facilities

New plasma fractionation facility

–79,000 cu. ft. cleanroom space

–Four purification suites

–Modular design for maximum flexibility

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Five-Year Financial Review

Revenue Net Income

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$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

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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

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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 expens es 5,670 6,617

Income taxes 3,117 822

Net Income for the period 4,448 591

Bas ic 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

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Market Data

Listing: TSX

Symbol: CNJ

Recent Share Price: $8.51 (Feb 21/07)

52-week range: $7.62 – $11.00

Shares Outstanding: 70,238,270

Market Capitalization: $598 million

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Building momentum…R

evenue

Time

WinRho® SDF plus other approved products

VIG

AIG

BTIG

RecombinantProteins

New Products

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Investment Summary

Fully integrated biopharmaceutical company

Stable and growing revenue base from existingapproved products and contract manufacturing

Broad pipeline focused on mitigating risk and drivinglong-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

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