PPT Development
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Transcript of 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.
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
Cangene is fully integrated
Develop from concept to commercialization Manufacture process sensitive biopharmaceuticals Sellniche marketing team for biodefense products and commercial partnerships
Hyperimmunes
Peptides Monoclonalantibodies
Recombinant proteins
Viruses
Toxins
Bacteria
Autoimmune / immune modulation
Products Applications
Developing Niche Biopharmaceuticals
Supporting a focus on the treatment of infectious disease
Approved Hyperimmunes
Approved Hyperimmunes
PRODUCT STATUS
Research/Preclinical Phase I Phase II Phase III Approved
WinRho® SDF (licensed indications)
VariZIG™
HepaGam B™
Vaccinia immune globulin
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
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
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
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
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.
$1 billionCangene has attracted almost
in potential funding awarded by the U.S. government under BioShield I legislation
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
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
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
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
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
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
$30 billion
MRSA costs the U.S. healthcare system up to
each year.
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
2004Year
MR
SA
in
fect
ion
s as
% o
f st
ap
h in
fect
ion
s
Source: CDC
billions in salesBiologics with
are coming off patent in the next few years
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
Recombinant Protein Pipeline
Leucotropin® (cancer)
Accretropin™
PRODUCT STATUS
Research/Preclinical Phase I Phase II Phase III Approved
PEG-Leucotropin® (radiation)
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
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
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
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
State-Of-The-Art Facilities
Recent facility expansion approximately $35 million
State-Of-The-Art Facilities
New plasma fractionation facility
–79,000 cu. ft. cleanroom space
–Four purification suites
–Modular design for maximum flexibility
Five-Year Financial Review
Revenue Net Income
Reven
ue in
mill
ion
s C
an
ad
ian
$
20018016014012010080
60
40
20
0 -20
-10
0
10
20
30
40
50
Net
Inco
me in
mill
ion
s C
an
ad
ian
$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
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
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
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
Building momentum…R
evenue
Time
WinRho® SDF plus other approved products
VIG
AIG
BTIG
RecombinantProteins
New Products
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