tsx: fxa poised for aggressive growth 2010 annual general meeting august 2010
TRANSCRIPT
TSX: FXA
POISED FOR AGGRESSIVE GROWTH
2010 Annual General Meeting August 2010
Forward Looking Statements
Advisory Regarding Forward-Looking Statements This presentation contains certain forward-looking information and statements within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “would”, “project”, “could”, “should”, “contemplate”, “potential”, “depend”, “forecast”, “believe”, “plans”, “targets”, “intends” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements reflect the Company’s beliefs and are based on information currently available to us. These statements require Afexa to make assumptions that it believes are reasonable and are subject to inherent risks and uncertainties. Actual results and developments may differ materially from the results and developments discussed in the forward-looking statements as certain of these risks and uncertainties are beyond Afexa’s control. The forward-looking information and statements included in this news release are not guarantees of future performance and should not be unduly relied upon. Examples of such forward-looking statements in this presentation include, but are not limited to: •the expectation of positive and sustained growth and diversification for the Company and increased market penetration within Canada and internationally;•the Company’s goal to bring to market a basket of natural health products; •the Company’s belief that it will continue to be profitable and self-fund operations; •whether the Company’s product candidates, including in the areas of cholesterol management, COLD-FX pediatrics, allergy, cancer support, brain health, glucose management and TLR modulators will be successful in clinical trials leading to regulatory approvals and commercialization; •the expectation that Afexa will continue as a market leader in Canada; •whether Afexa will seek US botanical drug registration in the U.S. for one or more of its products and, if it does, whether Afexa will be successful in gaining such regulatory approval; •whether international market diversification will take place and if it does, whether Afexa will be successful in penetrating international markets;•whether Afexa will be successful in achieving suitable collaborations for international marketing;•whether the Company will meet its timelines for new product candidates;•whether Afexa will maintain its uniqueness in the marketplace; and•whether or not all of the corporate initiatives will lead to value creation and strengthening of the share price. The Company believes the expectations and assumptions reflected in the forward-looking information and statements contained herein are reasonable. However, no assurance can be given that these expectations and assumptions are correct and that the results, performance or achievements expressed in, or implied by, forward-looking statements within this disclosure will occur, or if they do, whether any benefits may be derived from them. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. The forward-looking information and statements contained in this presentation speak only as at the date of this AGM, and the Company assumes no obligation to publicly update or revise them to reflect new events or circumstances, except as may be required pursuant to applicable laws. Investors are encouraged to consult SEDAR filings for more details on forward-looking statements and associated risks.
Afexa’s Products
Parallel Growth Drivers
MarketDiversification
ProductDiversification
A Strong Scientific Team Led by Founder and Chief Scientific Officer, Dr. Jacqueline Shan
Market and Product Diversification Well Under Way
COLD-FX® is the Canadian market
leader for flu and colds
Profitable and able to self-fund full cycle of research, clinical studies, launch and marketing of new products
A proven marketing and sales platform for launching
new products into the Canadian marketplace
A proven science-based company pioneering natural
medicines that empower people to achieve their health potential
Positioned to focus on opportunities outside Canada
Parallel Growth Drivers
MarketDiversification
Penetrating an Established Market
Canada • Expanding market penetration of
commercialized products• Focus of current marketing efforts• Small household penetration
generally across Canada• Even higher growth potential in
Québec• Bringing new products to market
Co
nsu
mer
Pu
rch
ases
$
in M
illi
on
s
Source: Nielsen MarketTrack, National All Channels, Calendar Years
Clean up. Move labels to actual lines. Needs a summary point showing % growth in coldfx
Growing a Market Leader
COLD-FX 5 year compound annual growth rate of 48%
Total COLD-FX
Total Tylenol Cold/Flu
Total Advil Cold/Flu
Market Diversification
United States• COLD-FX® currently must be sold as
health supplement intended to boost immune system; this limits market potential
• Considering a New Drug Application (NDA) for Afexa product as a polymolecular botanical drug; larger market potential and expanded therapeutic claims
Market Diversification
Europe• Assessment of
regulatory requirements
Market Diversification
Asia• Distributor agreement in Hong Kong• Regulatory approval process under
way in China• Assessing Japan’s business
opportunities• Reviewing opportunities in other
Asian countries
Parallel Growth Drivers
ProductDiversification
Branching Out With
New Polymolecular Botanical Drugs
Polymolecular Botanical Drugs: Creating a New Class of Natural Medicines
• Also known as “botanical drugs” or “herbal drugs”
• In Canada considered to be novel proprietary botanical products with therapeutic claims supported by specific clinical trials
• Fundamentally differentiated from traditional herbal medicines
• COLD-FX belongs to this category of over-the-counter, non-traditional botanical products
Required to meet high clinical standards, similar to conventional pharmaceutical standards
• Track is multi-year to approval involving rigorous pre-clinical and clinical studies as well as toxicology testing, chemical standardization and scrutiny of plant sources and manufacturing processes
Polymolecular Botanical Drugs: Creating a New Class of Natural Medicines
ChemBioPrintProprietary Technology
Biological Fingerprinting
• Polymolecular active constituents are tested for multiple biological or pharmacological responses indicating health and/or therapeutic benefit
Chemical Fingerprinting
• Multiple chemical analysis combining different chromatographic detectors provides precise chemical identity of multiple active constituents of a product
Consists of two-dimensional fingerprinting
ChemBioPrintProprietary Technology
• Patented technology
• Applicable to all evidence-based multi-active component natural therapeutics
• For both discovery and standardization
• Pharmacologic and clinical validation
• Batch-to-batch consistency
Product Diversification: Multiple Paths
Commercialize existing products
beyond COLD-FX®
Advance multiple products through
clinical trials
Increase R&D into products with targeted applications
License third-party products that fit the Afexa profile
Discovery Pre-Clinical
Clinical Approval End-Product Launch
1 – 2 years 3 – 5 years 6 months – 2 years
Cholesterol Management
COLD-FX® Pediatrics
Seasonal Allergy
Cancer Support
Oxidative Stress & Brain Health
Glucose Management
Blood Pressure Management
TLR Therapeutics
•Anti-Viral
•Cancer Management
•Vaccine Adjuvant
Product Development
Approval End-Product Launch
• New proprietary formulation Lip-01 to improve cholesterol levels
• Pilot open clinical study in progress.
• Preliminary data signals suggest similar efficacy as pre-clinical studies
Cholesterol Management
Pre-ClinicalDiscovery Clinical
Photo: Yellow plaque deposits in artery
1 – 2 years 3 – 5 years 6 months – 2 years
High cholesterol affects ~40% of Canadian Adults
ClinicalDiscovery Pre-Clinical
COLD-FX Pediatrics
• Children 3-12 years old• First clinical trial
• Safety• Complete and successful
• Second clinical trial planned; randomized, double-blind, placebo-controlled
Approval End-Product Launch
1 – 2 years 3 – 5 years 6 months – 2 years
Discovery Pre-Clinical Clinical
Allergy Clinical Trial
• Positive pre-clinical lab studies complete
• Randomized, placebo-controlled, double-blind clinical trial in progress
• Targeted to be completed in next 12 months
Approval End-Product Launch
1 – 2 years 3 – 5 years 6 months – 2 years
Discovery Pre-Clinical Clinical
CLL Cancer Clinical Trial
• Clinical trial in Chronic Lymphocytic Leukemia (CLL) – National Cancer Institute and Wake Forest University• Available preliminary data presented at
American Society of Clinical Oncology (ASCO) June 2010
• Available results indicating positive signals – further analysis in progress
• Reduced sore throat and trend of reduced incidence of moderate-severe Acute Respiratory Illness
• Reduced serious adverse events (SAE) suggesting improved disease tolerability
• Exploring potential effect on immune system through strengthening mucosal integrity
• Next clinical trial in CLL in planning phase with Wake Forest University
Approval End-Product Launch
1 – 2 years 3 – 5 years 6 months – 2 years
•Positive pre-clinical lab studies in leukemia – McGill University
Discovery Pre-Clinical Clinical Approval End-Product Launch
Brain Health
• Proprietary active ingredients for REMEMBER-FX® and MEMORY-FX®
• Clinical trials have shown:
• Improves memory in normal adults
• Improves working memory in schizophrenia patients
• Reduces oxidative stress
• Planning additional clinical trial for oxidative stress and brain function
1 – 2 years 3 – 5 years 6 months – 2 years
• Clinical trial planned: open label; dose ranging; safety and effect size finding
• Discovered a potential polymolecular formulation extracted from two herbs
• Active constituents showed synergistic effect on increasing glucose uptake in cultured skeletal muscle cells
• Clinical trials showed reduced blood glucose levels
Glucose Management
Approval End-Product LaunchClinicalDiscovery Pre-Clinical
1 – 2 years 3 – 5 years 6 months – 2 years
•Approx. 285 million people worldwide are affected by diabetes
•Growing by approx. 7 million per year
Approval End-Product Launch
~25% of people worldwide are affected by hypertension
• Two possible polymolecular based formulations extracted from various plants discovered in lab testing
• Planning further pre-clinical studies
Blood Pressure Management
ClinicalDiscovery Pre-Clinical
1 – 2 years 3 – 5 years 6 months – 2 years
• TLR (Toll-like receptors) Modulators – a class of molecules targeting multi-organs and tissues including immune cells
• TLR modulators have shown promising therapeutic potential and supportive treatment for:
• Cancer
• Infectious diseases
• Adjuvants for vaccines
• Afexa’s research has discovered potential botanical TLR modulators
• Preliminary lab studies have demonstrated their possible anti-H1N1 and Herpes 2 (HSV-2) properties
TLR Therapeutics
Clinical Approval End-Product LaunchPre-ClinicalDiscovery
1 – 2 years 3 – 5 years 6 months – 2 years
Discovery Pre-Clinical
Clinical Approval End-Product Launch
1 – 2 years 3 – 5 years 6 months – 2 years
Cholesterol Management
COLD-FX® Pediatrics
Seasonal Allergy
Cancer Support
Oxidative Stress & Brain Health
Glucose Management
Blood Pressure Management
TLR Therapeutics
•Anti-Viral
•Cancer Management
•Vaccine Adjuvant
Product Development
Afexa’s Competitive Advantages
• Our patented ChemBioPrint discovery and standardization technology
• Our incredibly strong scientific team and clinical collaborators around the world
• Our leadership position in developing polymolecular botanical drugs
• Our leadership position in developing evidence-based natural health products in Canada, with an incredible success story with our flagship brand COLD-FX
Investing in Afexa
Maturing Canadian science company with highly accepted commercial products and huge
potential to leverage proven science across new medicines
and markets
Stock is under-valued and has tremendous upside potential and does not reflect the
laboratory and clinical breakthroughs
Board of Directors, composed of strong and
knowledgeable individuals from a wide range of disciplines, provides
oversight and guidance
Full spectrum of in-house professionals capable of building strongly branded products from
conceptualization to commercialization
Market and product diversification well
underway