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Immuron Ltd — Regulatory Filings 2006
Feb 27, 2006
35121_rns_2006-02-27_713ee61d-35ea-4822-aecf-dc1e9c3a783f.pdf
Regulatory Filings
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February 28th, 2006
Company Announcement Office Australian Stock Exchange Ltd (ASX) 4th Floor, 20 Bridge Street Sydney NSW 2000
Dear Sir/Madam
Please find herewith a company announcement "Anadis Investor Presentation" for release and distribution to the market immediately.
Yours sincerely
CONOR GRAHAM Managing Director & CEO

ANADIS
www.anadis.com.au www.travelan.com.au

Forward-looking statements
This presentation contains forward-looking statements which are subject to risks and uncertainties. These statements include those regarding the therapeutic and commercial potential of Anadis technologies and products in development and commercialisation.
Any statement describing the company's goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an "at-risk" statement. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements to be different from the statements in this presentation.
Actual results could differ materially depending on a number of factors including, but are not limited to, results of studies and trials, the timing and effects of regulatory actions, ability to penetrate markets, the strength of competition and the effectiveness of patent protection.
Anadis Highlights
· Lead product Travelan
- •Commercialised in Australia.
- .US Regulatory Compliant.
- •Canadian distributor appointed.
- •Additional International Registration Imminent.
- •Additional Gastrointestinal Indications Identified: Inflammatory Bowel
- Disorder (IBD) and Irritable Bowel Syndrome (IBS).
• EV-71 - preventative for Enterovirus 71
- .In Commercialisation "Scale-Up" phase.
- .Conservative estimates for Taiwan market alone in excess of 110 million doses per annum.
- . Continued research success with the Bio-Defence / Respiratory Protection - Anthrax Lethal Toxin 100% Neutralized
- Anadis offered \$970k grant for work on Decoy Profiling Technologies - to improve vaccine potency.


Collecting Antibodies BBBANADIS
Hyper-immunise ordinary dairy cows, with Anadis vaccines, during last trimester of pregnancy.
Post calving, use patented TACHS* to harvest high IgG Colostrum with high levels of specific antibodies as a result of hyper-immunisation, and high levels of other important and useful colostrum fractions. Tatura Anadis Colostrum Harvesting System

Use Hyperimmune Colostrum often in conjunction with other technologies eg. "Bio-Shield"

Purify colostrum to concentrate only specific antibodies
ANADIS

Travelan
- Travelan is a revolutionary over-the-counter (OTC) preparation scientifically and clinically proven to significantly reduce the risk of Travellers' Diarrhoea (more commonly known as Delhi Belly, Bali Belly, etc)
- Travellers' Diarrhoea is the number one health problem for international travellers, in terms of frequency and economic impact.
- Travelan is based on antibody technology and is not an antibiotic preparation. Unlike conventional treatment medications, Travelan is a preventative and significantly reduces the risk of being affected.
- Analysis by the Australian Government Analytical Laboratory, an IOC (International Olympic Committee) accredited laboratory confirmed the absence of any prohibited substances.
- Travelan can be safely used by international athletes during competition.
- Travelan is now available Australia wide through most pharmacies

ETEC in the presence of "Travelan" antibodies. A N A D I S
Travelan
- Travelan is currently being considered for the following markets: Singapore, India, Korea, United Arab Emirates, Thailand, Malaysia, South Africa and the UK and EU.
- Registration / Relevant Authority Approval is the key time hurdle preventing international sales.
- Travelan is protected by a number of patents. Imitation of Travelan is difficult due to the natural basis and in house "know-how" required to produce bloactives – hence the international appeal and keen distributor interest in the product.
- Anadis has received a "Green Light" to market in the US under GRAS (Generally Regarded as Safe) classification.
- Canadian distributor Valeo Pharma \ Baralex appointed. Registration expected end of April 2006, sales to begin shortly after.
- Registrations expected during 2006: Singapore, South Africa, India and others pending.
Travelan Global Forecast

Travelan Revenue Potential BBBANADI
- Assumed constant growth in the relevant markets until reaching expected sales levels where growth is restricted to 3% pa.
- Revenue assumed at AUD\$12.50 packet with no increase over time for clarity.
| Financial Year | |||||||
|---|---|---|---|---|---|---|---|
| Ending | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 |
| Market | Sales 000's Packs | 52000 | |||||
| Australia | 54 | 90 | 150 | 250 | 258 | 265 | 273 |
| s mmm Canada ⊸∞ |
45 | 76 | 126 | 210 | 350 | 361 | 371 |
| India | 389 | 648 | 1,080 | 1,800 | 3,000 | 3,090 | 3,183 |
| Malaysia | 65 | 108 | 180 | 300 | 500 | 515 | 530 |
| Old EU | 272 | 454 | 756 | 1,260 | 2,100 | 2,163 | |
| S. Africa | 39 | 65 | 108 | 180 | 300 | 309 | 318 |
| Singapore | 3 | 22 | 36 | 60 | 100 | 103 | 106 |
| Taiwan | 32 | 54 | 90 | 150 | 250 | 258 | 265 |
| Thailand | 6 | 11 | 18 | 30 | 50 | 52 | 53 |
| ÜK | i gref S | 97 pi |
162 | 270 | 450 | 750 | 773 |
| ŰS | 389 | 648 | 1,080 | 1,800 | 3,000 | 3,090 | 3,183 |
| Total Sales 000's | |||||||
| Packs | 1.032 | 2,090 | 3,484 | 5,806 | 9,518 | 10,892 | 11,218 |
| Revenue \$'000's | 12,906 | 26,127 | 43,545 | 72,575 | 118,969 | 136,147 | 140,231 |
Travelan in IBD and IBS
- Travelan has been identified for additional potential gastrointestinal therapeutic indications in the areas of Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Crohn's disease and Ulcerative colitis.
- Chronic Diarrhoea is prevalent in many lower gastrointestinal tract conditions.
- Reports by healthcare providers, including medical specialists, indicated patients experiencing an improvement in some symptoms (e.g. chronic diarrhoea) whilst taking Travelan during travel.
- Travelan will be added to the current treatment of stable IBD patients in a pilot study with beneficial therapeutic effects assessed through widely accepted disease activity markers.
- The scientific basis for this therapy in IBD, relate to the ability of Travelan antibodies to bind to bacterial products which are believed to mediate the persistent inflammation occurring with these conditions.
Travelan IBD Market Potential
| Financial Year | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 |
|---|---|---|---|---|---|---|
| AUS Patients | 70,000 | 73,500 | 77,175 | 81.034 | 85,085 | 89,340 |
| Utilising Therapy | 5% | 7% | 8% | 10% | 12% | 15% |
| Patients | 3500 | 5,145 | 6,174 | 8.103 | 10,210 | 13.401 |
| Rev/Patient/Annum | 338. | 345 | .352 | 359 | 366 | 373 |
| AUS Revenue \$'000s | \$1,183 | \$1,774 | \$2,171 | \$2,907 | \$3,736 | \$5,001 |
| US Patients | 1,000,000 | 1,050,000 | 1,102,500 | 1,157,625 | 1,215,506 | 1,276,282 |
| Utilising Therapy | 0% | ୀ% | 3% | 5% | 8% .kWK |
10% |
| Patients | 0 | 10,500 | 33.075 | 57,881 | 97,241 | 127,628 |
| Rev/Patient/Annum | 338 | 345 | 352 | 359. | 366. | 373 |
| US Revenue \$'000's | SO. | \$3,620 | \$11,631 | \$20,761 | \$35,577 | \$47,628 |
| Total Revenue \$'000's | \$1183 | \$5,394 | \$13,802 | \$23,668 | \$39,312 | \$52,629 |
This revenue estimates are restricted to the use of Travelan only in the IBD (Inflammatory-Bowel Disease) market. The IBS market is far larger.
Current IBD effects approximately 70,000 and 1,000,000 people in Australia and the US respectively. Travelan has a GRAS (Generally Regarded as Safe) classification in the US and can be sold into that market.
ANA
Assumptions: Patient Growth 5% pa; Revenue based 36 packets pa * \$12.50 * 75% patient compliance, Revenue growth fixed at 2% pa.
EV-71 - Enterovirus 71 Preventative PRANAI
- Anadis in conjunction with the Taiwanese Development Centre for Biotechnology (DCB) have developed a protective therapy against Enterovirus 71
- The WHO has classified Enterovirus 71 as an emerging 'disease state', and are comparing the disease with the spread of polio in Europe and North America in the late 19th century.
- Estimates for Taiwanese demand are in excess of 110 million doses per annum (this represents a penetration rate of around 30-35% of the target market (young children) for one dose per day during the summer months).
- Enterovirus 71, a polio like disease, is one of the viruses which causes 'hand, foot and mouth' or 'slapped cheek' disease in young children. A significant proportion of younger children can develop nervous signs such as fits, paralysis and in some cases fatalities can occur.

EV-71 Market Estimates EZZANIA
- This disease is concentrated in the Asia-Pacific region mainly Taiwan and China - outbreaks have also been reported in Hong Kong, Vietnam, Malaysia and Singapore
- With an Anadis proprietary vaccine for cattle, currently in use, it was proven in October 2005 that commercial levels of the bioactive proteins can be produced.
- Registration of the cattle vaccine expected Mar/Apr 2006 -implying first commercial supplies during Spring 2006. Vaccine scale-up to occur during Apr/May 2006.
- Revenue for Bioactive Proteins estimated at 30c per dose
- Anadis is working with Taiwanese partners for an increased role in the commercialisation of the product to further enhance margins.
- Initial distribution coinciding with northern hemisphere summer 2007.
- Potential additional markets include China, Hong Kong, Vietnam, Malaysia and other parts of Asia.

EV-71 Market Potential MAANADISM
- Estimates for Taiwanese demand are in excess of 110 million doses pa. China & Asia have been estimated to be one year later than Taiwan as distribution expands.
- Revenue with no increase over time in model.
| Financial Year | 2007 | 2008 | 2009 | 2010 | 2011 | 20YQ |
|---|---|---|---|---|---|---|
| Taiwan 000's doses | 20,000 | 40,000 | 60.000 | 80,000 | 110,000 | 115,000 |
| Revenue / dose | 030 | 0.30 | 0.301 | 0.301 | 0 30 | (0)(30) |
| Revenue \$000's | 6(000) | 12,000 | 18,000 | 24,000 | 33,000 | 34,500 |
| Ohina & Asia | 0 | 20,000 | 40,000 | 60,000 | 80,000 | 110,000 |
| Revenue / dose | 0.30 | 0.301 | 0.30 | 0.30 | —— ©.30 | 0.30 |
| Revenue \$'000's | 88 | 6,000 | 12,000 | 18,000 | 24000 | 334000 |
| Total Revenue \$'000's | 6,000 | 48,000 | 30,000 | 424000 | 574000 | 67.500 |
ANADIS
| Travelan and EV-71 Consolidated | |||||||
|---|---|---|---|---|---|---|---|
| BBBANADI | |||||||
| Financial Year | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | |
| Revenue \$'000's | |||||||
| Travelan for TD | 12,906 | 26,127 | 43,545 | 72,575 | 118,969 | 136,147 | |
| Travelan for IBD | 1,183 | 5,394 | 13,802 | 23,668 | 39,312 | 52,629 | |
| EV-71 | 6,000 | 18,000 | 30,000 | 42,000 | 57,000 | 67,500 | |
| Total | 20,089 | 49,521 | 87,347 | 138,243 | 215,281 | 256,276 |
- . Estimates are given for products in and on the verge of commercialisation.
- The following slides contain information in regard to our other projects, some hear product stage, which are also for large markets with unmet needs.
ANADIS
Bio-defence/Respiratory Project EMANAD
- Aim to develop neutralizing proteins to provide short term immediate protection against specific bioterrorism agents in battlefield and emergency response situations.
- Agents include Plague and Anthrax amongst others.
- Research in conjunction with the Defence Science and Technology Organisation (DSTO) focused on the cytotoxic effect of Anthrax Lethal Toxin and the protective action of specific bovine antibodies against lethal toxin protective antigen (PA) and Lethal Factor (LF) on delicate human lung epithelial cells.
- Colostrum derived antibodies for both PA and LF were equally effective in providing 100% protection from the cytotoxic effects of Lethal Toxin towards human lung cells.
- The full text is published in the Journal of Applied Toxicology and is available online at http://www3.interscience.wiley.com/cgibin/ ALINEXU1121412397FDFSTART

Bio-defence/Respiratory Project EZANAD
- The Bio-defense Project has recently expanded to include antibodies for the use in diagnostic systems.
- Anadis has now raised Ricin and Botulinum antibodies for the use in diagnostic kits, at the request of the Department of Defence.
- Anadis sees potential in civilian applications for these technologies in the respiratory medicine field - in particular Hay Fever and Asthma.
- Further work underway with US Bio-Defence Organisations.
- Current research has 12 month until completion. All intellectual property (IP) developed to be owned by Anadis.

Effect of exposure to inhabed lgG on lung histology Lungs of mice traded with whole rabbi FIG showed no pathological changes compared with intreated animals.

Pyloran and H. pylori
- The Pyloran research program focuses on the H. pylori bacteria, responsible for Gastritis and Gastric Ulcers.
- A successful phase II clinical trial was completed at the Alfred Hospital, Melbourne October 2003 showed a significant reduction in H. pylori infestation & symptoms
- OTC (Pyloran) Final formulation and commercialisation strategy under development
- Development of a human non-colostrum based oral H. pylori vaccine - several new targets (outer membrane molecules) identified.
| Country | Prevalence of H pylori infection |
|---|---|
| Korea | $\geq$ 20 million |
| Taiwan | $\approx 8$ million |
| Japan | $\approx$ 50 million |
| บร | $\approx$ 108 million |
| UK, France, Italy | $\approx 70$ million |
ANADIS
Bio-Shield 10
- Bio-Shield 10 is a set of patented technologies for the protection of delicate molecules in harsh environments such as in the acidic stomach or for these delicate molecules stored in air.
- Bio-Shield technologies are key components in our EV-71 and Pyloran formulations:
- Can be formulated for the protection of Antibodies, Enzymes, Proteins, Bacteria (in particularly pro-biotic "good bacteria") and other health promoting food additives.
- Significant interest shown by major food group confidential discussions underway.
- Anadis studies have shown over 90% of an oral dose of probiotics being destroyed, within 10 minutes. However 90% of Bio-Shield protected probiotics are still alive after 1 hour of exposure to the harsh stomach environment.
• Utilising Bio-Shielding technology, Anadis has kept probiotic bacteria viable on breakfast cereal for over 6 months.
DPT & Functional Foods 膀胱 A N A D I S
- Decoy Profiling Technologies are the subject of \$973,000 Ausindustry Commercial Ready Grant offered in November 2005.
- DPT enables the removal of 'decoy' materials from vaccines, leading to greatly increased levels of specific beneficial antibody production.
- Anadis believes DPT can improve vaccine technology to the extent which allows cost effective antibody production for the multi billion dollar Functional and Medical Food markets.
- This cost reduction will allow new products for 'Population Health', in addition to our current pipeline for 'Individual Recovery and Protection'.
- If Enterovirus 71 antibodies can be integrated into functional foods, this would provide an additional market significantly larger than that identified for the Anadis OTC EV-71 preventative.
A N A D T S
• DPT can reduce the antibody cost across our product pipeline.
Immune Stimulating Foods an Roman
- In November 2004, Anadis and TMI received a Commonwealth Food Innovations Grant (FIG) for approximately \$1m for research into a specialty milk powder for infant formula, aimed at the Asian market
- The aim is for this infant formula to have high levels of specific antioxidants which appear to be important in the immune development of children
- Conventionally artificial chemical forms of bioactives are "spiked" into the infant formula
- The Anadis technology allows for the cows to naturally include the antioxidants in the milk - packaged much the same way as human mothers milk.
| Market Potential | |
|---|---|
| Total market size for infant formula in | |
| Asia is approx. 290,000 metric ton, with | |
| a wholesale value in the order of | |
| AUD\$1.6 Billion - growing around 5% | |
| per annum. | |
| Markets % by Volume | |
| China | 52% |
| Indonesia | 16% |
| Japan | 12% |
| South Korea | 10% |
| Tawan | 10% |
ANADI
Taiwan
• This research has 1 year to continue with results pending.
Anadis Limited BEZONIA IN
- A Melbourne, Australia based Biopharmaceutical Company focused on Nutraceutical and Pharmaceutical product research and development.
- Specialists in developing bovine colostrum derived (polyclonal antibody) products - with short development timelines - for therapeutic use in humans.
- Utilising bovine colostrum as a natural product pathway enables development with a natural basis leading to an expectation of safety and international market acceptance.
- Anadis has a broad pipeline of products on a varying timeline, with products at (Travelan) or very near (EV-71) commercialisation.
- Bioactive ingredients manufacturer able to manage commercialisation and retain more product value than with the traditional "royalty" based models.
- Anadis is not apprehensive in cancelling failing research, with Board and Management allocating resources to avenues most likely to lead to commercial success. ANADIS
Anadis Limited
888 AN ADIS
- Investment Grade Biotechnology
- Products for large markets with un-met needs
- Travelan commercialised and preparing for international market distribution
- · EV-71 in commercialisation scale up phase.
- Pyloran, Bio-Shield 10 and Immune Stimulating Infant Formula, all in late stage development.
- Natural product bias, with corresponding attractiveness.
- Anadis highly successful in securing Government grant funding.
- Products protected by Patents and in house "know-how".
- "Blue Sky" opportunities not at the expense of real world products and business realities.
MENENTEN I K
. Anadis Limited - Delivering on the Promise of Biotechnology
Contact Information
Anadis Limited
8888 ANADI
- 4 Capital Link Drive Campbellfield VIC Australia 3061
- Telephone: +61 3 9358 6388 Facsimile: +61 3 9358 6399
- www.anadis.com.a
- www.travelan.com
Conor Graham - MD & CEO [email protected]/au
Arie Nudel - Investor Relations EU UM 1978 (PRESERVENT DE L'AU
