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Immuron Ltd — AGM Information 2007
Nov 12, 2007
35121_rns_2007-11-12_79c8d481-9661-4468-9c05-c7f7bec5041a.pdf
AGM Information
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Anadis Limited Annual General Meeting Chairman’s Address & CEO Presentation
13 November 2007
Dear Shareholders,
I would like to take this opportunity to revisit a number of statements I made in the Company’s annual report, which you received recently.
In the Chairman’s report I said “the company is now repositioned for new and larger global markets” and you were told that intensive structural changes had taken place. Well I want to make sure that you appreciate that some things have not changed from the “old Anadis”. In fact, we are proud of what has been accomplished in a number of our business activities over many years of hard work.
The Company’s Research & Development division, operating under the direction of Dr Grant Rawlin, has not changed and is a great source of satisfaction for Anadis. Some 12 scientists, employed by Anadis but operating in university laboratories, side by side with academic researchers and with access to state of art scientific and medical equipment. They have produced leading-edge dairy-derived technologies and patents of considerable commercial potential.
The Manufacturing operation at Campbellfield, driven by Fred Mears and a team of approximately seven people, generated revenue of over $4 million last year and is expected to see sales exceeding $8 million this financial year. This business remains unchanged and although deriving its revenue from contract manufacturing of third party functional food products, it contributes cash and, most importantly, indirectly assists the company’s own product development programs.
So we have the same management, same people, working within Anadis R&D and Manufacturing – two of the company’s most important divisions. And why am I telling you this? Because it takes years to build such effective core business functions. Since we have got that pretty right we have genuine reason to believe that lifting shareholder value in the short to mid-term is a real possibility.
Now, about the Company’s marketing. At Anadis we concede that better options could have been taken in the initial marketing of Travelan – our Travellers’ Diarrhoea preventative – in Australia, and sales so far have been disappointing ($120,000 last year). Our head of marketing David Lyon is coordinating the product’s distributors, and Travelan in the new blue pack is gaining a greater following. There is continuing effort, albeit with modest budgets, to get the product into international markets and you will hear more about this in Dr Rosenberg’s presentation shortly.
There have been significant changes at the top of Anadis. There are two key additions to the leadership of the company. Dr Zeil Rosenberg, our CEO, was appointed May this year and Dr Oren Fuerst has been appointed VP of Business Development. These gentlemen have very solid biotechnology industry credentials that are very relevant to Anadis. They operate out of New York and came highly recommended by industry associates of Anadis in the USA.
Our working together, particularly over the past six months, has produced very promising opportunities that will allow Anadis to expand its R&D, its technologies and its product pipeline. Dr Rosenberg will elaborate on this shortly, including an update on the Enterovirus 71 product program.
There are challenges in working at a distance but the significant markets for Anadis technology are international, and the USA particularly, has a large number of potential commercial interests and partnerships for your company. Our new senior management team is on the spot there to forge and manage commercial relationships.
Despite the additional cash contribution expected from third-party manufacturing and the continuing income from R&D grants, Anadis expects its R&D-driven business programs to require additional equity funding above the $700,000 secured in August this year. Further funding opportunities for the company are being actively pursued. Balancing the timing of cash injections and minimizing existing shareholder dilution are a constant challenge.
On behalf of the Board I express sincere thanks to the shareholders that have remained strong supporters of our Company. We welcome the new shareholders that joined in the recent capital raising and we are particularly pleased to have some new USA-based shareholders. Please be assured that Anadis’ hard-working employees are striving energetically to translate our strong scientific skills into a sustainable business.
Roman Zwolenski Chairman Anadis Limited
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November 2007AGM Update Dr. Zeil Rosenberg, CEO
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Organizational changes
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Change business model
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Position as a bio-pharmaceutical platform play
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Emphasis on high-value products
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Strengthen Intellectual Property
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Enhanced effort in clinical studies and data
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Strategic partnering
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Polyclonal Antibodies are families of proteins that bind to multiple pieces of antigen.
Monoclonal antibodies recognise only one piece of the puzzle.
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Proprietary proven platform technology
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Viruses, bacteria and toxins
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Cost effective method to harvest polyclonal antibodies from first-milking of immunized cow
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Antigen specific, primary, hyper-immune bovine colostrum
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Emerging interest in polyclonal vs monoclonal antibodies
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Rapid Development, manufacturing and regulatory pathway for use in new indications
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Current revenue ~tracking $8M
- Private label manufacturing and E.coli prevention product.
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Targeting addressable market size in excess of US$30bn
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Melbourne, Australia (Mfg. and R&D)
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• New York (CEO + Bus. Development)
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• Melbourne, Israel, USA (Clinical Studies)
Going Global
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Travelan (Travelers’ Diarrhoea) Sales above budget New business model- distributor/lic. Exploring use for military Protectyn (Gastric Ulcers) EV-Protec (EV-71 virus in Asia) Regulatory classification & claims will vary by country.
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Harvesting Antibodies: Anadis Proprietary Methods
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Use freeze dried Primary Hyperimmune Colostrum with other technologies eg. “Bio-Shield” oral delivery
Post calving, use the patented Harvesting System to harvest first-milking Colostrum with high levels of specific antibodies (IgG) as a result of hyperimmunisation, and high levels of other important colostrum fractions.
Immunize ordinary dairy cows, with Anadis’ gov’t approved & proprietary vaccines, during last trimester of pregnancy
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Purify colostrum to concentrate specific polyclonal antibodies.
Alternatively, Anadis has own experimental herds for clinical trial use
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Travelan™line extensions (1-2 years)
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Travelan Plus
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Added bacterial targets and pharma grade mfg.
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Alimentary Mucositis
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Reduce side effects in cancer patients & improve life quality
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Inflammatory bowel disease
Other major product targets Influenza A virus (avian and seasonal)
- C. difficile (major gastrointestinal problem/ bacterial overgrowth caused by antibiotics)
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Functional foods
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SPC Ardmona/Coca-Cola Amatil
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Bio-Defence- ‘Project Ectoplasm’
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Cancer therapy-stay tuned
BRING IN ADDED RESOURCES
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Safe, natural product => rapid regulatory path to market
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GRAS classification-Generally Regarded As Safe
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Safer than blood-based products in use now (e.g. serum IgG)
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Time from bench to market for new compound of 3-5 years
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Comparatively Inexpensive
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Compared to alternative antibody manufacturing systems
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Proprietary processes and other significant barriers
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Bovine vaccination during pregnancy with specialized vaccines
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Followed by harvesting, freeze drying and purifying primary colostrum
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Very high immunoglobulin levels in primary colostrum
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Antibodies against specific targets
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Many years of industry and academic research
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Significant IP filings across technology platform and indications
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Manufacturing infrastructure at Australian dairy high standards -BSE-free
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First application : Traveler’s Diarrhea � in market.
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E.coli antibody is the linkage to many serious bacterial GI infections.
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E.coli and related “microbial translocation” or “leaky gut” adverse effects
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Research based on work by Prof. Roy Robbins-Browne.
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Director, Microbiology and Immunology at Murdoch Children’s Research Institute & University of Melbourne.
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Expansion (marketable products over next 3-5 years):
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High Value target: Mucositis Rx and Prevention for cancer patients:
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Chemotherapy; Radiation Therapy; BMT.
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5M patients with 40% suffering from these side effects. Main competitor costs >$8,000/pt and with limited indication.
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Dairy-derived antibodies and antibody fragments
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Coating the Respiratory tract mucosal surface
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Immediate immune protection
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Solution can be modified rapidly to address new strains.
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Avian influenza focus to expedite time to market.
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Polyclonal antibodies potentially superior to monoclonal
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Complements vaccines - not competing
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Project research team leader: Prof. Lorena Brown, Professor, Dept. Microbiology and Immunology at the University of Melbourne.
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Recognized expert in influenza research
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4 animal studies completed; results being prepared for publication
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Additional animal planned along well defined pathway for avian influenza
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Human clinical studies possible in <18 months
Product launch est. 3-5 years. Market size >US$1 B
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Proprietary “Bioshielding” technology.
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Additional collaborations in process.
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Products for large consumer markets, with royalty and manufacturing income streams.
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Innovation satellite for SPC Ardmona, Coca Cola Amatil
- Antibody infused freeze dried fruits as one example
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Detect, neutralize and contain bio-threat (e.g. Anthrax) • Hydrogel based solution (polymer and polyclonal antibodies).
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• Leverage govt testing and R&D ->procurement.
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Australian government grant (2007) & project support.
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• Expand to other threat agents (including radiation).
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Initial target Anthrax – Anadis has already raised antibodies to other bioterrorism targets.
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In discussions with U.S. Dept.of Defense (DTRA).
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2-3 years from market
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Video clip at o
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www.kommotion.com.au/anadis/Hydr -el.mp4
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