Biota Holdings Limited. (BTA-ASX)

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August 28, 2009 Issue

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Anti-Infective Drug Development Company, Biota Has A Strategy Of Licensing Their Programs To Larger Global Pharma Companies In The Early Phases, Which Gives Them A Greater Opportunity Of Getting More Products To The Market

Company Profile:

Biota is a leading anti-infective drug development company, based in Melbourne, Australia. Biota's initial success was the discovery of zanamivir, the first-in-class neuraminidase inhibitor for the treatment and prevention of influenza. Zanamivir is licensed to GlaxoSmithKline and marketed as Relenza™. Relenza is used to treat seasonal influenza and is currently being stockpiled by various governments for defense against possible pandemic outbreaks of influenza.

Biota also has key partnerships with:

- Boehringer Ingelheim: where it has a license and collaboration agreement to develop and commercialize Biota's novel nucleoside analogues, designed to treat hepatitis C virus (HCV) infections and potentially other diseases; and
- Daiichi Sankyo Company, Limited: for the development of second generation influenza antivirals (called LANI or long-acting inhaled neuraminidase inhibitors).


Damian Lismore BA (Hons), FCA, MAICD Chief Financial Officer and Company Secretary

Damian was appointed Chief Financial Officer in 2005. His commercial background includes ten years with Price Waterhouse (now PwC) in Australia and six years with Deloittes Haskins & Sells in the UK. He has served as Group Financial Controller and General Manager Buying & Finance for the major Australian pharmaceutical company, Sigma; and as Managing Director of MNT Innovations, the commercial arm of the CRC (Co-operative Research Centre) for MicroTechnology.


Damian has extensive experience at all levels of the healthcare industry, particularly in acquisitions and restructures, commercialization of new technologies and dealing with the investment community.


Anti-Infective Drug Development

Biota Holdings Limited.
10/585 Blackburn Road
Notting Hill, Melbourne ,VIC 3168 Australia
Phone: 61-3-99153721




Interview conducted by: Lynn Fosse, Senior Editor,, Published – August 28, 2009

CEOCFO: Mr. Lismore, what is the broad vision at Biota?

Mr. Lismore: “Biota’s strategy is to create a successful and profitable anti-infective company. We seek to license our programs to major pharmaceutical companies relatively early so that we can access global pharma expertise and have a better chance of getting more products to market. The prize is having products in the market, generating significant royalties”


CEOCFO: What is your focus today?

Mr. Lismore: “The focus today is the announcement that we released on August 10, 2009, in relation to our second generation influenza treatment called laninamivir, which has proven successful in Phase III clinical trials in Asia.”


CEOCFO: Tell me about the program.

Mr. Lismore: “Laninamivir is effective against all influenza strains, including bird flu and swine flu. It is a second generation product. With the current focus on influenza laninamivir is very topical. Laninamivir is an inhaled product taken as a single dose. It is aimed at treating influenza or preventing a person contracting influenza. It is a new and novel long-acting product.”


CEOCFO: How are you going to get it out there?

Mr. Lismore: “We co-own the product with the major Japanese pharmaceutical company Daiichi Sankyo. They have announced that they will take this product to market in Japan subject to regulatory approval. Laninamivir should be on the market in Japan in approximately 15 months. We have said that we will seek a partnership with a large pharmaceutical company for the rest of the world.”


CEOCFO: What is the competitive landscape, and why is what you have special?

Mr. Lismore: “The market is large with governments spending approximately US$1bn annually on influenza products.


The competitive position of laninamivir is unique. Current treatments include both Relenza™, which Biota invented, and Tamiflu. Both of these products require two doses per day for five days. So the patient takes ten doses. Laninamivir is a single dose treatment, so there is very significant benefit for the patient. We expect laninamivir to present a very attractive option for the government stockpiling market”


CEOCFO: Can patients take it at home?

Mr. Lismore: “They can take it at the doctors or at home.”


CEOCFO: What other products or ideas are you working on?

Mr. Lismore: “We are also working on a human rhinovirus program that just completed a Phase IIa trial, which is an efficacy study. This study showed that the compound worked against the disease in man. The program is for those patients who have severe complications of the common cold virus, where there is a need for a treatment of this nature. We also have a hepatitis C (HCV) program which is licensed to Boehringer Ingelheim but that is at a very early stage.”


CEOCFO: Is there a common thread through the various products?

Mr. Lismore: “The common thread is we work with infectious diseases, although we are probably better known for our work with influenza.”


CEOCFO: What is the financial picture for Biota?

Mr. Lismore: “The company is profitable. We reported a A$38 million net profit on the 19th of August 2009. We have been cash accretive over the last few years and had $87 million cash at 30 June.


More importantly, we are forecasting a strong outlook next year and have recently announced we will return $20 million to shareholders in December.”


CEOCFO: What if any challenges do you see as you proceed forward?

Mr. Lismore: “The main challenges are associated with managing growth. There are plenty of opportunities out there and many other biotech companies that have run into financial trouble. We are looking to actively grow our programs and leverage our relationships with pharmaceutical companies.”


CEOCFO: What is your background in the commercialization of products?

Mr. Lismore: “I have worked extensively in all aspects of the health industry. I’ve been in biotech, pharmaceutical manufacturing, pharmaceutical wholesaling and retailing, so I actually have a pretty broad knowledge of how the health industry works. This helps in knowing how products get to market and the value at each part of the chain. I love working with innovative companies. At Biota we have great science and are very focused on getting more of our products to market.”


CEOCFO: In closing, why should potential investors pay attention to Biota?

Mr. Lismore: “Biota is one of those few biotech companies that is profitable; we have been cash accretive for the past couple of years. We produce great science and we have a proven track record of commercializing great science. We are forecasting a strong outlook for next year.


As an example, we receive a 7% royalty on all Relenza sales by the GlaxoSmithKline and GlaxoSmithKline will triple production capacity of Relenza to 190 million courses by the end of the year. We also have other follow up products. We talked briefly about laninamivir. So within two years there should be a second royalty stream. We think Biota is particularly well placed at this point in time, and quite strong financially.”


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“Biota is one of those few biotech companies that is profitable; we have been cash accretive for the past couple of years. We produce great science and we have a proven track record of commercializing great science. We are forecasting a strong outlook for next year.” - Damian T. Lismore, BA (Hons), FCA, MAICD does not purchase or make
recommendation on stocks based on the interviews published.