Biota Announces Preliminary Full Year Report

MELBOURNE, AUSTRALIA--(Marketwire - Aug 17, 2011) - Biota Holdings Limited (ASX: BTA)

Highlights

• BARDA awarded a major contract to Biota for the advanced development of laninamivir
  in the US. The US$231 million contract is in excess of the Company's market capitalisation and is a "game changing" opportunity for Biota.
• Inavir^® was launched in Japan, one of the two largest markets, earning $2.9 million
  in royalties.
• HRV Phase IIb clinical trial is well advanced with 232 subjects of the target 300 recruited last season. Enrolments are expected to recommence in the US in August.
• RSV lead candidate identified.
• Biota awarded US$2.9 million NIH grant for CDI antibacterial program.
• Cash: $70 million at 30 June 2011.
• Net Loss: $28.1million.

Biota Holdings Limited (ASX: BTA) today announced a net loss after tax of $28.1 million (F10: $16.2m profit). Loss before tax was $29.2 million (F10: $20.3m profit).

Total revenues were $17.1 million compared to $71.5 million in F2010 when the Company benefited from significant royalties from Relenza due to the H1N1 pandemic. Relenza royalties were $6.6 million (F10: $63.7m), Inavir royalties were $2.9m (F10: $Nil), and US National Institutes of Health grant income was $2.5 million (F10: $3.9m). Income under the BARDA contract was $0.6 million.

Commenting on the results today, Biota CEO Peter Cook said:

"Whilst there was a significant fall in Relenza royalties following the pandemic year, solid commercial progress continues to be made, such as the launch of Inavir^® in Japan our second royalty generating product. The contract from BARDA for the advanced development of laninamivir in the US was one of the most significant events in the Company's history. It provides US$231 million of non-dilutive funding, and opens up supply opportunities for laninamivir to the US government".

Reported expenses were $46.2 million (F10: $51.2m) including:

• Investment in research programs of $20.7 million (F10: $21.7m). In addition, $2.9 million (F10: $8.8m) of acquisition costs were amortised in the year in respect of antibacterial programs acquired in F2010; and
• Product development costs at $15.1 million (F10: $11.2m) focussed on laninamivir and the HRV Phase IIb clinical trial. $2.5 million of these costs were reimbursed by the NIH.

The income tax credit was $1.1 million, principally representing the credits arising on R&D expenditure in the UK. R&D credits in the UK are refunded in cash.

The Company's cash position at $70 million remains appropriate given the volatility in revenues and the investment stage of our major programs.

Significant Events

• The Office of Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services has contracted Biota Scientific Management (BSM) to complete and lodge a US FDA New Drug Application (NDA) for laninamivir for the treatment of influenza infection. The contract, valued up to US$231 million, will fund the early stage manufacturing, commissioning, scale-up, and all necessary Phase II and Phase III clinical trials for the US NDA. This funding is available to Biota at no cost to shareholders;
• Inavir was launched in Japan in October 2010 by Daiichi Sankyo. F2011 sales of ¥7.1 billion (A$85m) have been achieved providing Biota with royalties of $2.9 million. Japan is one of the world's largest markets for influenza antivirals;
• The Phase IIb clinical study of the HRV antiviral BTA798 in subjects with chronic asthma, commenced in July 2010. During the 2010 rhinovirus season the study recruited 232 patients against a target of 300. The trial is expected to complete enrolments in Q4 of this year and the study results available in Q2 2012; and
• A new lead candidate for the prevention and treatment of RSV has been identified and is in preclinical studies.

Outlook

The Company's focus remains clearly on those programs with an opportunity for commercial return. Delivery of key milestones under the BARDA contract for laninamivir will dominate activity as it provides a clear pathway to value for shareholders.

The Board continue to work with Piper Jaffray with the intention of extending the commercialisation of laninamivir and Biota's other products in development. Piper Jaffray's advice will centre on the best route to maximise and release shareholder value through merger, acquisition or listing opportunities available to the Company. Shareholders will continue to be updated at key events.

The HRV Phase IIb study is expected to complete recruitment by the end of the calendar year with key reporting of results in Q2 2012.

In uncertain times, cash will continue to be managed tightly and cash reserves will be deployed to compensate for the recognised seasonal and variable nature of the influenza market.

For Full report go to: http://www.biota.com.au/uploaded/154/1021778_37preliminaryfinalreport.pdf

About Biota

Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmith-Kline as Relenza. Biota research breakthroughs include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems.

In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza antivirals, of which the lead product lnavir^®, is approved for marketing in Japan. Biota holds a contract from the US Office of Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of laninamivir in the USA.

Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
Inavir^® is registered to Daiichi Sankyo.