Source: Blueprint Life Science Group

Biota Announces Financial Results for First Half of Fiscal 2012

BARDA Contract Well on Track and Full Phase 2b Results of Human Rhinovirus Study Expected in First Half of Calendar 2012

MELBOURNE, AUSTRALIA--(Marketwire - Feb 15, 2012) - Biota Holdings Limited (ASX: BTA) today announced financial results for the first half of the Company's fiscal 2012. The Company reported a half-year loss of $11 million compared to a net loss of $15.9 million in the corresponding half year. Total revenue was $7.8 million, compared to $8.1 million in 1H F2011. Revenue included $0.7 million of Relenza royalties (1H F11: $3.3m) and $0.7 million (1H F11: $1.2m) of royalties from laninamivir (Inavir). Total expenses were $19.4 million (1H F11: $24.8m). The Company's cash position at the end of the period totalled $56.5 million, confirming a sequential slow down in cash burn, a trend that is expected to continue over the next six months as the Company continues to balance the demands of its programs against the availability of cash from its royalty streams.

Of particular note in the first half, the Company reported that its contract with BARDA for laninaivir is progressing well with revenue of $4.3 million recognized in the first half of fiscal 2011. As previously announced, the contract, signed April 2011, included a $231 million investment by the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) toward further development of laninivir, Biota's long-acting neuroaminidase inhibitor for the treatment of influenza. The contract is fully funded over an estimated five-year period and is contingent upon the delivery of key milestones throughout the period.

Within the pipeline, the Company reported that the Phase IIb clinical study of HRV antiviral BTA798 in asthmatic subjects has completed enrolment, well ahead of schedule. Full results of the study are expected to be available early in the second calendar quarter of 2012. BTA798 has been allocated the generic name of "vapendavir" by the World Health Organisation.

"We are pleased to report encouraging progress made under our BARDA contract, as well as to see the very successful advance of our HRV antiviral program," said Biota CEO, Peter Cook. "The key business focus has been to ensure progress under the BARDA contract and manage cash and costs until the restocking of government neuraminidase inhibitor stockpiles improve Relenza royalty income. It is exciting to see the very successful advance of all our programs, although the short term focus will be on the near-term announcement of HRV Phase IIb results."

Significant Events

  • The main activities under the BARDA contract have been the recruitment of staff with experience in advanced clinical development and manufacturing, the appointment of suppliers and the transfer of the manufacturing know-how from Japan to the USA.

    Key achievements are:
    • Submission of the first 3 contract milestones;
    • Synthesis of the first batch of laninamivir (active pharmaceutical ingredients or API)
      to be produced outside of Japan; and
    • Injection moulding of inhalers using US approved polymers.

In parallel, the clinical team are planning for two Phase I studies that are expected to commence around June 2012.

  • Inavir royalties were $ 0.7 million. Prior to the recent heavy influenza outbreak in Japan, Daiichi Sankyo indicated that sales of Inavir were forecasted to be US$125 million and achieve a 33% share of the Japanese market, this season.
  • Daiichi Sankyo has initiated a further prophylaxis trial in Japan. The trial intends to recruit 1,500 subjects to evaluate Inavir's ability to prevent transmission of influenza A and B within families with a confirmed sufferer.
  • Relenza royalties were subdued at $0.7 million and thus far have not included any significant replacement of expired inventory in government stockpiles.
  • Considerable progress has been made on the RSV, HCV-NN and GYR programs. Biota expects to have nominated a lead candidate for each of these preclinical programs by mid-year.
  • The Board has made solid progress on how best to secure long term value recognition from laninamivir and Biota's other products, in conjunction with our advisor Piper Jaffray. Directors expect to be in a position to take a proposal to shareholders by mid 2012.

*all financial figures are in Australian dollars except for the BARDA contract which represents $231 million USD.

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 GlaxoSmithKline 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 marketed 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.

Contact Information:

Investor / Analyst Enquiries
Biota Holdings Limited
Peter Cook
T: +61 3 9915 3720
Damian Lismore
T: +61 3 9915 3721

Media Enquiries
Tim Duncan
Hinton & Associates
T: +61 3 9600 1979
M: +61 408 441 122
US Enquiries
Hershel Berry
Blueprint Life Science Group
M: +1 415 505 3745