Melbourne, Australia — 20 February 2008: Biota Holdings Limited (ASX: BTA) today announced a half year net profit after tax of AU$5.5 million, (1H F07: AU$4.1 million), a 35% improvement over first half F2007. Profit before tax was AU$7.5 million (1H F07: AU$4.1 million), up 83%. The result was driven by Relenza royalty revenues and growing collaboration income. Biota continues to achieve excellent progress on all of its drug development programs.
Total revenues were AU$30.4 million, up from AU$20.4 million in the comparable period last year, up 49%. Relenza royalties were AU$16.5 million (1H F07: AU$12.7 million) principally from sales of influenza pandemic stockpiling orders on GlaxoSmithKline (GSK). Collaboration income increased significantly to AU$9.6 million (1H F07: AU$5.9 million) reflecting activities from licensing agreements with MedImmune Inc. and more recently from Boehringer Ingelheim.
The Company also intends to undertake an on-market share buy-back of up to 5% of the issued ordinary shares, as part of its ongoing capital management strategy. The share buy-back will commence in approximately two weeks, following the normal regulatory notification process.
Commenting on the announcement today, Biota CEO Peter Cook said “This is a pleasing half year result and gives us the flexibility to extend our pipeline or progress existing programs further into clinic. In delivering major milestones under our licensed programs, we have been able to secure a significant added revenue stream to complement our Relenza royalty income”.
Total expenses of AU$22.9 million (1H F07: AU$16.3 million) reflect the costs associated with increased activity in both clinical and preclinical programs, some of which were reimbursed by licensees.
Expenditure associated with the litigation against GSK was AU$8.6 million (1H F07: AU$3.4 million) and reflects the preparation for trial, scheduled to commence on 4 August 2008.
Mr Cook added “The Supreme Court of Victoria has set a trial commencement date of 4 August 2008 and also has referred the matter to mediation to be completed by 31 July 2008. We remain firm in our commitment”.
Other Significant Events
Clinical programs are making solid progress Biota’s lead compound for the treatment of HRV in patients with compromised respiration, has successfully completed Phase I studies. Phase IIa (Challenge studies) are being developed for commencement as soon as practical. Biota’s long acting neuraminidase inhibitor (LANI) CS8958 has commenced Phase II studies both in Japan and elsewhere in Asia. The studies aim to test the effectiveness of CS8958 in adult patients with naturally acquired influenza A or B infection. Results are expected later in the year. CS8958 has commenced three complementary Phase I studies in the UK as an addition to earlier Phase I studies undertaken in Japan. Biota’s RSV candidate entered Phase I studies in July 2007. Biota has received its first milestone payment of US$3 million from MedImmune Inc., Biota’s RSV licensee. Results of the Phase I are expected later in 2008. The litigation against GSK in the Supreme Court of Victoria for GSK’s failure to use its best endeavours in the development and marketing of Relenza, has progressed significantly. Currently, mediation has been scheduled to be completed by 31 July 2008 and the trial to commence on 4 August 2008.
Copies of the Biota Holdings Interim Report for the half year ended 31 December 2007 are available on the ASX website (www.asx.com.au) or alternatively please reply to this email to request a copy.
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 have included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, licensed to MedImmune Inc. and novel nucleoside analogues designed to treat hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim. 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 has a key partnership with Daiichi-Sankyo for the development of second generation influenza antivirals. Inverness Medical markets Biota’s co-developed OIA FLU influenza diagnostics.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies. BioStar ® OIA® FLU and BioStar ® OIA® FLU A/B are registered trademarks of Inverness Medical.
*Further information available at www.biota.com.au
