Biota Announces Half Year Net Profit of $33.5 Million
February 16 2010 - 5:09PM
Business Wire
Biota:
Half year highlights
- Net profit up 364% to a record
$33.5 million for the half-year
- Laninamivir shown to be
effective for the treatment of influenza in Phase III clinical
trials in Asia, with NDA filed in Japan in February. Phase III
trials for prevention underway in Japan
- Research pipeline strengthened
with the addition of the antibacterial programs from Prolysis
- Strong cash position maintained:
$52 million at 31 December 2009 after $20 million capital return to
shareholders
- Biota added to S&P/ASX 200
Index in December 2009
Biota Holdings Limited (ASX: BTA) today announced a half year
net profit after tax of $33.5 million, (1H F09: $7.2m). Profit
before tax was $41.4 million (1H F09: $10.1m) benefiting
significantly from an increase in Relenza royalties.
Total revenue was $61.7 million, up 84% from $33.5 million on
the comparable period last year. Revenue included $56.7 million of
Relenza royalties (1H F09: $3.8m), $1.4 million (1H F09:$6.6m) of
collaboration income from licensing agreements with AstraZeneca and
Boehringer Ingelheim and grant income of $2.1 million (1H F09
$1.1m) from the US National Institutes of Health.
Commenting on the results today, Biota CEO Peter Cook said “This
is a very strong result for Biota. Whilst growth in Relenza
royalties is the major financial driver, progress with our key
projects and particularly laninamivir and the expansion of our
pipeline sets the scene for a very exciting future. The
implementation of our strategy, to have 2 or 3 royalty generating
products in the market at the same time, is well underway.”
Expenses were $20.3 million (1H F09: $23.4m) which included the
increase in research costs from the antibacterial programs of
Prolysis, the reduction in product development costs given the HRV
Phase IIa trial in F09 and the conclusion of the GSK litigation in
F09.
Additionally, the Company has provided for an income tax expense
at $7.9 million, assuming full year profitability and recovery of
all tax losses. Any tax payment would not occur until late
2010.
Other Significant Events
- Royalties have increased with
improved Relenza sales as a result of the swine flu pandemic,
resistance issues and side-effects with Tamiflu. In response GSK
invested heavily to significantly increase its production capacity
by December 2009. Governments worldwide have indicated their
intention to rebalance their anti-viral stockpiles with higher
proportions of Relenza;
- Biota’s long acting
neuraminidase inhibitor (second generation influenza antiviral)
laninamivir, successfully completed Phase III clinical trials for
influenza treatment with a series of multi-centred Asian studies
and an NDA was filed in Japan in February 2010. Phase III
prevention studies commenced in November 2009 in Japan, with
results possible by August 2010;
- Additional clinical studies to
those completed in Japan with laninamivir and funded by the US
National Institutes of Health, were also completed in the UK during
the period;
- The Hepatitis C program licensed
in 2006 has transferred to Boehringer Ingelheim. Future payments
under the Licence & Collaboration Agreement will occur when
pre-agreed development milestones are achieved. Biota will continue
to be involved in strategic development of its compounds;
- The MaxThera programs are
advancing although formal completion of their acquisition remains
subject to one outstanding condition which is expected to be met in
the near future; and
- A capital return of $20 million
was paid to shareholders in December 2009, after shareholder
approval was obtained at the Annual General Meeting.
Outlook
Based on the first half year, F2010 will be a record year,
considering:
- Relenza royalty income should
remain solid with market updates provided on a quarterly
basis;
- Strong cash flows from Relenza
royalties to 31 December 2009 of $62.9 million will significantly
add to the $52.0 million cash on hand;
- The development pipeline is
extensive and well funded;
- The commercial interest being
expressed in laninamivir and the intention to secure a licensee
outside of Japan, in the near future; and
- Costs remain under tight
control.
Returns to shareholders will be considered on the completion of
the financial year. Key drivers of cash and profit, which could
significantly affect the Company’s franking account balance,
including Relenza royalties and cash receipts, developments within
the laninamivir program and confirmation of the forecasted
expenditure rate on the new acquisitions, will have been
confirmed.
Full financial results can be found at www.biota.com.au.
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 novel nucleoside analogues designed to treat hepatitis C
virus (HCV) infections, licensed to Boehringer Ingelheim, and a
series of candidate drugs aimed at treatment of respiratory
syncytial virus (RSV) disease. 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 anti-virals, of which the lead product
laninamivir, is in late stage clinical development.
Relenza™ is a registered trademark of the GlaxoSmithKline group
of companies.
This release contains forward looking statements that involve
risks and uncertainties. Although we believe that the expectations
reflected in the forward looking statements are reasonable at this
time, Biota can give no assurance that these expectations will
prove to be correct. Actual results could differ materially from
those anticipated. Reasons may include risks associated with drug
development and manufacture, risks inherent in the regulatory
processes, delays in clinical trials, risks associated with patent
protection, future capital needs or other general risks or
factors.
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