Cheshire, UK--(Marketwire - November 20, 2007) -
PROTHERICS ANNOUNCES INTERIM RESULTS
FOR SIX MONTHS ENDED 30 SEPTEMBER 2007
Strong progress in broad late-stage pipeline
Sharp rise in revenues, gross profits and cash position
London, UK, Brentwood, TN, 20 November 2007 - Protherics PLC ("Protherics" or
the "Company"), the biopharmaceutical company focused on critical care and
cancer, today announces its unaudited interim results for the six months ended
30 September 2007.
Operational Highlights
* CroFabTM and DigiFabTM: stronger than expected market sales helped
drive 31% revenue growth over the corresponding six month period
in 2006
* CytoFabTM:
- AstraZeneca expected to start its expanded CytoFabTM phase 2
programme in Q4 2007
- excellent potency data from large-scale CytoFabTM manufacturing
process allows deferral of major manufacturing investment until
start of phase 3 study
- milestone payments schedule supports Protherics' manufacturing
programme
* Digoxin Immune Fab: recruitment in phase 2b "DEEP" study in severe
pre-eclampsia completed ahead of schedule and on track to report in
Q2 2008 (see separate release)
* VoraxazeTM:
- revenues significantly ahead of expectations due to cost
recovery programme in the US
- work on track to support resubmission of marketing application
in the US and meeting requested with EMEA
* OncoGelTM:
- phase 2b study initiated in oesophageal cancer following
encouraging phase 2a results
- independent safety review ongoing following treatment of the
first cohort of three patients in phase 1/2 primary brain cancer
(glioblastoma multiforme) study
* ProlarixTM: maximum tolerated dose determined and phase 2 to start in
the first half of 2008
* AcadraTM (acadesine): proof of concept phase 1/2 study initiated in
the EU
* CoVaccine HT was out-licensed to Nobilon B.V. (Organon BioSciences /
Schering Plough) for use in flu vaccines and ReGelTM was out-licensed to
Myungmoon Pharm. Co. Ltd., a South Korean pharmaceutical company, for
use in arthritis indications
Financial Highlights
* Revenues increased by 31% to GBP14.8m (2006: GBP11.3m) with
significant growth in CroFabTM and VoraxazeTM
* Gross profit up 32% to GBP8.2m (2006: GBP6.2m) delivering gross
margins of 55.4% (2006: 55.2%) on improved volumes
* R&D increased to GBP8.6m (2006: GBP7.1m) with investment in
CytoFabTM, VoraxazeTM as well as the new products acquired during
the previous financial year
* G&A expenses increased to GBP6.7m (2006: GBP4.1m) and includes
additional costs from the MacroMed acquisition
* Loss before tax of GBP6.1m (2006: GBP4.7m) reflects improved trading
performance offset by higher R&D and G&A
* Net cash increase of GBP6.9m (2006: GBP7.5m decrease) due to receipt
of GBP10m milestone payment from AstraZeneca in April 2007
* Strong cash position of GBP46.9m (2006: GBP17.9m) following fund
raising of GBP38.4m in January 2007 and the GBP10m milestone payment
from AstraZeneca.
Commenting on the results, Stuart Wallis, Chairman, said:
"Protherics delivered good progress in the first half with its broad clinical
pipeline and has today announced that the phase 2 DEEP study in pre-eclampsia
has completed recruitment. We have also generated a significant increase in
revenues and gross profits due to the strong market performance of CroFab and
DigiFab. With CytoFab, the scaled up manufacturing process has produced a
highly potent product, allowing us to defer much of our investment in
manufacturing until the start of phase 3 with no anticipated impact on product
launch. AstraZeneca is expected to start its CytoFab phase 2 programme
imminently.
"The rest of our development pipeline continues to advance as planned, with six
phase 2 programmes expected to be on-going in 2008, including the phase 2b
severe pre-eclampsia study which is on track to deliver results in the second
quarter of 2008. With a diverse and developing portfolio, strong trading and a
robust cash position, we are confident in Protherics' prospects."
| Ends |
There will be an analyst meeting at 9.30am UK time on Tuesday 20 November 2007
in London at the offices of Financial Dynamics at Holborn Gate, 26 Southampton
Buildings, WC2A 1PB. There will be a simultaneous conference call and webcast.
For further details, please contact Mo Noonan on +44 (0)20 7269 7116. To access
the webcast please visit
www.protherics.com
For further information contact:
Protherics PLC +44 (0) 20 7246 9950
+44 (0) 7919 480510
Andrew Heath, CEO
Rolf Soderstrom, Finance Director
Nick Staples, Corporate Affairs
Protherics Inc +1 615 327 1027
Saul Komisar, President
Financial Dynamics
London: Ben Atwell / Lara Mott +44 (0) 20 7831 3113
New York: Jonathan Birt / John Capodanno +1 212 850 5600
Notes for Editors:
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading biopharmaceutical company
focused on the development, manufacture and marketing of specialised products
for critical care and cancer.
Protherics has developed and manufactures two biologics for critical care which
are FDA approved and currently sold in the US: CroFabTM, a pit viper antivenom
and DigiFabTM, a digoxin antidote. The Company's strategy is to use the
revenues generated from its marketed and out-licensed products to help fund the
advancement of its broad, late stage pipeline.
Protherics has two major development opportunities in its critical care
portfolio. CytoFabTM is being developed by AstraZeneca, for the treatment of
severe sepsis, after a major GBP195 million licensing deal with AstraZeneca in
December 2005. An additional, expanded phase 2 programme is due to start
shortly. In addition, Protherics is currently undertaking a phase 2b study with
Digoxin Immune Fab for the treatment of pre-eclampsia. This study is expected to
report in the first half of 2008.
Protherics has a pipeline of four novel cancer products in clinical development,
and intends to undertake the sales and marketing of these products in the US and
or the EU. Protherics is preparing to resubmit a BLA for VoraxazeTM, an adjunct
to high dose methotrexate therapy, under a rolling submission in the US starting
in H1 2008.
Protherics has a strong cash position, with cash balances at 30 September 2007
of GBP46.9 million, having completed a GBP38 million equity fundraising in January
2007 and received a GBP10 million milestone payment from AstraZeneca in April
2007.
With headquarters in London, the Company has approximately 290 employees across
its operations in the UK, US and Australia.
For further information visit:
www.protherics.com
Disclaimer
This document contains forward-looking statements that involve risks and
uncertainties including with respect to future growth, technology acquisitions,
product sales and manufacturing, and regulatory approval of Protherics' products
for marketing and distribution. Although we believe that the expectations
reflected in such forward-looking statements are reasonable at this time, we can
give no assurance that such expectations will prove to be correct. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. Actual results could differ materially from those
anticipated in these forward-looking statements due to many important factors,
including the market for the Company's products, the timing and receipt of
regulatory approvals, the successful integration of acquired businesses and
intellectual property, and other factors discussed in Protherics' Annual Report
on Form 20-F and other reports filed from time to time with the U.S. Securities
and Exchange Commission. We do not undertake to update any oral or written
forward-looking statements that may be made by, or on behalf of, Protherics.
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