Cheshire, UK -- (MARKET WIRE) -- December 7, 2006 -- INTERIM RESULTS FOR SIX MONTHS ENDED 30 SEPTEMBER 2006
London, UK, Brentwood, TN, 7 December 2006 - 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 2006.
Three transactions and fundraising announced separately today
GBP38.2 million Cash Placing, Placing and Open Offer (underwritten by
Nomura Code Securities Limited and Piper Jaffray Ltd) to fund in-
licensing deals with Glenveigh Inc and Advancell, and the acquisition of
MacroMed Inc.
Operational Highlights
- CytoFab™
- AstraZeneca to expand global clinical development programme for
CytoFab™ in severe sepsis following positive discussions with US and EU
regulatory agencies
- Voraxaze™
- Responses to initial questions filed in Europe to support the
Marketing Authorisation Application (MAA) submitted in July 2005
- Clinical data package agreed with FDA; BLA to be resubmitted in US
following a request from the FDA for additional manufacturing-related
information
- Clinical programme initiated in the US to support the planned use of
Voraxaze™
- Prolarix™
- Medicines and Healthcare Products Regulatory Agency (MHRA) approval
for an improved formulation of caricotamide, one of the two components of
Prolarix™, for use in the phase 1 study being undertaken by Cancer Research UK
- Initiation of GMP manufacture and nonclinical programme to allow
phase 2 study in primary liver cancer to start in the second half of 2007
- Angiotensin Therapeutic Vaccine
- Rights to promising novel adjuvant acquired in June 2006 from
CoVaccine BV for use in new formulation; phase 2 study expected to start in the
second half of 2007
- DigiFab™
- Agreement with Roche Pharmaceuticals to replace its digoxin antidote
product, Digitalis Antidot®, with DigiFab™
Financial Highlights (for the six months to 30 September 2006)
- Revenues increased to GBP11.3 million (2005: GBP10.7 million) with higher
DigiFab™, CytoFab™ and Voraxaze™ revenues, offset by reduced
CroFab™ shipments to Fougera
- Gross profit increased to GBP6.2 million (2005: GBP3.0 million including
exceptional costs of GBP1.4 million) on product mix and improved manufacturing
yields
- R&D increased to GBP7.1 million (2005: GBP2.4 million) with increased
investment in CytoFab™ and Voraxaze™
- G&A expenses GBP4.1 million (2005: GBP4.2 million) as investment in sales and
marketing continued, offset by benefits on foreign exchange positions
- Loss before tax GBP4.7 million (2005: GBP3.7 million), as expected, following
increased CytoFab™ and R&D spending
- Net cash decrease of GBP7.5 million (2005: GBP1.0 million) after increased R&D
spending, capital investment and working capital movements
- Strong cash position at end of period of GBP17.9 million (2005: GBP6.3
million) following CytoFab™ upfront payment and equity contribution from
AstraZeneca
Commenting on the results, Stuart Wallis, Chairman, said:
"Protherics is entering a period of growth and expansion with a strong
cash position, increased revenues and improved gross margins. At the same
time, the three transactions announced today strengthen our leadership
position in polyclonal antibodies and substantially expand our cancer
pipeline."
| Ends |
A presentation and conference call for analysts will be held today at
10am UK time. Please call Mo Noonan on +44 (0)20 7269 7116 for further
details.
For further information contact:
Protherics PLC +44 (0) 20 7246 9950
+44 (0) 7919 480510
Andrew Heath, CEO
Barry Riley, Finance Director
Nick Staples, Corporate Affairs
Protherics Inc +1 615 327 1027
Saul Komisar, President
Financial Dynamics
London: David Yates/Ben Atwell +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 an integrated biopharmaceutical
company focused on the development and marketing of products for critical
care and cancer. With headquarters in London, the Company has 227
employees across its operations in the UK, US and Australia.
Protherics' strategy is to use the revenues generated from its marketed
products to help fund the advancement of its development pipeline. With a
proven track record in drug development, biopharmaceutical manufacturing
and regulatory affairs, Protherics' goal is to develop and attract
additional cancer and critical care products for its sales and marketing
teams to distribute in the US and Europe.
The most advanced products in the Company's portfolio are Voraxaze™,
administered when methotrexate blood levels remain dangerously high
following high doses for the treatment of cancer, which is expected to be
approved in the EU in the first half of 2007 and in the US from the
second half of 2008, subject to successful regulatory reviews; and
CytoFab™, which is expected to start an additional phase 2 study in
severe sepsis in 2007 following its out-license to AstraZeneca in late
2005.
Additional products in development include Prolarix™, a targeted cancer
therapy for primary liver cancer and other select tumours, currently in phase 1
with a phase 2a study planned for second half of 2007; and Angiotensin
Therapeutic Vaccine for the treatment of hypertension, where encouraging phase
2a results have been obtained and an additional phase 2a study with an improved
formulation is planned in the second half of 2007.
The majority of the Company's revenues (GBP17.7 million in the year ended 31 March
2006) are derived from two critical care products, CroFab™ (pit viper
antivenom) and DigiFab™ (digoxin antidote) which were developed by Protherics
and are sold, in the US, through Fougera Inc, a division of Altana Pharma AG.
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 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 consummation of fundraising and acquisition transactions, 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.
INTERIM STATEMENT
Corporate Development
Protherics' corporate strategy is to build a leading biopharmaceutical company,
focused on the development, manufacture and marketing of specialist products in
critical care and cancer. The three transactions announced today add a second
potential blockbuster to our critical care pipeline, alongside CytoFab™, and
doubles the size of our cancer portfolio in indications where we can leverage
the sales and marketing infrastructure we are establishing for Voraxaze™.
R & D pipeline update
Voraxaze™ - for the control of high dose methotrexate therapy in cancer
Voraxaze™ (glucarpidase) contains an enzyme that rapidly breaks down
methotrexate (MTX). It has been developed to prevent or reduce the serious
toxicity that can result when patients receiving high doses of MTX (HDMTX) for
the treatment of cancer have difficulty eliminating MTX from the body.
A Marketing Authorisation Application (MAA) for the use of Voraxaze™ as an
intervention treatment for patients experiencing or at risk of MTX toxicity from
delayed elimination was submitted in the EU in July 2005. Responses to
questions raised during an initial review of the MAA have been submitted to the
European Medicines Agency (EMEA) and we hope to receive marketing approval in
the first half of 2007.
On 15 September 2006, we submitted a Biological License Application (BLA) for
Voraxaze™ to the FDA in the US. Protherics announced on 7 November 2006 that
it had withdrawn this application in the US following a request from FDA for
additional manufacturing-related information, with the intention of resubmitting
the application once the additional data has been generated. Approval is
expected in the US from the second half of 2008, pending further detailed
discussion with the FDA.
Protherics recently initiated a small pilot study with the MD Anderson Centre in
Houston, Texas to investigate the planned repeated use of Voraxaze™ in patients
with delayed elimination of MTX. This is the first of several pilot studies in
a planned use development programme, to expand the indications for Voraxaze™
into the potentially much larger planned repeated use market. A second study is
expected to be initiated shortly at University College London Hospitals, UK. We
expect preliminary data from these studies in the first half of 2007. The data
will allow a pivotal study to be designed with a view to extending the
indication for Voraxaze™ to include its routine use on a planned basis.
Voraxaze™ continues to be available in both the US and Europe on a
compassionate use basis. In Europe, where it is possible to charge for its
supply, revenues for the six months ended 30 September 2006, amounted to GBP0.6
million (GBP0.3 million in 2005).
CytoFab™ - for sepsis resulting from uncontrolled infection
CytoFab™ is an anti-TNF-alpha polyclonal antibody fragment (Fab) product for
the treatment of sepsis. On 7 December 2005, we announced the signing of a major
licensing agreement for CytoFab™ with AstraZeneca. On 3 November 2006,
following consultations with regulators in the US and EU, AstraZeneca announced
its intention to expand the clinical development plan for CytoFab™ in severe
sepsis, with the addition of a 480 patient phase 2 programme prior to starting
phase 3 development. AstraZeneca's goal is to optimise the chances of showing a
statistically and clinically meaningful result with CytoFab™, in a single,
global phase 3 study, while ensuring an acceptable time to market.
Data from phase 2 will be used to more accurately estimate the number of
patients required, and confirm the appropriate dose for the phase 3 study, as
well as providing further supporting efficacy and safety data. This may enable a
shorter timetable for the phase 3 programme than originally anticipated by
AstraZeneca. The phase 2 programme will start in the second half of 2007 and is
expected to last up to 21 months. On completion, AstraZeneca intends to
initiate a single phase 3 study in the US, Europe and Japan.
Process scale-up is on-going at Protherics' approved manufacturing facility in
Wales, and large scale batches are being prepared for processing using the new
commercial process. Protherics expects to receive a further milestone payment
from AstraZeneca in 2007.
CytoFab™ revenues of GBP1.1 million were recognised in the six months ended 30
September 2006. There were no revenues in the corresponding six months period to
30 September 2005.
Prolarix™ - targeted therapy for liver cancer and certain other solid tumours
Prolarix™ is comprised of a small molecule prodrug, tretazicar, which is
converted to a highly cytotoxic agent when administered with a cosubstrate,
caricotamide, by an endogenous enzyme, NQO2, which has elevated activity in
certain tumours.
A phase 1 study of Prolarix™ is being run under the auspices of Cancer Research
UK (CRUK) and 13 patients have been recruited to date. One patient has received
all six cycles of treatment with disease stabilisation achieved at a relatively
low dose of Prolarix™. The dose of tretazicar is being escalated to determine
the maximum tolerated dose (MTD). CRUK has recently received Medicines and
Healthcare Products Regulatory Agency (MHRA) approval to use an improved
formulation of caricotamide in the study, allowing patient enrollment to
recommence. Once the MTD has been determined, an additional cohort of six
patients will be treated to evaluate the efficacy of Prolarix™. Further data
from the expanded phase 1 study should be available before the end of the first
half of 2007, and the study is now expected to report formally in the second
half of 2007.
The GMP manufacture of Prolarix™ is ongoing and the necessary supporting
non-clinical programme has been initiated, ahead of a planned phase 2 study in
primary liver cancer in the second half of 2007.
Angiotensin Therapeutic Vaccine - management of high blood pressure
Protherics' Angiotensin Therapeutic Vaccine is a vaccine designed to induce
endogenous antibodies to angiotensin, one of the key hormones involved in the
regulation of blood pressure. Encouraging clinical and preclinical results to
date suggest that effective neutralisation of angiotensin may cause a clinically
significant reduction in blood pressure in hypertensive patients.
A new formulation of Angiotensin Therapeutic Vaccine containing a novel adjuvant
called CoVaccine HT, has produced up to a 10-fold improvement in antibody
response in preclinical studies. We announced the acquisition of the CoVaccine
HT adjuvant from CoVaccine BV in June 2006. Protherics has now completed the
non-clinical safety testing of the CoVaccine HT adjuvant required to support
clinical use and has commenced manufacturing process development and scale up
for both the adjuvant and the vaccine.
Protherics intends to start a phase 2a study with the new formulation in the
second half of 2007. The goal of this study will be to confirm that the new
formulation increases levels of anti-angiotensin antibodies in hypertensive
patients and to establish whether this results in a reduction in blood pressure.
The market for the treatment of high blood pressure is estimated to be in excess
of US$30 billion per annum, and with positive phase 2a data, our Angiotensin
Therapeutic Vaccine could provide another major out-licensing opportunity for
Protherics.
Marketed Products, Business Environment and Financial Update
CroFab™ - pit viper antivenom
CroFab™ is a polyclonal antibody fragment for the management of crotalid (pit
viper) envenomations. It is currently the only product marketed for these bites
in the US, where there are around 8000 pit viper bites reported each year. We
believe that CroFab™ has captured around half of a potential $70-80 million
market opportunity.
CroFab™ sales were GBP7.2 million in the half year compared to GBP8.5 million in
the corresponding six months to 30 September 2005. A weaker dollar contributed
to this decline, but the major factor was a reduction in product shipped to
Fougera®, our distributor in the US. This is expected to reverse in the
second half of the current financial year, as shipments are planned to be higher
than the first half.
DigiFab™ - treatment for digoxin overdose
DigiFab™ is now the market leader in the US digoxin overdose market, estimated
to be worth approximately $25 million per annum. DigiFab™ sales to Fougera®
increased from GBP1.5 million to GBP1.9 million. Fougera's sales to the wholesale
market increased by 46% over the prior period as they continued to gain market
share. There was also an increase in product shipped to Fougera®.
We believe the European market can provide a further opportunity to grow
DigiFab™ sales and Protherics anticipates receiving marketing approval in the
UK in the first half of 2007, with subsequent approvals in Europe over the
following six to twelve months. We recently announced an agreement with Roche
Pharmaceuticals to replace its niche digoxin antidote product, Digitalis
Antidot® with DigiFab™ in those countries where it is currently available.
DigiFab™ will be marketed by our licensee Beacon Pharmaceuticals in most
mainland European countries, and by Protherics in certain other countries.
ViperaTAb™ - European viper antivenom
ViperaTAb™ sales improved to GBP0.3 million from GBP0.1 million as expected, due to
the increased availability of product.
US Derived Revenues
US derived revenues show the underlying sales performance in US dollars and the
effects of translating these into Sterling.
Half year to 30 September 2006 2006 2005 2005
(IFRS) $m GBPm $m GBPm
CroFab(TM) 13.3 7.2 15.2 8.5
DigiFab(TM) 3.5 1.9 2.7 1.5
ViperaTAb(TM) 0.6 0.3 0.2 0.1
Total 17.4 9.4 18.1 10.1
Average exchange
rate ($/GBP) 1.85 1.79
Voraxaze(TM), CytoFab(TM) and Other Revenues
Half year to 30 September 2006 2005
(IFRS) GBPm GBPm
Voraxaze(TM) 0.6 0.3
CytoFab(TM) 1.1 -
BSE 0.1 0.2
Other 0.1 0.1
_____ _____
1.9 0.6
US Derived 9.4 10.1
_____ _____
Total Revenues 11.3 10.7
Named patient sales of Voraxaze™ increased to GBP0.6 million in the half year
ended 30 September 2006 from GBP0.3 million in the corresponding six month period,
as awareness of the product in the medical community continues to build.
CytoFab™ revenues of GBP1.1 million for the six months represent a portion of the
initial upfront payment of GBP16.3 million received under the licensing agreement
with AstraZeneca, which is being recognised under IFRS over the estimated period
to product approval. Revenues from BSE testing continue to show the effects of
increased competition in Europe, declining to GBP0.1 million from GBP0.2 million.
Cost of Sales and Gross Profit
Cost of sales for the six month period was GBP5.0 million against GBP7.7 million in
the corresponding period, which included exceptional costs of GBP1.4 million
relating to a planned shutdown undertaken during the expansion of manufacturing
facilities. Excluding the exceptional costs, the figure for the corresponding
six month period was GBP6.3 million.
Gross margins on manufactured products (excluding milestone and royalty revenues
with no associated manufacturing cost) are shown in the table below:
Half year to 30 September 2006 2005
(IFRS) GBPm GBPm
Revenues* 10.0 10.4
Cost of Sales
(excluding exceptional costs**) 5.0 6.3
_____ ____
Gross Profit
(before exceptional costs) 5.0 4.1
____ _____
Gross Margin
(on manufactured products
before exceptional costs) 50% 39.4%
*Revenues include sales of CroFab™, DigiFab™, ViperaTAb™ and
Voraxaze™
**Cost of Sales in the six months to 30 September 2005 excludes exceptional
costs of GBP1.4 million associated with the major shutdown incurred to gain
regulatory qualification for the Company's expanded manufacturing facility in
Wales.
Margins have improved over the corresponding six month period due to a higher
proportion of DigiFab™ sales (a higher margin product) and a reduced level of
CroFab™ shipments, coupled with improved yields in the manufacturing process.
Research and Development
As planned, R&D expenditure has increased significantly to GBP7.1 million in the
half year from GBP2.4 million as work is well under way on developing and scaling
up the CytoFab™ manufacturing process. In addition, spending continued on
Voraxaze™ to support regulatory filings, and on Prolarix and Angiotensin
Therapeutic Vaccine.
General and Administrative Expenses
General and administrative expenses show a decrease to GBP4.1 million from GBP4.2
million after adjustments under IFRS for currency effects and charges on
employee options. Movements in the fair value of currency contracts and gains on
inter-group balances have produced a benefit of GBP0.7 million against a cost of
GBP0.4 million in the corresponding six month period. This is offset by an
increase in option charges of GBP0.2 million between the two periods. Underlying
general and administrative expenses are therefore increasing in line with
expectations as additional resources in sales and marketing and regulatory
capability have been added.
Finance Income and Costs
Finance income has increased to GBP0.5 million from GBP0.1 million in line with the
increased cash balances, while costs have remained stable at GBP0.2 million as
increased lease financing costs have been offset by conversions of the
Convertible Loan Notes issued at the time of the Enact Pharma acquisition.
Results Before and After Tax
Tax credits of GBP0.2 million on R&D expenditure are slightly higher than the
corresponding period, resulting in a loss before tax of GBP4.7 million and after
tax of GBP4.5 million, compared to corresponding pre and post tax losses of GBP3.7
million and GBP3.6 million.
Balance Sheet
Investment in property, plant and equipment over the period has increased
non-current assets to GBP20.7 million from GBP18.6 million at 31 March 2006 and
GBP17.7 million at 30 September 2005. Inventory levels have increased, following
the planned shutdown in the summer of 2005.
Current assets at 30 September 2006 were GBP34.1 million, which shows a decrease
from GBP41.6 million at the end of the last financial year, but up from GBP20.2
million at 30 September 2005, following the licensing deal with AstraZeneca
announced in December 2005. Total assets were GBP54.8 million against GBP60.1
million at 31 March 2006, a net result of continued spending on fixed assets and
working capital movements, and up from GBP37.9 million a year earlier.
Total liabilities decreased from GBP33.8 million at 31 March 2006 to GBP31.7 million
at 30 September 2006. Obligations under finance leases increased with the
investment in plant and equipment, while deferred income was released to the
income statement as licensing revenue was recognised. Trade payables declined as
payments were made for materials and equipment purchased for CytoFab™ process
scale-up and development. Major changes from the GBP14.1 million total liabilities
at 30 September 2005 relate to the deferment of the majority of the initial
GBP16.3 million licensing payments received from AstraZeneca.
Total equity was GBP23.1 million at the half year, compared to GBP26.4 million at 31
March 2006, but similar to the GBP23.7 million recorded at 30 September 2005.
Cash Flow
Net cash outflow from operations was GBP6.0 million in the six month period,
compared to an outflow of GBP0.3 million in the corresponding half year. This is a
result of increased losses and working capital movements, when inventories were
increased following the planned shutdown, and liabilities for materials and
equipment purchased for the CytoFab™ development project were settled. Cash
and cash equivalents at the end of the period were GBP17.9 million, down from
GBP25.4 million over the six months, but up from GBP6.3 million at 30 September
2005, following the subsequent GBP7.5 million share issue to AstraZeneca and
receipt of the initial GBP16.3 million under the licensing agreement.
Outlook
Protherics is undergoing a period of growth and expansion following the
CytoFab™ licensing deal with AstraZeneca and as we prepare to undertake our
first product launch in-house, with Voraxaze™. On completion of the
fundraising, and the three proposed corporate transactions announced today,
Protherics will have greatly expanded its pipeline, gaining additional products
to develop in-house (or with potential licensees). The products will also have
the potential to leverage the Voraxaze™ sales force which is currently being
recruited. We continue to anticipate the receipt of milestone payments from
AstraZeneca in line with the need for Protherics to invest in the manufacture of
CytoFab™. We expect to make significant progress in our pipeline in both the
near and mid term to deliver value for our shareholders.
Protherics PLC
CONSOLIDATED INCOME STATEMENT (UNAUDITED)
for the six months ended 30 September 2006
Six months Six Year
ended 30 months ended 31
September ended 30 March
2006 September 2006
2005
Notes GBP'000 GBP'000 GBP'000
Revenue 2 11,251 10,686 17,709
Cost of sales
Cost of sales excluding (5,046) (6,299) (9,930)
exceptional closedown costs
Exceptional closedown costs - (1,362) (1,362)
Total cost of sales 3 (5,046) (7,661) (11,292)
_____ _____ _____
Gross profit 6,205 3,025 6,417
Administrative expenses
Research and development (7,054) (2,374) (6,747)
General & administrative (4,110) (4,241) (9,203)
_____ _____ _____
Total administrative expenses (11,164) (6,615) (15,950)
_____ _____ _____
Operating loss 2 (4,959) (3,590) (9,533)
Finance income 472 103 401
Finance costs (199) (230) (431)
_____ _____ _____
Loss before tax (4,686) (3,717) (9,563)
Tax 5 165 148 75
_____ _____ _____
Loss for the period, (4,521) (3,569) (9,488)
attributable to equity
shareholders _____ _____ _____
Pence Pence Pence
Loss per share
Basic and diluted 4 (1.7) (1.5) (3.8)
All revenue and results arose from continuing operations.
CONSOLIDATED STATEMENT OF RECOGNISED INCOME AND EXPENSE (UNAUDITED)
for the six months ended 30 September 2006
Six months Six months Year
ended 30 ended 30 ended 31
September September March
2006 2005 2006
GBP'000 GBP'000 GBP'000
Exchange differences on 351 (29) (158)
translation of foreign
operations _____ _____ _____
Net income / (expense) 351 (29) (158)
recognised directly in equity
Loss for the period (4,521) (3,569) (9,488)
_____ _____ _____
Total recognised expense for (4,170) (3,598) (9,646)
the period
_____ _____ _____
All recognised income and expense is attributable to equity shareholders.
CONSOLIDATED BALANCE SHEET (UNAUDITED)
at 30 September 2006
30 September 30 September 31 March
2006 2005 2006
GBP'000 GBP'000 GBP'000
Non-current assets
Goodwill 9,199 9,199 9,199
Other intangible assets 1,265 1,102 1,060
Property, plant and 10,009 6,933 8,109
equipment
Deferred tax assets 179 461 206
_____ _____ _____
20,652 17,695 18,574
_____ _____ _____
Current assets
Inventories 11,404 9,641 10,887
Financial assets 172 - -
Tax receivables 604 491 717
Trade and other receivables 4,024 3,793 4,520
Cash and cash equivalents 17,921 6,255 25,438
_____ _____ _____
34,125 20,180 41,562
_____ _____ _____
Total assets 54,777 37,875 60,136
Current liabilities
Trade and other payables 13,803 7,896 15,722
Current tax liabilities 272 217 278
Financial liabilities
Obligations under finance 859 586 623
leases
Bank overdrafts, loans and 34 32 37
other borrowings
Derivative instruments - 363 136
_____ _____ _____
14,968 9,094 16,796
_____ _____ _____
Non-current liabilities
Trade and other payables 12,170 595 13,081
Financial liabilities
Borrowings 198 252 222
Convertible loan notes 2,233 2,943 2,469
Obligations under finance 2,153 1,258 1,216
leases
_____ _____ _____
16,754 5,048 16,988
_____ _____ _____
Total liabilities 31,722 14,142 33,784
_____ _____ _____
Net assets 23,055 23,733 26,352
_____ _____ _____
Equity
Share capital 5,216 4,898 5,186
Share premium account 87,315 78,528 86,770
Merger reserve 51,163 51,163 51,163
Equity reserve 266 317 263
Cumulative translation 160 (62) (191)
reserve
Retained earnings (121,065) (111,111) (116,839)
_____ _____ _____
Total equity 23,055 23,733 26,352
_____ _____ _____
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (UNAUDITED)
Share Share Merger
capital premium reserve
GBP'000 GBP'000 GBP'000
Balance at 1 April 2005 4,844 77,881 51,163
Currency translation - - -
adjustments
_____ _____ _____
Net expense recognised - - -
directly in equity
Loss for the period - - -
_____ _____ _____
Total recognised loss for the - - -
period
_____ _____ _____
New share capital subscribed 4 60 -
Conversion of convertible 50 587 -
loan notes
Employee share option scheme: - - -
- value of services provided
_____ _____ _____
Balance at 30 September 2005 4,898 78,528 51,163
_____ _____ _____
Balance at 1 October 2005 4,898 78,528 51,163
Currency translation - - -
adjustments
_____ _____ _____
Net expense recognised - - -
directly in equity
Loss for the period - - -
_____ _____ _____
Total recognised loss for the - - -
period
_____ _____ _____
New share capital subscribed 245 7,794 -
Conversion of convertible 43 448 -
loan notes
Employee share option scheme: - - -
- value of services provided
_____ _____ _____
Balance at 31 March 2006 5,186 86,770 51,163
_____ _____ _____
Balance at 1 April 2006 5,186 86,770 51,163
Currency translation - - -
adjustments
_____ _____ _____
Net income recognised - - -
directly in equity
Loss for the period - - -
_____ _____ _____
Total recognised gain / - - -
(loss) for the period
_____ _____ _____
New share capital subscribed 2 46 -
Issue of convertible loan - - -
notes
Conversion of convertible 28 499 -
loan notes
Employee share option scheme: - - -
- value of services provided
_____ _____ _____
Balance at 30 September 2006 5,216 87,315 51,163
_____ _____ _____
Equity Cumulative Retained Total
reserve translation earnings
reserve
GBP'000 GBP'000 GBP'000 GBP'000
Balance at 1 April 2005 378 (33) (107,662) 26,571
Currency translation - (29) - (29)
adjustments
_____ _____ _____ _____
Net expense recognised - (29) - (29)
directly in equity
Loss for the period - - (3,569) (3,569)
_____ _____ _____ _____
Total recognised loss for - (29) (3,569) (3,598)
the period
_____ _____ _____ _____
New share capital - - - 64
subscribed
Conversion of convertible (61) - - 576
loan notes
Employee share option - - 120 120
scheme: - value of
services provided _____ _____ _____ _____
Balance at 30 September 317 (62) (111,111) 23,733
2005
_____ _____ _____ _____
Balance at 1 October 2005 317 (62) (111,111) 23,733
Currency translation - (129) - (129)
adjustments
_____ _____ _____ _____
Net expense recognised - (129) - (129)
directly in equity
Loss for the period - - (5,919) (5,919)
_____ _____ _____ _____
Total recognised loss for - (129) (5,919) (6,048)
the period
_____ _____ _____ _____
New share capital - - - 8,039
subscribed
Conversion of convertible (54) - - 437
loan notes
Employee share option - - 191 191
scheme: - value of
services provided _____ _____ _____ _____
Balance at 31 March 2006 263 (191) (116,839) 26,352
_____ _____ _____ _____
Balance at 1 April 2006 263 (191) (116,839) 26,352
Currency translation - 351 - 351
adjustments
_____ _____ _____ _____
Net income recognised - 351 - 351
directly in equity
Loss for the period - - (4,521) (4,521)
_____ _____ _____ _____
Total recognised gain / - 351 (4,521) (4,170)
(loss) for the period
_____ _____ _____ _____
New share capital - 48
subscribed
Issue of convertible loan 30 30
notes
Conversion of convertible (27) - 500
loan notes
Employee share option - - 295 295
scheme: - value of
services provided _____ _____ _____ _____
Balance at 30 September 266 160 (121,065) 23,055
2006
_____ _____ _____ _____
CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED)
for the six months ended 30 September 2006
Six months to Six months to Year ended 31
30 September 2006 30 September 2005 31 March 2006
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Cash flows
from
operating
activities
Cash (6,302) (248) 12,609
generated
from
operations
Income tax - (10) (50)
paid
Income tax 290 - 5
received
_____ _____ _____
Net cash (6,012) (258) 12,564
(outflow) /
inflow from _____ _____ _____
operating
activities
Investing
activities
Interest 472 103 401
received
Proceeds on - - 52
disposal of
property,
plant and
equipment
Purchases (1,201) (279) (1,989)
of
property,
plant and
equipment
Purchases (293) - -
of other
intangible
non-current
assets
Capital - - 250
grants
received _____ _____ _____
Net cash (1,022) (176) (1,286)
used in
investing _____ _____ _____
activities
Financing
activities
Interest (94) (134) (257)
paid
Interest (88) (73) (133)
paid on
finance
leases
Repayment (12) (270) (171)
of
borrowings
Repayments (317) (155) (582)
of finance
leases
Issue of 78 70 8,049
shares
_____ _____ _____
Net cash (433) (562) 6,906
(used in) /
from _____ _____ _____
financing
activities
Net (7,467) (996) 18,184
(decrease)
/ increase
in cash and
cash
equivalents
Cash and 25,438 7,242 7,242
cash
equivalents
at the
beginning
of period
Effect of (50) 9 12
foreign
exchange _____ _____ _____
rate
changes
Cash and 17,921 6,255 25,438
cash
equivalents _____ _____ _____
at the end
of period
NOTES TO THE CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED)
for the six months ended 30 September 2006
Reconciliation of operating loss to net cash outflow from operating activities
Six months Six months Year
ended 30 ended 30 ended 31
September September March
2006 2005 2006
GBP'000 GBP'000 GBP'000
Operating loss (4,959) (3,590) (9,533)
Adjustments for:
Change in fair value of derivatives (308) 439 531
Deferred grant income (55) (71) (78)
Share-based payment costs 295 120 311
Depreciation of property, plant and 576 710 1,391
equipment
Amortisation of intangible fixed 66 55 114
assets
Loss on disposal of property, plant 50 61 108
and equipment
_____ _____ _____
Operating cash flows before (4,335) (2,276) (7,156)
movements in working capital
(Increase) / decrease in (628) 3,288 1,903
inventories
Decrease / (increase) in 282 (93) (1,135)
receivables
(Decrease) / increase in payables (1,621) (1,167) 18,997
_____ _____ _____
Net cash flows from operating (6,302) (248) 12,609
activities
_____ _____ _____
Analysis of net debt
1 April Cash Exchange Other 30
2006 flow movement non-cash September
changes 2006
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Cash at bank and in 25,438 (7,467) (50) - 17,921
hand
Overdraft - - - - -
_____ _____ _____ _____ _____
Cash and cash 25,438 (7,467) (50) - 17,921
equivalents
Loans - amounts (37) 2 1 - (34)
falling due in less
than one year
Loans - amounts (222) 10 14 - (198)
falling due in more
than one year
Obligations under (1,839) 317 5 (1,495) (3,012)
finance lease and hire
purchase obligations _____ _____ _____ _____ _____
23,340 (7,138) (30) (1,495) 14,677
_____ _____ _____ _____ _____
NOTES TO THE INTERIM STATEMENT
1. General information
The interim financial statements, which have been approved by the Directors on 7
December 2006, are unaudited and do not constitute full financial information as
defined in Section 240 of the Companies Act 1985 (as amended).
The comparative figures for the financial year ended 31 March 2006 are not the
company's statutory accounts for that financial year. Those accounts have been
reported on by the company's auditors and delivered to the registrar of
companies. The report of the auditors was (i) unqualified, (ii) did not include
a reference to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain a statement
under section 237(2) or (3) of the Companies Act 1985.
The financial information has been prepared using
accounting policies consistent with International Financial Reporting Standards
as adopted by the European Union (IFRS), and in accordance with those disclosed
in the financial statements for the year ended 31 March 2006.
2. Segment information
As at 30 September 2005, the Group is organised into two operating segments, the
sale, manufacture and development of pharmaceutical products and out-licensed
product royalties.
Six months ended 30 Sale, Out-licensed Consolidated
September 2006 manufacture product
and royalties
development of
pharmaceutical
products
GBP'000 GBP'000 GBP'000
Revenue
External sales 11,124 127 11,251
Inter-segment sales - - -
_____ _____ _____
Total revenue 11,124 127 11,251
_____ _____ _____
Operating (loss) / profit (5,086) 127 (4,959)
Finance income 472
Finance costs (199)
_____
Loss before tax (4,686)
Tax 165
_____
Loss for the period, (4,521)
attributable to equity
shareholders _____
Six months ended 30
September 2005
Revenue
External sales 10,462 224 10,686
Inter-segment sales - - -
_____ _____ _____
Total revenue 10,462 224 10,686
_____ _____ _____
Operating (loss) / profit (3,812) 222 (3,590)
Finance income 103
Finance costs (230)
_____
Loss before tax (3,717)
Tax 148
_____
Loss for the period, (3,569)
attributable to equity
shareholders _____
Year ended 31 March 2006
Revenue
External sales 17,269 440 17,709
Inter-segment sales - - -
_____ _____ _____
Total revenue 17,269 440 17,709
_____ _____ _____
Operating (loss) / profit (9,961) 428 (9,533)
Finance income 401
Finance costs (431)
_____
Loss before tax (9,563)
Tax 75
_____
Loss for the period, (9,488)
attributable to equity
shareholders _____
Interim measurement
A significant proportion of the Group's expected revenues arise from its
CroFab™ rattlesnake antivenom treatment and is subject to seasonal
fluctuations, with peak demand in the first six months of the Group's financial
year caused by the hibernation patterns of such snakes. In the year ended 31
March 2006, 74% of CroFab™ revenues arose in the six months ended 30 September
2005.
3. Cost of sales
During the six months ended 30 September 2005, the Group completed a major
facility upgrade and expansion of its manufacturing facility in Wales. During
this phase of the work, the facility was shutdown for a substantial part of the
financial period therefore incurring GBP1,362,000 of expenditure which, under
normal circumstances would have been absorbed into stock manufactured during the
period. These costs had no effect on the tax credit for the period.
4. Loss per share
The calculation of the basic and diluted loss per share is based on the
following data:
Six months Six months Year
ended 30 ended 30 ended 31
September September March
2006 2005 2006
GBP'000 GBP'000 GBP'000
Loss
Loss for the purposes of basic (4,521) (3,569) (9,488)
loss per share being net profit
attributable to equity
shareholders of the parent
Effect of dilutive potential - - -
ordinary shares
_____ _____ _____
Loss for the purposes of diluted (4,521) (3,569) (9,488)
loss per share
_____ _____ _____
Number of shares
Weighted average number of shares 260,425,531 242,960,097 246,854,698
for the purposes of basic loss
per share
Effect of dilutive potential
ordinary shares:
Share options - -
_____ _____ _____
Weighted average number of 260,425,531 242,960,097 246,854,698
ordinary shares for the purposes
of diluted loss per share _____ _____ _____
5. Taxation
Six Six months Year
months ended 30 ended 31
ended 30 September March
September 2005 2006
2006
GBP'000 GBP'000 GBP'000
Current tax:
UK current tax 185 150 325
Foreign tax - (2) (3)
Deferred tax (20) - (247)
_____ _____ _____
165 148 75
_____ _____ _____
Tax credits of GBP185,000 arose in the period to 30 September 2006 as a result
of research and development expenditure claimed under the Finance Act 2000
(2005: GBP150,000).
6. Other
Copies of this statement are being sent to all shareholders and will be
available to the public at the Company's registered office at The Heath Business
and Technical Park, Runcorn, Cheshire, WA7 4QX.
This information is provided by RNS
The company news service from the London Stock Exchange