Cheshire, UK , the international biopharmaceutical company
focused on critical care and cancer, today announces its
preliminary results for the 12 months ended 31 March 2008.
Financial Highlights - Trading revenues of GBP23.5 million (2007:
GBP18.5 million), delivering organic growth of 27% - Gross margin
on trading revenues increased to 47% (2007: 39%) - R&D
expenditure of GBP19.1 million (2007: GBP14.0 million) reflecting
planned increased investment in the development pipeline - Strong
financial position with GBP37.7 million of cash at year end (2007:
GBP40.0 million) Operational Highlights - AstraZeneca commenced its
CytoFabTM phase 2 programme in severe sepsis - Digoxin Immune Fab
phase 2b study reported in pre-eclampsia - OncoGelTM phase 2b study
commenced in oesophageal cancer and AcadraTM phase 1/2 study
started in B-cell chronic lymphocytic leukaemia (B-CLL) - Licensing
deals with Nobilon B.V. and MyungMoon Pharm. Co. Ltd. for non-core
assets Commenting on the results, Stuart Wallis, Chairman,
said:"Protherics has made good financial and clinical progress this
year and we are pleased to see continued strong performance from
our critical care products, CroFabTM and DigiFabTM. We expect
important news flow both this year and next as we advance our
pipeline of nine clinical development programmes. With a broad,
late-stage development pipeline supported by a strong cash
position, and the opportunity to sell our own products in 2010 we
can see a clear path to Protherics becoming a leading and
self-sustaining biopharmaceutical business." / Ends / There will be
an analyst meeting at 8.30am UK time today in London at the offices
of Piper Jaffray at One South Place, London EC2M 2RB. 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
please contact: Protherics Andrew Heath, CEO +44 (0) 20 7246 9950
Rolf Soderstrom, CFO +44 (0) 20 7246 9950 Nick Staples, Director of
Corporate Affairs +44 (0) 7919 480510 Saul Komisar, President
Protherics Inc +1 615 327 1027 Financial Dynamics - press enquiries
London: Ben Atwell, Lara Mott +44 (0) 20 7831 3113 New York: John
Capodanno +1 212 850 5600 Or visit www.protherics.com Protherics
(LSE: PTI, NASDAQ: PTIL) is a leading international
biopharmaceutical company focused on specialist products for
critical care and cancer. Protherics has produced two FDA approved
biologics for critical care use which are currently sold in the US:
CroFabTM, a North American pit viper antivenom and DigiFabTM, a
digoxin antidote. Protherics reported revenues of GBP26.1 million
for its year ended 31 March 2008 and a strong cash balance of
GBP37.7 million. 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 portfolio. CytoFabTM is
being developed by AstraZeneca, for the treatment of severe sepsis,
following a major licensing deal announced in December 2005.
AstraZeneca is conducting an additional phase 2 programme following
changes to the commercial manufacturing process. A new formulation
of Angiotensin Therapeutic Vaccine, for the treatment of
hypertension, is scheduled to enter a phase 2a study in mid 2008.
This formulation contains our novel adjuvant, CoVaccine HTTM, which
has improved the immune response in non-clinical models with a
range of vaccines in many species. Protherics also has four novel
products being developed in a range of cancer indications where it
intends to undertake the sales and marketing in the US and/or the
EU. With headquarters in London, the Company has approximately 300
employees across its operations in the UK, US and Australia.
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
elsewhere in this announcement and 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. PRELIMINARY STATEMENT Overview Despite
extremely turbulent financial markets in both the wider industry
and the biotechnology sector, Protherics made significant progress
during 2007-2008 towards achieving its goal of becoming a
self-sustaining international biopharmaceutical business. We
delivered a 27% increase in underlying trading revenues and an 8%
improvement in corresponding gross margin. At the same time, we
increased our investment in R&D and made excellent progress in
achieving our target of having nine clinical development programmes
in 2008. We finished the year with GBP37.7 million in cash and our
strong balance sheet provides us with the means to develop our
pipeline of valuable products to key decision points. In 2008 and
2009, major news flow is expected on key value drivers in our
pipeline as we look forward to results from AstraZeneca's phase 2
programme for CytoFabTM in severe sepsis, and the results from our
Angiotensin Therapeutic Vaccine proof of concept study in
hypertension. We also expect to report further progress with our
cancer pipeline, including the submission of a marketing
application for VoraxazeTM in the US, and results from proof of
concept studies for ProlarixTM, AcadraTM and OncoGelTM. These
results will determine the shape of our pipeline and pattern of
R&D investment for the next few years. In 2010, we expect to
begin our transformation into a commercial and self-funding
biopharmaceutical company as we start to sell CroFabTM, DigiFabTM
and potentially VoraxazeTM ourselves in the US. Protherics will
regain the US marketing rights to CroFabTM and DigiFabTM from its
distribution partner Nycomed in October 2010. We reported GBP20.5
million in sales from these products for the year ended 31 March
2008 and with the return of the marketing rights, we have an
opportunity to double our revenues and more than double our profits
from these two products. Importantly, this also provides us with an
ideal opportunity to establish a small sales force in the US,
through which we can sell VoraxazeTM and other hospital specialist
products in the future. We are proud of our track record of having
produced two products that are used in life threatening situations,
and we continue to develop a number of other valuable products in
our pipeline. With key pipeline news flow over the next 12-18
months and the transformational events of 2010 in sight, we can now
see a clear path to Protherics becoming a leading and
self-sustaining biopharmaceutical business. MARKETED PRODUCTS
CroFabTM - pit viper antivenom CroFabTM is a polyclonal antibody
fragment (Fab) for the management of minimal to moderate North
American crotalid (pit viper) envenomations. It is currently the
only product marketed for these bites in the US, where
approximately 8,000 pit viper bites are reported each year. We
believe that CroFabTM has captured more than half of a potential
USD70-80 million market in the US. Net sales are currently shared
equally with our distributor Fougera, a division of Nycomed.
Protherics' CroFabTM revenues were GBP15.7 million in the year
compared to GBP14.1 million in the previous year - up 17% at
constant exchange rates. Protherics will receive the full sales
value from CroFabTM once the current distribution agreement expires
in October 2010. DigiFabTM - treatment for digoxin overdose
DigiFabTM is a polyclonal antibody fragment (Fab) for the treatment
of life-threatening or potentially life-threatening digoxin
toxicity or overdose. It is the market leading product in the US
market, where it competes with Digibind� (GlaxoSmithKline). The US
market is estimated to be worth approximately USD25 million per
annum. We also anticipate gaining marketing authorisation in the UK
in the current financial year, followed by subsequent approvals in
the rest of Europe, allowing us to also compete with Digibind� in a
European market estimated to be worth EUR5-10 million per annum.
Net sales of CroFabTM and DigiFabTM in the US are currently shared
equally with our distributor Fougera. Protherics' DigiFabTM sales
were GBP4.8 million in the year compared to GBP2.7 million in the
previous year - up 82% at constant exchange rates. Protherics will
receive the full sales value from DigiFabTM in the US once the
current distributio n agreement expires in October 2010. R&D
PIPELINE UPDATE CytoFabTM (for sepsis resulting from uncontrolled
infection) phase 2 study commenced by AstraZeneca CytoFabTM is an
anti-TNF-alpha polyclonal antibody fragment (Fab) for the treatment
of sepsis, which we out-licensed to our partner, AstraZeneca, in
December 2005. It is estimated that sepsis affects around 3 million
people worldwide per annum and kills one in three patients.
Protherics believes that the severe sepsis market alone has the
potential to be worth up to USD8 billion per annum globally.
Protherics previously reported encouraging data from an 81 patient
phase 2b study with CytoFabTM in severe sepsis. In January 2008,
AstraZeneca commenced an additional phase 2 programme with
CytoFabTM following changes to the commercial manufacturing
process. AstraZeneca's phase 2 programme will consist of two
separate studies in patients with severe sepsis. The first study,
which is now underway, is designed to assess the safety,
tolerability, pharmacokinetics and pharmacodynamics of CytoFabTM
produced by the new manufacturing process. It will enrol up to 70
patients across multiple sites in the US and is expected to report
towards the end of the year or in early 2009. Following the
successful completion of this study, AstraZeneca intends to start a
second study to assess both the safety and the efficacy of
CytoFabTM in a much larger patient group. Protherics will receive
its next milestone payment of GBP10 million from AstraZeneca upon
the start of a pivotal phase 3 study which is anticipated in 2010.
Digoxin Immune Fab (treatment of pre-eclampsia) phase 2b study
reported Protherics has in-licensed the intellectual property
rights to use Digoxin Immune Fabs (DigiFabTM and GlaxoSmithKline's
Digibind^�) as potential treatments for pre-eclampsia, a
potentially life-threatening condition of pregnancy occurring in
approximately 10% of pregnancies worldwide. In April 2008, we
reported the headline results from the phase 2b"DEEP" study which
investigated the use of Digibind^� in 51 patients with severe
pre-eclampsia. In this small and challenging study, one of the two
primary endpoints was met when the deterioration in kidney function
during the 24-48 hours period of treatment was found to be
significantly less (pless than0.05) in patients receiving
Digibind^� than in patients receiving placebo. However, there was
no significant difference for the other primary endpoint, the use
of antihypertensive drugs, in this study. None of the mothers
receiving Digibind^� reported side effects to treatment. The clear
effect on kidney function provides support for Digibind� having a
pharmacologic effect in a serious condition for which there is no
approved therapy. Protherics intends to discuss the full data set
with other stakeholders in the programme, including
GlaxoSmithKline, to decide potential next steps. Angiotensin
Therapeutic Vaccine (management of high blood pressure) to start
phase 2a shortly Protherics' Angiotensin Therapeutic Vaccine is
designed to induce endogenous antibodies to angiotensin I, one of
the key hormones involved in the regulation of blood pressure.
Encouraging non-clinical and clinical results with our vaccine
suggest that effective neutralisation of angiotensin may cause a
clinically significant reduction in blood pressure in hypertensive
patients. We are also encouraged by data reported recently by Cytos
Biotechnology AG, that its angiotensin vaccine, CYT006-AngQb,
caused a statistically significant reduction in blood pressure and
was well-tolerated. Protherics will start a phase 2a study in mid
2008 with a new formulation of Angiotensin Therapeutic Vaccine
which incorporates our novel adjuvant, CoVaccine HTTM, which has
shown very promising non-clinical results. The goal of this study
is to establish whether the new formulation increases the
anti-angiotensin antibody response sufficiently to cause a
reduction in blood pressure in hypertensive patients. With proof of
concept data at the end of this phase 2a study, Protherics intends
out-licensing the programme to a pharmaceutical company with a
franchise in the global anti-hypertensive therapy market, currently
worth more than USD30 billion per annum. VoraxazeTM (for the
control of high dose methotrexate therapy in cancer) US marketing
application filing expected to start in coming months VoraxazeTM
contains an enzyme (glucarpidase) that rapidly breaks down the
cancer drug methotrexate (MTX). VoraxazeTM has been developed to
prevent or reduce the potentially life-threatening toxicity that
can occur when patients receiving high doses of MTX (HDMTX) for the
treatment of cancer have problems eliminating MTX from the body.
Protherics estimates that the market for VoraxazeTM intervention
use could be worth USD25-50 million per annum.To support potential
marketing applications in the US and EU, Protherics is undertaking
a small clinical study to further characterise a drug-drug
interaction between VoraxazeTM and leucovorin, in parallel to
carrying out additional manufacturing and analytical work. Three
consecutive planned conformance batches of VoraxazeTM, which are
required for regulatory approval, will be manufactured after the
summer shutdown at our manufacturing partner Eurogentec. This will
enable Protherics to start submitting a rolling Biological
Licensing Application ("BLA") to the US Food and Drug
Administration ("FDA") in the second half of 2008, leading to a
potential marketing approval in the US in the first half of 2010.
Following feedback from the EMEA, we are investigating the
availability of a suitable non-clinical model to support the
clinical benefit of using VoraxazeTM so that we can generate data
to support resubmission of a Marketing Authorisation Application in
the EU. VoraxazeTM is now being supplied under a Treatment Protocol
in the US where we are able to recover our development costs.
VoraxazeTM continues to be available in Europe and other countries
outside the US on a named patient basis. OncoGelTM (for the
loco-regional control of solid tumours) phase 2b study ongoing in
oesophageal cancer OncoGelTM is a novel, locally-administered,
sustained-release formulation of paclitaxel, an established
chemotherapeutic, for the treatment of solid tumours. Protherics is
developing the product in two lead indications: oesophageal cancer
and primary brain cancer. Protherics estimates that the US market
opportunity for OncoGelTM in these two indications alone is in
excess of USD250 million per annum. Our licensing partner, Diatos
S.A., has rights to the product outside of the US, Canada, Mexico
and Korea. Diatos S.A. is planning to initiate a clinical study of
OncoGelTM in the treatment of head and neck cancer. In January
2008, we initiated a randomised multinational phase 2b study to
evaluate OncoGelTM administered in combination with pre-operative
chemo-radiotherapy compared to pre-operative chemo-radiotherapy
alone in 124 patients with oesophageal cancer. The primary endpoint
of the study is a blinded assessment of tumour response, with
overall survival a secondary endpoint. Protherics expects to have
data available from the phase 2b study in 2010. We recently
received agreement from the FDA to a protocol amendment for our
phase 1/2 study of OncoGelTM in recurrent primary brain cancer
(glioblastoma multiforme). Following observations of fluid
accumulation in the three patients dosed in the first cohort,
subsequent patients in the study will have a drain surgically
inserted to allow the easy removal of any fluid that accumulates in
the brain. The FDA has requested additional non-clinical safety
data prior to further dose escalation in the study and so
recruitment will recommence in the meantime with a lower dose
volume of OncoGelTM. ProlarixTM (a targeted therapy for select
solid tumours) phase 2 to commence shortly in primary liver cancer
ProlarixTM is comprised of a small molecule prodrug, tretazicar,
which is converted by an endogenous enzyme, NQO2, to a highly
cytotoxic agent when administered with an enzyme cosubstrate,
caricotamide. The enzyme NQO2 has elevated activity in certain
tumours, in particular primary liver cancer (hepatocellular
carcinoma or HCC), offering a potentially selective therapeutic
effect. HCC is a devastating cancer which kills around 500,000
patients each year globally and, despite the recent approval of
sorafenib (Nexavar�, Onyx/Bayer), life expectancy for HCC patients
remains less than 12 months from diagnosis. ProlarixTM may also
have a role in the treatment of other solid tumours, such as
ovarian cancer and melanoma providing a wider potential market
opportunity for the drug. Our partner, Cancer Research UK, has
completed a phase 1 study of ProlarixTM and we are awaiting the
final study report. We have already reported that the maximum
tolerated dose has been determined and that tretazicar has been
shown to be rapidly eliminated from the blood in the presence of
caricotamide, suggesting that the prodrug has been activated. We
are pleased to report that Cancer Research UK yesterday presented
data from this study at the American Society of Clinical Oncology
(ASCO) Annual Meeting, showing evidence of DNA damage in tumour
tissue from patients treated at the maximum tolerated dose.
Encouraged by this data, Protherics plans to start a phase 2
programme shortly to investigate tumour responses in the lead
indication of HCC. This phase 2 programme will comprise an
open-label run-in study to a larger controlled study in which
ProlarixTM will be added to sorafenib and compared with sorafenib
alone. The open-label study should provide an early indication of
potential efficacy in HCC patients and results are expected from
this initial study in 2009. AcadraTM (acadesine; a selective
therapy for B-cell chronic lymphocytic leukemia) phase 1/2 underway
Most drugs used to treat B-cell Chronic Lymphocytic Leukemia
(B-CLL) not only kill B-cells, which over proliferative in this
disease, but also kill T-cells which help protect the body from
infection. As a result, patients who are treated with current
therapies have an increased risk of serious infection, a common
cause of death in patients with B-CLL. AcadraTM is a promising,
potentially selective, treatment which has been shown to cause the
death of B-cells whilst sparing T-cells when added to blood samples
taken from patients with B-CLL. It has also been shown to cause the
death of B-cells when added to the blood of patients who are
refractory to fludarabine, one of the most commonly used treatments
for B-CLL. It estimated that up to 160,000 patients develop B-CLL
globally per annum, and with two-thirds of patients requiring
treatment, we estimate that the market opportunity could be up to
USD250 million per annum. Protherics and its co-development
partner, Advancell, have initiated a phase 1/2 study of AcadraTM in
patients with recurrent or refractory B-CLL. The study is being
undertaken in Belgium, France and Spain and will enrol up to 30
B-CLL patients. Part I of the study is an open-label assessment of
the safety and tolerability of escalating single doses of AcadraTM
followed, in Part II, by an assessment of up to five repeated
doses. Part I of the study is expected to be completed in 2009,
with the intention of providing initial evidence of a potential
selective effect. OTHER ASSETS Progress was also made during the
year in realising value from our non-core assets gained through our
acquisitions of MacroMed Inc. and certain assets from CoVaccine
B.V. A licensing agreement for CoVaccine HTTM was signed with
Nobilon B.V., the human vaccine development unit of Organon
BioSciences recently acquired by Schering Plough. Nobilon will use
our CoVaccine HTTM adjuvant in the development of a seasonal
elderly flu vaccine and a pandemic flu vaccine. An agreement was
also signed with MyungMoon Pharm. Co. Ltd. for the use of ReGelTM,
our injectable, thermosensitive sustained release polymer delivery
system, for the formulation of anti-inflammatory products for the
treatment of arthritis. We also have feasibility studies on-going
with a number of other parties interested in our non-core assets.
OPERATIONS Having achieved the successful scale-up of the CytoFabTM
manufacturing process and supplied clinical trial material to
AstraZeneca, our focus has returned to revising our CroFabTM
manufacturing process to improve our gross margins. These process
changes will require a small clinical study prior to FDA approval
which is expected in the US in 2010. We have also been working
closely with Eurogentec, our manufacturing partner for VoraxazeTM,
to prepare for US approval and commercial supply. Headcount has
increased from 271 employees at 31 March 2007 to 303 employees at
31 March 2008. OUTLOOK Our goal is to become a leading
international biopharmaceutical company selling our own specialist
hospital products. Our plan is simple. We intend to use our current
cash, which we reported at GBP37.7 million at 31 March 2008, to
fund the pipeline to key decision points for each of our programmes
over the next two years. We have two main value drivers in the
pipeline with CytoFabTM, licensed to AstraZeneca, and our
Angiotensin Therapeutic Vaccine, which we intend to outlicense at
the end of phase 2a. Our R&D investment is, and will continue
to be, focused on the development of our niche cancer pipeline to
provide additional products for the Company to sell in future
years. The return of the US marketing rights for CroFabTM and
DigiFabTM, and the potential approval of VoraxazeTM in the US in
2010, will allow us to establish a commercial infrastructure and
help fund our development pipeline in the future. To capitalise on
this opportunity, Protherics must access and develop additional
products that can be sold through this sales force. We look forward
to selling our own products in the near future and moving the
Company to the next stage of its development. FINANCIAL REVIEW
Following a pleasing performance during the financial year ended 31
March 2008, we remain in a strong financial position, with
encouraging growth in trading revenues and gross margin, and a
healthy cash position. Revenues Trading revenues from our products,
which exclude CytoFabTM milestone revenues, increased by 27% in
2008. This strong organic growth was underpinned by increased
revenues for DigiFabTM and CroFabTM, together with increased
revenues from the US cost recovery programme and named patient
sales of VoraxazeTM. Total reported revenue for 2008 was GBP26.1
million, compared to GBP31.1 million in 2007, which included a
one-time GBP10 million CytoFabTM manufacturing milestone from
AstraZeneca. Revenue analysis *T 2008 2007 GBPm GBPm CroFabTM 15.7
14.1 DigiFabTM 4.8 2.7 VoraxazeTM 2.8 1.4 ViperaTAbTM 0.2 0.3
Trading revenues 23.5 18.5 CytoFabTM 2.3 12.2 Other 0.3 0.4 Total
revenues 26.1 31.1 *T CroFabTM revenues increased by 11% in 2008,
or 17% in constant currency, as a result of increased shipments of
CroFabTM to Fougera. Total DigiFabTM revenues were up 78% on a
reported basis, driven by increased shipments to Fougera and
increased royalties on US product sales. This reflects both a
rebalancing of stock levels held by our distributor to a more
normalised level and also increased market penetration. During 2008
the FDA approved cost recovery for VoraxazeTM in the US, which, in
combination with increased named patient sales in Europe, resulted
in turnover for VoraxazeTM doubling during the year. Gross Profit
on Trading Revenues *T 2008 2007 GBPm GBPm Trading revenues 23.5
18.5 Cost of Goods Sold 12.5 11.3 Gross Profit 11.0 7.2 Gross
margin on Trading Revenues 47% 39% *T Increased volumes of higher
margin products helped deliver an improved gross margin of 47% on
trading revenues compared to 39% in the previous year. As a result,
gross profits on manufactured products increased substantially from
GBP7.2 million to GBP11.0 million, a pleasing performance. R&D
and Administration Expenses Research and development expenditure
increased as was planned, to GBP19. 1 million from GBP14.0 million
as we stepped up our investment in our development pipeline. In
addition, we saw the full year impact of the development activities
arising from our acquisitions of OncoGelTM, and the in-licensing of
AcadraTM and Digoxin Immune Fab for pre-eclampsia, in January 2007.
No research and development expenditure has been capitalised.
General and Administration costs increased to GBP13.7 million
(2007: GBP10.2 million) as the full year impact of the acquisition
of MacroMed Inc., in January 2007, was included in the results for
the first time combined with the costs of managing the expanded
development pipeline. Finance income and costs Finance income of
GBP2.4 million increased from GBP1.2 million in the prior year
reflecting the higher cash balance maintained throughout the year.
Finance costs of GBP0.4 million (2007: GBP0.4 million) relate to
finance lease charges and convertible loan note interest. Results
after tax As expected, the loss after tax increased to GBP16.7
million (2007: GBP3.4 million), reflecting the increased
expenditure relating to enhanced development pipeline and the
acquisitions made in January 2007. The 2007 results included the
benefit of the GBP10 million AstraZeneca milestone. Balance Sheet
Non-current assets increased to GBP42.2 million from GBP40.6
million due to continued investment in property plant and
equipment. Current assets decreased to GBP52.6 million from GBP66.6
million reflecting the receipt of GBP10 million milestone payment
from AstraZeneca in April 2007 which was subsequently reinvested in
our development pipeline. Total liabilities increased to GBP33.3
million from GBP30.8 million in line with our higher levels of
R&D expenditure. Liquidity and cash flow Operating loss for the
year was GBP19.2 million compared to GBP4.4 milli on in 2007. The
receipt in April 2007 of the GBP10 million AstraZeneca milestone
together with reduced levels of working capital contributed to a
net cash inflow from operating activities of GBP0.2 million
compared to an outflow of GBP15.8 million in 2007. Investment in
property, plant and equipment increased to GBP3.5 million compared
to GBP1.2 million in 2007. The net decrease in cash during the year
was GBP2.4 million compared to an increase in 2007 of GBP14.6
million which included GBP36.2 million of proceeds from the share
issue in January 2007. Cash and cash equivalents were GBP37.6
million compared to GBP40.0 milli on in March 2007. Cash is
invested with institutions with the highest credit ratings, with
security being the principal investment objective. Currency effects
The majority of Protherics' revenues arise in US dollars while a
significant proportion of the manufacturing and administrative
costs are denominated in Sterling and Australian dollars. We manage
our currency exposure by using foreign exchange contracts on a
rolling twelve month basis. The difference between the fair value
of these contracts at each year end, together with any other
exchange gains or losses is reflected in administrative expenses
for the year. The effective overall translation rate applied to the
US dollars revenues in the year was approximately GBP/USD 1.98
compared to GBP/USD 1.91 in the previous year. Outlook We are
encouraged with the underlying performance of our key products in
2008 and expect trading to remain strong during 2009. We expect
continued growth from CroFabTM, DigiFabTM and VoraxazeTM and these
revenue streams, in conjunction with our existing cash balances,
underpin Protherics' ability to fund its broad development pipeline
to key decision points over the next two years. In 2010 we look
forward to the return of the marketing rights for CroFabTM and
DigiFabTM which will significantly enhance our financial capability
and provide the platform for developing our commercial strategy.
Consolidated Income Statement for the year ended 31 March 2008 *T
2008 2007 Notes GBP'000 GBP'000 Revenue 2 26,067 31,119 Cost of
sales (12,463) (11,334) Gross profit 13,604 19,785 Administrative
expenses Research and development (19,138) (13,978) General &
administrative (13,684) (10,161) Total administrative expenses
(32,822) (24,139) Operating loss 2 (19,218) (4,354) Finance income
2,382 1,155 Finance costs (415) (417) Loss before tax (17,251)
(3,616) Tax 3 509 259 Loss for the year (16,742) (3,357) Pence
Pence Basic and diluted loss per share 4 (4.9) (1.2) The results
relate to continuing operations Statement of Recognised Income
& Expense for the year ended 31 March 2008 2008 2007 GBP'000
GBP'000 Exchange differences on translation of foreign 236 749
operations Net income recognised directly in equity 236 749 Loss
for the year (16,742) (3,357) Total recognised loss since last
financial statements (16,506) (2,608) All recognised income and
expense is attributable to equity shareholders. Consolidated
Balance Sheet at 31 March 2008 2008 2007 Notes GBP'000 GBP'000
Non-current assets Goodwill 10,865 10,878 Intangible assets 19,119
19,652 Property, plant and equipment 11,884 9,987 Investment in
subsidiaries - - Deferred tax asset 345 99 42,213 40,616 Current
assets Inventories 10,205 10,707 Derivative instruments - 114 Tax
receivables 763 773 Trade and other receivables 3,975 15,066 Cash
and cash equivalents 5 37,660 39,989 52,603 66,649 Total assets
94,816 107,265 Current liabilities Trade and other payables 19,210
14,037 Current tax liabilities 370 273 Obligations under finance
leases 966 1,048 Bank overdrafts and loans 54 46 Derivative
instruments 170 - 20,770 15,404 Non-current liabilities Trade and
other payables 8,670 10,844 Borrowings 141 157 Convertible loan
notes 1,971 2,100 Obligations under finance leases 1,712 2,289
12,494 15,390 Total liabilities 33,264 30,794 Net assets 61,552
76,471 Shareholders' equity Share capital 6,806 6,783 Share premium
account 136,292 135,951 Shares to be issued 1,289 1,289 Merger
reserve 51,163 51,163 Equity reserve 203 220 Cumulative translation
reserve 794 558 Retained earnings (134,995) (119,493) Total equity
61,552 76,471 Consolidated Statement of Changes in Equity Share
Share Shares to be Merger capital premium issued reserve GBP'000
GBP'000 GBP'000 GBP'000 Balance at 1 April 2006 5,186 86,770 -
51,163 Currency translation - - - - adjustments Net income
recognised directly - - - - in equity Loss for the year - - - -
Total recognised profit / - - - - (loss) for the year New share
capital subscribed 1,560 48,499 - - Shares to be issued - - 1,289 -
New loan notes issued - - - - Conversion of convertible loan 37 682
- - notes Employee share option scheme - - - - Balance at 31 March
2007 6,783 135,951 1,289 51,163 Currency translation - - - -
adjustments Net income recognised directly - - - - in equity Loss
for the year - - - - Total recognised profit / - - - - (loss) for
the year New share capital subscribed 4 49 - - Conversion of
convertible loan 19 292 - - notes Employee share option scheme - -
- - Balance at 31 March 2008 6,806 136,292 1,289 51,163 Equity
Cumulative Retained Total reserve translation earnings reserve
GBP'000 GBP'000 GBP'000 GBP'000 Balance at 1 April 2006 263 (191)
(116,839) 26,352 Currency translation - 749 - 749 adjustments Net
income recognised directly - 749 - 749 in equity Loss for the year
- - (3,357) (3,357) Total recognised profit / - 749 (3,357) (2,608)
(loss) for the year New share capital subscribed - - - 50,059
Shares to be issued - - - 1,289 New loan notes issued 186 - - 186
Conversion of convertible loan (229) - - 490 notes Employee share
option scheme - - 703 703 Balance at 31 March 2007 220 558
(119,493) 76,471 Currency translation - 236 - 236 adjustments Net
income recognised directly - 236 - 236 in equity Loss for the year
- - (16,742) (16,742) Total recognised profit / - 236 (16,742)
(16,506) (loss) for the year New share capital subscribed - - - 53
Conversion of convertible loan (17) - - 294 notes Employee share
option scheme - - 1,240 1,240 Balance at 31 March 2008 203 794
(134,995) 61,552 Cash Flow Statements for the year ended 31 March
2008 2008 2007 Notes GBP'000 GBP'000 Cash flows from operating
activities Cash outflow from operations (126) (16,051) Income tax
received 282 293 Net cash inflow / (outflow) from operating 156
(15,758) activities Investing activities Interest received 2,382
1,155 Proceeds on disposal of property, plant and 2 2 equipment
Purchases of property, plant and equipment (3,471) (1,242)
Purchases of other intangible non-current assets - (4,092)
Acquisition of subsidiary, net of cash acquired - (374) Capital
grants received 9 - Net cash used in investing activities (1,078)
(4,551) Financing activities Interest paid (160) (170) Interest
paid on finance leases (238) (213) Repayment of borrowings (55)
(36) Repayments of finance leases (1,063) (837) Proceeds from issue
of loan note - 30 Proceeds from issue of shares 53 36,162 Net cash
(outflow) / inflow from financing (1,463) 34,936 activities Net
(decrease) / increase in cash and cash (2,385) 14,627 equivalents
Cash and cash equivalents at the beginning of 39,989 25,438 year
Effect of foreign exchange rate changes 12 (76) Cash and cash
equivalents at the end of year 5 37,616 39,989 Notes to the
Consolidated Cash Flow Statement for the year ended 31 March 2008
Reconciliation of loss for the year to net cash flow from operating
activities: 2008 2007 GBP'000 GBP'000 Loss for the year (16,742)
(3,357) Tax (509) (259) Finance costs 415 417 Finance income
(2,382) (1,155) Operating loss (19,218) (4,354) Adjustments for:
Change in fair value of derivatives 284 (250) Deferred grant income
(104) (111) Share-based payment costs 1,240 703 Depreciation of
property, plant and equipment 2,076 1,373 Amortisation of
intangible fixed assets 498 135 Loss on disposal of property, plant
and equipment 134 634 Operating cash flows before movements in
working (15,090) (1,870) capital Decrease in inventories 686 131
Decrease / (increase) in receivables 11,054 (10,575) Increase /
(decrease) in payables 3,224 (3,737) Net cash outflow from
operating activities (126) (16,051) *T 1. Notes to the preliminary
results Following European regulation issued in 2002, the Company
presents its consolidated financial statements in accordance with
International Financial Reporting Standards (IFRS), as adopted by
the European Union, and which have been prepared using accounting
policies consistent with those in the Company's last published
financial statements for the year ended 31 March 2007. The
financial information set out above does not constitute the
Company's statutory accounts for the years ended 31 March 2008 or
2007 but is derived from those accounts. Statutory accounts for
2007 have been delivered to the registrar of companies, and those
for 2008 will be delivered in due course. The auditors have
reported on those accounts; their report 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. Whilst the financial information
included in this preliminary announcement has been computed in
accordance with IFRS, as adopted by the EU, this announcement does
not itself contain sufficient information to comply with IFRS as
adopted by the EU. The Company expects to publish its full IFRS, as
adopted by the EU, financial statements for the year ended 31 March
2008 on 24th June 2008. 2. Segment informationFor management
purposes, the Group is organised into two operating segments: the
sale, manufacture and development of pharmaceutical products and
the out license of technology. These divisions are the basis on
which the Group reports its primary segment information. The
revenue and costs of each segment are clearly identifiable and
allocated to each segment accordingly. There are no inter-segmental
revenues. *T 2008 Sale, manufacture and Outlicensed Group
development of product pharmaceutical products royalties GBP'000
GBP'000 GBP'000 Revenue 25,843 224 26,067 Segment result (19,429)
211 (19,218) Finance income 2,382 Finance costs (415) Loss before
tax (17,251) Tax 509 Loss for the year (16,742) attributable to
equity shareholders 2007 Sale, manufacture and Outlicensed Group
development of product pharmaceutical products royalties GBP'000
GBP'000 GBP'000 Revenue 30,842 277 31,119 Segment result (4,621)
267 (4,354) Finance income 1,155 Finance costs (417) Loss before
tax (3,616) Tax 259 Loss for the year (3,357) attributable to
equity shareholders *T 3. Taxation An analysis of credit for the
year, all relating to continuing operations, is set out below: *T
2008 2007 GBP'000 GBP'000 Current tax UK corporation tax credit for
the current year - 353 Adjustment in respect of prior years UK
corporation tax 624 7 624 360 Foreign tax (351) 3 Total current
taxation 273 363 Deferred taxation Increase in estimate of
recoverable deferred tax asset 236 - Utilisation of losses - (104)
509 259 *T Corporation tax in the UK is calculated at 30% (2007:
30%) of the estimated assessable profit for the year. Taxes for
other jurisdictions are calculated at the rates prevailing in the
respective jurisdictions. The UK tax credits arising in respect of
the prior years were as a result of research and development
expenditure claimed under the Finance Act 2000. 4. Loss per share
Basic loss per share is calculated by dividing the loss
attributable to ordinary shareholders by the weighted average
number of ordinary shares outstanding during the year. For diluted
loss per share, the weighted average number of ordinary shares in
issue would be adjusted to assume conversion of all dilutive
potential ordinary shares. The Company would have three categories
of dilutive potential ordinary shares: share options, warrants and
the 6% convertible unsecured loan notes. The Company has been loss
making in both the current and prior year and as such, should the
Company be called upon to issue shares, the effect would be
anti-dilutive. The calculation of the basic and diluted loss per
share is based on the loss of GBP16,742,000 (2007: GBP3,357,000)
and on 339,541,951 ordinary shares (2007: 285,365,704) being the
weighted average number of ordinary shares in issue. 5. Cash &
cash equivalents *T 2008 2007 GBP'000 GBP'000 Cash at bank and in
hand 7,439 1,216 Short term bank deposits 30,221 38,773 37,660
39,989 Bank overdrafts (included in bank overdrafts and loans (44)
- under current liabilities) 37,616 39,989 *T 6. Other Copies of
this announcement are available from the Company Secretary at the
Company's registered office, The Heath Business & Technical
Park, Runcorn, Cheshire WA7 4QX. This information is provided by
RNS The company news service from the London Stock Exchange END
Contacts: RNS Customer Services 0044-207797-4400 Email Contact
http://www.rns.com
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