SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
3rd June 2008
PROTHERICS PLC
(Translation of Registrant’s Name Into
English)
The Heath Business & Technical Park
Runcorn, Cheshire, W47 4QF England
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F
X
Form
40-F
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 191(b)(7):
Indicate by check mark whether the registrant by
furnishing the information contained in this form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act
of 1934.
Yes
No
X
If “Yes” is marked, indicate below the
file number assigned to the registrant in connection with Rule 12g3-2(b):
82-
.
The Registrant is furnishing a copy of its
announcements as reported to the Company Announcements Office of the London Stock
Exchange.
PROTHERICS ANNOUNCES PRELIMINARY RESULTS
FOR YEAR ENDED 31 MARCH 2008
Strong increase in underlying revenues and robust
financial position
Solid progress across late stage
pipeline
London, UK, Brentwood, TN, 3 June
2008
- Protherics PLC, (“Protherics” or the
“Company”), the international biopharmaceutical company focused on
critical care and cancer, today announces its preliminary results for the 12
months ended 31 March 2008.
-
Trading revenues of £23.5 million (2007:
£18.5 million)
,
delivering organic growth of 27%
-
Gross
m
argin
on trading revenues increased to 47% (2007:
39%)
-
R&D expenditure of £19.1 million (2007:
£14.0 million) reflecting
planned
increased investment in the development
pipeline
-
Strong financial position with £37.7 million of
cash at year end (2007: £40.0 million)
-
AstraZeneca commenced its CytoFab™ phase 2
programme in severe sepsis
-
Digoxin Immune Fab phase 2b study reported in
pre-eclampsia
-
OncoGel™ phase 2b study commenced in oesophageal
cancer
and
Acadra™ 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, CroFab™ and DigiFab™.
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."
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
EC2
M 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:
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Nick Staples,
Director of Corporate Affairs
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Saul Komisar
, President Protherics Inc
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Financial Dynamics
- press enquiries
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London: Ben Atwell, Lara Mott
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New York
: John Capodanno
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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
: CroFab™, a
North American
pit viper antivenom and DigiFab™, a digoxin antidote.
Protherics reported revenues of £2
6.1
million for its year end
ed
31 March 2008 and
a
strong cash balance of £37.7 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. CytoFab™
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 HT™, 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
.
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.
Despite extremely turbulent financial markets in both the
wider industry and the biotechnology sector, Prother
ics 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 £37.7 million in cash and
our strong balance sheet provides us with the means to d
evelop 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 CytoFab™ 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 Voraxaze™ in the US,
and
results from
proof of concept
studies
for Prolarix™, Acadra™ and OncoGel™. 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 CroFab™, DigiFab™ and
potentially Voraxaze™ ourselves in the US. Protherics will regain
the
US
marketing rights to CroFab
™
and DigiFab
™
from its distribution partner Nycomed in October 2010.
We reported £20.5 million in sales from these products for the year
end
ed
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 Voraxaze™ 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.
CroFab™ - pit viper antivenom
CroFab
™
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
CroFab
™
has captured
more than
half of
a potential
US$70-80 million market
in the
US
.
Net sales are currently shared equally with our
distributor Fougera, a division of Nycomed. Protherics’
CroFab
™
revenues were £15.7 million in the year compared
to £14.1 million in the previous year - up 17% at constant exchange
rates. Protherics will receive the full sales value from CroFab
™
once the current distribution agreement expires in
October 2010.
DigiFab™ - treatment for digoxin
overdose
DigiFab
™
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 US$25 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 €5-10 million per
annum.
Net sales
of
CroFab™ and
DigiFab™
in the
US
are currently shared equally with
our distributor
Fougera
.
Protherics'
DigiFab
™
sales were £4.8 million in the year compared to
£2.7 million in the previous year - up 82% at constant exchange rates.
Protherics will receive the full sales
value
from DigiFab
™
in the
US
once the current distribution agreement expires in October
2010.
CytoFab™
(for sepsis resulting from uncontrolled infection) phase 2
study commenced by AstraZeneca
CytoFab™
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 $8 billion per annum
globally
.
Protherics previously reported encouraging
data from an
81 patient phase 2b study with CytoFab
™
in severe sepsis.
In January 2008, AstraZeneca commenced an additional phase 2
programme with CytoFab
™
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 CytoFab
™
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 CytoFab
™
in a much larger patient group. Protherics will receive
its next milestone payment of £10 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 (DigiFab™ 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
(p<0.05) 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
HT
™
, 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
US
$30 billion per annum.
Voraxaze
™
(for the control of high dose methotrexate therapy in
cancer) US marketing application
filing
expected
to start
in coming months
Voraxaze
™
contains an enzyme
(glucarpidase)
that rapidly breaks down the cancer drug methotrexate (MTX).
Voraxaze
™
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 Voraxaze
™
intervention use could be worth
US
$25
-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
Voraxaze
™
and
l
eucovorin
,
in parallel to
carrying out additional manufacturing
and analytical
work.
T
hree
consecutive
planned conformance batches of Voraxaze
™
,
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
Voraxaze
™
so that we can
generate data to
support
resubmi
ssion of
a Marketing Authorisation Application in the EU.
Voraxaze
™
is now being supplied under a Treatment Protocol in
the
US
where we are able to recover our development costs.
Voraxaze
™
continues to be available in Europe and other countries
outside the
US
on a named patient basis.
OncoGel™
(for the
loco-regional control of solid tumours) phase 2b study
ongoing in oesophageal cancer
OncoGel
™
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 OncoGel
™
in these two indications alone is in excess
of
US
$250 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 OncoGel™ in
the treatment of
head and neck cancer
.
In January 2008, we initiated a randomi
s
ed multinational phase 2b study to evaluate OncoGel
™
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 OncoGel
™
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 OncoGel
™
.
Prolarix
TM
(a targeted therapy for select solid tumours) phase 2
to commence shortly in primary liver cancer
Prolarix
™
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. Prolarix
™
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 Prolarix™
and
we are awaiting the
final
study
report
.
We have already reported that t
he 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 p
resented 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 Prolarix
™
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.
Acadra™ (acadesine; a selective therapy for
B-cell
c
hronic
l
ymphocytic
l
eukemia
) 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
increas
ed
risk of serious infection, a common cause of death in patients
with B-CLL. Acadra
™
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
US
$250 million per annum.
Protherics and its co-development partner, Advancell, have
initiated a phase 1/2 study of Acadra
™
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 Acadra
™
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.
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 HT
™
was signed with Nobilon B.V., the human vaccine
development unit of
Organon BioSciences
recently acquired by
Schering Plough. Nobilon will use our CoVaccine HT
™
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 ReGel™, 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.
Having achieved the successful
scale
-
up of the CytoFab™ manufacturing process and supplied
clinical trial material to AstraZeneca, our focus has returned to
revising
our CroFab
™
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 Voraxaze™, 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.
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 £37.
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 CytoFab
™
,
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 CroFab
™
and DigiFab
™
, and the potential approval of Voraxaze
™
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.
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.
Trading revenues from our products, which exclude
CytoFab
™
milestone revenues, increased by 27% in 2008. This strong
organic growth was underpinned by increased revenues for DigiFab
™
and CroFab
™
, together with increased
revenues
from the
US
cost recovery programme and named patient sales of
Voraxaze
™
. Total reported revenue for 2008 was £26.1 million,
compared to £31.1 million i
n 2007, which included a one-time
£10 million CytoFab
™
manufacturing milestone from AstraZeneca.
CroFab
™
revenues increased by 11% in 2008, or 17% in constant
currency, as a result of increased shipments of CroFab
™
to Fougera.
Total
DigiFab
™
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 Voraxaze
™
in the
US
, which, in combination with increased named patient sales
in
Europe
, resulted in turnover for Voraxaze
™
doubling during the year.
Gross Profit on Trading Revenues
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Gross margin on Trading Revenues
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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 £7.2 million to
£11
.0
million, a pleasing performance.
R&D and Administration Expenses
Research and development expenditure increased
as
was
planned, to £19.1 million from £14
.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 acquisition
s
of OncoGel
™
,
and
the
in
-
licensing of
Acadra
™
and Digoxin Immune Fab
for pre-eclampsia,
in January 2007. No research and development expenditure has
been capitalised.
General and Administration costs increased to £13.7
million (2007: £10.
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 of £2.4 million increased from £1.2
million in the prior year reflecting the higher cash balance maintained throughout
the year. Finance costs of £0.4
m
illion
(2007: £0.4 million) relate to finance lease
charges and convertible loan note interest.
As expected, the loss after tax increased to £16.7
million (2007: £3.4 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 £10 million AstraZeneca
milestone.
Non
-
current assets increased to £42.2 million from
£40.6 million due to continued investment in property plant and equipment.
Current assets decreased to £52.6 million from £66.6 million reflecting
the receipt of £10
m
illion
milestone payment from AstraZeneca in April 2007
which
was subsequently
reinvested in our development pipeline. Total liabilities
increased to £33.3 million from £30.8 million in line with our higher
levels of R&D expenditure.
Operating loss for the year was £19.2 million compared to
£4.4 million in 2007. The receipt in April 2007 of the £10 million
AstraZeneca milestone together with reduced levels of working capital contributed
to a net cash inflow from operating activities of £0.2 million compared to an
outflow of £15.8 million in 2007. Investment in property, plant and equipment
increased to £3.5 million compared to £1.2 million in 2007. The net
decrease in cash during the year was £2.
4
million compared to an increase in 2007 of £14.6
million which included £36.2 million of proceeds from the share issue in
January 2007.
Cash and cash equivalents were £37.
6
million compared to £40
.0
million in March 2007. Cash is invested with institutions
with the highest credit ratings
,
with security being the prin
cipal
investment objective.
The majority of Protherics' revenues arise in US
dollars
whil
e
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 £/US$ 1.98
compared to £/US$ 1.91 in the previous year.
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 CroFab
™
, DigiFab
™
and Voraxaze
™
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 CroFab
™
and DigiFab
™
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
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Total administrative expenses
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Basic and diluted loss per share
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The results relate to continuing operations
Statement of Recognised Income & Expense
for the year ended 31 March 2008
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Exchange differences on translation of foreign
operations
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Net income recognised directly in equity
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Total recognised loss since last financial
statements
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All recognised income and expense is attributable to equity
shareholders.
Consolidated Balance Sheet
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Property, plant and equipment
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Investment in subsidiaries
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Trade and other receivables
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Cash and cash equivalents
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Obligations under finance leases
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Bank overdrafts and loans
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Obligations under finance leases
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Cumulative translation reserve
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Consolidated Statement of Changes in Equity
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|
Currency translation adjustments
|
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|
|
|
Net
income
recognised directly in equity
|
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|
|
|
|
|
|
|
|
|
Total recognised
profit / (
loss
)
for the year
|
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|
|
New share capital subscribed
|
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|
|
|
|
|
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|
|
|
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|
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|
|
Conversion of convertible loan notes
|
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|
|
|
Employee share option scheme
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustments
|
|
|
|
|
Net
income
recognised
directly in equity
|
|
|
|
|
|
|
|
|
|
|
Total recognised profit / (loss) for the
year
|
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|
|
|
New share capital subscribed
|
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|
|
|
Conversion of convertible loan notes
|
|
|
|
|
Employee share option scheme
|
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|
|
|
|
|
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|
|
|
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Cumulative translation reserve
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|
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|
|
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|
|
|
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|
|
|
|
|
Currency translation adjustments
|
|
|
|
|
Net
income
recognised directly in equity
|
|
|
|
|
|
|
|
|
|
|
Total recognised
profit / (
loss
)
for the year
|
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|
|
|
New share capital subscribed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible loan notes
|
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|
|
|
Employee share option scheme
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustments
|
|
|
|
|
Net
income
recognised
directly in equity
|
|
|
|
|
|
|
|
|
|
|
Total recognised profit / (loss) for the
year
|
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|
|
|
New share capital subscribed
|
|
|
|
|
Conversion of convertible loan notes
|
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|
|
|
Employee share option scheme
|
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|
|
|
|
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|
for the year ended 31 March 2008
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Cash flows from operating activities
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|
Cash outflow from operations
|
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|
Net cash inflow / (outflow) from operating
activities
|
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|
|
|
|
|
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|
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Proceeds on disposal of property, plant and
equipment
|
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|
|
Purchases of property, plant and equipment
|
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|
Purchases of other intangible non-current
assets
|
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Acquisition of subsidiary, net of cash
acquired
|
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Net cash used in investing
activities
|
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Interest paid on finance leases
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Repayments of finance leases
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Proceeds from issue of loan note
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|
Proceeds from issue of shares
|
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Net cash (outflow) / inflow from financing
activities
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Net (decrease) / increase in cash and cash
equivalents
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Cash and cash equivalents at the beginning of
year
|
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|
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|
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Effect of foreign exchange rate changes
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|
|
Cash and cash equivalents at the end of
year
|
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|
|
|
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|
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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:
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|
Change in fair value of derivatives
|
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|
|
Share-based payment costs
|
|
|
Depreciation of property, plant and
equipment
|
|
|
Amortisation of intangible fixed
assets
|
|
|
Loss on disposal of property, plant and
equipment
|
|
|
Operating cash flows before movements in working
capital
|
|
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|
|
|
|
|
|
Decrease / (increase) in receivables
|
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Increase / (decrease) in payables
|
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|
Net cash outflow from operating activities
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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
24
th
June 2008.
For 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.
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Sale
,
manufacture and development of
pharmaceutical products
|
|
|
Sale
,
manufacture and development of
pharmaceutical products
|
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|
Loss for the year attributable to equity
shareholders
|
|
|
|
|
|
|
An analysis of credit for the year, all relating to continuing
operations, is set out below:
|
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|
UK
c
orporation tax credit for the current year
|
|
|
Adjustment in respect of prior years
|
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|
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|
|
|
|
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|
|
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|
|
|
|
|
|
Increase in estimate of recoverable deferred tax
asset
|
|
|
|
|
|
|
|
|
|
|
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.
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 £16,742,000 (2007: £3,357,000) 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
|
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|
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|
|
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|
|
Bank overdrafts (included in bank overdrafts and
loans under current liabilities)
|
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|
|
|
|
|
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.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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PROTHERICS PLC
|
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Date: 3rd June 2008
|
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By:
|
|
/s/ Rolf Soderstrom
|
|
|
|
|
|
Rolf Soderstrom
|
|
|
|
|
|
Finance Director
|
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