Interim Results
Proteome Sciences PLC
30 September 2004
Proteome Sciences plc
PRESS RELEASE
For immediate release 30th September 2004
RESULTS FOR THE SIX MONTHS ENDED 30TH JUNE 2004
HIGHLIGHTS
Financial
- Loss after taxation reduced to £2.26m (2003: £3.58m).
- Headline Loss (excluding non-cash items and associates) declined 19%
to £1.85m (2003: £2.27m).
- Cash balance at 30th June 2004 of £4.31m.
- Low and predictable cash burn.
Commercialisation
- License for high throughput stroke markers expected in next six
months.
- Progress on BSE ante-mortem test and vCJD with samples now coming
through.
- Biomarkers for early diagnosis of Alzheimer's discovered in CSF and
serum. No objective clinical diagnosis currently exists. Selection
of licensing partners underway.
- Discovery of novel kinases and good potential new Alzheimer's drug
targets.
- New areas of application for ProteoSHOP(R). Commercial deals expected
to commence in the near future.
- Advanced negotiations in process for Sensitizer(R) family reagents.
Veri-Q Inc
- Good scientific results achieved and EU approval to use microarray
platform for in vitro diagnostics should lead to fast track
commercialisation.
Intronn Inc
- Groups at Cornell and Duke Universities, USA have successfully used
and published results with SMaRT(R) for a broad range of new
applications.
- Further grant and scientific news expected shortly.
Commenting on these results, Christopher Pearce, Chief Executive of Proteome
Sciences, said:
'Our main focus remains the delivery of revenue from commercialising our
scientific research and intellectual property through licensing deals and
strategic alliances. Strong progress is being made with our existing partners
and anticipated commercialisation deals are most advanced in the areas of high
throughput stroke, ProteoSHOP(R) and Sensitizer(R).
We continue to keep a tight control of costs and expect to see further
efficiencies following the recent move of our research facilities in Frankfurt.
We are maintaining a low and predictable rate of cash burn and have sufficient
cash resources to support our ongoing requirements.
'We strongly believe that we will make considerable progress with
commercialisation and revenue generation over the rest of the year and during
2005. We remain very confident about our future prospects.'
- ENDS -
Attached: Chairman's statement, consolidated profit and loss account, balance
sheet, cashflow statement and notes to the financial information.
For further information please contact:
Proteome Sciences plc
www.proteomics.com
Christopher Pearce, Chief Executive Tel: +44 (0)1932 865065
Email: christopher.pearce@proteomics.com
Public Relations for Proteome Sciences
IKON Associates
Adrian Shaw Tel: +44 (0)1483 535102
Mobile: +44 (0)797 9900733
Email: adrian@ikonassociates.com
Notes to Editors:
Proteome Sciences plc applies high sensitivity proteomics to identify and
characterise differential protein expression in diseases for diagnostic,
prognostic and therapeutic applications. It has to date developed sensitive
blood assays for stroke, vCJD, BSE, solid organ transplant rejection and
Alzheimer's disease. The main focus of its research currently addresses
neurological, neurodegenerative, diabetes/obesity, oncology and cardiovascular
conditions.
In addition to its own proprietary biomarkers, Proteome Sciences has developed
ProteoSHOP(R) (Proteome Sciences High Output Proteomics), a toolbox that offers
high sensitivity and high throughput gel and gel-free proprietary technologies
for the identification of potential biomarkers and drug targets. These include
specialisation in membrane proteins and protein phosphorylation.
The Company has also developed a range of specialist reagents to improve the
performance and quantitation of protein separation and characterisation with
mass spectrometry, bioinformatics, statistics and pattern recognition. These
include Sensitizer(R), PST(R), qPST(TM) and TMT(R).
The process of commercialisation is being actively pursued across the portfolio
of the Company's programmes and technologies and to date licensing deals have
been signed for the commercialisation of tests for Stroke and TSEs.
Proteome Sciences is headquartered in Cobham, Surrey in the UK and has
laboratories at Kings College Hospital, London and in Frankfurt. It employs 40
full time scientists in addition to its corporate and business development
staff. The Company is listed on the Alternative Investment Market.
Chairman's Statement :
Dear Shareholder,
I am pleased to set out below the full text of the Company's half yearly
statement which was released to the Stock Exchange on 30th September, 2004. The
main events of the period can be summarised as follows :
Biomarkers
The news from Biosite at the end of July 2004 that our biomarkers were unlikely
to be on their first stroke point of care panel, which uses a whole blood
sample, because of potential interference from haemolysis was unexpected and
disappointing and diverted attention away from the significant progress made in
the period. A detailed statement was released at the AGM in August to put the
situation into proper context in relation to the diagnostic market for stroke,
where high throughput clinical laboratory applications account for over 90% of
the total market size and where plasma or serum samples from which red blood
cells have been removed is used. This has now been thoroughly investigated at
our laboratories and should not have any negative implications for the
commercialisation of our stroke markers for the main market application, high
throughput diagnosis. Biosite still have not completed the testing process for
all our biomarkers for haemolysis against highly characterised stroke patient
samples and they continue to evaluate these in parallel to the wider stroke
trials that they will shortly commence.
Active discussions are ongoing with the major global diagnostic companies that
dominate the high throughput stroke field and further collaboration and licence
agreements are anticipated in the next six months.
Progress is being maintained in our research collaborations, on BSE with IDEXX
Laboratories Inc. to develop an ante-mortem blood test for screening live herds
of cattle and with the Medical Research Council Prion Unit to develop blood bank
screening of vCJD, the human form of 'mad cow disease'. We have been frustrated
by the delays and lack of availability of samples in the past but that process
has started to be resolved with samples now coming through the system. Both of
these opportunities present enormous untapped potential and we have focused our
research activities to bring assays to the market as quickly as possible.
Rapid advances have been made in our neurodegenerative research, in particular
Alzheimer's disease, where we have established a very strong position in less
than 12 months for both diagnostic and therapeutic applications. Two grants
were awarded in early 2004, one under the EU 6th Framework to address patient
response to drugs for depression and the other for the early detection of
Alzheimer's disease in blood and the discovery of new targets for therapy. It
is widely considered that a patient will have had Alzheimer's for ten to fifteen
years before there are any clinical symptoms and onset increases dramatically in
those over 65. No objective clinical assays currently exist. In March 2004 we
announced a panel of CSF (cerebrospinal fluid) biomarkers, followed in June by
the discovery of novel serum biomarkers for the early detection of the disease
to be developed into a diagnostic assay. In a separate programme we presented
the discovery of novel kinase activity in Alzheimer's in the USA in May as good
potential new drug targets to prevent and / or delay the progression of
Alzheimer's. These are major areas of unmet need and the process to select the
appropriate licencing partners to develop the diagnostic assays is well
underway.
ProteoSHOP(R)
Proteome Sciences ProteoSHOP(R) toolbox continues to be developed and impressive
new data and results supporting a range of applications was presented at the
bi-annual proteomics conference in Siena at the beginning of September. This is
the main global stage for new technology, developments and applications in
proteomics. No major new techniques / developments were presented which
threatened or undermined the position Proteome Sciences has established and we
were one of the few delegates who showed validated data for disease application.
Proteome Sciences and its collaborators had a considerable representation in
the proceedings with 13 major presentations / poster sessions covering biomarker
discovery through to chemical tags, including new biomarkers in CJD and stroke.
Four significant new areas of application of ProteoSHOP(R) have been identified
from which we are convinced that we can realise major economic value and for
which our technical capabilities are ideally suited :
• Toxicoproteomics - Early toxicity / mechanisms of toxicity
• Pharmacoproteomics - Drug efficacy and mode of action
• Responder Profiling - Responder vs Non Responder
• Drug Discovery - Drugs failed under development
• Drug Refurbishment - Compounds that have gone off patent
It is expected that an announcement will be made in the near future concerning
the first ProteoSHOP(R) commercial deal and we see ProteoSHOP(R) being involved
in strategic alliances in three main areas of application : biomarkers, target
validation and toxicoproteomics in 2005.
Reagents
Particular emphasis and details were given in the last Annual Report and
Accounts to the Sensitizer(R) family of reagents, where the size and range of
opportunities is considerably greater than was originally anticipated. One of
the principal areas addressed at the Siena meeting related to the requirement to
simplify and / or reduce the amount of 'information' being generated and to
improve the performance and quantitation of protein separation and
characterisation with mass spectrometry, bioinformatics, statistics and pattern
recognition. Chemical mass tagging for the purpose of isobaric and isomeric
tagging was identified as a key technology to advance this process. Until the
high profile presentations of PST(R), qPST(TM) and TMT(R) at Siena, the peer
leaders in proteomics may not have appreciated the extent to which Proteome
Sciences had already developed and applied chemical tagging and its core
proteomics technologies to such a broad range of applications. The showcase
at the Siena conference provided an ideal backcloth to demonstrate the
Sensitizer family and accelerate the commercialisation process. Advanced
negotiations are underway for several of the reagents and licence agreements are
expected to be concluded shortly.
Veri-Q
Strong progress has been made on the microarray programme between Duke
University and NCSU. Data and results generated confirm that many
oligonucleotides used to manufacture microarrays are not fully deprotected and
consequently have poor hybridisation on the 'spotted' arrays, leading to
inaccurate results. As EU approval was granted earlier this month to use a
microarray platform for in vitro diagnostics, this should lead to fast track
commercialisation of the Veri-Q technology by way of outlicencing.
Intronn
Intronn's main research effort is directed to its therapeutic pipelines,
building a franchise in RNA therapeutics for the liver in haemophilia,
hypercholesterolemia and AAT deficiency (alpha 1-antitrypsin), a well as
addressing substantial commercial opportunities in cancer and molecular imaging.
Proteome Sciences increased its shareholding in June 2004 to a fully diluted
level of approximately 40% (compared to its previous holding of 30%) through the
subscription of US$3.5m. This was financed through the issuance and placing of
1.85m shares in Proteome Sciences. As in the past, the Intronn shareholding
will be held as a strategic investment.
The recent funding should enable Intronn to finance its progress through to
clinical trials, by which time it intends to enter into partnering programmes,
where significant portions of clinical and commercial development, including
upfront payments and sponsored research collaborations, will be provided by
strategic partners.
The research at Intronn using SMaRT(R) continues to advance well, in particular
in relation to the RNA programmes for liver related disorders. Very encouraging
results have been generated from the high capacity screen developed at Intronn
last year which show considerable improvements in trans-splicing efficiency
compared with traditional PTMs (pre-trans-splicing). It has been particularly
encouraging to see that a number of leading academic groups at Cornell and Duke
have independently used and applied SMaRT(R) successfully across a broad range
of new applications and published scientific papers in the major journals,
thereby providing strong external validation for SMaRT(R) technology. Further
news on grant developments and scientific results is expected shortly.
Financial Results
The financial results for the six months to 30th June, 2004 show a Headline Loss
(being the operating loss excluding non-cash operating costs and share of
associate's losses) of £1,846,850 compared with £2,267,873 in the corresponding
period in 2003. Non-cash operating costs (amortisation of goodwill,
depreciation and National Insurance on notional share option gains, as extracted
from the profit and loss account) were £183,542 against £962,573 in 2003. The
period to 30th June, 2004 also contains a share of associates' losses at Intronn
Inc of £229,223 (30th June, 2003 : £352,096). The loss on ordinary activities
after taxation for the six months to 30th June, 2004 was £2,259,615 (30th June,
2003 : £3,582,542). Cash at 30th June, 2004 stood at £4.3m.
The 37% reduction in the loss on ordinary activities after taxation for the
sixth month period is in part a reflection of the tight financial control of the
business following the acquisition of the German activities and also the
movement in non-cash items. Additional cost savings will be made following the
move of our research facilities in Frankfurt which was completed last month.
The company is well funded and continues to have a low and predictable rate of
cash burn with no major capital expenditure envisaged for the foreseeable
future.
Future Prospects
The main focus at Proteome Sciences is the conversion of our scientific research
and intellectual property into revenue through licence deals and strategic
alliances. In the near term this will be generated from the three main parts of
the business:- proprietary biomarkers for diagnostic and therapeutic
applications, (high throughput stroke, blood transfusion screening, Alzheimer's
disease and cancer), ProteoSHOP(R) where we expect to enter into a number of
strategic alliances and from reagents where we expect to conclude licences for
several of the Sensitizer(R) family reagents. These should become increasingly
visible as we move into 2005 and should generate sustainable and growing revenue
and royalties. We remain confident about our future prospects.
R.S. Harris
Chairman 30th September, 2004
Unaudited consolidated profit and loss account
For the Six Months ended 30th June, 2004
Six months ended Six months Year
30th June ended ended
2004 30th June 31st December
2003 2003
£ £ £
Turnover - continuing operations
47,342 108,720 170,051
Cost of sales (35,879) (64,571) (82,924)
Gross profit 11,463 44,149 87,127
Administrative expenses excluding non-cash items (2,158,079) (2,345,831) (5,021,346)
Amortisation of goodwill (324,480) (324,480) (648,960)
Depreciation (288,319) (301,271) (585,234)
N.I. on notional share option gains 429,257) (336,822) (713,943)
Administrative expenses (2,341,621) (3,308,404) (6,969,483)
Operating loss - continuing operations (2,330,158) (3,264,255) (6,882,356)
Share of associate's operating loss (229,223) (352,096) (573,024)
Group operating loss - continuing operations (2,559,381) (3,616,351) (7,455,380)
Interest receivable 89,377) 37,369) 124,682)
Interest payable and similar charges (1,611) (3,560) (5,905)
Loss on ordinary activities before taxation (2,471,615) (3,582,542) (7,336,603)
Tax credit on loss on ordinary activities 212,000 - 555,444
Loss for the financial period (2,259,615) (3,582,542) (6,781,159)
Headline loss (1,846,850) (2,267,873) (4,259,998)
Loss per share
Headline loss per share (note 3c) (1.53p) (1.99p) (3.65p)
Basic and diluted loss per share (note 3a) (1.87p) (3.14p) (5.81p)
Unaudited consolidated balance sheet
As at 30th June, 2004
30th June 30th June
2004 2003
£ £
Fixed Assets
Goodwill 6,096,534 5,840,641
Tangible assets 833,760 1,280,729
Investments in associates 1,048,611 574,826
Other investments 225,756 225,756
8,204,661 7,921,952
Current Assets
Debtors 1,180,177 928,748
Cash held on deposit as short term investment 3,300,000 1,164,162
Cash at bank and in hand 1,007,280 6,749,536
5,487,457 8,842,446
Creditors : Amounts falling due within one year (1,636,057) (1,941,965)
Net current assets 3,851,400 6,900,481
Total assets less current liabilities 12,056,061 14,822,433
Creditors : Amounts falling due after more than one year (110,000) (110,000)
Provisions for liabilities and charges (301,625) (353,761)
Net assets 11,644,436 14,358,672
Capital and reserves
Called-up share capital 1,224,009 1,189,211
Share premium account 24,164,336 21,331,605
Other reserve 10,755,000 10,755,000
Profit and loss account (24,498,909) (18,917,144)
Equity shareholders' funds 11,644,436 14,358,672
Unaudited consolidated cash flow statement
For six months 30th June, 2004
Six Months Six Months
ended ended
30th June 2004 30th June 2003
£ £
Net cash outflow from operating activities (2,025,849) (2,192,225)
Returns on investments and servicing of finance 87,766 33,809
Capital expenditure and financial investment (2,015,138) (11,904)
Cash outflow before use of liquid resources and financing (3,953,221) (2,170,320)
Management of liquid resources 1,495,161 2,185,093
Financing 2,100,117 5,828,268
(Decrease) / Increase in cash in the period (357,943) 5,843,041
Reconciliation of operating loss to operating cash flows
2004 2003
£ £
Operating loss (2,330,158) (3,264,255)
Depreciation charges 288,319 301,271
Amortisation charges 324,480 324,480
National Insurance on notional share option gains (429,257) 336,822
Loss on sale of tangible fixed assets 2,816 -)
Decrease / (increase) in debtors 194,352 (196,496)
(Decrease) / increase in creditors (76,401) 305,953
Net cash outflow from operating activities (2,025,849) (2,192,225)
Notes to the Financial Information
1. There has been no change to any of the accounting policies set out in
the 2003 statutory accounts.
2. Following the loss of £2,259,615 incurred in the period, the
Directors do not recommend the payment of a dividend.
3. a. The calculation of the loss per share for the six months
ended 30th June 2004 is based on the loss for the financial period of £2,259,615
and on 120,826,460 Ordinary Shares, being the weighted average number of shares
in issue and ranking for dividend during the period (six months ended 30th June
2003- loss £3,582,542, number of Ordinary Shares in issue and ranking for
dividend, 114,248,076).
b. The calculation of the loss per share for the year ended 31st
December 2003 is based on the loss for the year of £6,781,159 and on 116,739,021
Ordinary Shares, being the weighted average number of shares in issue and
ranking for dividend during the year.
c. The losses used to calculate the headline loss per share are as
follows :
Six Months Six Months Year
ended Ended Ended
30th June, 2004 30th June, 2003 31st December, 2003
£ £ £
Loss for the Financial Period (2,259,615) (3,582,542) (6,781,159)
Deduct / (Add)
Amortisation of Goodwill 324,480 324,480 648,960
Depreciation 288,319 301,271 585,234
National Insurance on Notional
Share Option Gains (429,257) 336,822 713,943
Share of Associate's Operating Loss 229,223 352,096 573,024
Headline Loss (1,846,850) (2,267,873) (4,259,998)
The Headline Loss per share is considered by the Directors to be a more
meaningful measurement of financial performance than the basic loss per share as
it excludes goodwill amortisation and other non-cash items and better reflects
the cash outflow of the business.
4. The preceding financial information does not constitute statutory
accounts as defined in Section 240 of the Companies Act 1985. The financial
information for the year to 31st December 2003 is based on the statutory
accounts for that year. Those accounts, upon which the auditors issued an
unqualified opinion, and which did not contain any statement under Section 237
(2) or (3) of the Companies Act 1985, have been delivered to the Registrar of
Companies.
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