TIDMPRM
RNS Number : 7560U
Proteome Sciences PLC
02 April 2019
Prior to publication, the information contained within this
announcement was deemed by the Company to constitute inside
information as stipulated under the Market Abuse Regulations (EU)
No. 596/2014 ("MAR"). With the publication of this announcement,
this information is now considered to be in the public domain.
02 April 2019
Proteome Sciences plc
("Proteome Sciences" or the "Company")
Results for the year ended 31 December 2018
and Notice of AGM
The Company is pleased to announce its audited results for the
year ended 31 December 2018.
Highlights:
-- Total revenues of GBP3.05m (FY17: GBP3.38m)
-- Proteomic (biomarker) services revenues of GBP0.75m (FY17: 0.79m)
-- TMT(R) sales and royalties of GBP2.10m (FY17: GBP1.90m) excluding exceptional payments
-- Total costs of GBP4.71m (FY17: GBP5.43m); administrative expenses reduced by 19.2%
-- Loss after tax of GBP1.31m (FY17: GBP2.50m)
-- Cash reserves at 31 December 2018 of GBP0.96m (FY17:GBP0.91m)
-- Extended exclusive TMT(R) licence agreement with Thermo
Scientific to include higher-plex tags
-- Introduced 'Super Depletion' work flow, transforming plasma protein quantification
-- Grew services business quarter by quarter, winning 30 new projects
-- Resolved R&D tax credit claims from previous years with HMRC
Post year-end:
-- Completed synthesis of higher-plex TMT(R) tags ahead of 2019 launch
-- Licensed GST-P stroke biomarker to Galaxy CCRO Inc., a US
start up developing a point of care test for the diagnosis and
timing of stroke onset
Jeremy Haigh, Chief Executive Officer of Proteome Sciences plc,
commented:
"Our clear focus in 2018 was to establish a sustainable
proteomics services platform, capitalising on the fiscal
reliability of our TMT(R) reagent business and the operational
clarity of a restructured organisation. Despite a much slower start
to the year than anticipated, we made significant progress with our
service proposition, demonstrating quarter on quarter growth in
work orders and recognised revenues, an expanding customer base and
receiving positive feedback among 30 projects initiated during the
year. With the near-term availability of higher-plex TMT(R) set to
add significant value to this asset, and the utility of
quantitative proteomics increasing in response to diagnostic
advances and disruptive technologies such as machine learning,
there is good reason to be optimistic about the future. Moreover,
the reliance on new operating models and external partnerships in
bioscience affords us an important commercial opportunity providing
that our service platform remains competitive.
After the efforts made last year, I am pleased to report that
2019 has started positively with an improving services business and
continuing growth from TMT(R) . We look forward to translating such
progress into shareholder value, and to providing further updates,
during the year."
Report and Accounts and Notice of AGM:
Copies of the Annual Report and Accounts together with notice of
the Annual General Meeting ("AGM") will be posted to shareholders
by 03 April 2019 and made available on the Company's website
(www.proteomics.com) by then. The AGM will be held at the offices
of Allenby Capital, 5 St Helen's Place, London, EC3A 6AB on 30
April 2019 at 2.30pm.
For further information please contact:
Proteome Sciences plc
Dr Jeremy Haigh, Chief Executive Officer Tel: +44 (0)20 7043 2116
Dr Ian Pike, Chief Scientific Officer
Richard Dennis, Chief Commercial Officer
Allenby Capital Limited (Nominated Adviser & Broker)
John Depasquale / Jeremy Porter Tel: +44 (0) 20 3328 5656
About Proteome Sciences plc. (www.proteomics.com)
Proteome Sciences plc is a specialist provider of contract
proteomics services to enable drug discovery, development and
biomarker identification, and employs proprietary workflows for the
optimum analysis of tissues, cells and body fluids. SysQuant(R) and
TMT(R) MS2 are unbiased methods for identifying and contextualising
new targets and defining mechanisms of biological activity, while
analysis using Super-Depletion and TMTcalibrator(TM) provides
access to over 8,500 circulating plasma proteins for the discovery
of disease-related biomarkers. Targeted assay development using
mass spectrometry delivers high sensitivity, interference-free
biomarker analyses in situations where standard ELISA assays are
not available.
The Company has its headquarters in London, UK, with laboratory
facilities in Frankfurt, Germany.
Chief Executive Officer's Statement
At the end of a year marked by political uncertainty and
economic restraint, both of which adversely affected the
biopharmaceutical sector in the second half, I can report a steady
12 months ending 31 December 2018. Revenues for the full year
decreased by 9.8% to GBP3.05m. Year on year sales and royalties
attributable to isobaric tandem mass tag (TMT(R) ) reagents grew
10.2% to GBP2.10m, excluding contributions from a significant
milestone payment late in 2017 and a research collaboration during
2018. Proteomics (biomarker) services decreased 5.5% to GBP0.75m
and were below expectations as the result of a slow first half to
the year. Total costs of GBP4.71m were 13.3% lower reflecting the
ongoing impact of restructuring and cost containment performed in
recent years, and losses after tax were significantly reduced to
GBP1.31m. Cash reserves at the year-end were GBP0.96m, similar to
the previous year, benefitting from the timely resolution of
R&D tax credit payments for both 2016 and 2017, and from
drawing down a share of the GBP1.00m loan facility made available
by Vulpes Investment Management in July 2018.
Services
Our clear focus in 2018 was to build a sustainable proteomics
(biomarker) services business. Conscious that much needed to be
done to establish our place as a preferred provider, particularly
in an environment favouring companies with broader technology
platforms than our own, progress was slower than we had hoped.
Revenues from a strengthening order book carried through from 2017
took longer to realise than anticipated, resulting in a weak first
half performance and negatively affecting our full year results
which were also materially reduced by the decision of Genting TauRx
Diagnostic Centre to discontinue a potentially valuable biomarker
assay development project in Alzheimer's disease (AD).
As predicted, the fourth quarter was the strongest for our
proteomics services, during which we recognised about 40% of the
annual service revenues and generated work orders to the value of
GBP0.25m. Momentum is certainly developing and, although it could
not make up for the disappointingly slow adoption of our services
platform at the start of the year, we remain encouraged by recent
progress, by the number and diversity of more than 30 new projects
which we won during 2018, and by the value of 14 work orders
contributing to a positive start in 2019. Just as importantly,
feedback from many of our customers has endorsed the inherent value
that can be realised from our proprietary proteomics workflows. Our
intention is to convert these projects into reliable, follow-on
business at greater scale, and to improve our operational
efficiency so that revenues can be generated more quickly from
committed work orders; we continue to reshape and consolidate the
business to achieve this.
A sales agent model was introduced in Europe at the start of
2018, akin to that initiated in the US during 2017. Cenibra GmbH
signed a contract covering German speaking countries and quickly
broadened our client base, allowing us to complete the transition
from direct sales staff in our primary commercial territories and
expand our sales activities without relinquishing cost control.
Although our original US agent has since been withdrawn, this was
not a reflection of the operating model which we continue to
believe offers the most efficient approach to commercialising our
services business.
As the proteomics market expands, and with it interest in using
unbiased methods to measure large numbers of proteins in biological
samples, our mass spectrometric (MS)-based techniques and workflows
continue to attract attention as a logical precursor to the
development of targeted assays. Extending our service offering, for
example by introducing new workflows such as Super Depletion, will
of course be fundamental to the future of this business. Good
Clinical Laboratory Practice (GCLP) accreditation has been an
important driver of increasing project interest, and
re-accreditation (now valid for 2 years) was completed in November
without major findings. Our annual ISO (International Organisation
for Standardisation) 9001:2015 certificate was also reissued
earlier in the year, confirming our commitment to quality
standards.
Promotional activities have increased despite a limited budget,
with attendance at many exhibitions in our primary markets of the
US and Europe as well as high volumes of customer calls leading to
requests for quotations. Currently, our customer base is
predominantly small and medium sized enterprises (SMEs) but we have
started engaging larger biopharmaceutical companies in discussion
and expect that this will translate into more substantial work
orders and preferred provider agreements of the sort recently
established with e-therapeutics plc. Converting such interest into
formal projects, and then efficiently into recognised revenues,
remains our primary objective and we are employing standard metrics
of service delivery to monitor and improve throughput. Importantly,
we retain the capacity to increase our workload by increasing our
existing MS utilisation rates without the need for significant
additional capital investment in our Frankfurt laboratory.
Licences
An amendment to our exclusive License and Distribution Agreement
with Pierce Biotechnology Inc. (a division of Thermo Fisher
Scientific Inc.) announced in April extended the current licence to
include intellectual property (IP) relating to a new class of
higher-plex TMT(R) reagents currently in development and on
schedule for launch in 2019. Such higher-plex technology represents
the next phase in the evolution of isobaric tagging, which will
enable further advances in the efficiency and utility of MS protein
analyses and has been a long-standing objective for both companies
in response to a clear customer need. Through this extension of our
exclusive relationship we see the potential to expand further a
market in which we are already dominant, with TMT(R) the
established standard for multiplex, quantitative proteomic
experiments. In addition to completing synthesis of these
higher-plex tags early in 2019, significant resources were directed
towards restocking our 10-plex supplies which should now provide
for anticipated commercial needs until late 2020.
TMT(R) sales and royalties remained predictably strong during
the year. There was continued growth of 20% in Thermo Scientific's
core market; however, this only translated into approximately 10%
growth in our underlying business, in part a consequence of
unfavourable exchange rates. This was insufficient to replace fully
the substantial milestone payment we received from Thermo
Scientific late last year resulting in a 11% reduction in our
overall TMT(R) -associated revenues. While a change in the ordering
pattern for stock reagents to support more flexible TMT(R) kit
manufacture may have led to somewhat slower growth in the early
months of the year, there is also some suggestion that orders in
the second half may have been delayed awaiting the availability of
higher-plex tags in 2019.
The Company is pleased to report that during the fourth quarter
Randox initiated the clinical validation study required for CE
(Conformité Européene) marked approval of its stroke diagnostic
array (based in part on the Company's IP) and anticipates good
progress in the coming months. Timelines for this trial have not
been provided by Randox, as sponsor, although completion should not
be expected until 2020. In addition, I am pleased that a further
non-exclusive licence to the Company's GST-P stroke biomarker IP
was concluded in January 2019 with Galaxy CCRO Inc. ("Galaxy"), a
recently formed US clinical contract research organisation, which
intends to develop a point of care test for the diagnosis and
timing of stroke onset in order to guide the use of specialist
thrombolytic treatment. Under the terms of the licence the Company
will receive equity in Galaxy as an initial fee, with subsequent
development milestones and a running royalty on any product sales.
Although the ultimate value of this licence is wholly dependent on
the performance of Galaxy, this deal demonstrates again the value
that may reside in our IP portfolio as we continue to seek future
collaborators and partners.
Research
Research investments were again limited to those directly
relevant to our commercial services. We chose to focus on
productivity improvements to our principal proteomics workflows,
the development of the clusterin blood test for neurodegeneration
and, particularly, the introduction of high-performance plasma
proteomics. The latter was in partnership with Pliant Therapeutics,
Inc., one of our customers, with whom we presented data at the
American Thoracic Society meeting in May. This was the first report
of our new Super Depletion method for abundant plasma proteins
combined with TMTcalibrator(TM) where we were able to quantify over
8,000 proteins and identify potential new biomarkers for idiopathic
pulmonary fibrosis (IPF). Super Depletion has subsequently become
an important and frequently requested element of our service
offering, demonstrating again the continuing importance of basic
research activities to ensure that we can refresh and update our
range of services.
Characterisation of the Clusterin Glycoform Assay has been
completed and provides early assessment of the level of brain
damage in neurodegeneration. We have developed a new quantitative
method to allow its use in assessing patients prior to their
enrolment in, and during, clinical trials. We will be evaluating
its final performance shortly and aim to launch it as our first
clinical-grade test under the GCLP certification. A tryptophan
metabolite assay is also scheduled for launch during 2019.
Among our publications in 2018 was the report of a collaboration
with the University of Eastern Finland, combining our SysQuant(R)
protein and phosphopeptide analysis with transcriptomics in order
to stage AD pathology. This has the potential to be a landmark
publication and we will maximise its value for commercial
activities.
Operating Environment
The positive environment created by US tax cuts at the start of
the year, encouraging sector-wide investment in several areas
important to us such as immuno-oncology, precision medicine and
digital health, quickly gave way to pre-Brexit speculation and
general market weakness following a series of high-profile clinical
stage failures. The resulting risk-averse environment significantly
slowed collaborative activities which, although having little
direct effect on our trading, forced many companies to focus
internally and retain strong cost containment measures. For our
part we continued a policy of cost reduction established in the
previous year by choosing not to replace staff who left the Company
through retirement and resignation, and recently removing two
further roles from the organisation. These reductions have:
-- minimised internal resources deployed in maintaining our IP
portfolio, which we continue to support but have narrowed in line
with our budget;
-- increased cross functional efficiencies by fundamentally
changing our approach to project management and leadership; and
-- enabled us to complete the transition to a sales agent model
in central Europe which is our preferred route to
commercialisation.
Costs were reduced as anticipated, with significant full year
savings from Company restructuring being partially offset by
investment in the development of our new, higher-plex TMT(R) tags.
These containment efforts will continue into 2019 in the full
expectation that we can further improve our organisational
efficiency.
Uncertainties surrounding the eligibility of our commercial
projects for R&D tax credits have been resolved after a
prolonged period of discussion with HMRC and claims for years
2016-17 have now been settled. As such, and to ensure that
prospective credit claims are positively received, the Company will
take forward its 2018 claim during 2019. We are grateful to Vulpes
Investment Management for showing confidence in our service
proposition to provide a loan facility of GBP1.00m, giving us some
additional working capital to start investing in a sustainable
services business.
Volatility in foreign exchanges during the year affected
non-sterling denominated revenues as well as costs associated with
the Frankfurt laboratory, but the overall effect on EBITDA was
neutral.
Like many other small organisations, implementation of the
General Data Protection Regulation (GDPR) 2016/679 in May created a
disproportionate workload but, as a result, our data protection
activities have been fully reviewed both internally and externally
to ensure we remain compliant. Updated policies for Social Media,
Data Protection and Anti-bribery, released throughout the
organisation, address the minimum requirements for a listed
company.
I was pleased to welcome Richard Dennis, our Chief Commercial
Officer, to the Board in April, and Allenby Capital as our broker
and AIM nominated adviser in December. I also want to thank our
customers for their valuable business and all the staff who worked
for Proteome Sciences during 2018, including those who have since
left the Company; our continued development as an organisation is a
direct consequence of their individual and collective efforts.
Outlook
The global proteomics market has been estimated at more than $35
billion by 2021, driven by factors such as the increasing
importance of companion diagnostics and precision medicine,
advances in digital health and rising R&D expenditure. Although
only a small proportion of this market is specifically directed
towards MS-based protein analysis, an opportunity clearly exists in
the post-genomic era to develop a successful services business if
the growing needs of biopharmaceutical customers can be addressed
predictably and efficiently. In particular, interest in adaptive
artificial intelligence (AI)-driven healthcare solutions could
become fundamental to the value of this proteomics market as the
success of such disruptive approaches will increasingly rely on the
provision and linkage of new data sets from novel technology
platforms and services such as our own.
We continue to broaden our range of services and are optimistic
that these, combined with a commitment to reliability, cost and
quality, will allow us to develop our presence in this important
and expanding market (particularly as the legitimate provision of
TMT(R) -based services in association with GCLP accreditation is
rare among our contract research competitors). Further investment
is vital, however, if we are to compete successfully and win
business, not just for the development of new assays and workflows,
but also for marketing campaigns, sales resources and website
development. Financial strength remains an important feature of any
vendor assessment process and will need to be carefully monitored
if we want to grow our business with larger companies involved in
clinical stage assets. The demand for our TMT(R) reagents remains
strong, providing reliable revenues, and we are confident that the
launch of higher-plex tags later in 2019 will further grow the
overall market for MS-based quantitative proteomics and
specifically for isobaric tags at
the expense of label-free methods.
In a year with more recognised unknowns than previously, it is
likely that volatility in the markets, political instability and
weakness in the bioscience sector carried over from 2018 will
continue to undermine investment. That being said, some
high-profile acquisitions by large pharmaceutical companies at the
start of this year suggested a strategic change at corporate level
after a quiet 2018 with renewed interest in consolidating
technologies and integrating services. The importance of new
partnerships and operating models as a means of accessing external
expertise and technology has never been greater in bioscience and
remains an active area of interest for us as we look to broaden our
service platform.
I would like to thank our shareholders for their continuing
support and patience, and look forward to communicating further
progress and meaningful revenue growth during 2019.
Jeremy Haigh
Chief Executive Officer
1 April 2019
Strategic Report
Review of the Business
The principal activities of the Group involve protein biomarker
research and development. As a leader in applied proteomics we use
high sensitivity proprietary techniques to detect and characterise
differentially expressed proteins in biological samples for
diagnostic, prognostic and therapeutic applications. In addition,
we invented and developed the technology for TMT(R) , and
manufacture these small, protein-reactive chemical reagents under
exclusive license to Thermo Scientific for multiplex quantitative
proteomics.
Proteome Sciences is a leading provider of contract research
services for the identification, validation and application of
protein biomarkers. Our clients are predominantly pharmaceutical
companies, but we also perform services for other sectors including
academic research. While we have several well-established workflows
that meet the needs of many customers, we retain our science-led
business focus wherever possible, developing new analytical methods
and data analysis tools to provide greater flexibility in the types
of studies we can deliver. Our contract service offering remains
centred on MS-based proteomics, and this is becoming more widely
implemented in drug development projects as the pharmaceutical
industry seeks to expand biological knowledge beyond genomics.
These services are fully aligned with the drug development process,
can be used in support of clinical trials and in vitro diagnostics,
and include proprietary bioinformatics capabilities.
Progress During 2018
Building a Competitive Services Business
The prevailing biopharmaceutical sector strategy to outsource
analytical needs rather than purchase the technology and personnel
to perform work in-house affords us a significant opportunity. In
addition, many smaller, virtual organisations are being created
from the site closures of larger companies and rely solely on
outsourced research and analysis. As MS can identify many more
proteins and post translational modifications (PTMs) than detected
with other laboratory-based technologies (e.g. ELISA), the quest to
find protein biomarkers which are predictive for disease status or
drug activity provides a clear focus for our sales and marketing
effort.
The US and Europe account for up to 80% of the total available
market in the field of proteomics and our current commercial
activities have therefore been directed towards these territories.
The use of the web, direct marketing programmes,
attendance/presentations at scientific conferences and, most
importantly, sales prospecting have all generated suitable leads
for business follow up and increased the number of quotes we issued
in 2018 to 57, more than a threefold increase on the previous year.
Commission-based agents and direct sales activity provide valuable
face-to-face connection with potential customers, and this
personalised approach allows us to demonstrate our high level of
technical competence which is essential in order to win contracts
for larger proteomic studies in both pre-clinical and ongoing
clinical trials.
Our ambition is to sell a high value analytical contract through
which we work with a client to establish their research needs,
develop a specific protocol to address them, and then process
samples they send us on a fee for service basis. Collaborations
usually start with a pre-clinical project to identify suitable
protein biomarkers which, in the absence of a suitable
antibody-based assay, drives an MS-based biomarker validation
project leading to the development of a targeted assay for use in
on-going clinical trials. More than half of our clients initiate a
pilot study that leads into either a larger protein discovery
project or a more valuable protein-based assay validation before
adopting the assay as part of a clinical trial, potentially
involving much larger sample numbers than in the initial protein
discovery phase.
Many smaller service-based companies offer MS capabilities to
this market, but very few retain the product licence required to
support TMT(R) -based commercial services. Using our superior
knowledge of TMT(R) , with a combination of Super Depletion and our
proprietary TMTcalibrator(TM), has enabled our services to quantify
sample protein numbers that are unachievable with other methods.
For the customer, this increases the chances that a protein-based
biomarker relevant to disease progression or drug treatment can be
identified. Such biomarkers are increasingly important in a
clinical programme, or for use as a companion diagnostic, and we
plan to promote this approach heavily in the future.
The Opportunity of Artificial Intelligence
There can be no doubt that advances in AI, or more specifically
machine learning, have the potential to revolutionise healthcare
provision and the efficiency of drug discovery and development.
Fundamental to the creation and validation of predictive algorithms
are the provision of high quality, well curated data, the
establishment of durable collaborations between digital health
companies and data generators, and the availability of data
scientists and bioinformaticians who are equipped to aggregate
disparate data sets and identify patterns which will generate
biological insights. MS proteomics is ideally placed for this
revolution, which therefore offers us a distinct opportunity to
address a new customer segment with our service platform. Rather
than being seen conventionally as just an extension of genomics,
protein analytics can become part of a solution through which the
growing ranks of AI companies can prove the utility of their
approach. We believe that the next phase of disruptive technology
in biopharmaceuticals is most likely to come from AI-driven
analysis of high quality, 'big data' proteomics.
The Rebirth of Plasma Proteomics - TMTcalibrator(TM) and Super
Depletion
Blood is one of the most commonly sampled body fluids, used
widely in diagnosing and monitoring disease. Unfortunately, the
presence of a few high-abundance proteins in large volumes of
circulating fluid makes new biomarker discovery particularly
challenging. We have been working to overcome these difficulties,
and thereby transform plasma proteomics, by combining extensive
protein depletion, TMT(R) labelling and tissue triggering.
At the American Thoracic Society in May, we presented results
from a study performed for Pliant Therapeutics Inc. that was the
first to combine our TMTcalibrator(TM) workflow with Super
Depletion - the removal of about 70 higher abundant proteins in
plasma. Remarkably, we could quantify a total of over 8,000
proteins in each sample, with 5,600 being quantified in all 30
patient samples studied. Previously, we would have expected protein
numbers in the region of 800 - 1,000. Such a significant increase
was further enhanced by new computational approaches that allowed
us to identify many PTM proteins which had direct relevance to lung
disease. Based on these results, a panel of 36 proteins that
differentiated diseased patients from healthy controls was
identified which may offer clinicians a better tool for diagnosing
lung disease and monitoring the effects of treatment.
The twin advantages of TMTcalibrator(TM) and Super Depletion in
increasing the number of disease-associated proteins detected in
body fluids are being recognised by our clients. We are actively
engaged in a number of these projects, supporting a range of
pre-clinical and clinical studies that should provide strong
revenues in 2019.
Targeting Clusterin
One of our earliest biomarker discoveries was the changed level
of plasma clusterin protein in patients with AD. While this has
become a promising biomarker candidate, there have been widely
conflicting reports describing clusterin level changes in AD
patients. We set out to explain how plasma clusterin could be
subject to such extreme differences and identified the extensive
modification of the protein by glycosylation (i.e. adding complex
sugar structures) as a likely reason. In particular, we identified
one site on the protein where eight different sugar structures were
being added, with levels that varied in patients with AD and,
importantly, which could distinguish rapidly progressing AD cases
from slower progressing disease or mild cognitive impairment
(MCI).
However, the methods used in our discovery experiments could not
be employed for screening thousands of individuals, so we had to
develop a simpler way to measure these eight different clusterin
glycoforms. Using well-established Selection Reaction Monitoring
(SRM) MS we have now developed the first test capable of routinely
measuring the levels of all eight clusterin glycoforms and are
setting up a validation study to replicate our initial discovery
and support the launch of the Clusterin Glycoform SRM Assay later
this year. In line with the development of other targeted
therapeutics, screening patients for their clusterin glycoform
levels prior to enrolment in clinical trials is likely to define a
better population for demonstrating drug efficacy.
Expanding the TMT(R) Product Portfolio
TMT(R) is now widely recognised as delivering the best
combination of quantitative accuracy and depth of proteome coverage
required by modern proteomics researchers. In a recent publication
from Harvard University, TMT(R) experiments were found to be
substantially better than label-free quantification in detecting
regulated proteins and this benefit was strongest for peptides
showing small changes in expression between samples. This advantage
was mostly explained by the ability to include many samples in a
single TMT(R) experiment where overall sensitivity is boosted and
there are fewer missing data points.
Other initiatives, such as our TMTcalibrator(TM) workflow and
Super Depletion (see above), are transforming the level of
sensitivity that can be achieved, and even being adopted with some
success to analyse samples of just a few cells. However, the need
to use several of the TMT(R) channels for the tissue trigger
reduces the number of individual samples that can be studied.
In response to this challenge, we have been working to increase
the number of tags in our TMT(R) reagent sets and have now
completed the production of a second-generation product. These new
TMT(R) reagents have 16 different channels providing a 60% increase
in sample multiplexing over the current TMT(R) 10plex reagents
(i.e. for standard workflows, analysis of 90 samples can be
achieved in only six sets of experiments compared with 10 sets
using standard TMT(R) ). For TMTcalibrator(TM) studies, the
opportunity to analyse 12 individual samples with a four-point
calibration curve or tissue trigger makes population-based studies
of plasma biomarkers viable for the first time.
Patent Applications and Proprietary Rights
Given ongoing cost containment and the changing focus of the
Company we continue to manage our portfolio of patents aggressively
to maximise its short, medium and longer-term value. In the fourth
quarter we undertook a strategic review of our patent portfolio and
will focus our investment in 22 families that cover our key
licensed technologies (TMT(R) , stroke biomarkers) and biomarkers
under development (AD, oncology). Seven patents were granted in
2018 relating to five separate families. We filed 16 new patents
relating to three families covering tryptophan metabolite assays
and TMT(R) tags.
Board Changes
On 24 April 2018 the Company announced that Mr Richard Dennis,
Chief Commercial Officer, had been appointed as an executive
director. Mr Dennis has over 30 years' experience in the sector and
prior to joining Proteome Sciences had held positions of increasing
responsibility and diversity in companies such as Quanterix Corp.
and Bioscale Inc.
Financial Review
Results and Dividends
The loss after tax for the year was GBP1.31m (2017: GBP2.50m).
The directors do not recommend the payment of a dividend (2017:
Nil). The Group results are stated in the Consolidated Income
Statement and reviewed in the Chief Executive Officer's
Statement.
Key Performance Indicators (KPI's)
(i) The directors consider that revenue and loss before/after
tax are important in measuring Group performance. The profile of
the Group has changed as a result of ongoing licensing agreements
and with the adoption/conclusion of other commercial agreements and
service contracts. The performance of the Group is set out in the
Chief Executive Officer's Statement.
(ii) The directors believe that the Group's rate of cash
expenditure and its effect on Group cash resources are important.
Net cash outflows from operating activities for FY2018 were
GBP0.50m (2017: GBP1.70m). Further details of cash flows in 2018
are set out in the Group's Consolidated Cash Flow Statement.
(iii) In a small business with a high proportion of
well-qualified and experienced staff, the rate of staff turnover is
vital. In FY2018 two members of staff resigned, and one retired.
These individuals were not replaced as a cost containment measure
and their responsibilities were redistributed within the
organisation. In addition, strategic decisions were made to remove
three unique roles from the business resulting in the redundancy of
three members of staff, two of whom only left in January 2019.
(iv) As a commercially oriented service-based business, contract
revenues from our proteomics (biomarker) services should increase
in absolute terms and as a proportion of total Group revenues; this
was not the case in 2018 (GBP0.75m; 25% vs GBP0.79m; 23% in 2017)
as it took longer than anticipated to recognise revenues from new
service orders, and total revenues were also down. Repeat business
always provides an important measure of customer satisfaction,
although in an expanding company it is arguable whether this metric
should necessarily be increasing: in 2018, 44% of our contracts
(56% by value) were from existing clients compared with 50% (42% by
value) in 2017.
(v) As the Company transitions to a primary contract research
business, conventional service-based metrics reflect our focus on
the time, cost and predictability of data delivery. We measure and
review customer response times from initial contact through to
generation of a final report and invoice, comparing these times
with our internal standards and to the delivery times provided in
final client proposals. For example, in 2018 our ambition was for
potential customers to receive formal statements of work from us
within 5 days of engagement, and our annual conversion rate into
fully executed projects was 66%.
Financial Performance
For the twelve-month period ending 31 December 2018 revenue
decreased 9.8% to GBP3.05m (2017: GBP3.38m).
-- Licences, sales and services revenue declined 12.4% to
GBP2.96m (2017: GBP3.38m). This is comprised of two revenue
streams: TMT(R) related revenue and Proteomic (Biomarker) Services.
Although core sales and royalties for TMT(R) tags increased by
10.2% to GBP2.10m, total TMT(R) related revenue actually decreased
by 11.1% (2017: GBP2.48m) because a significant milestone payment
in late 2017 from our exclusive distribution partner Thermo
Scientific could not be fully replaced through market growth and
research collaboration.
-- Grant income was GBP0.09m (2017: Nil).
The loss after tax was GBP1.31m (2017: GBP2.50m).
Taxation
Owing to the changing nature of our services business, with a
stronger focus on commercial activities, we have not fully assessed
our available R&D tax credit for 2018, and such amounts are
only recognised when reasonably assured.
Costs and Available Cash
The Group maintained a positive cash balance in 2018 and
continues to seek improved cash flows from commercial income
streams. Our operating costs have been significantly reduced.
-- Administrative expenses in 2018 were GBP3.24m (2017:
GBP4.01m). This is a decrease of 19.2%, representing full year cost
savings following the relocation of the UK Laboratory in 2017, and
further consolidation and restructuring during the year.
-- Staff costs for the year were GBP2.25m (2017: GBP2.54m).
-- Property costs of GBP0.32m were in line with previous years.
-- Other overheads decreased by GBP0.23m as a result of cost
containment initiatives driven by a review of patent
obligations.
-- Finance costs arise as a result of interest due on loans from
two major investors in the Company. Costs of GBP0.29m are
marginally higher than the prior year.
-- Loss after tax for 2018 was GBP1.31m (2017: GBP2.50m). The
net cash outflow from operating activities was GBP0.50m (2017:
GBP1.70m). Cash at the year-end was GBP0.96m (2017: GBP0.91m).
By order of the Board
Hamilton House
Mabledon Place
London WC1H 9BB
V Birse
Company Secretary
1 April 2019
Consolidated income statement
For the year ended 31 December 2018
Note Year ended Year ended
31 December 31 December
2018 2017
GBP'000
Revenue
Licences, sales and services 2,958 3,378
Grant services - 91 ___ -__2
Revenue- total 3,049 3,380
Cost of sales (1,180) (1,180)
_______ _______
Gross profit 1,869 2,200
Administrative expenses (3,239) (4,008)
_______ _______
Operating loss (1,370) (1,808)
Finance income - 1
Finance costs (289) (246)
_______ _______
Loss before taxation (1,659) (2,053)
Tax 346 (444)
_______ _______
Loss for the period attributable
to shareholders of the Company (1,313) (2,497)
_______ _______
Loss per share
Basic and diluted 3 (0.44p) (0.85p)
_______ _______
Consolidated statement of comprehensive income
For the year ended 31 December 2018
Year ended Year ended
31 December 31
2018 December
2017
GBP'000 GBP'000
Loss for the year (1,313) (2,497)
___ --___ _______
Other comprehensive income
for the year
Exchange differences on translation
of foreign operations 24 37
__________ __________
Loss and total comprehensive expense
for the year (1,289) (2,460)
__________ __________
Consolidated balance sheet
As at 31 December 2018
2018 2017
GBP'000 GBP'000
Non-current assets
Goodwill 4,218 4,218
Property, plant and equipment 56 281
_________ _________
4,274 4,499
__________ __________
Current assets
Inventories 1,147 946
Trade and other receivables 320 1,124
Contract assets 328
Cash and cash equivalents 958 908
__________ __________
2,753 2,978
__________ __________
Total assets 7,027 7,477
__________ __________
Current liabilities
Trade and other payables (541) (726)
Contract liabilities (25) -
Borrowings (9,936) (8,946)
__________ __________
(10,502) (9,672)
__________ __________
Net current liabilities (7,749) (6,694)
__________ __________
Non-current liabilities
Provisions (343) (363)
(343) (363)
__________ __________
Total liabilities (10,845) (10,035)
__________ __________
Net liabilities (3,818) (2,558)
__________ __________
Equity
Share capital 2,952 2,952
Share premium account 51,466 51,466
Share-based payment reserve 3,532 3,503
Merger reserve 10,755 10,755
Translation reserve (43) (67)
Retained loss (72,480) (71,167)
__________ __________
Total equity (deficit) (3,818) (2,558)
__________ __________
Consolidated statement of changes in equity
For the year ended 31 December 2018
Share Share Equity
Share premium based attributable Total
capital account payment Translation Merger Retained to owners (deficit)
reserve reserve reserve loss of the
parent
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January
2017 2,943 51,451 3,436 (104) 10,755 (68,670) (189) (189)
Loss for the
year - - - - - (2,497) (2,497) (2,497)
Exchange
differences
on
translation
of foreign
operations - - - 37 - - 37 37
Total
comprehensive
income for
the
year - - - 37 - - (2,460) (2,460)
--------------- ----------- ------------ ----------- ------------- ------------ ------------ ------------- -----------
Issue of share
capital 9 15 - - - - 24 24
Share issue
expenses - - - - - - - -
Credit to
equity
for
share-based
payment - - 67 - - - 67 67
__________ ___________ __________ ________ ___________ ___________ ___________ __________
At 31 December
2017 2,952 51,466 3,503 (67) 10,755 (71,167) (2,558) (2,558)
__________ ___________ __________ _______ _ ___________ ________ ________ __________
___ ___
Consolidated statement of changes in equity
For the year ended 31 December 2018
Share Share Equity
Share premium based attributable Total
capital account payment Translation Merger Retained to owners (deficit)
reserve reserve reserve loss of the
parent
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January
2018 2,952 51,466 3,503 (67) 10,755 (71,167) (2,558) (2,558)
Loss for the
year - - - - - (1,313) (1,313) (1,313)
Exchange
differences
on
translation
of foreign
operations - - - 24 - - 24 24
--------------- ----------- ------------ ----------- ------------- ------------ ------------ ------------- -----------
Total
comprehensive
income for
the
year - - - 24 - (1,313) (1,289) (1,289)
--------------- ----------- ------------ ----------- ------------- ------------ ------------ ------------- -----------
Issue of share
capital
Share issue
expenses - - - - - - - -
Credit to
equity
for
share-based
payment - - 29 - - - 29 29
__________ ___________ __________ ________ ___________ ___________ ___________ __________
At 31 December
2018 2,952 51,466 3,532 (43) 10,755 (72,480) (3,818) (3,818)
__________ ________ ______ ___ _____ ___________ ___ ___ ________ __________
___ ____ ________
Consolidated cash flow statement
For the year ended 31 December 2018
Group Group
Year ended Year ended
31 December 31 December
2018 2017
GBP'000 GBP'000
Operating loss (1,659) (2,053)
Adjustments for:
Net finance costs 289 245
Depreciation of property, plant
and equipment 229 332
Share-based payment expense 29 67
Operating cash flows before
movements in Working capital (1,112) (1,409)
(Increase) / Decrease in inventories (201) (346)
(Increase) / Decrease in receivables 77 (63)
Increase / (Decrease) in payables 6 118
Increase / (Decrease) in provisions (20) 2
__________ __________
Cash used in operations (1,250) (1,698)
Tax refunded 746 -
__________ __________
Net cash outflow from operating
activities (504) (1,698)
__________ __________
Cash flows from investing activities
Purchases of property, plant
and equipment (4) (23)
Interest received - 1
__________ __________
Net cash outflow from investing
activities (4) (22)
__________ __________
Financing activities
Proceeds on issue of shares/Borrowings 700 23
Share issue costs - -
Repayment of HP creditors (166) (220)
__________ __________
Net cash inflow from financing
activities 534 (197)
__________ __________
Net (decrease)/increase in
cash and cash equivalents 26 (1,917)
Cash and cash equivalents at
beginning of year 908 2,884
Foreign exchange differences 24 (59)
__________ __________
Cash and cash equivalents at
end of year 958 908
__________ __________
Notes to the Financial Information
1. Basis of Preparation
The financial information set out in this document does not
constitute the Company's statutory accounts for the years ended 31
December 2017 or 2018. Statutory accounts for the years ended 31
December 2017 and 31 December 2018, which were approved by the
directors on 1(st) April 2019, have been reported on by the
Independent Auditors. The Independent Auditor's reports on the
Annual Report and Financial Statements for years ended 31 December
2017 and 2018 were unqualified, did draw attention to a matter by
way of emphasis, being going concern and did not contain a
statement under 498(2) or 498(3) of the Companies Act 2006.
Statutory accounts for the year ended 31 December 2017 have been
filed with the Registrar of Companies. The statutory accounts for
the year ended 31 December 2018 will be delivered to the Registrar
of Companies in due course and will be posted to shareholders
shortly, and thereafter will be available from the Company's
registered office at Hamilton House, Mabledon Place, London WC1H
9BB and from the Company's website
http://www.proteomics.com/investors.
The financial information set out in these results has been
prepared using the recognition and measurement principles of
International Accounting Standards, and International Financial
Reporting Standards and Interpretations adopted for use in the
European Union (collectively Adopted IFRSs). The accounting
policies adopted in these results have been consistently applied to
all the years presented and are consistent with the policies used
in the preparation of the financial statements for the year ended
31 December 2017, except for those that relate to new standards and
interpretations effective for the first time for periods beginning
on (or after) 1 January 2018. New standards impacting the Group
that have be adopted in the annual financial statements for the
year ended 31 December 2018 are IFRS 9 Financial Instruments and
IFRS 15 Revenue from contracts with customers. Other new standards,
amendments and interpretations to existing standards, which have
been adopted by the Group have not been listed, since they have no
material impact on the financial statements.
2. Liquidity and Going Concern
The directors have reviewed the Group's going concern position
taking into account its current business activities, budgeted
performance and the factors likely to affect its future
development, set out in the Annual Report, and including the
Group's objectives, policies and processes for managing its working
capital, its financial risk management objectives and its exposure
to credit and liquidity risks.
The Group's financial statements have been prepared on a going
concern basis, which remains reliant on the group achieving an
adequate level of sales in order to maintain sufficient working
capital to support its activities. If sales are not in line with
cash flow forecasts, then additional funding will be required. The
directors have prepared cash-flow forecasts covering a period of at
least 12 months from the date of approval of the financial
statements, which foresee that the Group will be able to operate
within its existing facilities. However, the timeline required to
close sales contracts and the order value of individual sales
continues to vary considerably, which constrain the ability to
accurately predict revenue performance. Furthermore, the Group's
services are still in the development phase and as such, the
directors consider that costs could exceed income in the short
term.
As such, there is a risk that the Group's working capital may
prove insufficient to cover both operating activities and the
repayment of its debt facilities. In such circumstances, the group
would be obliged to seek additional funding through a placement of
shares or source other funding.
The Group is also dependent on the unsecured loan facility
provided by the Chairman of the Group, which under the terms of the
facility is repayable on demand. The directors have received
confirmation from the Chairman that he has no intention of seeking
its repayment, with the facility continuing to be made available to
the Group, on the existing terms for at least 12 months from the
date of approval of these financial statements.
On 2 July 2018, The Company secured a loan facility of GBP1.0m,
of which GBP0.7m was drawn at 31 December 2018, from Vulpes
Investment Management ('VIM'). Interest accrues at 2.5% per annum
above the UK sterling base rate of Barclays Bank plc and is
repayable alongside the principal loan on 31 December 2019. The
Company has received confirmation from VIM that they will not seek
repayment before May 2020.
The directors have concluded that the circumstances set forth
above represent a material uncertainty, which may cast significant
doubt about the Company and Group's ability to continue as going
concerns. However, they believe that taken as a whole, the factors
described above enable the Company and Group to continue as a going
concern for the foreseeable future. The financial statements do not
include the adjustments that would be required if the Company and
the Group were unable to continue as a going concern.
3. Loss per Share from Continuing Operations
The calculations of basic and diluted loss per ordinary share
are based on the following losses and numbers of shares.
2018 2017
GBP'000 GBP'000
Loss for the financial year (1,313) (2,497)
__ ______ __ ______
2018 2017
Number of Number of
shares shares
Weighted average number of ordinary shares
for the purposes of calculating basic earnings
per share: 295,182,056 295,182,056
In 2018 and 2017 the loss attributed to ordinary shareholders
and weighted average number of ordinary shares for the purpose of
calculating the diluted earnings per ordinary share are identical
to those used for basic earnings per ordinary share. This is
because the exercise of share options that are out of the money
would have the effect of reducing the loss per ordinary share and
is therefore not dilutive under the terms of the International
Financial Reporting Standard 33.
4. Cautionary Statement on Forward-looking Statements
Proteome Sciences ('the Group') has made forward-looking
statements in this preliminary announcement. The Group considers
any statements that are not historical facts as "forward-looking
statements". They relate to events and trends that are subject to
risk and uncertainty that may cause actual results and the
financial performance of the Group to differ materially from those
contained in any forward-looking statement. These statements are
made in good faith based on information available to them and such
statements should be treated with caution due to the inherent
uncertainties, including both economic and business risk factors,
underlying any such forward-looking information.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR SSFFAFFUSEEL
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April 02, 2019 02:01 ET (06:01 GMT)
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