TIDMOXP
RNS Number : 6364R
Oxford Pharmascience Group PLC
25 September 2017
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Interim results for the six months to 30 June 2016
Oxford Pharmascience Group Plc (AIM: OXP) is pleased to announce
its unaudited interim results for the six months to 30 June
2017.
-- Recent clinical work confirmed improved drug release
properties and additional market research amongst clinicians in the
US and the UK confirmed that the adaptable properties of
OXPzero(TM) NSAIDs could drive an important prescription switch
even without the gastrointestinal (GI) safety claim
-- Commercial out-reach restarted on this basis in June 2017
along with exploration of the utility of the technology in Animal
Health
-- Now at initial stages of contact with new prospective
partners across the world in relation to these opportunities
-- Provisional MHRA feedback identified further risk in UK OTC
regulatory pathway (details to be announced following receipt of
MHRA formal written response)
-- Seeking further feedback on OTC opportunities from other
regulatory agencies, specifically an agency in Europe and the US
FDA
-- While the Company believes it has a strong body of clinical
data and market research supporting the commercial potential of its
assets, regulatory requirements mean that value creation will take
further time and investment
-- Development activities suspended pending conclusion of a strategic review
-- Focus of review on optimal value realisation strategies at
the current stage of development and/or how to best obtain better
value from these assets over time
-- Findings to be communicated to shareholders in the coming weeks
Financial Summary
-- Revenue (calcium chew business) of GBP425k (2016: GBP370k),
consistent with delivery of market expectations for the full
year
-- Loss before tax of GBP1.4m (2016 loss: GBP1.0m) reflecting
higher levels of clinical and regulatory activity in the period
-- Cash, cash equivalents and money held on deposits of GBP21.0m
versus GBP22.1m at 30 June 2016
-- Cash management and tight cost control continue to be priorities
This announcement contains inside information.
For further information please contact:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer
Aubrey Powell /Lauren Kettle +44 20 7496 3000
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary
technology platforms to re-develop existing medicines to make them
better, safer or easier to take. The Company does not manufacture
or sell its own pharmaceutical products direct to consumers, but
instead seeks to license its technologies and dossiers to a network
of partners, mainly leading pharmaceutical companies with Rx
(prescription) and OTC (over the counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines
that are proven to be safe and effective but nevertheless still
have associated issues and side effects often affecting compliance.
By working with such medicines, the Company is able to develop new
innovative products for a fraction of the cost, in much quicker
timescales and without the high risk of failure associated with
developing new drugs.
Chairman and Chief Executive Officer's Joint Review
During the past six months the Group has been primarily focused
on commercialisation efforts alongside various activities aimed to
elucidate the best way forward for its various product
opportunities. This has included seeking feedback from medicines
regulators as well as conducting market research amongst clinicians
in the prescription (Rx) market as well amongst consumers in the
over-the-counter (OTC) market.
The Company's OXPzero(TM) platform technology provides several,
clinical-stage candidates available for licensing which solve key
unmet needs across multiple pain markets both in Rx and OTC. Our
OXPzero(TM) products are clinically proven to have fewer GI side
effects compared to standard form non-steroidal anti-inflammatory
drugs (NSAIDs), potentially enhancing safety and simplifying
therapy. OXPzero(TM) Ibuprofen is demonstrably faster with
fewer/reduced GI side effects than standard ibuprofen tablets,
providing faster onset and potentially faster pain relief. In the
past few months, however, the Company has received feedback from
regulatory agencies that has confirmed that the regulatory path to
product approval is complex and this has derailed the Company's
efforts to partner its assets, particularly in the US market where
attention had been focused.
Specifically, as reported in March 2017, the US FDA indicated to
the Company that in order to support an improved gastro-intestinal
(GI) safety claim, a clinical outcomes study would be required,
including measures such as assessment of the incidence of peptic
ulcer bleeding and related complications. Given that such an
outcomes based study would be lengthy and require a very large
sample size, the economic feasibility of obtaining regulatory
clearance in the US on the basis of such a claim was compromised.
The Company has since switched its commercial efforts to explore
markets outside the US. In the past months the Company also
completed clinical work demonstrating improved drug release
properties and conducted additional research amongst clinicians in
the US and the UK, confirming that the properties of OXPzero(TM)
NSAIDs could drive an important switch of prescriptions to our
products even without leveraging the GI safety claim. Using this
data, the Company re-started its commercial out-reach in June 2017
as well as initiating exploration of the utility of the technology
in Animal Health. These efforts are ongoing and the Company is at
initial stage of contact with a number of new prospective partners
across the world.
For the OTC market, the Company initiated market research to
validate the most commercially attractive product opportunities and
started work on a non-disclosed lead programme, as announced in May
2017. The Company's objective was to get the chosen product or
products fully developed and approved for sale in at least one
major geography and then to seek to commercialise via out-license,
product launch or both. The rationale behind this approach was that
based on regulatory feedback received to date, for taste masked OTC
products not leveraging the GI safety claim, the regulatory pathway
would be straightforward requiring only demonstration of
bioequivalence. However, the Company has recently received
provisional feedback from the UK medicines regulator, the MHRA,
highlighting that the OTC programme may also turn out to be more
complex than previously envisaged and that there are risks to the
viability of gaining OTC/GSL* regulatory approval. Details of the
MHRA feedback will be announced when a formal written response is
received from the MHRA. The Company is now seeking further feedback
from other regulatory agencies, specifically an agency in Europe
and the US FDA, and will have a better picture of the regulatory
position for these OTC markets in due course. Although product
development has progressed well and consumer research looks very
positive, given these issues the Company has decided that it will
suspend its lead programme until the regulatory situation is
clarified.
Overall, while the Company has built a strong body of clinical
data and market research supporting the commercial potential of its
assets, regulatory requirements have complicated the way forward
commercially both in Rx and OTC opportunities. The Company believes
its assets will ultimately create value but clearly this will take
further time and investment. At present the Company has suspended
development activities while the Board concludes a strategic review
to assess how to best realise the value of the Company's assets at
their current stage of development. Details of the Board's findings
will be communicated to shareholders in the coming weeks.
* In the UK OTC products can be available off the shelf under
General Sales List (GSL) while Pharmacy Medicines (P) need to be
sold from a registered pharmacy.
Financial Results
Revenue from the calcium chew business for the six months to 30
June 2017 was GBP425k (2016: GBP370k). Revenue performance for the
half year is consistent with delivery of market expectations for
the full year. The loss before tax was GBP1.4m (2016: loss of
GBP1.0m) reflecting the higher level of clinical and regulatory
activity in the period.
Cash, cash equivalents and money held on deposits at 30 June
2017 was GBP21.0m versus GBP22.1m at 30 June 2016, with a total of
GBP10.0m (2016: GBP10.0m) placed on deposit. The maturity profiles
of these deposits range from six to 12 months from the date of
inception. Cash management and tight cost control continue to be a
priority for the business.
David Norwood Marcelo Bravo
Chairman Chief Executive Officer
22 September 2017
Six months to 30 Six months to 30 Year to 31 December
June 2017 June 2016 2016
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
------------------------- ---------- ------------------------ ------------------------ -------------------------
Revenues 3 425 370 796
Cost of sales (311) (276) (596)
------------------------- ---------- ------------------------
Gross Profit 114 94 200
------------------------- ---------- ------------------------ ------------------------ -------------------------
Administrative
expenses (1,524) (1,117) (2,230)
Operating loss (1,410) (1,023) (2,030)
------------------------- ---------- ------------------------ ------------------------ -------------------------
Finance income 58 64 132
------------------------- ---------- ------------------------ ------------------------ -------------------------
Loss before tax (1,352) (959) (1,898)
Taxation 4 - 74 514
------------------------- ---------- ------------------------ ------------------------ -------------------------
Loss after tax
attributable to
equity holders of
the parent (1,352) (885) (1,384)
------------------------- ---------- ------------------------ ------------------------ -------------------------
Loss per share
Basic on loss for
the period (pence) 5 (0.11) (0.07) (0.11)
Diluted on loss for
the period (pence) 5 (0.11) (0.07) (0.11)
------------------------- ---------- ------------------------ ------------------------ -------------------------
The loss for the year arises from the Group's continuing
operations.
Share Based
Share Capital Share Premium Merger Reserve Payments Reserve Revenue Reserve Total Equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
At 30 June
2015 1,206 31,809 714 306 (9,367) 24,668
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (955) (955)
Share based
payment - - - 72 - 72
At 31 December
2015 1,206 31,809 714 378 (10,322) 23,785
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (885) (885)
Share based
payment - - - 82 - 82
At 30 June
2016 1,206 31,809 714 460 (11,207) 22,982
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (499) (499)
Share based
payment - - - 81 - 81
At 31 December
2016 1,206 31,809 714 541 (11,706) 22,564
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (1,352) (1,352)
Share based
payment - - - 54 - 54
At 30 June
2017 1,206 31,809 714 595 (13,058) 21,266
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
30 June 30 June 31 December
2017 2016 2016
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Assets
Non-current assets
Intangible assets 22 30 26
Property, plant and
equipment 1 3 2
--------------------------------- ----------
23 33 28
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Current assets
Inventories 16 3 14
Trade and other receivables 555 965 811
Short term investments
and cash on deposit 10,000 10,000 5,000
Cash and cash equivalents 10,972 12,120 16,878
--------------------------------- ---------- ----------------
21,543 23,088 22,703
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Total Assets 21,566 23,121 22,731
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Liabilities
Current liabilities
Trade and other payables (300) (139) (167)
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Net Assets 21,266 22,982 22,564
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Equity
Share capital 6 1,206 1,206 1,206
Share premium 6 31,809 31,809 31,809
Merger reserve 6 714 714 714
Share based payment
reserve 595 460 541
Revenue reserve (13,058) (11,207) (11,706)
--------------------------------- ---------- -----------------------------
Total Equity 21,266 22,982 22,564
--------------------------------- ---------- ---------------- --------------------- -----------------------------
Approved by the Board and authorised for issue on 22 September
2017.
Marcelo Bravo Chris Hill Chief Executive Officer Chief Financial
Officer
Six months to 30 June Six months to 30 June Year to 31 December
2017 2016 2016
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
---------------------------- --------------------------- --------------------------- ---------------------------
Operating Activities
Loss before tax (1,352) (959) (1,898)
Adjustment for non-
cash items:
Amortisation of
intangible assets 4 4 8
Depreciation of
property, plant and
equipment 1 1 2
Under provision of
taxes receivable - 74 -
Finance income (58) (64) (132)
Share based payment 54 82 163
(Increase)/Decrease in
inventories (2) 6 (5)
Decrease/(Increase) in
trade and other
receivables 256 22 (130)
Increase/(Decrease) in
trade and other
payables 133 (168) (140)
Taxes received - - 820
----------------------------- --------------------------- --------------------------- ---------------------------
Operating cash outflow (964) (1,002) (1,312)
Net cash outflow from
operations (964) (1,002) (1,312)
----------------------------- --------------------------- --------------------------- ---------------------------
Investing Activities
Finance income 58 64 132
(Purchase)/Sale of
short-term investment (5,000) - 5,000
Net cash
(outflow)/inflow from
investing activities (4,942) 64 5,132
----------------------------- --------------------------- --------------------------- ---------------------------
(Decrease)/Increase in
cash and cash
equivalents (5,907) (938) 3,820
Cash and cash
equivalents at start of
period 16,878 13,058 13,058
-----------------------------
Cash and cash
equivalents at end of
period 10,972 12,120 16,878
----------------------------- --------------------------- --------------------------- ---------------------------
Short term investments
at end of period 10,000 10,000 5,000
----------------------------- --------------------------- --------------------------- ---------------------------
Cash, cash equivalents
and deposits at end of
period 20,972 22,120 21,878
----------------------------- --------------------------- --------------------------- ---------------------------
1) BASIS OF PREPARATION
The interim financial statements of Oxford Pharmascience Group
Plc are unaudited condensed consolidated financial statements for
the six months to 30 June 2017. These include unaudited
comparatives for the six months to 30 June 2016 together with
audited comparatives for the year to 31 December 2016.
The condensed consolidated financial statements do not
constitute statutory accounts. The statutory accounts for the year
to 31 December 2016 have been reported on by the auditors to Oxford
Pharmascience Group Plc and have been filed with the Registrar of
Companies. The report of the auditors was unqualified and did not
contain a statement under section 498 of the Companies Act
2006.
2) SIGNIFICANT ACCOUNTING POLICIES
The condensed consolidated financial statements have been
prepared under the historical cost convention in accordance with
International Financial Reporting Standards as adopted by the
European Union.
The accounting policies adopted are consistent with those
followed in the preparation of the annual financial statements of
Oxford Pharmascience Group Plc for the year ended 31 December
2016.
3) SEGMENTAL REPORTING
Primary reporting format - business segments
At 30 June 2017, the Group operated in one business segment,
that of the development and commercialisation of medicines via
reformulation using advanced pharmaceutical technologies to add
value to generic and soon to be generic drugs. All revenues have
been generated from continuing operations and are from external
customers. Secondary reporting format - geographical segments
The Group operates in two main geographic areas, although all
are managed in the UK. The Group's revenue per geographical segment
is as follows:
Six months to 30 June Six months to 30 June Year to 31 December
2017 2016 2016
(Unaudited) (Unaudited) (Audited)
Revenues GBP'000 GBP'000 GBP'000
---------------------------- ---------------------------- ---------------------------- ----------------------------
Product sales
Middle East 48 51 51
Brazil 376 319 744
UK 1 - 1
---------------------------- ---------------------------- ---------------------------- ----------------------------
Total product sales 425 370 796
Total 425 370 796
---------------------------- ---------------------------- ---------------------------- ----------------------------
Segment operating loss (1,410) (1,023) (2,030)
----------------------------
Segment net assets 21,266 22,982 22,564
---------------------------- ---------------------------- ---------------------------- ----------------------------
All the Group's assets are held in the UK and all of its capital
expenditure arises in the UK.
4) TAXATION
The Group has accumulated losses available to carry forward
against future trading profits. No deferred tax asset has been
recognised in respect of tax losses since it is uncertain at the
balance sheet date as to whether future profits will be available
against which the unused tax losses can be utilised.
5) LOSS PER SHARE (BASIC AND DILUTED)
Basic loss per share is calculated by dividing the loss
attributable to equity holders of the parent by the weighted
average number of ordinary shares in issue during the period.
Diluted loss per share is calculated by adjusting the weighted
average number of ordinary shares in issue during the period to
assume conversion of all dilutive potential ordinary shares.
Six months to 30 June Six months to 30 June Year to 31 December
2017 2016 2016
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Loss attributable to
the equity holders of
the parent (1,352) (885) (1,384)
---------------------------- ---------------------------- ---------------------------- ----------------------------
No. No. No.
---------------------------- ---------------------------- ---------------------------- ----------------------------
Weighted average number
of ordinary shares in
issue during the
period 1,205,661,619 1,205,661,619 1,205,661,619
---------------------------- ---------------------------- ---------------------------- ----------------------------
Loss per share
Basic on loss for the
period (0.11)p (0.07)p (0.11)p
Diluted on loss for the
period (0.11)p (0.07)p (0.11)p
---------------------------- ---------------------------- ---------------------------- ----------------------------
The Company has issued employee options over 99,700,000 ordinary
shares which are potentially dilutive. There is however, no
dilutive effect of these issued options as there is a loss for each
of the periods concerned.
6) SHARE CAPITAL
Share capital Share premium Merger reserve Total
Oxford
Pharmascience
Group Plc Number GBP'000 GBP'000 GBP'000 GBP'000
----------------------- ------------------ ------------------ ------------------ ------------------- ------------
Total Ordinary
shares of 0.1 p
each as at 30
June 2014 1,005,661,619 1,006 12,570 714 14,290
----------------------- ------------------ ------------------ ------------------ ------------------- ------------
Total Ordinary
shares of 0.1 p
each as at 31
December 2014 1,005,661,619 1,006 12,570 714 14,290
----------------------- ------------------ ------------------ ------------------ ------------------- ------------
Issued for cash 25
June 2015 42,915,000 43 4,249 - 4,292
Issued for cash 26
June 2015 157,085,000 157 15,551 - 15,709
Expense of issue - - (561) - (561)
----------------------- ------------------ ------------
Total Ordinary
shares of 0.1 p
each as at 30
June 2015, 30
June 2016 and 30
June 2017 1,205,661,619 1,206 31,809 714 33,729
----------------------- ------------------ ------------------ ------------------ ------------------- ------------
As permitted by the provisions of the Companies Act 2006, the
Company does not have an upper limit to its authorised share
capital.
The acquisition of Oxford Pharmascience Limited in 2010 has been
accounted for as a re-organisation using the pooling of interests
method of accounting and under which the shares issued by the
Company are recorded at nominal value together with an amount
established as Merger reserve in order to replicate the total
issued capital of Oxford Pharmascience Limited as at the
acquisition date.
7) RELATED PARTY TRANSACTIONS
There are no purchases from or sales to related parties.
During the six month period ended 30 June 2017, the Company
entered into numerous transactions with its subsidiary Company
which net off on consolidation - these have not been shown.
In addition, during the period the Company paid remuneration to
the Directors' in accordance with their service contracts and
letters of appointment.
8) PRINCIPAL RISKS AND UNCERTAINTIES
The principal risks and uncertainties are consistent with those
described in the annual financial statements of Oxford
Pharmascience Group Plc for the year ended 31 December 2016.
9) INTERIM FINANCIAL REPORT
A copy of this interim report will be available on the Company's
website at www.oxfordpharmascience.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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