TIDMOXP
RNS Number : 7326Z
Oxford Pharmascience Group PLC
22 September 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or "the Company")
Interim results for the six months to 30 June 2015
Oxford Pharmascience Group Plc is pleased to announce its
unaudited interim results for the six months to 30 June 2015.
HIGHLIGHTS
-- Progression to clinic with two OXPzero(TM) NSAIDS for
assessment of both pharmacokinetics and reduction in gastric
irritation via endoscopy :
- OXP005 (250mg OXPzero(TM) Naproxen tablet)
- OXP001(2) (400mg Chewable OXPzero(TM) Ibuprofen tablet)
-- OXPzero(TM) Naproxen /OXP005:
- Encouraging proof of concept trial results announced July 2015
demonstrating:
- major statistically significant reduction in gastric
erosions
- comparable PK profile to the reference Naprosyn
- Programme initiated to further improve OXP005 to also meet
reduction in Lanza score endpoint.
-- OXPzero(TM) Ibuprofen - OXP001(2):
- Taste masking benefit demonstrated in clinical setting
- Successfully met optimisation objectives for immediate release
and complete drug absorption (announced in August 2015)
- Proof-of-concept trial ongoing with headline results on the
endoscopy phase expected to be released in Q4 2015, including
further PK data
-- GBP20 million gross proceeds raised from a placing of new
ordinary shares completed in June 2015, to enable the Company to
pursue a wider range of opportunities across its portfolio and
provide both flexibility and balance sheet strength as the Company
progresses into the commercialisation phase.
-- Total cash, cash equivalents and deposits of GBP24.1m at 30 June 2015 (2014: GBP8.2m).
Marcelo Bravo, Chief Executive Officer, commented:
"The Company has initiated contact with major pharmaceutical
companies in the NSAID space. With additional endoscopy data from
its further pilot clinical study for OXP001(2) expected by Q4 2015,
the plan remains to progress to partnering discussions with the aim
of maximising value for the Company and its shareholders.
In addition, the Company will be allocating resources to
investigate and pursue a wider range of opportunities leading with
the development of OXPzero(TM) Aspirin and also the evaluation of
further applications of its technologies.
Building upon the progress made this year, the Company is in a
strong position to proceed along its clinical pathway and to
diversify its pipeline. We look forward to announcing further
updates on the Company's programmes and pipeline over the coming
year."
For further information:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer
Aubrey Powell / Jen Boorer +44 20 7496 3000
OVERVIEW
The Company has made significant progress in 2015, with a clear
focus on its NSAID programme. Having progressed from the lab to the
clinic with two of the most important molecules in the
multi-billion dollar NSAIDs category, namely ibuprofen and
naproxen, we enter the second half of 2015 in a strong position,
with the technology moving ahead, a more robust clinical data set
in place, and a strong balance sheet.
We are very pleased that the data available to date demonstrates
that the technology is providing a class effect, significantly
reducing gastric erosions not only with ibuprofen but also with the
much more gastrointestinally aggressive naproxen molecule. In early
January, the Company announced that it had completed successful
development of clinical formulations of both OXPzero(TM) Ibuprofen
(OXP001(2)) and OXPzero(TM) Naproxen (OXP005) that demonstrated
immediate and complete drug release in vitro. Both formulations
proceeded to proof-of-concept trials in the subsequent months with
the objective of demonstrating reduced gastric irritation as well
as immediate and complete drug absorption. The two studies
conducted have both shown a major, statistically significant
reduction in median erosions (60% for ibuprofen in last year's
study with an early un-optimised formulation and 38% for naproxen
in the OXP005 study recently reported). Importantly, this year's
studies have also shown that the formulations are achieving
immediate release and complete drug absorption in vivo. Market
research previously commissioned by the Company amongst clinicians
and payors indicates a highly robust business case for the
OXPzero(TM) technology which could deliver significant returns for
shareholders.
The results to date for OXP005 are encouraging with results
showing a comparable PK profile to the reference Naprosyn. Building
upon this, the Company has initiated a programme to further improve
OXP005 to also meet reduction in Lanza score endpoint.
The Company is confident that additional endoscopy data from the
further pilot clinical study with OXP001(2) (now in the clinic)
will provide for a robust data package with which it will be able
to progress to partnering discussions later in 2015. Confirmation
of reduction in gastrointestinal erosions for OXP001(2) within the
range already established in our first two pilot trials will
validate OXPzero(TM) Ibuprofen as a disruptive compound in the $4bn
ibuprofen market.
Solid foundation for further progress
In readiness to move these assets forward to the commercial
stage, the Company has advanced the manufacturing process and
formulation development whilst strengthening its intellectual
property.
Having successfully raised GBP20m gross proceeds in June 2015,
the Company is in a very strong position and whilst building robust
data packages for OXP001(2) and OXP005 it is also now able to
diversify its pipeline. The Company believes there is significant
opportunity in cardiovascular disease (CVD) applications of the
OXPzero(TM) platform and is now in early formulation stage of an
OXPzero(TM) Aspirin product aimed at long-term anti-platelet
treatment for CVD. Additionally, the Company is exploring the
potential of further applications of both the OXPzero(TM) and
OXPtarget(TM) platform technologies with a view to selecting one to
three candidates to add into the pipeline. This review will not
only include applications already in development such as
OXPzero(TM) Diclofenac and Safestat(TM), but also a number of
further targets that have been identified in the past few
months.
FINANCIAL RESULTS
Revenue for the six months to 30 June 2015 was GBP342k (2014:
GBP336k), the majority derived from our partnership with Ache
Laboratorios in Brazil. Revenue performance for the half year is
consistent with delivery of market expectations for the full
year.
The loss before tax was GBP2.2m (2014: loss of GBP1.7m)
reflecting the higher level of clinical activity compared to the
prior period. As described above, the Company has run two
proof-of-concept clinical studies in the period, compared to one in
the comparative period, resulting in Research and Development
spending increasing to GBP1.5m from GBP1.0m in the first half of
2014.
Cash, cash equivalents and money held on deposits at the half
year-end was GBP24.1m (2014: GBP8.2m). At the period end, a total
of GBP15.0m (2014: GBPnil) has been placed on deposit across
different banks, all with strong credit ratings. The maturity
profiles of these deposits range from nine to 12 months.
The Company raised gross proceeds of GBP20.0m from a placing of
new ordinary shares at a price of 10 pence per share in June 2015
to certain existing and new institutional shareholders. Issue costs
associated with the placing were GBP0.56m. The additional funds
enable the Company to proceed along its clinical pathway with
confidence and also allows the expansion of the pipeline. Cash
management and tight cost control continue to be a priority for the
business and the additional funds raised will not change this
mentality.
OUTLOOK
The Company has initiated contact with major pharmaceutical
companies in the NSAID space. With additional endoscopy data from
its further pilot clinical study for OXP001(2) expected by Q4 2015,
the plan remains to progress to partnering discussions with the aim
of maximising value for the Company and its shareholders.
In addition, the Company will be allocating resources to
investigate and pursue a wider range of opportunities leading with
the development of OXPzero(TM) Aspirin and also the evaluation of
further applications of its technologies.
Building upon the progress made this year, the Company is in a
strong position to proceed along its clinical pathway and to
diversify its pipeline. We look forward to announcing further
updates on the Company's programmes and pipeline over the coming
year.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS TO 30 JUNE 2015
Six months to 30 Six months to 30 June Year to 31 December
June 2015 2014 2014
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
------------------------- ---------- ------------------------ --------------------------- ------------------------
Revenues 3 342 336 705
Cost of sales (256) (219) (482)
------------------------- ---------- ------------------------
Gross Profit 86 117 223
------------------------- ---------- ------------------------ --------------------------- ------------------------
Administrative
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expenses (2,254) (1,846) (3,719)
Operating loss (2,168) (1,729) (3,496)
------------------------- ---------- ------------------------ --------------------------- ------------------------
Finance income 9 - 32
------------------------- ---------- ------------------------ --------------------------- ------------------------
Loss before tax (2,159) (1,729) (3,464)
Taxation 4 - - 600
------------------------- ---------- ------------------------ --------------------------- ------------------------
Loss after tax
attributable to
equity holders of
the parent (2,159) (1,729) (2,864)
------------------------- ---------- ------------------------ --------------------------- ------------------------
Loss per share
Basic on loss for
the period (pence) 5 (0.21) (0.17) (0.29)
Diluted on loss for
the period (pence) 5 (0.21) (0.17) (0.29)
------------------------- ---------- ------------------------ --------------------------- ------------------------
The loss for the year arises from the Group's continuing
operations.
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS TO 30 JUNE 2015
Share Based Total
Share Capital Share Premium Merger Reserve Payments Reserve Revenue Reserve Equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
At 30
June
2013 898 8,561 714 69 (3,442) 6,800
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
Loss for
the
period - - - - (902) (902)
Issue of
shares 100 3,900 - - - 4,000
Expenses
of share
issue - (40) - - - (40)
Share
based
payment - - - 42 - 42
At 31
December
2013 998 12,421 714 111 (4,344) 9,900
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
Loss for
the
period - - - (1,729) (1,729)
Exercise
of share
options 8 149 - - - 157
Share
based
payment - - - 50 - 50
At 30
June
2014 1,006 12,570 714 161 (6,073) 8,378
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
Loss for
the
period - - - - (1,135) (1,135)
Share
based
payment - - - 77 - 77
At 31
December
2014 1,006 12,570 714 238 (7,208) 7,320
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
Loss for
the
period - - - - (2,159) (2,159)
Issue of
shares 43 4,249 - - - 4,292
Issue of
shares 157 15,551 - - - 15,708
Expenses
of share
issue - (561) - - - (561)
Share
based
payment - - - 68 - 68
At 30
June
2015 1,206 31,809 714 306 (9,367) 24,668
-------------- --------------------- ---------------------- --------------------- ---------------------- --------------------- ------------
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2015
30 June 2015 30 June 2014 31 December 2014
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
------------------- ---------- -------------------------- -------------------------- -----------------------------
Assets
Non-current
assets
Intangible
assets 38 47 43
Property,
plant and
equipment 4 6 5
------------------- ----------
42 53 48
------------------- ---------- -------------------------- -------------------------- -----------------------------
Current assets
Inventories 8 37 20
Trade and
other
receivables 854 384 838
Short term
investments
and cash on
deposit 15,000 - -
Cash and cash
equivalents 9,116 8,215 6,706
------------------- ---------- --------------------------
24,978 8,636 7,564
------------------- ---------- -------------------------- -------------------------- -----------------------------
Total Assets 25,020 8,689 7,612
------------------- ---------- -------------------------- -------------------------- -----------------------------
Liabilities
Current
liabilities
Trade and
other
payables (352) (311) (292)
------------------- ---------- -------------------------- -------------------------- -----------------------------
Net Assets 24,668 8,378 7,320
------------------- ---------- -------------------------- -------------------------- -----------------------------
Equity
Share capital 6 1,206 1,006 1,006
Share premium 6 31,809 12,570 12,570
Merger reserve 6 714 714 714
Share based
payment
reserve 306 161 238
Revenue
reserve (9,367) (6,073) (7,208)
------------------- ---------- -----------------------------
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Total Equity 24,668 8,378 7,320
------------------- ---------- -------------------------- -------------------------- -----------------------------
Approved by the Board and authorised for issue on 21 September
2015.
Marcelo Bravo Chris Hill
Chief Executive Officer Chief Financial Officer
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 JUNE 2015
Six months to 30 Six months to 30
June 2015 June 2014 Year to 31 December 2014
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
-------------------------- ------------------------- ------------------------- ---------------------------------
Operating Activities
Loss before tax (2,159) (1,729) (3,464)
Adjustment for non-
cash items:
Amortisation of
intangible assets 5 3 8
Depreciation of
property, plant and
equipment 1 - 2
Finance income (9) - (32)
Share based payment 68 50 127
Decrease/(increase) in
inventories 12 (16) 1
Increase in trade and
other receivables (16) (132) (191)
Increase/(decrease) in
trade and other
payables 60 (59) (78)
Taxes received - - 205
--------------------------- ------------------------- ------------------------- ---------------------------------
Operating cash outflow (2,038) (1,883) (3,422)
Net cash outflow from
operations (2,038) (1,883) (3,422)
--------------------------- ------------------------- ------------------------- ---------------------------------
Investing Activities
Finance income 9 - 32
Purchases of property,
plant and equipment - - (2)
Monies placed on
deposit (15,000) - -
Net cash
(outflow)/inflow from
investing activities (14,991) - 30
--------------------------- ------------------------- ------------------------- ---------------------------------
Financing Activities
Proceeds from share
option exercise - 157 157
Proceeds from issue
of share capital 20,000 - -
Expense of issue of
share capital (561) - -
-------------------------- -------------------------
Net cash inflow from
financing activities 19,439 157 157
--------------------------- ------------------------- ------------------------- ---------------------------------
Increase/(decrease) in
cash and cash
equivalents 2,410 (1,726) (3,235)
Cash and cash
equivalents at start
of period 6,706 9,941 9,941
---------------------------
Cash and cash
equivalents at end of
period 9,116 8,215 6,706
Monies placed on
deposit 15,000 - -
-------------------------- ------------------------- ------------------------- ---------------------------------
Cash, cash equivalents
and deposits at the
end of the period 24,116 8,215 6,706
--------------------------- ------------------------- ------------------------- ---------------------------------
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 JUNE 2015
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 2015. These include unaudited
comparatives for the six months to 30 June 2014 together with
audited comparatives for the year to 31 December 2014.
The Company was incorporated on 7 October 2009 as Oxford
Nutrascience Group Plc and changed its name to Oxford Pharmascience
Group Plc on 19 May 2011. The Company was specifically created to
implement a re-organisation in relation to Oxford Pharmascience
Limited (formerly Oxford Nutrascience Limited) which would permit
admission of the Group to the AIM market. Under the
re-organisation, Oxford Pharmascience Limited became a wholly owned
subsidiary of Oxford Pharmascience Group Plc on 27 January
2010.
Shareholders in the company at the time of the re-organisation
received shares in Oxford Pharmascience Group Plc in the same
proportionate interest as they had in Oxford Pharmascience Limited.
The business, operations, assets and liabilities of the Oxford
Pharmascience Group under the new holding company immediately after
the re-organisation were no different from those immediately before
the re-organisation and the Directors have therefore treated this
combination as a simple re-organisation using the pooling of
interests method of accounting.
The condensed consolidated financial statements do not
constitute statutory accounts. The statutory accounts for the year
to 31 December 2014 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
2014.
3) SEGMENTAL REPORTING
Primary reporting format - business segments
At 30 June 2015, the Group operated in one business segment,
that of the development and commercialisation of medicines via
reformulation using advanced pharmaceutic 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 four main geographic areas, although all
are managed in the UK. The Group's revenue per geographical segment
is as follows:
Six months to Six months to Year to
30 June 2015 30 June 2014 31 December 2014
(Unaudited) (Unaudited) (Audited)
Revenues GBP'000 GBP'000 GBP'000
--------------- ---------------------------------- ------------------------------------ ---------------------------------------
Product
sales
UK - 9 13
Middle
East - - 51
Brazil 317 302 641
Far East 25 25 -
--------------- ---------------------------------- ------------------------------------ ---------------------------------------
Total
product
sales 342 336 705
--------------- ---------------------------------- ------------------------------------ ---------------------------------------
Segment
operating
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