TIDMOXP
RNS Number : 1399J
Oxford Pharmascience Group PLC
07 September 2016
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
2016.
HIGHLIGHTS
-- Substantive progress in commercialisation discussions
regarding the Company's lead NSAID(1) assets, OXPzero(TM) Ibuprofen
and OXPzero(TM) Naproxen
-- Feedback has identified the key precursors to successful partnership outcomes, including:
o additional platform development
o clarity on regulatory pathway for over the counter (OTC) and
Prescription (Rx) product approval
-- Significant progress advancing the OXPzero(TM) technology platform:
o improvement of drug release in vitro
o scale-up and optimisation of the manufacturing process
o strengthening of the intellectual property (IP) portfolio
-- Loss before tax to 30 June 2016 of GBP1.0 million (2015:
GBP2.2 million) reflecting lower R&D activity in the first half
compared to the comparative period
-- Well-funded with period-end cash, cash equivalent and deposit
balances of GBP22.1 million (2015: GBP24.1million)
-- Planning to conduct small-scale exploratory pharmacokinetic
(PK) trials to validate the in vivo performance of formulation
improvements, with details to be announced separately in due
course
-- Ongoing dialogue including the initiation of broader outreach to include the Rx market
-- Proceeding to seek pre-IND meetings with the US FDA to clarify US regulatory pathway
Marcelo Bravo, Chief Executive Officer, commented:
"During the period we have made good progress in
commercialisation discussions regarding our lead assets,
OXPzero(TM) Ibuprofen and OXPzero Naproxen(TM), and our continuing
focus remains to progress these to market. We are making
significant progress advancing the OXPzero(TM) technology through
the improvement of the drug release characteristics, scale-up and
optimization of the manufacturing process and through additional
patent applications to strengthen the IP.
"We plan to clarify the regulatory pathway for product approval
in the US and alongside this we have expanded our business
development efforts, with a focus on the Rx market and on the
taste-masking applications of our technology in the OTC market
where we are in ongoing partnership discussions. While it is now
clear that a major licensing deal will take longer to generate, our
OXPzero(TM) NSAIDs have the potential to offer meaningful
advantages versus standard ibuprofen and naproxen, both in terms of
the improved gastrointestinal (GI) safety profile and
taste-masking, and we continue to believe there are significant,
disruptive and valuable opportunities in the $12bn global NSAIDs
market.
"We will update shareholders in due course on our commercial
discussions and wider development plans."
1- Non-steroidal anti-inflammatory drugs
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 / Jen Boorer +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.
About OXPzero(TM) NSAIDs
Specifically, by comparison with generic NSAIDs, OXPzero(TM)
Ibuprofen and OXPzero(TM) Naproxen are milder in the GI tract,
delivering major reduction in severe GI mucosal damage,
significantly mask the bitter taste/burn associated with NSAIDs,
and deliver an attractive pharmacokinetic profile with adaptable
drug release properties.
Chairman's and Chief Executive Officer's Joint Review
During the past six months the Group has been primarily focused
on commercialisation efforts, initially in over-the-counter (OTC)
markets, for its lead compounds OXPzero Ibuprofen(TM) and OXPzero
Naproxen(TM) and in technical activities in support of these
assets.
As reported in July, in the prior months the Company has held
discussions, both directly and through a major investment bank
adviser, with several global OTC companies with strategic interest
in the NSAIDs (non-steroidal anti-inflammatory drugs) market with
the aim of securing a partnership deal for the whole OXPzero(TM)
platform. These discussions confirmed to the Company that the
OXPzero(TM) technology, and particularly its gastrointestinal (GI)
safety profile, would be a potentially disruptive, differentiated
and very valuable asset in OTC markets. Feedback received indicates
that these OTC companies would prefer to see the assets further
developed and, importantly, to have more clarity on the regulatory
pathway(s) for OTC product approval, before committing to a
partnership agreement on either individual assets or on the
platform as a whole.
During discussions with prospective partners, it also became
clear that in OTC markets, the taste masking benefits of the
OXPzero(TM) technology are of significant interest. There are
multiple opportunities in this area including taste masked
non-tablet products for cough & cold remedies and taste masked
formulations for pain & fever, all areas in which paracetamol
based formulations currently dominate because of the ease of
masking the taste of paracetamol. Ibuprofen and naproxen have
inherent benefits in efficacy and duration of effect versus
paracetamol but cannot be easily incorporated in to non-tablet
formulations because of their taste profile. The Company is
currently involved in on-going partnership discussions for these
applications of its OXPzero(TM) technology and will update
shareholders in due course.
Alongside these discussions, the Company has been advancing the
technology, scaling-up and optimising the manufacturing process and
strengthening its intellectual property (IP) portfolio. In the past
six months, the Company has made significant progress in the
laboratory, exploring and defining modifications of the OXPzero(TM)
platform to affect release properties and enable
bioequivalence/fast release of different formulations against
different reference products. The Company has gained further
understanding of the adaptable release properties of the technology
and produced positive in vitro results that management believes
bode well for in vivo performance. The Company will be conducting
small scale exploratory pharmacokinetic (PK) clinical trials over
several months starting later this year to validate the in vivo
performance of these formulation improvements. Importantly, this is
expected to generate new IP that will further strengthen the
platform and provide longer patent life to the products once in
market.
Working with its CMO partner, Dipharma Francis Srl, the Company
has successfully developed and optimised the manufacturing process,
initially for OXPzero(TM) Ibuprofen, increasing process efficiency
and robustness. The process has been validated at an intermediate
scale which will support future phase II and phase III clinical
development and allow progression of the manufacturing process to
commercial scale batch production. The Company has also worked to
strengthen its IP portfolio by securing options to various patent
families that provide protection on specific aspects of the
manufacture of the materials. All of these patents are early in the
patent life cycle and if adopted will provide robust protection
over close to full patent life. More details on the above and on
the Company's other development programmes will be provided in a
technical update in due course.
Financial Results
Revenue from the calcium chew business for the six months to 30
June 2016 was GBP370k (2015: GBP342k). Revenue performance for the
half year is consistent with delivery of market expectations for
the full year. The loss before tax was GBP1.0m (2015: loss of
GBP2.2m) reflecting the higher level of clinical activity in the
prior period.
Cash, cash equivalents and money held on deposits at 30 June
2016 was GBP22.1m (before receipt of Research and Development tax
credit of GBP0.74 million) versus GBP24.1m at 30 June 2015, with a
total of GBP10.0m (2015: GBP15.0m) placed on deposit. The maturity
profiles of these deposits range from six to 12 months. Cash
management and tight cost control continue to be a priority for the
business.
Outlook
The Company is focussing its future plans on activities that
support the progression to market for OXPzero Ibuprofen(TM) and
OXPzero Naproxen(TM) : 1) continue commercial discussions with OTC
companies on specific taste-masked applications; 2) initiate
commercial discussions for prescription (Rx) applications with
companies with interests in the pain relief area and 3) proceed to
consultation with regulatory agencies to clarify the regulatory
pathway with focus initially in the United States. Building on the
in vitro laboratory work, described above, the Company will conduct
small scale exploratory PK trials to validate the in vivo
performance of these formulation improvements. Further details of
this work will be announced in due course.
Partnering discussions for taste masked applications are ongoing
with select companies both in North America and Europe. The
objective is to establish a small number of quality commercial
partnerships that demonstrate the commercial feasibility of the
technology, allowing the Company to progress the platform further
in terms of generating additional applications and building greater
value.
On the Rx front, the Company is establishing business
development advisory resource to initiate outreach to this market.
The prescription market for pain relief is more geographically
fragmented in nature than the OTC market and the Company will look
to form partnerships on a regional basis, with initial focus on the
United States, Europe and Asia.
On regulatory, the Company has prioritised seeking feedback from
the US regulator and has put together a team of advisors to prepare
and submit applications to request pre-IND meetings with the FDA,
to seek advice for both the OTC and Rx regulatory pathways.
Obtaining clarity from the FDA will be a major milestone to further
facilitate partnering discussions for the key US market.
The Group remains well-funded to complete this next stage of
work, with cash, cash equivalents and money held on deposit as at
30 June 2016 of GBP22.1 million.
David Norwood Marcelo Bravo
Chairman Chief Executive Officer
OXFORD PHARMASCIENCE GROUP PLC
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS TO 30 JUNE 2016
Six months to 30 Six months to 30 Year to 31 December
June 2016 June 2015 2015
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
------------------------- ---------- ------------------------- ------------------------- -------------------------
Revenues 3 370 342 749
Cost of sales (276) (256) (591)
------------------------- ---------- -------------------------
Gross Profit 94 86 158
------------------------- ---------- ------------------------- ------------------------- -------------------------
Administrative
expenses (1,117) (2,254) (4,131)
Operating loss (1,023) (2,168) (3,973)
------------------------- ---------- ------------------------- ------------------------- -------------------------
Finance income 64 9 96
------------------------- ---------- ------------------------- ------------------------- -------------------------
Loss before tax (959) (2,159) (3,877)
Taxation 4 74 - 763
------------------------- ---------- ------------------------- ------------------------- -------------------------
Loss after tax
attributable to
equity holders of
the parent (885) (2,159) (3,114)
------------------------- ---------- ------------------------- ------------------------- -------------------------
Loss per share
Basic on loss for
the period (pence) 5 (0.07) (0.21) (0.28)
Diluted on loss for
the period (pence) 5 (0.07) (0.21) (0.28)
------------------------- ---------- ------------------------- ------------------------- -------------------------
The loss for the year arises from the Group's continuing
operations.
OXFORD PHARMASCIENCE GROUP PLC
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS TO 30 JUNE 2016
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
2014 1,006 12,570 714 161 (6,073) 8,378
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (1,135) (1,135)
Share based
payment - - - 77 - 77
At 31 December
2014 1,006 12,570 714 238 (7,208) 7,320
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
Comprehensive
Income - - - - (2,159) (2,159)
Issue of
shares 200 19,800 - - - 20,000
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
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
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
------------------- --------------------- ---------------------- ---------------------- ---------------------- --------------------- --------------------
OXFORD PHARMASCIENCE GROUP PLC
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2016
30 June 2016 30 June 2015 31 December 2015
(Unaudited) (Unaudited) (Audited)
Notes GBP'000 GBP'000 GBP'000
------------------------------ ---------- ------------------ --------------------- -----------------------------
Assets
Non-current assets
Intangible assets 30 38 34
Property, plant and
equipment 3 4 4
------------------------------ ----------
33 42 38
------------------------------ ---------- ------------------ --------------------- -----------------------------
Current assets
Inventories 3 8 9
Trade and other
receivables 965 854 987
Short term investments
and cash on deposit 10,000 15,000 10,000
Cash and cash equivalents 12,120 9,116 13,058
------------------------------ ---------- ------------------
23,088 24,978 24,054
------------------------------ ---------- ------------------ --------------------- -----------------------------
Total Assets 23,121 25,020 24,092
------------------------------ ---------- ------------------ --------------------- -----------------------------
Liabilities
Current liabilities
Trade and other payables (139) (352) (307)
------------------------------ ---------- ------------------ --------------------- -----------------------------
Net Assets 22,982 24,668 23,785
------------------------------ ---------- ------------------ --------------------- -----------------------------
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 460 306 378
Revenue reserve (11,207) (9,367) (10,322)
------------------------------ ---------- -----------------------------
Total Equity 22,982 24,668 23,785
------------------------------ ---------- ------------------ --------------------- -----------------------------
Approved by the Board and authorised for issue on 6 September
2016.
Marcelo Bravo Chris Hill
Chief Executive Officer Chief Financial Officer
OXFORD PHARMASCIENCE GROUP PLC
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 30 JUNE 2016
Six months to 30 June Six months to 30 June Year to 31 December
2016 2015 2015
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
---------------------------- --------------------------- --------------------------- ---------------------------
Operating Activities
Loss before tax (959) (2,159) (3,877)
Adjustment for non-
cash items:
Amortisation of
intangible assets 4 5 9
Depreciation of
property, plant and
equipment 1 1 1
Under provision of
taxes receivable 74 - -
Finance income (64) (9) (96)
Share based payment 82 68 140
Decrease in inventories 6 12 11
Decrease/(increase) in
trade and other
receivables 22 (16) 75
(Decrease)/increasein
trade and other
payables (168) 60 15
Taxes received - - 539
----------------------------- --------------------------- --------------------------- ---------------------------
Operating cash outflow (1,002) (2,038) (3,183)
Net cash outflow from
operations (1,002) (2,038) (3,183)
----------------------------- --------------------------- --------------------------- ---------------------------
Investing Activities
Finance income 64 9 96
Purchase of short-term
investment - (15,000) (10,000)
Net cash outflow from
investing activities 64 (14,991) (9,904)
----------------------------- --------------------------- --------------------------- ---------------------------
Financing Activities
Proceeds from issue of
share capital - 20,000 20,000
Expense of issue of
share capital - (561) (561)
----------------------------- ---------------------------
Net cash inflow from
financing activities - 19,439 19,439
----------------------------- --------------------------- --------------------------- ---------------------------
(Decrease)/increase in
cash and cash
equivalents (938) 2,410 6,352
Cash and cash
equivalents at start of
period 13,058 6,706 6,706
-----------------------------
Cash and cash
equivalents at end of
period 12,120 9,116 13,058
----------------------------- --------------------------- --------------------------- ---------------------------
Monies placed on
short-term deposit 10,000 15,000 10,000
Cash, cash equivalents
and deposits at the end
of the period 22,120 24,116 23,058
----------------------------- --------------------------- --------------------------- ---------------------------
OXFORD PHARMASCIENCE GROUP PLC
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHSED 30 JUNE 2016
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 2016. These include unaudited
comparatives for the six months to 30 June 2015 together with
audited comparatives for the year to 31 December 2015.
The condensed consolidated financial statements do not
constitute statutory accounts. The statutory accounts for the year
to 31 December 2015 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
2015.
3) SEGMENTAL REPORTING
Primary reporting format - business segments
At 30 June 2016, 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 Six months to Year to
30 June 2016 30 June 2015 31 December 2015
(Unaudited) (Unaudited) (Audited)
Revenues GBP'000 GBP'000 GBP'000
--------------- -------------------------------------- ---------------------------------- -------------------------------------
Product
sales
Middle
East 51 25 25
Brazil 319 317 724
Total
product
sales 370 342 749
Total 370 342 749
--------------- -------------------------------------- ---------------------------------- -------------------------------------
Segment
operating
loss (1,023) (2,189) (3,973)
---------------
Segment
net
assets 22,982 24,668 23,785
--------------- -------------------------------------- ---------------------------------- -------------------------------------
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
2016 2015 2015
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Loss attributable to
the equity holders of
the parent (885) (2,159) (3,114)
---------------------------- ---------------------------- ---------------------------- ----------------------------
No. No. No.
---------------------------- ---------------------------- ---------------------------- ----------------------------
Weighted average number
of ordinary shares in
issue during the
period 1,205,661,619 1,007,970,975 1,109,361,109
---------------------------- ---------------------------- ---------------------------- ----------------------------
Loss per share
Basic on loss for the
period (0.07)p (0.21)p (0.28)p
Diluted on loss for the
period (0.07)p (0.21)p (0.28)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 and 30
June 2016 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 accountingand 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
The Group paid consultancy fees of GBP5k to Mr Anand Sharma
prior to his appointment to the Board on 25 February 2016. Mr
Sharma resigned on 20 July 2016.
There are no sales to related parties.
During the six month period ended 30 June 2016, 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) 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
IR UGUMGBUPQPWQ
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