We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Oxford Pharm Gp | LSE:OXP | London | Ordinary Share | GB00B3LXPB43 | ORD 0.001P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.50 | 1.45 | 1.55 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
0 | 0 | N/A | 0 |
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
(END) Dow Jones Newswires
September 07, 2016 02:01 ET (06:01 GMT)
1 Year Oxford Pharm Gp Chart |
1 Month Oxford Pharm Gp Chart |
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions