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OXP Oxford Pharm Gp

1.50
0.00 (0.00%)
09 May 2024 - Closed
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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

Oxford Pharmascience Group PLC Interim Results (6364R)

25/09/2017 7:00am

UK Regulatory


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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

IR LZLFLDKFFBBV

(END) Dow Jones Newswires

September 25, 2017 02:00 ET (06:00 GMT)

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