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 

(MORE TO FOLLOW) Dow Jones Newswires

September 22, 2015 02:00 ET (06:00 GMT)

      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) 
-------------------  ----------                                                          ----------------------------- 

(MORE TO FOLLOW) Dow Jones Newswires

September 22, 2015 02:00 ET (06:00 GMT)

     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 

(MORE TO FOLLOW) Dow Jones Newswires

September 22, 2015 02:00 ET (06:00 GMT)

Oxford Nutrascience (LSE:ONG)
Historical Stock Chart
Von Nov 2024 bis Dez 2024 Click Here for more Oxford Nutrascience Charts.
Oxford Nutrascience (LSE:ONG)
Historical Stock Chart
Von Dez 2023 bis Dez 2024 Click Here for more Oxford Nutrascience Charts.