Source - RNS
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 NSAID1 assets, OXPzeroTM Ibuprofen and OXPzeroTM 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 OXPzeroTM 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 £1.0 million (2015: £2.2 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 £22.1 million (2015: £24.1million)

·    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™ Ibuprofen and OXPzero Naproxen™, and our continuing focus remains to progress these to market. We are making significant progress advancing the OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM NSAIDs

Specifically, by comparison with generic NSAIDs, OXPzeroTM Ibuprofen and OXPzeroTM 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 IbuprofenTM and OXPzero NaproxenTM 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™ platform. These discussions confirmed to the Company that the OXPzero™ 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™ 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™ 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™ 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 OXPzeroTM 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 £370k (2015: £342k). Revenue performance for the half year is consistent with delivery of market expectations for the full year. The loss before tax was £1.0m (2015: loss of £2.2m) reflecting the higher level of clinical activity in the prior period. 

 

Cash, cash equivalents and money held on deposits at 30 June 2016 was £22.1m (before receipt of Research and Development tax credit of £0.74 million) versus £24.1m at 30 June 2015, with a total of £10.0m (2015: £15.0m) 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.

 

The Company is focussing its future plans on activities that support the progression to market for OXPzero IbuprofenTM and OXPzero NaproxenTM: 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 £22.1 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 June 2016

Six months to 30 June 2015

Year to 31 December 2015



(Unaudited)

(Unaudited)

(Audited)


Notes

£'000

£'000

£'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 Capital

Share Premium

Merger Reserve

Share Based Payments Reserve

Revenue Reserve

Total Equity


£'000

£'000

£'000

£'000

£'000

£'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

£'000

£'000

£'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 MONTHS ENDED 30 JUNE 2016

 

 

 



Six months to 30 June 2016

Six months to 30 June 2015

Year to 31 December 2015



(Unaudited)

(Unaudited)

(Audited)



£'000

£'000

£'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 MONTHS ENDED 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

£'000

£'000

£'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 2016

Six months to 30 June 2015

Year to 31 December 2015


(Unaudited)

(Unaudited)

(Audited)


£'000

£'000

£'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

£'000

£'000

£'000

£'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 £5k 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
 
 
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