25th Sep 2017 07:00
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 OXPzeroTM 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 £425k (2016: £370k), consistent with delivery of market expectations for the full year
· Loss before tax of £1.4m (2016 loss: £1.0m) reflecting higher levels of clinical and regulatory activity in the period
· Cash, cash equivalents and money held on deposits of £21.0m versus £22.1m 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 OXPzeroTM 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™ 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™ 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 OXPzeroTM 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 £425k (2016: £370k). Revenue performance for the half year is consistent with delivery of market expectations for the full year. The loss before tax was £1.4m (2016: loss of £1.0m) 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 £21.0m versus £22.1m at 30 June 2016, with a total of £10.0m (2016: £10.0m) 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 June 2017 | Six months to 30 June 2016 | Year to 31 December 2016 | |||
(Unaudited) | (Unaudited) | (Audited) | |||
Notes | £'000 | £'000 | £'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 Capital | Share Premium | Merger Reserve | Share Based Payments Reserve | Revenue Reserve | Total Equity | |
£'000 | £'000 | £'000 | £'000 | £'000 | £'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 2017 | 30 June 2016 | 31 December 2016 | ||
(Unaudited) | (Unaudited) | (Audited) | ||
Notes | £'000 | £'000 | £'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 2017 | Six months to 30 June 2016 | Year to 31 December 2016 | ||
(Unaudited) | (Unaudited) | (Audited) | ||
£'000 | £'000 | £'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 2017 | Six months to 30 June 2016 | Year to 31 December 2016 | |
(Unaudited) | (Unaudited) | (Audited) | |
Revenues | £'000 | £'000 | £'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 2017 | Six months to 30 June 2016 | Year to 31 December 2016 | |
(Unaudited) | (Unaudited) | (Audited) | |
£'000 | £'000 | £'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 | £'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, 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
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