Oxford Pharmascience Group plc ("Oxford Pharmascience" or the "Company") Interim results for the six months to 30 June 2017

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 OXPzeroTMNSAIDs 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 OXPzeroTMplatform 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 OXPzeroTMNSAIDs 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.

Oxford Pharmascience Group plc published this content on 25 September 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 25 September 2017 07:44:02 UTC.

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