5th Mar 2015 07:00
Oxford Pharmascience Group Plc
("Oxford Pharmascience" or the "Company")
Results for the Year Ended 31 December 2014 and Notice of AGM
Oxford Pharmascience (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces its results for the year ended 31 December 2014 and gives notice of its AGM to be held on 24 June 2015 at 2.00pm at the offices of Fasken Martineau LLP, Third Floor, 17 Hanover Square, London, W1S 1HU. The Report and Accounts and Notice of AGM will today be posted to shareholders.
OPERATIONAL HIGHLIGHTS
· Lead gastric safe NSAIDs programme broadened to include OXPzeroTM Naproxen, Diclofenac and Aspirin, as well as Ibuprofen
· Successful optimisation of the OXPzeroTM Ibuprofen to enable immediate release formulations and to solve drug release issues
· Clear commercialisation strategy with Proof-of-Concept clinical trials for OXPzeroTM Ibuprofen and Naproxen planned for 2015
· Strengthening of the Board with the recruitment of John Goddard and Karl Van Horn. Both individuals bring significant experience and expertise to the Board.
FINANCIAL HIGHLIGHTS
· Cash and cash equivalents balances of £6.7m as at 31 December 2014, providing sufficient working capital to take the Company to commercial inflection points in 2015 and beyond
· Operating loss of £3.50m (2013: £1.56m) reflecting a planned increase in R&D spend, primarily on the NSAIDs programme
Marcelo Bravo, Chief Executive, Oxford Pharmascience Group Plc, commented:
"We finish 2014 with sharp focus on our lead 'gastric safe' non-steroidal anti-inflammatory drugs (NSAIDs) programme which is redeveloping the most widely used NSAIDs, ibuprofen, naproxen, diclofenac and aspirin to make them significantly milder in the gastrointestinal (GI) tract. We believe that the Group is firmly on track to achieve the clinical milestones it has set out for 2015 and the Board believes that the Group is well placed to deliver significant shareholder value should the results of trials be as expected."
Contacts:
Oxford Pharmascience +44 20 7554 5875
Marcelo Bravo, Chief Executive
N+1 Singer +44 20 7496 3000
Aubrey Powell / Jen Boorer
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
We begin 2015 with sharp focus on our lead 'gastric safe' non-steroidal anti-inflammatory drugs (NSAIDs)programme which is redeveloping the most widely used NSAIDs, ibuprofen, naproxen, diclofenac and aspirin to make them significantly milder in the gastrointestinal (GI) tract. The most common side effects of traditional NSAIDs are that they can cause damage to the GI tract in the forms of erosions, ulcers and bleeding. Not widely appreciated, however, is that NSAIDs use also results in death (source: American journal of Gastroenterology estimates there are 15,000 - 20,000 such deaths per year in the USA alone). Yet these toxic effects remain largely a "silent epidemic," with most users unaware of the magnitude of the problem.
The global NSAIDs market, which in total is worth c.$12bn per year (source: Evaluate pharma), includes both an over-the-counter (OTC) market which is concentrated in the hands of several global brand owners and the prescription (Rx) market. The OXPZero™ technology can provide significant opportunity for commercial partners to differentiate and establish competitive advantage for their NSAID products while providing patients and health care systems with improved quality of care. In the OTC space, the technology offers brand owners the opportunity to leverage strong differentiating claims in consumer-led markets that are otherwise undifferentiated. This is particularly relevant as the OTC market has undergone considerable consolidation over the past year putting pressure on brand owners to innovate and differentiate. There is also a compelling business case in prescription markets where clinicians and payors are well aware of the problems caused by NSAIDs amongst patients using them to treat chronic conditions. Oxford Pharmascience (OXP) commissioned market research indicates a very robust prescription business case in the US with payor responses indicating broad reimbursement acceptance at $2 per day (vs. standard ibuprofen cost of $0.40 per day) for higher risk patients which represent 10 to 35% of total prescriptions depending on the condition.
The pivotal event for the Group in 2014 was the first in-human proof of concept trial (POC) of the OXPzero™ technology. This study tested OXP001, a 400mg tablet of OXPzero™ Ibuprofen against standard 400mg ibuprofen tablets over a seven day period with evaluation of GI tract erosions via endoscopy. The results of the trial announced in June 2014 showed that OXP001 was associated with significantly fewer erosions: the OXP001 arm displayed statistically significant 73% fewer erosions in the stomach and 89% fewer in the duodenum. The results were notable not only for the high level of GI erosions observed with standard ibuprofen after only seven days dosage, but, importantly also due to the dramatic reduction in erosions delivered by the OXPZero™ technology. Later in the financial year the Group also succeeded in carrying out further optimisation of the technology, to enable immediate release formulations and solve the drug release issues identified in the POC study for OXPzeroTM Ibuprofen.
Pipeline
Prior to this proof-of-concept study the Group was applying the OXPzero™ platform technology only as a taste masking technology for ibuprofen and intended to continue development through to market registration two taste-masked non-tablet forms of ibuprofen. However, given the strength and commercial significance of the proof-of-concept results the Group adjusted its commercial strategy and decided to apply the technology to other commonly used NSAIDs focusing on the benefit of reduced gastric irritation, thus significantly increasing the commercial potential of the Group's pipeline. The work of developing various taste-masked formulations continues but the Group does not intend to take these products through to registration. Instead, the Group will look to form strategic partnerships based on successful proof-of-concept data. This will allow a partner to tailor the registration of the product specifically to their needs.
In the second half of 2014 the Group accelerated the application of the technology to the most commonly used NSAIDs, namely naproxen, diclofenac and aspirin which alongside ibuprofen represent in excess of 80% of the vast NSAIDs market. The Group also carried out further optimisation of the technology to enable immediate release formulations and to solve drug release issues identified in the POC study.
In early 2015, the Group announced that it had successfully developed optimised immediate release formulations of OXPzero™ for both Ibuprofen and Naproxen and that it was proceeding to conduct proof-of-concept clinical studies with these products. OXPzero™ Ibuprofen headline pharmacokinetic (PK) data is expected by mid-2015 and headline endoscopy data is expected in Q3 2015. OXPzero™ Naproxen headline PK results are expected by the end of Q1 2015 and headline endoscopy data is expected in Q2 2015. Assuming the data from these studies is in line with expectations in confirming equivalent bioavailability vs. standard forms and confirmation of reduced gastrointestinal erosions, the Group believes that it will possess a robust data package with which it will be able to initiate partnering discussions during the second half of 2015. The third most commonly used NSAID for pain and inflammation is diclofenac and the Group is in advanced stage of development of OXPzero™ Diclofenac but does not intend to take this to the clinic at this stage. The Group is also in early formulation stage of an OXPzero™ Aspirin product aimed at long term anti-platelet treatment for cardiovascular disease. Further updates on this programme will be given throughout 2015.
The Group had announced that it had completed initial formulation development of Safestat™, its colon targeted drug delivery formulation of atorvastatin and was proceeding towards clinical proof of concept testing in late 2014. Given the focus on NSAIDs the Group has postponed this study but remains keenly interested in Safestat™ and the broader opportunities presented by this platform.
All of the OXP pipeline is protected by a comprehensive patent estate which is continually monitored to ensure optimal protection of Group IP.
Financial results
Over the last 12 months the Group has become increasingly focused on its development work across the NSAIDs platform. Nevertheless, as stated at the time of the interim results, the calcium supplement business continues to contribute revenue albeit at a lower level. Our revenue for the year to 31 December 2014 was £705k (2013: £1,029k). Our loss before tax was £3,464k (2013: loss of £1,536k), this increase is primarily as a result of the acceleration in 2014 of R&D investment in the NSAIDs programme. The Group continues to maintain a lean and agile business model which is able to both react quickly to opportunities whilst operating on a low cost base.
Cash and cash equivalents balance at the year-end were £6,706k (2013: £9,941k). This leaves the Group well-funded to deliver its NSAID portfolio through to anticipated commercial discussions and value inflection points in 2015 and beyond.
Outlook
The Board believes that the Group is on track to achieve the clinical milestones it has set out for 2015 and is well placed to deliver significant shareholder value should the results of trials be as expected. OXP has a small, yet highly skilled team and I would like to take this opportunity to thank them for their hard work and dedication in driving the development programmes forward. We look forward to continuing with the hard work during what will be an exciting and hopefully rewarding 2015.
David Norwood Marcelo Bravo
Chairman Chief Executive Officer
4 March 2015
OXFORD PHARMASCIENCE GROUP PLC
CONSOLIDATED INCOME STATEMENT
For the year ended 31 December 2014
Year to 31 December 2014 | Year to 31 December 2013 | |||
£'000 | £'000 | |||
Revenues | 705 | 1,029 | ||
Cost of sales | (482) | (693) | ||
Gross Profit | 223 | 336 | ||
Administrative expenses | (3,719) | (1,894) | ||
Operating loss | (3,496) | (1,558) | ||
Finance income | 32 | 22 | ||
Loss before tax | (3,464) | (1,536) | ||
Taxation | 600 | 49 | ||
Loss after tax attributable to equity holders of the parent | (2,864) | (1,487) | ||
Loss per share | ||||
Basic on loss for the period (pence) | (0.29) | (0.17) | ||
Diluted on loss for the period (pence) | (0.29) | (0.17) |
The loss for the year arises from the Group's continuing operations.
OXFORD PHARMASCIENCE GROUP PLC
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
For the year ended 31 December 2014
Share | Share | Merger | Share Based Payments | Revenue Deficit | Total | |
Capital | Premium | Reserve | Reserve | Reserve | Equity | |
£'000 | £'000 | £'000 | £'000 | £'000 | £'000 | |
At 31 December 2012 | 731 | 3,758 | 714 | 40 | (2,857) | 2,386 |
Comprehensive income | - | - | - | - | (1,487) | (1,487) |
Transactions with owners | ||||||
Issue of shares | 267 | 8,733 | - | - | - | 9,000 |
Expenses of share issue | - | (70) | - | - | - | (70) |
Share based payment | - | - | - | 71 | - | 71 |
Total transactions with owners | 267 | 8,663 | - | 71 | - | 9,001 |
At 31 December 2013 | 998 | 12,421 | 714 | 111 | (4,344) | 9,900 |
Comprehensive income | - | - | - | - | (2,864) | (2,864) |
Transactions with owners | ||||||
Exercise of share options | 8 | 149 | - | - | - | 157 |
Share based payment | - | - | - | 127 | 127 | |
Total transactions with owners | 8 | 149 | - | 127 | - | 284 |
At 31 December 2014 | 1,006 | 12,570 | 714 | 238 | (7,208) | 7,320 |
OXFORD PHARMASCIENCE GROUP PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
For the year ended 31 December 2014
31 December 2014 | 31 December 2013 | ||
£'000 | £'000 | ||
Assets | |||
Non-current assets | |||
Intangible assets | 43 | 51 | |
Property, plant and equipment | 5 | 5 | |
48 | 56 | ||
Current assets | |||
Inventories | 20 | 21 | |
Trade and other receivables | 838 | 252 | |
Cash and cash equivalents | 6,706 | 9,941 | |
7,564 | 10,214 | ||
Total Assets | 7,612 | 10,270 | |
Liabilities | |||
Current liabilities | |||
Trade and other payables | (292) | (370) | |
Net Assets | 7,320 | 9,900 | |
Equity | |||
Share capital | 1,006 | 998 | |
Share premium | 12,570 | 12,421 | |
Merger reserve | 714 | 714 | |
Share based payment reserve | 238 | 111 | |
Revenue deficit reserve | (7,208) | (4,344) | |
Total Equity | 7,320 | 9,900 |
Approved by the Board of Directors and authorised for issue on 4 March 2015.
Marcelo Bravo Christopher Hill
Chief Executive Officer Chief Financial Officer
Company number : 07036758
OXFORD PHARMASCIENCE GROUP PLC
CONSOLIDATED STATEMENT OF CASH FLOWS
For the year ended 31 December 2014
Year to 31 December 2014 | Year to 31 December 2013 | ||
£'000 | £'000 | ||
Operating Activities | |||
Loss before tax | (3,464) | (1,536) | |
Adjustment for non- cash items: | |||
Amortisation of intangible assets | 8 | 8 | |
Depreciation of property, plant and equipment | 2 | 2 | |
Finance income | (32) | (22) | |
Share based payment | 127 | 71 | |
Decrease in inventories | 1 | 21 | |
Increase in trade and other receivables | (191) | (38) | |
(Decrease)/increase in trade and other payables | (78) | 232 | |
Taxes received | 205 | 35 | |
Net cash outflow from operations | (3,422) | (1,227) | |
Investing Activities | |||
Finance income | 32 | 22 | |
Purchases of property, plant and equipment | (2) | (2) | |
Net cash inflow from investing activities | 30 | 20 | |
Financing Activities | |||
Proceeds from issue of share capital | - | 9,000 | |
Expense of issue of share capital | - | (70) | |
Proceeds from share option exercise | 157 | - | |
Net cash inflow from financing activities | 157 | 8,930 | |
(Decrease)/increase in cash and cash equivalents | (3,235) | 7,723 | |
Cash and cash equivalents at start of period | 9,941 | 2,218 | |
Cash and cash equivalents at end of period | 6,706 | 9,941 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
For the year ended 31 December 2014
The following notes have been extracted from the full notes to the audited report and accounts available on the Company's website www.oxfordpharmascience.com.
1. Summary of significant accounting policies
Basis of preparation
The Company's financial statements have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union ("IFRS") and IFRS interpretations as they apply to the financial statements of the Group for the period ended 31 December 2014 and applied in accordance with the Companies Act 2006.
Revenue recognition
Revenue is recognised to the extent that it is probable that economic benefits will flow to the group and the revenue can be reliably measured. Revenue is measured at the fair value of the consideration received or receivable for the sale of goods or services, excluding discounts, rebates, VAT and other sales taxes or duties.
The Group's income consists of sales of goods, licence fees, milestone and option payments, grant income and fees from research and development collaborations
Sale of goods is recognised when the Group has transferred to the buyer the significant risks and rewards of ownership.
Licence fees, option and milestone payments are recognised in full on the date that they are contractually receivable in those circumstances where:
· The amounts are not time related
· The amounts are not refundable
· The licensee has unrestricted rights to exploit the technology within the terms set by the licence
· The group has no further contractual duty to perform any future services
Where such fees or receipts are dependent upon future performance or financial commitments on behalf of the group, the revenue is recognised pro rata to the services or commitments being performed. Funds received which have not been recognised as revenue are treated as deferred revenue and recognised in trade and other payables.
Revenues from work or other research and testing carried out for third parties are recognised when the work to which they relate has been performed
Grant Income
Grant income is recognised as earned based on contractual conditions, generally as expenses are incurred.
Interest income
Interest income is recognised as interest accrues using the effective interest rate method.
Research and development
Research costs are charged to profit and loss as they are incurred. Certain development costs are capitalised as intangible assets when it is probable that the future economic benefits will flow to the Group. Such intangible assets are amortised on a straight-line basis from the point at which the assets are ready for use over the period of the expected benefit, and are reviewed for impairment at each year end date. Other development costs are charged against profit or loss as incurred since the criteria for their recognition as an asset are not met.
The criteria for recognising expenditure as an asset are:
· it is technically feasible to complete the product;
· management intends to complete the product and use or sell it;
· there is an ability to use or sell the product;
· it can be demonstrated how the product will generate probable future economic benefits;
· adequate technical, financial and other resources are available to complete the development, use and sale of the product; and
· expenditure attributable to the product can be reliably measured.
The costs of an internally generated intangible asset comprise all directly attributable costs necessary to create, produce and prepare the asset to be capable of operating in the manner intended by management. Directly attributable costs include employee costs incurred on technical development, testing and certification, materials consumed and any relevant third party cost. The costs of internally generated developments are recognised as intangible assets and are subsequently measured in the same way as externally acquired intangible assets. However, until completion of the development project, the assets are subject to impairment testing only.
2. Segmental information
At 31 December 2014 the Group operated as one segment, being the development and commercialisation of drug products from proprietary technology platforms. This is the level at which operating results are reviewed by the chief operating decision maker (the CEO) to make decisions about resources, and for which financial information is available. All revenues have been generated from continuing operations and are from external customers.
The Group operates in four main geographic areas, although all are managed in the UK. The Group's revenue per geographical area is as follows:
Year to | Year to | |
31 December 2014 | 31 December 2013 | |
Revenues | £'000 | £'000 |
Product sales | ||
UK | 13 | 17 |
Middle East | 51 | 95 |
Brazil | 641 | 881 |
Far East | - | 8 |
Other | - | 1 |
Total product sales | 705 | 1,002 |
Development income | - | 20 |
Grant income | - | 7 |
Total | 705 | 1,029 |
Segment operating loss | (3,496) | (1,558) |
Segment net assets | 7,320 | 9,900 |
* 2014: 100% (2013: 100%) of Brazil revenue is generated from one customer
All the Group's assets are held in the UK and all of its capital expenditure arises in the UK.
3. Loss per share
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.
31 December 2014 | 31 December 2013 | |
£'000 | £'000 | |
Loss attributable to the equity holders of the parent | (2,864) | (1,487) |
No. | No. | |
Weighted average number of ordinary shares in issue during the period | 1,003,295,548 | 877,206,949 |
Loss per share | ||
Basic on loss for the year | (0.29) | (0.17) |
Diluted on loss for the year | (0.29) | (0.17) |
The Company has issued employee options over 79,000,000 (2013: 14,500,000) 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.
4. Annual Report and Accounts
A copy of the Annual Report and Notice of AGM is being posted to shareholders today and will be made available on the Company's website:www.oxfordpharmascience.com.
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