2011 ANNUAL REPORT AND ACCOUNTS & AGM NOTIFICATION
Oxford UK - 27 April 2012: Oxford BioMedica plc (LSE: OXB) gives notice that copies of the 2011 Annual Report and Accounts and the Notice of Annual General Meeting have been sent to shareholders. These documents are available on the "Investors" section of the Company's website at www.oxfordbiomedica.co.uk. Oxford BioMedica plc has previously announced audited full year 2011 results in its notice of preliminary results on 6 March 2012.
Copies of these documents have been submitted to the UK Listing Authority for publication through the National Storage Mechanism, which is situated at The Financial Services Authority, 25 The North Colonnade, Canary Wharf, London, E14 5HS (UKLA telephone helpline: +44 (0) 20 7066 8333).
Further copies of the 2011 Annual Report and Accounts are available from the Company Secretary, Oxford BioMedica plc, Medawar Centre, Robert Robinson Avenue, Oxford Science Park, Oxford OX4 4GA (telephone number: +44 (0) 1865 783 000).
Oxford BioMedica plc also announces that its Annual General Meeting ("AGM") will be held on Thursday 7 June 2012. The meeting will be held at the offices of Covington & Burling LLP, 265 Strand, London WC2R 1BH, commencing at 10.00 a.m.
In accordance with the requirements of Rule 4.1 of the Disclosure Rules and Transparency Rules of the UK Financial Services Authority, the appendix to this announcement contains a description of the principal risks and uncertainties affecting the Group and a responsibility statement.
- Ends -
For further information, please contact:
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Tel: +44 (0)1865 783 000
Singer Capital Markets Limited:
Shaun Dobson/Claes Spång
Tel: +44 (0)20 3205 7500
Mary Clark/Sarah Macleod/Claire Dickinson
Tel: +44 (0)20 7920 2360
Notes to editors
1. Oxford BioMedica
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient LentiVector® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline with current partners and licensees including Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, VIRxSYS, Emergent BioSolutions and ImaginAb. Further information is available at www.oxfordbiomedica.co.uk.
1. Principal Risks and Uncertainties
Risk assessment and evaluation is an integral part of Oxford BioMedica's planning. Most of the Company's risks and uncertainties are common to all development-stage biopharmaceutical companies. Where possible, the Company's strategy is designed to manage and mitigate these issues. The Board has overall responsibility for the Group's systems of risk management and internal control. The management structure of the Group allows the Executive Directors to be personally involved in all material aspects of risk assessment, management and mitigation. The Board members have relevant qualification and experience, and they have access to external resources where required. The Board meets regularly and frequently enough for the full Board to stay informed in a timely manner and to oversee this activity. The following are the principal risks and uncertainties facing the business.
Intellectual Property and Patent Protection Risk
Oxford BioMedica's commercial success depends, amongst other things, on maintaining proprietary rights to its products and technologies and the Board gives high priority to the strategic management of the Company's intellectual property portfolio. There can be no assurance that Oxford BioMedica's products and technologies are adequately protected by intellectual property. If proceedings are initiated against the Company's patents, the defence of such rights could involve substantial costs and an uncertain outcome.
Third-party patents may emerge containing claims that impact Oxford BioMedica's freedom to operate. There can be no assurance that the Company will be able to obtain licences to these patents at reasonable cost, if at all, or be able to develop or obtain alternative technology. Oxford BioMedica aims to preserve the confidentiality of its technology. Where copyright, design right and/or "know how" protect the Company's products or technology, there can be no assurance that a competitor or potential competitor will not independently develop the same product or technology.
Rights of ownership over, and rights to licence and use, intellectual property depend on a number of factors, including the circumstances under which the intellectual property was created and the provisions of any agreements covering such intellectual property. There can be no assurance that changes to the terms within license agreements will not affect the entitlement of the Company to the relevant intellectual property or to license the relevant intellectual property from others.
Pre-clinical and Clinical Development
Oxford BioMedica currently has five products in active clinical trials: ProSavin®, TroVax®, RetinoStat®, StarGen™ and UshStat®. Results of pre-clinical studies are not necessarily indicative of results that may be obtained in clinical trials. The projected timetables for continued development of the technologies and related product candidates by the Company and/or its partners or licensees may be otherwise subject to delay or suspension. There is a risk that the failure of any one product candidate could have a significant and sustained adverse impact on the Company's share price. Furthermore, there is a risk that the failure of one product candidate in clinical development could have an adverse effect on the development of other product candidates, or on the Company's ability to enter into collaborations in respect of product candidates, or to raise additional funds.
Safety and Regulatory Risk
The clinical development and marketing approval of Oxford BioMedica's product candidates are regulated by healthcare regulatory agencies, such as the FDA, EMA, AFSSAPS and MHRA, in respective territories. The Company must conduct pre-clinical studies and clinical trials for each of its product candidates to demonstrate safety and efficacy, however there can be no assurance that the data collected will be sufficient to satisfy the relevant regulatory authorities. In addition, the continuation of a particular study after review by an independent data safety monitoring board or review body does not necessarily indicate that all clinical trials will ultimately be successfully completed.
During the development stage, regulatory reviews of clinical trial applications or amendments can prolong our anticipated development timelines. Similarly, there can be no assurance of gaining the necessary marketing approvals to commercialise our products. Each regulatory authority may impose its own restrictions on the product's use or may require additional data before granting approval.
Safety or efficacy issues may arise at any stage of the drug development process. Adverse or inconclusive results from pre-clinical testing or clinical trials may substantially delay, or halt, the development of Oxford BioMedica's product candidates, consequently affecting the Company's timelines for profitability. If regulatory approval is obtained, the product and manufacturer will be subject to continual review and there can be no assurance that such an approval will not be withdrawn or restricted.
Collaboration and Third-party Risk
Collaborations and licensing are an important component of Oxford BioMedica's strategy to realise value and manage risk. The Company is dependent on the successful outcome of relationships with outside parties as part of research, development, manufacture, commercialisation and marketing of products. There can be no assurance that the Company's existing relationships will not be terminated or require re-negotiation for reasons that may be unrelated to the potential of the programme.
Circumstances may also arise where the failure by collaborators and third parties, such as contract manufacturers, to perform their obligations in accordance with our agreements could delay, or halt entirely, development, production or commercialisation of our products, or adversely impact our cash flows. Currently, the Company's most important collaborators are Sanofi and Pfizer. If the relationship with either of these parties is adversely affected, Oxford BioMedica's development programme may also be adversely impacted.
Pharmaceutical Pricing and Government Risk
The ability of Oxford BioMedica and its partners to commercialise their products may depend on the availability of reimbursement from government health administration authorities, private health coverage insurers and other organisations. There is no assurance that adequate reimbursement will be available or that satisfactory price levels will be reached.
If satisfactory pricing cannot be obtained, the Company's future profitability would be adversely affected. In addition, there is increasing pressure by certain governments to contain healthcare costs by limiting both coverage and the level of reimbursement. Based on pre-clinical studies, Oxford BioMedica's LentiVector® platform product candidates have the unique potential to provide permanent therapeutic benefit from a single administration. The pricing of these therapies will depend on assessments of their cost-benefit and cost effectiveness.
All governments reserve the right to amend their policies in relation to the full, partial or non-reimbursement of the price of pharmaceutical products. These policies are subject to change at any time in any country and can impact profoundly upon the pharmaceutical industry as a whole or in part.
Competition Regulation and Risk
Oxford BioMedica is subject to UK and EU competition law which may impose fines on companies which enter into agreements that restrict competition in the EU e.g. licenses or patents which restrict competition. The Company's competitors and potential competitors include major pharmaceutical and biotechnology companies who may have superior research and development capabilities, drugs, manufacturing capability or marketing expertise.
Through the Company's collaborative strategy, Oxford BioMedica aims to work with leading companies in respective therapeutic areas. However, there can be no assurance that competitors will not succeed in establishing superior proprietary positions and developing products and technologies that are more effective or economic than the Company's.
The Company is of the opinion that, taking into account existing cash balances, the Group has sufficient working capital for its present requirements. Oxford BioMedica's future capital requirements to support operating activities and to implement Oxford BioMedica's business strategy are not yet known and will depend inter alia on the amount of new commercial funding that it can generate.
Oxford BioMedica's strategy is to add value to its priority in-house programmes by investing in further development. The Company aims to offset operating costs through partnering and other licensing income. Under the terms of the Company's current collaborations, the receipt of further income is dependent on the achievement of specific milestones related to development, regulatory or commercial progress. Similarly, the timing and magnitude of income from new collaborations is inherently unpredictable.
It is possible that the Company may require additional financing for the future operation of its business, including further equity funding as appropriate where dilution to the then existing Shareholders may result. The level and timing of future expenditure will depend on a number of factors, many of which are currently outside Oxford BioMedica's control. There is no certainty that adequate financial resources will be available on a timely basis.
While Oxford BioMedica has employment contracts with all of its personnel, the retention of their services cannot be guaranteed. Recruiting and retaining key management and scientific personnel is critical to the Company's success. The loss of those employees could weaken Oxford BioMedica's scientific and management capabilities, resulting in delays in the development of its drugs and impacting negatively on the Company's business.
Oxford BioMedica's product candidates use specialised manufacturing processes for which there are few suitable manufacturing contractors. There can be no assurance that the Company's current contractors will continue to make capacity available at economic prices, or that suitable new contractors will enter the market. Oxford BioMedica has taken steps to actively mitigate this risk by investing in its own manufacturing capability via the acquisition of a UK manufacturing facility in February 2011. There is no guarantee that the in-house capability that the Company is seeking to commission will be able to supply material for clinical use on a timely and cost effective basis.
Manufacturing processes that are effective and practical at the small scale required by the early stage of clinical development may not be appropriate at the higher scale required for later stages of clinical development or for commercial supply. There can be no assurance that Oxford BioMedica will be able to adapt current processes or develop new processes suitable for the scale required by later stages of clinical development or commercial supply in a timely or cost-effective manner, nor that the in-house facility or external contractors will be able to provide sufficient manufacturing capacity when required.
Gene Therapy Risk
No gene-based medicines are currently approved for sale in the USA or EU. The commercial success of Oxford BioMedica's products will depend, in part, on acceptance by the medical community and the public. Furthermore, specific regulatory requirements, over and above those imposed on other products, apply to gene therapy and there can be no assurance that additional requirements will not be imposed in the future. This may increase the cost and time required for successful development of the Company's products.
2. Directors' responsibility statement
Each of the Directors, whose names and functions are listed below confirm that, to the best of their knowledge:
· the Group Financial Statements, which have been prepared in accordance with IFRSs as adopted by the EU, give a true and fair view of the assets, liabilities, financial position and loss of the Group; and
· the Directors' Report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the principal risks and uncertainties that it faces.
Dr Andrew Heath
Deputy Chairman and Senior Independent Director
Dr Paul Blake
Chief Executive Officer
Chief Financial Officer
Dr Stuart Naylor
Chief Scientific Officer
Senior Vice President: Commercial Development
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