PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DEC 2016

RNS Number : 6201Z

Oxford Biomedica PLC

16 March 2017

 

                                                       OXFORD BIOMEDICA PLC             

PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2016

Oxford, UK - 16 March 2017: Oxford BioMedica plc (LSE: OXB), ("OXB" or "the Group") a leading gene and cell therapy group, today announces preliminary results for the twelve months ended 31 December 2016.

HIGHLIGHTS (INCLUDING POST-PERIOD END)

OPERATIONAL

Leading LentiVector^® delivery platform for gene and cell therapy partnerships

-     Novartis collaboration progressing well with blockbuster potential product CTL019 close to market and second undisclosed CAR-T programme

-      Strategic alliance established with Orchard Therapeutics to develop and supply lentiviral vectors for ex vivo treatments

-       Immune Design collaboration expanded, including licence to use lentiviral vector-based products for in vivo treatments for cancer

-       New R&D collaboration with Green Cross LabCell focused on gene modified natural killer (NK) cell-based therapies

-    200 litre bioreactor production process established at commercial scale with potential to increase yield substantially and reduce cost of a patient dose

-       Transgene Repression In Vector Production (TRiP) system developed to enhance the production titres of a broad range of gene therapy vectors

State-of-the-art bioprocessing and laboratory facilities

-       Major capacity expansion completed

-       MHRA approval granted for GMP vector manufacture

-       Vector production volume increased by 54% compared with 2015

Progress with proprietary product development

-   Ground-breaking long-term results seen from follow-up studies of patients treated with OXB-101 (for Parkinson's disease) and OXB-201 (for wet AMD)

-    OXB-102 (for Parkinson's disease) and OXB-202 (for corneal graft rejection) ready to start Phase I/II studies following out-licensing / spin out

-     OXB-302 (for solid cancer tumours) pre-clinical proof-of-concept achieved and ready for further development following out-licensing / spin out

-       SAR422459 (licensed to Sanofi for Stargardt disease) in Phase II development

FINANCIAL

-    Gross income ⁽¹⁾ increased by 64% to £30.8 million (2015: £18.8million)

-   Operating expenses excluding depreciation and amortisation and share based payments increased by 4% to £26.1 million (2015: £25.1 million)

-    EBITDA loss reduced to £7.1 million (2015: £12.1 million)

-    EBITDA loss in second six months reduced to £1.9 million (2015: £4.7 million)

-    Operating loss £11.3 million (2015: £14.1 million)

-    Net cash used in operating activities reduced to £5.1 million (2015: £13.1 million)

-    Capital expenditure £6.5 million (2015: £16.7 million)

-   Cash of £15.3 million (31 December 2015: £9.4 million) including $10 million (£8.1 million) ring-fenced under Oberland loan agreement

-    Fundraising of £17.5 million net

(1)   Gross income is the aggregate of revenue (£27.8 million) and other operating income (£3.0 million) (2015: £15.9 million and £2.9 million respectively)

CORPORATE

-    Tim Watts, Chief Financial Officer, will leave the Board and the Group in September 2017.  His successor, Stuart Paynter, will join the Group in August 2017.

Commenting on the Group's 2016 full year results, John Dawson, Oxford BioMedica's Chief Executive Officer, said:

"Oxford BioMedica has a world-leading lentiviral vector delivery (LentiVector^®) platform for gene and cell therapy which is becoming the platform of choice for lentiviral vector products. With state-of-the-art bioprocessing and laboratory facilities our gross income is growing rapidly and, as the manufacturer of the lentiviral vector for Novartis' blockbuster-potential therapy CTL019, we look forward to the product's launch as the Group will benefit from supplying the viral vector and a royalty on CTL019's sales. Beyond Novartis, we have added new revenue-generating partnerships and collaborations during 2016 which are progressing well and are confident we can add further relationships during 2017. The process to spin-out or out-license our priority product development candidates is well underway and I am optimistic we will have success with this in 2017. We will continue to invest in our platform technology in order to consolidate our leadership position and in our gene and cell therapy product concepts so that we exploit our LentiVector^® platform to the full."  

Conference call for analysts

A briefing for analysts will be held at 9:30am GMT today at 85 Gresham Street, London, EC2V 7NQ.  There will be a simultaneous live conference call with Q&A and the presentation will be available on the Group's website at www.oxfordbiomedica.co.uk.

Please visit the website approximately 10 minutes before the conference call to download the presentation slides.  Conference call details:

Participant dial-in: 08006940257
International dial-in: [phone]
Participant code: 89005113

An audio replay file will be made available shortly afterwards via the Group's website: www.oxfordbiomedica.co.uk

For further information, please contact:

Oxford BioMedica plc:    Tel: [phone]

John Dawson, Chief Executive Officer
Tim Watts, Chief Financial Officer

Financial PR Enquiries:  Tel: [phone]

Mary-Jane Elliott / Matthew Neal / Chris Welsh / Laura Thornton
Consilium Strategic Communications

Jefferies (Corporate Broker): Tel: [phone]

Gil Bar-Nahum

Simon Hardy

Lee Morton

Max Jones

Nicholas Moore

About Oxford BioMedica

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector^®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, Orchard Therapeutics and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.

Disclaimer

This press release contains "forward-looking statements", including statements about the discovery, development and commercialisation of products. Various risks may cause Oxford BioMedica's actual results to differ materially from those expressed or implied by the forward-looking statements, including adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. Oxford BioMedica disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CHAIRMAN'S STATEMENT

A year after joining Oxford BioMedica as Chairman, I am pleased to report that the Group has made good progress in reviewing and refining its strategy and advancing its operational activities. With the continued support of shareholders, the Group is progressing towards its goal of becoming a financially robust gene and cell therapy business.

Strategy

The field of gene and cell therapy holds significant promise, with the first commercial products now launched and others rapidly approaching the market. The gene and cell therapy market has the potential to grow into a multi-billion dollar sector and Oxford BioMedica has the expertise with lentiviral vectors to fully benefit from this opportunity.

During the first few months of 2016 the Board and management team reviewed the Group's strategy in the light of the evolution seen in the business and the sector since we signed the Novartis contract in 2014. I reported the results of this review in my statement in the 2015 Annual Report - the key conclusions were that the Group has an outstanding gene delivery platform (LentiVector^®) which can be used to develop our own gene and cell therapy products and also to assist in the development of third party products in exchange for revenues from process development, bioprocessing and IP-related royalties.

During the summer months we further refined the strategy. Taking into account the balance of risk and reward, given the substantial investment required over the next two to three years to conduct the Phase I/II studies and future development work for Phase III and commercialisation, we decided that the optimal way forward for the priority clinical product candidates is to spin them out into one or more product-focused special purpose vehicles (SPVs) with dedicated externally-sourced funding, or to out-licence them. This approach will ensure that the Group's priority clinical assets (OXB-102 for Parkinson's disease, OXB-202 for corneal graft rejection, and OXB-302 a CAR-T cell approach to targeting solid tumours) are advanced using external funding whilst capturing value via a potential combination of upfront payments and/or equity stakes, development milestones and royalties.

This strategy provides the right balance for our shareholders as the Group will have exposure to multiple products in the rapidly advancing gene and cell therapy field with the potential for significant economic upside. Concurrently, operational costs will be covered by revenues from bioprocessing work with partners, while using external funding for our priority development programmes will greatly reduce the Group's R&D expenditure. As a result, the Group's risk / reward profile will be closely managed and economic interests in the future success of exciting high-value new therapies will be retained.

Operational progress

Operationally the Group has made good progress during the year, providing Oxford BioMedica with world-leading, state-of-the-art gene therapy facilities. The major expansion of the bioprocessing and laboratory facilities was completed by mid-year and the necessary regulatory approvals for the manufacture of clinical grade lentiviral vectors have been received. As a result of this, the Group has now fully relocated its headquarters from the Medawar Centre, which had been the Group's headquarters for the past twenty years, to Windrush Court.

The Group continues to supply lentiviral vector to Novartis for its CTL019 clinical studies with production volumes increasing over the course of 2016 as our new facilities started production. Following impressive results of the ELIANA clinical study in r/r paediatric ALL patients, announced by Novartis in December 2016, Novartis indicated its intention to submit CTL019 for approval by the FDA in early 2017 and we look forward to continuing to supply vector to them.

The potential of our strategy and business model has already seen results with new partnerships and collaborations announced during 2016. Finally, we have made steady progress in preparing our priority product candidates for entry into clinical studies and we are encouraged by the significant interest shown from third parties wishing to invest in the next stage of development of these products.

Building financial resilience

I am very grateful to our existing and new shareholders who helped us to raise £17.5 million (net of expenses) during the year. The Group has substantially grown its revenues over the past three years and the operational cash burn has been reducing in parallel. The Board and management team are determined to fully utilise the expanded facilities to continue to grow the revenues to a point where the Group generates positive cash flow making it more financially robust.

Board changes and organisation

I was delighted to join the Group as Chairman in early 2016 and I thank Nick Rogers, the outgoing Chairman for his contribution to the Group over many years and also for his support during the three-month transition period. The Board was strengthened with the appointment of a new non-executive director and Audit Committee Chairman, Stuart Henderson, who has many years' experience of the healthcare and life sciences sectors from his time as an audit partner at Deloitte and Arthur Andersen. Daniel Soland and Paul Blake stepped down from the Board during the year and we recently announced that Tim Watts is retiring from executive roles and will leave the Company and the Board in September 2017. The Board thanks all of them for their valuable contributions.  Tim Watts will be succeeded by Stuart Paynter who will join the Company in August 2017.

I would also like to recognise and thank all the Group's employees for the outstanding contribution they have made which I know has demanded a huge effort. It is always the case that the success of an organisation depends first and foremost on its people and Oxford BioMedica is no exception to this.

Outlook

I look forward to 2017 with confidence that it will be a successful and important year for the Group. We are pleased to be supporting Novartis' breakthrough therapy, CTL019, which they believe is a potential blockbuster product. We hope that it will be approved and launched in the USA this year. I also believe that our other current partnership programmes will progress well and that we will be able to announce other similar collaborations that will help make the business model even more robust. I expect that we will find ways to advance our own priority programmes in a way that creates value for shareholders at an acceptable level of risk. By the end of 2017, I anticipate that the Group will have grown its partnerships and revenues significantly and that our own priority product candidates will be making progress with funding from third parties.

Dr Lorenzo Tallarigo

Chairman

CHIEF EXECUTIVE'S REVIEW

Building a successful gene and cell therapy business

In his Chairman's Statement, Lorenzo has explained our strategy and how it developed during 2016. Our business model is fundamentally built on our world- leading LentiVector® gene delivery platform, which is the result of over 20 years of pioneering science in the lentiviral vector field. Oxford BioMedica was the first organisation of any kind to administer lentiviral vectors in vivo, meaning that we had to solve many technical challenges to ensure that the vector we administered would be safe and sufficiently purified and concentrated to be effective. These experiences helped to give us the lead we have today. Lentiviral vectors are key components of many promising new gene and cell therapies, and so our LentiVector^® platform provides us with opportunities to generate short- and longer-term value through:

- In-house development: we have our own portfolio of LentiVector^® platform gene and cell therapy product candidates. During 2016, we decided that clinical studies for these candidates will be developed with third party finance, using either out-licensing or by spinning out the programmes into one or more special purpose vehicles. This will significantly reduce the cost and risk associated with clinical development while providing us with significant equity stakes and/or potential upfront, milestone and royalty payments as well as bioprocessing and process development revenues. We will continue to invest in early stage product concept development and pre-clinical studies with a view to maintaining a pipeline of candidates ready for clinical studies.

- Partnering: we can provide our bioprocessing and process development expertise and facilities to third parties who want to accelerate the development of their own lentiviral vector programmes, in return for which we receive short and medium term revenues and longer term royalties based on licences to our extensive know-how as well as our patents.

- Freedom-to-operate licensing: we can provide other organisations with licences to use our important patents relating to lentiviral vector safety features and manufacturing efficiencies.

Advancing our business

During 2016, we have made significant progress in these areas of our business. The two-year programme to expand our bioprocessing and laboratory facilities has been essential to the delivery of the Novartis contracts and to our strategy of building a revenue-generating and financially robust business. The expansion programme lasted from October 2014 to June 2016 with a £26 million capital investment. We now have two clean rooms, previously only one, in our Harrow House facility in Oxford and a third clean room at our Yarnton site just outside Oxford. We acquired Windrush Court in October 2014 and re-developed it to include a suite of state-of-the art biological laboratories which are large enough to handle the analysis of increasing volumes of vector manufacture and also the process development for our partners and our own technology development requirements. These facilities were all approved by the UK regulator in 2016. The increased capacity is leading to significant growth in our revenues with gross income rising to £31 million in 2016 from £19 million in 2015.

To date much of these increasing revenues come from our relationship with Novartis but we are already starting to diversify our revenues by working with more partners. I am proud that we are supporting Novartis in bringing CTL019 to the market by supplying the lentiviral vector needed for their clinical studies, assisting them in preparing the application for approval of CTL019 for r/r paediatric ALL and in developing the next generation of vector manufacturing processes.

We have also expanded our relationship with Immune Design and signed new partnerships and collaborations with Orchard Therapeutics and Green Cross LabCell. These demonstrate the power of our technology and the business model at work and discussions are underway with several other potential partners. We are determined to keep our leading position in lentiviral vector technology and we are therefore continuing to invest in R&D activities in this field.

We have decided that the optimum way to advance our product candidates which are ready to enter clinical studies is to reduce the financial risk to the Group by out-licensing or spinning them out into special purpose vehicles (SPVs). The intention with SPVs is that the Group will contribute the product and related IP to the SPVs with third parties contributing the necessary funding to carry out Phase I/II clinical studies. We would expect to own a substantial proportion of each SPV. I am pleased to report that our priority product candidates are all close to the point where they could enter clinical studies subject to the right funding model. We have already seen significant interest from both pharmaceutical companies and venture capitalists in our product candidates and I am confident that we will report progress with this in 2017. Since our LentiVector® platform has the potential to generate new gene and cell therapies, we intend to continue to invest in discovery research and pre-clinical product concepts to the point of being ready for clinical studies and potential spin out or out-licensing.

A promising future

In the coming year we intend to build on the progress of 2016. The progress of our Novartis collaboration underlines our credibility and strengthens our position as a partner-of-choice in this rapidly developing field. We anticipate Novartis reaching a significant milestone in the coming year, with the approval and launch of CTL019, for r/r paediatric ALL, representing the first ever launch of a therapeutic product incorporating our LentiVector® technology and leading to further bioprocessing revenues and a new royalty stream. Our recent agreement with Orchard Therapeutics for the development of cell therapies for life-threatening immune deficiency and metabolic disorders highlights the increasing industry demand for our proprietary lentiviral vector technology and I look forward to establishing further partnerships. In addition, we are focused on making progress in out-licensing or spinning out our in-house priority product candidates, allowing them to move quickly through clinical development to benefit both patients and shareholders.

Following a number of years of steady progress, we have built an enviable leadership position in the field of gene and cell therapy. With world-class facilities, unrivalled intellectual property and an exciting pipeline of products, I look forward to accelerating the progress in each area of the Group in 2017 as we move closer towards our goal of becoming a self-sustaining, world-class gene and cell therapy company.

John Dawson

Chief Executive Officer

OPERATIONAL REVIEW

Advancing our in-house products

During the first half of 2016, the Group concluded a review of its in-house portfolio to prioritise the product candidates with the most compelling value propositions based on risk, probability of success and reward. While highly promising, these priority products will require significant financial resources to progress through clinical studies in the coming years. Therefore, Oxford BioMedica is now pursuing an external funding strategy to advance their clinical-stage development through out-licensing or spinning out the assets into special purpose vehicles (SPVs) which could be funded by third parties. This approach will allow the Group to retain significant economic interest while removing the financial commitment associated with further development.

In recent months, the Group's three priority candidates OXB-102, OXB-202 and OXB-302 have continued to progress. The Group has entered discussions with a number of third-parties regarding potential out-licensing/ spin out, and if these are successful all three products are well positioned to move into the clinic.

·              OXB-102 targeting Parkinson's disease

Parkinson's disease affects over 1.7 million people in the US, Japan and EU5 alone, and it is a significant unmet medical need. Oxford BioMedica's second generation gene therapy targeting the disease, OXB-102, encodes three enzymes in the dopamine biosynthetic pathway and is designed for delivery as a single treatment directly into a key region of the brain implicated in Parkinson's disease. OXB-101 (ProSavin®), the Group's first generation approach, showed very encouraging efficacy and four-year duration in a Phase I/II clinical study which provides great encouragement for OXB-102. OXB-102 has delivered compelling proof-of-concept results in a 'gold standard' model of Parkinson's disease indicating potency 5-10 times greater than OXB-101, and the Group has completed manufacturing of GMP clinical study material in preparation for the next stage of development. The Group has been working on appropriate regulatory approvals for a planned three cohort Phase I/II study to be conducted in Cambridge and London, UK and Paris, France.

·              OXB-202 targeting corneal graft rejection

The cornea is one of the most successfully transplanted tissues but a significant number are rejected due to neovascularisation. Currently, approximately 100,000 transplants are performed each year, and this is predicted to increase significantly. Oxford BioMedica's gene therapy, OXB-202, genetically modifies the cornea using the LentiVector® platform to express two anti-angiogenic proteins that inhibit neovascularisation following transplant. This gene therapy has achieved impressive proof-of-concept results showing significantly reduced neovascularisation in a corneal rejection model. The Group has been working on appropriate regulatory approval for the initiation of a Phase I/II clinical study in the UK.

·              OXB-302 (CAR-T 5T4) targeting a range of cancers

Most solid tumours and a number of haematological malignancies express the 5T4 oncofoetal antigen, while its profile is highly restricted on normal tissues. This makes the antigen an attractive therapeutic target, and Oxford BioMedica's cell therapy, OXB-302, is designed to destroy cancer cells expressing the antigen. OXB-302 is based on a modified autologous T-cell that is engineered using a lentiviral vector to express a chimeric antigen receptor (CAR) targeting 5T4. When these CAR-T cells are infused into the patient they bind to the antigen, triggering normal immune mechanisms that kill the cancer cells. OXB-302 has completed pre-clinical development, delivering encouraging efficacy in an in vivo industry standard tumour challenge model.

OXB-302 has now completed pre-clinical studies which have demonstrated proof of concept in both in vitro and in in vivo industry-standard models. Highlights from the studies include the ability of 5T4 CAR-T cells to kill a wide range of 5T4 expressing tumour cell lines in vitro; the ability of T cells taken from patients with ovarian cancer to be re-programmed with the 5T4 CAR construct and respond functionally to their own tumour cells in vitro through the secretion of cytokines; and the ability of 5T4 CAR-T cells to control tumour cell growth in in vivo models. Further data will be presented in due course either at a conference or in a publication.

·              OXB-201 targeting Wet Age-related Macular Degeneration (Wet AMD)

In May 2016, data was presented at the Association for Research in Vision and Ophthalmology (ARVO) conference demonstrating that lentiviral vector gene expression measured in the eyes of patients treated in the Phase I/II study continued without significant decline for more than four years. We believe this is the first time such longevity of expression has been shown and the data reinforces the benefits of the Company's pioneering LentiVector® gene delivery platform in the treatment of chronic conditions.

·              OXB-301 cancer vaccine

In February 2017 the clinical investigators leading the open-label Phase I/II clinical trial in 53 patients with advanced colorectal cancer (TaCTiCC) presented a poster at the American Society of Clinical Oncology and Society for Immunotherapy of Cancer (ASCO-SITC) symposium. The study findings demonstrated that significant anti-5T4 immune responses were generated at treatment day 43. Secondary analysis revealed that both low dose cyclophosphamide and OXB-301 (TroVax®) independently induced highly beneficial anti-tumour immune responses, resulting in significant survival of end stage colorectal cancer patients, without any major toxicity. This was the first randomised study to show a benefit of immunotherapy in advanced colorectal cancer patients.

Partnership products

By providing our partners with access to our LentiVector^® gene delivery platform, Oxford BioMedica generates significant revenues while retaining the upside potential of milestone payments and royalties on future product sales. During 2016, the Group contributed to the progress of a number of partners' products towards the market:

Sanofi (SAR422459 and SAR421669)

Oxford BioMedica has previously licensed to Sanofi SAR422459, for the treatment of Stargardt disease, and SAR412669, for the treatment of Usher syndrome type 1B. These products have continued to make progress in their Phase I/II clinical studies. The Group has no further financial liability for the development of these products although it is supporting Sanofi with analysis of clinical study samples and is entitled to receive development milestone payments and royalties on future sales.

Novartis (CTL019)

Throughout 2016, the Group produced CTL019 batches for Novartis at our original Harrow House clean room and at our new facility at Yarnton. With significantly increased capacity now fully operational, production revenues have grown substantially compared to 2015. The Group also continued its process development activities for Novartis. In December 2016, Novartis announced the results of the ELIANA study which evaluated the efficacy and safety of CTL019 in relapsed/refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL). Novartis has indicated their intention to submit CTL019 for approval by the US regulatory authority in early 2017. Based on this the Group anticipates a potential launch in H2 2017, with further revenues for manufacturing batches of the lentiviral vector and royalties becoming payable on product sales.

Immune Design (LV305)

In the first half of 2016, Immune Design expanded its collaboration with Oxford BioMedica to include a licence for the use of lentiviral vector-based products in the in vivo treatment and prevention of cancer. Immune Design is currently progressing gene therapy products targeting NY-ESO-1 expressing tumours with clinical development underway in a number of cancers, including soft tissue sarcoma.

Orchard Therapeutics (ADA-SCID, MPS III A)

The Group signed a new collaboration with Orchard Therapeutics focusing on the development of transformative gene therapies for patients with serious life threatening orphan diseases. Oxford BioMedica will initially develop and supply lentiviral vectors for two of Orchard Therapeutics' stem cell based treatments, targeting primary immune deficiency and metabolic disorders.

Discovery and pre-clinical

The Group will continue to invest in the identification and early-stage development of novel gene and cell therapy products based on the LentiVector^® gene delivery platform. This approach is designed to provide an ongoing pipeline of next generation product candidates while also building new intellectual property to maintain Oxford BioMedica's leadership position in the gene and cell therapy field. The Group is currently investing in a number of product concepts including the new NK cell research and development collaboration with Green Cross LabCell. Where appropriate, the Group would also consider in-licensing suitable targets and technologies.

Bioprocessing

State-of-the-art commercial-scale facilities

During 2016, the Group completed its £26 million facilities expansion programme and obtained UK regulatory approval for GMP bioprocessing and analytical testing at its custom-built clean room production suites and state- of-the-art biological laboratories. The Group's GMP clean room footprint has increased three-fold to 1,200m².

The Group's expanded facilities are now fully operational, and provide capabilities for both current and next generation lentiviral vector production, as well as offering sufficient capacity for existing partners, future collaborations and in-house platform development work. During 2016, two clean room suites at the Group's Yarnton and Harrow House GMP bioprocessing facilities were dedicated to production for our partners. The third clean room suite, located at Harrow House which came into operation mid-year, has been used for the development of next generation processes designed to substantially improve bioprocessing yields and volume.

These production facilities are complemented by Oxford BioMedica's purpose-built laboratories at Windrush Court, which were approved by the UK regulatory authorities in July for analytical testing of GMP material. Following the completion of the expansion programme the Group has now moved out of its previous facilities at the Medawar Centre on the Oxford Science Park.

Next generation bioprocessing

Using its development expertise, Oxford BioMedica has successfully established a novel next generation lentiviral vector production process at commercial scale. This new process uses self-contained, single-use 200 litre bioreactors, greatly improving efficiency and increasing production capacity by approximately 600%. The serum-free, suspension cell line process boosts productivity, offering the prospect of significantly reduced cost per dose and substantially greater volumes allowing the possibility of developing therapies for indications requiring large doses of vector (e.g. liver or lung disease). This technological advance will allow Oxford BioMedica to address the industry's challenge of bridging clinical and commercial supply, thereby maintaining the Group's position as a partner-of-choice in the gene and cell therapy field.

Leveraging our industry-leading intellectual property

As an original pioneer of gene and cell therapy, we have a strong position in lentiviral vector intellectual property, in both patents and know-how. Between 2017 and 2023 many of the core patents will expire although we will still benefit from them over the period. However our extensive world-class know-how is now increasingly important to our business model. The know-how covers lentiviral vector optimisation, process development and manufacturing.

In 2016, we filed an international patent application for technology which increases vector yields and particle purity. The TRiP (Transgene Repression in vector Production) system represses the expression of transgene during the manufacturing process as this can adversely impact vector yield and purity.

During 2016, we also announced new data from two clinical studies indicating ground-breaking long-term four year sustained and, in one of the studies, dose-dependent gene expression with the Group's LentiVector® delivery platform.

In the Phase I/II study of OXB-101 for the treatment of Parkinson's disease (PD) 15 advanced stage patients were treated with OXB-101 in three dose cohorts and demonstrated a favourable safety profile and a statistically significant improvement in motor function relative to baseline at six and 12 months post-treatment. The follow-up data, which was presented in May 2016 at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), showed that the majority of patients continued to experience improvement in motor function relative to baseline over the four years since treatment.

In addition, in May 2016, new data were presented at the Association for Research in Vision and Ophthalmology (ARVO) conference. The new data demonstrates that lentiviral vector gene expression is dose-dependent and continued without significant decline for more than four years. We believe this is the first time gene therapy products have been directly measured in the eye and the longevity in both expression and efficacy to date reinforces the benefits of the Company's pioneering LentiVector® gene delivery platform in the treatment of chronic conditions.

FINANCIAL REVIEW

In 2016 we started to deliver the financial transformation of the Group. Gross income increased by 64% over 2015 and "EBIDA" losses (EBITDA adjusted by the R&D tax credit) were reduced from £8.1 million to £3.4 million.

The growth in gross income was enabled by our new bioprocessing and laboratory facilities coming online during 2016. During 2015, bioprocessing volume output was limited by having only our original GMP clean room suite in Harrow House operational. In 2016, we brought the second GMP clean room into operation at the start of the year, at our new Yarnton site, and the third suite (the second Harrow House suite) came online mid-year at the same time as the new and larger laboratories in Windrush Court. This extra capacity allowed us to step up the production of CTL019 vector production for Novartis and the facilities were all operated virtually continually throughout the year except for planned shutdown periods.

Whilst gross income grew by 64%, our operating costs however, other than Cost of Sales, grew by only 12% and by only 4% when depreciation, amortisation and share bonus payments are excluded. In 2015, I explained that we had grown our headcount and cost base significantly as we built the teams necessary to operate the facilities and processes in 2016. We have seen the benefit from this in 2016 as end-year headcount numbers rose by only 25 from 231 at December 2015 to 256 at December 2016, and we were able to operate the new facilities fully as soon as they became available.

The revenue growth to date has been dominated by our relationship with Novartis and we expect this relationship to continue to grow. But we have also started to bring in new business from partners such as Immune Design and Orchard Therapeutics and we expect that we will generate further such relationships in 2017.

The capital markets were challenging in 2016 but we were able to raise £19.6 million gross proceeds during the year from both existing shareholders and new investors. Having assessed the financial risk/reward profile we decided to continue the development of our priority product projects whilst minimising our expenditure by seeking funding for the clinical studies from third parties such as venture capital funds or larger pharmaceutical companies.

Key Financial Indicators

The Board regularly reviews the Key Financial Indicators set out below:

Key Financial Indicators (£m)	2016	2015	2014
Gross income
-               Bioprocessing/commercial development	24.0	12.4	7.2
-               Licences, milestones, grants	6.8	6.4	7.5
Total	30.8	18.8	14.7
EBITDA	(7.1)	(12.1)	(9.3)
EBIDA	(3.4)	(8.1)	(7.2)
Operating loss	(11.3)	(14.1)	(10.6)
Cash used in operations	5.9	14.9	7.4
Capex	6.5	16.7	5.6
Cash burn	11.5	29.8	11.6
Period end cash
-               Cash	15.3	9.4	14.2
-               Loan	34.4	27.3	1.0
Headcount
-               Year end	256	231	134
-               Average	247	196	113

Gross income

£m	2016	2015	2014
Revenue	27.8	15.9	13.6
Other operating income	3.0	2.9	1.1
Gross income	30.8	18.8	14.7

Gross income increased to £30.8 million, giving 64% growth over 2015 (£18.8 million). Revenues generated from bioprocessing/commercial development almost doubled to £24.0 million (from £12.4 million in 2015) due to using the new capacity in 2016 as described above and is up 233% since 2014. The £6.8 million income generated from licence upfront payments, performance incentives and grants has remained broadly constant over the past three years (2015 £6.4 million; 2014 £7.5 million) despite comprising individual items which are lumpy by nature.

A substantial portion of the gross income derives from our relationship with Novartis but revenue was also generated from the partnerships with Immune Design and Orchard Therapeutics, which we expect to grow in 2017.

EBITDA/EBIDA

EBITDA (Earnings Before Interest, Tax, Depreciation and Amortisation and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share options.

EBIDA is an internal measure used by the Group, defined as EBITDA with the R&D tax credit included. The Board refers to EBIDA periodically as the R&D tax credit is, in essence, a subsidy or grant which offsets the Group's R&D expenditure.

£m	2016	2015	2014
Gross income	30.8	18.8	14.7
Cost of sales	(11.8)	(5.8)	(4.4)
Operating expenses (excluding depreciation, amortisation and share option charge)	(26.1)	(25.1)	(19.6)
EBITDA	(7.1)	(12.1)	(9.3)
R&D tax credit	3.7	4.0	2.1
EBIDA	(3.4)	(8.1)	(7.2)

The doubling in 2016 of income generated from bioprocessing/commercial development has been broadly matched by the growth of the cost of sales (from £5.8 million to £11.8 million) which includes the raw materials, labour and overheads associated with bioprocessing. This resulted in the gross profit increasing to £15.9 million from £10.1 million in 2015, a growth of 57%.

The aggregate of cost of sales and operating expenses excluding the non-cash items of depreciation, amortisation and share option charge rose from £30.9 million in 2015 to £37.9 million in 2016.

£m	2016	2015
Raw materials, consumables and other external bioprocessing costs	9.3	6.1
Manpower-related	17.4	13.6
External R&D expenditure	2.8	3.0
Other costs	8.4	8.2
	37.9	30.9

The increase in manpower-related costs is due to the increase in the average headcount from 196 in 2015 to 247 in 2016.

Operating expenses other than cost of sales and excluding non-cash items (depreciation, amortisation and the charge for share options) increased by £1.0 million from £25.1 million in 2015 to £26.1 million in 2016, an increase of 4%.

With the increase in gross margin and modest increase in the operating expenses the EBITDA loss was reduced in 2016 to £7.1 million, from £12.1 million in 2015. The EBITDA and EBIDA losses were lower in the second six months of 2016 than in the first six months.

	Full year 2016	July-Dec 2016	Jan - July 2016
EBITDA (loss)	(7.1)	(1.9)	(5.2)
EBIDA (loss)	(3.4)	(0.8)	(2.6)

Operating loss and net loss

£m	2016	2015	2014
EBITDA	(7.1)	(12.1)	(9.3)
Depreciation, amortisation and share option charge	(4.2)	(2.0)	(1.3)
Operating loss	(11.3)	(14.1)	(10.6)
Interest	(4.9)	(1.9)	(0.2)
R&D tax credit	3.7	4.0	2.1
Foreign exchange revaluation (non-cash)	(4.1)	(1.0)	-
Net loss	(16.6)	(13.0)	(8.7)

The operating loss in 2016 was £11.3 million, compared with £14.1 million in 2015. 2016 saw a higher charge for depreciation, amortisation and share option charge (£4.2 million in 2016 compared with £2.0 million in 2015), as the new facilities entered operation thereby triggering the start of the depreciation charge on much of the £26 million capacity expansion programme that took place between October 2014 and June 2016.

The interest charge on the Oberland US$ loan facility was significantly higher at £4.9 million in 2016 compared with £1.9 million in 2015 caused by a combination of a full year charge in 2016 compared with only eight months in 2015, the impact of the substantial fall in sterling against the US$ following the outcome of the EU referendum in the UK, and the cost of providing for the potential 15% Internal Rate of Return (IRR) due to Oberland should the loan run to full maturity in 2022. Of the £4.9 million, £3.2 million is cash paid and £1.7 million represents the provision for the 15% IRR.

The R&D tax credit in 2016 was lower than 2015 which included a benefit relating to prior years. The tax credit results from a UK Government scheme which supports R&D expenditure in the UK.

The net loss in 2016 was also adversely impacted by the revaluation in sterling of the US$ denominated Oberland loan, caused by the fall in sterling against the US$. This does represent a potential increase in the sterling cost of repaying the loan should exchange rates remain as they are currently but it does not have an immediate cash impact. To some extent the Group expects to have a currency hedge against this liability as a significant portion of its anticipated future revenues are likely to be US$ denominated, such as the royalty stream arising from Novartis's sales to US CTL019 patients.

Segmental analysis

We presented an analysis of the business by segment for the first time in the 2015 Annual Report. The segments are "Partnering" which includes the bioprocessing and process development activities for third parties and which are revenue-generating, and "R&D" which includes the costs of our proprietary R&D activities in product and technology developments.

£m	Partnering	R&D	Total
2016
Gross income	27.9	2.9	30.8
EBITDA	3.0	(10.1)	(7.1)
Operating profit/(loss)	0.2	(11.5)	(11.3)
2015
Gross income	16.3	2.5	18.8
EBITDA	(2.7)	(9.4)	(12.1)
Operating loss	(3.9)	(10.2)	(14.1)

Partnering in 2016 saw an increase in gross income from £16.3 million to £27.9 million due mainly to the £11.6 million increase in bioprocessing and commercial development revenues. The additional volumes and revenues have enabled this segment to advance from making £2.7 million EBITDA losses in 2015 to £3.0 million EBITDA profits, an improvement of £5.7 million and to a small operating profit of £0.2 million. As bioprocessing volumes continue to grow, this segment should become profitable.

The R&D segment generated slightly higher costs in 2016 compared with 2015.

Cash flow

The Group held £15.3 million cash at 31 December 2016, having begun the year with £9.4 million. Net cash used in operations during 2016 was £5.1 million, down from £13.1 million in 2015. We concluded our major capacity expansion programme in the first half of the year with purchases of property, plant and equipment being £6.5 million compared with £16.7 million in 2015. Cash burn, the aggregate of these items, was therefore reduced from £29.8 million in 2015 to £11.5 million in 2016. The net proceeds from financing during 2016 was £17.5 million.

The analysis of net cash used in operations is set out below:

£m	2016	2015
Operating loss	(11.3)	(14.1)
Non-cash items included in operating loss (1)	4.2	2.0
EBITDA loss	(7.1)	(12.1)
Working capital movement	1.2	(2.8)
Cash used in operations	(5.9)	(14.9)
Interest paid, less received	(3.3)	(1.5)
R&D tax credit received	4.1	3.2
Net cash used in operations	(5.1)	(13.1)

(1)           Depreciation, amortisation, charge in relation to share schemes

Excluding the non-cash items from the operating loss, the EBITDA loss in 2016 was £7.1 million, significantly better than the £12.1 million EBITDA loss in 2015. A favourable working capital movement of £1.2 million in 2016 compared with an adverse movement of £2.8 million in 2015 resulted in the cash used in operations in 2016 being only £5.9 million, compared with £14.9 million in 2015.

Note that the EBITDA loss for the six months to 30 June 2016 was £5.2 million meaning that the EBITDA loss in the second half of the year was reduced to £1.9 million.

Balance sheet review

The most notable items on the balance sheet, including changes from 31 December 2015, are as follows:

-       Property, plant and equipment has increased by £3.1 million to £27.5 million as the additions of £6.5 million were partially offset by the depreciation charge of £3.3 million. £3.5 million of fully written down assets were disposed of when we left the Medawar Centre having reached the end of their useful lives.

-    Investments of £0.7 million represent the carrying value of the equity stake in Orchard Therapeutics, received as part of the strategic alliance announced in November 2016.

-       Trade and other receivables fell from £10.9 million to £6.9 million, due predominantly to a reduction in trade receivables, caused primarily by the timing and nature of receivables at each year end.

-     Trade and other payables fell from £9.3 million to £6.0 million, due to both lower trade payables and accruals at the end of 2016 compared with 2015 when the capacity expansion programme was underway.

-    Current liability provisions were £0.8 million at 31 December 2015 but nil at the end of 2016. This dilapidation provision had been in place to cover the costs of restoring the Medawar Centre to its original condition at the end of the lease in 2016 and was fully utilised during the year.

-     The loans balance has increased from £27.3 million to £34.4 million. This is the fair value, expressed in pounds sterling, of the $40 million drawn down under the $50 million Oberland loan facility. It has increased mainly due to the weakening to sterling against the US dollar during 2016.

Financial outlook

The Group expects that gross income (the aggregate of revenue and other operating income) will continue to grow strongly in 2017. We now have three GMP clean room suites and the new laboratory complex fully operational, we have added new revenue-generating partnerships during 2016 and we are confident that we can add further relationships during 2017, all of which will contribute to revenue growth. We will continue to manage our cost base carefully as we now have in place most of the resources necessary to support our plans for 2017. Our stated plan to spinout or out-licence our product candidates which are ready to enter clinical studies will mean that our expenditure on the priority programmes of OXB-102, OXB-202 and OXB-302 should be low although we will continue to invest in early stage concepts and pre-clinical studies, and also in our key LentiVector^® technology platform. The capacity expansion programme was completed in 2016 therefore capital expenditure is expected to be relatively modest in 2017.

Going concern

The Group held £15.3 million of cash at the end of 2016 and £15.2 million at 28 February 2017. During 2016 the cash burn was significantly reduced as a result of improved cash flow from operations and reduced capital expenditure and the directors expect further progress in 2017.  Taking this into account, in conjunction with currently known and probable cash flows, the Directors consider that the Group has sufficient cash resources and cash inflows to continue its activities for not less than twelve months from the date of these financial statements and have therefore prepared the financial statements on a going concern basis.  

Tim Watts

Chief Financial Officer
 

Consolidated statement of comprehensive income

for the year ended 31 December 2016

		Group
		2016	2015
Continuing operations	Notes	Total £'000	Total £'000
Revenue		27,776	15,909
Cost of sales		(11,835)	(5,839)
Gross profit		15,941	10,070
Research, development and bioprocessing costs		(24,299)	(20,274)
Administrative expenses		(5,957)	(6,741)
Other operating income		3,002	2,862
Operating loss		(11,313)	(14,083)
Finance income		34	26
Finance costs		(9,028)	(2,925)
Loss before tax		(20,307)	(16,982)
Taxation		3,666	3,963
Loss and total comprehensive expense for the year		(16,641)	(13,019)
Basic loss and diluted loss per ordinary share	4	(0.60p)	(0.51p)

The notes on pages 19 to 25 form part of this preliminary information.

Balance sheet

as at 31 December 2016

		Group
	Notes	2016 £'000	2015 £'000
Assets
Non-current assets
Intangible assets	5	1,330	1,743
Property, plant and equipment	6	27,514	24,396
Investments	7	657	-
		29,501	26,139
Current assets
Inventories	8	2,202	2,706
Trade and other receivables	9	6,904	10,930
Current tax assets		3,000	2,721
Cash and cash equivalents		15,335	9,355
		27,441	25,712
Current liabilities
Trade and other payables	10	6,003	9,286
Deferred income	11	3,313	3,045
Provisions	13	-	838
		9,316	13,169
Net current assets		18,125	12,543
Non-current liabilities
Loans	12	34,389	27,255
Provisions	13	622	533
		35,011	27,788
Net assets		12,615	10,894
Equity attributable to owners of the parent
Ordinary shares		30,879	25,741
Share premium account		154,036	141,677
Merger reserve		2,291	2,291
Treasury reserve		(102)	(102)
Accumulated losses		(174,489)	(158,713)
Total equity		12,615	10,894

The notes on pages 19 to 25 form part of this preliminary information.

Statement of cash flows

for the year ended 31 December 2016

		Group
		2016	2015
	Notes	£'000	£'000
Cash flows from operating activities
Cash used in operations	14	(5,929)	(14,866)
Interest paid		(3,258)	(1,494)
Tax credit received		4,131	3,247
Overseas tax paid		(50)	(5)
Net cash used in operating activities		(5,106)	(13,118)
Cash flows from investing activities
Purchases of property, plant and equipment		(6,458)	(16,716)
Interest received		47	38
Net cash used in investing activities		(6,411)	(16,678)
Cash flows from financing activities
Proceeds from issue of ordinary share capital		19,622	144
Costs of share issues		(2,125)	-
Loans received		-	27,812
Loans repaid		-	(3,000)
Net cash generated from financing activities		17,497	24,956
Net increase/(decrease) in cash and cash equivalents		5,980	(4,840)
Cash and cash equivalents at 1 January		9,355	14,195
Cash and cash equivalents at 31 December		15,335	9,355

The notes on pages 19 to 25 form part of this preliminary information.

Statement of changes in equity attributable to owners of the parent company

for the year ended 31 December 2016

		Ordinary shares	Share premium account	Merger reserve	Treasury reserve	Other reserves	Accumulated losses	Total equity
Group	Notes	£'000	£'000	£'000	£'000	£'000	£'000	£'000
At 1 January 2015		25,659	141,615	2,291	(226)	(682)	(145,618)	23,039
Year ended 31 December 2015:
Loss for the year		-	-	-	-	-	(13,019)	(13,019)
Total comprehensive expense for the year		-	-	-	-	-	(13,019)	(13,019)
Transactions with owners: Share options
Proceeds from shares issued		82	62	-	-	-	-	144
Value of employee services		-	-	-	-	-	730	730
Vesting of deferred share             award		-	-	-	124	-	(124)	-
Liquidation of BioMedica inc.		-	-	-	-	682	(682)	-
At 31 December 2015		25,741	141,677	2,291	(102)	-	(158,713)	10,894
Year ended 31 December 2016:
Loss for the year		-	-	-	-	-	(16,641)	(16,641)
Total comprehensive expense for the year		-	-	-	-	-	(16,641)	(16,641)
Transactions with owners: Share options
Proceeds from shares     issued		20	39	-	-	-	-	59
Value of employee     services		-	-	-	-	-	865	865
Issue of shares excluding               options		5,118	14,445	-	-	-	-	19,563
Cost of share issues		-	(2,125)	-	-	-	-	(2,125)
At 31 December 2016		30,879	154,036	2,291	(102)	-	(174,489)	12,615

The notes on pages 19 to 25 form part of this preliminary information.

 

NOTES TO THE PRELIMINARY FINANCIAL INFORMATION

for the year ended 31 December 2016

1   Basis of preparation

This financial information, for the years ended 31 December 2016 and 31 December 2015, does not constitute the statutory financial statements for the respective years, and is an extract from the financial statements. It is based on, and is consistent with, that in the Group's statutory accounts for the year ended 31 December 2016 and those financial statements will be delivered to the Registrar of Companies following the Company's Annual General Meeting. Financial statements for the year ended 31 December 2015 have been delivered to the Registrar of Companies. The auditors' reports on the financial statements for the years ended 31 December 2016 and 31 December 2015 were unqualified and did not contain statements under section 498 of the Companies Act 2006. The financial information in this report does not constitute a statutory financial statement within the meaning of sections 434-436 of the Companies Act 2006.

The financial statements have been prepared in accordance with IFRIC interpretations, as applicable to companies using International Financial Reporting Standards ('IFRS') as adopted by the European Union and with the Companies Act 2006 under the historic cost convention.  Whilst the financial information included in this preliminary announcement has been prepared in accordance with IFRSs adopted for use in the European Union, this announcement does not itself contain sufficient information to comply with IFRSs.

Copies of this announcement are available from the Company Secretary, and are on the Group's website. The audited statutory financial statements for the year ended 31 December 2016 are expected to be distributed to shareholders by 27 April 2017 and will be available at the registered office of the Company, Windrush Court, Transport Way, Oxford, OX4 6LT. Details can also be found on the Group's website at: www.oxfordbiomedica.co.uk.

This announcement was approved by the Board of Oxford BioMedica plc on 15 March 2017.

Going concern

The Group held £15.3 million of cash at the end of 2016 and £15.2 million at 28 February 2017. During 2016 the cash burn was significantly reduced as a result of improved cash flow from operations and reduced capital expenditure and the directors expect further progress in 2017.  Taking this into account, in conjunction with currently known and probable cash flows, the Directors consider that the Group has sufficient cash resources and cash inflows to continue its activities for not less than twelve months from the date of these financial statements and have therefore prepared the financial statements on a going concern basis.

2   Critical accounting judgements and estimates

In applying the Group's accounting policies, management is required to make judgements and assumptions concerning the future in a number of areas. Actual results may be different from those estimated using these judgements and assumptions. The key sources of estimation uncertainty and critical accounting judgements that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.

Revenue recognition

In October 2014, the Group entered into a series of contractual arrangements with Novartis, including a licence over the Group's existing LentiVector^® platform, a production and clinical supply agreement and an agreement covering process development.

Under these arrangements, the Group received $9.7m (£6.1m) in upfront payments of which $7.7m (£4.8m) was received in respect of a non-exclusive worldwide development and commercialisation licence in oncology under the Group's existing LentiVector^® intellectual property gene delivery platform.

Management judged that this amount should be recognised as a separate deliverable in 2014 discrete from amounts to be recognised over the period of the three year production contract. This judgement was based on management being satisfied that the customer was able and intended to realise value from this licence independently from any further intellectual property generated in the collaboration and that its fair value is sufficiently reliable. In reaching this judgement management had regard to several considerations including:

-     The existing intellectual property covered by the licence is sufficient to allow the vector for CTL019 to be bioprocessed for commercial use, and any intellectual property that might arise from the process development under the contract is not a pre-requisite for its commercial manufacture

-     The licence allows Novartis to use the existing intellectual property for other oncology products apart from CTL019

-     The other elements of the arrangements have an appropriate price and fair value (the residual elements)

-     The $7.7m fee is comparable with similar transactions with third parties that the Group has previously contracted, taking into account the stage of development and the market potential of the product

This judgement reflects both the separability of the licence for the existing intellectual property and the assessment of the fair values of each of the components of the Novartis agreements.

The remaining $2.0m of the $9.7m upfront payments are dependent on certain events and activities over the 3 year period. As at 31 December 2016, $1.2m had been recognised as revenue (2015: $0.4m).

Under the October 2014 contract, management judged that $1.2m of a $2m incentive payment for provision of source documentation to support a proposed BLA submission by Novartis should be recognised at year end on the basis that, based on the level of work performed, it is certain that the economic benefits of the transaction will flow to the entity, and the revenue and related costs can be measured reliably.

In 2016 the Group received £1.4m in one-off payments related to IP licences. Since these payments are non-refundable and there is no ongoing commitment from the Group, the amounts received have been recognised as revenue in the year. £657,000 of these items was received in the form of shares in a partner company. These have been recognised at fair value.

Intangible asset impairment

The Group has intangible assets arising from purchases of intellectual property rights and in-process R&D. Amortisation is charged over the assets' patent life on a straight line basis from the date that the asset becomes available for use. When there is an indicator of a significant and permanent reduction in the value of intangible assets, an impairment review is carried out. The impairment analysis is principally based on estimated discounted future cash flows. Actual outcomes could vary significantly from such estimates of discounted future cash flows due to the sensitivity of the assessment to the assumptions used. The determination of the assumptions is subjective and requires the exercise of considerable judgement. Any changes in key assumptions about the Group's business and prospects, or changes in market conditions affecting the Group, or its development partners, could materially affect whether an impairment exists. This risk is now concentrated on purchased patent rights which have been sublicensed to collaborative partners. At 31 December 2016 the book value of intangible assets was £1.3 million of which £1.1 million related to PrimeBoost technology.

Going concern

Management and the Directors have had to make estimates and important judgements when assessing the going concern status of the Group.  Going concern is as stated in Note 1 and the Financial review.

3   Taxation

The Group is entitled to claim tax credits in the United Kingdom for certain research and development expenditure. The amount included in the statement of comprehensive income for the year ended 31 December 2016 comprises the credit receivable by the Group for the year, less overseas tax paid in the year. The United Kingdom corporation tax research and development credit is paid in arrears once tax returns have been filed and agreed. The tax credit recognised in the financial statements, but not yet received, is included in current assets in the balance sheet. The amounts for 2016 have not yet been agreed with the relevant tax authorities.

	2016	2015
	£'000	£'000
Current tax
United Kingdom corporation tax research and development credit	(3,000)	(2,721)
Overseas taxation	50	5
	(2,950)	(2,716)
Adjustments in respect of prior periods
United Kingdom corporation tax research and development credit	(716)	(1,247)
Taxation credit	(3,666)	(3,963)

4   Basic loss and diluted loss per ordinary share

The basic loss per share of 0.60p (2015:0.51p) has been calculated by dividing the loss for the year by the weighted average number of shares in issue during the year ended 31 December 2016 (2,778,182,534: 2015: 2,570,202,150).

As the Group is loss-making, there were no potentially dilutive options in either year. There is therefore no difference between the basic loss per ordinary share and the diluted loss per ordinary share.

5   Intangible assets

Intangible assets comprise Intellectual Property rights.

		2016	2015
		£'000	£'000
At 1 January and 31 December		5,591	5,591
Accumulated amortisation and impairment
At 1 January		3,848	3,485
Amortisation charge for the year		335	363
Impairment charge for the year		78	-
At 31 December		4,261	3,848
Net book amount at 31 December		1,330	1,743

For intangible assets regarded as having a finite useful life, amortisation commences when products underpinned by the intellectual property rights become available for use. Amortisation is calculated on a straight line basis over the remaining patent life of the asset. Amortisation of £335,000 (2015: £363,000) is included in 'Research, development and bioprocessing' in the statement of comprehensive income.

6   Property, plant and equipment

	Freehold property	Short leasehold   improve-ments	Office  equipment and computers	Manufac-turing and Laboratory equipment	Assets under constru- ction1	Total
	£'000	£'000	£'000	£'000	£'000	£'000
Cost
At 1 January 2016	6,938	7,397	1,374	7,574	9,744	33,027
Additions at cost	-	206	506	1,526	4,220	6,458
Reclassifications	13,964	-	-	-	(13,964)	-
Disposals	-	(633)	(229)	(2,612)	-	(3,474)
At 31 December 2016	20,902	6,970	1,651	6,488	-	36,011
Accumulated depreciation
At 1 January 2016	921	2,909	753	4,048	-	8,631
Charge for the year	1,385	522	353	1,080	-	3,340
Disposals	-	(633)	(229)	(2,612)	-	(3,474)
At 31 December 2016	2,306	2,798	877	2,516	-	8,497
Net book amount at 31 December 2016	18,596	4,172	774	3,972	-	27,514

	Freehold property	Short leasehold   improve-ments	Office  equipment and computers	Manufac-turing and Laboratory equipment	Assets under constru- ction1	Total
	£'000	£'000	£'000	£'000	£'000	£'000
Cost
At 1 January 2015	6,887	2,623	820	5,335	646	16,311
Additions at cost	51	863	554	2,239	13,009	16,716
Disposals	-	3,911	-	-	(3,911)	-
At 31 December 2015	6,938	7,397	1,374	7,574	9,744	33,027
Accumulated depreciation
At 1 January 2015	698	2,579	595	3,495	-	7,367
Charge for the year	223	330	158	553	-	1,264
At 31 December 2015	921	2,909	753	4,048	-	8,631
Net book amount at 31 December 2015	6,017	4,488	621	3,526	9,744	24,396

1      Assets under construction represent the capitalisation of construction works at the Harrow House and Yarnton manufacturing facilities, and the Windrush Court laboratories.

7   Investments

On 29 November 2016, as part of a strategic alliance with Orchard Therapeutics, the Group received a 1.95 % equity stake in Orchard. This investment has been classified at fair value through the profit & loss (2016: £657,000; 2015: £nil). As Orchard Therapeutics is a private company, the equity investment has not been valued based on observable market data.

8   Inventories

	2016	2015
	£'000	£'000
Raw Materials	2,120	2,217
Work in progress	82	489
Total inventory	2,202	2,706

Inventories constitute raw materials held for commercial bioprocessing purposes, and work-in-progress inventory related to contractual bioprocessing obligations.

During 2016, the Group wrote down £29,000 of inventory which is not expected to be used in production or sold onwards.

9   Trade and other receivables

			2016	2015
			£'000	£'000
Trade receivables			1,969	7,374
Accrued income			2,919	1,155
Other receivables			238	31
Other tax receivable			1,330	1,522
Prepayments			448	848
Total trade and other receivables			6,904	10,930

The fair value of trade and other receivables are the current book values.

Included in the Group's trade receivable balance are debtors with a carrying amount of £47,000 (2015: £826,000) which were past due at the reporting date, all of which have since been received.

10 Trade and other payables

			2016	2015
			£'000	£'000
Trade payables			1,576	3,588
Other taxation and social security			442	384
Accruals			3,985	5,314
Total trade and other payables			6,003	9,286

11 Deferred income

Deferred income arises when the Group has received payment for services in excess of the stage of completion of the service being provided.

12 Loans

In May 2015, the Group entered into the $50 million Oberland Facility. The Group has used $40 million (£26.1 million) of the facility to finance the Group's expansion of its bioprocessing and laboratory capacity in order to enable it to deliver on commitments under its bioprocessing agreement with Novartis. The Group drew down $25 million (£16.3 million) of the loan in May 2015 and a further $15 million (£9.8 million) in September 2015 to ensure adequate finance for the ongoing capacity expansion programme. The remaining funds under the Oberland Facility are available to be drawn down in minimum tranches of $5 million at the Group's option prior to 31 March 2017 and the proceeds of such drawdowns may be used only for certain permitted acquisitions and licensing activities as approved by Oberland in its sole discretion. The Oberland Facility is repayable not later than 1 May 2022 and may be prepaid at any time. Over the course of the loan term, interest is payable quarterly at an annual interest rate of 9.5 per cent. plus the greater of 1 per cent. and three month LIBOR. Under the terms of the Oberland Facility, loans are issued at an original discount of 2.5 per cent. In addition to interest, a repayment fee is also payable upon any repayment including on exit. Oxford BioMedica will also pay an additional amount of 0.35 per cent. of its annual worldwide net revenue, as calculated from the Group's financial statements, from 1 April 2017 to 31 December 2025 for each $5 million of loan drawn down over $30 million. This revenue participation may be retired at any time upon payment of an exit fee. In the event that the loan is repaid after the second anniversary there may be a true-up payment payable to Oberland in the event that the aggregate of the interest payments, revenue participation payments and exit fee do not in aggregate provide a return of 15 per cent. per annum to Oberland. The outstanding balance at year end is £34.4 million (2015: £27.3 million).

The Group is required to maintain a cash balance not less than $10 million (approximately £8.1 million) while the Oberland Facility is outstanding. The Oberland Facility is secured by a pledge over substantially all of the Group's assets. Drawdowns of additional tranches are subject to certification by Oxford BioMedica that representations and warranties under the Oberland Facility agreement remain true and correct as of the drawdown date, and certifications relating to no default or material adverse effect.

In 2013, the Group was awarded a funding package of £7.1 million under the UK Government's Advanced Manufacturing Supply Chain Initiative. Of this package, £5.3 million was a loan facility bearing interest at 6 per cent., and £1.8 million was in the form of grant finance. In April 2014, the Group drew down £1 million from the AMSCI facility. In March 2015, the Group drew down a further £2 million from the AMSCI facility. During May 2015, the loan facility was terminated and the outstanding balance was repaid.

13 Provisions

			Dilapidations £'000
At 1 January 2016			1,371
Unwinding of discount			5
Utilisation of provision			(833)
Additional provision recognised			79
At 31 December 2016			622
At 1 January 2015			535
Unwinding of discount			3
Additional provision recognised			833
At 31 December 2015			1,371

The dilapidations provision relates to anticipated costs of restoring the leasehold Medawar and Yarnton properties in Oxford, UK to their original condition at the end of leases in 2016 and 2024 respectively, discounted using the rate per the Bank of England nominal yield curve. The equivalent rate was used in 2015. The provisions will be utilised at the end of the leases if they are not renewed, and for that reason, the provision in respect of the Medawar Centre was released in 2016 at the end of the lease.

14 Cash flows from operating activities

Reconciliation of loss before tax to net cash used in operations:

			2016	2015
			£'000	£'000
Continuing operations
Operating loss			(11,313)	(14,083)
Adjustment for:
Depreciation			3,340	1,264
Amortisation of intangible assets			335	363
Charge for impairment			78	-
Charge in relation to employee share schemes			865	730
Non-cash revenues			(657)	-
Changes in working capital:
Decrease / (increase) in trade and other receivables			4,026	(5,777)
(Decrease) / increase in trade and other payables			(3,283)	2,982
Increase in deferred income			268	118
(Decrease) / increase in provisions			(749)	836
Increase in investments			657	-
Decrease / (Increase) in inventory			504	(1,299)
Net cash used in operations			(5,929)	(14,866)

 

END

 

 

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