Oxford Biomedica Regulatory News (OXB)

Business Update

Building the Group for future growth

Oxford, UK - 18 March 2020: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, announces today an unaudited trading and business update to 31 December 2019 and post period end review. The Group expects to announce its preliminary results on 23 April 2020.

Trading Update: Strong underlying growth as we build for the future

· Revenues from the underlying bioprocessing and commercial development business were, as expected, stronger in the second half compared to the first half and continued to grow in the second half of 2019 over the second half of 2018. Despite the capacity constraints within the business growth in full year bioprocessing and commercial development revenues of c.20% was achieved driven by double digit growth across both activities

· Revenues from milestones, licences and royalties are expected to decline c.36% on the prior year with the £11.5 million ($15 million) Axovant milestone and strongly growing royalties unable to compensate for the sizable licence income received on signing the Sanofi (Bioverativ) and Axovant agreements in 2018. The timing of receipt of milestone and licence revenues are, by nature, hard to predict especially when connected to the execution of new licence and supply agreements

· Total revenues for the full year are excepted to be c.£65 million, a slight decline on the prior year due to lower milestone and licensing revenue

· Overall operating EBITDA is expected to show a low single digit loss in the second half due to lower milestone and licensing revenues as indicated above. H1 2019 EBITDA loss was £1.4 million

· Cash at 31 December was £16 million reflecting the continued capital expenditure in the second half on the planned new OxBox bioprocessing facility. Operating cash outflow for the year was c.£7 million

· The Group strengthened its balance sheet through the repayment of the $55 million Oaktree loan following the £53.5 million equity investment by Novo Holdings A/S who are now a 10.1% shareholder

Business Update: Capitalising on our market leading LentivectorTM platform

· Novartis extended its commercial supply agreement by a further five years in December and extended the number of lentiviral vector programmes in the collaboration from two to five. The agreement guarantees a minimum of $75 million in manufacturing revenues in addition to undisclosed process development fees and a mid-single digit £ million facility reservation fee, with other financial terms, such as royalties, as previously agreed. In the first quarter of 2020 the Group started work on an additional vector construct for Novartis which now takes the total number of active vector constructs to six

· Today, the Group has entered into a major new licence and five-year clinical supply agreement with Juno Therapeutics Inc (a fully owned subsidiary of Bristol Myers Squibb Inc) for initially four CAR-T and TCR-T programmes. Oxford Biomedica will receive a $10 million upfront payment and up to $86 million in development and regulatory milestones in addition to undisclosed process development, scale up and batch revenues for these programmes. On approval the Group would receive an undisclosed royalty on sales and up to $131 million in sales-based milestone payments - see separate announcement issued today

· In June, the Group entered into an R&D collaboration and option and licence agreement with Santen Pharmaceutical Co Ltd for the development of gene therapy vectors for an undisclosed inherited retinal disease

· Oxford Biomedica announced it had entered a research and development collaboration with Microsoft in March to improve yield and quality of next generation gene therapy vectors using intelligent cloud and machine learning

· The new OxBox manufacturing facility completed construction according to plan by the end of 2019. Commercial material is on track to be produced from the first production line by the end of the first half of 2020

· Our partner, Axovant, announced twelve month follow-up data in January 2020 from the first cohort of the SUNRISE-PD study on two patients where a continued improvement in UPRDS Part III 'OFF' Score at twelve months over the six month data was reported

· Our partner, Orchard Therapeutics, announced in January that it plans to initiate a rolling BLA filing in the US for OTL-101 in ADA-SCID in the first half of 2020, with anticipated completion of filing within twelve months 

Pipeline Update

Partner pipeline - Strong growth in programmes

· Today's agreement with Juno Therapeutics Inc. further adds to our partner funded pipeline which has doubled since the start of 2019 from nine to eighteen programmes. We also expect the pipeline to further expand as the year progresses

Proprietary pipeline - Internal pipeline review now completed

· OXB-302 is our priority candidate and targets haematological tumours with our CAR-T 5T4. The 5T4 antigen has been shown to be highly expressed on various haematological tumours as well as most solid tumours with restricted expression on normal tissues. We continue to advance preclinical work on OXB-302 as we ready the programme for entry into the clinic

· OXB-203, currently in preclinical studies, is targeting Wet AMD and uses our technology to deliver a gene to express afibercept (a VEGF-trap). This programme builds on the demonstrated long term gene expression data we have seen with its predecessor OXB-201, for which work has now been halted. In addition, OXB-202, for corneal graft rejection, will also no longer be further advanced

· In addition, the Group is continuing preclinical work on OXB-204 (LCA10) and OXB-103 (ALS) and a new preclinical program, OXB-401 (liver indication), has been initiated. Work on OXB-208 (RP1) has been halted

· The Group is targeting the spin out / out-licence of one in-house product candidate during 2020

Board Change

Following four years as Non-executive Chairman, Dr Lorenzo Tallarigo has informed the Group of his intention to retire from Oxford Biomedica's board. Lorenzo will continue as Chairman while the Group completes a search for his replacement.

COVID-19 Update

The Group has implemented a daily senior management working group to monitor current COVID-19 developments, GOV.UK guidance, to risk assess the Group's supply chain and to direct the Group's phased response. The Group is working with staff, customers and suppliers to monitor any potential disruption and, so far, the Group has not experienced any and does not currently expect to experience significant supply issues or any changes in customer demand. The Group continually assesses the risks for employees and has regularly communicated with staff on the ongoing situation and has implemented steps to contain any spread such as publicising good personal hygiene practices, enforcing a travel management prevention strategy and allowing people to work from home.

Outlook: Maximising the opportunities for growth as the leading LentiVectorTM specialists

The Group has developed a world-leading position in the fast-growing cell and gene therapy market and with OxBox construction now completed we continue to strengthen our position with our existing customers and other leading pharma and biotech companies. Further, as we expand the number of license and supply agreements, we continue to grow the underlying bioprocessing and development activities supplemented by attractive upsides from milestones and royalties as partner programmes progress. We go into the year with a strong business development pipeline and in 2020 we are targeting the out-licencing of one product from our internal pipeline and completion of two further platform deals.

John Dawson, Chief Executive Officer of Oxford Biomedica, commented:

"2019 has been another transformative year where we have made significant progress in building the foundations for the future growth of the Group. In the year we demonstrated the strength of our existing business partnerships through the five year extension to our agreement with Novartis. Continued momentum has been provided by the completion of OxBox, our new bioprocessing facility and today's announcement of another major new licence and supply agreement. We have significantly transformed our balance sheet and closed the year debt free and with a healthy cash position, all buoyed by the investment from Novo Holdings. We are very encouraged by the current level of business development activities and although the timing of further deals remains hard to predict, we look forward to the future with great confidence."

-Ends-

About Oxford Biomedica

Oxford Biomedica (LSE:OXB) is a leading, fully integrated, 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, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, 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 550 people. Further information is available at www.oxb.com