Preliminary results for the year ended 31 December 2019

Oxford Biomedica plc
Preliminary results for the year ended 31 December 2019

 Building the Group for future growth

Oxford, UK – 6 May 2020: Oxford Biomedica plc (LSE: Oxford Biomedica), (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, today announces its preliminary results for the year ended 31 December 2019.

FINANCIAL HIGHLIGHTS

• Bioprocessing and commercial development revenues increased to £47.3 million (2018: £40.5 million). Despite the capacity constraints within the business, growth in full year revenues of 17% was achieved, driven by double digit growth across both activities

• Licences, milestones & royalties revenues were £16.8 million (2018: £26.3 million) with a £11.5 million ($15 million) contribution from the Axovant milestone and strongly growing royalties. These revenues were 36% lower than the prior year which saw significant licence income received on signing the Sanofi (Bioverativ) and Axovant agreements in 2018

• Total revenues decreased by 4% to £64.1 million (2018: Revenue of £66.8 million) due to lower milestone and licensing revenue

• Operating expenses increased by 57% from £26.6 million to £41.8 million reflecting investment in bioprocessing operations and people in preparation for the Oxbox bioprocessing facility coming online in 2020

• Operating EBITDA loss incurred of £5.2 million (2018: £13.4 million profit)

• Operating loss incurred of £14.5 million (2018: £13.9 million profit)

• Capital expenditure £25.8 million (2018: £10.1 million) reflecting the continued capital expenditure on the new Oxbox bioprocessing facility

• Cash of £16.2 million (31 December 2018: £32.2 million)

• Cash outflow before financing activities increased by £25.7 million to £22.9 million (2018: £2.8 million inflow)

• £53.5 million of equity raised from new Investor Novo Holdings which was used to fully repay the £43.6 million ($55 million) Oaktree loan facility

OPERATIONAL HIGHLIGHTS (including post period-end events)

Novartis partnership
• 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 includes a minimum of $75 million over five years in manufacturing batch revenues in addition to undisclosed process development fees, with other financial terms, such as royalties, as previously agreed

• Kymriah^® roll out accelerating in relapsed and refractory B-cell acute lymphoblastic leukaemia and relapsed and refractory diffuse large B-cell lymphoma with reimbursement approved in 20 countries in at least one indication

• Continued strong performance as sole global supplier of lentiviral vector for Kymriah^® CAR-T therapy

New partnerships
• Collaboration, option and licence agreement established with Santen Pharmaceutical Co Ltd for development of gene therapy vectors targeting an inherited retinal disease

• Collaboration established with Microsoft Research to leverage machine learning and cloud computing to improve process efficiency and reduce costs

 Proprietary product development
• First patient dosing in second cohort of SUNRISE-PD phase II study in Parkinson’s disease triggered £11.5 million ($15 million) milestone payment from partner Axovant

• The Group’s 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

Expansion of bioprocessing and laboratory facilities
• Development of major new 84,000 sqft (7,800 sqm) bioprocessing facility on target with initial building phase completed, validation ongoing and first commercial batches anticipated H1 2020

• Occupation of new 32,000 sqft (2,970 sqm) Windrush Innovation Centre (WIC) commenced during 2019 with increased utilization expected during 2020.

POST PERIOD HIGHLIGHTS

• In March new licence and five-year clinical supply agreement signed with Juno Therapeutics / Bristol Myers Squibb for initially four CAR-T and TCR-T programmes. $10 million upfront payment and up to $217 million in development, regulatory and sales related milestones in addition to undisclosed process development, scale up and batch revenues and an undisclosed royalty on sales

• 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

• In April the Group has joined a Consortium led by the Jenner Institute, Oxford University, to rapidly develop, scale-up and manufacture a potential vaccine candidate for COVID-19 called ChAdOx1 nCoV-19. AstraZeneca subsequently entered into an agreement with Oxford University for the global development and distribution of the vaccine on 30th April.  While the potential impact on the Group is currently uncertain, should clinical trials be successful the Group will provide access to its large scale GMP manufacturing facilities including Oxbox to support the manufacturing scale up for Oxford University and AstraZeneca.

• Subsequent to year end the Group identified an issue regarding an aspect of certain process development work performed on behalf of a customer in 2018 and 2019 which potentially could give rise to a material claim against the Group. The Group has been in communication with the third party but is not yet in a position to verify or validate any information relating to this matter due to the very recent timing of this issue being identified. 

John Dawson, Chief Executive Officer of Oxford Biomedica, said:
“Oxford Biomedica made good progress during 2019, extending our commercial supply agreement with Novartis for another five years, establishing a new partnership with Santen and delivering our new facilities expansion on target. Beyond the period end we also signed a new major new agreement with Juno Therapeutics / Bristol Myers Squibb. The cell and gene therapy sector continues to grow rapidly and we remain at the forefront of its innovation. Our new collaboration with Microsoft is harnessing the power of artificial intelligence to further boost the efficiency of our world-leading LentiVector^® delivery platform, as we continue the process to industrialise lentiviral vector development and manufacture. We are building an exciting business, and with the significant investment by Novo Holdings in 2019, our simplified Statement of financial position places us in a stronger position to realise the potential of our world-leading technology.”

Analyst briefing
Management will be hosting a briefing for analysts via conference call and webcast at 13:00 BST (8:00 ET) on 6 May 2020.  

Dial-in details are:
UK dial-in: +44 (0) 203 0095709
US dial-in: +16467871226
Participant code: 2898781

A live webcast of the presentation will be available on Oxford Biomedica’s website at https://edge.media-server.com/mmc/p/5h7ea8cf or by clicking here.

-Ends-

Enquiries:
Oxford Biomedica plc
John Dawson, Chief Executive Officer
T: +44 (0)1865 783 000

Stuart Paynter, Chief Financial Officer
T: +44 (0)1865 783 000

Catherine Isted, Head of Corporate Development & IR
T: +44 (0)1865 954 161 / E: ir@oxb.com

Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
T: +44 (0)20 3709 5700

About Oxford Biomedica
Oxford Biomedica (LSE:Oxford Biomedica) 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