Oxford, UK – 4 September 2019: Oxford Biomedica plc (“Oxford Biomedica” or “the Group”) (LSE: Oxford Biomedica), a leading gene and cell therapy group, today announces interim results for the six months ended 30 June 2019.
FINANCIAL HIGHLIGHTS
Revenues were £32.1 million, a decrease of 9% (H1 2018: £35.3 million) reflecting the significant licence income received in H1 2018. However, bioprocessing and commercial development revenues increased 23% over H1 2018
Operating EBITDA1 loss and operating loss of £1.4 million and £6.1 million respectively (H1 2018: £11.9 million and £9.4 million profit) were incurred due to lower revenues and increased expenditure to strengthen the Group’s operational and strategic capacity in preparation for further volume growth in bioprocessing volumes
£11.5 million ($15 million) Axovant milestone achieved in H1 2019 with the dosing of the first patient in the second cohort of the AXO-Lenti-PD Parkinson’s disease clinical trial
Novo Holdings A/S invested £53.5 million in the Group, representing 10.1% of the outstanding shares after the capital increase. The proceeds from the transaction were used to fully repay the debt facility of £43.6 million ($55 million) with Oaktree Capital Management in addition to providing funding to further develop Oxford Biomedica’s platform and product portfolio. This leaves the Group with a simplified, stronger balance sheet and removed the lien over the Group’s assets
Cash generated from operations was £1.3 million compared to £18.3 million in H1 2018 reflecting the Axovant and Sanofi (Bioverativ) licence fees received in H1 2018
Cash at 30 June 2019 was £26.1 million (31 December 2018: £32.2 million), reflecting expenditure in relation to the ongoing build and fit out of the new OxBox bioprocessing facility and the net cash inflow from the investment by Novo Holdings A/S after the loan facility repayment
OxBox bioprocessing facility construction is progressing as planned with the Group’s capital expenditure increasing to £14.9 million in H1 2019 compared to £6.0 million in H1 2018, the cost of which was partly offset by £2.0 million of Innovate grant funding received to support the UK’s efforts to produce viral vectors and ensure adequate supply to service expected demand
1Operating EBITDA is defined as Earnings Before Net Finance Costs, Tax, Depreciation, Amortisation, Fair value adjustments of available-for-sale assets and share based payments. A reconciliation to GAAP measures is provided on page 8.
OPERATIONAL HIGHLIGHTS
Progress with proprietary product development
The first patient of the second cohort in the SUNRISE-PD Phase 2 trial was dosed for the treatment of Parkinson’s disease in April 2019 triggering a £11.5 million ($15 million) milestone to Oxford Biomedica. Axovant expects initial data from this cohort in the fourth quarter of 2019. While the milestone is recognised in the first half, payment is due in the second half and hence was included in trade receivables at period end
Leading LentiVector® delivery platform for gene and cell therapy partnerships
Oxford Biomedica entered into an R&D collaboration and option & licence agreement with Santen Pharmaceutical Co Ltd for development of gene therapy vectors for an undisclosed inherited retinal disease
Oxford Biomedica is entitled to an undisclosed milestone payment from Santen on the exercise of the option to the LentiVector® platform as well as development milestones and up to a 10% royalty on net sales. Santen has worldwide commercial rights to the programme, while Oxford Biomedica retains an option to co-fund and participate in development and commercialisation of the product in the US and Europe
Novartis Collaboration
Oxford Biomedica is the sole global supplier of lentiviral vector for Kymriah® and the collaboration with Novartis continues to perform well
Global roll out of Kymriah® in both relapsed and refractory B-cell acute lymphoblastic leukaemia (r/r ALL) and relapsed and refractory diffuse large B-cell lymphoma (r/r DLBCL) indications continues at pace with 19 countries worldwide that have approved reimbursement in at least one indication
Innovation
R&D collaboration announced with Microsoft to improve gene and cell therapy manufacturing using intelligent cloud and machine learning with the aim of improving yield and quality of the next generation gene therapy vectors
Increasing use of robotics and automation across the platform aided in part by Innovate UK grants
Building the Future
The development and fit out of the new 84,000 sqft manufacturing facility is progressing as planned with completion of the building phase by the end of 2019. The site is expected to be fully operational by the end of the second quarter 2020
Successful conversion of a second GMP production suite to bioreactor process during H1 2019
Lease signed for an additional 32,000 sqft discovery and innovation facility next to Windrush Court. The Windrush Innovation Centre will be staffed by multidisciplinary teams and will focus on driving innovations and technological advances to support both the product pipeline and platform
Commenting on the Group’s interim results, John Dawson, Oxford Biomedica’s Chief Executive Officer, said:
“Oxford Biomedica has continued to make strong progress in first half of 2019 building on the existing and new partnerships signed in 2018. We are delighted with the 23% growth in bioprocessing and commercial development revenues and also the new collaborations we have signed with Santen and Microsoft. Our expansion to meet the fast growing demand in the cell and gene therapy arena is progressing as planned and we expect further deals to be signed this year. The addition of Novo Holdings as a shareholder and the paying down of the Oaktree loan puts the Group on a far stronger footing to maximise the opportunity we see in front of us.”
Conference call for analysts:
A briefing for analysts will be held at 13:00 BST / 8:00 EST on 4 September 2019 at 85 Gresham Street, London, EC2R 7HE. There will be a simultaneous live conference call with Q&A and the presentation will be available on the Group’s website at www.oxb.com.
Please visit the website approximately 10 minutes before the conference call to download the presentation slides. Conference call details:
Participant UK dial-in: +44 (0) 203 009 5710
Participant US dial-in: +1 9177 200178
Participant code: 2819988
A live webcast of the presentation will be available on Oxford Biomedica’s website here.
To see the interim results in full click here.
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
Sarah MacLeod, Head of Communications | T: +44 (0)1865 783 000 / E: media@oxb.com
Consilium Strategic Communications | T: +44 (0)20 3709 5700
Mary-Jane Elliott/Matthew Neal
Peel Hunt (Joint Corporate Brokers) | T: +44 (0)20 7418 8900
James Steel
Dr. Christopher Golden
WG Partners (Joint Corporate Brokers) | T: +44 (0)20 3705 9321
David Wilson
Claes Spång
About Oxford Biomedica
Oxford Biomedica (LSE:Oxford Biomedica) 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, Bioverativ (now part of Sanofi), Axovant Sciences (now 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 480 people. Further information is available at www.oxb.com