15 March 2018

OXFORD BIOMEDICA PLC: PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2017

 

Oxford, UK – 15 March 2018: Oxford BioMedica plc (“OXB” or “the Group”; LSE: OXB), a leading gene and cell therapy group, today announces preliminary results for the 12 months ended 31 December 2017 and a post-period update.

 

FINANCIAL HIGHLIGHTS (INCLUDING POST PERIOD END)

  • Gross Income1 increased by 28% to £39.4 million (2016: £30.8 million)
  • Operating expenses excluding depreciation and amortisation and share based payments decreased by 12% to £22.9 million (2016: £26.1 million)
  • EBITDA loss significantly reduced to £1.9 million (2016: £7.1 million)
  • EBIDA (EBITDA adjusted by the R&D tax credit) profit of £0.8 million (2016: £3.4 million loss)
  • Operating loss for the period reduced 50% to £5.7 million (2016: £11.3 million)
  • Cash outflow before financing activities reduced by £9.2 million to an inflow of £1.0 million (2016: £8.3 million outflow)
  • Capital expenditure reduced to £2 million (2016: £6.4 million)
  • Debt refinanced on significantly improved terms with $55 million Oaktree Capital facility
  • A charge of £3.9 million (2016: Nil) was incurred upon the termination of the Oberland loan facility
  • Cash at 31 December 2017 of £14.3 million2 (2016: £15.3 million)
  • Successful £20.5 million (gross) equity Placing to fund further bioprocessing capacity to service anticipated increased demand
  • Gross Income is the aggregate of revenue (£37.6 million) and other operating income (£1.8 million) (2016: £27.8 million and £3.0 million respectively)
  • Includes $5m ring fenced under Oaktree agreement

 

OPERATIONAL HIGHLIGHTS

Leading LentiVector® delivery platform for gene and cell therapy partnerships

  • Major commercial supply agreement signed with Novartis for the lentiviral vector to produce CTL019 (tisagenlecleucel, brand name Kymriah™) and additional CAR-T products; over $100 million revenue potential over three years
  • $105 million collaboration and licence agreement completed with Bioverativ to access OXB’s LentiVector® platform and manufacturing technologies for haemophilia gene therapies
  • Lentiviral vector demand is increasing and the Group is in several discussions regarding a range of additional collaborations

 

Novartis’ product Kymriah™

  • First ever LentiVector-Enabled™ product approval for the Novartis product Kymriah™ (tisagenlecleucel) in children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) in the US
  • Kymriah™ sBLA submitted in the USA by Novartis in r/r diffuse large B-cell lymphoma (DLBCL) in adults; product undergoing expedited review under breakthrough designation
  • CTL019 European Marketing Authorisation (EMA) Application filed by Novartis for r/r B-cell ALL in children and young adults and for r/r DLBCL in adults
  • Primary analysis of results from the pivotal JULIET trial demonstrating that Kymriah™ (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer
  • US FDA Priority Review for Kymriah™ for adults with r/r DLBCL and EMA accelerated assessment for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

 

Progress with proprietary product development

  • Partnering discussions ongoing for OXB’s in-house priority development programmes, with a planned spin-out legal structure to be established for ocular products
  • The Group continued to invest modestly in programmes to maintain momentum and to continue to enhance their value
  • Phase I/II clinical study to be initiated shortly for lead in-house programme OXB-102 in Parkinson’s disease to further enhance product value

 

Preparing to service the expected lentiviral vector demand

  • Successful facilities inspections completed by US and UK regulators; FDA & MHRA approval granted for lentiviral vector commercial manufacture and supply
  • Funds secured and additional premises identified in Oxford for new bioprocessing facility comprising four GMP manufacturing suites, fill finish facilities and warehouse and office space
  • £2 million Innovate UK collaboration established to further enhance LentiVector® suspension technology
  • £3 million grant awarded by Innovate UK to support the UK’s efforts to produce viral vectors and ensure adequate supply to meet future demand.

 

Board appointment

Dr. Heather Preston appointed to the Group’s Board as a Non-Executive Director – see separate announcement issued today.

“2017 has been a transformational year for Oxford BioMedica, underlined by the first ever approval of a LentiVector-Enabled™ product of Novartis, Kymriah™. This milestone was rapidly followed by a further US filing in an additional oncology indication, and filings for both indications in Europe. Building on our stronger operational and financial foundations, we established a $105 million collaboration with Bioverativ to provide access to our world-leading technology and we are making good progress in our other partnering discussions. In the coming year, we intend to build on this momentum, broadening our portfolio of collaborations and partnering our proprietary programmes. Having established the world-class LentiVector® platform, Oxford BioMedica is delivering on its promise, enabling revolutionary gene and cell therapies for patients around the world.”

John Dawson

Oxford BioMedica’s Chief Executive Officer

Conference call for analysts:

A briefing for analysts will be held at 9.30pm GMT on 15 March 2018 in the Guildhall Room 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: 0800 376 7922
International dial-in: +44 (0) 207 192 8000
Participant code: 9051999

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: +44 (0)1865 783 000

John Dawson, Chief Executive Officer

Stuart Paynter, Chief Financial Officer

 

Financial PR Enquiries:                                                             Tel: +44 (0)20 3709 5700

Consilium Strategic Communications

Mary-Jane Elliott / Matthew Neal /

Philippa Gardner / Laura Thornton

 

Peel Hunt (Joint Corporate Broker):                                            Tel: +44 (0)20 7418 8900

James Steel / Christopher Golden

 

WG Partners (Joint Corporate Broker):                                       Tel: +44 (0)20 3705 9321

David Wilson / Claes Sprang

 

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, Bioverativ, Sanofi, GSK, Orchard Therapeutics, GC LabCell 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 300 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.

 

***Please click here for the full release***


Back to previous page