Oxford, UK – 17 September 2020: 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 2020.
FINANCIAL HIGHLIGHTS
Continued strong growth was seen in bioprocessing and commercial development, where revenues increased by 24% to £23.4 million (H1 2019: £18.8 million)
• Licences, milestones & royalties were £10.6 million (H1 2019: £13.3 million), a decline of 20% as the growing royalties and licence fee revenue from Juno/BMS in H1 2020 was not able to match the large £11.5 million ($15 million) milestone payment received from Axovant in H1 2019
• Operating expenses increased by 41% to £29.1million (H1 2019: £20.6 million)
• Operating EBITDA1 loss and operating loss were £0.4 million and £5.8 million respectively (H1 2019 losses of £1.4 million and £6.1 million respectively)
• Gross proceeds of £40.0 million (£38.6m net of expenses) were raised from new and existing investors through a successful placing in June 2020. This provided additional funding to the Group in order to continue to leverage the significant opportunities in the growing cell and gene therapy market, both with current and future partners, and also provided additional resources for the Group manufacture of potential COVID-19 vaccine candidates
• Cash consumed during operations was £0.9 million compared to £1.3 million generated in H1 2019
• Cash at 30 June 2020 was £50.6 million (31 December 2019: £16.2 million), which included proceeds from the placing earlier in June
• The Group’s capital expenditure decreased to £5.3 million (H1 2019: £14.9 million) following the completion of the first phase of construction of the Oxbox bioprocessing facility at the end of 2019
.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 9.
OPERATIONAL HIGHLIGHTS (including post period-end events)
Juno Therapeutics / Bristol Myers Squibb Partnership
• In March, a new licence and five-year clinical supply agreement was signed with Juno Therapeutics / Bristol Myers Squibb initially for multiple CAR-T and TCR-T programmes. A £7.8 million ($10 million) upfront payment was received by the Group and up to $217 million could be paid in development, regulatory and sales related milestones in addition to undisclosed process development, scale up and batch revenues and with an undisclosed royalty on sales
Novartis Partnership
• Post the extension of the Novartis partnership by a further five years announced in December 2019, the collaboration continues to strengthen with a sixth vector construct added in the first quarter of 2020
• Global roll out of Kymriah® in both relapsed or refractory B-cell acute lymphoblastic leukaemia (r/r ALL) and relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) indications continues at pace, with more than 25 countries worldwide having approved reimbursement in at least one indication in over 250 qualified treatment centres
• In August, Novartis announced positive data from the Phase II ELARA trial of Kymriah® in patients with relapsed or refractory (r/r) follicular Lymphoma (FL), with filing for this indication anticipated in the US during 2021. Novartis received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for r/r FL earlier this year
COVID-19 Vaccine and Agreement with AstraZeneca
• In April, the Group joined a consortium led by the Jenner Institute, Oxford University to rapidly develop, scale and manufacture a potential vaccine for COVID-19, ChAdOx1 nCOV-19. Subsequently, AstraZeneca entered into an agreement with Oxford University for the global development and distribution of the vaccine, renaming the programme AZD1222
• In May, the Group entered into a one year clinical and commercial supply agreement with AstraZeneca to GMP manufacture the adenoviral vector based COVID-19 vaccine candidate (AZD1222) with multiple batches to be produced through 2020
• In June, Oxford Biomedica signed a five-year agreement with VMIC (Vaccines Manufacturing and Innovation Centre) to enable the rapid manufacture of viral vector based vaccines and with VMIC to provide equipment for two GMP suites in Oxbox to further scale up AZD1222 or other viral vector vaccine candidates
• In September, the Group announced an 18-month supply agreement under a three-year Master Supply and Development Agreement with AstraZeneca for large-scale manufacture of AZD1222, for which the Group was paid a £15 million capacity reservation fee. The Group expects, subject to satisfactory scale up of the process and continuation of the vaccine programme, to receive additional revenues in excess of £35 million until the end of 2021
Other Partnership news and updates
• In July, the Group announced that it had signed a three-year Clinical Supply Agreement (CSA) with Axovant Gene Therapies for the manufacture and supply of Parkinson’s disease gene therapy programme AXO-Lenti-PD. This CSA builds on the worldwide licence agreement signed between the two companies in June 2018
• In August, the Group signed a development, manufacture and licence agreement with Beam Therapeutics Inc. for next generation CAR-T programmes and put in place a three year clinical supply agreement. This now takes the total number of the Group’s partner programmes to 20
Corporate Developments and Expansion
• Following completion of the building phase of the new 84,000 sqft manufacturing facility (Oxbox) at the end of 2019, the MHRA regulatory approval of the first two suites was received in May. The first partner batches were being produced within Oxbox by the end of the second quarter 2020
• In June, the Group welcomed Dr Roch Doliveux as Non-executive Chairman, following the retirement of prior Chairman Dr. Lorenzo Tallarigo
John Dawson, Oxford Biomedica’s Chief Executive Officer, said:
“The first six months of the year, continuing into the second half of 2020, have probably been the busiest I have known in my time at Oxford Biomedica, set against the backdrop of one of the most unusual times in our working history. I am incredibly proud of all of the team for truly excelling in these challenging times. Oxford Biomedica’s position as a world leading Lentiviral vector company continues to grow and since the onset of the COVID-19 pandemic, not only have we signed seven partner/collaboration agreements including a major new agreement with Juno Therapeutics, but we have also grown the underlying bioprocessing and commercial development revenues by 24% and signed two agreements with AstraZeneca for manufacture of their potential COVID-19 vaccine. The successful Placing in June allows us to continue to exploit the significant opportunities we see in the growing cell and gene therapy market and maximise the opportunities ahead. We look forward to what will be a busy second half of the year and thank our staff for their dedication and resilience during these unprecedented times.”
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Analyst briefing
Management will be hosting a briefing for analysts via conference call and webcast at 13:00 (8:00 ET) today, 17 September 2020.
Dial-in details are:
US Participant Toll Free Dial-In Number: (833) 922-1411
US Participant International US-Toll Dial-In Number: +1 (918) 922-6506
UK Participant Local Dial-In Number: (0) 20 3107 0289
UK Participant Toll-Free Dial-In Number: +44 (0) 80 0028 8438
Conference ID: 7266616
In order to join the call, all participants will be required to provide the Conference ID Number listed above
To see the interim results in full click here.
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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
Peel Hunt (Joint Corporate Brokers):
James Steel / Dr. Christopher Golden, T: +44 (0)20 7418 8900
WG Partners (Joint Corporate Brokers):
David Wilson / Claes Spång, T: +44 (0)20 3705 9321
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, Beam Therapeutics, 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. Additionally, the Group has signed a 3-year master supply and development agreement with AstraZeneca for large-scale manufacturing of the adenoviral based COVID-19 vaccine candidate, AZD1222. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available at www.oxb.com