TIDMOXB
RNS Number : 5430G
Oxford Biomedica PLC
18 March 2020
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 GBP11.5 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.GBP65
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 GBP1.4
million
-- Cash at 31 December was GBP16 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.GBP7 million
-- The Group strengthened its balance sheet through the
repayment of the $55 million Oaktree loan following the GBP53.5
million equity investment by Novo Holdings A/S who are now a 10.1%
shareholder
Business Update: Capitalising on our market leading
Lentivector(TM) 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 GBP 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
LentiVector(TM) 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-
Enquiries:
Oxford Biomedica plc T: +44 (0)1865 783 000
John Dawson, Chief Executive Officer T: +44 (0)1865 783 000
Stuart Paynter, Chief Financial Officer T: +44 (0)1865 954 161 / E: ir@oxb.com
Catherine Isted, Head of Corporate
Development & IR
T: +44 (0)20 3709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
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(R) ), 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
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