The information contained within this
announcement is deemed by the Group to constitute inside
information as stipulated under the Market Abuse Regulation (EU)
No. 596/2014 (as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018). Upon the publication of this
announcement via the Regulatory Information Service, this inside
information is now considered to be in the public domain.
OXFORD BIOMEDICA
PLCINTERIM RESULTS FOR THE SIX MONTHS ENDED 30
JUNE 2023
- Newly appointed Chief Executive
Officer, Dr. Frank Mathias, is leading a transformation to position
Oxford Biomedica as a pure-play CDMO; strategic and operational
streamlining ongoing
- Transformation into a pure-play
CDMO by 1 January 2024, with £30 million of annualised costs
savings
- Strong execution and delivery of
commercial strategy evidenced by client base expanding by 50% since
the end of 2022, with a robust growing business pipeline across all
key vector types and clinical stages
- On track for revenue growth in 2024
from existing and new client programmes, targeting broadly
breakeven Operating EBITDA by year-end 2024
- Medium term guidance provided;
3-year revenue CAGR in excess of 30% and Operating EBITDA margins
in excess of 20% by the end of 2026
- Entered into exclusive negotiations
with respect to a proposed acquisition of ABL Europe from Institut
Mérieux, as part of pure-play CDMO transformation. The proposed
transaction would include:
- Addition of ABL Europe’s facilities
in Lyon and Strasbourg allowing Oxford Biomedica to gain a
footprint in the EU and expand Oxford Biomedica’s capacity to
address increased client demand
- Consideration of £12.9 million (€15
million), including the value of £8.6 million (€10million) of
pre-completion cash funding in ABL Europe from Institut
Mérieux
- Institut Mérieux providing an
additional £17.2 million (€20 million) of committed future funding
in exchange for Oxford Biomedica shares, with timing at Oxford
Biomedica’s discretion
- Institut Mérieux to become a major
shareholder in Oxford Biomedica by building its ownership of Oxford
Biomedica shares through purchases in the open market with the
intention of reaching, in aggregate, approximately 10 per cent of
the Company’s enlarged issued share capital
Oxford, UK – 20 September 2023:
Oxford Biomedica plc (“Oxford Biomedica” or “the Group”) (LSE:
OXB), a quality and innovation-led cell and gene therapy CDMO today
announces interim results for the six months ended 30 June
2023.
Dr. Frank Mathias,
Oxford Biomedica’s Chief Executive Officer, said:
“Oxford Biomedica is a market leader in the
fast-growing gene and cell therapy market. Our expertise and
unmatched track record sets us apart, and our focus on being a
pure-play cell and gene therapy CDMO gives us a unique position in
the market. Six months into the role, I am fully focused on
sustainable growth and our path to profitability - accelerating us
to being a pure-play CDMO. With the cell and gene therapy industry
at an inflection point, I believe that we are in the right market
at the right time, and well-equipped to succeed with our highly
skilled workforce and leading-edge technology.
“This has required a transformation and a change
of mindset. We are adapting our structure and processes to better
serve our clients and work more efficiently. We will now work
together as one company with aligned operations from our
headquarters here in Oxford, UK, a footprint in the US, and will
offer multiple vector types from our multiple sites. I value our
staff tremendously and thank everyone for their hard work and
contribution to Oxford Biomedica both now and into the future.
“’I’m especially excited to announce the
potential acquisition of ABL Europe today, from Institut Mérieux,
as part of our transformation strategy. This would bring us the
opportunity to gain a footprint in the EU and greatly enhance our
capacity to address the increase in client demand we are seeing. It
would also enable us to become an end-to-end CDMO capable of
serving customers across both sides of the Atlantic and across
vector modalities, leveraging cutting edge science and
innovation.
“We are already seeing the success of our new
commercial strategy and increased market recognition. Not only did
we grow our client base by 50% since the start of the year, but at
the end of July we had signed more client orders than we had in the
whole of 2022 (excluding COVID-19 vaccine manufacturing). We aim to
be the partner of choice for pharma and biotech companies
developing life changing cell and gene therapies, enabling them to
get their products to market faster and reach more patients. Having
already made significant progress, the Board and I are extremely
excited about the future of Oxford Biomedica.”
FINANCIAL HIGHLIGHTS
(including post-period events)
- Total revenue decreased by 33% to
£43.1 million (H1 2022: £64.0 million) and bioprocessing and
commercial development revenues decreased by 29% to £40.6 million
(H1 2022: £57.3 million), with the non-recurrence of COVID-19
vaccine revenue partly offset by double-digit growth in lentiviral
vector revenues and a full six months of revenues from Oxford
Biomedica Solutions.
- License, milestones & royalties
were £2.5 million (H1 2022: £6.7 million), a decrease of 63% due to
a generally lower level of milestone payments from existing clients
and relatively lower license fees from new clients in the
period.
- Operating EBITDA1 loss and
operating loss of £33.7 million and £50.7 million respectively (H1
2022: Operating EBITDA loss and operating loss of £5.8 million and
£19.2 million respectively), the higher losses compared to prior
year driven by the non-recurrence of COVID-19 vaccine revenue as
well the full six-monthly impact of operating expenditure from the
acquisition of Oxford Biomedica Solutions in March 2022.
- Cash at 30 June 2023 was 9% higher
at £129.4 million compared to £118.5 million at 30 June 2022. The
net cash position was 16% higher at £90.1 million as of 30 June
2023 (30 June 2022: £78.7 million).
- Cash and net cash at 31 August 2023
were £121.4 million and £83.0 million respectively.
1
Operating EBITDA (Earnings Before Net Finance Costs, Tax,
Depreciation, Amortisation, fair value adjustments of assets at
fair value through profit and loss, and Share Based Payments) is a
non-GAAP measure often used as a surrogate for operational cash
flow as it excludes from operating profit or loss all non-cash
items, including the charge for share options. A reconciliation to
GAAP measures is provided on page 14.
OUTLOOK AND FINANCIAL
GUIDANCE:
Significant revenue growth anticipated in 2024
vs. 2023 as existing client programmes progress through
development, supplemented by new client wins reflecting a
significant step up in business development activities.
- Accelerating towards broadly
breakeven Operating EBITDA1 by the end of 2024; the Group’s revenue
backlog1 at 30 June 2023 stood at £95 million; this is the amount
of future revenue available to earn from current orders. The Group
expects to grow this backlog significantly going forward based on
high levels of business development activity driving new client
acquisition as well as orders from existing clients.
- Aiming to achieve three-year
revenue CAGR in excess of 30% resulting in at least a doubling of
revenues by the end of 2026 compared to c.£90 million in 2023. With
increased operational efficiencies, targeted cost management and
targeted investment, the Group aims to achieve Operating EBITDA1
margins in excess of 20% by the end of 2026.
- As a result of the business
transformation towards a quality and innovation-led pure-play CDMO,
cost reductions will be completed by the end of December 2023. The
ongoing cost base from 1 January 2024 is anticipated to be reduced
by c.£30 million on an annualised basis compared to 2023. A one-off
restructuring cost of c.£10 million is expected to be incurred in
the current financial year.
- Group revenues for 2023 are
expected to be approximately £90 million; below current market
expectations due to lower milestone and license payments than
previously expected and reduced or delayed bioprocessing orders
from clients. More than 90% of forecasted revenues for the second
half of the year are covered by existing binding purchase orders
and rolling client forecasts.
- Financial impact from the proposed
transaction to acquire ABL Europe announced today is excluded from
mid-term guidance pending completion of the transaction.
- Revenue backlog represents ordered
CDMO revenues available to earn. The value of customer orders
included in revenue backlog only includes the value of work for
which the customer has signed a financial commitment for OXB to
undertake, whereby any changes to agreed values will be subject to
either change orders or cancellation fees.
ANALYST BRIEFING
Oxford Biomedica’s management team, led by new
CEO, Dr. Frank Mathias, Stuart Paynter, CFO, and Dr. Sebastien
Ribault, CCO, will be hosting a briefing and Q&A session for
analysts at 13:00 BST / 8:00 EST today, 20 September, at One
Moorgate Place Chartered Accountants Hall, 1 Moorgate Pl, London
EC2R 6EA, United Kingdom.
A live webcast of the presentation will be
available via this link. The presentation will be available on
Oxford Biomedica’s website at www.oxb.com
If you would like to dial in to the call and ask
a question during the live Q&A, please email
Oxfordbiomedica@consilium-comms.com
NotesUnless otherwise defined,
terms used in this announcement shall have the same meaning as
those used in the 2022 Annual report and accounts.
Enquiries:
Oxford Biomedica plc: |
|
Sophia Bolhassan, VP, Corporate Affairs and IR |
T: +44 (0)1865 783 000/ E: ir@oxb.com |
|
|
ICR Consilium: |
T: +44 (0)20 3709 5700 |
Mary-Jane Elliott |
|
Matthew Neal |
|
Davide Salvi |
|
Peel Hunt (Joint Corporate Brokers): |
T: +44 (0)20 7418 8900 |
James Steel |
|
Dr. Christopher Golden |
|
|
|
JP Morgan (Joint Corporate
Brokers): |
T: +44 (0)20 7134 7329 |
James Mitford |
|
Manita Shinh |
|
ABOUT OXFORD BIOMEDICAOxford
Biomedica (LSE: OXB) is a quality and innovation-led cell and gene
therapy CDMO with a mission to enable its clients to deliver life
changing therapies to patients around the world.
One of the original pioneers in cell and gene
therapy, the Company has more than 25 years of experience in viral
vectors; the driving force behind the majority of gene therapies.
The Company collaborates with some of the world’s most innovative
pharmaceutical and biotechnology companies, providing viral vector
development and manufacturing expertise in lentivirus,
adeno-associated virus (AAV) and adenoviral vectors. Oxford
Biomedica’s world-class capabilities span from early-stage
development to commercialisation. These capabilities are supported
by robust quality-assurance systems, analytical methods and depth
of regulatory expertise.
Oxford Biomedica, a FTSE4Good constituent, is
headquartered in Oxford, UK. It has locations across Oxfordshire,
UK and near Boston, MA, US. Learn more at www.oxb.com,
www.oxbsolutions.com, and follow us on LinkedIn and YouTube.
OVERVIEW
The Group is completing its strategy to
transform into a quality and innovation-led pure-play CDMO, and
further establishing its global leadership in developing and
manufacturing high-quality viral vectors for cell and gene therapy.
These efforts have been led by Dr. Frank Mathias, the Group’s newly
appointed CEO, who joined in March this year. During this period,
Dr. Mathias has reviewed the Group’s operations and is now
executing his plan to finalise the transformation of the Group into
a pure-play CDMO, dedicated to serving pharmaceutical and biotech
clients across the cell and gene therapy space.
As part of this transformation, the Group is
streamlining operations for enhanced efficiency and
client-centricity. The Group now operates as a unified global
company, headquartered in Oxford, UK, with operations in Oxford,
UK, and Bedford, MA, US. This global alignment ensures that Oxford
Biomedica is able to service its growing pipeline of potential new
business opportunities and win more clients and programmes at
different stages and across different vector types.
To accelerate the Group’s transformation into a
pure-play CDMO, the Group is taking necessary steps to reorganise
the business and its workforce. As a result, Oxford Biomedica has
decided to discontinue the development of its therapeutic products
and focus on building a high-quality, high-service, innovation-led
CDMO. Ultimately the Group expects to accelerate towards broadly
Operating EBITDA breakeven by the end of 2024, and deliver strong
shareholder returns. The reorganisation of the business completes
the Group’s evolution into a commercially high-performing entity,
primed for sustained growth, and providing the highest levels of
service and technical capabilities to its target client base.
OPERATIONAL REVIEW
CDMO Services
The Group, with its global leadership position
in developing and manufacturing high-quality viral vectors for cell
and gene therapies, continues to see momentum in the number of
client programmes across all key viral vector types. Currently, its
CDMO portfolio comprises 41 client programmes at various stages of
clinical development, spanning preclinical studies through to
commercial stage. This diversified client portfolio is a testament
to Oxford Biomedica’s capabilities across all key viral vectors and
the breadth of its service offerings.
During the first half of 2023, the Group grew
its portfolio of clients and programmes, with multiple expanded and
new agreements signed for the development and manufacture of
lentivirus, AAV and adenoviral vectors. The Group’s client
portfolio includes 24 clients, with over a third of these clients
working with the Group on more than one programme. This successful
growth demonstrates Oxford Biomedica’s success in executing its new
commercial strategy, including lead generation and qualification,
and ability to convert pipeline to client onboarding.
|
H1 2022* |
H1 2023* |
|
14 clients |
24 clients |
|
28 client programmes |
41 client programmes |
Cell line, process development & pilot scale
production** (Preclinical) |
15 |
25 |
Early-stage clinical supply (Phase I /
2) |
10 |
14 |
Late-stage, process characterization &
validation (Phase 3) |
1 |
1 |
Commercial product supply (Commercial) |
2*** |
1 |
* H1 2022 as per the H1 2022 results release,
including post-period events. H1 2023 as of this results
release. ** Includes undisclosed stage programmes
***Includes the manufacture of the Oxford AstraZeneca COVID-19
vaccine.
Novartis Oxford Biomedica
continues its strong and long-term relationship with Novartis and
is currently working with Novartis on multiple client programmes.
These include vector supply for Novartis’ new T-Charge™ platform, a
next-generation platform that aims to revolutionise CAR-T cell
therapy, which is being studied in a Phase II trial to assess
YTB323 treatment in participants with severe refractory systemic
lupus erythematosus.
The Group remains the sole global supplier of
lentiviral vectors for Kymriah® (tisagenlecleucel, formerly
CTL019), the first ever FDA-approved CAR-T cell therapy which is
available for the treatment of three different indications.
Kymriah® is available in more than 400 qualified treatment
centres in 30 countries having coverage for at least one
indication.
ArcellxDuring the period,
Oxford Biomedica continued to progress its relationship with
Arcellx around their lead programme, CART-ddBCMA, which is
currently being investigated in a pivotal Phase 2 study and has
been granted Fast Track, Orphan Drug, and Regenerative Medicine
Advanced Therapy Designations by the FDA, for the treatment of
relapsed or refractory multiple myeloma.
Juno Therapeutics, Inc. (a wholly owned
subsidiary of Bristol Myers Squibb Company) The Group
maintains its collaboration with Juno Therapeutics (Juno), focusing
on multiple distinct CAR-T/TCR-T programmes.
Juno has adopted Process C, the Group’s
best-in-class perfusion bioreactor process for one Phase I and one
preclinical programme. This cutting-edge technology offers the
potential to deliver superior yield and quality, whilst reducing
the costs of goods for manufacturing.
Cabaletta In August 2023,
Oxford Biomedica announced its expanded relationship with Cabaletta
Bio, Inc., adding CD19 as a new target, following the License and
Supply Agreement announced in January 2022. Oxford Biomedica
initially licensed its LentiVector® platform to Cabaletta Bio for
their DSG3-CAART product candidate, and the agreement has now been
extended to grant a non-exclusive license to Cabaletta under Oxford
Biomedica’s LentiVector® platform IP for Cabaletta’s CD19-CAR T
programme, CABA-201, a 4-1BB-containing fully human CD19-CAR T cell
investigational therapy. Cabaletta Bio has received two IND
clearances to date for CABA-201 and plans to initiate a Phase 1/2
clinical trial for patients with systemic lupus erythematosus and
lupus nephritis and a separate Phase 1/2 clinical trial for
patients with myositis.
Further client
updates Among the new lentiviral vector programmes
initiated during the period, one stands out as the Group's
inaugural 'transferred-in' lentiviral vector technology project. In
this arrangement, the new client has predefined the methods and
processes, with the Group undertaking the development work. This
collaboration is with an undisclosed US-based biotech firm
dedicated to engineering cells as medicines. The Group is
responsible for manufacturing and supplying viral vectors for the
company's primary oncology programme.
Post-period end, Oxford Biomedica signed an
agreement with Kyverna Therapeutics (“Kyverna”), a clinical-stage
cell therapy company with the mission of engineering a new class of
therapies for serious autoimmune diseases. Kyverna’s anti-CD19
chimeric antigen receptor (CAR) T-cell therapies, KYV-101 and
KYV-201, have the potential to offer new hope to patients who have
exhausted current treatment options. Kyverna’s KYV-101 CAR T-cell
product is currently being tested in a Phase 1 clinical trial in
lupus nephritis in the U.S. and a Phase 1/2 trial in Germany.
The Group’s AAV business also continued to
mature, with agreements signed with three new AAV clients for
process development work for programmes in indications including
cystic fibrosis, and gene therapies targeting rare diseases and
auditory indications.
Following the success of the adenoviral vector
work with AstraZeneca to manufacture the Oxford AstraZeneca
COVID-19 vaccine, the Group has continued to grow its portfolio of
adenoviral vector programmes. Two new adenoviral vector agreements
with Oxford University have been signed, including a Clinical
Supply Agreement for the manufacture and supply of adenoviral
vectors for a vaccine against the Lassa virus, and a second
agreement for the supply of adenoviral vector for their programme
in Middle East Respiratory Syndrome (MERS) signed post-period. The
Lassa virus and MERS have both been identified by the World Health
Organisation as priority disease areas for research and development
in emergency contexts.
Client programmes using the Group’s platform
technologies continue to advance, including next-generation CAR-T
developer, Beam Therapeutics Inc., announcing post-period end, the
dosing of the first patient into their Phase 1/2 trial
of BEAM-201 in relapsed/refractory T-cell acute lymphoblastic
leukaemia/T-cell lymphoblastic lymphoma (T-ALL/ T-LL). BEAM-201 is
a CD7-targeting allogeneic CAR-T therapy that incorporates four
edits to increase the potency and persistence of cells and Phase
1/2 trials are expected to start in Q3 2023.
Business development Work has
progressed to ensure that the commercial team is sufficiently
resourced and optimally positioned to leverage the expected
increase in cell and gene therapy opportunities under the
leadership of the Group’s newly appointed Chief Commercial Officer,
Dr. Sebastien Ribault, who joined the Group from Merck KGaA in
November 2022. To support this growth, the commercial team has
doubled in size over the last year, and now has a vector-agnostic
approach covering lentivirus, AAV, and other vectors including
adenoviral vectors. The team operates in three different areas;
Commercial Operations, Sales, and Strategy, Marketing and Corporate
Development and are located across the East and West Coast of the
US as well as Europe, within close proximity to potential and
existing clients.
As part of this commercial strategy, the Group
is planning the introduction of manufacturing of lentiviral vectors
at our Bedford, MA site and AAV to our Oxford site, opening up new
potential revenue opportunities. It is expected that by adding
lentiviral vector and AAV capabilities to both sites, investing in
our platform and innovating in a client-focussed way, we will work
with a broader range of companies and support them as they grow and
progress through clinical trials, further expanding our reach into
the cell and gene therapy sector. This global-focused strategy not
only aims to drive sustainable and predictable revenue growth but
also ensures the Group is strategically positioned to cater to the
anticipated surge in demand from the rapidly maturing gene and cell
therapy sector – marked by more approvals, more late-stage trials,
and an increasing number of therapies in development.
The Group’s new commercial strategy has already
started to show success and momentum as demonstrated by a growth in
both orders and pipeline. The orders signed at the end of July 2023
were materially in excess of the number of orders signed for the
financial year ended 2022 (excluding COVID-19 vaccine orders).
There has also been consistent growth in the business development
pipeline, which grew by over 40% from January to July 2023, and
includes all segments from early phase clinical programmes through
to late-stage programmes close to commercialisation.
Innovation
The Group takes a client-centric approach to
innovation, developing solutions in response to challenges
experienced in the cell and gene therapy field that deliver value
to our clients. The TetraVecta™ system, the Group’s latest
innovation, launched in May 2023. This 4th generation lentiviral
vector delivery system allows for higher quality, potency, safety
and packaging capacity of lentiviral vectors, and enables cell and
gene therapy companies to overcome previous barriers in therapeutic
development, due to the size, complexity, or interference of the
payload to be delivered. The TetraVecta™ system is the result of
years of development and understanding of industry challenges and
can be used to accelerate the adoption of in vivo gene therapies,
as well as support the creation of high-titre stable producer cell
lines for previously unachievable payloads. The new technology is
currently being investigated by a number of existing clients and
several CDMOs.
Work continues on the project which Oxford
Biomedica initiated last year with Orchard Therapeutics utilising
the Group’s proprietary LentiStable™ technology. As part of the
project, Oxford Biomedica’s LentiStable™ technology platform is
being used to develop a producer cell line capable of producing
high titre lentiviral vectors. The project is focusing on
developing high-performing candidate clones for Orchard
Therapeutics’ OTL-203, an investigational hemopoietic stem cell
(HSC) gene therapy in development for the potential treatment of
mucopolysaccharidosis type I Hurler’s syndrome (MPS-IH).
Gene therapeutics pipeline
The Group has concluded the review of strategic
options for its therapeutics portfolio and, in line with its
strategy to become a pure play CDMO, has decided to discontinue
work on internal product development from the second half of
2023.
No material costs associated with the
therapeutics portfolio are expected to be carried by the Group post
2023.
Corporate and organisational
development
The Group’s Bedford, MA site is based near
Boston, US and is led by Mark Caswell who joined the Group in July
2023 and has succeeded Tim Kelly who has stepped down from the
business. Mark Caswell joined the Group as Site Head of US
Operations and has more than 25 years’ experience in the
biopharmaceutical industry, including as Head of Operations at the
Portsmouth, New Hampshire site of Lonza Biologicals. Before Lonza,
Mr. Caswell worked for over 18 years at Sanofi Genzyme (previously
Genzyme) in positions of increasing responsibility, most recently
as Director, Global Engineering and Technology.
In January, Dr. Sam Rasty announced his
intention not to stand for re-election at the Group’s AGM and
stepped down from the Board in June. Sam joined the Board in
December 2020 and was a member of the Scientific and Technology
Advisory Committee, and also a member of the Audit Committee until
December 2021.
In April, Leone Patterson was appointed to the
Board as an Independent Non-Executive Director. Ms. Patterson has
extensive public company biotech experience, including in the cell
and gene therapy industry, and has managed significant growth
within international commercial companies working across areas
including strategy, finance, operations, and governance.
Potential transaction to
acquire ABL
Europe
Oxford Biomedica has entered into exclusive
negotiations with respect to the proposed acquisition by Oxford
Biomedica of ABL Europe SAS (“ABL Europe”) from Institut Mérieux SA
(“Institut Mérieux”). ABL Europe is a pure play European CDMO with
specialised expertise in the development and manufacturing of
solutions for biotechs and biopharma including viruses for gene
therapy, oncolytic viruses and vaccine candidates. This proposed
transaction would form part of Oxford Biomedica’s transformation to
be a world-leading quality-focused and innovation-led CDMO in the
cell and gene therapy field.
Under the proposed transaction, Oxford Biomedica
would acquire ABL Europe for a consideration of £12.9 million (€15
million), including the value of £8.6 million (€10 million) of
pre-completion cash funding from Institut Mérieux in ABL Europe, in
exchange for new Oxford Biomedica shares. In addition, as part of
the proposed transaction, Institut Mérieux would also commit to
provide Oxford Biomedica with £17.2 million (€20 million) of
additional funding, to cover capex and potential future operating
losses, in exchange for new Oxford Biomedica shares.
Under the proposed transaction, Institut Mérieux
would further build its ownership of Oxford Biomedica by acquiring
up to £8.6 million (€10 million) of additional Oxford Biomedica
existing ordinary shares in the market from the date of this
announcement to 31 March 2024. Institut Mérieux intends to build
its ownership of Oxford Biomedica shares through purchases in the
open market so as to reach, in aggregate, approximately 10 per cent
of the Company’s enlarged issued share capital.
ENVIRONMENTAL, SOCIAL AND
GOVERNANCE
The Group remains committed to its role as a
responsible business and implementing its Environmental, Social and
Governance (ESG) strategy, which is focused on five pillars:
People; Community; Environment; Innovation and Supply Chain.
The Group has continued its commitment to review
OXB policies to ensure they are inclusive, progressive and offer
equal opportunities to all our employees.
On the environmental pillar, the Group has
undertaken climate-based risk modelling, with an expert advisor, to
assess resilience against physical and transitional risks posed by
climate change.
The Group is fully committed to responsible
supply chain management and the Group’s supplier code of conduct
has been distributed to its top 250 suppliers for their acceptance
or submission of their own equivalent code of conduct.
On the community pillar, the Group donated
£50,000 to the Disasters and Emergencies Committee for the Turkey
and Syria earthquake appeal and further donations of £3,000 have
been made to the Group’s nominated charities, Oxfordshire Mind
(Registered Charity No. 261476) and Homeless Oxfordshire
(Registered Charity No. 297806).
Full details on our ESG pillars, including the
supplier code of conduct, can be found on our ESG webpage at
www.oxb.com
Financial Review
The first half of 2023 has been a period of
transition with the Group executing on its strategy of transforming
into a quality and innovation-led pure-play cell and gene therapy
CDMO. Lentiviral vector manufacturing volumes have continued their
post pandemic upward trajectory, with revenues from the core
business achieving double digit revenue growth compared to the
first half of 2022. COVID-19 vaccine bioprocessing volumes reduced
to zero, which is reflected in the overall variance from the prior
year.
As part of its evolution into a quality and
innovation-led pure-play viral vector CDMO, the Group has made the
difficult decision to streamline roles, affecting approximately 200
positions in both the UK and the US. This move will ensure
strategic alignment of resources while optimising cost
efficiency.
The Group achieved total revenues of £43.1
million and incurred an Operating EBITDA loss of £33.7 million in
the first half of 2023 compared to revenues of £64.0 million and an
Operating EBITDA loss of £5.8 million in the prior year. The
variance in revenues from the prior year reflects the
non-recurrence of any COVID-19 vaccine bioprocessing volumes in H1
2023, partly offset by double-digit growth in lentiviral vector
revenues and a full six months of revenues from Oxford Biomedica
Solutions. At a cost level, there was an increase in operating
expenditure in the first half of 2023 due to the impact of the full
six months of operational expenditure of Oxford Biomedica Solutions
which was acquired during March 2022, and inflationary cost
increases.
In September, post-period end, Oxford Biomedica
announced that it had entered into exclusive negotiations with
Institut Mérieux for the proposed acquisition of ABL Europe. This
potential transaction would broaden the Company’s customer base in
Europe and the cell and gene therapy space and offer cross-selling
opportunities with ABL Europe’s existing customer base. ABL Europe
had forecasted revenues of c.€15million for the year ended 31
December 2023 and EBITDA of c.€ (1.7)m at 31 December 2022
In July, post-period end, Homology Medicines
Inc. (“Homology”), a genetic medicines company and client of Oxford
Biomedica’s US business announced an update on their business,
including a review of strategic alternatives. Any amounts
outstanding at period end and expected to be billed during H2 2023
for bioprocessing and commercial development work are expected to
be received in the normal course of business, however the Group is
assuming that no further revenues will be received from Homology
beyond the current financial year.
At the end of June, the Group completed a sale
and leaseback of its Harrow House facility for £4.5 million to
Kadans Science Partner. Under the agreement, Kadans have granted
the Group an occupational lease of the property for approximately
15 years at a rent of £0.5 million per annum rising to £0.6 million
after 5 years, with a further market rent review after 10 years. In
the year the Group has recognised a profit on the sale of £0.5
million, a right of use asset of £2.2 million and a lease liability
of £3.1 million.
The key financial indicators used by the Board
are set out in the table below and the highlights are:
- Total revenue (£43.1 million)
decreased by 33% over H1 2022 (£64.0 million) with the
non-recurrence of COVID-19 vaccine revenues partly offset by
double-digit growth in lentiviral vector revenues and a full six
months of revenues from Oxford Biomedica Solutions.
- Operational losses (Operating
EBITDA1 loss and Operating loss) of £33.7 million and £50.7 million
respectively, were higher than the prior year due to the full
six-monthly impact of operating expenditure from the acquisition of
Oxford Biomedica Solutions in March 2022, inflationary cost
increases and then also the non-recurrence of vaccine bioprocessing
revenues.
- Operational activities consumed
cash of £5.4 million compared to £24.5 million in H1 2022. The
lower level of cash consumed was due to the larger operational loss
in H1 2023 being offset by a large working capital inflow, as
opposed to a working capital outflow in H1 2022.
- Capital expenditure decreased from
£6.0 million in H1 2022 to £4.9 million due mainly to lower levels
of purchasing of bioprocessing and laboratory equipment.
- Cash burn2 was £10.2 million in H1
2023 (H1 2022: £32.2 million) mainly due to increased Operating
EBITDA losses offset by positive working capital movements driven
by a decrease in trade receivables and other debtors.
- Cash at 30 June 2023 was £129.4
million compared to £118.5 million at 30 June 2022. The net cash
position was £90.1 million as at 30 June 2023 (30 June 2022: £78.7
million).
- Operating EBITDA (Earnings Before
Net Finance Costs, Tax, Depreciation, Amortisation, fair value
adjustments of assets at fair value through profit and loss, and
Share Based Payments) is a non-GAAP measure often used as a
surrogate for operational cash flow as it excludes from operating
profit or loss all non-cash items, including the charge for share
options. A reconciliation to GAAP measures is provided on page
14.
- Cash (burn)/inflow is net cash
generated from operating activities less net finance costs paid and
capital expenditure. A reconciliation to GAAP measures is provided
on page 14.
|
|
|
|
KEY FINANCIAL INDICATORS (£m) |
H1 2023 |
H1 2022 |
Revenues |
|
|
Bioprocessing/commercial development |
40.6 |
57.3 |
Licence fees, milestones & royalties |
2.5 |
6.7 |
Total |
43.1 |
64.0 |
|
|
|
Operating loss |
(50.7) |
(19.2) |
Operating EBITDA1 |
(33.7) |
(5.8) |
Cash consumed by operating activities |
(5.4) |
(24.5) |
Capital expenditure |
(4.9) |
(6.0) |
Cash burn2 |
(10.2) |
(32.2) |
|
|
|
Period end cash |
129.4 |
118.5 |
Net cash3 |
90.1 |
78.7 |
|
|
|
Headcount |
|
|
Period end |
891 |
959 |
Average |
891 |
920 |
- Operating EBITDA (Earnings Before
Net Finance Costs, Tax, Depreciation, Amortisation, fair value
adjustments of assets at fair value through profit and loss, and
Share Based Payments) is a non-GAAP measure often used as a
surrogate for operational cash flow as it excludes from operating
profit or loss all non-cash items, including the charge for share
options. A reconciliation to GAAP measures is provided on page
14.
- Cash (burn)/inflow is net cash
generated from operating activities less net finance costs paid and
capital expenditure. A reconciliation to GAAP measures is provided
on page 14.
- Net cash is cash less external
loans.
The Group evaluates its performance inter alia
by making use of three alternative performance measures as part of
its Key Financial Indicators (see table above). The Group believes
that these Non-GAAP measures, together with the relevant GAAP
measures, provide an accurate reflection of the Group’s performance
over time. The Board has taken the decision that the Key Financial
Performance Indicators against which the business will be assessed,
are Revenue, Operating EBITDA and Operating profit/(loss).
Revenue
Revenues were £43.1 million in H1 2023, 33%
below the £64.0 million achieved in H1 2022.
£m |
H1 2023 |
H1 2022 |
Bioprocessing/commercial development |
40.6 |
57.3 |
Licence fees, milestones & royalties |
2.5 |
6.7 |
Revenue |
43.1 |
64.0 |
Revenues from bioprocessing/commercial
development were 29% lower in H1 2023 as compared to H1 2022,
largely due to the non-recurrence of revenues from the
manufacturing of vaccine batches for AstraZeneca. This was partly
offset by a double digit increase in revenues from lentiviral
vector as well as AAV commercial development and manufacturing
activities performed on behalf of the Group’s existing clients.
Revenues from licence fees, milestones and
royalties have decreased compared to the prior year due to a
generally lower level of milestones achieved from existing clients
and license fees from new clients, as compared to H1 2022.
Operating EBITDA
£m |
H1 2023 |
H1 2022 |
Revenue |
43.1 |
64.0 |
Other operating income |
1.4 |
0.9 |
Gain on sale of property |
0.5 |
- |
Total expenses1 |
(78.7) |
(70.7) |
Operating EBITDA |
(33.7) |
(5.8) |
Depreciation, amortisation, share option charge and fair value
adjustments of available-for-sale assets |
(17.0) |
(13.4) |
Operating loss |
(50.7) |
(19.2) |
1 Cost of goods plus research, development,
bioprocessing and administrative expenses excluding depreciation,
amortisation and share option charge. A reconciliation to GAAP
measures is provided on page 12.
Total expenses in H1 2023 were £78.7 million,
compared with £70.7 million in H1 2022, a 11% increase over H1
2022. The increase was driven by the full six month impact in H1
2023 of the consolidation of the results of Oxford Biomedica
Solutions, acquired during March 2022, as well as inflationary
increases.
As a result of the lower revenues and increased
operational spend, the Operating EBITDA loss in H1 2023 was £33.7
million, £27.9 million higher than the prior period (H1 2022
Operating EBITDA loss of £5.8 million).
Total expenses
In order to provide the users of the accounts
with a more detailed explanation of the reasons for the
period-on-period movements of the Group’s operational expenses
included within Operating EBITDA, the Group has added together cost
of goods, research and development, bioprocessing and
administrative costs and has removed depreciation, amortisation and
the share option charge as these are non-cash items which do not
form part of the Operating EBITDA alternative performance measure.
As Operating profit/(loss) is assessed separately as a key
financial performance measure, the year-on-year movement in these
non-cash items is then individually analysed and explained
specifically in the Operating and Net profit/(loss) section.
Expense items included within Total Expenses are then categorised
according to their relevant nature with the year-on-year movement
explained in the second table below:
|
|
|
£m |
H1 2023 |
H1 2022 |
Research and development costs1 |
31.4 |
27.3 |
Bioprocessing costs1 2 |
30.3 |
12.4 |
Administrative expenses1 |
12.9 |
16.5 |
Operating expenses |
74.6 |
56.2 |
Depreciation, amortisation & share option charge |
(17.0) |
(13.4) |
Adjusted operating expenses |
57.6 |
42.8 |
Cost of Sales |
21.1 |
27.9 |
Total expenses1 |
78.7 |
70.7 |
|
|
|
1 Includes operational expenditure for Oxford
Biomedica Solutions for the full six months as opposed to from
March onwards during 2022.2 Bioprocessing costs have increased from
the prior period due to the lower recovery of batch manufacturing
costs which is also reflected in decreased cost of goods in H1
2023.
The table below shows total expenses by nature
(excluding depreciation, amortisation and other non-cash
items):
£m |
H1 2023 |
H1 2022 |
Raw materials, consumables and other external bioprocessing
costs |
15.9 |
15.8 |
Personnel-related |
47.1 |
40.4 |
External R&D expenditure |
1.5 |
1.9 |
Due diligence costs |
- |
5.1 |
Other costs |
14.2 |
7.5 |
Total expenses |
78.7 |
70.7 |
Raw materials, consumables and other external
bioprocessing costs have increased slightly as a result of a higher
number of lentiviral vector batches manufactured in H1 2023 as
compared to H1 2022. Personnel related costs are higher due to the
full six month impact of payroll costs of employees acquired as
part of the acquisition of Oxford Biomedica Solutions in March
2022. External R&D expenditure was lower as a result of a lower
level of research and development project spend incurred in the
platform division. Due diligence costs relate to the establishment
of Oxford Biomedica Solutions during 2022. Other costs have
increased compared to H1 2022 due to the full six month impact of
the expenditure of Oxford Biomedica Solutions, foreign exchange
losses of £0.5 million (H1 2022: £2.4 million gain), and
inflationary increases in the administrative and facility
expenditure.
Operating profit/(loss) and net
profit/(loss)
£m |
H1 2023 |
H1 2022 |
Operating EBITDA1 |
(33.7) |
(5.8) |
Depreciation, amortisation and share option charge |
(17.0) |
(13.4) |
Operating loss |
(50.7) |
(19.2) |
Financing |
(1.7) |
(8.2) |
Taxation |
(0.3) |
(0.2) |
Net loss |
(52.7) |
(27.6) |
1 Operating EBITDA (Earnings Before Net Finance
Costs, Tax, Depreciation, Amortisation, fair value adjustments of
assets at fair value through profit and loss, and Share Based
Payments) is a non-GAAP measure often used as a surrogate for
operational cash flow as it excludes from operating profit or loss
all non-cash items, including the charge for share options. A
reconciliation to GAAP measures is provided above.
In arriving at the Operating loss, the Operating
EBITDA loss of £33.7 million was further impacted by depreciation,
amortisation and the share option charge.
Depreciation and amortisation increased by £3.6
million mainly due to Oxford Biomedica Solutions’ fixed assets and
intangible asset depreciation and amortisation for the full six
month period as opposed to the period from when they were acquired.
The share option charge remained relatively stable compared to the
prior period.
The impact of these charges resulted in an
operating loss of £50.7 million in the first half of 2023 compared
to a loss of £19.2 million in the prior year’s corresponding
period.
The finance charge decreased by £6.6 million
mainly due to foreign exchange gains of £1.7 million as opposed to
foreign exchange losses of £4.9 million on the Oaktree loan in H1
2022, an increase in interest received of £2.2 million due to
improved interest rates on cash balances held by the Group but
offset by a £2.1 million increase in IFRS 16 interest on the lease
liabilities related to the Group’s Boston and Windrush Court
facilities.
The corporation tax expense which is based on
the notional tax charge on the RDEC tax credit, included within
research and development costs, has increased due to the increase
in corporation tax rates, as well as an increase in the expected
RDEC tax credit.
Other Comprehensive IncomeThe
Group recognised a loss on other comprehensive income in H1 2023 of
£4.6 million (2022: £10.8 million gain) in relation to movements on
the foreign currency translation reserve.
The translation reserve comprises all foreign
currency differences arising from the translation of the financial
statements of foreign operations, including gains arising from
monetary items that in substance form part of the net investment in
foreign operations.
Segmental analysis
The Group reports its results within two
segments, namely the “Platform” segment which includes the revenue
generating bioprocessing and process development activities for
third parties, and internal technology projects to develop new
potentially saleable technology, improve the Group’s current
processes and bring development and manufacturing costs down. The
other segment, “Product”, includes the costs of researching and
developing new product candidates.
H1 2023
£m |
Platform |
Product |
Total |
Revenues |
43.0 |
0.1 |
43.1 |
Operating EBITDA1 |
(28.7) |
(5.0) |
(33.7) |
Operating loss |
(44.6) |
(6.1) |
(50.7) |
H1 2022
£m |
Platform |
Product |
Total |
Revenues |
64.0 |
0.0 |
64.0 |
Operating EBITDA1 |
(0.8) |
(5.0) |
(5.8) |
Operating loss |
(13.2) |
(6.0) |
(19.2) |
1 Operating EBITDA (Earnings Before Net Finance
Costs, Tax, Depreciation, Amortisation, fair value adjustments of
assets at fair value through profit and loss, and Share Based
Payments) is a non-GAAP measure often used as a surrogate for
operational cash flow as it excludes from operating profit or loss
all non-cash items, including the charge for share options. A
reconciliation to GAAP measures is provided on page 14.
Revenues from the platform segment decreased
when compared to H1 2022 due to the non-recurrence of vaccine
batches manufactured for AstraZeneca, partly offset by higher
lentiviral and AAV manufacturing volumes. Operating results were
negatively impacted by the lower revenues as well as Oxford
Biomedica Solutions’ operational expenditure for the full six
months as opposed to, in 2022, the period since they were
acquired.
Revenues from the product segment were higher
due to an increased level of clinical development activities for
clients. Product operating expenses were higher due to increased
research, development and preclinical product expenditure, but also
increased manpower costs. The Group has concluded the review of
strategic options for its product portfolio and, in line with its
strategy to become a pure-play CDMO, has decided to discontinue
work on internal product development from the second half of 2023.
No material costs associated with the Product segment are expected
to be carried by the Group post 2023.
In 2023 the Senior Executive Team re-assessed
the reporting segments to reflect the way the business will be
managed in future. Management reporting is currently being reworked
to align with these new segments and the Group expects to be able
to report on these new segments during H2 2023 and thereafter. No
changes from the current basis have been reflected in these Interim
financial statements.
Cash flow
|
|
|
£m |
H1 2023 |
H1 2022 |
Operating loss |
(50.7) |
(19.2) |
Depreciation, amortisation and share option charge |
17.0 |
13.4 |
Operating EBITDA1 |
(33.7) |
(5.8) |
Working capital |
24.8 |
(19.3) |
R&D tax credit received |
3.5 |
0.6 |
Cash consumed in operations |
(5.4) |
(24.5) |
Interest received less paid/(paid less received) |
0.1 |
(1.7) |
Capital expenditure |
(4.9) |
(6.0) |
Cash burn |
(10.2) |
(32.2) |
1 Operating EBITDA (Earnings Before Net Finance
Costs, Tax, Depreciation, Amortisation, fair value adjustments of
assets at fair value through profit and loss, and Share Based
Payments) is a non-GAAP measure often used as a surrogate for
operational cash flow as it excludes from operating profit or loss
all non-cash items, including the charge for share options. A
reconciliation to GAAP measures is provided on page 14.
Operating losses for the first six months of
2023 were £31.5 million higher than the £19.2 million loss incurred
in H1 2022. The positive inflow from working capital was mainly as
a result of the decrease in trade and other receivables due to
amounts received from clients outstanding as at December 2022. The
2021 RDEC tax credit was received in January 2023. Interest was
received as opposed to paid (H1 2022) due to improved interest
rates on cash balances held by the Group offset by increased IFRS
16 interest due on the lease liability related to the Group’s
Boston and Windrush Court facilities. Capital expenditure decreased
by £1.1 million compared to H1 2022 due mainly to lower levels of
purchasing of bioprocessing and laboratory equipment.
Statement of financial
position
The most notable items on the Statement of
financial position, including changes from 31 December 2022, are as
follows:
Non-current assets – Intangible assets and
goodwill decreased from £105.9 million to £97.9 million due to
amortisation of £3.6 million and foreign exchange movements of £4.4
million. Property, plant and equipment decreased from £133.8
million to £120.6 million due to disposals of property of £7.1
million, depreciation of £11.2 million, foreign exchange movements
of £2.6 million, offset by capital expenditure of £8.2 million on
mainly plant and equipment.
Current assets – Inventories increased slightly
to £13.5 million from £12.6 million at 31 December 2022, mainly as
a result of inventory purchased in preparation of the expected
increased bioprocessing activities in the second half of 2023.
Trade and other receivables have decreased by £26.9 million mainly
as a result of the receipt of amounts outstanding from clients as
at December 2022, but also lower levels of un-invoiced client work
as compared to year end.
Current liabilities – Trade and other payables
have decreased from £36.6 million at the start of the year to £26.2
million due to lower levels of client and other operational
activities leading to lower levels of accruals and trade creditors
outstanding. Contract liabilities have increased by £4.1 million
due to the invoicing of orders received in advance for the goods
and services being provided by the Group. Lease liabilities
increased by £0.4 million as the recognition of the lease liability
on our Harrow House facility more than offset lease payments during
the period. Deferred income decreased due to the recognition of
grant income related to production capacity expansion.
Non-current liabilities – Provisions increased
by £0.5 million as a result of the recognition of a liability for
the costs of restoring the newly leased Harrow House manufacturing
facility to its original state at the end of the lease term.
Contract liabilities have increased by £4.5 million due to the
invoicing of orders received in advance for the goods and services
being provided by the Group. The put option liability to acquire
the remaining 20% of Oxford Biomedica Solutions that the Group
doesn’t already own has decreased from £38.2 million at 31 December
2022 to £20.3 million at the end of June 2023 due to a decrease in
the value at which the option is expected to be exercised.
The Group’s cash resources at 1 January 2023
were £141.3 million. Cash used in operations was £5.4 million.
which includes £3.5 million RDEC tax credit received. Other
significant cash flows were £4.4 million received from the sale of
Harrow House facility, £4.9 million of capex expenditure, £5.3
million of lease liability payments and a negative impact from
exchange rates on cash balances held of £1.3 million. The cash
balance at 30 June 2023 was £129.4 million with a net cash position
of £90.1 million.
Post balance sheet event
Homology Medicines Inc. strategic updateAs a
result of Homology Medicines Inc. announcing an update on their
business, including strategic alternatives in July 2023, the Group
will perform an impairment review for the Oxford Biomedica
Solutions’ CGU as at 31 December 2023 to assess any potential
impairment of the intangible assets and fixed assets of the CGU
during H2 2023. Any resultant impairment charge will be booked in
the December 2023 year-end financial statements.
Potential transaction to acquire ABL
EuropeOxford Biomedica has entered into exclusive negotiations for
the proposed acquisition of ABL Europe SAS. Terms of the proposed
transaction would include a consideration of €15million, (including
the value of £8.6 million (€10 million) of pre-completion cash
funding in ABL Europe from Institut Mérieux), in exchange for
Oxford Biomedica shares. In addition, Institut Mérieux would also
commit to provide Oxford Biomedica with £17.2 million (€20 million)
of additional funding, to cover capex and potential future
operating losses, in exchange for new Oxford Biomedica shares.
In addition, under the proposed transaction,
Institut Mérieux would further build its ownership of Oxford
Biomedica by acquiring up to £8.6 million (€10 million) of
additional Oxford Biomedica existing ordinary shares in the market
from the date of this announcement to 31 March 2024. Institut
Mérieux intends to build its ownership of Oxford Biomedica shares
through purchases in the open market so as to reach, in aggregate,
approximately 10 per cent of the Company’s enlarged issued share
capital.
Financial outlook
Oxford Biomedica is reorganising its business as
it finalises its transformation towards a pure-play cell and gene
therapy CDMO. As part of this transformation the Group is expected
to incur a one-off restructuring cost of c.£10 million in the
second half of 2023. The Group has concluded the review of
strategic options for its therapeutics products portfolio and spend
on therapeutic products will be ceased during H2 2023. In addition,
there will be a streamlining of the organisational structure and
adopting of a more client-focused R&D strategy.
Group revenues for 2023 are expected to be
approximately £90 million, below current market expectations due to
lower milestone and license payments than previously expected, and
reduced or delayed bioprocessing orders from clients. Significant
revenue growth is expected in 2024 vs. 2023, driven by high levels
of business development activity. This includes existing client
programmes progressing through development and the acquisition of
new clients, notwithstanding a slowdown in the biotech funding
environment.
The Group has a high level of visibility over
revenues for the remainder of 2023 with more than 90% of forecasted
revenues for the second half of the year covered by existing
binding purchase orders and rolling client forecasts. The Group’s
revenue backlog at 30 June 2023 stood at £95 million; this is the
amount of future revenue available to earn from current orders. The
Group expects to grow this backlog significantly going forward
based on high levels of business development activity driving new
client acquisition, as well as orders from existing clients. The
strong execution and delivery of commercial strategy gives strong
visibility in and confidence in 2024 revenue growth.
Whilst the outcome of Homology’s strategic
review is not yet known, the Group expects Homology to remain a
client of the Group with contracted revenues for the remainder of
2023; and is prudently assuming that no further revenues are
expected from 2024 onwards. Homology remains well capitalised with
cash and short term investments of £100.8 million ($127.1 million)
as of 30 June 2023. In addition, they recently reported encouraging
data from their Phase I trial evaluating gene editing candidate
HMI-103 in adults with PKU.
The Operating EBITDA loss (after restructuring
costs) for the second half of 2023 is expected to be approximately
£10 million better than the first half. As a result of business
transformation and cost reductions completed in 2023, the ongoing
cost base from 2024 is anticipated to be reduced by c.£30m on an
annualised basis compared to 2023.
Capex levels are expected to be similar in the
second half of 2023 to the first half of 2023 with the Group taking
a cautious approach to planning significant new projects.
With a strong cash position of £121.4 million
and a net cash position of £83.0 million as at 31 August 2023, the
Group is well financed.
Medium term guidance
In 2024 and beyond, the Group expects to
continue to grow lentiviral vector and AAV manufacturing and
development revenues through the successful development of existing
client relationships and the continued targeting of new client
relationships. Further, the group is already accelerating towards
broadly breakeven Operating EBITDA by the end of 2024 with a leaner
cost base and positive momentum in business development activities,
including growth in both orders and pipeline.
Building on its leading position in lentiviral
vectors, the Group aims to ultimately have a market leading
position in the viral vector outsourced supply market across all
key vector types. The Group aims to achieve three-year revenue CAGR
in excess of 30%, and at least a doubling of revenues by the end of
2026 from the approximately £90 million being indicated for 2023,
with this growth being maintainable into the longer term. This will
be supported by the strength of the Group’s revenue backlog,
growing pipeline of potential new business opportunities, and the
progress being made by the newly expanded business development team
and the new commercial strategy.
With increased operational efficiencies,
targeted cost management, and targeted investment the Group aims to
achieve Operating EBITDA margins in excess of 20% by the end of
2026.
Financial impact from the potential transaction
to acquire ABL Europe announced today is excluded from mid-term
guidance pending completion of the transaction.
Finally, management reporting for the financial
year 2023 will reflect the Group’s new structure as a pure-play
CDMO. Future guidance is anticipated to be split by the new
reporting segments.
Principal risks and
uncertainties
Risk assessment and evaluation is an integral
and well-established part of the Group’s management processes. The
Group’s management framework incorporates the implementation of a
mitigation strategy, each tailored to the specific risk in
question. Details of our principal risks and uncertainties can be
found on pages 64 to 68 of the 2022 Annual report & accounts
which is available on the Group’s website at www.oxb.com. A summary
of these risks is provided below. We have seen increased risk with
regards to the execution of the business plan for Oxford Biomedica
Solutions, and the risks associated with moving into the AAV
sector, and a decrease in product liability risk as a result of the
Group discontinuing product development. The remaining risks have
been assessed not to have changed materially.
Commercialisation risks
- Failure or delays in the execution of
the business plan for Oxford Biomedica Solutions
- Risks associated with the move into
the AAV sector
- Discontinuation of product development
by collaborators and partners
- Unable to keep up with rapid
technological changes
Supply chain and business execution risks
- Failure of key third party
suppliers
- Bioprocessing failures
- Cyber attacks
- Failure to attract, develop and retain
talented and capable workforce
Legal, regulatory and compliance risks
- Adverse outcomes of litigation;
governmental; or regulatory inspections
- Infringement of IP and patents
Economic and financial risks
- Impacts of climate change
- Exposure to foreign currency
fluctuations
- Claims from product liability
- Impacts from the war in Ukraine and
COVID-19
Going concern
The financial position of the Group, its cash
flows and liquidity position are described in the primary
statements and notes to these interim financial statements.
The Group made a loss for the period ended 30
June 2023 of £52.7 million, consumed net cash flows from operating
activities of £5.4 million, and ended the period with cash and cash
equivalents of £129.4 million. The Group sold its Harrow House
facility in a sale and leaseback transaction for £4.5 million to
Kadans, whilst also agreeing an occupational lease of the property
for 15 years. In considering the basis of preparation of the
Interim financial statements, the Directors have prepared cash flow
forecasts for a period of at least 12 months from the date of
approval of these financial statements, based in the first instance
on the Group’s 2023 latest view,, and forecasts for 2023 and 2024.
The Directors have undertaken a rigorous assessment of the
forecasts in a base case scenario and assessed identified downside
risks and mitigating actions.
These cash flow forecasts also take into
consideration severe but plausible downside scenarios
including:
- Commercial challenges leading to a
substantial manufacturing and development revenue downside
affecting both the LentiVector® platform and AAV businesses;
- No revenues from new
customers;
- Decreases in forecasted existing
customer milestones and removal of any future license revenues,
and
- The potential impacts of a
recession on the Group and its customers including expected
revenues from existing customers under long term contracts.
Under both the base case and mitigated downside
scenario, the Group and parent company has sufficient cash
resources to continue in operation for a period of at least 12
months from the date of approval of these financial statements.
In the event of the downside scenarios
crystallising, the Group would continue to meet its existing loan
covenants until December 2024 without taking any mitigating
actions, but the Board has mitigating actions in place that are
entirely within its control that would enable the Group to reduce
its spend within a reasonably short time-frame to increase its cash
covenant headroom as required by the loan facility with Oaktree
Capital Management.
The Board has confidence in the Group’s ability
to continue as a going concern for the following reasons:
- As noted above, the Group has cash
balances of £129.4 million at the end of June 2023, and £121.4
million at the end of August 2023;
- More than 90% of 2023 forecasted
revenues are covered by binding purchase orders and rolling
customer forecasts which give confidence in the level of revenues
forecast over the next 12 months; and
- The Group’s history of being able
to access capital markets including raising £77.0 million of equity
during 2022;
- The Group’s history of being able
to obtain loan financing when required for purposes of both capital
expenditure and operational purposes, as recently evidenced by the
US$85 million one-year facility and US$50 million replacement
four-year facility obtained with Oaktree;
- The Group intends to delay the
construction element of its OXBOX manufacturing facility expansion
to now take place during 2028 and 2029;
- The completion of the potential
transaction to acquire ABL Europe is subject to successful
completion of due diligence, regulatory approvals and final Board
approval. The Board of Oxford Biomedica do not intend to approve
the transaction if it is expected to materially impact our ability
to continue as a going concern;
- The Group’s ability to continue to
be successful in winning new customers and building its brand as
demonstrated by successfully entering into new customer agreements
including with Arcellx, Cargo Therapeutics and Oxford University
over the last 6 months;
- The Group has the ability to
control capital expenditure costs and lower other operational
spend, as necessary.
Taking account of the matters described above,
the Directors remain confident that the Group will have sufficient
funds to continue to meet its liabilities as they fall due for at
least 12 months from the date of approval of the financial
statements and therefore have prepared the financial statements on
a going concern basis.Consolidated Statement of
Comprehensive Expensefor
the six months ended 30 June
2023
|
|
|
|
|
|
Six months ended 30 June
2023Unaudited |
Six months ended 30 June 2022Unaudited |
|
Notes |
£’000 |
£’000 |
Revenue |
|
43,061 |
64,027 |
Cost of sales |
|
(21,122) |
(27,899) |
Gross profit |
|
21,939 |
36,128 |
Bioprocessing costs |
|
(30,314) |
(12,383) |
Research and development costs |
|
(31,417) |
(27,310) |
Administrative expenses |
|
(12,838) |
(16,479) |
Other operating income |
|
1,402 |
925 |
Gain on sale and leaseback |
|
472 |
- |
Change in fair value of available-for-sale asset |
|
8 |
(38) |
Operating loss |
|
(50,748) |
(19,157) |
|
|
|
|
Finance income |
|
2,217 |
50 |
Finance costs |
6 |
(3,813) |
(8,277) |
Loss before tax |
|
(52,344) |
(27,384) |
Taxation |
|
(317) |
(250) |
Loss for the period |
|
(52,661) |
(27,634) |
Other comprehensive (expense)/
income |
|
|
|
Foreign currency translation differences |
|
(4,640) |
10,825 |
Other comprehensive (expense)/
income for the period |
|
(4,640) |
10,825 |
|
|
|
|
Total comprehensive expense |
|
(57,301) |
(16,809) |
Loss attributable to: |
|
|
|
Owners of the Company |
|
(47,956) |
(25,483) |
Non-controlling interests |
|
(4,705) |
(2,151) |
|
|
(52,661) |
(27,634) |
Total comprehensive (expense)/income attributable
to: |
|
|
|
Owners of the Company |
|
(51,349) |
(17,419) |
Non-controlling interests |
|
(5,952) |
610 |
|
|
(57,301) |
(16,809) |
Basic and diluted loss
per share |
5 |
(49.74p) |
(27.29p) |
The notes on pages 20 to 41 form part of this
financial information.
Consolidated
Statement of
Financial
Position as at 30
June 2023
|
|
|
|
|
Notes |
30
June2023Unaudited£’000 |
31 December2022Audited£’000 |
Assets |
|
|
|
Non-current assets |
|
|
|
Intangible assets & Goodwill |
7 |
97,884 |
105,886 |
Property, plant and equipment |
8 |
120,554 |
133,780 |
Trade and other receivables |
10 |
4,931 |
5,010 |
|
|
223,369 |
244,676 |
Current assets |
|
|
|
Inventory |
9 |
13,542 |
12,625 |
Assets held for sale |
|
31 |
23 |
Trade and other receivables |
10 |
34,693 |
61,571 |
Cash and cash equivalents |
11 |
129,430 |
141,285 |
|
|
177,696 |
215,504 |
Current liabilities |
|
|
|
Trade and other payables |
12 |
26,208 |
36,579 |
Contract liabilities |
|
22,469 |
18,370 |
Deferred income |
|
681 |
894 |
Lease liabilities |
13 |
3,666 |
3,295 |
Deferred tax liabilities |
|
506 |
525 |
|
|
53,530 |
59,663 |
Net current assets |
|
124,166 |
155,841 |
|
|
|
|
Non-current liabilities |
|
|
|
Lease liabilities |
13 |
71,047 |
71,206 |
Loans |
14 |
38,436 |
39,780 |
Provisions |
15 |
8,954 |
8,424 |
Contract liabilities |
|
4,600 |
76 |
Deferred income |
|
1,032 |
1,069 |
Put option liability |
16 |
20,270 |
38,182 |
Deferred tax liabilities |
|
5,040 |
5,588 |
|
|
149,379 |
164,325 |
Net assets |
|
198,156 |
236,192 |
|
|
|
|
Shareholders’ equity |
|
|
|
Share capital |
17 |
48,260 |
48,132 |
Share premium |
17 |
380,247 |
379,953 |
Other reserves |
|
(11,970) |
(24,887) |
Accumulated losses |
|
(244,428) |
(198,545) |
Equity attributable to owner of the Company |
|
172,109 |
204,653 |
Non-controlling interests |
19 |
26,047 |
31,539 |
Total equity |
|
198,156 |
236,192 |
The notes on pages 20 to 41 form part of this
financial information.Consolidated Statement of Cash
Flowsfor the six
months ended 30 June
2023
|
|
|
|
|
Notes |
Six months ended30 June
2023Unaudited£’000 |
Six months ended30 June 2022Unaudited£’000 |
Cash flows from operating activities |
|
|
|
Cash consumed in operations |
18 |
(8,916) |
(25,069) |
Tax credit received |
|
3,502 |
558 |
Net cash used in operating activities |
|
(5,414) |
(24,511) |
|
|
|
|
Cash flows from investing activities |
|
|
|
Acquisition of subsidiary, net of cash acquired |
|
- |
(99,206) |
Purchases of property, plant and equipment |
8 |
(4,854) |
(6,009) |
Proceeds on disposal of property, plant and equipment |
|
4,420 |
35 |
Interest received |
|
2,217 |
50 |
Net cash generated from/ (used in) investing activities |
|
1,783 |
(105,130) |
|
|
|
|
Cash flows from financing activities |
|
|
|
Proceeds from issue of ordinary share capital |
|
422 |
80,082 |
Costs of share issues |
|
- |
(2,952) |
Interest paid |
|
(2,094) |
(1,732) |
Loan arrangement fees |
|
- |
(2,205) |
Payment of lease liabilities |
|
(2,222) |
(1,484) |
Payment of lease liabilities interest |
|
(2,999) |
- |
Loans received |
|
- |
64,866 |
Net cash (used in)/generated from financing activities |
|
(6,893) |
136,575 |
Net (decrease)/ increase
in cash and cash equivalents |
|
(10,524) |
6,934 |
Cash and cash equivalents at 1 January 2023 |
|
141,285 |
108,944 |
Movement in foreign currency balances |
|
(1,331) |
2,632 |
Cash and cash equivalents at 30 June
2023 |
11 |
129,430 |
118,510 |
The notes on pages 20 to 41 form part of this
financial information.
Statement of Changes in Equity
Attributable to Owners of the Parent for
the six months ended 30 June
2023
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
capital£’000 |
Share
premium£’000 |
Merger reserve£’000 |
Other Equity
£’000 |
Translation
reserve£’000 |
Accumulated Losses£’000 |
Total£’000 |
Non- Controlling
Interest£’000 |
|
TotalEquity£’000 |
NCI |
At 1 January 2022 |
43,088 |
307,765 |
2,291 |
- |
- |
(165,806) |
187,338 |
- |
|
187,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended 30 June 2022: |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
- |
- |
- |
- |
- |
(25,483) |
(25,483) |
(2,151) |
|
(27,634) |
|
Other comprehensive income |
- |
- |
- |
- |
8,064 |
- |
8,064 |
2,761 |
|
10,825 |
|
Total comprehensive expense
for the period |
- |
- |
- |
- |
8,064 |
(25,483) |
(17,419) |
610 |
|
(16,809) |
|
Transactions with owners: |
|
|
|
|
|
|
|
|
|
|
|
Share options |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from shares issued |
12 |
75 |
- |
- |
- |
(4) |
83 |
- |
|
83 |
|
Value of employee services |
- |
- |
- |
- |
- |
1,959 |
1,959 |
233 |
|
2,192 |
|
Issue of shares excluding options |
4,938 |
75,062 |
- |
- |
- |
- |
80,000 |
- |
|
80,000 |
|
Costs of share issues |
- |
(2,952) |
- |
- |
- |
- |
(2,952) |
- |
|
(2,952) |
|
Total contributions |
4,950 |
72,185 |
- |
- |
- |
1,955 |
79,090 |
233 |
|
79,323 |
|
Changes in ownership interests: |
|
|
|
|
|
|
|
|
|
|
|
Acquisition of subsidiary with NCI (Note 19) |
- |
- |
- |
- |
- |
- |
- |
48,418 |
|
48,418 |
|
Acquisition of NCI without change in control |
- |
- |
- |
- |
- |
11,279 |
11,279 |
(11,279) |
- |
- |
|
Recognition of put option |
- |
- |
- |
(38,996) |
- |
- |
(38,996) |
- |
|
(38,996) |
|
Revaluation of put option |
- |
- |
- |
740 |
- |
- |
740 |
- |
7 |
740 |
|
At 30 June 2022 |
48,038 |
379,950 |
2,291 |
(38,256) |
8,064 |
(178,055) |
222,032 |
37,982 |
|
260,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended 31 December 2022: |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
- |
- |
- |
- |
- |
(13,674) |
(13,674) |
(3,851) |
|
(17,525) |
|
Other comprehensive expense |
- |
- |
- |
- |
(239) |
- |
(239) |
(11) |
|
(250) |
|
Total comprehensive expense
for the period |
- |
- |
- |
- |
(239) |
(13,674) |
(13,913) |
(3,862) |
|
(17,775) |
|
Transactions with owners: |
|
|
|
|
|
|
|
|
|
|
|
Share options |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from shares issued |
94 |
3 |
- |
- |
- |
(25) |
72 |
- |
|
72 |
|
Value of employee services |
- |
- |
- |
- |
- |
3,963 |
3,963 |
316 |
|
4,279 |
|
Deferred tax on share options |
- |
- |
- |
- |
- |
125 |
125 |
- |
|
125 |
|
Total contributions |
94 |
3 |
- |
- |
- |
4,063 |
4,160 |
316 |
|
4,476 |
|
Changes in ownership interests: |
|
|
|
|
|
|
|
|
|
|
|
Acquisition of subsidiary with NCI (Note 19) |
- |
- |
- |
- |
- |
- |
- |
(13,776) |
|
(13,776) |
|
Acquisition of NCI without change in control |
- |
- |
- |
- |
- |
(10,879) |
(10,879) |
10,879 |
- |
- |
|
Put Option recognition |
- |
- |
- |
(740) |
- |
- |
(740) |
- |
7 |
(740) |
|
Revaluation of put option |
- |
- |
- |
3,993 |
- |
- |
3,993 |
- |
7 |
3,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2022 |
48,132 |
379,953 |
2,291 |
(35,003) |
7,825 |
(198,545) |
204,653 |
31,539 |
236192 |
236,192 |
|
At 1 January 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended 30 June 2023: |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
- |
- |
- |
- |
- |
(47,956) |
(47,956) |
(4,705) |
|
(52,661) |
|
Other comprehensive expense |
- |
- |
- |
- |
(3,393) |
- |
(3,393) |
(1,247) |
|
(4,640) |
|
Total comprehensive expense
for the period |
- |
- |
- |
- |
(3,393) |
(47,956) |
(51,349) |
(5,952) |
|
(57,301) |
|
Transactions with owners: |
|
|
|
|
|
|
|
|
|
|
|
Share options |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from shares issued |
128 |
294 |
- |
- |
- |
- |
422 |
- |
|
422 |
|
Value of employee services |
- |
- |
- |
- |
- |
2,073 |
2,073 |
460 |
|
2,533 |
|
Total contributions |
128 |
294 |
- |
- |
- |
2,073 |
2,495 |
460 |
|
2,955 |
|
Changes in ownership interests: |
|
|
|
|
|
|
|
|
|
|
|
Revaluation of put option |
- |
- |
- |
16,310 |
- |
- |
16,310 |
- |
|
16,310 |
|
At 30 June 2023 |
48,260 |
380,247 |
2,291 |
(18,693) |
4,432 |
(244,428) |
172,109 |
26,047 |
|
198,156 |
|
The notes on pages 20 to 41 form part of this
financial information.
Notes to the Financial
Information
1. General information
and basis of preparationThis condensed set of financial
statements has been prepared in accordance with IAS 34 Interim
Financial Reporting as adopted for use in the UK, as well as the
Disclosure Guidance and Transparency Rules of the Financial Conduct
Authority. The annual financial statements of the Group
are prepared in accordance with UK-adopted international accounting
standards. As required by the Disclosure Guidance and Transparency
Rules of the Financial Conduct Authority, the condensed set of
financial statements has been prepared applying the accounting
policies and presentation that were applied in the preparation of
the Group’s published consolidated financial statements for the
year ended 31 December 2022. However, selected explanatory notes
are included to explain events and transactions that are
significant to an understanding of the changes in the Group’s
financial position and performance since the last annual financial
statements.
The financial information set out above does not
constitute the Company’s Statutory Accounts. Statutory accounts for
the year ended 31 December 2022 were approved by the Board of
Directors and have been delivered to the Registrar of Companies.
The report of the auditor (i) was unqualified, (ii) included no
references to any matters to which the auditor drew attention by
way of emphasis without qualifying their report, and (iii) did not
contain a statement under section 498 (2) or (3) of the Companies
Act 2006
These interim financial statements have been
prepared applying consistent accounting policies to those applied
by the Group in the 2022 Annual Report.
These condensed consolidated interim financial
statements were approved by the Board of Directors on 20 September
2023. They have not been audited.
Oxford Biomedica plc, the parent company in the
Group, is a public limited company incorporated and domiciled in
the UK and is listed on the London Stock Exchange.
All material related party transactions in the
first six months of 2023 are described in note 21 of these interim
financial statements. There was no material change in related
parties from those described in the last annual report.
2. Going
concernGoing concern
The financial position of the Group, its cash
flows and liquidity position are described in the primary
statements and notes to these interim financial statements.
The Group made a loss for the period ended 30
June 2023 of £52.7 million, consumed net cash flows from operating
activities of £5.4 million, and ended the period with cash and cash
equivalents of £129.4 million. The Group sold its Harrow House
facility in a sale and leaseback transaction for £4.5 million to
Kadans, whilst also agreeing an occupational lease of the property
for 15 years. In considering the basis of preparation of the
Interim financial statements, the Directors have prepared cash flow
forecasts for a period of at least 12 months from the date of
approval of these financial statements, based in the first instance
on the Group’s 2023 latest view, and forecasts for 2023 and 2024.
The Directors have undertaken a rigorous assessment of the
forecasts in a base case scenario and assessed identified downside
risks and mitigating actions.
These cash flow forecasts also take into
consideration severe but plausible downside scenarios
including:
- Commercial challenges leading to a
substantial manufacturing and development revenue downside
affecting both the LentiVector® platform and AAV businesses;
- No revenues from new
customers;
- Decreases in forecasted existing
customer milestones and removal of any future license revenues,
and
- The potential impacts of a
recession on the Group and its customers including expected
revenues from existing customers under long term contracts.
Under both the base case and mitigated downside
scenario, the Group and parent company has sufficient cash
resources to continue in operation for a period of at least 12
months from the date of approval of these financial statements.
In the event of the downside scenarios
crystallising, the Group would continue to meet its existing loan
covenants until December 2024 without taking any mitigating
actions, but the Board has mitigating actions in place that are
entirely within its control that would enable the Group to reduce
its spend within a reasonably short time-frame to increase its cash
covenant headroom as required by the loan facility with Oaktree
Capital Management.
The Board has confidence in the Group’s ability
to continue as a going concern for the following reasons:
- As noted above, the Group has cash
balances of £129.4 million at the end of June 2023, and £121.4
million at the end of August 2023;
- More than 90% of 2023 forecasted
revenues are covered by binding purchase orders and rolling
customer forecasts which give confidence in the level of revenues
forecast over the next 12 months; and
- The Group’s history of being able
to access capital markets including raising £77.0 million of equity
during 2022;
- The Group’s history of being able
to obtain loan financing when required for purposes of both capital
expenditure and operational purposes, as recently evidenced by the
US$85 million one-year facility and US$50 million replacement
four-year facility obtained with Oaktree;
- The Group intends to delay the
construction element of its OXBOX manufacturing facility expansion
to now take place during 2028 and 2029;
- The completion of the potential
transaction to acquire ABL Europe is subject to successful
completion of due diligence, regulatory approvals and final Board
approval. The Board of Oxford Biomedica do not intend to approve
the transaction if it is expected to materially impact our ability
to continue as a going concern;
- The Group’s ability to continue to
be successful in winning new customers and building its brand as
demonstrated by successfully entering into new customer agreements
including with Arcellx, Cargo Therapeutics and Oxford University
over the last 6 months;
- The Group has the ability to
control capital expenditure costs and lower other operational
spend, as necessary.
Taking account of the matters described above,
the Directors remain confident that the Group will have sufficient
funds to continue to meet its liabilities as they fall due for at
least 12 months from the date of approval of the financial
statements and therefore have prepared the financial statements on
a going concern basis.
3. Accounting
policies The accounting policies, including the
classification of financial instruments, applied in these interim
financial statements are consistent with those of the annual
financial statements for the year ended 31 December 2022, as
described in those financial statements.
Judgements
Contract revenues: Identification of
performance obligations, allocation of revenue and timing of
revenue recognition
The Group has identified three key areas of
judgement within the collaboration agreements entered into during
the period. Firstly, in relation to the number of distinct
performance obligations contained within each collaboration
agreement; secondly the fair value allocation of revenue to each
performance obligation; and thirdly the timing of revenue
recognition based on the achievement of the relevant performance
obligation. The sales royalties contained within the collaboration
agreements qualify for the royalty exemption available under IFRS
15 and will only be recognised as the underlying sales are made
even though the performance obligation, in terms of the technology
license, has already been met.
The judgements with regards to the number of
distinct performance obligations and the fair value allocation of
revenue to each performance obligation takes place on a
contract-by-contract basis across numerous contracts entered into
by the Group. As these judgements take place across numerous
contracts, each with different characteristics, it is not practical
to provide a quantitative analysis of the impact of applying
different judgements, and the Directors do not believe that
disclosing a range of outcomes resulting from applying different
judgements provides meaningful information to the reader of the
financial statements. Consequently, no quantitative analysis has
been provided for these judgements.
Number of distinct performance obligations
Upon review of certain client contracts and
preparation of accounting papers setting out the accounting
treatment as per IFRS 15, the Group is required to exercise
judgement in identifying the distinct performance obligations
contained within the contract. These have been identified as
being:
- The
granting of technology licences
-
Milestones relating to bioprocessing or process development
activities
The fair value allocation of revenue to each
performance obligation
Because there is no readily available market
price for many of the performance obligations contained in the
client contracts, the Group exercises judgment in estimating the
stand alone selling price of each of these performance obligations.
Key areas of judgement are assessed to be:
• |
The stand alone selling price of technology licences. The Group
assesses the stand alone selling price of licences by reference to
the stand alone selling price of previously recognised client
technology licences, and the size of the market of the target
indication and other market related observable inputs |
• |
The stand alone selling price of bioprocessing batches. The Group
assesses the stand alone selling price of the batches in terms the
stand alone selling price of its other client contract batch
selling prices |
• |
The stand alone selling price in terms of the annual full time
equivalent rate to charge for process development activities. The
Group assesses the full time equivalent rate in terms the stand
alone equivalent rate of its other client contract equivalent
rates |
Timing of revenue recognition: technology
licence revenues
One of the key judgemental areas identified
within the collaboration agreements is the timing of recognition of
licence revenue based on the achievement of the relevant
performance obligation. The individual factors and aspects relating
to licence revenue are assessed as part of the IFRS 15 accounting
paper prepared for each agreement and a judgement is made as to
whether the licence fee performance obligation related to the
granting of the licence to the client has been achieved. If it was
judged that the performance obligations on licences granted in 2023
had not been met, revenues would have been £413,000 lower with the
revenue expected to be recognised in future when the performance
obligations were deemed to have been met.
Estimations
The key assumptions concerning the future, and
other key sources of estimation uncertainty at the reporting date,
that have a significant risk of causing a material adjustment to
the carrying amounts of assets and liabilities within the next
financial year, are discussed below. The nature of estimation means
that actual outcomes could differ from those
estimates.
Impairment assessment of Oxford
Biomedica Solutions Cash Generating Unit (CGU)
Oxford Biomedica Solutions has been identified
as a CGU (cash generating unit) of the business. During H1 2023 an
impairment trigger was identified in that it was assessed that the
CGU did not meet the original revenues forecasted as part of the
acquisition of Oxford Biomedica Solutions. Therefore, an impairment
assessment has been performed as at 30 June 2023. The recoverable
amount of the CGU is deemed to be the higher of its fair value in
use less cost of disposal, or value in use. The Group has
determined that the recoverable amount of the CGU is the value in
use of the Oxford Biomedica Solutions CGU as it expects this value
to be higher than the fair value in use less costs of disposal
The Group estimated the value in use of the
Oxford Biomedica Solutions CGU through a discounted cash flow
calculation which calculates the present value of the CGU taking
into consideration the forecasted cash flows over the estimated
useful life of the acquired intangible assets, as well as the
calculation of the terminal value at the end of the cash flow
period.
Management have prepared the value in use
calculation based on an approved forecast of 15 years because the
estimated useful life of the acquired intangibles is expected to be
greater than 5 years and the CGU is still expected to be in its
initial growth phase at the end of 5 years.
Sensitivity Calculation:
Key estimation uncertainty inputs which directly
impact the valuation of the CGU are assessed to be:
- Revenue
growth rates – these are the expected growth rates for a start-up
CDMO entity over the initial growth period after which growth rates
are brought down to more inflationary levels
-
Discount rate – the discount rate may be impacted by economic and
market factors, as well as changes to the risk free rate of return
which impacts debt borrowing rates. Should the discount rate
calculated by management be adjusted, this may impact the value of
the CGU. The discount rate has been calculated based on the current
risk free rate, the NASDAQ biotechnology Index’s expected rate of
return, and the Group’s cost of debt,
- Useful
life of intangible asset – management have assessed this to be 15
years.
Sensitivities
|
|
|
30 June 2023 |
Higher/Longer |
Lower/Shorter |
Effect in millions of pounds: |
|
|
Forecast Revenues 10% higher or
lower |
56 |
(57)1 |
Term of forecast 1 year longer or short |
(1) 1 |
(4) 1 |
Discount rate 1% lower or higher |
(28)1 |
36 |
- Would result in an impairment
charge to intangibles as of 30 June 2023.
Other judgemental inputs are:
-
Operational expenditure and capital expenditure – the cash flows of
Oxford Biomedica Solutions are based on the management approved
forecasts. These forecast may change in future or the actual
results vary,
- Long
term inflation rates in the United States,
- Ability
of the CGU to acquire new clients and increase revenues from
existing clients,
-
Expected volatility of cash flows – should the expected volatility
of Oxford Biomedica Solutions cash flows vary, this may impact the
value of the CGU.
Based on the valuation of the CGU through a
discounted cash flow calculation, the Group has assessed that an
impairment of Oxford Biomedica Solutions was not required at 30
June 2023.
Percentage of completion of
bioprocessing batch revenues
Bioprocessing of clinical/commercial product for
partners is recognised on a percentage of completion basis over
time as the processes are carried out. Progress is determined based
on the achievement of verifiable stages of the bioprocessing
process. Revenues are recognised on a percentage of completion
basis and as such require judgement in terms of the assessment of
the correct stage of completion including the expected costs of
completion for that specific bioprocessing batch. The value of the
revenue recognised with regards to the bioprocessing batches which
remain in progress at period end is £25,385,000. If the assessed
percentage of completion was 10 percentage points higher or lower,
revenue recognised in the period would have been £3,285,000 higher
or £3,578,000 lower.
Percentage of completion of fixed price
process development revenues
As it satisfies its performance obligations the
Group recognises revenue and the related contract asset with
regards to fixed price process development work packages. Revenues
are recognised on a percentage of completion basis and as such
require judgement in terms of the assessment of the correct
percentage of completion for that specific process development work
package. The value of the revenue recognised with regards to the
work packages which remain in progress at period end is
£24,244,000. If the assessed percentage of completion was 10
percentage points higher or lower, revenue recognised in the period
would have been £2,424,000 higher or lower.
Provision for out of specification
bioprocessing batches
Bioprocessing of clinical/commercial product for
partners is recognised on a percentage of completion basis over
time as the processes are carried out. Progress is determined based
on the achievement of verifiable stages of the process.
As the Group has now been bioprocessing product
across a number of years, and also in a commercial capacity, the
Group has assessed the need to include an estimate of bioprocessed
product for which revenue has previously been recognised and which
may be reversed should the product go out of specification during
the remaining period over which the product is bioprocessed. In
calculating this estimate the Group has looked at historical rates
of out of specification batches across the last five years and has
applied the percentage of out of specification batches to total
batches produced across the assessed period to the revenue
recognised on batches which have not yet completed the
bioprocessing process at period end. The Group makes specific
provisions for product batches where it is considered that the
average overall historical failure rate does not adequately cover
the perceived risk of revenue recognised on those specific batches
having to be subsequently reversed.
This estimate, based on the historical average
percentage as well as certain specific provisions, may be
significantly higher or lower depending on the number of
bioprocessing batches actually going out of specification in
future. The estimate will increase or decrease based on the number
of bioprocessing batches undertaken, the percentage of completion
of those bioprocessing batches, and the number of batches which go
out of specification over the assessment period.
Consequently, bioprocessing revenue of £1.3
million (31 December 2022: £2.6 million) has not been recognised
during the six months ended 30 June 2023 with the corresponding
credit to contract liabilities. This revenue will be recognised as
the batches complete bioprocessing.
Amortisation of
intangibles assets (developed technology)
The estimated useful life of developed
technology acquired by the Group is 15 years as the Group expects
the technology to generate cash flows for a total of 15 years. The
estimate of 15 years is based on management’s experience of the
time period over which the technology acquired as part of the
acquisition of Oxford Biomedica Solutions will become fully
obsolete. Over time as the platform technology is improved, parts
of the technology become obsolete as they are superseded by new
technology until after 15 years the original technology is expected
to have been fully replaced by newer/improved technology.
If the estimated useful life of the assets had
been 10 years, the estimated amortisation for the six months ended
30 June 2023 would be £1.8 million higher (2022: £1.2m); whilst, if
the estimated useful life of the assets had been 20 years, the
estimated amortisation for the six months ended 30 June 2023 would
be £0.9 million lower (2022: £0.6m).
Valuation of put option
liability
Where a put option with non-controlling
shareholders exists on their equity interests, a liability for the
fair value of the exercise price of the option is recognised. On 10
March 2022, the Group recognised a put option liability to acquire
the remaining 20% of Oxford Biomedica Solutions that it doesn’t
already own, from Homology Medicines. The option is subsequently
recognised at amortised cost taking account of adjustments to the
present value of the estimated future contractual cash flows. At 30
June 2023 the put option liability was adjusted to £20.3 million
(Dec 2022: £38.2m).
The Group estimates the value of the put
liability using a Monte Carlo simulation which calculates the
expected future exercise value of the put option, taking into
consideration Oxford Biomedica Solutions’ forecasted revenues over
the period up until the expected exercise date along with the
expected volatility of those revenues over that same period. The
expected future exercise value is then discounted to the present
using a discount rate in order to capture the counter party risk of
the expected payment.
Key estimation uncertainty inputs which directly
impact the valuation of the put option liability are assessed to
be:
- Revenues of Oxford Biomedica Solutions
–the revenues of Oxford Biomedica Solutions are based on the
management approved forecast up until the end of the option period.
Should the forecast change or the actual results vary this may
impact the value of the put option liability. 1
- Expected volatility of revenues –
should the expected volatility of Oxford Biomedica Solutions’
revenues vary, this may impact the value of the put option
liability,
- Discount rate – the discount rate may
be impacted by economic and market factors, as well as changes to
the risk free rate of return which impacts debt borrowing rates.
Should the discount rate calculated by management be adjusted, this
may impact the value of the put option. Management has calculated
the discount rate based on the risk free rate, the expected return
from similar companies and the Group’s cost of debt.
|
Fair value |
|
Put option
liability |
|
|
30 June 2023 |
Increase |
Decrease |
Effect in millions of pounds: |
|
|
Revenues of Oxford Biomedica Solutions: 10% higher or lower |
2.1 |
(2.2) |
Discount rate 1% lower or higher |
0.3 |
(0.4) |
1 The forecasted revenues of Oxford Biomedica
Solutions over the option period are expected to be negatively
impacted by the announcement of Homology Medicines to look at
strategic alternatives to their business. This is expected to lead
to a decrease in the fair value of the put option liability as at
31 December
2023.4. Segmental
analysisThe chief operating decision-makers have been
identified as the Senior Executive Team (SET), comprising the
Executive Directors, Chief Technical Officer, Chief Medical
Officer, Chief Scientific Officer, Chief Business and Corporate
Development Officer, Chief Operations Officer, General Counsel,
Chief People Officer and Chief Information Officer. The SET
monitors the performance of the Group in two business segments:
(i) Platform
– this segment consists of the revenue generating bioprocessing and
process development activities undertaken for third parties. It
also includes internal technology developments and the costs
involved in developing platform related intellectual
property;(ii) Product – this
segment consists of the clinical and preclinical development of in
vivo and ex-vivo gene and cell therapy products which are owned by
the Group.
Revenues, other operating
income and operating
loss by segmentOperating EBITDA
and Operating profit/(loss) represent the Group’s measures of
segment profit & loss as they are a primary measure used for
the purpose of making decisions about allocating resources and
assessing performance of segments.
|
Platform |
Product |
Total |
H1 2023 |
£’000 |
£’000 |
£’000 |
Revenue |
42,975 |
86 |
43,061 |
Other operating income |
1,402 |
- |
1,402 |
Operating EBITDA¹ |
(28,705) |
(5,021) |
(33,726) |
Depreciation, amortisation and share based payment |
(15,948) |
(1,082) |
(17,030) |
Change in fair value of available-for-sale asset |
8 |
- |
8 |
Operating loss |
(44,645) |
(6,103) |
(50,748) |
Net finance cost |
|
|
(1,596) |
Loss before tax |
|
|
(52,344) |
|
Platform |
Product |
Total |
H1 2022 |
£’000 |
£’000 |
£’000 |
Revenue |
64,024 |
3 |
64,027 |
Other operating income |
925 |
- |
925 |
Operating EBITDA¹ |
(780) |
(5,005) |
(5,785) |
Depreciation, amortisation and share based payment |
(12,350) |
(984) |
(13,334) |
Change in fair value of available-for-sale asset |
(38) |
- |
(38) |
Operating loss |
(13,168) |
(5,989) |
(19,157) |
Net finance cost |
|
|
(8,227) |
Loss before tax |
|
|
(27,384) |
1 Operating EBITDA (Earnings Before Net Finance
Costs, Tax, Depreciation, Amortisation, fair value adjustments of
assets at fair value through profit and loss, and Share Based
Payments) is a non-GAAP measure often used as a surrogate for
operational cash flow as it excludes from operating profit or loss
all non-cash items, including the charge for share options. A
reconciliation to GAAP measures is provided on page 14.
Other operating income of £1.4 million (2022:
£0.9 million) includes grant income of £0.3 million (2022: £0.4
million) and £1.1m (2022: £0.5m) of income for the provision of
support services to Homology Medicines and is included within the
Platform segment. No grant income to fund clinical and preclinical
development is included within the Product segment.
Costs are allocated to the segments on a
specific basis as far as is possible. Costs which cannot readily be
allocated specifically are apportioned between the segments using
relevant metrics such as headcount or direct costs. Finance costs
are not allocated to segments as they have been assessed to be
group costs rather than relating to a specific segment.
No intangible assets or fixed assets of any
significant value have been assessed to be assigned specifically to
the Product division and therefore no impairment has been required
as a result of the decision by the Group to discontinue work on
product development from the second half of 2023.
The acquired business of Oxford Biomedica
Solutions has been included in the Platform Segment.
The Group has concluded the review of strategic
options for its product portfolio and, in line with its strategy to
become a pure-play CDMO, has decided to discontinue work on
internal product development from the second half of 2023. No
material costs associated with the Product segment are expected to
be carried by the Group post 2023.
Disaggregation of
revenueRevenue is disaggregated by the type of revenue
which is generated by the commercial arrangement. Revenue shown in
the table below is denominated in sterling and is primarily
generated in the UK and US.
For the six months ended 30 June
|
Platform |
Product |
Total |
2023 |
£’000 |
£’000 |
£’000 |
Bioprocessing/Commercial development |
40,446 |
86 |
40,532 |
Licence fees, Milestones & Royalties |
2,529 |
- |
2,529 |
Total |
42,975 |
86 |
43,061 |
|
Platform |
Product |
Total |
2022 |
£’000 |
£’000 |
£’000 |
Bioprocessing/Commercial development |
57,301 |
3 |
57,304 |
Licence fees, Milestones & Royalties |
6,723 |
- |
6,723 |
Total |
64,024 |
3 |
64,027 |
Revenue by geographical
location
Revenue by client location |
30
June2023£’000 |
30 June2022£’000 |
UK |
1,292 |
35,305 |
Europe |
12,309 |
8,150 |
US |
29,460 |
20,176 |
Rest of world |
- |
396 |
Total |
43,061 |
64,027 |
In the first half of 2023 5 clients (2022: 1)
each generated more than 10% of the Group’s revenue.
5. Basic
earnings and diluted
earnings per ordinary shareThe
basic loss per share of 49.74p (2022: 27.29p loss) has been
calculated by dividing the loss for the period attributable to the
owners of the company by the weighted average number of shares in
issue during the six months ended 30 June 2023, being 96,521,209
(2022: 93,371,295).
As the Group made a loss in the period and prior
period, there were no potentially dilutive options therefore there
is no difference between the basic loss per ordinary share and the
diluted loss per ordinary share.
6. Finance
CostsFinance costs of £3.8 million (2022: £8.3 million)
consists of loan interest £2.3 million (2022: £2.3 million),
foreign exchange gains relating to loans £1.7 million (2022: £4.9
million loss) and lease liability interest recognised in accordance
with IFRS 16 (Leases) of £3.2 million (2022: £1.1 million).
.
|
|
|
Goodwill |
Developed technology |
Patents |
Total |
|
|
Note |
£’000 |
£’000 |
£’000s |
£’000 |
Cost |
|
|
|
|
|
|
At 1 January 2023 |
|
|
661 |
111,405 |
1,811 |
113,877 |
Effects of movements in exchange rates |
|
|
(28) |
(4,675) |
- |
(4,703) |
At 30 June 2023 |
|
|
633 |
106,730 |
1,811 |
109,174 |
Amortisation and impairment |
|
|
|
|
|
|
At 1 January 2023 |
|
|
- |
6,188 |
1,803 |
7,991 |
Charge for the period |
|
|
- |
3,626 |
1 |
3,627 |
Effects of movements in exchange rates |
|
|
- |
(328) |
- |
(328) |
At 30 June 2023 |
|
|
- |
9,486 |
1,804 |
11,290 |
Net book amount at 30 June
2023 |
|
633 |
97,244 |
7 |
97,884 |
Net book amount at 31 December 2022 |
|
|
661 |
105,217 |
8 |
105,886 |
7. Intangible assets
& goodwill
The Cash-generating unit (CGU) identified is the
manufacturing and process development operations of Oxford
Biomedica Solutions located at the Bedford, Massachusetts site in
the United States. The CGU was tested for impairment at 30 June
2023 as a result of a trigger being identified, with no impairment
being identified.
Due to a tax deduction not being available on a
portion of the developed technology intangible asset, a deferred
tax liability of £7.3 million was recognised at the acquisition
date, with the liability expected to unwind in line with the 15
year useful life of the developed technology intangible asset.
8. Property, plant &
equipment
|
Freehold property |
LeaseholdImprove-ments |
Office equipment and
computers |
Bio-processing
and Laboratory equipment |
Right-of-use assets |
Total |
|
£’000 |
£’000 |
£’000 |
£’000 |
£’000s |
£’000 |
Cost |
|
|
|
|
|
|
At 1 January 2023 |
9,848 |
60,228 |
12,420 |
48,596 |
57,146 |
188,238 |
Additions at cost |
- |
1,583 |
414 |
2,858 |
3,359 |
8,214 |
Disposals |
(9,848) |
- |
(60) |
(139) |
(4,089) |
(14,136) |
Change of Estimate |
- |
- |
- |
- |
(470) |
(470) |
Effects of movements in exchange rates |
- |
(1,276) |
(41) |
(614) |
(1,110) |
(3,041) |
At 30 June 2023 |
- |
60,535 |
12,733 |
50,701 |
54,836 |
178,805 |
Depreciation |
|
|
|
|
|
|
At 1 January 2023 |
6,494 |
11,440 |
9,042 |
18,386 |
9,096 |
54,458 |
Charge for the period |
336 |
3,081 |
1,153 |
3,958 |
2,680 |
11,208 |
Effects of movements in exchange rates |
- |
(138) |
(5) |
(91) |
(171) |
(405) |
Disposals |
(6,830) |
- |
(58) |
(122) |
- |
(7,010) |
At 30 June 2023 |
- |
14,383 |
10,132 |
22,131 |
11,605 |
58,251 |
Net book amount at 30 June
2023 |
- |
46,152 |
2,601 |
28,570 |
43,231 |
120,554 |
Net book amount at 31 December 2022 |
3,354 |
48,788 |
3,378 |
30,210 |
48,050 |
133,780 |
9. Inventory
|
30
June2023£’000 |
31 December2022£’000 |
Raw materials |
13,542 |
12,625 |
Inventory |
13,542 |
12,625 |
Inventories constitute raw materials held for
bioprocessing, research and development purposes.
During 2023, the Group wrote off £781,000 (2022:
£304,000) of inventory which is not expected to be used in
production or sold onwards.
10. Trade and other
receivables
|
|
|
Current |
30
June2023£’000 |
31 December2022£’000 |
Trade receivables |
14,351 |
34,109 |
Contract assets |
6,171 |
10,897 |
Other receivables |
2,837 |
4,832 |
Other tax receivable |
6,174 |
7,757 |
Prepayments |
5,160 |
3,976 |
Total trade and other receivables |
34,693 |
61,571 |
Non-current |
30
June2023£’000 |
31 December2022£’000 |
Other receivables |
4,931 |
5,010 |
Non – current trade and other receivables
constitute other receivables of £4,931,000 (Dec 22: £5,010,000)
which are deposits held in escrow as part of the Windrush
Innovation Centre, Oxbox and Patriot’s Park lease arrangements.
11. Cash
and cash equivalents
|
30 June |
31 December |
|
2023 |
2022 |
|
£’000 |
£’000 |
Cash at bank and in hand |
129,430 |
141,285 |
Cash and cash equivalents includes £1.5 million
in relation to improvement works at Harrow House agreed under the
sale and leaseback arrangement.
12.
Trade and other payables
|
30
June2023£’000 |
31 December2022£’000 |
Trade payables |
9,234 |
13,604 |
Other taxation and social security |
773 |
2,347 |
Accruals |
16,201 |
20,628 |
Total trade and other payables |
26,208 |
36,579 |
13. LeasesThe
Group leases many assets including land and buildings, equipment
and IT equipment. Information about leases for which the Group is a
lessee is presented below:
Right-of-use assets
|
|
|
|
|
|
Property£‘000 |
Bioprocessing andLaboratory
equipment £‘000 |
Total£’000 |
Balance at 1 January 2023 |
46,000 |
2,050 |
48,050 |
Additions |
3,359 |
- |
3,359 |
Disposals |
(4,089) |
- |
(4,089) |
Depreciation charge for the period |
(2,307) |
(373) |
(2,680) |
Change in Estimate |
(470) |
- |
(470) |
Effects of movements in exchange rates |
(939) |
- |
(939) |
Balance at 30 June 2023 |
41,554 |
1,677 |
43,231 |
The additions in the period related to the
Harrow House sale and lease back entered into in the first half of
2023, whilst disposals in the period related to the US business’
Patriot’s Park facility.Lease liabilities
|
30 June
2023£’000 |
Maturity analysis – contractual undiscounted cash
flows |
|
Less than one year |
8,951 |
One to five years |
35,550 |
Six to ten years |
40,228 |
More than ten years |
22,616 |
Total undiscounted cash flows at 30 June
2023 |
107,345 |
|
30 June
2023£’000 |
Lease liabilities included in the Statement of Financial
Position |
|
Current |
3,666 |
Non-current |
71,047 |
Total lease liabilities at 30 June
2023 |
74,713 |
Amounts recognised in the
statement of comprehensive income
|
30 June
2023£’000 |
Interest on lease liabilities |
2,999 |
Expense relating to short-term leases |
- |
Amounts recognised in the statement of
cash flows
|
30 June
2023£’000 |
Total cash outflow for leases |
5,220 |
14. LoansOn 10
March 2022, the Group drew down an US$85 million loan facility with
Oaktree to finance the acquisition of Oxford Biomedica Solutions
under a 1 year facility agreement maturing in 2023. Over the course
of the term loan interest was payable quarterly with a nominal
interest rate on the loan of 8.5%.
On 7 October 2022, the loan facility was
refinanced with Oaktree. Under the terms of such refinancing, the
Company has partially repaid the outstanding amounts and amended
the facility into a new senior secured four year term loan facility
provided by Oaktree in a principal amount of US$50 million. The
Term Loan carries a variable interest rate, which is capped at
10.25% per annum and payable quarterly in cash, with up to 50% of
interest for the first twelve months payable in kind as additional
loan principal, at the option of the Company. The interest rate is
subject to downward adjustment following the satisfaction of
certain commercial conditions.
The Company also has secured the option, subject
to the same commercial conditions as the amended facility and
available for a three- year period, to draw down a further US$25
million from Oaktree to fund certain permitted acquisitions. If the
option were to be exercised, it would be assessed against meeting
the substantial modification requirements under IFRS 9.
The terms include financial covenants including
holding a minimum of US$20 million cash at all times, restrictions
on the level of indebtedness the Group may enter into or
distributions made by the Group. The Oaktree facility was secured
by a pledge over substantially all of the Group’s assets.
|
30
June2023£’000 |
31 December2022£’000 |
Balance at 1 January |
39,780 |
- |
New loan |
- |
64,866 |
Interest accrued |
2,261 |
5,564 |
Interest paid |
(2,094) |
(4,554) |
Foreign exchange movement |
(1,672) |
7,964 |
Amortised fees |
161 |
588 |
Loan repayment |
- |
(31,424) |
Arrangement fees |
- |
(3,224) |
Closing balance |
38,436 |
39,780 |
15. ProvisionsThe
dilapidations provisions relate to the anticipated costs of
restoring the leasehold Oxbox, Yarnton, Corporate office,
Wallingford Warehouse, Windrush Court, Windrush Innovation Centre
and Harrow House properties to their original condition at the end
of the lease terms ending between 2024 and 2037 respectively.
The future anticipated costs of restoring the
properties are calculated by inflating the current expected
restoration costs using the 3 year historic UK Consumer Price
Inflation rate, up to the end of the lease term.
The Group recognised a provision for restoration
costs of the Harrow House site following a sale and lease back
transaction in H1 2023.
16. Put option
liability
|
|
|
|
30 June |
31 December |
|
2023 |
2022 |
|
£’000 |
£’000 |
Balance at 1 January |
38,182 |
- |
Recognised at fair value |
- |
38,996 |
Revaluation |
(17,912) |
(814) |
Closing balance |
20,270 |
38,182 |
On 10th March 2022, the Group recognised a put
option liability to acquire the remaining 20% of Oxford Biomedica
Solutions that it doesn’t already own from Homology Medicines. The
fair value of the option at the date of acquisition was assessed to
be £39 million.
At 30th June 2023 the fair value of the Put
option liability was £20.3 million (Dec 2022: £38.2m). The
forecasted revenues of Oxford Biomedica Solutions over the option
period are expected to be negatively impacted by the announcement
of Homology Medicines to look at strategic alternatives to their
business. This is expected to lead to a decrease in the fair value
of the put option liability as at 31 December 2023.
17. Share capital and
Share premiumAt 31 December 2022 and 30 June 2023 Oxford
Biomedica had an issued share capital of 96,263,165 and 96,521,209
ordinary 50 pence shares respectively.
317,474 shares were created as a result of the
exercise of options by employees during the period.
18. Cash
flows from operating activitiesReconciliation of
operating (loss)/profit
to net cash (used
in)/generated from
operations
|
|
|
|
Six months ended |
Six months ended |
|
30 June 2023 |
30 June 2022 |
|
£’000 |
£’000 |
Continuing operations |
|
|
Loss before tax |
(52,344) |
(27,384) |
Adjustment for: |
|
|
Depreciation |
11,208 |
8,816 |
Amortisation of intangible assets |
3,627 |
2,320 |
Loss on disposal of property, plant and equipment |
29 |
27 |
Gain on sale and leaseback |
(472) |
- |
Loss on disposal of intangible assets |
- |
23 |
Amortisation of loan fees |
- |
283 |
Net finance costs |
1,596 |
8,227 |
Charge in relation to employee share scheme |
2,532 |
2,202 |
Change in fair value of available-for-sale asset |
(8) |
38 |
Changes in working capital: |
|
|
Decrease/(increase) in contract assets and trade and other
receivables |
23,991 |
(26,365) |
(Decrease)/increase in trade and other payables |
(6,536) |
7,282 |
Increase/(decrease) in contract liabilities and deferred
income |
8,374 |
(6) |
Decrease in inventories |
(917) |
(532) |
Increase in provisions |
4 |
- |
Net cash used in operations |
(8,916) |
(25,069) |
19. Non-controlling
interest (“NCI”)The following table
summarises the information relating to the Group’s subsidiary that
has material NCI:
|
2023 |
2022 |
|
£’000 |
£’000 |
NCI percentage |
20% |
20% |
|
|
|
Non-current assets |
156,378 |
185,736 |
Current assets |
14,933 |
44,040 |
Non-current liabilities |
(28,673) |
(525) |
Current liabilities |
(12,405) |
(39,342) |
Net assets |
130,233 |
189,909 |
Net assets attributable to NCI |
26,047 |
37,982 |
|
|
|
Revenue |
13,636 |
7,273 |
|
|
|
Loss |
(23,522) |
(10,753) |
Other comprehensive (expense)/ income |
(6,237) |
13,801 |
Total comprehensive
(expense)/income |
(29,759) |
3,048 |
|
|
|
Loss allocated to NCI |
(4,705) |
(2,151) |
Other comprehensive (expense)/
income allocated to NCI |
(1,247) |
2,761 |
|
|
|
Cash flows from operating activities |
(13,689) |
(3,308) |
Cash flows from investment activities |
2,874 |
37,672 |
Cash flow from financing activities (dividends to NCI: nil) |
(6,644) |
265 |
Net (decrease)/ increase
in cash and cash equivalents |
(17,459) |
34,629 |
20.
Capital commitmentsAt 30 June 2023, the Group had
commitments of £2,811,547 for capital expenditure for leasehold
improvements, plant and equipment not provided in the financial
statements (June 2022 £4,752,000). Additionally, the Group also had
a Capital commitment of £48,935,000 for leasehold improvements in
respect of the expansion of its OXBOX manufacturing facility as a
result of the £50 million equity investment by Serum Life Sciences
in September 2021.
21. Related party
transactions
|
Transactions for the six months ended |
Balance outstanding |
|
30 June 2023 |
30 June 2022 |
30 June 2023 |
30 June 2022 |
|
£ ‘000s |
£ ‘000s |
£ ‘000s |
£ ‘000s |
Sales of goods and services |
|
|
|
|
Homology Medicines, Inc. |
12,872 |
7,273 |
7,777 |
7,273 |
|
|
|
|
|
Purchase of services |
|
|
|
|
Homology Medicines, Inc. |
384 |
1,661 |
22 |
1,661 |
|
|
|
|
|
Other |
|
|
|
|
Homology Medicines, Inc. – rental income |
1,071 |
568 |
572 |
568 |
All outstanding balances with related parties
are to be settled in cash within six months of the reporting date.
None of the balances is secured.
22. Post balance sheet
eventHomology Medicines Inc. strategic updateIn July,
post-period end, Homology Medicines Inc. a genetic medicines
company and client of Oxford Biomedica’s US business announced an
update on their business, including strategic alternatives. Whilst
future bioprocessing and commercial development work has been
impacted, the Group expects no other business impact and any
amounts outstanding at period end are expected to be received in
the normal course of business.
As a result of Homology Medicines Inc.
announcing an update on their business, including strategic
alternatives in July 2023, the Group will perform an impairment
review for the Oxford Biomedica Solutions’ CGU as at 31 December
2023 to assess any potential impairment of the intangible assets
and fixed assets of the CGU during H2 2023. Any resultant
impairment charge will be booked in the December 2023 year-end
financial statements.
Potential transaction to acquire ABL
EuropeOxford Biomedica has entered into exclusive negotiations for
the proposed acquisition of ABL Europe. Terms of the proposed
transaction would include a consideration of €15million, (including
the value of £8.6 million (€10 million) of pre-completion cash
funding in ABL Europe from Institut Mérieux), in exchange for
Oxford Biomedica shares. In addition, Institut Mérieux would also
commit to provide Oxford Biomedica with £17.2 million (€20 million)
of additional funding, to cover capex and potential future
operating losses, in exchange for new Oxford Biomedica shares.
In addition, under the proposed transaction,
Institut Mérieux would further build its ownership of Oxford
Biomedica by acquiring up to £8.6 million (€10 million) of
additional Oxford Biomedica existing ordinary shares in the market
from the date of this announcement to 31 March 2024. Institut
Mérieux intends to build its ownership of Oxford Biomedica shares
through purchases in the open market so as to reach, in aggregate,
approximately 10 per cent of the Company’s enlarged issued share
capital.
23. Statement of
Directors’ responsibilitiesThe Directors of Oxford
Biomedica plc are set out on page 43 of this report. We
confirm that to the best of our knowledge:
-
the condensed set of financial statements has been prepared in
accordance with IAS 34 Interim Financial Reporting as adopted for
use in the UK.
-
the interim management report includes a fair review of the
information required by:
-
DTR 4.2.7R of the Disclosure Guidance and Transparency Rules, being
an indication of important events that have occurred during the
first six months of the financial year and their impact on the
condensed set of financial statements; and a description of the
principal risks and uncertainties for the remaining six months of
the year; and
-
DTR 4.2.8R of the Disclosure Guidance and Transparency Rules, being
related party transactions that have taken place in the first six
months of the current financial year and that have materially
affected the financial position or performance of the entity during
that period; and any changes in the related party transactions
described in the last annual report that could do so.
By order of the Board
Frank MathiasChief Executive
Officer20 September 2023
Independent review report to Oxford
Biomedica plc
Report on the condensed consolidated
interim financial statements
Our conclusionWe have reviewed
Oxford Biomedica plc’s condensed consolidated interim financial
statements (the “interim financial statements”) in the Press
Release of Oxford Biomedica plc for the 6 month period ended
30 June 2023 (the “period”).
Based on our review, nothing has come to our
attention that causes us to believe that the interim financial
statements are not prepared, in all material respects, in
accordance with UK adopted International Accounting Standard 34,
'Interim Financial Reporting' and the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom’s Financial
Conduct Authority.
The interim financial statements comprise:
- the
Consolidated statement of financial position as at
30 June 2023;
- the
Consolidated statement of comprehensive income for the period then
ended;
- the
Consolidated statement of cash flows for the period then
ended;
- the Statement
of changes in equity attributable to owners of the parent for the
period then ended; and
- the explanatory
notes to the interim financial statements.
The interim financial statements included in the
Press Release of Oxford Biomedica plc have been prepared in
accordance with UK adopted International Accounting Standard 34,
'Interim Financial Reporting' and the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom’s Financial
Conduct Authority.
Basis for conclusionWe
conducted our review in accordance with International Standard on
Review Engagements (UK) 2410, ‘Review of Interim Financial
Information Performed by the Independent Auditor of the Entity’
issued by the Financial Reporting Council for use in the United
Kingdom (“ISRE (UK) 2410”). A review of interim financial
information consists of making enquiries, primarily of persons
responsible for financial and accounting matters, and applying
analytical and other review procedures.
A review is substantially less in scope than an
audit conducted in accordance with International Standards on
Auditing (UK) and, consequently, does not enable us to obtain
assurance that we would become aware of all significant matters
that might be identified in an audit. Accordingly, we do not
express an audit opinion.
We have read the other information contained in
the Press Release and considered whether it contains any apparent
misstatements or material inconsistencies with the information in
the interim financial statements.
Conclusions relating to going
concernBased on our review procedures, which are less
extensive than those performed in an audit as described in the
Basis for conclusion section of this report, nothing has come to
our attention to suggest that the directors have inappropriately
adopted the going concern basis of accounting or that the directors
have identified material uncertainties relating to going concern
that are not appropriately disclosed. This conclusion is based on
the review procedures performed in accordance with ISRE (UK) 2410.
However, future events or conditions may cause the group to cease
to continue as a going concern.
Responsibilities for the interim financial
statements and the review
Our responsibilities and those of the
directorsThe Press Release, including the interim
financial statements, is the responsibility of, and has been
approved by the directors. The directors are responsible for
preparing the Press Release in accordance with the Disclosure
Guidance and Transparency Rules sourcebook of the United Kingdom’s
Financial Conduct Authority. In preparing the Press Release,
including the interim financial statements, the directors are
responsible for assessing the group’s ability to continue as a
going concern, disclosing, as applicable, matters related to going
concern and using the going concern basis of accounting unless the
directors either intend to liquidate the group or to cease
operations, or have no realistic alternative but to do so.
Our responsibility is to express a conclusion on
the interim financial statements in the Press Release based on our
review. Our conclusion, including our Conclusions relating to going
concern, is based on procedures that are less extensive than audit
procedures, as described in the Basis for conclusion paragraph of
this report. This report, including the conclusion, has been
prepared for and only for the company for the purpose of complying
with the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom’s Financial Conduct Authority and for no other
purpose. We do not, in giving this conclusion, accept or assume
responsibility for any other purpose or to any other person to whom
this report is shown or into whose hands it may come save where
expressly agreed by our prior consent in writing.
PricewaterhouseCoopers LLPChartered
AccountantsReading20 September 2023
Shareholder Information
|
|
DirectorsRoch Doliveux(Chair)Frank Mathias(Chief
Executive Officer appointed 27 March 2023)Stuart Paynter(Chief
Financial Officer)Stuart Henderson(Deputy Chairman and Senior
Independent Director)Michael Hayden(Non-executive Director)Siyamak
Rasty(Independent Non-executive Director resigned 23 June
2023)Heather Preston(Independent Non-executive Director)Robert
Ghenchev(Non-executive Director)Kay Davies(Independent
Non-executive Director)Catherine Moukheibir(Independent
Non-executive Director)Namrata P. Patel(Independent Non-executive
Director)Leone Patterson(Independent Non-executive Director
appointed 1 May 2023) |
Financial adviser and joint brokerPeel Hunt7th
Floor100 Liverpool StreetLondon EC2M 2ATFinancial adviser
and joint brokerJ.P. Morgan Securities plc 25 Bank
StreetCanary WharfLondonE14 5JPFinancial and Corporate
CommunicationsICR Consilium85 Gresham StLondon EC2V
7NQRegistered AuditorPricewaterhouseCoopers LLP3
Forbury place23 Forbury RoadReadingRG1
3JHSolicitorCovington & Burling LLP22
Bishopsgate London EC2N 4BQRegistrarsLink
Group10th FloorCentral Square29 Wellington StreetLeeds LS1
4DLCompany Secretary and Registered OfficeNatalie
WalterWindrush CourtTransport WayOxford OX4 6LTTel: +44 (0) 1865
783 000Fax: +44 (0) 1865 783 001enquiries@oxb.comwww.oxb.com |
Oxford Biomedica (LSE:OXB)
Historical Stock Chart
From Feb 2025 to Mar 2025
Oxford Biomedica (LSE:OXB)
Historical Stock Chart
From Mar 2024 to Mar 2025