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REG - Oxford Biomedica PLC - Interim results

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RNS Number : 0454N  Oxford Biomedica PLC  20 September 2023

 

 

 

 

 

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 PLC

INTERIM 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:

 

o  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

o  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

o  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

o  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 EBITDA(1) 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 EBITDA(1) by the
end of 2024; the Group's revenue backlog(1) 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
EBITDA(1) 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.

 

1        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
(https://stream.brrmedia.co.uk/broadcast/64d61e5caa74fc619cf738e7/65002a8361114eed62584fd2)
. The presentation will be available on Oxford Biomedica's website at
www.oxb.com (http://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

 

Notes

Unless 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 (mailto: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 BIOMEDICA

Oxford 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 (https://www.oxb.com/) , www.oxbsolutions.com
(https://oxbsolutions.com/) , and follow us on LinkedIn
(https://www.linkedin.com/company/oxford-biomedica/) and YouTube
(https://www.youtube.com/user/OxfordBioMedica) .

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**      15                    25

 (Preclinical)

 Early-stage clinical supply                                    10                    14

 (Phase I / 2)

 Late-stage, process characterization & validation              1                     1

 (Phase 3)

 Commercial product supply                                      2***                  1

 (Commercial)

* 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.

 

Arcellx

During 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 (http://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 EBITDA(1) 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 burn(2) 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).

 

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.

2      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 EBITDA(1)                           (33.7)           (5.8)
 Cash consumed by operating activities         (5.4)            (24.5)
 Capital expenditure                           (4.9)            (6.0)
 Cash burn(2)                                       (10.2)           (32.2)

 Period end cash                               129.4            118.5
 Net cash(3)                                   90.1             78.7

 Headcount
 Period end                                    891              959
 Average                                       891              920

 

 

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.

2.     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.

3.     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 expenses(1)                                                              (78.7)   (70.7)
 Operating EBITDA                                                               (33.7)   (5.8)
 Depreciation, amortisation, share option charge and fair value adjustments of  (17.0)   (13.4)
 available-for-sale assets
 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 costs(1)                     31.4     27.3
 Bioprocessing costs(1) (2)                            30.3     12.4
 Administrative expenses(1)                            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 expenses(1)                                     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 EBITDA(1)                                 (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 Income

The 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 EBITDA(1)  (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 EBITDA(1)  (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 EBITDA(1)                                 (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 update

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 Europe

Oxford 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 (http://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 Expense

for the six months ended 30 June 2023

 

                                                                Six months ended  Six months ended

                                                                30 June 2023      30 June 2022

                                                                Unaudited         Unaudited
                                                         Notes  £'000             £'000
 Revenue                                                        43,061            64,027
 Cost of sales                                                  (21,122)           (27,899)
 Gross profit                                                   21,939             36,128
                                                                (30,314)          (12,383)

 Bioprocessing costs
 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)
                                                         5      (49.74p)          (27.29p)

 Basic and diluted loss per share

 

 

 

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 June                             31 December

                                                     2023                                2022

                                                     Unaudited                           Audited

                                                     £'000                               £'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 Flows

for the six months ended 30 June 2023

 

                                                          Notes  Six months ended  Six months ended

                                                                 30 June 2023      30 June 2022

                                                                 Unaudited         Unaudited

                                                                 £'000             £'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
                                                                 (10,524)          6,934

 Net (decrease)/ increase in cash and cash equivalents
 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         Share     premium         Merger reserve      Other               Translation reserve  Accumulated Losses  Total       Non-                           Total               NCI

                                               capital       £'000                     £'000               Equity              £'000                £'000               £'000       Controlling Interest           Equity

                                               £'000                                                       £'000                                                                    £'000                          £'000
 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 preparation

 

This 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 concern

 

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.

 

 

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                             56             (57)(1)
 lower
 Term of forecast 1 year longer or short                     (1) (1)        (4) (1)
 Discount rate 1% lower or higher                            (28)(1)                       36

1      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 analysis

 

The 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 segment

Operating 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 revenue

Revenue 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 June  30 June

                             2023     2022

                             £'000    £'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 share

 

The 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 Costs

 

Finance 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                       Leasehold       Office equipment  Bio-processing and     Right-of-use assets  Total

                       property                       Improve-ments   and computers     Laboratory equipment
                       £'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                          -        46,152          2,601             28,570                 43,231               120,554

 30 June 2023
 Net book amount at 31 December 2022         3,354    48,788          3,378             30,210                 48,050               133,780

 

 

 

 

9.   Inventory

 

                30 June  31 December

                2023     2022

                £'000    £'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 June                    31 December

                    2023                       2022

                    £'000                      £'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 June           31 December

              2023              2022

              £'000             £'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 June   31 December

                                     2023      2022

                                     £'000     £'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. Leases

 

The 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      Bioprocessing and   Total

                                         £'000         Laboratory          £'000

                                                       equipment

                                                       £'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. Loans

On 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 June                 31 December

                2023                    2022

                £'000                   £'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. Provisions

 

The 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 10(th) 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 30(th) 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 premium

 

At 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 activities

 

Reconciliation 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 commitments

 

At 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 event

 

Homology Medicines Inc. strategic update

In 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 Europe

Oxford 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' responsibilities

 

The 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:

o  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

o  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 Mathias

Chief Executive Officer

20 September 2023

 

Independent review report to Oxford Biomedica plc

Report on the condensed consolidated interim financial statements

Our conclusion

We 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 conclusion

We 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 concern

Based 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 directors

The 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 LLP

Chartered Accountants

Reading

20 September 2023

 

 

Shareholder Information

 

 

 Directors                                                    Financial adviser and joint broker

 Roch Doliveux                                                Peel Hunt

 (Chair)                                                      7(th) Floor

                                                              100 Liverpool Street

 Frank Mathias                                                London EC2M 2AT

 (Chief Executive Officer appointed 27 March 2023)

                                                              Financial adviser and joint broker

 Stuart Paynter                                               J.P. Morgan Securities plc

 (Chief Financial Officer)                                    25 Bank Street

                                                              Canary Wharf

 Stuart Henderson                                             London

 (Deputy Chairman and Senior Independent Director)            E14 5JP

 Michael Hayden                                               Financial and Corporate Communications

 (Non-executive Director)                                     ICR Consilium

                                                              85 Gresham St

 Siyamak Rasty                                                London EC2V 7NQ

 (Independent Non-executive Director resigned 23 June 2023)

                                                              Registered Auditor

 Heather Preston                                              PricewaterhouseCoopers LLP

 (Independent Non-executive Director)                         3 Forbury place

                                                              23 Forbury Road

 Robert Ghenchev                                              Reading

 (Non-executive Director)                                     RG1 3JH

 Kay Davies                                                   Solicitor

 (Independent Non-executive Director)                         Covington & Burling LLP

                                                              22 Bishopsgate

 Catherine Moukheibir                                         London EC2N 4BQ

 (Independent Non-executive Director)

                                                              Registrars

 Namrata P. Patel                                             Link Group

 (Independent Non-executive Director)                         10th Floor

                                                              Central Square

 Leone Patterson                                              29 Wellington Street

 (Independent Non-executive Director appointed 1 May 2023)    Leeds LS1 4DL

                                                              Company Secretary and Registered Office

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