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REG - Allergy Therapeutics - Unaudited Preliminary Results 2023

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RNS Number : 7517N  Allergy Therapeutics PLC  27 September 2023

 

 

Allergy Therapeutics PLC

("Allergy Therapeutics" or the "Group")

 

 

Unaudited Preliminary Results for the Year ended 30 June 2023

-     Pivotal Phase III Grass G306 MATA MPL trial underway and on track to
report interim trial results in, or around, November 2023

-     Phase I VLP Peanut PROTECT trial progressing as planned with both
healthy volunteers and peanut allergic patients receiving doses via
short-course subcutaneous allergen-specific immunotherapy ("SCIT") and skin
prick testing ("SPT") respectively

-     Trading of core portfolio showing signs of recovery after
manufacturing pause, with revenue of £61.0m (2022: £72.8m)

-     £40.75m senior secured loan facility (the "Loan Facility") secured
in April

-     Equity refinancing of the Loan Facility underway

 

27 September 2023 Allergy Therapeutics (AIM: AGY), the fully integrated
specialty pharmaceutical company specialising in allergy vaccines, today
announces its unaudited preliminary results for the year ended 30 June 2023.

Highlights (including post-period events)
Financial

-       Revenue of £61.0m (2022: £72.8m) from commercial portfolio.
Revenue reduction a

consequence of the short-term pause in production that occurred during October
and November 2022

-       Operating loss pre-research and development costs ("R&D")
and exceptional costs 1  (#_ftn1) is £13.3m (2022: profit of £3.4m).  This
reflects the significant reduction in revenue and ongoing programme of
continuous improvement across the supply chain and quality systems, together
with higher manufacturing and labour costs

-       Exceptional costs of £14.0m consist of a £11.3m charge for the
non-cash fair value accounting of the G306 Contingent Payment (as defined
below) associated with the Loan Facility and fundraising costs of £2.7m. It
is expected that the Equity Financing (as defined below) will repay all
amounts outstanding under the Loan Facility, therefore the G306 Contingent
Payment will not be payable and the associated £11.3m accounting charge will
be reversed in the subsequent accounting period

-       Increase in research and development costs to £20.1m (2022:
£15.7m) following the initiation of the Phase III G306 trial for Grass MATA
MPL and in preparation for the Phase 1 VLP Peanut PROTECT trial

-       Full year net loss of £51.0m (2022: net loss of £13.8m)
reflecting the reduction in revenue, increase in research and development
costs and exceptional funding costs

-       Pursuant to the subscription and debt financing announced in
September 2022, the Group received net proceeds of £6.5m from the issue of
new ordinary shares in October 2022 and received a further £10.0m from the
issue of loan notes in February 2023. The loan notes were repaid in May 2023
upon entering into the Loan Facility

-       Cash balance of £14.8m at 30 June 2023 (2022: £20.5m)
following £26.0m partial draw down of the Loan Facility providing ongoing
support for the Group's two key clinical trials

Operational

-       Pivotal G306 Phase III trial investigating Grass MATA MPL
underway with interim results expected in, or around, November 2023

-       First cohort of peanut allergic patients in the Phase I VLP
Peanut PROTECT trial received the peanut allergy vaccine candidate via SPT in
March 2023

-       The PROTECT trial has subsequently progressed to dose escalation
in the healthy subject cohorts, with cohorts 1 and 2 progressing as planned
and approval granted to commence dosing in cohorts 3 and 4. Additionally,
escalating subcutaneous dosing in peanut allergic patient is to commence
imminently

-       No safety signal has been observed in healthy subjects during
escalating dosing to date

Post Period

-       Cash balance as at 31 August 2023 of £19.1m following an
aggregate draw down £40.075m of the Loan Facility

-       Outstanding foreign direct investment ("FDI") clearance required
for the Equity Financing announced 6 April 2023 was received on 22 September
2023 allowing expected repayment of amounts owed pursuant to the Loan Facility

-       On 26 September 2023, the Group entered into an amendment to the
Loan Facility with Southern Fox and ZQ Capital (acting through an affiliate)
(the "Lenders") (the "Extension Facility") pursuant to which, subject to
completion of the Equity Financing, the repayment of all amounts due under the
Loan Facility in full and the grant of the Additional Security 2  (#_ftn2) ,
the Lenders have agreed, on an uncommitted basis, to make available to the
Group an additional total principal sum of up to £15.0m (the "Additional
Facility Amount"). Under the Extension Facility, the Additional Facility
Amount may be drawn by the Group during the period to 31 January 2024 with a
minimum drawdown amount of £3 million per utilisation, and interest of 18 per
cent. per annum shall be payable on any such amounts drawn. A drawdown under
the Extension Facility shall require the consent of the Lenders and as such
the Additional Facility Amount does not represent committed funding. The
Extension Facility must be repaid in full by 31 December 2025. To provide
security for any amounts drawn under the Extension Facility, the existing
security package under the Loan Facility will remain in place following
repayment of the Loan Facility on or around completion of the Equity Financing
and the Additional Security will be granted

-       Appointment of Shaun Furlong as Chief Financial Officer who
started his new role in August 2023

 

 

Manuel Llobet, CEO of Allergy Therapeutics, stated:

 

"This financial year has been challenging, however, the Group has made good
progress in recovering manufacturing capacity and developing robust quality
systems that are well-placed to support future growth. The R&D programmes
have progressed as planned with two key trials running concurrently (Grass
MATA MPL, "G306", and VLP Peanut, "PROTECT") with interim results from the
pivotal Phase III trial of our grass pollen immunotherapy candidate and safety
and tolerability data from the first-in-human PROTECT trial of our peanut
allergy vaccine candidate expected later in 2023. The business looks forward
to a very exciting year with the outcome of these two key trials."

 

This announcement contains inside information for the purposes of the market
abuse regulation (EU) no. 596/2014 as it forms part of United Kingdom domestic
law by virtue of the European (withdrawal) act 2018, as amended ("MAR").

- ENDS -

For further information, please contact: Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

 

Panmure Gordon (Nominated Adviser and Broker)

+44 (0) 20 7886 2500

Emma Earl, Mark Rogers, Freddy Crossley, Corporate Finance

Rupert Dearden, Corporate Broking

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Davide Salvi
allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

 

 

 

Notes for editors:

 

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology Group,
headquartered in the UK, focused on the treatment and diagnosis of allergic
disorders, including aluminium free immunotherapy vaccines that have the
potential to cure disease. The Group sells proprietary and third-party
products from its subsidiaries in nine major European countries and via
distribution agreements in an additional ten countries. Its broad pipeline of
products in clinical development includes vaccines for grass, tree, house dust
mite and peanut. For more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com/) . (http://www.allergytherapeutics.com/)

Chairman's Report

Introduction

Financial year 2023 has been challenging for the business following the short-term pause in production that occurred during October and November 2022 ("Manufacturing Pause") which resulted in the need for significant additional funding, the delay in publication of the Group's 2022 annual report and accounts and the subsequent suspension of the Group's shares from trading which occurred on 3 January 2023.
 
I would like to thank our major shareholders, ZQ Capital Management Limited and Southern Fox Investments Limited, for their support and commitment in helping to resolve the Group's near-term funding requirements through the execution of the Loan Facility which was entered into with the Group in April 2023. This paved the way for the Group to publish its 2022 annual report and accounts together with its interim results for the six months ended 31 December 2022 and the restoration of its shares to trading on AIM on 19 June 2023.

 

The Group has since made good headway in streamlining the supply chain and
improving its manufacturing and quality systems.  These improvements support
the future growth of the business as we move towards a portfolio comprised
mainly of registered products and away from named-patient products.

 

Demand remained robust in our key markets throughout the year and our teams
have responded with agility, flexibility and determination to ensure that
recovery of production output has supported patient demand to the best of its
ability.

 

Our R&D pipeline continues to progress well and clinical development for
the Group's innovative, sub-cutaneous peanut allergy vaccine candidate, VLP
Peanut is continuing as planned. The pivotal Phase III G306 trial evaluating
efficacy and safety of the Group's short-course grass pollen immunotherapy,
Grass MATA MPL, began in Q3 of calendar year 2022, with the interim trial
results expected in, or around, November 2023. The results of the G306 trial
are expected to support the Group's submission to register the product with
European health authorities and will be a key milestone towards the Group's
strategy of entering the US market.

Performance

In September 2022 the Group announced a subscription and debt financing by
Southern Fox Investments Limited and ZQ Capital Management Limited (acting
through its affiliate SkyGem Acquisition Limited) providing net proceeds of
£6.5m following the issue of new ordinary shares in October 2022 followed by
a further £10.0m from the issue of loan notes in February 2023. As part of
this financing the Group issued an aggregate 33,333,332 warrants to subscribe
for new ordinary shares at an exercise price of 30 pence per warrant.

 

Following the resumption of manufacturing after the Manufacturing Pause, the
Group has been implementing a programme of continuous improvements across its
supply chain and quality systems, which is designed to improve efficiency and
enable future growth.

 

The Manufacturing Pause caused a material gap in funding which resulted in the
Group entering into the Loan Facility with existing substantial shareholders
ZQ Capital Management Limited (acting through its affiliate SkyGem
International Holdings Limited) and Southern Fox Investments Limited. The Loan
Facility of £40.75m was used to repay the £10.0m loan notes issued in
February 2023, and to fund working capital, capital expenditure and continuing
to finance the Group's clinical pipeline which the Board believes remains
highly valuable.  In conjunction with the Loan Facility, the Group also
entered into an equity commitment agreement to raise gross proceeds of
£40.75m, which will be used to repay principal amounts outstanding and
accrued interest thereon under the £40.75 million debt Facility.

Following receipt of the final FDI clearance as announced on 22 September
2023, the Group expects to shortly announce the commencement of the Open Offer
as part of the Equity Financing. Pursuant to the terms of the facility
agreement and Equity Commitment Agreement, the Group is required to apply the
proceeds of the Equity Financing in repaying the Loan Facility on or around
completion of the Equity Financing. The Group will therefore repay all
remaining outstanding amounts under the facility agreement on or around the
completion of the Equity Financing.

 

 
 
 
Board and Senior Management updates

In November 2022 Nick Wykeman stepped down as Chief Financial Officer ("CFO")
in order to pursue a non-executive career. On behalf of the Board and everyone
at Allergy Therapeutics I would like to thank Nick for his contribution and
wish him the very best for the future.

 

In December 2022, Anthony Parker and Zheqing (Simon) Shen were appointed as
Non-Executive Directors of Allergy Therapeutics. Anthony represents Southern
Fox Investments Limited ("Southern Fox") and Simon represents SkyGem
Acquisitions Limited ("ZQ Capital") an affiliate of ZQ Capital Management
Limited, both significant shareholders of Allergy Therapeutics. On 28 December
2022, Scott Leinenweber, representing Abbott Laboratories resigned as a
Non-Executive Director. We thank Scott for his valued contribution during his
tenure. On 10 February 2023, Sara Goldsbrough resigned as Company Secretary,
we thank Sara for her valuable contributions to the business. Karley Cheesman
was appointed Company Secretary on 13 February 2023.

During November 2022, Martin Hopcroft joined the business as Interim CFO,
supporting the business with a strong focus on cash control and the successful
completion of the £40.75m Loan Facility. Martin completed his interim
assignment and left the business in August 2023. On behalf of the Board and
everyone at Allergy Therapeutics, I would like to thank Martin for his
contribution to the Group and wish him the very best for the future.

 

In August 2023, Shaun Furlong was appointed CFO. Shaun has significant
financial experience, joining Allergy Therapeutics as Group Financial
Controller in April 2022 and previously holding senior finance roles within
blue-chip companies across multiple sectors, including Legal & General,
Hastings Direct, Volution Group and American Express. He brings significant
experience plus a fresh perspective to the Group's Finance function.

 

  Outlook

The Group expects to shortly announce the commencement of the Open Offer as
part of the Equity Financing. Pursuant to the terms of the facility agreement
and Equity Commitment Agreement, the Group is required to apply the proceeds
of the Equity Financing in repaying the Loan Facility on or around completion
of the Equity Financing. The Group will therefore repay all remaining
outstanding amounts under the facility agreement on or around the completion
of the Equity Financing

 

Subject to the timing and volume of sales in the quarter to December 2023, the
Group now expects additional funding to be required from around November 2023
onwards and is working on initiatives which, if successful, may extend that
requirement into early 2024. Discussions with certain shareholders are ongoing
regarding the size and source of future funding. These discussions continue to
be positive. Whilst there are no binding arrangements at this stage, in the
interim, agreement has been reached on the £15.0m Extension Facility,
although this does not represent committed funding.

 

Our R&D portfolio is on track to address unmet needs that allergy patients
continue to face through the Group's pioneering research and products. With
the read-out of two key trials, the upcoming year will be vital in
demonstrating that the portfolio can be leveraged to deliver transformational
change to patients.

 

The ongoing discussions surrounding further funding, coupled with the
financing and loans notes provided by our major shareholders underline the
confidence held in the Group and the future potential that can be leveraged
from the R&D pipeline. The Group is planning for success, and preparations
are underway to prepare for relevant health authority submissions that will
support the pillars of growth for the Group.

 

Finally, I would like to thank all of our employees at Allergy Therapeutics
for their commitment and performance in these tough conditions.

CEO Report

Introduction

The focus of the Group since the Manufacturing Pause has been to streamline
and modernise the supply chain of the business to permit future growth and
ensure sufficient supply to the market.

 

We remain highly confident in our innovative allergy immunotherapy pipeline
which we believe has the potential to transform the lives of patients and
those of people around them. For Grass MATA MPL, following on from the ~40%
improvement in the combined symptom and medication score compared to placebo
seen in the exploratory field study G309, the pivotal Phase III G306 trial
began in Autumn 2022 and interim data are expected in, or around, November
2023. The Phase I PROTECT study investigating the safety and tolerability of
VLP Peanut commenced in March 2023 with preliminary safety data expected later
in 2023. We hope that results of both trials will support our mission to bring
transformative treatment options to help people worldwide.

Clinical development
 

Transforming Allergy grass pollen treatment; Grass MATA MPL

Prior to the 2023 grass pollen season, the first patients were dosed in the
pivotal Phase III G306 trial. This trial is evaluating the efficacy and safety
of Grass MATA MPL, our short-course subcutaneous allergen-specific
immunotherapy candidate that aims to address the cause of symptoms of allergic
rhinoconjunctivitis due to grass pollen. Using an adjuvant system comprising
MicroCrystalline Tyrosine ("MCT®") adsorbed allergoids, and the adjuvant
Monophosphoryl-lipid A ("MPL"), this innovative technology only requires
patients to receive six injections prior to the grass allergy season to be
protected. The clinical trial, commenced in December 2022 and, is being
conducted at sites in the US and Europe. Interim data readout is expected in,
or around, November 2023.

Subject to success of the Phase III G306 trial, the Group expects to be able
to use the data (along with a further required one-year paediatric trial,
G308, which is yet to be funded) to support a clinical registration of Grass
MATA MLP in Germany under the TAV (Therapy Allergy Ordinance) regulatory
framework. The additional paediatric G308 data may also potentially be used to
support a future US filing. The registration of the product in the US, post
the G306 trial, will also require completion of the safety database before a
Biological Licence Application ("BLA") can be filed with the FDA.

 

The total US allergy immunotherapy market is estimated to be worth $2bn with
around 25% of the patients suffering from grass allergy. This offers the
potential for peak sales for Grass MATA MPL of about $300m to $400m per annum.

 

Next Generation immunotherapy; VLP Peanut

The clinical development of the Group's innovative, short-course peanut
allergy vaccine candidate, VLP Peanut, via subcutaneous injection, is
progressing as planned. The Phase I PROTECT trial is a first- in-human study
evaluating the safety and tolerability of VLP Peanut in healthy and peanut
allergic adult subjects. The trial, which is being run in centres in the US,
is being conducted in two parts:

•           Part A: Open-label study of healthy subjects (Group
A1) who are undergoing subcutaneous dosing with ascending concentrations of
VLP Peanut. Peanut allergic subjects (Group A2) underwent skin prick tests
performed with ascending concentrations of the vaccine candidate.

 

•           Part B:  Following satisfactory safety results from
Part A, the study  has proceeded to a double-blind, placebo-controlled Part B
enrolling peanut allergic patient who  are receiving subcutaneous injections
of the vaccine candidate.

While the trial protocol does not allow reporting of results mid-trial, to
avoid biasing the outcome, we are communicating the transitions between
cohorts, to update on the trial's progress.

 

In March 2023, following acceptance by the FDA of the Group's IND
("Investigational New Drug") application and successful site initiations, the
first cohort of peanut allergic patients received the peanut allergy vaccine
candidate via SPT. The trial then progressed to evaluate dose escalation in
healthy subject cohorts.

 

Cohorts 1 and 2 of part A1 have completed dosing. The remaining two cohorts
(Cohort 3 and 4) are now due to commence following the agreement of the
external safety review committee (SRC) to proceed with dose escalation as
announced on 26 September 2023.

 

 

The SRC has also provided the go-ahead to progress subcutaneous dose
escalation in peanut allergic subjects, which marks the start of the early
proof of concept phase (Part B) of the PROTECT trial.

No safety signal has been observed in healthy subjects to date.

We are hugely encouraged by the progress to date of the PROTECT trial and
believe that the data provide assurance of the hypo-allergic safety profile of
VLP Peanut, a key step in realising the potential of this transformative
option for peanut allergy sufferers.

 

Financial Performance
 
Overview

The Group achieved sales of £61.0m for the financial year. This represents a
16% reduction compared to £72.8m in 2022. The decline in revenue was a
consequence of the Manufacturing Pause.

The operating loss before R&D and exceptional costs 3  (#_ftn3) was
£13.3m (2022: £3.4m profit). There were exceptional costs of £14.0m,
£11.3m relating to the G306 Contingent Payment and £2.7m relating to
fundraising costs. The results for the year reflect the decline in revenue
caused by the Manufacturing Pause, an ongoing programme of continuous
improvement across the supply chain and quality systems, together with higher
manufacturing and labour costs.

 

After an increase in research and development costs to support the initiation
of the Phase III G306 clinical trial for Grass MATA MPL and preparation for
the Phase I PROTECT study for VLP Peanut, the operating loss was £36.1
million (2022: £12.2 million loss).

Outlook

The Group is optimistic of a successful readout of the Phase III G306 clinical
trial with Grass MATA MPL and is already laying the groundwork to commence
discussions with relevant regulators that would support registration once the
full trial data are available. Our mission to address the unmet needs of
allergy patients continues to drive everything we do, and we also eagerly
await the results of our second R&D pipeline asset in the Phase I PROTECT
trial where we are evaluating the safety of the VLP Peanut candidate. Both
clinical programmes are key to the future success of the Group, and we look
forward to the upcoming year where we can further demonstrate the
transformative potential of our pipeline.

 

As a result of the manufacturing capacity that needs to be allocated to
producing investigational medicinal product batches for use in clinical
trials, as previously reported sales for the financial year to 30 June 2024
are expected to be slightly lower than for the year ended 30 June 2023, while
costs and overheads before R&D costs are expected to be slightly higher.
The planned investment in clinical trials for the G306 Grass MATA MPL Phase
III study, long-term G308 Grass MATA MPL paediatric study and Phase I VLP
PROTECT study will result in a very significant increase in research and
development costs, subject to funding. A further increase in investment in
plant and equipment is also planned to support the continuing improvements in
manufacturing and quality.

Following receipt of the FDI regulatory approvals, the Group expects to
shortly announce the commencement of the Open Offer as part of the Equity
Financing. Pursuant to the terms of the Facility Agreement and Equity
Commitment Agreement, the Group is required to apply the proceeds of the
Equity Financing in repaying the Loan Facility on or around completion of the
Equity Financing. The Group will therefore repay all remaining outstanding
amounts under the Facility Agreement on or around the completion of the Equity
Financing.

 

Subject to the timing and volume of sales in the quarter to December 2023, the
Group now expects additional funding to be required from around November 2023
onwards and is working on initiatives which, if successful, may extend that
requirement into early 2024. Discussions with certain shareholders are ongoing
regarding the size and source of future funding. These discussions continue to
be positive. Whilst there are no binding arrangements at this stage, in the
interim, agreement has been reached on the £15.0m Extension Facility,
although this does not represent committed funding.

 

 

 

Financial review

 

Overview

The Group made an operating loss pre-R&D and exceptional costs 4  (#_ftn4)
of £13.3m for the year ended 30 June 2023 (2022: £3.4m profit). This loss is
a consequence of the Manufacturing Pause that occurred during October and
November 2022 and the ongoing programme of continuous improvement across the
supply chain and quality systems, together with higher manufacturing and
labour costs.

Including R&D expenses of £20.1m (2022: £15.7m), the Group reported an
operating loss of £36.1m (2022: operating loss of £12.2m).

The net loss after interest and tax for the year is £51.0m (2002: loss of
£13.8m) after the one off exceptional costs relating to financing activities.

 
Revenue

Reported revenue decreased by 16% to £61.0m (2022: £72.8m).

 

Revenue was down in almost all markets. Revenue from Germany was 54% (2022:
59%) of total revenue reflecting the supply disruption in the year, however
orders remain robust.

Gross profit

Cost of sales increased to £26.3m (2022: £23.3m) reflecting investment in
the supply chain. The gross margin was 57% (2022: 68%) reflecting the fixed
nature of the manufacturing facility costs despite the lower sales volume,
leading to a gross profit of £34.6m (2022: £49.5m).

Operating expenses

Sales, marketing, and distribution costs decreased by £2.3m to £23.7m (2022:
£26.0m) mainly as a result of cost control activities.

Total operating expenses were £9.1m higher than the prior year at £71.6m
(2022: £62.5m) mainly due to exceptional fundraising costs of £2.7m and
R&D expenditure that rose by £4.4m to £20.1m (2022: £15.7m) due to
investment in the G306 trial for Grass MATA MPL and preparation for the VLP
Peanut PROTECT study.

 

Non-R&D operating costs of £51.5m increased by £4.7m (2022: £46.8m) of
which £2.7m related to fundraising costs.

 

Financing costs

 

Financing costs include £11.3m in relation to the G306 Contingent Payment
(see financing section for more information).  The G306 Contingent Payment
charge represents a non-cash expense included at fair value as at 30 June
2023. Assuming the Equity Financing repays all amounts outstanding under the
Loan Facility within nine months of the date of the facility no liability for
the G306 Contingent Payment would crystallise and the fair value at the next
reporting date (31 December 2023) would be zero. Consequently, the accounting
charge could be reversed in this subsequent period.

 

Other income in the year of £0.9m (2022: £0.7m) was due to R&D tax
credits in the UK and Spain.

 

Tax

The current year tax charge is predominantly comprised of liabilities for tax
in the Spanish and German subsidiaries. The overall charge in the income
statement is £1.2m (2022: £1.1m).

 

 

 

 

Balance sheet

Property, plant and equipment increased by £3.8m to £24.0m (2022: £20.2m)
reflecting investment in the Worthing energy centre and upgrade of plant in
the UK.

 

Goodwill remained the same at £3.3m (2022: £3.3m), whilst other intangible
assets decreased by £0.6m to £1.1m (2022: £1.7m) due to amortisation
exceeding additions.

 

Total current assets, excluding cash, decreased to £19.4m (2022: £21.9m).
Trade and other receivables have decreased by £2.7m, mainly due to
prepayments related to R&D trial activities and maintenance contracts.

Cash and cash at hand decreased to £14.8m from £20.5m and there was a net
cash outflow of £5.6m in the year (2022: net outflow of £19.8m) as a result
of trading losses and investment in R&D. Shareholder loans of £36m were
drawn down during the year of which £10m was repaid at the balance sheet
date.

 

The fair value of derivative financial instruments was a liability of £0.1m
in 2023 (2022: liability of £0.1m) due to exchange rate fluctuations.

 

Retirement benefit obligations, which relate solely to the German pension
scheme, decreased to £7.8m (2022: £8.3m). The decrease in the liability was
mainly driven by experience gains of the scheme.

 

Net assets of the Group decreased from £38.4m to net liabilities of £4.8m
primarily driven by the trading losses, G306 Contingent Payment of £11.3m,
increased research and development, supply chain improvements.

 

Assuming the Equity Financing repays all amounts outstanding under the Loan
Facility within nine months of the date of the facility, thereby avoiding the
G306 Contingent Payment the balance sheet net liability position would improve
by £11.3m by reversal of the contingent payment charge and £40.075m less
costs for the conversion of the loan to equity, thereby resulting in a
positive net asset position, in the absence of any other movements.

 

Currency

 

Group Treasury Policy mandates the use of forward exchange contracts to
mitigate exposure to the effects of exchange rates where expenditure / income
is committed and / or reasonably certain. At 30 June 2023 the Group was in the
process of renegotiating with key suppliers and allowing previous hedge
contracts to complete before entering into new forward contracts.

 

With over 90% of revenues and approximately 50% of costs (excluding research
and development costs) denominated in Euros, and approximately 60% of research
and development costs denominated in US dollars, movements in the currency
markets may have an effect on the Group's operational finances.

Financing

 

In October 2022, the Group raised £7.0m via an issue of 35,000,000 ordinary
shares at a price of 20 pence per ordinary share from Southern Fox Investments
Limited and ZQ Capital Management Limited (acting through its affiliate SkyGem
Acquisition Limited), both related parties to the Group, and then issued to
them loan notes to raise a further £10.0m. In conjunction with the issue of
loan notes, the Group issued 33,333,332 warrants to the note purchasers to
subscribe for new ordinary shares at a warrant exercise price of 30 pence per
warrant. Net proceeds raised from the subscription in October 2022 were
£6.5m. Net proceeds of £10.0m from the loan notes were received in February
2023.

On 6 April 2023, the Group entered into the Loan Facility pursuant to which
the Group's existing substantial shareholders ZQ Capital Management Limited
(acting through its affiliate SkyGem International Holdings Limited) and
Southern Fox Investments Limited, agreed to make available to the Group a
secured term loan facility in an aggregate principal amount of £40.75m. The
purpose of the facility was to refinance the existing £10.0m loan notes
issued in February 2023, to facilitate the continuation of the Group's pivotal
Phase III G306 trial for Grass MATA MPL, to continue other key clinical trial
activities including the Phase I PROTECT study for VLP Peanut and to provide
working capital.

In conjunction with the Loan Facility, the Group also entered into an equity
commitment agreement with ZQ Capital Management Limited (acting through its
affiliate SkyGem International Holdings Limited) and Southern Fox Investments
Limited to conditionally subscribe for new ordinary shares of 0.1 pence each
in the capital of the Group at an issue price of 1 pence per new share to
raise gross proceeds of £40.75m.

 

The Equity Financing is comprised of a direct subscription by each of ZQ
Capital Management Limited and Southern Fox Investments Limited for, a minimum
in aggregate, 3,385,510,000 new shares at the issue price and an open offer,
where qualifying shareholders (excluding the three largest shareholders ZQ
Capital Management Limited, Southern Fox Investments Limited and Abbott
Laboratories (together Abbott Laboratories (Chile) Holdco SPA and Yissum
Holdings Limited)) will be offered the opportunity to subscribe for
689,102,532 new shares at the issue price. The proceeds of the Equity
Financing will be used to repay principal amounts outstanding and accrued
interest thereon of approximately £42.5m under the debt Facility.

Under the terms of a contingent payment letter dated 6 April 2023 entered into
between the Group and the Lenders in connection with the Loan Facility ("G306
Contingent Payment Letter"), the Group will be obliged to pay a substantial
finance premium ("G306 Contingent Payment") equal to 250 per cent of any
principal amount of the loan outstanding under the Loan Facility to the
Lenders on a successful G306 data read-out. There is a clause that would
negate the G306 Contingent Payment if the Group is able to repay the Loan
Facility in full before 6 January 2024 (being nine months from the date of the
facility agreement). The liability (if due) would be payable on 31(st)
December 2025 (unless there is a breach of the underlying agreements in which
case it would become immediately payable). The Group therefore intends,
subject to satisfaction (or waiver, if capable of being waived) of the equity
conditions, to complete the Equity Financing and repay all amounts outstanding
under the facility agreement within nine months of the date of the facility
agreement, thereby avoiding the G306 Contingent Payment being triggered.

The Group's debt on its balance sheet consists of shareholder loans of £26.0m
(2022: £nil) and previously taken out bank loans arranged to fund development
of products in the Spanish market of £1.5m. (2022: £2.4m)

 

As explained more fully in Note 1, basis of preparation, the Directors have
adopted the Going Concern basis in preparing the unaudited consolidated
financial statements whilst noting material uncertainties due to the need to
secure additional near-term funding.  Discussions with certain shareholders
are ongoing regarding the size and source of future funding. These discussions
continue to be positive. Whilst there are no binding arrangements at this
stage, in the interim, agreement has been reached on the £15.0m Extension
Facility, although this does not represent committed funding.

Unaudited consolidated income statement

 

for the year ended 30 June 2023

 

 

                                                    Year to       Year to       Year to       Year to
                                                    30 June 2023  30 June 2023  30 June 2022  30 June 2022
                                          Note      £'000         £'000         £'000          £'000
 Revenue                                  3                       60,952                      72,768
 Cost of sales                                                    (26,342)                    (23,262)
 Gross profit                                                     34,610                      49,506
 Sales, marketing and distribution costs                          (23,705)                    (26,004)
 Administration expenses - other                    (25,088)                    (20,828)
 Research and development costs                     (20,121)                    (15,659)
 Total administrative expenses                                    (45,209)                    (36,487)
 Exceptional fundraising costs                                    (2,681)                     -
 Other income                             5                       856                         740
 Operating loss                                                   (36,129)                    (12,245)
 Finance income                           6                       329                         257
 Finance expense -Exceptional                  7    (11,280)                    -
 Finance expense - Other                       7    (2,749)                     (669)
 Total finance expense                                            (14,029)                    (669)
 Loss before tax                                                  (49,829)                    (12,657)
 Income tax                                                       (1,197)                     (1,119)
 Loss for the year                                                (51,026)                    (13,776)
 Loss per share                           8
 Basic (pence per share)                                          (7.61)p                     (2.14)p
 Diluted (pence per share)                                        (7.61)p                     (2.14)p

 

Unaudited consolidated statement of comprehensive income

 

for the year ended 30 June 2023

 

 

                                                                            Year to                                             Year to
                                                                            30 June 2023                                        30 June 2022
                                                                      Note  £'000                                               £'000
 Loss for the year                                                          (51,026)                                            (13,776)
 Items that will not be reclassified subsequently to profit or loss:
 Remeasurement of retirement benefit obligations                                                   762                          3,094
 Remeasurement of investments - retirement benefit assets                                        (552)                          (193)
 Revaluation gains - freehold land and buildings                            428                                                 -
 Deferred tax movement - freehold land and buildings                        -                                                   -
 Total other comprehensive income                                           638                                                 2,901
 Items that may be reclassified subsequently to profit or loss:
 Exchange differences on translation of foreign operations                                          193                         265
 Total comprehensive loss                                                                   (50,195)                            (10,610)

 

 

 

Unaudited consolidated balance sheet

 

as at 30 June 2023

 

                                         Note  30 June 2023  30 June 2022
                                               £'000         £'000
 Assets
 Non-current assets
 Property, plant and equipment                 23,977        20,190
 Intangible assets - goodwill                  3,346         3,347
 Intangible assets - other                     1,054         1,688
 Investments - retirement benefit asset        5,813         5,962
 Total non-current assets                      34,190        31,187
 Current assets
 Inventories                             9     11,593        11,410
 Trade and other receivables             10    7,772         10,468
 Cash and cash equivalents                     14,845        20,515
 Total current assets                          34,210        42,393
 Total assets                                  68,400        73,580
 Liabilities
 Current liabilities
 Trade and other payables                      (17,174)      (15,669)
 Current borrowings                      11    (648)         (952)
 Lease liabilities                             (1,155)       (1,316)
 Derivative financial instruments              (79)          (116)
 Total current liabilities                     (19,056)      (18,053)
 Net current assets                            15,154        24,340
 Non-current liabilities
 Retirement benefit obligations                (7,758)       (8,319)
 Deferred taxation liability                   (346)         (406)
 Non-current provisions                        (148)         (144)
 Other non-current liabilities           7     (11,280)      -
 Lease liabilities                             (7,747)       (6,764)
 Long-term borrowings                    11    (26,848)      (1,497)
 Total non-current liabilities                 (54,127)      (17,130)
 Total liabilities                             (73,183)      (35,183)
 Net current (liabilities)/assets              (4,783)       38,397
 Equity
 Capital and reserves
 Issued share capital                    12    689           654
 Share premium                                 119,030       112,576
 Merger reserve                                40,128        40,128
 Reserve - share-based payments                2,906         2,799
 Revaluation reserve                           1,501         1,073
 Reserve - warrants                            412           -
 Foreign exchange reserve                      (730)         (923)
 Retained earnings                             (168,719)     (117,910)
 Total equity                                  (4,783)       38,397

 

 

 

Unaudited consolidated statement of changes in equity

for the year ended 30 June 2023

                                                                                                           Reserve -                           Foreign
                                                                                Issued   Share    Merger   share-based  Revaluation  Reserve-  exchange  Retained                      Total
                                                                                capital  premium  reserve  payment      reserve      warrants  reserve   earnings                      equity
                                                                                £'000    £'000    £'000    £'000        £'000        £'000     £'000     £'000                         £'000
 At 30 June 2021                                                                651      112,576  40,128   2,693        1,073        -         (1,188)   (107,398)                     48,535
 Exchange differences on translation of foreign operations                      -        -        -        -            -            -         265       -                             265
 Remeasurement of net defined benefit liability                                 -        -        -        -            -            -         -         3,094                         3,094
 Remeasurement of investments - retirement benefit assets                       -        -        -        -            -            -         -         (193)                         (193)
 Total other comprehensive income                                               -        -        -        -            -            -         265       2,901                         3,166
 Loss for the year after tax                                                    -        -        -        -            -            -         -         (13,776)                      (13,776)
 Total comprehensive loss                                                       -        -        -        -            -            -         265       (10,875)                      (10,610)
 Transactions with owners:
 Share-based payments                                                           -        -        -        469          -            -         -         -                             469
 Shares issued                                                                  3        -        -        -            -            -         -         -                             3
 Transfer of lapsed options to retained earnings                                -        -        -        (363)        -            -         -         363                           -
 At 30 June 2022                                                                654      112,576  40,128   2,799        1,073        -         (923)     (117,910)                     38,397
 Exchange differences on translation of foreign operations                      -        -        -        -            -            -         193       -                             193
 Valuation gains taken to equity (land and buildings) - net of deferred tax     -        -        -        -            428          -         -         -                             428
 Remeasurement of net defined benefit liability                                 -        -        -        -            -            -         -         762                           762
 Remeasurement of investments - retirement benefit assets                       -        -        -        -            -            -         -         (552)                         (552)
 Total other comprehensive income                                               -        -        -        -            428          -         193                    210              831
 Loss for the year after tax                                                    -        -        -        -            -            -         -         (51,026)                      (51,026)
 Total comprehensive loss                                                       -        -        -        -            428          -         193       (50,816)                      (50,195)
 Transactions with owners:
 Share-based payments                                                           -        -        -        114          -            -         -         -                             114
 Shares issued                                                                  35       6,454    -        -            -            -         -         -                             6,489
 Transfer of lapsed options to retained earnings                                -        -        -        (7)          -            -         -         7                             -
 Warrants issued                                                                -        -        -        -            -            412       -         -                             412
 At 30 June 2023                                                                689      119,030  40,128   2,906        1,501        412       (730)     (168,719)                     (4,783)

Unaudited consolidated cash flow statement

 

for the year ended 30 June 2023

 

                                                                       Year to       Year to
                                                                       30 June 2023  30 June 2022
                                                                 Note  £'000         £'000
 Cash flows from operating activities
 Loss before tax                                                       (49,829)      (12,657)
 Adjustments for:
 Finance income                                                  6     (329)         (257)
 Finance expense                                                 7     14,029        669
 Non-cash movements on defined benefit pension plan                    104           (23)
 Depreciation and amortisation                                         4,226         4,166
 Net monetary value of above-the-line
 R&D tax credit                                                  5     (856)         (740)
 Charge for share-based payments                                       114           469
 Movement in fair valuation of derivative financial instruments        (37)          641
 Loss on disposal of fixed asset                                       -             8
 Decrease/(increase) in trade and other receivables                    3,106         (4,246)
 (Increase) in inventories                                             (142)         (572)
 Increase/(decrease) in trade and other payables                       1,697         (1,067)
 Net cash used by operations                                           (27,917)      (13,609)
 Income tax paid                                                       (828)         (213)
 Net cash used by operating activities                                 (28,745)      (13,822)
 Cash flows from investing activities
 Interest received                                                     82            58
 Payments for retirement benefit investments                           (159)         (179)
 Payments for property, plant and equipment                            (5,715)       (3,056)
 Net cash used in investing activities                                 (5,792)       (3,177)
 Cash flows from financing activities
 Proceeds from issue of equity shares                                  6,489         3
 Repayment of bank loan borrowings                                     (961)         (957)
 Interest paid on bank loan borrowings                                 (1,720)       (168)
 Repayment of principal on lease liabilities                           (586)         (1,311)
 Interest paid on lease liabilities                                    (321)         (373)
 Proceeds from shareholder borrowings                                  36,000        -
 Repayment of shareholder loan borrowing                               (10,000)      -
 Net cash generated/(used) in financing activities                     28,901        (2,806)
 Net decrease in cash and cash equivalents                             (5,636)       (19,805)
 Effects of exchange rates on cash and cash equivalents                (34)          47
 Cash and cash equivalents at the start of the year                    20,515        40,273
 Cash and cash equivalents at the end of the year                      14,845        20,515
 Cash at bank and in hand                                              14,845        20,515
 Bank overdraft                                                        -             -
 Cash and cash equivalents at the end of the year                      14,845        20,515

 

 

Notes to the financial statements

For the year ended 30 June 2023

 

1.  Basis of preparation

The financial information set out in this preliminary announcement does not
constitute statutory accounts as defined in Section 435 of the Companies Act
2006. The financial statements are unaudited.

 

Allergy Therapeutics PLC is an international commercial biotechnology Group
focused on the treatment and diagnosis of allergic disorders including
immunotherapy vaccines that have the potential to cure disease.

The Group's financial statements have been prepared in accordance with IFRS in
issue as adopted by the UK and with those parts of the Companies Act 2006 that
are relevant to the Group preparing its accounts in accordance with UK-adopted
IFRS.

Allergy Therapeutics PLC is the Group's parent company. The company is a
limited liability company incorporated and domiciled in England. The address
of Allergy Therapeutics PLC's registered office and its principal place of
business is Dominion Way, Worthing, West Sussex BN14 8SA and its shares are
listed on the AIM.

The audited annual report and accounts for the year ended 30 June 2022 were
signed by the Board of Directors on 16 June 2023 and delivered to the
Registrar of Companies. The audited annual report and accounts for the year
ended 30 June 2022 included a qualification for limitation of scope in respect
of the carrying value of insurance policy assets related to the pension scheme
of the Group's German subsidiary. The Board of Directors made relevant
enquiries of the scheme's insurer and were unable to obtain all of the
relevant information required under IAS (UK) 500 about the controls and
valuation of the underlying assets at 30 June 2022, therefore were unable to
obtain sufficient, appropriate audit evidence.

 

The annual report and accounts for the year ended 30 June 2022 did not contain
a statement under Section 498(2) or Section 498(3).

 

This preliminary announcement of results for the year ended 30 June 2023
(including comparatives) has been prepared under the historical cost
convention except for land and buildings, and derivative financial
instruments, which have been measured at fair value. It was approved and
authorised for issue by the Board of Directors on 26 September 2023.

 

New standards adopted

There are no IFRS or IAS interpretations that are effective for the first time
in this financial period that have had a material impact on the Group.

 

Standards, amendments and interpretations to existing standards that are not yet effective and have not been adopted early by the Group

At the date of authorisation of these financial statements, several new, but
not yet effective, standards and amendments to existing standards and
interpretations have been published by the IASB. None of these standards or
amendments to existing standards have been adopted early by the Group.

Management anticipates that all relevant pronouncements will be adopted for
the first period beginning on or after the effective date of the
pronouncement. New standards, amendments and interpretations not adopted in
the current year have not been disclosed as they are not expected to have a
material impact on the Group's financial statements.

 

Going concern

The operating loss for the year was £36.1m (2022: £12.2m loss) and the net
cash outflow from operations was £28.7m (2022: net cash outflow £13.8m). The
outflow was due to reduced sales, increased expenditure on R&D and other
cost increases. Excluding the R&D expenditure and exceptional financing
costs, the Group reported an operating loss of £13.3m (2022: operating profit
of £3.4m).

 

Net assets of the Group decreased from £38.4m to net liabilities of £4.8m
primarily driven by the trading losses, G306 Contingent Payment of £11.3m,
increased research and development and supply chain improvements.

 

Assuming the Equity Financing repays all amounts outstanding under the Loan
Facility within nine months of the date of the facility, thereby avoiding the
G306 Contingent Payment the balance sheet net liability position would improve
by £11.3m by reversal of the contingent payment charge and £40.075m less
costs for the conversion of the loan to equity, thereby resulting in a
positive net asset position, in the absence of any other movements.

 

The Directors acknowledge that a material uncertainty exists over the Group's
ability to access additional sources of finance, which will be required
regardless of the outcome of the Phase III G306 trial and regardless of the
planned Equity Financing.

Under the terms of the G306 Contingent Payment Letter, the Group will be
obligated to pay the G306 Contingent Payment equal to 250% of the principal
amount of the loan outstanding on a successful data read-out of the Phase III
G306 trial, if any liability remains outstanding under the terms of the loan
agreement at 6 January 2024.

 

The Directors have reasonable expectations that the Phase III G306 trial will
be successful, and that appropriate additional financing can be obtained for
the Group now that FDI clearance has been received and the Group expects to
launch the Equity Financing shortly. Accordingly, they have prepared these
financial statements on a going concern basis.

 

Notwithstanding the Loan Facility and planned refinancing of the Loan Facility
through the Equity Financing, the Group expects that additional funding will
be required from around November 2023 onwards and is working on initiatives
which, if successful, may extend that requirement into early 2024. The funds
are required for working capital, capital expenditure and continuing research
and development programmes.

 

Discussions with certain shareholders are ongoing regarding the size and
source of future funding. These discussions continue to be positive. Whilst
there are no binding arrangements at this stage, in the interim agreement has
been reached on the £15.0m Extension Facility, although this does not
represent committed funding.

 

It is therefore considered that material uncertainties exist which may cast
significant doubt on the Group's ability to continue as a going concern and
therefore they may be unable to realise their assets and discharge their
liabilities in the normal course of business. These unaudited preliminary
results do not include any adjustments that would result from the basis of
preparation being inappropriate.

 

2.  Accounting policies

 

The principal accounting policies adopted in the preparation of these
financial statements are set out below. These policies have been consistently
applied to all years presented unless otherwise stated.

Consolidation

The Group's financial statements consolidate those of the parent company and
all of its subsidiaries drawn up to 30 June 2023. The parent controls a
subsidiary if it is exposed, or has rights, to variable returns from its
involvement with the subsidiary and has the ability to affect those returns
through its power over the subsidiary.

 

Subsidiaries are fully consolidated from the date on which control is
transferred to the Group. They are deconsolidated on the date control ceases.

 

Intercompany transactions, balances and unrealised gains and losses on
transactions between Group companies are eliminated except for unrealised
losses if they show evidence of impairment.

 

Where necessary, adjustments are made to the financial statements of
subsidiaries to bring accounting policies used into line with those used in
the Group.

 

The Group applies the acquisition method in accounting for business
combinations. The consideration transferred by the Group to obtain control of
a subsidiary is calculated as the sum of the acquisition date fair values of
assets transferred, liabilities incurred, and the equity interests issued by
the Group, which includes the fair value of any liability arising from a
contingent consideration arrangement. Acquisition costs are expensed as
incurred.

 

The Group recognises identifiable assets acquired and liabilities assumed in a
business combination regardless of whether they have been previously
recognised in the acquiree's financial statements prior to the acquisition.
Assets acquired and liabilities assumed are measured at their acquisition date
fair values.

Goodwill is stated after separate recognition of identifiable intangible
assets. It is calculated as the excess of the sum of a) fair value of
consideration transferred; b) the recognised amount of any non-

controlling interest in the acquiree; and c) acquisition date fair value of
any existing equity interest in the acquiree, over the acquisition date fair
values of identifiable net assets. If the fair values of identifiable net
assets exceed the sum calculated above, the excess amount (i.e., gain on a
bargain purchase) is recognised in profit or loss immediately.

 

Goodwill

Goodwill arising from business combinations is the difference between the fair
value of the consideration paid and the fair value of the assets and
liabilities and contingent liabilities acquired. It is initially recognised as
an intangible asset at cost and is subject to impairment testing on an annual
basis or more frequently if circumstances indicate that the asset may have
been impaired. Details of impairment testing are described in the accounting
policies.

 

 
Intangible assets acquired as part of a business combination

Intangible assets acquired in a business combination are identified and
recognised separately from goodwill where they satisfy the definition of an
asset and can be identifiable. The cost of such intangible assets is their
fair value at the acquisition date.

 

Subsequent to initial recognition, intangible assets acquired in a business
combination are reported at cost less accumulated amortisation and accumulated
impairment losses. Intangible assets are amortised over their useful economic
life as follows:

 

 

Trade
names
15 years

Customer
relationships
5 years

Know-how and
patents
10 years

Distribution
agreements
15 years/period of contract

 

Externally acquired intangible assets

Intangible assets acquired separately are measured on initial recognition at
cost. Following initial recognition, intangible assets are carried at cost
less any accumulated amortisation and any accumulated impairment losses.

Intangible assets are amortised over their useful economic life as below and
assessed for impairment whenever there is an indication that the intangible
asset may be impaired. The amortisation period and the amortisation method for
intangible assets is reviewed at least at each financial year end:

 

 

Computer
software
7 years

Other
intangibles
15 years

 

Changes in the expected useful life or the expected pattern of consumption of
future economic benefits embodied in the asset are accounted for by changing
the amortisation period or method, as appropriate, and are treated as changes
in accounting estimates. The amortisation expense on intangible assets is
recognised in the consolidated income statement in the expense category
consistent with the function of the intangible asset in either administration
costs or marketing and distribution costs.

 

Internally generated intangible assets

An internally generated intangible asset arising from development (or the
development phase) of an internal project is recognised if, and only if, all
of the following have been demonstrated:

 

·      the technical feasibility of completing the intangible asset so
that it will be available for use or sale;

·      the intention to complete the intangible asset and use or sell
it;

·      the ability to use or sell the intangible asset;

·      how the intangible asset will generate probable future economic
benefits;

·      the availability of adequate technical, financial and other
resources to complete the development and to use or sell the intangible asset;
and

·      the ability to measure reliably the expenditure attributable to
the intangible asset during its development.

 

The amount initially recognised for internally generated intangible assets is
the sum of the expenditure incurred from the date when the intangible asset
first meets the recognition criteria listed above. Where no internally
generated intangible asset can be recognised, R&D expenditure is charged
to the consolidated income statement in the period in which it is incurred.

 

After initial recognition, internally generated intangible assets are reported
at cost less accumulated amortisation and accumulated impairment losses.
Amortisation shall begin when the asset is available for use, i.e., when it is
in the location and condition necessary for it to be capable of operating in
the manner intended by Management.

 

Amortisation of all intangible assets is calculated on a straight-line basis
over the useful economic life using the following annual rates:

 

 

Manufacturing
know-how
15 years

Non-competing
know-how
4 years

Other
intangibles
15 years

 

These periods were selected to reflect the assets' useful economic lives to
the Group.

 

The cost of amortising intangible assets is included within administration
expenses in the consolidated income statement.

 

Segmental reporting

The Group's operating segments are market-based and are reported in a manner
consistent with the internal reporting provided to the Group's Chief Operating
Decision Maker ("CODM") which has been identified as the Executive Directors.
The CODM is responsible for allocating resources and assessing the performance
of the operating segments.

In identifying its operating segments, management follow the Group's revenue
lines which represent the main geographical markets within which the Group
operates. These operating segments are managed separately as each requires
different local expertise, regulatory knowledge and a specialised marketing
approach. Each market-based operating segment is engaged in production,
marketing and selling within a particular economic environment that is
different from that in segments operating in other economic environments. All
inter-segment transfers are carried out at arm's length prices.

 

Foreign currency translation
Functional and presentational currency

Items included in the financial statements of each of the Group's entities are
measured using the currency of the primary economic environment in which the
entity operates (the functional currency). The Group's presentational currency
is Sterling, which is also the functional currency of the Group's parent.

 

Transactions and balances

Foreign currency transactions are translated into the functional currency
using the exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of such transactions
and from the translation, at reporting period end exchange rates, of monetary
assets and liabilities denominated in foreign currencies, are recognised in
the consolidated income statement. Non-monetary items are carried at
historical cost or translated using the exchange rate at the date of the
transaction or a weighted average rate as an approximation where this is not
materially different.

 

Foreign operations

In the Group's financial statements, all assets, liabilities and transactions
of Group entities with a functional currency other than Sterling are
translated into Sterling upon consolidation. The functional currency of the
entities in the Group has remained unchanged during the reporting period.

 

On consolidation, assets and liabilities have been translated into Sterling at
the closing rate at the reporting date. Goodwill and fair value adjustments
arising on the acquisition of a foreign entity have been treated as assets and
liabilities of the foreign entity and translated into Sterling at the closing
rate. Income and expenses have been translated into Sterling at the weighted
average rate over the reporting period which approximates to actual rates.
Exchange differences are charged or credited to other comprehensive income
("OCI") and recognised in the currency translation reserve in equity.

OCI includes those items which would be reclassified to profit or loss and
those items which would not be reclassified to profit or loss.

 

Revenue recognition

The Group's revenue recognition policy is as follows:

 

Revenue generated from a contract for the sale of goods is recognised on
delivery when all conditions have been fulfilled to the customer, such as the
supply of vaccines.

The Group recognises revenue in accordance with the requirements of IFRS 15
and the five-step model set out within the standard as follows:

 

STEP 1 Identifying the contract with the customer

The Group accounts for contracts with customers within the scope of IFRS 15
only when all of the following criteria are met:

 

 

a.    the Group and the customer have approved the contract (in writing,
orally or in accordance with other customary business practices) and are
committed to perform their respective obligations;

b.    the Group can identify each party's rights regarding the services to
be transferred;

c.    the Group can identify the payment terms for services to be
transferred;

d.    the contract has commercial substance (i.e., the risk, timing or
amount of the Group's future cash flows is expected to change as a result of
the contract); and

e.    it is probable that the Group will collect the consideration to which
it will be entitled in exchange for the services that will be transferred to
the customer. In evaluating whether collectability of an amount of
consideration is probable, the Group considers only the customer's ability and
intention to pay that amount of consideration when it is due.

 

Significant new contracts with distributors are reviewed by senior management
to ensure the relevant terms are identified and agreed.

Substantially all sales are via purchase orders received from the customer
which specify the product to be delivered.

 

STEP 2 Identifying the performance obligations

At contract inception, the Group assesses the goods or services promised
within the contract and identifies as a performance obligation, each promise
to transfer to the customer either:

 

a.    a good or service that is distinct; or

b.    a series of distinct services that are substantially the same and
that have the same pattern of transfer to the customer.

With the exception of trivial amounts, the only identifiable performance
obligation is the delivery of products.

 

STEP 3 Determining the transaction price

For the majority of supplies, the goods are sold at an agreed list price (or a
variation of the list price as agreed between the parties). In these cases,
there is no variable consideration.

There is no material difference between the timing of cash receipts and the
timing of revenue recognition in respect of revenue contracts.

 

STEP 4 Allocating the transaction price to the separate performance
obligations

There is only one performance obligation and accordingly the transaction price
is allocated to the delivery of the product.

 

STEP 5 Recognising revenue when performance obligations are satisfied

The performance obligation is satisfied at the point in time when the product
is delivered to the customer. Each transaction is recognised as a separate
chargeable event. There are no further obligations.

 

 

Agent vs principal considerations

Upon inception of a contract with a customer, the Group considers whether it
is acting as agent or as principal in accordance with IFRS 15. The Group
considers that it is acting as a principal if it controls the specified good
or service before that good or service is transferred to a customer. In doing
so, the Group has determined that it has acted as a principal and not as an
agent as part of all of its contracts with customers. In reaching this
conclusion, the Directors considered the following arrangements:

 

Arrangements for sales through distributors

For all distributor arrangements, the distributor is invoiced at the time of
delivery and title to the product passes upon full and final settlement of the
invoice to which the delivery relates. The distributor has full discretion
over the setting of the final selling price to the end customer and is
responsible for all customer returns of product.

 

Arrangements for sales through agents

For all agreements with agents, the agent places orders with the Group and
goods are then shipped to them. The Group, however, holds title to these
products until they are sold on to a third party.

 

The selling price to the end user is set by the relevant government body and
the agent receives a fixed percentage of this selling price. The agent
notifies the Group monthly on stock levels and this is reconciled to a
statement which generates an invoice for payment by the agent. The Group is
responsible for any customer returns of product. Revenue is recognised by the
Group when the products are sold by the agent.

 

Statutory rebates

In Germany, pharmaceutical companies are required to pay a manufacturer's
rebate to the government as a contribution to the cost of medicines paid for
by the state and private health funds. The rebates are not considered to meet
the definition of variable consideration as set out in IFRS 15.50-53. This is
because at the point of entering into a contract with a customer on which a
rebate is likely to apply (for example, the supply of an allergy vaccine to a
patient in Germany), there is no variability relating to the consideration to
be received by the Group in exchange for the supply of the goods - the sales
price and associated rebate is crystallised at the point of the supply. The
calculation of the rebate to be repaid by the Group is carried out and
invoiced in arrears by the various health insurer rebate centres in Germany.
Accordingly, the rebate is considered to be a reduction in the selling price
and is therefore deducted from the transaction price.

 

IFRS 15 other disclosures

All revenue recognised in the income statement is from contracts with
customers and no other revenue has been recognised.

Disclosures regarding impairment losses are detailed in Note 10, Trade and
other receivables.

A disaggregation of revenue is reported in Note 3, Revenue. Revenue by segment
is reported in Note 4, Segmental reporting.

Revenue for each item is recognised when the goods are provided to the client
and the obligation to pay the Group arises at the same time. Control passes to
the customer once the goods are delivered, at which point the Group becomes
entitled to consideration for the goods provided. The Group sells on credit
and debtors are typically recovered between 20 to 90 days later. Further
details regarding this are detailed in Note 10, Trade and other receivables.

As at 30 June 2023 there were no remaining performance obligations for revenue
recognised in the year.

All obligations pertaining to revenue recognised have been met. No revenue was
recognised relating to obligations not yet performed. No revenue has been
recognised in the period relating to obligations met in the preceding period.

Significant judgements regarding the timing of transactions or price are
detailed in Note 2, Judgements in applying accounting policies.

The transaction price is set out in individual contractual agreements and
there is a range of prices based on the goods sold.

No assets were recognised from costs to obtain or fulfil a contract with any
customer.

 

Presentation of material items

In preparing the financial statements the Directors consider whether there
have been any material or unusual items. These items are disclosed separately
on the face of the primary financial statements.

 
Expenditure recognition

Operating expenses are recognised in the consolidated income statement upon
utilisation of the service or at the date of their origin.

 

Leasing

The right-of-use asset is initially measured at the amount of the lease
liability plus any lease payments made at or before the commencement date
(less any lease incentives received), plus any initial direct costs incurred
in agreeing the lease, plus an estimate of future dismantling, removal and
restoration costs. After the initial measurement, the right-of-use asset is
accounted for using the cost model set out in IAS 16, Property, Plant and
Equipment, which is based on depreciating the asset over the estimated useful
economic life.

 

In connection with the Group's right-of-use assets, as at 30 June 2023 there
were no lease payments that had been made prior to the commencement of the
lease, nor any lease incentives, nor has the Group made any structural or
other changes to any right-of-use assets that would require material costs in
respect of dismantling, removal or restoration.

 

The initial recognition of the lease liability has been based on discounting
the cash flows associated with the lease using the rate implicit in the lease
agreement, or where this is not available, the Group's incremental borrowing
rate, which the Directors consider to be similar to the Group's bank borrowing
rate. After initial measurement the Group charges the lease liability with the
interest cost to unwind the discount factor and reduces the liability by the
amount of contractual payments made annually.

In reviewing the leases, the Directors took into consideration those which
were long-term leases, those which were short-term leases, the underlying
asset value and the lease and non-lease components.

Leases of low-value assets and short-term leases with a term of 12 months or
less have continued to be recognised as an operating expense and it was
determined that all of these short-term leases had termination clauses of
three months or less and therefore could be readily terminated if required.
The Directors have set a guideline of £5,000 or less lease value as the
threshold for determining the value of a potential lease asset. All the
short-term leases are therefore also considered low-value assets and have been
excluded from right-of-use assets.

Low-value and short-term leases

Where the Group is a lessee, payments on low-value and short-term operating
lease agreements are recognised as an expense on a straight-line basis over
the lease term. Associated costs, such as maintenance and insurance, are
expensed as incurred. Benefits received and receivable as an incentive to
enter into an operating lease are also spread on a straight-line basis over
the lease term.

 

Inventories

Inventory is carried at the lower of cost or net realisable value. The costs
of raw materials, consumables, work in progress and finished goods are
measured by means of weighted average cost using standard costing techniques.
The cost of finished goods and work in progress comprises direct production
costs such as raw materials, consumables, utilities and labour, and production
overheads such as employee costs, depreciation on equipment used in
production, maintenance and indirect factory costs. Standard costs are
reviewed regularly to ensure relevant measures of utilisation, production lead
time and appropriate levels of manufacturing expense are reflected in the
standards.

 

Net realisable value is calculated based on the selling price in the normal
course of business less any costs to sell.

 

Warrants

Pursuant to the subscription and debt financing announced in September 2022,
the Group received £6.5m of net share proceeds from the issue of new ordinary
shares in October 2022 and received £10.0m from the issue of loan notes on 28
February 2023, together with the issue of 33,333,332 warrants to subscribe for
new ordinary shares at a warrant exercise price of 30 pence per warrant.

 

The loan notes and the warrants are considered to be one hybrid financial
instrument and were fair valued at inception and recognised on this basis. The
loan notes were repaid during the year and the warrants will continue to be
held at their initial fair value without subsequent revaluation until
redemption. The fair value of the warrants was determined by an independent
third party using a Black Scholes valuation model.

 

Contingent Payment

Under the terms the G306 Contingent Payment Letter, the Group will be obliged
to pay a finance premium equal to 250 per cent. of the outstanding principal
amount of the loan outstanding under the Loan Facility to the Lenders on a
successful data read-out. The Group therefore intends, subject to satisfaction
(or waiver, if capable of being waived) of the equity conditions, to complete
the Equity Financing and repay all amounts outstanding under the Loan Facility
within nine months of the date of its announcement, thereby avoiding the G306
Contingent Payment being triggered.

 

The valuation of the G306 Contingent Payment has been determined by Management
using a weighted average approach and various assumptions as at 30 June 2023
around the probabilities of success of the G306 clinical trial, the value and
timing of the planned Equity Financing and the amount of drawn Loan Facility
principal at the point when the G306 clinical trial is successful.

 

The contingent payment liability is fair valued through profit and loss at
each reporting period and there have been no changes to the fair value since
initial recognition. The valuation of the contingent payment liability is
necessarily dependent on the assumptions that underpin it and the valuation
will change over time as estimates and assumptions are updated. In certain
circumstances where the G306 clinical trial is successful but the full amount
of the Loan Facility is repaid, no contingent payment will be payable.

 
Use of accounting estimates and judgements

Many of the amounts included in the financial statements involve the use of
judgement and/or estimation. These judgements and estimates are based on
Management's best knowledge of the relevant facts and circumstances, having
regard to prior experience, but actual results may differ from the amounts
included in the financial statements. Information about such judgements and
estimation is contained in the accounting policies and/or the notes to the
financial statements and the key areas are summarised below:

 

Judgements in applying accounting policies

a)   Capitalisation of development costs requires analysis of the technical
feasibility and commercial viability of the project concerned. Capitalisation
of the costs will be made only where there is evidence that an economic
benefit will accrue to the Group. To date, no development costs have been
capitalised and all costs have been expensed in the income statement as
R&D costs. Costs expensed in the year amounted to £20.1m (2022: £15.7m).

 

b)   In respect of net revenue relating to certain products there is a risk
that up to £13.6m cumulative

revenue recognised (2022: £11.2m cumulative) may be reversed due to a
retrospective change in

the level of rebate being applied.

 

Sources of estimation uncertainty

a)    Determining whether goodwill is impaired requires an estimation of
the value-in-use of the CGU to which the goodwill has been allocated. This
value-in-use calculation requires an estimation of the future cash flows
expected to arise from the CGU and a suitable discount rate to calculate the
present value.

 

Management has performed sensitivity analysis on the key assumptions in the
impairment model using reasonably possible changes in these key assumptions,
both individually and in combination.

 

Management has considered reasonably possible changes in key assumptions that
would cause the carrying amounts of goodwill or brands to exceed the value in
use for each asset. For both the German CGU and the Spanish CGU respectively,
there are no reasonably possible changes in key assumptions that would lead to
an impairment and the assumptions do not give rise to a key source of
estimation uncertainty.

 

b)    The Group operates equity-settled share-based compensation plans for
remuneration of its employees comprising LTIP schemes. Employee services
received in exchange for the grant of any share-based compensation are
measured at their fair values and expensed over the vesting period. The fair
value of this compensation is dependent on whether the provisional share
awards will ultimately vest, which in turn is dependent on future events which
are uncertain. The Directors use their judgement and experience of previous
awards to estimate the probability that the awards will vest, which impacts
the fair valuation of the compensation.

 

The key variables to be estimated are the number of awards that will lapse
before the vesting date due to leavers, and the number of awards that will
vest in relation to the non-market condition performance tests.

 

c)  The Group operates a partly funded non-contributory defined benefit
pension scheme for certain employees in Germany. The defined assets and
liabilities of this scheme are estimated using actuarial methods by an
independent expert.

 

d)  Under the terms of the G306 Contingent Payment Letter, the Group will be
obligated to pay the G306 Contingent Payment equal to 250 per cent of the
principal amount of the loan outstanding under the facility to the Lenders at
the date of a successful G306 data read-out if at 6 January 2024 any liability
remains outstanding under the terms of the facility agreement. The fair value
of the contingent payment requires an estimation of certain variables that
form part of the contingent payment.

 

3. Revenue

 

An analysis of revenue by category is set out in the table below:

 

                                   2023    2022
                                   £'000   £'000
 Sale of goods at a point in time  60,952  72,768
                                   60,952  72,768

 

 

4. Segmental reporting

The Group's operating segments are reported based on the financial information
provided to the Executive Directors, who are defined as the CODM, to enable
them to allocate resources and make strategic decisions.

The CODM reviews information based on geographical market sectors and assesses
performance at an EBITDA (operating profit before interest, tax, depreciation
and amortisation) and operating profit level. Management have identified that
the reportable segments are Central Europe (which includes the following
operating segments: Germany, Austria, Switzerland and the Netherlands),
Southern Europe (Italy, Spain and Other), and the Rest of World (including
UK).

 

For all material regions that have been aggregated, management consider that
they share similar economic characteristics. They are also similar in respect
of the products sold, types of customer, distribution channels and regulatory
environments.

 

Revenue by segment

 

                               Revenue        Inter-   Total    Revenue        Inter-   Total
                               from external  segment  segment  from external  segment  segment
                               customers      revenue  revenue  customers      revenue  revenue
                               2023           2023     2023     2022           2022     2022
                               £'000          £'000    £'000    £'000          £'000    £'000
 Central Europe
 Germany                       33,120         -        33,120   42,579         -        42,579
 Austria                       4,903          -        4,903    5,229          -        5,229
 Netherlands                   4,017          -        4,017    4,281          -        4,281
 Switzerland                   2,838          -        2,838    3,295          -        3,295
                               44,878         -        44,878   55,384         -        55,384
 Southern Europe
 Italy                         3,053          -        3,053    3,402          -        3,402
 Spain                         9,379          -        9,379    8,871          -        8,871
 Other                         396            -        396      562            -        562
                               12,828         -        12,828   12,835         -        12,835
 Rest of World (including UK)  3,246          28,731   31,977   4,549          39,371   43,920
                               60,952         28,731   89,683   72,768         39,371   112,139

 

Revenues from external customers in all segments are derived principally from
the sale of a range of pharmaceutical products designed for the immunological
treatment of the allergic condition.

Rest of World revenues include sales through distributors and agents in
several markets including the Czech Republic, Slovakia, Canada and South
Korea. Inter-segment revenues represent sales of product from the UK to the
operating subsidiaries. The price is set on an arm's-length basis which is
eliminated on consolidation.

The CODM also reviews revenue by segment on a budgeted constant currency
basis, to provide relevant year-on-year comparisons.

The Group has no customers which individually account for 10% or more of the
Group's revenue.

Depreciation and amortisation by segment

                               2023    2022
                               £'000   £'000
 Central Europe                1,217   1,173
 Southern Europe               740     728
 Rest of World (including UK)  2,269   2,265
                               4,226   4,166

 

EBITDA by segment

                                2023      2022
                                £'000     £'000
 Allocated EBITDA
 Central Europe                 3,181     4,186
 Southern Europe                1,452     1,187
 Rest of World (including UK)   (36,536)  (13,452)
 Allocated EBITDA               (31,903)  (8,079)
 Depreciation and amortisation  (4,226)   (4,166)
 Operating loss                 (36,129)  (12,245)
 Finance income                 329       257
 Finance expense                (14,029)  (669)
 Loss before tax                (49,829)  (12,657)

Total assets by segment

                                 2023      2022
                                 £'000     £'000
 Central Europe                  26,469    24,526
 Southern Europe                 10,555    11,686
 Rest of World (including UK)    75,725    79,209
                                 112,749   115,421
 Inter-segment assets            (11,558)  (9,278)
 Inter-segment investments       (32,791)  (32,563)
 Total assets per balance sheet  68,400    73,580

 

 

Included within Central Europe are non-current assets to the value of £2.6m
(2022: £2.6m) relating to goodwill and within Southern Europe assets to the
value of £3.7m (2022: £3.5m) relating to freehold land and buildings. There
were no material additions (excluding foreign exchange differences) to
non-current assets in any country except the UK where non-current asset
additions totalled £4.3m and comprised plant and machinery £3.5m, fixtures
and fittings £0.1m, computer equipment £0.2m, computer software £0.2m and
trademarks and registrations £0.3m (2022: £2.6m total).

 

Total liabilities by segment

 

                                      2023      2022
                                      £'000     £'000
 Central Europe                       (18,641)  (16,618)
 Southern Europe                      (6,462)   (10,046)
 Rest of World (including UK)         (59,638)  (17,797)
                                      (84,741)  (44,461)
 Inter-segment liabilities            11,558    9,278
 Total liabilities per balance sheet  (73,183)  (35,183)

5. Other income

 

                                                          2023    2022
                                                          £'000   £'000
 Net monetary value of above-the-line R&D tax credit      856     740

 

 

6. Finance income

 

                                2023                              2022
                                £'000                             £'000
 Bank interest                  82                                55
 Interest on investment assets  247                               199
 Other finance income                           -                 3
                                329                               257

 

Other finance income relates to the unwinding of the discount on accrued
revenue.

 

 

7. Finance expense

                                                             2023    2022
 Exceptional                                                 £'000   £'000
 G306 Contingent payment                                     11,280                  -

                                                             2023    2022
 Other                                                       £'000   £'000
 Interest on borrowing facility                              2,132   168
 Net interest expenses on defined benefit pension liability  283     128
 Interest on lease liabilities                               334     373
                                                             2,749   669

 Total                                                       14,029  669

 

 

8. Loss per share

                                                                             2023                              2022
                                                                             £'000                             £'000
 Loss after tax attributable to equity shareholders                          (51,026)                          (13,776)

                                                                             Shares                            Shares
                                                                             '000                              '000
 Issued Ordinary Shares at start of the year                                 644,105                           641,773
 Ordinary Shares issued in the year                                          35,000                            2,332
 Issued Ordinary Shares at end of the year                                   679,105                           644,105
 Weighted average number of Ordinary Shares for the year                     670,355                           642,990
 Potentially dilutive share options                                                          -                                 -
 Weighted average number of Ordinary Shares for diluted earnings per share   670,355                           642,990
 Basic earnings per Ordinary Share (pence)                                   (7.61)p                           (2.14)p
 Diluted earnings per Ordinary Share (pence)                                 (7.61)p                           (2.14)p

 

The diluted loss per share for 2023 does not differ from the basic loss per
share as the exercise of share options and warrants would have the effect of
reducing the loss per share and is therefore not dilutive under the terms of
IAS 33.

 

9. Inventories

 

                                2023    2022
                                £'000   £'000
 Raw materials and consumables  3,819   3,598
 Work in progress               4,775   3,265
 Finished goods                 2,999   4,547
                                11,593  11,410

The value of inventories measured at fair value less cost to sell was
£303,000 (2022: £719,000).

The movement in the value of inventories measured at fair value less cost to
sell during the year gave rise to a credit of £416,000 which was included
within the costs of goods sold in the consolidated income statement.

 

10. Trade and other receivables

                                  2023    2022
                                  £'000   £'000
 Trade receivables                2,366   2,694
 Other receivables                2,150   1,950
 VAT                              542     1,261
 Prepayments and accrued revenue  2,714   4,563
                                  7,772   10,468

 

All amounts due as shown above are short term. The carrying value of trade
receivables is considered a reasonable approximation of fair value. All trade
and other receivables have been reviewed for indicators of impairment. During
the year, £38,000 of trade receivables were written back and £43,000 of the
provision utilised. The impaired trade receivables are mostly due from private
customers in the Italian market who are experiencing financial difficulties.

The Group applies the IFRS 9 simplified model of recognising lifetime expected
credit losses for all trade receivables as these items do not have a
significant financing component.

All of the Group's trade receivables in the comparative periods have been
reviewed for indicators of impairment. The impaired trade receivables are
mostly due from customers in the private market that are experiencing
financial difficulties.

In measuring the expected credit losses, the trade receivables have been
assessed on a collective basis as they possess shared credit risk
characteristics. They have been grouped based on the days past due and
according to the geographical location of customers.

The expected loss rates are based on the payment profile over the past 24
months to 30 June 2023 and 30 June 2022 respectively as well as the
corresponding historical credit losses during that period.

The historical rates are adjusted to reflect current and forward-looking
macroeconomic factors affecting the customer's ability to settle the amount
outstanding.

Trade receivables are written off (i.e., derecognised) where there is no
reasonable expectation of recovery. An allowance is made for credit losses
when there is an indication that the debt may not be recovered. Failure to
make payments within five months from the invoice due date is considered an
indicator of possible non-recovery.

Expected loss allowance

                                       2023    2022
                                       £'000   £'000
 Balance brought forward               406     432
 Foreign exchange adjustments          42      1
 Write back of previous credit losses  (38)    (27)
 Utilised                              (43)    -
 Balance carried forward               367     406

 

This note includes disclosures relating to the credit risk exposures and
analysis relating to the allowance for expected credit losses. Both the
current and comparative impairment provisions apply the IFRS 9 expected loss
model.

 

On the above basis, the expected credit loss for trade receivables as at 30
June 2023 and 30 June 2022 was determined as follows:

 

 

                                                                 2023                              2022
                                                      Expected   Gross     Lifetime     Expected   Gross     Lifetime
                                                      credit     carrying  expected     credit     carrying  expected
                                                      loss rate  amount    credit loss  loss rate  amount    credit loss
                                                      %          £'000     £'000        %          £'000     £'000
 Trade receivables
 Current                                              -          1,637     -            -          1,980     -
 Not more than three months                           -          371       -            -          532       -
 More than three months but not more than six months  2%         297       6            5%         100       5
 More than six months but not more than one year      25%        59        15           33%        60        20
 More than one year                                   94%        369       346          89%        428       381
                                                                 2,733     367                     3,100     406

 

11. Borrowings

 

                      2023    2022
                      £'000   £'000
 Due within one year
 Bank loans           648     952
                      648     952

 

 

                                                                                                                   2023    2022
                                                                                                                   £'000   £'000
 Due in more than one year
 Shareholder loans                                                                                                 26,000  -
 Bank                                                                                                              848     1,497
 loans
                                                                                                                   26,848  1,497

 

 

In February 2023, the Group issued loan notes to two of its substantial
shareholders, Southern Fox Investments Limited and ZQ Capital Management
Limited, to raise £10.0m.

In April 2023, the Group entered into a senior secured facility agreement
pursuant to which the Group's existing substantial shareholders ZQ Capital
Management Limited (acting through its affiliate SkyGem International Holdings
Limited) and Southern Fox Investments Limited, agreed to make available to the
Group a secured term Loan Facility in an aggregate principal amount of £40.75
million.

The purpose of the facility was to refinance the existing £10.0 million loan
notes issued in February 2023 (which were duly repaid), to facilitate the
continuation of the Group's pivotal Phase III G306 trial for Grass MATA MPL,
to continue other key clinical trial activities including the Phase I study
for Peanut allergy and to finance trading and provide working capital.

At 30 June 2023, £26.0m of the secured facility had been drawn with £10.0m
used to repay the loan notes.

Interest accrues on the secured facility at the rate of 18% per annum and is
payable in full on redemption of the facilities. No interest was paid in the
year ended 30 June 2023.

In addition to the Loan Facility, the loans below were previously taken out by
Allergy Therapeutics Iberica S.L. The Bank Inter Loan is secured by way of a
charge on land and buildings owned by Allergy Therapeutics Iberica S.L.

 

                                            <1 year     1‑5 years
                     Interest rate          £'000       £'000
 BBVA                Fixed rate of 2.5%     129         188
 Bank Inter          1 month Euribor +5.0%  36          115
 CDTI (Loan 1)       Interest free          37          159
 Santander (Loan 1)  Fixed rate of 2.3%     89          53
 CDTI (Loan 2)       Fixed rate of 0.2%     31          -
 Santander (Loan 2)  Fixed rate of 2.3%     326         333
                                            648         848

 

12. Issued share capital

 

 

 

                                     2023                 2022
                                     Shares       £'000   Shares       £'000
 Authorised share capital
 Ordinary Shares of 0.10 pence each
 1 July and 30 June                  790,151,667  790     790,151,667  790
 Deferred shares of 0.10 pence each
 1 July and 30 June                  9,848,333    10      9,848,333    10
 Issued and fully paid
 Ordinary Shares of 0.10 pence
 At 1 July                           644,104,621  644     641,772,718  641
 Issued during the year:
 Issue of shares                     35,000,000   35      -            -
 Share options exercised             -            -       2,331,903    3
 At 30 June                          679,104,621  679     644,104,621  644
 Issued and fully paid
 Deferred shares of 0.10 pence
 At 1 July                           9,848,333    10      9,848,333    10
 Issued during the year              -            -       -            -
 At 30 June                          9,848,333    10      9,848,333    10
 Issued share capital                688,952,954  689     653,952,954  654

The deferred shares have no voting rights, dividend rights or value attached
to them.

No share options issued on vesting of LTIP awards were exercised in the year
(2022: £2,000)

13. Contingent liabilities

As previously reported in the Group's trading update for the year ended 30
June 2023, the Group's German subsidiary has received notification from the
German national health insurance association that manufacturer's rebates are
due on sales of certain products launched on the market from 1 September 2017.

After taking legal advice, the Group had considered the likelihood of any
payment of a rebate or other cash outflow in relation to this matter to be
below 50% and accordingly no provision has been made in the financial
statements for the year ended 30 June 2023. However, there is a risk that up
to £13.6 million cumulative revenue recognised in respect of certain products
in periods up to and including 30 June 2023 may need to be reversed due to the
level of rebate being claimed.

Subsequent to publication of the Group's unaudited preliminary results for the
year ended 30 June 2023 and following further discussions with the German
national health insurance association, it is possible that a provision for
rebates may be required in the results for the year ended 30 June 2023,
however the Group expects that any liability would be very significantly less
than the maximum rebate. The unaudited operating loss above is before any
provision for historic rebates.

 

14. Related party transactions and ultimate control

The Group's related parties include its subsidiary companies and its key
management and its key shareholders'.

There is no overall ultimate controlling party.

 

15. Post balance sheet events

On 26 September 2023, the Group entered into an amendment to the Loan Facility
with Southern Fox and ZQ Capital (acting through an affiliate) pursuant to
which, subject to completion of the Equity Financing, the repayment of all
amounts due under the Loan Facility in full and the grant of the Additional
Security, the Lenders have agreed, on an uncommitted basis, to make available
to the Group an additional total principal sum of up to £15.0m. Under the
Extension Facility, the Additional Facility Amount may be drawn by the Group
during the period to 31 January 2024 with a minimum drawdown amount of £3
million per utilisation, and interest of 18 per cent. per annum shall be
payable on any such amounts drawn. A drawdown under the Extension Facility
shall require the consent of the Lenders and as such the Additional Facility
Amount does not represent committed funding. The Extension Facility must be
repaid in full by 31 December 2025. To provide security for any amounts drawn
under the Extension Facility, the existing security package under the Loan
Facility will remain in place following repayment of the Loan Facility on or
around completion of the Equity Financing and the Additional Security will be
granted.

 

 1  (#_ftnref1) Operating loss / profit (pre-R&D) and exceptionals is
calculated by adding back total R&D expenditure and exceptional
fundraising costs for the year to the operating loss of the year to arrive at
an operating loss (pre-R&D) and exceptionals of £13.3m (2022: profit of
£3.4m)

 2  (#_ftnref2) "Additional Security" means a supplemental English law
security over substantially all of the assets of the Company and its
subsidiaries incorporated in England and Wales securing the Additional
Facility Amount

 3  (#_ftnref3) Operating loss / profit (pre-R&D) and exceptionals is
calculated by adding back total R&D expenditure and exceptional
fundraising costs for the year to the operating loss of the year to arrive at
an operating loss (pre-R&D) and exceptionals of £13.3m (2022: profit of
£3.4m)

 4  (#_ftnref4) Operating loss / profit (pre-R&D) and exceptionals is
calculated by adding back total R&D expenditure and exceptional
fundraising costs for the year to the operating loss of the year to arrive at
an operating loss (pre-R&D) and exceptionals of £13.3m (2022: profit of
£3.4m)

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
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