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REG - Shield Therapeutics - Audited results for the year ended 31 Dec 2023

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RNS Number : 0413O  Shield Therapeutics PLC  10 May 2024

Shield Therapeutics plc

 
("Shield" or the "Company" or the "Group")

 

Audited results for the year ended 31 December 2023

Posting of Annual Report & Accounts

Notice of AGM

 

London, UK, 10 May 2024:  Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company that delivers Accrufer®/Feraccru®
(ferric maltol), an innovative and differentiated specialty pharmaceutical
product, to address a significant unmet need for patients suffering from iron
deficiency (with or without anaemia) confirms its audited final results for
the year ended 31 December 2023.

 

Financial Highlights

·    Total 2023 revenue and other income: $17.5m, a 2.8x increase over
FY22

o  Accrufer® revenue: $11.6m, a 3.1x increase over FY22

o  Ex-U.S. revenue: $1.5m of royalty revenue from product sales in Europe

o  Other income revenue including Viatris milestone payments: $4.4m

·    Total 2023 Prescriptions: c.77,000, a 3.1x increase over FY22

·    Operating Loss: $31.3m compared to $49.8m in FY22

·    Cash and cash equivalents: $13.9m as of 31 December 2023

 

Operational Highlights

·    Launch of Accrufer® in the US with Shield's partner Viatris Inc.
with a 100-person dedicated sales team promoting Accrufer® to over 12,000
Health Care Professionals (HCPs)

·    Hiring and implementation of the Company's first direct sales team of
50 sales professionals along with six regional sales managers, all of whom are
promoting Accrufer® to HCPs

·    Increased net revenue per prescription (Rx) to $145/Rx in the second
half of the year vs $119/Rx in the first half

·    The Company's Canadian partner, KYE Pharmaceuticals, filed for
regulatory approval with Health Canada - decision expected in 2024

·    Shield's Chinese partner, ASK Pharma, continued to enroll patients
into a Phase 3 study

·    Strengthening of the senior management team with the appointment of
Santosh Shanbhag as Chief Financial Officer and Andy Hurley as Chief
Commercial Officer, to lead Shield's commercial team and our partnership with
Viatris Inc.

 

2023 Annual Report and Notice of Annual General Meeting

The Annual Report and Accounts and Notice of AGM will be sent to shareholders
today and in accordance with AIM Rule 26, these documents are also available
to view on the Company's website: Results, Reports & Presentations |
Shield Therapeutics plc
(https://www.shieldtherapeutics.com/investors-and-media/results-reports-and-presentations/)
.

 

This year the Company's AGM will be held at 2.00 pm (BST) on 20 June 2024 at
the offices of Shield Therapeutics plc, Northern Design Centre, Baltic
Business Quarter, Gateshead Quays, NE8 3DF.

 

If you wish to attend the AGM in your capacity as a shareholder, please bring
proof of shareholding or if shares are held through a nominee account, a
letter of representation, to facilitate your entry to the Meeting.

 

The Company will provide a facility for shareholders to join the AGM online
and telephonically and there will be an opportunity for shareholders to ask
questions. In order to facilitate the process, the Board would request that
shareholders register for the meeting and submit questions in advance, before
2.00pm (BST) on 18 June 2024.

To register for dial-in details and to submit any questions please contact
Walbrook PR via email at shield@walbrookpr.com or call +44 (0)20 7933 8780.

 

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Greg Madison, CEO                                                                              +44 (0) 191 511 8500

 Santosh Shanbhag, CFO

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel/Patrick Birkholm                                                                   +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ George Dollemore/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 Financial PR & IR Advisor
 Walbrook PR
 Charlotte Edgar / Alice Woodings                                                               +44 (0)20 7933 8780 or shield@walbrookpr.com (mailto:shield@walbrookpr.com)

 Investor Contact (US Advisor)

 LifeSci Advisors, LLC

 Joyce Allaire                                                                                  jallaire@lifesciadvisors.com (mailto:jallaire@lifesciadvisors.com)

 

About Iron Deficiency and Accrufer®/Feraccru®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anaemia (IDA) affect about 20 million people in the U.S. and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, Accrufer® has the potential to meet an important unmet
medical need for both physicians and patients.

 

Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. Accrufer®/Feraccru® has a novel mechanism of
absorption compared to other oral iron therapies and has been shown to be an
efficacious and well-tolerated therapy in a range of clinical trials. More
information about Accrufer®/Feraccru®, including the product label, can be
found at: www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

About Shield Therapeutics plc

Shield is a commercial-stage specialty pharmaceutical company that delivers
Accrufer®/Feraccru® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anaemia. The Company has
launched Accrufer® in the U.S. with an exclusive, multi-year commercial
agreement with Viatris Inc. (Viatris). Outside of the U.S., the Company has
licensed the rights to four specialty pharmaceutical companies. Feraccru® is
commercialised in the UK and European Union by Norgine B.V. (Norgine), which
also has marketing rights in Australia and New Zealand. Shield also has an
exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialisation of Accrufer®/ Feraccru® in China,
Hong Kong, Macau and Taiwan; with Korea Pharma Co., Ltd. for the Republic of
Korea (Korea Pharma); and with KYE Pharmaceuticals Inc. for Canada.

 

Accrufer®/Feraccru® has patent coverage until the mid-2030s.

Accrufer®/Feraccru® are registered trademarks of Shield Therapeutics.

 

Forward-Looking Statements:

This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of historical
fact should be considered forward-looking statements.  These forward-looking
statements are based on management's current expectations and include
statements related to the commercial strategy for Accrufer®/Feraccru®. These
statements are neither promises nor guarantees, but involve known and unknown
risks and uncertainties, many of which are beyond our control, that may cause
actual results and performance or achievements to be materially different from
management's expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with the Company's
business and results of operations, competition, and other market factors.
The forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and except as
required by law, the Company disclaims any obligation to update any
forward-looking statements contained in this release, even if subsequent
events cause its views to change.

 

Chairman and Chief Executive Officer's joint statement

 

Our growth journey for Shield Therapeutics took a major step forward in 2023
following a successful organisational expansion and new launch of Accrufer®
in the US with our partner Viatris Inc. This expanded reach and access to
additional resources provides a strong opportunity to continue our mission for
making Accrufer® the oral iron of choice for patients with iron deficiency,
with or without anaemia (ID/IDA). On the clinical side, we expect to complete
enrolment of our paediatric study in 2024, and subject to regulatory approval
this would open up additional opportunities in patients under 18 years of age.
On the ex-US partnering front, we expect to achieve key milestones in the
coming year in Canada, Korea and China as we seek to make ferric maltol
available across the globe.

 

Like a lot of growing businesses, we have encountered a number of challenges
through the year including a tighter financing environment, a volatile stock
price and some variability in the speed of growth of our US business following
the full sales force launch in May 2023.  One of the things I am proud of is
the Shield team's resilience and our focus on what it takes to achieve our
mission to make Accrufer® the oral iron of choice for patients with ID/IDA.

 

In the US, the Company went through a significant commercial expansion in the
first half of 2023, hiring our first direct sales team of 50 sales
professionals along with six regional sales managers, all of whom are
promoting Accrufer® to healthcare professionals. Our partner Viatris did the
same, and by May we had the full team of 100 sales professionals promoting
Accrufer® to approximately 12,000-13,000 HCPs. Awareness about Accrufer® as
an option to treat ID/IDA among the vast majority of these HCPs remains quite
low, and the objective of this expanded team is simple: increase awareness of
Accrufer®, generate prescriptions from these HCPs, and allow patients to
experience the benefits we believe Accrufer® can provide.

 

Over the course of the year, we tripled total prescriptions to over 77,000, an
increase of 3.1x as compared to all of 2022.  Shield announced a prescription
reporting issue from our 3(rd) party data provider earlier in the year, but we
have worked closely with our third-party data provider to rectify this and
also implemented an enhanced multi-source system.   First time writers of
Accrufer® saw a dramatic increase with 167% writing for the product for the
first time in 2023. The feedback on the product we hear from physicians
through our sales team continues to be very positive. All of these metrics
provide us additional confirmation in two key areas. First, that there is a
need from HCPs and patients for an effective and well tolerated oral iron.
Second, Accrufer® is highly promotionally sensitive, so the more HCPs we can
reach with sales and marketing efforts, the faster awareness can increase and
the opportunity increases to grow our prescriber base. While we have made
progress over the first 6+ months of this new commercial launch, there is much
opportunity still ahead of us.

 

On the financial side, we generated a total of $11.6 million in US net
revenues for Accrufer® with the bulk of those net sales coming in the second
half of the year following the commercial expansion. We also set out to
increase our net revenue per prescription, and saw that increase to $145/Rx in
the second half of the year vs $119/Rx in the first half of the year. We have
a number of initiatives directed to this goal coming in 2024, and expect this
to continue to increase while we grow our total prescriptions.

 

Our partnership with Viatris in the US was initiated in 2023 and has
progressed positively throughout the course of 2023. Both organisations are
focused on strategic alignment, excellent communication, strong collaboration
and focused execution. Together, we remain steadfast in our commitment to
making Accrufer® the oral iron of choice in the US.

 

All of the accomplishments and growth we experienced during 2023 would not be
possible without a strong team here at Shield. As we scaled up our sales
organisation significantly in the first half of 2023, we added additional
talent across human resources, information technology and sales operations to
help support our expanded team. Andy Hurley joined us as our Chief Commercial
Officer in April of last year to lead both Shield's commercial team and the
partnership with Viatris. We have a team of dedicated, smart and passionate
individuals who not only share in our Company vision for Accrufer®, but also
consistently display our values of agility, empowerment, collaboration and the
will to succeed.

 

 

Global partnerships and development

We have a number of partnerships across the globe and our objective is to
identify opportunities to bring Accrufer®/Feraccru® to patients with iron
deficiency in as many markets as possible.

 

In Europe, where Feraccru® is commercially available to patients through our
partnership with Norgine. We have a long standing relationship with Norgine,
and their efforts are primarily concentrated in those countries where we have
positive reimbursement, specifically Germany, UK and the Nordics. During 2023,
we saw 10% growth in packs sold, and a corresponding increase of 33% in our
royalty revenue.  For several years, the focus of the marketing and sales
efforts for Feraccru® has been toward the gastrointestinal specialty. More
recently, it has become clear that the oral iron market in many countries is
similar to that of the US, with women' health "OB/GYN" and General
Practitioner representing the bulk of oral iron prescriptions written. The
Norgine team in Germany has already begun their pivot towards a more focused
selling and marketing approach to OB/GYNs with some success. We continue to
work with our partner to drive further depth into these specialties not only
in Germany but in other markets as well.

 

Excellent progress continues to be made in our development stage partnerships
in Canada, Republic of Korea and China. In Canada, our partner KYE
Pharmaceuticals filed for regulatory approval with Health Canada, and we
expect a decision in 2024. The team at KYE has been preparing for launch
pending approval and will be ready to go in 2024. Korea Pharma, our partner in
South Korea, completed the pharmacokinetic (PK) study last year, and we are
awaiting results of that study in 1H 2024. This is the only study that is
required for a regulatory filing, and if successful, would lead to a filing
for approval in the second half of 2024. Lastly, our partner in China, ASK
Pharma, is enrolling patients into a Phase 3 study that is similar in design
to the studies conducted by Shield leading to EMA and FDA approval. The study
picked up momentum in the second half of 2023 and is targeted to complete
enrolment in late 2024. Each of these markets represent a growth opportunity
with many patients challenged in treating their iron deficiency. Shield
receives various milestones and royalties on net sales across each of these
geographies.

 

Paediatric study

Shield is enrolling patients in a paediatric study, which if successful, could
lead to an expansion of the indication and uses for Accrufer®/Feraccru® in
both US and EU markets. The study, a requirement of both FDA and EMA, is
enrolling patients with iron deficiency ranging from 12 months to 17 years of
age. This is another population where iron deficiency is prevalent and similar
challenges to OTC irons exist. As part of this study, Shield is using a new
liquid formulation, which, if approved may offer an alternative approach for
those who can't swallow our current capsule formulation.

 

Outlook

 

Our Company went through a period of significant expansion and growth over
the past twelve months, and we have dramatically increased the number of
prescriptions for Accrufer® in the US as we continue to build out awareness
of the product and fine-tune our commercial efforts. We see an oral iron
market which has clear needs based on physician and patient feedback for a
product that delivers both effectiveness and tolerability. As we move into
2024, we will come upon the one-year anniversary of our full commercial launch
alongside Viatris, and expect our commercial execution to continue to improve.
We have exciting plans to add additional resources in the areas of marketing
and patient access programmes, which we believe will help achieve continued
growth in prescriptions along with our continued improvement in financial
metrics. We should complete our paediatric study during 2024, opening up
expansion opportunities in both the US and EU in future years. Lastly, our
ex-US partnerships continue to progress not only making Accrufer®/Feraccru®
available around the globe, but also adding to our revenues through both
milestones and royalties.

 

Hans Peter Hasler, Chairman

Greg Madison, Chief Executive Officer

 

 

Financial Review

 

Change in Presentation Currency

On 1 January 2023, the Group changed its reporting currency from sterling to
US dollars to provide greater transparency in the Group's performance for
investors and other stakeholders and to reduce exchange rate volatility in
reported figures, given that c. 90% of the Group's revenue and c. 90% of the
Group's operating expenditure originate in US dollars. In accordance with IAS
8, Accounting Policies, Changes in Accounting Estimates and Errors, this
change in presentational currency was applied retrospectively and accordingly,
prior year comparatives have been restated. Financial information included in
the consolidated financial statements for years ended 31 December 2022 and
2021 has been restated in US dollars.

 

Revenue

Revenue in 2023 was $13.1 million (2022: $5.5 million), comprising $11.6
million (2022: $3.6 million) net product revenues from Accrufer® sales in the
US, $1.5 million income from Feraccru® sales in Europe by Norgine (2022: $1.5
million).

 

The 77,012 prescriptions of Accrufer® sold in the US yielded net revenue of
$11.6 million (2022: $3.8 million from 25,200 prescriptions). A significant
number of the 2022 and 2023 prescription sales are still subsidised through
patient assistant programmes, resulting in a net average sales price of $137
(2022: $133) per prescription in 2023.

 

In December 2022, the Group signed an exclusive, multi-year collaborative
sales agreement for Accrufer® in the US with Viatris. This collaboration
resulted in a 100-person dedicated sales team promoting Accrufer® to over
12,000 Health Care Professionals (HCPs) who write the majority of oral iron
prescriptions. The Company received a $5.0 million upfront payment upon
execution of the agreement. An amount of $4.3 million of that upfront payment
was recorded in other operating income during 2023.

 

Royalty revenue from Norgine, Shield's licence partner in Europe, increased
year on year at $0.6 million in 2022 to $0.8 million in 2023 driven by 10%
increase in total packs sold. Germany now accounts for c.62% of the total net
sales of Feraccru® in Europe, followed by the United Kingdom with c.22%.

 

Cost of sales

Cost of sales of $9.0 million (2022: $3.0 million) includes the manufacturing
and shipping cost of the prescriptions sold in the US, the finished packs
supplied to Norgine for sale in Europe and the 5% royalty payable to Vitra
Pharmaceuticals Limited ("Vitra") on net sales.

 

Vitra was the original owner of the intellectual property underpinning
Accrufer®/Feraccru® and, under the terms of the 2010 Asset Purchase
Agreement, is entitled to receive either a 5% royalty on net sales or 10% of
any licence upfront and sales milestones. For the Norgine licence covering
European commercialisation, Vitra chose in 2018 to receive 5% on net sales
whereas for the ASK Pharm agreement covering China, the Korea Pharma agreement
covering the Republic of Korea and the KYE Pharmaceuticals agreement covering
Canada, Vitra elected to receive 10% of the upfront and sales milestones
instead of future sales royalties.

 

Selling, general and administrative expenses

Selling, general and administrative expenses were $38.0 million in 2023 (2022:
$33.6 million). The increase is due to the expansion within the US as the
development of the relationship with Viatris continued. The average number of
persons employed by the Group increased from 28 in 2022 to 73 in 2023, with an
increase from 12 to 61 staff directly related to the US commercial function.

 

The share based payment charge to the income statement was $0.9 million in
2022 and 2023.

 

Impairment of intangible assets

Following the completion of the collaborative sales agreement for Accrufer®
in the United States with Viatris, the Group carried out a review of the
recoverable amount of its intangible assets. As a result of this review, the
Directors concluded that the Group should concentrate the use of its resources
on the commercial development of Accrufer®/ Feraccru® and the ongoing
paediatric study. During 2022, based on that conclusion, along with the
limited remaining patent life of PT20, the Directors decided to write off the
assets related to the Phosphate Therapeutics Limited business, resulting in an
impairment loss of $18.1 million in the Group's statement of profit and loss
for the year ended 31 December 2022. There was no impact in 2023.

 

Research and development

The Group spent $4.5 million (2022: $3.5 million) on research and development.
Of that total spend, $2.7 million (2022: $2.2 million) have been capitalised
as additions to intangible assets, as management deemed that it is probable
that these costs will generate future economic benefits. The balance of $1.8
million (2022: $1.3 million) was expensed in the current year. Research and
development expenditure is predominantly related to the ongoing paediatric
study.

 

Financial income

Financial income of $0.5 million was reported in 2023 (2022: $0.9 million).
This income was generated primarily through currency gains on the cash held in
US Dollars.

 

Financial expense

Financial expense of $1.6 million was reported in 2023 (2022: $0.5 million).
The expense was primarily related to interest charged on the shareholder loan
and later the long-term loan with SWK Holdings.

 

Balance sheet

Cash at 31 December 2023 was $13.9 million (31 December 2022: $3.4 million).

 

Intangible assets at 31 December 2023 were $16.9 million (31 December 2022:
$14.2 million), comprised of capitalised Feraccru® development costs
including the ongoing paediatric pharmacokinetic study and capitalised
Feraccru® patent and trademark cost, incurred to strengthen the Group's
intellectual property.

 

Inventories are $3.2 million (31 December 2022: $1.8 million). The increase in
inventories is due to the Group adding inventory to keep up with the
increasing demand within the US market.

 

Trade and other receivables increased from $6.5 million at 31 December 2022 to
$13.5 million at 31 December 2023, reflecting the increase in trading volume
in the US.

 

The current tax asset of $0.6 million at 31 December 2023 (31 December 2022:
$0.5 million) relates to the anticipated R&D tax credit claim in respect
of the 2023 and 2022 financials years.

 

Non-current liabilities are comprised of a long-term loan from SWK Holdings
which was fully drawn down in October 2023. During 2023 there was a
convertible shareholder loan from AOP Health, which was fully repaid in
October 2023. The fair value of the conversion feature of this loan, which
will be revalued at each balance sheet date, was separated from the value of
the loan principal amount in accordance with IFRS 9. At 31 December 2022, the
fair value of the conversion feature was $0.6 million and the remaining loan
balance was $6.7 million.

 

Trade and other payables increased from $11.4 million at 31 December 2022 to
$12.7 million at 31 December 2023 as a result of the larger trading volume in
the US. Additionally, the balance at 31 December 2022 of $4.3 million
represents Viatris upfront payment, received in 2022, which has been
recognised as other income in 2023.

 

Lease liabilities have increased from $0.1 million in 2022 to $0.4 million in
2023. The increase is as a result of moving into a new office in the US.

 

Cash flow

Net cash inflow in 2023 was $10.1 million, increasing the cash on hand from
$3.4 million at 31 December 2022 to $13.9 million at 31 December 2023. Net
cash outflows from operating activities was $37.1 million, comprised of $33.3
million loss for the year, adjusted for non-cash items of $3.9 million
(including depreciation and amortisation of $1.1 million, share-based payments
of $0.9 million, net financial expense of $1.0 million, and income tax of $0.9
million) and net investments in increasing the Group's working capital of $7.7
million.

 

Net cash outflows from investing activities of $2.4 million are the result of
capitalised development expenditure of $2.7 million, the acquisition of
tangible assets of $0.2 million and financial income of $0.5 million.

 

Net cash inflows from financing activities of $49.7 million are attributable
to the net proceeds from the convertible shareholder loan of $10.0 million,
the net proceeds from the SWK Holdings loan of $19.4 million and net proceeds
from an equity raise of $26.4 million.

 

Going concern

At 31 December 2023, the Group held $13.9 million in cash. The Group's
unaudited cash balance at 31 March 2024 was $10.4 million.

 

Since then, the Group has implemented a $10.0m accounts receivable facility
with Sallyport Commercial Finance LLC, and also amended its current $20.0m
Credit Agreement with SWK to lower the revenue covenant associated with debt.
The Group is planning to use these funds to drive continuing growth in sales
volumes of Accrufer® in the US. Management have considered the funding
requirements of the Group through the preparation of detailed cash flow
forecasts for the period to December 2025, including the prospective
Accrufer® sales revenues and the related commercial operating costs.

 

These forecasts show that the Group's monthly cash flows start to turn
positive by H2'25 and that the recent accounts receivable facility should
provide sufficient cash to allow the business to continue in operations for at
least 12 months from the balance sheet date. The Directors have considered
scenarios in which sales revenues fall below base case forecasts. In these
circumstances mitigating actions such as reduction of discretionary marketing,
general and administrative, and production related expenditure combined with
the reliance on the full $10.0m accounts receivable facility could be taken to
preserve cash. The Directors also believe that other forms of finance, such as
royalty finance are likely to be available to the Group.

 

Based on the above factors, the Directors believe that it remains appropriate
to prepare the financial statements on a going concern basis.

 

Financial outlook

The exclusive, multi-year collaborative sales agreement signed with Viatris in
December 2022 to co-commercialise Accrufer® in the US has already enabled
Accrufer® to be on path to be the oral iron of choice in the US Market.
Management expects continued growth in Accrufer® prescriptions in 2024 and
2025 driven by the 100-person sales team that is promoting Accrufer® to over
12,000 HCPs.

 

The Company is focused on maximising revenues, continuing to grow Accrufer®
prescriptions in the US, and to continue to improve net prices per Accrufer®
script in 2024 and 2025.

 

With the support of the Viatris partnership, management estimates that
Accrufer® has the potential to use its existing resources to support growth
and scale of Accrufer® in the US and expects the Group to turn cash flow
positive by H2 2025.

 

Santosh Shanbhag

Chief Financial Officer

 

 

Consolidated statement of profit and loss and other comprehensive income

for the year ended 31 December 2023

 

                                                                                2023      2022
                                                                                $000      $000
 Revenue                                                                        13,085    5,499
 Cost of sales                                                                  (9,058)   (3,041)

 Gross profit                                                                   4,027     2,458

 Other operating income                                                         4,412     862
 Operating costs - selling, general and administrative expenses                 (37,960)  (33,646)

 Operating loss before impairment and research and development expenditure      (29,521)  (30,326)
 Impairment of intangible assets                                                -         (18,106)
 Research and development expenditure                                           (1,810)   (1,320)

 Operating loss                                                                 (31,331)  (49,752)

 Financial income                                                               518       888
 Financial expense                                                              (1,562)   (479)

 Loss before tax                                                                (32,375)  (49,343)
 Taxation                                                                       (918)     (446)

 Loss for the year                                                              (33,293)  (49,789)

 Other comprehensive income
 Items that are or may be reclassified subsequently to profit or loss:
 Foreign currency translation differences - foreign operations                  (1,890)   2,686

 Total comprehensive expenditure for the year                                   (35,182)  (47,103)
 Loss per share
 Basic and diluted loss per share in cents                                      (5)       (21)

 

 

Group Balance Sheet

for the year ended 31 December 2023

                                            2023       Restated   Restated

                                                       2022       2021
                                            $000       $000       $000
 Non-current assets
 Intangible assets                          16,863     14,208     36,220
 Property, plant and equipment              673        238        410
                                            17,536     14,446     36,630

 Current assets
 Inventories                                3,203      1,757      2,206
 Trade and other receivables                13,498     6,487      3,952
 Current tax asset                          614        526        777
 Cash and cash equivalents                  13,948     3,402      16,345
                                            31,263     12,172     23,280

 Total assets                               48,799     26,618     59,910

 Non-current liabilities
 Long-term loan                             (19,836)   -          -
 Convertible shareholder loan               -          (6,683)    -
 Fair value of loan conversion feature      -          (562)      -
 Lease liabilities                          (195)      -          -
                                            (20,031)   (7,245)    -

 Current liabilities
 Trade and other payables                   (12,721)   (11,444)   (4,200)
 Other liabilities                          (800)      (1,278)    (148)
 Lease liabilities                          (214)      (107)      (210)
                                            (13,735)   (12,829)   (4,558)

 Total liabilities                          (33,766)   (20,074)   (4,558)

 Net assets                                 15,033     6,544      55,352

 Equity
 Share capital                              (15,011)   (5,371)    (4,574)
 Share premium                              (198,759)  (169,482)  (167,424)
 Merger reserve                             (43,240)   (43,240)   (43,240)
 Currency translation reserve               8,452      10,342     7,656
 Deposit for shares                         -          100        -
 Retained earnings                          233,525    201,107    152,230

 Total equity                               (15,033)   (6,544)    (55,352)

 Group statement of changes in equity

 for the year ended 31 December 2023
                                                            Issued capital  Deposit for shares  Share premium  Merger reserve  Currency translation reserve  Accumulated deficit  Total

                                                            $000            $000                $000           $000            $000                          $000                 $000
 Balance at 1 January 2022 (restated)                       4,574                               167,424        43,240          (7,656)                       (152,230)            55,352
 Loss for the year                                          -               -                   -              -               -                             (49,789)             (49,789)
 Other comprehensive income:
 Foreign currency translation differences                   -               -                   -              -               (2,686)                       -                    (2,686)
 Total comprehensive expense for the year                   -               -                   -              -               (2,686)                       (49,789)             (52,475)
 Transactions with owners, recorded directly in equity
 Share options exercised                                    42              -                   68             -               -                             -                    110
 Loan conversion                                            755             -                   1,990          -               -                             -                    2,745
 Deposit for shares                                         -               (100)               -              -               -                             -                    (100)
 Equity-settled share-based payment transactions            -               -                   -              -               -                             912                  912
 Balance at 31 December 2022                                5,371           (100)               169,482        43,240          (10,342)                      (201,107)            6,544
 Loss for the year                                          -               -                   -              -               -                             (33,293)             (33,293)
 Other comprehensive income:
 Foreign currency translation differences                   -               -                   -              -               1,890                         -                    1,890
 Total comprehensive expense for the year                   -               -                   -              -               1,890                         (33,293)             (31,403)
 Transactions with owners, recorded directly in equity
 Equity placing                                             6,556           100                 19,819         -               -                             -                    26,475
 Warrants exercised                                         98              -                   345            -               -                             -                    443
 Loan conversion                                            2,986           -                   9,113          -               -                             -                    12,099
 Equity-settled share-based payment transactions            -               -                   -              -               -                             875                  875
 Balance at 31 December 2023                                15,011          -                   198,759        43,240          (8,452)                       (233,524)            15,033

Group statement of cash flows

for the year ended 31 December 2023

                                                                   2023      2022
                                                                   $'000     $'000
 Cash flows from operating activities
 Loss for the year                                                 (33,293)  (49,789)
 Adjustments for:
 Depreciation and amortisation                                     1,071     2,662
 Equity-settled share-based payment expenses                       875       912
 Financial income                                                  (518)     (888)
 Financial expense                                                 1,562     479
 Impairment of intangible assets                                   -         18,106
 Movement in fair value of loan conversion option                  -         843
 Income tax                                                        918       446
                                                                   (29,385)  (27,229)
 (Increase)/decrease in inventories                                (1,446)   215
 Increase in trade and other receivables                           (7,007)   (2,787)
 Increase in trade and other payables                              1,907     7,272
 (Decrease)/increase in other liabilities                          (478)     (775)
 Income tax (paid)/received                                        (717)     714
 Net cash flows from operating activities                          (37,126)  (22,591)
 Cash flows from investing activities
 Financial income                                                  518       36
 Additions to intangible assets                                    -         -
 Additions to tangible assets                                      (239)     (64)
 Capitalised development expenditure                               (2,709)   (2,221)
 Net cash flows from investing activities                          (2,430)   (2,249)
 Cash flows from financing activities
 Interest paid                                                     (613)     (403)
 Proceeds from equity raise                                        26,375    -
 Warrants exercised                                                442       -
 Repayment of convertible shareholder loan                         (5,448)   -
 Proceeds from convertible shareholder loan                        10,000    9,080
 Proceeds from long-term loan                                      19,446    -
 Deposit for shares                                                -         (100)
 Proceeds of share options exercised                               -         105
 Total cash outflow for leases                                     (546)     (152)
 Net cash flows from financing activities                          49,656    8,530
 Net increase/(decrease) in cash                                   10,100    (11,812)
 Effects of currency translation on cash and cash equivalents      446       (1,131)
 Cash and cash equivalents at 1 January                            3,402     16,345
 Cash and cash equivalents at 31 December                          13,948    3,402

 

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