REG - Shield Therapeutics - Interim results for the six months ended 30 Jun 25
21/08/2025 12:15
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RNS Number : 2993W Shield Therapeutics PLC 21 August 2025
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Interim results for the six months ended 30 June 2025
Total Revenues grew 1.8x compared to H1 2024 to $21.4 million
c.84,000 ACCRUFeR® prescriptions sold, with c.1.4x increase in average net
selling price from H1 2024 to $214
Significant progress in global partnerships in Canada, Republic of Korea,
China, and Japan
Guidance remains on track to turn cash flow positive by the end of 2025
London, UK, August 21, 2025: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces its unaudited interim results for the six months ended 30 June 2025,
reporting a substantial increase in Group revenues, ACCRUFeR® prescription
sales and average net selling price. The Company remains on track to achieve
its prior guidance of turning cash flow positive by the end of 2025.
Financial Highlights H1 2025
· Group revenues: $21.4 million, increasing 1.8x over H1 2024 ($12.1
million)
o ACCRUFeR® revenue: $19.2 million, increasing 1.8x over H1 2024 ($11.0
million)
o Ex-US revenue: $2.2 million in milestones and royalties from global
partners in Europe, Canada and Japan (H1 2024: $1.1 million)
· Group Loss significantly narrowed: $9.5 million loss compared to
$15.5 million loss in H1 2024 driven primarily by higher ACCRUFeR® revenues
alongside streamlining business expenditures within the Group.
· Cash and cash equivalents: $10.8 million (31 December 2024: $6.5
million). The increase in cash balance was primarily driven by the addition of
$10.0 million of gross proceeds from the equity funding received post year
end, the continued growth in ACCRUFeR® revenues in the US, the milestone
payments received from VITAL-NET, Inc. of c.$335,000 supporting the exclusive
licensing agreement in Japan for ACCRUFeR®, and from Norgine BV in Europe of
c.$552,000 supporting the pediatric filing process with the EMA.
Operational Highlights H1 2024
· Commercialisation of ACCRUFeR® in the US: Continued growth and
strong market results with our partner, Viatris Inc.
o ACCRUFeR® total prescriptions grew to c.84,000, increasing 1.3x over H1
2024 (c.65,200). The growth was primarily driven within the six large states
of Texas, New York, Florida, Georgia, California, and North Carolina and by
expanding the efforts in digital marketing initiatives to increase HCP and
patient awareness. Consignment-based prescriptions which are dispensed at a
significantly subsidised price to patients represented c.25% of the total
prescriptions in H1 2025 compared to c.44% in H1 2024.
o ACCRUFeR® average net selling price steadily increased to $231 in Q2 2025
driven by successful execution of our market access strategies and reducing
the impact of consignment-based prescriptions. Average net selling price in H1
2025 was $214, increasing c.1.4x from $158 in H1 2024.
· Global ACCRUFeR®/FeRACCRU® development programs: Continued progress
in commercial and development stage partnerships in Canada, Japan, China, and
the pediatric study:
o Kye Pharmaceuticals ("Kye") in Canada: Kye launched ACCRUFeR® in Canada
in March 2025, following the approval from Health Canada for ACCRUFeR®
(ferric maltol) as a prescription drug for the treatment of adults with iron
deficiency anemia (IDA). ACCRUFeR® is currently the sole prescription-only
oral treatment option indicated for IDA in Canada and is available by
prescription through pharmacies across Canada. In accordance with the
collaborative agreement, Shield is eligible to receive further milestone
payments upon the achievement of specified calendar net sales targets and will
also receive double-digit royalties on net sales of ACCRUFeR® for the term of
the agreement.
o VITAL-NET in Japan: The Company entered into an exclusive licence
agreement in April 2025 with VITAL-NET, Inc. for the development and
commercialisation of ACCRUFeR®/FeRACCRU® (ferric maltol) in iron deficiency
(ID) patients in pulmonary hypertension (PH) and inflammatory bowel disease
(IBD). Shield received an initial payment of c. $665,000, c.$335,000 of which
was received in Q2 2025, and expects regulatory and sales milestones, along
with double-digit royalties on net sales. VITAL-NET will undertake and be
responsible for all costs, including clinical and regulatory, related to
activities required to achieve marketing authorisation and commercialisation
of ACCRUFeR® in Japan.
o ASK Pharma ("ASK") in China: ASK has successfully completed the Phase 3
confirmatory study in adult patients with IBD and IDA, which is the final
study required to support the filing of a new drug application (NDA) in China
for the commercialisation of ACCRUFeR®/ FeRACCRU®. The Company expects the
NDA to be filed with the Chinese National Medical Products Administration
(NMPA) later in 2025, and pending successful review, approval in China is
anticipated by the end of 2026.
o Pediatric study: Regulatory submissions to the EMA and FDA were made in Q2
2025 for the approval of ACCRUFeR® in the pediatric population. This followed
the positive results from the Phase 3 pediatric clinical trial
(FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of
the new oral liquid suspension in children with iron deficiency anemia (IDA).
The Company received c. $552,000 in H1 2025 from Norgine BV in Europe when the
file was accepted for review by EMA. Pending successful reviews, approval in
Europe and US is anticipated in 2026.
Anders Lundstrom, CEO of Shield Therapeutics, commented: "We are encouraged by
ACCRUFeR®'s strong performance in H1 2025, following the increasing market
adoption of ACCRUFeR®, which further validates its substantial potential.
Operationally, we made significant progress globally, including the launch of
ACCRUFeR® in Canada, a new licensing agreement in Japan, and the successful
completion of a key Phase 3 study in China. We also submitted regulatory
filings for pediatric use in both Europe and the U.S. following positive trial
results. We remain committed to driving sustained growth and establishing
ACCRUFeR® as the preferred oral iron therapy for patients with iron
deficiency, with or without anemia. Our cash position strengthened to $10.8
million, and we remain on track to turn cash flow positive by year-end. These
results reflect the growing demand for ACCRUFeR® and the successful execution
of our strategy to expand access to patients worldwide."
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
Anders Lundstrom, CEO +44 (0) 191 511 8500
Santosh Shanbhag, CFO investorrelations@shieldtx.com
Stephanie Hicks, Investor Relations
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel +44 (0)20 7418 8900
Joint Broker +44 (0)20 7220 0500
Cavendish Ltd
Geoff Nash / Isaac Hooper / Nigel Birks / Harriet
Ward
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 anemia (IDA) affect about 20 million people in the US 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. The drug 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 anemia. The Company launched
ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration agreement
with Viatris Inc. Outside of the U.S., the Company licensed the rights to five
specialty pharmaceutical companies. FeRACCRU® is commercialised in the UK and
European Union by Norgine B.V., 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, KYE Pharmaceuticals Inc. for
Canada and with VITAL-NET, Inc. For Japan.
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.
Operational Review
Commercialisation of ACCRUFeR® in the US
Shield continues to make excellent progress into the vast ID/IDA market with
significant revenue potential for ACCRUFeR®. We are seeing the positive
impact of key strategic initiatives undertaken such as the rebalancing of the
consignment business and restructuring of the sales force in Q4 2024, as well
as implementation of digital marketing initiatives to increase HCP and patient
awareness during the first half of 2025.
These key initiatives have resulted in ACCRUFeR® generating revenues of
approximately $19.2 million in the first half of 2025 representing an increase
of about 1.8x over the first half of 2024. These revenues were generated
through approximately 84,000 prescriptions predominantly in the six large
states of Texas, New York, Florida, Georgia, California, and North Carolina.
Consignment-based prescriptions which are dispensed at a significantly
subsidised price to patients and were not yet reimbursed by payors represented
about 25% of the total prescriptions in H1 2025, representing a significant
reduction compared to around 44% in H1 2024. This resulted in the average net
selling price of ACCRUFeR® steadily increasing to $231 in Q2 2025 and an
average net selling price in H1 2025 of $214, increasing c.1.4x from $158 in
H1 2024.
Overall, we continue to receive very positive views from both physicians and
patients. The feedback reaffirms that there is a clear need from health care
professionals (HCPs) and patients for an effective and well tolerated oral
iron, and ACCRUFeR® is steadily becoming the oral iron of choice for patients
with ID/IDA. Our efforts since the launch of ACCRUFeR® with our partner
Viatris in mid-2023 have also shown that the more HCPs we can reach through
sales and marketing efforts, the faster we can increase awareness and grow our
prescriber base. Awareness of ACCRUFeR® as an option to treat iron
deficiency, with or without anemia (ID/IDA) among many of these HCPs remains
quite low, and our objective is simple: increase awareness of ACCRUFeR®,
generate prescriptions from HCPs, and allow patients to experience the
benefits we believe ACCRUFeR® can provide. While we have made continued
progress over the first six months of this year, there is much opportunity
still ahead of us to make ACCRUFeR® the oral iron of choice for patients with
iron ID/IDA, thus changing the treatment paradigm.
Global partnerships and development
We are proud to collaborate with a growing network of global partners, and our
strategic focus is on expanding these relationships further. Our goal is to
identify new opportunities to bring ACCRUFeR®/FeRACCRU® to patients with
iron deficiency across as many markets as possible. During H1 2025, royalty
and milestone revenues were $2.2 million which were received from our global
partners across Europe, Canada, and Japan (H1 2024: $1.1 million). These
included milestone payments received from VITAL-NET, Inc. of c. $335,000
supporting the exclusive licensing agreement in Japan for ACCRUFeR®, and from
Norgine BV in Europe of c. $552,000 when the file was accepted for review by
EMA.
· Norgine BV ("Norgine") in Europe: We have a long-standing
relationship with Norgine for the distribution of FeRACCRU® in Europe and
their efforts are primarily concentrated in those countries where we have
positive reimbursement, specifically Germany, UK and the Nordics. Royalty and
milestone revenues accounted for $1.5 million from FeRACCRU® sales in Europe
and the UK by Norgine, including a milestone payment of $552,000 on the
acceptance of the pediatric filing process by EMA.
· Kye Pharmaceuticals ("Kye") in Canada: Kye launched ACCRUFeR® in
Canada in March 2025, following the approval from Health Canada for ACCRUFeR®
(ferric maltol) as a prescription drug for the treatment of adults with IDA.
ACCRUFeR® is currently the sole prescription-only oral treatment option
indicated for IDA in Canada and is available by prescription through
pharmacies across Canada. In accordance with the collaborative agreement,
Shield is eligible to receive further milestone payments upon the achievement
of specified calendar net sales targets and will also receive double-digit
royalties on net sales of ACCRUFeR® for the term of the agreement.
· VITAL-NET in Japan: The Company entered into an exclusive licence
agreement in April 2025 with VITAL-NET, Inc. for the development and
commercialisation of ACCRUFeR®/FeRACCRU® (ferric maltol) in iron deficiency
(ID) patients in pulmonary hypertension (PH) and inflammatory bowel disease
(IBD). Shield received an initial payment of c. $665,000, c.$335,000 of which
was received in Q2 2025, and expects regulatory and sales milestones, along
with double-digit royalties on net sales. VITAL-NET will undertake and be
responsible for all costs, including clinical and regulatory, related to
activities required to achieve marketing authorisation and commercialisation
of ACCRUFeR® in Japan.
· ASK Pharma ("ASK") in China: ASK has successfully completed the Phase
3 confirmatory study in adult patients with IBD and IDA, which is the final
study required to support the filing of an NDA in China for the
commercialisation of ACCRUFeR®/FeRACCRU®. The Company expects the NDA to be
filed with the Chinese National Medical Products Administration (NMPA) in
2025, and pending successful review, approval in China is anticipated by the
end of 2026.
· Korea Pharma ("KP") in Korea: KP filed a New Drug Application in 2024
for ACCRUFeR® in the Republic of Korea (South Korea) following the successful
completion of a pharmacokinetic (PK) study. Pending successful review by the
Korean Ministry of Food and Drug Safety (MFDS), approval in Korea is
anticipated by the end of 2025.
Pediatric study
Following the positive results from the Phase 3 pediatric clinical trial
(FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of
the new oral liquid pediatric suspension in children with iron deficiency
anemia (IDA) in Q3 2024, the Company filed for regulatory submission to the
EMA and FDA in Q2 2025 for the approval of ACCRUFeR® in the pediatric
population. The study was a requirement of both the FDA and EMA, that enrolled
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 over-the-counter iron 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. The
Company received c.$552,000 from Norgine BV in Europe when the file was
accepted to file by EMA. Pending successful review, approval in Europe and US
is anticipated in 2026.
Outlook
The Group continued to execute the expansion and growth of ACCRUFeR® in the
first half of 2025. We have substantially increased revenues, the net selling
price and the number of prescriptions for ACCRUFeR® in the US as we continue
to build awareness of the product and refine our commercial efforts. We see an
oral iron market which has clear unmet needs, based on physician and patient
feedback, for a product that delivers both effectiveness and tolerability. As
we move into the second half of 2025, Shield and our partner Viatris expect to
achieve continued growth in ACCRUFeR® prescriptions in the US along with
further improvement of other financial metrics. Additionally, 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. The Company remains on track to achieve its prior
guidance of turning cash flow positive by the end of 2025.
Financial Review
Revenue
Revenue in the first six months of 2025 (H1 2025) amounted to $21.4 million
(H1 2024: $12.1 million), of which $19.2 million (H1 2024: $11.0 million) was
derived from ACCRUFeR® sales in the US. The balance of $2.2 million (H1
2024: $1.1 million) represents revenues from our global partners including
royalties from Norgine in respect of sales of FeRACCRU® in Europe.
Approximately 84,000 prescriptions of ACCRUFeR® were sold in the US in H1
2025 and that yielded a net revenue of $19.2 million (H1 2024: $11.0 million
from approximately 65,200 prescriptions). Additionally, the average net
selling price in H1 2025 was $214, increasing c.1.4x from $158 in H1 2024.
Cost of sales
Cost of sales in H1 2025 amounted to $10.9 million (H1 2024: $6.7 million).
The H1 2025 cost of sales comprises manufacturing costs of the prescriptions
sold in the US and in Europe, plus the 45% share of the US net product
revenues payable to Viatris and 5% royalty on net sales, payable to Vitra
Pharmaceuticals Ltd (Vitra).
Selling, general and administrative expenses
Selling, general and administrative expenses were $15.6 million in H1 2025 (H1
2024: $18.8 million). The decrease is directly attributable to the close
management of operational costs in order to streamline the business to cash
flow positivity by the end of 2025.
Research and development
In H1 2025, $0.7 million in development costs were expensed in the statement
of profit and loss (H1 2024: $0.8 million). In addition, $1.3 million (H1
2024: $1.5 million) of development expenditure was recorded directly to the
balance sheet in accordance with the underlying conditions for capitalisation
(disclosed in the detail in the notes of the Company's 2024 annual report).
These development costs and expenditure have been spent in connection with the
ongoing pediatric study.
Loss for the period
The loss for H1 2025 was $9.5 million (H1 2024: $15.5 million) which includes
financial income of $0.2 million (H1 2024: $0.2 million), financial expense of
$3.8 million (H1 2024: $1.6 million) and taxation of $0.2 million (H1 2024:
$0.0 million).
Balance sheet
Intangible assets on 30 June 2025 were $19.5 million (31 December 2024: $18.2
million), comprised of $18.4 million of capitalised ACCRUFeR®/FeRACCRU®
development expenditure (31 December 2024: $17.1 million) and $1.1 million
expenditure related patents and trademarks (31 December 2024: $1.0 million) to
strengthen the Group's intellectual property.
Inventory on 30 June 2025 amounted to $6.7 million (31 December 2024: $5.7
million), which comprises work in progress and finished product available for
sale.
Trade and other receivables decreased to $23.7 million on 30 June 2025 from
$25.0 million on 31 December 2024.
The current tax asset of $0.1 million (31 December 2024: $0.3 million)
represents anticipated R&D tax credits.
Included within long-term creditors of $26.9 million (31 December 2024 $26.2
million) is $20.0 million due to SWK Holdings LLC and $6.9 million due to AOP.
The loan with SWK Holdings LLC has a loan maturity date of 28 September
2028. The Group received $5.7 million from AOP in cash in exchange for the
right to receive the $11.4 million China approval milestone payment that may
be paid to Shield by Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma,
Shield's commercial partner for ACCRUFeR® in China).
Cash and cash equivalents on 30 June 2025 amounted to $10.8 million (31
December 2024: $6.5 million).
Trade and other payables increased from $23.2 million on 31 December 2024 to
$36.9 million on 30 June 2025. The increase is largely attributed to the
revenue share payment due to Viatris on growing ACCRUFeR® sales, and the
usage of the accounts receivable financing mentioned above.
Cash flow
Net cash inflow from operations in H1 2025 was $8.3 million (H1 2024: $3.6
million outflow). The H1 2025 loss for the period was $9.5 million but, after
adjusting for various non-cash items, the actual cash outflow from this loss
was $4.7 million (H1 2024: $12.9 million). Working capital cash inflows were
$9.3 million in H1 2024 increasing to $13.0 million in H1 2025, mainly due to
the growing sales of ACCRUFeR® in the US, the usage of the accounts
receivable financing (see note 11) mentioned above, and the benefit of the
R&D tax credits received in the UK.
Net cash outflow from investing activities in H1 2025 was $1.1 million (H1
2024: $0.8 million) driven primarily by the capitalised development
expenditure offset by financial income.
The net cash outflow from financing activities in H1 2025 was $3.9 million (H1
2024: $1.9 million) primarily attributable to the interest paid on the Group's
long-term loan financing.
Going concern
For the reasons set out in detail under Note 2 of the attached condensed
interim financial statements as of and for the six months ended 30 June 2025,
the Directors believe that it remains appropriate to prepare the financial
statements on a going concern basis.
Consolidated statement of profit and loss and other comprehensive income
for the six months ended 30 June 2025
Note Year
Six months ended ended
30 June Six months ended 31 December
2025 30 June 2024
(unaudited) 2024 (audited)
$000 (unaudited) $000
$000
Revenue 4 21,447 12,132 32,180
Cost of sales (10,860) (6,675) (17,250)
Gross profit 10,587 5,457 14,930
Other operating income - 52 97
Operating costs - selling, general and administrative expenses 5 (15,637) (18,815) (36,013)
Operating loss before impairment and research and development expenditure (20,986)
(5,050) (13,306)
Research and development expenditure (741) (752) (1,887)
Operating loss (5,791) (14,058) (22,873)
Financial income 169 203 266
Financial expense (3,755) (1,625) (3,949)
Loss before tax (9,377) (15,480) (26,556)
Taxation (158) 2 (626)
Loss for the period (9,535) (15,478) (27,182)
Other comprehensive income
Items that are or may be reclassified subsequently to profit or loss:
Foreign currency translation differences - foreign operations (4,372) (402) (646)
Total comprehensive expenditure for the period (13,907) (15,880) (27,828)
Loss per share
Basic and diluted loss per share (in US cents) 6 $(0.01) $(0.02) $(0.03)
Group balance sheet
at 30 June 2025
Note
30 June 30 June 3
1
2025 2024 D
e
(unaudited) (unaudited) c
e
$000 $000 m
b
e
r
2
0
2
4
(
a
u
d
i
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e
d
)
$
0
0
0
Non-current assets
Intangible assets 7 19,508 17,401 18,168
Property, plant and equipment 228 524 373
Restricted cash 8 1,000 1,000 1,000
20,736 18,925 19,541
Current assets
Inventories 9 6,749 4,035 5,661
Trade and other receivables 23,693 15,406 24,968
Current tax asset 107 296 286
Restricted cash - - 500
Cash and cash equivalents 10,814 8,099 6,524
41,363 27,836 37,939
Total assets 62,099 46,761 57,480
Non-current liabilities
Long-term loan (26,949) (19,679) (26,174)
(26,949) (19,679) (26,174)
Current liabilities
Trade and other payables 10 (36,919) (19,364) (23,188)
Lease liabilities (99) (292) (196)
Other liabilities 11 (12,989) (6,885) (9,239)
(50,007) (26,541) (32,623)
Total liabilities (76,956) (46,220) (58,797)
Net (liabilities)/assets (14,857) 541 (1,317)
Equity
Share capital 12 (19,908) (15,011) (19,908)
Share premium (203,188) (198,759) (203,188)
Merger reserve (43,240) (43,240) (43,240)
Currency translation reserve 12,178 8,050 7,806
Accumulated deficit 269,015 248,419 259,847
Total deficit/(equity) 14,857 (541) 1,317
Group statement of changes in equity
for the six months ended 30 June 2025
Share Share Merger Currency translation Retained Total
capital premium reserve reserve earnings $000
$000 $000 $000 $000 $000
Balance at 1 January 2024 (audited) 15,011 198,759 43,240 (8,452) (233,525) 15,033
Loss for the year - - - - (27,182) (27,182)
Other comprehensive income:
Foreign currency translation differences - - - 646 - 646
Total comprehensive expense for the year - - - 646 (27,182) (26,536)
Transactions with owners, recorded directly in equity
Equity placing 4,897 4,429 - - - 9,326
Equity-settled share-based payment transactions - - - - 860 860
Balance at 31 December 2024 (audited) 19,908 203,188 43,240 (7,806) (259,847) (1,317)
Loss for the period - - - - (9,535) (9,535)
Other comprehensive income:
Foreign currency translation differences - - - (4,372) - (4,372)
Total comprehensive expense for the period - - - (4,372) (9,535) (13,907)
Transactions with owners, recorded directly in equity
Equity placing - - - - - -
Loan conversion - - - - - -
Equity-settled share-based payment transactions - - - - 367 367
Balance at 30 June 2025 (unaudited) 19,908 203,188 43,240 (12,178) (269,015) (14,857)
Group statement of cash flows
for the six months ended 30 June 2025
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2025 2024 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
Cash flows from operating activities
Loss for the period (9,535) (15,478) (27,182)
Adjustments for:
Depreciation and amortization 708 601 1,425
Equity-settled share-based payment expenses 367 584 860
Financial income (169) (203) (266)
Financial expense 3,755 1,625 3,949
Income tax 158 - 626
(4,716) (12,871) (20,588)
Increase in inventories (717) (832) (2,458)
Increase in trade and other receivables (4,072) (1,908) (1,142)
Decrease/(increase) in restricted cash 500 (1,000) (1,500)
Increase in trade and other payables 16,086 6,643 10,467
Increase in other liabilities 979 5,212 9,213
Income tax received/(paid) 196 1,191 (762)
Net cash flows from operating activities 8,258 (3,565) (6,770)
Cash flows from investing activities
Financial income 169 203 266
Acquisition of tangible assets - (34) (35)
Capitalised development expenditure (1,312) (978) (2,386)
Net cash flows from investing activities (1,143) (809) (2,155)
Cash flows from financing activities
Cash raised from equity placing - 122
Interest paid (3,755) (1,782) (3,949)
Legal fees in relation to equity placing (80) - (233)
Proceeds from convertible milestone monetisation - - 5,700
Total cash outflow from leases (97) (117) (213)
Net cash flows from financing activities (3,932) (1,899) 1,427
Net increase/(reduction) in cash 3,183 (6,273) (7,498)
Effect of exchange rate fluctuations on cash held 1,107 424 74
Cash and cash equivalents at beginning period 6,524 13,948 13,948
Cash and cash equivalents at period end 10,814 8,099 6,524
Notes
for the six months ended 30 June 2025
1. General information
Shield Therapeutics plc (the "Company") is incorporated in England and Wales
as a public limited company. The Company trades on the London Stock Exchange's
AIM market, having been admitted on 26 February 2016.
The Company is domiciled in England and the registered office of the Company
is at Northern Design Centre, Baltic Business Quarter, Gateshead Quays NE8
3DF.
The financial statements in this interim report comprise the Company and its
subsidiaries (together referred to as the 'Group'). The Group is engaged in
the late-stage development and commercialisation of clinical stage
pharmaceuticals to treat unmet medical needs.
This interim report, which is not audited, has been prepared in accordance
with the measurement and recognition criteria of EU Adopted International
Financial Reporting Standards. It does not include all the information
required for full annual financial statements and should be read in
conjunction with the consolidated financial statements of the Group as at and
for the year ended 31 December 2024. This financial information does not
constitute statutory financial statements as defined in Section 435 of the
Companies Act 2006. The comparative figures for the year ended 31 December
2024 are not the Company's statutory accounts for that financial year. Those
accounts have been reported on by the Company's auditor and delivered to the
Registrar of Companies. The report of the auditors was unqualified. The
auditor has reported on those accounts; their report was unqualified and did
not contain a statement under Section 498 (2) or (3) of the Companies Act
2006.
The interim report was approved by the board of directors 21 August 2025.
2. Accounting policies
The accounting policies applied in these interim financial statements are
consistent with those of the annual financial statements for the year ended 31
December 2024, as described in those annual financial statements.
Going concern
At 30 June 2025, the Group held $10.8 million in cash.
The Directors have considered the funding requirements of the Group through
the preparation of detailed cash flow forecasts for the period to December
2026, 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 in H2 2025 and that the funding detailed above
should provide sufficient cash to allow the business to continue in operations
for at least twelve months from the date of this report. The Directors have
considered scenarios in which sales revenues fall below forecasts. In these
circumstances mitigating actions such as reduction of discretionary selling
and marketing expenditure could be taken to preserve cash. The Directors also
believe that other forms of finance, such as debt finance or 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.
3. Critical accounting judgments and key sources of estimation uncertainty
In the application of the Group's accounting policies, management is required
to make judgments, estimates and assumptions about the carrying amounts of
assets and liabilities that are not readily apparent from other sources.
The significant judgments made in relation to the financial statements are:
Capitalisation of development expenditure
Development expenditure amounting to $2.4 million was capitalised during the
year because the conditions described in Note 2 were met. Other related
expenditures worth $1.9 million including employee costs, patent maintenance
costs and regulatory costs have not been capitalised as there is considerable
uncertainty as to whether this expenditure will have future benefits. The
significant estimates which may lead to material adjustment in the next
accounting period are:
Valuation of intellectual property associated with ACCRUFeR®/FeRACCRU®
The valuation of intellectual property associated with ACCRUFeR®/FeRACCRU®
(including patents, development costs and the Company's investment in Shield
TX (Switzerland) AG) is based on cash flow forecasts for the underlying
business and an assumed appropriate cost of capital and other inputs to arrive
at a fair value for the asset. The realisation of its value is ultimately
dependent on the successful commercialisation of the asset. If commercial
returns are lower than current expectations this may lead to impairment. No
impairment has been recognised to date.
4. Segmental reporting
The following analysis by segment is presented in accordance with IFRS 8 on
the basis of those segments whose operating results are regularly reviewed by
the Chief Operating Decision Maker (considered to be the Board of Directors)
to assess performance and make strategic decisions about the allocation of
resources. Segmental results are calculated on an IFRS basis.
A brief description of the segments of the business is as follows:
· ACCRUFeR®/FeRACCRU® - development and commercialisation of the
Group's lead ACCRUFeR®/FeRACCRU® product
· PT20 - development of the Group's secondary asset (all related
assets were written off effective 31 December 2022)
Operating results, which cannot be allocated to an individual segment are
recorded as central and unallocated overheads.
Six months ended Six months ended
30 June 30 June
2025 (unaudited) 2024
(unaudited)
ACCRUFeR®/ FeRACCRU® Central and unallocated $000 ACCRUFeR®/ FeRACCRU® Central and unallocated $000
$000 PT20 Total $000 PT20 Total
$000 $000 $000 $000
Revenue 21,447 - - 21,447 12,132 - - 12,132
Operating loss (4,273) (20) (1,506) (5,791) (12,412) - (1,652) (14,058)
Financial income 169 169 203 203
Financial expense (3,755) (3,755) (1,625) (1,625)
Tax (158) (158) 2
Loss for the period (5,250) (9,535) (15,478)
Year ended 31 December
2024
(audited)
ACCRUFeR®/ FeRACCRU® Central and unallocated $000
$000 PT20 Total
$000 $000
Revenue 32,180 - - 32,180
Operating loss (19,555) 6 (3,323) (22,873)
Financial income 266 266
Financial expense (3,949) (3,949)
Tax (626) (626)
Loss for the period (7,632) (27,182)
The revenue analysis in the table below is based on the country of
registration of the fee-paying party.
$19.2 million revenue (H1 2024: $11.0 million) was derived from ACCRUFeR®
sales in the US and $1.5 million (H1 2024: $1.1 million) of royalty income
with our European partner.
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2025 2024 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
USA 19,207 10,955 29,274
The Netherlands 1,485 1,067 2,142
Canada 420 - 320
Japan 335 322
South Korea - 110 122
21,447 12,132 32,180
5. Operating costs - selling, general and administrative expenses
Operating costs are comprised of:
Six months ended 30 June 2025 Six months ended 30 June 2024 Year ended 31 December 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
Selling costs 10,643 12,341 23,829
General and administrative expenses 4,286 5,703 10,759
Depreciation and amortization 708 771 1,425
15,637 18,815 36,013
6. Loss per share
The basic loss per share of $0.01 (H1 2024: $0.02) has been calculated by
dividing the loss for the period by the weighted average number of shares of
1,041,690,484 in issue during the six months ended 30 June 2025 (six months
ended 30 June 2024: 782,056,367).
Although there are potentially dilutive ordinary shares these would not serve
to increase or reduce the loss per ordinary share, as the Group is
loss-making. There is therefore no difference between the loss per ordinary
share and the diluted loss per ordinary share.
7. Intangible assets
ACCRUFeR®/ ACCRUFeR®/
FeRACCRU® FeRACCRU®
patents and trademarks development costs Total
$000 $000 $000
Cost
Balance at 1 January 2024 (audited) 2,410 19,832 22,242
Additions - externally purchased 2,386 2,386
Effect of change in foreign currency (44) (240) (284)
Balance at 31 December 2024 (audited) 2,366 21,978 24,344
Additions - externally purchased - 1,312 1,312
Effect of change in foreign currency 216 827 1,043
Balance at 30 June 2025 (unaudited) 2,582 24,117 26,6998
Accumulated amortization
Balance at 1 January 2024 (audited) 1,227 4,152 5,379
Charge for the period 122 714 836
Effect of change in foreign currency (28) (11) (39)
Balance at 31 December 2024 (audited) 1,321 4,855 6,176
Charge for the period 63 368 431
Effect of change in foreign currency 123 461 584
Balance at 30 June 2025 (unaudited) 1,507 5,684 7,191
Net book values
30 June 2025 (unaudited) 1,075 18,433 19,508
31 December 2024 (audited) 1,045 17,123 18,168
8. Restricted cash
The Group has $1.0 million (H1 2024: $1.0 million) of restricted cash held
within an escrow account in relation to the accounts receivable financing with
Sallyport Commercial Finance, LLC.
9. Inventories
Six months ended 30 June 2025 Six months ended 30 June 2024 Year ended 31 December 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
Work in progress 4,937 1,284 3,502
Finished goods 1,811 2,751 2,159
6,749 4,035 5,661
10. Trade and other payables
Six months ended 30 June 2025 Six months ended 30 June 2024 Year ended 31 December 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
Trade payables 16,098 3,674 6,518
Accruals 20,821 15,690 16,670
36,919 19,364 23,188
11. Other liabilities
Six months ended 30 June 2025 Six months ended 30 June 2024 Year ended 31 December 2024
(unaudited) (unaudited) (audited)
$000 $000 $000
Taxation and social security 58 33 48
Accounts receivable financing 12,844 6,835 8,999
Other payables 87 17 192
12,989 6,885 9,239
12. Share capital
Six months ended 30 June 2025 Six months ended 30 June 2025 Six months ended 30 June 2024 Number Six months ended 30 June 2024 Year ended Year ended 31 December 2024
Number 000 31 December 2024
000 $000 $000 Number $000
000
At beginning of period 1,041,690 19,908 782,056 15,011 782,056 15,011
Exercise of share options - - - -
Equity placing - - - - 259,634 4,897
Total shares authorised and in issue at end of period - fully paid 1,041,690 19,908 782,056 15,011 1,041,690 19,908
No share options were exercised during the six months ended 30 June 2025 (six
months ended 30 June 2024 Nil)
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