REG - Shield Therapeutics - Audited results for year ended 31 December 2025
Thu 12:45
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RNS Number : 8611Z Shield Therapeutics PLC 09 April 2026
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Audited results for the year ended 31 December 2025
2025 Group net revenues and other income of $49.7M with ACCRUFeR® net
revenues growing 56% to $45.8M Generated positive cash flow in Q4 2025 and
expects to deliver an operating profit in 2026
Substantial progress made in expanding global patient access of ferric maltol
London, UK, 9 April 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces its audited results for the year ended 31 December 2025. 2025
represents the strongest year on record for ACCRUFeR®, with record
prescription volumes, increased average net selling prices, and record
revenues. A key milestone was achieved in Q4 2025, with the Company reaching
cash flow positivity, providing increased strategic and financial flexibility.
2025 Financial Highlights: Meaningful gains in revenue, and cash flow
· ACCRUFeR® net revenue in the US grew 56% over 2024 revenues
contributing c. $46M to the total 2025 net revenues and other income of c.
$50M ($32M FY 24). Ex-U.S. contributed $3.9M in revenues from royalty and
milestones from global partners, primarily for product sales in Europe (2024:
$2.9M).
· Loss for the year were reduced to $17.7M compared to $27.2M in
2024 driven by total revenue growth and disciplined operating expense
management.
· Cash and cash equivalents were $11.6M as of 31 December 2025, and
the company achieved positive net operating cash flow in Q4 2025. The terms of
the Company's senior secured debt with SWK/Runway were amended to provide
improved terms and expanded to increase available funds to up to $50M,
including $15M for potential future M&A transactions. $22M of the total
$50M has been drawn as of 31 December 2025.
2025 US Commercial performance: Growing ACCRUFeR® into the market leader
· ACCRUFeR® became the #1 branded prescription oral iron in the US
during 2025.
· c.199,000 ACCRUFeR® prescriptions were dispensed in the US with
an average net selling price of $223 representing a 21% increase compared to
2024.
· >15K ACCRUFeR® prescribers in 2025, representing a 26%
increase compared to 2024
· Commercial performance was driven by the combination of increased
investment in digital marketing and the realignment of the US sales team that
focused on territories and providers with the highest potential, optimal
payer coverage and strong ACCRUFeR® performance.
· Shield received the 2025 Titan Brand Award for Best Rebranding
Effort and Best Healthcare Rebranding for ACCRUFeR®
2025 Regulatory & pipeline progression: Extending reach across new markets
· FDA approved an extension of the ACCRUFeR® indication to include
adolescents following priority review, now indicated for patients aged 10
years and older
· ACCRUFeR® launched in Canada through partnership with Kye
Pharmaceuticals, Inc.
· Regulatory approval granted in the Republic of Korea by the
Ministry of Food and Drug Safety (MFDS)
· China partner ASK submitted a marketing authorisation application
to the NMPA in Q1 2026
· Exclusive licence agreement signed with MEDLEAP Pharma in Japan;
Phase II clinical trial initiated in pulmonary arterial hypertension (PAH)
Anders Lundstrom, Chief Executive Officer, commented: "Our mission is to
ensure every patient living with iron deficiency has access to a treatment
that works. In 2025, our team delivered, ACCRUFeR® became the number one
branded prescription oral iron in the US, with ~199,000 prescriptions written,
and we reached cash flow positivity in Q4. With FDA approval now extended to
adolescents aged 10 and over, we can help even more patients. None of this
happens without the dedication of our people and partners who show up every
day for patients."
2025 Annual Report and Notice of Annual General Meeting
The Annual Report and Accounts and Notice of AGM will be sent to shareholders
and in accordance with AIM Rule 26, these documents will also be available to
view on the Company's website as of 10 April 2026.
This year the Company's AGM will be held at 2.00 pm (BST) on 18 June 2026 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.
Shield is pleased to announce the launch of its new interactive investor hub.
Designed for both existing and prospective shareholders, the platform brings
together all Shield Therapeutics content into one integrated location, making
it easier to stay informed and engaged with the Company's progress.
The Company will provide a facility for shareholders to join the AGM via its
new investor hub. In order to facilitate the process, the Board would request
that shareholders register for the meeting and submit questions in advance,
before 2.00 pm (BST) on 16 June 2026.
To register your attendance and to submit any questions please contact
Investor Relations via email at investorrelations@shiedtx.com or call +44
(0)191 511 8500.
How to sign up for the Shield Therapeutics plc investor hub:
1. Visit shieldtherapeutics.com (http://shieldtherapeutics.com/)
2. Follow the prompts to sign up for an investor hub account
3. Complete your account profile
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
https://shieldtherapeutics.com/link/Pd6j7e
(https://shieldtherapeutics.com/link/Pd6j7e)
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel +44 (0)20 7418 8900
Joint Broker
Cavendish Ltd
Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
Ward
+44 (0)20 7220 0500
About Iron Deficiency and ACCRUFeR®/FeRACCRU®
Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for children and 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 and is now the
#1 branded prescription oral iron in the US market today (*data source - IQVIA
Xponent PlanTrak).
ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for patients suffering from iron deficiency, with or without anemia.
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 has
launched ACCRUFeR® in the U.S. to include pediatric patients 10 years of age
and older with an exclusive, multi-year collaboration agreement with Viatris.
Outside of the U.S., the Company has licensed the rights to five specialty
pharmaceutical companies. FeRACCRU® is commercialised in the UK and European
Union by Norgine B.V., to include pediatric patients 12 years of age and older
and also have marketing rights in Australia and New Zealand. FeRACCRU® is
also commercialised in Canada by Kye Pharmaceuticals Inc. 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, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc.
for Japan.
ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.
ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.
Chairman and Chief Executive Officer's joint statement
Over the past twelve months, Shield Therapeutics has delivered strong
operational and commercial performance, reflecting the efficient execution of
its strategic priorities and the continued collaboration with commercial and
development partners.
Shield's 2025 performance represents the strongest year on record for
ACCRUFeR®, with record prescription volumes, increased net selling prices,
and record revenues. A key milestone was achieved in the fourth quarter, with
the Company reaching cash flow positivity, providing increased strategic and
financial flexibility moving into 2026.
All of the above was achieved because of the efforts of our very talented and
dedicated employees and partners.
In 2025 Shield reported total revenues of c. $50M and in the US ACCRUFeR®
revenues increased by 56% compared with 2024. U.S. prescriptions rose to
c.199,000, supported by a 21% increase in net average selling price to $223.
During the year, ACCRUFeR® became the #1 branded prescription oral iron in
the U.S.
This achievement followed the successful restructuring of the sales
organisation and increased investment in digital marketing. The marketing
initiatives resulted in Shield receiving the 2025 Titan Brand Award for Best
Rebranding Effort and Best Healthcare Rebranding for ACCRUFeR®.
Our Regulatory progress continued with the U.S. Food and Drug Administration
(FDA) approving an extension of the ACCRUFeR® indication to include
adolescents following a priority review. ACCRUFeR® is now indicated for the
treatment of iron deficiency in adult and pediatric patients aged 10 years and
older. These results underscore the Company's focus on improving patient
outcomes and expanding access to effective therapies globally.
We are also advancing our international expansion strategy. ACCRUFeR® was
launched in Canada through its partnership with Kye Pharmaceuticals, Inc., and
regulatory approval was granted in the Republic of Korea by the Ministry of
Food and Drug Safety (MFDS). In China, Shield's partner, Beijing Aosaikang
Pharmaceutical Co. Ltd. (ASK), finalised the clinical program and submitted a
marketing authorisation application to the National Medical Products
Administration (NMPA) in the first quarter of 2026. In addition, Shield
entered into an exclusive license agreement with MEDLEAP Pharma in Japan,
which has initiated a Phase II clinical trial evaluating ACCRUFeR® in a new
orphan indication, pulmonary arterial hypertension (PAH).
Financially, Shield enters 2026 with a strengthened balance sheet. Key
developments included the successful restructuring of long-term debt with SWK
on favourable terms and expansion of available capital to support M&A and
future business development activities.
Looking ahead, Shield's strategic priorities for 2026 include:
· Continued growth in ACCRUFeR® net revenues
· Diversification of revenue streams beyond adult ID/IDA in the U.S.
· Achievement of sustained profitability
We will continue to manage our business with foresight and caution,
representing the interests of patients suffering from anemia and the interests
of our shareholders.
Hans Peter Hasler, Chairman
Anders Lundstrom, Chief Executive Officer
Financial Review
Revenue
In 2025, total revenue (excluding other income) reached $49.7M, up from $32.2M
in 2024. This includes $45.8M (2024: $29.3M) in net product revenue from
ACCRUFeR® sales in the U.S., with c.199,000 prescriptions (2024: c.150,000
prescriptions). The average net selling price grew 21% compared to 2024 to
$223 driven primarily by a reduction in the consignment business from 35% in
2024 to 22% in 2025 of the total prescriptions dispensed. The consignment
business represents prescriptions that were dispensed at a subsidised price to
patients and were not yet reimbursed by payors.
Additionally, royalty and milestone revenues accounted for $3.9M (2024 $2.9M)
including $2.3M from FeRACCRU® sales in Europe by Norgine, with Germany and
United Kingdom accounting for 63% and 24% (2024: 67% and 21%) respectively.
Milestone payments accounted for $0.7M from our European and Japanese
partners.
Cost of sales
The cost of sales for 2025 totaled $26.7M, compared to $17.3M in 2024. This
includes a 45% revenue share with Viatris Inc. on the sales of ACCRUFeR® in
the United States, manufacturing and shipping costs for prescriptions sold in
the U.S., finished packs supplied to Norgine for sale in Europe, and a 5%
royalty on net sales payable to Vitra Pharmaceuticals Limited (Vitra) who are
the original owners of the intellectual property behind ACCRUFeR®/
FeRACCRU®.
Selling, general and administrative expenses
Selling, general and administrative expenses were $31.6M in 2025 (2024:
$36.0M). The decrease was driven primarily due to the restructuring of the
ACCRUFeR® sales force announced in Q4 2024. The share based payment charge to
the income statement was $0.8M in 2025 (2024 $0.9M).
Research and development
The Group spent $1.8M (2024: $4.3M) on research and development. Of that total
spend, $0.3M (2024: $2.4M) 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 $1.5M (2024: $1.9M) was
expensed in the current year. Research and development expenditure is
predominantly related to the pediatric study.
Financial income
Financial income of $0.3M was reported in 2025 (2024: $0.3M). This income was
generated primarily through interest receivable from treasury bank account
interest.
Financial expense
Financial expense of $7.4M was reported in 2025 (2024: $3.9M). The expense was
primarily related to interest charged on the long-term loan with SWK Holdings,
the AOP milestone financing and the interest charged on the financing
arrangement with Sallyport Commercial Financing.
Balance sheet
As of 31 December 2025, cash stood at $11.6M, up from $6.5M on 31 December
2024. As at 31 March 2026 the Group's unaudited cash balance was $12.4M.
Intangible assets increased to $18.9M as of 31 December 2025, up from $18.2M
in 2024. This includes capitalised development costs for ACCRUFeR®/
FeRACCRU®, such as the ongoing pediatric pharmacokinetic study, and costs
related to ACCRUFeR®/ FeRACCRU® patents and trademarks, which were incurred
to strengthen the Group's intellectual property.
Inventories grew to $9.2M (31 December 2024: $5.7M), reflecting the Group's
efforts to build inventory in response to growing demand in the U.S. market.
Trade and other receivables as of 31 December 2025 were $24.3M, down from
$25.0M at 31 December 2024. This is due to higher trading volumes in the U.S.,
alongside $10.0M owed by AOP from the equity placing on 29 December 2024,
which was paid on 3 January 2025.
The current tax asset stood at $0.1M at 31 December 2025, down from $0.3M in
2024. This relates to the expected R&D tax credit claim for the 2024
financial years.
Non-current liabilities include a long-term loan from SWK Holdings for $21.7M
and milestone financing from AOP for $8.4M. Both loans are accounted for using
an effective interest rate method in line with IFRS 9.
Trade and other payables were $37.4M as of 31 December 2025, compared to
$23.2M at 31 December 2024. This increase is primarily due to the growth in
trading volumes in the U.S. Other liabilities were $12.7M (2024: $9.2M) which
included $10.6M (2024: $9.0M) of accounts receivable financing with Sallyport
Commercial Finance.
Lease liabilities decreased from $0.2M in 2024 to $Nil in 2025.
Cash flow
Net cash inflow in 2025 was $5.0M, increasing the cash on hand from $6.5M at
31 December 2024 to $11.6M at 31 December 2025. Net cash outflows from
operating activities was $3.4M (2024: $6.8M), comprised of $17.7M (2024:
$27.2M) loss for the year, adjusted for non-cash items of $9.5M (2024: $6.6M)
(including depreciation and amortisation of $1.1M (2024: $1.4M), share-based
payments of $0.8M (2024: $0.9M), net financial expense of $7.4M (2024: $3.9M)
and income tax of $0.5M (2024: $0.6M)) and a net decrease in the Group's
working capital of $4.8M (2024: $13.8M).
Net cash outflows from investing activities of $0.2M (2024: $2.2M outflow) are
the result of capitalised development expenditure and tangible asset additions
of $0.3M (2024: $2.4M) and financial income of $0.1M (2024: $0.3M).
Net cash inflows from financing activities of $8.6M (2024: $1.4M) are
attributable to $12.0M (2024: $0.1M) of equity raised, $1.7M (2024: $5.7M) of
loan finance raised less interest paid of $4.8M (2024: $3.9M) and legal fees
in relation to the equity raise of $NilM (2024: $0.2M).
Going concern
At 31 December 2025, the Group held $11.6M in cash. The Group's unaudited cash
balance at 31 March 2026 was $12.4M. The forecasts show that the Group's cash
flows continue to be positive for 2026 and that the recent, extended loan
facility (approved December 2025) 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, administrative, and
production related expenditure combined with the reliance on the full $15.0M
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.
Recent shifts in U.S. economic policy, including the imposition of tariffs on
imported goods such as pharmaceuticals and active pharmaceutical ingredients
(APIs), present ongoing risks and uncertainties for our business. These
measures may lead to increased costs, supply chain disruptions, and margin
pressure, particularly if alternative sourcing options are limited or
similarly affected. The evolving nature of U.S. trade policy, including the
potential for future tariffs or retaliatory actions by other countries,
creates added unpredictability that may impact our operational planning and
financial performance. We continue to monitor these developments and evaluate
strategies to mitigate potential impacts.
Financial outlook
Building on the strong momentum of 2025, ACCRUFeR® is poised for a
transformative 2026. We anticipate strong growth in 2026, driven by its
existing sales force, marketing programs, and improved patient access - with
the usual seasonal patterns expected to continue.
Globally, we are addressing a critical market need for an oral iron therapy
that balances clinical efficacy with superior tolerability. Our international
expansion continues through key partnerships: Norgine's sustained growth of
FeRACCRU® in Europe, Kye Pharmaceuticals' launch in Canada, the anticipated
launch by Korea Pharma in Korea, and the regulatory progression in China with
ASK alongside the Phase ii clinical trials initiated in Japan. The milestones
and royalties generated through these partnerships will only bolster our
global revenue streams.
Maintaining a rigorous focus on investment returns and working capital, Shield
transitioned to being cash-flow positive at the end of 2025. This disciplined
financial management, coupled with the continued scaling of ACCRUFeR®,
positions the Company to become a profitable, self-sustaining entity in 2026.
Santosh Shanbhag
Chief Financial Officer
Consolidated statement of profit and loss and other comprehensive income
for the year ended 31 December 2025
2025 2024
$'000 $'000
Revenue 49,701 32,180
Cost of sales (26,662) (17,250)
Gross profit 23,039 14,930
Other operating income 36 97
Operating costs - selling, general and administrative expenses (31,586) (36,013)
Research and development expenditure (1,539) (1,887)
Operating loss (10,050) (22,873)
Financial income 327 266
Financial expense (7,418) (3,949)
Loss before tax (17,141) (26,556)
Taxation (514) (626)
Loss for the year (17,655) (27,182)
Other comprehensive income
Items that are or may be reclassified subsequently to profit or loss:
Foreign currency translation differences - foreign operations 1,058 646
Total comprehensive loss for the year (16,597) (26,536)
Loss per share
Basic and diluted loss per share (in cents) (2) (3)
Consolidated balance sheet
at 31 December 2025
2025 2024
$'000 $'000
Non-current assets
Intangible assets 18,887 18,168
Property, plant and equipment 113 373
Restricted cash 1,000 1,000
20,000 19,541
Current assets
Inventories 9,214 5,661
Trade and other receivables 24,275 24,968
Current tax asset 105 286
Restricted cash - 500
Cash and cash equivalents 11,621 6,524
45,215 37,939
Total assets 68,215 57,480
Non-current liabilities
Long-term loan (30,135) (26,174)
(30,135) (26,174)
Current liabilities
Trade and other payables 37,427) (23,188)
Other liabilities (12,730) (9,239)
Lease liabilities - (196)
(50,157) (32,623)
Total liabilities (80,292) (58,797)
Net liabilities (15,077) (1,317)
Equity
Share capital (20,435) (19,908)
Share premium (204,613) (203,188)
Warrants reserve (94) -
Merger reserve (43,240) (43,240)
Currency translation reserve 6,748 7,806
Accumulated deficit 276,711 259,847
Total equity 15,077 1,317
Group statement of changes in equity
for the year ended 31 December 2025
Issued capital Share premium Warrants reserve Merger Currency translation reserve Accumulated deficit Total
reserve
$'000 $'000 $'000 $'000 $'000 $'000 $'000
Balance at 1 January 2024 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 19,908 203,188 - 43,240 (7,806) (259,847) (1,317)
Loss for the year - - - - - (17,655) (17,655)
Other comprehensive income:
Foreign currency translation differences - - - - 1,058 - 1,058
Total comprehensive expense for the year - - - - 1,058 (17,655) (16,597)
Transactions with owners, recorded directly in equity
Equity placing 517 1,425 - - - - 1,942
Share options exercised 10 - - - - - 10
Warrants issued - - - 94 - - 94
Equity-settled share-based payment transactions - - - - - 791 791
Balance at 31 December 2025 20,435 204,613 94 43,240 (6,748) (276,711) (15,077)
Consolidated statement of cash flows
for the year ended 31 December 2025
2025 2024
Cash flows from operating activities $'000 $'000
Loss for the year (17,655) (27,182)
Adjustments for:
Depreciation and amortisation 1,115 1,425
Equity-settled share-based payment expenses 791 860
Financial income (327) (266)
Financial expense 7,418 3,949
Income tax 514 626
(8,144) (20,588)
Increase in inventories (3,431) (2,458)
Increase in trade and other receivables (8,654) (1,142)
Decrease/(increase) in restricted cash 500 (1,500)
Increase in trade and other payables 16,759 10,467
(Decrease)/increase in other liabilities - 9,213
Income tax paid (410) (762)
Net cash flows from operating activities (3,380) (6,770)
Cash flows from investing activities
Financial income 91 266
Additions to tangible assets (24) (35)
Capitalised development expenditure (276) (2,386)
Net cash flows from investing activities (209) (2,155)
Cash flows from financing activities
Interest paid (4,838) (3,949)
Proceeds from equity raise 11,954 122
Legal fees in relation to equity raise - (233)
Proceeds from milestone monetisation - 5,700
Proceeds from long-term loan 1,708 -
Payment of lease liabilities (196) (213)
Net cash flows from financing activities 8,628 (1,427)
5,039 (7,498)
Net (decrease)/increase in cash
Effect of foreign exchange differences 58 74
Cash and cash equivalents at 1 January 6,524 13,948
Cash and cash equivalents at 31 December 11,621 6,524
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