REG - Shield Therapeutics - Q4 2025 Trading Update

Shield TherapeuticsAnnouncement

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RNS Number : 6821P  Shield Therapeutics PLC  21 January 2026

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
(EU) No. 596/2014 (as it forms part of domestic law in the United Kingdom by
virtue of the European Union (Withdrawal) Act 2018). Upon the publication of
this announcement via the Regulatory Information Service, this inside
information is now considered to be in the public domain.

 

Shield Therapeutics plc

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

 

Q4 2025 Trading Update

 

Generated positive Cash flow in Q4 2025 with Total Group Revenues of c. $50m
for full year 2025

ACCRUFeR® revenues grew 56% to c. $46m in 2025 with 21% increase in average
net selling price to $223

and 33% growth in total prescriptions to c.199,000

Company expects to deliver an operating profit in 2026

 

London, UK, 21 January 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that, in line with the Company's guidance, Shield has achieved
positive operating cash flow in Q4 2025 and provides an unaudited full
year trading update for the year ended 31 December 2025 ("FY25"). This period
reflects the transition of the Company to a sustainable enterprise driven by
continued ACCRUFeR® growth in the US and effective cost and working capital
management. The Company also announces that it expects to deliver an operating
profit in 2026.

 

The Company reported total revenues of c. $50m for FY25 ($32m revenues and
other income in FY24) with ACCRUFeR® revenues growing 56% in the US and
contributing $46m ($29m in FY24) through 21% growth in average net selling
price to $223 and 33% growth in total prescriptions to c.199,000.

 

Q4 2025 Key Business Metrics:

·    ACCRUFeR® net revenues of $13.5m ($11.2m Q4 2024).

·    ACCRUFeR® prescriptions of c. 61,000 (c. 41,000 in Q4 2024)
representing the highest dispenses in any quarter since launch.
Consignment-based prescriptions decreased c. 21% (c. 22% in Q4 2024) that were
dispensed at a subsidised price to patients and were not yet reimbursed by
payors.

·    ACCRUFeR® average net selling price of $222 ($237 in Q4 2024)
impacted by an increase in covered rebated prescriptions compared to prior
quarters.

·    Cash and cash equivalents of $11.6m as of 31 December 2025 ($8.6m as
of 30 September 2025), achieving positive operative cash flow of $1m excluding
the receipt of net proceeds of $1.96m from the amended Senior Secured Debt
Financing announced in the quarter.

Anders Lundstrom, Chief Executive Officer, commented: "Reaching cash flow
positivity is a significant milestone in the Company's history that allows us
to continue to grow our business without the need for further external
financing. The efforts of the sales teams, together with our strategic
marketing initiatives, delivered our strongest year on record for ACCRUFeR®,
achieving new highs in prescription volumes, net selling price, and revenues.
ACCRUFeR®'s strong performance in the fourth quarter along with a
strengthened balance sheet exiting 2025 gives us the momentum and financial
flexibility to achieve our 2026 strategic priorities."

 

Investor Presentation

CEO, Anders Lundstrom, and CFO, Santosh Shanbhag, will be hosting a live
online presentation relating to the Q4 2025 Trading Update via the Investor
Meet Company platform at 2:00 pm (GMT) on 22 January 2026.

 

The presentation is open to all existing and potential investors. Questions
can be submitted pre-event via your Investor Meet Company dashboard up until
1.00 pm (BST) on 22 January 2026 or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to meet Shield
Therapeutics plc via:

https://www.investormeetcompany.com/shield-therapeutics-plc/register-investor
(https://www.investormeetcompany.com/shield-therapeutics-plc/register-investor)

 

Investors who already follow Shield Therapeutics plc on the Investor Meet
Company platform will automatically be invited.

 

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/Christopher Golden                                                                 +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 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 leading #1
branded prescription oral iron the market today for ID/IDA (data source -
IQVIA Xponent PlanTrak).

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 has
launched ACCRUFeR® in the U.S. 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., 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,
with Kye Pharmaceuticals Inc. for Canada, and with VITAL-NET for Japan.

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

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