REG - Shield Therapeutics - Q1 2026 Trading Update

Shield TherapeuticsAnnouncement

Today 07:01

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RNS Number : 6954C  Shield Therapeutics PLC  01 May 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")

 

Q1 2026 Trading Update

 

Group net revenues of $18M with strong year on year ACCRUFeR® net revenue
growth of 54% to $9.9M

Planned CFO Transition; Anders Lundstrom, CEO to serve as Interim CFO

 

London, UK, 1 May 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company focused on iron deficiency, today
releases its unaudited Q1 2026 trading update and announces a CFO transition.

 

In Q1 2026, unaudited Group net revenues were $18M with earnings before
interest and taxes (EBIT) of c.$2.5M. ACCRUFeR® revenues grew 54% year on
year to $9.9M, reflecting typical seasonal insurance dynamics in addition to
decreased funding across federally subsidised state level programs.
Specifically, the Medicaid program in New York, representing approximately 19%
of ACCRUFeR® sales, has newly introduced Prior Authorisation (PA)
requirements for prescription approvals which will impact sales in this State.
It is too early to determine the impact of this measure and to part mitigate
it Shield is actively pivoting to business driven by commercial plans.

 

CFO Santosh Shanbhag will be stepping down from his role effective 1 June 2026
to pursue a new role. The Company has appointed Anders Lundstrom, CEO as the
interim CFO and has commenced a search for a permanent successor.

Q1 2026 Key Business Metrics:

·    Group net revenue of $18M (Q1 2025: $7M) and positive EBIT of c.
$2.5M (Q1 2025: $4.4M loss) primarily driven by the achievement of the $7.9M
development milestone payment by ASK in China, and increased ACCRUFeR® sales
in the US

·    ACCRUFeR® net revenues increased by 54% to $9.9M (Q1 2025: $6.4M)
with expected seasonal trend and a strong March performance representing
nearly 46% of total Q1 net product revenues

·    ACCRUFeR® average net price of $190 (Q1 2025: $187) with c. 53,000
prescriptions dispensed in Q1 2026 (c. 36,800 in Q1 2025). c.26% of the total
prescriptions were consignment-based prescriptions that were dispensed at a
significantly subsidised price to patients and were not reimbursed by payors.
This is expected to be reduced over the course of the year.

·    Cash and cash equivalents of $12.4M as of 31 March 2026 compared to
$11.6M on 31 December 2025. primarily driven by working capital and cost
management. Additionally, the vast majority of the AOP loan payment has been
made in Q1 2026 upon receipt of the milestone payment from ASK.

·    Global regulatory and pipeline progression: Chinese NMPA accepts MAA
submission for ACCRUFeR® and EMA approves FeRACCRU® indication extension to
include children >12 yrs.

Anders Lundstrom, Chief Executive Officer, commented: "ACCRUFeR® delivered
strong year on year growth in Q1 2026. Our global progress, including the NMPA
MAA acceptance in China and EMA approval of FeRACCRU® in children over
12yrs., reflects the breadth of this asset's value. I am pleased with the
team's ability to rapidly pivot our sales efforts towards business driven by
commercial plans in NY to offset some of the impact of the new Medicaid PA
requirements."

 

"I also want to thank Santosh on behalf of the Board and the entire Shield
team. His financial leadership was instrumental in turning the Company cash
flow positive and building the foundation for profitability. We wish him every
success ahead." Santosh Shanbhag added: "It has been a privilege to serve as
CFO during such a pivotal period. I'm proud of what we've built together and
have full confidence in the team and the path ahead."

 

Investor Presentation

Further to the launch of our new interactive Investor Hub, CEO, Anders
Lundstrom, CFO, Santosh Shanbhag, and CCO Andy Hurley will be hosting a live
webinar relating to the Q1 2026 Trading Update at 2:15 pm (BST) on 5 May 2026.
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. Questions
can be submitted pre-event via your Investor Hub dashboard up until 2.15 pm
(BST) on 5 May 2026 or at any time during the live presentation.

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

 

To access the webinar please visit: https://shieldtherapeutics.com/webinars
(https://shieldtherapeutics.com/webinars)

 

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/ya2b7e
 (https://shieldtherapeutics.com/link/ya2b7e)

 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.

 

 

 

 

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