TIDMSTX
RNS Number : 9330B
Shield Therapeutics PLC
17 February 2022
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Provides Full Year Trading Update and
Reports Progress on the Commercialization of
Accrufer(R)/Feraccru(R)
London, UK, 17 February, 2022: Shield Therapeutics plc (LSE:
STX), a commercial stage specialty pharmaceutical company, is
pleased to provide an update on trading for the year ended 31
December 2021, as well as an update on the Company's progress on
the commercialization of its lead product Accrufer(R)/Feraccru(R)
(ferric maltol), an effective, well tolerated, low-dose novel
formulation of oral iron replacement therapy with an adverse event
profile and discontinuation rate well below the published 40-60%
rate for conventional oral iron therapy.
Unaudited, Revenue and Cash for the year ended 31 December 2021
:
Total Revenue of GBP 1.5 million in line with market
expectations (FY20: GBP10.4 million) including:
-- Net product revenue of GBP 0.1 million from U.S. product sales (FY20: nil)
-- Royalty revenue of GBP 0.9 million from product sales in the EU (FY20: GBP0.7 million)
-- Milestone payments of GBP 0.5 million from the upfront
payment of Korea Pharma on signing of the license agreement for
commercialization in the Republic of Korea (FY20: GBP9.7 million
from ASK Pharma in China)
Cash on hand of GBP 12.1 million (30 June 2021: GBP22.6 million;
31 December 2020: GBP2.9 million)
U.S. Update : Shield launched Accrufer(R) in July, 2021 and
reports:
-- Payer coverage increased since last update in December, now
covering 60 million commercial lives resulting from several
additional contracts being executed including Cigna, Humana, and
Highmark
-- Awareness of Accrufer(R) among target prescribers doubled since launch to 65%
-- Healthcare professionals generated approximately 2500
prescriptions for Accrufer(R) since launch into our patient
assistance and reimbursement hub with significant growth seen from
3(rd) quarter to 4(th) quarter
"Our priorities for the US launch of Accrufer(R) were to
increase awareness, generate clinical experience, and expand payer
coverage, and we have made significant progress across each of
these priorities." said Greg Madison, Chief Executive Officer,
Shield. "We have been very pleased by the initial feedback and
reactions of healthcare providers to Accrufer(R), and it is clear
there is a need for an effective and well tolerated oral iron
therapy for the millions of patients with iron deficiency. We will
remain focused on continuing the strong momentum in the US and
ensuring the Group has the resources required to deliver on this
goal. We believe Accrufer(R)/Feraccru(R) has the potential to be
the "best in class" oral iron replacement product and our efforts
over the last six months have set the Company up to expand access
and grow sales in 2022 and beyond."
Ex-U.S. Update: Feraccru(R) was launched in the European Union
and the UK in 2019. Shield reports that:
-- Feraccru(R) volume in Europe increased by 60% (YoY) through
the efforts of our partner, Norgine BV, driven in particular by
increased demand in Germany
-- Out-licensing agreements were signed with two new partners,
Korea Pharma Co and KYE Pharmaceuticals, that will bring
Accrufer(R)/Feraccru(R) to the Republic of Korea and Canada, upon
completion of the respective clinical and regulatory processes
Clinical/Registration Update : Shield reported that:
-- A Phase 3 pediatric study was initiated in the U.S. & UK in Q3 2021
-- Norgine BV submitted the reimbursement dossier for Spain in late Q4 2021
-- Beijing Aosaikang Pharmaceutical Co., Ltd ("ASK Pharma"),
completed a pharmacokinetics study in China, a critical regulatory
requirement and are now enrolling patients in the Phase 3 trial
Greg further commented: "We added two new partners, in Korea
Pharma Co., Ltd. (Republic of Korea) and Kye Pharmaceuticals Inc
(Canada), who are excited and motivated to progress through the
regulatory and clinical pathways to approval. The initiation of the
Phase 3 study in China is also a major milestone towards potential
approval in this territory. I am pleased by the excellent progress
that our worldwide strategic partners are making to bring
Accrufer(R)/Feraccru(R) to more patients worldwide."
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Greg Madison, CEO +44 (0) 191 511 8500
Hans-Peter Rudolf, CFO
Nominated Adviser and Joint
Broker
Peel Hunt LLP
James Steel/Christopher Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/ George Dollemore/Alice
Lane/Nigel Birks +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR
Paul McManus/Lianne Applegarth/Alice +44 (0)20 7933 8780 or shield@walbrookpr.com
Woodings
Investor Contact (US Advisor)
LifeSci Advisors, LLC
John Mullaly +1 617 429 3548 or jmullaly@lifesciadvisors.com
About Accrufer (R) /Feraccru (R)
Accrufer(R)/Feraccru(R) (ferric maltol) is a novel, stable,
non-salt based oral therapy for adults with iron deficiency, with
or without anemia. Accrufer(R)/Feraccru(R) 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(R)/ Feraccru(R) ,
including the product label, can be found at: www.accrufer.com and
www.feraccru.com
About Shield Therapeutics plc
Shield is a commercial stage specialty pharmaceutical company
with a focus on addressing iron deficiency with its lead product
Accrufer(R)/Feraccru(R) (ferric maltol). The Group has launched
Accrufer(R) in the US and Feraccru(R) is commercialized in the UK
and European Union by Norgine B.V., who also have the marketing
rights in Australia and New Zealand. Shield also has an exclusive
license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialization of Accrufer(R) /
Feraccru(R) in China, Hong Kong, Macau and Taiwan, with Korea
Pharma Co., Ltd. in the Republic of Korea, and with KYE
Pharmaceuticals Inc. in Canada.
Accrufer(R)/Feraccru(R) has patent coverage until the
mid-2030s
Accrufer(R)/Feraccru(R) are registered trademarks of the Shield
Group
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(R)/Feraccru(R) 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, 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 Group'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 Group disclaims any obligation to
update any forward-looking statements contained in this release,
even if subsequent events cause our views to change.
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END
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