TIDMSTX
RNS Number : 5804G
Shield Therapeutics PLC
20 July 2023
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Business Update and U.S. Q2 2023 Highlights
Strong Q2 2023 with U.S. Accrufer(R) Prescription Growth
Total U.S. prescriptions increased by 50% in 2(nd) quarter to
15,800, including 30% growth in June
Completion of commercial expansion to 100 sales representatives,
refreshed brand positioning and marketing campaign launched in
May
London, UK, 20 July, 2023: Shield Therapeutics plc (LSE: STX), a
commercial stage pharmaceutical company that delivers
Accrufer(R)/Feraccru(R) (ferric maltol), an innovative and
differentiated specialty pharmaceutical product, to address a
significant unmet need for patients suffering from iron deficiency
(with or without anemia) reports a business update covering recent
developments, including strong Q2 2023 U.S. Accrufer(R) growth.
The Company saw strong prescription growth in Q2 and 1H 2023.
Total prescriptions for the 2(nd) quarter of 2023 increased to over
15,800, a 50% increase compared to Q1 2023, and a 173% rise
compared to the same period in 2022. In the first half of 2023,
total prescriptions grew to approximately 26,300 which exceeds the
total prescription volume for all of 2022 and represents an
increase of 210% compared to 1H 2022.
The substantial growth in H1 puts Shield on track to meet its
2023 Goal for U.S. Accrufer(R) prescriptions :
Snapshot of increasing Q2 KPI metrics - (all comparisons are
sequential to Q1 2023)
-- Increase in total prescriptions - - Over 15,800, grew 50%
o May grew 28% vs April, and June grew 30% vs May
-- Increase in new prescriptions - grew 63%
-- Increase in first time writers - grew 157%
-- Positive clinical experiences leading to follow-up prescriptions
o High percentage of repeat writers - 73% of the HCP's who wrote
an Rx in Q1 '23 wrote another prescription in Q2
Substantial market opportunity: As the first and only FDA
approved oral iron to treat ID/IDA with a broad label, Accrufer(R)
has the potential to meet an important unmet medical need for both
physicians and patients.
Key drivers in making Accrufer(R) the oral iron treatment of
choice in the U.S. include:
-- Shield/Viatris commercial expansion, completed in May -
Build-out of the expanded, launch-savvy 100-person combined sales
team (50/50 Shield and Viatris), was completed according to plan in
May. The new, combined sales team is well-positioned to target the
12,000+ highest US prescribers.
-- Refreshed branding and new marketing campaign for patients
and prescribers - Shield launched its new, innovative "Ironic"
campaign in May, focused on taking the "irony out of oral iron"
with refreshed branding for patients and prescribers . Feedback
from the field on this new approach has been very positive.
-- New Chief Commercial Officer : Andy Hurley, hired in April
provides dedicated leadership and expertise to lead the newly
expanded commercial team to build the Accrufer(R) brand and deliver
further success for Shield.
Shield Chief Executive Officer Greg Madison commented : "I am
pleased to report that Shield's commercial growth strategy for
Accrufer(R)/Ferracru(R) is continuing to deliver encouraging
results, even at this early stage, as evidenced by progress across
each of our key performance indicators for the first half of 2023.
We've achieved this through excellent collaboration with our
partner Viatris - completing our commercial expansion, refreshing
the brand positioning and launching a bold, new innovative
marketing campaign, and increasing our presence at medical
conferences. Looking ahead, the growth in Accrufer(R) prescriptions
seen in the 2(nd) quarter provides further reason for optimism in
the second half of the year, as the still relatively new teams hit
full stride. We continue to believe there is a very substantial
market opportunity for Accrufer(R) and we are looking to identify
ways to maximise the momentum we are building in order to further
drive continued Accrufer(R) growth."
Cash and Balance Sheet Items
-- Cash on hand of US$13.6 million (unaudited) at 30 June 2023,
excluding receipt of shared marketing costs for Q2 2023 from
co-commercialization partner Viatris. Cash burn is in line with
management expectations, and cash on hand is sufficient to fund
operations to cash flow positive by end of 2024 based on internal
estimates.
-- AOP debt-to-equity conversion of US$9.5 million in the period
reduced remaining loan balance to US$5.5 million at 30 June 2023,
which is non-interest bearing for the remainder of 2023.
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/Patrick Birkholm +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/ George Dollemore/Alice
Lane/Nigel Birks/Harriet Ward +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR
Paul McManus/Lianne Applegarth/ +44 (0)20 7933 8780 or shield@walbrookpr.com
Alice Woodings
Investor Contact (US Advisor)
LifeSci Advisors, LLC
John Mullaly +1 617 429 3548 or jmullaly@lifesciadvisors.com
About Iron Deficiency and Accrufer(R)/Feraccru(R)
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(R) has the potential to meet an important unmet
medical need for both physicians and patients.
Accrufer(R)/Feraccru(R) (ferric maltol) is a novel, stable,
non-salt-based oral therapy for adults with ID/IDA.
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
that delivers Accrufer(R)/Feraccru(R) (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(R) in the
U.S. with an exclusive, multi-year collaboration agreement with
Viatris. Outside of the U.S., the Company licensed the rights to
four specialty pharmaceutical companies. Feraccru(R) is
commercialized in the UK and European Union by Norgine B.V.
(Norgine), 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
commercialization of Accrufer(R)/ Feraccru(R) in China, Hong Kong,
Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of
Korea (Korea Pharma), and with KYE Pharmaceuticals Inc. for
Canada.
Accrufer(R)/Feraccru(R) has patent coverage until the
mid-2030s.
Accrufer(R)/Feraccru(R) 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(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 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.
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