TIDMSTX
RNS Number : 7763L
Shield Therapeutics PLC
15 January 2021
Shield Therapeutics plc
("Shield" or the "Group" or the "Company")
Business and trading update
London, UK, 15 January 2021: Shield Therapeutics plc (LSE: STX),
a commercial stage pharmaceutical company with a focus on
addressing iron deficiency with its lead product
Feraccru(R)/Accrufer(R) (ferric maltol), provides a business and
unaudited trading update for the year ended 31 December 2020.
Operational highlights
-- Feraccru(R) 2020 sales volumes in Europe increased by 70% year-on-year
-- China IND application submitted
-- First stage of paediatric study plan completed
-- Teva challenge to Shield's European patents withdrawn
-- Shield continues to evaluate options for launching Accrufer(R) in the US
-- US partnering discussions remain ongoing with a number of parties
Financial highlights
-- Trading for the year was in line with market expectations
-- Revenues for 2020 expected to be GBP9.4 million (2019: GBP0.7 million)
-- Cash position as at 31 December 2020 was GBP2.9 million (2019: GBP4.1 million)
-- Shareholder loan facilities provide means to extend cash runway until late 2021
Business update
US commercialisation
As reported in December 2020, we are currently evaluating both
out-licensing and Shield-led alternatives for the launch and
commercialisation of Accrufer(R) in the US. Discussions are ongoing
with a number of potential out-licencing partners. Preparation of a
Shield-led launch is being led by a US commercial team comprising
four managers who have extensive experience of launching and
commercialising multiple pharmaceutical products in the US. The
work in the US is well advanced and covers preparations for all
activities and organisational matters which will be implemented
quickly should we decide to launch Accrufer(R) ourselves including
the supply chain, pricing and market access, selling and marketing,
and regulatory compliance. Discussions are also taking place with
several companies which could co-promote or sub-license Accrufer(R)
in specific therapy areas which could complement a Shield led
launch. Launch stocks of Accrufer(R) have been manufactured in
readiness for whichever option we choose. We are also evaluating
various alternatives for the financing of the $30 million - $40
million we estimate the Group needs to reach cash flow break even
in the event of the Shield-led launch.
Europe
The number of Feraccru(R) packs sold in Germany and the UK
increased by around 70% in 2020 compared with 2019. Shield's
revenue arising from these sales is expected to be GBP0.7 million
(2019: GBP0.6 million), an increase of 18%. This is less than the
stated headline 70% increase in packs sold because 2019 revenue was
inflated by the initial sale of Shield's inventory of Feraccru(R)
packs to Norgine when Norgine took over marketing from Shield in
early 2019. Sales and marketing activities have inevitably been
impacted by the coronavirus pandemic, particularly in the UK, but
demand for Feraccru(R) has increased and there are signs that
patients and their doctors are becoming more wary of being treated
with intravenous iron which requires hospital visits.
Norgine are using the updated AEGIS H2H detailed study results
to reconfirm pricing and reimbursement strategy for Feraccru(R) in
the major European markets of France, Italy and Spain.
China
ASK Pharm, our licence partner in China has submitted the
Investigational New Drug (IND) application for Feraccru(R) to the
Chinese regulatory authorities. As we have previously reported, it
is probable that the authorities will require only one further
study, expected to be a 12-week Phase III study in 120 inflammatory
bowel disease patients. Clinical supplies have been manufactured
for the study which could get underway in H1 2021. The study is
expected to complete during 2022 and marketing approval and product
launch could follow in 2023. On approval, Shield is due to receive
an $11.4 million milestone payment from ASK Pharm and tiered
royalties of 10% or 15% of net sales.
Business development
Although the US has been our commercialisation priority, during
2020 we have continued to have discussions with potential partners
in several other countries and are aiming to complete a new licence
transaction in 2021.
Paediatric study
The first stage of the paediatric study plan, which was to
compare the relative bioavailability of the liquid formulation
required for children with the adult capsule, completed during Q4
2020. The study report from this stage will be completed by the end
of Q1 2021 and we expect to be able to start the main paediatric
study in 120 children around mid-2021. Successful completion of
this study could lead to expansion of the available market and
potentially further patent protection.
Reanalysis of AEGIS-H2H study
The reanalysis of the H2H (head-to-head) study in which
Feraccru(R)/Accrufer(R) was compared with intravenous iron
demonstrated that Feraccru(R)/Accrufer(R) is a credible alternative
to IV therapy for iron deficiency anaemia, and maintains
haemoglobin levels over the long term. A manuscript covering this
study has been submitted to a relevant journal for peer-reviewed
publication in due course.
Manufacturing
Towards the end of 2020 we successfully converted Feraccru(R)
capsules from gelatin to HPMC (hydroxypropyl methylcellulose) which
provides an improved product with regards to stability and are more
suitable for vegetarians and vegans. Also the FDA have approved an
immediate extension to the shelf life of Accrufer(R) packs from 21
months to 24 months and ongoing studies should, in due course,
demonstrate stability out to 36 months.
Intellectual property
As we reported in October 2020, following the filing of Shield's
defence, Teva Pharmaceuticals has withdrawn both its appeal against
the European Patent Office's decision with regard to Shield's
patent No.2668175, which covers a "Process for preparing an iron
hydroxypyrone" and their opposition with regard to Shield's patent
No.3160951 which covers "Crystalline Forms of Ferric Maltol." For
the latter patent, this means that the patent will continue to
provide protection through to October 2035.
Financial update
Unaudited revenues of GBP9.4 million for 2020 (2019: GBP0.7
million), include GBP8.7 million from the upfront payment received
from ASK Pharm on signing of the licence agreement covering China,
Taiwan, Hong Kong and Macau. A further GBP0.7 million came from
royalties relating to Norgine's sales of Feraccru(R) in Europe.
The Group's cash balances at 31 December 2020 amounted to GBP2.9
million (2019: GBP4.1 million). As previously reported, loan
facilities from two shareholders amounting to approximately GBP4.4
million would allow the Group to extend the Group's cash runway
until late 2021.
Commenting on this update, Tim Watts, CEO of Shield Therapeutics
plc, said: "2020 has been a positive year for Shield on many
fronts. European sales volume growth of around 70% despite the
COVID pandemic is very encouraging for the long term with launches
still to come in France, Italy and Spain and many other European
markets, and the withdrawal of Teva's opposition to our European
patents has removed a significant uncertainty. Progress by ASK
Pharm in defining the necessary development path to product
approval suggests that a launch in the huge market of China is
possible by 2023. In the US our knowledge of the iron deficiency
market and the great opportunity for Accrufer(R) has developed
massively during the year such that we are now evaluating a
Shield-led launch in the US as an alternative to out-licensing the
product. We aim to give clarity on the US by the end of March and I
am sure that 2021 will be a transformational year for Shield."
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Tim Watts, CEO +44 (0)20 7186 8500
Nominated Adviser and Joint
Broker
Peel Hunt LLP
James Steel/Dr Christopher
Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/Matt Radley/Alice
Lane +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR +44 (0)20 7933 8780 or shield@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7584 391
Paul McManus/Lianne Cawthorne 303
About Shield Therapeutics plc
Shield is a de-risked, specialty pharmaceutical company focused
on commercialising its lead product, Feraccru(R)/Accrufer(R), a
novel, non-salt based oral therapy for adults with iron deficiency
with or without anaemia. Feraccru(R)/Accrufer(R) has been approved
for use in the United States, European Union, UK and Switzerland
and has exclusive IP rights until the mid-2030s. Feraccru(R) is
commercialised in the UK and European Union by Norgine B.V. and the
Company is currently in the process of evaluating commercialisation
options for the US market, including the potential launch of
Accrufer (R) in the US by Shield. Shield also has an exclusive
licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialisation of
Feraccru(R)/Accrufer(R) in China, Hong Kong, Macau and Taiwan.
For more information, please visit www.shieldtherapeutics.com .
Follow Shield on Twitter @ShieldTx
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