REG - Shield Therapeutics - Unaudited Full Year Trading Update

Shield TherapeuticsAnnouncement

21/02/2024 07:00

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RNS Number : 8985D  Shield Therapeutics PLC  21 February 2024

 

Shield Therapeutics plc

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

 

Unaudited Full Year Trading Update

 

Full year 2023 total revenue and other income of $17.5m compared to $6.2m in
2022

 

Full year 2023 Accrufer® revenue of $11.6m, approximately three times more
than the prior year

 

21% increase in H2 Accrufer® average net selling price to $145/prescription

 

London, UK, 21 February 2024: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company that delivers Accrufer®/Feraccru®
(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) today announces topline results for Q4
2023 and provides an unaudited trading update for the year ended 31 December
2023 ("FY23").

 

The operational progress made by Shield and its partnership with Viatris to
create a new 100-person sales team, increase payer coverage, launch new brand
campaigns, and ultimately deliver a tripling of U.S. Accrufer® prescriptions
and revenues in 2023 - has been notable. In addition, recent market research
reaffirms the unmet need in Accrufer's® target patient population, as
healthcare professionals and patients continue to seek a well-tolerated and
effective oral iron. During the fourth quarter of 2023, Shield strengthened
its sales leadership and marketing organizations which will help drive more
focused execution and prescription growth. The Company has also seen positive
improvements in its gross-to-net in 2023 and expects that to accelerate
further in 2024.

 

Business Metrics:

·    Cash: $13.9m as of 31 December 2023

·    Total 2023 revenue and other income: $17.5m, a 2.8x increase over
FY22

o  Accrufer® revenue: $11.6m, a 3.1x increase over FY22

o  Ex-U.S. revenue: $1.5m

o  Other income revenue including Viatris milestone payments: $4.4m

·    U.S. Q4 2023 Revenue: $4.3m

·    Average net selling price: c.$145/prescription in H2 2023, an
increase of c.21% compared with H1 2023

·    Total 2023 Prescriptions: c.77k, a 3.1x increase over FY22

 

Shield has recently identified that the projection methodology used by its
third-party data provider resulted in an overstatement of total prescriptions
in 2023. This development was partly responsible for the Group not achieving
previously indicated guidance of total prescriptions in FY23 of 100k to 130k.
Revised prescription numbers and quarterly growth rates are included in the
table below. Previously reported Group financials including revenues, net
revenues per Accrufer® prescription, and compliance with financial covenants
on the Group's debt instrument are not affected by this change. The Company is
working closely with its third-party data provider to ensure future
consistency of data reporting.

 

 2023 Accrufer® Rx
 In thousands        Q1    Q2    Q3    Q4    2023
 Prior Reported TRx  10.5  15.8  27.8  36.4  90.5
 Updated TRx         10.1  14.9  23.3  28.6  77.0
 Actual Growth Rate  --    47%   58%   22%   206%

 

With these revised prescription numbers, Shield is revisiting its previously
communicated guidance and plans to provide additional updates at the time of
the Company's final results, expected to be published in April 2024. Shield
has also undertaken several important measures to manage its cash flow,
including the reduction of operating expenses, and working capital
enhancements, to provide the necessary resources with the aim of turning cash
flow positive in the second half of 2025.

 

Greg Madison, CEO of Shield Therapeutics, said: "The progress made in the
market in 2023 has shown us that the opportunity for Accrufer® continues to
be significant. Quarterly prescription numbers grew throughout the year and we
saw a significant improvement in the average net selling price in the second
half. I'm also excited our new CFO, Santosh Shanbhag, has joined the team
bringing both strategic and financial leadership to our organization. Our
partnership with Viatris continues to progress very well and we remain
steadfast in our goal to make Accrufer® the oral iron of choice for
patients."

 

Investor presentation

CEO, Greg Madison, and CFO, Santosh Shanbhag, will be hosting a live online
presentation relating to the trading update via the Investor Meet Company
platform at 14:00 (GMT) on Thursday 22 February 2024.

 

The presentation is open to all existing and potential investors. Questions
can be submitted pre-event via your Investor Meet Company dashboard up until
09:00 (GMT) the day before the meeting 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.

 

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 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.

 

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Greg Madison, CEO                                                                              +44 (0) 191 511 8500
 Santosh Shanbhag, CFO

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel/Patrick Birkholm                                                                   +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ George Dollemore/Nigel Birks/Harriet                                               +44 (0)20 7220 0500
 Ward

 Financial PR & IR Advisor
 Walbrook PR
 Paul McManus/Charlotte Edgar/                                                                  +44 (0)20 7933 8780

                                                                                              shield@walbrookpr.com (mailto:shield@walbrookpr.com)
 Alice Woodings

 Investor Contact (US Advisor)

 LifeSci Advisors, LLC

 Joyce Allaire                                                                                  jallaire@lifesciadvisors.com

 

 

 

 

 

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 U.S. 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.

 

Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. Accrufer®/Feraccru® 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 commercial
agreement with Viatris Inc. (Viatris). Outside of the U.S., the Company has
licensed the rights to four specialty pharmaceutical companies. Feraccru® 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®/ Feraccru® 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®/Feraccru® has patent coverage until the mid-2030s.

 

Accrufer®/Feraccru® 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®/Feraccru®. 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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