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")
Q3 Trading
Update
ACCRUFeR® US Net Revenues of
$7.2 million following 20% Increase in Q3 Prescriptions over Q2
and 86% increase over Q3 2023
Financial foundation
strengthened via accounts receivable financing expansion to $15
million and
implementation of a 10% cost saving plan to the Group's operating
cost base
Non-binding terms agreed
with AOP Health for the provision of $10 million of new equity to
drive growth, expecting positive cash flow by the
end of 2025
London, UK, 29 October 2024: Shield Therapeutics plc (LSE: STX), a commercial stage
pharmaceutical company specialising in iron deficiency, provides an
unaudited trading update for Q3 2024 as well as
confirming a $5 million extension to its working capital financing
facility with Sallyport Commercial Finance
("Sallyport"), the implementation of a 10% cost saving
plan to its operating cost base, and the entering into of a
non-binding term sheet with AOP Health International Management AG
("AOP Health") for the potential provision of $10 million of new
equity.
ACCRUFeR®
performance
During the third quarter of 2024, Shield
reported net revenues of $7.2 million from c.43,500 prescriptions
of ACCRUFeR® with an average net selling price of $167 ("NSP") per
prescription that included the impact of the summer buying pattern
by wholesalers and pharmacies in June and July. Excluding July, the
average NSP in Q3 was $192 per prescription and expectations are
that NSP can be maintained at a similar level throughout Q4.
Key Performance Indicators (KPIs) for Q3 2024
were:
·
Total ACCRUFeR®
Net Sales: $7.2 million, representing 4% growth
compared to $6.9 million in Q2 24 and 76% growth compared to Q3
2023. The growth rate difference between revenues and prescription
demand are due to the impact of wholesalers buying ahead of the
July 4th weekend during the last week of
June.
·
Total
Prescriptions: -c. 43,500, an increase of 20% over Q2 2024 and an 86% increase
over Q3 2023.
·
Average net selling
price: $167 per
prescription vs. $171 in Q2 2024 and $148 in Q3 2023. Excluding
July, the average net selling price in Q3 2024 was $192 per
prescription.
·
Total Group
Revenues: $8.0 million including
royalties and milestones from global partners for Q3 2024 resulting
in $20.0 million of revenue for the 9 months ended 30 September
2024. The Board's internal estimates indicate that trading remains
in line with market expectations for 2024 and is expected to meet
the total revenue covenant target of $31.5 million for full year
2024 under the debt facility agreement with SWK Funding
LLC.
Balance sheet and cash resources
At 30 September 2024 Shield held
cash and cash equivalents of $7.7 million vs. $8.1 million as at 30
June 2024.
Following analysis of the Q3 2024
ACCRUFeR® performance and the consequential impact on internal
projections, the Board has concluded that additional capital is
required whilst also taking measures to lower its operating cost
base to help achieve the Company's goal of becoming cash flow
positive by the end of 2025. Accordingly, Shield has agreed an
expansion of its working capital financing with Sallyport from $10
million to $15 million and is implementing a reduction of 10% to
its operating cost base to extend its cash runway, based on current
internal estimates, into Q2 2025. Shield has also entered into a
non-binding term sheet with AOP Health for the provision of $10
million of new equity to help the Company achieve its aim of
becoming cash flow positive by the end of calendar 2025.
Shield's rate of cash burn remains highly dependent on the sales
growth for ACCURUFeR® achieving the Company's internal
forecast.
Additional support from AOP Health
Shield's largest shareholder, AOP
Health, has executed a non-binding term sheet to subscribe for
ordinary shares of 1.5 pence each in Shield ("Ordinary Shares") at
a subscription price of 4.0 pence per Ordinary Share, to raise
aggregate gross proceeds of a minimum of $10 million (the
"Subscription"). Should the Subscription proceed, AOP Health
(excluding any of its concert parties) would come to hold shares
carrying more than 50% of the voting rights in Shield. Therefore,
the Subscription is conditional, inter alia, upon the (i) granting
of a waiver by The Panel on Takeovers and Mergers (the "Takeover
Panel") from the obligation of AOP Health to make an offer under
Rule 9 of the Takeover Code; (ii) approval of the waiver proposed
to be granted by the Takeover Panel, by an independent vote of
Shield's shareholders (excluding AOP Health and its concert
parties), at a meeting of Shield's shareholders (the "General
Meeting"); and (iii) approval of the issue and allotment of the
Ordinary Shares in connection with the Subscription for the
purposes of the Companies Act 2006, at the General Meeting. The
Subscription would also be a related party transaction under the
AIM Rules. Further details of the Subscription and the
General Meeting will be made available to the public via the
Regulatory Information Service and will be included in a circular
to be posted to Shield's shareholders and made available on
Shield's website in Q4 2024. Shield may incorporate a broader
equity offering to existing shareholders and other investors should
the Subscription proceed.
If the Subscription is approved by
Shield shareholders, AOP Health and their concert parties would
subsequently be able to increase its aggregate interest in Ordinary
Shares without incurring any obligation to make an offer for the
Company under Rule 9 of the Takeover Code.
There can be no certainty that the
Subscription will proceed, and Shield will make further
announcements as required.
Anders Lundstrom, Interim Chief Executive Officer,
commented: "It has been another successful quarter for
Shield as we work towards becoming cash flow positive by the end of
FY 2025. We continue to see increased demand for ACCRUFeR® in the
US and across all our territories. Net sales, total prescriptions
and the net selling price of ACCRUFeR® are all showing positive
trends, and with a strengthened balance sheet and tight control of
our cost base we will continue to build momentum behind ACCRUFeR®
and make the steps required to transition to cash flow positive by
the end of 2025."
Investor presentation
Interim CEO, Anders Lundstrom, and
CFO, Santosh Shanbhag, will be hosting a live online presentation
relating to the Q3 trading update via the Investor Meet Company
platform at 2pm (GMT) on Thursday 31
October 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 9am
(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
Investors who already follow Shield
Therapeutics plc on the Investor Meet Company platform will
automatically be invited.
For further
information please contact:
Shield Therapeutics plc
|
www.shieldtherapeutics.com
|
Anders Lundstrom, interim
CEO
Santosh Shanbhag, CFO
|
+44 (0)
191 511 8500
|
Nominated Adviser and Joint Broker
|
|
Peel Hunt LLP
|
|
James Steel/Patrick
Birkholm
|
+44 (0)20
7418 8900
|
|
|
Joint Broker
Cavendish Ltd
Geoff Nash/ Rory Sale /Nigel
Birks/Harriet
Ward
|
+44 (0)20
7220 0500
|
|
|
Financial PR & IR Advisor
|
|
Walbrook PR
|
|
Lianne Applegarth / Alice
Woodings
|
+44 (0)20
7933 8780 or shield@walbrookpr.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 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.
ACCRUFeR®/FeRACCRU® (ferric maltol)
is a novel, stable, non-salt-based oral therapy for adults with
ID/IDA. 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 and 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 collaboration agreement with 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., 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, 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.