Shield Therapeutics : 2022 Annual Report and Accounts

Investment case

1

Large US defined market

~20 million individuals with anaemia1

13.4 million annual oral iron prescriptions (OTC)

2

FDA approved potential best in class solution

Accrufer®, an FDA approved therapy, oral iron solution with minimal (<5%) gastrointestinal adverse reactions* and discontinuations2

3

Viatris collaborative sales agreement

Increase Accrufer® adoption and revenues

100-person combined sales team to call on 12,000+ HCPs

4

Unmet need

Conventional irons (OTC) have poor tolerability and high discontinuation rates mainly due to gastrointestinal side effects

5

Experienced team

Senior leadership team has extensive US commercial experience building brands and launching new products

6

Strong resources and significant revenue potential

Recent fundraise of US$35.1 million allows potential to cash flow breakeven by year end 2024

US$2.3 billion market opportunity** Patent coverage through to mid-2030s

Shield is a commercial stage pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol), a novel, stable, non-salt-based oral therapy for adults with iron deficiency, with or without anaemia.

Shield's proprietary lead product, Accrufer®/Feraccru®, has been approved for use in the US, the EU, the UK, Australia and Switzerland.

The product has patent coverage until the mid-2030s. The Group launched Accrufer® in the US with an exclusive, multi-year collaboration agreement with Viatris Inc. Feraccru®

is commercialised in the UK and European Union by Norgine B.V.,

that also have the marketing rights in Australia and New Zealand. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation 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.

Licence Agreement in Canada for Accrufer® with KYE Pharmaceuticals

Execution of convertible shareholder loan of US$10m from AOP Health

Execution of Collaborative Sales Agreement for Accrufer® in US with Viatris

2020

Licence Agreement in China for

Feraccru® with ASK Pharma

2018

Licence Agreement in Europe, Australia

and New Zealand for Feraccru® with Norgine

Completion of Phase III study in CKD (US NDA enabling)

2013

Completion of Phase III study in IBD (EU MAA-enabling)

2010

Commitment by first corporate investor (AOP Health)

Acquisition of ST10 asset from Vitra Pharma

2008

2023

Completion of US$20m (£16m) equity raise

Amendment of convertible shareholder loan to increase balance to US$20m

2021

Completion of US$38m (£27m) equity raise US Launch of Accrufer®

Licence Agreement in Korea for Accrufer® with Korea Pharma

2019

FDA approves Accrufer® for treatment of iron deficiency in adults

2016

Issuance of marketing authorisation for Feraccru® by EMA

Admission to London Stock Exchange's AIM Market

2011

VC funding with investment from W Health (Inventages)

2008

Shield Therapeutics Limited formed and registered in the UK

Strategic collaboration announced with Viatris Inc.

Shield Therapeutics and Viatris sign Collaborative Sales Agreement for Accrufer® in the United States (December 2022)

Strategic

Key terms of agreement include:

• Upfront payment: Shield will receive a US$5 million one-time payment
• Milestone payments: Viatris will pay Shield a series of sales milestones up to a total of US$30 million, linked to annual net sales ranging from US$100 million to US$250 million
• Revenue split and marketing costs: Shield and Viatris will share revenues and marketing expenses following an agreed upon split between them, with Shield retaining a slightly higher percentage of each. Companies will pay for their own respective sales force and related selling costs

We are excited that through our Global Healthcare Gateway® we have become the Partner of Choice® for Shield to support the commercialisation of Accrufer® in the US and thus expand access to those living with iron deficiency. This collaboration is a great opportunity to leverage our commercial capabilities while furthering Viatris' mission to empower people worldwide to live healthier at every stage of life."

Jose Cotarelo

Head of North America, Viatris

report