Shield Thera Regulatory News (STX)

Shield Therapeutics plc

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

Shield Therapeutics and Viatris sign Collaborative Sales Agreement for Accrufer® in the United States

Accelerates revenue growth for Accrufer® in $2 billion oral iron market in the US

Agreement significantly Expands Commercial Resources for Accrufer®, and leverages Viatris' well established US commercial infrastructure

London, UK - December 13, 2022: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company focused on the commercialization of Accrufer®/Feraccru® (ferric maltol), today announced that it has entered into an exclusive, multi-year agreement with Viatris Inc. (NASDAQ: VTRS), a global healthcare company, to co-commercialize Accrufer® (ferric maltol), a novel, oral iron therapy differentiated from other conventional irons by its efficacy, well-tolerated formulation, and broad indication, in the United States.

The oral iron market in the United States is an estimated US$2 billion market opportunity, and Accrufer® is the only FDA approved oral iron to treat iron deficiency, with or without anemia. This new collaboration expands the commercial footprint and resources for Accrufer®, as the brand aspires to be the oral iron of choice in the US market. The collaboration will result in a 100 person sales team who will promote Accrufer® to over 12,000 Health Care Professionals who write the majority of oral iron prescriptions. In addition, Shield and Viatris will also deploy additional resources in digital marketing, market access, distribution and commercial operations via a shared cost model.

Greg Madison, Shield CEO, commented: "We are thrilled to work with Viatris via the company's unique Global Healthcare Gateway®, in bringing Accrufer® to patients suffering from iron deficiency, with or without anemia. Shield has built a solid foundation for Accrufer® since our launch with a small commercial sales team and we believe this agreement with Viatris will markedly accelerate the adoption and growth of Accrufer®. Viatris' well established commercial infrastructure including strong prescriber relationships, best in class digital marketing and direct to patient capabilities, and extensive market access experience makes them an ideal partner for Shield and Accrufer®. Working together with Viatris, I believe Accrufer® can become the oral iron treatment of choice and we look forward to getting started right away."

Jose Cotarelo, Head of North America, Viatris, commented: "We are excited that through our Global Healthcare Gateway® we have become the Partner of Choice® for Shield to support the commercialization of Accrufer® in the U.S. 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."

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 its own respective sales force and related selling costs.

Evolution Life Science Partners acted as strategic advisor for Shield Therapeutics, plc

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About Accrufer®/Feraccru®

Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt based oral therapy for adults with iron deficiency, with or without anemia. Accrufer®/Feraccru® has a novel mechanism of action 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 with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol). The Group has launched Accrufer® in the US. Feraccru® is commercialized in the UK and European Union by Norgine B.V., who also have the 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. in the Republic of Korea, and with KYE Pharmaceuticals Inc. in Canada.

Accrufer®/Feraccru® has patent coverage until the mid-2030s

Accrufer®/Feraccru® are registered trademarks of the Shield Group