Unaudited Full Year Trading Update

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

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.

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.