Shield Thera Regulatory News (STX)

Shield Therapeutics plc

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

Q3 2023 U.S. Commercial Highlights

Continued U.S. Accrufer® Growth Momentum for Q3 2023, with Strong KPIs

Increase in average net selling price of 24% to $148/prescription

Total Q3 2023 U.S. net revenue of $4.1 million

Prescriptions for Q3 2023 increased 76% sequentially, exceeding 54,000 for the first nine months of 2023

London, UK, 07 December, 2023:  Shield Therapeutics plc (LSE: STX, "Shield"), a commercial stage pharmaceutical company that delivers Accrufer®/Feraccru® (ferric maltol), an innovative and differentiated specialty pharmaceutical product, to address a significant unmet medical need for patients suffering from iron deficiency (with or without anemia) today summarizes key highlights of the Q3 2023 U.S. commercialization for Accrufer®, including total prescriptions of more than 54,000 for the first nine months of 2023, and 76% sequential quarterly growth in prescriptions to over 27,750, for Q3 2023.

Key Q3 Results (all percent comparisons are sequential to Q2 2023 unless otherwise indicated)

· Total Prescriptions -- Over 27,750, increased 76%

· Average Net Selling Price - Increase of 24% to $148/prescription compared to H1 2023

· Revenue - U.S. Q3 net revenue of $4.1MM (unaudited)

· New Prescriptions - increased 87%

· First time writers -- increased 27%

· Repeat Writers - 77% of the HCP's who wrote an Rx in Q3 2023 had also written one in Q2 2023

Greg Madison, CEO of Shield Therapeutics, commented: "Shield continues to make excellent progress on the U.S. commercial launch of Accrufer®. As we approach the one-year anniversary of the announcement of the Viatris agreement, I am pleased to report that the collaboration continues to deliver excellent results, based on the stand-out performance of the combined commercial team, which has produced consistent and strong sequential prescription growth and key performance indicators (KPI), which are trending towards previous guidance. In addition, we have made positive strides towards our goal of increasing our average net selling price and expect further progress in 2024.

"Reflecting on our year-to-date performance, I am proud to share that we continue to stay focused on our goal of making Accrufer® the "oral iron of choice" and a trusted brand for patients and providers in the U.S. and beyond," continued Mr. Madison. "We are building a strong and dedicated team, underscored by the recent addition of our Vice President of Marketing, Emily Bulat, and continue our progress towards the recruitment of a new Chief Financial Officer. I remain very optimistic about the growth prospects for Accrufer® as we look ahead to 2024."  

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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 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 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.