North East pharmaceuticals firm Shield Therapeutics has secured a $10m shareholder loan after seeing a strong start to the new financial year and a “transformational” 2021.
The Gateshead company’s main drug, which treats iron deficiency anaemia, was first launched in Europe under the Ferracru brand in 2019 but is now available in the US and other countries outside out Europe as Accrufer.
The company presented full year results for 2021 as well as a business update, in which is saw revenues of £1.5m, a significant drop on 2020’s £10.4m which had been boosted by a licensing deal in China. Losses for the year also widened from £2.6m to £17.9m, primarily as a result of £11.4m in costs related to the US launch activities. Net cash stood at £12.1m, up from £2.9m.
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Since the year end it said prescriptions for the iron deficiency anaemia product have doubled between Q4 of 2021 and Q1 of 2022, topping 3,900 total prescriptions during the first quarter through its 30-person sales team. Women’s health practitioners accounted for more than 50% of Accrufer prescriptions.
Shield also gained FDA approval to raise Accrufer’s product shelf life from 24 to 36 months, giving additional flexibility in manufacturing and storage timelines. It also sealed a licensing agreement in January to sell the drug in Canada.
CEO Greg Madison said: “I am extremely proud of the team here at Shield and the incredible work they have done. 12 months ago, awareness of Accrufer and its clinical application was low along with the company’s profile so it’s rewarding to stand here today with a rapidly growing business highlighted by increasing prescriptions, expanding payer coverage, growing awareness and first-time writers.
“That, coupled with a dynamic new commercial leadership team who bring not only expertise but passion and belief that we can alter the dynamics of how patients are treated for iron deficiency, with or without anaemia. Based on all our collective insights, we are even more confident today about Accrufer becoming the oral iron of choice, and the potential for significant value creation.
“The team here at Shield will continue to work tirelessly in our pursuit to ensure the millions of patients seeking treatment for their iron deficiency, will have the opportunity to experience the benefits of Accrufer.”
Meanwhile, Shield has agreed a financing transaction – subject to the approval of Shield shareholders – through an executed binding letter of intent, to extend the group’s cash runway until the end of 2022. The shareholder loan for $10m (around £8.24m) will come from AOP Orphan International AG, which owns 13.1% of the company’s share capital and is secured against the US intellectual property rights associated with Accrufer. It will be repayable in cash in the event that Shield secures a further debt or equity financing of around $30m (£24.7m) or, in any event, by December 31, 2023.
Before agreeing the shareholder loan, the company started efforts to raise $30m in equity which would have given it access to a larger debt facility but it said that “due to the extremely challenging equity market conditions it became apparent that it was unlikely such an equity financing could be closed at this time”.
Hans Peter Hasler, non-executive chairman added: “Despite the continued challenges thrown at us by the Covid-19 pandemic, Shield had a transformational 2021 which included the successful completion of a £27.6m fundraise, the launch of Accrufer in the US and a further licence agreement secured in the Republic of Korea.
“The successful fundraise enabled Shield to establish a US entity and make the product available to physicians from July 2021. I would like to acknowledge the vast expertise and dedication shown by the team to enable Accrufer to be launched in such a pivotal territory so that we can continue to realise our global ambitions of improving patients’ lives all over the world.”