GCISTX hails ‘transformational’ 2020 while it prepares for US launch of Accrufer®
(STX ) has looked back on the year ended 31 December 2020 as “transformational” as the group now prepares for the US launch of Accrufer® in June.
The commercial stage pharmaceutical firm which is focused on treating iron deficiency posted revenue for the year at £10.4m (2019: £0.7m) with £9.7m of this due to the $11.4m received from ASK Pharm on the signing of the Chinese licence agreement in January 2020.
Over the period, Shield slashed its losses to £2.6m from £8.8m in 2019 while operational cash inflow before working capital movements was reported at £1.3m for the year.
Following anomalies that surfaced in March 2020 regarding the analysis of data from the AEGIS-H2H clinical study, Shield conducted a full data re-analysis which compared Feraccru®/Accrufer®, an oral product, with intravenous iron therapy over a 52-week period.
Within this study, Feraccru®/Accrufer® was identified to be a ‘highly credible alternative’ to IV therapy, particularly for maintaining haemoglobin levels over the long term, It noted.
Shield said its ‘most significant effort’ in 2020 was finding a route to the US market for Accrufer®. After several discussions with potential partners, Shield decided to self-launch, a move which it believes can generate greater value for shareholders than a licence deal.
As at 31 December 2020, Shield held cash of £2.9m (2019: £4.1m). In addition, last month, shareholders approved an equity fundraise which raised £27.8 m net of expenses and as a result, the Group's unaudited cash balance as at 31 March 2021 stood at £28.2m which the Group plans to utilise to launch Accrufer® in the US during the second quarter of 2021.
The Board anticipates that rising sales of Accrufer® in the US should result in the Company’s monthly cash flow turning positive between 15-18 months after the initial launch as well as hold the potential for net sales to reach $100 million in the third year after launch.
‘Instead of receiving a royalty stream, perhaps averaging 15%-20%, on a US partner's sales, we will now benefit from a high margin product whose sales could grow to $300 million to $400m over the next five to six years and which is patent protected until 2035,’ it noted.
Shield said it will also incur the costs of the main stage of the paediatric study which is expected to start in mid-2021 and last for 2-2½ years and cost c.£4.5m over that time.
“The last fifteen months have presented a number of challenges, including the pandemic, and I am very proud of the way in which our employees have worked tirelessly to overcome the challenges and would like to thank them all for their contribution,” said CEO, Tim Watts.
He said, “However I believe Shield this period has been transformational for Shield and the Group is now well placed for substantial future growth. I am excited about the prospects for Accrufer®, which we remain on track to launch in the US by the end of June 2021, and we will update shareholders in mid-May as to our progress towards the US launch."
View from Vox
Shield Therapeutics has told investors that it believes the first US launch of an oral HIF inhibitor for chronic kidney disease (CKD) patients, which is anticipated for next quarter, ‘is likely to increase the need for effective and well tolerated oral iron replacement therapy.’
Shield has stated that the US market opportunity for Accrufer® is ‘substantial and growing’ and in Shield's head-to-head study, Accrufer® was identified to be a credible alternative to IV therapy particularly for maintaining haemoglobin levels over the long term.
Potential sales estimates for Accrufer® in the US are forecasted to exceed $100 million from the third year following launch and to reach $300 million-$400 million by years five to six.
Despite shares having more than halved in recent months following the news that STX would not be signing a US marketing deal before the end of 2020, STX’s Directors believe its recent fundraising fulfils the necessary requirements for a Shield-led US launch of Accrufer®, a pathway they view as having the potential to generate significant returns for shareholders.
Shares in Shield Therapeutics were trading 7.69% higher today at 49p following the news.
Reasons to STX
Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru®/Accrufer®, a novel, non-salt based oral therapy for adults with iron deficiency with or without anaemia.
Proven and Approved
The Group’s Feraccru®/Accrufer® product has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru® is commercialised across the UK and European Union by Norgine B.V. and the Company is currently in the process of evaluating commercialisation options for the US market, including the potential launch of Accrufer® in the US by Shield.
Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical to develop and commercialise Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.
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