Shield Therapeutics (STX ) has reported significant progress in the last two months since the successful fundraise in March 2021.
Whilst there are still some critical dependencies on third parties, including companies setting up services for us and Government agencies which could potentially disrupt its plans, Management believe they remain on track for the US launch by the end of June 2021.
Since the fundraise in mid-March 2021, preparatory work has accelerated dramatically with five key workstreams underway:
Establishing operational capability - Shield has now established Shield Therapeutics, Inc., a wholly-owned US subsidiary of Shield Therapeutics plc., and in the process of setting up the product supply chain and delivery logistics. Product will be in stocks at the Company’s wholesaler by mid-June.
Marketing - Market research amongst prescribers continues to support the Company's belief that Accrufer® has the potential to address a large unmet medical need.
Branding - The brand strategy will include a fully integrated marketing plan including both personal and non-personal promotion.
Sales - Working in conjunction with a well-established contract sales organisation, Shield now has a scalable sales team that will be working to build awareness and educate health care providers on the clinical value of Accrufer®. This sales organisation will be 100% dedicated to the promotion of Accrufer®. At launch, Shield will have 30 sales representatives, trained and ready to promote Accrufer®.
Medical Affairs - The medical affairs team will provide scientific and clinical support to the medical community with comprehensive collateral and materials healthcare professionals have come to expect from Shield. All materials will be made available online and through a team of medical science liaison (“MSL”) employees. The Company also plans to run several Advisory Board meetings targeted at relevant specialists and Key Opinion Leaders in the field between late May and mid-July.
Market Access – The Market access team will address price setting and discounting with US payers, which include private insurance plans and the Federal Medicare and Medicaid plans. The team will also develop mechanisms to support patients by reducing patient co-pay requirements. The headline price of a pharmaceutical product in the US is known as the Wholesaler Acquisition Cost (WAC) and for Accrufer® this has been set at $500 per pack (which contains 30 days' supply at two capsules per day) and has now been published by First Data Bank and Red Book.
National Account Managers – NAMs are already actively engaging payer organisations to provide their patients access to Accrufer®. This process is underway but it will take 12-18 months before we have comprehensive coverage across a large proportion of payers and our sales forecasts in the early months take account of this.
Commenting on the progress to date, Tim Watts, CEO of Shield Therapeutics plc, said: "A huge amount has been achieved in the last two months since the fundraise completed and I am very grateful to all Shield employees, and in particular to Brian Groch and his US team, for the efforts they are making to prepare for launch. This is a very exciting time for Shield and I am looking forward immensely to the Accrufer® launch and the large opportunity available."
View from Vox
Shield Therapeutics has said it believes 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.
In addition, today’s news that the company has acquired an additional listing on this US market is expected to increase STX’s visibility to US investors ahead of Accrufer®’s launch.
Despite shares having more than halved in recent months towards 33p, following the news that STX would not be signing a US marketing deal before the end of 2020, the shares have since recovered strongly to open up at 56.5p with investors now clear on the progress being made in the US and the pathway to generate significant revenue becoming clearer to the market.
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.