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Shield Therapeutics targeting more lucrative Feraccru out-licence deals in 2019

One deal covering Europe, Australia and New Zealand helped to significantly bump up Shield’s 2018 results and the plan is to sign more lucrative agreements covering China and the US

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A decision from US regulators on Feraccru is expected by the end of July

Shield Therapeutics PLC (LON:STX) expects to sign more out-licence agreements in the coming months for Feraccru – its flagship iron deficiency treatment.

The AIM company struck a deal which gave Dutch pharma group Norgine the right to sell the drug in Europe, Australia and New Zealand towards the end of 2018.

As part of the agreement, Shield received an upfront £11mln fee, while it also stands to receive another £45mln or so in milestone payments, as well as a cut of any sales.

READ: Feraccru shows its mettle in head-to-head study

That upfront payment meant Shield recorded revenue of £11.9mln in the 12 months ended 31 December (2017: £0.6mln), while its loss narrowed significantly to £1.8mln (2017: £19.6mln).

It also means the company has enough cash to see it through until the third quarter of 2020.

The plan is to secure more of those deals, with China and the US the main targets.

Shield is waiting on approval for Feraccru from US regulators and a decision one way or the other is expected by the end of July.

Should the Food and Drug Administration give Feraccru the thumbs-up, it would allow the pill to be sold into the most lucrative medicine market in the world.

Recent data should help prove Shield’s case, with a head-to-head Phase IIIb confirming Feraccru’s “non-inferiority” to Ferinject, which is the current standard-of-care.

US approval would unlock huge market

“2018 was a year of transition and Shield is now well positioned to deliver further positive news through 2019,” said chief executive Carl Sterritt.

“I expect Norgine to continue to develop the sales performance of Feraccru in the UK and Germany, and we anticipate concluding further out-licence agreements to cover additional geographies.

“In the US I look forward to the 27 July 2019 PDUFA date, which has the potential to unlock the world's largest prescription pharmaceutical market to Feraccru, which has continued to demonstrate its effectiveness over the last 12 months in two demanding clinical trials.”

Cash runway better-than-expected

“Shield released its 2018 results this morning but having pre-released the key financial metrics earlier this year there are no surprises,” said analysts at City broker Liberum.

“The company did, however, make note of its expectation of signing an out-licensing deal in China this year as well as reiterating its belief in the strength of its IP against the on-going challenge from Teva.

“Lastly it noted that its cash runway now extends into Q3 2020 vs. our previous expectation for some time in Q2 2020.”

In a note to clients, analysts at Liberum Capital Shield pointed out that “having pre-released the key financial metrics earlier this year there are no surprises” in Shield’s final.

They added: “The key data points remains the FDA's approval decision on Feraccru due by the 27 July 2019.”

Liberum repeated a ‘buy; rating and 116p target price on Shield shares, which in early afternoon trading on Wednesday were changing hands at 73.25p each, down 4.3% on Tuesday’s close.

 -- Updates share price and analyst comment --

Quick facts: Shield Therapeutics PLC

Price: 181 GBX

LSE:STX
Market: LSE
Market Cap: £212.11 m
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Shield's Feraccru likely to command 'high market share and branded pricing'

Capital Network analyst Emma Ulker assesses recent progress made at Shield Therapeutics PLC (LON:STX) with its lead asset Feraccru. The drug's approved and marketed in Europe, with a US approval decision pending for July 27. Feraccru is an oral product absorbed in the gut. It's also...

on 11/5/19

3 min read