20 September 2017

Shield Therapeutics plc - Interim Report for the Six Months Ended 30 June 2017

 

 

London, UK, 20 September 2017. Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, today announces its unaudited interim results for the six months ended 30 June 2017.

 

Highlights (including post period end)

Operational

  • Continued focus on early Feraccru® commercialisation initiatives in our first European target markets:
    • Commercial team reorganised with Country Managers now reporting directly to the CEO to deliver increased focus on sales traction and maximise resources
    • More than 20 specialist staff driving product recognition and sales ramp in Germany and the UK
    • Application submitted to the EMA to extend the label for Feraccru to all patients with IDA
  • Delivering on strategy to out-license Feraccru across non-core markets via agreement with AOP for Scandinavia and Ewopharma for Switzerland
  • Clinical progress across multiple trials:
    • The AEGIS-CKD pivotal Phase 3 study has recruited 97% of the required subjects with Last Patient In expected imminently, resulting in primary top line data expected in early 2018
    • AEGIS-H2H study progressing as per previous guidance, with data expected in H1 2018
    • Data from the paediatric pharmaco-kinetic study also expected in H1 2018
  • Pre-approval notification for Feraccru was received from the Swiss regulatory authority in June 2017 with first revenues from our recently signed commercial partner expected in early 2018
  • Significant new patent grants received for Feraccru’s Composition of Matter patent extending and enhancing the product’s IP coverage from 2023 through to 2035 in the USA, Europe, Australia, and Canada

Financial

  • Reported revenues of £142,000 (H1 2016: £240,000, which included initial stocking orders in UK) 
  • H1 2017 ‘in market demand’ (the metric Shield uses to represent the number of packs being sold to patients) and partner revenues together totalled c. £0.18 million meeting guidance stated at the time of the June 2017 equity financing
  • Net loss of £9.6m (H1 2016: £8.9m);
  • Adjusted net loss (excluding exceptional items) of £8.4m (H1 2016: £5.1m);
  • Net cash of £21.5m (H1 2016: £28.5m), which includes net proceeds raised during the period via the warrant exercise and placing of £11.9m net.

Board and Management

The Board has appointed Dr Karl Keegan as interim CFO following Joanne Estell’s recent resignation.  Furthermore, having undertaken a detailed review of operational effectiveness the Company has reorganised its commercialisation operations to a more country-focused ‘in-market’ structure with the General Managers now reporting directly to the CEO.  This has resulted in a small number of central commercial staff leaving the organisation, including Paul Steckler, the head of our central commercial operations.  The Group does not intend to replace these positions.

 

“Shield has continued to make progress in bringing the substantial benefits of Feraccru to IDA patients with IBD in Germany and the UK. Frustratingly, whilst prescriber, clinical investigator and patient feedback on the positive impact of Feraccru has continued to be reassuringly positive, recent market penetration has been slower than originally anticipated due to certain short term operational issues. We believe the issues are being addressed by more focus on in-country operations. Considering Feraccru’s potential more widely, in addition to continuing to successfully out-licence Feraccru in additional markets, we have also been granted a composition of matter patent in Europe and the USA, which now provides broad commercial protection through 2035. Also, we have submitted an application to the EMA to extend the label for Feraccru to all patients with IDA and the approval of this application in early 2018 would open up the larger commercial opportunity across Europe earlier than originally anticipated. We will also be ready to take full advantage of the positive data we anticipate generating from the soon to report AEGIS-CKD study, which is expected to facilitate a regulatory filing in the USA and increase the current 330,000 patient opportunity for Feraccru in IBD-IDA in Europe to upwards of 2.5 million patients with IBD or CKD related IDA in the EU5 and the USA. Finally, I was also pleased we augmented our balance sheet through the £11.9m net proceeds raised from the warrant exercise and placing in June. The Group has a clear strategy upon which we continue to focus and I look forward to announcing further progress in the coming months.”

Carl Sterritt

CEO of Shield Therapeutics plc

Webcast and conference call for analysts

A briefing for analysts will be held at 9.30am BST on 20 September 2017 in the Guildhall Room at 85 Gresham Street, London EC2V 7NQ. There will be a simultaneous webcast and live conference call with Q&A. The presentation and access to the webcast will be on Shield’s website at  www.shieldtherapeutics.com.

Dial in details:

Participant local dial-in:                                                                                          +44 (0) 1452 555566

Participant free phone dial-in:                                                                                           08006940257

Participant code:                                                                                                                     79287285

To access the audio webcast, please follow this link or alternatively visit the Shield Therapeutics investor relations page.

An audio replay file will be made available shortly afterwards via the Company website: www.shieldtherapeutics.com

 

 

For further information please contact:

 

Shield Therapeutics plc                                                                                            +44 (0)207 186 8500

Carl Sterritt, Chief Executive Officer

Karl Keegan, Interim Chief Financial Officer

 

Nominated Advisor and Joint Broker                                                                         +44 (0)203 100 2222

Liberum Capital Limited

Christopher Britton/Steve Pearce

 

Joint Broker                                                                                                              +44 (0)207 418 8900

Peel Hunt LLP

James Steel/Dr Christopher Golden

 

Financial PR Advisor                                                                                                 +44 (0)203 709 5700

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal

 

US Investor Relations                                                                                                  +1 (212) 867 1762

Lazar Partners                                                                                            

Fern Lazar/David Carey

 

 

About Shield Therapeutics plc

Shield Therapeutics is a specialty pharmaceutical company focused on the commercialisation and development of late-stage, hospital-focused pharmaceuticals which address areas of unmet medical need.  Our clear purpose is to help our patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives.  The Group has a marketed product, Feraccru, for the treatment of iron deficiency anaemia (IDA) in adult patients with inflammatory bowel disease (IBD) which has exclusive IP rights until the mid-2030s in key territories.  Shield Therapeutics, headquartered in London, is listed on LSE's AIM under the ticker STX.  For more information please visit www.shieldtherapeutics.com.

 

Glossary

CCG – clinical commissioning groups

IDA – Iron Deficiency Anaemia

IBD – Inflammatory Bowel Disease

MAA – Marketing Authorisation Approval

 

Note

This announcement is released by Shield Therapeutics plc and contains inside information for the purposes of the Market Abuse Regulation (EU) 596/2014 ("MAR") and is disclosed in accordance with the Company's obligations under Article 17 of MAR. The person who arranged for the release of this announcement on behalf of Shield Therapeutics plc was Carl Sterritt, Chief Executive Officer.

 

 

*** Please see click here for full Interim report ***


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