22 February 2018
Business and Trading Update
Change of results date for the year ended 31 December 2017
Revenues for the year ended 31 December 2017 expected to be £637,000 (2016: £304,000), in line with Board expectations
Year-end unaudited cash position was £13.3m (2016: £21.0m)
Cost rationalisation programme being implemented
Current cash runway extended to at least the end of Q4 2018
Board leading a full review of Shield’s strategic options
Feraccru remains commercially available through Shield Therapeutics and it European partners, with more patients than ever being treated
Detailed analysis of the AEGIS-CKD pivotal Phase III full dataset underway and expected to be complete before the end of March 2018
Results for the year ended 31 December 2017 will be announced on 11 April 2018
London, UK, 22 February 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs, with an initial focus on addressing iron deficiency anaemia, today announces a business update, a brief trading update for the year ended 31 December 2017 and confirmation that the Board has initiated a full review of the Company’s strategic options. Feraccru, the Company’s lead asset, is approved and marketed in Europe for the treatment of iron deficiency anemia (IDA), initially in patients with inflammatory bowel disease (IBD).
Trading update for year ended 31 December 2017:
Trading for FY 2017 was in line with Board expectations and 2018 trading started positively. Revenues for the 12 months ended 31 December 2017 are expected to be £637,000 (2016: £304,000) with more patients than ever being treated with Feraccru. At the year end the Company’s unaudited cash position was £13.3m (2016: £21.0m).
Following announcement of the unexpected and disappointing initial top-line results from the AEGIS-CKD pivotal Phase III study of Feraccru, the Company is currently reviewing and analysing the full dataset from the study, with the aim of fully understanding the results and assessing whether any unexpected confounding factors have unduly affected the reported outcome. The Company anticipates it will have completed its review and analysis before the end of March 2018 and will update the market as soon as possible thereafter.
Alongside this analysis, the Board has initiated a complete review of the various strategic options available to the Company, particularly the options for Feraccru to deliver significant value to shareholders. The outcome of this strategic review will be closely linked to the full analysis of the AEGIS-CKD dataset, subsequent discussions with FDA on the most efficient way to achieve an approval for Feraccru in the USA and the application to the EMA to broaden its approved indication in Europe, a decision on which is still expected during H1 2018.
To maximise the strategic options available to the Company, Shield has immediately focused on taking positive actions to preserve cash following the AEGIS-CKD initial topline data readout. The Board now estimates that the Company has sufficient cash resources to fund the business until at least the end of Q4 2018. This is being primarily achieved through a significant reduction in Shield’s own headcount and promotional activities related to Feraccru, with identification of further cost containment remaining an ongoing priority. Feraccru will remain commercially available through Shield Therapeutics, as well as being actively marketed by and available through, our commercial partners in Scandinavia, Switzerland and Central Eastern Europe.
Change of results date for the year ended 31 December 2017:
As a result of a change in focus for Shield’s finance team since the AEGIS-CKD initial trial results, the Company will now announce its results for the year ended 31 December 2017 on 11 April 2018 and not as previously announced on 28 February 2018.
“We remain disappointed by the initial results from the AEGIS-CKD study, but whilst we seek clarity on what has happened, it is important that the Company protects its financial resources and extends its cash runway to maximise the strategic options available to us. With the commercialisation activities of Feraccru having gained ground in Germany and the UK, product awareness growing and evermore patients benefitting from Feraccru therapy, this is a regrettable but necessary step as it will impact many of the staff who have helped to build the business and set it up for the success we anticipated would follow. However, we have no doubt there is significant value in Shield’s assets, not least because of the frequent positive feedback we continue to receive from prescribers and patients who use Feraccru. The Board is committed to ensuring the Company is focused on realising this value on behalf of its shareholders and will provide further details on future strategy as soon as it is able.”
Carl SterrittChief Executive Officer of Shield Therapeutics
Other Feraccru pipeline events:
Feraccru in Europe – possible extension of commercial label
In September 2017, Shield submitted an application to the European Medicines Agency, to broaden the existing commercial label for Feraccru to include the treatment of all patients with ID, which has the potential to significantly expand the market opportunity for Feraccru in Europe. We continue to expect a final decision from the EMA on this application during the first half of 2018.
Feraccru AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron (Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint data from the AEGIS-H2H study is expected to be available in the second half of 2018.
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Fleur Wood, Director, Investor Relations
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
This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014. The person who arranged for the release of this announcement on behalf of Shield was Carl Sterritt, Chief Executive Officer.
Feraccru is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies. When salt-based oral iron therapies are ingested, the iron must dissociate from the salt in the GI tract to allow the iron to be absorbed and treat the IDA. This free iron readily chelates to form insoluble clumps and produces damaging free radicals that together cause a range of mild-to-severe GI adverse events, including nausea, bloating and constipation, leading to poor tolerability, reduced patient compliance and ultimately treatment failure. In addition, many patients with IDA are concurrently treated with medicines that raise the pH in the gut which further reduces the effect of salt-based oral iron therapies as they require highly acidic conditions to be absorbed. Feraccru is not an iron salt, and iron can be absorbed from the ferric maltol molecule, as a result, it does not routinely cause the same treatment-limiting intolerance issues. Feraccru has been shown in clinical trials to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.
Currently, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru. IV iron therapies, however, are invasive, costly, inconvenient and complex to administer, and also come with potentially life-threatening, spontaneous hypersensitivity reactions.
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs. 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 IDA in adult patients with IBD which has exclusive IP rights until the mid-2030's. For more information please visit www.shieldtherapeutics.com.
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations and include statements related to the timing of future results of Feraccru trials and the timing and success of the Group’s regulatory plans and commercial strategy for Feraccru. These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results, performance or achievements to be materially different from management’s expectations expressed or implied by the forward-looking statements, including, but not limited to, risks associated with the regulatory approval process, the Group’s business and results of operations, competition and other market factors. The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.