11 April 2018
Preliminary Results for the Year Ended 31 December 2017
London, UK, 11 April 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 with its approved product, Feraccru®, today announces its preliminary Group results for the year ended 31 December 2017.
Highlights (including post period)
- Feraccru was out licensed across additional markets via agreements with AOP for Scandinavia and EWO pharma for Switzerland
- Pre-approval notification for Feraccru received from the Swiss regulatory authority in June 2017
- Progress across clinical trials:
- Feraccru AEGIS-H2H IIIb study progressing, with results expected in the second half of 2018
- Recruitment of paediatric pharmaco-kinetic study completed with data available during 2018
- Completion of recruitment into AEGIS-CKD pivotal Phase III study of Feraccru in the treatment of IDA in patients with Chronic Kidney Disease (CKD), results issued post year end
- Grants received for Feraccru's Composition of Matter patent in significant additional territories including the US, Europe, Australia and Canada providing broad protection through to 2035
- Application submitted to the European Medicines Agency (EMA) to extend the label for Feraccru to adult patients with iron deficiency (ID)
- Revenue of £637,000 (2016: £304,000) was recorded during the year
- Net loss of £19.6 million (2016: £15.0 million)
- Adjusted net loss* of £17.0 million (2016: £9.4million)
- Net cash of £13.3 million (2016: £21.0 million), which includes net proceeds raised during the year via the Warrant exercise, subscription and placing of £11.9 million
*Adjusted net loss is defined as net loss adjusted for exceptional items (see Note 9).
- The number of patients being treated with Feraccru in the initial target markets of Germany and the UK have continued to increase month on month through the first few months of 2018
- In March 2018, the European Commission (EC) adopted the EMA’s Decision to extend the approved indication for Feraccru (Ferric Maltol) to include treatment of all adults with iron deficiency (ID) with or without anaemia, thereby increasing Feraccru’s commercial opportunity increasing the eligible patient population
- Previously Feraccru had only been approved and marketed in Europe for the treatment of Iron Deficiency Anaemia (IDA) in adult patients with Inflammatory Bowel Disease (IBD), a market opportunity of c. 330,000 patients. The label expansion in Europe represents a market opportunity of c. 40 million patients with iron deficiency
- AEGIS-CKD pivotal Phase III study of Feraccru:
- In February 2018, an initial top line indicated that Feraccru had failed to meet the study’s primary endpoint
- In March 2018, Shield conducted its detailed analyses of the data from the double-blind period of the AEGIS-CKD study which identified that the initial reporting of top line data had been confounded by a number of patient-specific events that the Company believed directly and adversely impacted the primary endpoint analysis. It also highlighted that, with these data points removed, the primary and secondary endpoint of the study would have been met
- The Company presented these analyses to the FDA in a previously scheduled pre-NDA submission meeting in March 2018 and subsequent final minutes of this meeting were received in early April
- These minutes form the official record of this meeting with the FDA and provided Shield with the necessary guidance to progress submission without the need to conduct additional pivotal clinical trials in CKD patients
- The NDA will be submitted as soon as possible in 2018 and the work will be funded within the Company’s current cash resources
- Further routine analyses of the dataset will continue to deepen the Company’s understanding of the positive impact of Feraccru on IDA in CKD patients
Following the initial top-line results from the AEGIS-CKD pivotal Phase III study of Feraccru, the Group announced a Business and Trading update and confirmed that a cost rationalisation programme was being implemented to significantly conserve the Company’s available financial resources. It also confirmed that the Board would be leading a full review of Shield’s strategic options. The outcome of the FDA’s deliberations on its submissions has helped inform the Group’s ongoing strategic review.
“Expansion of Feraccru’s commercial activities in 2017, through an increase in promotional events, improved market access and sales people in the field saw awareness and use of the product increase, even within Feraccru’s initial narrow label which existed through Q1-2018. “We have been making progress in Germany and the UK, continuing to bring the substantial benefits of Feraccru to patients. Product awareness is growing, and more patients than ever are benefitting from Feraccru. During the first months of 2018 we have continued to see positive month-on-month growth in demand for Feraccru in both Germany and the UK. With the approval of a broad label to treat iron deficiency, the potential for Feraccru to become a mainstay of therapy for patients with this debilitating condition is very real. In addition, we continue to successfully out-license Feraccru in additional markets, with further discussions ongoing. Looking forwards, we have engaged a third party to evaluate ways of more rapidly leveraging the value of Feraccru in Europe and together we are considering a range of partnering structures. These could likely include upfront payments which would further extend the Company’s cash runway, together with sales-based royalties that would provide revenue throughout the life of a partnering agreement. “The Composition of Matter patent grants for Feraccru in major pharmaceutical markets now also provides broad protection of Feraccru’s intellectual property through to 2035, further adding to the value of Feraccru. Post period in March 2018, following the Company’s submission of an application to the EMA to broaden the label for Feraccru in Europe, we were delighted that the European Commission rapidly adopted the CHMP’s recommendation to extend the approved indication for Feraccru to include treatment of all adults with iron deficiency with or without anaemia, providing Feraccru with a much larger commercial opportunity through a very significant increase in patients who could potentially be treated with Feraccru. This was an important step for Shield as it should result in Feraccru being used earlier in the evolution of disease in patients affected by this debilitating condition. “After the unexpected and disappointing initial top-line results from the AEGIS-CKD pivotal Phase III study of Feraccru in February, I am reassured that we have rapidly been able to understand what occurred in the study to prepare a data package which underpinned a constructive pre-NDA meeting with the FDA. Having now considered their formal feedback, we are confident in moving forward with our original plan to finalise and submit a New Drug Application to FDA as quickly as possible.”
Carl SterrittCEO of Shield Therapeutics plc
Summary and outlook
As a result of the Company taking positive actions to preserve cash following the initial AEGIS-CKD study top-line results reporting, the Board believes that the Company has sufficient cash resources to fund the business until at least the end of Q4 2018. However, as this is being primarily achieved through a significant reduction in Shield’s own headcount and promotional activities related to Feraccru, with further cost containment remaining an ongoing priority, this is likely to impact sales of Feraccru. However, we are evaluating ways of maintaining Feraccru’s share of voice in the marketplace to continue to build on the solid progress made to date.
The outcome of the FDA’s deliberations on the Company’s submissions has helped provide guidance to the Group’s ongoing strategic review and some initial decisions have been shared below. The Board will continue to update shareholders on further decisions in respect of the Company’s future strategy. Beyond this, another key event for 2018 will be readout of the AEGIS-H2H IIIb study, due in H2 2018, which is within the extended cash runway. If successful, this will primarily be used to support broader pricing and reimbursement activities in Europe.
While these significant post-period developments dominate our agenda, the Board continues to evaluate the Group’s options and focus on ensuring value is realised for its shareholders.
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Karl Keegan, Interim Chief Financial Officer
Fleur Wood, Director, Investment 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/Christopher Golden
Financial PR Advisor +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
About Shield Therapeutics plc
Shield Therapeutics 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 all adults with iron deficiency with or without anaemia which has exclusive IP rights until the mid-2030's. For more information please visit www.shieldtherapeutics.com.
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.