Slide 1: Interim results for the six months ended 30 June 2020
Shield Therapeutics plc Interim results for the six months Preliminary ended results for30 June the year2020 ending 31 December 2018 September 2020 3 April 2019 1
Slide 2: Disclaimer
Disclaimer These slides have been prepared by Shield Therapeutics plc (the "Company") solely for your information and for use at a presentation for the purpose of providing background information on the Company, its business and the industry in which it operates. For the purposes of this notice, "pr
Slide 3: Operational Highlights (including post-period end)
Operational Highlights (including post-period end) • Licence agreement signed for Feraccru®/Accrufer® with Jiangsu Aosaikang Pharmaceutical Co. Ltd (“ASK Pharm”) covering China, Hong Kong, Macau and Taiwan • Net sales of Feraccru® in Europe for first 6 months of 2020 up 50% over previous 6 months •
Slide 4: China commercialisation – ASK Pharm
China commercialisation – ASK Pharm* • Exclusive licence to develop and commercialise Feraccru® in China, Hong Kong, Macau and Taiwan • $11.4 million upfront licence payment • $11.4 million development milestone on regulatory approval • Up to $40 million in sales milestones • Tiered royalties of 10%
Slide 5: Europe commercialisation
Europe commercialisation Net sales of Feraccru® in Europe for first 6 months of 2020 up 50% over previous 6 months Packs sold in Germany and UK H1 2018 H2 2018 H1 2019 H2 2019 H1 2020 Packs sold Pricing & reimbursement submissions in France, Italy, Spain and other EU markets will re-start as soon as
Slide 6: AEGIS-H2H (Head-to-Head)
AEGIS-H2H (Head-to-Head) • Comparison of patients treated with Feraccru® compared with intravenous (IV) iron therapy • Study intended for health economics, pricing and reimbursement (not a regulatory study) • Primary “non-inferiority” endpoint defined as % of “responders” at 12 weeks but patients we
Slide 7: H2H - Hb concentration – average change from baseline by visit (ITT)
H2H - Hb concentration – average change from baseline by visit (ITT) Hb concentration - g/dL 3.5 3 2.5 2 1.5 1 0.5 0 Week 4 Week 12 Week 24 Week 36 Week 52 ITT - FM ITT - IV 7
Slide 8: H2H - Average Hb concentration by visit (ITT)
H2H - Average Hb concentration by visit (ITT) Hb concentration - g/dL 14 12 10 8 6 4 2 0 Baseline Week4 Week 12 Week 24 Week 36 Week 52 ITT - FM ITT - IV 8
Slide 9: H2H - IV infusions (ITT population)
H2H - IV infusions (ITT population) Number of patients receiving infusions at/after week 12 visit 50 40 30 20 10 0 1 infusion 2 infusions 3 infusions 4 infusions 5 infusions 6 infusions 9
Slide 10: US update
US update • Top priority for 2020 • Need to achieve – Optimal financial terms – Partner that can exploit Accrufer® across the full range of therapy areas where ID is prevalent • Engaged with multiple companies, many signed confidentiality agreements • Several submitted non-binding offers • More deta
Slide 11: Paediatric Programme
Paediatric Programme • Liquid formulation developed, manufactured, released and now in USA • First phase – crossover study to confirm liquid formulation equivalent to capsules – 32 healthy adult volunteers – Recruitment starting imminently – Expected to complete by end 2020 • Main study – Will start
Slide 12: Financial headlines
ou ay wv Financial headlines
Slide 13: Financial position
Financial position • Revenues of £8.9 million (H1 2019: £0.4 million) – $11.4m (£8.7m) China upfront • Profit for the period of £3.1 million (H1 2019 loss: £4.2 million) – SG&A £4.8m includes China transaction costs and costs related to US process – R&D £0.7m is low due to delayed start to paediatri
Slide 14: Outlook for H2/Full Year 2020
Outlook for H2/Full Year 2020 • Feraccru® royalties from Norgine sales in UK and Germany expected to continue to grow – Launches in France, Italy & Spain subject to pricing and reimbursement negotiations and not expected until late 2021 at earliest • H2 2020 SG&A cost base to continue at levels seen
Slide 15: Newsflow and summary
ou ay wv Newsflow and summary
Slide 16: Anticipated newsflow
Anticipated newsflow Indicative timing Event H2 2020 Potential out-licensing agreement for Accrufer® in USA H2 2020 Potential start of formulation work for PT201 End 2020 Conclusion of first stage of paediatric study Q1 2021 Further update on European sales (1) Subject to funding 16
Slide 17: Summary
Summary • Licence agreement signed for Feraccru®/Accrufer® covering China, Hong Kong, Macau and Taiwan – may require only a Phase III study in IBD • Strong Feraccru® sales growth in Germany and England – Other major EU markets from late 2021 onwards • H2H reanalysis completed – Confirms that Feraccr
Slide 18: Contact: Tim Watts, CEO
Contact: Tim Watts, CEO Tel: +44 (0)207 186 8500 info@shieldtx.com www.shieldtherapeutics.com To be kept up to date with Shield Therapeutics plc news and to receive relevant investor communications on the Company going forward, please email Walbrook PR at shield@walbrookpr.com to subscribe
Slide 19: Results: P&L (unaudited)
Results: P&L (unaudited) £’000 H1 2020 H1 2019 (restated)1 Revenue 8,919 430 Gross profit 7,908 119 Selling, general & administration (4,834) (3,575) Research and development (681) (1,273) Operating profit/(loss) 2,393 (4,729) Financial income 355 47 Profit/(loss) before tax 2,748 (4,682) Taxation 3
Slide 20: Results: Balance sheet
Results: Balance sheet £’000 30 Jun 31 Dec 2020 2019 (unaudited) (audited) Intangible assets & PPE 28,646 29,924 Inventory & receivables 3,080 2,254 Cash 6,515 4,141 Total assets 38,241 36,319 Current liabilities (2,774) (4,174) Net Assets 35,467 32,145 20
Slide 21: Results: Cashflow (unaudited)
Results: Cashflow (unaudited) £’000 H1 2020 H1 2019 (restated)1 Cashflow from operating activities 2,041 (1,943) Cashflow from investing activities 356 (1,148) (includes capitalised R&D) Cashflow from financing activities (23) (77) Net increase/(decrease) in cash 2,374 (3,168) Cash at start of perio