Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — FY2020 Earnings Presentation
25 slides from Shield Therapeutics's earnings presentation, April 2021
Slide 1: Preliminary results for the year ending 31 December 2020
Preliminary results for the year ending 31 December 2020 Tim Watts, CEO Hans-Peter Rudolf, CFO April 2021
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: 2020 operational highlights (including post-period end)
2020 operational highlights (including post-period end) During 2020 • Feraccru® licensed to ASK Pharm in China • AEGIS-H2H re-analysis confirms Feraccru®/Accrufer® is a credible alternative to IV therapy for iron deficiency anaemia • Teva withdraw all oppositions to Shield’s European patents • 2020
Slide 4: US opportunity
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Slide 5: Accrufer Market Opportunity Overview
Accrufer® Market Opportunity Overview • Iron deficiency is a large, diverse and undertreated market • ~10 million ID patients in US: ~5 million patients treated annually for IDA • Existing 1st line therapies are poorly tolerated iron salts: ~10-11 million TRx annually • 2nd line therapy is intraveno
Slide 6: Large Number of HCPs Writing for Oral Iron but Much Smaller Number for IV Iron
Large Number of Healthcare Professionals (‘HCPs’) Writing for Oral Iron but a Much Smaller Number Writing for IV Iron Total Number of HCPs Writing Oral Iron by Specialty (n=~460,000) 16% Target the Highest Rx Writers and Most Productive Specialties* for Oral Iron (D8-D10) 2% 31% 2% • ~11,000 Rx writ
Slide 7: Market Research & Competitor Data Confirm the Unmet Need
Market Research¹ & Competitor Data2 Confirm the Unmet Need Existing Therapy Avg. Value Ratings Physicians believe there is an unmet need in the market….. IV Branded Iron Therapy IV Generic Iron Therapy • Iron replacement therapy is generally considered an area Oral Branded Iron Therapy of unmet need
Slide 8: Accrufer US sales potential
Accrufer® US sales potential Sales estimates generated by management consultants/3rd parties support the potential for Accrufer® sales to exceed $100m from the third year following launch and to reach $300m-$400m by years 5-6 • At approximately $1,000 per patient per year (assuming 4 packs per year,
Slide 9: Planning for a Successful US Launch of Accrufer
Planning for a Successful US Launch of Accrufer®: Medical Affairs Major Work Streams in Process Lit Review* Med Ed Agency Selection KOL Advisory Boards Scientific Message Platform KOL Identification MSL Training Curriculum MSL Materials Lexicon Pharmacovigilance Planning & Monitoring Agency(s) Selec
Slide 10: Feraccru outside USA
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Slide 11: Feraccru marketed by Norgine in Europe
Europe • Feraccru® is now marketed by Norgine in Germany, UK, Scandinavia (since Q4 2020, previously AOP) and Belgium (since January 2021) Packs sold Volume growth of 70% despite COVID Norgine launched in Shield withdrew all Q1 2019 in Germany selling resource in and UK Feb 2018 due to cash constrai
Slide 12: Australia, China and other markets
Australia, China and other markets Australia • Norgine also have commercialisation rights in Australia and New Zealand • In March 2021 Feraccru® became listed in the Australia Register of Therapeutic Goods. Pricing negotiations will take place during 2021 China • ASK Pharm will complete development
Slide 13: R&D
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Slide 14: AEGIS H2H study results
AEGIS H2H study results Although the H2H study did not demonstrate non-inferiority of Feraccru®/Accrufer® to IV iron at the 12 week visit, the mean increase in Hb of 2.45g/dL is clinically meaningful. And from weeks 12- 52, Feraccru®/Accrufer ® maintained Hb levels effectively and conveniently By we
Slide 15: Paediatric study
Paediatric study • A post-approval requirement of both EMA and FDA is to evaluate safety and tolerability (primary end points) of Feraccru®/Accrufer® in infants, children and adolescents – Secondary endpoints include change in Hb concentration and achieving Hb concentration within normal range by We
Slide 16: PT20 – a treatment for hyperphosphatemia
PT20 – a treatment for hyperphosphatemia • Elevated phosphate levels in the blood is a ubiquitous complication of moderately and severely reduced kidney function • Standard of care for phosphate control remains the prescription of phosphate binders. Older phosphate binders suffer from side effects,
Slide 17: Financial Highlights
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Slide 18: 2020 financial highlights
2020 financial highlights • Revenues of £10.4 million (2019: £0.7 million) • £9.7m from ASK Pharm – $11.4m (£8.7m) licence upfront received grossed up by £1m re withholding tax borne by ASK Pharm (added to tax charge so no net impact) • £0.7m from Norgine re European sales • Loss for the year of £2.
Slide 19: Outlook & Newsflow
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Slide 20: Outlook & Newsflow
Outlook & Newsflow Commercial • US launch of Accrufer® planned for June 2021 • Further country launches of Feraccru® in Europe towards end 2021/early 2022 • Potential further commercialisation out-license transactions during 2021 Development • Start of paediatric Stage 2 in summer 2021 • Start of PT
Slide 21: Shield Therapeutics
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Slide 22: Appendix
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Slide 23: Results: P&L
Results: P&L £’000 2020 2019 Revenue 10,387 719 Gross Profit 9,033 234 Selling, General & Admin* (8,608) (6,773) Research and development (2,579) (2,496) Operating loss (2,154) (9,035) Financial income/(expense) 268 (31) Loss before tax (1,886) (9,066) Taxation (744) 266 Loss for the year (2,630) (8
Slide 24: Results: Balance sheet
Results: Balance sheet £’000 31 Dec 31 Dec 2020 2019 Intangible assets & PPE 27,298 29,924 Inventory & receivables 2,290 2,254 Cash 2,940 4,141 Total assets 32,528 36,319 Current liabilities (2,252) (4,174) Net Assets 30,276 32,145 24
Slide 25: Results: Cashflow
Results: Cashflow £’000 2020 2019 Cashflow from operating activities (1,400) (4,066) Cashflow from investing activities (20) (1,366)* Cashflow from financing activities (47) (203) Net decrease in cash (1,467) (5,635) Cash at start of period 4,141 9,776 Currency gains 266 - Cash at period end 2,940 4