Shield Therapeutics PLC · LSE:STX
Shield Therapeutics — Shares Magazine/AJ Bell webinar (January 2021)
24 slides from Shield Therapeutics's conference presentation, Jan 20, 2021
Slide 1: Investor Presentation: Shares Magazine/AJ Bell webinar
Investor Presentation Shares Magazine/AJ Bell webinar 20 January 2021 Page 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: Agenda
Agenda Company Overview & Investment Highlights How is Feraccru®/Accrufer® distinguished from competitors US Market Opportunity Europe/China Cash Summary 3
Slide 4: Company Overview & Investment Highlights
Company Overview & Investment Highlights 4
Slide 5: Introduction to Shield Therapeutics plc
Introduction to Shield Therapeutics plc • AIM-listed biotech company (STX.L) • Market capitalisation ~£64m (@15Jan2021) • Primary focus is on developing and commercialising Feraccru®/Accrufer® • A novel oral therapy for treating iron deficiency (ID) in adults, with or without anaemia • Approved in t
Slide 6: Investment Highlights
Investment Highlights 1 Current valuation underpinned by commercialisation licence deals in Europe and China • Europe – commercialisation by Norgine BV, currently marketed in Germany, UK and Scandinavia. Launches in France, Italy and Spain expected in 2021/2022 • China – licensed to Beijing Aosaikan
Slide 7: How is Feraccru/Accrufer distinguished from competitors
How is Feraccru®/Accrufer® distinguished from competitors 7
Slide 8: Current ID treatment paradigm: significant unmet need
Current ID treatment paradigm: significant unmet need Patient diagnosed with iron deficiency Unmet Need 1st line treatment ▪ >80% of the Rx iron market volume comes from orals which are primarily generic* • Oral: ▪ ~10m-11m TRx annually for oral products* • Mostly salt-based iron compounds ▪ Annual
Slide 9: Feraccru/Accrufer is a novel and different oral formulation
Feraccru®/Accrufer® is a novel and different oral formulation Feraccru® mechanism of action: • Feraccru® is a low dose oral formulation of a non-salt complex of Fe3+, which is stable in the GI tract – 30mg capsules, 2x daily – Other oral irons are salts and require the Fe to dissociate to be absorbe
Slide 10: Head-to-head study – comparison with leading IV therapy
Head-to-head study – comparison with leading IV therapy* • 79% of the 122 IV patients who were actually dosed received more than one infusion before the Week 12 visit • 68 patients received further infusions from Week 12 visit onwards – although note that by Weeks 24, 36 and 52 the number of IV pati
Slide 11: Feraccru/Accrufer positioning to address both oral and IV segments
Feraccru®/Accrufer® positioning to address both oral and IV segments With its broad indication and its efficacy and tolerability, Patients Feraccru®/Accrufer® can target multiple therapy areas and capture diagnosed with prescriptions from both older oral iron salts and IV products iron deficiency Or
Slide 12: US Market Opportunity
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Slide 13: ~10M patients suffer from IDA across multiple therapeutic areas in the US
~10M Patients suffer from IDA1 across multiple therapeutic areas in the US ~10-11 million oral Rx annually; ~2.3 million IV doses annually • Chronic Kidney Disease (CKD) 5% • 37m patients (dialysis & non-dialysis) 2 • ~50% of patients at risk3 17% • ~2.5m patients have Stage 3 or 4 CKD with IDA3 29%
Slide 14: Market research confirms the unmet need
Market research confirms the unmet need* Physicians believe there is an unmet need in Existing Therapy Avg. Value Ratings the market….. IV Branded Iron Therapy • Iron replacement therapy is generally considered IV Generic Iron Therapy an area of unmet need • Key needs are effectiveness and GI tolera
Slide 15: Other factors supporting use of Accrufer
Other factors supporting use of Accrufer® COVID-19 Launch of HIF inhibitors Many ID/IDA patients have an underlying condition A new oral class of agents for the treatment of making them more susceptible to COVID-19 anaemia in CKD including: • Chronic kidney disease Stimulate endogenous erythropoieti
Slide 16: US commercialisation options
US commercialisation options Out-licence to 3rd party Shield-led launch Financial terms Summary • Licence upfront – one-off receipt on signing • Shield retains full control over Accrufer® in US • Sales royalties based on annual sales - typical • Also retains full ownership of Accrufer® profits royal
Slide 17: Planning for successful Shield US launch
Planning for successful Shield US launch • Shield has recruited 4 experienced US commercial executives to plan and lead US launch – Currently on fixed term consultancy contracts pending firm decision for Shield to launch in US, at which point the intention is that they will become Shield US employee
Slide 18: Accrufer US sales and profit potential
Accrufer® US sales and profit potential • On average, patients assumed to take 4-5 months’ Accrufer® to allow time for restoration and maintenance of normal Hb levels • At $200-$250 net sales price per pack => $1,000 per patient per year Potential Year 5 sales • Sales of $200m pa therefore require 2
Slide 19: Europe/China
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Slide 20: Feraccru in Europe & China
Feraccru® in Europe & China Europe China Licensed to Norgine Licensed to ASK Pharm • Sales royalties 25%-40% (Shield pays cost • IND application submitted - likely to of goods) require only one Phase III 12-week study in • Sales milestones – up to €50m 120 IBD patients • On market in Germany, Englan
Slide 21: Cash position / Summary
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Slide 22: Cash position
Cash position • Cash at 31 December 2020 - £2.9m • Convertible loan facilities agreed with shareholders AOP (10.7%) and Dr Christian Schweiger (3.5%, also a board member) – ~£4.4m in total – 1st 50% tranche available 1 February 2021, 2nd 50% tranche available if needed during rest of 2021 – Interest
Slide 23: Summary
Summary • Feraccru®/Accrufer® has unique attributes of efficacy, tolerability and breadth of application in ID • ID is a large global market, including in the USA • We are evaluating both out-licence and Shield-led launch alternatives • To prepare for a Shield launch scenario, we have recruited 4 ex
Slide 24: Subscribe to Shield Therapeutics news
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 [email protected] to subscribe Page 24
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