Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (December 2020)
29 slides from Shield Therapeutics's investor presentation, Dec 16, 2020
Slide 1: Investor Presentation 16 December 2020
Investor Presentation 16 December 2020 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 commercialisation - Summary of last 18 months US Market Opportunity Europe/China Cash Summary Page 3
Slide 4: Company Overview & Investment Highlights
Company Overview & Investment Highlights Page 4
Slide 5: Introduction to Shield Therapeutics plc
Introduction to Shield Therapeutics plc • AIM-listed biotech company (STX.L) • Market capitalisation ~£71m (@15Dec2020) • Primary focus is on developing and commercialising Feraccru®/Accrufer® • A novel oral therapy for treating iron deficiency (ID) in adults • Approved in the USA and EU • Patent pr
Slide 6: Investment Highlights
Investment Highlights 1 Current £71m 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 Aos
Slide 7: How is Feraccru/Accrufer distinguished from competitors
How is Feraccru®/Accrufer® distinguished from competitors Page 7
Slide 8: Iron deficiency (ID)
Iron deficiency (ID) • Iron is a key component of haemoglobin (Hb) – ID is the most common cause of anaemia (iron deficiency anaemia or “IDA”) • ID is caused by malnutrition or bleeding and is associated with many diseases, in particular: – Inflammatory bowel disease (IBD), Chronic kidney disease (C
Slide 9: Iron replacement therapy
Iron replacement therapy Typically initiated with oral, followed by IV therapy if needed Patient diagnosed with iron deficiency Oral • Iron salts 1st line treatment • Inexpensive and convenient to take but… • Not well tolerated = poor compliance = unable to restore iron levels • Poor absorption = sl
Slide 10: 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 11: Regulatory clinical studies used for approval in Europe and USA
Regulatory clinical studies used for approval of Feraccru®/Accrufer® in Europe and USA AEGIS-IBD (Inflammatory Bowel Disease) • Feraccru provides rapid results – met primary end-point (change in Hb from baseline) at 12 weeks • delivered 2.3g/dL rise in 12 weeks with 1g/dL in only 4 weeks • Works ove
Slide 12: 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 patie
Slide 13: 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 14: US commercialisation Summary of last 18 months
US commercialisation Summary of last 18 months Page 14
Slide 15: Summary of last 18 months' out-licence activities
Summary of last 18 months’ outlicence activities • FDA approval – July 2019 • Intent to out-licence US commercialisation – contacted >100 companies • Strong interest in Accrufer® from many companies – Particularly from smaller/mid-size companies focused on one therapy area, typically seeking to lice
Slide 16: Learnings and opportunities arising over last 18 months
Learnings and opportunities arising over last 18 months • Detailed discussions with many potential out-licence counterparties provided us with a wide variety of information about the US market and how counterparties proposed to launch and promote Accrufer® - e.g. – Pricing and interactions with insu
Slide 17: US Market Opportunity
US Market Opportunity Page 17
Slide 18: ~10M patients suffer from iron deficiency anaemia across multiple therapeutic areas
~10M Patients suffer from iron deficiency anaemia1 across multiple therapeutic areas in the US ~10 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
Slide 19: 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 tolerab
Slide 20: 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 21: 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 22: 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 23: 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 24: Europe/China
a) GB LS a) Y) S) a a wo S) = 2 ce < es pd u Pe ca ES s © e pe wn o 2 a jee) iE > fe) = a E Europe/China
Slide 25: Feraccru in Europe & China
Feraccru® in Europe & China Europe China Licensed to Norgine Licensed to ASK Pharm • Sales royalties 25%-40% (Shield pays cost • Likely to require only one Phase III study in of goods) IBD • Sales milestones – up to €50m • Potential approval & launch in 2023 • On market in Germany, England & • $11.4
Slide 26: Cash position & Summary
Cash position & Summary Page 26
Slide 27: Cash position
Cash position • Cash at 30 November - £3.8m – Cash runway extends into Q2 2021 (assuming minimal US expenditure) • 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, 2n
Slide 28: 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 • These positive attributes, perversely, have contributed to the reasons why it has proved difficult to secure an out-licence transaction
Slide 29: Subscribe to Shield Therapeutics plc 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 shield@walbrookpr.com to subscribe Page 29
Shield Therapeutics — Investor Presentation (December 2020) on 6ix