Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (March 2021)
32 slides from Shield Therapeutics's investor presentation, Mar 9, 2021
Slide 1: Investor Presentation
Investor Presentation 9 March 2021 Tim Watts, CEO Brian Groch, CCO
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: Investment Highlights & Company Overview
Investment Highlights & Company Overview
Slide 4: Overview of Shield Therapeutics
Overview of Shield Therapeutics: Revenue Generating Pharmaceutical Company Focused on the Treatment of Iron Deficiency • AIM-listed biotech company (STX.L) – Market capitalization ~£46m (@8March2021) • Primary focus is on developing and commercializing Feraccru®/Accrufer® – A novel oral treatment fo
Slide 5: Investment Highlights
Investment Highlights • Accrufer® is a novel, oral, FDA-approved, US launch-ready, high margin iron replacement therapy • U.S. iron deficiency market is large and undertreated, with significant unmet needs beyond current treatments • Accrufer has been proven in clinical studies in IBD and CKD patien
Slide 6: Clinical Overview
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Slide 7: 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) (e.g ulcerative colitis (U
Slide 8: Current Iron Deficiency Treatment Paradigm: Significant Unmet Need Remains
Current Iron Deficiency Treatment Paradigm: Significant Unmet Need Remains Patient diagnosed with iron deficiency Unmet Need 1st line treatment ▪ 80%+ of the Rx patient/unit volume comes from the • Oral: orals which are primarily generic* • Mostly salt-based iron compounds • ~10m-11m TRx annually fo
Slide 9: Accrufer (Ferric Maltol) is Uniquely Positioned to Address Unmet Needs
Accrufer® (Ferric Maltol) is Uniquely Positioned to Address Unmet Needs in Iron Deficiency Patients • Accrufer® is a low dose (30mg BID) oral Accrufer® Mechanism of Action formulation of a non-salt complex of Fe3+, which is stable in the GI tract: • Other oral irons are salts, and require the Fe to
Slide 10: Accrufer has Established a Robust Efficacy and Safety Profile in IBD and CKD Patients
Accrufer® has Established a Robust Efficacy and Safety Profile in IBD and CKD Patients Accrufer®’s Pivotal Phase 3a Trials Summary Phase 3a AEGIS-IBD (UC & CD): ▪ Phase 3 clinical study designed to investigate the efficacy and safety of ferric maltol compared with placebo in patients with UC or CD w
Slide 11: Health Economics-Based Phase 3b Trial: AEGIS H2H Study
Health Economics-Based Phase 3bTrial: AEGIS H2H Study Phase 3b head-to-head, non-inferiority study compared the efficacy and safety of Accrufer® vs. Injectafer® IV* (ferric carboxymaltose or FCM) at 12 weeks in IBD patients with IDA and hemoglobin as low as 8.0g/dL. Primary endpoint was either 2g/dL
Slide 12: Accrufer in the Treatment Algorithm Can Address Both Oral and IV Segments
Accrufer® in the Treatment Algorithm Can Address Both Oral and IV Segment of the Market • ID/IDA in multiple primary diseases Patients • Failure to treat ID leads to anaemia, as diagnosed with well as much more serious consequences (e.g. immune & heart iron deficiency complications) Accrufer® • Low
Slide 13: US Market Overview & Opportunity
US Market Overview & Opportunity
Slide 14: 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 15: Iron Deficiency is a Serious and Prevalent Disease
Iron Deficiency is a Serious and Prevalent Disease ~10M Patients Are at Risk for Iron Deficiency Across Multiple Therapeutic Areas in US • Chronic Kidney Disease (CKD) • 37m patients (dialysis & non-dialysis) • ~50% of patients at risk 5% • ~2.5m patients have Stage 3 or 4 CKD with IDA 17% 29% • Wom
Slide 16: Large Number of HCPs Writing for Oral Iron but Much Smaller Number for IV Iron
Large Number of 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 writers account for 30% of TRx (D
Slide 17: 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 18: Accrufer's Unique Product Profile for Higher Risk ID/IDA Patients
Accrufer®’s Unique Product Profile Make it an Ideal Iron Replacement Therapy for Higher Risk ID/IDA Patients – Especially During COVID-19 COVID-19 & At-Risk Patient Populations Many ID/IDA patients also have an underlying Underlying Medical Conditions & Other Risk condition making them more suscepti
Slide 19: AstraZeneca, Roxadustat – HIF-PH Inhibitor: A Rising Tide Lifts All Boats
AstraZeneca, Roxadustat – HIF - PH Inhibitor: “A Rising Tide Lifts All Boats” • Roxadustat expected to launch in US market in 2021 (subject to FDA approval) • Roxadustat is a first-in-class, orally administered small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor that promot
Slide 20: HIF-PH Inhibitors Launch and IV Iron Therapies Anticipate Changes
As Roxadustat and Other HIF PF Inhibitors Prepare to Launch, IV Iron Therapies Are Anticipating Changes to the Overall Iron Management Protocols Rockwell Medical (distributor of Triferic® solution and powder) presented three potential iron management options for HIF-PHI patients. (slide below taken
Slide 21: 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 22: Creating HCP Awareness and Driving Demand in a COVID-19 Environment
Creating HCP Awareness and Driving Demand in a COVID-19 Environment Multiple industry studies are reporting a decline in live sales rep interactions and more time being dedicated to “remote” engagements • Bain & Company “Post–COVID-19, Doctors Want Both In-Person and Virtual Visits with Sales Reps”
Slide 23: Prior Market Research with US Payers
Prior Market Research with US Payers Qualitative Market Research with Payers, June 2020 • 10 payers representing 200m+ lives • Included national traditional payers, national and regional PBMs, and payers who covered commercial, Medicare and Medicaid • Objective: to understand current iron treatment
Slide 24: 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 25: Europe/China, Paediatric study, Intellectual Property
Europe/China Paediatric study Intellectual Property
Slide 26: Feraccru in Europe & China
Feraccru® in Europe & China Europe China Licensed to Norgine (September 2018) Licensed to ASK Pharm (January 2020) • £11m upfront received • $11.4m upfront received • Sales royalties 25%-40% (Shield pays cost • IND application submitted - likely to of goods) require only one Phase III 12-week study
Slide 27: 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 28: Accrufer / Feraccru Patent portfolio
Accrufer® / Feraccru® Patent portfolio 2021 2023 2025 2027 2029 2031 2033 2035 P005 (Process) Patent Term Extension P007 (Method of use – high gastric pH) – US only Granted Fully P009 (Alternate process) P010 (Dosing regimen – 30mg) P012 (Crystalline form) Pending P014 (Dosing regimen) ▪ Orange Book
Slide 29: Cash Forecast & Use of Proceeds
Cash Forecast & Use of Proceeds
Slide 30: Cash requirement, sources and use of proceeds
Cash requirement, sources and use of proceeds Cash requirement • The Group’s cash flow forecasts, including the US launch of Accrufer® and the paediatric study, show that the Group should start to breakeven on a monthly basis within 15-18 months after launch • $30m-$40m should provide the finance ne
Slide 31: Investment Highlights
Investment Highlights • Accrufer® is a novel, oral, FDA-approved, US launch-ready, high margin iron replacement therapy • U.S. iron deficiency market is large and undertreated, with significant unmet needs beyond current treatments • Accrufer has been proven in clinical studies in IBD and CKD patien
Slide 32: Shield Therapeutics PLC
= = SHIELD THERAPEUTICS PLC Improving Lives Together
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