Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (December 2021)
28 slides from Shield Therapeutics's investor presentation, December 2021
Slide 1: Shield Therapeutics Investor Presentation
SHIELD THERAPEUTICS Investor Presentation December 2021 A Potential Best in Class Oral Iron Replacement Therapy
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
Investment Highlights for effective, well-tolerated iron Near Term Significant replacement therapy for iron deficiency, a from expanded reimbursement, increasing Value inflection Unmet Need 15MM patients & 13.4MM annual sales & commercial partnerships Catalysts prescriptions opportunity approved pro
Slide 4: Shield Team
Shield Team Experienced leader with a track record of building organizations and launching specialty Greg Madison pharmaceuticals with brands including Renvela ®, Feraheme®, and Auryxia®. Prior Exec roles at Melt CEO Pharmaceuticals, Keryx Biopharmaceuticals, AMAG, Genzyme Responsible for establishi
Slide 5: Iron Deficiency: 15MM U.S. Patients, A Source of Morbidity and Mortality
Iron Deficiency (ID) without & with Anemia (IDA): 15MM U.S. Patients: A Source of Morbidity and Mortality Caused by malnutrition, malabsorption, or bleeding Increased risk of preterm labor, perinatal Higher IBD symptom burden complications, newborn and maternal mortality Decreased QoL in IBD Associa
Slide 6: Current ID Treatment Options: 90% of Prescriptions are Oral
Current ID Treatment Options: 90% of Prescriptions are Oral Oral IV Convenient, readily available Fast iron repletion Less efficient absorption Better bioavailability and absorption Poor tolerability No compliance issues Slower iron repletion Inconvenient Exacerbation of IBD Infusion required Poor c
Slide 7: Adverse Events with Current Oral Iron Can Limit Patient Adherence
Adverse Events Associated with Current Oral Iron Treatments Can Limit Patient Adherence 40-60% 50% 52% Estimated overall Estimated overall Of IBD patients with IDA adherence with oral iron adherence with oral iron reduce or withdraw oral for IDA due to all AEs1 for IDA due to GI AEs2 iron dose due t
Slide 8: Iron Deficiency Treatment Algorithm: An Unsatisfactory Cycle
Iron Deficiency Treatment Algorithm An Unsatisfactory Cycle of Switches and Discontinuations OTC/RX OTC/RX Iron #1 Iron #2 ~40-70% GI side effect rate drives patients to switch or stop therapy OTC/Generic RX Oral Iron OTC/RX Iron #3 = Stop Treatment Patients and Health Care Providers (HCPs) are Seek
Slide 9: Design of Conventional Ferrous Iron Products Require High Doses of Iron
Design of Conventional Ferrous Iron Products Require High Doses of Iron Conventional Formulated as a ferrous salt taken 1-3X/day Iron ~300 mg daily dose of elemental iron required to achieve therapeutic Dose hemoglobin increase (1) Ferrous salts dissociate prior to intestinal uptake1 (2) Inefficient
Slide 10: Accrufer is a Novel Formulation of Oral Iron
Accrufer® is a Novel Formulation of Oral Iron Accrufer® Proprietary maltol formulation, dosed 2X/day1 Daily doses of ~60 mg of elemental iron significantly increased hemoglobin Dose levels over 12 weeks, maintained over 52 and 64 weeks across studies1 Good tolerability, bioavailability and absorptio
Slide 11: The Accrufer Opportunity To Become the Oral Iron Treatment of Choice
The Accrufer® Opportunity To Become the Oral Iron Treatment of Choice U.S. Market Initial Upside Opportunity Positioning Target U.S. Prescriptions: 13.4 MM (U.S.)* Treatment of choice before or after oral Move to 1st line Treatment of Choice, with iron failure (i.e. 1st or 2nd line therapy) market e
Slide 12: Accrufer's Peak Net U.S. Sales Potential: $500MM+
Accrufer®’s Peak Net U.S. Sales Potential1: $500MM+ Oral Iron Therapy: 13.4MM Rx (2021, US) Est. Peak Net US Market Share Number of Rx’s Net Price/Month per Rx Sales Initial Accrufer® Target: 40% High Case 3.5MM $250 $875MM WAC Price = $500/mo 25% Base Case 2.2MM $250 $550MM Est. GTN2 = 50% Est. Cov
Slide 13: Commercial and Medicaid Represent 2/3rds of Reimbursement for Oral Irons
Commercial and Medicaid Represent 2/3rds of Reimbursement for Oral Irons Other 2% Initial Focus on Commercial Segment Cash Commercial 31% 28% For covered patients, out-of-pocket costs are expected to be $10/month And Medicaid Drug Rebate Program Will begin additional focus on key states in H2: 2022
Slide 14: Significant Progress with Commercial Payers – 40M+ Lives Covered
Significant Progress with Commercial Payers – 40M+ Lives Covered Expect Additional Increases in 2022 Commercial Payers, % Covered Lives ~22% Coverage Additional today lives available under these contracts 1 2 3 14
Slide 15: Multiple Market Research Studies Confirm Clinicians Want a Well-Tolerated Oral Iron
Multiple Market Research Studies Confirm Clinicians are Looking for an Effective, Well-Tolerated Oral Iron Solution June 2021: Baseline HCP ATU (n=101) February 2021: HCP ID/IDA Market Insight Research (n=39) May 2021: ID/IDA & Accrufer® Concept and Message Testing (n=50) June 2021: Baseline HCP ATU
Slide 16: HCP Response to Accrufer is Positive
HCP Response to Accrufer® is Positive HCPs have a Positive Overall Reaction to the Product and are Interested to Learn More Overall Reaction Interest in Learning More Positive Extremely Positive Interested Extremely Interested 58% 60% 58% 55% 55% 10% 18% 16% 20% 45% 15% 19% 50% 40% 39% 38% 40% 26% P
Slide 17: HCPs Anticipate Robust Initial Use of Accrufer in 1st or 2nd Line
HCP’s Anticipate Robust Initial Use of Accrufer® Instead of Conventional Oral Irons in 1st or 2nd Line Position POTENTIAL IRON PRODUCT USE LINE OF THERAPY IV Iron Rx Oral Iron Therapies 1st line, before other OTC or Rx generic oral iron treatments OTC Oral lron Supplements Product X 2nd line, after
Slide 18: HCP Targeting Launch Strategy
HCP Targeting Launch Strategy ~4K HCPs ~11% TRx Oral Market Volume 30 sales reps in field in H2:2021 covering 4,000 high prescribing HCPs ~70% of volume is driven by PCPs & ~61K HCPs OB/GYNs ~55% TRx Oral Market Volume Additional reps to be phased in coinciding with increased payer coverage Oral TRx
Slide 19: Accrufer Strategic Map
Accrufer® Strategic Map = Where We Are Today: Unknown Option = 2022 Solid Base of 2023 Broad Use of Accrufer® Believers for ID/IDA Therapy 1 2 3 4 5 Redefine Increase Brand Build Accrufer® Raise Patient Minimize Patient Expectations of Oral Awareness Advocates Awareness Barriers to Access: Iron Ther
Slide 20: HCP Multi-Channel Engagement
HCP Multi-Channel Engagement Media & Digital Platforms Objective: drive brand awareness & education Utilize media mix to reach clinicians • Targeted Display • Search • Newsletters • Endemic Site Placements • Content Sponsorships • EMR/EHR Full media plan began 10/1/2021 20
Slide 21: HCP Promotion Snapshot
HCP Promotion Snapshot CRM Leverage Current Creative Campaign with Segmented Unify data, optimize engagement & access via direct Message Platform to Drive Immediate Sales of Accrufer® mail, email, fax blasts, etc. Accrufer.com Office Support Build upon existing website framework Keep Accrufer® top-o
Slide 22: Patient Launch Snapshot
Patient Launch Snapshot Introduce Accrufer® as the Preferred Oral Iron Tx for Patients with ID and IDA Media Targeted digital and traditional media Website Development placements to drive brand awareness Development and launch of patient site including education materials, copay assistance and testi
Slide 23: Accrufer: A $2.2B U.S. Market Opportunity for Iron Deficiency
Accrufer®: A $2.2B U.S. Market Opportunity for Iron Deficiency Iron deficiency with or without anemia Accrufer® is an effective, well tolerated low-dose oral iron with an adverse event and discontinuation rate well below • 15MM patients published 40-60% rate for conventional oral iron therapy. • A m
Slide 24: Ex-US Launch Adds Upside
Ex-US Launch Adds Upside Attracting Key Partners to Drive Adoption and Revenue International Brands: Feraccru®/Accrufer® Target Geographies: EU, China, Korea, Japan, Canada 24
Slide 25: Attractive Ex-US Deals Provide Upfronts, Milestones & Royalties
Attractive Ex-US Deals Provide Upfronts, Milestones & Royalties Approval Royalty on Sales Partner Geography Upfront Status Milestone Net Sales Milestones China, Hong Kong, $11.4MM $11.4MM* 10-15% Up to $40MM Phase 3 Macau and Taiwan Nominal royalty Europe, Australia $14.5MM N/A*** 25-40%** Up to $58
Slide 26: Near Term Value Inflection Points
Near Term Value Inflection Points US Operations License Partners Clinical Commercial Uptake EU Payer Agreements Pediatric Study Payer Agreements New Partner Licenses Daily Dose Usage Co-Promotion Regulatory Approvals (China, Korea) 26
Slide 27: Investment Highlights
Investment Highlights for effective, well-tolerated iron Near Term Significant replacement therapy for iron deficiency, a from expanded reimbursement, increasing Value inflection Unmet Need 15MM patients & 13.4MM annual sales & commercial partnerships Catalysts prescriptions opportunity approved pro
Slide 28: Shield Therapeutics
SHIELD THERAPEUTICS A Potential Best in Case Oral Iron Replacement Therapy Greg Madison (CEO): gmadison@shieldtherapeutics.com Hans-Peter Rudolf (CFO) José Menoyo (CMO) jmullaly@lifesciadvisors.com www.shieldtherapeutics.com
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