Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (March 2022)
30 slides from Shield Therapeutics's investor presentation, March 2022
Slide 1: Shield Therapeutics Investor Presentation March 2022
SHIELD THERAPEUTICS Investor Presentation March 2022 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: Operational & Financial Highlights
Operational & Financial Highlights • Awareness of Accrufer® among target prescribers doubled since launch to 65% • Generated ~2500 prescriptions for Accrufer® since launch in July 2021 with significant quarterly growth • Payer coverage increased from 40M to 60M commercial lives since last update in
Slide 5: Ex-US Partnerships – Update on Progress
Ex-US Partnerships – Update on Progress Partner Geography Status Pharmacokinetics study completed China, Hong Kong, Macau and Taiwan Enrolling Phase 3 clinical trial 60% Y/Y volume increase (EU) Europe, Australia and New Zealand Reimbursement dossier submitted for Spain Republic of Korea Program/reg
Slide 6: U.S. Market for Accrufer - $2.2B Opportunity
U.S. Market for Accrufer®- $2.2B Opportunity 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 major source of mor
Slide 7: Iron Deficiency With & Without Anemia: 15MM U.S. Patients
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 8: 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 9: Adverse Events Associated with Current Oral Iron Treatments Can Limit 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 10: Iron Deficiency Treatment Algorithm: Cycle of Switches and Discontinuations
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 11: 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 12: HCPs Have Low Satisfaction Rates With Available Oral Iron Treatments
HCPs have low satisfaction rates Iron Deficiency with (ID)without available & with Anemia (IDA): 15MMoral iron treatments U.S. Patients: Satisfaction with Iron Deficiency Treatment Stated Importance When Selecting IRT (Top Mentions) % rating 6,7 (Top-2 Box) % rating 6,7 (Top-2 Box) 82% PCPs Has a go
Slide 13: 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 14: Accrufer US Launch
ACCRUFeR® US Launch (ferric maltol) www.accrufer.com www.accruferhcp.com 14
Slide 15: Prepare for Launch with an Integrated Approach
repare for Laun with an Integrated Approach 2 ro) 1 ° 4 Phase III Clinical Trials Regulatory Prep Regulatory Review @ NDA Submission @ NDA Approval tree ACM Conduct Payer, Physician, Create Initial form Physician Finalize Peesttum Patient Market Research alue Prop Message Testing Pricing Brand Condu
Slide 16: US Initiation for Accrufer
US Initiation for Accrufer® 16
Slide 17: Accrufer Launch Priorities
Accrufer® Launch Priorities 1 2 3 Increase Brand Generate Clinical Initiate Payer Awareness Experience Coverage Expand HCP Primarily via Patient Focus on PBM’s and Awareness Access Programs Commercial Long Term Future: Brand Leader in Oral Iron Therapy 17
Slide 18: HCP Targeting Launch Strategy
HCP Targeting Launch Strategy Oral Iron Market TRx Volume by Specialty ~4K HCPs 13% ~11% TRx Oral Market Volume 30 sales reps in field in H2:2021 4% PCP covering 4,000 high prescribing HCPs 3% OB/GYN 1% 42% NP/PA Gastro Nephrology ~61K HCPs Hem/Onc ~55% TRx Oral Market Volume All Other 29% 8% Oral T
Slide 19: Positive Increase in Awareness Among Targeted HCPs
Positive Increase in Awareness Among Targeted HCPs Total HCPs Total HCPs (n=101) (n=142) 100% % of HCPs Aware of Accrufer 80% 35% 69% +34% 60% 40% 65% 20% 31% 0% Baseline (Jun 2021) Wave I (Dec 2021) Aware Unware Aided Awareness: Which best describes your level of experience/familiarity with the the
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: Accrufer Launch Priorities
Accrufer® Launch Priorities 1 2 3 Increase Brand Generate Clinical Initiate Payer Awareness Experience Coverage Expand HCP Primarily via Patient Focus on PBM’s and Awareness Access Programs Commercial Long Term Future: Brand Leader in Oral Iron Therapy 21
Slide 22: Driving Clinical Experience through Patient Assistance Program
Driving Clinical Experience through Patient Assistance Program 22
Slide 23: Health Care Professionals Demand Increasing
Health Care Professionals (HCPs) Demand Increasing 2,000 % Rx's by Specialty 1,788 1,800 1,600 5% 1,400 1,200 16% 1,000 42% 800 653 600 36% 400 200 - Q3 Q4 Primary Care OB/GYN NP/PA Other Source: CoAssist written and dispenses through 31 Dec 2021, Xponent dispenses through 31 Dec 2021 23
Slide 24: HCPs Report Accrufer Performs Well Where It Matters Most
HCPs report Accrufer® performs WELL where it matters most Accrufer® Performance % rating 5, 6,7 (Top-3 Box) Among Attributes Rated as Most Important (n=40) Has a good 83% safety profile Is well-tolerated 60% Convenient dosing and 73% administration Effective therapy 65% Acceptable OOP 50% cost to pa
Slide 25: HCPs Who Have Never Used Accrufer Likely to Prescribe
HCP’s who have never used Accrufer® indicate they are likely to prescribe Accrufer Non-Users Likelihood to Prescribe Accrufer 4% 10% 5% 16% 12% 64% 7-Extremely 72% Likely 24% 32% 69% 73% 30% 6 48% 38% 32% 5 27% 1, 2, 3, 4- 36% Not at all 27% 29% 32% Likely to Neutral PCPs OB/GYNs NP/PAs Specialists
Slide 26: Accrufer Launch Priorities
Accrufer® Launch Priorities 1 2 3 Increase Brand Generate Clinical Initiate Payer Awareness Experience Coverage Expand HCP Primarily via Patient Focus on PBM’s and Awareness Access Programs Commercial Long Term Future: Brand Leader in Oral Iron Therapy 26
Slide 27: Payer Access Increased in January – 60M+ Lives Covered
Payer Access Increased in January – 40m (Dec) up to now 60M+ Lives Covered December 2021 January 2022 Commercial Payers, % Covered Lives ~33% Coverage Additional today lives available under these contracts 27
Slide 28: Observations and Insights from First Six Months
Observations and Insights from First Six Months • Accrufer® Awareness is critical – while increasing, a lot of room to grow • Key messages around tolerability and effectiveness is on point – continue to reinforce • Payer coverage continues to grow • Evolution of the organization and approach on-goin
Slide 29: Accrufer 2022 Priorities
Accrufer® 2022 Priorities 1 2 3 4 Increase Brand Expand and Minimize Raise Awareness and Awareness Accelerate HCP Patient Barriers Activate the Patient Adoption to Access Expand HCP Drive Breadth and Depth Expand Payer Coverage Utilize Digital and Social Awareness of Prescribing Media to Efficiently
Slide 30: Q&A Discussion
Q&A Discussion www.accrufer.com www.accruferhcp.com 30
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