Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (October 2024)
25 slides from Shield Therapeutics's investor presentation, October 2024
Slide 1: Corporate Presentation
Corporate Presentation October 2024 Changing the Treatment Paradigm for Patients with Iron Deficiency Anemia 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: Shield Therapeutics
Shield Therapeutics Fast Growing, Mission Driven, Speciality Pharmaceutical Company ACCRUFeR®/FeRACCRU® (ferric maltol), is the only FDA approved oral iron broadly indicated for use in adults suffering from iron deficiency, with or without anaemia. Also approved by EMA and Health Canada. Vast market
Slide 4: Management team
Management team Anders Lundstrom Santosh Shanbhag Lucy Huntington-Bailey Andy Hurley David Childs Dr. Jackie Mitchell CEO* CFO General Counsel Chief Commercial Officer VP, Manufacturing and VP, Quality, Clinical and Strategic Alliance Regulatory Affairs *Board Member and Interim CEO 4
Slide 5: Iron Deficiency without & with Anaemia (ID/IDA)
Iron Deficiency without & with Anaemia (ID/IDA) A highly prevalent and serious condition Significant impact on quality of life Symptoms include extreme fatigue, IRON DEFICIENCY NEWS Oct 23 -- More Than a Third of headache, vertigo, numbness in Women Under 50 Are Iron-Deficient, extremities, cognitiv
Slide 6: Current treatment options for treating ID/IDA by HCPs
Current treatment options for treating ID/IDA by HCPs Rx and OTC Multiple brands and some generics Guidelines recommend ferrous salts “iron salts” are first line treatment with Requires infusion at hematology or 93% of volume oral iron replacement hospital clinic therapy to treat ID/IDA Mix of brand
Slide 7: HCPs struggling to treat IDA because patients can't tolerate GI side effects
Universal problem: HCP’s are struggling to treat IDA because patients can’t tolerate the GI side effects of oral iron salts Oral ferrous salts dissociate in the stomach. Unabsorbed iron (Fe+) generates reactive oxidative species (ROS), causing irritation and damage to the intestinal lining and gastr
Slide 8: Consistent treatment paradigm across all patients
Consistent treatment paradigm across all patients Oral Iron Replacement Switches/Discontinuations Oral Iron TIME IV Iron 93% ferrous salts Untreated IDA 8
Slide 9: Significant window of opportunity exists for ACCRUFeR
Significant window of opportunity exists for ACCRUFeR® Oral Iron IV Iron 93% ferrous salts Iron replacement that patients will actually take A well tolerated oral iron that effectively normalizes and maintains Hb, ferritin, and TSAT levels1 1. Data from AEGIS 1 and 2 study. 9
Slide 10: ACCRUFeR designed for efficacy and tolerability
ACCRUFeR® designed for efficacy and tolerability ACCRUFeR® remains tightly bound in the stomach Unique MOA (mechanism of action) Shields and Delivers Elemental Iron to the Small Intestine 1, 2 The maltol shield protects iron from the stomach, remaining tightly bound as it passes through Proprietary
Slide 11: ACCRUFeR: Demonstrated efficacy, established safety and tolerability
ACCRUFeR®: Demonstrated efficacy, established safety and unprecedented Indication Expansion for Pediatric Patients: tolerability Pivotal Trial of ACCRUFeR® / FeRACCRU® Data from three Phase 3 Studies in IBD and CKD populations showcase consistent effectiveness to increase and maintain (ferric maltol
Slide 12: Global partnerships continue to progress
Global partnerships continue to progress Deals include upfronts, milestones & double-digit royalties United States EU+1 Canada Republic of Korea China +2 Co-Commercial Currently Approved by Health Filed for approval; Phase 3 Study ongoing Agreement, Dec. 2022 commercialized across Canada in August 2
Slide 13: Our Commercial Partnership Mission
Our Commercial Partnership Mission To make ACCRUFeR® the oral iron of choice in the US 13 13
Slide 14: A significant market, ripe for innovative disruption
A significant market, ripe for innovative disruption Estimated number of iron deficient individuals ~20 MILLION with and without anemia in the US* Large, defined market: ~12M prescriptions per year >85% of prescriptions written by GP’s and OB/GYN Unsatisfied market driven by Little to no innovation
Slide 15: Total prescription oral iron replacement therapy market
Total prescription oral iron replacement therapy (IRT) market Addressable 12 M Rx | +550K HCPs* Total oral IRT ferrous salts Rx Expanded 6 M Rx | 50K HCPs* 50% Addressable Market Rx 1.3% ACCRUFeR® market share Current 1.8 M Rx | 12.5 K HCPs** 3% ACCRUFeR® market share current sales & marketing footp
Slide 16: Concentrated prescriber base creates broader opportunity for ACCRUFeR
Concentrated prescriber base creates a broader opportunity for ACCRUFeR® to realize incremental market share ADDRESSABLE Market Concentration Curve 100% 90% HCP TRx 80% ADDRESSABLE +550K 12 MM % ADDRESSABLE TRx 70% 60% 50% EXPANDED 50K 6 MM 50% 6 MM TRx 40% 30% CURRENT 12.5K 1.8 MM 20% 15% 1.8 MM TR
Slide 17: The ID/IDA market is ideal for big upside potential
The ID/IDA market is ideal for big upside potential for ACCRUFeR® ID/IDA Market Dynamics as Viewed by Shield and Viatris • Large Unmet Need • Concentrated Prescriber Base • Uniquely positioned to address unmet need • Promotionally Sensitive • Minimal Branded Competition • Highly Engageable Audience
Slide 18: PCPs and OB/GYNs prescribe ~85% of the expanded market
PCPs and OB/GYNs prescribe ~85% of the expanded market OB/GYN 12% Expanded Market By Specialty* Nephrologist 6MM | 50K HCPs PRIMARY CARE 3% 72% Other 5% Gastrointerologist 1% HEM/ONC 7% *2023 TRx Data IQVIA Xponent PlanTrak + consignment 18
Slide 19: OB/GYN and PCP ID/IDA Patients
OB/GYN and PCP ID/IDA Patients OB/GYN PCP 55% 19% 17% 45% 14% 12% 9% 9% 7% 6% Pregnant Menorrhagia Gastric Chronic IBD Geriatric CHF CKD Pregnant Menorrhagia Gastric Chronic IBD Geriatric CHF CKD Bypass ulcers Bypass ulcers HCP QUANT. April 2024 n= 200 HCPs (30 OB/GYN, 170 PCP) 19
Slide 20: High propensity to prescribe ACCRUFeR; low awareness a barrier
OB/GYNs and PCPs: high propensity to prescribe ACCRUFeR®; Low awareness is a significant barrier to growth Quantitative Analysis April 2024 PREFERENCE SHARE LOW unaided awareness of ACCRUFeR® 69% switch to PCPs OBGYN 45% GI side ACCRUFeR® N = 170 N = 30 effects ACCRUFeR® 19% 10% Benchmark 29% 59% No
Slide 21: 2024 business priorities
2024 business priorities Growth in Expand global Increased balance ACCRUFeR® patient access of sheet and Revenues, TRx & ferric maltol operational flexibility Gross to Net Q3 2024 Q3 2024 Q3 2024 $7.2M ACCRUFeR® Net Revenues $7.7M cash and cash equivalents Paediatric pivotal trail shows highly 8.1M
Slide 22: Continued growth in ACCRUFeR in the US in Q3 2024
Continued growth in ACCRUFeR® in the US in Q3 2024 ACCRUFeR® TRx ACCRUFeR® Net Revenues ACCRUFeR® Net Price Per Script 2024 Quarterly 2024 Quarterly 2024 Quarterly Excluding July*: $192 $7.2M* c. 43,500 $6.9M $171 $167 c. 36,400 $139 c. 28,800 $4.1M Q1 24 Q2 24 Q3 24 Q1 24 Q2 24 Q3 24 Q1 24 Q2 24 Q3
Slide 23: Goal to be cash flow positive by end of 2025
Goal to be cash flow positive by end of 2025: ACCRUFeR® revenues, strengthening balance sheet and ~10% reduction in operating base $20M Term Loan $15M AR Factoring $5.7M Milestone Monetization Potential $10M Equity Raise • Sept. 2028 maturity • Expanding from $10M to $15M • Monetization of $11.4M •
Slide 24: Shield Therapeutics
Shield Therapeutics Fast Growing, Mission Driven, Speciality Pharmaceutical Company • Vast market opportunity with significant revenue potential • ACCRUFeR®/FeRACCRU® (ferric maltol) approved by the FDA, EMA, and Health Canada • Shield-Viatris partnership driving growth in ACCRUFeR® prescriptions, n
Slide 25: Thank You!
Thank You! Anders Lundstrom –Chief Executive Officer* Santosh Shanbhag – Chief Financial Officer www.shieldtherapeutics.com 25 *Board Member and Interim CEO
Shield Therapeutics — Investor Presentation (October 2024) on 6ix