Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (August 2024)
29 slides from Shield Therapeutics's investor presentation, August 2024
Slide 1: Corporate Presentation
Corporate Presentation August 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 Specialty Pharmaceutical Company Vast market opportunity in iron deficiency replacement therapy market. Traditional oral irons often lead to discontinuation due to intolerable GI side effects or insufficient efficacy1 ACCRUFeR®/FeRACCRU® (ferric malto
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 Anemia (ID/IDA)
Iron Deficiency without & with Anemia (ID/IDA) Highly prevalent and a 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, cognitive
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: Universal problem: HCPs struggling to treat IDA because of 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 unprecedented tolerability
ACCRUFeR®: Demonstrated efficacy, established safety and unprecedented Indication Expansion for tolerability Pediatric Patients: Data from three Phase 3 Studies in IBD and CKD populations showcase consistent effectiveness to increase and maintain Shield recently completed, a hemoglobin in normal ran
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 Sold over 90,000 Decision on approval PK Study completed Phase 3 Study ongoing Agreement, Dec. 2022 packs in 2023 expected in 2024 F
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 (IRT) market
Total prescription oral iron replacement therapy (IRT) market Addressable 12MM Rx | +550K HCPs* Total oral IRT ferrous salts Rx Expanded 6 MM Rx | 50K HCPs* 50% Addressable Market Rx 1.3% ACCRUFeR® market share Current 1.8 MM Rx | 12.5 K HCPs** 3% ACCRUFeR® market share current sales & marketing foo
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 for ACCRUFeR
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: OB/GYNs and PCPs: high propensity to prescribe; 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: Positive ACCRUFeR growth trajectory following 2023 sales expansion
Positive ACCRUFeR® growth trajectory following 2023 sales expansion ACCRUFeR® TRx 2022 - 2024 Half Yearly 65,200 100 sales reps shared between Shield and Viatris 52,000 Averaging 25% quarter over quarter growth following field expansions with 25,000 Viatris (five quarters) 17,000 26% Increase in 2nd
Slide 22: Broad access to ACCRUFeR for HCPs and patients
Broad access to ACCRUFeR® for HCP’s and patients Commercial Plans and PBM’s: State Medicaid Programs Covered Not covered 22
Slide 23: Positive ACCRUFeR growth trajectory following 2023 sales expansion
Positive ACCRUFeR® growth trajectory following 2023 sales expansion ACCRUFeR® Net Revenues 2022 - 2024 ACCRUFeR® Net Price Per Script 2022 - 2024 Half Yearly Half Yearly $158 $146 $11M $124 $119 $8.4M $3.1M $2.3M H2 2022 H1 2023 H2 2023 H1 2024 H2 2022 H1 2023 H2 2023 H1 2024 Note: 2024 ACCRUFeR® WA
Slide 24: 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 Q2 2024 Q2 2024 Q2 2024 $6.9M ACCRUFeR® Net Revenues $8.1M cash on hand KP Pharma (Korea) filing for 69% increase vs. Q1 24 appr
Slide 25: Robust increase in ACCRUFeR prescriptions in Q2 2024
Robust increase in ACCRUFeR® prescriptions in Q2 2024 ACCRUFeR® TRx 2023 - 2024 Quarterly 26% 36,400 Continued focused execution by the combined Shield-Viatris field sales 28,500 28,800 teams 23,400 Large states such as California, New 14,900 York, and Florida continue to drive increase in prescript
Slide 26: 69% sequential Q2 24 ACCRUFeR revenue growth
69% sequential Q2 24 ACCRUFeR® revenue growth driven by robust increases in prescriptions and average net selling price per Rx ACCRUFeR® Net Revenues 2023 - 2024 ACCRUFeR® Net Price Per Script 2023 - 2024 Quarterly Quarterly 23% $171 69% $6.9M $148 $143 $139 $120 $118 $4.3M $4.1M $4.1M $1.9M $1.2M Q
Slide 27: $8.1M Cash Balance at H1 2024 excluding $5.7M from milestone monetization
$8.1M Cash Balance at H1 2024 excluding $5.7M from milestone monetization $20M Term Loan $10M AR Factoring $5.7M Milestone Monetization Sept. 2028 maturity Through Apr ’25, extendable to 2026 Monetization of $11.4M milestone upon Interest rate SOFR + 9.25% Advance rate on eligible ACCRUFeR® ACCRUFeR
Slide 28: Shield Therapeutics
Shield Therapeutics Fast Growing, Mission Driven Specialty Pharmaceutical Company Vast market opportunity in iron deficiency replacement therapy market. Traditional oral irons often lead to discontinuation due to intolerable GI side effects or insufficient efficacy1 ACCRUFeR®/FeRACCRU® (ferric malto
Slide 29: Thank You!
Thank You! Anders Lundstrom –Chief Executive Officer* Santosh Shanbhag – Chief Financial Officer www.shieldtherapeutics.com 29 *Board Member and Interim CEO
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