Shield Therapeutics Plc · LSE:STX
Shield Therapeutics — Investor Presentation (April 2024)
23 slides from Shield Therapeutics's investor presentation, April 2024
Slide 1: Changing the Treatment Paradigm for Patients with Iron Deficiency Anemia
Changing the Treatment Paradigm for Patients with Iron Deficiency Anemia Corporate Presentation Corporate Presentation April 2024
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 is an Innovative Specialty Pharmaceutical Company; Strong US Momentum Building
Shield is an Innovative Specialty Strong US Momentum Building Pharmaceutical Company • Accrufer/Feraccru (ferric maltol), is the only oral • Signed co-commercialization agreement with iron broadly indicated for use in adults suffering Viatris at end of ‘22 and launched 100-person from iron deficienc
Slide 4: Iron Deficiency (ID) without & with Anemia (IDA): 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 in pregnancy Decreased QoL i
Slide 5: Current Treatment Paradigm Across Patients by HCPs
Current Treatment Paradigm Across Patients by HCPs Oral Iron Replacement Therapy Guidelines recommend first line treatment with oral iron therapy to treat ID/IDA 93% IV Iron ferrous salts 5
Slide 6: Patients Can't Tolerate The GI Side Effects Of Oral Iron Salts
Universal Problem: Patients Are Struggling To Treat IDA Because They Can’t Tolerate The GI Side Effects Of Oral Iron Salts Oral ferrous salts dissociate in the stomach. Unabsorbed Fe+ generates reactive oxidative species (ROS), causing irritation and damage to the intestinal lining and GI side effec
Slide 7: Consistent Treatment Paradigm Across All Patients
Consistent Treatment Paradigm Across All Patients Oral Iron Replacement Therapy Oral Iron Switches/Discontinuations Untreated IDA 93% IV Iron ferrous salts 7
Slide 8: Significant Window of Opportunity Exists for ACCRUFeR
Significant Window of Opportunity Exists ACCRUFeR Oral Iron Replacement Therapy ACCRUFeR Fe 2+ 93% IV Iron ferrous salts A tolerable oral iron that effectively normalizes and maintains Hb, ferritin, and TSAT levels and avoids the need for patients requiring IV iron 8
Slide 9: Accrufer: Demonstrated Efficacy, Safety and Unprecedented Tolerability
Accrufer®: Demonstrated Efficacy, Established Data from three Phase 3 studies Safety and Unprecedented Tolerability demonstrated consistent efficacy in both the IBD and CKD populations and supported a Proprietary Accrufer® maltol formulation and unique MOA broad label as a treatment for delivers a t
Slide 10: A Significant Market, Ripe for Innovative Disruption
A Significant Market, Ripe for Innovative Disruption Estimated number of individuals with ~20 MILLION anemia in the U.S.* Large, defined market: 13.4M prescriptions per year, majority OTC iron Total available US market opportunity of US$2.3B** Unsatisfied market driven by Little to no innovation amo
Slide 11: Our Commercial Partnership Mission
OUR COMMERCIAL PARTNERSHIP MISSION To make Accrufer® the oral iron of choice in the U.S. 11
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 Agreement, Dec. 2022 Sold over 90,000 Decision on approval PK Study completed Phase 3 Study ongoing 100-person combined packs in 2
Slide 13: Financial Highlights for 2023 (unaudited)
Financial Highlights for 2023 (unaudited) Revenues and Other Income of $17.5m (2022 - $6.2m) • 3x increase of net product revenue from Accrufer® sales in US to $11.6m • Average Net Selling Price for Accrufer® increased to $145 per prescription in H2 ($119 H1) • Other income of $4.4m includes remaind
Slide 14: 2024 Business Priorities
2024 Business Priorities Grow Accrufer® Path to Cash Expand Global TRx and Gross to Flow Positive in Patient Access to Net H2’25 Ferric Maltol Q1 2024 Q1 2024 Q1 2024 $4m Net Revenues US Cash balance of $10.4m KP Pharma (Korea) PK Accrufer® Study completed, filing for Revised Revenue ~28,800 TRx’s a
Slide 15: Positive Growth Trajectory of Accrufer following Sales Expansion
Grow Accrufer® TRx and Gross Positive Growth Trajectory of Accrufer following Sales Expansion to Net Achieved 28,800 Prescriptions in Q1 2024 30,000 28,800 28,500 • Q1 Growth of 1% vs Q4 (174% vs Q1 ‘23) 25,000 23,400 • Strong growth in California and New York 20,000 (+29%) offset by decline in Texa
Slide 16: Transition and Lack of Texas Medicaid PBM in 1st Quarter Impacts Growth
Transition and Lack of Texas Medicaid PBM in 1st Quarter Impacts Growth 10,000 Average Quarterly 8,900 9,400 • Texas represented 35% of all 9,000 Growth 24% Accrufer TRx in 2H 2023 -28% 8,000 37% 7,000 40% 6,700 • Growing average of 24% Q/Q with 6,400 strong demand from HCP’s +7% 6,000 19% 5,000 5,0
Slide 17: Following Medicaid Access in Q3, NY and California showing significant growth
Grow Accrufer® TRx and Gross Following Medicaid Access in Q3, NY and California showing to Net significant growth California & New York Prescription Volume Texas Prescription Volume Quarterly Quarterly 10,000 10,000 9,400 24% 8,900 9,000 9,000 8,000 8,000 7,000 6,700 7,000 6,400 Average Quarterly 6,
Slide 18: Broad Access to Accrufer for HCPs and Patients
Grow Accrufer® TRx and Gross Broad Access to Accrufer® for HCP’s and Patients to Net Commercial Plans and PBM’s: State Medicaid Programs Shield offers Comprehensive Patient Access Program available for Commercial Patients where patients pay no more than $25/month for Accrufer® 18
Slide 19: Positive underlying improvements for GTN offset by Texas Medicaid issue
Grow Accrufer® TRx and Gross to Net Positive underlying improvements for GTN offset by Texas Medicaid issue $200 • Positive improvements in Medicaid Best Price and PA Submissions in Q1 offset $150 ~$145 ~$140 by decline in paid prescriptions in Texas ~$119 • Favorable base rebates with $100 commerci
Slide 20: PA Submission Rates Increasing following changes to Patient Access Programs
Grow Accrufer® TRx and Gross to Net PA Submission Rates Increasing following changes to Patient Access Programs in Q4 PA Submission % 60% 53% Changes to Patient Access Program in October 51% 50% requiring submission of Prior Authorization (PA) to access $25 cash price 40% 39% Increased PA Submission
Slide 21: Expect to turn cash flow positive in H2 2025
Path to Cash Flow Positive in H2 2025 Expect to turn cash flow positive in H2 2025 utilizing current resources and access to the new accounts receivable facility $10m Accounts Amended Revenue Cash Flow Positive Receivable Financing Covenant on $20m debt in H2 2025 Sallyport Commercial Finance SWK Ho
Slide 22: Key Milestones in 2024
Key Milestones in 2024 Grow Accrufer® Path to Cash Expand Global TRx and Gross to Flow Positive in Patient Access to Net H2’25 Ferric Maltol Growth in US Accrufer® TRx Cash balance of $10.4m KP Pharma (Korea) filing for and Revenues approval 2H ‘24 Revised Revenue Covenants Continued Improvement in
Slide 23: Thank You!
Thank You! Greg Madison – Chief Executive Officer Santosh Shanbhag – Chief Financial Officer www.shieldtherapeutics.com/
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