Shield Therapeutics PLC · LSE:STX
Shield Therapeutics — H1 2021 Earnings Presentation
24 slides from Shield Therapeutics's earnings presentation, August 2021
Slide 1: Interim Results for the six months ended 30 June 2021
Interim Results for the six months ended 30 June 2021 August 2021 Improving Lives Together
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: Operational Highlights
Improving Lives Together Operational Highlights Results for Six Months Ended 30 June 2021
Slide 4: Operational Highlights
Operational Highlights (including post-period end) • Accrufer® launched in USA effective 1 July 2021 • 51% growth in Feraccru® sales volumes in Europe • Chinese authorities confirm regulatory approval pathway for Feraccru® in China • First stage of Feraccru® / Accrufer® paediatric study completed •
Slide 5: US Launch of Accrufer
US Launch of Accrufer® • Recruitment and training of 30 sales rep’s during Q2 2021, followed by launch effective 1 July 2021 • Recent market research confirms positioning and opportunity; initial feedback from field indicates ‘high’ level of interest in Accrufer® • Face-to-face contact with physicia
Slide 6: US Market Opportunity
US Market Opportunity Iron Replacement Market is Large with PCPs Writing 50% of the Rx and Oral Therapies Making Up 90% of the Volume 17% ~550K clinicians writing for oral and/or IV iron yearly PCPs make up over 50% of the volume 1% ~10 million Rx’s per year for oral iron 10% Generics and OTC 51% 65
Slide 7: Clinicians Feedback – 1 of 3
Clinicians Feedback – 1 of 3 Clinicians are seeking a well tolerated and effective oral iron Satisfaction Current satisfaction with oral IRT (OTC and prescription) is Most Important Attributes in IRT Selection low. Importance % rating 6,7 (Top 2 Box) PCPs OB/GYNs Specialists PCPs Well‐tolerated 86
Slide 8: Clinicians Feedback – 2 of 3
Clinicians Feedback – 2 of 3 Clinicians want more from their oral iron, however awareness of Accrufer® is low Treatment Awareness and Usage: Accrufer® Unmet Needs Physicians want more oral ID/IDA treatments with fewer side effects and better Unaided Aided (Heard of) tolerability. 62% PCPs OB/GYNs
Slide 9: Clinicians Feedback – 3 of 3
Clinicians Feedback – 3 of 3 Clinicians respond favorably to Accrufer® profile Overall Reaction Interest in Learning More Line of Therapy 58% 60% 58% 55% 55% 7‐Extremely 31% 1st line, before other OTC or Rx 10% positive 45% 7‐Extremely 44% 35% generic oral iron treatments 18% 16% 20% 15% interested
Slide 10: Critical Success Factors
Critical Success Factors Strategic Imperatives 1 2 3 4 Increase Accrufer Redefine Make it easy to awareness Build Accrufer expectations of start & stay on among target advocates oral iron therapy therapy HCPs 10
Slide 11: US Launch of Accrufer
11 US Launch of Accrufer® 003 ACCRUFER’ (ferric maltol) 30 mg capsules Discover the legend of tolerable oral iron EMCGLOBIN RISING ‘formulated to provide both effectiveness ‘al iron replacement!
Slide 12: Key Tactical Assets
Key Tactical Assets HCP Promotional Tools Patient Access Materials Digital Tactics 12
Slide 13: US Launch of Accrufer
US Launch of Accrufer® • Market research confirms need for well tolerated and effective oral iron • Low awareness of Accrufer® at launch, however… • Interest level is ‘high’ for Accrufer® profile • Payer discussions ongoing Key focus areas: Increase awareness of Accrufer® Generate clinical experienc
Slide 14: European Sales of Feraccru
European Sales of Feraccru® Packs Sold in Europe 2020 volume growth of 70% despite COVID +51% pandemic Norgine launched in Q1 2019 in Germany and UK H1 2019 H2 2019 H1 2020 H2 2020 H1 2021 • Number of Feraccru® packs sold in Europe increased by 51% in H1 2021 compared to H2 2020 • UK and Germany acc
Slide 15: Regulatory Approval Pathway in China
Regulatory Approval Pathway in China • Chinese regulatory authority (CDE) approved Investigational New Drug (IND) application for Feraccru® to conduct two studies: o Phase III study in 120 IBD patients for 12 weeks, and in parallel o Pharmacokinetic / pharmacodynamic study • ASK Pharm (license partn
Slide 16: Product Development
Product Development Paediatric Study Update • Agreement with EMA/FDA for Feraccru® / Accrufer® Paediatric Investigational Plan (PIP) / Pediatric Development Plan (PDP) • Single Phase III protocol covering ages 1 month to 17 years, plus suspension / capsule crossover in healthy volunteers, including
Slide 17: Korea License Deal for Accrufer
Korea License Deal for Accrufer® (August 2021) • Exclusive license agreement for Accrufer with Korea Pharma in Republic of Korea • Korea Pharma will undertake and pay for all activities to achieve marketing authorisation and commercialise Accrufer® in Korea • Korea Pharma responsible for all clinica
Slide 18: Financial Review
Improving Lives Together Financial Review Results for Six Months Ended 30 June 2021
Slide 19: Financial Highlights
Financial Highlights • Revenue of GBP 0.5 million (H1 2020: GBP 8.9 million) • Loss for period of GBP 7.3 million (H1 2020 Profit: GBP 3.1 million) • Net cash outflow from operating activities of GPB 8.0 million (H1 2020 inflow: GBP 2.0 million) • Net proceeds from share placing in March 2021 of GBP
Slide 20: Outlook
Outlook • Ramp-up of revenue from Accrufer sales in USA: o Increase in sales volumes, plus o Increase of payer coverage by signing reimbursement agreements with various providers • Continuing increase in expenditures related to build-out of commercial activities in USA, plus recruitment for paediatr
Slide 21: Contact
Contact: Greg Madison, CEO Hans‐Peter Rudolf, CFO Tel: +44 (0)191 511 8500 info@shieldtx.com www.shieldtherapeutics.com To be kept up to date with Shield Therapeutics plc news and to receive relevant investor communications on the Company going forward, please email Walbrook PR at shield@walbrookpr.
Slide 22: Consolidated Statement of Profit and Loss
Interim Results 2021 Consolidated Statement of Profit and Loss For six-month period ended 30 June 2021 30 June 2020 In GBP thousands (unaudited) (unaudited) Revenue 481 8’919 Cost of sales -411 -1’011 Gross profit 70 7’908 Selling, general & administration -6’121 -4’834 Research and development -1’5
Slide 23: Consolidated Balance Sheet
Interim Results 2021 Consolidated Balance Sheet Balance at 30 June 2021 31 Dec 2020 In GBP thousands (unaudited) (audited) Non-current assets 26’075 27’298 Inventories & receivables 3’731 2’290 Cash and cash equivalents 22’602 2’940 Total assets 52’408 32’528 Current liabilities -1’394 -2’252 Net as
Slide 24: Consolidated Statement of Cash Flows
Interim Results 2021 Consolidated Statement of Cash Flows For six-month period ended 30 June 2021 30 June 2020 In GBP thousands (unaudited) (unaudited) Cash flows from operating activities -8’037 2’041 Cash flows from investing activities -64 356 Cash flows from financing activities 27’702 -23 Net i