Opthea Limited · ASX:OPT
Opthea — Investor Day (January 2025)
53 slides from Opthea's investor day presentation, Jan 29, 2025
Slide 1: Transforming Patient Outcomes with Superior Vision Gains
Transforming Patient Outcomes with Superior Vision Gains Investor Event | New York City | January 28, 2025 NASDAQ (OPT); ASX (OPT.AX)
Slide 2: Disclaimer and Forward-looking Statements
Disclaimer and Forward-looking Statements This presentation includes general background information about the activities of Opthea Limited (ABN 32 006 340 567) (“Opthea” or “Company”) and its affiliates and subsidiaries (together, the “Opthea Group”). The information contained in this presentation i
Slide 3: Featured Speakers
Featured Speakers Opthea Management Joined by Global Retina Thought Leader Fred Guerard, PharmD, MS Mike Campbell Charles C. Wykoff, MD, PhD Chief Investigator for COAST Chief Executive Officer Chief Commercial Officer Clinical Advisory Board Member ✓ Graybug Vision, CEO ✓ Viatris, Sr. VP of Eye Car
Slide 4: Focus of Today Is U.S. Sozinibercept Commercial Readiness Preparations
Focus of Today Is U.S. Sozinibercept Commercial Readiness Preparations Topic Speaker Welcome Fred Guerard, PharmD, MS Wet AMD Unmet Medical Needs Charles C. Wykoff, MD, PhD Sozinibercept Wet AMD Clinical Data Overview Wet AMD U.S. Commercial Market Dynamics Mike Campbell Sozinibercept Customer Insig
Slide 5: Sozinibercept Has the Potential to Be the First Product in 20 Years to Deliver Superior Visual Outcomes
Sozinibercept Has the Potential to Be the First Product in 20 Years to Deliver Superior Visual Outcomes Addressing High • Despite wide use of anti-VEGF-A therapy, wet AMD patients still experience loss in vision long term1 Unmet Need • Every letter of vision counts to improve quality of life and red
Slide 6: Anticipated Clinical and Manufacturing Timelines Support BLA Submission in 1H26
Anticipated Clinical and Manufacturing Timelines Support BLA Submission in 1H26 and Potential Approval by End of CY2026 Drug product PPQ ShORe topline data release in early CY25 in mid-CY25 Potential BLA approval as early as end of CY26 COAST topline data BLA submission in early 2Q CY25 in 1H CY26 F
Slide 7: Opthea Investor Day Agenda
Opthea Investor Day Agenda Topic Speaker Welcome Fred Guerard, PharmD, MS Wet AMD Unmet Medical Needs Charles C. Wykoff, MD, PhD Sozinibercept Wet AMD Clinical Data Overview Wet AMD U.S. Commercial Market Dynamics Mike Campbell Sozinibercept Customer Insights Strategic Outlook Fred Guerard, PharmD,
Slide 8: Wet AMD Unmet Medical Needs & Sozinibercept Clinical Data Overview
Wet AMD Unmet Medical Needs & Sozinibercept Clinical Data Overview Charles C. Wykoff, MD, PhD 8
Slide 9: Last Therapy to Improve Visual Outcomes for Wet AMD Was Launched Nearly Two Decades Ago
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Last Therapy to Improve Visual Outcomes for Wet AMD Patients Was Launched Nearly Two Decades Ago Current Wet AMD Treatment Landscape 2006 2011 2019 20
Slide 10: Majority of Patients Achieve Suboptimal Vision Outcomes Despite Standard of Care
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Despite Treatment with Standard of Care Anti-VEGF-A Therapies, the Majority of Patients Achieve Suboptimal Vision Outcomes Despite treatment with anti
Slide 11: Effect of Treatment Paradigm Change in nAMD on Outcomes
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Effect of Treatment Paradigm Change in nAMD on Outcomes Based on Results From a 12-year Follow-up of 42,161 patients1,2 Number of Number of Visit/inje
Slide 12: Visual Outcomes Are the #1 Factor in Patients' Anti-VEGF-A Preference
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Visual Outcomes Are the #1 Factor in Patients’ Anti-VEGF-A Preference Relative Importance of Treatment Attributes for Patients Receiving Anti-VEGF-A M
Slide 13: Improving Vision Now the Largest Unmet Need in Wet AMD for Retina Specialists
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Improving Vision Now the Largest Unmet Need in Wet AMD for Retina Specialists ASRS PAT Survey 2023 ASRS PAT Survey 2024 What are the greatest unmet ne
Slide 14: Emerging Treatments for Wet AMD: Better Vision Outcomes or Durability
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Emerging Treatments for Wet AMD: Better Vision Outcomes or Durability Sozinibercept is the only late-stage drug in development targeting better vision
Slide 15: Sozinibercept, a First-In-Class VEGF-C/D Trap Inhibitor
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept, a First-In-Class VEGF-C/D “Trap” Inhibitor, Has the Potential to Address the Limitations of Anti-VEGF-A Therapies Faricimab (Vabysmo®)1
Slide 16: Published Evidence Supports Broader VEGF Pathway Inhibition with Sozinibercept
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Published Evidence Supports Broader VEGF Pathway Inhibition with Sozinibercept Circulating VEGF-C Levels Significantly VEGF-C Stimulates RetinalAngiog
Slide 17: Only Drug in Development Having Demonstrated Superiority in Combination with Anti-VEGF-A
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept Is the Only Drug in Development Having Demonstrated Superiority in Combination with Anti-VEGF-A Therapy for Wet AMD 1 Superior vision ga
Slide 18: Sozinibercept Combination Demonstrated Over 30% Improvement in Visual Acuity
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept 2 mg Combination Therapy Demonstrated Over 30% Improvement in Visual Acuity over Ranibizumab Monotherapy Phase 2b Primary Endpoint Achie
Slide 19: Sozinibercept Was Well Tolerated
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept Was Well Tolerated Safety of Combination Therapy Comparable to Standard of Care Monotherapy Sozinibercept Sozinibercept Sham + anti-VEGF
Slide 20: Similar Rate of Intraocular Inflammation Between Standard Of Care and Sozinibercept
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Similar Rate of Intraocular Inflammation Between Standard Of Care and Sozinibercept in Combination Therapy Sozinibercept Sozinibercept Sham + anti-VEG
Slide 21: Global Pivotal Program Involves 33 Countries and ~400 Sites
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Global Pivotal Program Involves 33 Countries and ~400 Sites Multi-center, sham controlled, double-masked trials in treatment Combination with Afliberc
Slide 22: Pivotal Trial Design Supports Potential Broad Label for Use With Any Anti-VEGF-A Therapy
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Pivotal Trial Design Supports Potential Broad Label for Use With Any Anti-VEGF-A Therapy Key Secondary Endpoints Primary Endpoint Topline Data (Baseli
Slide 23: Phase 2b Superiority Data Informed Enrichment of Phase 3
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Phase 2b Superiority Data Informed Enrichment of Phase 3 Occult & Minimally Classic Lesions (RAP Absent) Total Patient Population (RAP Absent) Represe
Slide 24: Phase 3 Enrolled a Higher Proportion of Patients With Best Responding Lesion Types
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Phase 3 Enrolled a Higher Proportion of Patients With Best Responding Lesion Types Compared to Phase 2b Phase 2b Phase 3 Sham + 2 mg sozinibercept + r
Slide 25: Higher Proportion of Patients With Best Responding Lesion Types
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Higher Proportion of Patients With Best Responding Lesion Types Occult (RAP Absent) Lesion Types PCV Lesion Types Phase 2b Proportion of Phase 2b Prop
Slide 26: Sozinibercept Has the Potential to Transform Wet AMD Clinical Practice
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept Has the Potential to Transform Wet AMD Clinical Practice Design supports potential broad label for combination with any anti-VEGF-A 1 th
Slide 27: Wet AMD U.S. Commercial Market Dynamics & Sozinibercept Customer Insights
Wet AMD U.S. Commercial Market Dynamics & Sozinibercept Customer Insights Mike Campbell 27
Slide 28: Superior Vision Is the #1 Unmet Need in Wet AMD Across Patients, Retina Specialists, and Payers
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Superior Vision Is the #1 Unmet Need in Wet AMD Across Patients, Retina Specialists, and Payers Sozinibercept integrates seamlessly into a highly attr
Slide 29: Opthea Commercial Leadership Team Has Strong Track Record Launching Retina Therapies
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Opthea Commercial Leadership Team Has Strong Track Record and Experience Launching New Retina Therapies Mike Campbell Anthony Bonifazio Anand Sundaram
Slide 30: Sozinibercept Designed to Tap into the Entire Anti-VEGF-A Market
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept Designed to Tap into the Entire Anti-VEGF-A Market With a Broad Combination Indication and No Direct Competitors Branded VEGF-A Inhibito
Slide 31: U.S. Wet AMD Market Is Well-Established with High Diagnosis and Treatment Rates
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook U.S. Wet AMD Market Is Well-Established with High Diagnosis and Treatment Rates ~1.5M U.S. Wet AMD Prevalence1 Diagnosis Rate2 80% 1.2M Diagnosed Pati
Slide 32: High Concentration of Injection Volume Enables a Lean Commercial Footprint
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook High Concentration of Injection Volume in U.S. Wet AMD Market Enables a Lean Commercial Footprint U.S. Wet AMD HCP Concentration Curve1 ~1,400 HCPs re
Slide 33: U.S. Physicians Continue to Use Branded Therapies
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook U.S. Physicians in the Wet AMD Market Continue to Use Branded Therapies, Despite Increasing Availability of Lower-Cost Options % of Wet AMD Patients o
Slide 34: Buy-and-Bill Business Model Supports Combination Therapy for Retina Practices
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Buy-and-Bill Business Model Supports Combination Therapy for Retina Practices Practices directly Practices "buy" store and inject product the product
Slide 35: Robust U.S. Market Research Informs Commercial Launch Strategy
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Robust U.S. Market Research Informs Commercial Launch Strategy 350 Retina Specialists surveyed in three rounds of market research 16 Medical Directors
Slide 36: All Customers Highlight Vision as the #1 Unmet Need in Wet AMD
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook All Customers Highlight Vision as the #1 Unmet Need in Wet AMD Patients Retina Specialists Payers Sozinibercept Value Proposition Highly Aligns with C
Slide 37: Combination Therapy Delivering Superior Vision Would Meet Patients' Highest-Ranking Attribute
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Combination Therapy Delivering Superior Vision Would Meet Patients’ Highest-Ranking Attribute When Selecting Wet AMD Therapy Vision is the #1 unmet ne
Slide 38: Improving Vision Is the Largest Unmet Need for Retina Specialists
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Improving Vision Is the Largest Unmet Need in Wet AMD for Retina Specialists Vision is the #1 unmet need for retina specialists Which factors are more
Slide 39: Retina Specialists Willing to Administer Second Injection to at Least 24% of Patients
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook U.S. Retina Specialists Are Willing to Administer Second Injection to at Least 24% of Their Patients for Additional BCVA Improvement Vision is the #1
Slide 40: Sozinibercept Could Serve Clinical and Non-Clinical Needs for Retina Specialists
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept Has the Potential to Serve Both Clinical and Non- Clinical Needs for Retina Specialists Vision is the #1 unmet need for retina specialis
Slide 41: U.S. Payer's Top Product Attributes Are Related to Vision
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook U.S. Payer’s Top 5 Product Attributes Are Related to Vision Vision is the #1 unmet need for payers Product Attributes Ranked by Importance in Plan’s C
Slide 42: Payer Mix Supports a Favorable Access Environment for Sozinibercept
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Payer Mix Supports a Favorable Access Environment for Sozinibercept Vision is the #1 unmet need for payers . Wet AMD Payer Mi 1 U.S Me dicare x >90% M
Slide 43: Phase 2b Profile Met Desired Threshold to Potentially Support Broad Coverage
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Sozinibercept's Clinical Profile Demonstrated in Phase 2b Met the Desired Threshold to Potentially Support Broad Coverage in the U.S. Vision is the #1
Slide 44: Payers Confirmed Coverage for Potential Broad Label with Any Anti-VEGF-A
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Payers Confirmed Coverage for Potential Broad Sozinibercept Label in Combination with Any Anti-VEGF-A Assuming Positive Phase 3 Vision is the #1 unmet
Slide 45: Payers Indicated Combination Could Be Priced Comparably to Branded Anti-VEGF-A
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Payers Indicated Sozinibercept Combination Therapy with Any Anti-VEGF-A Could Be Priced Comparably to Branded Anti-VEGF-A Therapies Vision is the #1 u
Slide 46: Designed to Deliver on Highly Aligned Customer Priorities
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Soziniberept Designed to Deliver on Highly Aligned Customer Priorities Patients Retina Specialists Payers Superior Vision Is the #1 Unmet Need in Wet
Slide 47: Vision Is the Most Important Attribute for Patients Choosing Wet AMD Therapy
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Vision Is the Most Important Attribute for Patients When Choosing Their Wet AMD Therapy Planning strategies to activate patients on superior vision th
Slide 48: Physicians Would Treat a Minimum of 24% of Patients with Sozinibercept
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Physicians Indicate They Would Treat a Minimum of 24% of Their Patients with Sozinibercept for Any Additional Vision Improvement Sozinibercept is diff
Slide 49: Payers View a 20% Relative Improvement on Vision as Meaningful
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Payers View a 20% Relative Improvement on Vision as Meaningful to Potentially Support Broad Sozinibercept Coverage in Wet AMD Engaging payers early in
Slide 50: Superior Vision Is the #1 Unmet Need Across Retina Specialists, Patients, and Payers
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Superior Vision Is the #1 Unmet Need in Wet AMD Across Retina Specialists, Patients, and Payers Sozinibercept integrates seamlessly into a highly attr
Slide 51: Strategic Outlook
Strategic Outlook Fred Guerard, PharmD
Slide 52: Progress & Next Steps
Investor Day Tracker: Wet AMD Unmet Need & Sozinibercept Clinical Data Commercial Market Dynamics & Sozinibercept Customer Insights Strategic Outlook Advancing Therapeutic Innovations to Transform Patient Outcomes with Superior Vision Gains We are dedicated to advancing sozinibercept to improve pati
Slide 53: Question & Answer Session
Question & Answer Session Fred Guerard, PharmD, MS Charles C. Wykoff, MD, PhD Mike Campbell Anthony Bonifazio Anand Sundaram Chief Executive Officer Chief Investigator for COAST Chief Commercial Officer VP, Market Access VP, Marketing Clinical Advisory Board Member