Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Corporate Update (July 2025)
33 slides from Astellas Pharma's corporate update, July 2025
Slide 1: IZERVAY US Commercial Update
IZERVAY TM (avacincaptad pegol intravitreal solution) US Commercial Update July 2025 FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 2: Cautionary Statement Regarding Forward-Looking Information
Cautionary Statement Regarding Forward-Looking Information 2 In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These sta
Slide 3: Introductions
Introductions 3 Presenters Q&A Participants Dr. Arshad M. Khanani, MD, MA, FASRS Mike Petroutsas Director of Clinical Research, Sierra Eye Associates President, Head of US at Astellas Clinical Professor, University of Nevada Marci English, MPH Claus Zieler Senior Vice President Chief Commercial & Me
Slide 4: Clinical Perceptions of GA and IZERVAY
Clinical Perceptions of GA and IZERVAY Dr. Arshad Khanani, MD FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 5: Geographic Atrophy (GA) - A Serious Condition that Leads to Irreversible Vision Loss
Geographic Atrophy (GA) - A Serious Condition that Leads 5 to Irreversible Vision Loss Progression of Age-Related Macular Degeneration (AMD) EARLY INTERMEDIATE ADVANCED Small waste deposits, called drusen, Deposits increase in number and/or In addition to drusen, vision loss form in the back of the
Slide 6: When it Comes to Patients' Vision, Time is Critical
When it Comes to Patients’ Vision, Time is Critical 6 DIAGNOSIS 1.6 YEARS 2 YEARS 2.5 YEARS 67% of patients with bilateral ~50% of patients with GA is the median time for GA to GA lose the ability to drive1* lose 2 lines of vision2† reach the central fovea3‡ 77% of patients reported GA impacted thei
Slide 7: Time Lost is Vision Lost
Time Lost is Vision Lost 7 What may be happening to the retina What may be happening to your patient’s vision Representation of vision loss for illustrative purposes only. FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 8: Reasons to Treat
Reasons to Treat 8 In a survey of people with Your patient’s vision Though the speed of self-reported GA, 84% of will never be better progression can vary, than it is today1 GA does progress for them said they would try every patient1 a new treatment to slow GA in hopes of preserving their vision fo
Slide 9: Yet Thousands of Patients with GA are Still Waiting to be Treated
Yet Thousands of Patients with GA are Still Waiting to be Treated 9 ~ 1.5 million patients in the US are thought to live with GA; a large portion of which may be undiagnosed.1,2 Despite the availability of therapies, market research has shown only ~15% of diagnosed GA patients are being treated2 1.
Slide 10: At this point, I feel like a week is extra. It would be life-changing.
10 “ It’s not a miracle, but [slowing] the progression means I would be able to see a little longer. At this point, I feel like a week is extra. It would be life-changing. It would give “ me some comfort, some hope. ~GA patient FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 11: Why IZERVAY?
Why IZERVAY? FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 12: Early Treatment Landscape
Early Treatment Landscape 12 No approved treatments prior to 2023; SYFOVRE events led to broader retina community questions complement inhibitors ASRS issues letter to ECPs SYFOVRE about SYFOVRE RV cases IZERVAY SYFOVRE safety signals FDA approval Apellis provides update FDA approval published at AS
Slide 13: IZERVAY's Safety Record
IZERVAY’s Safety Record 13 No retinal vasculitis cases across GATHER clinical trial program for GA GATHER1 GATHER2 347K (0-12 months) (0-24 months) Adverse events of special interest IZERVAY Sham IZERVAY Sham (n=67) (n=110) (n=225) (n=222) Intraocular inflammation (IOI) 1 0 1 0 Endophthalmitis 0 0 1
Slide 14: #1 Prescribed FDA-approved Treatment for New Patients
#1 Prescribed FDA-approved Treatment for New Patients* 14 *Based on Symphony data from 3/24-1/25. May not represent entire patient population. IZERVAY is the only treatment to demonstrate a statistically significant reduction in rate of GA growth across two Phase 3 trials at 12 months1,2 CI=confiden
Slide 15: Patient Case Study
Patient Case Study FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 16: Patient Case Study: Projection Only
Patient Case Study: 16 PROJECTION ONLY FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 17: Real IZERVAY Patient Stories
Real IZERVAY Patient Stories FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 18: Jan's Story
JAN’S STORY FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 19: US Progress Update: IZERVAY Roadmap
US Progress Update: IZERVAY Roadmap Claus Zieler, Chief Commercial & Medical Affairs Officer (CCMAO) FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 20: Evolution of IZERVAY's Commercial Journey (Launch – Q1/FY2025)
Evolution of IZERVAY’s Commercial Journey (Launch – Q1/FY2025) 20 IZERVAY Sales Trend Delayed Label C Update sNDA Approval D Permanent B J-code IZERVAY Launch A Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 FY2023 FY2024 FY2025 FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 21: US Business Update
US Business Update 21 Q1/FY2025 Act * YoY Q1 Performance \ basis 15.9 bil. yen +3.2 (+25%) -Record high quarterly sales- • Returned to growth trajectory, with a +22% QoQ growth $ basis $110M +29 (+35%) • Continues to be #1 chosen treatment for new patient start FY2025 FCST QoQ Growth ($ basis) New
Slide 22: US GA Market Dynamics
US GA MARKET DYNAMICS Initiatives to Expand the Market FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 23: More than A Million Patients Have GA; The Market Potential is Large
More than A Million Patients Have GA; The Market Potential is Large 23 1.5M1,2 GA Patients 800K1 Diagnosed ~170K2 Treated with Complement Inhibitors (CIs) ~45%2 IZERVAY Total Share 1. Jaffe GJ, Westby K, Csaky KG, et al. Ophthalmology. 2021 Apr;128(4):576-586. 2. Astellas Pharma US, Inc. Izervay. Da
Slide 24: Drivers to Unlocking GA Market Potential
Drivers to Unlocking GA Market Potential 24 Educate Educate Educate Retina Specialists Patients Upstream FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 25: Top Users of CI Treat a Large Proportion of their GA Patients
Top Users of CI Treat a Large Proportion of their GA Patients; 25 Utilization of CIs Needs to be Broadened to Wider Retina Community Retina Specialists Treating with Complement Inhibitors (CIs) (Average CI vs. anti-VEGF use ) 1:3 vs 1:14 Top Accounts* Average Accounts* * Claims data on file FOR USE
Slide 26: Increasing Efforts to Educate Retina Specialists on the Value of Early Treatment
Increasing Efforts to Educate Retina Specialists on the Value of Early 26 Treatment with IZERVAY 84% of GA patients said they are motivated to try new treatment* Patients want treatments to preserve their vision longer Sales Force Expansion Compelling Message Evolution Increased frequency and high-t
Slide 27: Competitive DTC Investment Accelerating Patient Education
Competitive DTC Investment Accelerating Patient Education 27 FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 28: DTC – Early in Our Journey, Investing for Long-term Success
DTC – Early in Our Journey, Investing for Long-term Success 28 Driving increased interest among GA patients 2B+ Media Impressions 2M+ Qualified Visits to IZERVAY.com 72% IZERVAY Brand Awareness 77% Patients who plan to ask for IZERVAY “(The ad) gives hope of possibly slowing the progression of GA do
Slide 29: Expanding the Market through Eye Doctor Education and Patient Referral
Expanding the Market through Eye Doctor Education and Patient Referral 29 Upstream Optometrists Earlier & Ophthalmologists Stage GA Patients Strategic, broader upstream focus on Ongoing consumer education via increasing referrals to treating DTC/influencer/patient ambassadors physicians FOR USE WITH
Slide 30: Sales Outlook
SALES OUTLOOK FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 31: Expected Market Evolution
Expected Market Evolution* 31 Today: 2025 Acceleration: 2027 Expansion: 2029 ~15% of diagnosed patients treated Percent of treated patients grows to >35% patients treated as result of with Complement Inhibitors (CIs) by ~25-35%, via expansion to middle broader upstream awareness & cutting-edge, earl
Slide 32: Strong Outlook for IZERVAY
Strong Outlook for IZERVAY 32 Strong US performance to compensate the downside of ex-US Reinforcing confidence in realizing 200-400B JPY peak sales from the US alone + Potential Upside Ex-US Expansion Increase Upstream Efforts Peak Sales Acceleration 200-400B JPY Broaden Retina Specialists Educa
Slide 33: Q&A
Q&A FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.