Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — Investor Presentation (February 2020)
41 slides from Eyepoint's investor presentation, Feb 20, 2020
Slide 1: Investor Presentation February 2020
INVESTOR PRESENTATION FEBRUARY 2020 NASDAQ: EYPT Exhibit 99.1
Slide 2: Forward-looking statements
Various statements made in this presentation are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. This presentation is intended for communication for investors only. Nothing in this presentation should be construed as promoting the use of YU
Slide 3: An Emerging Leader in Ophthalmology
AN EMERGING LEADER IN OPHTHALMOLOGY YUTIQ® and DEXYCU® launched in 2019 driving a growing commercial business Veteran executive team with deep experience in commercial product launches and drug development Strategic focus to become go-to partner for commercialization in ophthalmology Focused on orga
Slide 4: Pipeline
1 Alimera Sciences, Inc. owns worldwide rights to ILUVIEN® for DME and rights for YUTIQ® for non-infectious posterior uveitis in the EMEA with a royalty payable to EyePoint. 2 Excludes China, Hong Kong, Macau and Taiwan PIPELINE Program Preclin. Phase 1 Phase 2 Phase 3 Commercial Rights DEXYCU® post
Slide 5: Durasert and Verisome: Proprietary, FDA Approved Technologies
Durasert® Verisome® Durasert® and Verisome®: Proprietary, FDA Approved Technologies Ocular insert for long-term delivery of small molecules Approved products1: YUTIQ® (2018, EyePoint) - Posterior Segment Uveitis ILUVIEN® (2014, Alimera) - DME RETISERT® (2005, B&L) - Uveitis VITRASERT® (1996, B&L) -
Slide 6: Q4 2019 Momentum Continues into 2020: Recent News
Vorolanib license completed TKI molecule in EYP-1901 brings promising efficacy signal from prior human clinical trials as oral therapy License agreement finalized after completion of initial intra-vitreal safety and PK studies of EYP-1901 by EyePoint Advancing as six-month intra-vitreal treatment us
Slide 7: EYP-1901 – 6-Month Durasert Vorolanib TKI Opportunity
EYP-1901 – 6-Month Durasert® Vorolanib -Tyrosine Kinase Inhibitor (TKI) Opportunity in wet AMD, Diabetic Retinopathy and Retinal Vein Occlusion
Slide 8: EYP-1901 – Addressable Market Sizes (U.S.)
(1) Assumes percentage treated with anti-VEGF is same for Macular Edema from RVO, and RVO without Macular Edema (2) Includes percentage treated with lasers and steroids Sources: KOL insights; Datamonitor 2019; Kodiak Sciences; Cowen Therapeutic Categories Outlook 2019; AAO; Centers for Disease Contr
Slide 9: EYP-1901 – Vorolanib Receptor Targeting
Vorolanib Inhibits VEGFR, PDGFR, c-Kit, CSF1R and Flt-3 EYP-1901 – VOROLANIB RECEPTOR TARGETING The enzymes VEGFR-2, PDGFRβ, and Flt-3 are pro-angiogenic proteins Each of these important targets is strongly inhibited by both vorolanib and sunitinib with comparable IC50 values Vorolanib and sunitinib
Slide 10: Molecule Demonstrates Positive Efficacy Signal From Oral Delivery
1 – Study completed by Tyrogenix, Inc. 2- Jackson TL et al. JAMA Ophthalmology July 2017 Volume 135, Number 7, 2017 – page 766 3 -Jackson TL et al. JAMA Ophthalmology July 2017 Volume 135, Number 7, 2017 – page 765 4 -Jackson TL et al. JAMA Ophthalmology July 2017 Volume 135, Number 7, 2017 – page 7
Slide 11: Oral Delivery Trial - Preliminary Evidence of BCVA Improvements
1 – Study completed by Tyrogenix, Inc. Phase 1 Oral Delivery Trial - Preliminary Evidence of BCVA Improvements and Ocular Safety VOROLANIB CLINICAL HISTORY1 - wAMD 15 completers (60%) with no rescue through 24 weeks (shown in graph) 25/35 completed with 10 discontinued due to systemic AEs and non-dr
Slide 12: Oral Delivery Trial - Reduced Rescue Injections
Phase 1 Oral Delivery Trial - Reduced Rescue Injections over 6 months X-82 is prior program name for vorolanib 1 – Study completed by Tyrogenix, Inc. VOROLANIB CLINICAL HISTORY1 - wAMD Clear dose response with daily oral dosing between 50 mg and 200 mg Subjects dosed at 300 mg dropped out due to GI
Slide 13: Oral Delivery Trial - Central Subfield Thickness
Phase 1 Oral Delivery Trial – Central Subfield Thickness Maintained or Reduced over 6 months 1 – Study completed by Tyrogenix, Inc. Mean ± Standard Error. VOROLANIB CLINICAL HISTORY1 Subjects Who Completed 6 Months Treatment Day 14
Slide 14: Phase 2b Oral Delivery Trial in wAMD
Double-masked, placebo-controlled dose finding study evaluating 50, 100 and 200 mg daily orally vs. placebo in wAMD patients Diagnosed for >6 months and receiving IVT anti-VEGF at least every 8 weeks for the past two injections with evidence of reduction in macular fluid or thickness by OCT Objectiv
Slide 15: Prematurely Terminated by DSMB Due to Negative Systemic AEs
Study started in March 2015 and enrolled 157 patients Randomized 40, 39, 39 and 39 patients at 50, 100, 200 mg and placebo respectively The trial was expected to take place for 56 weeks (52 weeks with additional 4 weeks of follow up) Study stopped prematurely at the second interim analysis (36 weeks
Slide 16: BCVA Stable Through 12 Months
X-82 is prior program name for vorolanib 1 – Study completed by Tyrogenix, Inc. BCVA was Stable Through 12-Months in Patients Already Controlled by Current Anti-VEGF Therapies VOROLANIB CLINICAL HISTORY1 Phase 2b Oral Delivery Trial in wAMD
Slide 17: ~50% Fewer Rescue Interventions vs. Placebo
BCVA stabilization was achieved with ~50% fewer rescue interventions vs. placebo X-82 is prior program name for vorolanib 1 – Study completed by Tyrogenix, Inc. VOROLANIB CLINICAL HISTORY1 Phase 2b Oral Delivery Trial in wAMD
Slide 18: EYP-1901 Activity in Validated Laser CNV Mini Pig Model
Observed Efficacy Signal in Fluorescein Angiography (FA) Results Using 6-month EYP-1901 Insert 1 – Study completed by EyePoint Pharmaceuticals, Inc. CTLF = Corrected Total Lesion Fluorescence Integrated Density (Area of lesion X Mean fluorescence background readings) High = high dose; Low = low dose
Slide 19: EYP-1901 – Development Plan
EYP-1901 – DEVELOPMENT PLAN Type B Pre-IND meeting completed with FDA (Jan 2020) Preliminary safety toxicity study in mini pig complete and supportive Non-GLP rabbit PK and safety complete 2-week data demonstrated tissue concentration above IC50 range 2 month complete, data supportive to initiate GL
Slide 20: YUTIQ50
YUTIQ50 : aot cy) ~ + — Se —- EYEPOINT PHARMACEUTICALS
Slide 21: YUTIQ50 – Development Plan
YUTIQ®50 – DEVELOPMENT PLAN ~60 patient trial; 2:1 randomization 6-Month release data results comparable to 3-year YUTIQ Anticipate filing under sNDA with 6-month approval clock 6-month Treatment for Chronic Non-Infectious Uveitis Affecting the Posterior Segment
Slide 22: Commercial Programs
Commercial Programs ~ > a E Ww te t -- : = a EYEPOINT PHARMACEUTICALS
Slide 23: Two Commercial Products Launched in 2019
TWO COMMERCIAL PRODUCTS LAUNCHED IN 2019 Postoperative inflammation following ocular surgery Chronic non-infectious uveitis affecting the posterior segment of the eye 33 dedicated KAMs targeting high-volume ambulatory surgical centers (ASCs) Permanent and specific J-Code with solid reimbursement exp
Slide 24: DEXYCU Significant Market Opportunity: U.S. Cataract Surgery
U.S. Cataract Surgery Very Large and Growing * Based upon company estimates for 2018. Source: imaged from the American Optometric Association. DEXYCU® - Significant Market Opportunity ~$2B Intraocular lens is inserted Intraocular lens is positioned Diseased lens is removed Cataract Surgeries in 2018
Slide 25: Post-cataract Regimen Requires Multiple Daily Eyedrops
Post-cataract Treatment Regimen Requires Multiple Daily Eyedrops *Source: Vigamox/Besivance product labeling (not specifically indicated for this use, but are commonly prescribed for use). **Source: Prolensa/Bromday product labeling (not specifically indicated for this use, but are commonly prescrib
Slide 26: DEXYCU: First FDA-approved Single-dose Intracameral Steroid
1 Wong V. et al. Pharmacokinetic Study of 10090 in the Anterior Chamber of Rabbits (2013). Note: Refer to the full DEXYCU® product label at www.eyepointpharma.com. DEXYCU® Detectable up to 22 days after single injection(1) Suspension placed behind the iris First and Only FDA-approved Single-dose, Su
Slide 27: DEXYCU Demonstration
DEXYCU DEMONSTRATION Please see video at company website: https://eyepointpharma.com/case-study-series/
Slide 28: Statistically Significant Inflammation Reduction
Statistically Significant Inflammation Reduction Note: Refer to the full DEXYCU® product label at www.eyepointpharma.com. DEXYCU® * *P≤0.05 vs. placebo Day 8 Primary endpoint Placebo (n=80) DEXYCU® (n=156) * * * 3x clearance vs. placebo at day 8 40 percentage point difference vs. placebo (97.5% CI)
Slide 29: IOP Elevation Versus Placebo Not Clinically Significant
% of patients IOP Elevation Versus Placebo Not Clinically Significant Data on file. Phase III Study 13-04. Post hoc analysis. DEXYCU® IOP Intervals on POD 1 IOP Intervals on POD 3 IOP Intervals on POD 8 IOP Intervals on POD 15 % of patients % of patients % of patients
Slide 30: Phase 3 Study – Safety Results
Phase 3 Study – Safety Results Note: Refer to the full DEXYCU® product label at www.eyepointpharma.com. DEXYCU® Safety, n (%) Placebo N=80 517 mcg N=156 Any TEAE in Study Eye 51 (63.8) 72 (46.2) Any Ocular SAE in Study Eye 0 0 Any Non-ocular SAE 4 (5.0) 4 (2.6) Study Eye AEs Occurring in ³5% of at L
Slide 31: DEXYCU Sales Process
DEXYCU® SALES PROCESS Average Time (weeks) to Account Re-Order 1 Introduce Introduce DEYXCU and its clinical and safety data to target physician Educate Educate the ASC where physician operates about DEXYCU profile Sample Schedule a physician and staff DEXYCU trial and training Order ASC places firs
Slide 32: DEXYCU 2019 Performance
4Q2019 customer demand increased 86% as compared to 3Q2019 4Q2019 net revenue in $2.8–$3.1M range FY2019 net revenue in $4.4–$4.7M range Month Over Month Growth Accelerating DEXYCU® 2019 PERFORMANCE Customer Demand
Slide 33: Market Potential Based on Account Penetration
Market Potential Based on Account Penetration Through 12/31/19 ASC: Ambulatory Surgical Center Data based on internal estimates DEXYCU® DEXYCU Market Potential $2.0B DEXYCU ASCs in-serviced to date $170M ASCs Re-Ordering $105M Value of Current ASC Accounts Ordering Value of Trained Accounts Value of
Slide 34: YUTIQ Market
YUTIQ® Market Patients in the U.S. with Chronic Non-infectious Posterior Segment Uveitis ~60K–100K ~30,000 new cases of blindness per year in the U.S. 3rd leading cause of blindness in the U.S. Uveitis is: Inflammation of the Uveal tract (iris, ciliary body, choroid), or adjacent structures (lens, r
Slide 35: YUTIQ Sustained Release of Fluocinolone
YUTIQ® YUTIQ® Is Designed to Deliver a Sustained Release of Fluocinolone for Patients with Chronic Noninfectious Posterior Uveitis for Up To 36 Months Durasert® Technology Packaging YUTIQ Placement
Slide 36: Recurrence Rate at Six and Twelve Months vs Sham
Recurrence Rate at Six and Twelve Months vs Sham * Sham includes standard of care. Note: Refer to the full YUTIQ® product label at www.eyepointpharma.com YUTIQ® 4.4x 3.1x p < 0.01 p < 0.01 p < 0.01 p < 0.01 YUTIQ Patients more likely to be recurrence free 2.5x 1.8x YUTIQ Patients more likely to be r
Slide 37: Reduced Probability of Uveitis Recurrence Through 36 Months
Single Insert Reduced Probability of Uveitis Recurrence Through 36 Months Note: Sham patients include patients that received rescue therapy. YUTIQ® YUTIQ Median Time to First Recurrence: 1,051 Days 3 years ITT Population
Slide 38: Safety – Select Adverse Events
Safety – Select Adverse Events 1 Includes macular edema and cystoid macular edema 2 Includes eye pain and procedural pain 3 Includes hypotony, intraocular pressure decreased and procedural hypotension Note: Refer to the full YUTIQ® product label at www.eyepointpharma.com YUTIQ® Safety, n (%) YUTIQ®
Slide 39: YUTIQ 2019 Performance
4Q2019 customer demand increased 43% as compared to 3Q2019 4Q2019 net revenue in $4.1–$4.5M range FY2019 net revenue in $11.4–$11.8M range Strong Monthly Demand Growth Continues YUTIQ® 2019 PERFORMANCE Customer Demand
Slide 40: Key Access Agreements to Expand Product Reach
KEY ACCESS AGREEMENTS TO EXPAND PRODUCT REACH DEXYCU® and YUTIQ® added to the Federal Supply Schedule Access to U.S. veterans and other federal agencies Nine Million VA beneficiaries added Three-year agreement for DEXYCU® Vizient’s network includes more than 50% of the nation’s acute care providers,
Slide 41: An Emerging Leader in Ophthalmology
AN EMERGING LEADER IN OPHTHALMOLOGY YUTIQ® and DEXYCU® launched in 2019 driving a growing commercial business Veteran executive team with deep experience in commercial product launches and drug development Strategic focus to become go-to partner for commercialization in ophthalmology Focused on orga
EyePoint Pharmaceuticals — Investor Presentation (February 2020) on 6ix