Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — Investor Presentation (October 2018)
33 slides from Eyepoint's investor presentation, Oct 15, 2018
Slide 1: Investor Presentation October 2018
NASDAQ: EYPT Investor Presentation October 2018 Exhibit 99.2
Slide 2: Forward Looking Safe Harbor Statements
Forward Looking SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. This presentation is intended for communication f
Slide 3: EyePoint Highlights: Transformational Opportunity in Ophthalmology
Acquired Icon Bioscience to transform business and accelerate growth Two ophthalmology launches in 1H 2019 Strong leadership team with seasoned executives at the helm Executing on strategy to expand ophthalmology portfolio and utilize existing platform Obtained $80M+ in capital from new institutiona
Slide 4: Management and Board of Directors
Management with Proven Commercial Track Record and Highly Experienced Board of Directors Göran Ando, M.D. Chairman of the Board Dr. David J Mazzo Director Nancy Lurker President and CEO Michael W Rogers Director Doug Godshall Director Dr. Jay Duker Director Kristine Peterson Director Ron Eastman Dir
Slide 5: Transforming Into a Commercial Stage Specialty Biopharmaceutical Company
Transforming Into a Commercial Stage Specialty Biopharmaceutical Company YUTIQ™ Approved by FDA for Posterior Segment Uveitis on 10/12/18 Transformative acquisition of Icon Bioscience Inc on 3/28/18 added DEXYCU™ (approved by FDA on 2/9/18) to pipeline. EW and other investors commit total proceeds o
Slide 6: EyePoint Pharmaceuticals' Product Pipeline
EyePoint Pharmaceuticals' Product Pipeline Product / Program Preclin. Phase 1 Phase 2 Phase 3 Approval Market Rights DEXYCU™ post-operative inflammation 1H 2019 Launch WW YUTIQ™ three-year treatment for posterior segment uveitis 1Q 2019 Launch U.S.(1) YUTIQ™ shorter duration treatment for posterior
Slide 7: Prevention of Post Ocular Surgery Inflammation
Prevention of Post Ocular Surgery Inflammation
Slide 8: DEXYCU: Well Positioned for Commercial Success
DEXYCUTM: Well Positioned for Commercial Success 3.1% annual growth rate in the U.S. Most performed surgery in the U.S. Cataract surgeries per year 4.4 Million Surveyed cataract surgeons have expressed strong intent to use DEXYCU™ Major advance in treatment of post cataract surgery inflammation Ambu
Slide 9: Current Post-Cataract Regimen Requires Polypharmacy and Burdens Patients
Current Post-Cataract Regimen Requires Polypharmacy and Places Significant Burden on Patients and Physician Offices * Source: Vigamox/Besivance product labeling (not specifically indicated for this use, but are commonly prescribed for use). ** Source: Prolenza/Bromday product labeling (not specifica
Slide 10: DEXYCU Uses Verisome Technology to Deliver Dexamethasone
DEXYCUTM Uses Verisome® Technology to Deliver 517mg of Dexamethasone1 Administered as a single dose of 5-mL, intraocularly into the posterior chamber inferiorly behind the iris at the end of ocular surgery Formulated in the fully bioerodible Verisome® technology Wong V. et al. Pharmacokinetic Study
Slide 11: DEXYCU (dexamethasone intraocular suspension) 9% Profile
DEXYCUTM (dexamethasone intraocular suspension) 9% Profile Single dose (5mL) administered intraocularly in the posterior chamber at the end of surgery Encapsulated in the fully bioerodible Verisome® technology for extended release of API Wong V. et al. Pharmacokinetic Study of 10090 in the Anterior
Slide 12: Phase 3 Study 13-04 Results: Efficacy
Phase 3 Study 13-04 Results—Efficacy Placebo (n=80) 517mg (n=156) Percentage of Patients with POD 8 ACC Grade=0 ANTERIOR CHAMBER CELL (ACC) COUNT OF ZERO AT DAY 8 Percentage of Patients with ACC = 0 at Day 8 Note: Subjects who received rescue medicine were treated as failure. Difference vs. Placebo
Slide 13: DEXYCU Rapidly Reduces Inflammation
DEXYCUTM Rapidly Reduces Inflammation as Early as Day 1 with Statistical Significance at Day 3 through Day 30 * *P≤0.05 vs placebo Day 8 Primary endpoint Placebo (n=80) DEXYCU™ (n=156) * * *
Slide 14: Phase 3 Study 13-04 Safety Results
Phase 3 Study 13-04 Safety Results 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 Least One Active Treatment Group Intraocular pressure increased 7 (8.8) 21 (13
Slide 15: Placebo-controlled Phase 3 Clinical Study: IOP Levels
DEXYCU™ (dexamethasone intraocular suspension) 9% Placebo-controlled Phase 3 Clinical Study – IOP Levels Data on file. Phase III Study 13-04. Post hoc analysis. % of patients % of patients % of patients % of patients
Slide 16: Market Research Shows High Intent To Use
Market Research Involving Over 100 Cataract Surgeons Shows High Intent To Use 86% indicated intent to use 72% of patients would be appropriate candidates (see product label for warnings, precautions, and adverse reactions) 87% would recommend to a colleague upon commercial availability Primary marke
Slide 17: Cataract Surgery Market Potential
Cataract Surgery Market Potential US Cataract Surgery Market Over 4 million surgeries in 2017 Steroid drops used post surgery in majority of patients C-Code effective October 2018; valid for 3 years once commercial sale commences Precedent exists for extended C-Code reimbursement period post 3 year
Slide 18: Verisome Technology Dexamethasone Detectable up to 22 Days
In Preclinical Model Verisome® Technology Dexamethasone (Suspension 9%) is Detectable up to 22 Days with Just One Intraocular Injection Verisome® technology allows for the creation of a sphere containing active drug Droplet formation in aqueous media keeps delivery system intact and provides extende
Slide 19: Chronic Non-Infectious Posterior Segment Uveitis
Chronic Non-Infectious Posterior Segment Uveitis
Slide 20: High Unmet Need Opportunities
High Unmet Need Opportunities YUTIQTM micro insert for chronic non-infectious posterior segment uveitis approved by FDA on 10/12/18 Two Phase 3 studies with a p value of 0.01 over 12 months Consistent micro dosing over time without drug peaks and valleys Corticosteroids remain the standard of care f
Slide 21: YUTIQ: Well Positioned for Commercial Success
YUTIQTM: Well Positioned for Commercial Success Estimated to cause up to 10% of legal blindness in the U.S., or ~30,000 new cases of blindness per year (third largest cause of blindness) Patients in the U.S. with severe risk of blindness 55K-120K Corticosteroids remain the standard of care for poste
Slide 22: YUTIQ Specifically Tailored to Provide Benefit in Severe Disease
YUTIQ™ Specifically Tailored to Provide Benefit in Severe Disease Uveitis is inflammation of the uveal tract (iris, ciliary body, choroid) or adjacent structures The disease is chronic and patients often experience flares of inflammation and swelling that can lead to severe vision loss and blindness
Slide 23: YUTIQ 3-year Posterior Segment Uveitis Clinical Program
YUTIQ™ 3-year Posterior Segment Uveitis Clinical Program INSERTER TRIAL: EASE OF ADMINISTRATION Study 006 clinical trial: 26 patients Primary end-point: Ease of administration Result: Positive usability Study 001 Phase 3 clinical trial: 129 patients Primary end-point: Prevention of recurrence Result
Slide 24: Primary Efficacy Endpoint: Recurrence Rate at 6 and 12 Months
Primary Efficacy Endpoint of Study 001 & Study 005: Recurrence Rate at 6 and 12 months Study 001 (Recurrence Rate at 6 and 12 Months) Study 005 (Recurrence Rate at 6 and 12 Months) 7.6x 25.9x 1.8x 2.2x p < 0.001 p < 0.001 p < 0.001 p < 0.001 YUTIQTM Patients more likely to be recurrence free YUTIQTM
Slide 25: Systemic and Local Medications at Months
Systemic and Local Medications at 12 months ITT population – observed data (STUDY PSV-FAI-001) YUTIQTM patients received substantially less systemic and local rescue medication LESS USE OF RESCUE Sham includes standard of care. *
Slide 26: Reduced Probability of Uveitis Recurrence After a Single YUTIQ Insert
Reduced Probability of Uveitis Recurrence Through Day 380 After a Single YUTIQ™ FA Insert (STUDY PSV-FAI-001) Note: Sham patients include patients that received rescue therapy ITT Population FAI Hazard Ratio Sham vs. YUTIQ 7.08
Slide 27: Mean IOP Elevation and Cataract Surgery at 12 Months
YUTIQTM Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Mean IOP Elevation and Cataract Surgery at 12 Months Percentage mm Hg n = 84 n = 39 Δ = 1.1 mm Hg n = 93 n = 49 Δ = 2.0 mm Hg 14/42 1/21 11/61 3/35 *Sham includes standard of care. * *
Slide 28: YUTIQ 6-month vs. 3-year Implant In Vitro Release Rate
YUTIQ™ 6-month vs. 3-year Implant Vitro Release Rate Comparison For Long term in vitro release rate matched with the 3-year insert NOTE: Release rate compared to rate meeting specifications for stability of clinical lot used in Iluvien clinical trials at pre-determined time points (in orange). Poten
Slide 29: Potential for Two Innovative Ophthalmology Product Launches in 2019
Potential for Two Innovative Ophthalmology Product Launches in 2019 DEXYCUTM YUTIQTM FDA approved 2/09/18 Expected launch 1H 2019 FDA approved 10/12/18 Positioned for Commercial Success Experienced Ophthalmology VP Marketing Several Senior Marketers Senior Ophthalmology Medical Affairs, and MSLs VP
Slide 30: Commercial Preparations Underway
Commercial Preparations Underway Medical Education Plan Being Executed VP of Medical Affairs in place Multiple KOL Advisory Boards & significant presence at key Congresses Robust Publication plan and key papers on track for publish MSL team near complete Contract Sales Organization Initiated in 2Q 2
Slide 31: Durasert: Approved Technology for Ocular Delivery
Durasert™: Approved Technology for Ocular Delivery EyePoint is one of few companies that has developed FDA-approved extended-release inserts EyePoint will continue to evaluate potential partnerships that utilize Durasert technology OZURDEX (2009, Allergan) BRVO, CRVO, NIU, DME RETISERT (2005, B&L) U
Slide 32: Financial Highlights
Financial Highlights Pro forma* Cash of $67.4M $20M Debt Pro forma* 95.2M Shares *Represents cash and shares outstanding as of June 30, 2018, adjusted to reflect warrant exercise in September 2018
Slide 33: EyePoint Highlights: Transformational Opportunity in Ophthalmology
Acquired Icon Bioscience to transform business and accelerate growth Two ophthalmology launches in 1H 2019 Strong leadership team with seasoned executives at the helm Executing on strategy to expand ophthalmology portfolio and utilize existing platform Posterior segment uveitis Postoperative inflamm
EyePoint Pharmaceuticals — Investor Presentation (October 2018) on 6ix