psivida Transforms into Commercial Stage Specialty BioPharmaceutical Company Investor Presentation May 2018 NASDAQ: EYPT

Transcription

1 psivida Transforms into Commercial Stage Specialty BioPharmaceutical Company Investor Presentation May 2018 NASDAQ: EYPT

2 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 for investors only. Nothing in this presentation should be construed as promoting the use of Dexycu or product candidates. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema ("DME"), which depends on Alimera's ability to continue as a going concern; Alimera's ability to obtain marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN; the number of clinical trials and data required for the Durasert technology for the treatment of non-infectious uveitis affecting the posterior segment of the eye, uveitis marketing application approval in the U.S.; our ability to use data in promotion for Durasert micro insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye, U.S. NDA approval which includes clinical trials outside the U.S. U.S. NDA including clinical trials outside the U.S.; our ability to successfully commercialize DEXYCU in the U.S.; our ability to obtain stockholder approval for portions of the EW and SWK investments; our ability to successfully commercialize Durasert three-year uveitis, if approved, in the U.S.; potential off-label sales of ILUVIEN for uveitis; consequences of fluocinolone acetonide side effects; the development of our next-generation Durasert shorter-duration treatment for posterior segment uveitis; potential declines in Retisert royalties; efficacy and the future development of an implant to treat severe osteoarthritis; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements, including our agreement with Alimera; termination or breach of current license agreements, including our agreement with Alimera; our dependence on contract research organizations, vendors and investigators; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of the potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized. 2

3 Positioned for Commercial Success President and CEO: Nancy Lurker has a proven track record, having launched and grown many products generating billions in revenue Executive Vice President and GM US: Leonard Blum is a highly experienced biopharma commercial executive with over 30 years of experience managing commercial operations of emerging growth companies. Leonard has led multiple product launches at the national and global level in multiple therapeutic categories Chief Medical Officer: Dr. Dario Paggiarino brings extensive expertise in global drug development programs focused on retinal disease 3

4 Positioned for Commercial Success Recently strengthened team with seasoned healthcare executives Experienced Ophthalmology VP Marketing Several Senior Marketers Senior Ophthalmology Medical Affairs, and MSLs VP Market Access Hired with strong Payor background and track record of success National Sales Director on track for Hire in late 2Q DURASERT Approved Technology 4

5 Accelerating Our Transformation to a Commercial Company Through Organic Growth, Acquisition and Additional Funding DEXYCU (dexamethasone intraocular suspension) 9% approved by FDA on 2/9/18 YUTIQ Posterior Segment Uveitis NDA accepted by FDA 3/19/18 psivida acquired Icon Bioscience Inc. 3/28/18 EW Healthcare Partners SWK Holdings YUTIQ Posterior Segment Uveitis PDUFA 11/5/18 5

6 Strategic Rationale for Transactions TRANSFORMATIVE ACQUISITION AND FINANCING DRIVEN BY A SHARED VISION WITH OUR NEW PARTNERS, EW HEALTHCARE AND SWK TWO POTENTIAL NEAR TERM OPHTHALMOLOGY LAUNCHES FUNDING FROM TWO PREMIER PARTNERS REMAIN OPPORTUNISTIC IN EXPANDING OUR OPHTHALMOLOGY PORTFOLIO 6

7 Premier Financial Partners EW Healthcare Partners (formerly Essex Woodlands) leading equity investment up to $60.5M; SWK Holdings providing up to $20M in debt EW s initial investment of $9.5M on 3/28/18 EW leading an additional tranche Up to $25.5M for units consisting of 1 share of common stock and 1 warrant to purchase common stock* Common stock price equal to the lower of a 15% premium to the initial investment price ($1.10) or a 20% discount to the 20-day VWAP at closing Warrant strike price equal to the lower of a 30% premium to the initial investment price ($1.10) or a 20% discount to the 20-day VWAP at the time of exercise. Warrants are cash-exercise only, and must be exercised no later than 15 days after the issuance of a pass-through reimbursement code for DEXYCU EW Healthcare Partners is a large, healthcare-only investor with a strong track record in similar investments (AxoGen, Abiomed, EUSA) Deep domain expertise and active partner in building value Long-term, growth-driven orientation Supports and will assist with a buy and build strategy *Subject to shareholder approval. 7

8 EyePoint Pharmaceuticals' Product Pipeline Product Preclinical Phase 1 Phase 2 Phase 3 Filing Commercial Dexycu (dexamethasone intraocular suspension) 9% YUTIQ three-year treatment for posterior segment uveitis YUTIQ shorter duration treatment for posterior segment uveitis YUTIQ knee OA DURASERT TKI for Wet AMD Collaboration on front of the eye disease (Glaucoma) IBI Potential Indication Glaucoma NSAID Potential Indication: Cataract Surgery Inflammation 8

9 Two Potential Near Term Launches DEXYCU YUTIQ FDA APPROVED 2/09/18 NDA ACCEPTED posterior segment uveitis 3/19/18 PDUFA 11/05/18 EXPECTED LAUNCH 1H 2019 LAUNCH 1H 2019 Assuming positive FDA review POTENTIAL FOR 2 INNOVATIVE OPHTHALMOLOGY PRODUCT LAUNCHES

10 High Unmet Need Opportunities LARGE GROWING MARKET WITH A CONCENTRATED SURGEON PRESCRIBER BASE Major advance in treatment of post cataract surgery inflammation Target cataract surgeons have expressed strong intent to use DEXYCU (dexamethasone intraocular suspension) 9% Limited competition Clear pathway to reimbursement within Medicare Part B and Commercial/Medicare Advantage (C-Code pass through reimbursement for three years post issuance of code) Ped study future opportunity to expand DEXYCU label and exclusivity UVEITIS THIRD LEADING CAUSE OF BLINDNESS IN THE US YUTIQ micro insert for non infectious posterior segment uveitis accepted for review by FDA 3/19/18 Two Phase III studies with p <.001 over 12 months Consistent micro dosing over time without drug peaks and valleys Corticosteroids remain the standard of care for posterior segment uveitis Treatment goal is to prevent flares, which can lead to blindness Please see Important Safety Information on slides 27 & 28 and full Prescribing Information 10

11 Uveitis Market Potential US PREVALANCE ESTIMATES OF 55K-110K High Unmet Need Corticosteroids standard of care Prevention of flares is treatment goal $80-$100M Peak Revenue Potential 11

12 Cataract Surgery Market Potential 2018 US Cataract Surgery Market Over 4 million surgeries in 2018 Steroid drops used post surgery in majority of patients $150-$200M Peak revenue potential in three year reimbursement window Downside risk should reimbursement not be extended Two year C Code Extension granted to three ASC drugs in March

13 Four Pillars for Commercial Success Commercial Sales Marketing Market Access Medical Education 13

14 Commercial Four Pillar Strategy Underway Medical Education Plan Being Executed ü ü ü 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 on Track for Q Initiation ü Dedicated sales team ü Sales representatives and back office support managed by CSO ü National Sales Director and DMs managed by EyePoint Pharmaceuticals Payor and Reimbursement Team Build Underway ü Experience VP of Market Access Hired ü Reimbursement support services will be provided ü Discussions underway for third party logistics (3PL)

15 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 extended drug release via diffusion DROPLET IMAGES UNDER OPTICAL MICROSCOPY Source: Wong V. et al. Pharmacokinetic Study of in the Anterior Chamber of Rabbits (2013). Data on file. API

16 Dexamethasone Intraocular Suspension 9% Product Profile Administered as a single dose of via 5µL, intraocularly in the posterior chamber at the end of surgery Encapsulated in the fully bioerodible Verisome technology Refer to the full Dexycu product label at Source: Wong V. et al. Pharmacokinetic Study of in the Anterior Chamber of Rabbits (2013). Data on file. 16

17 Dexamethasone Intraocular Suspension 9% Product Profile Clearing of anterior chamber cells significantly lower versus placebo at day 3, 8,15 and 30 for 517 µg Warnings and precautions include increase in intraocular pressure, delayed healing, exacerbation of infection and cataract progression Most common AE s reported occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis Refer to the full Dexycu product label at

18 DEXYCU Strong Patent Estate 1. Use of Sustained Release Dexamethasone in Post-Cataract Surgery Inflammation US App. No. 14/893,381 May 23, Dose Guide for Injection Syringe US App. No. 14/113,803 April 25, Sustained Release of Pharmaceutical Agents from Citrate-based Verisome Formulations US App. No. 6,960,346 B2 July 3, Sustained Release of Pharmaceutical Agents from Citrate-based Verisome Formulations US App. No. 7,560,120 B2 July 3,

19 Cataract Surgery Is the Most Commonly Performed Surgery in the US ~4 MILLION SURGERIES PER YEAR GROWING AT RATE OF 3.1% A YEAR 925 AMBULATORY SURGICAL CENTERS THAT PERFORM 500 OR MORE PER YEAR Source: Market Scope,

20 Post Cataract Treatment Goals Currently Require Polypharmacy Control Inflammation Prevent Infection Reduce Pain/Edema STEROID ANTIBIOTIC NSAID

21 This Can Place a Significant Burden On Patients STEROID ANTIBIOTIC NSAID Week 1 Week 2 Week 3 Week 4 3-4/day 3/day* 1/day** 3-4/day 2/day 1/day 1/day 70+ Drops 21 Drops 14 Drops Up To 105+ Drops Over 4 Weeks *Source: Vigamox/Besivance product labeling (not specifically indicated for this use, but are commonly prescribed for use) **Source: Prolenza/Bromday product labeling (not specifically indicated for this use, but are commonly 21 prescribed for use)

22 Physician Perspective On Current Treatment Paradigm POOR PATIENT COMPLIANCE WITH DROP REGIMEN COULD LEAD TO POOR OUTCOMES SIGNIFICANT NUMBER OF PATIENT CALL BACKS ARE TIME CONSUMING AND DISRUPTIVE TO OFFICE PATIENTS/CAREGIVERS ARE FRUSTRATED AND CONFUSED WITH REGIMEN WHICH IMPACTS SATISFACTION SIMPLIFYING THE REGIMEN WOULD REPRESENT A SIGNIFICANT INNOVATION Primary market research on file September

23 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 market research on file September 2017 Refer to the full Dexycu product label at 23

24 Approved YUTIQ technology products Approved 1996 Vitrasert CMV retinitis 20,000x less drug Approved 2005 Retisert Uveitis 200,000x less drug Approved 2012 Iluvien DME 400,000x less drug DURASERT Approved Technology 24

25 Durasert: Approved Technology For Ocular Delivery Long Duration Up to 3 years from single injection minimizes ocular injections every 2-3 months; now focusing on 6-9 month regimen Proprietary Sustained Polymer Technology Tailored to be bio-erodible or non-erodible Broadly Applicable Can deliver many types of small molecule drugs Lasts for 3 Years Durasert Approved Technology Strong Patent Estate Issued patents covering Durasert technology and inserter extend until

26 Uveitis represents a significant unmet medical need UVEITIS is inflammation of the uveal tract (iris, ciliary body, choroid) or adjacent structures DURASERT Approved Technology Posterior Segment Anterior Segment 26

27 YUTIQ 3-year Posterior Segment Uveitis Clinical Program FIRST PHASE 3 TRIAL: PREVENTION OF RECURRENCE PRIMARY ANALYSIS COMPLETED Study 001 Phase 3 clinical trial: 129 patients Primary end-point: Prevention of recurrence Result: p < SECOND PHASE 3 TRIAL: PREVENTION OF RECURRENCE PRIMARY ANALYSIS COMPLETED Study 005 Phase 3 clinical trial: 153 patients Primary end-point: Prevention of recurrence Result: p < INSERTER TRIAL: EASE OF ADMINISTRATION PRIMARY ANALYSIS COMPLETED Study 006 clinical trial: 26 patients Primary end-point: Ease of administration Result: Positive usability 27

28 Primary Efficacy END-POINT Study 001: Recurrence Rates at 6 and 12 months 6 MONTHS RECURRENCE 27.6% YUTIQ eyes vs 90.5% sham YUTIQ eyes 7.6X more likely to be recurrence free Primary end-point achieved p < MONTHS RECURRENCE 37.9% YUTIQ eyes vs 97.6% sham YUTIQ eyes 25.9X more likely to be recurrence free Evidence of durable response p <

29 Primary Efficacy END-POINT Study 005: Recurrence Rates at 6 and 12 months 6 MONTHS RECURRENCE 25.7% YUTIQ eyes vs 59.6% sham YUTIQ eyes 1.8X more likely to be recurrence free Primary end-point achieved p < MONTHS RECURRENCE 36.6% YUTIQ eyes vs 71.2% sham YUTIQ eyes 2.2X more likely to be recurrence free Evidence of durable response p <

30 Systemic and local medications at 12 months ITT population observed data (STUDY PSV-FAI-001) Therapy YUTIQ Sham Systemic steroids or immunosuppressants 19.5% 40.4% Intra-periocular steroids 6.9% 61.9% 30

31 REDUCED PROBABILITY OF UVEITIS RECURRENCE THROUGH DAY 380 AFTER A SINGLE YUTIQ FA INSERT STUDY PSV-FAI-001 ITT Population FAI Hazard Ratio Sham vs. YUTIQ 7.08 PP Population FAI Hazard Ratio Sham vs. YUTIQ

32 Safety: Mean IOP Elevation at 6 Months Versus baseline 10. Mean IOP elevation: month 6 vs baseline 7.5 mm Hg n = 87 n = PSV-FAI-001 = 1.4 mmhg n = n = 50 = 1.1 mmhg PSV-FAI YUTIQ sham

33 Safety: Cataract Surgery through 6 months 30. Cataract surgery through 6 months [phakic eyes only] Percentage /42 3/ /21 3/ PSV-FAI-001 YUTIQ sham PSV-FAI-005

34 YUTIQ Short Duration vs. 3-year Implant Vitro Release Rate Comparison Long term in vitro release rate matched with the 3-year insert For 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)

35 Financial Highlights CASH: $16.3M At Mar 31, 2018 Projected $38M June 30, 2018 Tranche 2 subject to shareholder approval $15M Debt $54M Shares 35

36 Conclusion Acquisition of Icon Bioscience accelerates our transition Dexycu (dexamethasone intraocular suspension) 9% FDA approved 2/9/18 YUTIQ posterior segment uveitis NDA under regulatory review; PDUFA of 11/5/18 Two products leverage our commercial infrastructure Large growing cataract market with concentrated prescriber base Surveyed cataract surgeons and surveyed uveitis specialists. High intent to use Dexycu among cataract surgeons and YUTIQ posterior segment for uveitis among uveitis specialist Launch ready potentially 1H 2019 for two products following commercial scale up Experienced leadership team with track record of commercial successes 36

37 Thank You!