UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 27, 2019

 

 

EyePoint Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

480 Pleasant Street

Watertown, MA 02472

(Address of Principal Executive Offices, and Zip Code)

(617) 926-5000

Registrant’s Telephone Number, Including Area Code

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company   ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

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On November 27, 2019, EyePoint Pharmaceuticals, Inc. posted an updated corporate presentation on its website at www.eyepointpharma.com. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference herein.

Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Investor Presentation November 2019 NASDAQ: EYPT Exhibit 99.1

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION 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 YUTIQ®, DEXYCU® or other product candidates. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our commercialization of YUTIQ and DEXYCU, the potential for our products to alter the treatment landscape for ocular diseases; our expectations regarding the regulatory pathway for our YUTIQ line extension shorter-acting treatment for non-infectious uveitis affecting the posterior segment of the eye; the expected use of proceeds from our 2019 debt refinancing and equity offering our anticipation that we will need to raise additional capital to fund the Company’s operations until our cash flows reach a level sufficient to fund our operating plan through 2020; and our expectation that the Company’s existing cash and cash equivalents at September 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operating plan into 2020, 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 are risks and uncertainties inherent in our business including, without limitation: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the regulatory approval and successful release of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; potential off-label sales of ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye; consequences of fluocinolone acetonide side effects for YUTIQ; consequences of dexamethasone side effects for DEXYCU; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; Alimera’s ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera’s ability to commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; declines in Retisert royalties; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; our dependence on contract research organizations, contract sales 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; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. 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. FORWARD LOOKING

An Emerging Leader in Ophthalmology Launched YUTIQ® (Feb 4, 2019) and DEXYCU® (Mar 12, 2019) (Permanent and unique J codes for DEXYCU and YUTIQ in place) Strategic focus to become go-to partner for commercialization in ophthalmology Chronic non-infectious uveitis affecting the posterior segment of the eye Postoperative inflammation following ocular surgery ® Program Pipeline addressing significant market opportunities with innovative therapies improving standard of care Focused on organic and inorganic product growth leveraging proprietary technologies and select product acquisition to build top-line revenue and expand pipeline Veteran executive team with deep experience in commercial product launches and clinical development

Ophthalmology Product Pipeline Program Preclin. Phase 1 Phase 2 Phase 3 Commercial Rights DEXYCU® - post-operative inflammation WW YUTIQ® three-year treatment for chronic non-infectious uveitis affecting the posterior segment U.S.(1) YUTIQ® 50 (sNDA) 6-month treatment for chronic non-infectious uveitis affecting the posterior segment WW EYP-1901 - TKI Durasert™ 6-month wet AMD treatment WW Launched/J-Code In-Place Launched/J-Code In-Place IND enabling studies 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.

Durasert™ Verisome™ Durasert™ and Verisome™: Proven, FDA Approved Technologies Ocular insert for long-term delivery of small molecules Approved products: YUTIQ® (2018, EyePoint) ILUVIEN® (2012, Alimera) - DME RETISERT ® (2005, B&L) – Uveitis VITRASERT® (1996, B&L) -CMV retinitis Microsphere suspension short-term delivery of small and potentially large molecules Approved products: DEXYCU ® (2019, EyePoint) Proprietary Ocular Delivery Technologies

2019: A Transformational Year YUTIQ® 50 (6-month) regulatory pathway reviewed with FDA with approval pathway clarified EYP-1901 - Durasert™ TKI for wet-AMD advanced into IND enabling studies Durasert™ and Verisome® technologies positioned for partnering and organic pipeline growth Multiple product opportunities under evaluation for both in-license and out-license Management team enhanced DEXYCU® Launched March 12, 2019 Jan Feb Mar Apr 2019 YUTIQ® Launched February 4, 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 minimal reimbursement issues 12 dedicated KAMs targeting uveitis specialists Permanent and specific J-Code effective as of October 1, 2019

* Based upon company estimates for 2018. Source: imaged from the American Optometric Association. DEXYCU® Market U.S. Cataract Surgery Intraocular lens is inserted Intraocular lens is positioned Diseased lens is removed Cataract Surgeries in 2018 4.8 Million* 8% annual growth rate in the U.S. Most performed surgery in the U.S. Baby boomers; longer life expectancy Improvements to intraocular lenses (IOLs) Experienced surgeons Steroids after surgery typically needed to prevent inflammation Step 2 Step 3 Step 1 Cornea Iris Incision Lens implant New lens

* 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 prescribed for use). DEXYCU Market Opportunity Post-cataract treatment regimen requires multiple daily eyedrops Wk 1 Wk 2 Wk 3 Wk 4 21 Drops Up to 100 Drops Over Four Weeks 14 Drops 70 Drops Physician Perspective Poor patient compliance with drops could lead to poor outcomes Patient call backs are time consuming and disruptive to physician office Patients/caregivers are frustrated and confused with regimen Steroid Control Inflammation Prevent Infection Reduce Pain/Edema Antibiotic NSAID 3–4/day 3–4/day 2/day 1/day 3/day* 1/day**

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, Sustained-release, Intracameral Steroid for the Treatment of Postoperative Inflammation Following Ocular Surgery Single dose (5mL) administered in the posterior chamber (behind the iris) at the end of surgery Encapsulated in bioerodible Verisome® technology for extended release of dexamethasone Verisome® Technology DEXYCU® Kit DEXYCU® Placement Dexamethasone

DEXYCU Demonstration Please see video at company website: https://eyepointpharma.com/case-study-series/

DEXYCU® Sales Process 1. Introduce Introduce DEYXCU and its clinical and safety data to target physician 2. Educate Educate the ASC where physician operates about DEXYCU profile 3. Sample Schedule a physician and staff DEXYCU trial and training 4. Order ASC places first order and files DEXYCU reimbursement claim 5. Re-Order Once reimbursement is confirmed, schedule additional patients for DEXYCU and provide ongoing ASC surgical support Average Time to Account Re-Order

DEXYCU® Launch Progress Update Third Quarter Ended 9/30/19 207% Of all ASCs orders placed in Q3 were repeat orders Increase of customer orders compared to Q2 September 2019 represented the highest volume month for repeat orders to date 37% Of total Q3 order volume from repeat orders 74%

Month over month growth accelerating DEXYCU® Cumulative Orders Since Launch DEXYCU® month over month growth of cumulative orders averaged 62.5% in the 3rd quarter

Data based on internal estimates DEXYCU® Market Potential Based on Account Penetration thru 9/30/19 Value of Target Accounts Value of Trained Accounts Value of Current ASC Accounts Ordering Value of Current ASC Accounts with 3+ Orders DEXYCU Market Potential $2.5B DEXYCU ASCs in-serviced to Date $120M ASCs Re-Ordering $97M ASCs Re-Ordering 3+ $28M

DEXYCU® Statistically Significant Inflammation Reduction Note: Refer to the full DEXYCU® product label at www.eyepointpharma.com. * *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) Patients with Anterior Chamber Cells (ACC) Clearing at Each Visit

% of patients Data on file. Phase III Study 13-04. Post hoc analysis. DEXYCU® IOP Elevation Versus Placebo Not Clinically Significant 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

Note: Refer to the full DEXYCU® product label at www.eyepointpharma.com. DEXYCU® Phase 3 Study – 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 (13.5) Corneal Edema 8 (10.0) 12 (7.7) Eye Pain 7 (8.8) 4 (2.6) Anterior Chamber Inflammation 10 (12.5) 8 (5.1) Dry Eye 0 6 (3.8)

YUTIQ® Market Patients in the U.S. with Chronic Non-infectious Posterior Segment Uveitis ~55K–120K ~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, retina, vitreous, optic nerve), Acute or Chronic, A precursor to severe vision loss or blindness Often lifelong

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

YUTIQ® Consistent micro dosing of steroid up to three years Significantly reduces the recurrence of flares that cause blindness Primary Goal of Therapy in Uveitis

* Sham includes standard of care. Note: Refer to the full YUTIQ® product label at www.eyepointpharma.com YUTIQ® Recurrence Rate at Six and Twelve Months Vs Sham 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 recurrence free Study 1 (Recurrence Rate at 6 and 12 Months) Study 2 (Recurrence Rate at 6 and 12 Months)

Note: Sham patients include patients that received rescue therapy. YUTIQ® Single Insert Reduced Probability of Uveitis Recurrence Through 36 Months YUTIQ Median Time to First Recurrence: 1,051 Days 3 years ITT Population

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 – Select Adverse Events Safety, n (%) YUTIQ® n=226 Placebo n=94 Visual Acuity Reduced 33 (15%) 11 (12%) Macular Edema1 25 (11) 33 (35) Uveitis 22 (10) 33 (35) Conjunctival Hemorrhage 17 (8) 5 (5) Eye Pain2 17 (8) 12 (13) Hypotony of the Eye3 16 (7) 1 (1) Anterior Chamber Inflamm. 12 (5) 6 (6) Dry Eye 10 (4) 3 (3)

YUTIQ® Launch Progress Update Third Quarter Ended 9/30/19 17% Of customers were repeat customers Increase of customer orders compared to Q2 Continued strong reception of the YUTIQ® product profile from uveitis specialists 53% Of total order volume from repeat orders 85%

YUTIQ® Cumulative Orders Since Launch YUTIQ® month over month growth of cumulative orders averaged 22% in the 3rd quarter

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, including 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers

An Emerging Leader in Ophthalmology Launched YUTIQ® (Feb 4, 2019) and DEXYCU® (Mar 12, 2019) (Permanent and unique J codes for DEXYCU and YUTIQ in place) Strategic focus to become go-to partner for commercialization in ophthalmology Chronic non-infectious uveitis affecting the posterior segment of the eye Postoperative inflammation following ocular surgery ® Program Pipeline addressing significant market opportunities with innovative therapies improving standard of care Focused on organic and inorganic product growth leveraging proprietary technologies and select product acquisition to build top-line revenue and expand pipeline Veteran executive team with deep experience in commercial product launches and clinical development