EyePoint Pharmaceuticals Reports Fiscal 2018 Fourth Quarter & Full Year Financial Results and Highlights Recent Progress
-Substantial progress made in the Company’s accelerated transformation into a commercial entity
-YUTIQ™ PDUFA date of
-Commercial preparations underway for launch of DEXYCU™ in the first half of calendar year 2019
-Balance sheet strengthened by
-Conference call and webcast today,
“During EyePoint’s fiscal fourth quarter, we made significant clinical, corporate and financial achievements that have contributed to the Company’s rapid advancement towards commercialization,” said Nancy Lurker, President and Chief Executive Officer of
Ms. Lurker continued, “Our clinical and research teams continue to add to the body of evidence supporting YUTIQ for the treatment of non-infectious posterior segment uveitis with multiple presentations at the 36th Annual Scientific Meeting of the American Society of
Key Commercial Preparations
- As EyePoint accelerates its transformation from a clinical-stage company into a commercial company ahead of future ophthalmic product launches, the Company has strengthened its infrastructure to support its growth across multiple functions, including finance, sales and marketing and regulatory, including the following personnel additions in newly created positions:
David Price, Chief Financial Officer, brings more than 25 years of financial experience in the healthcare, investment banking and accounting sectors; and
- John (Jack) Weet, Ph.D., SVP, Regulatory Affairs & Quality, brings over 40 years of experience in regulatory affairs to EyePoint. He has extensive expertise in the oversight of FDA relations and negotiations across multiple therapeutic areas, including ocular disease.
- The Company has continued to execute on its four-pillar commercialization plan, which is to execute on a robust medical education road map, train and hire a top tier sales team, gain payor access and launch with a compelling marketing strategy. Notably, EyePoint has consummated an agreement with a premier contract sales organization to ensure a fully trained and highly seasoned field organization at launch. The Company has also established and begun executing its medical education, product marketing and market access plans ahead of product launch.
Strengthened Balance Sheet
June 2018, EW Healthcare Partners, an established healthcare-focused investment firm, Rosalind Advisorsand another accredited investor contributed an aggregate of $25.5 millionof growth capital to EyePoint following stockholder approval of the financing. The closing of this financing, coupled with the closing, in March 2018, of the initial tranche of $9.5 millionof equity financing led by EW Healthcare Partners, resulted in total gross proceeds to the Company of $35.0 million. Under the terms of the second tranche securities purchase agreement, funds affiliated with EW Healthcare Partnersand the other second tranche investors received warrants to purchase an additional 20,184,224 shares of the Company's common stock, which, if exercised in full, would provide the Company with additional gross proceeds of up to approximately $28.9 millionto further strengthen its balance sheet. The warrants are cash-exercise only and are exercisable until the close of business on September 28, 2018.
- At the 36th Annual Scientific Meeting of the American Society of
Retina Specialiststhat took place from July 20-25, 2018in Vancouver, three presentations highlighted twelve-month efficacy and safety data supporting YUTIQ for the treatment of non-infectious posterior segment uveitis. Highlights from each of the presentations include:
- Confirmatory 1-Year Study Results of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAi) to Treat Non-infectious Posterior Segment Uveitis. Efficacy results from this three-year prospective, Phase 3 study showed a decrease in recurrence of uveitis in FAi versus sham eyes at twelve months. Safety results demonstrated that 23.8% and 7.7% of FAi and sham subjects, respectively, experienced intraocular pressure (IOP) increases of greater than or equal to 12mm Hg, with one of the FAi study eyes requiring IOP lowering surgery. The results of this study support previous findings that the FAi is safe and effective to both treat and prevent recurrent uveitis.
- Controlling Uveitic Recurrences: Results From a Phase 3 Study of 0.18 mg Fluocinolone Acetonide Insert in Non-infectious Posterior Uveitis. Data from the first year of this three-year study showed a lower inflammation recurrence rate in FAi randomized eyes than in sham eyes (37.9% vs. 97.6%, respectively). A total of 63 recurrences were reported in FAi-treated eyes, versus 105 recurrences in the sham-treated eyes. This data adds to the growing body of evidence evaluating the role of FAi in decreasing the rate of inflammation occurrence.
- Injectable Fluocinolone Acetonide Intravitreal Insert Reduces the Need for Adjunctive Treatment in Non-infectious Posterior Segment Uveitis. Analysis of the full intent-to-treat cohort at one year indicated that a single intravitreal injection of FAi provided effective anti-inflammatory treatment for one year and significantly reduced the need for adjunctive therapies. 6.9% of FAi eyes, versus 61.9% of sham eyes, received at least one intra/peri-ocular steroid injection. Of the 6 FAi eyes that required intra/peri-ocular steroid injection, four required only a single injection through twelve months while half of the 26 sham eyes required multiple injections up to a maximum of five.
- Göran Ando, M.D. was added to EyePoint’s Board of Directors in
June 2018and was appointed Chairman of the Board on September 7, 2018. Dr. Ando is the former Chairman of the Board of Novo Nordisk A/S(NYSE:NVO), a global pharmaceutical company, and brings more than 35 years of successful global drug development and general management experience to EyePoint.
- EyePoint completed its delisting from the Australian Securities Exchange (ASX) on
May 7, 2018. The Company’s decision to delist from the ASX was due to, among other things, a lower proportion of the Company's common stock held by Australian shareholders, low trading volume on the ASX and the costs of maintaining the listing.
- EyePoint secured transitional pass-through reimbursement from the
Centers for Medicare & Medicaid Services(CMS) for DEXYCU and was assigned a C-code. The code, C9034, will become effective on October 1, 2018. Approximately 40% of patients who undergo cataract surgery are covered by Medicare Part B. Drugs that are administered as part of the cataract surgery procedures can be covered under a CMS administered transitional-pass-through payment.
- YUTIQ PDUFA date of
November 5, 2018. YUTIQ has been accepted for filing by the FDAand is currently under standard review with a PDUFA date of November 5, 2018. Posterior segment uveitis is a high unmet need area with limited treatment options and the third leading cause of blindness in the U.S. If approved, the Company plans to launch YUTIQ in the U.S. in the first half of 2019.
- Launch DEXYCU and YUTIQ - subject to YUTIQ FDA approval and successful production of commercial supply of DEXYCU - in the first half of 2019. The Company anticipates two potential near-term product launches, including DEXYCU, a dropless, long-acting therapeutic for the treatment of postoperative inflammation, which was approved by the
FDA, and YUTIQ, a three-year treatment of non-infectious posterior segment uveitis, which is currently under standard review with a PDUFA date of November 5, 2018.
Fiscal Fourth Quarter and Full Year 2018 Results
Revenue for the quarter ended
Operating expenses for the quarter ended
Revenue for the year ended
Royalty income increased to
Net loss for the year ended
Conference Call Information
EyePoint will host a conference call today, Wednesday, September 12, 2018, at 8:30 AM ET, to discuss the fourth quarter and fiscal year 2018 financial results, recent accomplishments, clinical developments and commercial launch plans. To access the conference call, please dial (877) 312-7507 (local) or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 5782568. A live webcast will be available on the Investor Relations section of the corporate website at http://www.eyepointpharma.com.
A replay of the call will be available beginning September 12, 2018, at approximately 11:30 AM ET and ending on September 19, 2018 at
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. 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; the number of clinical trials, including clinical trials conducted outside the U.S., and data required for marketing approval for YUTIQ in the U.S.; our ability to use data in promotion for YUTIQ; our ability to successfully produce commercial supply of DEXYCU and commercialize DEXYCU in the U.S.; our ability to successfully build a commercial infrastructure and enter into and maintain commercial agreements for the launch of DEXYCU and, if approved, YUTIQ; our ability to successfully commercialize YUTIQ, if approved, in the U.S.; potential off-label sales of ILUVIEN® for non-infectious posterior segment uveitis (“NIPU”); consequences of fluocinolone acetonide side effects; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema (“DME”) which depends on the ability of
FINANCIAL TABLES FOLLOW
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended||Year Ended|
|June 30,||June 30,|
|Collaborative research and development||$||218||$||461||$||1,343||$||6,569|
|Research and development||4,765||4,213||16,178||14,880|
|Sales and marketing||1,512||-||1,512||-|
|General and administrative||4,220||2,624||11,545||11,235|
|Total operating expenses||10,497||6,837||29,235||26,115|
|Loss from operations||(9,782||)||(6,136||)||(26,274||)||(18,576||)|
|Interest and other income||27||20||101||91|
|Change in fair value of derivative liability||(23,953||)||-||(26,278||)||-|
|Net loss per common share:|
|Basic and diluted||$||(0.62||)||$||(0.16||)||$||(1.15||)||$||(0.52||)|
|Weighted average common shares outstanding:|
|Basic and diluted||55,387||38,673||46,226||35,344|
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||June 30,|
|Cash and cash equivalents||$||38,776||$||16,898|
|Other current assets||1,133||842|
|Total current assets||39,909||17,740|
|Intangible assets, net||31,358||364|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||6,663||$||5,240|
|Accrued development milestone||15,000||-|
|Total current liabilities||21,663||5,290|
|Other long-term liabilities||1,231||51|
|Accumulated other comprehensive income||838||833|
|Total stockholders' equity||11,687||13,336|
|Total liabilities and stockholders' equity||$||71,670||$||18,677|
Source: EyePoint Pharmaceuticals, Inc.