EyePoint Pharmaceuticals Reports Fiscal First Quarter 2019 Financial Results and Highlights Recent Clinical and Operational Developments
-YUTIQ™ approved by U.S.
-Exclusive license granted to Ocumension Therapeutics to develop and commercialize EyePoint’s three-year micro-insert product using theDurasert™ technology for posterior segment uveitis in
-Commercial preparations underway for anticipated launch of DEXYCU™ in the first half of calendar year 2019-
-Cash injection of
-Conference call and webcast today, November 6th, at
“The approval of YUTIQ™ by the U.S.
Recent Clinical & Operational Highlights
October 2018, the U.S. Food and Drug Administration( FDA) approved YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, a three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ utilizes the Company’s Durasert™ drug delivery technology and is an intravitreal micro-insert designed to deliver drug consistently over 36 months. The approval occurred 24 days in advance of the PDUFA date of November 5th.
- At the
American Academy of Ophthalmology(AAO) 2018 Annual Meeting in Chicago, IL, 24-month efficacy and safety data supporting YUTIQ was presented during the Retina Subspecialty day at a breakthrough presentation entitled, “24-month Evaluation of Fluocinolone Acetonide Intravitreal Insert Treatment for Non-Infectious Posterior Uveitis”. These data demonstrated that the recurrence rate in randomized eyes treated with YUTIQ was significantly lower than in sham eyes (59.8% vs. 97.6%, respectively; p<0.001) at 24-months of the three-year trial. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints.
- In August, safety and efficacy data from the Phase 3 clinical trial of DEXYCU compared to prednisolone acetate 1.0% ophthalmic drops for the treatment of inflammation post-cataract surgery were published in the
Journal of Cataract & Refractive Surgery. In this open label trial, results demonstrated similar safety and efficacy between both products in treating inflammation post cataract surgery with a patient preference of DEXYCU compared to drops.
- EyePoint granted Ocumension Therapeutics, a
China-based ophthalmology company, an exclusive license to develop and commercialize EyePoint’s three-year micro insert product using the Durasert technology for chronic, non-infectious uveitis affecting the posterior segment of the eye in the greater Chinaterritory, which is comprised of China, Hong Kong, Macauand Taiwan. EyePoint will receive a one-time upfront payment of $1.75 millionand is eligible to receive up to an additional $10.0 millionif certain future prespecified development, regulatory and commercial sales milestones are achieved by Ocumension. Ocumension will be responsible for funding the clinical development of EyePoint’s three-year micro-insert product using the Durasert technology for chronic, non-infectious posterior segment uveitis in Greater China. EyePoint will supply product for the clinical trials.
John Landis, Ph.D., M.S., was appointed to the EyePoint Board of Directors in October 2018. Dr. Landis brings more than 30 years of pharmaceutical research and development experience from senior level roles held at Schering-Plough Corporation, Pharmacia Corporationand The Upjohn Company.
- EyePoint’s Board of Directors approved a change of the Company’s fiscal year-end to
December 31from the current fiscal year-end of June 30. The Company believes this change will align its financial reporting periods to that of its peer group in the industry and better facilitate assessment of the Company's financial performance. The Company will file transitional audited financial statements on Form 10-KT for the six-month period ending December 31, 2018.
Fiscal First Quarter 2019 Results
Revenue for the three months ended
Operating expenses for the quarter ended September 30, 2018 increased to
Cash and cash equivalents at
Conference Call Information
EyePoint will host a conference call today,
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, plan or believe may occur in the future, including but not limited to statements about our plans to commercialize YUTIQ and DEXYCU, the expected timing of release of the 24-month and 36-month patient follow-up data for YUTIQ and our expectations regarding the timing of a filing of an application for approval of a next-generation, shorter-duration treatment for posterior segment uveitis, 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; our ability to successfully produce commercial supply of YUTIQ and DEXYCU and commercialize YUTIQ and 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 YUTIQ; the development of our next-generation YUTIQ short-acting treatment for uveitis; 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 Alimera Sciences, Inc. (“Alimera”) to continue as a going concern; 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 obtain marketing approval for ILUVIEN in its licensed territories for NIPU; potential declines in Retisert royalties; 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, 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; effects of the potential exit of the United Kingdom from the European Union; 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.
FINANCIAL TABLES FOLLOW
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended|
|Collaborative research and development||$||56||$||140|
|Research and development||6,233||3,819|
|Sales and marketing||3,646||-|
|General and administrative||4,161||2,572|
|Total operating expenses||14,040||6,391|
|Loss from operations||(13,554||)||(6,006||)|
|Interest and other income, net||129||23|
|Change in fair value of derivative liability||(18,886||)||-|
|Net loss per common share:|
|Basic and diluted||$||(0.44||)||$||(0.15||)|
|Weighted average common shares outstanding:|
|Basic and diluted||75,170||39,430|
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||June 30,|
|Cash and cash equivalents||$||55,764||$||38,776|
|Other current assets||1,878||1,133|
|Total current assets||57,642||39,909|
|Intangible assets, net||30,744||31,358|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||7,418||$||6,663|
|Accrued development milestone||15,000||15,000|
|Total current liabilities||22,418||21,663|
|Other long-term liabilities||1,269||1,231|
|Accumulated other comprehensive income||838||838|
|Total stockholders' equity||47,705||11,687|
|Total liabilities and stockholders' equity||$||88,855||$||71,670|
Source: EyePoint Pharmaceuticals, Inc.