EyePoint Pharmaceuticals Provides Business Update and Preliminary Fourth Quarter and Full-Year 2020 Net Product Revenues
- IND filed in
- Anticipated Phase 1 clinical trial initiation in Q1 2021 -
- Q4 2020 net product revenues are estimated to be
- Sequential quarterly increases in customer demand of 30% and 10% for DEXYCU® and YUTIQ®, respectively -
“EyePoint had a pivotal year in 2020 as we significantly improved our balance sheet, advanced our pipeline and navigated our commercial business through pandemic closures to be well-poised for a strong 2021,” said
EYP-1901 leverages the Company’s proprietary Durasert® drug delivery technology that is currently used in four FDA-approved products, including YUTIQ. EYP-1901 uses a bioerodible formulation of Durasert coupled with a clinically validated anti-VEGF molecule, vorolanib. Vorolanib has demonstrated efficacy and ocular safety through Phase 2 trials in wet AMD as an oral therapy. In addition to the current program to evaluate EYP-1901 as a potential treatment for wet AMD, EYP-1901 is also anticipated to be studied in additional retinal applications, including diabetic retinopathy and retinal vein occlusion.
December 2020, the Company filed an IND application with the FDA for EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment for wet AMD, using its proprietary bioerodible Durasert delivery technology. A Phase 1 trial is anticipated to begin in the first quarter of 2021.
- Positive results from a good laboratory practice (GLP) preclinical toxicology study of EYP-1901 indicated no unexpected safety observations and confirmed the rationale for the filing of an IND.
Fourth Quarter Commercial Performance
- Net product revenue for YUTIQ is estimated to be between $3.7 and
$3.9million and between $13.6 and $13.8million for the fourth quarter and full-year ended December 31, 2020, respectively.
- Net product revenue for DEXYCU is estimated to be between $2.5 and
$2.7million and between $6.7 and $6.9million for the fourth quarter and full-year ended December 31, 2020, respectively.
- Customer demand of approximately 6,200 units for DEXYCU and 500 units of YUTIQ for the fourth quarter ended
December 31, 2020, increases of 30% and 10%, respectively over Q3 2020.
- DEXYCU co-promotion partner, ImprimisRx®, began driving volume through their experienced cataract surgery field force, materially adding to Q4 customer demand.
December 2020, Ocumension Therapeutics (1477.HK), EyePoint’s partner in Asia, made a $15.7 million equity investment in EyePoint. Under the terms of the investment, Ocumension purchased approximately 3.01 million shares of EyePoint’s common stock at a five-day trailing volume weighted average price as of the close of trading on December 29, 2020 of approximately $5.22 per share.
December 2020, the Company announced a royalty monetization agreement with SWK Holdings Corporation (SWK) for royalties payable to EyePoint under its license agreement with Alimera Sciences, Inc. (Alimera) for ILUVIEN®. EyePoint has received a one-time $16.5 million payment from SWK and, in return, SWK is entitled to receive future royalties payable to EyePoint under the Alimera license agreement. $15million of net proceeds from the transaction were applied against existing long-term debt obligations with CRG Servicing LLC (CRG) and the remaining $1.5 million will be used to advance product pipeline programs. The transaction also resulted in a reduction of annual interest payments of approximately $1.7 million.
December 2020, the Company announced a 1-for-10 reverse stock split and maintained compliance with the $1.00minimum closing bid price required for continued listing on the Nasdaq Global Market.
- The Company estimates that it had cash and cash equivalents of approximately $44 million on December 31, 2020.
The preliminary fourth quarter and full-year 2020 revenue results and cash on hand included in this release were calculated prior to the completion of a review by the Company’s independent registered public accounting firm and are therefore subject to adjustment.
Cash and cash equivalents are estimated to be approximately $44 million on December 31, 2020. Cash on hand, combined with cash inflows from anticipated product sales and continued cash conservation activities are expected to fund the Company’s operating plan into the second half of 2021, assuming no significant increase in COVID-19-related closures that would considerably decrease the frequency of ophthalmology office visits or the number of cataract surgical procedures performed across the U.S.
About EyePoint Pharmaceuticals
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 expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a vital, novel six-month treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; and preliminary financial information as of December 31, 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: the extent to which COVID-19 impacts our business; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; 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 development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; potential off-label sales in the U.S. by Alimera Sciences 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; our ability to market and sell products; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; 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; the potential for our preliminary financial information to change in connection with the finalization of our financial results for the fourth quarter of 2020; 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.
Lisa SherSternIR Direct: 212-698-8700 Lisa.email@example.com Media Contact Tom Gibson Tom Gibson CommunicationsDirect: (201) 476-0322 Tom@tomGibsoncommunications.com
Source: EyePoint Pharmaceuticals, Inc.