EyePoint Pharmaceuticals Reports Second Quarter 2022 Financial Results and Highlights Recent Corporate Developments
– First patient dosed in the Phase 2 DAVIO 2 clinical trial for wet age-related macular degeneration (wet AMD) –
– Presented positive twelve-month safety and efficacy data from Phase 1 DAVIO clinical trial for EYP-1901 in wet AMD at
– Announced in conjunction with OcuMension Therapeutics, approval of New Drug Application by China’s
– Net product revenue of
– Management to host a conference call and webcast today at 8:30 a.m. ET –
“We continue to make significant progress at EyePoint, with the recent Phase 2 clinical trial initiation for EYP-1901 for the treatment of wet AMD, demonstrating the team’s continued strong execution in advancing our innovative pipeline,” said
R&D Highlights and Updates
- The first patient was dosed in the Phase 2 DAVIO 2 clinical trial of EYP-1901 for the treatment of wet AMD in
July 2022 . The twelve-month, randomized, controlled DAVIO 2 trial is expected to enroll approximately 150 patients previously treated with a standard-of-care anti-VEGF therapy, and topline data is expected in the second half of 2023. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).
- Final twelve-month data from the Phase 1 DAVIO clinical trial of EYP-1901 for wet AMD was presented at the ASRS 2022 Annual Meeting in
July 2022 . Data presented reinforced a positive safety and efficacy profile for EYP-1901 and showed no dose limiting toxicities, no reports of ocular serious adverse events (SAEs) and no drug-related systemic SAEs. There were no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, or posterior segment inflammation. The data also confirmed stable best corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (-2.76 μm), and a clinically significant 74% reduction in treatment burden (79% at six-months). These data also showed that 53% of eyes did not require any supplemental anti-VEGF injections up to six-months and 35% up to twelve months following a single dose of EYP-1901.
- In a poster presentation at the
Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting inMay 2022 , the Company provided an update on the YUTIQ® CALM registry study. Data from this Phase IV, multi-center registry study indicated effective control of non-infectious uveitis, with no significant changes in visual acuity and without major safety signals. The CALM study is a joint collaboration between EyePoint and theCleveland Clinic and could become a valuable resource in furthering the understanding of posterior segment uveitis.
Recent Corporate Highlights
Karen Zaderej , M.B.A. was appointed to the Company’s Board of Directors inJuly 2022 .Ms. Zaderej brings more than 35 years of biopharmaceutical and medical device experience to the role, and currently serves as the President and CEO of AxoGen, a leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair.
- In
July 2022 , the Company announced that the CMS indicated its intention not to provide further pass-through extension to expiring products, including DEXYCU® in its draft 2023 CMS HOPPS (Hospital Outpatient Prospective Payment System) rule. If the draft rule becomes final, DEXYCU will lose pass-through separate reimbursement status onDecember 31, 2022 and will instead be bundled into the general Cataract procedure reimbursement code starting onJanuary 1, 2023 . The Company intends to request longer pass-through status given the ongoing pandemic.
Anthony (Tony) Adamis , M.D. was elected to the Company’s Board of Directors inJune 2022 .Dr. Adamis is a highly accomplished ophthalmology executive with more than 30 years of research and development experience in the biopharmaceutical industry. He is best-known for his co-discovery of the role of vascular endothelial growth factor (VEGF) in ocular disease, including wet AMD and NPDR.
- In
June 2022 , the Company and OcuMension Therapeutics announced that China’sNational Medical Products Administration (NMPA) has approved YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
- The Company entered into an exclusive license agreement with Betta Pharmaceuticals Co. Ltd. (Betta) to develop and commercialize EYP-1901 in
China ,Hong Kong ,Macau andTaiwan (the Territory) inMay 2022 . Under the terms of this agreement, EyePoint retains all ophthalmic rights for EYP-1901 in the entire world outside of the Territory. Concurrently, EyePoint and Betta affiliate,Equinox Sciences LLC executed an amendment to their 2020 exclusive license agreement, expanding EyePoint’s exclusive rights to develop and commercialize vorolanib, the tyrosine kinase inhibitor used in EYP-1901, through localized delivery for the treatment of all ophthalmic diseases in the entire world outside of the Territory.
Commercial Performance in Second Quarter 2022
- Net product revenue for YUTIQ and DEXYCU was
$7.4 million and$3.9 million , respectively.
- Customer demand for YUTIQ was approximately 900 units, representing approximately 40% growth from Q1 2022.
- Customer demand for DEXYCU was approximately 14,700 units, consistent with Q1 2022.
Review of Results for the Second Quarter ended
For the second quarter ended
Net revenue from royalties and collaborations for the second quarter ended
Operating expenses for the second quarter ended
Cash and investments at
Financial Outlook
We expect the cash, cash equivalents and investments on hand on
Conference Call Information
EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the second quarter ended
About
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; 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. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investors:
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Direct: 412-327-9499
aphillips@greenroompr.com
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 11,318 | $ | 8,738 | $ | 20,328 | $ | 15,540 | ||||||||
| License and collaboration agreements | 49 | 94 | 108 | 435 | ||||||||||||
| Royalty income | 198 | 181 | 423 | 361 | ||||||||||||
| Total revenues | 11,565 | 9,013 | 20,859 | 16,336 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales, excluding amortization of acquired intangible assets | 1,734 | 1,929 | 3,511 | 3,319 | ||||||||||||
| Research and development | 12,992 | 5,605 | 22,937 | 11,084 | ||||||||||||
| Sales and marketing | 6,883 | 6,659 | 13,576 | 12,318 | ||||||||||||
| General and administrative | 8,557 | 5,184 | 17,106 | 10,299 | ||||||||||||
| Amortization of acquired intangible assets | 615 | 615 | 1,230 | 1,230 | ||||||||||||
| Total operating expenses | 30,781 | 19,992 | 58,360 | 38,250 | ||||||||||||
| Loss from operations | (19,216 | ) | (10,979 | ) | (37,501 | ) | (21,914 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 362 | 280 | 423 | 281 | ||||||||||||
| Interest expense | (552 | ) | (1,376 | ) | (1,745 | ) | (2,722 | ) | ||||||||
| Gain (loss) on extinguishment of debt | - | 2,065 | (1,559 | ) | 2,065 | |||||||||||
| Total other expense, net | (190 | ) | 969 | (2,881 | ) | (376 | ) | |||||||||
| Net loss | $ | (19,406 | ) | $ | (10,010 | ) | $ | (40,382 | ) | $ | (22,290 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.52 | ) | $ | (0.35 | ) | $ | (1.08 | ) | $ | (0.83 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 37,322 | 28,744 | 37,288 | 26,750 | ||||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 82,134 | $ | 178,593 | ||||
| Marketable securities | 89,033 | 32,965 | ||||||
| Accounts and other receivables, net | 22,594 | 18,354 | ||||||
| Prepaid expenses and other current assets | 8,851 | 4,217 | ||||||
| Inventory | 3,254 | 3,616 | ||||||
| Total current assets | 205,866 | 237,745 | ||||||
| Operating lease right-of-use assets | 4,787 | 2,252 | ||||||
| Intangible assets, net | 21,519 | 22,749 | ||||||
| Other assets | 1,261 | 626 | ||||||
| Total assets | $ | 233,433 | $ | 263,372 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 21,370 | $ | 21,807 | ||||
| Deferred revenue | 1,137 | 1,069 | ||||||
| Short-term borrowings | 10,475 | - | ||||||
| Other current liabilities | 408 | 782 | ||||||
| Total current liabilities | 33,390 | 23,658 | ||||||
| Long-term debt | 29,181 | 36,562 | ||||||
| Deferred revenue - noncurrent | 14,070 | 14,560 | ||||||
| Operating lease liabilities - noncurrent | 4,826 | 1,860 | ||||||
| Other long-term liabilities | 600 | 2,352 | ||||||
| Total liabilities | 82,067 | 78,992 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 760,243 | 752,636 | ||||||
| Accumulated deficit | (609,479 | ) | (569,097 | ) | ||||
| Accumulated other comprehensive income | 602 | 841 | ||||||
| Total stockholders' equity | 151,366 | 184,380 | ||||||
| Total liabilities and stockholders' equity | $ | 233,433 | $ | 263,372 | ||||
Source: EyePoint Pharmaceuticals, Inc.
