EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments
– Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD achieving all primary and secondary endpoints; initiation of the first Phase 3 clinical trial expected in 2H 2024 –
– Dosed first patient in Phase 2 VERONA clinical trial of EYP-1901 in DME; topline data expected in 1Q 2025 –
– Phase 2 PAVIA clinical trial topline data of EYP-1901 in moderately severe-to-severe NPDR anticipated in 2Q 2024 –
– Announced appointment of
–
– Management to host a conference call and webcast today at
“2023 was an exceptional year of execution and results for
R&D Highlights and Updates
- Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 clinical trial of EYP-1901 in wet AMD in
December 2023 . DAVIO 2 met all primary and secondary endpoints with both EYP-1901 doses demonstrating a statistically non-inferior change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). - DAVIO 2 Phase 2 data and sub-group analyses which underscore the favorable clinical profile of EYP-1901, were presented at Angiogenesis, Exudation, and Degeneration 2024 Meeting and at the 47th Annual Meeting of the
Macula Society inFebruary 2024 . - The Company plans to conduct an end of Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) inApril 2024 , with the initiation of the first Phase 3 pivotal trial in wet AMD expected in the second half of 2024. - Announced first patient dosed in the Phase 2 VERONA clinical trial of EYP-1901 for the treatment of diabetic macular edema (DME). Topline data are expected in the first quarter of 2025.
- Accepted to present at the upcoming 2024
Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. The Company will be presenting an encore presentation of the DAVIO 2 clinical trial results, the design and function of EYP-1901, plasma PK data of EYP-1901, and the mechanism of action (MOA) of vorolanib and differentiation from other anti-VEGF TKIs.
Recent Corporate Highlights
- Announced the appointment of
Ramiro Ribeiro , M.D., Ph.D. as Chief Medical Officer in March.Dr. Ribeiro joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development. - Completed an upsized underwritten public offering with gross proceeds of
$230.0 million in December. The Company sold 13,529,411 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,764,705 shares of common stock. The shares of common stock were sold at a public offering price of$17.00 per share.
Review of Results for the Fourth Quarter Ended
For the quarter ended
Net revenue from royalties and collaborations for the quarter ended
Operating expenses for the quarter ended
Net non-operating income totaled
Review of Results for the Full Year Ended
For the full year ended
Net revenue from royalties and collaborations for the full year ended
Operating expenses for the full year ended
Net non-operating expense totaled
Cash, cash equivalents and investments in marketable securities on
Financial Outlook
We expect that our cash, cash equivalents, and investments on
Conference Call Information
EyePoint will host a conference call today at
About
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of
EYEPOINT PHARMACEUTICALS 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 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential
Investors:
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Direct: 412-327-9499
aphillips@greenroompr.com
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands) | ||||||||||
| 2023 | 2022 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 281,263 | $ | 95,633 | ||||||
| Marketable securities | 49,787 | 48,928 | ||||||||
| Accounts and other receivables, net | 805 | 15,503 | ||||||||
| Other current assets | 9,039 | 9,858 | ||||||||
| Inventory | 3,906 | 2,886 | ||||||||
| Total current assets | 344,800 | 172,808 | ||||||||
| Operating lease right-of-use assets | 4,983 | 6,038 | ||||||||
| Other assets | 5,401 | 1,510 | ||||||||
| Total assets | $ | 355,184 | $ | 180,356 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 24,025 | $ | 22,278 | ||||||
| Deferred revenue | 38,592 | 1,205 | ||||||||
| Short-term borrowings | - | 10,475 | ||||||||
| Other current liabilities | 646 | 579 | ||||||||
| Total current liabilities | 63,263 | 34,537 | ||||||||
| Long-term debt | - | 29,310 | ||||||||
| Deferred revenue, less current portion | 20,692 | 13,557 | ||||||||
| Operating lease liabilities - noncurrent | 4,906 | 5,984 | ||||||||
| Other long-term liabilities | - | 600 | ||||||||
| Total liabilities | 88,861 | 83,988 | ||||||||
| Stockholders' equity: | ||||||||||
| Capital | 1,007,605 | 766,933 | ||||||||
| Accumulated deficit | (742,146 | ) | (671,351 | ) | ||||||
| Accumulated other comprehensive income | 864 | 786 | ||||||||
| Total stockholders' equity | 266,323 | 96,368 | ||||||||
| Total liabilities and stockholders' equity | $ | 355,184 | $ | 180,356 | ||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
| (Unaudited) | |||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||
| Three Months Ended |
Twelve Months Ended |
||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||||
| Revenues: | |||||||||||||||||||
| Product sales, net | $ | 749 | $ | 9,857 | $ | 14,232 | $ | 39,905 | |||||||||||
| License and collaboration agreements | 13,029 | 202 | 30,797 | 362 | |||||||||||||||
| Royalty income | 250 | 474 | 989 | 1,137 | |||||||||||||||
| Total revenues | 14,028 | 10,533 | 46,018 | 41,404 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Cost of sales, excluding amortization of acquired intangible assets | 998 | 3,410 | 4,632 | 8,326 | |||||||||||||||
| Research and development | 17,951 | 15,543 | 64,662 | 49,642 | |||||||||||||||
| Sales and marketing | 185 | 5,915 | 11,689 | 25,507 | |||||||||||||||
| General and administrative | 11,248 | 8,496 | 40,102 | 34,817 | |||||||||||||||
| Amortization of acquired intangible assets | - | 205 | - | 2,050 | |||||||||||||||
| Impairment of acquired intangible assets | - | 20,699 | - | 20,699 | |||||||||||||||
| Total operating expenses | 30,382 | 54,268 | 121,085 | 141,041 | |||||||||||||||
| Loss from operations | (16,354 | ) | (43,735 | ) | (75,067 | ) | (99,637 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Interest and other income, net | 2,338 | 1,064 | 6,949 | 2,131 | |||||||||||||||
| Interest expense | - | (781 | ) | (1,247 | ) | (3,189 | ) | ||||||||||||
| Gain (loss) on extinguishment of debt | - | - | (1,347 | ) | (1,559 | ) | |||||||||||||
| Total other expense, net | 2,338 | 283 | 4,355 | (2,617 | ) | ||||||||||||||
| Net loss | $ | (14,016 | ) | $ | (43,452 | ) | $ | (70,712 | ) | $ | (102,254 | ) | |||||||
| Provision for income taxes | $ | (83 | ) | $ | - | $ | (83 | ) | $ | - | |||||||||
| Net loss | $ | (14,099 | ) | $ | (43,452 | ) | $ | (70,795 | ) | $ | (102,254 | ) | |||||||
| Net loss per common share - basic and diluted | $ | (0.33 | ) | $ | (1.16 | ) | $ | (1.82 | ) | $ | (2.74 | ) | |||||||
| Weighted average common shares outstanding - basic and diluted | 42,168 | 37,352 | 38,904 | 37,317 | |||||||||||||||
Source: EyePoint Pharmaceuticals, Inc.
