EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments
- Positive topline efficacy and safety data from Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD
- Initiation of 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
- Appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer
- $331M of cash and investments on December 31, 2023, with cash runway through topline data of Phase 3 trials for EYP-1901 for wet AMD in 2026
- None.
Insights
The announcement by EyePoint Pharmaceuticals regarding the successful completion of the Phase 2 DAVIO 2 trial for EYP-1901 in wet Age-related Macular Degeneration (AMD) is a significant milestone that could have material implications for the company's financial trajectory. The positive efficacy and safety data not only bolster the drug's profile but also pave the way for a Phase 3 clinical trial, a critical step towards potential commercialization. The company's cash position of $331 million as of December 31, 2023, is robust, providing a runway through the expected Phase 3 trial data release in 2026. This financial cushion is vital for sustaining operations and funding ongoing trials without the immediate need for additional capital raises, which could dilute shareholder value.
Furthermore, the sale of rights to YUTIQ® for $82.5 million plus future royalties demonstrates an effective strategy in monetizing assets to fund core development programs. Investors should monitor the planned end of Phase 2 meeting with the FDA as it will provide insights into the regulatory path ahead and any potential challenges. The anticipation of Phase 2 data for other clinical trials, such as the VERONA trial in Diabetic Macular Edema (DME), adds to the pipeline's depth, potentially diversifying the company's revenue sources if successful. However, it's important to consider the inherent risks of clinical development, as any setbacks could significantly impact the company's valuation and stock performance.
From a medical research perspective, the positive outcomes of the Phase 2 DAVIO 2 trial for EYP-1901 in wet AMD suggest a promising therapeutic advancement. Wet AMD is a leading cause of vision loss in older adults and current treatments often require frequent intraocular injections. If EYP-1901 can reduce treatment frequency while maintaining efficacy, it could offer a significant improvement in patient quality of life and adherence to treatment regimens. The drug's progression to Phase 3 trials will be closely watched by the medical community for its potential to shift the treatment paradigm.
Additionally, the initiation of the Phase 2 VERONA trial for EYP-1901 in DME and the anticipated data from the PAVIA trial in NPDR represent important steps in addressing other serious retinal diseases. The outcomes of these trials could expand the therapeutic applications of EYP-1901, potentially offering a new option for patients with few alternatives. It is crucial for stakeholders to understand the scientific underpinnings of these trials and the unmet medical needs they aim to address. Positive results could lead to significant improvements in patient outcomes and create substantial market opportunities for EyePoint Pharmaceuticals.
EyePoint Pharmaceuticals' progress in its clinical trials positions the company in a dynamic segment of the ophthalmology market, which is experiencing growth due to an aging global population and rising prevalence of retinal diseases. The wet AMD market alone is highly competitive and lucrative, with the demand for treatments projected to increase. The company's potential first-mover advantage with a long-acting treatment like EYP-1901 could capture significant market share if the drug's Phase 3 trials are successful and if it gains regulatory approval.
Moreover, the company's strategic appointment of Dr. Ramiro Ribeiro as Chief Medical Officer could enhance its research and development capabilities. His expertise may be instrumental in navigating the complex regulatory environment and in driving the clinical programs towards successful outcomes. The market will also assess the impact of the company's financial results and R&D milestones on its stock performance, with investor sentiment potentially buoyed by the recent positive developments. Nonetheless, the competitive landscape, including the presence of established players and alternative treatments, will require continuous innovation and effective marketing strategies post-approval to maintain a strong market position.
– 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 Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer –
–
– Management to host a conference call and webcast today at 8:30 a.m. ET –
WATERTOWN, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and highlighted recent corporate developments.
“2023 was an exceptional year of execution and results for EyePoint Pharmaceuticals. The highlights include positive data from our Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD, the continued advancement of our ongoing Phase 2 trials in NPDR and DME and the strengthening of our balance sheet with a
Dr. Duker continued, “We anticipate topline data for the Phase 2 PAVIA clinical trial of EYP-1901 in moderately severe-to-severe non-proliferative diabetic retinopathy (NPDR) in the second quarter of 2024. We are excited about the potential of EYP-1901 in NPDR, a chronic disease where over
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 in February 2024.
- The Company plans to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in April 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 December 31, 2023
For the quarter ended December 31, 2023, total net revenue was
Net revenue from royalties and collaborations for the quarter ended December 31, 2023, totaled
Operating expenses for the quarter ended December 31, 2023, totaled
Net non-operating income totaled
Review of Results for the Full Year Ended December 31, 2023
For the full year ended December 31, 2023, total net revenue was
Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled
Operating expenses for the full year ended December 31, 2023, totaled
Net non-operating expense totaled
Cash, cash equivalents and investments in marketable securities on December 31, 2023, totaled
Financial Outlook
We expect that our cash, cash equivalents, and investments on December 31, 2023, will enable us to fund operations through topline data for the planned Phase 3 clinical trials of EYP-1901 for wet AMD in 2026.
Conference Call Information
EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI91be5d0e320646e887cf4047c70fe73c. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. Pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.
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 U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2301; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved 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 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:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands) | ||||||||||
| December 31, | December 31, | |||||||||
| 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 | ||||||
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
| (Unaudited) | |||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||
| 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 | |||||||||||||||
FAQ
What are the key highlights of EyePoint Pharmaceuticals' recent corporate developments?
What is the cash and investments position of EyePoint Pharmaceuticals as of December 31, 2023?
Who was appointed as the Chief Medical Officer of EyePoint Pharmaceuticals?
What are the upcoming milestones for EyePoint Pharmaceuticals' clinical trials?
