EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2022 Financial Results and Highlights Recent Corporate Developments
– Phase 2 DAVIO 2 clinical trial in wet AMD on track with topline data anticipated by year-end 2023 –
– Phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy (NPDR) on track with enrollment completion anticipated in 4Q 2023 –
– Net product revenues for Full Year 2022 of
– Management to host a conference call and webcast today at 8:30 a.m. ET –
“2022 was an exciting year of continued execution for
R&D Highlights and Updates
- Enrollment remains on track for the Phase 2 DAVIO 2 clinical trial studying EYP-1901 as a potential six-month maintenance treatment for wet AMD, with topline data anticipated by year-end 2023.
- The Phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential nine-month treatment in NPDR continues on track with enrollment completion anticipated in 4Q 2023.
- EyePoint and Rallybio announced a research collaboration in February to evaluate Rallybio’s complement inhibitor C5 (component 5) using EyePoint’s proprietary Durasert® technology for sustained intraocular drug delivery. The initial focus will be on developing a potential long-acting treatment for geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss.
- The Company will present preclinical data on the neuroprotective effect of vorolanib in a mouse model of retinal detachment as well as clinical data, including an update on the YUTIQ® CALM registry study and an encore presentation of EYP-1901 final twelve-month Phase 1 DAVIO results, at the 2023 ARVO Annual Meeting in April. The CALM study is a Phase 4, multi-center registry study and a collaboration between EyePoint and the
- An encore presentation of the EYP-1901 final twelve-month Phase 1 DAVIO results was presented at the
Macula Society46th Annual Meeting in February 2023and at the Retina Society55th Annual Scientific Meeting in November 2022.
- Data from the YUTIQ® CALM registry study was presented as a poster presentation by
Pouya Dayani, M.D., titled “CALM: Retrospective Registry Study to Collect Real-World Data on the Fluocinolone Acetonide Intravitreal Implant 0.18 Mg for the Treatment of Chronic Non-Infectious Uveitis Affecting the Posterior Segment - Year 1 Update” at the Retina Society55th Annual Scientific Meeting in November 2022.
Recent Corporate Highlights
- The Company entered into a lease agreement for the construction of a 40,000-square-foot standalone commercial manufacturing facility in
Northbridge, Massachusettsto support global product supply of EYP-1901 and YUTIQ. The Company was awarded $1.9 million of state and local grants for the facility with rent payments commencing upon completion of construction in the second half of 2024. Jay S. Duker, M.D., who has served as the Company’s Chief Operating Officer (COO) since November 2021, was promoted to the additional role of President in January 2023. In addition to continuing to oversee his duties as COO, in his expanded role, Dr. Dukerwill also oversee regulatory affairs.
YUTIQ Commercial Performance in Fourth Quarter 2022
Net product revenue for YUTIQ was
Customer demand for YUTIQ was approximately 980 units in the fourth quarter of 2022 compared to approximately 890 units for 3Q 2022, a 10% increase.
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
Non-operating income, net, totaled
Review of Results for the Full Year Ended
For the full year ended December 31, 2022, total net revenue was $41.4 million compared to $36.9 million for the full year ended December 31, 2021. Net product revenue for the full year ended December 31, 2022 was $39.9 million, compared to net product revenues for the full year ended December 31, 2021 of $35.3 million.
Net revenue from royalties and collaborations for the full year ended December 31, 2022 totaled $1.5 million compared to $1.6 million in the corresponding period in 2021.
Operating expenses for the full year ended December 31, 2022 totaled $141.0 million versus $92.2 million in the prior year period. This increase was primarily driven by a one-time
Non-operating expense, net, totaled $2.6 million and net loss was $102.3 million, or (
Cash, cash equivalents and investments in marketable securities on
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 fourth quarter and year ended
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 and non-proliferative diabetic retinopathy; 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®; the loss of pass-through reimbursement status for DEXYCU as of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended
||Twelve Months Ended
|Product sales, net||$||9,857||$||11,185||$||39,905||$||35,312|
|License and collaboration agreements||202||162||362||756|
|Cost of sales, excluding amortization of acquired intangible assets||3,410||3,033||8,326||8,177|
|Research and development||15,543||8,918||49,642||28,500|
|Sales and marketing||5,915||7,811||25,507||27,503|
|General and administrative||8,496||9,217||34,817||25,575|
|Amortization of acquired intangible assets||205||615||2,050||2,460|
|Impairment of acquired intangible assets||20,699||-||20,699||-|
|Total operating expenses||54,268||29,594||141,041||92,215|
|Loss from operations||(43,735||)||(18,050||)||(99,637||)||(55,276||)|
|Other income (expense):|
|Interest and other income, net||1,064||6||2,131||292|
|Gain (loss) on extinguishment of debt||-||-||(1,559||)||2,065|
|Total other expense, net||283||(1,382||)||(2,617||)||(3,141||)|
|Net loss per common share - basic and diluted||$||(1.16||)||$||(0.59||)||$||(2.74||)||$||(2.03||)|
|Weighted average common shares outstanding - basic and diluted||37,352||32,700||37,317||28,758|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||95,633||$||178,593|
|Accounts and other receivables, net||15,503||18,354|
|Other current assets||9,858||4,217|
|Total current assets||172,808||237,745|
|Operating lease right-of-use assets||6,038||2,252|
|Intangible assets, net||—||22,749|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||22,278||$||21,807|
|Other current liabilities||579||782|
|Total current liabilities||34,537||23,658|
|Deferred revenue, less current portion||13,557||14,560|
|Operating lease liabilities - noncurrent||5,984||1,860|
|Other long-term liabilities||600||2,352|
|Accumulated other comprehensive income||786||841|
|Total stockholders' equity||96,368||184,380|
|Total liabilities and stockholders' equity||$||180,356||$||263,372|
Source: EyePoint Pharmaceuticals, Inc.