EyePoint Pharmaceuticals Reports Third Quarter 2022 Financial Results and Highlights Recent Corporate Developments
– Initiated Phase 2 DAVIO 2 clinical trial for wet age-related macular degeneration (wet AMD) and Phase 2 PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR) –
– Presented positive twelve-month safety and efficacy data from Phase 1 DAVIO clinical trial for EYP-1901 in wet AMD at
– Net product revenue of
– Management to host a conference call and webcast today at 8:30 a.m. ET –
“In the third quarter, we continued to execute on key catalysts across our clinical-stage pipeline with the initiation of two Phase 2 clinical trials studying EYP-1901 in wet AMD and NPDR, following our encouraging positive safety and efficacy Phase 1 data,” said
R&D Highlights and Updates
- The first patient was dosed in the Phase 2 PAVIA clinical trial of EYP-1901 for the treatment of NPDR in
September 2022. This twelve-month, randomized, controlled trial is expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg), or to the control group receiving a sham injection. More information about the study is available at clinicaltrials.gov (identifier: NCT05383209).
- 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. This twelve-month, randomized, controlled trial is expected to enroll approximately 150 patients previously treated with a standard-of-care anti-VEGF therapy, randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. Topline data is expected in the fourth quarter of 2023. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).
- The Company will be presenting data at the
Retina Society55th Annual Scientific Meeting in November 2022. Sunil Patel, M.D., Ph.D. will present an encore oral presentation of the EYP-1901 final twelve-month Phase 1 DAVIO results with an additional subset analysis of patients with no excess fluid at screening. Also, data from the YUTIQ® CALM registry study will be 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”. The CALM study is a Phase 4, multi-center registry study and a collaboration between EyePoint and the Cleveland Clinic.
- Final twelve-month data from the Phase 1 DAVIO clinical trial of EYP-1901 for wet AMD was presented at the AAO 2022 Annual Meeting in
September 2022and topline data was presented at the ASRS 2022 Annual Meeting in July 2022. The data 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 73% reduction in treatment burden (75% at six-months).
Recent Corporate Highlights
October 2022, the Company and ImprimisRx mutually terminated an agreement for the commercialization of DEXYCU effective December 31, 2022. This is a result of the proposed “Medicare Hospital Outpatient Prospective Payment System and ASC Payment System Proposed Rule” published in the Federal Registerby the Center for Medicare & Medicaid Services(CMS) on July 26, 2022, not containing an extension of the pass-through payment period for DEXYCU® beyond December 31, 2022. The final rule was published on November 1, 2022, confirming that CMS will not extend pass-through reimbursement status for DEXYCU beyond December 31, 2022. Karen Zaderejwas appointed to the Company’s Board of Directors in July 2022. Ms. Zaderejbrings more than 35 years of biopharmaceutical and medical device experience to the board, and currently serves as the President and CEO of AxoGen.
Commercial Performance in Third Quarter 2022
Net product revenue for YUTIQ and DEXYCU was
Customer demand for YUTIQ and DEXYCU was approximately 890 units and 14,100 units, respectively.
Review of Results for the Third Quarter ended
For the third quarter ended
Net revenue from royalties and collaborations for the third quarter ended
Operating expenses for the third quarter ended
Cash and investments at
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 third quarter 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 at the end of 2022; 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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended
||Nine Months Ended
|Product sales, net||$||9,720||$||8,587||$||30,048||$||24,127|
|License and collaboration agreements||52||159||160||594|
|Cost of sales, excluding amortization of acquired intangible assets||1,405||1,825||4,916||5,144|
|Research and development||11,162||8,498||34,099||19,582|
|Sales and marketing||6,016||7,374||19,592||19,692|
|General and administrative||9,212||6,060||26,321||16,358|
|Amortization of acquired intangible assets||615||615||1,845||1,845|
|Total operating expenses||28,410||24,372||86,773||62,621|
|Loss from operations||(18,398||)||(15,313||)||(55,902||)||(37,226||)|
|Other income (expense):|
|Interest and other income, net||640||6||1,067||286|
|Gain (loss) on extinguishment of debt||-||—||(1,559||)||2,065|
|Total other expense, net||(22||)||(1,382||)||(2,900||)||(1,759||)|
|Net loss per common share - basic and diluted||$||(0.49||)||$||(0.58||)||$||(1.58||)||$||(1.42||)|
|Weighted average common shares outstanding - basic and diluted||37,338||28,766||37,305||27,429|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||75,362||$||178,593|
|Accounts and other receivables, net||20,876||18,354|
|Prepaid expenses and other current assets||10,436||4,217|
|Total current assets||192,102||237,745|
|Operating lease right-of-use assets||6,319||2,252|
|Intangible assets, net||20,904||22,749|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||22,116||$||21,807|
|Other current liabilities||496||782|
|Total current liabilities||34,256||23,658|
|Deferred revenue - noncurrent||13,798||14,560|
|Operating lease liabilities - noncurrent||6,235||1,860|
|Other long-term liabilities||600||2,352|
|Accumulated other comprehensive income||653||841|
|Total stockholders' equity||136,350||184,380|
|Total liabilities and stockholders' equity||$||220,490||$||263,372|
Source: EyePoint Pharmaceuticals, Inc.