EyePoint Pharmaceuticals Reports Third Quarter 2021 Financial Results and Highlights Recent Corporate Developments
– Positive 3-month safety data for Phase 1 EYP-1901 DAVIO trial for the potential treatment of wet AMD featured at
– Topline data for DAVIO trial to be presented at
– Net product revenues of
– Management to host a conference call and webcast today at 8:30 AM ET –
“We continue to advance our pipeline, announcing positive 3-month safety data for all dose levels in our Phase 1 DAVIO trial at the
October 2021, the Company reported positive 3-month safety results for all dose levels from its ongoing DAVIO trial of EYP-1901 for wet-AMD at the ASRS 2021 Annual Meeting. Adverse events (AEs) reported in the 3-month safety results were all mild to moderate in severity with no ocular serious adverse events (SAEs) or drug-related systemic SAEs reported. In addition, there were no reported AEs related to significant intraocular inflammation, best corrected visual acuity (BCVA) reduction, or elevation of intra-ocular pressure (IOP). Further, no events of endophthalmitis, retinal detachment, or migration into the anterior chamber were reported.
September 2021, the Company announced that a late-breaking abstract highlighting topline data for the Phase 1 DAVIO trial of EYP-1901 in wet AMD was selected for presentation at the AAO 2021 Annual Meeting. The presentation is scheduled for November 13, 2021.
October 2021, the Company reported preliminary data from its ongoing YUTIQ® CALM real-world registry study at Retina Societyand ASRS. The study is collecting data on patients who have received the fluocinolone acetonide intravitreal implant 0.18 mg and includes patients 18 years of age and older with a diagnosis of chronic noninfectious uveitis affecting the posterior segment. Interim baseline data on patients in the registry as of August 2021show that most patients enrolled to date at entry suffer from uveitis of substantial disease duration (mean 57 months, or 4.75 years) and also have a variety of etiologies, mostly unknown, and previous treatments in their medical history. Following injection with YUTIQ® most patients have experienced relatively controlled intraocular inflammation as measured by anterior chamber cell count and vitreous haze.
Recent Business Highlights
November 1, 2021, the Company appointed Jay S. Duker, M.D. as its Chief Operating Officer. In his new role, Dr. Dukerwill be responsible for overseeing all clinical development, research, product development and manufacturing. Dr. Dukerjoined EyePoint as Chief Strategic Scientific Officer on a part-time basis in 2020, after serving as an independent member of the EyePoint Board of Directors since 2016. Dr. Dukerhas spent over 30 years in academic ophthalmology, and for the past 21 years served as Chair of the Department of Ophthalmologyat Tufts Medical Centerand the Tufts University School of Medicine, a position he relinquished to join EyePoint full time.
Commercial Performance in Third Quarter 2021
- Net product revenue for YUTIQ® and DEXYCU was
$3.9million and $4.7 million, respectively.
- Customer demand of approximately 560 units of YUTIQ and approximately 13,100 units for DEXYCU, compared to approximately 540 units and 10,900 units, respectively for Q2 2021 customer demand.
Review of Results for the Third Quarter ended
For the quarter ended
Net revenue from royalties and collaborations for the quarter ended September 30, 2021 totaled $0.5 million compared to $9.9 million in the corresponding period in 2020.
Operating expenses for the quarter ended September 30, 2021 totaled $24.4 million versus $17.7 million in the prior year period. This increase was primarily due to a
Cash and cash equivalents at September 30, 2021 totaled $119.7 million compared to $44.9 million at December 31, 2020.
We expect the cash on hand at
Conference Call Information
EyePoint will host a conference call today, at 8:30 AM ET to discuss the results for the third quarter ended
EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA on
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 anticipated use of proceeds for the proposed 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 our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; 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; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; 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 products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|Product sales, net||$||8,587||$||5,758||$||24,127||$||14,151|
|License and collaboration agreement||159||9,535||594||11,590|
|Cost of sales, excluding amortization of acquired intangible assets||1,825||1,882||5,144||3,363|
|Research and development||8,498||4,090||19,582||12,219|
|Sales and marketing||7,374||5,269||19,692||19,483|
|General and administrative||6,060||5,796||16,358||14,949|
|Amortization of acquired intangible assets||615||615||1,845||1,845|
|Total operating expenses||24,372||17,652||62,621||51,859|
|Loss from operations||(15,313||)||(1,957||)||(37,226||)||(24,553||)|
|Other income (expense):|
|Interest and other income, net||6||(4||)||286||58|
|Gain on extinguishment of debt||—||—||2,065||—|
|Total other income (expense), net||(1,382||)||(1,844||)||(1,759||)||(5,372||)|
|Net loss per common share - basic and diluted||$||(0.58||)||$||(0.30||)||$||(1.42||)||$||(2.44||)|
|Weighted average common shares outstanding - basic and diluted||28,766||12,794||27,429||12,277|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||119,710||$||44,909|
|Accounts and other receivables, net||13,602||9,453|
|Prepaid expenses and other current assets||3,892||3,419|
|Total current assets||141,775||63,118|
|Operating lease right-of-use assets||2,402||2,610|
|Intangible assets, net||23,364||25,209|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||18,102||$||13,256|
|Other current liabilities||796||687|
|Total current liabilities||19,933||14,888|
|Deferred revenue - noncurrent||14,792||15,616|
|Operating lease liabilities - noncurrent||2,019||2,330|
|Other long-term liabilities||2,363||2,365|
|Accumulated other comprehensive income||841||841|
|Total stockholders' equity||92,748||18,541|
|Total liabilities and stockholders' equity||$||168,251||$||91,717|
Source: EyePoint Pharmaceuticals, Inc.