EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results and Highlights Recent Corporate Developments
– Positive EYP-1901 DAVIO Phase 1 eight-month data was presented at Angiogenesis, Exudation, and Degeneration 2022 virtual meeting on
– Phase 2 trials for EYP-1901 in wet AMD and NPDR are expected to initiate in Q3 2022 and 2H 2022, respectively, with top-line data from wet AMD trial anticipated in 2H 2023
– Net product revenues for Full Year 2021 of
– Management to host a conference call and webcast today at 8:30 a.m. ET
“2021 was an exceptional year for
February 2022, the Company presented eight-month data from the DAVIO Phase 1 clinical trial of EYP-1901 for wet AMD at the Angiogenesis, Exudation, and Degeneration 2022 virtual meeting. The data continued to show no dose limiting toxicities, no reports of ocular serious adverse events (SAEs) and no drug-related systemic SAEs, consistent with the six-month data presented in November 2021. The DAVIO data has also shown that following a single dose of EYP-1901, 53% and 41% of patients did not require a supplemental anti-VEGF treatment up to six and nine months, respectively. The treatment burden was reduced by 79% and 75% at six months and eight months respectively compared to prior to dosing with EYP-1901. Additionally, the eight-month data confirmed continued stable and sustained best corrected visual acuity (BCVA) (-3.0 ETDRS letters) and central subfield thickness/optical coherence tomography (CST/OCT) (+13 μm).
January 2022, the Company announced it completed a positive Type C meeting with the U.S. Food and Drug Administration(FDA) and expects to initiate a Phase 2 trial of EYP-1901 for wet AMD in Q3 2022 and in NPDR in 2H 2022 with initial top-line data for the wet AMD trial anticipated in 2H 2023.
Recent Business Highlights
January 2022, the Company appointed Michael C. Pineas its Chief Corporate Development and Strategy Officer. In this new role, Mr. Pinewill be responsible for overseeing all of EyePoint’s clinical and commercial business development and strategy. Mr. Pinehas almost 20 years of business development and strategy experience and joins EyePoint Pharmaceuticalsafter serving as Senior Vice President of Business Development and Strategy at Medexus Pharmaceuticals.
December 2021, the Company and Harrow Health’s ImprimisRx announced an expanded U.S.commercial alliance for DEXYCU, giving ImprimisRx full responsibility for U.S.sales and marketing activities for DEXYCU, absorbing the majority of EyePoint’s DEXYCU commercial organization. EyePoint Pharmaceuticalswill retain the DEXYCU NDA, revenue recognition, manufacturing, and distribution responsibilities for all markets. The amended agreement expands the commercial alliance previously established in August 2020between the companies.
November 2021, the Company completed an upsized underwritten public offering with gross proceeds of $115.4 million. The Company sold 5,122,273 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock. The shares of common stock were sold at a public offering price of $13.75 per share, and the pre-funded warrants were sold at a purchase price of $13.74 per pre-funded warrant.
November 2021, the Company appointed Jay S. Duker, M.D. as its Chief Operating Officer. In his 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 Fourth Quarter 2021
- Net product revenue for YUTIQ and DEXYCU was
$5.8million and $5.4 million, respectively.
- Customer demand for YUTIQ was approximately 650 units compared to approximately 560 units for Q3 2021, an increase of 16%.
- Customer demand for DEXYCU was approximately 13,800 units, compared to approximately 13,100 units for Q3 2021, an increase of 5%.
Review of Results for the Fourth Quarter ended
For the quarter ended
Net revenue from royalties and collaborations for the quarter ended December 31, 2021 totaled $0.4 million compared to $0.5 million in the corresponding period in 2020.
Operating expenses for the quarter ended December 31, 2021 totaled $29.6 million versus $19.9 million in the prior year period. This increase was primarily due to a
Review of Results for the Full Year Ended
For the full year ended December 31, 2021, total net revenue was $36.9 million compared to $34.4 million for the full year ended December 31, 2020. Net product revenue for the full year ended December 31, 2021 was $35.3 million, compared to net product revenues for the full year ended December 31, 2010 of $20.8 million.
Net revenue from royalties and collaborations for the full year ended December 31, 2021 totaled $1.6 million compared to $13.6 million in the corresponding period in 2020.
Operating expenses for the full year ended December 31, 2021 totaled $92.2 million versus $71.7 million in the prior year period. This increase was largely due to a
Cash and investments on December 31, 2021 totaled $211.6 million compared to $44.9 million as of December 31, 2020.
We expect the cash 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 six-month treatment for serious eye diseases, including wet age-related macular degeneration; 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®; 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
||Twelve Months Ended
|Product sales, net||$||11,185||$||6,680||$||35,312||$||20,831|
|License and collaboration agreements (including licensing fees from a related party of
|Cost of sales, excluding amortization of acquired intangible assets||3,033||2,461||8,177||5,824|
|Research and development||8,918||5,205||28,500||17,424|
|Sales and marketing||7,811||5,810||27,503||25,293|
|General and administrative||9,217||5,777||25,575||20,726|
|Amortization of acquired intangible assets||615||615||2,460||2,460|
|Total operating expenses||29,594||19,868||92,215||71,727|
|Loss from operations||(18,050||)||(12,737||)||(55,276||)||(37,290||)|
|Other income (expense):|
|Interest and other income, net||6||-||292||58|
|Gain (loss) on extinguishment of debt||-||(905||)||2,065||(905||)|
|Total other income (expense), net||(1,382||)||(2,732||)||(3,141||)||(8,104||)|
|Net loss per common share - basic and diluted||$||(0.59||)||$||(1.07||)||$||(2.03||)||$||(3.54||)|
|Weighted average common shares outstanding - basic and diluted||32,700||14,501||28,758||12,836|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||178,593||$||44,909|
|Accounts and other receivables, net (including due from a related party of
|Prepaid expenses and other current assets||4,217||3,419|
|Total current assets||237,745||63,118|
|Operating lease right-of-use assets||2,252||2,610|
|Intangible assets, net||22,749||25,209|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||21,807||$||13,256|
|Other current liabilities||782||687|
|Total current liabilities||23,658||14,888|
|Deferred revenue - noncurrent||14,560||15,616|
|Operating lease liabilities - noncurrent||1,860||2,330|
|Other long-term liabilities||2,352||2,365|
|Accumulated other comprehensive income||841||841|
|Total stockholders' equity||184,380||18,541|
|Total liabilities and stockholders' equity||$||263,372||$||91,717|
Source: EyePoint Pharmaceuticals, Inc.