Full Press Release Details
EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results and Highlights Recent Corporate Developments
- 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 $35.3 million, a 70% increase vs Full Year 2020 of $20.8 million
- Management to host a conference call and webcast today at 8:30 a.m. ET
WATERTOWN, Mass., March 3, 2022 (GLOBE NEWSWIRE) - EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced financial results for the fourth quarter and year ended December 31, 2021 and highlighted recent corporate developments.
"2021 was an exceptional year for EyePoint Pharmaceuticals as we made significant strides across clinical, financial and commercial fronts, highlighted by positive interim Phase 1 DAVIO data from our lead pipeline program, EYP-1901 for wet age-related macular degeneration (wet AMD), and the strengthening of our balance sheet with over $230 million in proceeds from two successful follow-on offerings during the year," said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. "In the year ahead, our priority remains on advancing EYP-1901 into a Phase 2 clinical trial for wet AMD in Q3 2022 and in non-proliferative diabetic retinopathy (NPDR) later in the second half of this year. We believe EYP-1901 has the potential to change the current treatment paradigm in wet AMD from an intensive monthly or bi-monthly regimen to a far less burdensome six-month maintenance therapy for the majority of patients."
Ms. Lurker continued, "Our commercial team delivered a strong 2021 with $35.3 million of net product revenue, a 70% increase over 2020, driven in part by record customer demand for both YUTIQ and DEXYCU in Q4 2021 despite the impact of the ongoing pandemic."
Recent Business Highlights
Commercial Performance in Fourth Quarter 2021
Review of Results for the Fourth Quarter ended December 31, 2021
For the quarter ended December 31, 2021, total net revenue was $11.5 million compared to $7.1 million for the quarter ended December 31, 2020. Net product revenue for the quarter ended December 31, 2021 was $11.2 million, compared to net product revenues for the quarter ended December 31, 2020 of $6.7 million.
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 $3.7 million increase in R&D expense, a $3.4 million increase in G&A expense, a $2.0 million increase in sales and marketing expense, and a $0.6 million increase in cost of sales. Non-operating expense, net, totaled $1.4 million and net loss was $19.4 million, or ($.59) per share, compared to a net loss of $15.5 million, or ($1.07) per share, for the prior year period.
Review of Results for the Full Year Ended December 31, 2021
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 $11.1 million increase in R&D expense, a $4.8 million increase in G&A expense, a $2.4 million increase in cost of sales, and a $2.2 million increase in sales and marketing expense. Non-operating expense, net, totaled $3.1 million and net loss was $58.4 million, or $2.03 per share, compared to a net loss of $45.4 million, or $3.54 per share, for the prior year period.
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 December 31, 2021 and expected net cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.
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, 2021 and recent corporate developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 5058194. A live webcast will be available on the Investor Relations section of the corporate website at http://www.eyepointpharma.com. A replay of the webcast will also be available on the corporate website.
About EyePoint Pharmaceuticals, Inc.
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, a potential six-month intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. Durasert's proven intravitreal drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
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.
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EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 11,185 | $ | 6,680 | $ | 35,312 | $ | 20,831 | ||||||||
| License and collaboration agreements (including licensing fees from a related party of $61 and $0 for the three months ended December 31, 2021 and 2020, respectively and $543 and $11,500 for the years ended December 31, 2021 and 2020, respectively) | 162 | 352 | 756 | 11,942 | ||||||||||||
| Royalty income | 197 | 99 | 871 | 1,664 | ||||||||||||
| Total revenues | 11,544 | 7,131 | 36,939 | 34,437 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| 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 | ||||||||||||
| Interest expense | (1,388 | ) | (1,827 | ) | (5,498 | ) | (7,257 | ) | ||||||||
| 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 | $ | (19,432 | ) | $ | (15,469 | ) | $ | (58,417 | ) | $ | (45,394 | ) | ||||
| 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 |
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 178,593 | $ | 44,909 | ||||
| Marketable securities | 32,965 | - | ||||||
| Accounts and other receivables, net (including due from a related party of $414 and $104 at December 31, 2021 and 2020, respectively) | 18,354 | 9,453 | ||||||
| Prepaid expenses and other current assets | 4,217 | 3,419 | ||||||
| Inventory | 3,616 | 5,337 | ||||||
| Total current assets | 237,745 | 63,118 | ||||||
| Operating lease right-of-use assets | 2,252 | 2,610 | ||||||
| Intangible assets, net | 22,749 | 25,209 | ||||||
| Other assets | 626 | 780 | ||||||
| Total assets | $ | 263,372 | $ | 91,717 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 21,807 | $ | 13,256 | ||||
| Deferred Revenue | 1,069 | 945 | ||||||
| Other current liabilities | 782 | 687 | ||||||
| Total current liabilities | 23,658 | 14,888 | ||||||
| Long-term debt | 36,562 | 37,977 | ||||||
| Deferred revenue - noncurrent | 14,560 | 15,616 | ||||||
| Operating lease liabilities - noncurrent | 1,860 | 2,330 | ||||||
| Other long-term liabilities | 2,352 | 2,365 | ||||||
| Total liabilities | 78,992 | 73,176 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 752,636 | 528,380 | ||||||
| Accumulated deficit | (569,097 | ) | (510,680 | ) | ||||
| Accumulated other comprehensive income | 841 | 841 | ||||||
| Total stockholders' equity | 184,380 | 18,541 | ||||||
| Total liabilities and stockholders' equity | $ | 263,372 | $ | 91,717 |