UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 2, 2022, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 and certain other information. A copy of the press release is furnished as Exhibit 99.1 hereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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Press Release of EyePoint Pharmaceuticals, Inc., dated November 2, 2022 |
104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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EYEPOINT PHARMACEUTICALS, INC. |
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Date: |
November 2, 2022 |
By: |
/s/ George O. Elston |
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George O. Elston |
Exhibit 99.1
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 American Society of Retina Specialists (ASRS) 2022 Annual Meeting and American Academy of Ophthalmology (AAO) 2022 Annual Meeting –
– Net product revenue of $9.7 million in Q3 2022; a 13% increase from Q3 2021 –
– Management to host a conference call and webcast today at 8:30 a.m. ET –
WATERTOWN, Mass., November 2, 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 third quarter ended September 30, 2022 and highlighted recent corporate developments.
“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 Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “There is a great unmet need in wet AMD and NPDR for convenient, safe and efficacious long-acting treatment options that maintain the patient’s existing vision proactively. Bolstered by our strong balance sheet, we are well-positioned to advance EYP-1901 through these trials and explore its potential to significantly improve the lives of patients living with these serious eye disorders.”
Ms. Lurker continued, “Our commercial team delivered a strong quarter with $9.7 million in net product revenue, driven by strong customer demand for YUTIQ® by retinal specialists.”
R&D Highlights and Updates
Recent Corporate Highlights
Commercial Performance in Third Quarter 2022
Net product revenue for YUTIQ and DEXYCU was $7.3 million and $2.4 million, respectively.
Customer demand for YUTIQ and DEXYCU was approximately 890 units and 14,100 units, respectively.
Review of Results for the Third Quarter ended September 30, 2022
For the third quarter ended September 30, 2022, total net revenue was $10.0 million compared to $9.1 million for the quarter ended September 30, 2021. Net product revenue for the third quarter was $9.7 million, compared to net product revenues for the third quarter ended September 30, 2021 of $8.6 million.
Net revenue from royalties and collaborations for the third quarter ended September 30, 2022 totaled $0.3 million compared to $0.5 million in the corresponding period in 2021.
Operating expenses for the third quarter ended September 30, 2022 totaled $28.4 million versus $24.4 million in the prior year period, primarily driven by investment in personnel across the organization, including non-cash stock compensation, and ongoing clinical trial and development costs for EYP-1901. Non-operating expense, net, totaled $0.02 million and net loss was $18.4 million, or ($.49) per share, compared to a net loss of $16.7 million, or ($0.58) per share, for the prior year period.
Cash and investments at September 30, 2022 totaled $157.3 million compared to $171.2 million at June 30, 2022.
Financial Outlook
We expect the cash, cash equivalents and investments on hand on September 30, 2022 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 third quarter ended September 30, 2022 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BIc813a58533cb4c0191e12c73ab3f1232. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint Pharmaceuticals
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, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert 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 posterior segment uveitis, 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 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.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands except per share data)
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Three Months Ended |
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Nine Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenues: |
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Product sales, net |
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$ |
9,720 |
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$ |
8,587 |
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$ |
30,048 |
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$ |
24,127 |
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License and collaboration agreements |
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52 |
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159 |
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160 |
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594 |
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Royalty income |
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240 |
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313 |
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663 |
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674 |
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Total revenues |
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10,012 |
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9,059 |
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30,871 |
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25,395 |
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Operating expenses: |
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Cost of sales, excluding amortization of acquired intangible assets |
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1,405 |
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1,825 |
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4,916 |
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5,144 |
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Research and development |
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11,162 |
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8,498 |
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34,099 |
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19,582 |
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Sales and marketing |
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6,016 |
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7,374 |
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19,592 |
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19,692 |
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General and administrative |
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9,212 |
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6,060 |
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26,321 |
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16,358 |
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Amortization of acquired intangible assets |
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615 |
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615 |
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1,845 |
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1,845 |
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Total operating expenses |
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28,410 |
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24,372 |
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86,773 |
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62,621 |
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Loss from operations |
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(18,398 |
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(15,313 |
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(55,902 |
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(37,226 |
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Other income (expense): |
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Interest and other income, net |
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640 |
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6 |
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1,067 |
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286 |
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Interest expense |
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(662 |
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(1,388 |
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(2,408 |
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(4,110 |
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Gain (loss) on extinguishment of debt |
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— |
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— |
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(1,559 |
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2,065 |
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Total other expense, net |
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(22 |
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(1,382 |
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(2,900 |
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(1,759 |
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Net loss |
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$ |
(18,420 |
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$ |
(16,695 |
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$ |
(58,802 |
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$ |
(38,985 |
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Net loss per common share - basic and diluted |
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$ |
(0.49 |
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$ |
(0.58 |
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$ |
(1.58 |
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$ |
(1.42 |
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Weighted average common shares outstanding - basic and diluted |
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37,338 |
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28,766 |
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37,305 |
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27,429 |
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EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)
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September 30, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
75,362 |
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$ |
178,593 |
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Marketable securities |
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81,897 |
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32,965 |
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Accounts and other receivables, net |
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20,876 |
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18,354 |
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Prepaid expenses and other current assets |
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10,436 |
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4,217 |
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Inventory |
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3,531 |
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3,616 |
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Total current assets |
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192,102 |
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237,745 |
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Operating lease right-of-use assets |
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6,319 |
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2,252 |
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Intangible assets, net |
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20,904 |
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22,749 |
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Other assets |
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1,165 |
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626 |
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Total assets |
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$ |
220,490 |
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$ |
263,372 |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
22,116 |
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$ |
21,807 |
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Deferred revenue |
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1,169 |
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1,069 |
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Short-term borrowings |
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10,475 |
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— |
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Other current liabilities |
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496 |
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782 |
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Total current liabilities |
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34,256 |
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23,658 |
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Long-term debt |
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29,251 |
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36,562 |
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Deferred revenue - noncurrent |
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13,798 |
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14,560 |
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Operating lease liabilities - noncurrent |
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6,235 |
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1,860 |
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Other long-term liabilities |
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600 |
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2,352 |
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Total liabilities |
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84,140 |
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78,992 |
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Stockholders' equity: |
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Capital |
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763,596 |
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752,636 |
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Accumulated deficit |
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(627,899 |
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(569,097 |
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Accumulated other comprehensive income |
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653 |
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841 |
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Total stockholders' equity |
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136,350 |
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184,380 |
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Total liabilities and stockholders' equity |
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$ |
220,490 |
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$ |
263,372 |
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