EyePoint, Inc 10-Q for FY2025 Q2
EyePoint, Inc. (EYPT)
About this 10-Q
EyePoint, Inc filed this 10-Q on August 7, 2025, covering the quarter ended June 30, 2025 (FY2025 Q2).
Headline figures
Quarter ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $5.33M
- down 43.7% from $9.48M a year earlier
- Net loss
- $59.43M
- compared with a net loss of $30.83M a year earlier
- Diluted EPS
- -$0.85
- compared with -$0.58 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
COMMISSION FILE NUMBER
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
(
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
There were
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q
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Item 1. |
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Condensed Consolidated Balance Sheets – June 30, 2025 and December 31, 2024 |
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4 |
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Condensed Consolidated Statements of Cash Flows – Six Months Ended June 30, 2025 and 2024 |
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7 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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27 |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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28 |
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Item 4. |
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Item 5. |
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28 |
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Item 6. |
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29 |
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30 |
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2
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Financial Statements
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
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June 30, |
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December 31, |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Accounts and other receivables, net |
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Prepaid expenses and other current assets |
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Inventory |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Restricted cash |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Deferred revenue |
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Other current liabilities |
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Total current liabilities |
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Deferred revenue – noncurrent |
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Operating lease liabilities – noncurrent |
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Other noncurrent liabilities |
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Total liabilities |
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Stockholders' equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive income (loss) |
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Total stockholders' equity |
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Total liabilities and stockholders' equity |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
3
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands except per share data)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenues: |
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Product sales, net |
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$ |
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$ |
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$ |
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$ |
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License and collaboration agreements |
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Royalty income |
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Total revenues |
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Operating expenses: |
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Cost of sales |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other (expense) income: |
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Interest and other income, net |
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Total other income, net |
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Net loss before income taxes |
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$ |
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$ |
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$ |
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$ |
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Provision for income taxes |
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( |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
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$ |
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Net loss per share: |
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Basic and diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average common shares outstanding: |
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Basic and diluted |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale |
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( |
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( |
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( |
) |
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( |
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Comprehensive income (loss) |
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$ |
( |
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$ |
( |
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$ |
( |
) |
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$ |
( |
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See notes to condensed consolidated financial statements.
4
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited)
(In thousands except share data)
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Number of |
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Par Value |
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Paid-In |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Balance at April 1, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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( |
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( |
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Issuance of stock, net of issue costs |
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— |
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— |
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— |
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— |
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— |
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— |
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Cashless exercise of warrants |
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( |
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— |
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— |
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— |
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Employee stock purchase plan |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Vesting of stock units |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at June 30, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Balance at April 1, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Employee stock purchase plan |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Vesting of stock units |
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— |
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( |
) |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at June 30, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Number of |
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Par Value |
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Paid-In |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Balance at January 1, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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( |
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( |
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Issuance of stock, net of issue costs |
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— |
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— |
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— |
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— |
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Cashless exercise of warrants |
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( |
) |
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— |
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— |
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— |
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Employee stock purchase plan |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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Vesting of stock units |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at June 30, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Balance at January 1, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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( |
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( |
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Employee stock purchase plan |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Vesting of stock units |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at June 30, 2025 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
5
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
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Six Months Ended |
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|||||
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June 30, |
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|||||
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2025 |
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2024 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
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Adjustments to reconcile net loss to cash flows used in |
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Depreciation of property and equipment |
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Amortization of debt discount and premium and discount on |
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( |
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( |
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Stock-based compensation |
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Deferred income tax |
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( |
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Changes in operating assets and liabilities: |
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Accounts receivable and other current assets |
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( |
) |
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Other assets |
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( |
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Inventory |
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( |
) |
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Accounts payable and accrued expenses |
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Right-of-use assets and operating lease liabilities |
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Deferred revenue |
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( |
) |
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( |
) |
Other noncurrent liabilities |
|
|
( |
) |
|
|
|
|
Net cash (used in) provided by operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Sales and maturities of marketable securities |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by investing activities |
|
|
|
|
|
( |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
Payment of equity issue costs |
|
|
( |
) |
|
|
( |
) |
Net settlement of stock units to satisfy statutory tax withholding |
|
|
( |
) |
|
|
( |
) |
Proceeds from exercise of stock options and employee stock purchase plan |
|
|
|
|
|
|
||
Principal payments on finance lease obligations |
|
|
( |
) |
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
( |
) |
|
|
|
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
Cash, cash equivalents and restricted cash at beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
||
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Lease liability arising from obtaining right-of-use assets |
|
$ |
|
|
$ |
|
||
Property and equipment additions in accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
||
Stock issuance costs in accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
||
See notes to condensed consolidated financial statements.
6
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The accompanying condensed consolidated financial statements of EyePoint Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, the Company), as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 are unaudited. Certain information in the footnote disclosures of these financial statements has been condensed or omitted in accordance with the rules and regulations of the Securities and Exchange Commission. These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of management, these statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2024, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods indicated. The preparation of financial statements in accordance with United States (U.S.) generally accepted accounting principles requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the entire 2025 fiscal year or any future period.
The Company is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™1, f/k/a EYP-1901, is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. DURAVYU™ is currently in
On May 27, 2025, the Company announced enrollment was completed in the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™. The Company is focused on completing patient enrollment in the LUCIA clinical trial for DURAVYU™ in the third quarter of 2025 and reporting top-line data for both the LUGANO and LUCIA clinical trials in the second half of 2026. The Company completed a positive EOP2 meeting with the US FDA in July 2025 and is waiting for the formal meeting minutes to finalize the pivotal program for DURAVYU™ in DME with an anticipated start in 2026.
Liquidity
The Company had cash, cash equivalents and investments in marketable securities of $
1. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
7
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2024, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or the SEC, on March 6, 2025, or the 2024 Form 10-K. Since the date of those financial statements, there have been no material changes to the Company's significant accounting policies.
In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU was issued to address investor requests for more transparency about income tax information through improvements to income tax disclosure primarily related to the rate reconciliation and income taxes paid information, and to improve the effectiveness of income tax disclosures. This ASU is effective for public entities for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 will be effective for the Company in the first quarter of its fiscal year ending December 31, 2025. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03—Income Statement —Reporting Comprehensive Income —Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statement disclosures.
Product Revenue Reserves and Allowances
For the three and six months ended June 30, 2025, the Company’s product revenues were primarily from the Company’s existing supply agreements with commercial partners. For the three and six months ended June 30, 2025 the Company’s product revenues were $
The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2025 and 2024 (in thousands):
|
|
Chargebacks, |
|
|
Government |
|
|
|
|
|
|
|
||||
|
|
and Fees |
|
|
Rebates |
|
|
Returns |
|
|
Total |
|
||||
Beginning balance at January 1, 2025 |
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
||||
Provision related to sales in the current year |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjustments related to prior period sales |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Deductions applied and payments made |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Ending Balance at June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Chargebacks, |
|
|
Government |
|
|
|
|
|
|
|
||||
|
|
and Fees |
|
|
Rebates |
|
|
Returns |
|
|
Total |
|
||||
Beginning balance at January 1, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Provision related to sales in the current year |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Adjustments related to prior period sales |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deductions applied and payments made |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Ending Balance at June 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Chargebacks, discounts and fees and rebates are recorded as a component of accrued expenses on the condensed consolidated balance sheets (See Note 6).
8
License and Collaboration Agreements and Royalty Income
ANI (formerly Alimera) Product Rights Agreement (PRA) and Commercial Supply Agreement
On
Additionally, pursuant to the PRA, the Company transferred and assigned to ANI certain assets and certain contracts with third parties related to YUTIQ®, including the new drug application for YUTIQ® (collectively, the Asset Transfer). Pursuant to the PRA, ANI paid the Company a $
On the Closing Date, the Company and ANI also entered into a commercial supply agreement (CSA), pursuant to which, during the term of the PRA, the Company agreed to manufacture and exclusively supply to ANI agreed-upon quantities of YUTIQ® necessary for ANI to commercialize YUTIQ® in the United States at certain cost plus amounts, subject to adjustments and potential extensions and terminations set forth in the CSA. The CSA with ANI automatically terminated on May 31, 2025.
Revenue from sales of product supply to ANI under the CSA was $
Ocumension Therapeutics
The Company entered into an Exclusive License Agreement on November 2, 2018, as amended by a Memorandum of Understanding dated March 1, 2019, a Memorandum of Understanding dated August 18, 2020, a Supply and Quality Agreement on February 19, 2019 and a Memorandum of Understanding on August 26, 2024. Pursuant to the license agreement and Memorandum of Understanding signed with the Company, Ocumension has:
9
Revenue from sales of product supply to Ocumension under the supply agreement was $
Exclusive License Agreement with Betta Pharmaceuticals, Co., Ltd.
On May 2, 2022, the Company entered into an exclusive license agreement (the Betta License Agreement) with Betta Pharmaceuticals Co., Ltd. (Betta), an affiliate of Equinox Sciences, LLC (Equinox). Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale, and import the Company’s product candidate, DURAVYU™, an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™ (the Licensed Product), in the field of ophthalmology (the Betta Field) in the greater area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory). The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory.
In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory. The royalties are payable on a Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Licensed Product in a region and continuing until the later of (i) the date that is twelve (12) years after first commercial sale of such Licensed Product in such region, and (ii) the first day of the month following the month in which a generic product corresponding to such Licensed Product is launched in the relevant region. The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region.
Betta is responsible for all costs relating to development, registration, manufacturing, marketing, advertising, promotional, launch, and sales activities in connection with the Licensed Products in the Betta Field in the Betta Territory. Betta is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in the Betta Field in the Betta Territory. The Betta License Agreement also requires Betta to achieve certain diligence milestones relating to regulatory filings, patient dosing, and regulatory approval by certain specified deadlines set forth in the Betta License Agreement, subject to certain exceptions and extensions as set forth in the Betta License Agreement. Betta’s development activities will be conducted pursuant to a development plan subject to periodic updates. In the event that the Company conducts a global registrational clinical trial for a Licensed Product in the Betta Field, Betta will have the right to participate in such clinical trial by including clinical trial sites in the Betta Territory in accordance with the terms of the Betta License Agreement. The Company has also agreed to provide certain technology transfer and other support services to Betta subject to certain conditions and limitations set forth in the Betta License Agreement.
Revenue from license and collaboration revenue or royalty income for the three and six months ended June 30, 2025 and 2024 related to this agreement was immaterial.
Prepaid expenses and other current assets consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Prepaid expenses |
|
$ |
|
|
$ |
|
||
Prepaid clinical expenses |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
As of June 30, 2025 and December 31, 2024 the Company had $
10
Inventory consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
||
Accrued expenses consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Personnel costs |
|
$ |
|
|
$ |
|
||
Clinical trial costs |
|
|
|
|
|
|
||
Professional and legal fees |
|
|
|
|
|
|
||
Sales chargebacks, rebates and other revenue reserves |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
On
On January 23, 2023, the Company entered into a lease agreement (the Northbridge Lease) for its new standalone commercial manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new
Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the respective lease components. The expected lease terms include non-cancellable lease periods. Renewal option periods have not been included in the determination of the lease terms as they are not deemed reasonably certain of exercise. Variable lease payments, such as common area maintenance, real estate taxes, and property insurance are not included in the determination of the lease’s ROU asset or lease liability.
As of June 30, 2025 the weighted average remaining term of the Company’s operating leases was
11
Supplemental balance sheet information related to operating leases are as follows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
|
$ |
|
|
$ |
|
|||
Operating lease liabilities – noncurrent portion |
|
|
|
|
|
|
||
Total operating lease liabilities |
|
$ |
|
|
$ |
|
||
The elements of lease expense were as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Lease expense included in: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Variable lease costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total lease expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Cash paid for amounts included in the measurement of operating lease liabilities was $
The Company’s total future minimum lease payments under non-cancellable leases at June 30, 2025 were as follows (in thousands):
|
|
Operating Leases |
|
|
Remainder of 2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments |
|
$ |
|
|
Less imputed interest |
|
|
( |
) |
Total |
|
$ |
|
|
ATM Facility
In August 2020, the Company entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, the Company may, at its option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. The Company will pay Cantor a commission of
During the three and six months ended June 30, 2025 and 2024, the Company did
12
Warrants to Purchase Common Shares
The Company issued
As of June 30, 2025,
Equity Incentive Plan
The 2023 Long-Term Incentive Plan (the “2023 Plan”), approved by the Company’s stockholders on
Starting March 2022, the Company granted non-statutory stock options to new employees as inducement awards to enter into employment with the Company. The grants were approved by the Compensation Committee of the Board of Directors and awarded in accordance with Nasdaq Listing Rule 5635(c)(4). Although not awarded under any equity incentive plans, the grants are subject to and governed by the terms and conditions of the applicable plan in effect at the time of the grant.
Stock Options
The following table provides a reconciliation of stock option activity under the Company’s equity incentive plan and for inducement awards for the six months ended June 30, 2025:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
|
|
|
|
|
|
|
|
(in years) |
|
|
(in thousands) |
|
||||
Outstanding at January 1, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company's stock options generally vest over
13
In determining the grant date fair value of option awards during the six months ended June 30, 2025, the Company applied the Black-Scholes option pricing model based on the following key assumptions:
|
|
Six Months Ended |
|
|
June 30, 2025 |
Option life (in years) |
|
|
Stock volatility |
|
|
Risk-free interest rate |
|
|
Expected dividends |
|
The following table summarizes information about employee, non-executive director and external consultant stock options for the six months ended June 30, 2025 (in thousands except per share amount):
|
|
Six Months Ended |
|
|
|
|
June 30, 2025 |
|
|
Weighted average grant date fair value per share |
|
$ |
|
|
Total cash received from exercise of stock options |
|
|
|
|
Total intrinsic value of stock options exercised |
|
|
|
|
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) issued to date under the 2016 Plan and the 2023 Plan generally vest on a ratable annual basis over
The following table provides a reconciliation of RSU activity under the 2016 Plan and the 2023 Plan for the six months ended June 30, 2025:
|
|
Number of Restricted Stock Units |
|
|
Weighted Average Grant Date Fair Value |
|
||
Nonvested at January 1, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Nonvested at June 30, 2025 |
|
|
|
|
$ |
|
||
At June 30, 2025, the weighted average remaining vesting term of the RSUs was
Employee Stock Purchase Plan
The Company’s Employee Stock Purchase Plan (the ESPP) allows qualified participants to purchase the Company’s common stock twice a year at
The Company estimated the fair value of the option component of the ESPP shares at the date of grant using a Black-Scholes valuation model. During the three and six months ended June 30, 2025, the compensation expense from ESPP shares was approximately $
14
Stock-Based Compensation Expense
The Company’s condensed consolidated statements of operations and comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Compensation expense included in: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
At June 30, 2025, there was approximately $
The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis by valuation hierarchy (in thousands):
|
|
June 30, 2025 |
|
|||||||||||||||||||||
|
|
Carrying |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Cash |
|
|
Marketable Securities |
|
||||||
Level 1: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Level 2: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
U.S. Agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
|
|
December 31, 2024 |
|
|||||||||||||||||||||
|
|
Carrying |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Cash |
|
|
Marketable Securities |
|
||||||
Level 1: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Level 2: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
U.S. Agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
15
At June 30, 2025, a total of $
The Company’s cash equivalents and marketable securities are classified within Level 1 or Level 2 on the basis of valuations using quoted market prices or alternative pricing sources and models utilizing market observable inputs, respectively. The marketable securities have been valued on the basis of valuations provided by third-party pricing services, as derived from such services’ pricing models. Inputs to the models may include, but are not limited to, reported trades, executable bid and ask prices, broker/dealer quotations, prices, or yields of securities with similar characteristics, benchmark curves, or information pertaining to the issuer, as well as industry and economic events. The pricing services may use a matrix approach, which considers information regarding securities with similar characteristics to determine the valuation for a security, and have been classified as Level 2.
The carrying amounts of accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short-term maturity.
Business Segment
The Company operates in
Significant segment expenses are as follows (in thousands):
|
Three Months Ended |
|
Six Months Ended |
|
||||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Total revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
DURAVYU™ direct research and development expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other direct research and development expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Personnel expense (including stock-based compensation) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Facilities expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Intellectual property expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Legal, corporate and professional expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Provision for income taxes |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
Interest and other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment expenses* |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
*Other segment expenses include cost of goods sold and other expenses required to operate as a public company, such as insurance, software and contracted services.
Legal Proceedings
The Company is subject to various routine legal proceedings and claims incidental to its business, which management believes will not have a material effect on the Company’s financial position, results of operations or cash flows.
16
U.S. Department of Justice Subpoena
In August 2022, the Company received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU® (DOJ Investigation). The Company is cooperating fully with the government in connection with this matter. At this time, the Company is unable to predict the duration, scope or outcome of this matter or whether it could have a material impact on the Company's financial condition, results of operations, or cash flow.
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. For periods in which the Company reports net income, diluted net income per share is determined by adding to the basic weighted average number of common shares outstanding the total number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive.
Common stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows:
|
|
As of June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Stock options |
|
|
|
|
|
|
||
ESPP |
|
|
|
|
|
|
||
Restricted stock units |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Nancy S. Lurker, the former Chief Executive Officer and Executive Vice Chair of the Company and current Vice Chair of the Board is a member of the board of directors of Altasciences, the parent company of Calvert Laboratories, Inc. (Calvert Labs), an entity with which the Company conducts business. The Company recorded $
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
Various statements made in this Quarterly Report on Form 10-Q are forward-looking and involve risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements give our current expectations or forecasts of future events and are not statements of historical or current facts. These statements include, among others, statements about:
Forward-looking statements also include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies, and objectives of management for future operations; any plans or expectations with respect to product research, development, and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. We often, although not always, identify forward-looking statements by using words or phrases such as “likely”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “plan”, “project”, “forecast”, and “outlook”.
18
The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements:
We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as supplemented by the risks set forth under Item 1A of this Quarterly Report on Form 10-Q, describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. 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.
EYEPOINT®, DEXYCU®, YUTIQ®, Durasert®, DURAVYU®, DELIVERING INNOVATION TO THE EYE®, and WITH AN EYE ON PATIENTS® are our trademarks. Retisert® and Vitrasert® are Bausch & Lomb’s trademarks. YUTIQ® is licensed to ANI and Ocumension in their respective territories. ILUVIEN® is ANI’s trademark. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners.
19
Our Business
Overview
We are a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, f/k/a EYP-1901, is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert™. DURAVYU™ is presently in two global Phase 3 clinical trials (LUGANO and LUCIA) as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and completed a positive Phase 2 clinical trial for diabetic macular edema (DME) meeting primary and secondary endpoints. Additional pipeline programs include EYPT-2301, a promising TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
On May 27, 2025, we announced enrollment was completed in the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™. We are focused on completing patient enrollment in the LUCIA clinical trial for DURAVYU™ in the third quarter of 2025 and reporting top-line data for both the LUGANO and LUCIA clinical trials in the second half of 2026. We also completed a positive EOP2 meeting with the US FDA in July 2025 and are waiting for the formal meeting minutes to finalize the pivotal program for DURAVYU™ in DME with an anticipated start in 2026.
Recent Developments
R&D Highlights
Critical Accounting Policies and Estimates
The preparation of consolidated financial statements in conformity with GAAP requires that we make certain estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. We base our estimates, judgments, and assumptions on historical experience, anticipated results, and trends, and on various other factors that we believe are reasonable under the circumstances at the time. By their nature, these estimates, judgments, and assumptions are subject to an inherent degree of uncertainty. Actual results may differ from our estimates under different assumptions or conditions. In our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, we set forth our critical accounting policies and estimates, which included revenue recognition, reserves for variable consideration associated with our commercial revenue and recognition of expense in outsourced clinical trial agreements. See Note 2 of the notes to our unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for a description of our accounting policies and estimates.
20
Results of Operations
Three months ended June 30, 2025 Compared to Three months ended June 30, 2024:
|
|
Three Months Ended |
|
|
|
|
||||||||||
|
|
June 30, |
|
|
Change |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
Amounts |
|
|
% |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
— |
|
|
$ |
1,068 |
|
|
$ |
(1,068 |
) |
|
|
-100 |
% |
License and collaboration agreements |
|
|
5,333 |
|
|
|
7,782 |
|
|
|
(2,449 |
) |
|
|
-31 |
% |
Royalty income |
|
|
— |
|
|
|
627 |
|
|
|
(627 |
) |
|
|
-100 |
% |
Total revenues |
|
|
5,333 |
|
|
|
9,477 |
|
|
|
(4,144 |
) |
|
|
-44 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
165 |
|
|
|
1,401 |
|
|
|
(1,236 |
) |
|
|
-88 |
% |
Research and development |
|
|
55,498 |
|
|
|
29,822 |
|
|
|
25,676 |
|
|
|
86 |
% |
Sales and marketing |
|
|
35 |
|
|
|
50 |
|
|
|
(15 |
) |
|
|
-30 |
% |
General and administrative |
|
|
11,862 |
|
|
|
12,750 |
|
|
|
(888 |
) |
|
|
-7 |
% |
Total operating expenses |
|
|
67,560 |
|
|
|
44,023 |
|
|
|
23,537 |
|
|
|
53 |
% |
Loss from operations |
|
|
(62,227 |
) |
|
|
(34,546 |
) |
|
|
(27,681 |
) |
|
|
80 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
2,894 |
|
|
|
3,720 |
|
|
|
(826 |
) |
|
|
-22 |
% |
Total other income, net |
|
|
2,894 |
|
|
|
3,720 |
|
|
|
(826 |
) |
|
|
-22 |
% |
Net loss before income taxes |
|
$ |
(59,333 |
) |
|
$ |
(30,826 |
) |
|
$ |
(28,507 |
) |
|
|
92 |
% |
Provision for income taxes |
|
$ |
(93 |
) |
|
$ |
— |
|
|
$ |
(93 |
) |
|
|
-100 |
% |
Net loss |
|
$ |
(59,426 |
) |
|
$ |
(30,826 |
) |
|
$ |
(28,600 |
) |
|
|
93 |
% |
Net loss per share - basic and diluted |
|
$ |
(0.85 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.27 |
) |
|
|
47 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
69,926 |
|
|
|
53,206 |
|
|
|
16,720 |
|
|
|
31 |
% |
Product Sales, Net
Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $1.1 million, or 100%, to $0 for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was due to the fact that there were no shipments during the second quarter of 2025.
License and Collaboration Agreement
License and collaboration agreement revenue decreased by $2.4 million, or 31%, to $5.3 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to lower recognition of deferred revenue related to the agreement to license YUTIQ® product rights to ANI.
Royalty Income
Royalty income decreased by $0.6 million, or 100%, to $0 for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025.
Cost of Sales
Cost of sales decreased by $1.2 million, or 88%, to $0.2 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to immaterial products sales.
21
Research and Development
The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:
|
|
Three Months Ended |
|
|||||
|
|
June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Direct research and development expenses by program: |
|
|
|
|
|
|
||
DURAVYU™ |
|
$ |
37,349 |
|
|
$ |
16,376 |
|
Other direct research and development |
|
|
1,003 |
|
|
|
373 |
|
Unallocated expenses: |
|
|
|
|
|
|
||
Personnel (including stock based compensation) |
|
|
12,703 |
|
|
|
10,543 |
|
Facilities |
|
|
1,302 |
|
|
|
266 |
|
Other |
|
|
3,141 |
|
|
|
2,264 |
|
Total research and development expenses |
|
$ |
55,498 |
|
|
$ |
29,822 |
|
Research and development expenses increased by $25.7 million, or 86%, to $55.5 million for the three months ended June 30, 2025 compared to the same period the prior year. This increase was primarily attributable to (i) a $26.0 million increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD, offset by a $5.0 million decrease due to a one-time license milestone payment in the second quarter of 2024, (ii) $2.2 million increase in personnel costs, (iii) $1.0 million increase in facility and IT expenses for our Northbridge commercial manufacturing facility, (iv) $0.9 million increase in other professional services to support Phase 3 clinical trials and (v) $0.6 million increase in clinical trial material expense for Phase 3 clinical trials. We anticipate R&D expenses will continue at similar levels in future periods due to our ongoing Phase 3 clinical trials and Northbridge commercial manufacturing facility.
Sales and Marketing
Sales and marketing expenses remained consistent and were immaterial, for the three months ended June 30, 2025 compared to the same period the prior year.
General and Administrative
General and administrative expenses decreased by $0.9 million, or 7%, to $11.9 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily attributable to lower personnel costs driven by non-cash stock compensation.
Interest (Expense) Income
Interest income from investments in marketable securities and institutional money market funds decreased by $0.8 million, or 22%, to $2.9 million for the three months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities.
22
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024:
|
|
Six Months Ended |
|
|
|
|
||||||||||
|
|
June 30, |
|
|
Change |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
Amounts |
|
|
% |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
715 |
|
|
$ |
1,726 |
|
|
$ |
(1,011 |
) |
|
|
-59 |
% |
License and collaboration agreements |
|
|
16,382 |
|
|
|
18,345 |
|
|
|
(1,963 |
) |
|
|
-11 |
% |
Royalty income |
|
|
12,689 |
|
|
|
1,090 |
|
|
|
11,599 |
|
|
|
1064 |
% |
Total revenues |
|
|
29,786 |
|
|
|
21,161 |
|
|
|
8,625 |
|
|
|
41 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
970 |
|
|
|
2,160 |
|
|
|
(1,190 |
) |
|
|
-55 |
% |
Research and development |
|
|
114,072 |
|
|
|
60,011 |
|
|
|
54,061 |
|
|
|
90 |
% |
Sales and marketing |
|
|
70 |
|
|
|
56 |
|
|
|
14 |
|
|
|
25 |
% |
General and administrative |
|
|
25,738 |
|
|
|
26,801 |
|
|
|
(1,063 |
) |
|
|
-4 |
% |
Total operating expenses |
|
|
140,850 |
|
|
|
89,028 |
|
|
|
51,822 |
|
|
|
58 |
% |
Loss from operations |
|
|
(111,064 |
) |
|
|
(67,867 |
) |
|
|
(43,197 |
) |
|
|
64 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
6,536 |
|
|
|
7,757 |
|
|
|
(1,221 |
) |
|
|
-16 |
% |
Total other income, net |
|
|
6,536 |
|
|
|
7,757 |
|
|
|
(1,221 |
) |
|
|
-16 |
% |
Net loss before income taxes |
|
$ |
(104,528 |
) |
|
$ |
(60,110 |
) |
|
$ |
(44,418 |
) |
|
|
74 |
% |
Provision for income taxes |
|
$ |
(93 |
) |
|
$ |
— |
|
|
$ |
(93 |
) |
|
|
-100 |
% |
Net loss |
|
$ |
(104,621 |
) |
|
$ |
(60,110 |
) |
|
$ |
(44,511 |
) |
|
|
74 |
% |
Net loss per share - basic and diluted |
|
$ |
(1.50 |
) |
|
$ |
(1.13 |
) |
|
$ |
(0.37 |
) |
|
|
33 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
69,847 |
|
|
|
53,059 |
|
|
|
16,788 |
|
|
|
32 |
% |
Product Sales, Net
Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $1.0 million, or 59%, to $0.7 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily driven by lower product shipments compared to the same period the prior year.
License and Collaboration Agreement
License and collaboration agreement revenue decreased by $2.0 million, or 11%, to $16.4 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was due to lower recognition of deferred revenue related to the agreement to license YUTIQ® product rights to ANI.
Royalty Income
Royalty income increased by $11.6 million, or 1064%, to $12.7 million for the six months ended June 30, 2025 compared to the same period the prior year. The increase in revenue recognized was due mainly to the recognition of the remaining $12.7 million of deferred SWK royalty revenue. On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN® and YUTIQ® for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. As a result, the Company terminated the RPA effective March 18, 2025.
Cost of Sales
Cost of sales decreased by $1.2 million, or 55%, to $1.0 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily due to lower product sales.
23
Research and Development
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Direct research and development expenses by program: |
|
|
|
|
|
|
||
DURAVYU™ |
|
$ |
79,247 |
|
|
$ |
30,086 |
|
Other direct research and development |
|
|
1,988 |
|
|
|
80 |
|
Unallocated expenses: |
|
|
|
|
|
|
||
Personnel (including stock based compensation) |
|
|
25,089 |
|
|
|
26,093 |
|
Facilities |
|
|
2,198 |
|
|
|
308 |
|
Other |
|
|
5,550 |
|
|
|
3,444 |
|
Total research and development expenses |
|
$ |
114,072 |
|
|
$ |
60,011 |
|
Research and development expenses increased by $54.1 million, or 90%, to $114.1 million for the six months ended June 30, 2025 compared to the same period the prior year. This increase was attributable primarily to (i) a $54.2 million increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD, offset by a $5.0 million decrease due to a one-time license milestone payment in the second quarter of 2024, (ii) $2.1 million increase in other professional services to support Phase 3 clinical trials, (iii) $1.9 million increase in clinical trial material expense for Phase 3 clinical trials and (iv) $1.9 million increase in facility and IT expenses for our Northbridge commercial manufacturing facility, offset by a decrease of $1.0 million in personnel costs driven by non-cash stock compensation. We anticipate clinical trial expenses will continue at similar levels in future periods due to our ongoing Phase 3 clinical trials.
Sales and Marketing
Sales and marketing expenses remained consistent and were immaterial, for the six months ended June 30, 2025 compared to the same period the prior year.
General and Administrative
General and administrative expenses decreased by $1.1 million, or 4%, to $25.7 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was primarily attributable to lower personnel costs driven by non-cash stock compensation.
Interest (Expense) Income
Interest income from investments in marketable securities and institutional money market funds decreased by $1.2 million, or 16%, to $6.5 million for the six months ended June 30, 2025 compared to the same period the prior year. This decrease was driven by lower cash available for investment in marketable securities and general decrease in market interest rates.
Liquidity and Capital Resources
We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at June 30, 2025 we had a total accumulated deficit of $977.6 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Financing Activities
In August 2020, the Company entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald& Co (Cantor). Pursuant to the ATM Facility, the Company may, at its option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. The Company will pay Cantor a commission of 3.0% of the gross proceeds from any future sales of such shares. During the three months ended June 30, 2025 and 2024, we did not sell any shares of our common stock under our ATM offering facility.
24
Future Funding Requirements
At June 30, 2025, we had cash, cash equivalents, and investments in marketable securities of $255.7 million. We expect the cash, cash equivalents and investments in marketable securities on June 30, 2025 will enable us to fund operations for the next 12 months and into 2027, beyond the topline data expected in 2026. Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company.
Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for DURAVYU™ and EYP-2301, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to:
We expect to seek additional funding to sustain our future operations and while we have successfully raised capital in the past, the ability to raise capital in future periods is not assured. We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders. Collaboration, licensing or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms. If available, additional equity financing may be dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’ equity, and funding through collaboration, licensing or other commercial agreements may be on unfavorable terms, including requiring us to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, if any, postpone or cancel the pursuit of product candidates, or otherwise significantly curtail our operations to reduce our cash requirements and extend our capital.
25
Our condensed consolidated statements of historical cash flows are summarized as follows (in thousands):
|
|
|
|
|
|
|
||||||
|
|
Six months ended |
|
|
|
|
||||||
|
|
June 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|||
Net loss |
|
$ |
(104,621 |
) |
|
$ |
(60,110 |
) |
|
$ |
(44,511 |
) |
Changes in operating assets and liabilities |
|
|
(23,795 |
) |
|
|
(11,031 |
) |
|
|
(12,764 |
) |
Other adjustments to reconcile net loss to cash flows from |
|
|
12,707 |
|
|
|
19,792 |
|
|
|
(7,085 |
) |
Net cash (used in) provided by operating activities |
|
$ |
(115,709 |
) |
|
$ |
(51,349 |
) |
|
$ |
(64,360 |
) |
Net cash (used in) provided by investing activities |
|
$ |
87,861 |
|
|
$ |
(139,589 |
) |
|
$ |
227,450 |
|
Net cash (used in) provided by financing activities |
|
$ |
(713 |
) |
|
$ |
444 |
|
|
$ |
(1,157 |
) |
Operating cash outflows for the six months ended June 30, 2025 totaled $115.7 million primarily due to our net loss of $104.6 million reduced by $12.7 million of non-cash expenses, which included $14.7 million of stock-based compensation, partially offset by $2.9 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $23.8 million, which included $28.6 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $4.8 million in other working capital adjustments.
Operating cash outflows for the six months ended June 30, 2024 totaled $51.4 million primarily due to our net loss of $60.1 million reduced by $19.8 million of non-cash expenses, which included $21.4 million of stock-based compensation, partially offset by $2.3 million for amortization of discount on available for sale of marketable securities. This was further offset by changes in working capital of $11.0 million, including $14.3 million of deferred revenue related to the agreement to license YUTIQ® product rights to Alimera.
For the six months ended June 30, 2025, $89.4 million of net cash was provided by the sales of marketable securities, and $1.5 million was used for the purchase of property and equipment.
For the six months ended June 30, 2024, $137.5 million of net cash was used for the purchase of marketable securities, and $2.1 million was used for the purchase of property and equipment.
Net cash used in financing activities for the six months ended June 30, 2025 totaled $0.7 million and consisted mainly of the following:
Net cash provided by financing activities for the six months ended June 30, 2024 totaled $0.4 million and consisted of the following:
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure, particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving its desired objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended June 30, 2025 covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
27
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
We are subject to various routine legal proceedings and claims incidental to our business, which management believes will not have a material effect on our financial position, results of operations or cash flows.
We previously disclosed that in August 2022, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing and promotional practices, including as pertain to DEXYCU®. We are cooperating fully with the government in connection with this matter. At this time, we are unable to predict the duration, scope, or outcome of this matter or whether it could have a material impact on our financial condition, results of operation or cash flow.
Item 1A. Risk Factors
There have been no material changes to the risk factors previously disclosed in Part I, “Item 1A, Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 6, 2025.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
(c)
Rule 10b5-1 Trading Arrangements
The Company permits officers and directors to adopt written trading plans, known as “Rule 10b5-1 trading arrangements”, as such term defined in Item 408(a) of Regulation S-K for the purchase or sale of the Company's securities, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. During the three months ended June 30, 2025, our executive officers and directors
Name and Title of Director or Officer |
Action |
Date of Adoption |
|
of the Plan or Termination Date |
|
Aggregate Number of Shares of Common Stock that may be Sold under the Plan |
|
|
Adoption |
|
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|
||||
28
Item 6. Exhibits
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|
|
|
Incorporated by Reference to SEC Filing |
||||
Exhibit No. |
|
Exhibit Description |
|
Form |
|
SEC Filing Date |
|
Exhibit No. |
|
|
|
|
|
|
|
|
|
2.1# |
|
|
8-K |
|
05/18/23 |
|
2.1 |
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|
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|
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3.1 |
|
|
8-K12G3 |
|
06/19/08 |
|
3.1 |
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|
|
|
|
3.2 |
|
Certificate of Amendment of the Certificate of Incorporation of pSivida Corp. |
|
10-K |
|
09/13/17 |
|
3.2 |
|
|
|
|
|
|
|
|
|
3.3 |
|
|
8-K |
|
04/02/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
3.4 |
|
|
8-K |
|
06/27/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
3.5 |
|
|
10-K |
|
09/18/18 |
|
3.5 |
|
|
|
|
|
|
|
|
|
|
3.6 |
|
Amendment No. 1 to the By-Laws of EyePoint Pharmaceuticals, Inc. |
|
8-K |
|
11/06/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.7 |
|
|
8-K |
|
06/23/20 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
3.8 |
|
|
8-K |
|
12/08/20 |
|
3.1 |
|
|
|
|
|
|
|
|
|
|
4.1 |
|
|
8-K12G3 |
|
06/19/08 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
4.2 |
|
|
8-K |
|
11/19/21 |
|
4.1 |
|
|
|
|
|
|
|
|
|
|
10.1† |
|
EyePoint Pharmaceuticals, Inc. Amendment No 2. to 2023 Long-Term Incentive Plan |
|
8-K |
|
06/20/25 |
|
10.1 |
|
|
|
|
|
|
|
|
|
31.1* |
|
|
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|
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|
31.2* |
|
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|
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|
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|
|
|
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|
|
32.1** |
|
|
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|
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|
|
32.2** |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
104 |
Cover Page Interactive Data File (embedded within the inline XBRL document and included in Exhibit 101) |
* Filed herewith
** Furnished herewith
† Indicates management contract or compensatory arrangement.
29
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 thereunto duly authorized.
|
EyePoint Pharmaceuticals, Inc. |
|
|
|
|
Date: August 7, 2025 |
By: |
/s/ Jay S. Duker |
|
Name: |
Jay S. Duker, M.D. |
|
Title: |
President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
Date: August 7, 2025 |
By: |
/s/ George O. Elston |
|
Name: |
George O. Elston |
|
Title: |
Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
30
Exhibit 31.1
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
CERTIFICATIONS
I, Jay S. Duker, certify that:
Date: August 7, 2025
/s/ Jay S. Duker |
Name: Jay S. Duker, M.D. |
Title: President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
CERTIFICATIONS
I, George O. Elston, certify that:
Date: August 7, 2025
/s/ George O. Elston |
Name: George O. Elston |
Title: Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
|
Exhibit 32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
In connection with the Quarterly Report of EyePoint Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jay S. Duker, President and Chief Executive Officer of the Company, certify that to the best of my knowledge:
Date: August 7, 2025
/s/ Jay S. Duker |
Name: Jay S. Duker, M.D. |
Title: President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
In connection with the Quarterly Report of EyePoint Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, George O. Elston, Chief Financial Officer of the Company, certify that to the best of my knowledge:
Date: August 7, 2025
/s/ George O. Elston |
Name: George O. Elston |
Title: Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |