Item 1. Financial Statements
Item 1.
Financial Statements.
Ocular Therapeutix, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
March 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
349,681
$
392,102
Accounts receivable, net
25,221
32,388
Inventory
3,269
3,040
Prepaid expenses and other current assets
9,523
13,457
Total current assets
387,694
440,987
Property and equipment, net
10,784
9,389
Restricted cash
1,614
1,614
Operating lease assets
5,828
5,945
Total assets
$
405,920
$
457,935
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
4,626
$
4,176
Accrued expenses and other current liabilities
31,080
35,117
Deferred revenue
64
128
Operating lease liabilities
2,156
1,933
Total current liabilities
37,926
41,354
Other liabilities:
Operating lease liabilities, net of current portion
4,866
5,345
Derivative liability
13,852
13,246
Deferred revenue, net of current portion
14,000
14,000
Notes payable, net
69,202
68,505
Other non-current liabilities
144
141
Total liabilities
139,990
142,591
Commitments and contingencies (Note 15)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2025 and December 31, 2024, respectively
—
—
Common stock, $ 0.0001 par value; 400,000,000 and 400,000,000 shares authorized and 159,262,024 and 157,749,490 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively
16
16
Additional paid-in capital
1,221,051
1,206,412
Accumulated deficit
( 955,137 )
( 891,084 )
Total stockholders’ equity
265,930
315,344
Total liabilities and stockholders’ equity
$
405,920
$
457,935
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended
March 31,
2025
2024
Revenue:
Product revenue, net
$
10,634
$
14,715
Collaboration revenue
64
59
Total revenue, net
10,698
14,774
Costs and operating expenses:
Cost of product revenue
1,262
1,326
Research and development
42,857
20,735
Selling and marketing
14,148
10,183
General and administrative
16,348
14,147
Total costs and operating expenses
74,615
46,391
Loss from operations
( 63,917 )
( 31,617 )
Other income (expense):
Interest income
3,826
3,922
Interest expense
( 2,984 )
( 4,051 )
Change in fair value of derivative liabilities
( 978 )
( 5,152 )
Loss on extinguishment of debt
—
( 27,950 )
Total other expense, net
( 136 )
( 33,231 )
Net loss
$
( 64,053 )
$
( 64,848 )
Net loss per share, basic
$
( 0.38 )
$
( 0.49 )
Weighted average common shares outstanding, basic
169,396,989
132,021,945
Net loss per share, diluted
$
( 0.38 )
$
( 0.49 )
Weighted average common shares outstanding, diluted
169,396,989
132,021,945
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended
March 31,
2025
2024
Cash flows from operating activities:
Net loss
$
( 64,053 )
$
( 64,848 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense
10,456
7,978
Non-cash interest expense
1,436
1,968
Change in fair value of derivative liabilities
978
5,152
Depreciation and amortization expense
981
920
Loss on extinguishment of debt
—
27,950
Changes in operating assets and liabilities:
Accounts receivable
7,167
( 367 )
Prepaid expenses and other current assets
3,934
128
Inventory
( 229 )
( 269 )
Accounts payable
7
1,693
Operating lease assets
117
413
Accrued expenses
( 5,145 )
( 14,031 )
Deferred revenue
( 64 )
( 59 )
Operating lease liabilities
( 256 )
( 515 )
Net cash used in operating activities
( 44,671 )
( 33,887 )
Cash flows from investing activities:
Purchases of property and equipment
( 1,933 )
( 255 )
Net cash used in investing activities
( 1,933 )
( 255 )
Cash flows from financing activities:
Proceeds from exercise of stock options
4,183
4,870
Proceeds from issuance of common stock and pre-funded warrants upon private placement, net of issuance costs
—
316,353
Net cash provided by financing activities
4,183
321,223
Net increase in cash, cash equivalents and restricted cash
( 42,421 )
287,081
Cash, cash equivalents and restricted cash at beginning of period
393,716
197,571
Cash, cash equivalents and restricted cash at end of period
$
351,295
$
484,652
Supplemental disclosure of cash flow information:
Cash paid for interest
$
2,140
$
12,967
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses
$
564
$
392
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share data)
(Unaudited)
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Equity
Balances at December 31, 2024
157,749,490
$
16
$
1,206,412
$
( 891,084 )
$
315,344
Issuance of common stock upon exercise of stock options
880,115
—
4,183
—
4,183
Issuance of common stock upon vesting of restricted stock units
632,419
—
—
—
—
Stock-based compensation expense
—
—
10,456
—
10,456
Net loss
—
—
—
( 64,053 )
( 64,053 )
Balances at March 31, 2025
159,262,024
$
16
$
1,221,051
$
( 955,137 )
$
265,930
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share data)
(Unaudited)
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Equity
Balances at December 31, 2023
114,963,193
$
12
$
788,697
$
( 697,578 )
$
91,131
Issuance of common stock upon exercise of stock options
1,025,384
—
4,870
—
4,870
Issuance of common stock upon vesting of restricted stock units
532,717
—
—
—
—
Issuance of common stock and pre-funded warrants upon private placement, net of issuance costs
32,413,560
3
316,350
—
316,353
Issuance of common stock in connection with conversion of Convertible Notes
5,769,232
—
52,499
—
52,499
Stock-based compensation expense
—
—
7,978
—
7,978
Net loss
—
—
—
( 64,848 )
( 64,848 )
Balances at March 31, 2024
154,704,086
$
15
$
1,170,394
$
( 762,426 )
$
407,983
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
(Unaudited)
1. Nature of the Business
Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a fully-integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI (also known as OTX-TKI), the Company’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in two repeat-dosing Phase 3 clinical trials for the treatment of wet age-related macular degeneration (“wet AMD”), which the Company refers to as the SOL-1 and the SOL-R trials. The Company has also completed a Phase 1 clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy (“NPDR”), which the Company refers to as the HELIOS trial. The Company is currently planning its next steps for AXPAXLI for the treatment of NPDR and diabetic macular edema (“DME”).
The Company also leverages the ELUTYX technology in its commercial product DEXTENZA, a corticosteroid approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate PAXTRAVA (also known as OTX-TIC), which is a travoprost intracameral injection that is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma (“OAG”) or ocular hypertension (“OHT”).
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, dependence on specific programs, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. Approved products will require significant sales, marketing and distribution support. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.
The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of March 31, 2025, the Company had an accumulated deficit of $ 955,137 . Based on its current operating plan which includes estimates of anticipated cash inflows from product sales and cash outflows from operating expenses and capital expenditures, the Company believes that its existing cash and cash equivalents of $ 349,681 as of March 31, 2025 will enable it to fund its planned operating expenses, debt service obligations and capital expenditures at least through the next 12 months from the issuance date of these unaudited condensed consolidated financial statements while the Company observes a minimum liquidity covenant of $ 20,000 in its credit facility (Note 7).
The future viability of the Company is dependent on the Company’s ability to generate cash flows from the sales of the Company’s product candidates, such as AXPAXLI, if and as approved, and the sales of DEXTENZA, and to raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings, collaborations, strategic alliances, licensing agreements, royalty agreements, or marketing and distribution agreements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding on a timely basis, in sufficient amounts, or at all, the Company could be
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forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, any of which could adversely affect its business prospects, or the Company may be unable to continue operations.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 3, 2025. The following information updates, and should be read in conjunction with, the significant accounting policies described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
Accounting for Stock-Based Compensation
The Company measures all stock options and other stock-based awards granted to employees, directors, and nonemployees at the fair value on the date of the grant. The fair value of the awards is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. For awards with both service and market conditions, the Company generally determines the requisite service period as the longer of the service period and the period derived from the underlying valuation. The straight-line method of expense recognition is applied to all awards with either service-only conditions or both service and market conditions. For awards that include both service and performance conditions, the Company starts recognizing the fair value of the awards as expense when achievement of the underlying performance conditions is probable, based on the portion of the requisite service period completed.
The Company recognizes compensation expense for only the portion of awards that is expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment will be recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods.
Compensation expense related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look-back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six -month withholding period prior to the purchase date.
The Company classifies stock-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Use of Estimates
The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
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Unaudited Interim Financial Information
The balance sheet at December 31, 2024 was derived from the Company’s audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2025, the results of operations for the three months ended March 31, 2025 and 2024, and cash flows for the three months ended March 31, 2025 and 2024 have been made. The results of operations for the three months ended March 31, 2025 and 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09 Income Taxes - Improvements to Income Tax Disclosures . The amendments require (i) enhanced disclosures in connection with an entity’s effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.
In November 2024, the FASB issued ASU No. 2024-03 Disaggregation of Income Statement Expenses . The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.
3. Licensing Agreements and Deferred Revenue
Incept License Agreement (in-licensing)
On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License Agreement”). Under the Incept License Agreement, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license.
The terms and conditions of the Incept License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $ 511 and $ 440 for the three months ended March 31, 2025 and 2024, respectively. The Incept Royalties have been charged to cost of product revenue.
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AffaMed License Agreement (out-licensing)
On October 29, 2020, the Company entered into a license agreement (“AffaMed License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis and for the Company’s PAXTRAVA product candidate (collectively the “AffaMed Licensed Products”) regarding OAG or OHT, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
The terms and conditions of the AffaMed License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
The Company recognized collaboration revenue related to its performance obligation regarding the conduct of a Phase 2 clinical trial of PAXTRAVA (the “Phase 2 Clinical Trial of PAXTRAVA performance obligation”) of $ 64 and $ 59 for the three months ended March 31, 2025 and 2024, respectively.
As of March 31, 2025, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of PAXTRAVA performance obligation was $ 64 . This amount is expected to be recognized as this performance obligation is satisfied through June 2025.
Deferred revenue activity for the three months ended March 31, 2025 was as follows:
Deferred Revenue
Deferred revenue at December 31, 2024
$
14,128
Amounts recognized into revenue
( 64 )
Deferred revenue at March 31, 2025
$
14,064
4. Cash Equivalents and Restricted Cash
The Company’s unaudited condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statement of cash flows is as follows:
March 31,
March 31,
2025
2024
Cash and cash equivalents
$
349,681
$
482,888
Restricted cash (current)
—
150
Restricted cash (non-current)
1,614
1,614
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows
$
351,295
$
484,652
The Company held restricted cash as security deposits for its real estate leases.
5. Inventory
Inventory consisted of the following:
March 31,
December 31,
2025
2024
Raw materials
$
187
$
214
Work-in-process
1,805
1,489
Finished goods
1,277
1,337
$
3,269
$
3,040
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6. Expenses
Accrued expenses and other current liabilities consisted of the following:
March 31,
December 31,
2025
2024
Accrued payroll and related expenses
$
8,383
$
14,272
Accrued rebates and programs
4,465
5,265
Accrued professional fees
3,595
1,879
Accrued research and development expenses
12,301
11,054
Accrued interest payable on Barings Credit Facility (Note 9)
736
592
Accrued other
1,600
2,055
$
31,080
$
35,117
7. Financial Liabilities
Barings Credit Agreement
On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $ 82,474 (the “Total Credit Facility Amount”). The Company borrowed the full amount of $ 82,474 at closing and received proceeds of $ 77,290 , after the application of an original issue discount and fees. Indebtedness under the Barings Credit Facility matures on the earlier to occur of (i) the six-year anniversary of the Closing Date and (ii) the date that is 91 days prior to the maturity date for the Company’s Convertible Notes (as defined below). Indebtedness under the Barings Credit Facility incurs interest based on the Secured Overnight Financing Rate (“SOFR”), subject to a minimum 1.50 % floor, plus 6.75 %. The Company is obligated to make interest payments on its indebtedness under the Barings Credit Facility on a monthly basis, commencing on the Closing Date; to pay annual administration fees; and to pay, on the maturity date, any principal and accrued interest that remains outstanding as of such date. In addition, the Company is obligated to pay a fee in an amount equal to the Total Credit Facility Amount, which amount shall be reduced by the total amount of interest and principal prepayment fees paid under the Barings Credit Agreement (such fee, the “Barings Royalty Fee”). The Company is required to pay the Barings Royalty Fee in installments to Barings, for the benefit of the lenders, on a quarterly basis in an amount equal to three and one-half percent ( 3.5 %) of the net sales of DEXTENZA occurring during such quarter, subject to the terms, conditions and limitations specified in the Barings Credit Agreement, until the Barings Royalty Fee is paid in full. The Barings Royalty Fee is due and payable upon a change of control of the Company. The Company may, at its option, prepay any or all of the Barings Royalty Fee at any time without penalty. In connection with the Barings Credit Agreement, the Company granted the lenders thereto a first-priority security interest in all assets of the Company, including its intellectual property, subject to certain agreed-upon exceptions. The Barings Credit Agreement includes customary affirmative and negative covenants and requires the Company to maintain a minimum liquidity amount of $ 20,000 .
The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “Barings Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the consolidated statements of operations and comprehensive loss (Note 9).
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A summary of the Barings Credit Facility at March 31, 2025 and December 31, 2024 is as follows:
March 31,
December 31,
2025
2024
Barings Credit Facility
$
82,474
82,474
Less: unamortized discount
( 13,272 )
( 13,969 )
Total
$
69,202
68,505
As of March 31, 2025, the full principal for the Barings Credit Facility of $ 82,474 was due for repayment in 2029.
Convertible Notes
On March 1, 2019, the Company issued $ 37,500 of convertible notes, which accrued interest at an annual rate of 6 % of their outstanding principal amount which was payable, along with the principal amount, at maturity unless earlier converted, repurchased or redeemed (as amended the “Convertible Notes”). The terms and conditions of the Convertible Notes are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
The Company has determined that the embedded conversion option was required to be separated from the Convertible Notes and has accounted for the embedded conversion option as a freestanding derivative instrument subject to derivative accounting (the “Conversion Option Derivative Liability”).
On March 28, 2024, the Company issued 5,769,232 shares of its common stock with a total fair value of $ 52,499 to the holder of the Convertible Notes in connection with the conversion of the principal amount of the Convertible Notes (the “Conversion”) and paid the holder $ 11,361 for accrued interest. The extinguishment of obligations under the Convertible Notes and the resulting derecognition of the principal of the Convertible Notes ($ 37,500 ), the unamortized discount ($ 27,950 ), and the Conversion Option Derivative Liability ($ 15,000 ), resulted in a net loss of $ 27,950 , which was charged to loss on extinguishment of debt on the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024.
8. Derivative Liability
Barings Credit Agreement
The Barings Credit Agreement (Note 7) contains the embedded Barings Royalty Fee Obligation, which meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the “Royalty Fee Derivative Liability”). The Royalty Fee Derivative Liability was recorded at fair value upon the entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period. The Royalty Fee Derivative Liability was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Barings Royalty Fee Obligation and then valuing the instrument without the embedded Barings Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 9 for details regarding the determination of fair value.
A roll-forward of the Royalty Fee Derivative Liability is as follows:
Royalty Fee Derivative Liability
Balance at December 31, 2024
$
13,246
Change in fair value
606
Balance at March 31, 2025
$
13,852
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Convertible Notes
The Convertible Notes (Note 7), which were extinguished in March 2024, contained the Conversion Option Derivative Liability, an embedded conversion option that met the criteria to be bifurcated and accounted for separately from the Convertible Notes. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and was subsequently remeasured to fair value at each reporting period. The Conversion Option Derivative Liability was initially valued and was subsequently remeasured using a “with-and-without” method. The “with-and-without” methodology involved valuing the whole instrument on an as-is basis with the embedded conversion option and then valuing the instrument without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option was the fair value of the derivative, recorded as the Conversion Option Derivative Liability.
9. Risks and Fair Value
Concentration of Credit Risk and of Significant Suppliers and Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at three accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.
Three specialty distributor customers accounted for the following percentages of the Company’s total revenue:
Three Months Ended March 31,
2025
2024
Customer 1
39
%
51
%
Customer 2
24
20
Customer 3
8
13
Three specialty distributor customers accounted for the following percentages of the Company’s accounts receivable, net:
As of
March 31,
December 31,
2025
2024
Customer 1
47
%
46
%
Customer 2
27
28
Customer 3
7
8
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Change in Fair Value of Derivative Liabilities
Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following:
Three Months Ended
March 31,
2025
2024
Change in the fair value of the Conversion Option Derivative Liability
$
—
$
2,598
Change in the fair value of Royalty Fee Derivative Liability
( 606 )
( 7,235 )
Barings Royalty Fee
( 372 )
( 515 )
Total
$
( 978 )
$
( 5,152 )
Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2025 and December 31, 2024 and indicate the level of the fair value hierarchy utilized to determine such fair value:
Fair Value Measurements as of
March 31, 2025 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
334,599
$
—
$
—
$
334,599
Liability:
Derivative liability
$
—
$
—
$
13,852
$
13,852
Fair Value Measurements as of
December 31, 2024 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
378,112
$
—
$
—
$
378,112
Liability:
Derivative liability
$
—
$
—
$
13,246
$
13,246
Barings Credit Agreement and Royalty Fee Derivative Liability
At March 31, 2025, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $ 69,938 , comprised of the $ 69,202 non-current liability (Note 7) and $ 736 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $ 74,200 at March 31, 2025. At December 31, 2024, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $ 69,097 , comprised of the $ 68,505 non-current liability (Note 7) and $ 592 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $ 73,608 at December 31, 2024.
The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.
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The main inputs to valuing the Royalty Fee Derivative Liability are as follows:
As of
March 31,
December 31,
2025
2024
Revenue volatility
56.7
%
64.0
%
Revenue discount rate
15.5
%
16.0
%
10. Equity
In June 2024, the Company adopted an amendment to its restated certificate of incorporation, as amended, increasing the number of the authorized shares of its common stock by 200,000,000 shares to 400,000,000 shares.
In February 2024, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company issued and sold to the Investors in a private placement an aggregate of 32,413,560 shares of the Company’s common stock, par value $ 0.0001 per share (the “Shares”), at a price of $ 7.52 per share, and, to certain Investors in lieu of Shares, pre-funded warrants to purchase 10,805,957 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a price of $ 7.519 per Pre-Funded Warrant (the “2024 Private Placement”). Each Pre-Funded Warrant issued in the 2024 Private Placement has an exercise price of $ 0.001 per share, is currently exercisable and will remain exercisable until the Pre-Funded Warrant is exercised in full. The 2024 Private Placement closed on February 26, 2024. The Company received total net proceeds from the 2024 Private Placement of approximately $ 316,353 after deducting placement agent fees and offering expenses. The Company accounts for the Pre-Funded Warrants as a component of permanent equity. In connection with entering into the Securities Purchase Agreement, also on February 21, 2024, the Company entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to register for resale the Shares and the shares of the Company’s common stock issuable upon exercise of the Pre-Funded Warrants (together with the Shares, the “Registrable Securities”). The Company filed a registration statement regarding the Registrable Securities on Form S-3 with the SEC on March 25, 2024.
In March 2024, the Company issued 5,769,232 shares of its common stock to the holder of the Convertible Notes in connection with the Conversion. The newly issued shares of common stock were valued at fair value, being the closing price of the Company’s common stock on that day, and resulted in an increase in additional paid-in capital of $ 52,499 .
In August 2021, the Company and Jefferies LLC (“Jefferies”) entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $ 100,000 from time to time through Jefferies, acting as agent. In November 2023, the Company filed a prospectus in connection with the 2021 Sales Agreement for the issuance and sale of common stock having an aggregate offering price of up to $ 100,000 thereunder (the “Sales Agreement Prospectus”). The Company has not offered or sold shares under the 2021 Sales Agreement since the filing of the Sales Agreement Prospectus including during the three months ended March 31, 2025 and 2024, respectively.
11. Stock-Based Awards
For the three months ended March 31, 2025, the Company had three stock-based compensation plans under which it was able to grant stock-based awards, the 2021 Stock Incentive Plan, as amended (the “2021 Plan”), the 2019 Inducement Stock Incentive Plan, as amended (the “2019 Inducement Plan”), and the 2014 Employee Stock Purchase Plan (the “ESPP”) (collectively, the “Stock Plans”). The 2021 Plan and the 2019 Inducement Plan provide for the grant of non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”), performance stock units (“PSUs”), stock appreciation rights and other stock-based awards. The 2021 Plan also provides for the grant of incentive stock options.
The terms and conditions of the Stock Plans are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
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As of March 31, 2025, 2,346,204 , 635,606 , and 393,055 shares of common stock remained available for issuance under the 2021 Plan, the 2019 Inducement Plan, and the ESPP, respectively.
Stock options, RSUs and PSUs
During the three months ended March 31, 2025, the Company granted options to purchase 3,223,226 shares of common stock at a weighted exercise price of $ 7.40 per share. Of these, options to purchase 3,057,334 shares of common stock were granted under the 2021 Plan, and options to purchase 165,892 shares of common stock were granted under the 2019 Inducement Plan.
During the three months ended March 31, 2025, the Company granted 2,313,896 RSUs. Of these, 2,267,021 RSUs were granted under the 2021 Plan, and 46,875 RSUs were granted under the 2019 Inducement Plan. Each RSU is settleable for one share of common stock upon vesting.
On February 11, 2025, the Company granted 1,500,000 PSUs to its Executive Chairman, President and Chief Executive Officer under the 2021 Plan. Each PSU is settleable for one share of common stock upon vesting. The PSUs are allocated equally across four tranches, which can be earned during a five-year performance period commencing on the grant date (the “Performance Period”), if the Company’s consecutive 60-day closing stock price average meets or exceeds per share price hurdles of $ 15.00 , $ 20.00 , $ 25.00 and $ 30.00 , as applicable. All PSUs are subject to a service condition. The PSUs earned during the first three years of the Performance Period are subject to additional service-based vesting requirements through the third anniversary of the grant date. The fair value of each tranche of the PSUs was estimated using a Monte Carlo simulation. The main inputs to valuing each tranche include the risk-free interest rate, expected volatility, the contractual term of five years , and no expected dividend yield. The requisite service period for each tranche was derived from the Monte Carlo simulation, taking into account the three-year minimum service requirement. On February 11, 2025, the Company’s board of directors also approved a grant of 2,750,000 performance stock options (the “Performance Option Award”) to the Company’s Executive Chairman, President and Chief Executive Officer under the 2021 Plan which can be earned based on the same conditions as those described above for the PSUs. The Performance Option Award is contingent upon stockholder approval of an increase in the number of shares of common stock authorized under the 2021 Plan and is, in accordance with the guidance of Accounting Standards Codification Topic 718 Compensation—Stock Compensation , not deemed granted for financial accounting purposes until such approval is obtained.
During the three months ended March 31, 2025, 1,048,631 stock options and 102,777 RSUs expired or were forfeited.
Stock-based Compensation
The Company recorded stock-based compensation expense related to stock options, RSUs and PSUs in the following expense categories of its unaudited condensed consolidated statements of operations and comprehensive loss:
Three Months Ended
March 31,
2025
2024
Research and development
$
3,018
$
1,453
Selling and marketing
1,177
837
General and administrative
6,261
5,688
$
10,456
$
7,978
During the three months ended March 31, 2025, the Company modified the terms of certain stock options and RSUs that were previously granted to former executives of the Company, resulting in incremental stock-based compensation expense of $ 1,542 .
As of March 31, 2025, the Company had an aggregate of $ 82,580 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.88 years.
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12. Income Taxes
The Company did not provide for any income taxes in its unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, respectively. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at March 31, 2025 and December 31, 2024, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized.
13. Net Loss Per Share
Basic net loss per share was calculated as follows for the three months ended March 31, 2025 and 2024:
Three Months Ended
March 31,
2025
2024
Numerator:
Net loss attributable to common stockholders
$
( 64,053 )
$
( 64,848 )
Denominator:
Weighted average common shares outstanding, basic
169,396,989
132,021,945
Net loss per share - basic
$
( 0.38 )
$
( 0.49 )
For the three months ended March 31, 2025 and 2024, respectively, there was no dilutive impact from potentially issuable common shares, therefore, diluted net loss per share was the same as basic net loss per share. As of March 31, 2025 and 2024, respectively, the Pre-Funded Warrants (Note 10) are included in the calculation of basic and diluted net loss per share.
The Company excluded the following potentially issuable common shares, outstanding as of March 31, 2025 and 2024, respectively, from the computation of diluted net loss per share for the three months ended March 31, 2025 and 2024, respectively, because they had an anti-dilutive impact:
Three Months Ended March 31,
2025
2024
Options to purchase common stock
21,182,163
20,660,472
Restricted stock units
4,968,304
3,253,436
Performance stock units
1,500,000
—
27,650,467
23,913,908
14. Segment Reporting
The Company operates as a single operating segment. Its operations consist of developing and commercializing innovative therapies for retinal diseases and other eye conditions based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology.
Resources are allocated and performance is assessed by the Company’s Chief Executive Officer and the Company’s Chief Financial Officer and Chief Operating Officer, who the Company has determined to be, collectively, the Company’s Chief Operating Decision Maker (“CODM”).
The accounting policies for the Company’s one segment are the same as those described in Note 2 Summary of Significant Accounting Policies . The CODM evaluates the performance of its one segment and allocates resources based on Net Loss.
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The following table provides information about the Company’s single segment:
Three Months Ended March 31,
2025
2024
Revenue
$
10,698
$
14,774
Cost of product revenue
1,262
1,326
Research and development (a)
Direct program expenses
AXPAXLI for wet AMD
24,455
5,493
Other clinical and preclinical programs
1,081
3,215
Unallocated expenses
Personnel costs
8,983
7,128
All other costs
3,255
802
Selling and marketing (a)
12,817
9,262
General and administrative (a)
9,661
8,344
Facilities (b)
1,664
1,923
Stock-based compensation
10,456
7,978
Depreciation
981
920
Interest income
3,826
3,922
Interest expense
( 2,984 )
( 4,051 )
Loss from debt extinguishment
—
( 27,950 )
Other non-operating items
( 978 )
( 5,152 )
Net loss
$
( 64,053 )
$
( 64,848 )
(a) excluding stock-based compensation, depreciation, and facilities expenses
(b) excluding stock-based compensation and depreciation
15. Commitments and Contingencies
Indemnification Agreements
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. To date, the Company has not incurred any material costs as a result of such indemnifications.
16. Related Party Transactions
The Company has engaged Boston Image Reading Center LLC (“BIRC”) to provide certain clinical development-related services to the Company. Nadia Waheed, M.D. M.P.H., who has served as the Company’s Chief Medical Officer since June 1, 2024, is a Director of BIRC. For the three months ended March 31, 2025, the Company incurred fees for clinical development-related services rendered by BIRC of $ 26 . As of March 31, 2025 and December 31, 2024, there was $ 0 and $ 0 recorded in accounts payable for BIRC, respectively. As of March 31, 2025 and December 31, 2024, there was $ 17 and $ 5 recorded in accrued expenses for BIRC, respectively.
Jeffrey Heier, M.D., a former member of the Company’s Board of Directors and the Company’s current Chief Scientific Officer, and Peter Kaiser, M.D., the Company’s current Chief Development Officer, are each affiliated with i2Vision, Inc. and its affiliated entities (collectively “i2Vision”). The Company has engaged i2Vision to provide services with respect to the clinical advancement of AXPAXLI. For the three months ended March 31, 2025, the Company recorded a net credit for fees and expenses related to services rendered by i2Vision that were previously recorded as expense of $ 165 . The Company incurred no fees and expenses related to services rendered by i2Vision for the three months ended March 31, 2024. As of March 31, 2025 and December 31, 2024, there was $ 7 and $ 132 recorded in accounts payable for i2Vision, respectively. As of March 31, 2025 and December 31, 2024, there was $( 49 ) and $ 383 recorded in accrued expenses for i2Vision, respectively. As of March 31, 2025 and December 31, 2024, there was $ 0 and $ 176 recorded in prepaid expenses and other current assets for i2Vision, respectively.
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The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company. Christopher White, who served as the Company’s Chief Business Officer until March 6, 2024, is the brother of a partner at WilmerHale who has not participated in providing legal services to the Company. Upon Mr. White’s departure, WilmerHale ceased to be a related party to the Company. For the three months ended March 31, 2024, the Company incurred fees for legal services rendered by WilmerHale of approximately $ 1,080 .
The Company had engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Dr. Heier, to provide advice or expertise on one or more of the Company’s development-stage drug or medical device products relating to retinal diseases or conditions under a consultant agreement (the “Heier Consulting Agreement”). On February 21, 2024, the Company entered into an employment agreement with Dr. Heier (the “Heier Employment Agreement”) under which Dr. Heier agreed to serve as Chief Scientific Officer of the Company. In connection with entering into the Heier Employment Agreement, the Heier Consulting Agreement was terminated. In addition, in connection with his commencement of employment, Dr. Heier resigned from the Company’s board of directors, effective February 21, 2024. Compensation for the consulting services was in the form of cash and stock-based awards. The total grant date fair value of stock-based awards granted to Dr. Heier was $ 96 , which was recognized to expense on a straight-line basis over the respective vesting periods. The Company incurred cash-based fees for services rendered by Heier Consulting of approximately $ 5 for the three months ended March 31, 2024 before the termination of the Heier Consulting Agreement.
17. Subsequent Events
No subsequent events noted.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.