OCULAR THERAPEUTIX, INC 10-Q

Item 1. Financial Statements. Ocular Therapeutix, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ 2024 2023 Assets ​ ​ Current assets: ​ ​ ​ Cash and cash equivalents ​ $ 482,888 ​ $ 195,807 Accounts receivable, net ​ 26,546 ​ 26,179 Inventory ​ 2,574 ​ 2,305 Restricted cash ​ ​ 150 ​ ​ 150 Prepaid expenses and other current assets ​ 7,666 ​ 7,794 Total current assets ​ 519,824 ​ 232,235 Property and equipment, net ​ 11,450 ​ 11,739 Restricted cash ​ 1,614 ​ 1,614 Operating lease assets ​ ​ 6,059 ​ ​ 6,472 Total assets ​ $ 538,947 ​ $ 252,060 Liabilities and Stockholders’ Equity ​ ​ ​ ​ Current liabilities: ​ ​ ​ ​ Accounts payable ​ $ 6,453 ​ $ 4,389 Accrued expenses and other current liabilities ​ 16,040 ​ 28,666 Deferred revenue ​ 263 ​ 255 Operating lease liabilities ​ ​ 1,542 ​ ​ 1,586 Total current liabilities ​ 24,298 ​ 34,896 Other liabilities: ​ ​ ​ ​ Operating lease liabilities, net of current portion ​ ​ 6,407 ​ ​ 6,878 Derivative liabilities ​ ​ 19,624 ​ ​ 29,987 Deferred revenue, net of current portion ​ ​ 14,068 ​ ​ 14,135 Notes payable, net ​ 66,456 ​ 65,787 Other non-current liabilities ​ ​ 111 ​ ​ 108 Convertible Notes, net ​ — ​ 9,138 Total liabilities ​ 130,964 ​ 160,929 Commitments and contingencies (Note 14) ​ ​ ​ ​ Stockholders’ equity: ​ ​ ​ ​ Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2024 and December 31, 2023, respectively ​ — ​ — Common stock, $ 0.0001 par value; 200,000,000 shares authorized and 154,704,086 and 114,963,193 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively ​ 15 ​ 12 Additional paid-in capital ​ 1,170,394 ​ 788,697 Accumulated deficit ​ ( 762,426 ) ​ ( 697,578 ) Total stockholders’ equity ​ 407,983 ​ 91,131 Total liabilities and stockholders’ equity ​ $ 538,947 ​ $ 252,060 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ ​ 3 Table of Contents 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, ​ 2024 2023 Revenue: ​ ​ Product revenue, net ​ $ 14,715 ​ $ 13,214 Collaboration revenue ​ 59 ​ 160 Total revenue, net ​ 14,774 ​ ​ 13,374 Costs and operating expenses: ​ ​ ​ Cost of product revenue ​ 1,326 ​ ​ 1,214 Research and development ​ 20,735 ​ ​ 14,747 Selling and marketing ​ 10,183 ​ ​ 10,835 General and administrative ​ 14,147 ​ ​ 9,127 Total costs and operating expenses ​ 46,391 ​ ​ 35,923 Loss from operations ​ ( 31,617 ) ​ ​ ( 22,549 ) Other income (expense): ​ ​ ​ Interest income ​ 3,922 ​ ​ 563 Interest expense ​ ( 4,051 ) ​ ​ ( 1,768 ) Change in fair value of derivative liabilities ​ ​ ( 5,152 ) ​ ​ ( 6,563 ) Loss on extinguishment of debt ​ ​ ( 27,950 ) ​ ​ — Other expense ​ — ​ ​ ( 1 ) Total other income (expense), net ​ ( 33,231 ) ​ ​ ( 7,769 ) Net loss ​ $ ( 64,848 ) ​ $ ( 30,318 ) Net loss per share, basic ​ $ ( 0.49 ) ​ $ ( 0.39 ) Weighted average common shares outstanding, basic ​ 132,021,945 ​ 77,386,287 Net loss per share, diluted ​ $ ( 0.49 ) ​ $ ( 0.39 ) Weighted average common shares outstanding, diluted ​ 132,021,945 ​ 77,386,287 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 4 Table of Contents Ocular Therapeutix, Inc. Condensed Consolidated Statements of Cash Flows (In thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ 2024 2023 Cash flows from operating activities: ​ ​ ​ Net loss ​ $ ( 64,848 ) ​ $ ( 30,318 ) Adjustments to reconcile net loss to net cash used in operating activities ​ ​ ​ ​ Stock-based compensation expense ​ 7,978 ​ 4,572 Non-cash interest expense ​ 1,968 ​ 1,228 Change in fair value of derivative liabilities ​ ​ 5,152 ​ ​ 6,563 Depreciation and amortization expense ​ 920 ​ 483 Loss on extinguishment of debt ​ 27,950 ​ — Gain on disposal of property and equipment ​ — ​ ( 1 ) Changes in operating assets and liabilities: ​ ​ ​ ​ Accounts receivable ​ ( 367 ) ​ 201 Prepaid expenses and other current assets ​ 128 ​ ( 718 ) Inventory ​ ( 269 ) ​ ( 292 ) Accounts payable ​ 1,693 ​ 1,025 Operating lease assets ​ ​ 413 ​ ​ 417 Accrued expenses ​ ( 14,031 ) ​ ( 2,628 ) Deferred revenue ​ ​ ( 59 ) ​ ​ ( 160 ) Operating lease liabilities ​ ( 515 ) ​ ( 345 ) Net cash used in operating activities ​ ( 33,887 ) ​ ( 19,973 ) Cash flows from investing activities: ​ ​ ​ Purchases of property and equipment ​ ( 255 ) ​ ( 3,379 ) Net cash used in investing activities ​ ( 255 ) ​ ( 3,379 ) Cash flows from financing activities: ​ ​ ​ Proceeds from issuance of short-term bridge loan ​ — ​ 2,000 Proceeds from exercise of stock options ​ 4,870 ​ 78 Repayment from issuance of short-term bridge loan ​ ​ — ​ ​ ( 2,000 ) 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 ​ 321,223 ​ 78 Net increase (decrease) in cash, cash equivalents and restricted cash ​ 287,081 ​ ( 23,274 ) Cash, cash equivalents and restricted cash at beginning of period ​ 197,571 ​ 104,064 Cash, cash equivalents and restricted cash at end of period ​ $ 484,652 ​ $ 80,790 Supplemental disclosure of cash flow information: ​ ​ ​ Cash paid for interest ​ $ 12,967 ​ $ 701 Supplemental disclosure of non-cash investing and financing activities: ​ ​ ​ Additions to property and equipment included in accounts payable and accrued expenses ​ $ 392 ​ $ 646 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 5 Table of Contents 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. ​ ​ ​ ​ 6 Table of Contents 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, 2022 77,201,819 ​ $ 8 ​ $ 652,213 ​ $ ( 616,842 ) ​ $ 35,379 Issuance of common stock upon exercise of stock options 26,443 ​ — ​ 78 ​ — ​ 78 Issuance of common stock upon vesting of restricted stock units ​ 288,376 ​ — ​ — ​ — ​ — Stock-based compensation expense — ​ — ​ 4,572 ​ — ​ 4,572 Net loss — ​ — ​ — ​ ( 30,318 ) ​ ( 30,318 ) Balances at March 31, 2023 77,516,638 ​ $ 8 ​ $ 656,863 ​ $ ( 647,160 ) ​ $ 9,711 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ ​ ​ 7 Table of Contents 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 biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration, diabetic retinopathy, and other diseases and conditions of the eye. AXPAXLI (axitinib intravitreal implant), the Company’s product candidate for retinal disease, is based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology. 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, 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. The Company is currently commercializing DEXTENZA (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and for the treatment of ocular itching associated with allergic conjunctivitis, in the United States. The Company’s most advanced product candidate, AXPAXLI, is in Phase 3 clinical development for the treatment of wet age-related macular degeneration; the Company’s other advanced programs and product candidates are in either Phase 1 or Phase 2 clinical development. 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, 2024, the Company had an accumulated deficit of $ 762,426 . 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 $ 482,888 as of March 31, 2024 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 DEXTENZA and sales of our product candidates, if and as approved, and 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, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. ​ ​ 8 Table of Contents 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2024. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2024. Warrants The Company accounts for issued warrants, including pre-funded warrants, as either liability or equity. Warrants are considered liabilities if they are mandatorily redeemable and they require settlement in cash or other assets, or a variable number of shares. Contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. If warrants do not otherwise require liability classification, the Company assesses whether the warrants are indexed to its common stock. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. ​ 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. Unaudited Interim Financial Information The balance sheet at December 31, 2023 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, 2024 and for the three months ended March 31, 2024 and 2023 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, 2023 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. 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, 2024 and results of operations and cash flows for the three months ended March 31, 2024 and 2023 have been made. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024. 9 Table of Contents Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board and adopted by the Company as of the specified effective date. The Company believes that recently issued accounting pronouncements that are not yet effective will not have a material impact on our consolidated financial statements and disclosures. ​ 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, 2023, filed with the SEC on March 11, 2024. Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $ 440 and $ 417 for the three months ended March 31, 2024 and 2023, respectively. The Incept Royalties have been charged to cost of product revenue. 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 open-angle glaucoma or ocular hypertension, 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, 2023, filed with the SEC on March 11, 2024. 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 $ 59 and $ 160 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of PAXTRAVA performance obligation was $ 331 . 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, 2024 was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Deferred Revenue Deferred revenue at December 31, 2023 ​ $ 14,390 Amounts recognized into revenue ​ ​ ( 59 ) Deferred revenue at March 31, 2024 ​ $ 14,331 ​ ​ 10 Table of Contents 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, ​ 2024 2023 Cash and cash equivalents ​ $ 482,888 ​ $ 79,026 Restricted cash (current) ​ ​ 150 ​ ​ — Restricted cash (non-current) ​ ​ 1,614 ​ ​ 1,764 Total cash, cash equivalents and restricted cash as shown on the statements of cash flows ​ $ 484,652 ​ $ 80,790 ​ The Company held restricted cash as security deposits for its real estate leases. ​ ​ ​ 5. Inventory Inventory consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ ​ 2024 2023 Raw materials ​ $ 329 ​ $ 302 ​ Work-in-process ​ ​ 915 ​ ​ 1,012 ​ Finished goods ​ 1,330 ​ 991 ​ ​ ​ $ 2,574 ​ $ 2,305 ​ ​ ​ 6. Expenses Accrued expenses and other current liabilities consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ 2024 2023 Accrued rebates and programs ​ $ 5,487 ​ $ 5,117 Accrued payroll and related expenses ​ ​ 5,367 ​ ​ 8,156 Accrued professional fees ​ 1,887 ​ 691 Accrued other ​ 1,576 ​ 1,525 Accrued interest payable on Barings Credit Facility (Note 7) ​ ​ 885 ​ ​ 803 Accrued research and development expenses ​ 838 ​ 1,488 Accrued interest payable on Convertible Notes (Note 7) ​ — ​ 10,886 ​ ​ $ 16,040 ​ $ 28,666 ​ ​ 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 11 Table of Contents 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. In the event the Company completes a change of control transaction or a sale of all or substantially all of its assets on or prior to the twelve-month anniversary of the Closing Date, the Barings Royalty Fee is subject to a reduction to an amount that is equal to 30 % of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such transaction was entered into by the Company after the date that is six months, but before the date that is twelve months, after the Closing Date. 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 negative covenants restricting the Company from making payments to the holders of the Convertible Notes, except in connection with a proposed conversion to equity and with respect to certain permitted expenses and requiring the Company to maintain a minimum liquidity amount of $ 20,000 . The Barings Credit Agreement also includes customary affirmative and negative covenants. 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). A summary of the Barings Credit Facility at March 31, 2024 and December 31, 2023 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ 2024 2023 Barings Credit Facility ​ $ 82,474 ​ ​ 82,474 Less: unamortized discount ​ ​ ( 16,018 ) ​ ​ ( 16,687 ) Total ​ $ 66,456 ​ ​ 65,787 ​ As of March 31, 2024, 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, 2023, filed with the SEC on March 11, 2024. The Company determined that the embedded conversion option was required to be separated from the Convertible Notes and 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 (Note 10) 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 12 Table of Contents net loss of $ 27,950 , which was charged to losses on extinguishment of debt on the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024. MidCap Credit Agreement The Company entered into a credit and security agreement in 2014 (as amended, the “MidCap Credit Agreement”) establishing a credit facility (the “MidCap Credit Facility”). The terms and conditions of the MidCap Credit Agreement and the MidCap Credit Facility are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. In connection with entering into the Barings Credit Facility, in August 2023 the Company paid MidCap Financial Trust, as administrative agent, and its other lenders an aggregate of $ 26,157 in satisfaction of the Company’s obligations under the MidCap Credit Facility. In connection with its satisfaction of its obligations, the Company extinguished the MidCap Credit Facility, and all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released. On March 12, 2023, the Company requested, and received, a protective advance of $ 2,000 under the MidCap Credit Agreement as a short-term bridge loan in response to the closure of Silicon Valley Bank by the California Department of Financial Protection and Innovation. This protective advance was deemed a credit extension. The Company repaid the full principal amount of $ 2,000 in March 2023. ​ ​ ​ 13 Table of Contents 8. Derivative Liability Barings Credit Agreement The Barings Credit Agreement (Note 7) contains an embedded Royalty Fee Obligation that 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 Royalty Fee Obligation and then valuing the instrument without the embedded 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: ​ ​ ​ ​ ​ ​ ​ As of Balance at December 31, 2023 ​ $ 12,389 Change in fair value ​ ​ 7,235 Balance at March 31, 2024 ​ $ 19,624 ​ Convertible Notes The Convertible Notes (Note 7), which were extinguished in March 2024, contained the Conversion Option Derivative Liability, an embedded conversion option that meets 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 involves 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 is the fair value of the derivative, recorded as the Conversion Option Derivative Liability. Refer to Note 9 for details regarding the determination of fair value. A roll-forward of the Conversion Option Derivative Liability is as follows: ​ ​ ​ ​ ​ ​ ​ As of Balance at December 31, 2023 ​ $ 17,598 Change in fair value ​ ​ ( 2,598 ) Balance at March 28, 2024 ​ ​ 15,000 Extinguishment in connection with Conversion ​ ​ ( 15,000 ) Balance at March 31, 2024 ​ $ — ​ ​ ​ ​ ​ ​ 14 Table of Contents 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 two 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the ​ For the ​ ​ ​ Three Months Ended ​ Three Months Ended ​ ​ ​ March 31, ​ March 31, ​ ​ ​ 2024 ​ 2023 ​ Customer 1 ​ ​ 51 % ​ 52 % Customer 2 ​ ​ 20 ​ ​ 25 ​ Customer 3 ​ ​ 13 ​ ​ 13 ​ ​ Three specialty distributor customers accounted for the following percentages of the Company’s accounts receivable, net: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ ​ March 31, ​ ​ December 31, ​ ​ 2024 ​ ​ 2023 Customer 1 ​ ​ 51 % ​ 50 % Customer 2 ​ ​ 24 ​ ​ 28 ​ Customer 3 ​ ​ 13 ​ ​ 11 ​ ​ 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the ​ For the ​ ​ ​ Three Months Ended ​ Three Months Ended ​ ​ ​ March 31, ​ March 31, ​ ​ ​ 2024 ​ 2023 Change in the fair value of the Conversion Option Derivative Liability ​ $ 2,598 ​ $ ( 6,563 ) ​ Change in the fair value of Royalty Fee Derivative Liability ​ ​ ( 7,235 ) ​ ​ — ​ Barings Royalty Fee ​ ​ ( 515 ) ​ ​ — ​ Total ​ $ ( 5,152 ) ​ $ ( 6,563 ) ​ 15 Table of Contents ​ 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, 2024 and December 31, 2023 and indicate the level of the fair value hierarchy utilized to determine such fair value: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements as of ​ ​ March 31, 2024 Using: ​ Level 1 Level 2 Level 3 Total Assets: ​ ​ ​ ​ Cash equivalents: ​ ​ ​ ​ Money market funds ​ $ 475,764 ​ $ — ​ $ — ​ $ 475,764 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Liability: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Derivative liability ​ $ — ​ $ — ​ $ 19,624 ​ $ 19,624 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements as of ​ ​ December 31, 2023 Using: ​ Level 1 Level 2 Level 3 Total Assets: ​ ​ ​ ​ Cash equivalents: ​ ​ ​ ​ Money market funds ​ $ 187,951 ​ $ — ​ $ — ​ $ 187,951 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Liability: ​ ​ ​ ​ Derivative liabilities ​ $ — ​ $ — ​ $ 29,987 ​ $ 29,987 ​ ​ Barings Credit Agreement and Royalty Fee Derivative Liability At March 31, 2024, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $ 67,341 , comprised of the $ 66,456 non-current liability (Note 7) and $ 885 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $ 75,929 at March 31, 2024. At December 31, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $ 66,590 comprised of the $ 65,787 non-current liability (Note 7) and $ 803 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $ 72,295 at December 31, 2023. 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. ​ ​ ​ ​ 16 Table of Contents The main inputs to valuing the Royalty Fee Derivative Liability are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ ​ March 31, ​ December 31, ​ ​ ​ 2024 ​ 2023 ​ Revenue volatility ​ ​ 70.0 % ​ 67.0 % Revenue discount rate ​ ​ 16.1 % ​ 15.8 % ​ Convertible Notes and Conversion Option Derivative Liability At December 31, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $ 20,024 , comprised of the $ 9,138 non-current liability (Note 7) and $ 10,886 accrued interest (Note 6). The fair value of the Convertible Notes with and without the conversion option as of December 31, 2023 was estimated using a binomial lattice approach. The use of this approach required the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes was the bond yield that pertained to the host instrument without the conversion option. The significant assumption used in determining the bond yield was the market yield movements of a comparable instrument issued as of the valuation date, which was assessed and updated each period. The main input when determining the fair value for disclosure purposes was the bond yield which was updated each period to reflect the yield of a comparable instrument issued as of the valuation date. The fair value of the Conversion Option Derivative Liability immediately before the Conversion was determined based on the intrinsic value of the separated conversion option. ​ ​ 10. Equity On February 21, 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. On March 28, 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 . On August 9, 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. The Company did no t offer or sell shares of its common stock under the 2021 Sales Agreement during the three months ended March 31, 2024 and 2023, respectively. 17 Table of Contents ​ 11. Stock-Based Awards For the three months ended March 31, 2024, 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 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, 2023, filed with the SEC on March 11, 2024. On February 20, 2024, the Company’s board of directors amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 1,054,000 to 3,804,000 shares of common stock. On January 1, 2024, the number of shares available for issuance under the ESPP increased from 398,784 to 606,186 . During the three months ended March 31, 2024, the Company granted options to purchase 5,817,746 shares of common stock at a weighted exercise price of $ 7.29 per share. Of these, options to purchase 4,290,727 shares of common stock were granted under the 2021 Plan, and options to purchase 1,527,019 shares of common stock were granted under the 2019 Inducement Plan. During the three months ended March 31, 2024, the Company granted 2,278,416 restricted stock units (“RSUs”). Of these, 1,343,137 RSUs were granted under the 2021 Plan, and 935,279 RSUs were granted under the 2019 Inducement Plan. Each RSU is settleable for one share of common stock upon vesting. During the three months ended March 31, 2024, 308,681 stock options and 119,604 RSUs expired or were forfeited. As of March 31, 2024, 994,099 , 819,077 , and 606,186 shares of common stock remained available for issuance under the 2021 Plan, the 2019 Inducement Plan, and the ESPP, respectively. The Company recorded stock-based compensation expense related to stock options and RSUs in the following expense categories of its unaudited condensed consolidated statements of operations and comprehensive loss: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ 2024 2023 Research and development ​ $ 1,453 ​ $ 1,141 ​ Selling and marketing ​ 837 ​ 1,043 ​ General and administrative ​ 5,688 ​ 2,388 ​ ​ ​ $ 7,978 ​ $ 4,572 ​ ​ As of March 31, 2024, the Company had an aggregate of $ 52,872 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 3.1 years. ​ 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, 2024 and 2023, respectively. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at March 31, 2024 and December 31, 2023, 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. ​ 18 Table of Contents 13. Net Loss Per Share Basic net loss per share was calculated as follows for the three months ended March 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2024 2023 Numerator: ​ ​ Net loss attributable to common stockholders ​ $ ( 64,848 ) ​ $ ( 30,318 ) Denominator: ​ ​ Weighted average common shares outstanding, basic ​ 132,021,945 ​ 77,386,287 Net loss per share - basic ​ $ ( 0.49 ) ​ $ ( 0.39 ) ​ For the three months ended March 31, 2024 and 2023, 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, 2024, 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, 2024 and 2023, respectively, from the computation of diluted net loss per share for the three months ended March 31, 2024 and 2023, respectively, because they had an anti-dilutive impact. ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2024 2023 Options to purchase common stock 20,660,472 ​ 16,546,260 Restricted stock units 3,253,436 ​ 1,708,741 Shares issuable in connection with conversion of Convertible Notes, if converted — ​ 5,769,232 ​ 23,913,908 ​ 24,024,233 ​ ​ ​ 14. 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. ​ 15. Related Party Transactions 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. The Company incurred fees for legal services rendered by WilmerHale of approximately $ 1,080 and $ 394 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, there was $ 0 and $ 298 recorded in accounts payable for WilmerHale. As of March 31, 2024 and December 31, 2023, there was $ 1,014 and $ 0 recorded in accrued expenses for WilmerHale. The Company has engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Jeffrey Heier, M.D. a former member of the Company’s Board of Directors and the Company’s current Chief Scientific Officer, 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. 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 on a part-time basis, working 50% of a full-time schedule. In connection with 19 Table of Contents 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 and $ 2 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, there was $ 0 and $ 6 recorded in accounts payable for Heier Consulting. As of March 31, 2024 and December 31, 2023, there was $ 5 and $ 0 recorded in accrued expenses for Heier Consulting. ​ 16. Subsequent Events On April 16, 2024, the board of directors of the Company amended the Company’s 2019 Inducement Plan, as amended, to increase the aggregate number of shares issuable thereunder from 3,804,000 to 4,804,000 shares of common stock. On May 1, 2024 the Company executed a separation and release of claims agreement (the “Separation Agreement”) with Antony Mattessich, who served as the Company’s President and Chief Executive Officer until April 14, 2024. In accordance with the terms of his employment agreement and subject to the Separation Agreement becoming effective, Mr. Mattessich is entitled to receive, among other consideration, (i) twenty-four ( 24 ) months of pay at his most recent base salary rate; (ii) the acceleration of any equity awards (including for any stock options and restricted stock units) held by him that vest solely based on his continued performance of services to the Company, so such equity awards become vested, exercisable and nonforfeitable with respect to the portion of such equity awards that would otherwise have vested, become exercisable or become nonforfeitable as of May 2, 2026; and (iii) a period of 24 months to exercise stock option awards, subject to the terms of the stock incentive plans under which such options have been granted and the final exercise dates under the stock option agreements evidencing the grant of such stock options. The Company cannot make an estimate of the impact of the Separation Agreement on its consolidated financial statements at this time. ​ ​ 20 Table of Contents ​