Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36554 | |
Entity Registrant Name | Ocular Therapeutix, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-5560161 | |
Entity Address, Address Line One | 24 Crosby Drive | |
Entity Address, City or Town | Bedford | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01730 | |
City Area Code | 781 | |
Local Phone Number | 357-4000 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | OCUL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 79,418,626 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001393434 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 110,550 | $ 102,300 |
Accounts receivable, net | 23,589 | 21,325 |
Inventory | 2,257 | 1,974 |
Prepaid expenses and other current assets | 4,862 | 4,028 |
Total current assets | 141,258 | 129,627 |
Property and equipment, net | 12,494 | 9,856 |
Restricted cash | 1,764 | 1,764 |
Operating lease assets | 6,868 | 8,042 |
Total assets | 162,384 | 149,289 |
Current liabilities: | ||
Accounts payable | 3,984 | 5,123 |
Accrued expenses and other current liabilities | 28,887 | 24,097 |
Deferred revenue | 317 | 576 |
Operating lease liabilities | 1,878 | 1,599 |
Total current liabilities | 35,066 | 31,395 |
Other liabilities: | ||
Operating lease liabilities, net of current portion | 7,251 | 8,678 |
Derivative liabilities | 24,022 | 6,351 |
Deferred revenue, net of current portion | 14,197 | 13,387 |
Notes payable, net | 65,124 | 25,257 |
Other non-current liabilities | 106 | 93 |
Convertible Notes, net | 8,765 | 28,749 |
Total liabilities | 154,531 | 113,910 |
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 September 30, 2023 and December 31, 2022, respectively | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized and 79,412,114 and 77,201,819 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 8 | 8 |
Additional paid-in capital | 676,203 | 652,213 |
Accumulated deficit | (668,358) | (616,842) |
Total stockholders' equity | 7,853 | 35,379 |
Total liabilities and stockholders' equity | $ 162,384 | $ 149,289 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 79,412,114 | 77,201,819 |
Common stock, shares outstanding | 79,412,114 | 77,201,819 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Total revenue, net | $ 15,081 | $ 11,965 | $ 43,642 | $ 37,419 |
Costs and operating expenses: | ||||
Cost, Product and Service [Extensible List] | Product revenue, net | Product revenue, net | Product revenue, net | Product revenue, net |
Cost of product revenue | $ 1,377 | $ 1,073 | $ 3,895 | $ 3,528 |
Research and development | 15,019 | 13,719 | 44,860 | 39,919 |
Selling and marketing | 9,315 | 10,186 | 31,304 | 29,390 |
General and administrative | 8,584 | 8,531 | 25,915 | 23,875 |
Total costs and operating expenses | 34,295 | 33,509 | 105,974 | 96,712 |
Loss from operations | (19,214) | (21,544) | (62,332) | (59,293) |
Other income (expense): | ||||
Interest income | 1,212 | 285 | 2,524 | 375 |
Interest expense | (3,426) | (1,797) | (7,187) | (5,175) |
Change in fair value of derivative liabilities | 6,722 | (1,133) | 1,290 | 8,598 |
Gains and losses on extinguishment of debt, net | 14,190 | 14,190 | ||
Other income (expense), net | 1 | (1) | (1) | |
Total other income (expense), net | 18,698 | (2,644) | 10,816 | 3,797 |
Net loss | $ (516) | $ (24,188) | $ (51,516) | $ (55,496) |
Net loss per share, basic | $ (0.01) | $ (0.31) | $ (0.66) | $ (0.72) |
Weighted average common shares outstanding, basic | 79,373,272 | 76,975,839 | 78,276,341 | 76,829,434 |
Net loss per share, diluted | $ (0.25) | $ (0.31) | $ (0.77) | $ (0.73) |
Weighted average common shares outstanding, diluted | 85,142,504 | 76,975,839 | 84,045,573 | 82,598,666 |
Product revenue, net | ||||
Revenue: | ||||
Total revenue, net | $ 14,950 | $ 11,913 | $ 43,193 | $ 36,555 |
Collaboration revenue | ||||
Revenue: | ||||
Total revenue, net | $ 131 | $ 52 | $ 449 | $ 864 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (51,516) | $ (55,496) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 13,497 | 12,730 |
Non-cash interest expense | 4,553 | 3,616 |
Change in fair value of derivative liabilities | (1,290) | (8,598) |
Depreciation and amortization expense | 2,025 | 1,618 |
Gains and losses on extinguishment of debt, net | (14,190) | |
Gain (loss) on disposal of property and equipment | (1) | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,264) | 1,333 |
Prepaid expenses and other current assets | (834) | 1,433 |
Inventory | (283) | (295) |
Accounts payable | (73) | 501 |
Operating lease assets and liabilities | 26 | (331) |
Accrued expenses | 2,019 | (293) |
Deferred revenue | 551 | 1,136 |
Net cash used in operating activities | (47,780) | (42,645) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (5,628) | (1,565) |
Net cash used in investing activities | (5,628) | (1,565) |
Cash flows from financing activities: | ||
Proceeds from issuance of short-term bridge loan | 2,000 | |
Proceeds from issuance of Barings notes payable | 82,474 | |
Proceeds from exercise of stock options | 543 | 514 |
Proceeds from issuance of common stock pursuant to employee stock purchase plan | 418 | 482 |
Payments of debt refinancing costs | (5,184) | |
Proceeds from issuance of common stock upon public offering, net of issuance costs | 9,532 | |
Repayment of short-term bridge loan | (2,000) | |
Repayment of MidCap notes payable | (26,125) | |
Net cash provided by financing activities | 61,658 | 996 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 8,250 | (43,214) |
Cash, cash equivalents and restricted cash at beginning of period | 104,064 | 165,928 |
Cash, cash equivalents and restricted cash at end of period | 112,314 | 122,714 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 2,865 | 1,521 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable and accrued expenses | $ 267 | $ 477 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 8 | $ 633,795 | $ (545,804) | $ 87,999 |
Balance, shares at Dec. 31, 2021 | 76,731,940 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 129 | 129 | ||
Issuance of common stock upon exercise of stock options, shares | 27,674 | |||
Stock-based compensation expense | 4,209 | 4,209 | ||
Net loss | (12,542) | (12,542) | ||
Balance at Mar. 31, 2022 | $ 8 | 638,133 | (558,346) | 79,795 |
Balance, shares at Mar. 31, 2022 | 76,759,614 | |||
Balance at Dec. 31, 2021 | $ 8 | 633,795 | (545,804) | 87,999 |
Balance, shares at Dec. 31, 2021 | 76,731,940 | |||
Stockholders' Equity (Deficit) | ||||
Net loss | (55,496) | |||
Balance at Sep. 30, 2022 | $ 8 | 647,521 | (601,300) | 46,229 |
Balance, shares at Sep. 30, 2022 | 77,010,385 | |||
Balance at Mar. 31, 2022 | $ 8 | 638,133 | (558,346) | 79,795 |
Balance, shares at Mar. 31, 2022 | 76,759,614 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 11 | 11 | ||
Issuance of common stock upon exercise of stock options, shares | 9,469 | |||
Issuance of common stock in connection with employee stock purchase plan | 482 | 482 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 140,943 | |||
Stock-based compensation expense | 4,281 | 4,281 | ||
Net loss | (18,766) | (18,766) | ||
Balance at Jun. 30, 2022 | $ 8 | 642,907 | (577,112) | 65,803 |
Balance, shares at Jun. 30, 2022 | 76,910,026 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 374 | 374 | ||
Issuance of common stock upon exercise of stock options, shares | 100,359 | |||
Stock-based compensation expense | 4,240 | 4,240 | ||
Net loss | (24,188) | (24,188) | ||
Balance at Sep. 30, 2022 | $ 8 | 647,521 | (601,300) | 46,229 |
Balance, shares at Sep. 30, 2022 | 77,010,385 | |||
Balance at Dec. 31, 2022 | $ 8 | 652,213 | (616,842) | 35,379 |
Balance, shares at Dec. 31, 2022 | 77,201,819 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 78 | 78 | ||
Issuance of common stock upon exercise of stock options, shares | 26,443 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 288,376 | |||
Stock-based compensation expense | 4,572 | 4,572 | ||
Net loss | (30,318) | (30,318) | ||
Balance at Mar. 31, 2023 | $ 8 | 656,863 | (647,160) | 9,711 |
Balance, shares at Mar. 31, 2023 | 77,516,638 | |||
Balance at Dec. 31, 2022 | $ 8 | 652,213 | (616,842) | 35,379 |
Balance, shares at Dec. 31, 2022 | 77,201,819 | |||
Stockholders' Equity (Deficit) | ||||
Net loss | (51,516) | |||
Balance at Sep. 30, 2023 | $ 8 | 676,203 | (668,358) | 7,853 |
Balance, shares at Sep. 30, 2023 | 79,412,114 | |||
Balance at Mar. 31, 2023 | $ 8 | 656,863 | (647,160) | 9,711 |
Balance, shares at Mar. 31, 2023 | 77,516,638 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 403 | 403 | ||
Issuance of common stock upon exercise of stock options, shares | 97,435 | |||
Issuance of common stock in connection with employee stock purchase plan | 418 | 418 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 176,406 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 73,117 | |||
Issuance of common stock upon public offering, net of issuance costs | 8,824 | 8,824 | ||
Issuance of common stock upon public offering, net of issuance costs, shares | 1,370,208 | |||
Stock-based compensation expense | 4,413 | 4,413 | ||
Net loss | (20,682) | (20,682) | ||
Balance at Jun. 30, 2023 | $ 8 | 670,921 | (667,842) | 3,087 |
Balance, shares at Jun. 30, 2023 | 79,233,804 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 62 | 62 | ||
Issuance of common stock upon exercise of stock options, shares | 16,216 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 17,376 | |||
Issuance of common stock upon public offering, net of issuance costs | 708 | 708 | ||
Issuance of common stock upon public offering, net of issuance costs, shares | 144,718 | |||
Stock-based compensation expense | 4,512 | 4,512 | ||
Net loss | (516) | (516) | ||
Balance at Sep. 30, 2023 | $ 8 | $ 676,203 | $ (668,358) | $ 7,853 |
Balance, shares at Sep. 30, 2023 | 79,412,114 |
Nature of the Business
Nature of the Business | 9 Months Ended |
Sep. 30, 2023 | |
Nature of the Business | |
Nature of the Business | 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 focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology ELUTYX. The Company’s mission is to build an ophthalmology-focused biopharmaceutical company that capitalizes on the gaps that the Company believes increasingly exist in the ophthalmology sector between single-product companies and large, multi-product pharmaceutical companies. 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. Recently approved products will require significant sales, marketing and distribution support up to and including upon their launch. 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. 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; the Company’s other advanced 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 September 30, 2023, the Company had an accumulated deficit of $668,358. As of September 30, 2023, the Company had existing cash and cash equivalents of $110,550. Based on the Company’s 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 as of September 30, 2023 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 beyond that point is dependent on the Company’s ability to generate cash flows from the sale of DEXTENZA 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 6, 2023. 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, 2022 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 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, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. 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 September 30, 2023 and results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022 have been made. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board and adopted by us 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. |
Licensing Agreements and Deferr
Licensing Agreements and Deferred Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Licensing Agreements and Deferred Revenue | |
Licensing Agreements and Deferred Revenue | 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”). Under the Incept License, 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 are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $451 and $1,264 for the three and nine months ended September 30, 2023, respectively, and $0 and $744 for the three and nine months ended September 30, 2022, 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 (“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 OTX-TIC 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 License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. In June 2023, the Company received a milestone payment of $1,000 from AffaMed in connection with AffaMed receiving approval of its Clinical Trial Application to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery by China’s National Medical Products Administration. The Company has allocated the amount to the performance obligation regarding the license, regulatory filings and manufacturing of DEXTENZA as an addition to deferred revenue. In March 2022, the Company invoiced AffaMed $2,000 for a clinical trial support payment in connection with the initiation by the Company of the OTX-TIC Phase 2 clinical trial and allocated the amount to the performance obligation regarding the conduct of a Phase 2 clinical trial of OTX-TIC (the “Phase 2 Clinical Trial of OTX-TIC performance obligation”) as an addition to deferred revenue. Payment was received by the Company during the three months ended June 30, 2022. The Company recognized collaboration revenue related to the Phase 2 Clinical Trial of OTX-TIC performance obligation of $131 and $449 for the three and nine months ended September 30, 2023, respectively, and $52 and $864 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of OTX-TIC performance obligation was $514. This amount is expected to be recognized as this performance obligation is satisfied through June 2025. Deferred revenue activity for the three and nine months ended September 30, 2023 was as follows: Deferred Revenue Deferred revenue at December 31, 2022 $ 13,963 Additions 1,000 Amounts recognized into revenue (449) Deferred revenue at September 30, 2023 $ 14,514 |
Cash Equivalents and Restricted
Cash Equivalents and Restricted Cash | 9 Months Ended |
Sep. 30, 2023 | |
Cash Equivalents and Restricted Cash | |
Cash Equivalents and Restricted Cash | 4. Cash Equivalents and Restricted Cash As of September 30, 2023 and December 31, 2022, the Company held restricted cash of $1,764, respectively, on its unaudited condensed consolidated balance sheets. The Company held restricted cash as security deposits for its real estate leases. 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: September 30, September 30, 2023 2022 Cash and cash equivalents $ 110,550 $ 120,950 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 112,314 $ 122,714 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory | |
Inventory | 5. Inventory Inventory consisted of the following: September 30, December 31, 2023 2022 Raw materials $ 293 $ 309 Work-in-process 947 899 Finished goods 1,017 766 $ 2,257 $ 1,974 |
Expenses
Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Expenses | |
Expenses | 6. Expenses Accrued expenses and other current liabilities consisted of the following: September 30, December 31, 2023 2022 Accrued payroll and related expenses $ 7,862 $ 7,509 Accrued rebates and programs 4,679 3,560 Accrued professional fees 1,347 1,228 Accrued research and development expenses 2,285 1,816 Accrued interest payable on Convertible Notes 10,319 8,756 Accrued interest payable on Barings Note 858 — Accrued other 1,537 1,228 $ 28,887 $ 24,097 |
Financial Liabilities
Financial Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Financial Liabilities | |
Financial Liabilities | 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 $77,790, 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 at a SOFR-based rate, 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. In the event the Company completes a change of control transaction 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 (i) of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such change of control 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 The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “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. For the three and nine months ended September 30, 2023, Barings Royalty Fees were $388 and $388, respectively. A summary of the Barings Credit Facility at September 30, 2023 is as follows: September 30, 2023 Barings Credit Facility $ 82,474 Less: unamortized discount (17,350) Total $ 65,124 As of September 30, 2023, 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 accrue interest at an annual rate of 6% of their outstanding principal amount which is payable, along with the principal amount, at maturity (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, 2022, filed with the SEC on March 6, 2023, except with respect to the amendment as described below. Concurrently with entering into the Barings Credit Agreement, on August 2, 2023, the Company and the holders of the Convertible Notes extended the maturity of the Convertible Notes, which would otherwise have matured on March 1, 2026, to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, unless earlier converted, repurchased or redeemed (the “Amendment”). The Company accounted for the Amendment as an extinguishment of debt in accordance with the guidance in Accounting Standards Codification Topic 470-50 Debt cash upon conversion. The allocation of a portion of the total fair value of the Convertible Notes to the Conversion Option Derivative Liability results in a discount on the Convertible Notes. Application of ASC 470-50 resulted in a gain on extinguishment of $14,907, which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the quarter ended September 30, 2023. The Company presents accrued interest after the Amendment in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets because the Convertible Notes are currently convertible, and the interest is payable in cash. The Company is amortizing the discount to interest expense over the term of the Convertible Notes using the effective interest method. The effective annual interest rate for the Convertible Notes was 19.4% as of September 30, 2023. A summary of the Convertible Notes at September 30, 2023 and December 31, 2022 is as follows: Convertible Notes September 30, December 31, 2023 2022 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount and current portion (28,735) (8,751) Total $ 8,765 $ 28,749 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, 2022, filed with the SEC on March 6, 2023, except with respect to Amendments No. 1 and 2 to the MidCap Credit Agreement as described in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 7, 2023. Under the MidCap Credit Facility, the Company had a total borrowing capacity of $25,000, which was fully drawn down as of June 30, 2023. In August 2023, in connection with the Company’s establishment of the Barings Credit Facility, the Company paid an aggregate of $26,157 to MidCap Financial Trust and the other lenders party to the MidCap Credit Agreement, comprised of $25,017 in principal and interest accrued thereunder and $1,140 in exit and prepayment fees, in satisfaction of the Company’s obligations under the MidCap Credit Agreement. In connection with the payment, all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released. The extinguishment of the MidCap Credit Facility has resulted in a loss of $717, which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the quarter ended September 30, 2023. 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. |
Derivative Liability
Derivative Liability | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Liability | |
Derivative Liability | 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 Barings Credit Facility 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 Barings Credit Facility 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. Convertible Notes The Convertible Notes (Note 7) contain 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 is subsequently remeasured to fair value at each reporting period. The Convertible Notes were initially valued and are 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 Convertible Notes 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. |
Risks and Fair Value
Risks and Fair Value | 9 Months Ended |
Sep. 30, 2023 | |
Risks and Fair Value | |
Risks and Fair Value | 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. For the three and nine months ended September 30, 2023, three specialty distributor customers accounted for 47%, 24% and 12%, and 51%, 23%, and 11%, respectively, of the Company’s gross product revenue, and at September 30, 2023, three specialty distributor customers accounted for 51%, 26%, and 11% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total revenue for the three and nine months ended September 30, 2023, or accounts receivable at September 30, 2023. For the three and nine months ended September 30, 2022, three specialty distributor customers accounted for 42%, 30%, and 14%, and 41%, 27% and 18%, respectively, of the Company’s gross product revenue. At December 31, 2022, three specialty distributor customers accounted for 52%, 24%, and 15% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total revenue for the three and nine months ended September 30, 2022, or accounts receivable at December 31, 2022. 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 Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Change in the fair value of the Conversion Option Derivative Liability $ 7,144 $ (1,133) $ 1,712 $ 8,598 Change in the fair value of Royalty Fee Derivative Liability (34) — (34) — Barings Royalty Fees (Note 7) (388) — (388) — $ 6,722 $ (1,133) $ 1,290 $ 8,598 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 September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of September 30, 2023 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 101,480 $ — $ — $ 101,480 Liability: Derivative liabilities $ — $ — $ 24,022 $ 24,022 Fair Value Measurements as of December 31, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 30,188 $ — $ — $ 30,188 Liability: Derivative liabilities $ — $ — $ 6,351 $ 6,351 At September 30, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $65,982 comprised of the $65,124 non-current liability (Note 7) and $858 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $69,159 at September 30, 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. The main inputs to valuing the Royalty Fee Derivative Liability are as follows: As of September 30, 2023 Revenue volatility 60.0 % Revenue discount rate 16.4 % The main inputs to valuing the Royalty Fee Derivative Liability as of the Closing Date were revenue volatility of 61.0% and a revenue discount rate of 15.8%. A roll-forward of the Royalty Fee Derivative Liability is as follows: As of Balance at August 2, 2023 $ 12,604 Change in fair value 34 Balance at September 30, 2023 $ 12,638 At September 30, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $19,084, comprised of the $8,765 non-current liability (Note 7) and $10,319 accrued interest (Note 6). At December 31, 2022, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $37,505, comprised of the $28,749 non-current liability (Note 7) and $8,756 accrued interest (Note 6). The estimated fair value of the Convertible Notes, without the Conversion Option Derivative Liability, was $19,357 and $33,177 at September 30, 2023 and December 31, 2022, respectively. The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The use of this approach requires the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. The main input when determining the fair value for disclosure purposes is the bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. To determine the gain on extinguishment related to the Amendment of the Convertible Notes as of August 2, 2023 (Note 7), the Company has determined the fair value of the Convertible Notes with and without the conversion option immediately before and immediately after the Amendment based on the same approach. 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. The main inputs to valuing the Convertible Notes with the conversion option on a recurring basis are as follows: As of September 30, December 31, 2023 2022 Company's stock price $ 3.14 $ 2.81 Volatility 76.3 % 93.8 % Bond yield 22.7 % 16.2 % The main inputs to valuing the Convertible Notes with the conversion option immediately before the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 78.5%, and a bond yield of 22.6%. The main inputs to valuing the Convertible Notes with the conversion option immediately after the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 77.8%, and a bond yield of 22.9%. A roll-forward of the Conversion Option Derivative Liability, including the impact from accounting for the Convertible Notes Amendment, is as follows: As of Balance at December 31, 2022 $ 6,351 Change in fair value 5,432 Balance at June 30, 2023 11,783 Change in fair value (827) Balance at August 2, 2023 before the Convertible Notes Amendment 10,956 Change in fair value from Convertible Notes Amendment 6,745 Balance at August 2, 2023 after the Convertible Notes Amendment 17,701 Change in fair value (6,317) Balance at September 30, 2023 $ 11,384 |
Equity
Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity | |
Equity | 10. Equity 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. During the three and nine months ended September 30, 2023, the Company sold |
Stock-Based Awards
Stock-Based Awards | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Awards | |
Stock-Based Awards | 11. Stock-Based Awards For the three and nine months ended September 30, 2023, 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, 2022, filed with the SEC on March 6, 2023. During the three and nine months ended September 30, 2023, the Company granted options to purchase 190,250 and 3,430,991 shares of common stock, respectively at a weighted exercise price of $4.50 and $4.04 per share, respectively, all under the 2021 Plan. During the three and nine months ended September 30, 2023, the Company granted 47,800 and 1,078,631 restricted stock units, or RSUs, respectively, all under the 2021 Plan. Each RSU is equivalent to one share of common stock upon vesting. During the three and nine months ended September 30, 2023, a total of 232,939 and 793,146, respectively, stock options and RSUs expired or were forfeited. At the Company’s Annual Meeting of Stockholders held on June 14, 2023, the Company’s stockholders approved an amendment of the Company’s 2021 Plan which increased the number of shares of common stock of the Company issuable under the 2021 Plan by 3,900,000 shares. As of September 30, 2023, 6,046,323, 545,750, and 513,069 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 Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Research and development $ 1,115 $ 1,060 $ 3,390 $ 3,157 Selling and marketing 934 1,169 2,948 3,499 General and administrative 2,463 2,011 7,159 6,074 $ 4,512 $ 4,240 $ 13,497 $ 12,730 As of September 30, 2023, the Company had an aggregate of $20,573 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.14 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | 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 and nine months ended September 30, 2023 and 2022, respectively. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at September 30, 2023 and December 31, 2022, 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. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 13. Net Loss Per Share Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders $ (516) $ (24,188) $ (51,516) $ (55,496) Denominator: Weighted average common shares outstanding, basic 79,373,272 76,975,839 78,276,341 76,829,434 Net loss per share - basic $ (0.01) $ (0.31) $ (0.66) $ (0.72) Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2023 2022 Net loss attributable to common stockholders, basic $ (516) $ (51,516) $ (55,496) Interest expense on Convertible Notes 1,004 3,232 3,425 Change in fair value of derivative liability and gains on extinguishment of debt (22,051) (16,619) (8,598) Net loss attributable to common stockholders, diluted $ (21,563) $ (64,903) $ (60,669) Weighted average common shares outstanding, basic 79,373,272 78,276,341 76,829,434 Shares issuable upon conversion of Convertible Notes, as if converted 5,769,232 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 85,142,504 84,045,573 82,598,666 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.77) $ (0.73) For the three months ended September 30, 2022 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. The Company excluded the following potentially issuable common shares, outstanding as of September 30, 2023 and 2022, from the computation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022 because they had an anti-dilutive impact. Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Options to purchase common stock 16,306,543 13,795,937 16,306,543 13,795,937 Restricted stock units 1,653,363 1,050,339 1,653,363 1,050,339 Shares issuable upon conversion of Convertible Notes, if converted — — — — 17,959,906 14,846,276 17,959,906 14,846,276 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 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. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions | |
Related Party Transactions | 15. Related Party Transactions The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company. The Company's Chief Business Officer’s sister is a managing 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 $323 and $956 for the three and nine months ended September 30, 2023, respectively, and approximately $342 and $876 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023 and December 31, 2022, there was $135 and $0 recorded in accounts payable for WilmerHale. As of September 30, 2023 and December 31, 2022, there was $0 and $24 recorded in accrued expenses for WilmerHale. The Company has engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Dr. Jeffrey Heier, a member of the Company’s Board of Directors, 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. Compensation for these services is in the form of cash and stock-based awards. The total grant date fair value of stock-based awards granted to Heier Consulting is $96, which is 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 $13 and $18 for the three and nine months ended September 30, 2023, respectively, and approximately $21 and $21 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023 and December 31, 2022, there was $7 and $3 recorded in accounts payable for Heier Consulting. As of September 30, 2023 and December 31, 2022, there was $0 and $0 recorded in accrued expenses for Heier Consulting. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 6, 2023. |
Use of Estimates | 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 | Unaudited Interim Financial Information The balance sheet at December 31, 2022 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 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, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. 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 September 30, 2023 and results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022 have been made. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board and adopted by us 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. |
Licensing Agreements and Defe_2
Licensing Agreements and Deferred Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Licensing Agreements and Deferred Revenue | |
Schedule of deferred revenue | Deferred Revenue Deferred revenue at December 31, 2022 $ 13,963 Additions 1,000 Amounts recognized into revenue (449) Deferred revenue at September 30, 2023 $ 14,514 |
Cash Equivalents and Restrict_2
Cash Equivalents and Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Cash Equivalents and Restricted Cash | |
Reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet to the total amounts shown in the statement of cash flows | September 30, September 30, 2023 2022 Cash and cash equivalents $ 110,550 $ 120,950 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 112,314 $ 122,714 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory | |
Components of inventory | September 30, December 31, 2023 2022 Raw materials $ 293 $ 309 Work-in-process 947 899 Finished goods 1,017 766 $ 2,257 $ 1,974 |
Expenses (Tables)
Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Expenses | |
Schedule of accrued expenses | September 30, December 31, 2023 2022 Accrued payroll and related expenses $ 7,862 $ 7,509 Accrued rebates and programs 4,679 3,560 Accrued professional fees 1,347 1,228 Accrued research and development expenses 2,285 1,816 Accrued interest payable on Convertible Notes 10,319 8,756 Accrued interest payable on Barings Note 858 — Accrued other 1,537 1,228 $ 28,887 $ 24,097 |
Financial Liabilities (Tables)
Financial Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Notes | |
Debt Instrument [Line Items] | |
Summary of debt | A summary of the Convertible Notes at September 30, 2023 and December 31, 2022 is as follows: Convertible Notes September 30, December 31, 2023 2022 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount and current portion (28,735) (8,751) Total $ 8,765 $ 28,749 |
Barings Credit Facility | |
Debt Instrument [Line Items] | |
Summary of debt | A summary of the Barings Credit Facility at September 30, 2023 is as follows: September 30, 2023 Barings Credit Facility $ 82,474 Less: unamortized discount (17,350) Total $ 65,124 |
Risks and Fair Value (Tables)
Risks and Fair Value (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of change in fair value of derivative liabilities | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Change in the fair value of the Conversion Option Derivative Liability $ 7,144 $ (1,133) $ 1,712 $ 8,598 Change in the fair value of Royalty Fee Derivative Liability (34) — (34) — Barings Royalty Fees (Note 7) (388) — (388) — $ 6,722 $ (1,133) $ 1,290 $ 8,598 |
Schedule of assets and liabilities measured at fair Value on recurring basis | Fair Value Measurements as of September 30, 2023 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 101,480 $ — $ — $ 101,480 Liability: Derivative liabilities $ — $ — $ 24,022 $ 24,022 Fair Value Measurements as of December 31, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 30,188 $ — $ — $ 30,188 Liability: Derivative liabilities $ — $ — $ 6,351 $ 6,351 |
Royalty Fee Derivative Liability [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of main inputs to valuing the Derivative Liability | As of September 30, 2023 Revenue volatility 60.0 % Revenue discount rate 16.4 % As of Balance at August 2, 2023 $ 12,604 Change in fair value 34 Balance at September 30, 2023 $ 12,638 |
Convertible Notes | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of main inputs to valuing the Derivative Liability | As of September 30, December 31, 2023 2022 Company's stock price $ 3.14 $ 2.81 Volatility 76.3 % 93.8 % Bond yield 22.7 % 16.2 % |
Summary of roll-forward of the derivative liability, including the impact from accounting for the Convertible Notes Amendment | As of Balance at December 31, 2022 $ 6,351 Change in fair value 5,432 Balance at June 30, 2023 11,783 Change in fair value (827) Balance at August 2, 2023 before the Convertible Notes Amendment 10,956 Change in fair value from Convertible Notes Amendment 6,745 Balance at August 2, 2023 after the Convertible Notes Amendment 17,701 Change in fair value (6,317) Balance at September 30, 2023 $ 11,384 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Awards | |
Schedule of stock-based compensation expense related to stock options | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Research and development $ 1,115 $ 1,060 $ 3,390 $ 3,157 Selling and marketing 934 1,169 2,948 3,499 General and administrative 2,463 2,011 7,159 6,074 $ 4,512 $ 4,240 $ 13,497 $ 12,730 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Schedule of basic and diluted net (loss) income per share attributable to common stockholders | Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders $ (516) $ (24,188) $ (51,516) $ (55,496) Denominator: Weighted average common shares outstanding, basic 79,373,272 76,975,839 78,276,341 76,829,434 Net loss per share - basic $ (0.01) $ (0.31) $ (0.66) $ (0.72) Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2023 2022 Net loss attributable to common stockholders, basic $ (516) $ (51,516) $ (55,496) Interest expense on Convertible Notes 1,004 3,232 3,425 Change in fair value of derivative liability and gains on extinguishment of debt (22,051) (16,619) (8,598) Net loss attributable to common stockholders, diluted $ (21,563) $ (64,903) $ (60,669) Weighted average common shares outstanding, basic 79,373,272 78,276,341 76,829,434 Shares issuable upon conversion of Convertible Notes, as if converted 5,769,232 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 85,142,504 84,045,573 82,598,666 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.77) $ (0.73) |
Schedule of antidilutive securities, excluded from computation of diluted net loss per share | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Options to purchase common stock 16,306,543 13,795,937 16,306,543 13,795,937 Restricted stock units 1,653,363 1,050,339 1,653,363 1,050,339 Shares issuable upon conversion of Convertible Notes, if converted — — — — 17,959,906 14,846,276 17,959,906 14,846,276 |
Nature of the Business (Details
Nature of the Business (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Aug. 02, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Nature of Business | ||||
Accumulated deficit | $ 668,358 | $ 616,842 | ||
Cash and cash equivalents | 110,550 | $ 102,300 | $ 120,950 | |
Barings Credit Facility | ||||
Nature of Business | ||||
Debt Instrument, covenants, minimum liquidity requirement | $ 20,000 | $ 20,000 |
Licensing Agreements and Defe_3
Licensing Agreements and Deferred Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2023 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaboration Agreement | ||||||
Revenue recognized | $ 15,081 | $ 11,965 | $ 43,642 | $ 37,419 | ||
Total deferred revenue: | ||||||
Deferred revenue, beginning balance | 13,963 | |||||
Additions | 1,000 | |||||
Amounts recognized into revenue | (449) | |||||
Deferred revenue, ending balance | 14,514 | 14,514 | ||||
License Agreement | AffaMed | ||||||
Collaboration Agreement | ||||||
Milestone payment received | $ 1,000 | |||||
License Agreement | AffaMed | OTX-TIC Product | ||||||
Collaboration Agreement | ||||||
Revenue recognized | 131 | 52 | 449 | 864 | ||
Amount invoiced for initiation of OTX-TIC program | $ 2,000 | |||||
Transaction price allocated to performance obligations partially unsatisfied | 514 | 514 | ||||
License Agreement | Incept | ||||||
Collaboration Agreement | ||||||
Royalties paid | $ 451 | $ 0 | $ 1,264 | $ 744 |
Cash Equivalents and Restrict_3
Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Cash Equivalents and Restricted Cash | ||||
Cash and cash equivalents | $ 110,550 | $ 102,300 | $ 120,950 | |
Restricted cash | 1,764 | 1,764 | 1,764 | |
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows | $ 112,314 | $ 104,064 | $ 122,714 | $ 165,928 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw materials | $ 293 | $ 309 |
Work-in-process | 947 | 899 |
Finished goods | 1,017 | 766 |
Total inventory | $ 2,257 | $ 1,974 |
Expenses - Summary (Details)
Expenses - Summary (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Expenses | ||
Accrued payroll and related expenses | $ 7,862 | $ 7,509 |
Accrued rebates and programs | 4,679 | 3,560 |
Accrued professional fees | 1,347 | 1,228 |
Accrued research and development expenses | 2,285 | 1,816 |
Accrued interest payable on Convertible Notes | 10,319 | 8,756 |
Accrued interest payable on Barings Note | 858 | |
Accrued other | 1,537 | 1,228 |
Total | $ 28,887 | $ 24,097 |
Financial Liabilities - Barings
Financial Liabilities - Barings Credit Agreement - Terms (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Aug. 02, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Financial Liabilities | ||||
Principal amount of debt issued | $ 37,500 | $ 37,500 | $ 37,500 | |
Royalty fees | (388) | (388) | ||
Barings Credit Facility | ||||
Financial Liabilities | ||||
Borrowing capacity under the agreement | $ 82,474 | |||
Principal amount of debt issued | 82,474 | |||
Proceeds from issuance of debt, net | $ 77,790 | |||
Royalty fees payable as percentage of net sales. | (3.50%) | |||
Minimum liquidity amount | $ 20,000 | 20,000 | 20,000 | |
Barings Royalty Fees | $ 388 | $ 388 | ||
Barings Credit Facility | SOFR-based rate | ||||
Financial Liabilities | ||||
Interest rate floor (as a percent) | 1.50% | |||
Basis spread (as a percent) | 6.75% | |||
Change of control, Entered on or Prior to Six Months After the Closing Date | Barings Credit Facility | ||||
Financial Liabilities | ||||
Royalty fees payable reduction , percentage of total credit facility amount. | 20% | |||
Change of control, Entered After Six Months, but Before Twelve Months, After Closing Date. | Barings Credit Facility | ||||
Financial Liabilities | ||||
Royalty fees payable reduction , percentage of total credit facility amount. | 30% |
Financial Liabilities - Barin_2
Financial Liabilities - Barings Credit Agreement - Summary (Details) - Barings Credit Facility $ in Thousands | Sep. 30, 2023 USD ($) |
Credit Agreement | |
Debt instrument carrying amount | $ 82,474 |
Less: unamortized discount | (17,350) |
Total | 65,124 |
Due for repayment in 2029 | $ 82,474 |
Financial Liabilities - Convert
Financial Liabilities - Convertible Notes, Terms (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Aug. 02, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Mar. 01, 2019 | |
Financial Liabilities | |||||
Principal amount of debt issued | $ 37,500 | $ 37,500 | $ 37,500 | ||
Gain (loss) on extinguishment of debt | $ 14,190 | $ 14,190 | |||
Convertible Notes | |||||
Financial Liabilities | |||||
Principal amount of debt issued | $ 37,500 | ||||
Interest rate (as a percent) | 6% | ||||
Effective annual interest rate (as a percent) | 19.40% | 19.40% | |||
Extinguishment of debt, amount | $ 51,090 | ||||
Fair value of convertible notes including conversion option | 36,183 | ||||
Debt instrument fair value | 18,482 | $ 19,357 | $ 19,357 | $ 33,177 | |
Conversion option derivative liability, fair value | 17,701 | ||||
Convertible Notes, fair value portion included in accrued expenses | $ 9,943 | ||||
Gain (loss) on extinguishment of debt | $ 14,907 |
Financial Liabilities - Conve_2
Financial Liabilities - Convertible Notes, Summary (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Financial Liabilities | ||
Convertible Notes | $ 37,500 | $ 37,500 |
Less: unamortized discount and current portion | (28,735) | (8,751) |
Total | $ 8,765 | $ 28,749 |
Financial Liabilities - MidCap
Financial Liabilities - MidCap Credit Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Mar. 12, 2023 | Aug. 31, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | |
Financial Liabilities | ||||||
Repayment of debt | $ 26,125 | |||||
Gain (loss) on extinguishment of debt | $ 14,190 | 14,190 | ||||
Repayment of Protective Advance | 2,000 | |||||
Proceeds From Issuance of Protective Advance | $ 2,000 | |||||
MidCap Credit Facility | ||||||
Financial Liabilities | ||||||
Borrowing capacity under the agreement | $ 25,000 | |||||
Repayment of debt including principal, interest, exit and prepayment fees | $ 26,157 | |||||
Repayment of debt | 25,017 | |||||
Payment of exit and prepayment fees in satisfaction of debt obligation | 1,140 | |||||
Gain (loss) on extinguishment of debt | $ 717 | |||||
Repayment of Protective Advance | $ 2,000 | |||||
Proceeds From Issuance of Protective Advance | $ 2,000 |
Risks and Fair Value - Concentr
Risks and Fair Value - Concentration of Credit Risk (Details) - Customer - customer | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Total revenue | |||||
Concentration risk | |||||
Number of major customers | 3 | 3 | |||
Total revenue | Customer one | |||||
Concentration risk | |||||
Concentration risk | 47% | 42% | 51% | 41% | |
Total revenue | Customer two | |||||
Concentration risk | |||||
Concentration risk | 24% | 30% | 23% | 27% | |
Total revenue | Customer three | |||||
Concentration risk | |||||
Concentration risk | 12% | 14% | 11% | 18% | |
Accounts receivable | |||||
Concentration risk | |||||
Number of major customers | 3 | 3 | |||
Accounts receivable | Customer one | |||||
Concentration risk | |||||
Concentration risk | 51% | 52% | |||
Accounts receivable | Customer two | |||||
Concentration risk | |||||
Concentration risk | 26% | 24% | |||
Accounts receivable | Customer three | |||||
Concentration risk | |||||
Concentration risk | 11% | 15% |
Risks and Fair Value - Change i
Risks and Fair Value - Change in Fair Value of Derivative lLabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Barings Royalty Fees | $ (388) | $ (388) | ||
Total | 6,722 | $ (1,133) | 1,290 | $ 8,598 |
Conversion Option Derivative Liability | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Change in fair value of derivative liability | $ 7,144 | $ (1,133) | $ 1,712 | $ 8,598 |
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Total | Total | Total | Total |
Royalty Fee Derivative Liability | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Change in fair value of derivative liability | $ (34) | $ (34) | ||
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Total | Total | Total | Total |
Risks and Fair Value - Fair Val
Risks and Fair Value - Fair Value Measurement (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Aug. 02, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Liability: | ||||
Derivative liabilities | $ 11,384 | $ 11,783 | $ 6,351 | |
Notes Payable, Noncurrent | 65,124 | 25,257 | ||
Non-current liability | 8,765 | 28,749 | ||
Barings Credit Facility | ||||
Liability: | ||||
Notes payable, amortized cost, including accrued interest | 65,982 | |||
Notes Payable, Noncurrent | 65,124 | |||
Accrued interest | 858 | |||
Estimated fair value | 69,159 | |||
Convertible Notes | ||||
Liability: | ||||
Convertible debt, amortized cost, including accrued interest | 19,084 | 37,505 | ||
Non-current liability | 8,765 | 28,749 | ||
Accrued interest | 10,319 | 8,756 | ||
Estimated fair value | 19,357 | $ 18,482 | 33,177 | |
Recurring Basis | ||||
Liability: | ||||
Derivative liabilities | 24,022 | 6,351 | ||
Money Market Funds | Recurring Basis | ||||
Assets: | ||||
Cash equivalents | 101,480 | 30,188 | ||
Level 1 | Money Market Funds | Recurring Basis | ||||
Assets: | ||||
Cash equivalents | 101,480 | 30,188 | ||
Level 3 | Recurring Basis | ||||
Liability: | ||||
Derivative liabilities | $ 24,022 | $ 6,351 |
Risks and Fair Value - The main
Risks and Fair Value - The main inputs to valuing the Royalty Fee Derivative Liability (Details)) $ in Thousands | 2 Months Ended | 6 Months Ended | ||
Aug. 02, 2023 USD ($) | Sep. 30, 2023 USD ($) | Aug. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Balance at beginning of period | $ 11,783 | $ 6,351 | ||
Change in fair value | $ 6,317 | $ 827 | (5,432) | |
Balance at end of period | 11,384 | $ 11,783 | ||
Royalty Fee Derivative Liability [Member] | ||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Balance at beginning of period | 12,604 | |||
Change in fair value | 34 | |||
Balance at end of period | $ 12,604 | $ 12,638 | ||
Revenue volatility | Royalty Fee Derivative Liability [Member] | Level 3 | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Derivative Liability, Measurement Input | 0.610 | 0.600 | ||
Revenue discount rate | Royalty Fee Derivative Liability [Member] | Level 3 | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Derivative Liability, Measurement Input | 0.158 | 0.164 |
Risks and Fair Value - Measurem
Risks and Fair Value - Measurement inputs (Details) - Convertible Notes | Sep. 30, 2023 | Dec. 31, 2022 |
Company's stock price | ||
Derivative Liability | ||
Debt instrument, measurement input | 3.14 | 2.81 |
Company's stock price | Conversion option immediately before the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.0430 | |
Company's stock price | Conversion option immediately after the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.0430 | |
Volatility | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.763 | 0.938 |
Volatility | Conversion option immediately before the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.785 | |
Volatility | Conversion option immediately after the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.778 | |
Bond yield | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.227 | 0.162 |
Bond yield | Conversion option immediately before the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.226 | |
Bond yield | Conversion option immediately after the amendment | ||
Derivative Liability | ||
Debt instrument, measurement input | 0.229 |
Risks and Fair Value - Derivati
Risks and Fair Value - Derivative Roll-Forward (Details) - USD ($) $ in Thousands | 2 Months Ended | 6 Months Ended | ||
Aug. 02, 2023 | Sep. 30, 2023 | Aug. 31, 2023 | Jun. 30, 2023 | |
Roll forward of the derivative liability | ||||
Balance at beginning of period | $ 11,783 | $ 6,351 | ||
Change in fair value | $ (6,317) | $ (827) | 5,432 | |
Balance at end of period | 11,384 | $ 11,783 | ||
Conversion option immediately after the amendment | ||||
Roll forward of the derivative liability | ||||
Balance at beginning of period | $ 17,701 | |||
Change in fair value | $ 6,745 | |||
Balance at end of period | 17,701 | |||
Conversion option immediately before the amendment | ||||
Roll forward of the derivative liability | ||||
Balance at beginning of period | $ 10,956 |
Equity - Additional information
Equity - Additional information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Aug. 09, 2021 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Equity | ||||||
Net proceeds from issuance of common stock | $ 9,532 | |||||
Common Stock | ||||||
Equity | ||||||
Number of shares issued | 144,718 | 1,370,208 | ||||
Common Stock | 2021 Sales Agreement | ||||||
Equity | ||||||
Maximum aggregate proceeds from offering | $ 100,000 | |||||
Number of shares issued | 144,718 | 0 | 1,514,926 | 0 | ||
Gross proceeds | $ 734 | $ 9,897 | ||||
Net proceeds from issuance of common stock | $ 708 | $ 9,532 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 item $ / shares shares | Jun. 30, 2023 shares | Sep. 30, 2023 item $ / shares shares | Jun. 14, 2023 shares | |
Stock-Based Awards | ||||
Stock options and RSUs expired or were forfeited (in shares) | 232,939 | 793,146 | ||
Common Stock | ||||
Stock-Based Awards | ||||
Issuance of common stock upon public offering, net of issuance costs, shares | 144,718 | 1,370,208 | ||
2021 Incentive Plan | ||||
Stock-Based Awards | ||||
Number of shares of common stock available for issuance | 6,046,323 | 6,046,323 | 3,900,000 | |
2021 Incentive Plan | Common Stock | ||||
Stock-Based Awards | ||||
Shares issuable under options, granted (in shares) | 190,250 | 3,430,991 | ||
Exercise price (in dollars per share) | $ / shares | $ 4.50 | $ 4.04 | ||
2019 Inducement Plan | ||||
Stock-Based Awards | ||||
Number of shares of common stock available for issuance | 545,750 | 545,750 | ||
2014 Employee Stock Purchase Plan | ||||
Stock-Based Awards | ||||
Number of shares of common stock available for issuance | 513,069 | 513,069 | ||
2014 Stock Incentive Plan | ||||
Stock-Based Awards | ||||
Number of stock based compensation plans | item | 3 | 3 | ||
Restricted Stock Units (RSUs) | 2021 Incentive Plan | ||||
Stock-Based Awards | ||||
Granted (in shares) | 47,800 | 1,078,631 |
Stock-Based Awards - Stock-Base
Stock-Based Awards - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-Based Awards | ||||
Stock-based compensation expense | $ 4,512 | $ 4,240 | $ 13,497 | $ 12,730 |
Unrecognized stock-based compensation cost | 20,573 | $ 20,573 | ||
Weighted average period of unrecognized stock-based compensation cost expected to be recognized | 2 years 1 month 20 days | |||
Research and development expense | ||||
Stock-Based Awards | ||||
Stock-based compensation expense | 1,115 | 1,060 | $ 3,390 | 3,157 |
Selling and marketing expense | ||||
Stock-Based Awards | ||||
Stock-based compensation expense | 934 | 1,169 | 2,948 | 3,499 |
General and administrative expense | ||||
Stock-Based Awards | ||||
Stock-based compensation expense | $ 2,463 | $ 2,011 | $ 7,159 | $ 6,074 |
Net Loss Per Share - Basic (Det
Net Loss Per Share - Basic (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Basic net loss per share attributable to common stockholders: | ||||||||
Net loss | $ (516) | $ (20,682) | $ (30,318) | $ (24,188) | $ (18,766) | $ (12,542) | $ (51,516) | $ (55,496) |
Weighted average common shares outstanding, basic | 79,373,272 | 76,975,839 | 78,276,341 | 76,829,434 | ||||
Net loss per share, basic | $ (0.01) | $ (0.31) | $ (0.66) | $ (0.72) |
Net Loss Per Share - Diluted Ne
Net Loss Per Share - Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Reconciliation of net loss attributable to common stockholders for basic and diluted net loss per share | ||||
Net income (loss) attributable to common stockholders, basic | $ (516) | $ (51,516) | $ (55,496) | |
Interest expense Convertible Notes | 1,004 | 3,232 | 3,425 | |
Change in fair value of derivative liability and gains on extinguishment of debt | (22,051) | (16,619) | (8,598) | |
Net loss attributable to common stockholders, diluted | $ (21,563) | $ (64,903) | $ (60,669) | |
Weighted average common shares outstanding, basic | 79,373,272 | 76,975,839 | 78,276,341 | 76,829,434 |
Shares issuable upon conversion of Convertible Notes, as if converted | 5,769,232 | 5,769,232 | 5,769,232 | |
Weighted average common shares outstanding, diluted | 85,142,504 | 76,975,839 | 84,045,573 | 82,598,666 |
Net loss per share attributable to common stockholders, diluted | $ (0.25) | $ (0.31) | $ (0.77) | $ (0.73) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss Per Share | ||||
Total common stock equivalents | 17,959,906 | 14,846,276 | 17,959,906 | 14,846,276 |
Options to Purchase Common Stock | ||||
Net Loss Per Share | ||||
Total common stock equivalents | 16,306,543 | 13,795,937 | 16,306,543 | 13,795,937 |
Restricted Stock Units (RSUs) | ||||
Net Loss Per Share | ||||
Total common stock equivalents | 1,653,363 | 1,050,339 | 1,653,363 | 1,050,339 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Related Party Transactions | |||||
Accounts payable | $ 3,984 | $ 3,984 | $ 5,123 | ||
Accrued expenses | 28,887 | 28,887 | 24,097 | ||
WilmerHale | Legal Fees. | Chief Business Officer | |||||
Related Party Transactions | |||||
Expenses incurred | 323 | $ 342 | 956 | $ 876 | |
Accounts payable | 135 | 135 | 0 | ||
Accrued expenses | 0 | 0 | 24 | ||
Heier Consulting LLC | Related Party | |||||
Related Party Transactions | |||||
Accounts payable | 7 | 7 | 3 | ||
Accrued expenses | 0 | $ 0 | $ 0 | ||
Total grant date fair value of stock-based awards granted | $ 96 | ||||
Heier Consulting LLC | Related Party | Service | |||||
Related Party Transactions | |||||
Expenses incurred | $ 13 | $ 21 | $ 18 | $ 21 |