Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 02, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | EyePoint Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001314102 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | EYPT | |
Entity Common Stock, Shares Outstanding | 53,518,210 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity File Number | 000-51122 | |
Entity Tax Identification Number | 26-2774444 | |
Entity Address, Address Line One | 480 Pleasant Street | |
Entity Address, City or Town | Watertown | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02472 | |
City Area Code | 617 | |
Local Phone Number | 926-5000 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 90,769 | $ 281,263 |
Marketable securities | 189,479 | 49,787 |
Accounts and other receivables, net | 1,375 | 805 |
Prepaid expenses and other current assets | 9,636 | 9,039 |
Inventory | 3,672 | 3,906 |
Total current assets | 294,931 | 344,800 |
Property and equipment, net | 6,899 | 5,251 |
Operating lease right-of-use assets | 22,269 | 4,983 |
Restricted cash | 150 | 150 |
Total assets | 324,249 | 355,184 |
Current liabilities: | ||
Accounts payable | 14,296 | 6,504 |
Accrued expenses | 13,341 | 17,521 |
Deferred revenue | 33,335 | 38,592 |
Other current liabilities | 1,130 | 646 |
Total current liabilities | 62,102 | 63,263 |
Deferred revenue - noncurrent | 11,678 | 20,692 |
Operating lease liabilities - noncurrent | 22,164 | 4,906 |
Total liabilities | 95,944 | 88,861 |
Contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock, $.001 par value, 5,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Common stock, $.001 par value, 300,000,000 shares authorized at June 30, 2024 and December 31, 2023; 52,160,305 and 49,043,074 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 52 | 49 |
Additional paid-in capital | 1,029,717 | 1,007,556 |
Accumulated deficit | (802,256) | (742,146) |
Accumulated other comprehensive income | 792 | 864 |
Total stockholders' equity | 228,305 | 266,323 |
Total liabilities and stockholders' equity | $ 324,249 | $ 355,184 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
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 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 52,160,305 | 49,043,074 |
Common stock, shares outstanding | 52,160,305 | 49,043,074 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues: | ||||
Total revenues | $ 9,477 | $ 9,105 | $ 21,161 | $ 16,788 |
Operating expenses: | ||||
Cost of sales | 1,401 | 1,792 | 2,160 | 2,432 |
Research and development | 29,822 | 15,730 | 60,011 | 29,348 |
Sales and marketing | 50 | 5,288 | 56 | 11,025 |
General and administrative | 12,750 | 9,056 | 26,801 | 18,298 |
Total operating expenses | 44,023 | 31,866 | 89,028 | 61,103 |
Loss from operations | (34,546) | (22,761) | (67,867) | (44,315) |
Other (expense) income: | ||||
Interest and other income, net | 3,720 | 1,623 | 7,757 | 2,825 |
Interest expense | 0 | (435) | 0 | (1,247) |
Loss on extinguishment of debt | 0 | (1,347) | 0 | (1,347) |
Total other (expense) income, net | 3,720 | (159) | 7,757 | 231 |
Net loss | $ (30,826) | $ (22,920) | $ (60,110) | $ (44,084) |
Net loss per share - basic | $ (0.58) | $ (0.61) | $ (1.13) | $ (1.17) |
Net loss per share - diluted | $ (0.58) | $ (0.61) | $ (1.13) | $ (1.17) |
Weighted average common shares outstanding - basic | 53,206 | 37,576 | 53,059 | 37,531 |
Weighted average common shares outstanding - diluted | 53,206 | 37,576 | 53,059 | 37,531 |
Net Income (Loss) | $ (30,826) | $ (22,920) | $ (60,110) | $ (44,084) |
Other comprehensive gain (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | (44) | (1) | (72) | 56 |
Comprehensive loss | (30,870) | (22,921) | (60,182) | (44,028) |
Product [Member] | ||||
Revenues: | ||||
Total revenues | 1,068 | 5,273 | 1,726 | 12,667 |
License and Collaboration Agreements [Member] | ||||
Revenues: | ||||
Total revenues | 7,782 | 3,597 | 18,345 | 3,631 |
Royalty Income [Member] | ||||
Revenues: | ||||
Total revenues | $ 627 | $ 235 | $ 1,090 | $ 490 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income [Member] |
Balance at Dec. 31, 2022 | $ 96,368 | $ 34 | $ 766,899 | $ (671,351) | $ 786 |
Balance, shares at Dec. 31, 2022 | 34,082,934 | ||||
Net Income (Loss) | (44,084) | (44,084) | |||
Other comprehensive gain (loss) | 56 | 56 | |||
Employee stock purchase plan | 248 | 248 | |||
Employee stock purchase plan, shares | 63,721 | ||||
Exercise of stock options | 5 | 5 | |||
Exercise of stock options, shares | 880 | ||||
Vesting of stock units | (169) | (169) | |||
Vesting of stock units, shares | 158,583 | ||||
Stock-based compensation | 4,838 | 4,838 | |||
Balance at Jun. 30, 2023 | 57,262 | $ 34 | 771,821 | (715,435) | 842 |
Balance, shares at Jun. 30, 2023 | 34,306,118 | ||||
Balance at Mar. 31, 2023 | 78,390 | $ 34 | 770,028 | (692,515) | 843 |
Balance, shares at Mar. 31, 2023 | 34,301,926 | ||||
Net Income (Loss) | (22,920) | (22,920) | |||
Other comprehensive gain (loss) | (1) | (1) | |||
Exercise of stock options | 5 | 5 | |||
Exercise of stock options, shares | 880 | ||||
Vesting of stock units, shares | 3,312 | ||||
Stock-based compensation | 1,788 | 1,788 | |||
Balance at Jun. 30, 2023 | 57,262 | $ 34 | 771,821 | (715,435) | 842 |
Balance, shares at Jun. 30, 2023 | 34,306,118 | ||||
Balance at Dec. 31, 2023 | $ 266,323 | $ 49 | 1,007,556 | (742,146) | 864 |
Balance, shares at Dec. 31, 2023 | 49,043,074 | 49,043,074 | |||
Net Income (Loss) | $ (60,110) | (60,110) | |||
Other comprehensive gain (loss) | (72) | (72) | |||
Issuance of stock, net of issue costs | 18 | 18 | |||
Cashless exercise of warrants | $ 2 | (2) | |||
Cashless exercise of warrants, shares | 2,206,442 | ||||
Employee stock purchase plan | 268 | 268 | |||
Employee stock purchase plan, shares | 25,015 | ||||
Exercise of stock options | 4,918 | $ 1 | 4,917 | ||
Exercise of stock options, shares | 521,716 | ||||
Vesting of stock units | (4,434) | (4,434) | |||
Vesting of stock units, shares | 364,058 | ||||
Stock-based compensation | 21,394 | 21,394 | |||
Balance at Jun. 30, 2024 | $ 228,305 | $ 52 | 1,029,717 | (802,256) | 792 |
Balance, shares at Jun. 30, 2024 | 52,160,305 | 52,160,305 | |||
Balance at Mar. 31, 2024 | $ 249,934 | $ 50 | 1,020,478 | (771,430) | 836 |
Balance, shares at Mar. 31, 2024 | 49,885,701 | ||||
Net Income (Loss) | (30,826) | (30,826) | |||
Other comprehensive gain (loss) | (44) | (44) | |||
Cashless exercise of warrants | $ 2 | (2) | |||
Cashless exercise of warrants, shares | 2,180,776 | ||||
Exercise of stock options | 624 | 624 | |||
Exercise of stock options, shares | 77,532 | ||||
Vesting of stock units | (78) | (78) | |||
Vesting of stock units, shares | 16,296 | ||||
Stock-based compensation | 8,695 | 8,695 | |||
Balance at Jun. 30, 2024 | $ 228,305 | $ 52 | $ 1,029,717 | $ (802,256) | $ 792 |
Balance, shares at Jun. 30, 2024 | 52,160,305 | 52,160,305 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (60,110) | $ (44,084) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation of property and equipment | 665 | 237 |
Amortization of debt discount and premium and discount on available-for-sale marketable securities | (2,267) | (295) |
Provision for excess and obsolete inventory | 0 | 693 |
Loss on extinguishment of debt | 0 | 1,347 |
Stock-based compensation | 21,394 | 4,838 |
Changes in operating assets and liabilities: | ||
Accounts receivable and other current assets | (1,168) | 3,953 |
Inventory | 233 | (1,909) |
Accounts payable and accrued expenses | 3,636 | 3,680 |
Right-of-use assets and operating lease liabilities | 539 | 385 |
Deferred revenue | (14,271) | 71,343 |
Net cash (used in) provided by operating activities | (51,349) | 40,188 |
Cash flows from investing activities: | ||
Purchases of marketable securities | (184,995) | (5,851) |
Sales and maturities of marketable securities | 47,500 | 52,284 |
Purchases of property and equipment | (2,094) | (880) |
Net cash (used in) provided by investing activities | (139,589) | 45,553 |
Cash flows from financing activities: | ||
Payment of equity issue costs | (307) | 0 |
Payment of long-term debt | 0 | (30,000) |
Payment of extinguishment of debt costs | 0 | (1,350) |
Borrowings under revolving facility | 0 | 5,300 |
Repayment under revolving facility | 0 | (15,775) |
Net settlement of stock units to satisfy statutory tax withholding | (4,434) | (169) |
Proceeds from exercise of stock options | 5,185 | 253 |
Principal payments on finance lease obligations | 0 | (36) |
Net cash provided by (used in) financing activities | 444 | (41,777) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (190,494) | 43,964 |
Cash, cash equivalents and restricted cash at beginning of period | 281,413 | 95,783 |
Cash, cash equivalents and restricted cash at end of period | 90,919 | 139,747 |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | ||
Cash and cash equivalents | 90,769 | 139,597 |
Restricted cash | 150 | 150 |
Total cash, cash equivalents and restricted cash at end of period | 90,919 | 139,747 |
Supplemental cash flow information: | ||
Cash interest paid | 0 | 1,405 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Lease liability arising from obtaining right-of-use assets | 17,656 | 0 |
Property and equipment additions in accounts payable and accrued expenses | $ 220 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (30,826) | $ (22,920) | $ (60,110) | $ (44,084) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | The Company permits officers and directors to adopt written trading plans, known as “Rule 10b5-1 trading arrangements”, as such term defined in Item 408(a) of Regulation S-K for the purchase or sale of the Company's securities, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. During the three months ended June 30, 2024, our executive officers and directors adopted, modified or terminated Rule 10b5-1 trading arrangements for the purchase or sale of our common stock as noted below: Name and Title of Director or Officer Action Date of Adoption Duration of the Plan or Termination Date Aggregate Number of Shares of Common Stock that may be Sold under the Plan The Nancy S. Lurker 2020 Irrevocable Trust, Director Adoption June 06, 2024 June 05, 2025 100,000 |
Name | Nancy S. Lurker |
Title | Director |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | June 06, 2024 |
Rule 10b5-1 Arrangement Terminated | true |
Termination Date | June 05, 2025 |
Aggregate Available | 100,000 |
Rule 10b5-1 Arrangement Terminated [Flag] | true |
Operations
Operations | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Operations | 1. Operations The accompanying condensed consolidated financial statements of EyePoint Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, the Company), as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023 are unaudited. Certain information in the footnote disclosures of these financial statements has been condensed or omitted in accordance with the rules and regulations of the Securities and Exchange Commission. These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. In the opinion of management, these statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2023, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods indicated. The preparation of financial statements in accordance with United States (U.S.) generally accepted accounting principles requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the entire 2024 fiscal year or any future period. The Company is committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary bioerodible Durasert E technology (Durasert E ) for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU , previously EYP-1901, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E , DURAVYU is currently in Phase 2 clinical trials for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States and diabetic macular edema (DME). The Company is also advancing EYP-2301, a promising TIE-2 agonist, razuprotafib, formulated in Durasert E to potentially improve outcomes in serious retinal diseases. The Company plans to identify and advance additional product candidates through clinical and regulatory development for its pipeline. This may be accomplished through internal discovery efforts, research collaborations and/or in-licensing arrangements and potential acquisitions of additional products, product candidates or technologies. Liquidity The Company had cash, cash equivalents and investments in marketable securities of $ 280.2 million at June 30, 2024. The Company has a history of operating losses and has not had significant recurring cash inflows from revenue. The Company’s operations have been financed primarily from sales of its equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income, and other fees received from its collaboration partners. The Company anticipates that it will continue to incur losses as it continues the research and development of its product candidates, and the Company does not expect revenues to generate sufficient funding to sustain its operations in the near-term. The Company expects to continue fulfilling its funding needs through cash inflows from revenues, licensing and research collaboration transactions, additional equity capital raises and other arrangements. The Company believes that its cash, cash equivalents and investments in marketable securities of $ 280.2 million at June 30, 2024 will enable the Company to fund its current and planned operations for at least the next twelve months from the date these condensed consolidated financial statements were issued. Actual cash requirements could differ from management’s projections due to many factors, including the timing and results of the Company’s clinical trials for DURAVYU , additional investments in research and development programs, competing technological and market developments and the costs of any strategic acquisitions and/or development of compleme ntary business opportunities. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or the SEC, on March 8, 2024, or the 2023 Form 10-K. Since the date of those financial statements, there have been no material changes to the Company's significant accounting policies. Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers (ASC 606), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value-add and other taxes collected on behalf of third parties are excluded from revenue. Product sales, net — Effective January 2023, commercial sales of DEXYCU ® were no longer supported by the Company, remaining available only through specialty distributors. Effective May 2023, YUTIQ ® has been and continues to be sold under commercial supply agreements with Alimera Sciences, Inc. (Alimera) and Ocumension Therapeutics (Ocumension) (see Note 3). Prior to the above dates, the Company sold YUTIQ ® and DEXYCU ® to a limited number of specialty distributors and specialty pharmacies (collectively the Distributors) in the U.S., with whom the Company had entered into formal agreements, for delivery to physician practices for YUTIQ ® and to hospital outpatient departments and ambulatory surgical centers (ASCs) for DEXYCU ® . The Company recognized revenue on sales of its products when Distributors obtained control of the products, which occurred at a point in time, typically upon delivery. In addition to agreements with Distributors, the Company also entered into arrangements with healthcare providers, ASCs, and payors that provided for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to their purchase of the Company's products from Distributors. Reserves for variable consideration — Product sales were recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration included trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that were offered within contracts between the Company and its Distributors, payors, and other contracted purchasers relating to the Company's product sales. These reserves were based on the amounts earned, or to be claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled. Overall, these reserves reflected the Company's best estimates of the amount of consideration to which it was entitled based on the terms of the respective underlying contracts. The actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from the estimates, the Company adjusts these estimates, which would affect product revenue and earnings in the period such variances become known. Distribution fees — The Company compensated its Distributors for services explicitly stated in the Company’s contracts and were recorded as a reduction of revenue in the period the related product sale was recognized. Provider chargebacks and discounts — Chargebacks were discounts that represented the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to the Company’s Distributors. These Distributors charged the Company for the difference between what they paid for the product and the Company’s contracted selling price. These reserves were established in the same period that the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Reserves for chargebacks consisted of amounts that the Company expected to pay for units that remained in the distribution channel inventories at each reporting period-end that the Company expected to be sold under a contracted selling price, and chargebacks that Distributors had claimed, but for which the Company had not yet settled. Government rebates — The Company was subject to discount obligations under state Medicaid programs and Medicare. These reserves were recorded in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability which was included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company’s liability for these rebates consisted of invoices received for claims from prior quarters that had not been paid or for which an invoice had not yet been received, estimates of claims for the current quarter, and estimated future claims that would be made for product that had been recognized as revenue, but which remained in the distribution channel inventories at the end of each reporting period. Payor rebates — The Company contracted with certain private payor organizations, primarily insurance companies, for the payment of rebates with respect to utilization of its products. The Company estimated these rebates and recorded such estimates in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Co-Payment assistance — The Company offered co-payment assistance to commercially insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance was based on an estimate of claims and the cost per claim that the Company expected to receive associated with product that had been recognized as revenue. Product returns — The Company generally offered a limited right of return based on its returned goods policy, which included damaged product and remaining shelf life. The Company estimated the amount of its product sales that may be returned and recorded. License and collaboration agreement revenue — The Company analyzes each element of its license and collaboration arrangements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to the Company of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For licenses that are combined with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time, when (or as) the associated performance obligation in the contract is satisfied. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of June 30, 2024. Royalties — The Company recognizes revenue from license arrangements with its commercial partners’ net sales of products. Such revenues are included as royalty income. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. The Company’s commercial partners are obligated to report their net product sales and the resulting royalty due to the Company typically within 60-days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company recognizes royalty income each quarter and subsequently determines a true-up when it receives royalty reports and payment from its commercial partners. Historically, these true-up adjustments have been immaterial. Sale of Future Royalties — The Company has sold its rights to receive certain royalties on product sales. In the circumstance where the Company has sold its rights to future royalties under a royalty purchase agreement (RPA) and also maintains limited continuing involvement in the arrangement (but not significant continuing involvement in the generation of the cash flows that are due to the purchaser), the Company defers recognition of the proceeds it receives for the sale of royalty streams and recognizes such unearned revenue as revenue under the units-of-revenue method over the life of the underlying license agreement. Under the units-of-revenue method, amortization for a reporting period is calculated by computing a ratio of the proceeds received from the purchaser to the total payments expected to be made to the purchaser over the term of the agreement, and then applying that ratio to the period’s cash payment. Estimating the total payments expected to be received by the purchaser over the term of such arrangements requires management to use subjective estimates and assumptions. Changes to the Company’s estimate of the payments expected to be made to the purchaser over the term of such arrangements could have a material effect on the amount of revenues recognized in any particular period. Research Collaborations — The Company recognizes revenue over the term of the statements of work under any funded research collaborations. Revenue recognition for consideration, if any, related to a license option right is assessed based on the terms of any such future license agreement or is otherwise recognized at the completion of the research collaborations. Please refer to Note 3 for further details on the license and collaboration agreements into which the Company has entered and corresponding amounts of revenue recognized during the current and prior year periods. Cost of sales — Cost of sales consist of costs associated with the manufacture of YUTIQ ® and DEXYCU ® , certain period costs for DEXYCU ® product revenue, product shipping, and as applicable, royalty expense. The inventory costs for YUTIQ ® include purchases of various components, the active pharmaceutical ingredient (API), and direct labor and overhead for the product manufactured in the Company’s Watertown, Massachusetts facility. The inventory costs for DEXYCU ® include purchased components, the API and third-party manufacturing, and assembly. For the three and six months ended June 30, 2024 and 2023, DEXYCU ® product revenue-based royalty expense as a component of cost of sales was immaterial. Recently Adopted and Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07— Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This ASU was issued to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. This ASU applies to all public entities that are required to report segment information in accordance with Topic 280, Segment Reporting. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the standard should be applied retrospectively. ASU 2023-07 will be effective for the Company for the annual period of its fiscal year ending December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09 —Income Taxes (Topic 740) : Improvements to Income Tax Disclosures. This ASU was issued to address investor requests for more transparency about income tax information through improvements to income tax disclosure primarily related to the rate reconciliation and income taxes paid information, and to improve the effectiveness of income tax disclosures. This ASU is effective for public entities for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 will be effective for the Company in the first quarter of its fiscal year ending December 31, 2025. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 3. Revenue Product Revenue Reserves and Allowances From January 1, 2023 through May 17, 2023 (the date the Company entered into the product rights agreement (PRA) with Alimera, pursuant to which the Company granted an exclusive license and rights to its YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg (YUTIQ ® ) product to Alimera, the Company’s product revenues were primarily from sales of YUTIQ ® in the U.S. For the three and six months ended June 30, 2024, the Company’s product revenues were primarily from the Company’s existing commercial supply agreements with Alimera and Ocumension. For the three-and six-month peri ods ended June 30, 2024, the Company’s product revenues were made up of $ 1.1 million and $ 1.7 million from the sales of YUTIQ ®. For the three-and six-month periods ended June 30, 2023, the Company’s product revenues were made up of $ 5.3 million and $ 12.7 million from the sales of YUTIQ ® . Sales of DEXYCU ® for the three and six months ended June 30, 2024 and 2023 were immaterial. The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2024 and 2023 (in thousands): Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2024 $ 83 $ — $ 677 $ 760 Provision related to sales in the current year — — — — Adjustments related to prior period sales 70 — — 70 Deductions applied and payments made ( 130 ) — ( 54 ) ( 184 ) Ending balance at June 30, 2024 $ 23 $ — $ 623 $ 646 Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2023 $ 859 $ 158 $ 871 $ 1,888 Provision related to sales in the current year 1,358 — — 1,358 Adjustments related to prior period sales 40 ( 55 ) ( 154 ) ( 169 ) Deductions applied and payments made ( 1,696 ) ( 103 ) ( 111 ) ( 1,910 ) Ending balance at June 30, 2023 $ 561 $ — $ 606 $ 1,167 Returns estimates are recorded as a reduction of accounts receivable on the condensed consolidated balance sheets. Chargebacks, discounts and fees and rebates are recorded as a component of accrued expenses on the condensed consolidated balance sheets (See Note 6). License and Collaboration Agreements and Royalty Income Eyebiotech Limited On May 17, 2024, the Company entered into a license agreement (the Eyebiotech License Agreement) with Eyebiotech Limited (Eyebiotech). Under this agreement, the Company granted Eyebiotech a non-exclusive, sublicensable, assignable license to certain patent rights to make, have made, use, offer to sell, sell, import, and export licensed products for therapeutic ophthalmological uses worldwide. In consideration for the rights granted, Eyebiotech made a one-time upfront payment of $ 0.5 million to the Company upon execution of the Eyebiotech License Agreement. Additionally, Eyebiotech agreed to pay certain milestone payments and tiered royalties based on the achievement of development and regulatory milestones and the annual net sales of licensed products, respectively. The Company classified the cash proceeds of the $ 0.5 million upfront payment received from Eyebiotech as license and collaboration revenue upon the execution of the Eyebiotech License Agreement, as this was the only performance obligation identified. This amount is not an advance payment for the provision of future goods or services and is included in the current transaction price. The non-exclusive, sublicensable, assignable license is a functional, right-to-use license, and, therefore, any consideration associated with it is recognized at a point in time. During the three months ended June 30, 2024, the Company recorded $ 0.5 million in license and collaboration revenue related to the upfront payment. On July 12, 2024, Merck & Co., Inc. announced the completion of the acquisition of Eyebiotech. Eyebiotech is now a wholly-owned subsidiary of Merck & Co., Inc. The acquisition does not materially impact the terms of the Eyebiotech License Agreement. Alimera Product Rights Agreement and Commercial Supply Agreement On May 17, 2023 (the Closing Date), the Company entered into a PRA with Alimera. Under the PRA, the Company granted to Alimera an exclusive and sublicensable right and license (the License) under the Company’s and its affiliates’ interest in certain of the Company’s and its affiliates’ intellectual property to develop, manufacture, sell, commercialize, and otherwise exploit certain products, including YUTIQ ® , for the treatment and prevention of uveitis in the entire world except Europe, the Middle East and Africa (EMEA). Additionally, pursuant to the PRA, the Company transferred and assigned to Alimera certain assets (the Transferred Assets) and certain contracts with third parties related to YUTIQ ® , including the new drug application for YUTIQ ® (collectively, the Asset Transfer). Pursuant to the PRA, Alimera paid the Company a $ 75.0 million upfront payment. Alimera will also make four quarterly payments of $ 1.875 million to the Company totaling $ 7.5 million during 2024. Alimera will also pay royalties to the Company from 2025 to 2028 at a percentage of low-to-mid double digits of Alimera’s related U.S. annual net sales of certain products (including YUTIQ ® ) in excess of certain thresholds, beginning at $ 70 million in 2025, and increasing annually thereafter. Upon Alimera’s payment of the Upfront Payment and the 2024 quarterly payments, the licenses and rights granted to Alimera will automatically become perpetual and irrevocable. Payments received from Alimera are non-refundable. On the Closing Date, the Company and Alimera also entered into a commercial supply agreement (CSA), pursuant to which, during the term of the PRA, the Company agreed to manufacture and exclusively supply to Alimera agreed-upon quantities of YUTIQ ® necessary for Alimera to commercialize YUTIQ ® in the United States at certain cost plus amounts, subject to adjustments and potential extensions and terminations set forth in the CSA (the Supply Transaction and together with the License and the Asset Transfer, the Transaction). The Company classified the cash proceeds of the $ 75.0 million Upfront Payment received from Alimera as deferred revenue at the Closing Date, pursuant to the PRA and the CSA because the License and supply units to be delivered under both agreements comprise a single, combined performance obligation as Alimera will not have the right or ability to manufacture YUTIQ ® (or have YUTIQ ® manufactured by a third-party contract manufacturing organization) over the initial two-year term pursuant to the CSA. The combined performance obligation is satisfied over time using the units delivered output method to measure progress based on initial estimated supply units of YUTIQ ® over the two-year term for purposes of recognizing revenue, such that revenue is recognized based on the value transferred in the form of units of product in the satisfaction of a performance obligation. Through this method, the Company compares the actual units delivered to date with the current estimated total to be delivered in the contractual term to measure the satisfaction of the performance obligation and recognize revenue. The Company will monitor its estimate of total units to be delivered to determine if an adjustment is needed to ensure that revenue is recognized proportionally for units delivered to date relative to the total units expected to be delivered for the combined performance obligation. Such estimates of the total delivery will be reassessed on an ongoing basis. If the Company determines that a change in estimate is necessary, it will adjust revenue using a cumulative catch-up method. During the three and six months ended June 30, 2024, the Company recognized $ 0.6 million and $ 1.2 million , respectively, of revenue from sales of product supply to Alimera under the CSA and recorded this amount in product sales, net on the condensed consolidated statements of operations and comprehensive loss. The Company recognized $ 7.1 million and $ 17.5 million of license and collaboration revenue related to the PRA during the three and six months ended June 30, 2024, respectively, and $ 3.2 million of license and collaboration revenue related to the PRA during the three and six months ended June 30, 2023. As of June 30, 2024, the Company had $ 31.8 million and $ 0 as current and non-current deferred revenue recognized under the PRA, respectively. On June 24, 2024, Alimera announced that it entered into a definitive agreement to be acquired by ANI Pharmaceuticals, Inc. The proposed acquisition does not materially impact the terms of the PRA or CSA. SWK Royalty Purchase Agreement Pursuant to a royalty purchase agreement (RPA) with SWK Funding LLC (SWK), the Company sold its right to receive royalty payments on future sales of products subject to a licensing and development agreement, as amended, with Alimera (the Amended Alimera Agreement) for an upfront cash payment of $ 16.5 million. The Company classified the proceeds received from SWK as deferred revenue at inception of the RPA and is recognizing revenue as royalty payments are made from Alimera to SWK. The Company recognized $ 0.3 million and $ 0.6 million of royalty revenue related to the RPA for the three and six months ended June 30, 2024, respectively, and $ 0.2 million and $ 0.5 million of royalty revenue related to the RPA for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, the Company had $ 1.5 million and $ 11.7 million as current and non-current deferred revenue recognized under the RPA, respectively. As of December 31, 2023, the Company classified $ 1.4 million and $ 12.4 million as current and non-current deferred revenue recognized under the RPA, respectively. Ocumension Therapeutics Pursuant to license agreements and a Memorandum of Understanding signed with the Company, Ocumension has: • An exclusive license for the development and commercialization of its three-year micro insert using the Durasert technology for the treatment of posterior segment uveitis of the eye (YUTIQ ® in the U.S.) in Mainland China, Hong Kong, Macau, and Taiwan at its own cost and expense in return for royalties based on sales with the Company supplying products for clinical trials and commercial sale; • An exclusive license for the development and commercialization in Mainland China, Hong Kong, Macau, and Taiwan of DEXYCU ® for the treatment of post-operative inflammation following ocular surgery at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale; and • Exclusive rights to develop and commercialize YUTIQ ® and DEXYCU ® products under its own brand names in South Korea and other jurisdictions across Southeast Asia in Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam, at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale. During the three and six months ended June 30, 2024 and 2023, the Company recognized $ 0.5 million of revenue from sales of product supply to Ocumension under the supply agreement and recorded this amount in product sales, net on the condensed consolidated statements of operations and comprehensive loss. Royalty income of $ 0.3 million and 0.5 million was recorded f or the three and six months ended June 30, 2024. No royalty income was recorded for the three and six months ended June 30, 2023. License and collaboration revenue related to additional technical assistance during the three and six months ended June 30, 2024 and 2023 was immaterial. Exclusive License Agreement with Betta Pharmaceuticals, Co., Ltd. On May 2, 2022, the Company entered into an exclusive license agreement (the Betta License Agreement) with Betta Pharmaceuticals Co., Ltd. (Betta), an affiliate of Equinox Sciences, LLC (Equinox) (see Note 10). Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale, and import the Company’s product candidate, DURAVYU , an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E (the Licensed Product), in the field of ophthalmology (the Betta Field) in the greater area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory). The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory. In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory. The royalties are payable on a Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Licensed Product in a region and continuing until the later of (i) the date that is twelve (12) years after first commercial sale of such Licensed Product in such region, and (ii) the first day of the month following the month in which a generic product corresponding to such Licensed Product is launched in the relevant region. The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region. Betta is responsible for all costs relating to development, registration, manufacturing, marketing, advertising, promotional, launch, and sales activities in connection with the Licensed Products in the Betta Field in the Betta Territory. Betta is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in the Betta Field in the Betta Territory. The Betta License Agreement also requires Betta to achieve certain diligence milestones relating to regulatory filings, patient dosing, and regulatory approval by certain specified deadlines set forth in the Betta License Agreement, subject to certain exceptions and extensions as set forth in the Betta License Agreement. Betta’s development activities will be conducted pursuant to a development plan subject to periodic updates. In the event that the Company conducts a global registrational clinical trial for a Licensed Product in the Betta Field, Betta will have the right to participate in such clinical trial by including clinical trial sites in the Betta Territory in accordance with the terms of the Betta License Agreement. The Company has also agreed to provide certain technology transfer and other support services to Betta subject to certain conditions and limitations set forth in the Betta License Agreement. Revenue from license and collaboration revenue or royalty income for the three and six months ended June 30, 2024 and 2023 related to this agreement was immaterial. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): June 30, December 31, Prepaid expenses $ 3,300 $ 1,695 Prepaid clinical 5,271 6,335 Other 1,065 1,009 Total prepaid expenses and other current assets $ 9,636 $ 9,039 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory Inventory consisted of the following (in thousands): June 30, December 31, Raw materials $ 1,486 $ 1,303 Work in process 921 882 Finished goods 1,265 1,721 Total inventory $ 3,672 $ 3,906 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following (in thousands): June 30, December 31, 2024 2023 Personnel costs $ 6,991 $ 12,631 Clinical trial costs 4,865 3,305 Professional fees 606 666 Sales chargebacks, rebates and other revenue reserves 646 760 Other 233 159 Total accrued expenses $ 13,341 $ 17,521 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | 7. Leases On January 23, 2023, the Company entered into a lease agreement (Northbridge Lease) for its new standalone commercial manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new 41,141 square-foot manufacturing facility will be Current Good Manufacturing Practice (cGMP) compliant to meet U.S. FDA and European Medicines Agency (EMA) standards and will support DURAVYU clinical supply and commercial readiness upon regulatory approval. In addition, the building will have the capacity and capabilities for pipeline expansion. The lease includes a non-cancellable lease term of fifteen years and four months , with two options to extend the lease term for two additional terms of either five years or ten years at 95 % of the then-prevailing fair market rent. The lease term, under ASC 842, commenced during the second quarter of 2024. The Company’s obligation to pay base rent will begin four months following the qualification of the premises. The qualification of the premises is anticipated to occur during the fourth quarter of 2024. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises. The Company recognized an initial increase of $ 17.7 million to its lease liabilities and $ 17.9 million to its ROU assets resulting from the Northbridge Lease during the second quarter of 2024. Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the respective lease components. The expected lease terms include non-cancellable lease periods. Renewal option periods have not been included in the determination of the lease terms as they are not deemed reasonably certain of exercise. Variable lease payments, such as common area maintenance, real estate taxes, and property insurance are not included in the determination of the lease’s ROU asset or lease liability. As of June 30 , 2024 the weighted average remaining term of the Company’s operating leases was 12.6 years and the weighted average discount rate was 11.56 %. Supplemental balance sheet information related to operating leases as of June 30, 2024 and December 31, 2023 are as follows (in thousands): June 30, December 31, 2024 2023 Other current liabilities – operating lease current portion $ 1,130 $ 563 Operating lease liabilities – noncurrent portion 22,164 4,906 Total operating lease liabilities $ 23,294 $ 5,469 The elements of lease expense were as follows (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Lease expense included in: Research and development $ 518 $ 291 $ 809 $ 582 General and administrative 65 65 130 129 Variable lease costs 63 14 135 59 Total lease expense $ 646 $ 370 $ 1,074 $ 770 Cash paid for amounts included in the measurement of operating lease liabilities was $ 0.2 million and $ 0.3 million for the six months ended June 30, 2024 and 2023. The Company’s total future minimum lease payments under non-cancellable leases at June 30, 2024 were as follows (in thousands): Operating Leases Remainder of 2024 $ 1,227 2025 3,794 2026 4,136 2027 4,225 2028 3,322 Thereafter 31,900 Total lease payments $ 48,604 Less imputed interest ( 25,310 ) Total $ 23,294 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity ATM Facility In August 2020, the Company entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, the Company may, at its option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. The Company will pay Cantor a commission of 3.0 % of the gross proceeds from any future sales of such shares. During the three and six months ended June 30, 2024 and 2023, the Company did no t sell any shares of its common stock under the ATM Facility. During July 2024 the Company sold 1,299,506 shares of its common stock under the ATM facility at a weighted average price of $ 9.36 per share for gross proceeds of approximately $ 12.2 million. Share issue costs, including sales agent commissions, totaled approximately $ 0.4 million. Warrants to Purchase Common Shares Pursuant to a credit agreement, the Company issued a warrant to SWK to purchase (i) 40,910 shares of the Company’s common stock on March 28, 2018 at an exercise price of $ 11.00 per share with a seven-year term and (ii) 7,773 shares of the Company’s common stock on June 26, 2018 at an exercise price of $ 19.30 per share with a seven-year term. In January 2024, SWK exercised their warrants in full via cashless exercise resulting in the net share issuance of 25,666 shares. The Company issued 3,272,727 shares of Pre-Funded Warrants (PFW) to purchase common stock, in connection with the November 2021 underwritten public offering. On April 18, 2024, 2,181,818 PFWs were exercised in full as a cashless exercise, resulting in a net issuance of 2,180,776 shares of common stock. As of June 30, 2024 1,090,909 PFWs were outstanding. The PFWs were included in the basic and diluted net loss per share calculation during the three and six months ended June 30, 2024. . |
Share-Based Payment Awards
Share-Based Payment Awards | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Payment Awards | 9. Share-Based Payment Awards Equity Incentive Plan Prior to June 20, 2024, the Company had authorized the issuance of 9,400,000 shares of the Company ’ s common stock under the 2016 Long-Term Incentive Plan (the 2016 Plan), of which 373,256 shares remained available for future grants. The 2023 Long-Term Incentive Plan (the “2023 Plan”), approved by the Company’s stockholders on June 20, 2023 (the “Adoption Date”), originally provided for the issuance of up to 3,500,000 shares of the Company’s common stock reserved for issuance under the 2023 Plan plus any additional shares of the Company’s common stock that were available for grant under the 2008 and the 2016 Incentive Plan (the “2008 & 2016 Plan”) at the Adoption Date or would otherwise become available for grant under the 2008 Plan as a result of subsequent termination or forfeiture of awards under the 2008 or 2016 Plan. At the Company’s Annual Meeting of Stockholders held on June 20, 2024 , the Company’s stockholders approved an amendment to the 2023 Plan to increase the number of shares authorized for issuance by 4,000,000 shares. At June 30, 2024, a total of approximately 4,386,256 shares were available for new awards under the 2023 Plan. Starting March 2022, the Company granted non-statutory stock options to new employees as inducement awards to enter into employment with the Company. The grants were approved by the Compensation Committee of the Board of Directors and awarded in accordance with Nasdaq Listing Rule 5635(c)(4). Although not awarded under any equity incentive plans, the grants are subject to and governed by the terms and conditions of the applicable plan in effect at the time of the grant. Stock Options The following table provides a reconciliation of stock option activity under the Company’s equity incentive plan and for inducement awards for the six months ended June 30, 2024: Number of Weighted Weighted Aggregate (in years) (in thousands) Outstanding at January 1, 2024 6,304,767 $ 9.98 Granted 1,843,282 20.89 Exercised ( 521,716 ) 9.43 Forfeited ( 140,386 ) 7.60 Expired ( 59,256 ) 22.96 Outstanding at June 30, 2024 7,426,691 $ 12.67 7.83 $ 10,801 Exercisable at June 30, 2024 3,139,191 $ 12.14 6.43 $ 4,456 The Company's stock options generally vest over four years with 25 % vesting after one year of service followed by ratable monthly vesting over the remaining three years . Nonemployee awards are granted similar to the Company’s employee awards. All option grants have a 10 -year term. Options to purchase a total of 1,425,129 shares of the Company’s common stock vested during the six months ended June 30, 2024. In determining the grant date fair value of option awards during the six months ended June 30, 2024, the Company applied the Black-Scholes option pricing model based on the following key assumptions: Option life (in years) 5.50 - 6.08 Stock volatility 97 % - 100 % Risk-free interest rate 3.84 % - 4.60 % Expected dividends 0.0 % The following table summarizes information about employee, non-executive director and external consultant stock options for the six months ended June 30, 2024 (in thousands except per share amount): Six Months Ended June 30, 2024 Weighted average grant date fair value per share $ 16.62 Total cash received from exercise of stock options 4,917 Total intrinsic value of stock options exercised 7,269 Time-Vested Restricted Stock Units Time-vested restricted stock units (RSUs) issued to date under the 2016 Plan and the 2023 Plan generally vest on a ratable annual basis over 3 years. The related stock-based compensation expense is recorded over the requisite service period, which is the vesting period. The fair value of all time-vested RSUs is based on the closing share price of the Company’s common stock on the date of grant. The following table provides a reconciliation of RSU activity under the 2016 Plan and the 2023 Plan for the six months ended June 30, 2024: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2024 1,333,192 $ 5.31 Granted 636,100 20.40 Vested ( 557,000 ) 6.23 Forfeited ( 33,469 ) 7.57 Nonvested at June 30, 2024 1,378,823 $ 11.85 At June 30, 2024, the weighted average remaining vesting term of the RSUs was 1.59 years. Employee Stock Purchase Plan The Company’s Employee Stock Purchase Plan (the ESPP) allows qualified participants to purchase the Company’s common stock twice a year at 85 % of the lesser of the average of the high and low sales price of the Company’s common stock on (i) the first trading day of the relevant offering period and (ii) the last trading day of the relevant offering period. The number of shares of the Company’s common stock each employee may purchase under this plan, when combined with all other employee stock purchase plans, is limited to the lower of an aggregate fair market value of $ 25,000 during each calendar year, or 5,000 shares of the Company’s common stock in any one offering period. The Company has maintained consecutive six-month offering periods since August 1, 2019 . During the three and six months ended June 30 , 2024, 25,015 shares of the Company’s common stock were issued pursuant to the ESPP. The Company estimated the fair value of the option component of the ESPP shares at the date of grant using a Black-Scholes valuation model. During the three and six months ended June 30, 2024, the compensation expense from ESPP shares was approximately $ 0.1 million and $ 0.2 million. During the three and six months ended June 30, 2023, the compensation expense from ESPP shares was approximately $ 0.03 million and $ 0.08 million. Stock-Based Compensation Expense The Company’s condensed consolidated statements of comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Compensation expense included in: Research and development $ 3,610 $ 902 $ 11,438 $ 2,142 Sales and marketing — ( 200 ) — 230 General and administrative 5,085 1,086 9,956 2,466 $ 8,695 $ 1,788 $ 21,394 $ 4,838 During the three and six months ended June 30, 2024, the Company modified certain stock options and restricted stock awards in connection with the termination of executives resulting in incremental compensation expense of $ 0.1 million and $ 5.7 million, respectively. At June 30, 2024, there was approximately $ 36.5 million of unrecognized compensation expense related to outstanding equity awards under the 2023 Plan, the 2016 Plan, the inducement awards and the ESPP that is expected to be recognized as expense over a weighted average period of approximately 1.7 years. |
License and Asset Purchase Agre
License and Asset Purchase Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Asset Purchase Agreements | 10. License and Asset Purchase Agreements Equinox Science, LLC In February 2020, the Company entered into an Exclusive License Agreement (the Equinox License Agreement) with Equinox, pursuant to which Equinox granted the Company an exclusive, sublicensable, royalty-bearing right and license to certain patents and other Equinox intellectual property to research, develop, make, have made, use, sell, offer for sale, and import the compound vorolanib and any pharmaceutical products comprising the compound for local delivery to the eye for the prevention or treatment of age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion using the Company’s proprietary localized delivery technologies (the Original Field), in each case, throughout the world except China, Hong Kong, Taiwan, and Macau (the Company Territory). In consideration for the rights granted by Equinox, the Company (i) made a one time, non-refundable, non-creditable upfront cash payment of $ 1.0 million to Equinox in February 2020, and (ii) agreed to pay milestone payments totaling up to $ 50 million upon the achievement of certain development and regulatory milestones, consisting of (a) completion of a Phase II clinical trial for the compound or a licensed product, (b) the filing of a new drug application or foreign equivalent for the compound or a licensed product in the United States, European Union, or United Kingdom, and (c) regulatory approval of the compound or a licensed product in the United States, European Union or United Kingdom. The Company also agreed to pay Equinox tiered royalties based upon annual net sales of licensed products in the Company Territory. The royalties are payable with respect to a licensed product in a particular country in the Company Territory on a country-by-country and licensed product-by-licensed product basis until the later of (i) twelve years after the first commercial sale of such licensed product in such country and (ii) the first day of the month following the month in which a generic product corresponding to such licensed product is launched in such country. The royalty rates range from the high-single digits to low-double digits depending on the level of annual net sales. The royalty rates are subject to reduction during certain periods when there is no valid patent claim that covers a licensed product in a particular country. On May 2, 2022, concurrent with the Company entering into the Betta License Agreement (see Note 3), the Company entered into Amendment #1 to the Equinox License Agreement, pursuant to which the Original Field was expanded to cover the prevention or treatment of ophthalmology indications using the Company’s proprietary localized delivery technologies and certain conforming changes were made to the Equinox License Agreement in connection therewith. For the both the three and six months ended June 30, 2024 the Company recorded $ 5.0 million of R&D expenses in connection with the milestone payment for completion of a Phase II clinical trial for the compound or a licensed product under the Equinox License Agreement. No R&D expense was recorded for the three and six months ended June 30, 2023 related to the Equinox License Agreement. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 11. Fair Value Measurements The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis by valuation hierarchy (in thousands): June 30, 2024 Carrying Gross Gross Fair Value Cash Marketable Securities Level 1: Money market funds $ 64,561 $ — $ — $ 64,561 $ 64,561 $ — Subtotal $ 64,561 $ — $ — $ 64,561 $ 64,561 $ — Level 2: Commercial paper $ 94,145 $ — $ ( 18 ) $ 94,127 $ 7,978 $ 86,149 U.S. Treasury securities $ 41,195 $ — $ ( 13 ) $ 41,182 $ — $ 41,182 U.S. Agency securities $ 62,165 $ 3 $ ( 20 ) $ 62,148 $ — $ 62,148 Subtotal $ 197,505 $ 3 $ ( 51 ) $ 197,457 $ 7,978 $ 189,479 Total $ 262,066 $ 3 $ ( 51 ) $ 262,018 $ 72,539 $ 189,479 December 31, 2023 Carrying Gross Gross Fair Value Cash Marketable Securities Level 1: Money market funds $ 270,476 $ — $ — $ 270,476 $ 270,476 $ — Subtotal $ 270,476 $ — $ — $ 270,476 $ 270,476 $ — Level 2: Commercial paper $ 19,295 $ 8 $ — $ 19,303 $ 1,998 $ 17,305 U.S. Treasury securities 17,762 8 — 17,771 2,990 14,781 U.S. Agency securities 17,694 8 ( 1 ) 17,701 — 17,701 Subtotal $ 54,751 $ 24 $ ( 1 ) $ 54,775 $ 4,988 $ 49,787 Total $ 325,227 $ 24 $ ( 1 ) $ 325,251 $ 275,464 $ 49,787 At June 30, 2024 and December 31, 2023, a total of $ 64.6 million or 24.6 %, and a total of $ 270.5 million or 98.2 %, respectively, of the Company’s interest-bearing cash equivalent balances were concentrated in one institutional money market fund that has investments consisting primarily of Repurchase Agreements, U.S Treasuries, and U.S. Government Agency Debts. The Company had $ 8.0 million or 11.0 %, and a total $ 5.0 million or 1.8 % of the Company's interest-bearing cash equivalent balance which consisted of investment-grade Commercial paper and investment-grade U.S. Treasury securities at June 30, 2024, and December 31, 2023, respectively. Generally, these deposits may be redeemed upon demand and, therefore, the Company believes they have minimal risk. The Company’s cash equivalents and marketable securities are classified within Level 1 or Level 2 on the basis of valuations using quoted market prices or alternative pricing sources and models utilizing market observable inputs, respectively. The marketable securities have been valued on the basis of valuations provided by third-party pricing services, as derived from such services’ pricing models. Inputs to the models may include, but are not limited to, reported trades, executable bid and ask prices, broker/dealer quotations, prices, or yields of securities with similar characteristics, benchmark curves, or information pertaining to the issuer, as well as industry and economic events. The pricing services may use a matrix approach, which considers information regarding securities with similar characteristics to determine the valuation for a security, and have been classified as Level 2. The carrying amounts of accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short-term maturity. |
Contingencies
Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | 12. Contingencies Legal Proceedings The Company is subject to various routine legal proceedings and claims incidental to its business, which management believes will not have a material effect on the Company’s financial position, results of operations or cash flows. U.S. Department of Justice Subpoena In August 2022, the Company received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU ® (DOJ Investigation). The Company is cooperating fully with the government in connection with this matter. At this time, the Company is unable to predict the duration, scope or outcome of this matter or whether it could have a material impact on the Company's financial condition, results of operations, or cash flow. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 13. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. For periods in which the Company reports net income, diluted net income per share is determined by adding to the basic weighted average number of common shares outstanding the total number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive. Potentially dilutive shares were not included in the calculation of diluted net loss per share for each of the three and six months ended June 30, 2024 and 2023 as their inclusion would be anti-dilutive. Potential common stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows: As of June 30, 2024 2023 Stock options 7,426,691 6,170,968 ESPP 9,102 38,434 Warrants — 48,683 Restricted stock units 1,378,823 1,260,219 8,814,616 7,518,304 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions On May 17, 2024, the Company executed the Eyebiotech License Agreement with Eyebiotech. The Chief Executive Officer (David Guyer) and Chief Scientific Officer (Anthony Adamis) of Eyebiotech are members of the Company’ s board of directors. The Company recorded $ 0.5 million in license and collaboration revenue in connection with the upfront payment pursuant to the Eyebiotech License Agreement. On December 18, 2023, the Company entered into a consulting agreement with Dr. John Landis who also serves as the Company's Chair of the Science Committee and a member of the board of directors. Pursuant to the terms of the consulting agreement, Dr. Landis is entitled to receive an annual compensation payment of up to $ 0.6 million in exchange for performing certain research and development services as the Company's interim head of development. On January 5, 2024, pursuant to the consulting agreement, the Company granted Dr. Landis (i) stock options to purchase 20,000 shares of the Company’s common stock and (ii) 10,000 of restricted stock units. All equity grants to Dr. Landis vest after one year . He also received the Board stock option award to purchase 25,014 shares of the Company’s common stock. The compensation expense related to the consulting agreement recognized by the Company for the three and six months ended June 30, 2024, was $ 0.2 million and $ 0.4 million, respectively. Additionally, the Company recorded accounts payable of $ 0.1 million in the accompanying consolidated balance sheets related to services provided by Dr. Landis, as of June 30, 2024. Services under this agreement concluded during the second quarter of 2024. Nancy S. Lurker, the former Chief Executive Officer and Executive Vice Chair of the Company and current Vice Chair of the Board is a member of the board of directors of Altasciences, the parent company of Calvert Laboratories, Inc. (Calvert Labs), an entity with which the Company conducts business. The Company recorded $ 0.3 million and $ 0.9 million of research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss related to preclinical and analytical services provided by Altasciences for the three and six months ended June 30, 2024, respectively. Additionally, the Company recorded accounts payable of $ 0.6 million and $ 0.3 million, and prepaid expenses of $ 0.2 million and $ 0.5 million in the accompanying condensed consolidated balance sheets related to services provided by Altasciences, as of June 30, 2024 and December 31, 2023, respectively. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events FDA Warning Letter On July 12, 2024, the Company received a warning letter from the FDA (Warning Letter) pertaining to YUTIQ ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at the Company’s Watertown facility in February 2024. The Warning Letter does not represent a final FDA determination of compliance. The Warning Letter requires the Company to implement improvements to the process by which the Company investigates unexplained discrepancies, the implementation of additional written procedures for production and process control, and the adoption of additional control procedures to monitor the output and to validate the performance of manufacturing processes. The Company timely responded to the FDA on August 1, 2024 and is addressing the FDA's observations. Based on current information, the Company believes that the supply of YUTIQ ® to patients should not be materially interrupted and that the Company’s other products in development, including DURAVYU , are not impacted by this regulatory action. Nancy S. Lurker Separation Agreement On July 10, 2024, Nancy S. Lurker’s term as Executive Vice Chair of the Company expired in accordance with the terms of her Employment Letter Agreement, dated September 16, 2016 and amended on January 3, 2023 and July 10, 2023. Ms. Lurker continues to serve as a member and Vice Chair of the Board of Directors of the Company. On August 6, 2024, Ms. Lurker and the Company entered into a severance agreement and general release (the “Separation Agreement”). Pursuant to the Separation Agreement, subject to Ms. Lurker agreeing to a release of claims and complying with certain other continuing obligations contained therein, the Company will pay Ms. Lurker a lump sum cash payment equal to $ 0.3 million, less applicable taxes and withholdings. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers (ASC 606), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value-add and other taxes collected on behalf of third parties are excluded from revenue. Product sales, net — Effective January 2023, commercial sales of DEXYCU ® were no longer supported by the Company, remaining available only through specialty distributors. Effective May 2023, YUTIQ ® has been and continues to be sold under commercial supply agreements with Alimera Sciences, Inc. (Alimera) and Ocumension Therapeutics (Ocumension) (see Note 3). Prior to the above dates, the Company sold YUTIQ ® and DEXYCU ® to a limited number of specialty distributors and specialty pharmacies (collectively the Distributors) in the U.S., with whom the Company had entered into formal agreements, for delivery to physician practices for YUTIQ ® and to hospital outpatient departments and ambulatory surgical centers (ASCs) for DEXYCU ® . The Company recognized revenue on sales of its products when Distributors obtained control of the products, which occurred at a point in time, typically upon delivery. In addition to agreements with Distributors, the Company also entered into arrangements with healthcare providers, ASCs, and payors that provided for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to their purchase of the Company's products from Distributors. Reserves for variable consideration — Product sales were recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration included trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that were offered within contracts between the Company and its Distributors, payors, and other contracted purchasers relating to the Company's product sales. These reserves were based on the amounts earned, or to be claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled. Overall, these reserves reflected the Company's best estimates of the amount of consideration to which it was entitled based on the terms of the respective underlying contracts. The actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from the estimates, the Company adjusts these estimates, which would affect product revenue and earnings in the period such variances become known. Distribution fees — The Company compensated its Distributors for services explicitly stated in the Company’s contracts and were recorded as a reduction of revenue in the period the related product sale was recognized. Provider chargebacks and discounts — Chargebacks were discounts that represented the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to the Company’s Distributors. These Distributors charged the Company for the difference between what they paid for the product and the Company’s contracted selling price. These reserves were established in the same period that the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Reserves for chargebacks consisted of amounts that the Company expected to pay for units that remained in the distribution channel inventories at each reporting period-end that the Company expected to be sold under a contracted selling price, and chargebacks that Distributors had claimed, but for which the Company had not yet settled. Government rebates — The Company was subject to discount obligations under state Medicaid programs and Medicare. These reserves were recorded in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability which was included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company’s liability for these rebates consisted of invoices received for claims from prior quarters that had not been paid or for which an invoice had not yet been received, estimates of claims for the current quarter, and estimated future claims that would be made for product that had been recognized as revenue, but which remained in the distribution channel inventories at the end of each reporting period. Payor rebates — The Company contracted with certain private payor organizations, primarily insurance companies, for the payment of rebates with respect to utilization of its products. The Company estimated these rebates and recorded such estimates in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Co-Payment assistance — The Company offered co-payment assistance to commercially insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance was based on an estimate of claims and the cost per claim that the Company expected to receive associated with product that had been recognized as revenue. Product returns — The Company generally offered a limited right of return based on its returned goods policy, which included damaged product and remaining shelf life. The Company estimated the amount of its product sales that may be returned and recorded. License and collaboration agreement revenue — The Company analyzes each element of its license and collaboration arrangements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to the Company of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For licenses that are combined with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time, when (or as) the associated performance obligation in the contract is satisfied. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of June 30, 2024. Royalties — The Company recognizes revenue from license arrangements with its commercial partners’ net sales of products. Such revenues are included as royalty income. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. The Company’s commercial partners are obligated to report their net product sales and the resulting royalty due to the Company typically within 60-days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, the Company recognizes royalty income each quarter and subsequently determines a true-up when it receives royalty reports and payment from its commercial partners. Historically, these true-up adjustments have been immaterial. Sale of Future Royalties — The Company has sold its rights to receive certain royalties on product sales. In the circumstance where the Company has sold its rights to future royalties under a royalty purchase agreement (RPA) and also maintains limited continuing involvement in the arrangement (but not significant continuing involvement in the generation of the cash flows that are due to the purchaser), the Company defers recognition of the proceeds it receives for the sale of royalty streams and recognizes such unearned revenue as revenue under the units-of-revenue method over the life of the underlying license agreement. Under the units-of-revenue method, amortization for a reporting period is calculated by computing a ratio of the proceeds received from the purchaser to the total payments expected to be made to the purchaser over the term of the agreement, and then applying that ratio to the period’s cash payment. Estimating the total payments expected to be received by the purchaser over the term of such arrangements requires management to use subjective estimates and assumptions. Changes to the Company’s estimate of the payments expected to be made to the purchaser over the term of such arrangements could have a material effect on the amount of revenues recognized in any particular period. Research Collaborations — The Company recognizes revenue over the term of the statements of work under any funded research collaborations. Revenue recognition for consideration, if any, related to a license option right is assessed based on the terms of any such future license agreement or is otherwise recognized at the completion of the research collaborations. Please refer to Note 3 for further details on the license and collaboration agreements into which the Company has entered and corresponding amounts of revenue recognized during the current and prior year periods. Cost of sales — Cost of sales consist of costs associated with the manufacture of YUTIQ ® and DEXYCU ® , certain period costs for DEXYCU ® product revenue, product shipping, and as applicable, royalty expense. The inventory costs for YUTIQ ® include purchases of various components, the active pharmaceutical ingredient (API), and direct labor and overhead for the product manufactured in the Company’s Watertown, Massachusetts facility. The inventory costs for DEXYCU ® include purchased components, the API and third-party manufacturing, and assembly. For the three and six months ended June 30, 2024 and 2023, DEXYCU ® product revenue-based royalty expense as a component of cost of sales was immaterial. Recently Adopted and Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07— Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This ASU was issued to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. This ASU applies to all public entities that are required to report segment information in accordance with Topic 280, Segment Reporting. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the standard should be applied retrospectively. ASU 2023-07 will be effective for the Company for the annual period of its fiscal year ending December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09 —Income Taxes (Topic 740) : Improvements to Income Tax Disclosures. This ASU was issued to address investor requests for more transparency about income tax information through improvements to income tax disclosure primarily related to the rate reconciliation and income taxes paid information, and to improve the effectiveness of income tax disclosures. This ASU is effective for public entities for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 will be effective for the Company in the first quarter of its fiscal year ending December 31, 2025. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements. |
Recently Adopted and Recently Issued Accounting Pronouncements | Recently Adopted and Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07— Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This ASU was issued to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. This ASU applies to all public entities that are required to report segment information in accordance with Topic 280, Segment Reporting. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the standard should be applied retrospectively. ASU 2023-07 will be effective for the Company for the annual period of its fiscal year ending December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09 —Income Taxes (Topic 740) : Improvements to Income Tax Disclosures. This ASU was issued to address investor requests for more transparency about income tax information through improvements to income tax disclosure primarily related to the rate reconciliation and income taxes paid information, and to improve the effectiveness of income tax disclosures. This ASU is effective for public entities for annual periods beginning after December 15, 2024. Early adoption is permitted. ASU 2023-09 will be effective for the Company in the first quarter of its fiscal year ending December 31, 2025. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue Allowances and Reserves | The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2024 and 2023 (in thousands): Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2024 $ 83 $ — $ 677 $ 760 Provision related to sales in the current year — — — — Adjustments related to prior period sales 70 — — 70 Deductions applied and payments made ( 130 ) — ( 54 ) ( 184 ) Ending balance at June 30, 2024 $ 23 $ — $ 623 $ 646 Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2023 $ 859 $ 158 $ 871 $ 1,888 Provision related to sales in the current year 1,358 — — 1,358 Adjustments related to prior period sales 40 ( 55 ) ( 154 ) ( 169 ) Deductions applied and payments made ( 1,696 ) ( 103 ) ( 111 ) ( 1,910 ) Ending balance at June 30, 2023 $ 561 $ — $ 606 $ 1,167 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): June 30, December 31, Prepaid expenses $ 3,300 $ 1,695 Prepaid clinical 5,271 6,335 Other 1,065 1,009 Total prepaid expenses and other current assets $ 9,636 $ 9,039 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): June 30, December 31, Raw materials $ 1,486 $ 1,303 Work in process 921 882 Finished goods 1,265 1,721 Total inventory $ 3,672 $ 3,906 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): June 30, December 31, 2024 2023 Personnel costs $ 6,991 $ 12,631 Clinical trial costs 4,865 3,305 Professional fees 606 666 Sales chargebacks, rebates and other revenue reserves 646 760 Other 233 159 Total accrued expenses $ 13,341 $ 17,521 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases as of June 30, 2024 and December 31, 2023 are as follows (in thousands): June 30, December 31, 2024 2023 Other current liabilities – operating lease current portion $ 1,130 $ 563 Operating lease liabilities – noncurrent portion 22,164 4,906 Total operating lease liabilities $ 23,294 $ 5,469 |
Summary of Lease Expense | The elements of lease expense were as follows (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Lease expense included in: Research and development $ 518 $ 291 $ 809 $ 582 General and administrative 65 65 130 129 Variable lease costs 63 14 135 59 Total lease expense $ 646 $ 370 $ 1,074 $ 770 |
Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases | The Company’s total future minimum lease payments under non-cancellable leases at June 30, 2024 were as follows (in thousands): Operating Leases Remainder of 2024 $ 1,227 2025 3,794 2026 4,136 2027 4,225 2028 3,322 Thereafter 31,900 Total lease payments $ 48,604 Less imputed interest ( 25,310 ) Total $ 23,294 |
Share-Based Payment Awards (Tab
Share-Based Payment Awards (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Option Activity Under Plan | The following table provides a reconciliation of stock option activity under the Company’s equity incentive plan and for inducement awards for the six months ended June 30, 2024: Number of Weighted Weighted Aggregate (in years) (in thousands) Outstanding at January 1, 2024 6,304,767 $ 9.98 Granted 1,843,282 20.89 Exercised ( 521,716 ) 9.43 Forfeited ( 140,386 ) 7.60 Expired ( 59,256 ) 22.96 Outstanding at June 30, 2024 7,426,691 $ 12.67 7.83 $ 10,801 Exercisable at June 30, 2024 3,139,191 $ 12.14 6.43 $ 4,456 |
Schedule of Key Assumptions Used | In determining the grant date fair value of option awards during the six months ended June 30, 2024, the Company applied the Black-Scholes option pricing model based on the following key assumptions: Option life (in years) 5.50 - 6.08 Stock volatility 97 % - 100 % Risk-free interest rate 3.84 % - 4.60 % Expected dividends 0.0 % |
Summary of Information about Stock Options | The following table summarizes information about employee, non-executive director and external consultant stock options for the six months ended June 30, 2024 (in thousands except per share amount): Six Months Ended June 30, 2024 Weighted average grant date fair value per share $ 16.62 Total cash received from exercise of stock options 4,917 Total intrinsic value of stock options exercised 7,269 |
Summary of Restricted Stock Unit Activity | The following table provides a reconciliation of RSU activity under the 2016 Plan and the 2023 Plan for the six months ended June 30, 2024: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2024 1,333,192 $ 5.31 Granted 636,100 20.40 Vested ( 557,000 ) 6.23 Forfeited ( 33,469 ) 7.57 Nonvested at June 30, 2024 1,378,823 $ 11.85 |
Compensation Expense from Stock-Based Payment Awards | The Company’s condensed consolidated statements of comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Compensation expense included in: Research and development $ 3,610 $ 902 $ 11,438 $ 2,142 Sales and marketing — ( 200 ) — 230 General and administrative 5,085 1,086 9,956 2,466 $ 8,695 $ 1,788 $ 21,394 $ 4,838 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Carried at Fair Value Measured on Recurring Basis | The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis by valuation hierarchy (in thousands): June 30, 2024 Carrying Gross Gross Fair Value Cash Marketable Securities Level 1: Money market funds $ 64,561 $ — $ — $ 64,561 $ 64,561 $ — Subtotal $ 64,561 $ — $ — $ 64,561 $ 64,561 $ — Level 2: Commercial paper $ 94,145 $ — $ ( 18 ) $ 94,127 $ 7,978 $ 86,149 U.S. Treasury securities $ 41,195 $ — $ ( 13 ) $ 41,182 $ — $ 41,182 U.S. Agency securities $ 62,165 $ 3 $ ( 20 ) $ 62,148 $ — $ 62,148 Subtotal $ 197,505 $ 3 $ ( 51 ) $ 197,457 $ 7,978 $ 189,479 Total $ 262,066 $ 3 $ ( 51 ) $ 262,018 $ 72,539 $ 189,479 December 31, 2023 Carrying Gross Gross Fair Value Cash Marketable Securities Level 1: Money market funds $ 270,476 $ — $ — $ 270,476 $ 270,476 $ — Subtotal $ 270,476 $ — $ — $ 270,476 $ 270,476 $ — Level 2: Commercial paper $ 19,295 $ 8 $ — $ 19,303 $ 1,998 $ 17,305 U.S. Treasury securities 17,762 8 — 17,771 2,990 14,781 U.S. Agency securities 17,694 8 ( 1 ) 17,701 — 17,701 Subtotal $ 54,751 $ 24 $ ( 1 ) $ 54,775 $ 4,988 $ 49,787 Total $ 325,227 $ 24 $ ( 1 ) $ 325,251 $ 275,464 $ 49,787 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares | Potential common stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows: As of June 30, 2024 2023 Stock options 7,426,691 6,170,968 ESPP 9,102 38,434 Warrants — 48,683 Restricted stock units 1,378,823 1,260,219 8,814,616 7,518,304 |
Operations - Additional Informa
Operations - Additional Information (Detail) $ in Millions | Jun. 30, 2024 USD ($) |
Operations [Line Items] | |
Cash, cash equivalents and investments in marketable securities | $ 280.2 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
May 17, 2024 | Dec. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2025 | Dec. 31, 2024 | Dec. 31, 2023 | |
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | $ 9,477,000 | $ 9,105,000 | $ 21,161,000 | $ 16,788,000 | |||||
Alimera Sciences, Inc. [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Product rights agreement, closing date | May 17, 2023 | ||||||||
Receipt of upfront license fee | $ 75,000,000 | ||||||||
Eyebiotech License Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Upfront cash payment | $ 500,000 | ||||||||
Receipt of upfront license fee | 500,000 | ||||||||
RPA [Member] | SWK [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Upfront cash payment | 16,500,000 | ||||||||
Revenue | 300,000 | 200,000 | 600,000 | 500,000 | |||||
Deferred revenue, current | 1,500,000 | 1,500,000 | $ 1,400,000 | ||||||
Deferred revenue, non-current | 11,700,000 | 11,700,000 | $ 12,400,000 | ||||||
RPA [Member] | Product Rights Agreement and the Supply Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 3,200,000 | ||||||||
YUTIQ [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 1,100,000 | 5,300,000 | 1,700,000 | 12,700,000 | |||||
Product [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 1,068,000 | 5,273,000 | 1,726,000 | 12,667,000 | |||||
Product [Member] | Ocumension Therapeutics [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 500,000 | 500,000 | 500,000 | 500,000 | |||||
Product [Member] | Product Rights Agreement and the Supply Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 600,000 | 1,200,000 | |||||||
License and Collaboration Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 7,782,000 | 3,597,000 | 18,345,000 | 3,631,000 | |||||
License and Collaboration Agreement [Member] | Eyebiotech License Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | $ 500,000 | 500,000 | |||||||
Royalty Income [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 627,000 | 235,000 | 1,090,000 | 490,000 | |||||
Royalty Income [Member] | Ocumension Therapeutics [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | 300,000 | $ 0 | 500,000 | 0 | |||||
Product Rights Agreement [Member] | Alimera Sciences, Inc. [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Upfront cash payment | 75,000,000 | ||||||||
Deferred revenue, current | 31,800,000 | 31,800,000 | |||||||
Deferred revenue, non-current | 0 | $ 0 | |||||||
Product Rights Agreement [Member] | Alimera Sciences, Inc. [Member] | Scenario, Forecast [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Guaranteed payments | $ 1,875,000 | $ 7,500,000 | |||||||
Product Rights Agreement [Member] | Alimera Sciences, Inc. [Member] | Maximum [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Royalties payment period | 2028 | ||||||||
Product Rights Agreement [Member] | Alimera Sciences, Inc. [Member] | Maximum [Member] | Scenario, Forecast [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Royalty payments | $ 70,000,000 | ||||||||
Product Rights Agreement [Member] | Alimera Sciences, Inc. [Member] | Minimum [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Royalties payment period | 2025 | ||||||||
Product Rights Agreement [Member] | Product Rights Agreement and the Supply Agreement [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Revenue | $ 7,100,000 | $ 17,500,000 | $ 3,200,000 | ||||||
Supply Agreement [Member] | Alimera Sciences, Inc. [Member] | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Initial term of the supply agreement | 2 years | ||||||||
Initial Term of Estimated Supply Units | 2 years |
Revenue - Product Revenue Allow
Revenue - Product Revenue Allowance and Reserves (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | $ 760 | $ 1,888 |
Provision related to sales in the current year | 1,358 | |
Adjustments related to prior period sales | 70 | (169) |
Deductions applied and payments made | (184) | (1,910) |
Ending balance | 646 | 1,167 |
Chargebacks, Discounts and Fees [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 83 | 859 |
Provision related to sales in the current year | 1,358 | |
Adjustments related to prior period sales | 70 | 40 |
Deductions applied and payments made | (130) | (1,696) |
Ending balance | 23 | 561 |
Government and Other Rebates [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 158 | |
Adjustments related to prior period sales | (55) | |
Deductions applied and payments made | (103) | |
Ending balance | 0 | |
Returns [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 677 | 871 |
Adjustments related to prior period sales | (154) | |
Deductions applied and payments made | (54) | (111) |
Ending balance | $ 623 | $ 606 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid expenses | $ 3,300 | $ 1,695 |
Prepaid clinical | 5,271 | 6,335 |
Other | 1,065 | 1,009 |
Total prepaid expenses and other current assets | $ 9,636 | $ 9,039 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,486 | $ 1,303 |
Work in process | 921 | 882 |
Finished goods | 1,265 | 1,721 |
Total inventory | $ 3,672 | $ 3,906 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Personnel costs | $ 6,991 | $ 12,631 |
Clinical trial costs | 4,865 | 3,305 |
Professional fees | 606 | 666 |
Sales chargebacks, rebates and other revenue reserves | 646 | 760 |
Other | 233 | 159 |
Total accrued expenses | $ 13,341 | $ 17,521 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 6 Months Ended | ||
Jan. 23, 2023 ft² Tranche | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | |
Disclosure Of Leases [Line Items] | |||
Operating lease weighted average remaining lease term | 12 years 7 months 6 days | ||
Operating lease weighted average discount rate | 11.56% | ||
Operating lease payments | $ 0.2 | $ 0.3 | |
Massachusetts [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease description | The lease term, under ASC 842, commenced during the second quarter of 2024. The Company’s obligation to pay base rent will begin four months following the qualification of the premises. | ||
Increase in lease liabilities | 17.7 | ||
Increase in ROU assets | $ 17.9 | ||
Massachusetts [Member] | New Premises [Member] | |||
Disclosure Of Leases [Line Items] | |||
Original lease term | 15 years 4 months | ||
Lease existence of option to extend | true | ||
Lease option to extend | The lease includes a non-cancellable lease term of fifteen years and four months, with two options to extend the lease term for two additional terms of either five years or ten years at 95% of the then-prevailing fair market rent. | ||
Number of renewal options | Tranche | 2 | ||
Lease renewal rate at 95% of market rent at time of renewal | 95% | ||
Area of property covered | ft² | 41,141 | ||
Massachusetts [Member] | Minimum [Member] | New Premises [Member] | |||
Disclosure Of Leases [Line Items] | |||
Additional lease renewal option period | 5 years | ||
Massachusetts [Member] | Maximum [Member] | New Premises [Member] | |||
Disclosure Of Leases [Line Items] | |||
Additional lease renewal option period | 10 years |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Related to Operating Leases (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
Other current liabilities – operating lease current portion | $ 1,130 | $ 563 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Operating lease liabilities - noncurrent portion | $ 22,164 | $ 4,906 |
Total operating lease liabilities | $ 23,294 | $ 5,469 |
Leases - Summary of Lease Expen
Leases - Summary of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Lease expense included in: | ||||
Variable lease cost | $ 63 | $ 14 | $ 135 | $ 59 |
Total lease expense | 646 | 370 | 1,074 | 770 |
Research and Development [Member] | ||||
Lease expense included in: | ||||
Total lease expense, excluding variable lease costs | 518 | 291 | 809 | 582 |
General and Administrative [Member] | ||||
Lease expense included in: | ||||
Total lease expense, excluding variable lease costs | $ 65 | $ 65 | $ 130 | $ 129 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Operating Leases | ||
Remainder of 2024 | $ 1,227 | |
2025 | 3,794 | |
2026 | 4,136 | |
2027 | 4,225 | |
2028 | 3,322 | |
Thereafter | 31,900 | |
Total lease payments | 48,604 | |
Less imputed interest | (25,310) | |
Total | $ 23,294 | $ 5,469 |
Loan Agreements - Additional In
Loan Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Loan Agreement [Line Items] | ||||
Loss on extinguishment of debt | $ 0 | $ (1,347) | $ 0 | $ (1,347) |
Payment of exit fee | $ 0 | $ 1,350 |
Stockholders' Equity - Equity F
Stockholders' Equity - Equity Financings - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Apr. 18, 2024 | Jul. 31, 2024 | Aug. 31, 2020 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Class Of Stock [Line Items] | |||||||
Common stock issued | 2,180,776 | ||||||
Share issuance costs | $ 307 | $ 0 | |||||
At-the-Market Offering [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Stock issuances, sales agent commission maximum percentage | 3% | ||||||
At-the-Market Offering [Member] | Common Stock [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock issued | 0 | 0 | 0 | 0 | |||
At-the-Market Offering [Member] | Subsequent Event [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Price per share | $ 9.36 | ||||||
Gross proceeds from issuance of common stock | $ 12,200 | ||||||
Share issuance costs | $ 400 | ||||||
At-the-Market Offering [Member] | Subsequent Event [Member] | Common Stock [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock issued | 1,299,506 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Common Shares - Additional Information (Detail) - $ / shares | 6 Months Ended | |||||
Apr. 18, 2024 | Jun. 26, 2018 | Mar. 28, 2018 | Jun. 30, 2024 | Jan. 31, 2024 | Nov. 30, 2021 | |
Class Of Stock [Line Items] | ||||||
Pre Funded Warrants to purchase common stock | 3,272,727 | |||||
Pre Funded Warrants Outstandings | 1,090,909 | |||||
Pre-funded warrants shares included in net loss per share calculation | 1,090,909 | |||||
Warrants were exercised in cashless exercise | 2,181,818 | |||||
Net issuance of common shares | 2,180,776 | |||||
SWK [Member] | Warrants [Member] | ||||||
Class Of Stock [Line Items] | ||||||
share issuance, net | 25,666 | |||||
SWK [Member] | Senior Secured Term Loan [Member] | Warrants [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Warrants issued to purchase shares of common stock | 7,773 | 40,910 | ||||
Exercise price of issued warrants | $ 19.30 | $ 11 | ||||
Warrants exercise period | 7 years | 7 years |
Share-Based Payment Awards - Eq
Share-Based Payment Awards - Equity Incentive Plan - Additional Information (Detail) - shares | Jun. 20, 2024 | Jun. 20, 2023 | Jun. 30, 2024 | Jun. 19, 2024 |
2016 Long Term Incentive Plan [Member] | ||||
Class Of Stock [Line Items] | ||||
Number of common stock, authorized for issuance | 9,400,000 | |||
Shares remained available for grant | 373,256 | |||
2023 Long Term Incentive Plan [Member] | ||||
Class Of Stock [Line Items] | ||||
Equity incentive plan, approval date | Jun. 20, 2024 | Jun. 20, 2023 | ||
Number of common stock, authorized for issuance | 4,000,000 | 3,500,000 | ||
Shares available for grant under the Long Term Incentive Plan | 4,386,256 |
Share-Based Payment Awards - St
Share-Based Payment Awards - Stock Option Activity Under Company's Equity Incentive Plan (Detail) - Equity Incentive Plan and Inducement Awards [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | 6,304,767 |
Number of Options, Granted | 1,843,282 |
Number of Options, Exercised | (521,716) |
Number of Options, Forfeited | (140,386) |
Number of Options, Expired | (59,256) |
Number of Options Outstanding, Ending balance | 7,426,691 |
Number of Options, Exercisable at June 30, 2023 | 3,139,191 |
Weighted Average Exercise Price Outstanding, Beginning balance | $ 9.98 |
Weighted Average Exercise Price, Granted | 20.89 |
Weighted Average Exercise Price, Exercised | 9.43 |
Weighted Average Exercise Price, Forfeited | 7.6 |
Weighted Average Exercise Price, Expired | 22.96 |
Weighted Average Exercise Price Outstanding, Ending balance | 12.67 |
Weighted Average Exercise Price, Exercisable at June 30, 2023 | $ 12.14 |
Weighted Average Remaining Contractual Life, Outstanding at June 30, 2023 | 7 years 9 months 29 days |
Weighted Average Remaining Contractual Life, Exercisable at MarchJune 30, 2023 | 6 years 5 months 4 days |
Aggregate Intrinsic Value, Outstanding at June 30, 2023 | $ 10,801 |
Aggregate Intrinsic Value, Exercisable at June 30, 2023 | $ 4,456 |
Share-Based Payment Awards - _2
Share-Based Payment Awards - Stock Options - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 shares | |
2016 and 2023 Long Term Incentive Plan [Member] | |
Class Of Stock [Line Items] | |
Contractual life of option grants | 10 years |
Stock Compensation Plan [Member] | |
Class Of Stock [Line Items] | |
Ratable monthly vesting period | 4 years |
Award vesting percentage | 25% |
Cliff vesting period | 3 years |
Common stock vested during the period | 1,425,129 |
Share-Based Payment Awards - Su
Share-Based Payment Awards - Summary of Company Applied the Black-Scholes Option Pricing (Detail) - 2016 and 2023 Long Term Incentive Plan [Member] | 6 Months Ended |
Jun. 30, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock volatility, minimum | 97% |
Stock volatility, maximum | 100% |
Risk-free interest rate, minimum | 3.84% |
Risk-free interest rate, maximum | 4.60% |
Expected dividends | 0% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Option life (in years) | 5 years 6 months |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Option life (in years) | 6 years 29 days |
Share-Based Payment Awards - _3
Share-Based Payment Awards - Summary of Information about Stock Options (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Total cash received from exercise of stock options | $ 5,185 | $ 253 |
Equity Incentive Plans [Member] | ||
Weighted-average grant date fair value per share | $ 16.62 | |
Total cash received from exercise of stock options | $ 4,917 | |
Total intrinsic value of stock options exercised | $ 7,269 |
Share-Based Payment Awards - Ti
Share-Based Payment Awards - Time-Vested Restricted Stock Units - Additional Information (Detail) - RSU [Member] - 2016 and 2023 Long Term Incentive Plan [Member] | 6 Months Ended |
Jun. 30, 2024 | |
Class Of Stock [Line Items] | |
Ratable annual vesting period of equity awards | 1 year 7 months 2 days |
Annual Basis [Member] | |
Class Of Stock [Line Items] | |
Ratable annual vesting period of equity awards | 3 years |
Share-Based Payment Awards - _4
Share-Based Payment Awards - Summary of Restricted Stock Unit Activity (Detail) - 2016 and 2023 Long Term Incentive Plan [Member] - RSU [Member] | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Stock Units Outstanding, Beginning Balance | shares | 1,333,192 |
Number of Stock Units, Granted | shares | 636,100 |
Number of Stock Units, Vested | shares | (557,000) |
Number of Stock Units, Forfeited | shares | (33,469) |
Number of Stock Units Outstanding, Ending Balance | shares | 1,378,823 |
Weighted Average Grant Date Fair Value Nonvested, Beginning balance | $ / shares | $ 5.31 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 20.4 |
Weighted Average Grant Date Fair value, Vested | $ / shares | 6.23 |
Weighted Average Grant Date Fair value, Forfeited | $ / shares | 7.57 |
Weighted Average Grant Date Fair Value Nonvested, Ending balance | $ / shares | $ 11.85 |
Share-Based Payment Awards - Em
Share-Based Payment Awards - Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 25, 2019 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Class Of Stock [Line Items] | ||||||
Employee stock purchase plan | $ 268,000 | $ 248,000 | ||||
Common stock, shares issued | 52,160,305 | 52,160,305 | 49,043,074 | |||
Stock-based compensation expense | $ 8,695,000 | $ 1,788,000 | $ 21,394,000 | 4,838,000 | ||
ESPP [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Price of common stock purchased twice a year under ESPP, percent | 85% | |||||
Employee stock purchase plan | $ 25,000 | |||||
Employee stock purchase plan, shares | 5,000 | 25,015 | 25,015 | |||
Consecutive six month offering period | Aug. 01, 2019 | |||||
Stock-based compensation expense | $ 100,000 | $ 30,000 | $ 200,000 | $ 80,000 |
Share-Based Payment Awards - Co
Share-Based Payment Awards - Compensation Expense from Stock-Based Payment Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 8,695 | $ 1,788 | $ 21,394 | $ 4,838 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 3,610 | 902 | 11,438 | 2,142 |
Sales and Marketing [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 0 | (200) | 0 | 230 |
General and Administrative Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 5,085 | $ 1,086 | $ 9,956 | $ 2,466 |
Share-Based Payment Awards - _5
Share-Based Payment Awards - Stock-Based Compensation Expense - Additional Information (Detail) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Unrecognized compensation expense | $ 36.5 | $ 36.5 |
Unrecognized compensation expense weighted average period | 1 year 8 months 12 days | |
Stock Option and Restricted Stock Awards [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Incremental compensation expense | $ 0.1 | $ 5.7 |
License and Asset Purchase Ag_2
License and Asset Purchase Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Feb. 29, 2020 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Collaborative Agreements And Contracts [Line Items] | |||||
Research and development | $ 29,822,000 | $ 15,730,000 | $ 60,011,000 | $ 29,348,000 | |
Equinox Science, LLC [Member] | |||||
Collaborative Agreements And Contracts [Line Items] | |||||
Non-refundable and non-creditable upfront cash payment | $ 1,000,000 | ||||
Research and development | $ 5,000,000 | $ 0 | $ 5,000,000 | $ 0 | |
Equinox Science, LLC [Member] | Maximum [Member] | |||||
Collaborative Agreements And Contracts [Line Items] | |||||
Payment upon achievement of development and regulatory milestones | $ 50,000,000 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Carried at Fair Value Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities | $ 189,479 | $ 49,787 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 262,066 | 325,227 |
Gross Unrealized Gains | 3 | 24 |
Gross Unrealized Losses | (51) | (1) |
Fair Value | 262,018 | 325,251 |
Cash Equivalents | 72,539 | 275,464 |
Marketable Securities | 189,479 | 49,787 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 64,561 | 270,476 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 64,561 | 270,476 |
Cash Equivalents | 64,561 | 270,476 |
Marketable Securities | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 64,561 | 270,476 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 64,561 | 270,476 |
Cash Equivalents | 64,561 | 270,476 |
Marketable Securities | 0 | 0 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 197,505 | 54,751 |
Gross Unrealized Gains | 3 | 24 |
Gross Unrealized Losses | (51) | (1) |
Fair Value | 197,457 | 54,775 |
Cash Equivalents | 7,978 | 4,988 |
Marketable Securities | 189,479 | 49,787 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 94,145 | 19,295 |
Gross Unrealized Gains | 0 | 8 |
Gross Unrealized Losses | (18) | 0 |
Fair Value | 94,127 | 19,303 |
Cash Equivalents | 7,978 | 1,998 |
Marketable Securities | 86,149 | 17,305 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | U.S. Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 41,195 | 17,762 |
Gross Unrealized Gains | 0 | 8 |
Gross Unrealized Losses | (13) | 0 |
Fair Value | 41,182 | 17,771 |
Cash Equivalents | 0 | 2,990 |
Marketable Securities | 41,182 | 14,781 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | U.S. Agency securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 62,165 | 17,694 |
Gross Unrealized Gains | 3 | 8 |
Gross Unrealized Losses | (20) | (1) |
Fair Value | 62,148 | 17,701 |
Cash Equivalents | 0 | 0 |
Marketable Securities | $ 62,148 | $ 17,701 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 189,479 | $ 49,787 |
Interest-bearing cash equivalent consisted of money market fund | 64,600 | 270,500 |
Interest-bearing cash equivalent consisted of investment-grade commercial paper | 8,000 | 5,000 |
Interest-bearing cash equivalent consisted of investment-grade U.S.Treasury securities | $ 8,000 | $ 5,000 |
Investment Instruments [Member] | Credit Concentration Risk [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Percentage of concentration risk | 24.60% | 98.20% |
Investment Instruments [Member] | Credit Concentration Risk [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Percentage of concentration risk | 11% | 1.80% |
Investment Instruments [Member] | Credit Concentration Risk [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Percentage of concentration risk | 11% | 1.80% |
Net Loss per Share - Potentiall
Net Loss per Share - Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares (Detail) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 8,814,616 | 7,518,304 |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 7,426,691 | 6,170,968 |
ESPP [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 9,102 | 38,434 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 0 | 48,683 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 1,378,823 | 1,260,219 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
May 17, 2024 | Jan. 05, 2024 | Dec. 18, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Related Party Transaction [Line Items] | ||||||||
Revenues | $ 9,477,000 | $ 9,105,000 | $ 21,161,000 | $ 16,788,000 | ||||
Total stock-based compensation expense | 8,695,000 | 1,788,000 | 21,394,000 | 4,838,000 | ||||
Research and development expense | 29,822,000 | 15,730,000 | 60,011,000 | 29,348,000 | ||||
Prepaid expenses | 3,300,000 | 3,300,000 | $ 1,695,000 | |||||
License and Collaboration Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Revenues | 7,782,000 | $ 3,597,000 | 18,345,000 | $ 3,631,000 | ||||
Eyebiotech License Agreement [Member] | License and Collaboration Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Revenues | $ 500,000 | 500,000 | ||||||
Altasciences Company Inc [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Accounts payable | $ 600,000 | $ 600,000 | 300,000 | |||||
Other Liability, Related Party [Extensible Enumeration] | Accounts Payable, Current | Accounts Payable, Current | ||||||
Research and development expense | $ 300,000 | $ 900,000 | ||||||
Prepaid expenses | 200,000 | 200,000 | $ 500,000 | |||||
Dr. John Landis [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Annual Compensation Payment | $ 600,000 | |||||||
Total stock-based compensation expense | 200,000 | 400,000 | ||||||
Accounts payable | $ 100 | $ 100 | ||||||
Other Liability, Related Party [Extensible Enumeration] | Accounts Payable, Current | Accounts Payable, Current | ||||||
Dr. John Landis [Member] | Employee Stock Option | ||||||||
Related Party Transaction [Line Items] | ||||||||
Number of Options, Granted | 20,000 | |||||||
Contractual life of option grants | 1 year | |||||||
Dr. John Landis [Member] | Restricted stock units [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Number of Stock Units, Granted | 10,000 | |||||||
Dr. John Landis [Member] | Board Stock Option Award [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Number of Options, Granted | 25,014 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) $ in Millions | Aug. 08, 2024 USD ($) |
Subsequent Event [Member] | Separation Agreement [Member] | Nancy S. Lurker's [Member] | |
Subsequent Event [Line Items] | |
Cash Payment Related to Release of Claims and Obligations | $ 0.3 |