Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 04, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
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 | 34,044,255 | ||
Entity Public Float | $ 192,416,944 | ||
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 Annual Report | true | ||
Document Transition Report | false | ||
Entity Incorporation, State or Country Code | DE | ||
Title of 12(b) Security | Common Stock, par value $0.001 | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 34 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | Boston, Massachusetts | ||
Documents Incorporated by Reference | Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant’s proxy statement for the 2022 annual meeting of stockholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2021. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 178,593,000 | $ 44,909,000 |
Marketable securities | 32,965,000 | 0 |
Accounts and other receivables, net (including due from a related party of $414 and $104 at December 31, 2021 and 2020, respectively) | 18,354,000 | 9,453,000 |
Prepaid expenses and other current assets | 4,217,000 | 3,419,000 |
Inventory | 3,616,000 | 5,337,000 |
Total current assets | 237,745,000 | 63,118,000 |
Property and equipment, net | 476,000 | 630,000 |
Operating lease right-of-use assets | 2,252,000 | 2,610,000 |
Intangible assets, net | 22,749,000 | 25,209,000 |
Restricted cash | 150,000 | 150,000 |
Total assets | 263,372,000 | 91,717,000 |
Current liabilities: | ||
Accounts payable | 7,385,000 | 4,811,000 |
Accrued expenses | 14,422,000 | 8,445,000 |
Deferred revenue | 1,069,000 | 945,000 |
Other current liabilities | 782,000 | 687,000 |
Total current liabilities | 23,658,000 | 14,888,000 |
Long-term debt | 36,562,000 | 37,977,000 |
Deferred revenue - noncurrent | 14,560,000 | 15,616,000 |
Operating lease liabilities - noncurrent | 1,860,000 | 2,330,000 |
Other long-term liabilities | 2,352,000 | 2,365,000 |
Total liabilities | 78,992,000 | 73,176,000 |
Contingencies (Note 16) | ||
Stockholders’ equity: | ||
Preferred stock, $.001 par value, 5,000,000 shares authorized, no shares issued and outstanding | ||
Common stock, $.001 par value, 300,000,000 shares authorized at December 31, 2021 and 2020, respectively; 33,905,826 and 18,139,981 shares issued and outstanding at December 31, 2021 and 2020, respectively | 34,000 | 18,000 |
Additional paid-in capital | 752,602,000 | 528,362,000 |
Accumulated deficit | (569,097,000) | (510,680,000) |
Accumulated other comprehensive income | 841,000 | 841,000 |
Total stockholders’ equity | 184,380,000 | 18,541,000 |
Total liabilities and stockholders’ equity | $ 263,372,000 | $ 91,717,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Due from related party | $ 414,000 | $ 104,000 |
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 | 33,905,826 | 18,139,981 |
Common stock, shares outstanding | 33,905,826 | 18,139,981 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | ||
Total revenues | $ 36,939 | $ 34,437 |
Operating expenses: | ||
Cost of sales, excluding amortization of acquired intangible assets | 8,177 | 5,824 |
Research and development | 28,500 | 17,424 |
Sales and marketing | 27,503 | 25,293 |
General and administrative | 25,575 | 20,726 |
Amortization of acquired intangible assets | 2,460 | 2,460 |
Total operating expenses | 92,215 | 71,727 |
Loss from operations | (55,276) | (37,290) |
Other income (expense): | ||
Interest and other income, net | 292 | 58 |
Interest expense | (5,498) | (7,257) |
Gain (loss) on extinguishment of debt | 2,065 | (905) |
Total other expense, net | (3,141) | (8,104) |
Net loss | $ (58,417) | $ (45,394) |
Net loss per share: | ||
Basic and diluted | $ (2.03) | $ (3.54) |
Weighted average common shares outstanding: | ||
Basic and diluted | 28,758 | 12,836 |
Net loss | $ (58,417) | $ (45,394) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | 1 | |
Other comprehensive income (loss) | 1 | |
Comprehensive loss | (58,417) | (45,393) |
Product [Member] | ||
Revenues: | ||
Total revenues | 35,312 | 20,831 |
License and Collaboration Agreement [Member] | ||
Revenues: | ||
Total revenues | 756 | 11,942 |
Royalty Income [Member] | ||
Revenues: | ||
Total revenues | $ 871 | $ 1,664 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
License and Collaboration Agreement [Member] | ||
Revenue from related parties | $ 543 | $ 11,500 |
CONSOLIDATED STATEMENTS OF STOC
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, 2019 | $ 8,330 | $ 11 | $ 472,765 | $ (465,286) | $ 840 |
Balance, shares at Dec. 31, 2019 | 10,941,659 | ||||
Net loss | (45,394) | (45,394) | |||
Other comprehensive income | 1 | 1 | |||
Issuance of stock, net of issue costs | 49,853 | $ 7 | 49,846 | ||
Issuance of stock, net of issue costs, shares | 7,100,815 | ||||
Employee stock purchase plan | 294 | 294 | |||
Employee stock purchase plan, shares | 33,697 | ||||
Vesting of stock units | (90) | (90) | |||
Vesting of stock units, shares | 63,810 | ||||
Stock-based compensation | 5,547 | 5,547 | |||
Balance at Dec. 31, 2020 | $ 18,541 | $ 18 | 528,362 | (510,680) | 841 |
Balance, shares at Dec. 31, 2020 | 18,139,981 | 18,139,981 | |||
Net loss | $ (58,417) | (58,417) | |||
Issuance of stock and pre-funded warrants, net of issue costs | 216,586 | $ 16 | 216,570 | ||
Issuance of stock and pre-funded warrants, net of issue costs, shares | 15,635,811 | ||||
Employee stock purchase plan | 273 | 273 | |||
Employee stock purchase plan, shares | 43,365 | ||||
Exercise of stock options | 100 | 100 | |||
Exercise of stock options, shares | 8,112 | ||||
Vesting of stock units | (150) | (150) | |||
Vesting of stock units, shares | 78,557 | ||||
Stock-based compensation | 7,447 | 7,447 | |||
Balance at Dec. 31, 2021 | $ 184,380 | $ 34 | $ 752,602 | $ (569,097) | $ 841 |
Balance, shares at Dec. 31, 2021 | 33,905,826 | 33,905,826 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (58,417) | $ (45,394) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Amortization of intangible assets | 2,460 | 2,460 |
Depreciation of property and equipment | 311 | 189 |
Amortization of debt discount | 628 | 745 |
Non-cash interest expense | 0 | 977 |
(Gain) loss on extinguishment of debt | (2,065) | 905 |
Provision for excess and obsolescence inventory | 1,278 | 0 |
Stock-based compensation | 7,447 | 5,547 |
Changes in operating assets and liabilities: | ||
Accounts receivable and other current assets | (10,603) | 4,846 |
Inventory | 1,347 | (3,200) |
Accounts payable and accrued expenses | 8,476 | 1,872 |
Right-of-use assets and operating lease liabilities | (28) | 72 |
Deferred revenue | (931) | 16,546 |
Net cash used in operating activities | (50,097) | (14,435) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (32,965) | 0 |
Purchases of property and equipment | (156) | (362) |
Net cash used in investing activities | (33,121) | (362) |
Cash flows from financing activities: | ||
Proceeds from issuance of stock and pre-funded warrants, net of issuance costs | 216,825 | 49,918 |
Proceeds under paycheck protection program loan | 0 | 2,041 |
Payment of long-term debt principal | 0 | (13,794) |
Payment of extinguishment of debt costs | 0 | (828) |
Net settlement of stock units to satisfy statutory tax withholding | (150) | (90) |
Proceeds from exercise of stock options | 373 | 294 |
Principal payments on finance lease obligations | (146) | (49) |
Net cash provided by financing activities | 216,902 | 37,492 |
Effect of foreign exchange rate changes on cash and cash equivalents | 0 | 0 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 133,684 | 22,695 |
Cash, cash equivalents and restricted cash at beginning of year | 45,059 | 22,364 |
Cash, cash equivalents and restricted cash at end of year | 178,743 | 45,059 |
Supplemental cash flow information: | ||
Cash interest paid | 4,846 | 5,510 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Stock issuance costs | 294 | 0 |
Accrued term loan exit fee | 0 | 122 |
Payments forgiven under paycheck protection program loan | $ 2,041 | $ 0 |
Operations
Operations | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Operations | 1. EyePoint Pharmaceuticals, Inc. (together with its subsidiaries, the “Company”), incorporated in Delaware, is a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary Durasert ® technology for sustained intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF treatment initially targeting 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. The Company’s product candidate pipeline also includes YUTIQ 50, a potential six-month treatment for non-infectious uveitis affecting the posterior segment of the eye, one of the leading causes of blindness under a supplemental New Drug Application (“sNDA”) strategy. The Company also has two commercial products: YUTIQ ® ® Local drug delivery for treating ocular diseases is a significant challenge due to the effectiveness of the blood-eye barrier. This barrier makes it difficult for systemically-administered drugs to reach the eye in sufficient quantities to have a beneficial effect without causing unacceptable adverse side effects to other organs. The Company’s validated Durasert technology, which has already been included in four products approved for marketing by the U.S. Food and Drug Administration (“FDA”), is designed to provide consistent, sustained delivery of small molecule drugs over a period of months to years through a single intravitreal injection. The Company’s lead product candidate, EYP-1901, combines a bioerodible formulation of its proprietary Durasert sustained-release technology with vorolanib, a tyrosine kinase inhibitor (“TKI”) that has demonstrated anti-VEGF activity. Current FDA approved anti-VEGF treatments for wet AMD require monthly or bi-monthly intravitreal injections in a physician’s office. The Company is currently evaluating EYP-1901 in a Phase 1 clinical trial as a potential six-month sustained delivery treatment for wet AMD and reported positive six-month interim safety and efficacy data in November 2021. In February 2022, the Company updated the results of the DAVIO clinical trial through 8-months reporting continued positive safety and efficacy results. The Company expects to initiate a Phase 2 clinical trial in wet AMD in the third quarter of 2022 and a Phase 2 clinical trial in diabetic retinopathy later in the second half of 2022. YUTIQ ® ® DEXYCU ® ® The Company is also developing YUTIQ 50 as a potential six-month intravitreal treatment for chronic non-infectious uveitis affecting the posterior segment of the eye. The Company dosed the first patient in a Phase 3 clinical trial in November 2021. The Effects of the COVID-19 Coronavirus Pandemic The ongoing COVID-19 coronavirus pandemic (the “Pandemic”) has had a material and adverse impact on the Company’s business, including as a result of measures that the Company, other businesses, and government have taken and will likely continue to take. This includes a significant impact on cash flows from expected revenues due to the closure of ambulatory surgery centers for DEXYCU and a significant reduction in physician office visits impacting YUTIQ in 2020. The ongoing Pandemic continued to have an adverse impact on the Company’s revenues, financial condition and cash flows through 2021. For the year ended December 31, 2021, the Company recorded impairment charges of $1.2 million to cost of sales, excluding amortization of acquired intangible assets and $0.1 million to sales and marketing expense, respectively, associated with the write-off of obsolete inventory of DEXYCU units and DEXYCU sample units, respectively, whose inventory levels were higher than the Company’s updated forecasts of future demand for those units. Additionally, the emergence of the Omicron variant has continued to have an adverse impact on the Company’s revenues, financial condition and cash flows into the first quarter of 2022 and may continue to cause intermittent or prolonged periods of reduced patient services at the Company’s customers’ facilities, which may negatively affect customer demand. The progression of the Pandemic and its effects on the Company’s business and operations are uncertain at this time. Depending on the future developments that are uncertain and difficult to predict, including new information that may emerge concerning the Pandemic, the Company’s revenues, financial condition and cash flows may be adversely affected in the future as well. The Company is continuously monitoring the Pandemic and its potential effect on the Company’s financial position, results of operations and cash flows. This uncertainty could have an impact in future periods on certain estimates used in the preparation of the Company’s periodic financial results, including reserves for variable consideration related to product sales, realizability of certain receivables, assessment for excess or obsolete inventory, and impairment of long-lived assets. Uncertainty around the extent and duration of the Pandemic, and any future related financial impact cannot be reasonably estimated at this time. Liquidity The Company had cash, cash equivalents, and investments in marketable securities of $211.6 million at December 31, 2021. 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 from its product sales 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 of its product sales, 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 $211.6 million at December 31, 2021, coupled with expected cash inflows from its product sales will enable the Company to fund its current and planned operations for at least the next twelve months from the date these consolidated financial statements were issued. A ctual cash requirements could differ from management’s projections due to many factors, including the continued effect of the Pandemic on the Company’s business and the medical community, the timing and results of the Company’s clinical trials for EYP-1901, additional investments in research and development programs, the success of ongoing commercialization efforts for YUTIQ and DEXYCU, the actual costs of these ongoing commercialization efforts, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Basis of Presentation The consolidated financial statements are presented in U.S. dollars in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and include the accounts of EyePoint Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts and disclosure of assets and liabilities at the date of the consolidated financial statements and the reported amounts and disclosure of revenues and expenses during the reporting periods. Significant management estimates and assumptions include, among others, those related to reserves for variable consideration related to product sales, revenue recognition for multiple-deliverable arrangements, recognition of expense in outsourced clinical trial agreements, recording of excess or obsolete inventory write-offs and reserves, and realization of deferred tax assets. Actual results could differ from these and other estimates and there may be changes to the Company’s estimates in future periods. Foreign Currency The functional currency of the Company and each of its subsidiaries is the currency of the primary economic environment in which each such entity operates—the U.S. dollar or the Pound Sterling. Assets and liabilities of the Company’s foreign subsidiary are translated at period-end exchange rates. Amounts included in the consolidated statements of comprehensive loss and cash flows are translated at the weighted average exchange rates for the period. Gains and losses from currency translation are included in accumulated other comprehensive income as a separate component of stockholders’ equity in the consolidated balance sheets. The balance of accumulated other comprehensive income attributable to foreign currency translation was $841,000 and $841,000 at December 31, 2021 and 2020, respectively. Foreign currency gains or losses arising from transactions denominated in foreign currencies, whether realized or unrealized, are recorded in interest and other income, net in the consolidated statements of comprehensive loss and were not material for all periods presented. Cash Equivalents Cash equivalents represent highly liquid investments with maturities of three months or less at the date of purchase, principally consisting of institutional money market funds and investment-grade commercial paper. Marketable Securities Marketable securities consist of investments with an original or remaining maturity of greater than three months but less than six months at the date of purchase. The Company has historically classified its marketable securities as available-for-sale. Accordingly, the Company records these investments at fair value, with unrealized gains and losses excluded from earnings and reported, net of tax, in accumulated other comprehensive income, which is a component of stockholders’ equity. If the Company determines that a decline of any investment is other-than-temporary, the investment is written down to fair value. Marketable securities at December 31, 2021 consisted of investment-grade commercial paper. The Company had no marketable security investments at December 31, 2020. The Company’s investment policy, approved by the Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. During fiscal 2021, $33.0 million of marketable securities were purchased and $0 matured. The fair value of marketable securities is determined based on quoted market prices at the balance sheet date of the same or similar instruments. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts through to the earlier of sale or maturity. Such amortization and accretion amounts are included in interest and other income, net in the consolidated statements of comprehensive loss. The cost of marketable securities sold is determined by the specific identification method. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and investments in marketable securities. At December 31, 2021, a total of $155.6 million, or 90.4% of the Company’s interest-bearing cash equivalent balances, were concentrated in one U.S. Government institutional money market fund that had investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. $16.5 million, or 9.6% of the Company’s interest-bearing cash equivalent balances consisted of investment-grade commercial paper. Generally, these investments may be sold upon demand and, therefore, the Company believes they have minimal risk. The Company had investments of $33.0 million and $0 in marketable securities at December 31, 2021 and 2020, respectively. The Company’s investment policy, approved by the Company’s Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. As of December 31, 2021, accounts receivable from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 54.7% and 38.3% of total accounts receivable, respectively. For the year ended December 31, 2021, revenues from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 46.6% and 43.1% of total revenues, respectively. As of December 31, 2020, accounts receivable from ASD Specialty Healthcare LLC and McKesson Specialty Care Distribution LLC accounted for 56.0% and 37.0% of total accounts receivable, respectively. For the year ended December 31, 2020, revenues from ASD Specialty Healthcare LLC, Ocumension Therapeutics, and McKesson Specialty Care Distribution LLC accounted for 39.0%, 33.0%, and 18.0% of total revenues, respectively. Fair Value Measurements The Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. The Company categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These levels are: • Level 1 – Inputs are quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets and liabilities. • Level 2 – Inputs are directly or indirectly observable in the marketplace, such as quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities with insufficient volume or infrequent transaction (less active markets). • Level 3 – Inputs are unobservable estimates that are supported by little or no market activity and require the Company to develop its own assumptions about how market participants would price the assets or liabilities. 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. Accounts and Other Receivables, Net Receivables arise primarily from the Company’s products sold in the U.S. The balance in accounts and other receivables, net consists primarily of amounts due from customers, net of applicable revenue reserves. The majority of the Company’s accounts receivable have standard payment terms that require payment within 120-127 days. The Company performs ongoing credit evaluations of its customers’ financial condition and continuously monitor collections and payments from its customers and The allowance for credit losses is estimated based on the Company’s analysis of trends in overall receivables aging, specific identification of certain receivables that are at risk of not being paid, past collection experience and current economic trends. iven the nature and limited history of collectability of the Company’s accounts receivable, Inventory Inventory is stated at the lower of cost or net realizable value, net on a first-in, first-out (“FIFO”) basis. The inventory costs for YUTIQ include purchases of various components and the active pharmaceutical ingredient (“API”) and internal labor and overhead for the product manufactured in the Company’s Watertown, MA facility. The inventory costs for DEXYCU include purchased components, the API and third-party manufacturing and assembly. Capitalization of inventory costs begins after FDA approval of the product. Prior thereto, inventory costs of products and product candidates are recorded as research and development expense, even if this inventory may later be sold as commercial product. The Company assesses the recoverability of inventory and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Write-downs are based on the age of the inventory, lower of cost or market, along with significant management judgments concerning future demands for the inventory. Such impairment charges, should they occur, are recorded within cost of sales, excluding amortization of acquired intangible assets. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory might be recorded in future periods. Cost of The 2.3 1.3 Debt and Equity Instruments Debt and equity instruments are classified as either liabilities or equity in accordance with the substance of the contractual arrangement. Derivative Instruments Derivative financial liabilities are recorded at fair value, with gains and losses arising from changes in fair value recognized in change in fair value of derivative liability within the consolidated statements of comprehensive loss at each period end while such instruments are outstanding. The Company’s derivative liabilities from certain financing transactions were primarily valued using Monte Carlo simulation models. Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives (generally three to five years) using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the remaining non-cancellable lease term or their estimated useful lives. Repair and maintenance costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are derecognized from the respective accounts and any gain or loss is recognized. Capitalized Software Development Cost The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as software business applications used in the normal course of business, are capitalized in accordance with ASC 350 Intangibles – Goodwill and Other Leases The Company leases real estate and office equipment under operating leases. Its primary real estate lease contains rent holiday and rent escalation clauses. The Company determines whether the arrangement is or contains a lease at inception. Operating leases are recognized on the consolidated balance sheets as ROU assets, current portion of lease liabilities and long-term lease liabilities. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. Impairment of Intangible Assets The Company’s finite life intangible assets include the DEXYCU product (utilizing the Verisome technology) following the March 2018 acquisition of Icon. The DEXYCU intangible asset is being amortized on a straight-line basis over its estimated useful life of thirteen years. The intangible asset lives were determined based upon the anticipated period that the Company would derive future cash flows from the intangible assets, considering the effects of legal, regulatory, contractual, competitive and other economic factors. The Company continually monitors whether events or circumstances have occurred that indicate that the remaining estimated useful life of its intangible assets may warrant revision. The Company assesses potential impairments to its intangible assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when the future undiscounted net cash flows expected to result from the use of an asset are less than its carrying value. If the Company considers an asset to be impaired, the impairment charge to be recognized is measured as the amount by which the carrying value of the asset exceeds its estimated fair value. 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 each 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 — The Company sells YUTIQ and DEXYCU to a limited number of specialty distributors and specialty pharmacies (collectively the “Distributors”) in the U.S., with whom the Company has entered into formal agreements, for delivery to physician practices for YUTIQ and to hospital outpatient departments and ambulatory surgical centers for DEXYCU. The Company recognizes revenue on sales of its products when Distributors obtain control of the products, which occurs at a point in time, typically upon delivery. In addition to agreements with Distributors, the Company also enters into arrangements with healthcare providers, ambulatory surgical centers, and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products from Distributors. Reserves for variable consideration — Product sales are recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration include trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that are offered within contracts between the Company and its Distributors, payors, and other contracted purchasers relating to the Company’s product sales. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount is to be settled. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. 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 compensates its Distributors for services explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product sale is recognized. Provider chargebacks and discounts — Chargebacks are discounts that represent 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 charge the Company for the difference between what they pay for the product and the Company’s contracted selling price. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability . Reserves for chargebacks consist of amounts that the Company expects to pay for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold under a contracted selling price, and chargebacks that Distributors have claimed, but for which the Company has not yet settled. Government rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor rebates — The Company contracts with certain private payor organizations, primarily insurance companies, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Co-Payment assistance — The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. Product returns — The Company generally offers a limited right of return based on its returned goods policy, which includes damaged product and remaining shelf life. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to trade receivables, net on the condensed consolidated balance sheets. 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 up-front 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. 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 December 31, 2021. 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 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 (including feasibility study agreements). 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 (including feasibility study agreements). 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. Deferred Revenue Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue. Research and Development Research and development costs are charged to operations as incurred. These costs include all direct costs, including cash and stock-based compensation and benefits for research, clinical development, quality assurance, quality control, operations and medical affairs personnel, amortization of intangible assets, third-party costs and services for clinical trials, clinical materials, pre-clinical programs, regulatory and medical affairs, external consultants, and other operational costs related to the Company’s research and development of its product candidates. Stock-Based Compensation Compensation cost related to share-based payment awards is based on the fair value of the instrument on the grant date and is recognized on a graded vesting basis over the requisite service period for each separately vesting tranche of the awards. The Company may also grant share-based payment awards that are subject to objectively measurable performance and service criteria. Compensation expense for performance-based awards begins at such time as it becomes probable that the respective performance conditions will be achieved. The Company continues to recognize the grant date fair value of performance-based awards through the vesting date of the respective awards so long as it remains probable that the related performance conditions will be satisfied. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model and the fair value of performance stock units, restricted stock units and deferred stock units based on the observed grant date fair value of the underlying Common Stock. Net Loss per Share Basic net loss per share is computed by dividing 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 weighted-average number of common shares outstanding the average number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive. As of December 31, 2021, 3,272,727 shares of Pre-Funded Warrants to purchase common stock, issued in connection with the November 2021 underwritten public offering (see Note 10), were included in the basic and diluted net loss per share calculation. Outstanding potential Common Stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows: Year Ended December 31, Year Ended December 31, 2021 2020 Stock options 2,517,680 1,338,880 ESPP 23,965 27,713 Warrants 48,683 48,683 Restricted stock units 291,575 149,004 2,881,903 1,564,280 Comprehensive Loss Comprehensive loss is comprised of net loss, foreign currency translation adjustments and unrealized gains and losses on available-for-sale marketable securities. Income Tax The Company accounts for income taxes under the asset and liability method. Deferred income tax assets and liabilities are computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future benefit to be derived from tax credits and loss carry forwards. Such deferred income tax computations are measured based on enacted tax laws and rates applicable to the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is provided against net deferred tax assets if, based on the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the uncertainty. The Company accounts for interest and penalties related to uncertain tax positions as part of its income tax benefit. Recently Adopted and Recently Issued Accounting Pronouncements New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective dates. Unless otherwise disclosed below, the Company believes that recently issued and adopted pronouncements will not have a material impact on the Company’s financial position, results of operations and cash flows or do not apply to the Company’s operations. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”) : Simplifying the Accounting for Income Taxes. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) : Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. |
Product Revenue Reserves and Al
Product Revenue Reserves and Allowances | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Product Revenue Reserves and Allowances | 3 . Product Revenue Reserves and Allowances The Company’s product revenues have been primarily from sales of YUTIQ and DEXYCU in the U.S. Net product revenues by product for the years ended December 31, 2021 and 2020 were as follows (in thousands): Year Ended December 31, 2021 2020 YUTIQ (A) $ 16,959 $ 13,878 DEXYCU (B) 18,353 6,953 Total product sales, net $ 35,312 $ 20,831 (A) Included approximately $25 and $205 of revenue recognized from YUTIQ product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. (B) Included approximately $283 and $8 of revenue recognized from DEXYCU product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. The following table summarizes activity in each of the product revenue allowance and reserve categories for the years ended December 31, 2021 and 2020 (in thousands): Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2021 $ 574 $ 535 $ 603 $ 1,712 Provision related to sales in the current year 7,274 5,337 785 13,396 Adjustments related to prior period sales (50 ) (22 ) (200 ) (272 ) Deductions applied and payments made (6,645 ) (4,029 ) (809 ) (11,483 ) Ending balance at December 31, 2021 $ 1,153 $ 1,821 $ 379 $ 3,353 Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2020 $ 1,618 $ 271 $ 352 $ 2,241 Provision related to sales in the current year 2,141 1,056 978 4,175 Adjustments related to prior period sales (387 ) — 50 (337 ) Deductions applied and payments made (2,798 ) (792 ) (777 ) (4,367 ) Ending balance at December 31, 2020 $ 574 $ 535 $ 603 $ 1,712 Returns 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 7). License and Collaboration Agreements and Royalty Income Alimera Pursuant to a licensing and development agreement, as amended, Alimera Sciences, Inc. has a worldwide exclusive license to develop, make, market and sell ILUVIEN in return for royalties based on sales and patent fee reimbursements. Total revenue was $54,000 and $1.7 million for the years ended December 31, 2021 and 2020, respectively. In addition to patent fee reimbursements in those periods, the Company recorded royalty income totaled $0 and $1.7 million for the years ended December 31, 2021 and 2020, respectively. SWK Royalty Purchase Agreement On December 17, 2020, the Company entered into a royalty purchase agreement (the “RPA”) with SWK Funding LLC (“SWK”). Under the RPA, the Company sold its right to receive royalty payments on future sales of products subject to the Amended Alimera Agreement for an upfront cash payment of $16.5 million. Except for the rights to the royalties, the Company retains all rights and obligations under the Amended Alimera Agreement, pursuant to which, Alimera owns worldwide rights to the Company’s Durasert technology in ILUVIEN for DME and rights for ILUVIEN (currently marketed by the Company as YUTIQ in the U.S.) for non-infectious posterior uveitis in the EMEA. Alimera has the sole rights to utilize the intellectual property developed under the Amended Alimera Agreement. There has been no intellectual property developed jointly by Alimera and the Company as part of the Amended Alimera Agreement. The Company cannot utilize the intellectual property for the indication licensed to Alimera in order to manufacture and sell ILUVIEN. The Company’s ongoing efforts under the Amended Alimera Agreement will consist of continuing to maintain and enforce its patents as well as providing safety data and regulatory support as necessary. None of these obligations require significant efforts on the part of the Company with respect to the generation of sales in the market. The Company will only be required to expend more extensive efforts if litigation were to arise that requires the Company to protect its patents rights pursuant to the terms of the Amended Alimera Agreement. Historically, such a defense has not been required. Similarly, regulatory support and safety data is only provided on an ad-hoc basis depending on the regulatory requests , which has been minimal historically . It remains Alimera’s sole responsibility to manufacture, actively market and promote the products under the Amended Alimera Agreement to generate the sales, which ultimately generate the royalties to be paid to SWK. The Company classified the proceeds received from SWK as deferred revenue, to be recognized as revenue under the units-of-revenue method over the life of the RPA because of the Company’s limited continuing involvement in the Amended Alimera Agreement. SWK has no recourse and the Company assumes no credit risk in event that Alimera fails to make a royalty payment. The Company must only forward all material correspondence from Alimera to SWK, including royalty reports, notices and any other correspondence with respect to royalties to SWK. SWK has the right to audit and inspect the books and records pertaining to net sales and royalties under the Amended Alimera Agreement. Neither the Company nor SWK has the unilateral ability to cancel the transaction. There is no cap or limitation on the royalties to be received by SWK in the future and its return will reflect all royalties paid by Alimera. Because the transaction was structured as a non-cancellable sale, the Company does not have significant continuing involvement in the generation of the cash flows due to SWK and there is no limitation on the rates of return to SWK, the Company recorded the total proceeds of $16.5 million as deferred revenue under royalty sale agreement. The deferred revenue is being recognized as revenue over the life of the RPA under the “units-of-revenue” method. Under this method, amortization for a reporting period is calculated by computing a ratio of the proceeds received from SWK to the payments expected to be made by Alimera to SWK over the term of the Amended Alimera Agreement, and then applying that ratio to the period’s cash payment. The Company recognized $872,000 of royalty revenue related to the RPA for the year ended December 31, 2021, in connection with the royalty payment of $2.8 million for the year ended December 31, 2021, from Alimera to SWK, pursuant to the Amended Alimera Agreement. No revenue was recognized related to the RPA for the year ended December 31, 2020. As of December 31, 2021, the Company has $1.1 million and $14.6 million as current and non-current deferred revenue recognized under royalty sale agreement, respectively. As of December 31, 2020, the Company classified $885,000 and $15.6 million as current and non-current deferred revenue recognized under royalty sale agreement, respectively. OncoSil Medica l The Company entered into an exclusive, worldwide royalty-bearing license agreement in December 2012, amended and restated in March 2013, with OncoSil Medical UK Limited (f/k/a Enigma Therapeutics Limited), a wholly-owned subsidiary of OncoSil Medical Ltd (“OncoSil”) for the development of BrachySil, the Company’s previous product candidate for the treatment of pancreatic and other types of cancer. The Company received an upfront fee of $100,000 and is entitled to 8% sales-based royalties, 20% of sublicense consideration and milestone payments based on aggregate product sales. OncoSil is obligated to pay an annual license maintenance fee of $100,000 by the end of each calendar year, the most recent of which was received in December 2021. For each calendar year commencing with 2014, the Company is entitled to receive reimbursement of any patent maintenance costs, sales-based royalties and sales-based royalties earned, but only to the extent such amounts, in the aggregate, exceed the $100,000 annual license maintenance fee. In March 2020, the U.S. Food and Drug Administration granted Breakthrough Device Designation for the OncoSil™ device for treatment of unresectable locally advanced pancreatic cancer (LAPC) in combination with chemotherapy. In April 2020, the British Standards Institute (BSI) grants European CE marking for the OncoSil™ System and designates OncoSil™ a breakthrough device for the treatment of locally advanced pancreatic cancer (LAPC) in combination with chemotherapy. As of December 31, 2021, OncoSil has received regulatory approval in the EU, United Kingdom, Switzerland, Singapore, Malaysia, Hong Kong, New Zealand, Turkey, and Israel. The Company has no consequential performance obligations under the OncoSil license agreement. For the years ended December 31, 2021 and 2020, revenue of $100,000 and $100,000 was recorded for this agreement, respectively. Ocumension Therapeutics In November The Company was required to provide a fixed number of hours of technical assistance support to Ocumension at no cost, which support has been completed and no future performance obligation exists. Ocumension is responsible for all development, regulatory and commercial costs, including any additional technical assistance requested. Ocumension has a first right of negotiation for an additional exclusive license to the Company’s shorter-duration line extension candidate for this indication. In August 2019, the Company received a $1.0 million development milestone payment from Ocumension triggered by the approval of its Investigational New Drug (“IND”) in China for this program. The IND allows the importation of finished product into China for use in a clinical trial to support regulatory filing. In January 2020, the Company entered into an exclusive license agreement with Ocumension 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. Pursuant to the terms of the license agreement, the Company received upfront payments of $2.0 million from Ocumension in February 2020 and will be eligible to receive up to (i) $6.0 million upon the achievement by Ocumension of certain prescribed development and regulatory milestones, and (ii) $6.0 million commercial sales-based milestones. In addition, the Company is entitled to receive mid-single digit sales-based royalties. In exchange, Ocumension will receive exclusive rights to develop and commercialize DEXYCU in Mainland China, Hong Kong, Macau and Taiwan, at its own cost and expense with the Company supplying product for clinical trials and commercial sale. In addition, Ocumension will receive a fixed number of hours of technical assistance support from the Company at no cost. In August 2020, the Company entered into a Memorandum of Understanding (“2020 MOU”), pursuant to which, the Company received a one-time non-refundable payment of $9.5 million (the “Accelerated Milestone Payment”) from Ocumension as a full and final payment of the combined remaining development, regulatory and sales milestone payments under the Company’s license agreements with Ocumension for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and for the treatment of post-operative inflammation following ocular surgery, respectively. Upon payment of the Accelerated Milestone Payment, the remaining $11.75 million in combined remaining development and sales milestone payments under the Company’s original were permanently extinguished and will no longer be due and owed to the Company. In exchange, Ocumension also received 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, Other than a fixed number of hours of technical assistance support to be provided at no cost by the Company, Ocumension is responsible for all development, regulatory and commercial costs, including any additional technical assistance requested. All technical assistance was provided during 2020. The Chief Executive Officer of Ocumension became a director of the Company starting December 31, 2020, pursuant to a Share Purchase Agreement pursuant to which the Company sold to Ocumension 3,010,722 shares of common stock, at which time, Ocumension became a related party of the Company. During the years ended December 31, 2021 and 2020, in addition to $308,000 and $213,000 of revenue from product sales, respectively, the Company recognized approximately $543,000 and $11.5 million of license and collaboration revenue, respectively, including $499,000 and $0 of revenue related to additional technical assistance, respectively. As of December 31, 2021 and 2020, no deferred revenue was recorded for this agreement, respectively. The Company recognized $0 Research Collaborations The Company from time to time enters into funded agreements to evaluate the potential use of its technology systems for sustained release of third-party drug candidates. Consideration received is generally recognized as revenue over the term of the 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. Revenues under research collaborations totaled $60,000 and $ 255,000 At December 31, 2021 and 2020, $0 and $60,000 deferred revenue was recorded for the research collaborations, respectively. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 4 . Inventory consisted of the following (in thousands): December 31, 2021 December 31, 2020 Raw materials $ 2,727 $ 2,664 Work in process 405 747 Finished goods 484 1,926 Total inventory $ 3,616 $ 5,337 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 5 . The reconciliation of intangible assets for the years ended December 31, 2021 and 2020 (in thousands): Year Ended Year Ended December 31, December 31, 2021 2020 Patented technologies Gross carrying amount at beginning of period $ 68,322 $ 68,322 Gross carrying amount at end of period 68,322 68,322 Accumulated amortization at beginning of period (43,113 ) (40,653 ) Amortization expense (2,460 ) (2,460 ) Accumulated amortization at end of period (45,573 ) (43,113 ) Net book value at end of period $ 22,749 $ 25,209 The net book value of the Company’s intangible assets at December 31, 2021 and 2020 is summarized as follows (in thousands): Estimated Remaining Useful Life at December 31, December 31, December 31, 2021 2020 2021 (Years) Patented technologies DEXYCU / Verisome $ 22,749 $ 25,209 9.25 $ 22,749 $ 25,209 The Company amortizes its intangible assets with finite lives on a straight-line basis over their respective estimated useful lives. Amortization expense totaled $2.5 million in each of the two years ended December 31, 2021 and 2020, respectively. In connection with the Icon Acquisition, the initial purchase price of $32.0 million was attributed to the DEXYCU product intangible asset. This finite-lived intangible asset is being amortized on a straight-line basis over its expected remaining useful life of 9.25 years at the rate of approximately $2.5 million per year. Amortization expense was reported as a component of cost of sales for the years ended December 31, 2021 and 2020, respectively. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6 . Property and equipment, net consisted of the following (in thousands): December 31, December 31, 2021 2020 Property and equipment $ 1,477 $ 1,403 Leasehold improvements 255 255 Gross property and equipment 1,732 1,658 Accumulated depreciation and amortization (1,256 ) (1,028 ) $ 476 $ 630 Depreciation expense totaled $311,000 and $189,000 in the years ended December 31, 2021 and 2020, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 7 . Accrued expenses consisted of the following (in thousands): December 31, December 31, 2021 2020 Personnel costs $ 7,321 $ 5,686 Clinical trial costs 753 — Professional fees 712 647 Sales chargebacks, rebates and other revenue reserves 2,974 1,109 Commissions due to commercialization partner for DEXYCU 1,518 254 Other 1,144 749 $ 14,422 $ 8,445 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 8. Leases On May 17, 2018, the Company amended the lease for its headquarters in Watertown, Massachusetts. The original five-year lease for approximately 13,650 square feet of combined office and laboratory space was set to expire in April 2019. Under the amendment, the Company leased an additional 6,590 square feet of rentable area of the building, with a commencement date of September 10, 2018. The amendment extended the term of the lease for the combined space through May 31, 2025, and the landlord provided the Company a construction allowance of up to $670,750 to be applied toward renovations and improvements within the total space. On April 5, 2021, the Company further amended the lease to include an additional 1,409 square feet of rentable area of the building through May 31, 2025, with a commencement date of July 1, 2021. On March 8, 2022, the Company further amended the lease (i) to extend the term to May 31, 2028 for 13,650 square feet of laboratory and manufacturing operations space, with the landlord agreeing to provide the Company a construction allowance of up to $555,960 to be applied toward upgrades and improvements within the space; (ii) to rent an additional 11,999 square feet of office space within the building through May 31, 2028, with an anticipated commencement date in the third quarter of 2022; and (iii) to terminate a portion of the lease comprising 7,999 square feet of office space in the building on May 31, 2025. The Company previously provided a cash-collateralized $150,000 irrevocable standby letter of credit as security for the Company’s obligations under the lease, which will remain in effect through the period that is four months beyond the expiration date of the amended lease. The Company will also be required to pay its proportionate share of certain operating costs and property taxes applicable to the leased premises in excess of new base year amounts. In July 2017, the Company leased approximately 3,000 square feet of office space in Basking Ridge, New Jersey under a lease term extending through June 2022, with two five-year The Company identified and assessed the following significant assumptions in recognizing its right-of-use (“ROU”) assets and corresponding lease liabilities: • As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company utilized the borrowing rate under its existing 5-year term loan facility (see Note 9) as the discount rate. • 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 combined lease component. • The expected lease terms include noncancelable 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 December 31, 2021, the weighted average remaining term of the Company’s operating leases was 3.4 years and the lease liabilities arising from obtaining ROU assets reflect a weighted average discount rate of 12.5%. Supplemental balance sheet information related to operating leases as of December 31, 2021 and 2020, respectively are as follows (in thousands): December 31, December 31, 2021 2020 Other current liabilities - operating lease current portion $ 645 $ 568 Operating lease liabilities – noncurrent portion 1,860 2,330 Total operating lease liabilities $ 2,505 $ 2,898 Operating lease expense recognized related to ROU assets was $885,000 and $852,000, excluding $30,000 and $36,000 of variable lease costs, during each of the years ended December 31, 2021 and 2020, respectively, and were included in general and administrative expense in the Company’s statement of comprehensive loss. Cash paid for amounts included in the measurement of operating lease liabilities was $920,000 and $867,000 for the years ended December 31, 2021 and 2020, respectively. The Company Supplemental balance sheet information related to the finance lease as of December 31, 2021 and 2020, respectively are as follows (in thousands): December 31, December 31, 2021 2020 Property and equipment, at cost $ 371 $ 239 Accumulated amortization (205 ) (52 ) Property and equipment, net $ 166 $ 187 Other current liabilities – $ 137 $ 119 Other long-term liabilities 36 71 Total finance lease liabilities $ 173 $ 190 The components of finance lease expense recognized during the years ended December 31, 2021 and 2020 related to ROU assets were $151,000 and $52,000, respectively. Interest on lease liabilities were $23,000 and $9,000 during the years ended December 31, 2021 and 2020, respectively. Cash paid for amounts included in the measurement of finance lease liabilities was operating cash flows of $23,000 and financing cash flows of $146,000 during the year ended December 31, 2021, respectively. Cash paid for amounts included in the measurement of finance lease liabilities was operating cash flows of $9,000 and financing cash flows of $49,000 during the year ended December 31, 2020, respectively. As of December 31, 2021, the weighted average remaining term of the Company’s finance lease was 1.3 years and the lease liabilities arising from obtaining ROU assets reflect a weighted average discount rate of 12.5%. T he Company’s total future minimum lease payments under non-cancellable leases at December 31, 2021 were as follows (in thousands): Operating Leases Finance Leases 2022 911 149 2023 877 37 2024 894 — 2025 373 — Total lease payments $ 3,055 $ 186 Less imputed interest (550 ) (13 ) Total $ 2,505 $ 173 |
Loan Agreements
Loan Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Loan Agreements | 9 . Paycheck Protection Program Loan On April 8, 2020, the Company applied to Silicon Valley Bank (the “SVB”) for a Paycheck Protection Program Loan (the “PPP Loan”) of $2.0 million that is administered by the U.S. Small Business Administration (the “SBA”), under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). On April 22, 2020, the PPP Loan was approved and the Company received the PPP Loan proceeds. The PPP Loan bears interest at a fixed rate of 1.0% per annum and has a two-year The Paycheck Protection Program Flexibility Act of 2020 (the “PPP Flexibility Act”), enacted on June 5, 2020, amended the Paycheck Protection Program, among others, as follows: (i) extended the covered period from 8 weeks to the earlier of 24 weeks from the date the PPP Loan is originated and December 31, 2020, during which PPP funds needed to be expended in order to be forgiven . A borrower may submit a loan forgiveness application any time on or before the maturity date of the loan – including before the end of the covered period – if the borrower has used all of the loan proceeds for which the borrower is requesting forgiveness; (ii ) at least 60% of PPP funds must be spent on payroll costs, with the remaining 40% available to spend on other eligible expenses; (iii) payments are deferred until the date on which the amount of forgiveness determined is remitted to the lender. If a borrower fails to seek forgiveness within 10 months after the last day of its covered period, then payments will begin on the date that is 10 months after the last day of the covered period. In addition, the PPP Flexibility Act modified the CARES Act by increasing the maturity date for loans made after the effective date from two years to a minimum maturity of five years from the date on which the borrower applies for loan forgiveness. Existing PPP loans made before the new legislation retain their original two-year term, but may be renegotiated between a lender and a borrower to match the 5-year term permitted under the PPP Flexibility Act The Company used all of the loan proceeds from the PPP Loan to pay expenses during the covered period that the Company believes were for eligible purposes. On September 25, 2020, the Company submitted an application to SVB for full loan forgiveness. On June 19, 2021, the Company received notification from SVB that the PPP Loan of $2.0 million has been fully forgiven by the SBA, and that payment and all accrued interest of $24,000 thereon were remitted by the SBA to SVB on June 16, 2021. In connection with the full loan forgiveness, the Company recorded a gain on extinguishment of debt of approximately $2.1 million in the year ended December 30, 2021. CRG Term Loan Agreement On February 13, 2019 (the “CRG Closing Date”), the Company entered into the CRG Loan Agreement among the Company, as borrower, CRG Servicing LLC, as administrative agent and collateral agent (the “Agent”), and the lenders party thereto from time to time (the “Lenders”), On the CRG Closing Date, $35 million of the CRG Loan was advanced (the “CRG Initial Advance”). The Company utilized the proceeds from the CRG Initial Advance for the repayment in full of all outstanding obligations under its prior credit agreement (the “SWK Credit Agreement”) with SWK. In April 2019, the Company exercised its option to borrow an additional $15 million of the CRG Loan (the “CRG Second Advance”). The Company did not draw any additional funds under the CRG Loan by the final draw deadline of March 31, 2020. The CRG Loan is due and payable on December 31, 2023 (the “Maturity Date”). The CRG Loan bears interest at a fixed rate of 12.5% per annum payable in arrears on the last business day of each calendar quarter. The Company is required to make quarterly, interest only payments until the Maturity Date. So long as no default has occurred and is continuing, the Company may elect on each applicable interest payment date to pay 2.5% of the 12.5% per annum interest as Paid In-Kind (“PIK”), whereby such PIK amount would be added to the aggregate principal amount and accrue interest at 12.5% per annum. Through December 31, 2021, PIK amounts of $ 0 In connection with the CRG Initial Advance, a 1.5% financing fee of $525,000 and an expense reimbursement of $350,000 were deducted from the net borrowing proceeds. In connection with the CRG Second Advance, a 1.5% financing fee of $225,000 was deducted from the net borrowing proceeds. Upon the occurrence of a bankruptcy-related event of default, all amounts outstanding with respect to the CRG Loan become due and payable immediately, and upon the occurrence of any other Event of Default (as defined in the CRG Loan Agreement), all or any amounts outstanding with respect to the CRG Loan may become due and payable upon request of the Agent or majority Lenders. Subject to certain exceptions, the Company is required to make mandatory prepayments of the CRG Loan with the proceeds of assets sales and in the event of a change of control of the Company. In addition, the Company may make a voluntary prepayment of the CRG Loan, in whole or in part, at any time. All mandatory and voluntary prepayments of the CRG Loan are subject to the payment of prepayment premiums as follows: (i) if prepayment occurs on or prior to December 31, 2019, an amount equal to 10% of the aggregate outstanding principal amount of the CRG Loan being prepaid, (ii) if prepayment occurs after December 31, 2019 and on or prior to December 31, 2020, 5% of the aggregate outstanding principal amount of the CRG Loan being prepaid, which was waived on December 17, 2020 when the Company paid $15.0 million against the CRG Loan obligations in connection with the consummation of the RPA agreement (see Note 3), and (iii) if prepayment occurs after December 31, 2020 and on or prior to December 31, 2021, an amount equal to 3% of the aggregate outstanding principal amount of the Loan being prepaid. No prepayment premium is due on any principal prepaid after December 31, 2021. Certain of the Company’s existing and future subsidiaries are guaranteeing the obligations of the Company under the CRG Loan Agreement. The obligations of the Company under the CRG Loan Agreement and the guarantee of such obligations are secured by a pledge of substantially all of the Company’s and the guarantors’ assets. The CRG Loan Agreement contains affirmative and negative covenants customary for financings of this type, including limitations on our and our subsidiaries’ abilities, among other things, to incur additional debt, grant or permit additional liens, make investments and acquisitions, merge or consolidate with others, dispose of assets, pay dividends and distributions and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the CRG Loan Agreement contains the following financial covenants requiring the Company and the Guarantors to maintain: • • on January 1, 2019 and ending on December 31, 2019 January 1, 2020 and ending on December 31, 2020 January 1, 2021 and ending on December 31, 2021 January 1, 2022 and ending on December 31, 2022 In November 2019, CRG waived the financial covenant associated with the Company’s revenue derived from sales of its products, DEXYCU and YUTIQ, for the twelve-month period ending December 31, 2019. In October 2020, CRG (i) waived the financial covenant associated with the Company’s revenue derived from sales of its products, DEXYCU and YUTIQ, for the twelve-month period ending December 31, 2020 and (ii) amended the financial covenant associated with the Company’s minimum product revenue to $ 45 twelve-month period ending December 31, 2021. There were no other material changes to the Loan Agreement and the Company incurred no incremental charges for the issuance of the waivers. The total debt discount related to the CRG Second Advance was approximately $1.1 million and consisted of (i) the accrual of a $900,000 exit fee; and (ii) the $225,000 upfront fee. This amount is being amortized as additional interest expense over the term of the Loan using the effective interest rate method. On December 17, 2020, the Company paid $15.0 million against the CRG Loan obligations in connection with the consummation of the RPA agreement (see Note 3). This payment included (i) a $13.8 million principal portion of the CRG Loan (ii) the $828,000 Exit Fee, and (iii) accrued and unpaid interest of $378,000 through that date. In connection with the partial prepayment of the CRG Loan, the Company recorded a loss on partial extinguishment of debt of $905,000 in the year ended December 31, 2020, associated with the write-off of the remaining balance of unamortized debt discount related to the partial prepayment of the CRG Loan. Amortization of debt discount under the CRG Loan totaled $628,000 and $745,000 for the years ended December 31, 2021 and 2020, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 10. Stockholders’ Equity Equity Financings Common Stock Offerings In November 2021, the Company sold 5,122,273 shares of its common stock in an underwritten public offering at a price of $13.75 per share, including the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of the Company’s common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock at a price of $13.74 per pre-funded warrant. The gross proceeds of the offering to the Company were approximately $115.4 million. Underwriter discounts and commissions and other share issue costs totaled approximately $7.2 million. The pre-funded warrants were classified as a component of permanent equity because they met the permanent equity criteria classification. The pre-funded warrants are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable and permit the holders to receive a fixed number of shares of common stock upon exercise. The pre-funded warrants do not embody an obligation for the Company to repurchase its shares and do not provide any guarantee of value or return. In February 2021, the Company sold 10,465,000 shares of its common stock in an underwritten public offering at a price of $11.00 per share, including the exercise in full by the underwriters of their option to purchase up to 1,365,000 additional shares of the Company’s common stock. The gross proceeds of the offering to the Company were approximately $115.1 million. Underwriter discounts and commissions and other share issue costs totaled approximately $7.2 million. On December 31, 2020, the Company entered into a Share Purchase Agreement (the “Share Purchase Agreement”) with Ocumension, pursuant to which the Company sold to Ocumension 3,010,722 shares of Common Stock, at a purchase price of approximately $5.22 per share, which was the five-day volume weighted average price of the Common Stock as of the close of trading on December 29, 2020. The aggregate gross proceeds from the Transaction were approximately $15.7 million. Share issue costs totaled approximately $0.1 million. In February 2020, the Company sold 1,500,000 shares of the Company’s common stock in an underwritten public offering at a price of $14.50 per share for gross proceeds of $21.75 million. Underwriter discounts and commissions and other share issue costs totaled approximately $1.8 million. At the Annual Meeting of Stockholders held on June 23, 2020, the Company’s stockholders approved the adoption of an amendment to the Company’s Certificate of Incorporation, to increase the number of authorized shares of its common stock from 150,000,000 shares to 300,000,000 shares. The Company filed the Certificate of Amendment on June 23, 2020. 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 Fitzgerald, 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 year ended December 31, 2020, the Company sold 2,590,093 shares of its Common Stock at a weighted average price of $5.74 per share for gross proceeds of approximately $14.9 million. Share issue costs, including sales agent commissions, totaled $646,000 during the reporting period. During the year ended December 31, 2021, the Company sold 48,538 shares of its Common Stock at a weighted average price of $11.37 per share for gross proceeds of approximately $552,000. Share issue costs, including sales agent commissions, totaled approximately $53,000 during the reporting period. Warrants to Purchase Common Shares The following table provides a reconciliation of fixed price warrants to purchase shares of the Company’s Common Stock for the years ended December 31, 2021 and 2020: Year Ended Year Ended December 31, December 31, 2021 2020 Number of Warrants Weighted Average Exercise Price Number of Warrants Weighted Average Exercise Price Balance at beginning of period 48,683 $ 12.33 48,683 $ 12.33 Balance and exercisable at end of period 48,683 $ 12.33 48,683 $ 12.33 Pursuant to a credit agreement, the Company issued a warrant to SWK Funding LLC to purchase (i) 40,910 Initial Advance Warrant Shares on March 28, 2018 at an exercise price of $11.00 per share with a seven-year seven-year |
Share-Based Payment Awards
Share-Based Payment Awards | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Payment Awards | 1 1 . Equity Incentive Plans The 2016 Long-Term Incentive Plan (the “2016 Plan”), approved by the Company’s stockholders on December 12, 2016 (the “Adoption Date”), provides for the issuance of up to 300,000 shares of the Company’s Common Stock reserved for issuance under the 2016 Plan plus any additional shares of the Company’s Common Stock that were available for grant under the 2008 Incentive Plan (the “2008 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 Plan. At the Company’s Annual Meeting of Stockholders held on June 25, 2019, the Company’s stockholders approved an amendment to the 2016 Plan to increase the number of shares authorized for issuance by 1,100,000 shares. At the Company’s Annual Meeting of Stockholders held on June 22, 2021, the Company’s stockholders approved an amendment to the 2016 Plan to increase the number of shares authorized for issuance by 2,500,000 shares. At December 31, 2021, a total of 1,683,368 shares were available for new awards. Certain inducement awards, although not awarded under the 2016 Plan or the 2008 Plan, are subject to and governed by the terms and conditions of the 2016 Plan or 2008 Plan, as applicable. Stock Options The following table provides a reconciliation of stock option activity under the Company’s equity incentive plans and for inducement awards for the year ended December 31, 2021: Number of options Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at January 1, 2021 1,338,880 $ 20.86 Granted 1,313,727 12.59 Exercised (8,112 ) 12.26 Forfeited (75,448 ) 16.46 Expired (51,367 ) 31.04 Outstanding at December 31, 2021 2,517,680 $ 16.49 8.06 $ 775 Exercisable at December 31, 2021 916,461 $ 22.41 6.25 $ 103 In January 2019, the Company expanded the terms of its annual stock option grants to include vesting ratable monthly over four years, or with 25% vesting after one year followed by ratable monthly vesting over three years. Previously, the Company’s option grants generally had ratable annual vesting over three years, or 1-year cliff vesting. 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 297,361 shares of the Company’s Common Stock vested during the year ended December 31, 2021. In determining the grant date fair value of option awards during the years ended December 31, 2021 and 2020, the Company applied the Black-Scholes option pricing model based on the following key assumptions: Year Ended December 31, Year Ended December 31, 2021 2020 Option life (in years) 4.75 - 6.08 5.50 - 6.10 Stock volatility 72% - 83% 64% - 70% Risk-free interest rate 0.42% - 1.44% 0.32% - 1.76% Expected dividends 0.0% 0.0% The following table summarizes information about employee, consultant and director stock options under the Company’s equity incentive plans for the years ended December 31, 2021 and 2020 (in thousands except per share amounts): Year Ended December 31, Year Ended December 31, 2021 2020 Weighted-average grant date fair value per share $ 8.20 $ 7.07 Total cash received from exercise of stock options 100 — Total intrinsic value of stock options exercised 10 — Time-Vested Restricted Stock Units Time-vested restricted stock units (“RSUs”) issued to date under the 2016 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 Common Stock on the date of grant. The following table provides a reconciliation of RSU activity under the 2016 Plan for the year ended December 31, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2021 149,004 $ 13.85 Granted 242,399 12.96 Vested (89,795 ) 13.76 Forfeited (10,033 ) 12.15 Nonvested at December 31, 2021 291,575 $ 13.19 The weighted-average remaining vesting term of the RSUs at December 31, 2021 was 1.37 years. Deferred Stock Units There were no non-vested deferred stock units (“DSUs”) issued and outstanding to the Company’s non-executive directors at each of December 31, 2021 and 2020, respectively. Each DSU vests one year from the date of grant. Subsequent to vesting, the DSUs will be settled in shares of the Company’s Common Stock upon the earliest to occur of (i) each director’s termination of service on the Company’s Board of Directors and (ii) the occurrence of a change of control as defined in the award agreement. At December 31, 2021, there was no vested DSUs that have not been settled in shares of the Company’s Common Stock. Employee Stock Purchase Plan On June 25, 2019, the Company’s stockholders approved the adoption of the EyePoint Pharmaceuticals, Inc. 2019 Employee Stock Purchase Plan (the “ESPP”) and authorized up to 110,000 shares of Common Stock reserved for issuance to participating employees. At the Company’s Annual Meeting of Stockholders held on June 22, 2021, the Company’s stockholders approved an amendment to the ESPP to increase the number of shares authorized for issuance by 250,000 shares. 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. 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 year ended December 31, 2021, the compensation expense from ESPP shares was $113,000. During the year ended December 31, 2020, the compensation expense from ESPP shares was immaterial. Stock-Based Compensation Expense The Company’s statements of comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands): Year Ended December 31, Year Ended December 31, 2021 2020 Compensation expense included in: Research and development $ 2,294 $ 1,411 Sales and marketing 1,187 907 General and administrative 3,966 3,229 $ 7,447 $ 5,547 At December 31, 2021, there was approximately $9.3 million of unrecognized compensation expense related to outstanding equity awards under the 2016 Plan, the 2008 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 | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
License and Asset Purchase Agreements | 12. Aerpio Pharmaceuticals, Inc. In August 2021, the Company entered into an Asset Purchase Agreement with Aerpio Pharmaceuticals, Inc. (“Aerpio”), pursuant to which Aerpio sold to the Company all of its right, title and interest in and to certain of its patents and patent applications and other intellectual property, including but not limited to patents covering certain human protein tyrosine phosphate inhibitors and methods of use. In consideration for the rights purchased from Aerpio, the Company made a one time, non-refundable, non-creditable upfront cash payment of $450,000 to Aerpio in August 2021. The Company recorded $450,000 of R&D expense for the year ended December 31, 2021, due to the early stage of its preclinical drug development activities. Equinox Science, LLC In February 2020, the Company entered into an Exclusive License Agreement with Equinox Science, LLC (“Equinox”), pursuant to which Equinox granted us 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 the prevention or treatment of age-related macular degeneration, diabetic retinopathy and retinal vein occlusion using our proprietary localized delivery technologies, in each case, throughout the world except China, Hong Kong, Taiwan and Macau (the “Territory”). In 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 Territory. The royalties are payable with respect to a licensed product in a particular country in the 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 (collectively, the “Royalty Term”). The |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 13. The following tables summarize the Company’s assets carried at fair value measured on a recurring basis at December 31, 2021 and 2020, respectively, by valuation hierarchy (in thousands): December 31, 2021 Carrying Value Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Level 1: Money market funds $ 155,551 $ — $ — $ 155,551 $ 155,551 $ — Subtotal $ 155,551 $ — $ — $ 155,551 $ 155,551 $ — Level 2: Commercial paper $ 49,514 $ — $ — $ 49,514 $ 16,549 $ 32,965 Subtotal $ 49,514 $ — $ — $ 49,514 $ 16,549 $ 32,965 Total $ 205,065 $ — $ — $ 205,065 $ 172,100 $ 32,965 December 31, 2020 Carrying Value Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Level 1: Money market funds $ 23,538 $ — $ — $ 23,538 $ 23,538 $ — Total $ 23,538 $ — $ — $ 23,538 $ 23,538 $ — At December 31, 2021, a total of $155.6 million, or 90.4% of the Company’s interest-bearing cash equivalent balances, were concentrated in one U.S. Government institutional money market fund that had investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. $16.5 million, or 9.6% of the Company’s interest-bearing cash equivalent balances consisted of investment-grade commercial paper. Generally, these investments may be sold upon demand and, therefore, the Company believes they have minimal risk. The Company had investments of $33.0 million in marketable securities at December 31, 2021. 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. At December 31, 2020, substantially all of the Company’s interest-bearing cash equivalent balances were concentrated in one U.S. Government money market fund that has investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. The Company had no investments in marketable securities at December 31, 2020. The carrying amounts of accounts receivable, accounts payable and accrued expenses approximate fair value because of their short-term maturity. The fair value of the Company’s CRG Loan is determined using a discounted cash flow analysis based on market rates for observable similar instruments as of the condensed consolidated balance sheet dates. Accordingly, the fair value of the CRG Loan is categorized as Level 2 within the fair value hierarchy. At December 31, 2021, the fair value of the CRG Loan was approximately $38.7 million, and the carrying value of the CRG Loan was approximately $ 38.9 million, and consisted of $ 36.6 million of its carrying amount as reported in long-term debt, and $2.3 million of debt exit fee as reported in other long-term liabilities of the consolidated balance sheet, respectively. At December 31, 2020, the fair value of the CRG Loan was approximately $38.0 million, and the carrying value of the CRG Loan was approximately $38.3 million, and consisted of $36.0 million of its carrying amount as reported in long-term debt, and $2.3 million of debt exit fee as reported in other long-term liabilities of the condensed consolidated balance sheet, respectively. |
Retirement Plans
Retirement Plans | 12 Months Ended |
Dec. 31, 2021 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plans | 1 4 . Retirement Plans The Company operates a defined contribution plan intended to qualify under Section 401(k) of the U.S. Internal Revenue Code. Participating U.S. employees may contribute a portion of their pre-tax compensation, as defined, subject to statutory maximums. The Company matches employee contributions up to 5% of eligible compensation, subject to a stated calendar year Internal Revenue Service maximum. The Company operated a defined contribution pension plan for U.K. employees pursuant to which the Company made contributions on behalf of employees plus a matching percentage of elective employee contributions. This pension plan was terminated in the quarter ending September 30, 2016 following termination of employment of all U.K. employees. The Company contributed a total of $1.0 million and $690,000 for the years ended December 31, 2021 and 2020, respectively, in connection with these retirement plans. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 1 5 . Income Taxes The components of loss before income taxes are as follows (in thousands): Year Ended December 31, Year Ended December 31, 2021 2020 U.S. operations $ (58,517 ) $ (45,492 ) Non-U.S. operations 100 98 Loss before income taxes $ (58,417 ) $ (45,394 ) O n December 22, 2017, the Tax Cuts and Jobs Act (the “Tax Act”) was signed into law, making significant changes to the federal tax law. Amongst other things, the Tax Act reduces the federal corporate tax rate from 34% to 21% effective for tax years beginning after December 31, 2017 and has resulted in a remeasurement of the Company’s deferred tax assets included in the Company’s fiscal 2018 rate reconciliation. Year Ended December 31, Year Ended December 31, 2021 2020 Income tax benefit at statutory rate $ (12,268 ) $ (9,533 ) State income taxes, net of federal benefit (2,890 ) (2,760 ) Non-U.S. income tax rate differential — (8 ) Change in fair value of derivative — — Change in federal tax rate — — Research and development tax credits (693 ) (403 ) Permanent items 729 288 Changes in valuation allowance 15,748 13,068 Other, net (626 ) (652 ) Income tax benefit $ — $ — The significant components of deferred income taxes are as follows (in thousands): December 31, December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 84,026 $ 74,876 Deferred revenue 4,270 150 Lease liability 722 806 Stock-based compensation 7,822 6,847 Tax credits 5,446 4,503 Other 3,005 2,514 Total deferred tax assets 105,291 89,696 Deferred tax liabilities: Intangible assets 5,963 6,087 Right-of-use assets 615 713 Total deferred tax liabilities 6,578 6,800 Deferred tax assets, net 98,713 82,896 Valuation allowance 98,713 82,896 Total deferred tax liability $ — $ — The valuation allowance generally reflects limitations on the Company’s ability to use the tax attributes and reduces the value of such attributes to the more-likely-than-not realizable amount. Management assessed the available positive and negative evidence to estimate if sufficient taxable income will be generated to use the existing net deferred tax assets. Based on a weighting of the objectively verifiable negative evidence in the form of cumulative operating losses over the three-year period ended June 30, 2018, management believes that it is not more likely than not that the deferred tax assets will be realized and, accordingly, a full valuation allowance has been established. The valuation allowance increased $15.7 million and $13.1 million for the years ended December 31, 2021 and 2020, respectively, with such increases attributed to the re-measurement of the net deferred tax assets at the year-end dates. The Company has tax net operating loss and tax credit carry forwards in its individual tax jurisdictions. Including approximately $49.3 million related to the Icon acquisition, at December 31, 2021, the Company had U.S. federal net operating loss carry forwards of approximately $301.2 million. The net operating losses consist of $151.8 million, which expire at various dates between calendar years 2023 and 2038. The utilization of certain of these loss and tax credit carry forwards may be limited by Sections 382 and 383 of the Internal Revenue Code as a result of historical or future changes in the Company’s ownership. At December 31, 2021, the Company had state net operating loss carry forwards of approximately $222.6 million, which expire between 2033 and 2038, as well as U.S. federal and state research and development tax credit carry forwards of approximately $5.7 million, which expire at various dates between calendar years 2021 and 2038. In addition, at December 31, 2021 the Company had net operating loss carry forwards in the U.K. of £20.9 million (approximately $27.6 million), which are not subject to any expiration dates. The Company’s U.S. federal income tax returns for calendar years 2003 through 2020 remain subject to examination by the Internal Revenue Service. The Company’s U.K. tax returns for fiscal years 2006 through 2020 remain subject to examination. Through December 31, 2021, the Company had no unrecognized tax benefits in its consolidated statements of comprehensive loss and no unrecognized tax benefits in its consolidated balance sheets as of December 31, 2021 and 2020, respectively. As of December 31, 2021 and 2020, the Company had no accrued penalties or interest related to uncertain tax positions. |
Contingencies
Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Contingencies | 1 6 . Contingencies Legal Proceedings The Company is subject to various other 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. Securities and Exchange Commission Subpoena The Company previously disclosed that on May 14, 2020 it had received a subpoena from the Division of Enforcement of the SEC seeking production of certain documents and information on topics including product sales and demand, revenue recognition and accounting in relation to product sales, product sales and cash projections, and related financial reporting, disclosure and compliance matters. On May 4, 2021, the Company was advised by the SEC Division of Enforcement that it has concluded its investigation of the Company and that, based on the information it has to date, the Enforcement Division does not intend to recommend an enforcement action against the Company. |
Segment and Geographic Area Inf
Segment and Geographic Area Information | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Segment and Geographic Area Information | 1 7 . Segment and Geographic Area Information Business Segment The Company operates in one business segment, which is the business of developing and commercializing innovative ophthalmic products for the treatment of eye diseases. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker made such decisions and assessed performance at the company level, as one segment. Geographic Area Information The following table summarizes the Company’s revenues and long-lived assets, net by geographic area (in thousands): Revenues Long-lived assets, net Twelve Months Ended December 31, Twelve Months Ended December 31, At December 31, At December 31, 2021 2020 2021 2020 U.S. $ 35,988 $ 22,624 $ 476 $ 630 China 851 11,713 — — U.K. 100 100 — — Consolidated $ 36,939 $ 34,437 $ 476 $ 630 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 8 . Subsequent Events On March 9, 2022, the Company entered into a Loan and Security Agreement with Silicon Valley Bank (the “SVB Loan Agreement”). The SVB Loan Agreement provides (i) a senior secured term loan facility of $30 million (the “Term Loan”) and (ii) a senior secured revolving credit facility of up to $15.0 million in available credit (the “Revolving Facility” and together with the Term Loan, “the SVB Loan”). The maximum amount available for borrowing at any time under the Revolving Facility is limited to a borrowing base valuation, or 80% of the Company’s eligible accounts receivable. An unused commitment fee of 0.25% per annum applies to unutilized borrowing capacity under the Revolving Facility. The SVB Loan Agreement replaced its existing CRG Loan (see Note 9). Pursuant to the SVB Loan Agreement, the Company (i) made an initial draw of $30 million with respect to the Term Loan and of approximately $11.5 million with respect to the Revolving Facility, to pay off the CRG Loan, including the accrued interests through this date. Certain prepayment premiums apply to any repayments made (i) with respect to the Term Loan prior to the maturity date on January 1, 2027, and (ii) with respect to the Revolving Facility prior to the maturity date on January 1, 2027. The SVB Loan Agreement bears interest at (i) the greater of (x) Wall Street Journal Prime Rate plus 2.25% and (y) 5.50%, with respect to the Term Loan; (ii) the Wall Street Journal Prime Rate, with respect to the Revolving Facility; per annum payable in arrears on the last business day of each calendar month. Commencing on February 1, 2024, the Company is required to repay the principal amount of the Term Loan in 36 consecutive equal monthly installments plus monthly payments of accrued interest. Amounts borrowed under the Revolving Facility may be prepaid or repaid and, prior to the Revolving Facility Maturity Date, reborrowed, subject to the applicable terms and conditions set forth in the SVB Loan Agreement. The SVB Loan is due at maturity on January 1, 2027 (the “Maturity Date”). On the same date, the Company paid $41.4 million. This payment included (i) a $38.2 million principal portion of the CRG Loan (ii) an $2.3 million exit fee of 6% of the aggregate principal amount advanced under the CRG Loan (iii) accrued and unpaid interest of $0.9 million through that date. As a result of the early repayment of the CRG Loan, the Company expects to record a loss on extinguishment of debt of approximately $1.5 million for the quarter ending March 31, 2022 in association with the write-off of the remaining balance of unamortized debt discount. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements are presented in U.S. dollars in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and include the accounts of EyePoint Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts and disclosure of assets and liabilities at the date of the consolidated financial statements and the reported amounts and disclosure of revenues and expenses during the reporting periods. Significant management estimates and assumptions include, among others, those related to reserves for variable consideration related to product sales, revenue recognition for multiple-deliverable arrangements, recognition of expense in outsourced clinical trial agreements, recording of excess or obsolete inventory write-offs and reserves, and realization of deferred tax assets. Actual results could differ from these and other estimates and there may be changes to the Company’s estimates in future periods. |
Foreign Currency | Foreign Currency The functional currency of the Company and each of its subsidiaries is the currency of the primary economic environment in which each such entity operates—the U.S. dollar or the Pound Sterling. Assets and liabilities of the Company’s foreign subsidiary are translated at period-end exchange rates. Amounts included in the consolidated statements of comprehensive loss and cash flows are translated at the weighted average exchange rates for the period. Gains and losses from currency translation are included in accumulated other comprehensive income as a separate component of stockholders’ equity in the consolidated balance sheets. The balance of accumulated other comprehensive income attributable to foreign currency translation was $841,000 and $841,000 at December 31, 2021 and 2020, respectively. Foreign currency gains or losses arising from transactions denominated in foreign currencies, whether realized or unrealized, are recorded in interest and other income, net in the consolidated statements of comprehensive loss and were not material for all periods presented. |
Cash Equivalents | Cash Equivalents Cash equivalents represent highly liquid investments with maturities of three months or less at the date of purchase, principally consisting of institutional money market funds and investment-grade commercial paper. |
Marketable Securities | Marketable Securities Marketable securities consist of investments with an original or remaining maturity of greater than three months but less than six months at the date of purchase. The Company has historically classified its marketable securities as available-for-sale. Accordingly, the Company records these investments at fair value, with unrealized gains and losses excluded from earnings and reported, net of tax, in accumulated other comprehensive income, which is a component of stockholders’ equity. If the Company determines that a decline of any investment is other-than-temporary, the investment is written down to fair value. Marketable securities at December 31, 2021 consisted of investment-grade commercial paper. The Company had no marketable security investments at December 31, 2020. The Company’s investment policy, approved by the Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. During fiscal 2021, $33.0 million of marketable securities were purchased and $0 matured. The fair value of marketable securities is determined based on quoted market prices at the balance sheet date of the same or similar instruments. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts through to the earlier of sale or maturity. Such amortization and accretion amounts are included in interest and other income, net in the consolidated statements of comprehensive loss. The cost of marketable securities sold is determined by the specific identification method. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and investments in marketable securities. At December 31, 2021, a total of $155.6 million, or 90.4% of the Company’s interest-bearing cash equivalent balances, were concentrated in one U.S. Government institutional money market fund that had investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. $16.5 million, or 9.6% of the Company’s interest-bearing cash equivalent balances consisted of investment-grade commercial paper. Generally, these investments may be sold upon demand and, therefore, the Company believes they have minimal risk. The Company had investments of $33.0 million and $0 in marketable securities at December 31, 2021 and 2020, respectively. The Company’s investment policy, approved by the Company’s Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. As of December 31, 2021, accounts receivable from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 54.7% and 38.3% of total accounts receivable, respectively. For the year ended December 31, 2021, revenues from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 46.6% and 43.1% of total revenues, respectively. As of December 31, 2020, accounts receivable from ASD Specialty Healthcare LLC and McKesson Specialty Care Distribution LLC accounted for 56.0% and 37.0% of total accounts receivable, respectively. For the year ended December 31, 2020, revenues from ASD Specialty Healthcare LLC, Ocumension Therapeutics, and McKesson Specialty Care Distribution LLC accounted for 39.0%, 33.0%, and 18.0% of total revenues, respectively. |
Fair Value Measurements | Fair Value Measurements The Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. The Company categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These levels are: • Level 1 – Inputs are quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets and liabilities. • Level 2 – Inputs are directly or indirectly observable in the marketplace, such as quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities with insufficient volume or infrequent transaction (less active markets). • Level 3 – Inputs are unobservable estimates that are supported by little or no market activity and require the Company to develop its own assumptions about how market participants would price the assets or liabilities. 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. |
Accounts and Other Receivables, Net | Accounts and Other Receivables, Net Receivables arise primarily from the Company’s products sold in the U.S. The balance in accounts and other receivables, net consists primarily of amounts due from customers, net of applicable revenue reserves. The majority of the Company’s accounts receivable have standard payment terms that require payment within 120-127 days. The Company performs ongoing credit evaluations of its customers’ financial condition and continuously monitor collections and payments from its customers and The allowance for credit losses is estimated based on the Company’s analysis of trends in overall receivables aging, specific identification of certain receivables that are at risk of not being paid, past collection experience and current economic trends. iven the nature and limited history of collectability of the Company’s accounts receivable, |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value, net on a first-in, first-out (“FIFO”) basis. The inventory costs for YUTIQ include purchases of various components and the active pharmaceutical ingredient (“API”) and internal labor and overhead for the product manufactured in the Company’s Watertown, MA facility. The inventory costs for DEXYCU include purchased components, the API and third-party manufacturing and assembly. Capitalization of inventory costs begins after FDA approval of the product. Prior thereto, inventory costs of products and product candidates are recorded as research and development expense, even if this inventory may later be sold as commercial product. The Company assesses the recoverability of inventory and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Write-downs are based on the age of the inventory, lower of cost or market, along with significant management judgments concerning future demands for the inventory. Such impairment charges, should they occur, are recorded within cost of sales, excluding amortization of acquired intangible assets. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory might be recorded in future periods. Cost of The 2.3 1.3 |
Debt and Equity Instruments | Debt and Equity Instruments Debt and equity instruments are classified as either liabilities or equity in accordance with the substance of the contractual arrangement. |
Derivative Instruments | Derivative Instruments Derivative financial liabilities are recorded at fair value, with gains and losses arising from changes in fair value recognized in change in fair value of derivative liability within the consolidated statements of comprehensive loss at each period end while such instruments are outstanding. The Company’s derivative liabilities from certain financing transactions were primarily valued using Monte Carlo simulation models. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives (generally three to five years) using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the shorter of the remaining non-cancellable lease term or their estimated useful lives. Repair and maintenance costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are derecognized from the respective accounts and any gain or loss is recognized. |
Capitalized Software Development Cost | Capitalized Software Development Cost The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as software business applications used in the normal course of business, are capitalized in accordance with ASC 350 Intangibles – Goodwill and Other |
Leases | Leases The Company leases real estate and office equipment under operating leases. Its primary real estate lease contains rent holiday and rent escalation clauses. The Company determines whether the arrangement is or contains a lease at inception. Operating leases are recognized on the consolidated balance sheets as ROU assets, current portion of lease liabilities and long-term lease liabilities. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. |
Impairment of Intangible Assets | Impairment of Intangible Assets The Company’s finite life intangible assets include the DEXYCU product (utilizing the Verisome technology) following the March 2018 acquisition of Icon. The DEXYCU intangible asset is being amortized on a straight-line basis over its estimated useful life of thirteen years. The intangible asset lives were determined based upon the anticipated period that the Company would derive future cash flows from the intangible assets, considering the effects of legal, regulatory, contractual, competitive and other economic factors. The Company continually monitors whether events or circumstances have occurred that indicate that the remaining estimated useful life of its intangible assets may warrant revision. The Company assesses potential impairments to its intangible assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when the future undiscounted net cash flows expected to result from the use of an asset are less than its carrying value. If the Company considers an asset to be impaired, the impairment charge to be recognized is measured as the amount by which the carrying value of the asset exceeds its estimated fair value. |
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 each 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 — The Company sells YUTIQ and DEXYCU to a limited number of specialty distributors and specialty pharmacies (collectively the “Distributors”) in the U.S., with whom the Company has entered into formal agreements, for delivery to physician practices for YUTIQ and to hospital outpatient departments and ambulatory surgical centers for DEXYCU. The Company recognizes revenue on sales of its products when Distributors obtain control of the products, which occurs at a point in time, typically upon delivery. In addition to agreements with Distributors, the Company also enters into arrangements with healthcare providers, ambulatory surgical centers, and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products from Distributors. Reserves for variable consideration — Product sales are recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration include trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that are offered within contracts between the Company and its Distributors, payors, and other contracted purchasers relating to the Company’s product sales. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount is to be settled. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. 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 compensates its Distributors for services explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product sale is recognized. Provider chargebacks and discounts — Chargebacks are discounts that represent 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 charge the Company for the difference between what they pay for the product and the Company’s contracted selling price. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability . Reserves for chargebacks consist of amounts that the Company expects to pay for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold under a contracted selling price, and chargebacks that Distributors have claimed, but for which the Company has not yet settled. Government rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor rebates — The Company contracts with certain private payor organizations, primarily insurance companies, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Co-Payment assistance — The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. Product returns — The Company generally offers a limited right of return based on its returned goods policy, which includes damaged product and remaining shelf life. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to trade receivables, net on the condensed consolidated balance sheets. 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 up-front 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. 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 December 31, 2021. 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 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 (including feasibility study agreements). 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 (including feasibility study agreements). 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. Deferred Revenue Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue. |
Research and Development | Research and Development Research and development costs are charged to operations as incurred. These costs include all direct costs, including cash and stock-based compensation and benefits for research, clinical development, quality assurance, quality control, operations and medical affairs personnel, amortization of intangible assets, third-party costs and services for clinical trials, clinical materials, pre-clinical programs, regulatory and medical affairs, external consultants, and other operational costs related to the Company’s research and development of its product candidates. |
Stock-Based Compensation | Stock-Based Compensation Compensation cost related to share-based payment awards is based on the fair value of the instrument on the grant date and is recognized on a graded vesting basis over the requisite service period for each separately vesting tranche of the awards. The Company may also grant share-based payment awards that are subject to objectively measurable performance and service criteria. Compensation expense for performance-based awards begins at such time as it becomes probable that the respective performance conditions will be achieved. The Company continues to recognize the grant date fair value of performance-based awards through the vesting date of the respective awards so long as it remains probable that the related performance conditions will be satisfied. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model and the fair value of performance stock units, restricted stock units and deferred stock units based on the observed grant date fair value of the underlying Common Stock. |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed by dividing 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 weighted-average number of common shares outstanding the average number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive. As of December 31, 2021, 3,272,727 shares of Pre-Funded Warrants to purchase common stock, issued in connection with the November 2021 underwritten public offering (see Note 10), were included in the basic and diluted net loss per share calculation. Outstanding potential Common Stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows: Year Ended December 31, Year Ended December 31, 2021 2020 Stock options 2,517,680 1,338,880 ESPP 23,965 27,713 Warrants 48,683 48,683 Restricted stock units 291,575 149,004 2,881,903 1,564,280 |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss, foreign currency translation adjustments and unrealized gains and losses on available-for-sale marketable securities. |
Income Tax | Income Tax The Company accounts for income taxes under the asset and liability method. Deferred income tax assets and liabilities are computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future benefit to be derived from tax credits and loss carry forwards. Such deferred income tax computations are measured based on enacted tax laws and rates applicable to the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is provided against net deferred tax assets if, based on the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the uncertainty. The Company accounts for interest and penalties related to uncertain tax positions as part of its income tax benefit. |
Recently Adopted and Recently Issued Accounting Pronouncements | Recently Adopted and Recently Issued Accounting Pronouncements New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective dates. Unless otherwise disclosed below, the Company believes that recently issued and adopted pronouncements will not have a material impact on the Company’s financial position, results of operations and cash flows or do not apply to the Company’s operations. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”) : Simplifying the Accounting for Income Taxes. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) : Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares | Outstanding potential Common Stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows: Year Ended December 31, Year Ended December 31, 2021 2020 Stock options 2,517,680 1,338,880 ESPP 23,965 27,713 Warrants 48,683 48,683 Restricted stock units 291,575 149,004 2,881,903 1,564,280 |
Product Revenue Reserves and _2
Product Revenue Reserves and Allowances (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Disaggregation of Revenue | Net product revenues by product for the years ended December 31, 2021 and 2020 were as follows (in thousands): Year Ended December 31, 2021 2020 YUTIQ (A) $ 16,959 $ 13,878 DEXYCU (B) 18,353 6,953 Total product sales, net $ 35,312 $ 20,831 (A) Included approximately $25 and $205 of revenue recognized from YUTIQ product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. (B) Included approximately $283 and $8 of revenue recognized from DEXYCU product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. |
Product Revenue Allowance and Reserves | The following table summarizes activity in each of the product revenue allowance and reserve categories for the years ended December 31, 2021 and 2020 (in thousands): Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2021 $ 574 $ 535 $ 603 $ 1,712 Provision related to sales in the current year 7,274 5,337 785 13,396 Adjustments related to prior period sales (50 ) (22 ) (200 ) (272 ) Deductions applied and payments made (6,645 ) (4,029 ) (809 ) (11,483 ) Ending balance at December 31, 2021 $ 1,153 $ 1,821 $ 379 $ 3,353 Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2020 $ 1,618 $ 271 $ 352 $ 2,241 Provision related to sales in the current year 2,141 1,056 978 4,175 Adjustments related to prior period sales (387 ) — 50 (337 ) Deductions applied and payments made (2,798 ) (792 ) (777 ) (4,367 ) Ending balance at December 31, 2020 $ 574 $ 535 $ 603 $ 1,712 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): December 31, 2021 December 31, 2020 Raw materials $ 2,727 $ 2,664 Work in process 405 747 Finished goods 484 1,926 Total inventory $ 3,616 $ 5,337 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Reconciliation of Intangible Assets | The reconciliation of intangible assets for the years ended December 31, 2021 and 2020 (in thousands): Year Ended Year Ended December 31, December 31, 2021 2020 Patented technologies Gross carrying amount at beginning of period $ 68,322 $ 68,322 Gross carrying amount at end of period 68,322 68,322 Accumulated amortization at beginning of period (43,113 ) (40,653 ) Amortization expense (2,460 ) (2,460 ) Accumulated amortization at end of period (45,573 ) (43,113 ) Net book value at end of period $ 22,749 $ 25,209 |
Schedule of Net Book Value of Intangible Assets | The net book value of the Company’s intangible assets at December 31, 2021 and 2020 is summarized as follows (in thousands): Estimated Remaining Useful Life at December 31, December 31, December 31, 2021 2020 2021 (Years) Patented technologies DEXYCU / Verisome $ 22,749 $ 25,209 9.25 $ 22,749 $ 25,209 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, December 31, 2021 2020 Property and equipment $ 1,477 $ 1,403 Leasehold improvements 255 255 Gross property and equipment 1,732 1,658 Accumulated depreciation and amortization (1,256 ) (1,028 ) $ 476 $ 630 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): December 31, December 31, 2021 2020 Personnel costs $ 7,321 $ 5,686 Clinical trial costs 753 — Professional fees 712 647 Sales chargebacks, rebates and other revenue reserves 2,974 1,109 Commissions due to commercialization partner for DEXYCU 1,518 254 Other 1,144 749 $ 14,422 $ 8,445 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases as of December 31, 2021 and 2020, respectively are as follows (in thousands): December 31, December 31, 2021 2020 Other current liabilities - operating lease current portion $ 645 $ 568 Operating lease liabilities – noncurrent portion 1,860 2,330 Total operating lease liabilities $ 2,505 $ 2,898 |
Schedule of Supplemental Balance Sheet Information Related to Finance Lease | Supplemental balance sheet information related to the finance lease as of December 31, 2021 and 2020, respectively are as follows (in thousands): December 31, December 31, 2021 2020 Property and equipment, at cost $ 371 $ 239 Accumulated amortization (205 ) (52 ) Property and equipment, net $ 166 $ 187 Other current liabilities – $ 137 $ 119 Other long-term liabilities 36 71 Total finance lease liabilities $ 173 $ 190 |
Future Minimum Lease Payments Under Non-Cancellable Leases | T he Company’s total future minimum lease payments under non-cancellable leases at December 31, 2021 were as follows (in thousands): Operating Leases Finance Leases 2022 911 149 2023 877 37 2024 894 — 2025 373 — Total lease payments $ 3,055 $ 186 Less imputed interest (550 ) (13 ) Total $ 2,505 $ 173 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Reconciliation of Warrants to Purchase Common Stock | The following table provides a reconciliation of fixed price warrants to purchase shares of the Company’s Common Stock for the years ended December 31, 2021 and 2020: Year Ended Year Ended December 31, December 31, 2021 2020 Number of Warrants Weighted Average Exercise Price Number of Warrants Weighted Average Exercise Price Balance at beginning of period 48,683 $ 12.33 48,683 $ 12.33 Balance and exercisable at end of period 48,683 $ 12.33 48,683 $ 12.33 |
Share-Based Payment Awards (Tab
Share-Based Payment Awards (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity Under Plan | The following table provides a reconciliation of stock option activity under the Company’s equity incentive plans and for inducement awards for the year ended December 31, 2021: Number of options Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at January 1, 2021 1,338,880 $ 20.86 Granted 1,313,727 12.59 Exercised (8,112 ) 12.26 Forfeited (75,448 ) 16.46 Expired (51,367 ) 31.04 Outstanding at December 31, 2021 2,517,680 $ 16.49 8.06 $ 775 Exercisable at December 31, 2021 916,461 $ 22.41 6.25 $ 103 |
Schedule of Key Assumptions Used | In determining the grant date fair value of option awards during the years ended December 31, 2021 and 2020, the Company applied the Black-Scholes option pricing model based on the following key assumptions: Year Ended December 31, Year Ended December 31, 2021 2020 Option life (in years) 4.75 - 6.08 5.50 - 6.10 Stock volatility 72% - 83% 64% - 70% Risk-free interest rate 0.42% - 1.44% 0.32% - 1.76% Expected dividends 0.0% 0.0% |
Summary of Information about Stock Options | The following table summarizes information about employee, consultant and director stock options under the Company’s equity incentive plans for the years ended December 31, 2021 and 2020 (in thousands except per share amounts): Year Ended December 31, Year Ended December 31, 2021 2020 Weighted-average grant date fair value per share $ 8.20 $ 7.07 Total cash received from exercise of stock options 100 — Total intrinsic value of stock options exercised 10 — |
Summary of Restricted Stock Unit Activity | The following table provides a reconciliation of RSU activity under the 2016 Plan for the year ended December 31, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2021 149,004 $ 13.85 Granted 242,399 12.96 Vested (89,795 ) 13.76 Forfeited (10,033 ) 12.15 Nonvested at December 31, 2021 291,575 $ 13.19 |
Compensation Expense from Stock-Based Payment Awards | The Company’s statements of comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands): Year Ended December 31, Year Ended December 31, 2021 2020 Compensation expense included in: Research and development $ 2,294 $ 1,411 Sales and marketing 1,187 907 General and administrative 3,966 3,229 $ 7,447 $ 5,547 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Carried at Fair Value Measured on Recurring Basis | The following tables summarize the Company’s assets carried at fair value measured on a recurring basis at December 31, 2021 and 2020, respectively, by valuation hierarchy (in thousands): December 31, 2021 Carrying Value Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Level 1: Money market funds $ 155,551 $ — $ — $ 155,551 $ 155,551 $ — Subtotal $ 155,551 $ — $ — $ 155,551 $ 155,551 $ — Level 2: Commercial paper $ 49,514 $ — $ — $ 49,514 $ 16,549 $ 32,965 Subtotal $ 49,514 $ — $ — $ 49,514 $ 16,549 $ 32,965 Total $ 205,065 $ — $ — $ 205,065 $ 172,100 $ 32,965 December 31, 2020 Carrying Value Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Level 1: Money market funds $ 23,538 $ — $ — $ 23,538 $ 23,538 $ — Total $ 23,538 $ — $ — $ 23,538 $ 23,538 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Taxes | The components of loss before income taxes are as follows (in thousands): Year Ended December 31, Year Ended December 31, 2021 2020 U.S. operations $ (58,517 ) $ (45,492 ) Non-U.S. operations 100 98 Loss before income taxes $ (58,417 ) $ (45,394 ) |
Difference Between Expected Income Tax Benefit and Actual Income Tax Benefit | The difference between the Company’s expected income tax benefit, as computed by applying the blended statutory U.S. federal tax rate of 21% for the year ended December 31, 2021 and 21% for the year ended December 31, 2020, to loss before income taxes, and actual income tax benefit is reconciled in the following table (in thousands): Year Ended December 31, Year Ended December 31, 2021 2020 Income tax benefit at statutory rate $ (12,268 ) $ (9,533 ) State income taxes, net of federal benefit (2,890 ) (2,760 ) Non-U.S. income tax rate differential — (8 ) Change in fair value of derivative — — Change in federal tax rate — — Research and development tax credits (693 ) (403 ) Permanent items 729 288 Changes in valuation allowance 15,748 13,068 Other, net (626 ) (652 ) Income tax benefit $ — $ — |
Significant Components of Deferred Income Taxes | The significant components of deferred income taxes are as follows (in thousands): December 31, December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 84,026 $ 74,876 Deferred revenue 4,270 150 Lease liability 722 806 Stock-based compensation 7,822 6,847 Tax credits 5,446 4,503 Other 3,005 2,514 Total deferred tax assets 105,291 89,696 Deferred tax liabilities: Intangible assets 5,963 6,087 Right-of-use assets 615 713 Total deferred tax liabilities 6,578 6,800 Deferred tax assets, net 98,713 82,896 Valuation allowance 98,713 82,896 Total deferred tax liability $ — $ — |
Segment and Geographic Area I_2
Segment and Geographic Area Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Summary of Company's Revenues and Long-Lived Assets, Net, by Geographic Area | The following table summarizes the Company’s revenues and long-lived assets, net by geographic area (in thousands): Revenues Long-lived assets, net Twelve Months Ended December 31, Twelve Months Ended December 31, At December 31, At December 31, 2021 2020 2021 2020 U.S. $ 35,988 $ 22,624 $ 476 $ 630 China 851 11,713 — — U.K. 100 100 — — Consolidated $ 36,939 $ 34,437 $ 476 $ 630 |
Operations - Additional Informa
Operations - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($)Product_PeopleCase | |
Operations [Line Items] | |
Number of commercial products | Product | 2 |
Number of products approved | Product | 4 |
Cash, cash equivalents and investments in marketable securities | $ 211.6 |
Cost of Sales, Excluding Amortization of Acquired Intangible Assets [Member] | |
Operations [Line Items] | |
Impairment charges | 1.2 |
Sales and Marketing Expense [Member] | |
Operations [Line Items] | |
Impairment charges | $ 0.1 |
YUTIQ [Member] | |
Operations [Line Items] | |
Number of new cases of blindness annually | Case | 30,000 |
YUTIQ [Member] | Minimum [Member] | |
Operations [Line Items] | |
Number of people affected by posterior segment of eye in U.S. each year | _People | 60,000 |
YUTIQ [Member] | Maximum [Member] | |
Operations [Line Items] | |
Number of people affected by posterior segment of eye in U.S. each year | _People | 100,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) - USD ($) | Mar. 28, 2018 | Aug. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule Of Significant Accounting Policies [Line Items] | |||||
Accumulated other comprehensive income to foreign currency translation | $ 841,000 | $ 841,000 | |||
Marketable securities | 33,000,000 | 0 | |||
Purchases of marketable securities | 33,000,000 | ||||
Marketable securities matured | 0 | ||||
Interest-bearing cash equivalent consisted of money market fund | 155,600,000 | ||||
Interest-bearing cash equivalent consisted of investment-grade commercial paper | 16,500,000 | ||||
Allowance for credit loss | $ 0 | $ 0 | |||
Pre Funded Warrants to purchase common stock | 3,272,727 | ||||
Accounting Standards Update 2019-12 [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | ||||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 1, 2021 | ||||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | ||||
Icon Bioscience Inc [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of accelerated milestone payment received | 20.00% | ||||
DEXYCU [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Accrued revenue-based royalty expense | $ 2,500,000 | $ 2,300,000 | |||
DEXYCU [Member] | Icon Bioscience Inc [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Accrued revenue-based royalty expense | $ 0 | $ 1,300,000 | |||
Percentage of accelerated milestone payment received | 20.00% | ||||
Percentage of upfront payment received | 20.00% | ||||
Finite-lived intangible asset, useful life | 13 years | 9 years 3 months | |||
Minimum [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Accounts receivable standard payment terms | 120 days | ||||
Estimated useful lives of assets | 3 years | ||||
Maximum [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Accounts receivable standard payment terms | 127 days | ||||
Estimated useful lives of assets | 5 years | ||||
Investment Instruments [Member] | Credit Concentration Risk [Member] | Money Market Funds [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 90.40% | ||||
Investment Instruments [Member] | Credit Concentration Risk [Member] | Commercial Paper [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 9.60% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ASD Specialty Healthcare LLC [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 38.30% | 56.00% | |||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | McKesson Specialty Care Distribution LLC [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 54.70% | 37.00% | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | ASD Specialty Healthcare LLC [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 43.10% | 39.00% | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | McKesson Specialty Care Distribution LLC [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 46.60% | 18.00% | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Ocumension Therapeutics [Member] | |||||
Schedule Of Significant Accounting Policies [Line Items] | |||||
Percentage of concentration risk | 33.00% |
Significant Accounting Polici_5
Significant Accounting Policies - Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 2,881,903 | 1,564,280 |
Stock options [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 | 2,517,680 | 1,338,880 |
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 | 23,965 | 27,713 |
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 | 48,683 | 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 | 291,575 | 149,004 |
Product Revenue Reserves and _3
Product Revenue Reserves and Allowances - Disaggregation of Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | $ 36,939 | $ 34,437 | |
YUTIQ [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | [1] | 16,959 | 13,878 |
DEXYCU [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | [2] | 18,353 | 6,953 |
Product [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | $ 35,312 | $ 20,831 | |
[1] | Included approximately $25 and $205 of revenue recognized from YUTIQ product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. | ||
[2] | Included approximately $283 and $8 of revenue recognized from DEXYCU product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. |
Product Revenue Reserves and _4
Product Revenue Reserves and Allowances - Disaggregation of Revenue (Parenthetical) (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 36,939 | $ 34,437 | |
YUTIQ [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | [1] | 16,959 | 13,878 |
YUTIQ [Member] | Ocumension Therapeutics [Member] | Supply Agreement [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 25 | 205 | |
DEXYCU [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | [2] | 18,353 | 6,953 |
DEXYCU [Member] | Ocumension Therapeutics [Member] | Supply Agreement [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 283 | $ 8 | |
[1] | Included approximately $25 and $205 of revenue recognized from YUTIQ product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. | ||
[2] | Included approximately $283 and $8 of revenue recognized from DEXYCU product sales to Ocumension under a supply agreement for the years ended December 31, 2021 and 2020, respectively. |
Product Revenue Reserves and _5
Product Revenue Reserves and Allowances - Product Revenue Allowance and Reserves (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | $ 1,712 | $ 2,241 |
Provision related to sales in the current year | 13,396 | 4,175 |
Adjustments related to prior period sales | (272) | (337) |
Deductions applied and payments made | (11,483) | (4,367) |
Ending balance | 3,353 | 1,712 |
Chargebacks, Discounts and Fees [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 574 | 1,618 |
Provision related to sales in the current year | 7,274 | 2,141 |
Adjustments related to prior period sales | (50) | (387) |
Deductions applied and payments made | (6,645) | (2,798) |
Ending balance | 1,153 | 574 |
Government and Other Rebates [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 535 | 271 |
Provision related to sales in the current year | 5,337 | 1,056 |
Adjustments related to prior period sales | (22) | |
Deductions applied and payments made | (4,029) | (792) |
Ending balance | 1,821 | 535 |
Returns [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 603 | 352 |
Provision related to sales in the current year | 785 | 978 |
Adjustments related to prior period sales | (200) | 50 |
Deductions applied and payments made | (809) | (777) |
Ending balance | $ 379 | $ 603 |
Product Revenue Reserves and _6
Product Revenue Reserves and Allowances - Additional Information (Detail) - USD ($) | Dec. 17, 2020 | Mar. 31, 2013 | Aug. 31, 2020 | Feb. 29, 2020 | Jan. 31, 2020 | Aug. 31, 2019 | Nov. 30, 2018 | Dec. 31, 2021 | Dec. 31, 2020 |
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | $ 36,939,000 | $ 34,437,000 | |||||||
Icon Bioscience Inc [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Sales-based royalty expense | 0 | $ 1,300,000 | |||||||
Percentage of accelerated milestone payment received | 20.00% | ||||||||
Amended Alimera Science Inc Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 54,000 | $ 1,700,000 | |||||||
OncoSil Medical UK Limited [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 0 | ||||||||
Deferred revenue | $ 100,000 | 100,000 | |||||||
Receipt of upfront license fee | $ 100,000 | ||||||||
Royalty percentage earned from sales of product | 8.00% | ||||||||
Percentage of non-royalty consideration received from sublicense | 20.00% | ||||||||
License agreement commencement date | 2012-12 | ||||||||
Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Deferred revenue | $ 0 | $ 0 | |||||||
Receipt of upfront license fee | $ 9,500,000 | $ 2,000,000 | $ 1,750,000 | ||||||
Potential future payments based on achievement of development and regulatory milestones | 6,000,000 | $ 6,000,000 | 7,250,000 | ||||||
Potential future payments based on achievement of commercial-based milestones | 6,000,000 | $ 6,000,000 | 3,000,000 | ||||||
Development milestone payment received | $ 1,000,000 | ||||||||
Potential future payments based on achievement of combined remaining development and sales milestone | 11,750,000 | ||||||||
Potential future payments based on achievement of remaining development and regulatory milestones | 6,250,000 | ||||||||
Potential future payments based on achievement of remaining commercial-based milestones | 3,000,000 | ||||||||
Ocumension Therapeutics [Member] | Share Offering [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Issuance of stock, net of issue costs, shares | 3,010,722 | ||||||||
Ocumension Therapeutics [Member] | Maximum [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Product supply milestones and development milestones | 7,250,000 | ||||||||
Upon achievement of milestones | $ 21,250,000 | ||||||||
Royalty Income [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 871,000 | $ 1,664,000 | |||||||
Royalty Income [Member] | Amended Alimera Science Inc Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 0 | 1,700,000 | |||||||
RPA [Member] | SWK [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 872,000 | 0 | |||||||
Upfront cash payment | $ 16,500,000 | ||||||||
Royalty payments | 2,800,000 | ||||||||
Royalty Sale Agreement [Member] | SWK [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Deferred revenue | $ 16,500,000 | ||||||||
Deferred revenue, current | 1,100,000 | 885,000 | |||||||
Deferred revenue, non-current | 14,600,000 | 15,600,000 | |||||||
Collaborative Research and Development [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 60,000 | 255,000 | |||||||
Deferred revenue | 0 | 60,000 | |||||||
Collaborative Research and Development [Member] | OncoSil Medical UK Limited [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 100,000 | ||||||||
License and Collaboration Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 756,000 | 11,942,000 | |||||||
License and Collaboration Agreement [Member] | Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 543,000 | 11,500,000 | |||||||
Product [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 35,312,000 | 20,831,000 | |||||||
Product [Member] | Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 308,000 | 213,000 | |||||||
Technical Assistance [Member] | Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | $ 499,000 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,727 | $ 2,664 |
Work in process | 405 | 747 |
Finished goods | 484 | 1,926 |
Total inventory | $ 3,616 | $ 5,337 |
Intangible Assets - Reconciliat
Intangible Assets - Reconciliation of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Gross carrying amount at beginning of period | $ 68,322 | $ 68,322 |
Gross carrying amount at end of period | 68,322 | 68,322 |
Accumulated amortization at beginning of period | (43,113) | (40,653) |
Amortization expense | (2,460) | (2,460) |
Accumulated amortization at end of period | (45,573) | (43,113) |
Net book value at end of period | $ 22,749 | $ 25,209 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Net Book Value of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Intangible assets, net | $ 22,749 | $ 25,209 |
DEXYCU [Member] | ||
Intangible assets, net | $ 22,749 | $ 25,209 |
Finite lived intangible assets remaining amortization period | 9 years 3 months |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 28, 2018 | Dec. 31, 2021 | Dec. 31, 2020 |
Finite Lived Intangible Assets [Line Items] | |||
Amortization expense | $ 2,460 | $ 2,460 | |
DEXYCU [Member] | Icon Bioscience Inc [Member] | |||
Finite Lived Intangible Assets [Line Items] | |||
Purchase price of acquisition | $ 32,000 | ||
Annual amortization expense | $ 2,500 | ||
Finite-lived intangible asset, useful life | 13 years | 9 years 3 months |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | $ 1,732 | $ 1,658 |
Accumulated depreciation and amortization | (1,256) | (1,028) |
Property and equipment, net | 476 | 630 |
Property and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | 1,477 | 1,403 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | $ 255 | $ 255 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment Useful Life And Values [Abstract] | ||
Depreciation | $ 311 | $ 189 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Personnel costs | $ 7,321 | $ 5,686 |
Clinical trial costs | 753 | 0 |
Professional fees | 712 | 647 |
Sales chargebacks, rebates and other revenue reserves | 2,974 | 1,109 |
Commissions due to commercialization partner for DEXYCU | 1,518 | 254 |
Other | 1,144 | 749 |
Accrued expenses | $ 14,422 | $ 8,445 |
Leases - Additional Information
Leases - Additional Information (Detail) | Mar. 08, 2022USD ($)ft² | Dec. 31, 2021USD ($)ft²TrancheLease | Dec. 31, 2020USD ($) |
Disclosure Of Leases [Line Items] | |||
Loan facility term | 5 years | ||
Operating lease weighted average remaining lease term | 3 years 4 months 24 days | ||
Operating lease weighted average discount rate | 12.50% | ||
Operating lease expense | $ 885,000 | $ 852,000 | |
Variable lease cost | 30,000 | 36,000 | |
Operating lease payments | 920,000 | 867,000 | |
Finance lease, amortization expense of ROU asset | 151,000 | 52,000 | |
Interest expense on finance lease liability | 23,000 | 9,000 | |
Finance lease, operating cash flows | 23,000 | 9,000 | |
Finance lease, financing cash flows | $ 146,000 | $ 49,000 | |
Finance lease, weighted average Remaining term | 1 year 3 months 18 days | ||
Finance lease, weighted average discount rate, percent | 12.50% | ||
Caladrius [Member] | |||
Disclosure Of Leases [Line Items] | |||
Additional subleased property office area | ft² | 1,381 | ||
Basking Ridge Office Space [Member] | |||
Disclosure Of Leases [Line Items] | |||
Number of renewal options | Tranche | 2 | ||
Laboratory Equipment [Member] | |||
Disclosure Of Leases [Line Items] | |||
Number of finance leases | Lease | 3 | ||
First Lab Equipment [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease expiration month year | 2021-12 | ||
Second Lab Equipment [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease expiration month year | 2022-12 | ||
Third Lab Equipment [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease expiration month year | 2023-06 | ||
Massachusetts [Member] | Maximum [Member] | |||
Disclosure Of Leases [Line Items] | |||
Construction allowance | $ 670,750 | ||
Massachusetts [Member] | Original Lease [Member] | |||
Disclosure Of Leases [Line Items] | |||
Area of leased office and laboratory space | ft² | 13,650 | ||
Original lease term | 5 years | ||
Lease expiration month year | 2019-04 | ||
Massachusetts [Member] | Second Amendment Lease [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease commencement date | Sep. 10, 2018 | ||
Lease term expiration date | May 31, 2025 | ||
Additional Space leased | ft² | 6,590 | ||
Irrevocable standby letter of credit | $ 150,000 | ||
Massachusetts [Member] | Third Amendment Lease [Member] | |||
Disclosure Of Leases [Line Items] | |||
Area of leased office and laboratory space | ft² | 1,409 | ||
Lease commencement date | Jul. 1, 2021 | ||
Lease term expiration date | May 31, 2025 | ||
Massachusetts [Member] | Fourth Amendment Lease [Member] | Subsequent Event [Member] | |||
Disclosure Of Leases [Line Items] | |||
Area of leased office and laboratory space | ft² | 13,650 | ||
Lease term expiration date | May 31, 2028 | ||
Additional Space leased | ft² | 11,999 | ||
Termination portion of the lease | ft² | 7,999 | ||
Lease termination date | May 31, 2025 | ||
Massachusetts [Member] | Fourth Amendment Lease [Member] | Maximum [Member] | Subsequent Event [Member] | |||
Disclosure Of Leases [Line Items] | |||
Construction allowance | $ 555,960 | ||
NEW JERSEY | Basking Ridge Office Space [Member] | |||
Disclosure Of Leases [Line Items] | |||
Lease expiration month year | 2022-06 | ||
Area of leased office space | ft² | 3,000 | ||
Lease inception month year | 2017-07 | ||
Additional lease renewal option period | 5 years | ||
Lease renewal rate at 95% of market rent at time of renewal | 95.00% |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Related to Operating Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Other current liabilities - operating lease current portion | $ 645 | $ 568 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Operating lease liabilities - noncurrent | $ 1,860 | $ 2,330 |
Total operating lease liabilities | $ 2,505 | $ 2,898 |
Leases - Supplemental Balance_2
Leases - Supplemental Balance Sheet Related to Finance Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Property and equipment, at cost | $ 371 | $ 239 |
Accumulated amortization | (205) | (52) |
Property and equipment, net | $ 166 | $ 187 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property and equipment, net | Property and equipment, net |
Other current liabilities – finance lease current portion | $ 137 | $ 119 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Other long-term liabilities | $ 36 | $ 71 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Total finance lease liabilities | $ 173 | $ 190 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Non-Cancellable Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Leases | ||
2022 | $ 911 | |
2023 | 877 | |
2024 | 894 | |
2025 | 373 | |
Total lease payments | 3,055 | |
Less imputed interest | (550) | |
Total | 2,505 | $ 2,898 |
Finance Leases | ||
2022 | 149 | |
2023 | 37 | |
Total future minimum lease payments | 186 | |
Less imputed interest | (13) | |
Total | $ 173 | $ 190 |
Loan Agreements - Additional In
Loan Agreements - Additional Information (Detail) - USD ($) | Jun. 16, 2021 | Dec. 17, 2020 | Apr. 22, 2020 | Feb. 13, 2019 | May 31, 2021 | Oct. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 08, 2020 | Apr. 30, 2019 |
Term Loan Agreement [Line Items] | |||||||||||
Gain (loss) on extinguishment of debt | $ 2,065,000 | $ (905,000) | |||||||||
RPA [Member] | SWK Funding LLC [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Upfront cash payment | $ 16,500,000 | ||||||||||
Senior Secured Term Loan [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Amortization of debt discount (premium) | $ 628,000 | 745,000 | |||||||||
CRG Servicing LLC [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Restriction of the right to capitalize a portion of quarterly interest in the event of a loan default | So long as no default has occurred and is continuing, the Company may elect on each applicable interest payment date to pay 2.5% of the 12.5% per annum interest as Paid In-Kind (“PIK”), whereby such PIK amount would be added to the aggregate principal amount and accrue interest at 12.5% per annum. | ||||||||||
Upfront loan origination fee percentage | 1.50% | ||||||||||
Minimum liquidity amount | $ 5,000,000 | ||||||||||
Total debt discount | 3,200,000 | ||||||||||
CRG Servicing LLC [Member] | Period One [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Annual minimum product revenue | 15,000,000 | ||||||||||
Annual minimum product revenue period | on January 1, 2019 and ending on December 31, 2019 | ||||||||||
CRG Servicing LLC [Member] | Period Two [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Annual minimum product revenue | 45,000,000 | ||||||||||
Annual minimum product revenue period | January 1, 2020 and ending on December 31, 2020 | ||||||||||
CRG Servicing LLC [Member] | Period Three [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Annual minimum product revenue | 80,000,000 | $ 25,000,000 | $ 45,000,000 | ||||||||
Annual minimum product revenue period | January 1, 2021 and ending on December 31, 2021 | ||||||||||
Incremental charges for issuance of waivers | $ 0 | ||||||||||
CRG Servicing LLC [Member] | Period Four [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Annual minimum product revenue | $ 90,000,000 | ||||||||||
Annual minimum product revenue period | January 1, 2022 and ending on December 31, 2022 | ||||||||||
CRG Servicing LLC [Member] | Loan Prepayment Prior to December 31, 2019 [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Principal prepayment premium percentage | 10.00% | ||||||||||
CRG Servicing LLC [Member] | Loan Prepayment after December 31, 2019 and Prior to December 31, 2020 [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Principal prepayment premium percentage | 5.00% | ||||||||||
CRG Servicing LLC [Member] | Loan prepayment after December 31, 2020 and prior to December 31, 2021 [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Principal prepayment premium percentage | 3.00% | ||||||||||
CRG Servicing LLC [Member] | Loan prepayment after December 31 2021 [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Principal prepayment premium percentage | 0.00% | ||||||||||
CRG Servicing LLC [Member] | Senior Secured Term Loan [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Annual interest rate on term loan balance | 12.50% | ||||||||||
Gain (loss) on extinguishment of debt | $ (905,000) | ||||||||||
Agreement date | Feb. 13, 2019 | ||||||||||
Senior secured term loan borrowing facility | $ 60,000,000 | ||||||||||
Term loan agreement, initial advance | $ 35,000,000 | ||||||||||
Proceeds from issuance of long-term debt | $ 0 | ||||||||||
Maturity date | Dec. 31, 2023 | ||||||||||
Paid in Kind Interest Added to Principal | $ 0 | ||||||||||
Exit fee percentage payable upon repayment of the total secured term loan | 6.00% | ||||||||||
Upfront loan original fee payment, initial advance | $ 525,000 | ||||||||||
Reimbursement of lender's legal fees and other transaction costs | 350,000 | ||||||||||
Exit fee accrued | 2,100,000 | ||||||||||
Line of credit facility, legal and other transaction costs | 591,000 | ||||||||||
Repayment of senior secured term loan | 13,800,000 | ||||||||||
Payment of exit fee upon repayment of secured term loan | 828,000 | ||||||||||
Payment of accrued and unpaid interest through the date of the secured term loan refinancing | 378,000 | ||||||||||
CRG Servicing LLC [Member] | Senior Secured Term Loan [Member] | RPA [Member] | SWK Funding LLC [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Upfront cash payment | $ 15,000,000 | ||||||||||
CRG Servicing LLC [Member] | Second Advance [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Term loan agreement, additional loan advance | $ 15,000,000 | ||||||||||
Total debt discount | $ 1,100,000 | ||||||||||
CRG Servicing LLC [Member] | Second Advance [Member] | Senior Secured Term Loan [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
One-time upfront financing fee percentage applied to borrowing amounts under the line of credit facility | 1.50% | ||||||||||
Upfront loan original fee payment, initial advance | $ 225,000 | ||||||||||
Exit fee accrued | $ 900,000 | ||||||||||
CRG Servicing LLC [Member] | Initial Advance [Member] | Senior Secured Term Loan [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
One-time upfront financing fee percentage applied to borrowing amounts under the line of credit facility | 1.50% | ||||||||||
Upfront loan original fee payment, initial advance | $ 525,000 | ||||||||||
Paycheck Protection Program Loan [Member] | Silicon Valley Bank [Member] | CARES Act [Member] | |||||||||||
Term Loan Agreement [Line Items] | |||||||||||
Loan amount | $ 2,000,000 | ||||||||||
Loan proceeds date | Apr. 22, 2020 | ||||||||||
Annual interest rate on term loan balance | 1.00% | ||||||||||
Debt instrument term | 2 years | ||||||||||
Debt instrument, maturity date | Apr. 21, 2022 | ||||||||||
Debt Instrument Description | The Paycheck Protection Program Flexibility Act of 2020 (the “PPP Flexibility Act”), enacted on June 5, 2020, amended the Paycheck Protection Program, among others, as follows: (i) extended the covered period from 8 weeks to the earlier of 24 weeks from the date the PPP Loan is originated and December 31, 2020, during which PPP funds needed to be expended in order to be forgiven. A borrower may submit a loan forgiveness application any time on or before the maturity date of the loan – including before the end of the covered period – if the borrower has used all of the loan proceeds for which the borrower is requesting forgiveness; (ii) at least 60% of PPP funds must be spent on payroll costs, with the remaining 40% available to spend on other eligible expenses; (iii) payments are deferred until the date on which the amount of forgiveness determined is remitted to the lender. If a borrower fails to seek forgiveness within 10 months after the last day of its covered period, then payments will begin on the date that is 10 months after the last day of the covered period. In addition, the PPP Flexibility Act modified the CARES Act by increasing the maturity date for loans made after the effective date from two years to a minimum maturity of five years from the date on which the borrower applies for loan forgiveness. Existing PPP loans made before the new legislation retain their original two-year term, but may be renegotiated between a lender and a borrower to match the 5-year term permitted under the PPP Flexibility Act | ||||||||||
Debt instrument, loan forgiveness amount | $ 2,000,000 | ||||||||||
Debt instrument, accrued interest forgiveness amount | $ 24,000 | ||||||||||
Gain (loss) on extinguishment of debt | $ 2,100,000 |
Stockholders' Equity - Equity F
Stockholders' Equity - Equity Financings - Additional Information (Detail) - USD ($) | Dec. 31, 2020 | Nov. 30, 2021 | Feb. 28, 2021 | Aug. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 23, 2020 | Jun. 22, 2020 |
Class Of Stock [Line Items] | |||||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 300,000,000 | 300,000,000 | |||||
Equity Financings [Member] | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock, shares authorized | 150,000,000 | ||||||||
Equity Financings [Member] | Share Offering [Member] | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock issued | 5,122,273 | 10,465,000 | 1,500,000 | ||||||
Common stock, additional shares issued | 1,095,000 | 1,365,000 | |||||||
Pre-funded warrants issued to purchase common stock shares | 3,272,727 | ||||||||
Price per share | $ 13.75 | $ 11 | $ 14.50 | ||||||
Pre-funded warrants issued, price per share | $ 13.74 | ||||||||
Gross proceeds from issuance of common stock | $ 115,400,000 | $ 115,100,000 | $ 21,750,000 | ||||||
Share issuance costs | $ 7,200,000 | $ 7,200,000 | $ 1,800,000 | ||||||
Share Purchase Agreement [Member] | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock issued | 3,010,722 | ||||||||
Price per share | $ 5.22 | $ 5.22 | |||||||
Gross proceeds from issuance of common stock | $ 15,700,000 | ||||||||
Share issuance costs | $ 100,000 | ||||||||
At-the-Market Offering [Member] | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock issued | 48,538 | 2,590,093 | |||||||
Price per share | $ 5.74 | $ 11.37 | $ 5.74 | ||||||
Gross proceeds from issuance of common stock | $ 552,000 | $ 14,900,000 | |||||||
Share issuance costs | $ 53,000 | $ 646,000 | |||||||
Stock issuances, sales agent commission maximum percentage | 3.00% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Reconciliation of Warrants to Purchase Share of the Company's Common Stock (Detail) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Stockholders Equity Note [Abstract] | ||
Number of Warrants, Outstanding and exercisable, Beginning balance | 48,683 | 48,683 |
Number of Warrants, Outstanding and exercisable, Ending balance | 48,683 | 48,683 |
Weighted Average Exercise Price, Outstanding and exercisable, Beginning balance | $ 12.33 | $ 12.33 |
Weighted Average Exercise Price, Outstanding and exercisable, Ending balance | $ 12.33 | $ 12.33 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Common Shares - Additional Information (Detail) - SWK [Member] - Warrants [Member] - $ / shares | Jun. 26, 2018 | Mar. 28, 2018 | Dec. 31, 2021 |
Senior Secured Term Loan [Member] | |||
Class Of Stock [Line Items] | |||
Warrants issued in connection with term loan facility | 7,773 | 40,910 | |
Exercise price of issued warrants | $ 19.30 | $ 11 | |
Warrants exercise period | 7 years | 7 years | |
Investor [Member] | |||
Class Of Stock [Line Items] | |||
Weighted average remaining life of lender warrants | 3 years 3 months 18 days |
Share-Based Payment Awards - Eq
Share-Based Payment Awards - Equity Incentive Plans - Additional Information (Detail) - 2016 Long Term Incentive Plan [Member] - shares | Dec. 31, 2021 | Jun. 22, 2021 | Jun. 25, 2019 | Dec. 12, 2016 |
Class Of Stock [Line Items] | ||||
Number of common stock, authorized for issuance | 2,500,000 | 1,100,000 | 300,000 | |
Shares available for grant under the Long Term Incentive Plan, including forfeited and terminated awards transferred from the 2008 Incentive Plan | 1,683,368 |
Share-Based Payment Awards - St
Share-Based Payment Awards - Stock Option Activity Under Company's Equity Incentive Plan (Detail) - Equity Incentive Plans and Inducement Awards [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | shares | 1,338,880 |
Number of Options, Granted | shares | 1,313,727 |
Number of Options, Exercised | shares | (8,112) |
Number of Options, Forefeited | shares | (75,448) |
Number of Options, Expired | shares | (51,367) |
Number of Options Outstanding, Ending balance | shares | 2,517,680 |
Number of Options, Exercisable at December 31, 2021 | shares | 916,461 |
Weighted Average Exercise Price Outstanding, Beginning balance | $ / shares | $ 20.86 |
Weighted Average Exercise Price, Granted | $ / shares | 12.59 |
Weighted Average Exercise Price, Exercised | $ / shares | 12.26 |
Weighted Average Exercise Price, Forefeited | $ / shares | 16.46 |
Weighted Average Exercise Price, Expired | $ / shares | 31.04 |
Weighted Average Exercise Price Outstanding, Ending balance | $ / shares | 16.49 |
Weighted Average Exercise Price, Exercisable at December 31, 2021 | $ / shares | $ 22.41 |
Weighted Average Remaining Contractual Life, Outstanding at January 1, 2021 | 8 years 21 days |
Weighted Average Remaining Contractual Life, Exercisable at December 31, 2021 | 6 years 3 months |
Aggregate Intrinsic Value, Outstanding at January 1, 2021 | $ | $ 775 |
Aggregate Intrinsic Value, Exercisable at December 31, 2021 | $ | $ 103 |
Share-Based Payment Awards - _2
Share-Based Payment Awards - Stock Options - Additional Information (Detail) - shares | 1 Months Ended | 12 Months Ended |
Jan. 31, 2019 | Dec. 31, 2021 | |
2016 Long Term Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Ratable monthly vesting period | 4 years | |
Contractual life of option grants | 10 years | |
Stock Compensation Plan [Member] | ||
Class Of Stock [Line Items] | ||
Ratable monthly vesting period | 1 year | |
Cliff vesting period | 3 years | |
Common stock vested during the period | 297,361 | |
Newly Appointed Non Executive Director [Member] | ||
Class Of Stock [Line Items] | ||
Ratable annual vesting period | 3 years | |
External consultant [Member] | ||
Class Of Stock [Line Items] | ||
Cliff vesting period | 1 year |
Share-Based Payment Awards - Su
Share-Based Payment Awards - Summary of Company Applied the Black-Scholes Option Pricing (Detail) - 2016 Long Term Incentive Plan [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock volatility, minimum | 72.00% | 64.00% |
Stock volatility, maximum | 83.00% | 70.00% |
Risk-free interest rate, minimum | 0.42% | 0.32% |
Risk-free interest rate, maximum | 1.44% | 1.76% |
Expected dividends | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option life (in years) | 4 years 9 months | 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 | 6 years 1 month 6 days |
Share-Based Payment Awards - _3
Share-Based Payment Awards - Summary of Information about Stock Options (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Total cash received from exercise of stock options | $ 373 | $ 294 |
Equity Incentive Plans [Member] | ||
Weighted-average grant date fair value per share | $ 8.20 | $ 7.07 |
Total cash received from exercise of stock options | $ 100 | |
Total intrinsic value of stock options exercised | $ 10 |
Share-Based Payment Awards - Ti
Share-Based Payment Awards - Time-Vested Restricted Stock Units - Additional Information (Detail) - 2016 Long Term Incentive Plan [Member] | 1 Months Ended | 12 Months Ended |
Jan. 31, 2019 | Dec. 31, 2021 | |
Class Of Stock [Line Items] | ||
Ratable annual vesting period of equity awards | 4 years | |
RSU [Member] | ||
Class Of Stock [Line Items] | ||
Ratable annual vesting period of equity awards | 3 years | |
Weighted average remaining vesting term | 1 year 4 months 13 days |
Share-Based Payment Awards - _4
Share-Based Payment Awards - Summary of Restricted Stock Unit Activity (Detail) - 2016 Long Term Incentive Plan [Member] - RSU [Member] | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Stock Units Outstanding, Beginning Balance | shares | 149,004 |
Number of stock units, granted | shares | 242,399 |
Number of Stock Units, Vested | shares | (89,795) |
Number of Stock Units, Forfeited | shares | (10,033) |
Number of Stock Units Outstanding, Ending Balance | shares | 291,575 |
Weighted Average Grant Date Fair Value Nonvested, Beginning balance | $ / shares | $ 13.85 |
Weighted average grant date fair value, granted | $ / shares | 12.96 |
Weighted Average Grant Date Fair value, Vested | $ / shares | 13.76 |
Weighted Average Grant Date Fair value, Forfeited | $ / shares | 12.15 |
Weighted Average Grant Date Fair Value Nonvested, Ending balance | $ / shares | $ 13.19 |
Share-Based Payment Awards - De
Share-Based Payment Awards - Deferred Stock Units - Additional Information (Detail) - shares | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
2016 Long Term Incentive Plan [Member] | |||
Class Of Stock [Line Items] | |||
Ratable annual vesting period of equity awards | 4 years | ||
Non Executive Directors [Member] | |||
Class Of Stock [Line Items] | |||
Non-vested deferred stock units outstanding | 0 | 0 | |
Deferred Stock Units [Member] | |||
Class Of Stock [Line Items] | |||
Ratable annual vesting period of equity awards | 1 year | ||
Deferred Stock Units [Member] | 2016 Long Term Incentive Plan [Member] | |||
Class Of Stock [Line Items] | |||
Vested deferred stock units vested | 0 |
Share-Based Payment Awards - Em
Share-Based Payment Awards - Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) | Jun. 25, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 22, 2021 |
Class Of Stock [Line Items] | ||||
Employee stock purchase plan | $ 273,000 | $ 294,000 | ||
Common stock, shares issued | 33,905,826 | 18,139,981 | ||
Stock-based compensation expense | $ 7,447,000 | $ 5,547,000 | ||
ESPP [Member] | ||||
Class Of Stock [Line Items] | ||||
Number of common stock, authorized for issuance | 110,000 | 250,000 | ||
Price of common stock purchased twice a year under ESPP, percent | 85.00% | |||
Employee stock purchase plan | $ 25,000 | |||
Employee stock purchase plan, shares | 5,000 | |||
Consecutive six month offering period | Aug. 1, 2019 | |||
Common stock, shares issued | 43,365 | |||
Stock-based compensation expense | $ 113,000 |
Share-Based Payment Awards - Co
Share-Based Payment Awards - Compensation Expense from Stock-Based Payment Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 7,447 | $ 5,547 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 2,294 | 1,411 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 1,187 | 907 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 3,966 | $ 3,229 |
Share-Based Payment Awards - _5
Share-Based Payment Awards - Stock-Based Compensation Expense - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Unrecognized compensation expense | $ 9.3 |
Unrecognized compensation expense weighted average period | 1 year 8 months 12 days |
License and Asset Purchase Ag_2
License and Asset Purchase Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2021 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Agreements And Contracts [Line Items] | ||||
R&D expense | $ 28,500,000 | $ 17,424,000 | ||
Aerpio Pharmaceuticals, Inc [Member] | ||||
Collaborative Agreements And Contracts [Line Items] | ||||
Non-refundable and non-creditable upfront cash payment | $ 450,000 | |||
R&D expense | 450,000 | |||
Equinox Science, LLC [Member] | ||||
Collaborative Agreements And Contracts [Line Items] | ||||
Non-refundable and non-creditable upfront cash payment | $ 1,000,000 | |||
R&D expense | $ 0 | $ 1,000,000 | ||
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 ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities | $ 32,965,000 | $ 0 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying Value | 205,065,000 | 23,538,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 205,065,000 | 23,538,000 |
Cash Equivalents | 172,100,000 | 23,538,000 |
Marketable Securities | 32,965,000 | 0 |
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 | 155,551,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 155,551,000 | |
Cash Equivalents | 155,551,000 | |
Marketable Securities | 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 | 155,551,000 | 23,538,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 155,551,000 | 23,538,000 |
Cash Equivalents | 155,551,000 | 23,538,000 |
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 | 49,514,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 49,514,000 | |
Cash Equivalents | 16,549,000 | |
Marketable Securities | 32,965,000 | |
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 | 49,514,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 49,514,000 | |
Cash Equivalents | 16,549,000 | |
Marketable Securities | $ 32,965,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Feb. 13, 2019 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Interest-bearing cash equivalent consisted of money market fund | $ 155,600,000 | ||
Interest-bearing cash equivalent consisted of investment-grade commercial paper | 16,500,000 | ||
Marketable securities | 32,965,000 | $ 0 | |
CRG Servicing LLC [Member] | Senior Secured Term Loan [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Carrying value of loan | 38,900,000 | 38,300,000 | |
long-term debt | 36,600,000 | 36,000,000 | |
Exit fee accrued | $ 2,100,000 | ||
Fair value of loan | 38,700,000 | 38,000,000 | |
CRG Servicing LLC [Member] | Other Long-term Liabilities [Member] | Senior Secured Term Loan [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Exit fee accrued | $ 2,300,000 | $ 2,300,000 | |
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 | 90.40% | ||
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 | 9.60% |
Retirement Plans - Additional I
Retirement Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Compensation And Retirement Disclosure [Abstract] | ||
Maximum percentage of eligible compensation matched by employer | 5.00% | |
Employer contributions to retirement plans | $ 1 | $ 690,000 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
U.S. operations | $ (58,517) | $ (45,492) |
Non-U.S. operations | 100 | 98 |
Loss before income taxes | $ (58,417) | $ (45,394) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) £ in Millions | 12 Months Ended | ||||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2021GBP (£) | |
Statutory federal corporate income tax rate | 21.00% | 21.00% | 21.00% | 34.00% | |
Changes in valuation allowance | $ 15,748,000 | $ 13,068,000 | |||
Unrecognized tax benefits | 0 | 0 | |||
Accrued penalties or interest related to uncertain tax positions | 0 | $ 0 | |||
U.S. Federal [Member] | |||||
Operating loss carry forwards | 301,200,000 | ||||
Net operating loss carry forwards | $ 151,800,000 | ||||
Operating loss carry forwards, expiration range start dates | 2023 | ||||
Operating loss carry forwards, expiration range end dates | 2038 | ||||
Tax years that remain subject to examination | 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 | ||||
State [Member] | |||||
Operating loss carry forwards | $ 222,600,000 | ||||
Operating loss carry forwards, expiration range start dates | 2033 | ||||
Operating loss carry forwards, expiration range end dates | 2038 | ||||
United Kingdom Tax Authority [Member] | |||||
Operating loss carry forwards | $ 27,600,000 | £ 20.9 | |||
Tax years that remain subject to examination | 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 | ||||
Federal and State Research and Development Tax Credit Carryforward [Member] | |||||
Research and development tax credit carry forwards | $ 5,700,000 | ||||
Federal And State Tax [Member] | |||||
Research and development tax credit carry forwards expiration begin date | 2021 | ||||
Research and development tax credit carry forwards expiration end date | 2038 | ||||
Icon Bioscience Inc [Member] | U.S. Federal [Member] | |||||
Operating loss carry forwards | $ 49,300,000 |
Income Taxes - Difference Betwe
Income Taxes - Difference Between Expected Income Tax Benefit and Actual Income Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit at statutory rate | $ (12,268) | $ (9,533) |
State income taxes, net of federal benefit | (2,890) | (2,760) |
Non-U.S. income tax rate differential | 0 | (8) |
Change in fair value of derivative | 0 | 0 |
Change in federal tax rate | 0 | 0 |
Research and development tax credits | (693) | (403) |
Permanent items | 729 | 288 |
Changes in valuation allowance | 15,748 | 13,068 |
Other, net | (626) | (652) |
Income tax expense (benefit) | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Income Taxes (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 84,026 | $ 74,876 |
Deferred revenue | 4,270 | 150 |
Lease liability | 722 | 806 |
Stock-based compensation | 7,822 | 6,847 |
Tax credits | 5,446 | 4,503 |
Other | 3,005 | 2,514 |
Total deferred tax assets | 105,291 | 89,696 |
Deferred tax liabilities: | ||
Intangible assets | 5,963 | 6,087 |
Right-of-use assets | 615 | 713 |
Total deferred tax liabilities | 6,578 | 6,800 |
Deferred tax assets, net | 98,713 | 82,896 |
Valuation allowance | 98,713 | 82,896 |
Total deferred tax liability | $ 0 | $ 0 |
Segment and Geographic Area I_3
Segment and Geographic Area Information - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Number of business segments | 1 |
Segment and Geographic Area I_4
Segment and Geographic Area Information - Summary of Company's Revenues and Long-Lived Assets, Net, by Geographic Area (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 36,939 | $ 34,437 |
Long-lived assets, net | 476 | 630 |
Country US [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 35,988 | 22,624 |
Long-lived assets, net | 476 | 630 |
China [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 851 | 11,713 |
UNITED KINGDOM [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 100 | $ 100 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Mar. 09, 2022 | Dec. 17, 2020 | Feb. 13, 2019 | Mar. 31, 2022 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Subsequent Event [Line Items] | |||||||
Gain (loss) on extinguishment of debt | $ 2,065,000 | $ (905,000) | |||||
Senior Secured Term Loan [Member] | CRG Servicing LLC [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Senior secured facility | $ 60,000,000 | ||||||
Proceed from senior secured facility | $ 0 | ||||||
Maturity date | Dec. 31, 2023 | ||||||
Repayment of senior secured term loan | $ 13,800,000 | ||||||
Payment of exit fee upon repayment of secured term loan | 828,000 | ||||||
Exit fee percentage payable upon repayment of the total secured term loan | 6.00% | ||||||
Payment of accrued and unpaid interest through the date of the secured term loan refinancing | $ 378,000 | ||||||
Gain (loss) on extinguishment of debt | $ (905,000) | ||||||
Senior Secured Term Loan [Member] | CRG Servicing LLC [Member] | Forecast | |||||||
Subsequent Event [Line Items] | |||||||
Gain (loss) on extinguishment of debt | $ (1,500,000) | ||||||
Senior Secured Term Loan [Member] | Subsequent Event [Member] | Silicon Valley Bank [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Senior secured facility | $ 30,000,000 | ||||||
Proceed from senior secured facility | $ 30,000,000 | ||||||
Maturity date | Jan. 1, 2027 | ||||||
Debt instrument effective rate | 5.50% | ||||||
Senior Secured Term Loan [Member] | Subsequent Event [Member] | Silicon Valley Bank [Member] | Prime Rate Plus [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Revolving line bears interest rate | 2.25% | ||||||
Senior Secured Term Loan [Member] | Subsequent Event [Member] | CRG Servicing LLC [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Upfront cash payment | $ 41,400,000 | ||||||
Repayment of senior secured term loan | 38,200,000 | ||||||
Payment of exit fee upon repayment of secured term loan | $ 2,300,000 | ||||||
Exit fee percentage payable upon repayment of the total secured term loan | 6.00% | ||||||
Payment of accrued and unpaid interest through the date of the secured term loan refinancing | $ 900,000 | ||||||
Senior Secured Revolving Credit Facility [Member] | Subsequent Event [Member] | Silicon Valley Bank [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Senior secured facility | $ 15,000,000 | ||||||
Percentage of accounts receivable eligible for maximum amount borrowing | 80.00% | ||||||
Unused commitment fee | 0.25% | ||||||
Proceed from senior secured facility | $ 11,500,000 |