Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
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 | 28,741,475 | ||
Entity Public Float | $ 62,228,439 | ||
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 $0.001 | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | false | ||
Documents Incorporated by Reference | Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant’s proxy statement for the 2021 annual meeting of stockholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2020. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 44,909 | $ 22,214 |
Accounts and other receivables, net (including due from a related party of $104 and $0 at December 31, 2020 and 2019, respectively) | 9,453 | 11,368 |
Prepaid expenses and other current assets | 3,419 | 5,997 |
Inventory | 5,337 | 2,138 |
Total current assets | 63,118 | 41,717 |
Property and equipment, net | 630 | 357 |
Operating lease right-of-use assets | 2,610 | 3,078 |
Intangible assets, net | 25,209 | 27,669 |
Restricted cash | 150 | 150 |
Total assets | 91,717 | 72,971 |
Current liabilities: | ||
Accounts payable | 4,811 | 4,192 |
Accrued expenses | 8,445 | 6,832 |
Deferred revenue | 945 | 15 |
Other current liabilities | 687 | 481 |
Total current liabilities | 14,888 | 11,520 |
Long-term debt | 37,977 | 47,223 |
Deferred revenue - noncurrent | 15,616 | |
Operating lease liabilities - noncurrent | 2,330 | 2,898 |
Other long-term liabilities | 2,365 | 3,000 |
Total liabilities | 73,176 | 64,641 |
Contingencies (Note 17) | ||
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 and 150,000,000 shares authorized at December 31, 2020 and 2019, respectively; 18,139,981 and 10,941,659 shares issued and outstanding at December 31, 2020 and 2019, respectively | 18 | 11 |
Additional paid-in capital | 528,362 | 472,765 |
Accumulated deficit | (510,680) | (465,286) |
Accumulated other comprehensive income | 841 | 840 |
Total stockholders’ equity | 18,541 | 8,330 |
Total liabilities and stockholders’ equity | $ 91,717 | $ 72,971 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Due from related party | $ 104,000 | $ 0 |
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 | 150,000,000 |
Common stock, shares issued | 18,139,981 | 10,941,659 |
Common stock, shares outstanding | 18,139,981 | 10,941,659 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | ||
Total revenues | $ 34,437 | $ 20,365 |
Operating expenses: | ||
Cost of sales, excluding amortization of acquired intangible assets | 5,824 | 2,687 |
Research and development | 17,424 | 15,368 |
Sales and marketing | 25,293 | 29,772 |
General and administrative | 20,726 | 17,939 |
Amortization of acquired intangible assets | 2,460 | 2,460 |
Total operating expenses | 71,727 | 68,226 |
Loss from operations | (37,290) | (47,861) |
Other income (expense): | ||
Interest and other income, net | 58 | 1,054 |
Interest expense | (7,257) | (6,176) |
Loss on extinguishment of debt | (905) | (3,810) |
Total other expense, net | (8,104) | (8,932) |
Net loss | $ (45,394) | $ (56,793) |
Net loss per share: | ||
Basic and diluted | $ (3.54) | $ (5.44) |
Weighted average common shares outstanding: | ||
Basic and diluted | 12,836 | 10,431 |
Net loss | $ (45,394) | $ (56,793) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | 1 | 1 |
Other comprehensive income (loss) | 1 | 1 |
Comprehensive loss | (45,393) | (56,792) |
Product [Member] | ||
Revenues: | ||
Total revenues | 20,831 | 16,824 |
License and Collaboration Agreement [Member] | ||
Revenues: | ||
Total revenues | 11,942 | 1,361 |
Royalty Income [Member] | ||
Revenues: | ||
Total revenues | $ 1,664 | $ 2,180 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
License and Collaboration Agreement [Member] | ||
Revenue from related parties | $ 11,500 | $ 1,030 |
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, 2018 | $ 37,633 | $ 10 | $ 445,277 | $ (408,493) | $ 839 |
Balance, shares at Dec. 31, 2018 | 9,537,151 | ||||
Net loss | (56,793) | (56,793) | |||
Other comprehensive income | 1 | 1 | |||
Issuance of stock, net of issue costs | 22,627 | $ 1 | 22,626 | ||
Issuance of stock, net of issue costs, shares | 1,352,538 | ||||
Exercise of stock options | 414 | 414 | |||
Exercise of stock options, shares | 22,342 | ||||
Vesting of stock units | (120) | (120) | |||
Vesting of stock units, shares | 29,628 | ||||
Stock-based compensation | 4,568 | 4,568 | |||
Balance at Dec. 31, 2019 | $ 8,330 | $ 11 | 472,765 | (465,286) | 840 |
Balance, shares at Dec. 31, 2019 | 10,941,659 | 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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (45,394) | $ (56,793) |
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 | 189 | 144 |
Amortization of debt discount | 745 | 596 |
Non-cash interest expense | 977 | 1,052 |
Loss on extinguishment of debt | 905 | 3,810 |
Stock-based compensation | 5,547 | 4,568 |
Changes in operating assets and liabilities: | ||
Accounts receivable and other current assets | 4,846 | (15,304) |
Inventory | (3,200) | (1,859) |
Accounts payable and accrued expenses | 1,872 | 4,596 |
Right-of-use assets and operating lease liabilities | 72 | 46 |
Deferred revenue | 16,546 | (15) |
Net cash used in operating activities | (14,435) | (56,699) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (362) | (213) |
Net cash used in investing activities | (362) | (213) |
Cash flows from financing activities: | ||
Proceeds from issuance of stock, net of issuance costs | 49,918 | 22,627 |
Proceeds under paycheck protection program loan | 2,041 | |
Proceeds from issuance of long-term debt | 50,000 | |
Payment of debt issue costs | (1,341) | |
Payment of long-term debt principal | (13,794) | (20,000) |
Payment of extinguishment of debt costs | (828) | (2,716) |
Net settlement of stock units to satisfy statutory tax withholding | (90) | (120) |
Proceeds from exercise of stock options | 294 | 414 |
Payment of contingent development milestone | (15,000) | |
Principal payments on finance lease obligations | (49) | |
Net cash provided by financing activities | 37,492 | 33,864 |
Effect of foreign exchange rate changes on cash and cash equivalents | 1 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 22,695 | (23,047) |
Cash, cash equivalents and restricted cash at beginning of year | 22,364 | 45,411 |
Cash, cash equivalents and restricted cash at end of year | 45,059 | 22,364 |
Supplemental cash flow information: | ||
Cash interest paid | 5,510 | 4,870 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Accrued term loan exit fee | $ 122 | $ 3,000 |
Operations
Operations | 12 Months Ended |
Dec. 31, 2020 | |
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 extended intraocular drug delivery including EYP-1901, a potential twice-yearly sustained delivery intravitreal 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 YUTIQ50, a potential twice-yearly treatment for non-infectious uveitis affecting the posterior segment of the eye, one of the leading causes of blindness. 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”). The Company is currently evaluating EYP-1901 in a Phase 1 clinical trial as a potential twice-yearly sustained delivery intravitreal treatment for wet AMD. Current approved treatments for wet AMD require monthly or bi-monthly eye injections in a physician’s office, which can cause inconvenience and discomfort and often lead to reduced compliance and poor outcomes. In two prior clinical trials of vorolanib as an orally delivered therapy, vorolanib had a strong clinical signal with no significant ocular adverse events. The Company expects initial data from the Phase 1 clinical trial in the second half of 2021. YUTIQ ® ® DEXYCU ® ® The Company is also developing YUTIQ50 as a potential six-month intravitreal treatment for chronic non-infectious uveitis affecting the posterior segment of the eye. The Company has consulted with the FDA and identified a clinical pathway for a supplemental new drug application (“sNDA”) filing that the Company expects will involve a clinical trial of a small population. The Company is currently evaluating the timeline and investment requirements for the initiation of this trial. The Company is also seeking to enhance its long-term growth potential by expanding EYP-1901 beyond wet AMD into diabetic retinopathy (“DR”) and retinal vein occlusion (“RVO”), both large and growing ocular disease areas. The Company also plans to potentially identify and advance additional product candidates through clinical and regulatory development. The Company expects to utilize its internal discovery efforts, potential research collaborations and/or in-licensing arrangements with partner molecules and potential acquisition of additional ophthalmic products, product candidates or technologies that complement its current product portfolio. Effects of the COVID-19 Coronavirus Pandemic The outbreak of the COVID-19 coronavirus pandemic (the “Pandemic”) sequential growth in the third and fourth quarter of 2020, 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 and cash equivalents of $44.9 On February 4, 2021, the Company received net proceeds of approximately $108.0 million from the issuance of shares of the Company’s common stock (“Common Stock”) in an underwritten public offering (see Note 19). The Company has a history of operating losses and has not had significant recurring cash inflows from revenue. . from the issuance of Common Stock, at least the next twelve months from the date these consolidated financial statements were issued and therefore the conditions raising substantial doubt raised in prior periods has been alleviated. A the timing and results of the Company’s clinical trials for EYP-1901, investments commercialization |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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, and realization of deferred tax assets. Actual results could differ from these and other estimates. 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 $840,000 at December 31, 2020 and 2019, 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. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and marketable securities. At December 31, 2020, a total of $23.5 million, representing all 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. Generally, these deposits may be redeemed upon demand and, therefore, the Company believes they have minimal risk. The Company had no investments in marketable securities at December 31, 2020 and 2019, 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, 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. As of December 31, 2019, accounts receivable from the Specialty Distributor, an affiliate of the Third-party Logistics Provider (the “3PL”), ASD Specialty Healthcare LLC, FFF Enterprises, Inc., and McKesson Specialty Care Distribution LLC accounted for 37.0%, 34.0%, 15.0%, and 12.0% of total accounts receivable, respectively. For the year ended December 31, 2019, revenues from the Specialty Distributor, an affiliate of the 3PL, ASD Specialty Healthcare LLC, and Alimera Sciences accounted for 56.0%, 15.0%, and 10.0% 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 carrying amounts of cash equivalents, 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 120-157 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 it 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 sales, excluding amortization of acquired intangible assets, consist of costs associated with the manufacture of YUTIQ and DEXYCU, certain period costs for DEXYCU product revenue, product shipping and, as applicable, royalty expense. The inventory costs for YUTIQ include purchases of various components, the active pharmaceutical ingredient (“API”) and direct labor and overhead for the product manufactured in the Company’s Watertown, 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 a 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 accrued DEXYCU product revenue-based royalty expense of $2.3 million and $ 781,000 0 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. 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 adopted Accounting Standards Codification No. 842, Leases (“ASC 842”), as of January 1, 2019. The adoption of ASC 842 represents a change in accounting principle that establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all operating leases, with an exception provided for leases with a duration of one year or less. The Company applied ASC 842 using the modified retrospective transition approach which, allows companies to recognize existing leases at the adoption date without requiring comparable period presentation. Comparative periods are presented in accordance with the previous guidance in Accounting Standards Codification (“ASC”) 840, Leases. In adopting the new standard, the Company elected to utilize the available package of practical expedients permitted under the transition guidance within the new standard, which does not require the reassessment of the following: (i) whether existing or expired arrangements are or contain a lease, (ii) the lease classification of existing or expired leases, and (iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. Additionally, the Company elected to combine lease and non-lease components and to exclude leases with a term of 12 months or less. The adoption of this accounting standard resulted in recording operating lease ROU assets for three real estate operating lease arrangements and corresponding operating lease liabilities of $3.5 million and $3.7 million, respectively, as of January 1, 2019. The operating lease assets at adoption were lower than the operating lease liabilities because the balance of the Company’s deferred rent liabilities at December 31, 2018, which represented lease incentives, was reclassified into operating lease assets. The adoption of the standard did not have a material effect on the Company’s consolidated statements of operations or consolidated statements of cash flows. Under Topic 842, 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 The Company adopted Accounting Standards Codification No. 606 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 recogniz es revenue on sales of its products when Distributors obtain control of the products, which occur s at a point in time, typically upon delivery. In addition to agreements with Distributors , t he Company also enter s 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, 2020. 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 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. Reverse Stock Split On December 8, 2020, the Company’s stockholders approved a reverse stock split (the “reverse split”) of the Company’s issued and outstanding shares of Common Stock. As a result of the reverse split, every 10 shares of the Company’s Common Stock issued and outstanding were converted into one share of Common Stock. who would otherwise be entitled to a fractional share of Common Stock instead Stock-Based Compensation The Company may award stock options and other equity-based instruments to its employees, directors and consultants pursuant to stockholder-approved plans. In the fourth quarter of fiscal 2017, the Company early adopted Accounting Standards Update (“ASU”) No. 2016-09 (“ASU 2016-09”), Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting Compensation cost related to such 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. The numbers of shares in the following table reflect the Company’s one 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, 2020 2019 Stock options 1,338,880 1,090,973 ESPP 27,713 13,737 Warrants 48,683 48,683 Restricted stock units 149,004 78,684 1,564,280 1,232,077 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 February 2016, the FASB issued ASU No. 2016-02, Leases In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326) (“ASU 2016-13”) : Measurement of Credit Losses on Financial Instruments, The Company adopted ASU 2016-13 on January 1, 2020. The adoption of this standard did not have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”) : Simplifying the Accounting for Income Taxes. taxes to members of a consolidated group ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. Early adoption is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. This standard will be effective for the Company in the first quarter of its fiscal year ending December 31, 2021. The Company is currently evaluating the impact the adoption of this update will have on its consolidated financial |
Product Revenue Reserves and Al
Product Revenue Reserves and Allowances | 12 Months Ended |
Dec. 31, 2020 | |
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., which it began shipping to its customers in February 2019 and March 2019, respectively. Net product revenues by product for the years ended December 31, 2020 and 2019 were as follows (in thousands): Year Ended Year Ended December 31, 2020 December 31, 2019 YUTIQ (A) $ 13,878 $ 12,046 DEXYCU (B) 6,953 4,778 Total product sales, net $ 20,831 $ 16,824 (A) The Company recognized approximately $205,000 and $91,000 of revenue from YUTIQ product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. (B) The Company recognized approximately $8,000 and $0 of revenue from DEXYCU product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. The following table summarizes activity in each of the product revenue allowance and reserve categories for the years ended December 31, 2020 and 2019 (in thousands): 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 Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2019 $ — $ — $ — $ — Provision related to sales in the current year 2,301 429 732 3,462 Adjustments related to prior period sales — — — — Deductions applied and payments made (683 ) (158 ) (380 ) (1,221 ) Ending balance at December 31, 2019 $ 1,618 $ 271 $ 352 $ 2,241 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 $1.7 million and $2.1 million for the years ended December 31, 2020 and 2019, respectively. In addition to patent fee reimbursements in those periods, the Company recorded royalty income totaled $ 1.7 million and $ 2.0 million for the years ended December 31, 2020 and 2019, 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. 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. As no royalty payments have yet been paid to SWK, the Company has not recognized any revenue related to the RPA for the period ended December 31, 2020. 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 2020. 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, 2020, OncoSil has received regulatory approval in the EU, United Kingdom, Switzerland, Singapore, Malaysia and New Zealand. The Company has no consequential performance obligations under the OncoSil license agreement. For the years ended December 31, 2020 and 2019, revenue of $100,000 and $100,000 was recorded for this agreement, respectively. Ocumension Therapeutics In November 2018, the Company entered into an exclusive license agreement with Ocumension Therapeutics (“Ocumension”) for the development and commercialization of its three-year micro insert using the Durasert technology for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (YUTIQ in the U.S.) in Mainland China, Hong Kong, Macau and Taiwan. The Company received a one-time upfront payment of $1.75 million from Ocumension and is eligible to receive up to (i) $7.25 million upon the achievement by Ocumension of certain prescribed development and regulatory milestones, and (ii) $3.0 million commercial sales-based milestones. In addition, the Company is entitled to receive mid-single digit sales-based royalties. Ocumension has also received a special approval by the Hainan Province People's Government to market this product for chronic, non-infectious posterior segment uveitis in the Hainan Bo Ao Lecheng International Medical Tourism Pilot Zone (“Hainan Pilot Zone”). In March 2019, the Company entered into a Memorandum of Understanding (“2019 MOU”), pursuant to which, the Company will supply product for the clinical trials and Hainan Pilot Zone use. Paralleling to Ocumension’s normal registration process of the product with the Chinese Regulatory Authorities, the 2019 MOU modified the Company’s entitlement to the development and regulatory milestones of up to $7.25 million under the license agreement to product supply milestones or development milestones, whichever comes first, totaling up to $7.25 million. In August 2019, the Company began shipping this product to Ocumension. 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 (See Note 10), at which time, Ocumension became a related party of the Company. During the years ended December 31, 2020 and 2019, the Company recognized approximately $ 11.5 million and $ 1.0 million of license and collaboration revenue, respectively, in addition to $ and $ 91,000 of revenue from product sales, respectively. As of December 31, 2020 and 2019, no deferred revenue was recorded for this agreement, respectively. The Company recorded sales-based royalty expense of $1.3 million during the year ended December 31, 2020, with respect to partnering income equal to 20% of DEXYCU share of the Accelerated Milestone Payment received in August 2020 and upfront payment received in February 2020 from Ocumension, in connection with the Icon acquisition in March 2018. No 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 in the treatment of various diseases. Consideration received is generally recognized as revenue over the term of the 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). Revenues under research collaborations (including feasibility study agreements) totaled $255,000 and $135,000 for the years ended December 31, 2020 and 2019, respectively. At December 31, 2020 and 2019, $60,000 and $15,000 deferred revenue was recorded for the research collaborations (including feasibility study agreements), respectively. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | 4 . Inventory consisted of the following (in thousands): December 31, 2020 December 31, 2019 Raw materials $ 2,664 $ 1,476 Work in process 747 346 Finished goods 1,926 316 Total inventory $ 5,337 $ 2,138 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 5 . The reconciliation of intangible assets for the years ended December 31, 2020 and 2019 (in thousands): Year Ended Year Ended December 31, December 31, 2020 2019 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 (40,653 ) (38,193 ) Amortization expense (2,460 ) (2,460 ) Accumulated amortization at end of period (43,113 ) (40,653 ) Net book value at end of period $ 25,209 $ 27,669 The net book value of the Company’s intangible assets at December 31, 2020 and 2019 is summarized as follows (in thousands): Estimated Remaining Useful Life at December 31, December 31, December 31, 2020 2019 2020 (Years) Patented technologies DEXYCU / Verisome $ 25,209 $ 27,669 10.25 $ 25,209 $ 27,669 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, 2020 and 2019, 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 10.25 years at the rate of approximately $2.5 million per year. Amortization expense was reported as a component of cost of sales for the year ended December 31, 2020 and 2019, respectively. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6 . Property and equipment, net consisted of the following (in thousands): December 31, December 31, 2020 2019 Property and equipment $ 1,403 $ 1,095 Leasehold improvements 255 101 Gross property and equipment 1,658 1,196 Accumulated depreciation and amortization (1,028 ) (839 ) $ 630 $ 357 Depreciation expense totaled $189,000 and $144,000 in the years ended December 31, 2020 and 2019, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 7 . Accrued expenses consisted of the following (in thousands): December 31, December 31, 2020 2019 Personnel costs $ 5,686 $ 3,263 Clinical trial costs — 345 Professional fees 647 700 Sales chargebacks, rebates and other revenue reserves 1,109 1,889 Other 1,003 635 $ 8,445 $ 6,832 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
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 five-year Per the terms of the lease agreement, the Company does not have a residual value guarantee. 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 was extended 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 June 2022 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, 2020, the weighted average remaining term of the Company’s operating leases was 4.3 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, 2020 and 2019, respectively are as follows (in thousands): December 31, December 31, 2020 2019 Other current liabilities - operating lease current portion $ 568 $ 481 Operating lease liabilities – noncurrent portion 2,330 2,898 Total operating lease liabilities $ 2,898 $ 3,379 Operating lease expense recognized related to ROU assets was $852,000 and The Company is a party to two finance leases for laboratory equipment. The equipment leases expire in December 2021 December 2022 Supplemental balance sheet information related to the finance lease as of December 31, 2020 is as follows (in thousands): December 31, 2020 Property and equipment, at cost $ 239 Accumulated amortization (52 ) Property and equipment, net $ 187 Other current liabilities – $ 119 Other long-term liabilities 71 Total finance lease liabilities $ 190 The components of finance lease expense recognized during the year ended December 31, 2020 related to ROU assets was $52,000. Interest on lease liabilities was $9,000 during the year ended December 31, 2020. 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. The Company had no finance lease in 2019. As of December 31, 2020, the weighted average remaining term of the Company’s finance lease was 1.7 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, 2020 were as follows (in thousands): Operating Leases Finance Leases 2021 889 135 2022 849 75 2023 815 — 2024 830 — 2025 346 0 Total lease payments $ 3,729 $ 210 Less imputed interest (831 ) (20 ) Total $ 2,898 $ 190 |
Term Loan Agreement
Term Loan Agreement | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Term Loan Agreement | 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. No assurance is provided that the Company will obtain forgiveness of the PPP Loan in whole or in part. As of the date of this filing, the application for the PPP Loan forgiveness is still pending review. The PPP Loan proceeds of $2.0 million were recorded as a loan in accordance with ASC 470, Debt, 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 Funding LLC (“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 may draw up to an additional $10 million, subject to 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, 2020, total PIK amounts of $ 2.0 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: • liquidity in an amount which shall exceed the greater of (i) $5 million and (ii) to the extent the Company has incurred certain permitted debt, the minimum cash balance, if any, required of the Company by the creditors of such permitted debt; and • annual minimum product revenue from YUTIQ and DEXYCU: (i) for the twelve-month period beginning on January 1, 2019 and ending on December 31, 2019 , of at least $15 million, (ii) for the twelve-month period beginning on January 1, 2020 and ending on December 31, 2020 , of at least $45 million, (iii) for the twelve-month period beginning on January 1, 2021 and ending on December 31, 2021 , of at least $80 million and (iv) for the twelve-month period beginning on January 1, 2022 and ending on December 31, 2022 , of at least $90 million. 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 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 $ 745,000 SWK Credit Agreement On March 28, 2018 (the “SWK Closing Date”), the Company entered into the SWK Credit Agreement among the Company, as borrower, SWK, as agent, and the lenders party thereto from time to time, providing for a senior secured term loan of up to $20 million (the “SWK Loan”). On the SWK Closing Date, $15 million of the SWK Loan was advanced (the “SWK Initial Advance”). The remaining $5 million of the SWK Loan was advanced on June 26, 2018 (the “SWK Additional Advance”). In connection with the SWK Loan, the Company issued a warrant (the “SWK Warrant”) to the Agent to purchase (a) 40,910 shares of Common Stock (the “Initial Advance Warrant Shares”) at an exercise price of $1.10 per share and (b) 7,773 shares of Common Stock (the “Additional Advance Warrant Shares”) at an exercise price of $1.93 per share (see Note 10). The SWK Warrant is exercisable (i) with respect to the Initial Advance Warrant Shares, any time on or after the SWK Closing Date until the close of business on the 7-year anniversary of the SWK Initial Advance and (ii) with respect to the Additional Advance Warrant Shares, any time on or after the closing of the SWK Additional Advance until the close of business on the 7-year anniversary of the SWK Additional Advance. The Agent may exercise the SWK Warrant on a cashless basis at any time. In the event the Agent exercises the SWK Warrant on a cashless basis, the Company will not receive any proceeds. The Additional Advance Warrant Shares were recorded as a liability at the Closing Date and were remeasured at fair value at each reporting period until the date of the SWK Additional Advance. The aggregate fair value of the Additional Advance Warrant Shares at the Closing Date was $69,000. The Initial Advance Warrant Shares were recorded as equity on the Company’s balance sheet at their relative fair value of $284,000. The remaining $14.6 million of the proceeds received were allocated to the SWK Initial Advance term loan. Upon the closing of the SWK Additional Advance in June 2018, the Additional Advance Warrant Shares were at $87,000 and reclassified to equity. The total debt discount related to the SWK Initial Advance was $2.1 million and was comprised of (1) $1.8 million, which included a 1.5% upfront fee, a 6% exit fee (the “Exit Fee”) and legal and other transaction costs, which were ratably allocated to each of the two tranches of the SWK Loan based upon the total principal amount available to the Company under each tranche and (2) $353,000 related to the aggregate fair value of the Initial Advance Warrant Shares and the Additional Advance Warrant Shares. This amount was being amortized as additional interest expense over the term of the SWK Loan using the effective interest rate method. The total debt issue costs related to the SWK Additional Advance was $299,000 and was comprised of the allocated portions of the 1.5% upfront fee and the Exit Fee. This amount was recorded as a prepaid expense to be amortized ratably from the SWK Closing Date through December 31, 2018. Through the date of the SWK Additional Advance, $97,000 was amortized and the remaining balance of $202,000 was reclassified to debt discount in June 2018. Together with the 6% Exit Fee on the SWK Additional Advance and other transaction costs, total debt discount of $652,000 associated with the SWK Additional Advance was to be amortized over the remaining life of the SWK Additional Advance portion of the SWK Loan using the effective interest rate method. The SWK Loan was originally scheduled to mature on March 27, 2023 and bore interest at a per annum rate of the three-month LIBOR rate (subject to a 1.5% floor) plus 10.50%. On February 13, 2019, the Company repaid the SWK Loan in connection with the consummation of the CRG Loan Agreement. In addition to repayment of the $20 million principal balance, the Company paid (i) a $1.2 million prepayment penalty, (ii) the $1.2 million Exit Fee, (iii) accrued and unpaid interest of $664,000 through that date and (iv) an additional make-whole interest payment of $306,000 covering the additional period through what would have been the first anniversary of the SWK Loan. In connection with the prepayment of the SWK Loan, the Company recorded a loss on extinguishment of debt of $3.8 million in the three months ended March 31, 2019. In addition to the prepayment penalty and make-whole interest payment amounts, the loss on extinguishment of debt included the write-off of the remaining balance of unamortized debt discount of approximately $2.3 million. Amortization of debt discount under the SWK Loan totaled $84,000 in the first quarter of 2019 through the SWK loan extinguishment date. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 1 0 . Stockholders’ Equity 2020 Equity Financing 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, under a Form shelf registration statement that was declared effective by the SEC in December 2018, the Company may, at its option, offer and sell shares of its Common Stock from time to time for an aggregate offering price of up to $25.0 million. 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. Share Offering On December 31, 2020, the Company entered into In February 2020, the Company sold 1,500,000 shares of Common Stock in an underwritten public offering at a price of $14.5 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 (the “Annual Meeting”) 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. 2019 Equity Financing ATM Facility In January 2019, the Company entered into an at-the-market program (the “ATM Program”). Pursuant to the ATM Program, under a Form shelf registration statement that was declared effective by the SEC in December 2018, the Company may, at its option, offer and sell shares of its Common Stock from time to time for an aggregate offering price of up to $20.0 million. The Company will pay the sales agent a commission of up to 3.0% of the gross proceeds from any future sales of such shares. During the year ended December 31, 2019, the Company sold 299,888 shares of its Common Stock at a weighted average price of $ 15.03 per share for gross proceeds of approximately $4.5 million. Share issue costs, including sales agent commissions, totaled $221,000 during the reporting period. Share Offering In April 2019, the Company sold 1,052,650 shares of Common Stock in an underwritten public offering at a price of $19.00 per share for gross proceeds of $20.0 million. Underwriter discounts and commissions and other share issue costs totaled approximately $1.7 million. 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, 2020 and 2019: Year Ended Year Ended December 31, December 31, 2020 2019 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 Expired — — Balance and exercisable at end of period 48,683 $ 12.33 48,683 $ 12.33 In connection with the SWK Credit Agreement (see Note 9), the Company issued the SWK Warrant 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, 2020 | |
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 December 31, 2020, a total of 603,000 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, 2020: Number of options Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at January 1, 2020 1,090,973 $ 25.21 Granted 415,339 12.09 Exercised — — Forfeited (99,031 ) 23.27 Expired (68,401 ) 33.58 Outstanding at December 31, 2020 1,338,880 $ 20.86 7.55 $ 36 Exercisable at December 31, 2020 716,764 $ 25.05 6.50 $ — 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 413,000 shares of the Company’s Common Stock vested during the year ended December 31, 2020. In determining the grant date fair value of option awards, the key assumptions used to apply the Black-Scholes option pricing model for options granted under the 2016 Plan during the years ended December 31, 2020 and 2019 were as follows: Year Ended December 31, Year Ended December 31, 2020 2019 Option life (in years) 5.50 - 6.10 5.50 - 6.08 Stock volatility 64% - 70% 60% - 65% Risk-free interest rate 0.32% - 1.76% 1.37% - 2.63% 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, 2020 and 2019 (in thousands except per share amounts): Year Ended December 31, Year Ended December 31, 2020 2019 Weighted-average grant date fair value per share $ 7.07 $ 9.35 Total cash received from exercise of stock options — 414 Total intrinsic value of stock options exercised — 84 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, 2020: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2020 78,684 $ 18.34 Granted 152,575 12.42 Vested (71,657 ) 15.25 Forfeited (10,598 ) 17.17 Nonvested at December 31, 2020 149,004 $ 13.85 The weighted-average remaining vesting term of the RSUs at December 31, 2020 was 1.01 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, 2020 and 2019, 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, 2020, there were 1,916 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. 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 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, 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, 2020 2019 Compensation expense included in: Research and development $ 1,411 $ 1,073 Sales and marketing 907 715 General and administrative 3,229 2,780 $ 5,547 $ 4,568 At December 31, 2020, there was approximately $2.9 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 1.49 years. |
In-License Agreement
In-License Agreement | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
In-License Agreement | 12. In-License Agreement 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 consideration for the rights granted by Equinox, the Company (i) made a one time, non-refundable, non-creditable upfront cash payment of $1.0 million to Equinox in February 2020, and (ii) agreed to pay milestone payments totaling up to $50 million upon the achievement of certain development and regulatory milestones, consisting of (a) completion of a Phase II clinical trial for the compound or a licensed product, (b) the filing of a new drug application or foreign equivalent for the compound or a licensed product in the United States, European Union or United Kingdom and (c) regulatory approval of the compound or a licensed product in the United States, European Union or United Kingdom. The Company also agreed to pay Equinox tiered royalties based upon annual net sales of licensed products in the 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 Company recorded $1.0 million of R&D expense during the year ended December 31, 2020 for this license. |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Charges | 13. Restructuring Charges Fiscal Year 2020 Restructuring Plan On April 1, 2020, the Company committed to and announced a restructuring plan (the “Plan”) with regard to its commercial operations. The Plan is a result of decline in product demand associated with shut-downs of customer facilities and postponements of elective surgical procedures in response to the Pandemic. In connection with the Plan, the Company, among other things, downsized its current workforce, with reductions coming primarily from its external DEXYCU sales force and supporting commercial operations, as cataract surgery is considered a non-essential procedure due to the Pandemic. The Company recorded external DEXYCU sales force personnel and external DEXYCU sales force personnel and Exit or Disposal Cost Obligations sales and marketing expense and general and administrative expense, respectively. Employee Severance and Benefits Total Beginning balance at January 1, 2020 $ — $ — Restructuring charge 590 590 Cash payments (590 ) (590 ) Ending balance at December 31, 2020 $ - $ - |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 1 4 . Fair Value Measurements The following tables summarize the Company’s assets carried at fair value measured on a recurring basis at December 31, 2020 and 2019, respectively, by valuation hierarchy (in thousands): December 31, 2020 Description Total Carrying Value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash equivalents $ 23,538 $ 23,538 $ 23,538 $ 23,538 December 31, 2019 Description Total Carrying Value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash equivalents $ 19,976 $ 19,976 $ — $ — $ 19,976 $ 19,976 $ — $ — Financial instruments that potentially subject the Company to concentrations of credit risk have historically consisted principally of cash and cash equivalents. At December 31, 2020 and 2019, respectively, 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. These deposits may be redeemed upon demand and, therefore, generally have minimal risk. The Company’s cash equivalents are classified within Level 1 on the basis of valuations using quoted market prices. 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. The carrying value of the CRG Loan at December 31, 2020 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. The fair value of the CRG Loan was approximately $38.0 million at December 31, 2020. The fair value of the CRG Loan approximated its carrying value at December 31, 2019. The fair value of the PPP Loan approximated its carrying value of $2.0 million at December 31, 2020. |
Retirement Plans
Retirement Plans | 12 Months Ended |
Dec. 31, 2020 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plans | 1 5 . 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 $690,000 and $619,000 for the year ended December 31, 2020 and 2019, respectively, in connection with these retirement plans. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 1 6 . Income Taxes The components of loss before income taxes are as follows (in thousands): Year Ended December 31, Year Ended December 31, 2020 2019 U.S. operations $ (45,492 ) $ (56,866 ) Non-U.S. operations 98 73 Loss before income taxes $ (45,394 ) $ (56,793 ) On December 22, 2017, the Tax Cuts and Jobs Act Year Ended December 31, Year Ended December 31, 2020 2019 Income tax benefit at statutory rate $ (9,533 ) $ (11,927 ) State income taxes, net of federal benefit (2,760 ) (3,685 ) Non-U.S. income tax rate differential (8 ) 374 Change in fair value of derivative — — Change in federal tax rate — — Research and development tax credits (403 ) (150 ) Permanent items 288 55 Changes in valuation allowance 13,068 15,608 Other, net (652 ) (275 ) Income tax benefit $ — $ — The significant components of deferred income taxes are as follows (in thousands): December 31, December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 74,876 $ 66,400 Deferred revenue 150 8 Lease liability 806 923 Stock-based compensation 6,847 5,805 Tax credits 4,503 3,687 Other 2,514 1,473 Total deferred tax assets 89,696 78,296 Deferred tax liabilities: Intangible assets 6,087 7,559 Right-of-use assets 713 841 Total deferred tax liabilities 6,800 8,400 Deferred tax assets, net 82,896 69,896 Valuation allowance 82,896 69,896 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 $ million and $ 15.6 million for the year s ended December 31, 2020 and 2019 , 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, 2020 the Company had U.S. federal net operating loss carry forwards of approximately $269.1 million. The net operating losses consist of $151.8, 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, 2020, the Company had state net operating loss carry forwards of approximately $196.2 million, which expire between 2033 and 2038, as well as U.S. federal and state research and development tax credit carry forwards of approximately $4.7 million, which expire at various dates between calendar years 2021 and 2038. In addition, at December 31, 2020 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 2017 remain subject to examination by the Internal Revenue Service. The Company’s U.K. tax returns for fiscal years 2006 through 2019 remain subject to examination. Through December 31, 2020, 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, 2020 and 2019, respectively. As of December 31, 2020 and 2019, the Company had no accrued penalties or interest related to uncertain tax positions. |
Contingencies
Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Contingencies | 1 7 . 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 On May 14, 2020, the Company 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. The Company is cooperating fully in connection with this investigation. Based on procedures performed to date in relation to the Company’s revenue recognition practices, the Company has not identified any accounting items that are not in accordance with GAAP. At this time, the Company is unable to predict the duration, scope or outcome of this matter or whether it could have a material impact on the Company’s financial condition, results of operations or cash flow. |
Segment and Geographic Area Inf
Segment and Geographic Area Information | 12 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Segment and Geographic Area Information | 1 8 . 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, 2020 2019 2020 2019 U.S. $ 22,624 $ 19,144 $ 630 $ 357 China $ 11,713 $ 1,121 — — U.K. 100 100 — — Consolidated $ 34,437 $ 20,365 $ 630 $ 357 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 9 . Subsequent Events In February 2021, the Company sold 10,465,000 shares of Common Stock in an underwritten public offering at a price of $11.0 per share, including the exercise in full by the underwriters of their option to purchase up to 1,365,000 additional shares of Common Stock |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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, and realization of deferred tax assets. Actual results could differ from these and other estimates. |
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 $840,000 at December 31, 2020 and 2019, 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. |
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 marketable securities. At December 31, 2020, a total of $23.5 million, representing all 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. Generally, these deposits may be redeemed upon demand and, therefore, the Company believes they have minimal risk. The Company had no investments in marketable securities at December 31, 2020 and 2019, 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, 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. As of December 31, 2019, accounts receivable from the Specialty Distributor, an affiliate of the Third-party Logistics Provider (the “3PL”), ASD Specialty Healthcare LLC, FFF Enterprises, Inc., and McKesson Specialty Care Distribution LLC accounted for 37.0%, 34.0%, 15.0%, and 12.0% of total accounts receivable, respectively. For the year ended December 31, 2019, revenues from the Specialty Distributor, an affiliate of the 3PL, ASD Specialty Healthcare LLC, and Alimera Sciences accounted for 56.0%, 15.0%, and 10.0% 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 carrying amounts of cash equivalents, 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 120-157 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 it 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 sales, excluding amortization of acquired intangible assets, consist of costs associated with the manufacture of YUTIQ and DEXYCU, certain period costs for DEXYCU product revenue, product shipping and, as applicable, royalty expense. The inventory costs for YUTIQ include purchases of various components, the active pharmaceutical ingredient (“API”) and direct labor and overhead for the product manufactured in the Company’s Watertown, 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 a 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 accrued DEXYCU product revenue-based royalty expense of $2.3 million and $ 781,000 0 |
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. |
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 adopted Accounting Standards Codification No. 842, Leases (“ASC 842”), as of January 1, 2019. The adoption of ASC 842 represents a change in accounting principle that establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all operating leases, with an exception provided for leases with a duration of one year or less. The Company applied ASC 842 using the modified retrospective transition approach which, allows companies to recognize existing leases at the adoption date without requiring comparable period presentation. Comparative periods are presented in accordance with the previous guidance in Accounting Standards Codification (“ASC”) 840, Leases. In adopting the new standard, the Company elected to utilize the available package of practical expedients permitted under the transition guidance within the new standard, which does not require the reassessment of the following: (i) whether existing or expired arrangements are or contain a lease, (ii) the lease classification of existing or expired leases, and (iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. Additionally, the Company elected to combine lease and non-lease components and to exclude leases with a term of 12 months or less. The adoption of this accounting standard resulted in recording operating lease ROU assets for three real estate operating lease arrangements and corresponding operating lease liabilities of $3.5 million and $3.7 million, respectively, as of January 1, 2019. The operating lease assets at adoption were lower than the operating lease liabilities because the balance of the Company’s deferred rent liabilities at December 31, 2018, which represented lease incentives, was reclassified into operating lease assets. The adoption of the standard did not have a material effect on the Company’s consolidated statements of operations or consolidated statements of cash flows. Under Topic 842, 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 The Company adopted Accounting Standards Codification No. 606 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 recogniz es revenue on sales of its products when Distributors obtain control of the products, which occur s at a point in time, typically upon delivery. In addition to agreements with Distributors , t he Company also enter s 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, 2020. 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 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. |
Reverse Stock Split | Reverse Stock Split On December 8, 2020, the Company’s stockholders approved a reverse stock split (the “reverse split”) of the Company’s issued and outstanding shares of Common Stock. As a result of the reverse split, every 10 shares of the Company’s Common Stock issued and outstanding were converted into one share of Common Stock. who would otherwise be entitled to a fractional share of Common Stock instead |
Stock-Based Compensation | Stock-Based Compensation The Company may award stock options and other equity-based instruments to its employees, directors and consultants pursuant to stockholder-approved plans. In the fourth quarter of fiscal 2017, the Company early adopted Accounting Standards Update (“ASU”) No. 2016-09 (“ASU 2016-09”), Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting Compensation cost related to such 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. The numbers of shares in the following table reflect the Company’s one 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, 2020 2019 Stock options 1,338,880 1,090,973 ESPP 27,713 13,737 Warrants 48,683 48,683 Restricted stock units 149,004 78,684 1,564,280 1,232,077 |
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 February 2016, the FASB issued ASU No. 2016-02, Leases In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326) (“ASU 2016-13”) : Measurement of Credit Losses on Financial Instruments, The Company adopted ASU 2016-13 on January 1, 2020. The adoption of this standard did not have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”) : Simplifying the Accounting for Income Taxes. taxes to members of a consolidated group ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. Early adoption is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. This standard will be effective for the Company in the first quarter of its fiscal year ending December 31, 2021. The Company is currently evaluating the impact the adoption of this update will have on its consolidated financial statements , but does not believe the adoption of the new standard will have a material impact on the Company’s consolidated financial statements . |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 Stock options 1,338,880 1,090,973 ESPP 27,713 13,737 Warrants 48,683 48,683 Restricted stock units 149,004 78,684 1,564,280 1,232,077 |
Product Revenue Reserves and _2
Product Revenue Reserves and Allowances (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Disaggregation of Revenue | The Company’s product revenues have been primarily from sales of YUTIQ and DEXYCU in the U.S., which it began shipping to its customers in February 2019 and March 2019, respectively. Net product revenues by product for the years ended December 31, 2020 and 2019 were as follows (in thousands): Year Ended Year Ended December 31, 2020 December 31, 2019 YUTIQ (A) $ 13,878 $ 12,046 DEXYCU (B) 6,953 4,778 Total product sales, net $ 20,831 $ 16,824 (A) The Company recognized approximately $205,000 and $91,000 of revenue from YUTIQ product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. (B) The Company recognized approximately $8,000 and $0 of revenue from DEXYCU product sales to Ocumension for the years ended December 31, 2020 and 2019, 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, 2020 and 2019 (in thousands): 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 Chargebacks, Discounts and Fees Government and Other Rebates Returns Total Beginning balance at January 1, 2019 $ — $ — $ — $ — Provision related to sales in the current year 2,301 429 732 3,462 Adjustments related to prior period sales — — — — Deductions applied and payments made (683 ) (158 ) (380 ) (1,221 ) Ending balance at December 31, 2019 $ 1,618 $ 271 $ 352 $ 2,241 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): December 31, 2020 December 31, 2019 Raw materials $ 2,664 $ 1,476 Work in process 747 346 Finished goods 1,926 316 Total inventory $ 5,337 $ 2,138 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Reconciliation of Intangible Assets | The reconciliation of intangible assets for the years ended December 31, 2020 and 2019 (in thousands): Year Ended Year Ended December 31, December 31, 2020 2019 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 (40,653 ) (38,193 ) Amortization expense (2,460 ) (2,460 ) Accumulated amortization at end of period (43,113 ) (40,653 ) Net book value at end of period $ 25,209 $ 27,669 |
Schedule of Net Book Value of Intangible Assets | The net book value of the Company’s intangible assets at December 31, 2020 and 2019 is summarized as follows (in thousands): Estimated Remaining Useful Life at December 31, December 31, December 31, 2020 2019 2020 (Years) Patented technologies DEXYCU / Verisome $ 25,209 $ 27,669 10.25 $ 25,209 $ 27,669 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, December 31, 2020 2019 Property and equipment $ 1,403 $ 1,095 Leasehold improvements 255 101 Gross property and equipment 1,658 1,196 Accumulated depreciation and amortization (1,028 ) (839 ) $ 630 $ 357 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): December 31, December 31, 2020 2019 Personnel costs $ 5,686 $ 3,263 Clinical trial costs — 345 Professional fees 647 700 Sales chargebacks, rebates and other revenue reserves 1,109 1,889 Other 1,003 635 $ 8,445 $ 6,832 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases as of December 31, 2020 and 2019, respectively are as follows (in thousands): December 31, December 31, 2020 2019 Other current liabilities - operating lease current portion $ 568 $ 481 Operating lease liabilities – noncurrent portion 2,330 2,898 Total operating lease liabilities $ 2,898 $ 3,379 |
Schedule of Supplemental Balance Sheet Information Related to Finance Lease | Supplemental balance sheet information related to the finance lease as of December 31, 2020 is as follows (in thousands): December 31, 2020 Property and equipment, at cost $ 239 Accumulated amortization (52 ) Property and equipment, net $ 187 Other current liabilities – $ 119 Other long-term liabilities 71 Total finance lease liabilities $ 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, 2020 were as follows (in thousands): Operating Leases Finance Leases 2021 889 135 2022 849 75 2023 815 — 2024 830 — 2025 346 0 Total lease payments $ 3,729 $ 210 Less imputed interest (831 ) (20 ) Total $ 2,898 $ 190 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 and 2019: Year Ended Year Ended December 31, December 31, 2020 2019 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 Expired — — 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, 2020 | |
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, 2020: Number of options Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at January 1, 2020 1,090,973 $ 25.21 Granted 415,339 12.09 Exercised — — Forfeited (99,031 ) 23.27 Expired (68,401 ) 33.58 Outstanding at December 31, 2020 1,338,880 $ 20.86 7.55 $ 36 Exercisable at December 31, 2020 716,764 $ 25.05 6.50 $ — |
Schedule of Key Assumptions Used | In determining the grant date fair value of option awards, the key assumptions used to apply the Black-Scholes option pricing model for options granted under the 2016 Plan during the years ended December 31, 2020 and 2019 were as follows: Year Ended December 31, Year Ended December 31, 2020 2019 Option life (in years) 5.50 - 6.10 5.50 - 6.08 Stock volatility 64% - 70% 60% - 65% Risk-free interest rate 0.32% - 1.76% 1.37% - 2.63% 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, 2020 and 2019 (in thousands except per share amounts): Year Ended December 31, Year Ended December 31, 2020 2019 Weighted-average grant date fair value per share $ 7.07 $ 9.35 Total cash received from exercise of stock options — 414 Total intrinsic value of stock options exercised — 84 |
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, 2020: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Nonvested at January 1, 2020 78,684 $ 18.34 Granted 152,575 12.42 Vested (71,657 ) 15.25 Forfeited (10,598 ) 17.17 Nonvested at December 31, 2020 149,004 $ 13.85 |
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, 2020 2019 Compensation expense included in: Research and development $ 1,411 $ 1,073 Sales and marketing 907 715 General and administrative 3,229 2,780 $ 5,547 $ 4,568 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring And Related Activities [Abstract] | |
Schedule of Restructuring Charges | The Plan was completed during the fourth quarter of fiscal 2020. Employee Severance and Benefits Total Beginning balance at January 1, 2020 $ — $ — Restructuring charge 590 590 Cash payments (590 ) (590 ) Ending balance at December 31, 2020 $ - $ - |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 and 2019, respectively, by valuation hierarchy (in thousands): December 31, 2020 Description Total Carrying Value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash equivalents $ 23,538 $ 23,538 $ 23,538 $ 23,538 December 31, 2019 Description Total Carrying Value Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash equivalents $ 19,976 $ 19,976 $ — $ — $ 19,976 $ 19,976 $ — $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 U.S. operations $ (45,492 ) $ (56,866 ) Non-U.S. operations 98 73 Loss before income taxes $ (45,394 ) $ (56,793 ) |
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, 2020 and 21% for the year ended December 31, 2019 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, 2020 2019 Income tax benefit at statutory rate $ (9,533 ) $ (11,927 ) State income taxes, net of federal benefit (2,760 ) (3,685 ) Non-U.S. income tax rate differential (8 ) 374 Change in fair value of derivative — — Change in federal tax rate — — Research and development tax credits (403 ) (150 ) Permanent items 288 55 Changes in valuation allowance 13,068 15,608 Other, net (652 ) (275 ) 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, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 74,876 $ 66,400 Deferred revenue 150 8 Lease liability 806 923 Stock-based compensation 6,847 5,805 Tax credits 4,503 3,687 Other 2,514 1,473 Total deferred tax assets 89,696 78,296 Deferred tax liabilities: Intangible assets 6,087 7,559 Right-of-use assets 713 841 Total deferred tax liabilities 6,800 8,400 Deferred tax assets, net 82,896 69,896 Valuation allowance 82,896 69,896 Total deferred tax liability $ — $ — |
Segment and Geographic Area I_2
Segment and Geographic Area Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 2020 2019 U.S. $ 22,624 $ 19,144 $ 630 $ 357 China $ 11,713 $ 1,121 — — U.K. 100 100 — — Consolidated $ 34,437 $ 20,365 $ 630 $ 357 |
Operations - Additional Informa
Operations - Additional Information (Detail) $ in Thousands | Feb. 04, 2021USD ($) | Dec. 31, 2020USD ($)Product_PeopleCase | Dec. 31, 2019USD ($) |
Operations [Line Items] | |||
Number of commercial products | Product | 2 | ||
Number of products approved | Product | 4 | ||
Cash and cash equivalents | $ 44,909 | $ 22,214 | |
Proceeds from issuance of stock, net of issuance costs | $ 49,918 | $ 22,627 | |
Subsequent Event [Member] | |||
Operations [Line Items] | |||
Proceeds from issuance of stock, net of issuance costs | $ 108,000 | ||
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) | Dec. 08, 2020shares | Mar. 28, 2018 | Aug. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)Lease | Jan. 01, 2019USD ($) | Jul. 02, 2018USD ($) | Jul. 02, 2016USD ($) |
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Accumulated other comprehensive income to foreign currency translation | $ 841,000 | $ 840,000 | |||||||
Interest-bearing cash equivalent | 23,500,000 | ||||||||
Marketable securities | 0 | 0 | |||||||
Allowance for credit loss | 0 | 0 | |||||||
Operating lease liability | 2,898,000 | 3,379,000 | |||||||
Operating lease right-of-use assets | 2,610,000 | 3,078,000 | |||||||
Accumulated deficit | $ (510,680,000) | $ (465,286,000) | |||||||
Common stock, conversion basis | As a result of the reverse split, every 10 shares of the Company’s Common Stock issued and outstanding were converted into one share of Common Stock. | ||||||||
Reverse stock split | one-for-10 | ||||||||
Reverse stock split ratio | 0.1 | ||||||||
Common stock conversion | shares | 1 | ||||||||
Accounting Standards Update 2018-11 | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Operating lease liability | $ 3,700,000 | ||||||||
Number of real estate operating lease arrangements | Lease | 3 | ||||||||
Operating lease right-of-use assets | $ 3,500,000 | ||||||||
Accounting Standards Update 606 [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Accumulated deficit | $ 218,000 | ||||||||
Accounting Standards Update 2016-09 [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Accumulated deficit | $ (122,000) | ||||||||
Accounting Standards Update 2016-13 | |||||||||
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, 2020 | ||||||||
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 | $ 2,300,000 | $ 781,000,000 | |||||||
DEXYCU [Member] | Icon Bioscience Inc [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Accrued revenue-based royalty expense | $ 1,300,000 | $ 0 | |||||||
Percentage of accelerated milestone payment received | 20.00% | ||||||||
Percentage of upfront payment received | 20.00% | ||||||||
Finite-lived intangible asset, useful life | 13 years | 10 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 | 157 days | ||||||||
Estimated useful lives of assets | 5 years | ||||||||
ASD Specialty Healthcare LLC [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 56.00% | 34.00% | |||||||
ASD Specialty Healthcare LLC [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 39.00% | 15.00% | |||||||
Ocumension Therapeutics [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 33.00% | ||||||||
McKesson Specialty Care Distribution LLC [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 37.00% | 12.00% | |||||||
McKesson Specialty Care Distribution LLC [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 18.00% | ||||||||
3 PL [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 37.00% | ||||||||
3 PL [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 56.00% | ||||||||
FFF Enterprises, Inc. [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 15.00% | ||||||||
Alimera Sciences [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Percentage of concentration risk | 10.00% |
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, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common stock equivalents outstanding excluded from diluted earnings per share calculation | 1,564,280 | 1,232,077 |
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 | 1,338,880 | 1,090,973 |
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 | 27,713 | 13,737 |
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 | 149,004 | 78,684 |
Product Revenue Reserves and _3
Product Revenue Reserves and Allowances - Disaggregation of Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | ||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | $ 34,437 | $ 20,365 | |
YUTIQ [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | [1] | 13,878 | 12,046 |
DEXYCU [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | [2] | 6,953 | 4,778 |
Product [Member] | |||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||
Revenues | $ 20,831 | $ 16,824 | |
[1] | The Company recognized approximately $205,000 and $91,000 of revenue from YUTIQ product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. | ||
[2] | The Company recognized approximately $8,000 and $0 of revenue from DEXYCU product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. |
Product Revenue Reserves and _4
Product Revenue Reserves and Allowances - Disaggregation of Revenue (Parenthetical) (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | ||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 34,437,000 | $ 20,365,000 | |
YUTIQ [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | [1] | 13,878,000 | 12,046,000 |
YUTIQ [Member] | Ocumension Therapeutics [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 205,000 | 91,000 | |
DEXYCU [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | [2] | 6,953,000 | 4,778,000 |
DEXYCU [Member] | Ocumension Therapeutics [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 8,000 | $ 0 | |
[1] | The Company recognized approximately $205,000 and $91,000 of revenue from YUTIQ product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. | ||
[2] | The Company recognized approximately $8,000 and $0 of revenue from DEXYCU product sales to Ocumension for the years ended December 31, 2020 and 2019, respectively. |
Product Revenue Reserves and _5
Product Revenue Reserves and Allowances - Product Revenue Allowance and Reserves (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | $ 2,241 | $ 0 |
Provision related to sales in the current year | 4,175 | 3,462 |
Adjustments related to prior period sales | (337) | 0 |
Deductions applied and payments made | (4,367) | (1,221) |
Ending balance | 1,712 | 2,241 |
Chargebacks, Discounts and Fees [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 1,618 | 0 |
Provision related to sales in the current year | 2,141 | 2,301 |
Adjustments related to prior period sales | (387) | 0 |
Deductions applied and payments made | (2,798) | (683) |
Ending balance | 574 | 1,618 |
Government and Other Rebates [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 271 | 0 |
Provision related to sales in the current year | 1,056 | 429 |
Adjustments related to prior period sales | 0 | |
Deductions applied and payments made | (792) | (158) |
Ending balance | 535 | 271 |
Returns [Member] | ||
Disclosure Of Product Revenue Reserves And Allowances [Line Items] | ||
Beginning balance | 352 | 0 |
Provision related to sales in the current year | 978 | 732 |
Adjustments related to prior period sales | 50 | 0 |
Deductions applied and payments made | (777) | (380) |
Ending balance | $ 603 | $ 352 |
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, 2020 | Dec. 31, 2019 |
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | $ 34,437,000 | $ 20,365,000 | |||||||
Icon Bioscience Inc [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Sales-based royalty expense | $ 1,300,000 | 0 | |||||||
Percentage of accelerated milestone payment received | 20.00% | ||||||||
Amended Alimera Science Inc Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | $ 1,700,000 | 2,100,000 | |||||||
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] | 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 | 1,664,000 | 2,180,000 | |||||||
Royalty Income [Member] | Amended Alimera Science Inc Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 1,700,000 | 2,000,000 | |||||||
RPA [Member] | SWK [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 0 | ||||||||
Upfront cash payment | $ 16,500,000 | ||||||||
Royalty payments | 0 | ||||||||
Royalty Sale Agreement [Member] | SWK [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Deferred revenue | $ 16,500,000 | ||||||||
Deferred revenue, current | 885,000 | ||||||||
Deferred revenue, non-current | 15,600,000 | ||||||||
Collaborative Research and Development [Member] | OncoSil Medical UK Limited [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 100,000 | ||||||||
Collaborative Research and Development [Member] | Feasibility Study Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 255,000 | 135,000 | |||||||
Deferred revenue | 60,000 | 15,000 | |||||||
License and Collaboration Agreement [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 11,942,000 | 1,361,000 | |||||||
License and Collaboration Agreement [Member] | Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 11,500,000 | 1,000,000 | |||||||
Product [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | 20,831,000 | 16,824,000 | |||||||
Product [Member] | Ocumension Therapeutics [Member] | |||||||||
Disclosure of Product Revenue Reserves and Allowances [Line Items] | |||||||||
Revenue | $ 213,000 | $ 91,000 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,664 | $ 1,476 |
Work in process | 747 | 346 |
Finished goods | 1,926 | 316 |
Total inventory | $ 5,337 | $ 2,138 |
Intangible Assets - Reconciliat
Intangible Assets - Reconciliation of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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 | (40,653) | (38,193) |
Amortization expense | (2,460) | (2,460) |
Accumulated amortization at end of period | (43,113) | (40,653) |
Net book value at end of period | $ 25,209 | $ 27,669 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Net Book Value of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Intangible assets, net | $ 25,209 | $ 27,669 |
DEXYCU [Member] | ||
Intangible assets, net | $ 25,209 | $ 27,669 |
Finite lived intangible assets remaining amortization period | 10 years 3 months |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 28, 2018 | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 10 years 3 months |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | $ 1,658 | $ 1,196 |
Accumulated depreciation and amortization | (1,028) | (839) |
Property and equipment, net | 630 | 357 |
Property and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | 1,403 | 1,095 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Gross property and equipment | $ 255 | $ 101 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property Plant And Equipment Useful Life And Values [Abstract] | ||
Depreciation | $ 189 | $ 144 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Personnel costs | $ 5,686 | $ 3,263 |
Clinical trial costs | 0 | 345 |
Professional fees | 647 | 700 |
Sales chargebacks, rebates and other revenue reserves | 1,109 | 1,889 |
Other | 1,003 | 635 |
Accrued expenses | $ 8,445 | $ 6,832 |
Leases - Additional Information
Leases - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2020USD ($)ft²LeaseTranche | Dec. 31, 2019USD ($) | |
Disclosure Of Leases [Line Items] | ||
Loan facility term | 5 years | |
Operating lease weighted average remaining lease term | 4 years 3 months 18 days | |
Operating lease weighted average discount rate | 12.50% | |
Operating lease expense | $ 852,000 | $ 852,000 |
Variable lease cost | 36,000 | 36,000 |
Operating lease payments | 867,000 | 808,000 |
Finance lease, amortization expense of ROU asset | 52,000 | |
Interest expense on finance lease liability | 9,000 | |
Finance lease, operating cash flows | 9,000 | |
Finance lease, financing cash flows | 49,000 | |
Finance lease | $ 190,000 | $ 0 |
Finance lease, weighted average Remaining term | 1 year 8 months 12 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] | ||
Lease term expiration date | Dec. 31, 2021 | Dec. 31, 2022 |
Number of finance leases | Lease | 2 | |
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 term expiration date | Apr. 30, 2019 | |
Massachusetts [Member] | Second Amendment Lease [Member] | ||
Disclosure Of Leases [Line Items] | ||
Lease term expiration date | May 31, 2025 | |
Lease commencement date | Sep. 10, 2018 | |
Additional lease renewal option period | 5 years | |
Additional Space leased | ft² | 6,590 | |
Irrevocable standby letter of credit | $ 150,000 | |
NEW JERSEY | Basking Ridge Office Space [Member] | ||
Disclosure Of Leases [Line Items] | ||
Lease term expiration date | Jun. 30, 2022 | |
Lease commencement date | Jul. 31, 2017 | |
Additional lease renewal option period | 5 years | |
Area of leased office space | ft² | 3,000 | |
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, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Other current liabilities - operating lease current portion | $ 568 | $ 481 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherLiabilitiesCurrent |
Operating lease liabilities - noncurrent | $ 2,330 | $ 2,898 |
Total operating lease liabilities | $ 2,898 | $ 3,379 |
Leases - Supplemental Balance_2
Leases - Supplemental Balance Sheet Related to Finance Leases (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Property and equipment, at cost | $ 239,000 | |
Accumulated amortization | (52,000) | |
Property and equipment, net | 187,000 | |
Other current liabilities – finance lease current portion | $ 119,000 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Other long-term liabilities | $ 71,000 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |
Total finance lease liabilities | $ 190,000 | $ 0 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Non-Cancellable Leases (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Operating Leases | ||
2021 | $ 889,000 | |
2022 | 849,000 | |
2023 | 815,000 | |
2024 | 830,000 | |
2025 | 346,000 | |
Total lease payments | 3,729,000 | |
Less imputed interest | (831,000) | |
Total | 2,898,000 | $ 3,379,000 |
Finance Leases | ||
2021 | 135,000 | |
2022 | 75,000 | |
2025 | 0 | |
Total future minimum lease payments | 210,000 | |
Less imputed interest | (20,000) | |
Total | $ 190,000 | $ 0 |
Term Loan Agreement - Additiona
Term Loan Agreement - Additional Information (Detail) | Dec. 17, 2020USD ($) | Apr. 22, 2020USD ($) | Feb. 13, 2019USD ($) | Jun. 26, 2018USD ($)$ / sharesshares | Mar. 28, 2018USD ($)Tranche$ / sharesshares | Oct. 31, 2020USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Apr. 08, 2020USD ($) | Apr. 30, 2019USD ($) |
Term Loan Agreement [Line Items] | ||||||||||||
Proceeds from issuance of long-term debt | $ 50,000,000 | |||||||||||
Loss on extinguishment of debt | $ (905,000) | (3,810,000) | ||||||||||
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) | $ 745,000 | $ 512,000 | ||||||||||
Senior Secured Term Loan [Member] | Warrants [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Exercise price of issued warrants | $ / shares | $ 19.30 | $ 11 | ||||||||||
Initial Advance [Member] | Senior Secured Term Loan [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Proceeds from issuance of term loan, net of allocation to the debt warrant | $ 14,600,000 | |||||||||||
Initial Advance [Member] | Senior Secured Term Loan [Member] | Warrants [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Warrants issued in connection with loan | shares | 40,910 | |||||||||||
Exercise price of issued warrants | $ / shares | $ 1.10 | |||||||||||
Fair value of warrants issued | $ 284,000 | |||||||||||
Additional Advance [Member] | Senior Secured Term Loan [Member] | Warrants [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Warrants issued in connection with loan | shares | 7,773 | |||||||||||
Exercise price of issued warrants | $ / shares | $ 1.93 | |||||||||||
Warrants, contingent issuance fair value | $ 69,000 | |||||||||||
Revaluation of additional advance warrants shares reclassified to equity | $ 87,000 | |||||||||||
Additional Advance [Member] | SWK Senior Secured Term Loan [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Upfront loan origination fee percentage | 1.50% | |||||||||||
Exit fee percentage payable upon repayment of the total secured term loan | 6.00% | |||||||||||
Total debt discount | $ 652,000 | |||||||||||
Loan origination fee, exit fee and other loan transaction costs | 299,000 | |||||||||||
Amortization of deferred debt issue cost through the date of the Additional Advance | 97,000 | |||||||||||
Debt issuance costs remaining balance reclassified to debt discount | $ 202,000 | |||||||||||
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 | $ 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% | |||||||||||
Agreement date | Feb. 13, 2019 | |||||||||||
Senior secured term loan borrowing facility | $ 60,000,000 | |||||||||||
Term loan agreement, initial advance | $ 35,000,000 | |||||||||||
Line of Credit Facility, Remaining Borrowing Capacity subject to milestone achievement | $ 10,000,000 | |||||||||||
Maturity date | Dec. 31, 2023 | |||||||||||
Paid in Kind Interest Added to Principal | $ 2,000,000 | |||||||||||
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 | |||||||||||
Loss on extinguishment of debt | $ (905,000) | |||||||||||
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 | |||||||||||
SWK Funding LLC [Member] | Senior Secured Term Loan [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Agreement date | Mar. 28, 2018 | |||||||||||
Senior secured term loan borrowing facility | $ 20,000,000 | |||||||||||
Term loan agreement, initial advance | $ 15,000,000 | |||||||||||
Maturity date | Mar. 27, 2023 | |||||||||||
Exit fee percentage payable upon repayment of the total secured term loan | 6.00% | |||||||||||
Loss on extinguishment of debt | $ (3,800,000) | |||||||||||
Amortization of debt discount (premium) | 84,000 | |||||||||||
Senior secured term loan, additional advance that followed satisfaction of applicable conditions | $ 5,000,000 | |||||||||||
Write-off of remaining unamortized debt discount included as a component of the loss on extinguishment of debt | $ 2,300,000 | |||||||||||
SWK Funding LLC [Member] | Senior Secured Term Loan [Member] | Loan Refinancing [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Payment of exit fee upon repayment of secured term loan | 1,200,000 | |||||||||||
Payment of accrued and unpaid interest through the date of the secured term loan refinancing | 664,000 | |||||||||||
Prepayment penalty for voluntary repayment of the secured term loan | 1,200,000 | |||||||||||
Payment of additional make-whole interest from the loan refinancing date through the first anniversary of the secured term loan (Mar 28, 2019) | 306,000 | |||||||||||
SWK Funding LLC [Member] | Senior Secured Term Loan [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Repayment of senior secured term loan | $ 20,000,000 | |||||||||||
Interest rate | three-month LIBOR rate (subject to a 1.5% floor) plus 10.50%. | |||||||||||
LIBOR rate floor | 1.50% | |||||||||||
Interest rate percentage above LIBOR rate | 10.50% | |||||||||||
First Tranche Advance [Member] | SWK Senior Secured Term Loan [Member] | ||||||||||||
Term Loan Agreement [Line Items] | ||||||||||||
Upfront loan origination fee percentage | 1.50% | |||||||||||
Total debt discount | $ 2,100,000 | |||||||||||
Cost allocated tranches, number | Tranche | 2 | |||||||||||
Loan origination fee, exit fee and other loan transaction costs | $ 1,800,000 | |||||||||||
Aggregate fair value of warrants | $ 353,000 | |||||||||||
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% | 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 | |||||||||||
Proceeds from issuance of long-term debt | $ 2,000,000 | |||||||||||
Accrued interest expense | $ 14,000 |
Stockholders' Equity - 2020 Equ
Stockholders' Equity - 2020 Equity Financing - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Aug. 31, 2020 | Feb. 29, 2020 | Jan. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 23, 2020 | Jun. 22, 2020 | |
Class Of Stock [Line Items] | |||||||
Common stock, shares authorized | 300,000,000 | 150,000,000 | 300,000,000 | ||||
At-the-Market Offering [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock shares maximum aggregate offering price | $ 25,000,000 | $ 20,000,000 | |||||
Stock issuances, sales agent commission maximum percentage | 3.00% | 3.00% | |||||
Common stock issued | 2,590,093 | 299,888 | |||||
Weighted average common stock price per share | $ 5.74 | $ 15.03 | |||||
Gross proceeds from issuance of common stock | $ 14,900,000 | $ 4,500,000 | |||||
Share issuance costs | $ 646,000 | $ 221,000 | |||||
Share Purchase Agreement [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock issued | 3,010,722 | ||||||
Gross proceeds from issuance of common stock | $ 15,700,000 | ||||||
Share issuance costs | $ 100,000 | ||||||
Common stock price per share | $ 5.22 | ||||||
2020 Equity Financing [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock, shares authorized | 150,000,000 | ||||||
2020 Equity Financing [Member] | Share Offering [Member] | |||||||
Class Of Stock [Line Items] | |||||||
Common stock issued | 1,500,000 | ||||||
Gross proceeds from issuance of common stock | $ 21,750,000 | ||||||
Share issuance costs | $ 1,800,000 | ||||||
Price per share | $ 14.5 |
Stockholders' Equity - 2019 Equ
Stockholders' Equity - 2019 Equity Financing - Additional Information (Detail) - USD ($) | Apr. 01, 2019 | Aug. 31, 2020 | Jan. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
At-the-Market Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock shares maximum aggregate offering price | $ 25,000,000 | $ 20,000,000 | |||
Stock issuances, sales agent commission maximum percentage | 3.00% | 3.00% | |||
Common stock issued | 2,590,093 | 299,888 | |||
Weighted average common stock price per share | $ 5.74 | $ 15.03 | |||
Gross proceeds from issuance of common stock | $ 14,900,000 | $ 4,500,000 | |||
Share issuance costs | $ 646,000 | $ 221,000 | |||
2019 Equity Financing [Member] | Share Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock issued | 1,052,650 | ||||
Gross proceeds from issuance of common stock | $ 20,000,000 | ||||
Share issuance costs | $ 1,700,000 | ||||
Price per share | $ 19 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Reconciliation of Warrants to Purchase Share of the Company's Common Stock (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders Equity Note [Abstract] | ||
Number of Warrants, Outstanding and exercisable, Beginning balance | 48,683 | 48,683 |
Number of Warrants, Expired | 0 | 0 |
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, Expired | 0 | 0 |
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) - Warrants [Member] - $ / shares | Jun. 26, 2018 | Mar. 28, 2018 | Dec. 31, 2020 |
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 | 4 years 3 months 10 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, 2020 | Jun. 25, 2019 | Dec. 12, 2016 |
Class Of Stock [Line Items] | |||
Number of common stock, authorized for issuance | 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 | 603,000 |
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, 2020USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | shares | 1,090,973 |
Number of Options, Granted | shares | 415,339 |
Number of Options, Forefeited | shares | (99,031) |
Number of Options, Expired | shares | (68,401) |
Number of Options Outstanding, Ending balance | shares | 1,338,880 |
Number of Options, Exercisable at December 31, 2020 | shares | 716,764 |
Weighted Average Exercise Price Outstanding, Beginning balance | $ / shares | $ 25.21 |
Weighted Average Exercise Price, Granted | $ / shares | 12.09 |
Weighted Average Exercise Price, Forefeited | $ / shares | 23.27 |
Weighted Average Exercise Price, Expired | $ / shares | 33.58 |
Weighted Average Exercise Price Outstanding, Ending balance | $ / shares | 20.86 |
Weighted Average Exercise Price, Exercisable at December 31, 2020 | $ / shares | $ 25.05 |
Weighted Average Remaining Contractual Life, Outstanding at January 1, 2020 | 7 years 6 months 18 days |
Weighted Average Remaining Contractual Life, Exercisable at December 31, 2020 | 6 years 6 months |
Aggregate Intrinsic Value, Outstanding at January 1, 2020 | $ | $ 36 |
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, 2020 | |
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 | 413,000 | |
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, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock volatility, minimum | 64.00% | 60.00% |
Stock volatility, maximum | 70.00% | 65.00% |
Risk-free interest rate, minimum | 0.32% | 1.37% |
Risk-free interest rate, maximum | 1.76% | 2.63% |
Expected dividends | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option life (in years) | 5 years 6 months | 5 years 6 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option life (in years) | 6 years 1 month 6 days | 6 years 29 days |
Share-Based Payment Awards - _3
Share-Based Payment Awards - Summary of Information about Stock Options (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total cash received from exercise of stock options | $ 294 | $ 414 |
Equity Incentive Plans [Member] | ||
Weighted-average grant date fair value per share | $ 7.07 | $ 9.35 |
Total cash received from exercise of stock options | $ 414 | |
Total intrinsic value of stock options exercised | $ 84 |
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, 2020 | |
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 3 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, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Stock Units Outstanding, Beginning Balance | shares | 78,684 |
Number of stock units, granted | shares | 152,575 |
Number of Stock Units, Vested | shares | (71,657) |
Number of Stock Units, Forfeited | shares | (10,598) |
Number of Stock Units Outstanding, Ending Balance | shares | 149,004 |
Weighted Average Grant Date Fair Value Nonvested, Beginning balance | $ / shares | $ 18.34 |
Weighted average grant date fair value, granted | $ / shares | 12.42 |
Weighted Average Grant Date Fair value, Vested | $ / shares | 15.25 |
Weighted Average Grant Date Fair value, Forfeited | $ / shares | 17.17 |
Weighted Average Grant Date Fair Value Nonvested, Ending balance | $ / shares | $ 13.85 |
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, 2020 | Dec. 31, 2019 | |
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 | 1,916 |
Share-Based Payment Awards - Em
Share-Based Payment Awards - Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) | Jun. 25, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Class Of Stock [Line Items] | |||
Employee stock purchase plan | $ 294,000 | ||
Common stock, shares issued | 18,139,981 | 10,941,659 | |
ESPP [Member] | |||
Class Of Stock [Line Items] | |||
Number of common stock, authorized for issuance | 110,000 | ||
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 | ||
Offering period, start date | Aug. 1, 2019 | ||
Offering period, end date | Jan. 31, 2020 | ||
Common stock, shares issued | 33,697 |
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, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 5,547 | $ 4,568 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 1,411 | 1,073 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 907 | 715 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 3,229 | $ 2,780 |
Share-Based Payment Awards - _5
Share-Based Payment Awards - Stock-Based Compensation Expense - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Unrecognized compensation expense | $ 2.9 |
Unrecognized compensation expense weighted average period | 1 year 5 months 26 days |
In-License Agreement- Additiona
In-License Agreement- Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Feb. 29, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Agreements And Contracts [Line Items] | |||
R&D expense | $ 17,424 | $ 15,368 | |
Equinox Science, LLC [Member] | |||
Collaborative Agreements And Contracts [Line Items] | |||
Non-refundable and non-creditable upfront cash payment | $ 1,000 | ||
R&D expense | $ 1,000 | ||
Equinox Science, LLC [Member] | Maximum [Member] | |||
Collaborative Agreements And Contracts [Line Items] | |||
Payment upon achievement of development and regulatory milestones | $ 50,000 |
Restructuring Charges - Additio
Restructuring Charges - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring charges | $ 590,000 |
Employee Severance [Member] | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring charges | 590,000 |
DEXYCU [Member] | Sales and Marketing Expense [Member] | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring charges | 542,000 |
DEXYCU [Member] | General and Administrative Expense [Member] | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring charges | 48,000 |
DEXYCU [Member] | Employee Severance [Member] | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring charges | $ 590,000 |
Restructuring Charges - Schedul
Restructuring Charges - Schedule of Restructuring Charges (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Beginning balance | $ 0 |
Restructuring charge | 590 |
Cash payments | (590) |
Ending balance | 0 |
Employee Severance [Member] | |
Restructuring Cost And Reserve [Line Items] | |
Beginning balance | 0 |
Restructuring charge | 590 |
Cash payments | (590) |
Ending balance | $ 0 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Carried at Fair Value Measured on Recurring Basis (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Cash equivalents | $ 23,538 | $ 19,976 |
Total cash equivalents | 23,538 | 19,976 |
Quoted Prices in Active Markets (Level 1) [Member] | ||
Assets: | ||
Cash equivalents | 23,538 | 19,976 |
Total cash equivalents | 23,538 | 19,976 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Total cash equivalents | 0 | 0 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Total cash equivalents | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2020 | Feb. 13, 2019 |
Paycheck Protection Program Loan [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying value of loan | $ 2 | |
Fair value of loan | 2 | |
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 | 38.3 | |
long-term debt | 36 | |
Exit fee accrued | $ 2.1 | |
Fair value of loan | 38 | |
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 | $ 2.3 |
Retirement Plans - Additional I
Retirement Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | ||
Maximum percentage of eligible compensation matched by employer | 5.00% | |
Employer contributions to retirement plans | $ 690,000 | $ 619,000 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
U.S. operations | $ (45,492) | $ (56,866) |
Non-U.S. operations | 98 | 73 |
Loss before income taxes | $ (45,394) | $ (56,793) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) £ in Millions | 12 Months Ended | |||
Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2017 | Dec. 31, 2020GBP (£) | |
Statutory federal corporate income tax rate | 21.00% | 21.00% | 34.00% | |
Changes in valuation allowance | $ 13,068,000 | $ 15,608,000 | ||
Unrecognized tax benefits | 0 | |||
Accrued penalties or interest related to uncertain tax positions | 0 | 0 | ||
U.S. Federal [Member] | ||||
Operating loss carry forwards | 269,100,000 | |||
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 | |||
State [Member] | ||||
Operating loss carry forwards | $ 196,200,000 | |||
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 | |||
Federal and State Research and Development Tax Credit Carryforward [Member] | ||||
Research and development tax credit carry forwards | $ 4,700,000 | |||
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, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit at statutory rate | $ (9,533) | $ (11,927) |
State income taxes, net of federal benefit | (2,760) | (3,685) |
Non-U.S. income tax rate differential | (8) | 374 |
Change in fair value of derivative | 0 | 0 |
Change in federal tax rate | 0 | 0 |
Research and development tax credits | (403) | (150) |
Permanent items | 288 | 55 |
Changes in valuation allowance | 13,068 | 15,608 |
Other, net | (652) | (275) |
Income tax expense (benefit) | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Income Taxes (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 74,876 | $ 66,400 |
Deferred revenue | 150 | 8 |
Lease liability | 806 | 923 |
Stock-based compensation | 6,847 | 5,805 |
Tax credits | 4,503 | 3,687 |
Other | 2,514 | 1,473 |
Total deferred tax assets | 89,696 | 78,296 |
Deferred tax liabilities: | ||
Intangible assets | 6,087 | 7,559 |
Right-of-use assets | 713 | 841 |
Total deferred tax liabilities | 6,800 | 8,400 |
Deferred tax assets, net | 82,896 | 69,896 |
Valuation allowance | 82,896 | 69,896 |
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, 2020 | |
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, 2020 | Dec. 31, 2019 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 34,437 | $ 20,365 |
Long-lived assets, net | 630 | 357 |
Country US [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 22,624 | 19,144 |
Long-lived assets, net | 630 | 357 |
China [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 11,713 | 1,121 |
UNITED KINGDOM [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 100 | $ 100 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - Share Offering [Member] $ / shares in Units, $ in Millions | 1 Months Ended |
Feb. 28, 2021USD ($)$ / sharesshares | |
Common stock issued | shares | 10,465,000 |
Price per share | $ / shares | $ 11 |
Common stock, additional shares issued | shares | 1,365,000 |
Gross proceeds from issuance of common stock | $ | $ 115.1 |
Share issuance costs | $ | $ 7.1 |