Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 24, 2022 | Jun. 30, 2021 | |
Document Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-34475 | ||
Entity Registrant Name | OMEROS CORPORATION | ||
Entity Incorporation, State or Country Code | WA | ||
Entity Tax Identification Number | 91-1663741 | ||
Entity Address, Address Line One | 201 Elliott Avenue West | ||
Entity Address, City or Town | Seattle | ||
Entity Address, State or Province | WA | ||
Entity Address, Postal Zip Code | 98119 | ||
City Area Code | 206 | ||
Local Phone Number | 676-5000 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | OMER | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 62,726,515 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Public Float | $ 886,628,577 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001285819 | ||
Amendment Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Seattle, Washington |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 100,808 | $ 10,501 |
Short-term investments | 56,458 | 124,452 |
OMIDRIA contract royalty asset, short-term | 44,319 | |
Receivables, net | 38,155 | 3,841 |
Prepaid expense and other assets | 8,149 | 10,455 |
Current assets from discontinued operations | 2,036 | |
Total current assets | 247,889 | 151,285 |
OMIDRIA contract royalty asset | 140,251 | |
Property and equipment, net | 1,731 | 2,551 |
Right of use assets | 28,276 | 25,526 |
Restricted investments | 1,054 | 1,055 |
Advanced payments, non-current | 67 | 625 |
Total assets | 419,268 | 181,042 |
Current liabilities: | ||
Accounts payable | 13,400 | 4,199 |
Accrued expenses | 33,134 | 28,755 |
Current portion of lease liabilities | 5,255 | 3,782 |
Total current liabilities | 51,789 | 36,736 |
Lease liabilities, non-current | 29,126 | 28,770 |
Unsecured convertible senior notes, net | 313,458 | 236,288 |
Other accrued liabilities - noncurrent | 1,115 | |
Commitments and contingencies (Note 11) | ||
Shareholders' equity (deficit): | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at December 31, 2021 and December 31, 2020. | ||
Common stock, par value $0.01 per share, 150,000,000 shares authorized at December 31, 2021 and December 31, 2020; 62,628,855 and 61,671,231 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively. | 626 | 616 |
Additional paid-in capital | 706,288 | 751,304 |
Accumulated deficit | (683,134) | (872,672) |
Total shareholders' equity (deficit) | 23,780 | (120,752) |
Total liabilities and shareholders' equity (deficit) | $ 419,268 | $ 181,042 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 20,000,000 | 20,000,000 |
Preferred stock, Issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Common stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares | 150,000,000 | 150,000,000 |
Common stock, Issued shares | 62,628,855 | 61,671,231 |
Common stock, outstanding shares | 62,628,855 | 61,671,231 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Costs and expenses: | |||
Research and development | $ 118,775 | $ 107,612 | $ 106,324 |
Selling, general and administrative | 54,842 | 49,306 | 39,714 |
Total costs and expenses | 173,617 | 156,918 | 146,038 |
Loss from continuing operations | (173,617) | (156,918) | (146,038) |
Loss on early extinguishment of debt | (13,374) | ||
Interest expense | (19,669) | (26,751) | (22,657) |
Other income | 1,740 | 654 | 1,553 |
Loss from continuing operations before income tax benefit | (191,546) | (196,389) | (167,142) |
Income tax benefit (expense) | 0 | 23,256 | 19,774 |
Net loss from continuing operations | (191,546) | (173,133) | (147,368) |
Net income from discontinued operations, net of tax | 385,781 | 35,072 | 62,882 |
Net income (loss) | $ 194,235 | $ (138,061) | $ (84,486) |
Basic net loss per share continuing operations | $ (3.07) | $ (3.02) | $ (2.98) |
Basic net income per share discontinued operations | 6.19 | 0.61 | 1.27 |
Basic net income (loss) per share | 3.12 | (2.41) | (1.71) |
Diluted net loss per share continuing operations | (3.07) | (3.02) | (2.98) |
Diluted net income per share discontinued operations | 6.19 | 0.61 | 1.27 |
Diluted net income (loss) per share | $ 3.12 | $ (2.41) | $ (1.71) |
Weighted-average shares used to compute basic net loss per share (in shares) | 62,344,100 | 57,176,743 | 49,523,444 |
Weighted-average shares used to compute diluted net loss per share (in shares) | 62,344,100 | 57,176,743 | 49,523,444 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member]Cumulative effect adjustment | Additional Paid-in Capital [Member] | Retained Earnings [Member]Cumulative effect adjustment | Retained Earnings [Member] | Cumulative effect adjustment | Total |
Balance at Dec. 31, 2018 | $ 490 | $ 549,479 | $ (650,125) | $ (100,156) | |||
Balance (in shares) at Dec. 31, 2018 | 49,011,684 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock in direct offering, net of offering costs | $ 44 | 54,194 | 54,238 | ||||
Issuance of common stock in direct offering, net of offering costs (in shares) | 4,389,311 | ||||||
Issuance of common stock upon exercise of stock options | $ 8 | 7,590 | 7,598 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 799,815 | ||||||
Stock-based compensation | 13,785 | 13,785 | |||||
Net Income (loss) | (84,486) | (84,486) | |||||
Balance at Dec. 31, 2019 | $ 542 | 625,048 | (734,611) | (109,021) | |||
Balance (in shares) at Dec. 31, 2019 | 54,200,810 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock in direct offering, net of offering costs | $ 69 | 93,606 | 93,675 | ||||
Issuance of common stock in direct offering, net of offering costs (in shares) | 6,900,000 | ||||||
Issuance of common stock upon exercise of stock options | $ 5 | 5,017 | 5,022 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 556,421 | ||||||
Issuance of common stock upon grant of restricted stock awards | 155 | 155 | |||||
Issuance of common stock upon grant of restricted stock awards (in shares) | 14,000 | ||||||
Stock-based compensation | 14,770 | 14,770 | |||||
Purchases of 2026 Capped Calls | (23,223) | (23,223) | |||||
Equity component of 2026 Notes, net of issuance costs | 61,628 | 61,628 | |||||
Equity component of early extinguishment of 2023 Notes | (22,073) | (22,073) | |||||
Termination of the 2023 Capped Call contracts related to debt repurchased | 8,387 | 8,387 | |||||
Income tax benefit related to issuance of 2026 Notes | (12,011) | (12,011) | |||||
Net Income (loss) | (138,061) | (138,061) | |||||
Balance (ASU 2020-06) at Dec. 31, 2020 | $ (70,777) | $ (4,697) | $ (75,474) | ||||
Balance at Dec. 31, 2020 | $ 616 | 751,304 | (872,672) | (120,752) | |||
Balance (in shares) at Dec. 31, 2020 | 61,671,231 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock upon exercise of stock options and warrants | $ 10 | 8,372 | $ 8,382 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 921,023 | ||||||
Issuance of common stock upon exercise of stock options and warrants (in shares) | 945,924 | ||||||
Issuance of common stock upon grant of restricted stock awards | 91 | $ 91 | |||||
Issuance of common stock upon grant of restricted stock awards (in shares) | 11,700 | ||||||
At the market offering costs | (241) | (241) | |||||
Stock-based compensation | 17,539 | 17,539 | |||||
Net Income (loss) | 194,235 | 194,235 | |||||
Balance at Dec. 31, 2021 | $ 626 | $ 706,288 | $ (683,134) | $ 23,780 | |||
Balance (in shares) at Dec. 31, 2021 | 62,628,855 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | |||
Net income (loss) | $ 194,235 | $ (138,061) | $ (84,486) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 17,630 | 14,925 | 13,785 |
Consideration received on sale of OMIDRIA | (310,563) | ||
Non-cash interest expense | 1,696 | 11,649 | 9,232 |
Depreciation and amortization | 1,386 | 1,616 | 1,790 |
Loss on early extinguishment of debt | 13,374 | ||
Deferred income tax | (12,011) | ||
Fair value settlement upon termination of cap call contract | 838 | ||
Changes in operating assets and liabilities: | |||
Receivables | (34,314) | 31,344 | (12,367) |
Prepaid expenses and other assets | 4,900 | (4,024) | (1,310) |
Accounts payable and other expense | 14,640 | (19,736) | 13,283 |
Other liabilities non-current | 668 | ||
Net cash used in operating activities | (109,722) | (100,086) | (60,073) |
Investing activities: | |||
Cash proceeds on sale of OMIDRIA | 125,993 | ||
Purchases of property and equipment | (277) | (283) | (334) |
Purchases of investments | (32,006) | (133,194) | (58,217) |
Proceeds from the sale and maturities of investments | 100,000 | 66,446 | 55,150 |
Net cash provided by (used in) investing activities | 193,710 | (67,031) | (3,401) |
Financing activities: | |||
Proceeds from issuance of convertible senior notes | 225,030 | ||
Payments for debt issuance costs | (6,785) | ||
Purchases of capped calls related to convertible senior notes | (23,223) | ||
Payments for repurchases of convertible senior notes | (125,638) | ||
Proceeds from termination of capped call contracts | 7,549 | ||
Proceeds from issuance of common stock, net | 93,675 | 54,238 | |
Release in restricted investments | 99 | ||
Proceeds upon exercise of stock options and warrants | 8,383 | 5,022 | 7,598 |
At the market offering costs | (241) | ||
Payments on finance lease obligations | (1,823) | (1,195) | (1,139) |
Net cash provided by financing activities | 6,319 | 174,534 | 60,697 |
Net increase (decrease) in cash and cash equivalents | 90,307 | 7,417 | (2,777) |
Cash and cash equivalents at beginning of period | 10,501 | 3,084 | 5,861 |
Cash and cash equivalents at end of period | 100,808 | 10,501 | 3,084 |
Supplemental cash flow information | |||
Cash paid for interest | 17,876 | 11,603 | 13,462 |
Property acquired under finance lease | $ 289 | $ 216 | $ 1,440 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Basis of Presentation | |
Organization and Basis of Presentation | Note 1—Organization and Basis of Presentation General Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders. Our first drug product, OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, is marketed in the United States (the “U.S.”) for use during cataract surgery or intraocular lens replacement. We sold OMIDRIA and related business assets on December 23, 2021. See “Sale of OMIDRIA Assets” below for additional information. Our drug candidate narsoplimab is the subject of a biologics license application (“BLA”) pending before the U.S. Food and Drug Administration (“FDA”) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”). On October 18, 2021, we announced the receipt of a Complete Response Letter (“CRL”) from FDA regarding the BLA. In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval. In February 2022, we had a Type A meeting with FDA to discuss the CRL, including each of the review issues that FDA identified as presenting difficulties interpreting the treatment response in the pivotal trial. We are currently awaiting FDA’s response to our rebuttals to each of those review issues. We continue to believe that our BLA, as submitted, merits approval and that the data meet or exceed the threshold for substantial evidence of effectiveness. We also have multiple late-stage clinical development programs in our pipeline, which are focused on: complement-mediated disorders, including immunoglobulin A (“IgA”) nephropathy, atypical hemolytic uremic syndrome (“aHUS”) and COVID-19. Sale of OMIDRIA Assets On December 23, 2021, we closed on an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Rayner Surgical Inc. (“Rayner”) for the sale of our commercial product OMIDRIA and certain related assets including inventory and prepaid expenses (the “Transaction”). Rayner paid us $126.0 million in cash at closing, and we retained all outstanding accounts receivable, accounts payable and accrued expenses as of the closing date. We will receive a royalty on worldwide sales of OMIDRIA and potentially a $200.0 million milestone payment if separate payment for OMIDRIA is secured in the U.S. for a continuous period of at least four years before January 1, 2025. As a result of the divestiture, the results of OMIDRIA operations (e.g., revenues and operating costs) have been reclassified to discontinued operations in our consolidated statements of operations and comprehensive loss and excluded from continuing operations for all periods presented (See “Note 3 – Discontinued Operations”). Basis of Presentation Our consolidated financial statements include the financial position and results of operations of Omeros and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain prior year amounts in the balance sheet, statement of cash flows and the footnotes have been reclassified in the consolidated financial statements to conform to the current year presentation. Risks and Uncertainties As of December 31, 2021, we had cash, cash equivalents and short-term investments of $157.3 million and outstanding accounts receivable of $38.2 million. Our loss from continuing operations for the year ended December 31, 2021 was $191.5 million. This loss from operations does not include the $80.1 million in earnings from OMIDRIA included in discontinued operations which occurred prior to the sale, a large portion of which we expect to retain through royalties and expense reductions on a go forward basis. We plan to continue to fund our operations for the next twelve months with our existing cash and investments, our current accounts receivable, and OMIDRIA royalties. There is also the potential for us to receive a $200.0 million milestone related to achievement of long-term OMIDRIA separate payment. If FDA approval is granted for narsoplimab for HSCT-TMA within the next twelve months, sales of narsoplimab will also provide funds for our operations . We have a sales agreement to sell shares of our common stock, from time to time, in an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $150.0 million. Should it be determined to be strategically advantageous, we could pursue debt financings as well as public and private offerings of our equity securities, similar to those we have previously completed, or other strategic transactions, which may include licensing a portion of our existing technology. Management believes the assets on hand along with expected royalties received are adequate to finance our operations at least through March 2, 2023. Accordingly, the accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The outbreak of the novel strain of coronavirus that causes COVID-19 and the responses to the global pandemic by various governmental authorities, the medical community and others has had a significant impact on our business. Due to the unknown magnitude, duration, and outcome of the COVID-19 pandemic, it is not possible to estimate precisely the continued impact on our business, operations or financial results; however, the impact has been and could continue to be substantial. Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, OMIDRIA contract royalty asset valuation, stock-based compensation expense, and accruals for clinical trials and manufacturing of drug product. We base our estimates on historical experience and on various other factors, including the impact of the COVID-19 pandemic, that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Significant Accounting Policies | |
Significant Accounting Policies | Note 2—Significant Accounting Policies Discontinued Operations We review the presentation of planned or completed business dispositions in the consolidated financial statements based on the available information and events that have occurred. The review consists of evaluating whether the business meets the definition of a component for which the operations and cash flows are clearly distinguishable from the other components of the business and, if so, whether it is anticipated that after the disposal the cash flows of the component would be eliminated from continuing operations and whether the disposition represents a strategic shift that has a major effect on operations and financial results. Planned or completed business dispositions are presented as discontinued operations when all the criteria described above are met. For those divestitures that qualify as discontinued operations, all comparative periods presented are reclassified in the consolidated balance sheets. Additionally, the results of operations of a discontinued operation are reclassified to income from discontinued operations, net of tax, for all periods presented in the consolidated statements of operations and comprehensive loss. Results of discontinued operations include all revenues and expenses directly derived from such businesses; general corporate overhead is not allocated to discontinued operations. The OMIDRIA asset sale to Rayner qualifies as a discontinued operation and has been presented as such for all reporting periods presented. The Company included information regarding cash flows from discontinued operations (see “Note 3 – Discontinued Operations”). OMIDRIA Royalties and OMIDRIA Contract Royalty Assets Upon the closing of the Transaction, we have rights to receive future royalties from Rayner on OMIDRIA net sales at royalty rates that vary based on geography and certain regulatory contingencies. Therefore, future OMIDRIA royalties are treated as variable consideration. The sale of OMIDRIA qualifies as an asset sale. To measure the OMIDRIA contract royalty asset, we used the expected value approach which is the sum of the discounted probability-weighted royalty payments, net of tax, we would receive using a range of potential outcomes, to the extent that it is probable that a significant reversal in the amount of cumulative income recognized will not occur. Accordingly, the contract royalty asset excludes the achievement of the $200.0 million milestone payment and any foreign royalties to the extent it is probable that a significant reversal in the amount of cumulative income recognized will not occur. Royalties earned will be recorded as a reduction to the OMIDRIA contract royalty asset. The amount recorded in discontinued operations in future periods will reflect interest earned on the outstanding OMIDRIA contract royalty asset and any amounts received received different from the expected royalties recorded at closing. The OMIDRIA contract royalty asset will also be re-measured periodically using the expected value approach based on actual results and future expectations. Any required adjustment to the OMIDRIA contract royalty asset will be recorded into discontinued operations. Cash and Cash Equivalents, Short-Term Investments and Restricted Investments Cash and cash equivalents include highly liquid investments with a maturity of three months or less on the date of purchase. Short-term investment securities are classified as available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported as a separate component of shareholders’ equity. Amortization, accretion, interest, and dividends, realized gains and losses and declines in value judged to be other-than-temporary are included in other income. The cost of securities sold is based on the specific-identification method. Investments in securities with maturities of less than one year, or those for which management intends to use the investments to fund current operations, are included in current assets. We evaluate whether an investment is other-than-temporarily impaired based on the specific facts and circumstances. Factors that are considered in determining whether an other-than-temporary decline in value has occurred include: the market value of the security in relation to its cost basis; the financial condition of the investee; and the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment. Restricted investments held in money-market funds include security deposits held by our landlord. As of December 31, 2021 and 2020, all investments are classified as short-term and available-for-sale. Investment income, which is included as a component of other income, consists primarily of interest earned. Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner that approximates the first-in, first-out (“FIFO’) method. Costs include amounts related to third-party manufacturing, transportation, and internal labor and overhead. Capitalization of costs as inventory begins when regulatory approval of the drug candidate is reasonably assured in the U.S. or the European Union (‘EU”). We expense inventory costs related to drug candidates as research and development expenses prior to receiving regulatory approval in the respective territory. Inventory is reduced to net realizable value for excess and obsolete inventories based on forecasted demand. Inventory with an alternative future use is capitalized. Receivables, Net Receivables relate primarily to sales of OMIDRIA made to wholesalers prior to the sale to Rayner and include reductions for estimated chargebacks and product returns that are expected to be settled through reductions in receivables. Remaining receivables generally consist of amounts from subleases for space in our facilities. Considering the nature and historic collectability of our receivables, we concluded an allowance for doubtful accounts is not necessary as of December 31, 2021 and 2020. Property and Equipment, Net Property and equipment are stated at cost, and depreciation is calculated using the straight-line method over the estimated useful life of the assets, which is generally three Right-of-Use Assets and Related Lease Liabilities We record operating leases as right-of-use assets and recognize the related lease liabilities equal to the fair value of the lease payments using our incremental borrowing rate when the implicit rate in the lease agreement is not readily available. We recognize variable lease payments, when incurred. Costs associated with operating lease assets are recognized on a straight-line basis within operating expenses over the term of the lease. We record finance leases as a component of property and equipment and amortize these assets within operating expenses on a straight-line basis to their residual values over the shorter of the term of the underlying lease or the estimated useful life of the equipment. The interest component of a finance lease is included in interest expense and recognized using the effective interest method over the lease term. We account for leases with initial terms of 12 months or less as operating expenses on a straight-line basis over the lease term. Unsecured Convertible Senior Notes On January 1, 2021, we adopted Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion Options and Derivatives and Hedging—Contracts in Entity’s Own Equity 06 Transactions involving contemporaneous exchanges of cash between the same debtor and creditor in connection with the issuance of a new debt obligation and satisfaction of an existing debt obligation by the debtor are evaluated as a modification or an exchange transaction depending on whether the exchange is determined to have substantially different terms. The 6.25% Convertible Senior Notes (the “2023 Notes”) repurchase and issuance of the 5.25 % Convertible Senior Notes (“2026 Notes”) were deemed to have substantially different terms due to the significant difference between the value of the conversion option immediately prior to and after the exchange. Therefore, the repurchase of the 2023 Notes was accounted for as a debt extinguishment. (See “Note 9 – Unsecured Convertible Senior Debt”). Impairment of Long-Lived Assets We assess the impairment of long-lived assets, primarily property and equipment, whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability of these assets is measured by comparing the carrying value to future undiscounted cash flows that the asset is expected to generate. If the asset is impaired, the amount of any impairment will be reflected in the results of operations in the period of impairment. We have not recognized any impairment losses for the years ended December 31, 2021, 2020 and 2019. Revenue Recognition When we enter into a customer contract, we perform the following five steps: (i) identify the contract 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) we satisfy a performance obligation. Product Sales, Net We generally record revenue from product sales when the product is delivered to our wholesalers and title for the product is transferred. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability depending on how the amount is expected to be settled. Chargebacks and Rebates Provisions for chargebacks are determined utilizing historical and projected payer mix and information regarding sell-through and inventory on-hand received directly from wholesalers. Chargebacks are generally settled within four We provide reimbursement support services and financial assistance in the form of a rebate to patients whose commercial insurance is inadequate to cover the full cost of our drug product. We apply an experience ratio based on historical and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and is being reviewed and updated periodically to reflect actual results. Distribution Fees and Product Return Allowances We pay our wholesalers a distribution fee for services that they perform for us based on the wholesaler average cost value of their purchases. We record a provision against product sales for these charges at the time of sale to the wholesaler. We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the health care providers based on the frequency of their reorders. Research and Development Research and development expenses are comprised primarily of contracted research and manufacturing costs prior to approval; costs for personnel, including salaries, benefits and stock compensation; clinical study costs; contracted research; manufacturing costs prior to approval; consulting services; depreciation; materials and supplies; milestones; an allocation of our occupancy costs; and other expenses incurred to sustain our overall research and development programs. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and then recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. All other research and development costs are expensed as incurred. Selling, General and Administrative Selling, general and administrative expenses are comprised primarily of salaries, benefits, and stock-compensation costs for sales, marketing, and other personnel not directly engaged in research and development. Additionally, selling, general and administrative expenses include marketing and selling expenses, professional and legal services; patent costs; depreciation, an allocation of our occupancy costs; and other general corporate expenses. Advertising costs, which we consider to be media and marketing materials, are expensed as incurred and were $7.8 million, $5.6 million and $8.0 million during the years ended December 31, 2021, 2020 and 2019, respectively. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized. Stock-Based Compensation Stock-based compensation expense is recognized for all share-based payments based on estimated fair values. The fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental assumptions around volatility, forfeiture rates and expected option term. Compensation expense is recognized over the optionees’ requisite service periods, which is generally the vesting period, using the straight-line method. Forfeiture expense is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of net loss and certain changes in equity that are excluded from net loss. There was no difference between comprehensive loss and net loss for the years ended December 31, 2021, 2020 or 2019. Financial Instruments and Concentrations of Credit Risk Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of short-term investments is based on quoted market prices. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, our cash and cash equivalents balance held at a financial institution may exceeds the federally insured limits. To limit the credit risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and commercial paper. Major Customers Prior to the sale of OMIDRIA to Rayner, we sold OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2021, 2020 and 2019 and greater than 10% of accounts receivable as of December 31, 2021, 2020 and 2019 as noted below. 2021 2020 2019 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 20 % 16 % 25 % 36 % 25 % 23 % Distributor B 24 % 20 % 26 % 31 % 24 % 19 % Distributor C 40 % 46 % 32 % 10 % 29 % 33 % Distributor D 16 % 18 % 17 % 23 % 22 % 25 % |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations | |
Discontinued Operations | Note 3—Discontinued Operations On December 23, 2021, we closed an Asset and Purchase Agreement for the sale of OMIDRIA and certain related assets including inventory and prepaid expenses. We retained the outstanding accounts receivable and all outstanding liabilities related to OMIDRIA as of the closing date. Upon closing, we received an up-front cash payment of $126.0 million. We will also receive a 50% royalty on OMIDRIA net sales in the U.S. between December 23, 2021 and the earlier of January 1, 2025 or the payment of the $200.0 million milestone described below. After such date, we will receive a 30% royalty on OMIDRIA net sales in the U.S. (the “U.S. base royalty rate”) until the expiration or termination of the last issued and unexpired U.S. patent. The U.S. base royalty rate is reduced to 10% upon the occurrence of certain events described in the Asset Purchase Agreement, including during any specific period in which OMIDRIA is no longer eligible for separate payment. We will also receive a royalty of 15% on OMIDRIA net sales outside the U.S. on a country-by-country basis between the closing date and the expiration or termination of the last issued and unexpired OMIDRIA patent in such country. We will receive a $200.0 million milestone payment if, prior to January 1, 2025, separate payment for OMIDRIA is secured in the U.S. for a continuous period of at least four years. The sale of OMIDRIA was recorded as an asset sale and all comparative periods presented are required to be reclassified in the consolidated balance sheets. Additionally, the results of operations for OMIDRIA are reclassified to income from discontinued operations for all periods presented in the consolidated statements of operations and comprehensive loss. Net income from discontinued operations, net of tax is as follows: Year Ended December 31, 2021 2020 2019 (In thousands) Product sales, net $ 110,735 $ 73,813 $ 111,805 Royalty income 1,035 — — OMIDRIA income 111,770 73,813 111,805 Costs and expenses: Cost of product sales 1,364 902 865 Research and development 3,839 3,205 3,372 Selling, general and administrative 25,428 23,389 24,912 Total costs and expenses 30,631 27,496 29,149 Income before income tax expense 81,139 46,317 82,656 Income tax expense (1,006) (11,245) (19,774) Net income from discontinued operations, net of tax 80,133 35,072 62,882 Gain on sale of OMIDRIA, net 305,648 — — Net income from discontinued operations, net of tax $ 385,781 $ 35,072 $ 62,882 The gain on the sale of OMIDRIA included in discontinued operations for the year ended December 31, 2021 is as follows: (In thousands) Cash proceeds $ 125,993 OMIDRIA contract royalty asset 184,570 Gain on sale of OMIDRIA, gross 310,563 Transaction and closing costs (1,972) Restricted Stock Units ("RSUs") granted to transferred employees (1,419) Prepaid assets and inventory at cost (1,524) Gain on sale of OMIDRIA, net $ 305,648 Cash flow from discontinued operations is as follows: Year Ended December 31, 2021 2020 2019 (In thousands) Total operating cash flows from discontinued operations $ 56,344 $ 25,888 $ (11,886) Total investing cash flows from discontinued operations $ 125,993 $ — $ — |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | Note 4—Net Loss Per Share Our potentially dilutive securities include potential common shares related to our stock options, warrants, restricted stock units and unsecured convertible senior notes. Diluted earnings per share (“Diluted EPS”) considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would have an anti-dilutive effect. Diluted EPS excludes the impact of potential common shares related to our stock options in periods in which the option exercise price is greater than the average market price of our common stock for the period. Potentially dilutive securities excluded from Diluted EPS are as follows: Year Ended December 31, 2021 2020 2019 2023 Notes convertible to common stock (1) 4,941,739 7,932,791 10,923,843 Outstanding options to purchase common stock 1,707,371 1,585,332 2,664,841 Outstanding restricted stock units 2,642 — — Outstanding warrants to purchase common stock — 10,792 16,153 Total potentially dilutive shares excluded from loss per share 6,651,752 9,528,915 13,604,837 (1) The 2023 Notes are subject to a capped call arrangement that potentially reduces the dilutive effect as described in “Note 9 — Unsecured Convertible Senior Notes”. Any potential impact of the capped call arrangement is excluded from this table. |
Accounts Receivable, Net
Accounts Receivable, Net | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Receivable, Net. | |
Accounts Receivable, Net | Note 5—Accounts Receivable, Net Accounts receivable, net consists of the following: December 31, December 31, 2021 2020 (In thousands) Trade receivables, net $ 36,505 $ 3,771 Sublease and other receivables 1,650 70 Total accounts receivables, net $ 38,155 $ 3,841 Trade receivables are shown net of $2.0 million and $1.2 million of chargeback and product return allowances as of December 31, 2021 and 2020, respectively. |
Fair-Value Measurements
Fair-Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair-Value Measurements | |
Fair-Value Measurements | Note 6—Fair-Value Measurements As of December 31, 2021 and 2020, all investments were classified as short-term and available-for-sale. Investment income, which was included as a component of other income, consists of interest earned. On a recurring basis, we measure certain financial assets at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required: Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets; Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our fair-value hierarchy for our financial assets measured at fair value on a recurring basis are as follows: December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 56,458 $ — $ — $ 56,458 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 57,512 $ — $ — $ 57,512 December 31, 2020 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 124,452 $ — $ — $ 124,452 Money-market funds classified as non-current restricted investments 1,055 — — 1,055 Total $ 125,507 $ — $ — $ 125,507 Cash held in demand deposit accounts of $100.8 million and $10.5 million is excluded from our fair-value hierarchy disclosure as of December 31, 2021 and 2020, respectively. There were no unrealized gains or losses associated with our short-term investments as of December 31, 2021 or 2020. The carrying amounts for receivables, accounts payable and accrued liabilities, and other current monetary assets and liabilities, including lease financing obligations, approximate fair value. See “Note 9--Unsecured Convertible Senior Notes” for the carrying amount and estimated fair value of our 5.25% Convertible Senior Notes due 2026 and 6.25% Convertible Senior Notes due 2023. |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2021 | |
Certain Balance Sheet Accounts | |
Certain Balance Sheet Accounts | Note 7—Certain Balance Sheet Accounts Property and Equipment, Net Property and equipment, net consists of the following: December 31, December 31, 2021 2020 (In thousands) Finance leases $ 5,979 $ 5,690 Laboratory equipment 3,091 2,898 Computer equipment 1,069 985 Office equipment and furniture 625 625 Total cost 10,764 10,198 Less accumulated depreciation and amortization (9,033) (7,647) Total property and equipment, net $ 1,731 $ 2,551 For the years ended December 31, 2021, 2020 and 2019, depreciation and amortization expenses were $1.4 million, $1.6 million and $1.8 million, respectively. Accrued Expenses Accrued expenses consist of the following: December 31, December 31, 2021 2020 (In thousands) Sales rebates, fees and discounts $ 8,442 $ 3,326 Consulting and professional fees 7,455 5,393 Interest payable 5,172 5,205 Contract research and development 3,916 7,952 Employee compensation 3,706 3,948 Clinical trials 2,430 2,121 Other accrued expenses 2,013 810 Total accrued expenses $ 33,134 $ 28,755 |
Line of Credit
Line of Credit | 12 Months Ended |
Dec. 31, 2021 | |
Line of Credit | |
Line of Credit | Note 8—Line of Credit We have a Loan and Security Agreement with Silicon Valley Bank (“SVB”), which provides for a $50.0 million revolving line of credit facility (the “Line of Credit Agreement”). The Line of Credit Agreement is secured by all our assets excluding intellectual property and development program inventories and matures in August 2022. In connection with the execution of the Asset Purchase Agreement, on December 1, 2021 the Company and SVB entered into a Consent and Second Amendment to the Line of Credit Agreement, under which SVB provided its consent to the Transaction and release of liens with respect to the transferred assets. In addition, the amendment revised the original Line of Credit Agreement to provide that the borrowing base will include 85% of eligible monthly royalty payments, including those from the Rayner and its affiliates, less applicable discounts, credits and other offsets. Interest on amounts outstanding is payable monthly at a floating rate equal to the greater of 5.50% and the prime rate per annum. If the Line of Credit Agreement is terminated prior to the maturity date for any reason other than replacement with a new SVB credit facility or a new syndicated facility in which SVB acts as the agent, we are required to pay a termination fee of $1.0 million. We paid an initial commitment fee of $150,000 upon closing and have paid additional commitment fees of $150,000 on each of the first and second anniversaries of the closing date. The Line of Credit Agreement includes customary events of default that include, among other things, breach, non-payment, inaccuracy of representations and warranties, the occurrence of a material adverse change in our business or prospects for repayment of the Line of Credit Agreement, cross default to material indebtedness or material agreements, bankruptcy and insolvency, material judgments and a change in control. In the event of default, SVB may require all obligations under the Line of Credit Agreement to be immediately due and payable and charge a default rate of interest thereon. As of December 31, 2021 and 2020, we had no outstanding borrowings under the Line of Credit Agreement. |
Unsecured Convertible Senior No
Unsecured Convertible Senior Notes | 12 Months Ended |
Dec. 31, 2021 | |
Unsecured Convertible Senior Notes | |
Unsecured Convertible Senior Notes | Note 9—Unsecured Convertible Senior Notes On January 1, 2021, we adopted ASU 2020-06, Debt—Debt with Conversion Options and Derivatives and Hedging—Contracts in Entity’s Own Equity 06 In November 2018, we issued $210.0 million in aggregate principal amount on our 2023 Notes, and in August and September 2020, we issued an aggregate principal amount of $225.0 million on our 2026 Notes. We used a portion of the proceeds from the 2026 Notes to repurchase $115.0 million principal amount of the 2023 Notes and terminate a corresponding portion of the related capped call. Unsecured convertible senior notes outstanding at December 31, 2021 and 2020, respectively, are as follows: Balance as of December 31, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (1,282) (5,290) (6,572) Total unsecured convertible senior notes, net $ 93,718 $ 219,740 $ 313,458 Fair value of outstanding unsecured convertible senior notes (1) $ 87,163 $ 171,867 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ — $ — Balance as of December 31, 2020 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized discount (17,101) (60,544) (77,645) Unamortized issuance costs attributable to liability component (1,481) (4,616) (6,097) Total unsecured convertible senior notes, net $ 76,418 $ 159,870 $ 236,288 Fair value of outstanding unsecured convertible senior notes (1) $ 101,769 $ 246,779 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ 6,769 $ 21,749 Equity component $ 25,854 $ 63,544 Unamortized issuance costs (837) (1,916) Net carrying amount of equity component (2) $ 25,017 $ 61,628 (1) The fair value is classified as Level 3 due to the limited trading activity for the unsecured convertible senior notes. (2) Included in the consolidated balance sheet within additional paid-in capital. 2023 Convertible Senior Notes In November 2018, we issued $210.0 million in aggregate principal amount on our 2023 Notes. The 2023 Notes are unsecured and accrue interest at an annual rate of 6.25% per annum, payable semi-annually in arrears on May 15 and November 15 of each year. The 2023 Notes mature on November 15, 2023 unless earlier purchased, redeemed or converted in accordance with their terms. The 2023 Notes are convertible into cash, shares of our common stock or a combination thereof, as we elect at our sole discretion. The initial conversion rate is 52.0183 shares of our common stock per $1,000 of note principal (equivalent to an initial conversion price of approximately $19.22 per share of common stock), subject to adjustment in certain circumstances. To reduce the dilutive impact or potential cash expenditure associated with conversion of the 2023 Notes, we entered into a capped call transaction (the 2023 Capped Call), which essentially covers the number of shares of our common stock underlying the 2023 Notes when our common stock is trading between the initial conversion price of $19.22 per share and $28.84 per share. However, should the market price of our common stock exceed the $28.84 cap, then the conversion of the 2023 Notes would have an additional dilutive impact or may require a cash expenditure to the extent the market price exceeds the cap price. In August and September 2020, we issued the 2026 Notes and used approximately $125.6 million of the net proceeds to repurchase $115.0 million principal amount of the 2023 Notes (see “2026 Convertible Senior Notes” below). The settlement consideration was allocated between the repurchase of the liability and the equity component with the fair value of the liability component estimated to be $103.6 million based on the expected future cash flows associated with the $115.0 million principal amount discounted at a 9.9% effective interest rate. The remaining $22.0 million was accounted for as a repurchase of the equity component, reducing additional paid-in capital. As of the repurchase date of August 14, 2020, the carrying value of the repurchased 2023 Notes, net of unamortized debt discount and issuance costs, was $90.2 million. The difference between the $103.6 million fair value of the 2023 Notes repurchased and the carrying value of $90.2 million resulted in a $13.4 million loss on early extinguishment of debt. After giving effect to the repurchase, the total principal amount outstanding under the 2023 Notes as of August 14, 2020 was $95.0 million. In connection with the repurchase of $115.0 million in principal amount of the 2023 Notes, we terminated a proportionate amount of the related 2023 Capped Call for approximately 6.0 million underlying shares. Upon settlement, the Company received $7.5 million in cash and recorded a $0.8 million loss due to the change in fair value of the contract between signing and settlement dates. The proceeds were recorded as cash with a corresponding increase in additional paid-in capital, and the loss was recorded to other expense in the consolidated statements of operations and comprehensive loss. As of December 31, 2020, approximately 4.9 million shares remained outstanding on the 2023 Capped Call. The following table sets forth total interest expense recognized in connection with the 2023 Notes: Year Ended December 31, 2021 2020 2019 (In thousands) Contractual interest expense $ 5,938 $ 10,410 $ 13,089 Amortization of debt issuance costs 618 669 8,496 Amortization of debt discount — 7,728 736 Total $ 6,556 $ 18,807 $ 22,321 2026 Convertible Senior Notes In August and September 2020, we issued $225.0 million aggregate principal amount on our 2026 Notes. The issuance of the 2026 Notes and use of proceeds are as follows: (In thousands) 2026 Notes principal amount issued $ 225,030 Repurchase of 2023 Notes (125,638) Purchase of 2026 Capped Call (23,223) Termination of the 2023 Capped Call contracts related to debt repurchased 7,549 Issuance costs (6,785) Net proceeds available for corporate use $ 76,933 The 2026 Notes are unsecured and accrue interest at an annual rate of 5.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. The 2026 Notes mature on February 15, 2026, unless earlier purchased, redeemed or converted in accordance with their terms. The initial conversion rate is 54.0906 shares of our common stock per $1,000 of note principal (equivalent to an initial conversion price of approximately $18.4875 per share of common stock), which equals approximately 12.2 million shares issuable upon conversion, subject to adjustment in certain circumstances. The 2026 Notes are convertible at the option of the holders on or after November 15, 2025 at any time prior to the close of business on February 12, 2026, the second scheduled trading day immediately before the stated maturity date of February 15, 2026. Additionally, holders may convert their 2026 Notes at their option at specified times prior to the maturity date only if: (1) during any calendar quarter, beginning after September 30, 2020, that the last reported sale price per share of our common stock exceeds 130% of the conversion price of the 2026 Notes for each of at least 20 trading days in the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five -consecutive-trading-day period (such five -consecutive-trading-day period, the “measurement period”) in which the trading price per $1,000 principal amount of 2026 Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and the conversion rate on such trading day; (3) there is an occurrence of one or more certain corporate events or distributions of our common stock; or (4) we call the 2026 Notes for redemption. We may elect, at our sole discretion, to convert the 2026 Notes into cash, shares of our common stock or a combination thereof. Subject to the satisfaction of certain conditions, we may redeem in whole or in part the 2026 Notes at our option beginning August 15, 2023 through the 50th scheduled trading day immediately before the maturity date at a cash redemption price equal to the principal amount of the 2026 Notes to be redeemed plus any accrued and unpaid interest to, but excluding, the redemption date. The 2026 Notes are subject to redemption only if certain requirements are satisfied, including that the last reported sale price per share of our common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we send the related redemption notice and (ii) the trading day immediately before the date we send such notice. In order to reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2026 Notes, we entered into capped call transactions in connection with the issuances of the 2026 Notes (the 2026 Capped Call). The 2026 Capped Call will cover, subject to anti-dilution adjustments substantially similar to those applicable to the 2026 Notes, the number of shares of common stock underlying the 2026 Notes when our common stock is trading within the range of approximately $18.49 and $26.10 . However, should the market price of our common stock exceed the $26.10 cap, then the conversion of the 2026 Notes would have an additional dilutive impact or may require a cash expenditure to the extent the market price exceeds the cap price. The 2026 Capped Call will expire on various dates over the 50 -trading-day period ranging from December 2, 2025 to February 12, 2026, if not exercised earlier. The 2026 Capped Call is a separate transaction and not part of the terms of the 2026 Notes and was executed separately from the issuance of the 2026 Notes. The amount paid for the 2026 Capped Call was recorded as a reduction to additional paid-in capital in the condensed consolidated balance sheet. As of December 31, 2021, approximately 12.2 million shares remained outstanding under the 2026 Capped Call. We evaluated the accounting for the issuance of the 2026 Notes and concluded that the embedded conversion features meet the requirements for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet, and that the cash conversion guidance applies. Therefore, proceeds of $225.0 million are allocated first to the liability component based on the fair value of non-convertible debt with the residual proceeds allocated to the equity component for the conversion features. The Company allocated $6.8 million in issuance costs associated with the 2026 Notes to the liability and equity component in the same proportion as the $225.0 million in proceeds. Further, we concluded the 2026 Capped Call qualifies for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet. Consequently, the fair value of the 2026 Capped Call of $23.2 million is classified as equity, not accounted for as derivatives, and will not be subsequently remeasured. In accounting for the issuance of the 2026 Notes, we separated the 2026 Notes into liability and equity components, using an effective interest rate of 12.5% to determine the fair value of the liability component. The following table sets forth interest expense recognized related to the 2026 Notes: Year Ended December 31, 2021 2020 2019 (In thousands) Contractual interest expense $ 11,814 $ 4,397 $ — Amortization of debt issuance costs 1,078 230 — Amortization of debt discount — 3,022 — Total $ 12,892 $ 7,649 $ — Future minimum principal for the 2023 and 2026 Notes as of December 31, 2021 are as follows: (In thousands) 2022 $ — 2023 95,000 2024 — 2025 — 2026 225,030 Total future minimum principal payments under the convertible senior notes $ 320,030 |
Leases Liabilities
Leases Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | Note 10—Lease Liabilities We have operating leases related to our office and laboratory space. The initial term of the leases is through November 2027 and we have two options to extend the lease term, each by five years. We have finance leases for certain laboratory and office equipment that have lease terms expiring through March 2025. Lease-related assets and liabilities recorded on the balance sheet are as follows: December 31, December 31, 2021 2020 (In thousands) Assets Operating lease assets $ 28,276 $ 25,526 Finance lease assets, net 1,009 1,822 Total lease assets $ 29,285 $ 27,348 Liabilities Current: Operating leases $ 4,607 $ 2,740 Finance leases 648 1,042 Non-current: Operating leases 28,811 28,032 Finance leases 315 738 Total lease liabilities $ 34,381 $ 32,552 Weighted-average remaining lease term Operating leases 5.9 years 6.8 years Finance leases 1.7 years 1.9 years Weighted-average discount rate Operating leases 12.81 % 12.85 % Finance leases 12.70 % 11.85 % The components of total lease costs are as follows: Year Ended December 31, 2021 2020 (In thousands) Lease cost Operating lease cost $ 7,364 $ 6,055 Finance lease cost: Amortization 1,102 1,367 Interest 181 295 Variable lease cost 3,519 2,893 Sublease income (1,776) (1,300) Net lease cost $ 10,390 $ 9,310 The supplemental cash flow information related to leases during 2021 is as follows: Year Ended December 31, 2021 2020 (In thousands) Cash paid for amounts included in the measurement of lease liabilities Cash payments for operating leases $ 10,162 $ 10,103 Cash payments for financing leases $ 1,171 $ 1,490 The future maturities of our lease liabilities as of December 31, 2021 are as follows: Operating Finance Leases Leases (In thousands) 2022 $ 7,118 $ 702 2023 7,276 274 2024 7,438 71 2025 7,508 — 2026 7,302 — Thereafter 6,264 — Total undiscounted lease payments 42,906 1,047 Less interest (9,488) (84) Total lease liabilities $ 33,418 $ 963 In January 14, 2022, we entered into an agreement with our landlord to early terminate a portion of the rentable square footage of our office and lab premises. Effective December 31, 2021, the square footage was reduced by 13,904 square feet. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 11—Commitments and Contingencies Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $32.0 million as of December 31, 2021 if we cancel the work within specific time frames, either prior to commencing or during performance of the contracted services. Development Milestones and Product Royalties We have licensed a variety of intellectual property from third parties that we are currently developing or may develop in the future. These licenses may require milestone payments during the clinical development processes or upon approval of commercial sale as well as low single to low double-digit royalties on the net income or net sales of the product. For the years ended December 31, 2021 and December 31, 2020, we paid $0.5 million and $5.5 million in technology access fees. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Shareholders' Deficit | |
Shareholders' Deficit | Note 12—Shareholders’ Equity Common Stock As of December 31, 2021, we had reserved shares of common stock under our equity plans as follows: Options granted and outstanding 12,709,887 Restricted stock units granted and outstanding 222,000 Common stock warrants 200,000 Awards available under issuance under the 2017 Plan 6,046,652 Total shares reserved 19,178,539 Securities Offerings In December 2019, we sold 4.4 million shares of our common stock at a public offering price of $13.10 per share. After deducting underwriter discounts and offering expense, we received net proceeds from the transaction of $54.2 million. At the Market Sales Agreement Warrants In connection with various previously outstanding debt agreements we have issued warrants to purchase shares of our common stock as follows: Outstanding At December 31, 2021 Expiration Date Exercise Price 200,000 April 12, 2023 $ 23.00 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation. | |
Stock-Based Compensation | Note 13—Stock-Based Compensation Our equity plans provide for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, performance units, performance shares and other stock and cash awards to employees, directors and consultants. Stock options are granted with an exercise price not less than the fair market value of Omeros’ common stock on the date of the grant. Any unexercised options expire 10 years from grant date, and any unvested stock options granted which are subsequently canceled become available for future reissuance. Vesting schedules for our equity plans generally are as follows: Grant Type Vesting Schedule Employee initial options grants 25% at one-year anniversary, 1/48 Employee recurring options grants 1/48 Board member initial options grants 33+% per year for 3 years Board member recurring options grants 100% after one year Non-employee consultant options grants 1/12 1/48 Employee RSUs 50% after one year, 50% after two years In November 2020, restricted stock awards (“RSA’s”) totaling 14,000 shares with a fair value of $11.05 per share were granted to OMIDRIA sales employees. The awards vested immediately upon grant. In November 2021, RSA’s totaling 11,700 shares with a fair value of $7.80 per share were granted to OMIDRIA sales employees. The awards vested immediately upon grant. In December 2021, the Company granted 222,000 shares of RSUs with a fair value of $7.53 per share to employees of the Company who accepted offers to transition to Rayner after December 31, 2021. Stock-based compensation expense is as follows: Year Ended December 31, 2021 2020 2019 (In thousands) Continuing operations Research and development $ 6,791 $ 6,163 $ 6,008 Selling, general and administrative 8,154 7,614 6,959 Total stock-based compensation in continuing operations 14,945 13,777 12,967 Discontinued operations 2,685 1,148 818 Total Stock-based compensation $ 17,630 $ 14,925 $ 13,785 The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to stock option grants during the periods ended: Year Ended December 31, 2021 2020 2019 Estimated weighted-average fair value $ 10.54 $ 8.19 $ 9.93 Weighted-average assumptions: Expected volatility 81 % 77 % 80 % Expected life, in years 6.0 6.0 6.0 Risk-free interest rate 1.06 % 1.06 % 2.41 % Expected dividend yield — % — % — % Expected volatility is based on the historical volatility of our stock price weighted by grant issuances over the reporting period. We use the simplified method to calculate expected life used in the valuation of our stock options. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. Forfeiture expense is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. Stock option activity for all stock plans is as follows: Weighted- Average Aggregate Exercise Remaining Intrinsic Options Price per Contractual Life Value Outstanding Share (In years) (In thousands) Balance at December 31, 2020 11,938,528 $ 11.92 Granted 2,525,525 15.34 Exercised (921,023) 9.10 Forfeited (833,143) 14.85 Balance at December 31, 2021 12,709,887 $ 12.61 5.6 $ 261 Vested and expected to vest at December 31, 2021 12,348,044 $ 12.56 5.5 $ 261 Exercisable at December 31, 2021 9,295,395 $ 12.00 4.5 $ 261 The total intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019 was $7.8 million, $5.6 million and $5.4 million, respectively. At December 31, 2021, there were 3.4 million unvested options outstanding that vest over a weighted-average period of 2.6 years. The remaining estimated compensation expense to be recognized in connection with these unvested options is $27.7 million. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | Note 14—Income Taxes The components of income tax benefit from continuing operations are as follows: December 31, 2021 2020 2019 (In thousands) Current income tax expense: Federal $ — $ — $ — State — — — Total current income tax expense — — — Deferred income tax expense (benefit) Federal — (19,472) (16,716) State — (3,784) (3,058) Total deferred income tax expense (benefit) — (23,256) (19,774) Income tax expense (benefit) $ — $ (23,256) $ (19,774) In December 2019, the Financial Accounting Standards Board issued ASU 2019-12, Income Taxes (Topic 740), which is intended to simplify various aspects of the income tax accounting guidance. ASU 2019-12 eliminates the exception to the incremental approach of intra-period tax allocation when there is a loss from continuing operations and income or gain from other items. As the Company prospectively adopted ASU 2019-12 January 1, 2021, we did not apply any intraperiod allocation rules to 2021. To reflect intra-period tax allocation rules in prior years, we reclassified the tax benefit of income from discontinued operations to offset losses from continuing operations. During 2020, we recorded an income tax benefit of $23.3 million comprising $12.0 million related to the issuance of our 2026 and 2023 Notes, and an additional $11.2 million income tax benefit related to the sale of OMIDRIA assets to Rayner into income from continuing operations. During 2019, we recorded Under intraperiod allocation rules, the deferred tax liability related to the convertible debt and income earned from the sale of assets to Rayner, is a source of income that can be used to recognize the tax benefit of the current year loss through continuing operations. Deferred income taxes reflect the tax effect of net operating loss and tax credit carryforwards and the net temporary difference between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. For the year ended December 31, 2021, we recorded state income tax expense of $1.0 million as a component of net income from discontinued operations, net of tax related to the sale of OMIDRIA to Rayner which could not be offset by net operating losses and tax credit carryforwards. The our consolidated balance sheet as of December 31, 2021 and $0.7 million of deferred income tax liability is included in the table below. Significant components of deferred income taxes are as follows: December 31, 2021 2020 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 143,657 $ 149,993 Research and development tax credits 66,612 56,103 Stock-based compensation 11,327 10,586 Lease liability 9,995 8,646 Disallowed interest expense — 11,859 Other 17,862 7,411 Total deferred tax assets 249,453 244,598 Deferred tax liabilities: Property and equipment (102) (113) Gain on discontinued operations (42,212) — Equity component of Convertible Notes — (18,302) Right of use assets (6,467) (6,197) Total deferred tax liabilities (48,781) (24,612) Net deferred tax assets before valuation allowance 200,672 219,986 Less valuation allowance (201,340) (219,986) Net deferred tax liabilities $ (668) $ — Net deferred tax liabilities are are included as other accrued liabilities – noncurrent in our consolidated balance sheet as of December 31, 2021. As of December 31, 2021 and 2020, we had federal net operating loss carryforwards of approximately $630.6 million and $658.8 million, respectively, and state net operating losses of approximately $245.1 million and $257.1 million, respectively. In certain circumstances, due to ownership changes, our net operating loss and tax credit carryforwards may be subject to limitations under Section 382 of the Internal Revenue Code. To date, we have not completed a Section 382 study. Unless previously utilized, net operating losses of $407.7 million generated prior to 2018 will expire between 2032 and 2037. The net operating loss of $251.5 million generated after 2018 should carryforward indefinitely. Unless previously utilized, research and development tax credit carryforward will expire between 2022 and 2041. We have established a 100% valuation allowance due to the uncertainty of our ability to generate sufficient taxable income to realize the deferred tax assets. During 2021, our valuation allowance decreased $19.3 million due to utilizing NOLs to offset our income from discontinued operations. During 2020 our valuation allowance increased $37.8 million primarily due to incurring net operating losses during these periods. Reconciliation of income tax computed at federal statutory rates to the reported provisions for income taxes on continuing operations is as follows: Year ended December 31, 2021 2020 2019 U.S. Federal statutory rate on net loss (21.0) % (21.0) % (21.0) % State tax, net of federal tax benefit (1.6) % (3.1) % (2.8) % Change in valuation allowance 27.9 % 19.3 % 14.3 % Tax credits (5.5) % (6.2) % (3.0) % Other 0.2 % (0.8) % 0.7 % Effective tax rate (0.0) % (11.8) % (11.8) % We file federal and certain state income tax returns, which provides varying statutes of limitations on assessments. However, because of net operating loss carryforwards, substantially all our tax years remain open to federal and state tax examination. We recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense. To date, there have been no interest or penalties charged to us in relation to the underpayment of income taxes. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted and signed into law in response to COVID-19. The CARES Act, among other things, includes several significant provisions which impact corporate taxpayers' accounting for income taxes, including a modification to the utilization of net operating losses and interest expense deduction limitations. The provisions of the CARES Act do not impact our tax provision. |
401k Retirement Plan
401k Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
401(k) Retirement Plan | |
401(k) Retirement Plan | Note 15—401(k) Retirement Plan Our 401(k) retirement plan provides for an annual company discretionary match on employee contributions up to 4.0% of each participating employee’s eligible earnings, with a maximum company match of $4,000 per employee per year. All employees are eligible to participate. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation Our consolidated financial statements include the financial position and results of operations of Omeros and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain prior year amounts in the balance sheet, statement of cash flows and the footnotes have been reclassified in the consolidated financial statements to conform to the current year presentation. |
Risks and Uncertainties | Risks and Uncertainties As of December 31, 2021, we had cash, cash equivalents and short-term investments of $157.3 million and outstanding accounts receivable of $38.2 million. Our loss from continuing operations for the year ended December 31, 2021 was $191.5 million. This loss from operations does not include the $80.1 million in earnings from OMIDRIA included in discontinued operations which occurred prior to the sale, a large portion of which we expect to retain through royalties and expense reductions on a go forward basis. We plan to continue to fund our operations for the next twelve months with our existing cash and investments, our current accounts receivable, and OMIDRIA royalties. There is also the potential for us to receive a $200.0 million milestone related to achievement of long-term OMIDRIA separate payment. If FDA approval is granted for narsoplimab for HSCT-TMA within the next twelve months, sales of narsoplimab will also provide funds for our operations . We have a sales agreement to sell shares of our common stock, from time to time, in an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $150.0 million. Should it be determined to be strategically advantageous, we could pursue debt financings as well as public and private offerings of our equity securities, similar to those we have previously completed, or other strategic transactions, which may include licensing a portion of our existing technology. Management believes the assets on hand along with expected royalties received are adequate to finance our operations at least through March 2, 2023. Accordingly, the accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The outbreak of the novel strain of coronavirus that causes COVID-19 and the responses to the global pandemic by various governmental authorities, the medical community and others has had a significant impact on our business. Due to the unknown magnitude, duration, and outcome of the COVID-19 pandemic, it is not possible to estimate precisely the continued impact on our business, operations or financial results; however, the impact has been and could continue to be substantial. |
Segments | Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, OMIDRIA contract royalty asset valuation, stock-based compensation expense, and accruals for clinical trials and manufacturing of drug product. We base our estimates on historical experience and on various other factors, including the impact of the COVID-19 pandemic, that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. |
Discontinued Operations | Discontinued Operations We review the presentation of planned or completed business dispositions in the consolidated financial statements based on the available information and events that have occurred. The review consists of evaluating whether the business meets the definition of a component for which the operations and cash flows are clearly distinguishable from the other components of the business and, if so, whether it is anticipated that after the disposal the cash flows of the component would be eliminated from continuing operations and whether the disposition represents a strategic shift that has a major effect on operations and financial results. Planned or completed business dispositions are presented as discontinued operations when all the criteria described above are met. For those divestitures that qualify as discontinued operations, all comparative periods presented are reclassified in the consolidated balance sheets. Additionally, the results of operations of a discontinued operation are reclassified to income from discontinued operations, net of tax, for all periods presented in the consolidated statements of operations and comprehensive loss. Results of discontinued operations include all revenues and expenses directly derived from such businesses; general corporate overhead is not allocated to discontinued operations. The OMIDRIA asset sale to Rayner qualifies as a discontinued operation and has been presented as such for all reporting periods presented. The Company included information regarding cash flows from discontinued operations (see “Note 3 – Discontinued Operations”). |
OMIDRIA Royalties and OMIDRIA Contract Royalty Assets | OMIDRIA Royalties and OMIDRIA Contract Royalty Assets Upon the closing of the Transaction, we have rights to receive future royalties from Rayner on OMIDRIA net sales at royalty rates that vary based on geography and certain regulatory contingencies. Therefore, future OMIDRIA royalties are treated as variable consideration. The sale of OMIDRIA qualifies as an asset sale. To measure the OMIDRIA contract royalty asset, we used the expected value approach which is the sum of the discounted probability-weighted royalty payments, net of tax, we would receive using a range of potential outcomes, to the extent that it is probable that a significant reversal in the amount of cumulative income recognized will not occur. Accordingly, the contract royalty asset excludes the achievement of the $200.0 million milestone payment and any foreign royalties to the extent it is probable that a significant reversal in the amount of cumulative income recognized will not occur. Royalties earned will be recorded as a reduction to the OMIDRIA contract royalty asset. The amount recorded in discontinued operations in future periods will reflect interest earned on the outstanding OMIDRIA contract royalty asset and any amounts received received different from the expected royalties recorded at closing. The OMIDRIA contract royalty asset will also be re-measured periodically using the expected value approach based on actual results and future expectations. Any required adjustment to the OMIDRIA contract royalty asset will be recorded into discontinued operations. |
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments | Cash and Cash Equivalents, Short-Term Investments and Restricted Investments Cash and cash equivalents include highly liquid investments with a maturity of three months or less on the date of purchase. Short-term investment securities are classified as available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported as a separate component of shareholders’ equity. Amortization, accretion, interest, and dividends, realized gains and losses and declines in value judged to be other-than-temporary are included in other income. The cost of securities sold is based on the specific-identification method. Investments in securities with maturities of less than one year, or those for which management intends to use the investments to fund current operations, are included in current assets. We evaluate whether an investment is other-than-temporarily impaired based on the specific facts and circumstances. Factors that are considered in determining whether an other-than-temporary decline in value has occurred include: the market value of the security in relation to its cost basis; the financial condition of the investee; and the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment. Restricted investments held in money-market funds include security deposits held by our landlord. As of December 31, 2021 and 2020, all investments are classified as short-term and available-for-sale. Investment income, which is included as a component of other income, consists primarily of interest earned. |
Inventory | Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner that approximates the first-in, first-out (“FIFO’) method. Costs include amounts related to third-party manufacturing, transportation, and internal labor and overhead. Capitalization of costs as inventory begins when regulatory approval of the drug candidate is reasonably assured in the U.S. or the European Union (‘EU”). We expense inventory costs related to drug candidates as research and development expenses prior to receiving regulatory approval in the respective territory. Inventory is reduced to net realizable value for excess and obsolete inventories based on forecasted demand. Inventory with an alternative future use is capitalized. |
Receivables, Net | Receivables, Net Receivables relate primarily to sales of OMIDRIA made to wholesalers prior to the sale to Rayner and include reductions for estimated chargebacks and product returns that are expected to be settled through reductions in receivables. Remaining receivables generally consist of amounts from subleases for space in our facilities. Considering the nature and historic collectability of our receivables, we concluded an allowance for doubtful accounts is not necessary as of December 31, 2021 and 2020. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, and depreciation is calculated using the straight-line method over the estimated useful life of the assets, which is generally three |
Right-of-Use Assets and Related Lease Liabilities | Right-of-Use Assets and Related Lease Liabilities We record operating leases as right-of-use assets and recognize the related lease liabilities equal to the fair value of the lease payments using our incremental borrowing rate when the implicit rate in the lease agreement is not readily available. We recognize variable lease payments, when incurred. Costs associated with operating lease assets are recognized on a straight-line basis within operating expenses over the term of the lease. We record finance leases as a component of property and equipment and amortize these assets within operating expenses on a straight-line basis to their residual values over the shorter of the term of the underlying lease or the estimated useful life of the equipment. The interest component of a finance lease is included in interest expense and recognized using the effective interest method over the lease term. We account for leases with initial terms of 12 months or less as operating expenses on a straight-line basis over the lease term. |
Unsecured Convertible Senior Notes | Unsecured Convertible Senior Notes On January 1, 2021, we adopted Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion Options and Derivatives and Hedging—Contracts in Entity’s Own Equity 06 Transactions involving contemporaneous exchanges of cash between the same debtor and creditor in connection with the issuance of a new debt obligation and satisfaction of an existing debt obligation by the debtor are evaluated as a modification or an exchange transaction depending on whether the exchange is determined to have substantially different terms. The 6.25% Convertible Senior Notes (the “2023 Notes”) repurchase and issuance of the 5.25 % Convertible Senior Notes (“2026 Notes”) were deemed to have substantially different terms due to the significant difference between the value of the conversion option immediately prior to and after the exchange. Therefore, the repurchase of the 2023 Notes was accounted for as a debt extinguishment. (See “Note 9 – Unsecured Convertible Senior Debt”). |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We assess the impairment of long-lived assets, primarily property and equipment, whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability of these assets is measured by comparing the carrying value to future undiscounted cash flows that the asset is expected to generate. If the asset is impaired, the amount of any impairment will be reflected in the results of operations in the period of impairment. We have not recognized any impairment losses for the years ended December 31, 2021, 2020 and 2019. |
Revenue Recognition | Revenue Recognition When we enter into a customer contract, we perform the following five steps: (i) identify the contract 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) we satisfy a performance obligation. |
Product Sales, Net | Product Sales, Net We generally record revenue from product sales when the product is delivered to our wholesalers and title for the product is transferred. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability depending on how the amount is expected to be settled. |
Chargeback and Rebates | Chargebacks and Rebates Provisions for chargebacks are determined utilizing historical and projected payer mix and information regarding sell-through and inventory on-hand received directly from wholesalers. Chargebacks are generally settled within four We provide reimbursement support services and financial assistance in the form of a rebate to patients whose commercial insurance is inadequate to cover the full cost of our drug product. We apply an experience ratio based on historical and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and is being reviewed and updated periodically to reflect actual results. |
Distribution Fees and Product Return Allowances | Distribution Fees and Product Return Allowances We pay our wholesalers a distribution fee for services that they perform for us based on the wholesaler average cost value of their purchases. We record a provision against product sales for these charges at the time of sale to the wholesaler. We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the health care providers based on the frequency of their reorders. |
Research and Development | Research and Development Research and development expenses are comprised primarily of contracted research and manufacturing costs prior to approval; costs for personnel, including salaries, benefits and stock compensation; clinical study costs; contracted research; manufacturing costs prior to approval; consulting services; depreciation; materials and supplies; milestones; an allocation of our occupancy costs; and other expenses incurred to sustain our overall research and development programs. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and then recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. All other research and development costs are expensed as incurred. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative expenses are comprised primarily of salaries, benefits, and stock-compensation costs for sales, marketing, and other personnel not directly engaged in research and development. Additionally, selling, general and administrative expenses include marketing and selling expenses, professional and legal services; patent costs; depreciation, an allocation of our occupancy costs; and other general corporate expenses. Advertising costs, which we consider to be media and marketing materials, are expensed as incurred and were $7.8 million, $5.6 million and $8.0 million during the years ended December 31, 2021, 2020 and 2019, respectively. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense is recognized for all share-based payments based on estimated fair values. The fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental assumptions around volatility, forfeiture rates and expected option term. Compensation expense is recognized over the optionees’ requisite service periods, which is generally the vesting period, using the straight-line method. Forfeiture expense is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of net loss and certain changes in equity that are excluded from net loss. There was no difference between comprehensive loss and net loss for the years ended December 31, 2021, 2020 or 2019. |
Financial Instruments and Concentrations of Credit Risk | Financial Instruments and Concentrations of Credit Risk Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of short-term investments is based on quoted market prices. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, our cash and cash equivalents balance held at a financial institution may exceeds the federally insured limits. To limit the credit risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and commercial paper. |
Major Customers | Major Customers Prior to the sale of OMIDRIA to Rayner, we sold OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2021, 2020 and 2019 and greater than 10% of accounts receivable as of December 31, 2021, 2020 and 2019 as noted below. 2021 2020 2019 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 20 % 16 % 25 % 36 % 25 % 23 % Distributor B 24 % 20 % 26 % 31 % 24 % 19 % Distributor C 40 % 46 % 32 % 10 % 29 % 33 % Distributor D 16 % 18 % 17 % 23 % 22 % 25 % |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Significant Accounting Policies | |
Schedule of Revenue by Major Customers by Reporting Segments | 2021 2020 2019 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 20 % 16 % 25 % 36 % 25 % 23 % Distributor B 24 % 20 % 26 % 31 % 24 % 19 % Distributor C 40 % 46 % 32 % 10 % 29 % 33 % Distributor D 16 % 18 % 17 % 23 % 22 % 25 % |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations | |
Schedule of net income from discontinued operation | Year Ended December 31, 2021 2020 2019 (In thousands) Product sales, net $ 110,735 $ 73,813 $ 111,805 Royalty income 1,035 — — OMIDRIA income 111,770 73,813 111,805 Costs and expenses: Cost of product sales 1,364 902 865 Research and development 3,839 3,205 3,372 Selling, general and administrative 25,428 23,389 24,912 Total costs and expenses 30,631 27,496 29,149 Income before income tax expense 81,139 46,317 82,656 Income tax expense (1,006) (11,245) (19,774) Net income from discontinued operations, net of tax 80,133 35,072 62,882 Gain on sale of OMIDRIA, net 305,648 — — Net income from discontinued operations, net of tax $ 385,781 $ 35,072 $ 62,882 |
Schedule of gain on sale of Omidria | (In thousands) Cash proceeds $ 125,993 OMIDRIA contract royalty asset 184,570 Gain on sale of OMIDRIA, gross 310,563 Transaction and closing costs (1,972) Restricted Stock Units ("RSUs") granted to transferred employees (1,419) Prepaid assets and inventory at cost (1,524) Gain on sale of OMIDRIA, net $ 305,648 |
Schedule of cash flow from discontinued operation | Year Ended December 31, 2021 2020 2019 (In thousands) Total operating cash flows from discontinued operations $ 56,344 $ 25,888 $ (11,886) Total investing cash flows from discontinued operations $ 125,993 $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss Per Share | |
Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss per Share | Year Ended December 31, 2021 2020 2019 2023 Notes convertible to common stock (1) 4,941,739 7,932,791 10,923,843 Outstanding options to purchase common stock 1,707,371 1,585,332 2,664,841 Outstanding restricted stock units 2,642 — — Outstanding warrants to purchase common stock — 10,792 16,153 Total potentially dilutive shares excluded from loss per share 6,651,752 9,528,915 13,604,837 (1) The 2023 Notes are subject to a capped call arrangement that potentially reduces the dilutive effect as described in “Note 9 — Unsecured Convertible Senior Notes”. Any potential impact of the capped call arrangement is excluded from this table. |
Accounts Receivable, Net (Table
Accounts Receivable, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Receivable, Net. | |
Schedule of accounts receivable | December 31, December 31, 2021 2020 (In thousands) Trade receivables, net $ 36,505 $ 3,771 Sublease and other receivables 1,650 70 Total accounts receivables, net $ 38,155 $ 3,841 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair-Value Measurements | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 56,458 $ — $ — $ 56,458 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 57,512 $ — $ — $ 57,512 December 31, 2020 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 124,452 $ — $ — $ 124,452 Money-market funds classified as non-current restricted investments 1,055 — — 1,055 Total $ 125,507 $ — $ — $ 125,507 |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Certain Balance Sheet Accounts | |
Schedule of accounts receivable | December 31, December 31, 2021 2020 (In thousands) Trade receivables, net $ 36,505 $ 3,771 Sublease and other receivables 1,650 70 Total accounts receivables, net $ 38,155 $ 3,841 |
Property, Plant and Equipment | December 31, December 31, 2021 2020 (In thousands) Finance leases $ 5,979 $ 5,690 Laboratory equipment 3,091 2,898 Computer equipment 1,069 985 Office equipment and furniture 625 625 Total cost 10,764 10,198 Less accumulated depreciation and amortization (9,033) (7,647) Total property and equipment, net $ 1,731 $ 2,551 |
Accrued Expenses | December 31, December 31, 2021 2020 (In thousands) Sales rebates, fees and discounts $ 8,442 $ 3,326 Consulting and professional fees 7,455 5,393 Interest payable 5,172 5,205 Contract research and development 3,916 7,952 Employee compensation 3,706 3,948 Clinical trials 2,430 2,121 Other accrued expenses 2,013 810 Total accrued expenses $ 33,134 $ 28,755 |
Unsecured Convertible Senior _2
Unsecured Convertible Senior Notes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Instrument [Line Items] | |
Summary of unsecured convertible senior notes outstanding | Balance as of December 31, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (1,282) (5,290) (6,572) Total unsecured convertible senior notes, net $ 93,718 $ 219,740 $ 313,458 Fair value of outstanding unsecured convertible senior notes (1) $ 87,163 $ 171,867 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ — $ — Balance as of December 31, 2020 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized discount (17,101) (60,544) (77,645) Unamortized issuance costs attributable to liability component (1,481) (4,616) (6,097) Total unsecured convertible senior notes, net $ 76,418 $ 159,870 $ 236,288 Fair value of outstanding unsecured convertible senior notes (1) $ 101,769 $ 246,779 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ 6,769 $ 21,749 Equity component $ 25,854 $ 63,544 Unamortized issuance costs (837) (1,916) Net carrying amount of equity component (2) $ 25,017 $ 61,628 (1) The fair value is classified as Level 3 due to the limited trading activity for the unsecured convertible senior notes. (2) Included in the consolidated balance sheet within additional paid-in capital. |
Schedule of future minimum payments of debt | (In thousands) 2022 $ — 2023 95,000 2024 — 2025 — 2026 225,030 Total future minimum principal payments under the convertible senior notes $ 320,030 |
2023 Unsecured Convertible Senior Notes | |
Debt Instrument [Line Items] | |
Schedule of total interest expense recognized | Year Ended December 31, 2021 2020 2019 (In thousands) Contractual interest expense $ 5,938 $ 10,410 $ 13,089 Amortization of debt issuance costs 618 669 8,496 Amortization of debt discount — 7,728 736 Total $ 6,556 $ 18,807 $ 22,321 |
2026 Unsecured Convertible Senior Notes | |
Debt Instrument [Line Items] | |
Summary of issuance of the notes and use of proceeds | (In thousands) 2026 Notes principal amount issued $ 225,030 Repurchase of 2023 Notes (125,638) Purchase of 2026 Capped Call (23,223) Termination of the 2023 Capped Call contracts related to debt repurchased 7,549 Issuance costs (6,785) Net proceeds available for corporate use $ 76,933 |
Schedule of total interest expense recognized | Year Ended December 31, 2021 2020 2019 (In thousands) Contractual interest expense $ 11,814 $ 4,397 $ — Amortization of debt issuance costs 1,078 230 — Amortization of debt discount — 3,022 — Total $ 12,892 $ 7,649 $ — |
Leases Liabilities (Tables)
Leases Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Schedule of lease-related assets and liabilities recorded on the balance sheet | December 31, December 31, 2021 2020 (In thousands) Assets Operating lease assets $ 28,276 $ 25,526 Finance lease assets, net 1,009 1,822 Total lease assets $ 29,285 $ 27,348 Liabilities Current: Operating leases $ 4,607 $ 2,740 Finance leases 648 1,042 Non-current: Operating leases 28,811 28,032 Finance leases 315 738 Total lease liabilities $ 34,381 $ 32,552 Weighted-average remaining lease term Operating leases 5.9 years 6.8 years Finance leases 1.7 years 1.9 years Weighted-average discount rate Operating leases 12.81 % 12.85 % Finance leases 12.70 % 11.85 % |
Schedule of lease costs | Year Ended December 31, 2021 2020 (In thousands) Lease cost Operating lease cost $ 7,364 $ 6,055 Finance lease cost: Amortization 1,102 1,367 Interest 181 295 Variable lease cost 3,519 2,893 Sublease income (1,776) (1,300) Net lease cost $ 10,390 $ 9,310 |
Schedule of supplemental cash flow information | Year Ended December 31, 2021 2020 (In thousands) Cash paid for amounts included in the measurement of lease liabilities Cash payments for operating leases $ 10,162 $ 10,103 Cash payments for financing leases $ 1,171 $ 1,490 |
Schedule of operating and finance lease liability | Operating Finance Leases Leases (In thousands) 2022 $ 7,118 $ 702 2023 7,276 274 2024 7,438 71 2025 7,508 — 2026 7,302 — Thereafter 6,264 — Total undiscounted lease payments 42,906 1,047 Less interest (9,488) (84) Total lease liabilities $ 33,418 $ 963 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Shareholders' Deficit | |
Reserved Shares of Common Stock | Options granted and outstanding 12,709,887 Restricted stock units granted and outstanding 222,000 Common stock warrants 200,000 Awards available under issuance under the 2017 Plan 6,046,652 Total shares reserved 19,178,539 |
Schedule of Stockholders' Equity Note, Warrants or Rights | Outstanding At December 31, 2021 Expiration Date Exercise Price 200,000 April 12, 2023 $ 23.00 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation. | |
Schedule of equity plan | Vesting schedules for our equity plans generally are as follows: Grant Type Vesting Schedule Employee initial options grants 25% at one-year anniversary, 1/48 Employee recurring options grants 1/48 Board member initial options grants 33+% per year for 3 years Board member recurring options grants 100% after one year Non-employee consultant options grants 1/12 1/48 Employee RSUs 50% after one year, 50% after two years |
Stock-Based Compensation Expense | Year Ended December 31, 2021 2020 2019 (In thousands) Continuing operations Research and development $ 6,791 $ 6,163 $ 6,008 Selling, general and administrative 8,154 7,614 6,959 Total stock-based compensation in continuing operations 14,945 13,777 12,967 Discontinued operations 2,685 1,148 818 Total Stock-based compensation $ 17,630 $ 14,925 $ 13,785 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Year Ended December 31, 2021 2020 2019 Estimated weighted-average fair value $ 10.54 $ 8.19 $ 9.93 Weighted-average assumptions: Expected volatility 81 % 77 % 80 % Expected life, in years 6.0 6.0 6.0 Risk-free interest rate 1.06 % 1.06 % 2.41 % Expected dividend yield — % — % — % |
Schedule of Stock Option Activity | Weighted- Average Aggregate Exercise Remaining Intrinsic Options Price per Contractual Life Value Outstanding Share (In years) (In thousands) Balance at December 31, 2020 11,938,528 $ 11.92 Granted 2,525,525 15.34 Exercised (921,023) 9.10 Forfeited (833,143) 14.85 Balance at December 31, 2021 12,709,887 $ 12.61 5.6 $ 261 Vested and expected to vest at December 31, 2021 12,348,044 $ 12.56 5.5 $ 261 Exercisable at December 31, 2021 9,295,395 $ 12.00 4.5 $ 261 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of Components of Income Tax Expense (Benefit) | December 31, 2021 2020 2019 (In thousands) Current income tax expense: Federal $ — $ — $ — State — — — Total current income tax expense — — — Deferred income tax expense (benefit) Federal — (19,472) (16,716) State — (3,784) (3,058) Total deferred income tax expense (benefit) — (23,256) (19,774) Income tax expense (benefit) $ — $ (23,256) $ (19,774) |
Significant Components of Deferred Tax Assets | December 31, 2021 2020 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 143,657 $ 149,993 Research and development tax credits 66,612 56,103 Stock-based compensation 11,327 10,586 Lease liability 9,995 8,646 Disallowed interest expense — 11,859 Other 17,862 7,411 Total deferred tax assets 249,453 244,598 Deferred tax liabilities: Property and equipment (102) (113) Gain on discontinued operations (42,212) — Equity component of Convertible Notes — (18,302) Right of use assets (6,467) (6,197) Total deferred tax liabilities (48,781) (24,612) Net deferred tax assets before valuation allowance 200,672 219,986 Less valuation allowance (201,340) (219,986) Net deferred tax liabilities $ (668) $ — |
Reconciliation of Federal Statutory Tax Rate to Effective Income Tax | Year ended December 31, 2021 2020 2019 U.S. Federal statutory rate on net loss (21.0) % (21.0) % (21.0) % State tax, net of federal tax benefit (1.6) % (3.1) % (2.8) % Change in valuation allowance 27.9 % 19.3 % 14.3 % Tax credits (5.5) % (6.2) % (3.0) % Other 0.2 % (0.8) % 0.7 % Effective tax rate (0.0) % (11.8) % (11.8) % |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details) $ in Thousands | Dec. 23, 2021USD ($) | Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Cash proceeds on sale of OMIDRIA | $ 125,993 | |||
Milestone payment receivable | 200,000 | |||
Cash, cash equivalents and short-term investments | 157,300 | |||
Receivables, net | 38,155 | $ 3,841 | ||
Net loss from continuing operations | $ 191,546 | 173,133 | $ 147,368 | |
Number of Operating Segments | segment | 1 | |||
Discontinued Operation | Omidria Assets Disposal | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Cash proceeds on sale of OMIDRIA | $ 126,000 | $ 125,993 | ||
Milestone payment receivable | $ 200,000 | 200,000 | ||
Milestone period | 4 years | |||
Net income from discontinued operations, net of tax | 80,133 | $ 35,072 | $ 62,882 | |
Market Offerings | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Maximum Aggregate Offering Price | $ 150,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Property and Equipment (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Property, Plant and Equipment [Line Items] | |
Milestone payment receivable | $ 200 |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 10 years |
Significant accounting polici_5
Significant accounting policies - Unsecured Convertible Senior Notes (Details) - USD ($) $ in Thousands | 12 Months Ended | |||||||
Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Aug. 14, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | Nov. 15, 2018 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||
Stockholders' equity | $ 23,780 | $ (120,752) | $ (109,021) | $ (100,156) | ||||
Period chargebacks are generally settled | 28 days | |||||||
Period for product return past its expiration or damaged | 12 months | |||||||
Cumulative effect adjustment | ASU 2020-06 | ||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||
Stockholders' equity | (75,474) | |||||||
Convertible Debt | $ 75,500 | |||||||
2023 Unsecured Convertible Senior Notes | ||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||
Interest rate (as a percent) | 6.25% | 6.25% | 6.25% | |||||
Convertible Debt | $ 90,200 | |||||||
2026 Unsecured Convertible Senior Notes | ||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||
Interest rate (as a percent) | 5.25% | 5.25% |
Significant Accounting Polici_6
Significant Accounting Policies - Selling, General and Administrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Significant Accounting Policies | |||
Advertising expense | $ 7.8 | $ 5.6 | $ 8 |
Significant Accounting Polici_7
Significant Accounting Policies - Major Customers and Major Suppliers (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Distributor A | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 20.00% | 25.00% | 25.00% |
Distributor A | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 16.00% | 36.00% | 23.00% |
Distributor B | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 24.00% | 26.00% | 24.00% |
Distributor B | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 20.00% | 31.00% | 19.00% |
Distributor C | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 40.00% | 32.00% | 29.00% |
Distributor C | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 46.00% | 10.00% | 33.00% |
Distributor D | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 16.00% | 17.00% | 22.00% |
Distributor D | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 18.00% | 23.00% | 25.00% |
Discontinued Operations - Narra
Discontinued Operations - Narratives (Details) - USD ($) $ in Thousands | Dec. 23, 2021 | Dec. 31, 2021 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cash proceeds on sale of OMIDRIA | $ 125,993 | |
Milestone payment receivable | 200,000 | |
Discontinued Operation | Omidria Assets Disposal | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cash proceeds on sale of OMIDRIA | $ 126,000 | 125,993 |
Percentage of royalty receivable | 50.00% | |
Percentage of royalty receivable after January 1, 2025 or payment of milestone | 30.00% | |
Milestone payment receivable | $ 200,000 | $ 200,000 |
Milestone Period | 4 years | |
Percent of reduction in royalty receivable | 10.00% | |
Percentage of royalty receivable outside US | 15.00% |
Discontinued Operations - Net I
Discontinued Operations - Net Income Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Net income from discontinued operations, net of tax | $ 385,781 | $ 35,072 | $ 62,882 |
Discontinued Operation | Omidria Assets Disposal | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue | 111,770 | 73,813 | 111,805 |
Cost of product sales | 1,364 | 902 | 865 |
Research and development | 3,839 | 3,205 | 3,372 |
Selling, general and administrative | 25,428 | 23,389 | 24,912 |
Total costs and expenses | 30,631 | 27,496 | 29,149 |
Income before income tax benefit (expense) | 81,139 | 46,317 | 82,656 |
Income tax expense | (1,006) | (11,245) | (19,774) |
Net income from discontinued operations, net of tax | 80,133 | 35,072 | 62,882 |
Gain on disposal of OMIDRIA | 305,648 | ||
Net income from discontinued operations, net of tax | 385,781 | 35,072 | 62,882 |
Discontinued Operation | Omidria Assets Disposal | Product sales, net | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue | 110,735 | $ 73,813 | $ 111,805 |
Discontinued Operation | Omidria Assets Disposal | Royalty income | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue | $ 1,035 |
Discontinued Operations - Gain
Discontinued Operations - Gain Loss (Details) - USD ($) $ in Thousands | Dec. 23, 2021 | Dec. 31, 2021 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cash proceeds | $ 125,993 | |
Discontinued Operation | Omidria Assets Disposal | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cash proceeds | $ 126,000 | 125,993 |
OMIDRIA contract royalty asset | 184,570 | |
Gain on sale of OMIDRIA, gross | 310,563 | |
Transaction and closing costs | (1,972) | |
Restricted Stock Units ("RSUs") granted to transferred employees | (1,419) | |
Prepaid assets and inventory at cost | (1,524) | |
Gain on sale of OMIDRIA, net | $ 305,648 |
Discontinued Operations - Cash
Discontinued Operations - Cash Flow (Details) - Discontinued Operation - Omidria Assets Disposal - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Total operating cash flows from discontinued operations | $ 56,344 | $ 25,888 | $ (11,886) |
Total investing cash flows from discontinued operations | $ 125,993 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive shares excluded from loss per share | 6,651,752 | 9,528,915 | 13,604,837 |
2023 Unsecured Convertible Senior Notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive shares excluded from loss per share | 4,941,739 | 7,932,791 | 10,923,843 |
Outstanding options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive shares excluded from loss per share | 1,707,371 | 1,585,332 | 2,664,841 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive shares excluded from loss per share | 2,642 | ||
Outstanding warrants to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive shares excluded from loss per share | 10,792 | 16,153 |
Accounts Receivable, Net - Gran
Accounts Receivable, Net - Grant and Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Certain Balance Sheet Accounts | ||
Trade receivables, net | $ 36,505 | $ 3,771 |
Sublease and other receivables | 1,650 | 70 |
Total accounts receivables, net | 38,155 | 3,841 |
Chargeback and product return allowances | $ 2,000 | $ 1,200 |
Fair-Value Measurements - Recur
Fair-Value Measurements - Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as short-term investments | $ 56,458 | $ 124,452 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,055 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as short-term investments | 56,458 | 124,452 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,055 |
Total | 57,512 | 125,507 |
Fair Value, Measurements, Recurring | Level 1 | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as short-term investments | 56,458 | 124,452 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,055 |
Total | $ 57,512 | $ 125,507 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Nov. 30, 2018 | Nov. 15, 2018 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash and cash equivalents | $ 100,808 | $ 10,501 | |||
Unrealized gain (loss) on investments | $ 0 | $ 0 | |||
2023 Unsecured Convertible Senior Notes | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Interest rate (as a percent) | 6.25% | 6.25% | 6.25% | ||
2026 Unsecured Convertible Senior Notes | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Interest rate (as a percent) | 5.25% | 5.25% |
Certain Balance Sheet Account_2
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 10,764 | $ 10,198 | |
Less accumulated depreciation and amortization | (9,033) | (7,647) | |
Total property and equipment, net | 1,731 | 2,551 | |
Depreciation and amortization | 1,386 | 1,616 | $ 1,790 |
Finance leases | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 5,979 | 5,690 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 3,091 | 2,898 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 1,069 | 985 | |
Office equipment and furniture | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 625 | $ 625 |
Certain Balance Sheet Account_3
Certain Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued expenses | ||
Sales rebates, fees and discounts | $ 8,442 | $ 3,326 |
Consulting and professional fees | 7,455 | 5,393 |
Interest payable | 5,172 | 5,205 |
Contract research and development | 3,916 | 7,952 |
Employee compensation | 3,706 | 3,948 |
Clinical trials | 2,430 | 2,121 |
Other accrued expenses | 2,013 | 810 |
Total accrued expenses | $ 33,134 | $ 28,755 |
Line of Credit (Details)
Line of Credit (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument | ||
Outstanding amount | $ 313,458,000 | $ 236,288,000 |
Line of Credit Agreement | ||
Debt Instrument | ||
Maximum borrowing capacity | $ 50,000,000 | |
Borrowing option - percentage of eligible monthly royalty payments | 85.00% | |
Basis for variable rate | 5.50% | |
Debt termination fee | $ 1,000,000 | |
Payment of initial commitment fee | 150,000 | |
Additional commitment fees payable each of the first and second anniversaries of the closing date | 150,000 | |
Outstanding amount | $ 0 | $ 0 |
Unsecured Convertible Senior _3
Unsecured Convertible Senior Notes - Unsecured convertible senior notes outstanding (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2020 | Dec. 31, 2021 | Aug. 14, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | |||||
Principal amount | $ 320,030 | $ 320,030 | |||
Unamortized discount | (77,645) | (6,572) | |||
Unamortized issuance costs | (6,097) | ||||
Total unsecured convertible senior notes, net | 236,288 | 313,458 | |||
Stockholders' equity | (120,752) | 23,780 | $ (109,021) | $ (100,156) | |
2023 Unsecured Convertible Senior Notes | |||||
Debt Instrument [Line Items] | |||||
Principal amount | 95,000 | 95,000 | $ 95,000 | ||
Unamortized discount | (17,101) | (1,282) | |||
Unamortized issuance costs | (1,481) | ||||
Total unsecured convertible senior notes, net | 76,418 | 93,718 | |||
Fair value of outstanding unsecured convertible senior notes (1) | 101,769 | 87,163 | |||
Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount | 6,769 | ||||
Equity component | 25,854 | ||||
Unamortized issuance costs | (837) | ||||
Net carrying amount of equity component (2) | 25,017 | ||||
Convertible Debt | $ 90,200 | ||||
2026 Unsecured Convertible Senior Notes | |||||
Debt Instrument [Line Items] | |||||
Principal amount | 225,030 | 225,030 | |||
Unamortized discount | (60,544) | (5,290) | |||
Unamortized issuance costs | (4,616) | ||||
Total unsecured convertible senior notes, net | 159,870 | 219,740 | |||
Fair value of outstanding unsecured convertible senior notes (1) | 246,779 | $ 171,867 | |||
Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount | 21,749 | ||||
Equity component | 63,544 | ||||
Unamortized issuance costs | (1,916) | ||||
Net carrying amount of equity component (2) | 61,628 | ||||
Cumulative effect adjustment | ASU 2020-06 | |||||
Debt Instrument [Line Items] | |||||
Stockholders' equity | (75,474) | ||||
Convertible Debt | $ 75,500 |
Unsecured Convertible Senior _4
Unsecured Convertible Senior Notes - 2023 Unsecured Convertible Senior Notes (Details) $ / shares in Units, shares in Millions | Aug. 14, 2020USD ($)shares | Nov. 30, 2018USD ($)$ / shares | Dec. 31, 2020USD ($)shares | Nov. 15, 2018 |
Debt Instrument [Line Items] | ||||
Loss on early extinguishment of debt | $ 13,374,000 | |||
Adjustments to additional paid-in capital due to repurchase of the equity component | 22,073,000 | |||
Proceeds From Termination Of Capped Call Contracts | $ 7,549,000 | |||
2023 Unsecured Convertible Senior Notes | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 210,000,000 | |||
Interest rate (as a percent) | 6.25% | 6.25% | 6.25% | |
Conversion rate | 0.0520183 | |||
Value used in calculation of conversion rate | $ 1,000 | |||
Conversion price | $ / shares | $ 19.22 | |||
Proceeds from 2026 debt issuance used to repurchase 2023 Notes | $ 125,600,000 | |||
Principal amount of debt repurchased | 115,000,000 | |||
Fair value of the liability component | $ 103,600,000 | |||
Effective interest rate to determine fair value of liability component (as a percent) | 9.90% | |||
Amount outstanding | $ 90,200,000 | |||
Number of underlying shares | shares | 6 | |||
Settlement loss upon termination of cap call contract | $ 800,000 | |||
Number of shares outstanding on the 2023 Capped Call | shares | 4.9 | |||
Loss on early extinguishment of debt | 13,400,000 | |||
Adjustments to additional paid-in capital due to repurchase of the equity component | 22,000,000 | |||
Proceeds From Termination Of Capped Call Contracts | $ 7,500,000 | |||
2023 Unsecured Convertible Senior Notes | Minimum | ||||
Debt Instrument [Line Items] | ||||
Conversion price | $ / shares | 19.22 | |||
2023 Unsecured Convertible Senior Notes | Maximum | ||||
Debt Instrument [Line Items] | ||||
Conversion price | $ / shares | $ 28.84 |
Unsecured Convertible Senior _5
Unsecured Convertible Senior Notes - Interest expense recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
2023 Unsecured Convertible Senior Notes | |||
Interest Expense, Debt [Abstract] | |||
Contractual interest expense | $ 5,938 | $ 10,410 | $ 13,089 |
Amortization of debt issuance costs | 618 | 669 | 8,496 |
Amortization of debt discount | 7,728 | 736 | |
Total | 6,556 | 18,807 | $ 22,321 |
2026 Unsecured Convertible Senior Notes | |||
Interest Expense, Debt [Abstract] | |||
Contractual interest expense | 11,814 | 4,397 | |
Amortization of debt issuance costs | 1,078 | 230 | |
Amortization of debt discount | 3,022 | ||
Total | $ 12,892 | $ 7,649 |
Unsecured Convertible Senior _6
Unsecured Convertible Senior Notes - 2026 Unsecured Convertible Senior Notes (Details) $ / shares in Units, shares in Millions | 2 Months Ended | 12 Months Ended | |
Sep. 30, 2020USD ($)D$ / sharesshares | Dec. 31, 2020USD ($) | Dec. 31, 2021shares | |
Debt Instrument [Line Items] | |||
Repurchase of 2023 Notes | $ (125,638,000) | ||
Proceeds from termination of capped call contracts | 7,549,000 | ||
Issuance costs | $ (6,785,000) | ||
2026 Unsecured Convertible Senior Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 225,000,000 | ||
Interest rate (as a percent) | 5.25% | 5.25% | |
2026 Notes principal amount issued | $ 225,030,000 | ||
Repurchase of 2023 Notes | (125,638,000) | ||
Proceeds from termination of capped call contracts | 7,549,000 | ||
Issuance costs | (6,785,000) | ||
Purchase of 2026 Capped Call | (23,223,000) | ||
Net proceeds available for corporate use | $ 76,933,000 | ||
Conversion rate | 0.0540906 | ||
Value used in calculation of conversion rate | $ 1,000 | ||
Conversion price | $ / shares | $ 18.4875 | ||
Shares upon conversion | shares | 12.2 | ||
Capped Call Transactions, Threshold Trading Day Period | 50 days | ||
Number of shares outstanding on the 2026 Capped Call | shares | 12.2 | ||
Fair value of equity component | $ 23,200,000 | ||
Effective interest rate to determine fair value of liability component (as a percent) | 12.50% | ||
2026 Unsecured Convertible Senior Notes | Debt Conversion, After September 30, 2020 | |||
Debt Instrument [Line Items] | |||
Stock price trigger (as a percent) | 130.00% | ||
Trading days, number | D | 20 | ||
Consecutive trading days, period | D | 30 | ||
Consecutive business days, period | 5 days | ||
Consecutive trading-day period | 5 days | ||
Maximum product of the closing sale price of shares of the Company's common stock and the applicable conversion rate for such trading day (as a percent) | 98.00% | ||
2026 Unsecured Convertible Senior Notes | Debt Conversion, On Or After August 15, 2023 | |||
Debt Instrument [Line Items] | |||
Stock price trigger (as a percent) | 130.00% | ||
Trading days, number | D | 20 | ||
Consecutive trading days, period | D | 30 | ||
2026 Unsecured Convertible Senior Notes | Minimum | |||
Debt Instrument [Line Items] | |||
Conversion price | $ / shares | $ 18.49 | ||
2026 Unsecured Convertible Senior Notes | Maximum | |||
Debt Instrument [Line Items] | |||
Conversion price | $ / shares | $ 26.10 |
Unsecured Convertible Senior _7
Unsecured Convertible Senior Notes - Future minimum payments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
Total future minimum payments under the convertible senior notes | $ 320,030 | $ 320,030 |
2023 and 2026 Convertible Senior Notes | ||
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
2023 | 95,000 | |
2026 | 225,030 | |
Total future minimum payments under the convertible senior notes | $ 320,030 |
Leases (Details)
Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)ft²item | Dec. 31, 2020USD ($) | |
Leases | ||
Number of options to extend lease | item | 2 | |
Option to Extend | true | |
Expected lease term | 5 years | |
Classification on the Balance Sheet | ||
Right of use assets | $ 28,276 | $ 25,526 |
Finance lease assets, net | 1,009 | 1,822 |
Total lease assets | 29,285 | 27,348 |
Operating leases, current | $ 4,607 | $ 2,740 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Current | Operating And Finance Lease Liability Current |
Finance leases, current | $ 648 | $ 1,042 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Current | Operating And Finance Lease Liability Current |
Operating leases, non-current | $ 28,811 | $ 28,032 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Noncurrent | Operating And Finance Lease Liability Noncurrent |
Finance leases, non-current | $ 315 | $ 738 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Noncurrent | Operating And Finance Lease Liability Noncurrent |
Total lease liabilities | $ 34,381 | $ 32,552 |
Operating leases | 5 years 10 months 24 days | 6 years 9 months 18 days |
Finance leases | 1 year 8 months 12 days | 1 year 10 months 24 days |
Operating leases | 12.81% | 12.85% |
Finance leases | 12.70% | 11.85% |
Lease cost | ||
Operating lease cost | $ 7,364 | $ 6,055 |
Amortization | 1,102 | 1,367 |
Interest | 181 | 295 |
Variable lease cost | 3,519 | 2,893 |
Sublease income | (1,776) | (1,300) |
Net lease cost | 10,390 | 9,310 |
Cash payments for operating leases | 10,162 | 10,103 |
Cash payments for financing leases | $ 1,171 | $ 1,490 |
Area of operating leases | ft² | 13,904 |
Leases - Maturities (Details)
Leases - Maturities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Operating Leases | |
2022 | $ 7,118 |
2023 | 7,276 |
2024 | 7,438 |
2025 | 7,508 |
2026 | 7,302 |
Thereafter | 6,264 |
Total undiscounted lease payments | 42,906 |
Less interest | (9,488) |
Lease liabilities | 33,418 |
Finance Leases | |
2022 | 702 |
2023 | 274 |
2024 | 71 |
Total undiscounted lease payments | 1,047 |
Less interest | (84) |
Lease liabilities | $ 963 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies. | ||
Contract termination fees | $ 32 | |
Payment of technology access fees | $ 0.5 | $ 5.5 |
Shareholders' Equity - Reserved
Shareholders' Equity - Reserved Share of Common Stock (Details) | Dec. 31, 2021shares |
Reserved Common Stock [Line Items] | |
Shares reserved for further issuance | 19,178,539 |
Options granted and outstanding | |
Reserved Common Stock [Line Items] | |
Shares reserved for further issuance | 12,709,887 |
Restricted stock units granted and outstanding | |
Reserved Common Stock [Line Items] | |
Shares reserved for further issuance | 222,000 |
Common stock warrants | |
Reserved Common Stock [Line Items] | |
Shares reserved for further issuance | 200,000 |
Awards available under issuance under the 2017 Plan | |
Reserved Common Stock [Line Items] | |
Shares reserved for further issuance | 6,046,652 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||||
Issuance of stock (in shares) | 6,900,000 | 4,400,000 | |||
Share price (in USD per share) | $ 14.50 | $ 13.10 | $ 13.10 | ||
Proceeds from issuance of common stock, net | $ 93,700 | $ 54,200 | $ 93,675 | $ 54,238 | |
23.00 | |||||
Class of Stock [Line Items] | |||||
Shares of common stock right to purchase by warrant (in shares) | 200,000 | ||||
Warrant exercise price (in USD per share) | $ 23 | ||||
At The Market (ATM) Program | |||||
Class of Stock [Line Items] | |||||
Maximum aggregate offering price | $ 150,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - Outstanding options to purchase common stock - USD ($) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Unvested options outstanding (shares) | 3.4 | ||
Period for recognition | 2 years 7 months 6 days | ||
Unrecognized compensation expense | $ 27.7 | ||
Intrinsic value | $ 7.8 | $ 5.6 | $ 5.4 |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Contractual term | 10 years |
Stock-Based Compensation - Equi
Stock-Based Compensation - Equity plan (Details) - $ / shares | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 | Nov. 30, 2021 | Nov. 30, 2020 | Dec. 31, 2021 | |
Employee recurring grants | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Monthly vesting percentage | 2.083% | |||
Board member initial grants | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Vesting period | 3 years | |||
Yearly vesting percentage | 33.00% | |||
Board member recurring grants | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Vesting period | 1 year | |||
Yearly vesting percentage | 100.00% | |||
Non-employee consultant grants | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Monthly vesting percentage | 8.33% | |||
Non-employee consultant grants | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Monthly vesting percentage | 2.0833% | |||
Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Granted (in shares) | 11,700 | 14,000 | ||
Weighted average grant date fair value | $ 7.80 | $ 11.05 | ||
Restricted Stock Units | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Granted (in shares) | 222,000 | |||
Weighted average grant date fair value | $ 7.53 | |||
One year anniversary | Employee initial grants | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Yearly vesting percentage | 25.00% | |||
One year anniversary | Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Yearly vesting percentage | 50.00% | |||
Thereafter | Employee initial grants | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Monthly vesting percentage | 2.083% | |||
Thereafter | Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Yearly vesting percentage | 50.00% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation in continuing operations | $ 14,945 | $ 13,777 | $ 12,967 |
Discontinued operations | 2,685 | 1,148 | 818 |
Stock-based compensation expense | 17,630 | 14,925 | 13,785 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation in continuing operations | 6,791 | 6,163 | 6,008 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation in continuing operations | $ 8,154 | $ 7,614 | $ 6,959 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Equity Option - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Estimated weighted-average fair value (USD per share) | $ 10.54 | $ 8.19 | $ 9.93 |
Weighted Average | |||
Weighted-average assumptions | |||
Expected volatility | 81.00% | 77.00% | 80.00% |
Expected life, in years | 6 years | 6 years | 6 years |
Risk-free interest rate | 1.06% | 1.06% | 2.41% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Options Outstanding | |
Beginning balance (shares) | shares | 11,938,528 |
Granted (shares) | shares | 2,525,525 |
Exercised (shares) | shares | (921,023) |
Cancelled (shares) | shares | (833,143) |
Ending balance (shares) | shares | 12,709,887 |
Vested and expected to vest (shares) | shares | 12,348,044 |
Exercisable (shares) | shares | 9,295,395 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 11.92 |
Granted (USD per share) | $ / shares | 15.34 |
Exercised (USD per share) | $ / shares | 9.10 |
Cancelled (USD per share) | $ / shares | 14.85 |
Ending balance (USD per share) | $ / shares | 12.61 |
Vested and expected to vest (USD per share) | $ / shares | 12.56 |
Exercisable (USD per share) | $ / shares | $ 12 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 5 years 7 months 6 days |
Vested and expected to vest (in years) | 5 years 6 months |
Exercisable (in years) | 4 years 6 months |
Aggregate Intrinsic Value | |
Balance | $ | $ 261 |
Vested and expected to vest | $ | 261 |
Exercisable | $ | $ 261 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Total current income tax benefit | 0 | 0 | 0 |
Federal | 0 | (19,472) | (16,716) |
State | 0 | (3,784) | (3,058) |
Total deferred income tax benefit | 0 | (23,256) | (19,774) |
Income tax benefit | $ 0 | $ (23,256) | $ (19,774) |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 143,657 | $ 149,993 |
Research and development tax credits | 66,612 | 56,103 |
Stock-based compensation | 11,327 | 10,586 |
Lease liability | 9,995 | 8,646 |
Disallowed interest expense | 11,859 | |
Other | 17,862 | 7,411 |
Total deferred tax assets | 249,453 | 244,598 |
Deferred tax liabilities: | ||
Property and equipment | (102) | (113) |
Gain on discontinued operations | (42,212) | |
Equity component of Convertible Notes | (18,302) | |
Right of use assets | (6,467) | (6,197) |
Total deferred tax liabilities | (48,781) | (24,612) |
Net deferred tax assets before valuation allowance | 200,672 | 219,986 |
Less valuation allowance | (201,340) | (219,986) |
Net deferred tax liabilities | $ (668) | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Income tax benefit (expense) | $ 0 | $ 23,256 | $ 19,774 |
Net operating loss carryforwards with expiration | 407,700 | ||
Net operating loss carryforwards with no expiration | $ 251,500 | ||
Deferred tax assets, percentage of valuation allowance | 100.00% | ||
Income tax payable | $ 300 | ||
Net deferred tax liabilities | 668 | 0 | |
Increase (decrease) in deferred tax valuation allowance | (19,300) | 37,800 | |
Discontinued Operation | Omidria Assets Disposal | |||
Income Taxes | |||
Income tax benefit (expense) | (1,000) | 11,200 | $ 19,800 |
2023 and 2026 Convertible Senior Notes | |||
Income Taxes | |||
Income tax benefit (expense) | 12,000 | ||
Federal | |||
Income Taxes | |||
Operating Loss Carryforwards | 630,600 | 658,800 | |
State | |||
Income Taxes | |||
Operating Loss Carryforwards | $ 245,100 | $ 257,100 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
U.S. Federal statutory rate on net loss | (21.00%) | (21.00%) | (21.00%) |
State tax, net of federal tax benefit | (1.60%) | (3.10%) | (2.80%) |
Change in valuation allowance | 27.90% | 19.30% | 14.30% |
Tax credits | (5.50%) | (6.20%) | (3.00%) |
Other | 0.20% | (0.80%) | 0.70% |
Effective tax rate | (0.00%) | (11.80%) | (11.80%) |
401k Retirement Plan - Narrativ
401k Retirement Plan - Narrative (Details) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
401(k) Retirement Plan | |
Maximum percent of each employee's contributions matched by employer | 4.00% |
Maximum company match per employee | $ 4,000 |