Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 05, 2022 | |
Document Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
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 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 62,730,015 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001285819 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 14,136 | $ 100,808 |
Short-term investments | 108,427 | 56,458 |
OMIDRIA contract royalty asset, short-term | 43,794 | 44,319 |
Receivables, net | 14,479 | 38,155 |
Prepaid expense and other assets | 11,886 | 8,216 |
Total current assets | 192,722 | 247,956 |
OMIDRIA contract royalty asset | 126,812 | 140,251 |
Property and equipment, net | 1,921 | 1,731 |
Right of use assets | 23,129 | 28,276 |
Restricted investments | 1,054 | 1,054 |
Total assets | 345,638 | 419,268 |
Current liabilities: | ||
Accounts payable | 10,876 | 13,400 |
Accrued expenses | 23,480 | 33,134 |
Current portion of lease liabilities | 4,145 | 5,255 |
Total current liabilities | 38,501 | 51,789 |
Lease liabilities, non-current | 24,520 | 29,126 |
Unsecured convertible senior notes, net | 314,358 | 313,458 |
Other accrued liabilities - noncurrent | 961 | 1,115 |
Commitments and contingencies (Note 10) | ||
Shareholders' equity (deficit): | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at June 30, 2022 and December 31, 2021. | ||
Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2022 and December 31, 2021; 62,730,015 and 62,628,855 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively. | 627 | 626 |
Additional paid-in capital | 713,665 | 706,288 |
Accumulated deficit | (746,994) | (683,134) |
Total shareholders' equity (deficit) | (32,702) | 23,780 |
Total liabilities and shareholders' equity (deficit) | $ 345,638 | $ 419,268 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
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 | 62,730,015 | 62,628,855 |
Common stock, outstanding shares | 62,730,015 | 62,628,855 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Costs and expenses: | ||||
Research and development | $ 23,516 | $ 30,126 | $ 47,603 | $ 62,630 |
Selling, general and administrative | 13,922 | 15,484 | 24,881 | 28,270 |
Total costs and expenses | 37,438 | 45,610 | 72,484 | 90,900 |
Loss from continuing operations | (37,438) | (45,610) | (72,484) | (90,900) |
Interest expense | (4,927) | (4,910) | (9,868) | (9,807) |
Other income | 670 | 333 | 1,163 | 751 |
Net loss from continuing operations | (41,695) | (50,187) | (81,189) | (99,956) |
Net income from discontinued operations | 10,846 | 21,594 | 17,329 | 36,273 |
Net loss | $ (30,849) | $ (28,593) | $ (63,860) | $ (63,683) |
Basic net income (loss) per share continuing operations | $ (0.66) | $ (0.80) | $ (1.30) | $ (1.61) |
Basic net income (loss) per share discontinued operations | 0.17 | 0.34 | 0.28 | 0.59 |
Basic net income (loss) per share | (0.49) | (0.46) | (1.02) | (1.02) |
Diluted net income (loss) per share continuing operations | (0.66) | (0.80) | (1.30) | (1.61) |
Diluted net income (loss) per share discontinued operations | 0.17 | 0.34 | 0.28 | 0.59 |
Diluted net income (loss) per share | $ (0.49) | $ (0.46) | $ (1.02) | $ (1.02) |
Weighted-average shares used to compute basic net income (loss) per share (in shares) | 62,730,015 | 62,373,521 | 62,727,395 | 62,154,714 |
Weighted-average shares used to compute diluted net income (loss) per share (in shares) | 62,730,015 | 62,373,521 | 62,727,395 | 62,154,714 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital Cumulative effect adjustment | Additional Paid-in Capital | Accumulated Deficit Cumulative effect adjustment | Accumulated Deficit | Cumulative effect adjustment | Total |
Balance at Dec. 31, 2020 | $ 616 | $ (70,779) | $ 751,304 | $ (4,697) | $ (872,672) | $ (75,476) | $ (120,752) |
Balance (in shares) at Dec. 31, 2020 | 61,671,231 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Exercise of stock options and warrants | $ 6 | 6,327 | 6,333 | ||||
Exercise of stock options and warrants (in shares) | 580,781 | ||||||
At the market offering costs | (241) | (241) | |||||
Stock-based compensation expense | 3,271 | 3,271 | |||||
Net loss | (35,090) | (35,090) | |||||
Balance at Mar. 31, 2021 | $ 622 | 689,882 | (912,459) | (221,955) | |||
Balance (in shares) at Mar. 31, 2021 | 62,252,012 | ||||||
Balance at Dec. 31, 2020 | $ 616 | $ (70,779) | 751,304 | $ (4,697) | (872,672) | $ (75,476) | (120,752) |
Balance (in shares) at Dec. 31, 2020 | 61,671,231 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (63,683) | ||||||
Balance at Jun. 30, 2021 | $ 624 | 694,132 | (941,052) | (246,296) | |||
Balance (in shares) at Jun. 30, 2021 | 62,490,940 | ||||||
Balance at Mar. 31, 2021 | $ 622 | 689,882 | (912,459) | (221,955) | |||
Balance (in shares) at Mar. 31, 2021 | 62,252,012 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Exercise of stock options | $ 2 | 1,133 | 1,135 | ||||
Exercise of stock options (in shares) | 238,928 | ||||||
Stock-based compensation expense | 3,117 | 3,117 | |||||
Net loss | (28,593) | (28,593) | |||||
Balance at Jun. 30, 2021 | $ 624 | 694,132 | (941,052) | (246,296) | |||
Balance (in shares) at Jun. 30, 2021 | 62,490,940 | ||||||
Balance at Dec. 31, 2021 | $ 626 | 706,288 | (683,134) | 23,780 | |||
Balance (in shares) at Dec. 31, 2021 | 62,628,855 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Exercise of stock options and warrants | $ 1 | 413 | 414 | ||||
Exercise of stock options and warrants (in shares) | 101,160 | ||||||
Stock-based compensation expense | 3,892 | 3,892 | |||||
Net loss | (33,011) | (33,011) | |||||
Balance at Mar. 31, 2022 | $ 627 | 710,593 | (716,145) | (4,925) | |||
Balance (in shares) at Mar. 31, 2022 | 62,730,015 | ||||||
Balance at Dec. 31, 2021 | $ 626 | 706,288 | (683,134) | $ 23,780 | |||
Balance (in shares) at Dec. 31, 2021 | 62,628,855 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Exercise of stock options (in shares) | 101,160 | ||||||
Net loss | $ (63,860) | ||||||
Balance at Jun. 30, 2022 | $ 627 | 713,665 | (746,994) | (32,702) | |||
Balance (in shares) at Jun. 30, 2022 | 62,730,015 | ||||||
Balance at Mar. 31, 2022 | $ 627 | 710,593 | (716,145) | (4,925) | |||
Balance (in shares) at Mar. 31, 2022 | 62,730,015 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Stock-based compensation expense | 3,072 | 3,072 | |||||
Net loss | (30,849) | (30,849) | |||||
Balance at Jun. 30, 2022 | $ 627 | $ 713,665 | $ (746,994) | $ (32,702) | |||
Balance (in shares) at Jun. 30, 2022 | 62,730,015 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities: | ||
Net loss | $ (63,860) | $ (63,683) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Early termination of operating lease | (454) | |
Stock-based compensation expense | 6,964 | 6,388 |
Non-cash interest expense | 900 | 822 |
Depreciation and amortization | 469 | 745 |
Changes in operating assets and liabilities: | ||
Receivables | 23,676 | (27,997) |
Prepaid expenses and other assets | (3,668) | 6,010 |
OMIDRIA contract royalty asset | 13,964 | |
Accounts payable and accrued expense | (12,653) | 9,869 |
Net cash used in operating activities | (34,662) | (67,846) |
Investing activities: | ||
Purchases of investments | (103,169) | (4) |
Proceeds from the sale and maturities of investments | 51,200 | 63,500 |
Purchases of property and equipment | (103) | (100) |
Net cash provided by (used in) investing activities | (52,072) | 63,396 |
Financing activities: | ||
Proceeds upon exercise of stock options and warrants | 414 | 7,468 |
Payments on finance lease obligations | (352) | (576) |
At the market offering costs | (241) | |
Net cash provided by financing activities | 62 | 6,651 |
Net decrease in cash and cash equivalents | (86,672) | 2,201 |
Cash and cash equivalents at beginning of period | 100,808 | 10,501 |
Cash and cash equivalents at end of period | 14,136 | 12,702 |
Supplemental cash flow information | ||
Cash paid for interest | 8,998 | 9,012 |
Property acquired under finance lease | $ 557 | $ 39 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
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. We marketed our first drug product, OMIDRIA ® 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 post-action meeting with FDA to discuss the CRL. Although we felt that we adequately addressed all of the issues noted in the CRL, the meeting minutes included a number of the review division’s critiques that we believe had already been addressed and/or were inaccurate. As a result, in June 2022, we submitted a Formal Dispute Resolution Request. Formal Dispute Resolution is an official pathway that enables a sponsor to appeal a decision by an FDA review division to a higher authority within FDA, in this case the Office of New Drugs (“OND”). 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; however, there can be no assurances that the Formal Dispute Resolution process will provide a clear path to resubmission of our BLA, that resubmission will result in approval of our BLA, or that any identified path to BLA resubmission will be satisfactory in terms of the information, time and/or expenditure required. We are currently awaiting a decision from OND on the dispute. Unless the deciding official asks us for more information or notifies us that more time is needed to complete the review, we expect a decision on the dispute to be rendered in August 2022. 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 completed the sale of OMIDRIA and certain related assets and liabilities to Rayner Surgical Inc. (“Rayner”) pursuant to an Asset Purchase Agreement dated December 1, 2021 (the “Asset Purchase Agreement”). We received a payment of $126.0 million at closing and receive royalty payments 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) are included in discontinued operations in our condensed consolidated statements of operations and comprehensive loss for all periods presented (see “Note 3 – Discontinued Operations”). Basis of Presentation Our condensed 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 condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain prior year amounts in the condensed consolidated balance sheets, statements of operations, statements of stockholders’ equity (deficit) and statements of cash flows and the notes to the condensed consolidated financial statements have been reclassified in the condensed consolidated financial statements to conform to the current year presentation. Risks and Uncertainties As of June 30, 2022, we had cash, cash equivalents and short-term investments of $122.6 million and outstanding accounts receivable of $14.5 million. Our loss for the second quarter ended June 30, 2022 was $30.9 million and included $3.7 million of noncash operating expenses. Our loss for the six months ended June 30, 2022 was $63.9 million and included $7.9 million of noncash operating expenses. 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, we expect that 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 to be received are adequate to finance our operations at least through August 9, 2023. Accordingly, the accompanying condensed 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. 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 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 | 6 Months Ended |
Jun. 30, 2022 | |
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 condensed 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, for all periods presented in the condensed 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. The Company included information regarding cash flows from discontinued operations (see “Note 3 – Discontinued Operations”). OMIDRIA Royalties and OMIDRIA Contract Royalty Assets We have rights to receive future royalties from Rayner on OMIDRIA net sales at rates that vary based on geography and certain regulatory contingencies. Therefore, future OMIDRIA royalties are treated as variable consideration. The sale of OMIDRIA qualified as an asset sale under GAAP. 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 primarily be recorded as a reduction to the OMIDRIA contract royalty asset. The amount recorded in discontinued operations will reflect interest earned on the outstanding OMIDRIA contract royalty asset and any amounts received that are 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. OMIDRIA Revenue Recognition Prior to the sale of OMIDRIA on December 23, 2021, when we entered into a customer contract, we performed the following five steps: (i) identified the contract with a customer; (ii) identified the performance obligations in the contract; (iii) determined the transaction price; (iv) allocated the transaction price to the performance obligations in the contract; and (v) recognized revenue when (or as) we satisfy a performance obligation. We generally recorded OMIDRIA product sales when the product was delivered to our wholesalers. OMIDRIA product sales were recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances were established for these deductions in the same period when revenue was recognized, and actual amounts incurred were offset against the applicable accruals or allowances. We reflected 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. Inventory We expense inventory costs related to product candidates as research and development expenses until regulatory approval is reasonably assured in the U.S. or the European Union (the “EU”). Once approval is reasonably assured, costs including amounts related to third-party manufacturing, transportation and internal labor and overhead will be capitalized. 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 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. 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. |
Discontinued Operations
Discontinued Operations | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations | |
Discontinued Operations | Note 3—Discontinued Operations On December 23, 2021, we completed 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 receive a 50% royalty on OMIDRIA net sales in the U.S. until 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 until 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. During the three and six months ended June 30, 2022, we earned royalties of $17.2 million and $31.1 million on sales of OMIDRIA which we recorded as a reduction from the OMIDRIA contract royalty asset. We also recorded $17.1 million of income in discontinued operations representing interest income and remeasurement adjustments to the OMIDRIA contract royalty asset. The following schedule presents a rollforward of the OMIDRIA contract royalty asset (in thousands): OMIDRIA contract royalty asset at December 31, 2021 $ 184,570 Royalties earned (31,062) Royalty interest income and remeasurement adjustments 17,098 OMIDRIA contract royalty asset at June 30, 2022 $ 170,606 Net income from discontinued operations is as follows: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) Product sales, net $ — $ 28,823 $ — $ 49,884 Royalty interest income and remeasurement adjustments 10,102 — 17,098 — Total 10,102 28,823 17,098 49,884 Other (income), costs and expenses, net (744) 7,229 (231) 13,611 Net income from discontinued operations $ 10,846 $ 21,594 $ 17,329 $ 36,273 Cash flow from discontinued operations is as follows: Six Months Ended June 30, 2022 2021 (In thousands) Total operating cash flows from discontinued operations $ 13,983 $ (22,821) |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
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 (“RSUs”) 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: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 2023 Notes convertible to common stock (1) 4,941,739 4,941,739 4,941,739 4,941,739 Outstanding options to purchase common stock 88 2,401,024 1,963 2,901,430 Outstanding restricted stock units 208,819 — 207,736 — Total potentially dilutive shares excluded from net loss per share 5,150,646 7,342,763 5,151,438 7,843,169 (1) The 2023 Notes are subject to a capped call arrangement that potentially reduces the dilutive effect as described in “Note 8 — Unsecured Convertible Senior Notes.” Any potential impact of the capped call arrangement is excluded from this table. |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts | 6 Months Ended |
Jun. 30, 2022 | |
Certain Balance Sheet Accounts | |
Certain Balance Sheet Accounts | Note 5—Certain Balance Sheet Accounts OMIDRIA Contract Royalty Asset OMIDRIA contract royalty asset consists of the following: June 30, December 31, 2022 2021 (In thousands) Short-term contract royalty asset $ 43,794 $ 44,319 Long-term contract royalty asset 126,812 140,251 Total OMIDRIA contract royalty asset $ 170,606 $ 184,570 Receivables, net Receivables, net consists of the following: June 30, December 31, 2022 2021 (In thousands) Royalty and trade receivables, net $ 13,669 $ 36,505 Sublease and other receivables 810 1,650 Total receivables, net $ 14,479 $ 38,155 Trade receivables are net of product return and chargeback allowances. Product returns and chargeback allowances were $2.0 million as of December 31, 2021. Property and Equipment, Net Property and equipment, net consists of the following: June 30, December 31, 2022 2021 (In thousands) Finance leases $ 6,537 $ 5,979 Laboratory equipment 3,123 3,091 Computer equipment 1,076 1,069 Office equipment and furniture 625 625 Total cost 11,361 10,764 Less accumulated depreciation and amortization (9,440) (9,033) Total property and equipment, net $ 1,921 $ 1,731 For the three months ended June 30, 2022 and 2021, depreciation and amortization expense was $0.2 million and $0.4 million, respectively. For the six months ended June 30, 2022 and 2021, depreciation and amortization expense was $0.5 million and $0.7 million, respectively. Accrued Expenses Accrued expenses consists of the following: June 30, December 31, 2022 2021 (In thousands) Employee compensation $ 6,017 $ 3,706 Interest payable 5,172 5,172 Clinical trials 4,573 2,430 Consulting and professional fees 3,179 7,455 Contract research and development 2,889 3,916 Sales rebates, fees and discounts 255 8,442 Other accrued expenses 1,395 2,013 Total accrued expenses $ 23,480 $ 33,134 |
Fair-Value Measurements
Fair-Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair-Value Measurements | |
Fair-Value Measurements | Note 6—Fair-Value Measurements As of June 30, 2022, and December 31, 2021, all investments were classified as short-term and available-for-sale on the accompanying condensed consolidated balance sheets. 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 and liabilities measured at fair value on a recurring basis are as follows: June 30, 2022 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 108,427 $ — $ — $ 108,427 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 109,481 $ — $ — $ 109,481 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 Cash held in demand deposit accounts of $14.1 million and $100.8 million is excluded from our fair-value hierarchy disclosure as of June 30, 2022 and December 31, 2021, respectively. There were no unrealized gains or losses associated with our investments as of June 30, 2022 or December 31, 2021. The carrying amounts reported in the accompanying condensed consolidated balance sheets for receivables, accounts payable, other current monetary assets and liabilities approximate fair value. See “Note 8—Unsecured Convertible Senior Notes” for the carrying amount and estimated fair value of our outstanding convertible senior notes. |
Line of Credit
Line of Credit | 6 Months Ended |
Jun. 30, 2022 | |
Line of Credit | |
Line of Credit | Note 7—Line of Credit As of June 30, 2022, we had a Loan and Security Agreement with Silicon Valley Bank (“SVB”) providing for a $50.0 million revolving line of credit facility (the “Line of Credit Agreement”). The Line of Credit Agreement expired on August 2, 2022. |
Unsecured Convertible Senior No
Unsecured Convertible Senior Notes | 6 Months Ended |
Jun. 30, 2022 | |
Unsecured Convertible Senior Notes | |
Unsecured Convertible Senior Notes | Note 8—Unsecured Convertible Senior Notes In November 2018, we issued $210.0 million in aggregate principal amount of our 6.25% Convertible Senior Notes (the “2023 Notes ”) , and in August and September 2020, we issued $225.0 million in aggregate principal amount of our 5.25% Convertible Senior Notes (the “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 for the 2023 Notes, as described below. Unsecured convertible senior notes outstanding at June 30, 2022 and December 31, 2021 are as follows: Balance as of June 30, 2022 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (956) (4,716) (5,672) Total unsecured convertible senior notes, net $ 94,044 $ 220,314 $ 314,358 Fair value of outstanding unsecured convertible senior notes (1) $ 85,263 $ 132,064 Balance as of December 31, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized discount (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 (1) The fair value is classified as Level 3 due to the limited trading activity for the unsecured convertible senior notes. 2023 Unsecured Convertible Senior Notes Our 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. As of June 30, 2022, the unamortized debt issuance costs of $1.0 million will be amortized to interest expense at an effective interest rate of 7.0% over the remaining term. 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), which equals approximately 4.9 million shares of common stock issuable upon conversion, subject to adjustment in certain circumstances. To reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2023 Notes, we entered into a capped call transaction (the “2023 Capped Call”), which covers the number of shares of our common stock underlying the 2023 Notes when our common stock share price is trading between the initial conversion price of $19.22 and $28.84 . In connection with the partial repurchase of the 2023 Notes, we entered into a capped call termination contract to unwind a proportionate amount of the 2023 Capped Call. As of June 30, 2022, 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: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Contractual interest expense $ 1,484 $ 1,484 $ 2,969 $ 2,969 Amortization of debt issuance costs 164 153 325 303 Total $ 1,648 $ 1,637 $ 3,294 $ 3,272 2026 Unsecured Convertible Senior Notes Our 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. As of June 30, 2022, the unamortized debt issuance costs of $4.7 million will be amortized to interest expense at an effective interest rate of 5.9% over the remaining term. The 2026 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 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 of common stock issuable upon conversion, subject to adjustment in certain circumstances. To reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2026 Notes, we entered into capped call transactions (the “2026 Capped Calls”). The 2026 Capped Calls will cover the number of shares of our common stock underlying the 2026 Notes when our common stock share price is trading between the initial conversion price of $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 a dilutive impact or may require a cash expenditure to the extent the market price exceeds the cap price. The following table sets forth interest expense recognized related to the 2026 Notes: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Contractual interest expense $ 2,954 $ 2,954 $ 5,907 $ 5,907 Amortization of debt issuance costs 290 273 575 519 Total $ 3,244 $ 3,227 $ 6,482 $ 6,426 Future minimum payments for the 2023 Notes and 2026 Notes as of June 30, 2022 are as follows: (In thousands) 2023 $ 95,000 2024 — 2025 — 2026 225,030 2027 — Total future minimum principal payments under the 2023 Notes and 2026 Notes $ 320,030 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Leases | Note 9—Leases We have an operating lease for our office and laboratory facilities with an initial term that ends in 2027 with two options to extend the lease term by five years. On 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 laboratory facilities, which reduced the right of use asset by $4.7 million and related liability by $5.2 million. We recorded a non-cash gain of $0.5 million to early terminate the lease. In addition, we carry various finance leases for laboratory equipment. Supplemental lease information is as follows: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Lease cost Operating lease cost $ 1,663 $ 1,984 $ 2,870 $ 3,567 Finance lease cost: Amortization 122 288 320 611 Interest 36 40 92 89 Variable lease cost 722 992 1,582 1,804 Sublease income (453) (423) (945) (841) Net lease cost $ 2,090 $ 2,881 $ 3,919 $ 5,230 Cash paid for amounts included in the measurement of lease liabilities is as follows: Six Months Ended June 30, 2022 2021 (In thousands) Cash paid for amounts included in the measurement of lease liabilities Cash payments for operating leases $ 3,562 $ 3,578 Cash payments for financing leases $ 401 $ 436 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 10—Commitments and Contingencies Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $30.5 million as of June 30, 2022 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 three months and six months ended June 30, 2022 and June 30, 2021, development milestone expenses were insignificant. Should narsoplimab be approved, we would owe milestone payments to development partners and be obligated to pay low single-digit royalties on net sales of the product. |
Shareholders' Deficit
Shareholders' Deficit | 6 Months Ended |
Jun. 30, 2022 | |
Shareholders' Deficit | |
Shareholders' Deficit | Note 11—Shareholders’ Deficit Common Stock and Warrants On March 1, 2021, we entered into a sales agreement to sell shares of our common stock having an aggregate offering price of up to $150.0 million, from time to time, through an “at the market” equity offering program. As of June 30, 2022, we have not sold any shares under this program. In March 2021, a cashless exercise was executed for 43,115 warrants, resulting in the issuance of 24,901 shares of our common stock. As of June 30, 2022, 200,000 warrants remained outstanding with an exercise price of $23.00 per share. The warrants expire on April 12, 2023. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Compensation. | |
Stock-Based Compensation | Note 12—Stock-Based Compensation Our stock option plans provide for the grant of incentive and non-qualified stock options, restricted stock awards, RSUs, warrants and other stock awards to employees, non-employee directors and consultants. Stock-based compensation is as follows: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) Continuing operations Research and development $ 1,389 $ 1,390 $ 3,104 $ 2,840 Selling, general and administrative 1,793 1,522 3,970 3,132 Total stock-based compensation in continuing operations 3,182 2,912 7,074 5,972 Discontinued operations (110) 205 (110) 416 Total stock-based compensation $ 3,072 $ 3,117 $ 6,964 $ 6,388 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 all stock option grants: Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 Estimated weighted-average fair value $ 1.90 $ 2.19 Weighted-average assumptions: Expected volatility 82 % 82 % Expected life, in years 5.8 5.8 Risk-free interest rate 2.51 % 2.46 % Expected dividend yield — % — % Stock option activity for all stock plans and related information 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, 2021 12,709,887 $ 12.61 Granted 125,534 7.29 Exercised (101,160) 4.10 Forfeited (367,273) 13.96 Balance at June 30, 2022 12,366,988 $ 12.55 5.1 $ 46 Vested and expected to vest at June 30, 2022 12,106,495 $ 12.53 5.0 $ 42 Exercisable at June 30, 2022 9,865,506 $ 12.26 4.3 $ — As of June 30, 2022, there were 2.5 million unvested options outstanding that will vest over a weighted-average period of 2.2 years. The total estimated compensation expense yet to be recognized on outstanding options is $20.0 million. The Company has 204,500 shares of unvested RSUs outstanding as of June 30, 2022 that vest 50% on December 1, 2022 and 50% on December 1, 2023. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Significant Accounting Policies | |
Description of Business | 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. We marketed our first drug product, OMIDRIA ® 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 post-action meeting with FDA to discuss the CRL. Although we felt that we adequately addressed all of the issues noted in the CRL, the meeting minutes included a number of the review division’s critiques that we believe had already been addressed and/or were inaccurate. As a result, in June 2022, we submitted a Formal Dispute Resolution Request. Formal Dispute Resolution is an official pathway that enables a sponsor to appeal a decision by an FDA review division to a higher authority within FDA, in this case the Office of New Drugs (“OND”). 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; however, there can be no assurances that the Formal Dispute Resolution process will provide a clear path to resubmission of our BLA, that resubmission will result in approval of our BLA, or that any identified path to BLA resubmission will be satisfactory in terms of the information, time and/or expenditure required. We are currently awaiting a decision from OND on the dispute. Unless the deciding official asks us for more information or notifies us that more time is needed to complete the review, we expect a decision on the dispute to be rendered in August 2022. 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. |
Basis of Presentation | Basis of Presentation Our condensed 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 condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain prior year amounts in the condensed consolidated balance sheets, statements of operations, statements of stockholders’ equity (deficit) and statements of cash flows and the notes to the condensed consolidated financial statements have been reclassified in the condensed consolidated financial statements to conform to the current year presentation. |
Risks and Uncertainties | Risks and Uncertainties As of June 30, 2022, we had cash, cash equivalents and short-term investments of $122.6 million and outstanding accounts receivable of $14.5 million. Our loss for the second quarter ended June 30, 2022 was $30.9 million and included $3.7 million of noncash operating expenses. Our loss for the six months ended June 30, 2022 was $63.9 million and included $7.9 million of noncash operating expenses. 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, we expect that 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 to be received are adequate to finance our operations at least through August 9, 2023. Accordingly, the accompanying condensed 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. |
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 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 condensed 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, for all periods presented in the condensed 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. 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 We have rights to receive future royalties from Rayner on OMIDRIA net sales at rates that vary based on geography and certain regulatory contingencies. Therefore, future OMIDRIA royalties are treated as variable consideration. The sale of OMIDRIA qualified as an asset sale under GAAP. 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 primarily be recorded as a reduction to the OMIDRIA contract royalty asset. The amount recorded in discontinued operations will reflect interest earned on the outstanding OMIDRIA contract royalty asset and any amounts received that are 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. |
OMIDRIA Revenue Recognition | OMIDRIA Revenue Recognition Prior to the sale of OMIDRIA on December 23, 2021, when we entered into a customer contract, we performed the following five steps: (i) identified the contract with a customer; (ii) identified the performance obligations in the contract; (iii) determined the transaction price; (iv) allocated the transaction price to the performance obligations in the contract; and (v) recognized revenue when (or as) we satisfy a performance obligation. We generally recorded OMIDRIA product sales when the product was delivered to our wholesalers. OMIDRIA product sales were recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances were established for these deductions in the same period when revenue was recognized, and actual amounts incurred were offset against the applicable accruals or allowances. We reflected 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. |
Inventory | Inventory We expense inventory costs related to product candidates as research and development expenses until regulatory approval is reasonably assured in the U.S. or the European Union (the “EU”). Once approval is reasonably assured, costs including amounts related to third-party manufacturing, transportation and internal labor and overhead will be capitalized. |
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 |
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. |
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. |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations | |
Schedule of contract royalty asset | OMIDRIA contract royalty asset at December 31, 2021 $ 184,570 Royalties earned (31,062) Royalty interest income and remeasurement adjustments 17,098 OMIDRIA contract royalty asset at June 30, 2022 $ 170,606 |
Schedule of net income from discontinued operation | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) Product sales, net $ — $ 28,823 $ — $ 49,884 Royalty interest income and remeasurement adjustments 10,102 — 17,098 — Total 10,102 28,823 17,098 49,884 Other (income), costs and expenses, net (744) 7,229 (231) 13,611 Net income from discontinued operations $ 10,846 $ 21,594 $ 17,329 $ 36,273 |
Schedule of cash flow from discontinued operation | Six Months Ended June 30, 2022 2021 (In thousands) Total operating cash flows from discontinued operations $ 13,983 $ (22,821) |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss Per Share | |
Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss per Share | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 2023 Notes convertible to common stock (1) 4,941,739 4,941,739 4,941,739 4,941,739 Outstanding options to purchase common stock 88 2,401,024 1,963 2,901,430 Outstanding restricted stock units 208,819 — 207,736 — Total potentially dilutive shares excluded from net loss per share 5,150,646 7,342,763 5,151,438 7,843,169 (1) The 2023 Notes are subject to a capped call arrangement that potentially reduces the dilutive effect as described in “Note 8 — Unsecured Convertible Senior Notes.” Any potential impact of the capped call arrangement is excluded from this table. |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Certain Balance Sheet Accounts | |
Schedule of OMIDRIA contact royalty asset | June 30, December 31, 2022 2021 (In thousands) Short-term contract royalty asset $ 43,794 $ 44,319 Long-term contract royalty asset 126,812 140,251 Total OMIDRIA contract royalty asset $ 170,606 $ 184,570 |
Schedule of accounts receivable | June 30, December 31, 2022 2021 (In thousands) Royalty and trade receivables, net $ 13,669 $ 36,505 Sublease and other receivables 810 1,650 Total receivables, net $ 14,479 $ 38,155 |
Property, Plant and Equipment | June 30, December 31, 2022 2021 (In thousands) Finance leases $ 6,537 $ 5,979 Laboratory equipment 3,123 3,091 Computer equipment 1,076 1,069 Office equipment and furniture 625 625 Total cost 11,361 10,764 Less accumulated depreciation and amortization (9,440) (9,033) Total property and equipment, net $ 1,921 $ 1,731 |
Accrued Expenses | June 30, December 31, 2022 2021 (In thousands) Employee compensation $ 6,017 $ 3,706 Interest payable 5,172 5,172 Clinical trials 4,573 2,430 Consulting and professional fees 3,179 7,455 Contract research and development 2,889 3,916 Sales rebates, fees and discounts 255 8,442 Other accrued expenses 1,395 2,013 Total accrued expenses $ 23,480 $ 33,134 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair-Value Measurements | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | June 30, 2022 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 108,427 $ — $ — $ 108,427 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 109,481 $ — $ — $ 109,481 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 |
Unsecured Convertible Senior _2
Unsecured Convertible Senior Notes (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Instrument [Line Items] | |
Summary of unsecured convertible senior notes outstanding | Balance as of June 30, 2022 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (956) (4,716) (5,672) Total unsecured convertible senior notes, net $ 94,044 $ 220,314 $ 314,358 Fair value of outstanding unsecured convertible senior notes (1) $ 85,263 $ 132,064 Balance as of December 31, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized discount (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 (1) The fair value is classified as Level 3 due to the limited trading activity for the unsecured convertible senior notes. |
Schedule of future minimum payments of debt | (In thousands) 2023 $ 95,000 2024 — 2025 — 2026 225,030 2027 — Total future minimum principal payments under the 2023 Notes and 2026 Notes $ 320,030 |
2023 Unsecured Convertible Senior Notes | |
Debt Instrument [Line Items] | |
Schedule of total interest expense recognized | Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Contractual interest expense $ 1,484 $ 1,484 $ 2,969 $ 2,969 Amortization of debt issuance costs 164 153 325 303 Total $ 1,648 $ 1,637 $ 3,294 $ 3,272 |
2026 Unsecured Convertible Senior Notes | |
Debt Instrument [Line Items] | |
Schedule of total interest expense recognized | Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Contractual interest expense $ 2,954 $ 2,954 $ 5,907 $ 5,907 Amortization of debt issuance costs 290 273 575 519 Total $ 3,244 $ 3,227 $ 6,482 $ 6,426 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases | |
Schedule of lease costs | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) (In thousands) Lease cost Operating lease cost $ 1,663 $ 1,984 $ 2,870 $ 3,567 Finance lease cost: Amortization 122 288 320 611 Interest 36 40 92 89 Variable lease cost 722 992 1,582 1,804 Sublease income (453) (423) (945) (841) Net lease cost $ 2,090 $ 2,881 $ 3,919 $ 5,230 |
Schedule of supplemental cash flow information | Six Months Ended June 30, 2022 2021 (In thousands) Cash paid for amounts included in the measurement of lease liabilities Cash payments for operating leases $ 3,562 $ 3,578 Cash payments for financing leases $ 401 $ 436 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Compensation. | |
Stock-Based Compensation Expense | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 (In thousands) Continuing operations Research and development $ 1,389 $ 1,390 $ 3,104 $ 2,840 Selling, general and administrative 1,793 1,522 3,970 3,132 Total stock-based compensation in continuing operations 3,182 2,912 7,074 5,972 Discontinued operations (110) 205 (110) 416 Total stock-based compensation $ 3,072 $ 3,117 $ 6,964 $ 6,388 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Three Months Ended Six Months Ended June 30, 2022 June 30, 2022 Estimated weighted-average fair value $ 1.90 $ 2.19 Weighted-average assumptions: Expected volatility 82 % 82 % Expected life, in years 5.8 5.8 Risk-free interest rate 2.51 % 2.46 % 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, 2021 12,709,887 $ 12.61 Granted 125,534 7.29 Exercised (101,160) 4.10 Forfeited (367,273) 13.96 Balance at June 30, 2022 12,366,988 $ 12.55 5.1 $ 46 Vested and expected to vest at June 30, 2022 12,106,495 $ 12.53 5.0 $ 42 Exercisable at June 30, 2022 9,865,506 $ 12.26 4.3 $ — |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Dec. 23, 2021 | Jun. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Cash, cash equivalents and short-term investments | $ 122,600 | $ 122,600 | |||
Receivables, net | 14,479 | 14,479 | $ 38,155 | ||
Net loss | 30,900 | 63,860 | $ 63,683 | ||
Noncash operating expenses | 3,700 | 7,900 | |||
Maximum Aggregate Offering Price | 150,000 | 150,000 | |||
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 | ||||
Milestone payment receivable | $ 200,000 | $ 200,000 | $ 200,000 | ||
Milestone period | 4 years |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) $ in Millions | Jun. 30, 2022 | Dec. 23, 2021 |
Discontinued Operation | Omidria Assets Disposal | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Milestone payment receivable | $ 200 | $ 200 |
Discontinued Operations - Narra
Discontinued Operations - Narrative (Details) - Discontinued Operation - Omidria Assets Disposal - USD ($) $ in Millions | Dec. 23, 2021 | Jun. 30, 2022 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cash proceeds on sale of OMIDRIA | $ 126 | |
Percentage of royalty receivable | 50% | |
Percentage of royalty receivable after January 1, 2025 or payment of milestone | 30% | |
Milestone payment receivable | $ 200 | $ 200 |
Milestone Period | 4 years | |
Percent of reduction in royalty receivable | 10% | |
Percentage of royalty receivable outside US | 15% |
Discontinued Operations - OMIDR
Discontinued Operations - OMIDRIA contract royalty asset (Details) - Discontinued Operation - Omidria Assets Disposal - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
OMIDRIA contract royalty asset, beginning balance | $ 184,570 | |
Royalties earned | $ (17,200) | (31,062) |
Royalty interest income and remeasurement adjustments | 17,098 | |
OMIDRIA contract royalty asset, ending balance | $ 170,606 | $ 170,606 |
Discontinued Operations - Net I
Discontinued Operations - Net Income Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Net income from discontinued operations | $ 10,846 | $ 21,594 | $ 17,329 | $ 36,273 |
Discontinued Operation | Omidria Assets Disposal | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Revenue | 10,102 | 28,823 | 17,098 | 49,884 |
Other (income), costs and expenses, net | (744) | 7,229 | (231) | 13,611 |
Net income from discontinued operations | 10,846 | 21,594 | 17,329 | 36,273 |
Discontinued Operation | Omidria Assets Disposal | Product sales, net | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Revenue | $ 28,823 | $ 49,884 | ||
Discontinued Operation | Omidria Assets Disposal | Royalty interest income and remeasurement adjustments | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Revenue | $ 10,102 | $ 17,098 |
Discontinued Operations - Cash
Discontinued Operations - Cash Flow (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Discontinued Operation | Omidria Assets Disposal | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Total operating cash flows from discontinued operations | $ 13,983 | $ (22,821) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares excluded from net loss per share | 5,150,646 | 7,342,763 | 5,151,438 | 7,843,169 |
2023 Unsecured Convertible Senior Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares excluded from net loss per share | 4,941,739 | 4,941,739 | 4,941,739 | 4,941,739 |
Outstanding options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares excluded from net loss per share | 88 | 2,401,024 | 1,963 | 2,901,430 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares excluded from net loss per share | 208,819 | 207,736 |
Certain Balance Sheet Account_2
Certain Balance Sheet Accounts - Contract Royalty Asset and Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Certain Balance Sheet Accounts | ||
Short-term contract royalty asset | $ 43,794 | $ 44,319 |
Long-term contract royalty asset | 126,812 | 140,251 |
Total OMIDRIA contract royalty asset | 170,606 | 184,570 |
Royalty and trade receivables, net | 13,669 | 36,505 |
Sublease and other receivables | 810 | 1,650 |
Total receivables, net | $ 14,479 | 38,155 |
Chargeback and product return allowances | $ 2,000 |
Certain Balance Sheet Account_3
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||||
Total cost | $ 11,361 | $ 11,361 | $ 10,764 | ||
Less accumulated depreciation and amortization | (9,440) | (9,440) | (9,033) | ||
Total property and equipment, net | 1,921 | 1,921 | 1,731 | ||
Depreciation and amortization | 200 | $ 400 | 469 | $ 745 | |
Finance leases | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 6,537 | 6,537 | 5,979 | ||
Laboratory equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 3,123 | 3,123 | 3,091 | ||
Computer equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 1,076 | 1,076 | 1,069 | ||
Office equipment and furniture | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | $ 625 | $ 625 | $ 625 |
Certain Balance Sheet Account_4
Certain Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued expenses | ||
Employee compensation | $ 6,017 | $ 3,706 |
Interest payable | 5,172 | 5,172 |
Clinical trials | 4,573 | 2,430 |
Consulting and professional fees | 3,179 | 7,455 |
Contract research and development | 2,889 | 3,916 |
Sales rebates, fees and discounts | 255 | 8,442 |
Other accrued expenses | 1,395 | 2,013 |
Total accrued expenses | $ 23,480 | $ 33,134 |
Fair-Value Measurements - Recur
Fair-Value Measurements - Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as short-term investments | $ 108,427 | $ 56,458 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,054 |
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 | 108,427 | 56,458 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,054 |
Total | 109,481 | 57,512 |
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 | 108,427 | 56,458 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,054 |
Total | $ 109,481 | $ 57,512 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Fair-Value Measurements | ||
Cash and cash equivalents | $ 14,136 | $ 100,808 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Line of Credit (Details)
Line of Credit (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument | ||
Outstanding amount | $ 314,358 | $ 313,458 |
Line of Credit Agreement | ||
Debt Instrument | ||
Maximum borrowing capacity | 50,000 | |
Outstanding amount | $ 0 |
Unsecured Convertible Senior _3
Unsecured Convertible Senior Notes - Unsecured convertible senior notes outstanding (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Principal amount | $ 320,030 | $ 320,030 |
Unamortized discount | (6,572) | |
Unamortized debt issuance costs | (5,672) | |
Total unsecured convertible senior notes, net | 314,358 | 313,458 |
2023 Unsecured Convertible Senior Notes | ||
Debt Instrument [Line Items] | ||
Principal amount | 95,000 | 95,000 |
Unamortized discount | (1,282) | |
Unamortized debt issuance costs | (956) | |
Total unsecured convertible senior notes, net | 94,044 | 93,718 |
Fair value of outstanding unsecured convertible senior notes (1) | 85,263 | 87,163 |
2026 Unsecured Convertible Senior Notes | ||
Debt Instrument [Line Items] | ||
Principal amount | 225,030 | 225,030 |
Unamortized discount | (5,290) | |
Unamortized debt issuance costs | (4,716) | |
Total unsecured convertible senior notes, net | 220,314 | 219,740 |
Fair value of outstanding unsecured convertible senior notes (1) | $ 132,064 | $ 171,867 |
Unsecured Convertible Senior _4
Unsecured Convertible Senior Notes - 2023 Unsecured Convertible Senior Notes (Details) $ / shares in Units, shares in Millions | 1 Months Ended | ||
Nov. 30, 2018 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) shares | Aug. 14, 2020 USD ($) | |
Debt Instrument [Line Items] | |||
Unamortized debt issuance costs | $ 5,672,000 | ||
2023 Unsecured Convertible Senior Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 210,000,000 | ||
Interest rate (as a percent) | 6.25% | ||
Principal amount of debt repurchased | $ 115,000,000 | ||
Unamortized debt issuance costs | $ 956,000 | ||
Effective interest rate to determine fair value of liability component (as a percent) | 7% | ||
Conversion rate | 0.0520183 | ||
Value used in calculation of conversion rate | $ 1,000 | ||
Conversion price | $ / shares | $ 19.22 | ||
Shares upon conversion | shares | 4.9 | ||
Number of shares outstanding on the 2023 Capped Call | shares | 4.9 | ||
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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
2023 Unsecured Convertible Senior Notes | ||||
Interest Expense, Debt [Abstract] | ||||
Contractual interest expense | $ 1,484 | $ 1,484 | $ 2,969 | $ 2,969 |
Amortization of debt issuance costs | 164 | 153 | 325 | 303 |
Total | 1,648 | 1,637 | 3,294 | 3,272 |
2026 Unsecured Convertible Senior Notes | ||||
Interest Expense, Debt [Abstract] | ||||
Contractual interest expense | 2,954 | 2,954 | 5,907 | 5,907 |
Amortization of debt issuance costs | 290 | 273 | 575 | 519 |
Total | $ 3,244 | $ 3,227 | $ 6,482 | $ 6,426 |
Unsecured Convertible Senior _6
Unsecured Convertible Senior Notes - 2026 Unsecured Convertible Senior Notes (Details) $ / shares in Units, shares in Millions | 2 Months Ended | |
Sep. 30, 2020 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | ||
Unamortized debt issuance costs | $ 5,672,000 | |
2026 Unsecured Convertible Senior Notes | ||
Debt Instrument [Line Items] | ||
Principal amount | $ 225,000,000 | |
Interest rate (as a percent) | 5.25% | |
Unamortized debt issuance costs | $ 4,716,000 | |
Effective interest rate to determine fair value of liability component (as a percent) | 5.90% | |
Conversion rate | 0.0540906 | |
Value used in calculation of conversion rate | $ 1,000 | |
Conversion price | $ / shares | $ 18.4875 | |
Shares upon conversion | shares | 12.2 | |
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 | Jun. 30, 2022 | Dec. 31, 2021 |
Long-term Debt, Fiscal Year Maturity [Abstract] | ||
Total future minimum principal payments under 2023 Notes and 2026 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 principal payments under 2023 Notes and 2026 Notes | $ 320,030 |
Leases (Details)
Leases (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jan. 14, 2022 USD ($) | Jun. 30, 2022 USD ($) item | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) item | Jun. 30, 2021 USD ($) | |
Leases | |||||
Number of options to extend lease term | item | 2 | 2 | |||
Expected lease term | 5 years | 5 years | |||
Decrease in right of use asset due to lease termination | $ 4,700 | ||||
Decrease in lease liability due to lease termination | 5,200 | ||||
Non-cash gain of termination of lease | $ 500 | $ 454 | |||
Lease cost | |||||
Operating lease cost | $ 1,663 | $ 1,984 | 2,870 | $ 3,567 | |
Amortization | 122 | 288 | 320 | 611 | |
Interest | 36 | 40 | 92 | 89 | |
Variable lease cost | 722 | 992 | 1,582 | 1,804 | |
Sublease income | (453) | (423) | (945) | (841) | |
Net lease cost | $ 2,090 | $ 2,881 | 3,919 | 5,230 | |
Cash payments for operating leases | 3,562 | 3,578 | |||
Cash payments for financing leases | $ 401 | $ 436 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Jun. 30, 2022 USD ($) |
Commitments and Contingencies. | |
Contract termination fees | $ 30.5 |
Shareholders' Deficit - Additio
Shareholders' Deficit - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |
Mar. 31, 2021 | Jun. 30, 2022 | Mar. 01, 2021 | |
Class of Stock [Line Items] | |||
Maximum aggregate offering price | $ 150 | ||
Cashless exercise of warrants | 43,115 | ||
Exercise of stock options (in shares) | 101,160 | ||
Warrants outstanding | 200,000 | ||
Warrant exercise price (in USD per share) | $ 23 | ||
Warrant | |||
Class of Stock [Line Items] | |||
Exercise of stock options (in shares) | 24,901 | ||
At The Market (ATM) Program | |||
Class of Stock [Line Items] | |||
Maximum aggregate offering price | $ 150 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation in continuing operations | $ 3,182 | $ 2,912 | $ 7,074 | $ 5,972 |
Discontinued operations | (110) | 205 | (110) | 416 |
Total stock-based compensation | 3,072 | 3,117 | 6,964 | 6,388 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation in continuing operations | 1,389 | 1,390 | 3,104 | 2,840 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation in continuing operations | $ 1,793 | $ 1,522 | $ 3,970 | $ 3,132 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Outstanding options to purchase common stock - $ / shares | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Estimated weighted-average fair value (USD per share) | $ 1.90 | $ 2.19 |
Weighted Average | ||
Weighted-average assumptions: | ||
Expected volatility | 82% | 82% |
Expected life, in years | 5 years 9 months 18 days | 5 years 9 months 18 days |
Risk-free interest rate | 2.51% | 2.46% |
Expected dividend yield | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | |
Options Outstanding | |
Beginning balance (shares) | shares | 12,709,887 |
Granted (shares) | shares | 125,534 |
Exercised (shares) | shares | (101,160) |
Forfeited (shares) | shares | (367,273) |
Ending balance (shares) | shares | 12,366,988 |
Vested and expected to vest (shares) | shares | 12,106,495 |
Exercisable (shares) | shares | 9,865,506 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 12.61 |
Granted (USD per share) | $ / shares | 7.29 |
Exercised (USD per share) | $ / shares | 4.10 |
Forfeited (USD per share) | $ / shares | 13.96 |
Ending balance (USD per share) | $ / shares | 12.55 |
Vested and expected to vest (USD per share) | $ / shares | 12.53 |
Exercisable (USD per share) | $ / shares | $ 12.26 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 5 years 1 month 6 days |
Vested and expected to vest (in years) | 5 years |
Exercisable (in years) | 4 years 3 months 18 days |
Aggregate Intrinsic Value | |
Balance | $ | $ 46 |
Vested and expected to vest | $ | $ 42 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) shares | |
Outstanding options to purchase common stock | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Unvested options outstanding (shares) | 2,500,000 |
Period for recognition | 2 years 2 months 12 days |
Unrecognized compensation expense | $ | $ 20 |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Restricted stock units, unvested | 204,500 |
Yearly vesting percentage | 50% |