Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 05, 2021 | |
Document Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 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 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 62,495,645 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
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, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 12,702 | $ 10,501 |
Short-term investments | 60,956 | 124,452 |
Receivables, net | 31,838 | 3,841 |
Inventory | 978 | 1,355 |
Prepaid expense and other assets | 5,927 | 11,136 |
Total current assets | 112,401 | 151,285 |
Property and equipment, net | 1,907 | 2,551 |
Right of use assets | 29,824 | 25,526 |
Restricted investments | 1,054 | 1,055 |
Advanced payments, non-current | 205 | 625 |
Total assets | 145,391 | 181,042 |
Current liabilities: | ||
Accounts payable | 9,502 | 4,199 |
Accrued expenses | 33,321 | 28,755 |
Current portion of lease liabilities | 4,874 | 3,782 |
Total current liabilities | 47,697 | 36,736 |
Lease liabilities, non-current | 31,405 | 28,770 |
Unsecured convertible senior notes, net | 312,585 | 236,288 |
Commitments and contingencies (Note 9) | ||
Shareholders' deficit: | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at June 30, 2021 and December 31, 2020. | ||
Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 62,490,940 and 61,671,231 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively. | 624 | 616 |
Additional paid-in capital | 694,132 | 751,304 |
Accumulated deficit | (941,052) | (872,672) |
Total shareholders' deficit | (246,296) | (120,752) |
Total liabilities and shareholders' deficit | $ 145,391 | $ 181,042 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 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 | 62,490,940 | 61,671,231 |
Common stock, outstanding shares | 62,490,940 | 61,671,231 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue: | ||||
Product sales, net | $ 28,823 | $ 13,530 | $ 49,885 | $ 37,067 |
Costs and expenses: | ||||
Cost of product sales | 342 | 147 | 606 | 414 |
Research and development | 30,937 | 24,132 | 64,309 | 53,043 |
Selling, general and administrative | 21,560 | 16,931 | 39,598 | 34,967 |
Total costs and expenses | 52,839 | 41,210 | 104,513 | 88,424 |
Loss from operations | (24,016) | (27,680) | (54,628) | (51,357) |
Interest expense | (4,910) | (5,978) | (9,808) | (11,880) |
Other income | 333 | 364 | 753 | 912 |
Net loss | (28,593) | (33,294) | (63,683) | (62,325) |
Comprehensive loss | $ (28,593) | $ (33,294) | $ (63,683) | $ (62,325) |
Basic net loss per share | $ (0.46) | $ (0.61) | $ (1.02) | $ (1.14) |
Diluted net loss per share | $ (0.46) | $ (0.61) | $ (1.02) | $ (1.14) |
Weighted-average shares used to compute basic net loss per share | 62,373,521 | 54,513,337 | 62,154,714 | 54,406,575 |
Weighted-average shares used to compute diluted net loss per share | 62,373,521 | 54,513,337 | 62,166,295 | 54,406,575 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Operating activities: | ||
Net loss | $ (63,683) | $ (62,325) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 6,388 | 7,298 |
Non-cash interest expense | 822 | 5,159 |
Depreciation and amortization | 745 | 814 |
Changes in operating assets and liabilities: | ||
Receivables | (27,997) | 19,405 |
Inventory | 377 | (745) |
Prepaid expenses and other assets | 5,633 | 1,881 |
Accounts payable and accrued expenses | 9,869 | (18,225) |
Net cash used in operating activities | (67,846) | (46,738) |
Investing activities: | ||
Purchases of property and equipment | (100) | (210) |
Purchases of investments | (4) | (3,188) |
Proceeds from the sale and maturities of investments | 63,500 | 46,768 |
Net cash provided by investing activities | 63,396 | 43,370 |
Financing activities: | ||
Proceeds upon exercise of stock options and warrants | 7,468 | 2,778 |
At the market offering costs | (241) | |
Payments on finance lease obligations | (576) | (530) |
Net cash provided by financing activities | 6,651 | 2,248 |
Net (decrease) increase in cash and cash equivalents | 2,201 | (1,120) |
Cash and cash equivalents at beginning of period | 10,501 | 3,084 |
Cash and cash equivalents at end of period | 12,702 | 1,964 |
Supplemental cash flow information | ||
Cash paid for interest | 9,012 | 6,721 |
Property acquired under finance lease | $ 39 | $ 44 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2021 | |
Description of Business | |
Description of Business | Note 1—Description of Business Description of Business We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system, addiction and immune-related diseases, including cancers. Our first drug product, OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1%/0.3% Our drug candidate narsoplimab is the subject of a biologics license application (“BLA”) under priority review by the U.S. Food and Drug Administration (“FDA”) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”). 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 Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation (“Omeros”) and our wholly owned subsidiaries. All intercompany transactions have been eliminated, and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of June 30, 2021 and December 31, 2020 and for the three and six months ended June 30, 2021 and 2020 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2020 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2021. Risks and Uncertainties The COVID-19 pandemic and the responses to it by various governmental authorities, the medical community and others have had a significant impact on our business. It is not possible to estimate precisely the future impact of the COVID-19 pandemic on our business, operations or financial results due to the unknown magnitude, duration and outcome of the pandemic. We have filed with FDA our BLA for narsoplimab in HSCT-TMA, which has been granted priority review with an FDA action date of October 17, 2021 under the Prescription Drug User Fee Act (“PDUFA”). We anticipate, but cannot guarantee, that narsoplimab will receive FDA approval and will commercially launch in the U.S. in 2021. Our sales and marketing strategies for the commercial launch of narsoplimab for HSCT-TMA include various milestones at which we commit to incremental spending, providing for flexibility in the timing of costs incurred should the approval of narsoplimab be delayed. If approved, we cannot fully predict the timing or the magnitude of narsoplimab revenues. We plan to continue to fund our operations for the next twelve months with our cash and investments from sales of OMIDRIA and, if FDA approval is granted, from sales of narsoplimab for HSCT-TMA. In addition, we may utilize funds available under our line of credit, which allows us to borrow up to 85% of our available accounts receivable borrowing base, less certain reserves, or $50.0 million, whichever is less. The line of credit matures August 2, 2022 . We also entered into a sales agreement to sell shares of our common stock, from time to time, up to an aggregate offering amount of $150.0 million through an “at the market” equity offering program. Should it be necessary or 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. Should it be necessary to manage our operating expenses, we would reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities. 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, stock-based compensation expense and accruals for clinical trials as well as 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, 2021 | |
Significant Accounting Policies | |
Significant Accounting Policies | Note 2—Significant Accounting Policies 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. We generally record revenue from product sales when the product is delivered to our wholesalers. 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. 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 product candidate is reasonably assured in the U.S. or the European Union (“EU”). We expense inventory costs related to product 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. 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 as of the date of grant. 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. Recently Adopted Pronouncements On January 1, 2021, we adopted Accounting Standard Update (“ Debt—Debt with Conversion Options and Derivatives and Hedging—Contracts in Entity’s Own Equity On January 1, 2021, we adopted ASU 2019-12, Income Taxes |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | Note 3—Net Loss Per Share Our potentially dilutive securities include potential common shares related to our stock options, warrant 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. Shares of our common stock issuable under the unsecured convertible notes are calculated using the if-converted method and are excluded from the below table as their impact is anti-dilutive. 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, 2021 2020 2021 2020 Outstanding options to purchase common stock 2,401,024 2,216,697 2,901,430 1,937,863 Outstanding warrants to purchase common stock — 14,406 — 12,654 Total potentially dilutive shares excluded from loss per share 2,401,024 2,231,103 2,901,430 1,950,517 |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts | 6 Months Ended |
Jun. 30, 2021 | |
Certain Balance Sheet Accounts | |
Certain Balance Sheet Accounts | Note 4—Certain Balance Sheet Accounts Accounts Receivable, net Accounts receivable, net consist of the following: June 30, December 31, 2021 2020 (In thousands) Trade receivables, net $ 31,418 $ 3,771 Sublease and other receivables 420 70 Total accounts receivables, net $ 31,838 $ 3,841 Trade receivables are net of product return and chargeback allowances of $1.9 million and $1.2 million as of June 30, 2021 and December 31, 2020, respectively. Inventory Inventory consists of the following: June 30, December 31, 2021 2020 (In thousands) Raw materials $ 361 $ 109 Work-in-progress 230 462 Finished goods 387 784 Total inventory $ 978 $ 1,355 Property and Equipment, Net Property and equipment, net consists of the following: June 30, December 31, 2021 2020 (In thousands) Finance leases $ 5,690 $ 5,690 Laboratory equipment 2,998 2,898 Computer equipment 985 985 Office equipment and furniture 625 625 Total cost 10,298 10,198 Less accumulated depreciation and amortization (8,391) (7,647) Total property and equipment, net $ 1,907 $ 2,551 For the three months ended June 30, 2021 and 2020, depreciation and amortization expenses were $0.4 million for each of the two periods. For the six months ended June 30, 2021 and 2020, depreciation and amortization expenses were Accrued Expenses Accrued expenses consist of the following: June 30, December 31, 2021 2020 (In thousands) Sales rebates, fees and discounts $ 7,572 $ 3,326 Contract research and development 5,576 7,952 Consulting and professional fees 4,770 5,393 Interest payable 5,173 5,205 Employee compensation 7,872 3,948 Clinical trials 1,874 2,121 Other accrued expenses 484 810 Total accrued expenses $ 33,321 $ 28,755 |
Fair-Value Measurements
Fair-Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair-Value Measurements | |
Fair-Value Measurements | Note 5—Fair-Value Measurements As of June 30, 2021, and December 31, 2020, 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, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 60,956 $ — $ — $ 60,956 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 62,010 $ — $ — $ 62,010 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 $12.7 million and $10.5 million is excluded from our fair-value hierarchy disclosure as of June 30, 2021 and December 31, 2020, respectively. There were no unrealized gains or losses associated with our investments as of June 30, 2021 or December 31, 2020. 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 “Note7—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, 2021 | |
Line of Credit | |
Line of Credit | Note 6—Line of Credit We have a Loan and Security Agreement with Silicon Valley Bank, which provides for a $50.0 million revolving line of credit facility (the “Line of Credit Agreement”). Under the Line of Credit Agreement, we may draw, on a revolving basis, up to the lesser of $50.0 million or 85.0% of our eligible accounts receivable, less certain reserves. Interest on amounts outstanding is payable monthly at the greater of 5.5% or the prime rate. The line of credit matures August 2, 2022 and is secured by all our assets excluding intellectual property and development program inventories. As of June 30, 2021 and December 31, 2020, no amounts were outstanding under the Line of Credit Agreement. |
Unsecured Convertible Senior No
Unsecured Convertible Senior Notes | 6 Months Ended |
Jun. 30, 2021 | |
Unsecured Convertible Senior Notes | |
Unsecured Convertible Senior Notes | Note 7—Unsecured Convertible Senior Notes On January 1, 2021, we adopted ASU 2020-06 convertible Unsecured convertible senior notes outstanding at June 30, 2021 and December 31, 2020 are as follows: Balance as of June 30, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (1,596) (5,849) (7,445) Total unsecured convertible senior notes, net $ 93,404 $ 219,181 $ 312,585 Fair value of outstanding unsecured convertible senior notes (1) $ 104,856 $ 251,192 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ 9,856 $ 26,162 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 Condensed Consolidated Balance Sheet within additional paid-in capital at December 31, 2020. With adoption of ASU 2020-06 on January 1, 2021, amounts were reclassified to unsecured convertible senior notes, net. 2023 Unsecured Convertible Senior Notes On November 15, 2018, we issued $210.0 million in aggregate principal amount of our 6.25% convertible senior notes due 2023 (the “2023 Notes”). The 2023 Notes 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. On August 14, 2020, we issued the 5.25% convertible senior notes due 2026 (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 Unsecured Convertible Senior Notes” below). 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 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, 2021, 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, 2021 2020 2021 2020 (In thousands) (In thousands) Contractual interest expense $ 1,484 $ 3,281 $ 2,969 $ 6,563 Amortization of debt issuance costs 153 209 303 411 Amortization of debt discount - 2,417 — 4,748 Total $ 1,637 $ 5,907 $ 3,272 $ 11,722 2026 Unsecured Convertible Senior Notes 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 of common stock 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. 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. At our sole discretion, we may elect to convert the 2026 Notes into cash, shares of our common stock or a combination thereof at maturity. Subject to the satisfaction of certain conditions, beginning August 15, 2023, we may redeem in whole or in part the 2026 Notes at our option at a cash redemption price equal to the principal amount of the 2026 Notes plus any accrued and unpaid interest. 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, 2021 2020 2021 2020 (In thousands) (In thousands) Contractual interest expense $ 2,954 $ — $ 5,907 $ — Amortization of debt issuance costs 273 — 519 — Total $ 3,227 $ — $ 6,426 $ — Future minimum payments for the 2023 and 2026 Notes as of June 30, 2021 are as follows: (In thousands) 2021 $ — 2022 — 2023 95,000 2024 — 2025 — 2026 225,030 Total future minimum payments under the convertible senior notes $ 320,030 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Leases | Note 8—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. We carry various finance leases for laboratory equipment. Supplemental lease information is as follows: Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands) (In thousands) Lease cost Operating lease cost $ 1,984 $ 1,551 $ 3,567 $ 3,024 Finance lease cost: Amortization 288 345 611 703 Interest 40 70 89 159 Variable lease cost 992 565 1,804 1,102 Sublease income (423) (309) (841) (602) Net lease cost $ 2,881 $ 2,222 $ 5,230 $ 4,386 Cash paid for amounts included in the measurement of lease liabilities is as follows: Six Months Ended June 30, 2021 2020 (In thousands) Cash payments for operating leases $ 3,817 $ 4,284 Cash payments for financing leases $ 665 $ 689 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 9—Commitments and Contingencies 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 in connection with clinical development or commercial milestones as well as low single to low double-digit royalties on the net income or net sales of the product. For the three and six months ended June 30, 2021 and 2020, development milestone expenses were insignificant. We do not owe any royalties on OMIDRIA. Should narsoplimab be approved for HSCT-TMA, we would be obligated to pay low single-digit royalties on net sales of the product. |
Shareholders' Deficit
Shareholders' Deficit | 6 Months Ended |
Jun. 30, 2021 | |
Shareholders' Deficit | |
Shareholders' Deficit | Note 10—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, 2021, 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, 2021, 200,000 warrants remained outstanding with an exercise price of $23.00 per share. The warrants expire on April 12, 2023. Amendment of 2017 Omnibus Incentive Compensation Plan (the “Plan”) At the June 11, 2021 annual meeting, shareholders approved the increase of the number of shares of common stock authorized for issuance under the Plan by 4,000,000 , to bring the total number of shares of common stock authorized to 12,600,000 . Interim Condensed Consolidated Statements of Shareholders’ Deficit The changes in interim balances of the components of our shareholders’ deficit are as follows: Additional Common Paid-In Accumulated Stock Capital Deficit Total (In thousands) Balance January 1, 2021 $ 616 $ 751,304 $ (872,672) $ (120,752) Exercise of stock options and warrants 6 6,327 — 6,333 At the market offering costs — (241) — (241) Cumulative effect of adopting ASU 2020-06 — (70,779) (4,697) (75,476) Stock-based compensation expense — 3,271 — 3,271 Net loss — — (35,090) (35,090) Balance March 31, 2021 622 689,882 (912,459) (221,955) Exercise of stock options 2 1,133 — 1,135 Stock-based compensation expense — 3,117 — 3,117 Net loss — — (28,593) (28,593) Balance June 30, 2021 $ 624 $ 694,132 $ (941,052) $ (246,296) Additional Common Paid-In Accumulated Stock Capital Deficit Total (In thousands) Balance January 1, 2020 $ 542 $ 625,048 $ (734,611) $ (109,021) Exercise of stock options 3 2,709 — 2,712 Stock-based compensation expense — 3,476 — 3,476 Net loss — — (29,031) (29,031) Balance March 31, 2020 545 631,233 (763,642) (131,864) Exercise of stock options — 66 — 66 Stock-based compensation expense — 3,822 — 3,822 Net loss — — (33,294) (33,294) Balance June 30, 2020 $ 545 $ 635,121 $ (796,936) $ (161,270) |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Stock-Based Compensation. | |
Stock-Based Compensation | Note 11—Stock-Based Compensation Our stock option plans provide for the grant of incentive and non-qualified stock options, restricted stock awards, warrants and other stock awards to employees, non-employee directors and consultants. In July 2021, annual stock option grants exercisable for a total of approximately 2.1 million shares of common stock were awarded to eligible participants for the 2020 annual performance period. The options have an exercise price of $14.99 per share and vest monthly on a straight-line basis over four years. Stock-based compensation expense is as follows: Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands) Research and development $ 1,410 $ 1,631 $ 2,890 $ 3,078 Selling, general and administrative 1,707 2,191 3,498 4,220 Total $ 3,117 $ 3,822 $ 6,388 $ 7,298 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, 2021 June 30, 2021 Estimated weighted-average fair value $ 11.29 $ 12.79 Weighted-average assumptions: Expected volatility 81 % 81 % Expected life, in years 6.1 6.1 Risk-free interest rate 0.98 % 0.89 % 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, 2020 11,938,528 $ 11.92 Granted 307,450 18.53 Exercised (794,808) 9.40 Forfeited (135,617) 15.42 Balance at June 30, 2021 11,315,553 $ 12.24 5.7 $ 33,730 Vested and expected to vest at June 30, 2021 11,019,841 $ 12.20 5.6 $ 33,217 Exercisable at June 30, 2021 8,719,802 $ 11.82 4.9 $ 29,075 As of June 30, 2021, there were 2.6 million unvested options outstanding that will vest over a weighted-average period of 2.3 years. The total estimated compensation expense yet to be recognized on outstanding options is $20.2 million. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Significant Accounting Policies | |
Description of Business | Description of Business We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system, addiction and immune-related diseases, including cancers. Our first drug product, OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1%/0.3% Our drug candidate narsoplimab is the subject of a biologics license application (“BLA”) under priority review by the U.S. Food and Drug Administration (“FDA”) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”). 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 Corporation (“Omeros”) and our wholly owned subsidiaries. All intercompany transactions have been eliminated, and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of June 30, 2021 and December 31, 2020 and for the three and six months ended June 30, 2021 and 2020 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2020 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2021. |
Risks and Uncertainties | Risks and Uncertainties The COVID-19 pandemic and the responses to it by various governmental authorities, the medical community and others have had a significant impact on our business. It is not possible to estimate precisely the future impact of the COVID-19 pandemic on our business, operations or financial results due to the unknown magnitude, duration and outcome of the pandemic. We have filed with FDA our BLA for narsoplimab in HSCT-TMA, which has been granted priority review with an FDA action date of October 17, 2021 under the Prescription Drug User Fee Act (“PDUFA”). We anticipate, but cannot guarantee, that narsoplimab will receive FDA approval and will commercially launch in the U.S. in 2021. Our sales and marketing strategies for the commercial launch of narsoplimab for HSCT-TMA include various milestones at which we commit to incremental spending, providing for flexibility in the timing of costs incurred should the approval of narsoplimab be delayed. If approved, we cannot fully predict the timing or the magnitude of narsoplimab revenues. We plan to continue to fund our operations for the next twelve months with our cash and investments from sales of OMIDRIA and, if FDA approval is granted, from sales of narsoplimab for HSCT-TMA. In addition, we may utilize funds available under our line of credit, which allows us to borrow up to 85% of our available accounts receivable borrowing base, less certain reserves, or $50.0 million, whichever is less. The line of credit matures August 2, 2022 . We also entered into a sales agreement to sell shares of our common stock, from time to time, up to an aggregate offering amount of $150.0 million through an “at the market” equity offering program. Should it be necessary or 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. Should it be necessary to manage our operating expenses, we would reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities. |
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, stock-based compensation expense and accruals for clinical trials as well as 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. |
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. We generally record revenue from product sales when the product is delivered to our wholesalers. 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. |
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 product candidate is reasonably assured in the U.S. or the European Union (“EU”). We expense inventory costs related to product 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. |
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 as of the date of grant. 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. |
Recently Adopted Pronouncements | Recently Adopted Pronouncements On January 1, 2021, we adopted Accounting Standard Update (“ Debt—Debt with Conversion Options and Derivatives and Hedging—Contracts in Entity’s Own Equity On January 1, 2021, we adopted ASU 2019-12, Income Taxes |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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, 2021 2020 2021 2020 Outstanding options to purchase common stock 2,401,024 2,216,697 2,901,430 1,937,863 Outstanding warrants to purchase common stock — 14,406 — 12,654 Total potentially dilutive shares excluded from loss per share 2,401,024 2,231,103 2,901,430 1,950,517 |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Certain Balance Sheet Accounts | |
Schedule of accounts receivable | June 30, December 31, 2021 2020 (In thousands) Trade receivables, net $ 31,418 $ 3,771 Sublease and other receivables 420 70 Total accounts receivables, net $ 31,838 $ 3,841 |
Schedule of Inventory, Current | June 30, December 31, 2021 2020 (In thousands) Raw materials $ 361 $ 109 Work-in-progress 230 462 Finished goods 387 784 Total inventory $ 978 $ 1,355 |
Property, Plant and Equipment | June 30, December 31, 2021 2020 (In thousands) Finance leases $ 5,690 $ 5,690 Laboratory equipment 2,998 2,898 Computer equipment 985 985 Office equipment and furniture 625 625 Total cost 10,298 10,198 Less accumulated depreciation and amortization (8,391) (7,647) Total property and equipment, net $ 1,907 $ 2,551 |
Accrued Expenses | June 30, December 31, 2021 2020 (In thousands) Sales rebates, fees and discounts $ 7,572 $ 3,326 Contract research and development 5,576 7,952 Consulting and professional fees 4,770 5,393 Interest payable 5,173 5,205 Employee compensation 7,872 3,948 Clinical trials 1,874 2,121 Other accrued expenses 484 810 Total accrued expenses $ 33,321 $ 28,755 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair-Value Measurements | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | June 30, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as short-term investments $ 60,956 $ — $ — $ 60,956 Money-market funds classified as non-current restricted investments 1,054 — — 1,054 Total $ 62,010 $ — $ — $ 62,010 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 |
Unsecured Convertible Senior _2
Unsecured Convertible Senior Notes (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Instrument [Line Items] | |
Summary of unsecured convertible senior notes outstanding | Balance as of June 30, 2021 2023 Notes 2026 Notes Total (In thousands) Principal amount $ 95,000 $ 225,030 $ 320,030 Unamortized debt issuance costs (1,596) (5,849) (7,445) Total unsecured convertible senior notes, net $ 93,404 $ 219,181 $ 312,585 Fair value of outstanding unsecured convertible senior notes (1) $ 104,856 $ 251,192 Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount $ 9,856 $ 26,162 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 Condensed Consolidated Balance Sheet within additional paid-in capital at December 31, 2020. With adoption of ASU 2020-06 on January 1, 2021, amounts were reclassified to unsecured convertible senior notes, net. |
Schedule of future minimum payments of debt | (In thousands) 2021 $ — 2022 — 2023 95,000 2024 — 2025 — 2026 225,030 Total future minimum payments under the convertible senior 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, 2021 2020 2021 2020 (In thousands) (In thousands) Contractual interest expense $ 1,484 $ 3,281 $ 2,969 $ 6,563 Amortization of debt issuance costs 153 209 303 411 Amortization of debt discount - 2,417 — 4,748 Total $ 1,637 $ 5,907 $ 3,272 $ 11,722 |
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, 2021 2020 2021 2020 (In thousands) (In thousands) Contractual interest expense $ 2,954 $ — $ 5,907 $ — Amortization of debt issuance costs 273 — 519 — Total $ 3,227 $ — $ 6,426 $ — |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Schedule of lease costs | Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands) (In thousands) Lease cost Operating lease cost $ 1,984 $ 1,551 $ 3,567 $ 3,024 Finance lease cost: Amortization 288 345 611 703 Interest 40 70 89 159 Variable lease cost 992 565 1,804 1,102 Sublease income (423) (309) (841) (602) Net lease cost $ 2,881 $ 2,222 $ 5,230 $ 4,386 |
Schedule of supplemental cash flow information | Six Months Ended June 30, 2021 2020 (In thousands) Cash payments for operating leases $ 3,817 $ 4,284 Cash payments for financing leases $ 665 $ 689 |
Shareholders' Deficit (Tables)
Shareholders' Deficit (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Shareholders' Deficit | |
Schedule of Shareholders' Deficit | Additional Common Paid-In Accumulated Stock Capital Deficit Total (In thousands) Balance January 1, 2021 $ 616 $ 751,304 $ (872,672) $ (120,752) Exercise of stock options and warrants 6 6,327 — 6,333 At the market offering costs — (241) — (241) Cumulative effect of adopting ASU 2020-06 — (70,779) (4,697) (75,476) Stock-based compensation expense — 3,271 — 3,271 Net loss — — (35,090) (35,090) Balance March 31, 2021 622 689,882 (912,459) (221,955) Exercise of stock options 2 1,133 — 1,135 Stock-based compensation expense — 3,117 — 3,117 Net loss — — (28,593) (28,593) Balance June 30, 2021 $ 624 $ 694,132 $ (941,052) $ (246,296) Additional Common Paid-In Accumulated Stock Capital Deficit Total (In thousands) Balance January 1, 2020 $ 542 $ 625,048 $ (734,611) $ (109,021) Exercise of stock options 3 2,709 — 2,712 Stock-based compensation expense — 3,476 — 3,476 Net loss — — (29,031) (29,031) Balance March 31, 2020 545 631,233 (763,642) (131,864) Exercise of stock options — 66 — 66 Stock-based compensation expense — 3,822 — 3,822 Net loss — — (33,294) (33,294) Balance June 30, 2020 $ 545 $ 635,121 $ (796,936) $ (161,270) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stock-Based Compensation. | |
Stock-Based Compensation Expense | Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands) Research and development $ 1,410 $ 1,631 $ 2,890 $ 3,078 Selling, general and administrative 1,707 2,191 3,498 4,220 Total $ 3,117 $ 3,822 $ 6,388 $ 7,298 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Three Months Ended Six Months Ended June 30, 2021 June 30, 2021 Estimated weighted-average fair value $ 11.29 $ 12.79 Weighted-average assumptions: Expected volatility 81 % 81 % Expected life, in years 6.1 6.1 Risk-free interest rate 0.98 % 0.89 % 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 307,450 18.53 Exercised (794,808) 9.40 Forfeited (135,617) 15.42 Balance at June 30, 2021 11,315,553 $ 12.24 5.7 $ 33,730 Vested and expected to vest at June 30, 2021 11,019,841 $ 12.20 5.6 $ 33,217 Exercisable at June 30, 2021 8,719,802 $ 11.82 4.9 $ 29,075 |
Description of Business (Detail
Description of Business (Details) $ in Millions | 6 Months Ended | |
Jun. 30, 2021USD ($)segment | Mar. 01, 2021USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Number of operating segments | segment | 1 | |
At The Market (ATM) Program | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Maximum aggregate offering price | $ 150 | |
Line of Credit Agreement | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Borrowing option - percentage of eligible accounts receivable | 85.00% | |
Maximum borrowing capacity | $ 50 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares excluded from loss per share | 2,401,024 | 2,231,103 | 2,901,430 | 1,950,517 |
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 | 2,401,024 | 2,216,697 | 2,901,430 | 1,937,863 |
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 | 14,406 | 12,654 |
Certain Balance Sheet Account_2
Certain Balance Sheet Accounts - Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Certain Balance Sheet Accounts | ||
Trade receivables, net | $ 31,418 | $ 3,771 |
Sublease and other receivables | 420 | 70 |
Total accounts receivables, net | 31,838 | 3,841 |
Chargeback and product return allowances | $ 1,900 | $ 1,200 |
Certain Balance Sheet Account_3
Certain Balance Sheet Accounts - Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 361 | $ 109 |
Work-in-progress | 230 | 462 |
Finished goods | 387 | 784 |
Total inventory | $ 978 | $ 1,355 |
Certain Balance Sheet Account_4
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||||
Total cost | $ 10,298 | $ 10,298 | $ 10,198 | ||
Less accumulated depreciation and amortization | (8,391) | (8,391) | (7,647) | ||
Total property and equipment, net | 1,907 | 1,907 | 2,551 | ||
Depreciation and amortization | 400 | $ 400 | 745 | $ 814 | |
Finance leases | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 5,690 | 5,690 | 5,690 | ||
Laboratory equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 2,998 | 2,998 | 2,898 | ||
Computer equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | 985 | 985 | 985 | ||
Office equipment and furniture | |||||
Property, Plant and Equipment [Line Items] | |||||
Total cost | $ 625 | $ 625 | $ 625 |
Certain Balance Sheet Account_5
Certain Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued expenses | ||
Sales rebates, fees and discounts | $ 7,572 | $ 3,326 |
Contract research and development | 5,576 | 7,952 |
Consulting and professional fees | 4,770 | 5,393 |
Interest payable | 5,173 | 5,205 |
Employee compensation | 7,872 | 3,948 |
Clinical trials | 1,874 | 2,121 |
Other accrued expenses | 484 | 810 |
Total accrued expenses | $ 33,321 | $ 28,755 |
Fair-Value Measurements - Recur
Fair-Value Measurements - Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as short-term investments | $ 60,956 | $ 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 | 60,956 | 124,452 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,055 |
Total | 62,010 | 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 | 60,956 | 124,452 |
Money-market funds classified as non-current restricted investments | 1,054 | 1,055 |
Total | $ 62,010 | $ 125,507 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Fair-Value Measurements | ||
Cash and cash equivalents | $ 12,702 | $ 10,501 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Line of Credit (Details)
Line of Credit (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument | ||
Outstanding amount | $ 312,585 | $ 236,288 |
Line of Credit Agreement | ||
Debt Instrument | ||
Maximum borrowing capacity | $ 50,000 | |
Borrowing option - percentage of eligible accounts receivable | 85.00% | |
Outstanding amount | $ 0 | $ 0 |
Prime Rate | Line of Credit Agreement | ||
Debt Instrument | ||
Basis for variable rate | 5.50% |
Unsecured Convertible Senior _3
Unsecured Convertible Senior Notes - Unsecured convertible senior notes outstanding (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | Jan. 01, 2021 | |
Debt Instrument [Line Items] | |||
Principal amount | $ 320,030 | $ 320,030 | |
Unamortized discount | (7,445) | (77,645) | |
Unamortized issuance costs attributable to liability component | (6,097) | ||
Total unsecured convertible senior notes, net | 312,585 | 236,288 | |
Accumulated deficit | (941,052) | (872,672) | |
2023 Unsecured Convertible Senior Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | 95,000 | 95,000 | |
Unamortized discount | (1,596) | (17,101) | |
Unamortized issuance costs attributable to liability component | (1,481) | ||
Total unsecured convertible senior notes, net | 93,404 | 76,418 | |
Fair value of outstanding unsecured convertible senior notes | 104,856 | 101,769 | |
Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount | 9,856 | 6,769 | |
Equity component | 25,854 | ||
Unamortized issuance costs | (837) | ||
Net carrying amount of equity component | 25,017 | ||
2026 Unsecured Convertible Senior Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | 225,030 | 225,030 | |
Unamortized discount | (5,849) | (60,544) | |
Unamortized issuance costs attributable to liability component | (4,616) | ||
Total unsecured convertible senior notes, net | 219,181 | 159,870 | |
Fair value of outstanding unsecured convertible senior notes | 251,192 | 246,779 | |
Amount by which the unsecured convertible senior notes if-converted value exceeds their principal amount | $ 26,162 | 21,749 | |
Equity component | 63,544 | ||
Unamortized issuance costs | (1,916) | ||
Net carrying amount of equity component | $ 61,628 | ||
Cumulative effect adjustment | Accounting Standards Update 2020-06 | |||
Debt Instrument [Line Items] | |||
Accumulated deficit | $ (75,500) | ||
Convertible Debt | $ 75,500 |
Unsecured Convertible Senior _4
Unsecured Convertible Senior Notes - 2023 Unsecured Convertible Senior Notes (Details) - 2023 Unsecured Convertible Senior Notes $ / shares in Units, shares in Millions | Aug. 14, 2020USD ($) | Nov. 15, 2018USD ($)$ / shares | Jun. 30, 2021shares |
Debt Instrument [Line Items] | |||
Principal amount | $ 210,000,000 | ||
Interest rate (as a percent) | 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 | ||
Number of shares outstanding on the 2023 Capped Call | shares | 4.9 | ||
Minimum | |||
Debt Instrument [Line Items] | |||
Conversion price | $ / shares | 19.22 | ||
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
2023 Unsecured Convertible Senior Notes | ||||
Interest Expense, Debt [Abstract] | ||||
Contractual interest expense | $ 1,484 | $ 3,281 | $ 2,969 | $ 6,563 |
Amortization of debt issuance costs | 153 | 209 | 303 | 411 |
Amortization of debt discount | 2,417 | 4,748 | ||
Total | 1,637 | $ 5,907 | 3,272 | $ 11,722 |
2026 Unsecured Convertible Senior Notes | ||||
Interest Expense, Debt [Abstract] | ||||
Contractual interest expense | 2,954 | 5,907 | ||
Amortization of debt issuance costs | 273 | 519 | ||
Total | $ 3,227 | $ 6,426 |
Unsecured Convertible Senior _6
Unsecured Convertible Senior Notes - 2026 Unsecured Convertible Senior Notes (Details) - 2026 Unsecured Convertible Senior Notes $ / shares in Units, shares in Millions | Aug. 14, 2020USD ($)D$ / sharesshares |
Debt Instrument [Line Items] | |
Interest rate (as a percent) | 5.25% |
Conversion rate | 0.0540906 |
Value used in calculation of conversion rate | $ | $ 1,000 |
Conversion price | $ 18.4875 |
Shares upon conversion | shares | 12.2 |
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% |
Minimum | |
Debt Instrument [Line Items] | |
Conversion price | $ 18.49 |
Maximum | |
Debt Instrument [Line Items] | |
Conversion price | $ 26.10 |
Unsecured Convertible Senior _7
Unsecured Convertible Senior Notes - Future minimum payments (Details) - USD ($) $ in Thousands | Jun. 30, 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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($)item | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)item | Jun. 30, 2020USD ($) | |
Leases | ||||
Number of options to extend lease term | item | 2 | 2 | ||
Expected lease term | 5 years | 5 years | ||
Lease cost | ||||
Operating lease cost | $ 1,984 | $ 1,551 | $ 3,567 | $ 3,024 |
Amortization | 288 | 345 | 611 | 703 |
Interest | 40 | 70 | 89 | 159 |
Variable lease cost | 992 | 565 | 1,804 | 1,102 |
Sublease income | (423) | (309) | (841) | (602) |
Net lease cost | $ 2,881 | $ 2,222 | 5,230 | 4,386 |
Cash payments for operating leases | 3,817 | 4,284 | ||
Cash payments for financing leases | $ 665 | $ 689 |
Shareholders' Deficit - Narrati
Shareholders' Deficit - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Mar. 31, 2021 | Jun. 30, 2021 | Jun. 11, 2021 | Jun. 10, 2021 | Mar. 01, 2021 | |
Class of Warrant or Right [Line Items] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 794,808 | ||||
Cashless exercise of warrants | 43,115 | ||||
Warrants outstanding | 200,000 | ||||
Warrant exercise price (in USD per share) | $ 23 | ||||
Amended 2017 Omnibus Incentive Compensation Plan | |||||
Class of Warrant or Right [Line Items] | |||||
Number of shares authorized | 12,600,000 | 4,000,000 | |||
Outstanding warrants to purchase common stock | |||||
Class of Warrant or Right [Line Items] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 24,901 | ||||
At The Market (ATM) Program | |||||
Class of Warrant or Right [Line Items] | |||||
Maximum aggregate offering price | $ 150 |
Shareholders' Deficit- Equity T
Shareholders' Deficit- Equity Table (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Class of Stock [Line Items] | ||||||
Balance | $ (221,955) | $ (120,752) | $ (131,864) | $ (109,021) | $ (120,752) | $ (109,021) |
Exercise of stock options and warrants | 6,333 | |||||
Exercise of stock options | 1,135 | 66 | 2,712 | |||
At the market offering costs | (241) | |||||
Stock-based compensation expense | 3,117 | 3,271 | 3,822 | 3,476 | ||
Net loss | (28,593) | (35,090) | (33,294) | (29,031) | (63,683) | (62,325) |
Balance | (246,296) | (221,955) | (161,270) | (131,864) | (246,296) | (161,270) |
Cumulative effect adjustment | ||||||
Class of Stock [Line Items] | ||||||
Balance | (75,476) | (75,476) | ||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Balance | 622 | 616 | 545 | 542 | 616 | 542 |
Exercise of stock options and warrants | 6 | |||||
Exercise of stock options | 2 | 3 | ||||
Balance | 624 | 622 | 545 | 545 | 624 | 545 |
Additional Paid-in Capital | ||||||
Class of Stock [Line Items] | ||||||
Balance | 689,882 | 751,304 | 631,233 | 625,048 | 751,304 | 625,048 |
Exercise of stock options and warrants | 6,327 | |||||
Exercise of stock options | 1,133 | 66 | 2,709 | |||
At the market offering costs | (241) | |||||
Stock-based compensation expense | 3,117 | 3,271 | 3,822 | 3,476 | ||
Balance | 694,132 | 689,882 | 635,121 | 631,233 | 694,132 | 635,121 |
Additional Paid-in Capital | Cumulative effect adjustment | ||||||
Class of Stock [Line Items] | ||||||
Balance | (70,779) | (70,779) | ||||
Accumulated Deficit | ||||||
Class of Stock [Line Items] | ||||||
Balance | (912,459) | (872,672) | (763,642) | (734,611) | (872,672) | (734,611) |
Net loss | (28,593) | (35,090) | (33,294) | (29,031) | ||
Balance | $ (941,052) | $ (912,459) | $ (796,936) | (763,642) | $ (941,052) | (796,936) |
Accumulated Deficit | Cumulative effect adjustment | ||||||
Class of Stock [Line Items] | ||||||
Balance | $ (4,697) | $ (4,697) |
Stock-Based Compensation - Plan
Stock-Based Compensation - Plan (Details) - $ / shares shares in Millions | 1 Months Ended | 6 Months Ended |
Jul. 31, 2021 | Jun. 30, 2021 | |
Stock-Based Compensation. | ||
Shares granted | 2.1 | |
Exercise price (USD per share) | $ 14.99 | $ 18.53 |
Vesting period | 4 years |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 3,117 | $ 3,822 | $ 6,388 | $ 7,298 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,410 | 1,631 | 2,890 | 3,078 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 1,707 | $ 2,191 | $ 3,498 | $ 4,220 |
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, 2021 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Estimated weighted-average fair value (USD per share) | $ 11.29 | $ 12.79 |
Weighted Average | ||
Weighted-average assumptions | ||
Expected volatility | 81.00% | 81.00% |
Expected life, in years | 6 years 1 month 6 days | 6 years 1 month 6 days |
Risk-free interest rate | 0.98% | 0.89% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended |
Jul. 31, 2021 | Jun. 30, 2021 | |
Options Outstanding | ||
Beginning balance (shares) | 11,315,553 | 11,938,528 |
Granted (shares) | 2,100,000 | |
Granted (shares) | 307,450 | |
Exercised (shares) | (794,808) | |
Forfeited (shares) | (135,617) | |
Ending balance (shares) | 11,315,553 | |
Vested and expected to vest (shares) | 11,019,841 | |
Exercisable (shares) | 8,719,802 | |
Weighted-Average Exercise Price per Share | ||
Beginning balance (USD per share) | $ 12.24 | $ 11.92 |
Granted (USD per share) | $ 14.99 | 18.53 |
Exercised (USD per share) | 9.40 | |
Forfeited (USD per share) | 15.42 | |
Ending balance (USD per share) | 12.24 | |
Vested and expected to vest (USD per share) | 12.20 | |
Exercisable (USD per share) | $ 11.82 | |
Weighted- Average Remaining Contractual Life | ||
Balance (in years) | 5 years 8 months 12 days | |
Vested and expected to vest (in years) | 5 years 7 months 6 days | |
Exercisable (in years) | 4 years 10 months 24 days | |
Aggregate Intrinsic Value | ||
Balance | $ 33,730 | |
Vested and expected to vest | 33,217 | |
Exercisable | $ 29,075 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - Outstanding options to purchase common stock shares in Millions, $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Unvested options outstanding (shares) | shares | 2.6 |
Period for recognition | 2 years 3 months 18 days |
Unrecognized compensation expense | $ | $ 20.2 |