Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 25, 2020 | Jun. 30, 2019 | |
Document Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2019 | ||
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 Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Common Stock, Shares Outstanding | 54,205,177 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Public Float | $ 729,297,324 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001285819 | ||
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 3,084 | $ 5,861 |
Short-term investments | 57,704 | 54,637 |
Receivables, net | 35,185 | 22,818 |
Inventory | 1,147 | 88 |
Prepaid expense and other assets | 6,625 | 6,463 |
Total current assets | 103,745 | 89,867 |
Property and equipment, net | 3,829 | 3,845 |
Right of use assets | 27,082 | |
Restricted investments | 1,154 | 1,154 |
Advanced payments, non-current | 1,159 | 1,070 |
Total assets | 136,969 | 95,936 |
Liabilities and shareholders' deficit | ||
Accounts payable | 5,328 | 6,281 |
Accrued expenses | 46,627 | 30,186 |
Current portion of lease liabilities | 3,504 | |
Current portion of lease liabilities | 889 | |
Total current liabilities | 55,459 | 37,356 |
Lease liabilities, non-current | 32,318 | |
Lease liabilities, non-current | 1,578 | |
Unsecured convertible senior notes, net | 158,213 | 148,981 |
Deferred rent | 8,177 | |
Commitments and contingencies (Note 10) | ||
Shareholders' deficit: | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at December 31, 2019 and December 31, 2018. | ||
Common stock, par value $0.01 per share, 150,000,000 shares authorized at December 31, 2019 and December 31, 2018; 54,200,810 and 49,011,684 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively. | 542 | 490 |
Additional paid-in capital | 625,048 | 549,479 |
Accumulated deficit | (734,611) | (650,125) |
Total shareholders' deficit | (109,021) | (100,156) |
Total liabilities and shareholders' deficit | $ 136,969 | $ 95,936 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 | 54,200,810 | 49,011,684 |
Common stock, outstanding shares | 54,200,810 | 49,011,684 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues [Abstract] | |||
Product sales, net | $ 111,805 | $ 29,868 | $ 64,826 |
Costs and expenses: | |||
Cost of product sales | 865 | 512 | 1,078 |
Research and development | 109,696 | 89,860 | 55,599 |
Selling, general and administrative | 64,626 | 51,718 | 52,044 |
Total costs and expenses | 175,187 | 142,090 | 108,721 |
Loss from operations | (63,382) | (112,222) | (43,895) |
Loss on early extinguishment of debt | (12,993) | ||
Interest expense | (22,657) | (16,252) | (11,030) |
Other income | 1,553 | 1,781 | 1,444 |
Loss before income taxes | (84,486) | (139,686) | (53,481) |
Income tax benefit | 0 | 12,929 | 0 |
Net loss | (84,486) | (126,757) | (53,481) |
Comprehensive loss | $ (84,486) | $ (126,757) | $ (53,481) |
Basic and diluted net loss per share (USD per share) | $ (1.71) | $ (2.61) | $ (1.17) |
Weighted-average shares used to compute basic and diluted net loss per share ( in shares) | 49,523,444 | 48,582,636 | 45,539,362 |
Revenue, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' DEFICIT - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance (in shares) at Dec. 31, 2016 | 43,819,133 | |||
Balance at Dec. 31, 2016 | $ 438 | $ 432,002 | $ (469,887) | $ (37,447) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in direct offering, net of offering costs | $ 30 | 63,627 | 63,657 | |
Issuance of common stock in direct offering, net of offering costs (in shares) | 3,000,000 | |||
Issuance of common stock upon exercise of stock options | $ 14 | 11,755 | 11,769 | |
Issuance of common stock upon exercise of stock options (in shares) | 1,392,093 | |||
Stock-based compensation | 12,688 | 12,688 | ||
Net loss | (53,481) | (53,481) | ||
Balance (in shares) at Dec. 31, 2017 | 48,211,226 | |||
Balance at Dec. 31, 2017 | $ 482 | 520,072 | (523,368) | (2,814) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock upon exercise of stock options | $ 8 | 6,724 | 6,732 | |
Issuance of common stock upon exercise of stock options (in shares) | 800,458 | |||
Issuance of warrants in connection with debt amendment | 1,424 | 1,424 | ||
Stock-based compensation | 11,713 | 11,713 | ||
Premium paid for Capped Call in connection with Convertible Notes | (33,180) | (33,180) | ||
Equity component of issuance of Convertible Notes | 55,655 | 55,655 | ||
Tax benefit related to equity component of Convertible Notes | (12,929) | (12,929) | ||
Net loss | (126,757) | (126,757) | ||
Balance (in shares) at Dec. 31, 2018 | 49,011,684 | |||
Balance at Dec. 31, 2018 | $ 490 | 549,479 | (650,125) | (100,156) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in direct offering, net of offering costs | $ 44 | 54,194 | 54,238 | |
Issuance of common stock in direct offering, net of offering costs (in shares) | 4,389,311 | |||
Issuance of common stock upon exercise of stock options | $ 8 | 7,590 | $ 7,598 | |
Issuance of common stock upon exercise of stock options (in shares) | 799,815 | 799,815 | ||
Stock-based compensation | 13,785 | $ 13,785 | ||
Net loss | (84,486) | (84,486) | ||
Balance (in shares) at Dec. 31, 2019 | 54,200,810 | |||
Balance at Dec. 31, 2019 | $ 542 | $ 625,048 | $ (734,611) | $ (109,021) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities: | |||
Net loss | $ (84,486) | $ (126,757) | $ (53,481) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 13,785 | 11,713 | 12,688 |
Non-cash interest expense | 9,232 | 5,635 | 4,187 |
Depreciation and amortization | 1,790 | 962 | 551 |
Loss on early extinguishment of debt | 12,993 | ||
Deferred income tax | 0 | (12,929) | 0 |
Fair value adjustment to convertible notes in equity | 354 | ||
Changes in operating assets and liabilities: | |||
Receivables | (12,367) | (5,674) | (5,107) |
Inventory | (1,059) | 355 | 685 |
Prepaid expenses and other assets | (251) | (498) | (5,270) |
Accounts payable and accrued expenses | 13,283 | 10,109 | 9,520 |
Net cash used in operating activities | (60,073) | (103,737) | (36,227) |
Investing activities: | |||
Purchases of property and equipment | (334) | (567) | (350) |
Purchases of investments | (58,217) | (68,782) | (65,326) |
Proceeds from the sale and maturities of investments | 55,150 | 94,500 | 28,078 |
Net cash (used in) provided by investing activities | (3,401) | 25,151 | (37,598) |
Financing activities: | |||
Proceeds from issuance of convertible senior notes | 210,000 | ||
Proceeds from debt borrowings | 44,550 | ||
Proceeds upon exercise of stock options and warrants | 7,598 | 6,732 | 11,769 |
Proceeds from issuance of common stock, net | 54,238 | 63,657 | |
Release in restricted investments | 4,681 | ||
Repayment of debt | (132,077) | ||
Premium paid for capped call option | (33,180) | ||
Payments on debt prepayment and extinguishment | (11,902) | ||
Payments for debt issuance costs | (6,800) | ||
Principal payments on finance lease liabilities | (1,139) | ||
Principal payments on finance lease liabilities | (951) | (431) | |
Net cash provided by financing activities | 60,697 | 81,053 | 74,995 |
Net (decrease) increase in cash and cash equivalents | (2,777) | 2,467 | 1,170 |
Cash and cash equivalents at beginning of period | 5,861 | 3,394 | 2,224 |
Cash and cash equivalents at end of period | 3,084 | 5,861 | 3,394 |
Supplemental cash flow information | |||
Cash paid for interest | 13,462 | 8,896 | 6,895 |
Property acquired under finance lease | $ 1,440 | 2,118 | 1,141 |
Conversion of accrued interest to debt | 3,408 | $ 3,315 | |
Fair value of warrants issued in connection with debt amendment | $ 1,424 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2019 | |
Organization And Basis Of Presentation Disclosure [Abstract] | |
Organization and Basis of Presentation | Note 1—Organization and Basis of Presentation Organization 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, and immune-related diseases, including cancers. Our first drug product, OMIDRIA, is marketed in the United States (U.S.) for use during cataract surgery or intraocular lens replacement. Basis of Presentation Our consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). Certain prior year amounts in the balance sheet, statement of cash flows and the footnotes have been reclassified in the consolidated financial statements to conform to the current year presentation. Going Concern Discussion As of December 31, 2019, we had cash, cash equivalents and investments of $60.8 million, net working capital of $48.3 million and an accounts receivable based line of credit that allows us to borrow up to $50.0 million depending on our eligible accounts receivable borrowing base. We have incurred losses from operations of $63.4 million, $112.2 million and $43.9 million in 2019, 2018 and 2017, respectively, used cash in operating activities of $60.1 million, $103.7 million and $36.2 million in 2019, 2018 and 2017, respectively and anticipate that we will continue to incur losses until such time as revenues exceed operating costs. OMIDRIA pass-through reimbursement is scheduled to end on September 30, 2020. As such, we cannot predict with precision future OMIDRIA revenues due to the uncertain impact on sales of OMIDRIA in second half of 2020 and beyond. We plan to continue to fund our operations through proceeds from sales of OMIDRIA and, in addition, we may utilize funds available under our receivable-based line of credit, which allows us to borrow up to $50 million based on our available accounts-receivable borrowing base. Should it be necessary or determined to be strategically advantageous, we also could pursue debt financings, public and private offerings of our equity securities similar to those we have completed previously, and/or other strategic transactions, which may include licensing a portion of our existing technology. If these capital sources, for any reason, are needed but inaccessible, it would have a significantly negative effect on our financial condition. Should it be necessary to manage our operating expenses, we would reduce our projected cash requirements through reduction of our expenses by delaying clinical trials, reducing selected research and development efforts, and/or implementing other restructuring activities. The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern. Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, accruals for manufacturing of drug product, clinical drug supply and clinical trials, lease liabilities, and stock-based compensation expense. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2—Significant Accounting Policies Cash and Cash Equivalents, Short-Term Investments and Restricted Investments Cash and cash equivalents include highly liquid investments with a maturity of three months or less on the date of purchase. Short-term investment securities are classified as available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported as a separate component of shareholders’ deficit. Amortization, accretion, interest and dividends, realized gains and losses and declines in value judged to be other-than-temporary are included in other income. The cost of securities sold is based on the specific-identification method. Investments in securities with maturities of less than one year, or those for which management intends to use the investments to fund current operations, are included in current assets. We evaluate whether an investment is other-than-temporarily impaired based on the specific facts and circumstances. Factors that are considered in determining whether an other-than-temporary decline in value has occurred include: the market value of the security in relation to its cost basis; the financial condition of the investee; and the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment. Restricted investments are held in money-market funds. As of December 31, 2019 and 2018, all investments are classified as short-term and available-for-sale. Investment income, which is included as a component of other income, consists primarily of interest earned. Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner that approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing, transportation and internal labor and overhead. Capitalization of costs as inventory begins when the product candidate receives regulatory approval 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. Receivables, Net Receivables relate primarily to sales of OMIDRIA to wholesalers and include reductions for estimated chargebacks and product returns that are expected to be settled through reductions in receivables. Remaining receivables consist of amounts from subleases for space in our facilities. Considering the nature and historic collectability of our receivables, we concluded an allowance for doubtful accounts is not necessary as of December 31, 2019 and 2018. Property and Equipment, Net Property and equipment are stated at cost, and depreciation is calculated using the straight-line method over the estimated useful life of the assets, which is generally three recorded as property and equipment and is amortized over the shorter of the useful lives of the related assets or the lease term. Expenditures for repairs and maintenance are expensed as incurred. Right-of-Use Assets and Related Lease Liabilities On January 1, 2019, we adopted Accounting Standards Update (ASU) 2016-02, Leases , (Topic 842) using a modified retrospective approach versus recasting the prior periods presented. We elected the package of practical expedients permitted under the transition guidance, which allowed us to carryforward our historical assessment of whether (i) contracts contain leases, (ii) lease classifications and (iii) initial direct costs. Upon adoption we recognized right-of-use assets and lease liabilities of $17.7 million and $26.4 million, respectively. The balance of the net right-of-use asset included the reversal of the outstanding balance of deferred rent of $8.7 million. 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. Impairment of Long-Lived Assets We assess the impairment of long-lived assets, primarily property and equipment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability of these assets is measured by comparing the carrying value to future undiscounted cash flows that the asset is expected to generate. If the asset is considered to be impaired, the amount of any impairment will be reflected in the results of operations in the period of impairment. We have not recognized any impairment losses for the years ending December 31, 2019, 2018 and 2017. Revenue Recognition When we enter into a customer contract, we perform the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. Product Sales, Net We generally record revenue from product sales when the product is delivered to our wholesalers. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability depending on how the amount is expected to be settled. Chargebacks and Rebates: four We provide reimbursement support services and financial assistance in the form of a rebate to patients whose commercial insurance is inadequate to cover the full cost of OMIDRIA. We apply an experience ratio based on historical and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and is being reviewed and updated periodically to reflect actual results. We provide rebate payments for which ASCs qualify by meeting or exceeding purchase volumes of OMIDRIA under our purchase volume-discount program. We calculate rebate payment amounts due under this program based on actual qualifying purchase volumes and apply a contractual discount rate. For purchases of OMIDRIA not yet reported as sold-through to the ASC by our wholesalers, we apply an experience ratio to product sales to determine the rebate accrual. This experience ratio is being reviewed and updated periodically to reflect actual results. Distribution Fees and Product Return Allowances We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders. Research and Development Research and development expenses are comprised primarily of contracted research and manufacturing costs prior to approval; costs for personnel, including salaries, benefits and stock compensation; clinical study costs; contracted research; manufacturing costs prior to approval; consulting services; depreciation; materials and supplies; milestones; an allocation of our occupancy costs; and other expenses incurred to sustain our overall research and development programs. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and then recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. All other research and development costs are expensed as incurred. Selling, General and Administrative Selling, general and administrative expenses are comprised primarily of salaries, benefits, and stock-compensation costs for sales, marketing, and other personnel not directly engaged in research and development. Additionally, selling, general and administrative expenses include marketing and selling expenses, professional and legal services; patent costs; depreciation, an allocation of our occupancy costs; and other general corporate expenses. Advertising costs, which we consider to be media and marketing materials, are expensed as incurred and were $8.0 million, $2.5 million and $0.3 million during the years ended December 31, 2019, 2018 and 2017, respectively. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized. Stock-Based Compensation Stock-based compensation expense is recognized for all share-based payments based on estimated fair values. The fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental assumptions including volatility, forfeiture rates and expected option life. We use the straight-line method to allocate compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting period. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of net loss and certain changes in equity that are excluded from net loss. There was no difference between comprehensive loss and net loss for the years ended December 31, 2019, 2018 or 2017. Financial Instruments and Concentrations of Credit Risk Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of short-term investments is based on quoted market prices. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, our cash and cash equivalents balance held at a financial institution may exceeds the federally insured limits. To limit the credit risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and commercial paper. Major Customers We sell OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2019, 2018 and 2017 and greater than 10% of accounts receivable as of December 31, 2019, 2018 and 2017 as noted below. 2019 2018 2017 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 25 % 23 % 31 % 27 % 29 % 31 % Distributor B 24 % 19 % 27 % 25 % 26 % 23 % Distributor C 29 % 33 % 22 % 25 % 22 % 26 % Distributor D 22 % 25 % 20 % 23 % 23 % 20 % Major Suppliers We use a single contract manufacturer to supply the OMIDRIA drug product and a separate company to package OMIDRIA for commercial sale. We generally use different contract manufacturers to produce drug substance, drug product and to perform final packaging for our drug product candidates. We endeavor to maintain reasonable levels of drug supply for our commercial and clinical trial use and other manufacturers are available should we need to change suppliers. A change in suppliers, however, could cause a delay in delivery of OMIDRIA or our clinical trial material that would adversely affect our business. Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses , (Topic 326) which changes how entities account for credit losses on most financial assets and certain other instruments and expands disclosures. The standard is effective for annual and interim periods beginning after December 15, 2019 with early adoption permitted. We adopted the standard on January 1, 2020 and the adoption did not have a material impact on our consolidated financial statements and disclosures. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 3—Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common share equivalents outstanding for the period, determined using the treasury-stock method. Common share equivalents are excluded from the diluted net loss per share computations if their effect is anti-dilutive. The basic and diluted net loss per share amounts for the years ended December 31, 2019, 2018 and 2017 were computed based on the shares of common stock outstanding during the respective periods. Potentially dilutive securities excluded from the diluted net loss per share calculation are as follows: Year Ended December 31, 2019 2018 2017 Outstanding options to purchase common stock 11,207,931 10,313,138 9,657,259 Outstanding warrants to purchase common stock 243,115 243,115 100,602 Total potentially dilutive shares excluded from loss per share 11,451,046 10,556,253 9,757,861 |
Accounts Receivable, Net
Accounts Receivable, Net | 12 Months Ended |
Dec. 31, 2019 | |
Receivables [Abstract] | |
Accounts Receivable, Net | Note 4—Accounts Receivable, Net Accounts receivable, net consists of the following: December 31, 2019 2018 (In thousands) Trade receivables, net $ 35,074 $ 22,654 Sublease and other receivables 111 164 Total accounts receivables, net $ 35,185 $ 22,818 Trade receivables are shown net of $1.6 million and $0.4 million of chargeback and product return allowances as of December 31, 2019 and 2018, respectively. |
Fair-Value Measurements
Fair-Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair-Value Measurements | Note 5—Fair-Value Measurements As of December 31, 2019 and 2018, all investments were classified as short-term and available-for-sale. Investment income, which was included as a component of other income, consists of interest earned. On a recurring basis, we measure certain financial assets at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required: Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets; Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our fair-value hierarchy for our financial assets measured at fair value on a recurring basis are as follows: December 31, 2019 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 57,704 — — 57,704 Total $ 58,858 $ — $ — $ 58,858 December 31, 2018 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 54,637 — — 54,637 Total $ 55,791 $ — $ — $ 55,791 Cash held in demand deposit accounts of $3.1 million and $5.9 million is excluded from our fair-value hierarchy disclosure as of December 31, 2019 and 2018, respectively. There were no unrealized gains or losses associated with our short-term investments as of December 31, 2019 or 2018. The carrying amounts for receivables, accounts payable and accrued liabilities, and other current monetary assets and liabilities, including debt and lease financing obligations, approximate fair value. See “Note 8--Convertible Senior Notes” for the carrying amount and estimated fair value of our 6.25% Convertible Senior Notes due 2023. |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts | 12 Months Ended |
Dec. 31, 2019 | |
Receivables [Abstract] | |
Certain Balance Sheet Accounts | Note 6—Certain Balance Sheet Accounts Inventory Inventory consists of the following: December 31, December 31, 2019 2018 (In thousands) Raw materials $ 91 $ 83 Work-in-progress 338 — Finished goods 718 5 Total inventory $ 1,147 $ 88 Property and Equipment, Net Property and equipment, net consists of the following: December 31, 2019 2018 (In thousands) Finance leases $ 5,474 $ 4,034 Laboratory equipment 2,844 2,569 Computer equipment 921 862 Office equipment and furniture 625 625 Total cost 9,864 8,090 Less accumulated depreciation and amortization (6,035) (4,245) Total property and equipment, net $ 3,829 $ 3,845 For the years ended December 31, 2019, 2018 and 2017, depreciation and amortization expenses were $1.8 million, $1.0 million and $0.6 million, respectively. Accrued Expenses Accrued expenses consist of the following: December 31, 2019 2018 (In thousands) Contract research and development $ 24,107 $ 12,012 Sales rebates, fees and discounts 10,870 8,075 Consulting and professional fees 3,610 3,669 Employee compensation 3,546 2,714 Clinical trials 1,982 820 Interest payable 1,640 1,677 Other accrued expenses 872 1,219 Total accrued expenses $ 46,627 $ 30,186 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Note 7—Debt Note Payable In October 2016, we entered into a note payable agreement (the Note) and borrowed $80.0 million. In May 2018, we borrowed the remaining $45.0 million available under the Note and issued warrants to purchase up to 200,000 shares of our common stock with an exercise price of $23.00 per share and total fair value of $1.4 million. Interest accrued on the Note at an annual rate of 12.25% (4.00% of which we deferred by adding such amounts to the aggregate principal amount outstanding). The Note required us to pay a back-end lender facility fee equal to 5.00% of the aggregate principal amount borrowed and, upon early repayment, we were subject to a 4.0% prepayment fee. In November 2018, we issued $210.0 million in principal amount of unsecured convertible senior notes (see “Note 8--Convertible Senior Notes”) and repaid the Note. Upon repayment, we incurred a loss on early extinguishment of debt of $13.0 million associated with the unamortized lender facility fee, debt issuance costs, debt discount and prepayment fees upon repayment of the Note. Line of Credit In August 2019, we entered into 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 and 85.0% of our eligible accounts receivable, less certain reserves. The Line of Credit Agreement is secured by all our assets excluding intellectual property and development program inventories and matures in August 2022. Interest on amounts outstanding is payable monthly at a floating rate equal to the greater of 5.50% and the prime rate per annum. If the Line of Credit Agreement is terminated prior to the maturity date for any reason other than replacement with a new Silicon Valley Bank (SVB) credit facility or a new syndicated facility in which SVB acts as the agent, we are required to pay a termination fee of $1.0 million. We paid an initial commitment fee of $150,000 upon closing and are required to pay additional commitment fees of $150,000 on each of the first and second anniversaries of the closing date, or upon the earlier termination of, or default under, the Line of Credit Agreement. The Line of Credit Agreement requires a lockbox arrangement whereby our trade accounts receivable collections are deposited into a control account. Amounts deposited in the account are transferred daily to our operating account, except that during periods of reduced liquidity or upon an event of default, the amounts received in the control account are applied to reduce the outstanding obligations under the Line of Credit Agreement. The Line of Credit Agreement includes customary events of default that include, among other things, breach, non-payment, inaccuracy of representations and warranties, the occurrence of a material adverse change in our business or prospects for repayment of the Line of Credit, cross default to material indebtedness or material agreements, bankruptcy and insolvency, material judgments and a change in control. In the event of default, SVB may require all obligations under the Line of Credit Agreement to be immediately due and payable and charge a default rate of interest thereon. As of December 31, 2019, we had no outstanding borrowings under the Line of Credit Agreement. |
Convertible Senior Notes
Convertible Senior Notes | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | Note 8—Convertible Senior Notes In November 2018, we issued $210.0 million aggregate principal amount 6.25% Convertible Senior Notes due 2023 (the Convertible Notes) and received net proceeds of $24.0 million, as summarized below: (In thousands) Convertible Notes initially issued $ 210,000 Repayment of previously outstanding loan (146,046) Purchase of Capped Call (33,180) Issuance costs (6,800) Net proceeds available for corporate use $ 23,974 The Convertible 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, beginning on May 15, 2019. The Convertible Notes mature on November 15, 2023, unless earlier repurchased, redeemed or converted in accordance with their terms and are unsecured. The Convertible Notes will be 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. The Convertible Notes will be convertible at the option of the holders on or after May 15, 2023 at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date of November 15, 2023. Additionally, holders may convert their Convertible Notes at their option at specified times prior to the maturity date of November 15, 2023, only if: (1) during any calendar quarter beginning after March 31, 2019, the last reported sale price per share of our common stock exceeds 130% of the conversion price of the Convertible 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 Convertible 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) upon the occurrence of certain corporate events or distributions of our common stock; or (4) we call the Convertible Notes for redemption. Subject to the satisfaction of certain conditions, we may redeem all, but not less than all, of the Convertible Notes at our option prior to the maturity date at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus any accrued and unpaid interest. The Convertible Notes are subject to redemption only if certain requirements are satisfied, including that the last reported sale price per share of our common stock exceeds 150% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we send the related redemption notice and (ii) the trading day immediately before the date we send such notice. In order to reduce the dilutive impact or potential cash expenditure associated with conversion of the Convertible Notes, we used $33.2 million of the proceeds from sale of the Convertible Notes to enter into a capped call transaction (the Capped Call Transaction). The Capped Call Transaction will cover, subject to anti-dilution adjustments substantially similar to those applicable to the Convertible Notes, the number of shares of our common stock underlying the Convertible Notes when our common stock is trading between the initial conversion price of approximately $19.22 and $28.8360. However, if the market price of our common stock exceeds the $28.8360 cap price, then the conversion of the Convertible Notes would have a dilutive impact and/or require a cash expenditure to the extent the market price exceeds the cap price. We evaluated the accounting for the issuance of the Convertible Notes and concluded that the embedded conversion features meet the requirements for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet, and that the cash conversion guidance applies. Therefore, the Convertible Notes issuance proceeds of $210.0 million are allocated first to the liability component based on the fair value of non-convertible debt with otherwise identical residual terms with the residual proceeds allocated to equity for the conversion features. The debt issuance costs associated with the Convertible Notes of $6.8 million were allocated to the liability and equity component in the same proportion as the issuance proceeds. We also evaluated the interest feature on default and redemption features embedded in the Convertible Notes and concluded that they are clearly and closely related to the Convertible Notes, and therefore they would not be separately accounted for as a derivative. For the contingent interest features unrelated to our creditworthiness, we concluded that they should be separately accounted for as a compound derivative instrument with de-minimis value. Further, we concluded the Capped Call Transaction qualifies for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet. Consequently, the fair value of the Capped Call of $33.2 million is classified as equity and will not be subsequently remeasured. The balance of our Convertible Notes at December 31, 2019 and 2018, is as follows: December 31, December 31, 2019 2018 (In thousands) Principal amount $ 210,000 $ 210,000 Unamortized discount (47,660) (56,156) Unamortized issuance costs attributable to principal amount (4,127) (4,863) Total Convertible Notes, net $ 158,213 $ 148,981 Fair value of outstanding Convertible Notes $ 208,163 $ 186,900 Amount by which the Convertible Notes if-converted value exceeds their principal amount $ — $ — The unamortized debt discount and debt issuance costs related to the Convertible Notes are being amortized to interest expense using the effective interest method through the scheduled maturity of November 15, 2023. The estimated fair value of the Convertible Notes at December 31, 2019, as determined through consideration of quoted market prices, was $208.2 million. The fair value is classified as Level 3 due to the limited trading activity for the Convertible Notes. |
Lease Liabilities
Lease Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Lease liabilities | Note 9—Lease Liabilities We have operating leases related to our office and laboratory space. The initial term of the leases is through November 2027 and we have two options to extend the lease term, each by five years. We have finance leases for certain laboratory and office equipment that have lease terms expiring through December 2023. As described further in “Note 2--Significant Accounting Policies”, on January 1, 2019, we adopted ASU 2016-02, Leases, Classification on the Balance Sheet December 31, 2019 Assets (In thousands) Operating lease assets Right of use assets $ 27,082 Finance lease assets Property and equipment, net 2,973 Total lease assets $ 30,055 Liabilities Current: Operating leases Current portion of lease liabilities $ 2,282 Finance leases Current portion of lease liabilities 1,222 Non-current: Operating leases Lease liabilities, non-current 30,772 Finance leases Lease liabilities, non-current 1,546 Total lease liabilities $ 35,822 Weighted-average remaining lease term Operating leases 7.8 years Finance leases 2.5 years Weighted-average discount rate Operating leases 12.85 % Finance leases 12.17 % The components of total lease costs are as follows: Year Ended December 31, 2019 (In thousands) Lease cost Operating lease cost $ 4,604 Finance lease cost: Amortization 1,340 Interest 337 Short-term lease cost 275 Variable lease cost 2,045 Sublease income (913) Total lease cost $ 7,688 The supplemental cash flow information related to leases during 2019 is as follows: Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 6,951 Operating cash flows used for finance leases $ 337 Financing cash flows used for finance leases $ 1,139 The future maturities of our lease liabilities as of December 31, 2019 are as follows: Operating Finance Leases Leases (In thousands) 2020 $ 6,398 $ 1,434 2021 6,536 1,076 2022 6,678 490 2023 6,823 131 2024 6,972 27 Thereafter 19,590 — Total undiscounted lease payments 52,997 3,158 Less interest 19,943 390 Lease liabilities $ 33,054 $ 2,768 In 2019 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10—Commitments and Contingencies Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $22.7 million as of December 31, 2019 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 as well as low single to low double-digit royalties on the net income or net sales of the product. For the years ended December 31, 2019, 2018 and 2017, development milestones incurred were immaterial and we did not owe any royalties. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | Note 11—Shareholders’ Equity Common Stock As of December 31, 2019, we had reserved shares of common stock for the following purposes: Options granted and outstanding 11,207,931 Options available for future grant 5,397,602 Common stock warrants 243,115 Total shares reserved 16,848,648 Securities Offerings In August 2017, we sold 3.0 million shares of our common stock at a public offering price of $22.75 per share. After deducting underwriter discounts and offering expenses, we received net proceeds from the transaction of $63.6 million. Warrants In connection with various previously outstanding debt agreements we have issued warrants to purchase shares of our common stock as follows: Outstanding At December 31, 2019 Expiration Date Exercise Price 43,115 May 18, 2023 $ 9.94 200,000 April 12, 2023 $ 23.00 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Note 12—Stock-Based Compensation Our stock option plans provide for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units, performance shares and other stock and cash awards to employees, directors and consultants and subsidiary corporations’ employees and consultants. Stock options must be granted with exercise prices not less than the fair market value of the common stock subject to the stock option on the date of the grant and the options may not exceed 10 years. Any unvested stock options granted which are subsequently canceled become available for future grant. As of December 31, 2019, a total of 16.9 million shares were reserved for issuance under our stock plans and outstanding warrants, of which 5.4 million were available for future grants which includes shares registered in June 2019 under the Omeros Corporation 2017 Omnibus Incentive Compensation Plan, as amended and restated effective June 7, 2019. Stock-based compensation expense is as follows: Year Ended December 31, 2019 2018 2017 (In thousands) Research and development $ 6,095 $ 4,961 $ 5,240 Selling, general and administrative 7,690 6,752 7,448 Total $ 13,785 $ 11,713 $ 12,688 The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to stock option grants during the periods ended: Year Ended December 31, 2019 2018 2017 Estimated weighted-average fair value $ 9.93 $ 10.32 $ 8.66 Weighted-average assumptions: Expected volatility 80 % 78 % 74 % Expected term, in years 6.0 6.0 6.0 Risk-free interest rate 2.41 % 2.68 % 2.05 % Expected dividend yield — % — % — % During the years ended December 31, 2019 and 2018, we granted to non-employees options to purchase 20,000 shares and 20,000 shares of common stock, respectively. In connection with the non-employee options, we recognized expense of $0.2 million, $0.2 million, and $0.5 million during the years ended December 31, 2019, 2018 and 2017, respectively. Stock option activity for all stock plans is as follows: Weighted- Average Aggregate Exercise Remaining Intrinsic Options Price per Contractual Life Value Outstanding Share (In years) (In thousands) Balance at December 31, 2018 10,313,138 $ 11.22 Granted 2,098,705 14.23 Exercised (799,815) 9.50 Forfeited (404,097) 16.28 Balance at December 31, 2019 11,207,931 $ 11.72 6.0 $ 31,912 Vested and expected to vest at December 31, 2019 10,876,043 $ 11.65 6.0 $ 31,661 Exercisable at December 31, 2019 8,212,177 $ 10.87 5.1 $ 29,546 The total intrinsic value of options exercised during the years ended December 31, 2019, 2018 and 2017 was $5.4 million, $11.4 million and $16.4 million, respectively. At December 31, 2019, there were 3.0 million unvested options outstanding that will vest over a weighted-average period of 2.6 years. The remaining estimated compensation expense to be recognized in connection with these unvested options is $24.2 million. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 13—Income Taxes The components of income tax benefit are as follows: December 31, 2019 2018 2017 (In thousands) Current income tax benefit: Federal $ — $ — $ — State — — — Total current income tax benefit — — — Deferred income tax benefit: Federal — 11,261 — State — 1,668 — Total deferred income tax benefit — 12,929 — Income tax benefit $ — $ 12,929 $ — We have a history of losses and therefore have historically not made a provision for income taxes. However, in 2018 we recorded an income tax benefit of $12.9 million related to the issuance of our Convertible Notes. In accordance with intra-period tax allocation rules, the deferred tax liability related to the equity component of convertible debt is a source of income that can be used to recognize the tax benefit of the current year loss through continuing operations. The tax benefit related to the issuance of our Convertible Notes occurred in 2018 and does not recur in subsequent years. Deferred income taxes reflect the tax effect of net operating loss and tax credit carryforwards and the net temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of deferred income taxes are as follows: December 31, 2019 2018 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 126,794 $ 113,928 Research and development tax credits 40,654 35,739 Stock-based compensation 9,959 8,969 Deferred rent — 2,037 Lease liability 7,908 — Other 14,555 10,413 Total deferred tax assets 199,870 171,086 Deferred tax liabilities: Equity component of Convertible Notes (11,082) (12,706) Right of use assets (6,480) — Total deferred tax liabilities (17,562) (12,706) Net deferred tax assets before valuation allowance 182,308 158,380 Less valuation allowance (182,308) (158,380) Net deferred tax assets $ — $ — As of December 31, 2019 and 2018, we had federal net operating loss carryforwards of approximately $564.3 million and $513.2 million, respectively, and state net operating losses of approximately $170.5 million and $125.0 million, respectively. In certain circumstances, due to ownership changes, our net operating loss and tax credit carryforwards may be subject to limitations under Section 382 of the Internal Revenue Code. To date, we have not completed a Section 382 study. Unless previously utilized, our net operating loss and research and development tax credit carryforwards expire between 2020 and 2039. We have established a 100% valuation allowance due to the uncertainty of our ability to generate sufficient taxable income to realize the deferred tax assets. Our valuation allowance increased $23.9 million and $26.4 million in 2019 and 2018, respectively, primarily due to net operating losses incurred during these periods. Reconciliation of income tax computed at federal statutory rates to the reported provisions for income taxes is as follows: Year ended December 31, 2019 2018 2017 U.S. Federal statutory rate on net loss (21) % (21) % (34) % State tax, net of federal tax benefit (2) % (2) % (2) % Effects of statutory rate change — % — % 115 % Change in valuation allowance 28 % 19 % (60) % Tax credits (6) % (5) % (11) % Other 1 % — % (8) % Effective tax rate — % (9) % — % We file federal and certain state income tax returns, which provides varying statutes of limitations on assessments. However, because of net operating loss carryforwards, substantially all of our tax years remain open to federal and state tax examination. We recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense. To date, there have been no interest or penalties charged to us in relation to the underpayment of income taxes. |
401k Retirement Plan
401k Retirement Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |
401(k) Retirement Plan | Note 14—401(k) Retirement Plan Our 401(k) retirement plan provides for an annual company discretionary match on employee contributions up to 4.0% of each participating employee’s eligible earnings, with a maximum company match of $4,000 per employee per year. All employees are eligible to participate. |
Quarterly Information (Unaudite
Quarterly Information (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Information (Unaudited) | Note 15—Quarterly Information (Unaudited) The following table summarizes the unaudited statements of operations and comprehensive loss for each quarter of 2019 and 2018 (in thousands, except per share amounts): 2019 For the Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 21,779 $ 26,753 $ 29,856 $ 33,417 Total costs and expenses 41,018 36,091 40,957 57,121 Loss from operations (19,239) (9,338) (11,101) (23,704) Net loss (24,345) (14,453) (16,463) (29,225) Basic and diluted net loss per share $ (0.50) $ (0.29) $ (0.33) $ (0.58) 2018 For the Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 1,588 $ 1,655 $ 4,608 $ 22,017 Total costs and expenses 29,277 32,272 40,050 40,491 Loss from operations (27,689) (30,617) (35,442) (18,474) Net loss (30,054) (33,696) (39,472) (23,534) Basic and diluted net loss per share $ (0.62) $ (0.70) $ (0.81) $ (0.48) (1) As further described in Note 1, OMIDRIA was reimbursed under Medicare Part B from January 1, 2015 through December 31, 2017. For the period January 1, 2018 through September 30, 2018, OMIDRIA was not reimbursed separately for procedures covered under Medicare Part B. Beginning October 1, 2018, OMIDRIA was again reimbursed separately under Medicare Part B. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Organization | Organization 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, and immune-related diseases, including cancers. Our first drug product, OMIDRIA, is marketed in the United States (U.S.) for use during cataract surgery or intraocular lens replacement. |
Basis of Presentation | Basis of Presentation Our consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). Certain prior year amounts in the balance sheet, statement of cash flows and the footnotes have been reclassified in the consolidated financial statements to conform to the current year presentation. |
Segment | Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, accruals for manufacturing of drug product, clinical drug supply and clinical trials, lease liabilities, and stock-based compensation expense. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. |
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments | Cash and Cash Equivalents, Short-Term Investments and Restricted Investments Cash and cash equivalents include highly liquid investments with a maturity of three months or less on the date of purchase. Short-term investment securities are classified as available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported as a separate component of shareholders’ deficit. Amortization, accretion, interest and dividends, realized gains and losses and declines in value judged to be other-than-temporary are included in other income. The cost of securities sold is based on the specific-identification method. Investments in securities with maturities of less than one year, or those for which management intends to use the investments to fund current operations, are included in current assets. We evaluate whether an investment is other-than-temporarily impaired based on the specific facts and circumstances. Factors that are considered in determining whether an other-than-temporary decline in value has occurred include: the market value of the security in relation to its cost basis; the financial condition of the investee; and the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment. Restricted investments are held in money-market funds. As of December 31, 2019 and 2018, all investments are classified as short-term and available-for-sale. Investment income, which is included as a component of other income, consists primarily of interest earned. |
Inventory | Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner that approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing, transportation and internal labor and overhead. Capitalization of costs as inventory begins when the product candidate receives regulatory approval 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. |
Receivables, Net | Receivables, Net Receivables relate primarily to sales of OMIDRIA to wholesalers and include reductions for estimated chargebacks and product returns that are expected to be settled through reductions in receivables. Remaining receivables consist of amounts from subleases for space in our facilities. Considering the nature and historic collectability of our receivables, we concluded an allowance for doubtful accounts is not necessary as of December 31, 2019 and 2018. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, and depreciation is calculated using the straight-line method over the estimated useful life of the assets, which is generally three recorded as property and equipment and is amortized over the shorter of the useful lives of the related assets or the lease term. Expenditures for repairs and maintenance are expensed as incurred. |
Right-of-Use Assets and Related Lease Liabilities | Right-of-Use Assets and Related Lease Liabilities On January 1, 2019, we adopted Accounting Standards Update (ASU) 2016-02, Leases , (Topic 842) using a modified retrospective approach versus recasting the prior periods presented. We elected the package of practical expedients permitted under the transition guidance, which allowed us to carryforward our historical assessment of whether (i) contracts contain leases, (ii) lease classifications and (iii) initial direct costs. Upon adoption we recognized right-of-use assets and lease liabilities of $17.7 million and $26.4 million, respectively. The balance of the net right-of-use asset included the reversal of the outstanding balance of deferred rent of $8.7 million. 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. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We assess the impairment of long-lived assets, primarily property and equipment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability of these assets is measured by comparing the carrying value to future undiscounted cash flows that the asset is expected to generate. If the asset is considered to be impaired, the amount of any impairment will be reflected in the results of operations in the period of impairment. We have not recognized any impairment losses for the years ending December 31, 2019, 2018 and 2017. |
Revenue Recognition | Revenue Recognition When we enter into a customer contract, we perform the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. |
Product Sales, Net | Product Sales, Net We generally record revenue from product sales when the product is delivered to our wholesalers. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability depending on how the amount is expected to be settled. |
Chargeback and Rebates | Chargebacks and Rebates: four We provide reimbursement support services and financial assistance in the form of a rebate to patients whose commercial insurance is inadequate to cover the full cost of OMIDRIA. We apply an experience ratio based on historical and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and is being reviewed and updated periodically to reflect actual results. We provide rebate payments for which ASCs qualify by meeting or exceeding purchase volumes of OMIDRIA under our purchase volume-discount program. We calculate rebate payment amounts due under this program based on actual qualifying purchase volumes and apply a contractual discount rate. For purchases of OMIDRIA not yet reported as sold-through to the ASC by our wholesalers, we apply an experience ratio to product sales to determine the rebate accrual. This experience ratio is being reviewed and updated periodically to reflect actual results. |
Distribution Fees and Product Return Allowances | Distribution Fees and Product Return Allowances We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders. |
Research and Development | Research and Development Research and development expenses are comprised primarily of contracted research and manufacturing costs prior to approval; costs for personnel, including salaries, benefits and stock compensation; clinical study costs; contracted research; manufacturing costs prior to approval; consulting services; depreciation; materials and supplies; milestones; an allocation of our occupancy costs; and other expenses incurred to sustain our overall research and development programs. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and then recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. All other research and development costs are expensed as incurred. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative expenses are comprised primarily of salaries, benefits, and stock-compensation costs for sales, marketing, and other personnel not directly engaged in research and development. Additionally, selling, general and administrative expenses include marketing and selling expenses, professional and legal services; patent costs; depreciation, an allocation of our occupancy costs; and other general corporate expenses. Advertising costs, which we consider to be media and marketing materials, are expensed as incurred and were $8.0 million, $2.5 million and $0.3 million during the years ended December 31, 2019, 2018 and 2017, respectively. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense is recognized for all share-based payments based on estimated fair values. The fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental assumptions including volatility, forfeiture rates and expected option life. We use the straight-line method to allocate compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting period. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss is comprised of net loss and certain changes in equity that are excluded from net loss. There was no difference between comprehensive loss and net loss for the years ended December 31, 2019, 2018 or 2017. |
Financial Instruments and Concentrations of Credit Risk | Financial Instruments and Concentrations of Credit Risk Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of short-term investments is based on quoted market prices. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, our cash and cash equivalents balance held at a financial institution may exceeds the federally insured limits. To limit the credit risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and commercial paper. |
Major Customers | Major Customers We sell OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2019, 2018 and 2017 and greater than 10% of accounts receivable as of December 31, 2019, 2018 and 2017 as noted below. 2019 2018 2017 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 25 % 23 % 31 % 27 % 29 % 31 % Distributor B 24 % 19 % 27 % 25 % 26 % 23 % Distributor C 29 % 33 % 22 % 25 % 22 % 26 % Distributor D 22 % 25 % 20 % 23 % 23 % 20 % |
Major Suppliers | Major Suppliers We use a single contract manufacturer to supply the OMIDRIA drug product and a separate company to package OMIDRIA for commercial sale. We generally use different contract manufacturers to produce drug substance, drug product and to perform final packaging for our drug product candidates. We endeavor to maintain reasonable levels of drug supply for our commercial and clinical trial use and other manufacturers are available should we need to change suppliers. A change in suppliers, however, could cause a delay in delivery of OMIDRIA or our clinical trial material that would adversely affect our business. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses , (Topic 326) which changes how entities account for credit losses on most financial assets and certain other instruments and expands disclosures. The standard is effective for annual and interim periods beginning after December 15, 2019 with early adoption permitted. We adopted the standard on January 1, 2020 and the adoption did not have a material impact on our consolidated financial statements and disclosures. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Revenue by Major Customers by Reporting Segments | We sell OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2019, 2018 and 2017 and greater than 10% of accounts receivable as of December 31, 2019, 2018 and 2017 as noted below. 2019 2018 2017 Percentage Percentage Percentage Percentage Percentage Percentage of Total of Accounts of Total of Accounts of Total of Accounts Revenue Receivable Revenue Receivable Revenue Receivable Distributor A 25 % 23 % 31 % 27 % 29 % 31 % Distributor B 24 % 19 % 27 % 25 % 26 % 23 % Distributor C 29 % 33 % 22 % 25 % 22 % 26 % Distributor D 22 % 25 % 20 % 23 % 23 % 20 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss per Share | Year Ended December 31, 2019 2018 2017 Outstanding options to purchase common stock 11,207,931 10,313,138 9,657,259 Outstanding warrants to purchase common stock 243,115 243,115 100,602 Total potentially dilutive shares excluded from loss per share 11,451,046 10,556,253 9,757,861 |
Accounts Receivable, Net (Table
Accounts Receivable, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Receivables [Abstract] | |
Schedule of accounts receivable | December 31, 2019 2018 (In thousands) Trade receivables, net $ 35,074 $ 22,654 Sublease and other receivables 111 164 Total accounts receivables, net $ 35,185 $ 22,818 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | December 31, 2019 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 57,704 — — 57,704 Total $ 58,858 $ — $ — $ 58,858 December 31, 2018 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 54,637 — — 54,637 Total $ 55,791 $ — $ — $ 55,791 |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Receivables [Abstract] | |
Schedule of Inventory, Current | December 31, December 31, 2019 2018 (In thousands) Raw materials $ 91 $ 83 Work-in-progress 338 — Finished goods 718 5 Total inventory $ 1,147 $ 88 |
Property, Plant and Equipment | December 31, 2019 2018 (In thousands) Finance leases $ 5,474 $ 4,034 Laboratory equipment 2,844 2,569 Computer equipment 921 862 Office equipment and furniture 625 625 Total cost 9,864 8,090 Less accumulated depreciation and amortization (6,035) (4,245) Total property and equipment, net $ 3,829 $ 3,845 |
Accrued Expenses | December 31, 2019 2018 (In thousands) Contract research and development $ 24,107 $ 12,012 Sales rebates, fees and discounts 10,870 8,075 Consulting and professional fees 3,610 3,669 Employee compensation 3,546 2,714 Clinical trials 1,982 820 Interest payable 1,640 1,677 Other accrued expenses 872 1,219 Total accrued expenses $ 46,627 $ 30,186 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Debt | (In thousands) Convertible Notes initially issued $ 210,000 Repayment of previously outstanding loan (146,046) Purchase of Capped Call (33,180) Issuance costs (6,800) Net proceeds available for corporate use $ 23,974 December 31, December 31, 2019 2018 (In thousands) Principal amount $ 210,000 $ 210,000 Unamortized discount (47,660) (56,156) Unamortized issuance costs attributable to principal amount (4,127) (4,863) Total Convertible Notes, net $ 158,213 $ 148,981 Fair value of outstanding Convertible Notes $ 208,163 $ 186,900 Amount by which the Convertible Notes if-converted value exceeds their principal amount $ — $ — |
Lease Liabilities (Tables)
Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of lease-related assets and liabilities recorded on the balance sheet | Classification on the Balance Sheet December 31, 2019 Assets (In thousands) Operating lease assets Right of use assets $ 27,082 Finance lease assets Property and equipment, net 2,973 Total lease assets $ 30,055 Liabilities Current: Operating leases Current portion of lease liabilities $ 2,282 Finance leases Current portion of lease liabilities 1,222 Non-current: Operating leases Lease liabilities, non-current 30,772 Finance leases Lease liabilities, non-current 1,546 Total lease liabilities $ 35,822 Weighted-average remaining lease term Operating leases 7.8 years Finance leases 2.5 years Weighted-average discount rate Operating leases 12.85 % Finance leases 12.17 % |
Schedule of lease costs | Year Ended December 31, 2019 (In thousands) Lease cost Operating lease cost $ 4,604 Finance lease cost: Amortization 1,340 Interest 337 Short-term lease cost 275 Variable lease cost 2,045 Sublease income (913) Total lease cost $ 7,688 |
Schedule of supplemental cash flow information | Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 6,951 Operating cash flows used for finance leases $ 337 Financing cash flows used for finance leases $ 1,139 |
Schedule of operating and finance lease liability | Operating Finance Leases Leases (In thousands) 2020 $ 6,398 $ 1,434 2021 6,536 1,076 2022 6,678 490 2023 6,823 131 2024 6,972 27 Thereafter 19,590 — Total undiscounted lease payments 52,997 3,158 Less interest 19,943 390 Lease liabilities $ 33,054 $ 2,768 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Reserved Shares of Common Stock | Options granted and outstanding 11,207,931 Options available for future grant 5,397,602 Common stock warrants 243,115 Total shares reserved 16,848,648 |
Schedule of Stockholders' Equity Note, Warrants or Rights | Outstanding At December 31, 2019 Expiration Date Exercise Price 43,115 May 18, 2023 $ 9.94 200,000 April 12, 2023 $ 23.00 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation Expense | Year Ended December 31, 2019 2018 2017 (In thousands) Research and development $ 6,095 $ 4,961 $ 5,240 Selling, general and administrative 7,690 6,752 7,448 Total $ 13,785 $ 11,713 $ 12,688 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Year Ended December 31, 2019 2018 2017 Estimated weighted-average fair value $ 9.93 $ 10.32 $ 8.66 Weighted-average assumptions: Expected volatility 80 % 78 % 74 % Expected term, in years 6.0 6.0 6.0 Risk-free interest rate 2.41 % 2.68 % 2.05 % 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, 2018 10,313,138 $ 11.22 Granted 2,098,705 14.23 Exercised (799,815) 9.50 Forfeited (404,097) 16.28 Balance at December 31, 2019 11,207,931 $ 11.72 6.0 $ 31,912 Vested and expected to vest at December 31, 2019 10,876,043 $ 11.65 6.0 $ 31,661 Exercisable at December 31, 2019 8,212,177 $ 10.87 5.1 $ 29,546 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | December 31, 2019 2018 2017 (In thousands) Current income tax benefit: Federal $ — $ — $ — State — — — Total current income tax benefit — — — Deferred income tax benefit: Federal — 11,261 — State — 1,668 — Total deferred income tax benefit — 12,929 — Income tax benefit $ — $ 12,929 $ — |
Significant Components of Deferred Tax Assets | December 31, 2019 2018 (In thousands) Deferred tax assets: Net operating loss carryforwards $ 126,794 $ 113,928 Research and development tax credits 40,654 35,739 Stock-based compensation 9,959 8,969 Deferred rent — 2,037 Lease liability 7,908 — Other 14,555 10,413 Total deferred tax assets 199,870 171,086 Deferred tax liabilities: Equity component of Convertible Notes (11,082) (12,706) Right of use assets (6,480) — Total deferred tax liabilities (17,562) (12,706) Net deferred tax assets before valuation allowance 182,308 158,380 Less valuation allowance (182,308) (158,380) Net deferred tax assets $ — $ — |
Reconciliation of Federal Statutory Tax Rate to Effective Income Tax | Year ended December 31, 2019 2018 2017 U.S. Federal statutory rate on net loss (21) % (21) % (34) % State tax, net of federal tax benefit (2) % (2) % (2) % Effects of statutory rate change — % — % 115 % Change in valuation allowance 28 % 19 % (60) % Tax credits (6) % (5) % (11) % Other 1 % — % (8) % Effective tax rate — % (9) % — % |
Quarterly Information (Unaudi_2
Quarterly Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Unaudited Statements of Operations | The following table summarizes the unaudited statements of operations and comprehensive loss for each quarter of 2019 and 2018 (in thousands, except per share amounts): 2019 For the Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 21,779 $ 26,753 $ 29,856 $ 33,417 Total costs and expenses 41,018 36,091 40,957 57,121 Loss from operations (19,239) (9,338) (11,101) (23,704) Net loss (24,345) (14,453) (16,463) (29,225) Basic and diluted net loss per share $ (0.50) $ (0.29) $ (0.33) $ (0.58) 2018 For the Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 1,588 $ 1,655 $ 4,608 $ 22,017 Total costs and expenses 29,277 32,272 40,050 40,491 Loss from operations (27,689) (30,617) (35,442) (18,474) Net loss (30,054) (33,696) (39,472) (23,534) Basic and diluted net loss per share $ (0.62) $ (0.70) $ (0.81) $ (0.48) |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)segment | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Aug. 31, 2019USD ($) | |
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Cash, cash equivalents and marketable securities | $ 60,800 | $ 60,800 | ||||||||||
Net Working Capital Adjustments | 48,300 | 48,300 | ||||||||||
Operating Income (Loss) | 23,704 | $ 11,101 | $ 9,338 | $ 19,239 | $ 18,474 | $ 35,442 | $ 30,617 | $ 27,689 | 63,382 | $ 112,222 | $ 43,895 | |
Net cash used in operating activities | $ 60,073 | $ 103,737 | $ 36,227 | |||||||||
Number of operating segments | segment | 1 | |||||||||||
Line of Credit Agreement | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Borrowing capacity | $ 50,000 | $ 50,000 | $ 50,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 10 years |
Significant Accounting Polici_5
Significant Accounting Policies - Right-of-Use Assets and Related Lease Liabilities (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Dec. 31, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Right of use assets | $ 27,082 | |
Lease liabilities | $ 33,054 | |
Accounting Standards Update 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Lease, Practical Expedients, Package | true | |
Restatement Adjustment | Accounting Standards Update 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Right of use assets | $ 17,700 | |
Lease liabilities | 26,400 | |
Reversal deferred rent credit | $ 8,700 |
Significant Accounting Polici_6
Significant Accounting Policies - Chargebacks and Returns (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Period chargebacks are generally settled | 28 days |
Period for product return past its expiration or damaged | 12 months |
Significant Accounting Polici_7
Significant Accounting Policies - Advertising (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | |||
Advertising expense | $ 8 | $ 2.5 | $ 0.3 |
Significant Accounting Polici_8
Significant Accounting Policies - Major Customers and Major Suppliers (Details) - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Distributor A | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 25.00% | 31.00% | 29.00% |
Distributor A | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 23.00% | 27.00% | 31.00% |
Distributor B | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 24.00% | 27.00% | 26.00% |
Distributor B | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 19.00% | 25.00% | 23.00% |
Distributor C | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 29.00% | 22.00% | 22.00% |
Distributor C | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 33.00% | 25.00% | 26.00% |
Distributor D | Percentage of Total Revenue | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 22.00% | 20.00% | 23.00% |
Distributor D | Percentage of Accounts Receivable | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 25.00% | 23.00% | 20.00% |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Outstanding dilutive securities not included in diluted loss per share calculation | 11,451,046 | 10,556,253 | 9,757,861 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Outstanding dilutive securities not included in diluted loss per share calculation | 11,207,931 | 10,313,138 | 9,657,259 |
Warrants to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Outstanding dilutive securities not included in diluted loss per share calculation | 243,115 | 243,115 | 100,602 |
Accounts Receivable, Net - Gran
Accounts Receivable, Net - Grant and Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheet Related Disclosures [Abstract] | ||
Trade receivables, net | $ 35,074 | $ 22,654 |
Sublease and other receivables | 111 | 164 |
Total accounts receivables, net | 35,185 | 22,818 |
Chargeback and product return allowances | $ 1,600 | $ 400 |
Fair-Value Measurements - Recur
Fair-Value Measurements - Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as non-current restricted investments | $ 1,154 | $ 1,154 |
Money-market funds classified as short-term investments | 57,704 | 54,637 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds classified as non-current restricted investments | 1,154 | 1,154 |
Money-market funds classified as short-term investments | 57,704 | 54,637 |
Total | 58,858 | 55,791 |
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 non-current restricted investments | 1,154 | 1,154 |
Money-market funds classified as short-term investments | 57,704 | 54,637 |
Total | $ 58,858 | $ 55,791 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cash and cash equivalents | $ 3,084 | $ 5,861 | |
Unrealized gain (loss) on investments | $ 0 | $ 0 | |
Convertible Debt | Convertible Notes | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Interest Rate | 6.25% |
Certain Balance Sheet Account_2
Certain Balance Sheet Accounts - Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 91 | $ 83 |
Work-in-process | 338 | |
Finished goods | 718 | 5 |
Total inventory | $ 1,147 | $ 88 |
Certain Balance Sheet Account_3
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 9,864 | $ 8,090 | |
Less accumulated depreciation and amortization | (6,035) | (4,245) | |
Total property and equipment, net | 3,829 | 3,845 | |
Depreciation and amortization | 1,790 | 962 | $ 551 |
Finance leases | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 5,474 | 4,034 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 2,844 | 2,569 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 921 | 862 | |
Office equipment and furniture | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 625 | $ 625 |
Certain Balance Sheet Account_4
Certain Balance Sheet Accounts - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Contract research and development | $ 24,107 | $ 12,012 |
Sales rebates, fees and discounts | 10,870 | 8,075 |
Consulting and professional fees | 3,610 | 3,669 |
Employee compensation | 3,546 | 2,714 |
Clinical trials | 1,982 | 820 |
Interest payable | 1,640 | 1,677 |
Other accrued expenses | 872 | 1,219 |
Total accrued expenses | $ 46,627 | $ 30,186 |
Debt (Details)
Debt (Details) - USD ($) | May 31, 2018 | Aug. 31, 2019 | Nov. 30, 2018 | May 31, 2018 | Oct. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2019 |
Debt Instrument [Line Items] | |||||||
Loss on early extinguishment of debt | $ 12,993,000 | ||||||
CRG Loan | |||||||
Debt Instrument [Line Items] | |||||||
Debt issued | $ 45,000,000 | $ 80,000,000 | |||||
Interest Rate | 12.25% | ||||||
Deferred interest rate percentage | 4.00% | ||||||
Facility fee, as a percent | 5.00% | ||||||
Prepayment fee, as a percent | 4.00% | ||||||
Loss on early extinguishment of debt | $ 13,000,000 | ||||||
Convertible Debt | Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Convertible Notes initially issued | $ 210,000,000 | $ 210,000,000 | $ 210,000,000 | ||||
Interest Rate | 6.25% | ||||||
Line of Credit Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Borrowing capacity | $ 50,000,000 | 50,000,000 | |||||
Basis for variable rate | 5.50% | ||||||
Debt termination fee | $ 1,000,000 | ||||||
Payment of initial commitment fee | 150,000 | ||||||
Additional commitment fees payable each of the first and second anniversaries of the closing date | $ 150,000 | ||||||
Outstanding borrowings | $ 0 | ||||||
Line of Credit Agreement | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Borrowing option - percentage of eligible accounts receivable | 85.00% | ||||||
Warrants to purchase common stock | |||||||
Debt Instrument [Line Items] | |||||||
Total fair value of warrants | $ 1,400,000 | ||||||
Warrants to purchase common stock | CRG Loan | |||||||
Debt Instrument [Line Items] | |||||||
Warrant exercise price (in USD per share) | $ 23 | $ 23 | |||||
Warrants to purchase common stock | CRG Loan | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Shares of common stock right to purchase by warrant (in shares) | 200,000 | 200,000 |
Convertible Senior Notes - Net
Convertible Senior Notes - Net Proceeds (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended |
Nov. 30, 2018 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Proceeds from Convertible Debt | $ 210,000 | |
Issuance costs | $ (6,800) | |
CRG Loan | ||
Debt Instrument [Line Items] | ||
Repayment of previously outstanding loan | $ (146,046) | |
Convertible Debt | Convertible Notes | ||
Debt Instrument [Line Items] | ||
Proceeds from Convertible Debt | 210,000 | |
Issuance costs | (6,800) | |
Net proceeds available for corporate use | 23,974 | |
Convertible Debt | Capped Call Transaction | ||
Debt Instrument [Line Items] | ||
Purchase of Capped Call | $ (33,180) |
Convertible Senior Notes - Narr
Convertible Senior Notes - Narrative (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Nov. 30, 2018USD ($)D$ / shares | Jun. 30, 2019D | Dec. 31, 2018USD ($) | Dec. 31, 2019USD ($) | |
Debt Instrument [Line Items] | ||||
Proceeds from Convertible Debt | $ 210,000,000 | |||
Debt issuance costs | 6,800,000 | |||
Convertible Debt | Convertible Notes | ||||
Debt Instrument [Line Items] | ||||
Interest Rate | 6.25% | |||
Conversion rate | 0.0520183 | |||
Conversion Price | $ / shares | $ 19.22 | |||
Value used in calculation of conversion rate | $ 1,000 | |||
Percentage of Stock Price Trigger | 150.00% | 130.00% | ||
Trading Days | D | 20 | 20 | ||
Consecutive Trading Days | D | 30 | 30 | ||
Measurement Period | 5 days | |||
Percent Of Last Product Sale | 98.00% | |||
Proceeds from Convertible Debt | $ 210,000,000 | |||
Debt issuance costs | 6,800,000 | |||
Fair value | $ 186,900,000 | $ 208,163,000 | ||
Convertible Debt | Capped Call Transaction | ||||
Debt Instrument [Line Items] | ||||
Purchase of Capped Call | 33,180,000 | |||
Fair value | $ 33,200,000 | |||
Convertible Debt | Capped Call Transaction | Minimum | ||||
Debt Instrument [Line Items] | ||||
Conversion Price | $ / shares | $ 19.22 | |||
Convertible Debt | Capped Call Transaction | Maximum | ||||
Debt Instrument [Line Items] | ||||
Conversion Price | $ / shares | $ 28.8360 |
Convertible Senior Notes - Bala
Convertible Senior Notes - Balance of Convertible Notes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | |
Debt Instrument [Line Items] | |||
Total Convertible Notes, net | $ 158,213 | $ 148,981 | |
Convertible Debt | Convertible Notes | |||
Debt Instrument [Line Items] | |||
Convertible Notes initially issued | 210,000 | 210,000 | $ 210,000 |
Unamortized discount | (47,660) | (56,156) | |
Unamortized issuance costs attributable to principal amount | (4,127) | (4,863) | |
Total Convertible Notes, net | 158,213 | 148,981 | |
Fair value of outstanding Convertible Notes | 208,163 | 186,900 | |
Amount by which the Convertible Notes if-converted value exceeds their principal amount | $ 0 | $ 0 |
Lease Liabilities (Details)
Lease Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)item | |
Leases [Abstract] | |
Option to Extend | true |
Number of options to extend lease | item | 2 |
Term of contract | 5 years |
Classification on the Balance Sheet | |
Operating lease assets | $ 27,082 |
Finance lease assets | $ 2,973 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Property, Plant and Equipment, Net |
Total lease assets | $ 30,055 |
Operating Leases | $ 2,282 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Current |
Finance Lease | $ 1,222 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Current |
Operating | $ 30,772 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Noncurrent |
Finance | $ 1,546 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating And Finance Lease Liability Noncurrent |
Total lease liabilities | $ 35,822 |
Operating leases | 7 years 9 months 18 days |
Finance leases | 2 years 6 months |
Operating leases | 12.85% |
Finance leases | 12.17% |
Operating cash flows used for operating leases | $ 6,951 |
Operating cash flows used for finance leases | 337 |
Financing cash flows used for finance leases | 1,139 |
Lease cost | |
Operating lease cost | 4,604 |
Amortization | 1,340 |
Interest | 337 |
Short-term lease cost | 275 |
Variable lease cost | 2,045 |
Sublease income | (913) |
Total lease cost | $ 7,688 |
Lease Liabilities - Maturities
Lease Liabilities - Maturities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
2020 | $ 6,398 |
2021 | 6,536 |
2022 | 6,678 |
2023 | 6,823 |
2024 | 6,972 |
Thereafter | 19,590 |
Total undiscounted lease payments | 52,997 |
Less interest | 19,943 |
Lease liabilities | $ 33,054 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | omer:OperatingAndFinanceLeaseLiabilityCurrent omer:OperatingAndFinanceLeaseLiabilityNoncurrent |
Finance Lease, Liability, Statement of Financial Position [Extensible List] | omer:OperatingAndFinanceLeaseLiabilityCurrent omer:OperatingAndFinanceLeaseLiabilityNoncurrent |
Right of use assets | $ 27,082 |
Finance Leases | |
2020 | 1,434 |
2021 | 1,076 |
2022 | 490 |
2023 | 131 |
2024 | 27 |
Total undiscounted lease payments | 3,158 |
Less interest | 390 |
Lease liabilities | 2,768 |
Additional office and laboratory space | |
Operating Leases | |
Right of use assets | 10,400 |
Finance Leases | |
Lease liabilities | $ 10,400 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Dec. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Contract termination fees | $ 22.7 |
Shareholders' Equity - Reserved
Shareholders' Equity - Reserved Share of Common Stock (Details) | Dec. 31, 2019shares |
Reserved Common Stock [Line Items] | |
Total shares reserved | 16,848,648 |
Options granted and outstanding | |
Reserved Common Stock [Line Items] | |
Total shares reserved | 11,207,931 |
Options available for future grant | |
Reserved Common Stock [Line Items] | |
Total shares reserved | 5,397,602 |
Common stock warrants | |
Reserved Common Stock [Line Items] | |
Total shares reserved | 243,115 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2019 | Aug. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2017 | |
Class of Stock [Line Items] | ||||
Shares reserved for issuance | 16,900,000 | 16,900,000 | ||
Issuance of stock (in shares) | 4,400,000 | 3,000,000 | ||
Share price (in USD per share) | $ 13.10 | $ 22.75 | $ 13.10 | |
Proceeds from issuance of common stock, net | $ 54,200 | $ 63,600 | $ 54,238 | $ 63,657 |
9.94 | ||||
Class of Stock [Line Items] | ||||
Shares of common stock right to purchase by warrant (in shares) | 43,115 | 43,115 | ||
Warrant exercise price (in USD per share) | $ 9.94 | $ 9.94 | ||
23.00 | ||||
Class of Stock [Line Items] | ||||
Shares of common stock right to purchase by warrant (in shares) | 200,000 | 200,000 | ||
Warrant exercise price (in USD per share) | $ 23 | $ 23 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for issuance | 16,900,000 | |||
Shares available for future grants (shares) | 5,400,000 | |||
Stock-based compensation expense | $ 13,785 | $ 11,713 | $ 12,688 | |
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares granted (shares) | 1,600,000 | |||
Exercise price (USD per share) | 11.91 | |||
Stock options, average vesting period | 4 years | |||
Intrinsic value | $ 5,400 | $ 11,400 | 16,400 | |
Unvested options outstanding (shares) | 3,000,000 | |||
Period for recognition | 2 years 7 months 6 days | |||
Unrecognized compensation expense | $ 24,200 | |||
Stock Options | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Contractual term | 10 years | |||
Stock Options | Nonemployee | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares granted (shares) | 20,000 | 20,000 | ||
Stock-based compensation expense | $ 200 | $ 200 | $ 500 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 13,785 | $ 11,713 | $ 12,688 |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 6,095 | 4,961 | 5,240 |
Selling, general and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 7,690 | $ 6,752 | $ 7,448 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Equity Option - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Estimated weighted-average fair value (USD per share) | $ 9.93 | $ 10.32 | $ 8.66 |
Weighted Average | |||
Weighted-average assumptions | |||
Expected volatility | 80.00% | 78.00% | 74.00% |
Expected term, in years | 6 years | 6 years | 6 years |
Risk-free interest rate | 2.41% | 2.68% | 2.05% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Options Outstanding | |
Beginning balance (shares) | shares | 10,313,138 |
Granted (shares) | shares | 2,098,705 |
Exercised (shares) | shares | (799,815) |
Forfeited (shares) | shares | (404,097) |
Ending balance (shares) | shares | 11,207,931 |
Vested and expected to vest (shares) | shares | 10,876,043 |
Exercisable (shares) | shares | 8,212,177 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 11.22 |
Granted (USD per share) | $ / shares | 14.23 |
Exercised (USD per share) | $ / shares | 9.50 |
Forfeited (USD per share) | $ / shares | 16.28 |
Ending balance (USD per share) | $ / shares | 11.72 |
Vested and expected to vest (USD per share) | $ / shares | 11.65 |
Exercisable (USD per share) | $ / shares | $ 10.87 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 6 years |
Vested and expected to vest (in years) | 6 years |
Exercisable (in years) | 5 years 1 month 6 days |
Aggregate Intrinsic Value | |
Balance | $ | $ 31,912 |
Vested and expected to vest | $ | 31,661 |
Exercisable | $ | $ 29,546 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Total current income tax benefit | 0 | 0 | 0 |
Federal | 0 | 11,261 | 0 |
State | 0 | 1,668 | 0 |
Total deferred income tax benefit | 0 | 12,929 | 0 |
Income tax benefit | $ 0 | $ 12,929 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 126,794 | $ 113,928 |
Research and development tax credits | 40,654 | 35,739 |
Stock-based compensation | 9,959 | 8,969 |
Deferred rent | 2,037 | |
Lease liability | 7,908 | |
Other | 14,555 | 10,413 |
Total deferred tax assets | 199,870 | 171,086 |
Deferred tax liabilities: | ||
Equity component of Convertible Notes | (11,082) | (12,706) |
Right of use assets | (6,480) | |
Total deferred tax liabilities | 17,562 | 12,706 |
Net deferred tax assets before valuation allowance | 182,308 | 158,380 |
Less valuation allowance | (182,308) | (158,380) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes | |||
Income tax benefit | $ 0 | $ 12,929 | $ 0 |
Deferred tax assets, percentage of valuation allowance | 100.00% | ||
Increase (decrease) in deferred tax valuation allowance | $ 23,900 | 26,400 | |
Federal | |||
Income Taxes | |||
Operating Loss Carryforwards | 564,300 | 513,200 | |
State | |||
Income Taxes | |||
Operating Loss Carryforwards | $ 170,500 | $ 125,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
U.S. Federal statutory rate on net loss | (21.00%) | (21.00%) | (34.00%) |
State tax, net of federal tax benefit | (2.00%) | (2.00%) | (2.00%) |
Effects of statutory rate change | 0.00% | 0.00% | 115.00% |
Change in valuation allowance | 28.00% | 19.00% | (60.00%) |
Tax credits | (6.00%) | (5.00%) | (11.00%) |
Other | 1.00% | 0.00% | (8.00%) |
Effective tax rate | 0.00% | (9.00%) | 0.00% |
401k Retirement Plan - Narrativ
401k Retirement Plan - Narrative (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Retirement Benefits [Abstract] | |
Maximum percent of each employee's contributions matched by employer | 4.00% |
Maximum company match per employee | $ 4,000 |
Quarterly Information (Unaudi_3
Quarterly Information (Unaudited) - Quarterly Unaudited Statements of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 33,417 | $ 29,856 | $ 26,753 | $ 21,779 | $ 22,017 | $ 4,608 | $ 1,655 | $ 1,588 | $ 111,805 | $ 29,868 | $ 64,826 |
Revenue, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Total costs and expenses | $ 57,121 | $ 40,957 | $ 36,091 | $ 41,018 | $ 40,491 | $ 40,050 | $ 32,272 | $ 29,277 | $ 175,187 | $ 142,090 | $ 108,721 |
Loss from operations | (23,704) | (11,101) | (9,338) | (19,239) | (18,474) | (35,442) | (30,617) | (27,689) | (63,382) | (112,222) | (43,895) |
Net loss | $ (29,225) | $ (16,463) | $ (14,453) | $ (24,345) | $ (23,534) | $ (39,472) | $ (33,696) | $ (30,054) | $ (84,486) | $ (126,757) | $ (53,481) |
Basic and diluted net loss per share (USD per share) | $ (0.58) | $ (0.33) | $ (0.29) | $ (0.50) | $ (0.48) | $ (0.81) | $ (0.70) | $ (0.62) | $ (1.71) | $ (2.61) | $ (1.17) |