Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | OMER | |
Entity Registrant Name | OMEROS CORP | |
Entity Central Index Key | 0001285819 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 49,057,866 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 4,054,000 | $ 5,861,000 |
Short-term investments | 43,168,000 | 54,637,000 |
Receivables, net | 24,718,000 | 22,818,000 |
Inventory | 736,000 | 88,000 |
Prepaid expense and other assets | 4,195,000 | 6,463,000 |
Total current assets | 76,871,000 | 89,867,000 |
Property and equipment, net | 4,479,000 | 3,845,000 |
Right of use assets | 17,514,000 | 0 |
Restricted investments | 1,154,000 | 1,154,000 |
Advanced payments, non-current | 1,228,000 | 1,070,000 |
Total assets | 101,246,000 | 95,936,000 |
Liabilities and shareholders’ deficit | ||
Accounts payable | 7,121,000 | 6,281,000 |
Accrued expenses | 34,823,000 | 30,186,000 |
Current portion of lease liabilities | 2,561,000 | 889,000 |
Total current liabilities | 44,505,000 | 37,356,000 |
Lease liabilities, non-current | 26,578,000 | 1,578,000 |
Unsecured convertible senior notes, net | 151,182,000 | 148,981,000 |
Deferred rent | 0 | 8,177,000 |
Commitments and contingencies (Note 8) | ||
Deferred rent | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at March 31, 2019 and December 31, 2018. | 0 | 0 |
Common stock, par value $0.01 per share, 150,000,000 shares authorized at March 31, 2019 and December 31, 2018; 49,022,428 and 49,011,684 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively. | 490,000 | 490,000 |
Additional paid-in capital | 552,961,000 | 549,479,000 |
Accumulated deficit | (674,470,000) | (650,125,000) |
Additional paid-in capital | (121,019,000) | (100,156,000) |
Accumulated deficit | $ 101,246,000 | $ 95,936,000 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 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 | 49,022,428 | 49,011,684 |
Common stock, outstanding shares | 49,022,428 | 49,011,684 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Product sales, net | $ 21,779 | $ 1,588 |
Cost of product sales | ||
Cost of product sales | 131 | 203 |
Research and development | 26,255 | 18,140 |
Selling, general and administrative | 14,632 | 10,934 |
Total costs and expenses | 41,018 | 29,277 |
Loss from operations | (19,239) | (27,689) |
Interest expense | (5,600) | (2,825) |
Other income | 494 | 460 |
Net loss | (24,345) | (30,054) |
Comprehensive loss | $ (24,345) | $ (30,054) |
Basic and diluted net loss per share (USD per share) | $ (0.50) | $ (0.62) |
Weighted-average shares used to compute basic and diluted net loss per share (shares) | 49,014,009 | 48,284,019 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (24,345) | $ (30,054) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 3,374 | 2,966 |
Non-cash interest expense | 2,201 | 1,086 |
Depreciation and amortization | 377 | 223 |
Changes in operating assets and liabilities: | ||
Receivables | (1,900) | 16,962 |
Inventory | (648) | 196 |
Prepaid expenses and other assets | 2,110 | (840) |
Accounts payable and accrued expenses | 5,883 | (1,835) |
Net cash used in operating activities | (12,948) | (11,296) |
Investing activities: | ||
Purchases of property and equipment | (182) | (183) |
Purchases of investments | (281) | (270) |
Proceeds from the sale and maturities of investments | 11,750 | 9,000 |
Net cash provided by investing activities | 11,287 | 8,547 |
Financing activities: | ||
Proceeds upon exercise of stock options and warrants | 108 | 687 |
Payments on finance lease liabilities | (254) | (143) |
Net cash provided by (used in) financing activities | (146) | 544 |
Net decrease in cash and cash equivalents | (1,807) | (2,205) |
Cash and cash equivalents at beginning of period | 5,861 | 3,394 |
Cash and cash equivalents at end of period | 4,054 | 1,189 |
Cash paid for interest | ||
Cash paid for interest | 82 | 1,739 |
Conversion of accrued interest to notes payable | $ 0 | $ 838 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Organization and Significant Accounting Policies | Organization and Significant Accounting Policies 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 condensed 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 and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of March 31, 2019 and for the three months ended March 31, 2019 and 2018 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2018 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2018 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 1, 2019. We continue to advance a series of clinical and preclinical programs (including three programs currently in Phase 3). CMS granted transitional pass-through reimbursement status for OMIDRIA from January 1, 2015 through December 31, 2017 for patients covered by Medicare Part B. On October 1, 2018, OMIDRIA pass-through reimbursement was reinstated for a two-year period and quarterly OMIDRIA net sales returned to historical levels. We believe OMIDRIA sales will continue to grow in 2019; however, due to the recent re-introduction of OMIDRIA, we cannot predict with precision the extent of growth in OMIDRIA revenues in 2019. As a result, despite our significant historical growth in OMIDRIA sales, meaningful growth in OMIDRIA sales in 2019 and beyond are not included in the determination regarding our prospects as a going concern. Similarly, we are unable to include in the determination any proceeds from debt transactions or other financing instruments despite our successful track record in accessing capital through these avenues. We also have not included any potential partnerships related to our products or product candidates. The conditions described above, when evaluated within the constraints of the accounting literature, raise substantial doubt with respect to our ability to meet our obligations through May 9, 2020 and, therefore, to continue as a going concern. We plan to continue to fund our operations through proceeds from sales of OMIDRIA and, if necessary, through other revenue sources and financial instruments as noted above. If these capital sources, for any reason, are needed but inaccessible, it would have a significantly negative effect 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, stock-based compensation expense and accruals for clinical trials, manufacturing of drug product and clinical drug supply and contingencies. 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. 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. 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. We elected the package of practical expedients permitted under the transition guidance, which allowed us to carryforward our historical assessment of whether 1) contracts contain leases, 2) lease classifications and 3) initial direct costs. Upon adoption we recognized right-of-use assets and lease liabilities of $17.7 million and $26.4 million , respectively, in our Consolidated Balance Sheet. The balance of the net right-of-use asset resulted from the reversal of the outstanding balance of deferred rent of $8.7 million . We record operating leases on our Consolidated Balance Sheet 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 on our Consolidated Balance Sheet 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. Advance Payments 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. Stock-Based Compensation On January 1, 2019, we adopted ASU 2018-07, Compensation — Stock Compensation, (Topic 958) which simplifies the accounting for share-based payments granted to non-employees for services by aligning it with the accounting for share-based payments to employees, with certain exceptions. The adoption was immaterial to our consolidated financial statements. Stock-based compensation expense is recognized for all share-based payments made to employees, directors and non-employees based on estimated fair values as of the date of grant. The fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental assumptions including volatility, forfeiture rates and expected option life. We use the straight-line method to allocate stock-based compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting period. Recent Accounting Pronouncement Not Yet Adopted In June 2016, the Financial Accounting Standards Board (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 expect to adopt the standard on January 1, 2020 and are still in the process of evaluating the effect of adoption on our consolidated financial statements and disclosures. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 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 computation if their effect is anti-dilutive. The basic and diluted net loss per share amounts for the three months ended March 31, 2019 and 2018 were computed based on the shares of common stock outstanding during the respective periods. Potentially dilutive securities excluded from the diluted loss per share calculation are as follows: March 31, 2019 2018 Outstanding options to purchase common stock 11,840,521 9,640,452 Outstanding warrants to purchase common stock 243,115 100,602 Total potentially dilutive shares excluded from loss per share 12,083,636 9,741,054 |
Fair-Value Measurements
Fair-Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair-Value Measurements | Fair-Value Measurements As of March 31, 2019 , and December 31, 2018 , all investments were classified as short-term and available-for-sale on the accompanying Condensed Consolidated Balance Sheets. Investment income, which was included as a component of other income, consists of interest earned. On a recurring basis, we measure certain financial assets at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required: Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets; Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our fair value hierarchy for our financial assets and liabilities measured at fair value on a recurring basis are as follows: March 31, 2019 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 43,168 — — 43,168 Total $ 44,322 $ — $ — $ 44,322 December 31, 2018 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and 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 $4.1 million and $5.9 million is excluded from our fair-value hierarchy disclosure as of March 31, 2019 and December 31, 2018 , respectively. There were no unrealized gains or losses associated with our short-term investments as of March 31, 2019 or December 31, 2018 . The carrying amounts reported in the accompanying Condensed Consolidated Balance Sheets for receivables, accounts payable, other current monetary assets and liabilities approximate fair value. |
Certain Balance Sheet Accounts
Certain Balance Sheet Accounts | 3 Months Ended |
Mar. 31, 2019 | |
Receivables [Abstract] | |
Certain Balance Sheet Accounts | Accounts Receivable, net Accounts receivable, net consist of the following: March 31, December 31, (In thousands) Trade receivables, net $ 24,580 $ 22,654 Sublease and other receivables 138 164 Total accounts receivables, net $ 24,718 $ 22,818 Trade receivables are shown net of $0.4 million and $0.4 million of chargeback and product return allowances as of March 31, 2019 and December 31, 2018 , respectively. Inventory Inventory consists of the following: March 31, December 31, (In thousands) Raw materials $ 43 $ 83 Work-in-progress 392 — Finished goods 301 5 Total inventory $ 736 $ 88 Property and Equipment, Net Property and equipment, net consists of the following: March 31, December 31, (In thousands) Finance leases $ 4,863 $ 4,034 Laboratory equipment 2,717 2,569 Computer equipment 896 862 Office equipment and furniture 625 625 Total cost 9,101 8,090 Less accumulated depreciation and amortization (4,622 ) (4,245 ) Total property and equipment, net $ 4,479 $ 3,845 For the three months ended March 31, 2019 and 2018 , depreciation and amortization expenses were $0.4 million and $0.2 million , respectively. Accrued Expenses Accrued expenses consist of the following: March 31, December 31, (In thousands) Contract research and development $ 14,460 $ 12,012 Sales rebates, fees and discounts 8,161 8,075 Employee compensation 2,233 2,714 Consulting and professional fees 3,344 3,669 Interest payable 4,995 1,677 Clinical trials 913 820 Other accrued expenses 717 1,219 Total accrued expenses $ 34,823 $ 30,186 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes Payable In October 2016, we entered into a term loan agreement with CRG Servicing LLC (the CRG Loan) and, in November 2016, borrowed $80.0 million . In May 2018, we borrowed the remaining $45.0 million available under the CRG Loan and issued warrants to purchase up to 200,000 shares of our common stock with an exercise price of $23.00 per share. The warrants have a five-year term and remained outstanding as of March 31, 2019 . In November 2018, we issued unsecured convertible senior notes (see Note 6 - “Convertible Senior Notes”) and repaid the CRG Loan. Upon repayment, we incurred a loss on early extinguishment of debt of $13.0 million . As of March 31, 2019 and December 31, 2018 we did not have any notes payable outstanding. Convertible Senior Notes On November 15, 2018, we issued at face value $210.0 million aggregate principal amount of our 6.25% Convertible Senior Notes due 2023 (the Convertible Notes). The Convertible Notes are unsecured and accrue interest at an annual rate of 6.25% per annum, payable semi-annually in arrears on May 15 and November 15 of each year, beginning on May 15, 2019. 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. As of March 31, 2019, all Convertible Notes remain outstanding. The balance of our Convertible Notes at March 31, 2019 and December 31, 2018, is as follows: March 31, December 31, (In thousands) Principal amount $ 210,000 $ 210,000 Unamortized discount (54,130 ) (56,156 ) Unamortized issuance costs attributable to principal amount (4,688 ) (4,863 ) Total Convertible Notes, net $ 151,182 $ 148,981 For more details on our Convertible Notes see Part II, Item 8, Note 8 - “Convertible Senior Notes” in our Annual Report on Form 10-K for the year ended December 31, 2018. |
Convertible Senior Notes
Convertible Senior Notes | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | Notes Payable In October 2016, we entered into a term loan agreement with CRG Servicing LLC (the CRG Loan) and, in November 2016, borrowed $80.0 million . In May 2018, we borrowed the remaining $45.0 million available under the CRG Loan and issued warrants to purchase up to 200,000 shares of our common stock with an exercise price of $23.00 per share. The warrants have a five-year term and remained outstanding as of March 31, 2019 . In November 2018, we issued unsecured convertible senior notes (see Note 6 - “Convertible Senior Notes”) and repaid the CRG Loan. Upon repayment, we incurred a loss on early extinguishment of debt of $13.0 million . As of March 31, 2019 and December 31, 2018 we did not have any notes payable outstanding. Convertible Senior Notes On November 15, 2018, we issued at face value $210.0 million aggregate principal amount of our 6.25% Convertible Senior Notes due 2023 (the Convertible Notes). The Convertible Notes are unsecured and accrue interest at an annual rate of 6.25% per annum, payable semi-annually in arrears on May 15 and November 15 of each year, beginning on May 15, 2019. 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. As of March 31, 2019, all Convertible Notes remain outstanding. The balance of our Convertible Notes at March 31, 2019 and December 31, 2018, is as follows: March 31, December 31, (In thousands) Principal amount $ 210,000 $ 210,000 Unamortized discount (54,130 ) (56,156 ) Unamortized issuance costs attributable to principal amount (4,688 ) (4,863 ) Total Convertible Notes, net $ 151,182 $ 148,981 For more details on our Convertible Notes see Part II, Item 8, Note 8 - “Convertible Senior Notes” in our Annual Report on Form 10-K for the year ended December 31, 2018. |
Lease Liabilities
Lease Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Lease Liabilities | Lease Liabilities We have operating leases related to our office and laboratory space in The Omeros Building. 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 2021. The lease-related assets and liabilities recorded on the balance sheet are as follows. Prior year interim financial statements were not recast under the new standard and, therefore, those amounts are not presented below. Classification on the Balance Sheet March 31, 2019 Assets (In thousands) Operating lease assets Right of use assets $ 17,514 Finance lease assets Property and equipment, net 3,413 Total lease assets $ 20,927 Liabilities Current: Operating Leases Current portion of lease liabilities $ 1,415 Finance Lease Current portion of lease liabilities 1,146 Non-current: Operating Lease liability, non-current 24,683 Finance Lease liability, non-current 1,895 Total lease liabilities $ 29,139 Weighted-average remaining lease term Operating leases 8.6 years Finance leases 2.9 years Weighted-average discount rate Operating leases (1) 12.85 % Finance leases 12.31 % (1) Upon adoption of the new lease standard, Topic 842, the discount rate used for existing operating leases was established at January 1, 2019 and represents our incremental borrowing rate. The components of total lease costs are as follows: Three Months Ended (In thousands) Lease cost Operating lease cost $ 1,031 Finance lease cost: Amortization 290 Interest 82 Short-term lease cost 138 Variable lease costs 486 Sublease income (224 ) Total lease cost $ 1,803 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 from operating leases $ 1,647 Operating cash flows from finance leases $ 82 Financing cash flows from finance leases $ 254 The future maturities of our lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases (In thousands) 2019 $ 3,499 $ 1,060 2020 4,770 1,224 2021 4,880 866 2022 4,995 290 2023 5,112 95 Thereafter 20,728 — Total undiscounted lease payments $ 43,984 $ 3,535 Less interest (17,886 ) (494 ) Lease liabilities $ 26,098 $ 3,041 As of March 31, 2019, we have a lease for additional space in The Omeros Building that will commence in late 2019. The expected lease term is seven years and the monthly lease payments are approximately $0.1 million over the expected term lease. |
Lease Liabilities | Lease Liabilities We have operating leases related to our office and laboratory space in The Omeros Building. 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 2021. The lease-related assets and liabilities recorded on the balance sheet are as follows. Prior year interim financial statements were not recast under the new standard and, therefore, those amounts are not presented below. Classification on the Balance Sheet March 31, 2019 Assets (In thousands) Operating lease assets Right of use assets $ 17,514 Finance lease assets Property and equipment, net 3,413 Total lease assets $ 20,927 Liabilities Current: Operating Leases Current portion of lease liabilities $ 1,415 Finance Lease Current portion of lease liabilities 1,146 Non-current: Operating Lease liability, non-current 24,683 Finance Lease liability, non-current 1,895 Total lease liabilities $ 29,139 Weighted-average remaining lease term Operating leases 8.6 years Finance leases 2.9 years Weighted-average discount rate Operating leases (1) 12.85 % Finance leases 12.31 % (1) Upon adoption of the new lease standard, Topic 842, the discount rate used for existing operating leases was established at January 1, 2019 and represents our incremental borrowing rate. The components of total lease costs are as follows: Three Months Ended (In thousands) Lease cost Operating lease cost $ 1,031 Finance lease cost: Amortization 290 Interest 82 Short-term lease cost 138 Variable lease costs 486 Sublease income (224 ) Total lease cost $ 1,803 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 from operating leases $ 1,647 Operating cash flows from finance leases $ 82 Financing cash flows from finance leases $ 254 The future maturities of our lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases (In thousands) 2019 $ 3,499 $ 1,060 2020 4,770 1,224 2021 4,880 866 2022 4,995 290 2023 5,112 95 Thereafter 20,728 — Total undiscounted lease payments $ 43,984 $ 3,535 Less interest (17,886 ) (494 ) Lease liabilities $ 26,098 $ 3,041 As of March 31, 2019, we have a lease for additional space in The Omeros Building that will commence in late 2019. The expected lease term is seven years and the monthly lease payments are approximately $0.1 million over the expected term lease. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $13.7 million as of March 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 three months ended March 31, 2019 and the year ended December 31, 2018, development milestones incurred were immaterial and we did not owe any royalties. |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Deficit Common Stock For the three months ended March 31, 2019 , we received proceeds of $0.1 million upon the exercise of stock options which resulted in the issuance of 10,744 shares of common stock. For the three months ended March 31, 2018 , we received proceeds of $0.7 million upon the exercise of stock options and warrants which resulted in the issuance of 75,616 shares of common stock. Warrants In connection with the April 2018 amendment to the CRG Loan and the May 2018 borrowing under the CRG Loan, we 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 . The warrants have a five -year term and remain outstanding as of March 31, 2019 . Interim Condensed Consolidated Statements of Shareholders’ Deficit The changes in interim balances of the components of our shareholders’ deficit are as follows: Three Months Ended 2019 2018 (In thousands) Beginning and ending common stock $ 490 $ 483 Beginning additional paid-in capital $ 549,479 $ 520,071 Exercise of stock options 108 687 Stock-based compensation expense 3,374 2,966 Ending additional paid-in capital $ 552,961 $ 523,724 Beginning accumulated deficit $ (650,125 ) $ (523,368 ) Net loss (24,345 ) (30,054 ) Ending accumulated deficit $ (674,470 ) $ (553,422 ) |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense includes the amortization of stock options granted to employees and non-employees and has been reported in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three Months Ended 2019 2018 (In thousands) Research and development $ 1,494 $ 1,200 Selling, general and administrative 1,880 1,766 Total $ 3,374 $ 2,966 The fair value of each option grant to employees, directors and non-employees is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to all stock option grants: Three Months Ended 2019 2018 Estimated weighted-average fair value $ 9.47 $ 9.79 Weighted-average assumptions Expected volatility 81 % 76 % Expected term, in years 6.0 6.1 Risk-free interest rate 2.48 % 2.54 % Expected dividend yield — % — % Stock option activity for all stock plans and related information is as follows: Options Outstanding Weighted- Average Exercise Price per Share Remaining Contractual Life (In years) Aggregate Intrinsic Value (In thousands) Balance at December 31, 2018 10,313,138 $ 11.22 Granted 1,606,500 13.49 Exercised (10,744 ) 10.01 Forfeited (68,373 ) 14.67 Balance at March 31, 2019 11,840,521 $ 11.51 6.62 $ 71,857 Vested and expected to vest at March 31, 2019 11,402,367 $ 11.41 6.53 $ 70,182 Exercisable at March 31, 2019 7,815,290 $ 10.31 5.35 $ 56,232 At March 31, 2019 , there were 4,025,230 unvested options outstanding that will vest over a weighted-average period of 9.1 years and 554,083 shares were available to grant. The total estimated compensation expense to be recognized on our unvested options is $15.6 million . |
Organization and Significant _2
Organization and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of March 31, 2019 and for the three months ended March 31, 2019 and 2018 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2018 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2018 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 1, 2019. |
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. |
Recently Adopted Pronouncements and Recent Accounting Pronouncements | Stock-Based Compensation |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss per Share | Potentially dilutive securities excluded from the diluted loss per share calculation are as follows: March 31, 2019 2018 Outstanding options to purchase common stock 11,840,521 9,640,452 Outstanding warrants to purchase common stock 243,115 100,602 Total potentially dilutive shares excluded from loss per share 12,083,636 9,741,054 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | Our fair value hierarchy for our financial assets and liabilities measured at fair value on a recurring basis are as follows: March 31, 2019 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 1,154 $ — $ — $ 1,154 Money-market funds classified as short-term investments 43,168 — — 43,168 Total $ 44,322 $ — $ — $ 44,322 December 31, 2018 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and 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) | 3 Months Ended |
Mar. 31, 2019 | |
Receivables [Abstract] | |
Receivables | Accounts receivable, net consist of the following: March 31, December 31, (In thousands) Trade receivables, net $ 24,580 $ 22,654 Sublease and other receivables 138 164 Total accounts receivables, net $ 24,718 $ 22,818 Trade receivables are shown net of $0.4 million and $0.4 million of chargeback and product return allowances as of March 31, 2019 and December 31, 2018 , respectively. Inventory Inventory consists of the following: March 31, December 31, (In thousands) Raw materials $ 43 $ 83 Work-in-progress 392 — Finished goods 301 5 Total inventory $ 736 $ 88 Property and Equipment, Net Property and equipment, net consists of the following: March 31, December 31, (In thousands) Finance leases $ 4,863 $ 4,034 Laboratory equipment 2,717 2,569 Computer equipment 896 862 Office equipment and furniture 625 625 Total cost 9,101 8,090 Less accumulated depreciation and amortization (4,622 ) (4,245 ) Total property and equipment, net $ 4,479 $ 3,845 For the three months ended March 31, 2019 and 2018 , depreciation and amortization expenses were $0.4 million and $0.2 million , respectively. Accrued Expenses Accrued expenses consist of the following: March 31, December 31, (In thousands) Contract research and development $ 14,460 $ 12,012 Sales rebates, fees and discounts 8,161 8,075 Employee compensation 2,233 2,714 Consulting and professional fees 3,344 3,669 Interest payable 4,995 1,677 Clinical trials 913 820 Other accrued expenses 717 1,219 Total accrued expenses $ 34,823 $ 30,186 |
Schedule of Inventory, Current | Inventory consists of the following: March 31, December 31, (In thousands) Raw materials $ 43 $ 83 Work-in-progress 392 — Finished goods 301 5 Total inventory $ 736 $ 88 |
Property, Plant and Equipment | Property and equipment, net consists of the following: March 31, December 31, (In thousands) Finance leases $ 4,863 $ 4,034 Laboratory equipment 2,717 2,569 Computer equipment 896 862 Office equipment and furniture 625 625 Total cost 9,101 8,090 Less accumulated depreciation and amortization (4,622 ) (4,245 ) Total property and equipment, net $ 4,479 $ 3,845 |
Accrued Expenses | Accrued expenses consist of the following: March 31, December 31, (In thousands) Contract research and development $ 14,460 $ 12,012 Sales rebates, fees and discounts 8,161 8,075 Employee compensation 2,233 2,714 Consulting and professional fees 3,344 3,669 Interest payable 4,995 1,677 Clinical trials 913 820 Other accrued expenses 717 1,219 Total accrued expenses $ 34,823 $ 30,186 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Debt | The balance of our Convertible Notes at March 31, 2019 and December 31, 2018, is as follows: March 31, December 31, (In thousands) Principal amount $ 210,000 $ 210,000 Unamortized discount (54,130 ) (56,156 ) Unamortized issuance costs attributable to principal amount (4,688 ) (4,863 ) Total Convertible Notes, net $ 151,182 $ 148,981 |
Lease Liabilities (Tables)
Lease Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Lease, Cost [Table Text Block] | The lease-related assets and liabilities recorded on the balance sheet are as follows. Prior year interim financial statements were not recast under the new standard and, therefore, those amounts are not presented below. Classification on the Balance Sheet March 31, 2019 Assets (In thousands) Operating lease assets Right of use assets $ 17,514 Finance lease assets Property and equipment, net 3,413 Total lease assets $ 20,927 Liabilities Current: Operating Leases Current portion of lease liabilities $ 1,415 Finance Lease Current portion of lease liabilities 1,146 Non-current: Operating Lease liability, non-current 24,683 Finance Lease liability, non-current 1,895 Total lease liabilities $ 29,139 Weighted-average remaining lease term Operating leases 8.6 years Finance leases 2.9 years Weighted-average discount rate Operating leases (1) 12.85 % Finance leases 12.31 % (1) Upon adoption of the new lease standard, Topic 842, the discount rate used for existing operating leases was established at January 1, 2019 and represents our incremental borrowing rate. The components of total lease costs are as follows: Three Months Ended (In thousands) Lease cost Operating lease cost $ 1,031 Finance lease cost: Amortization 290 Interest 82 Short-term lease cost 138 Variable lease costs 486 Sublease income (224 ) Total lease cost $ 1,803 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 from operating leases $ 1,647 Operating cash flows from finance leases $ 82 Financing cash flows from finance leases $ 254 |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | The future maturities of our lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases (In thousands) 2019 $ 3,499 $ 1,060 2020 4,770 1,224 2021 4,880 866 2022 4,995 290 2023 5,112 95 Thereafter 20,728 — Total undiscounted lease payments $ 43,984 $ 3,535 Less interest (17,886 ) (494 ) Lease liabilities $ 26,098 $ 3,041 |
Finance Lease, Liability, Maturity [Table Text Block] | The future maturities of our lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases (In thousands) 2019 $ 3,499 $ 1,060 2020 4,770 1,224 2021 4,880 866 2022 4,995 290 2023 5,112 95 Thereafter 20,728 — Total undiscounted lease payments $ 43,984 $ 3,535 Less interest (17,886 ) (494 ) Lease liabilities $ 26,098 $ 3,041 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Schedule of Stockholders Equity [Table Text Block] | The changes in interim balances of the components of our shareholders’ deficit are as follows: Three Months Ended 2019 2018 (In thousands) Beginning and ending common stock $ 490 $ 483 Beginning additional paid-in capital $ 549,479 $ 520,071 Exercise of stock options 108 687 Stock-based compensation expense 3,374 2,966 Ending additional paid-in capital $ 552,961 $ 523,724 Beginning accumulated deficit $ (650,125 ) $ (523,368 ) Net loss (24,345 ) (30,054 ) Ending accumulated deficit $ (674,470 ) $ (553,422 ) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation Expense | Stock-based compensation expense includes the amortization of stock options granted to employees and non-employees and has been reported in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three Months Ended 2019 2018 (In thousands) Research and development $ 1,494 $ 1,200 Selling, general and administrative 1,880 1,766 Total $ 3,374 $ 2,966 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following assumptions were applied to all stock option grants: Three Months Ended 2019 2018 Estimated weighted-average fair value $ 9.47 $ 9.79 Weighted-average assumptions Expected volatility 81 % 76 % Expected term, in years 6.0 6.1 Risk-free interest rate 2.48 % 2.54 % Expected dividend yield — % — % |
Stock Option Activity and Related Information | Stock option activity for all stock plans and related information is as follows: Options Outstanding Weighted- Average Exercise Price per Share Remaining Contractual Life (In years) Aggregate Intrinsic Value (In thousands) Balance at December 31, 2018 10,313,138 $ 11.22 Granted 1,606,500 13.49 Exercised (10,744 ) 10.01 Forfeited (68,373 ) 14.67 Balance at March 31, 2019 11,840,521 $ 11.51 6.62 $ 71,857 Vested and expected to vest at March 31, 2019 11,402,367 $ 11.41 6.53 $ 70,182 Exercisable at March 31, 2019 7,815,290 $ 10.31 5.35 $ 56,232 |
Organization and Significant _3
Organization and Significant Accounting Policies (Detail) | 3 Months Ended | ||
Mar. 31, 2019USD ($)segment | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |||
Number of operating segments | segment | 1 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right of use assets | $ 17,514,000 | $ 0 | |
Lease liabilities | $ 26,098,000 | ||
Accounting Standards Update 2016-02 [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right of use assets | $ 17,700,000 | ||
Lease liabilities | 26,400,000 | ||
Deferred Rent Credit | $ 8,700,000 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 12,083,636 | 9,741,054 |
Outstanding options 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 | 9,640,452 | |
Outstanding 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 | 100,602 |
Fair-Value Measurements - Finan
Fair-Value Measurements - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | $ 44,322 | $ 55,791 |
Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 1,154 | 1,154 |
Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 43,168 | 54,637 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 44,322 | 55,791 |
Level 1 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 1,154 | 1,154 |
Level 1 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 43,168 | 54,637 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Level 2 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Level 2 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Level 3 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Level 3 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | $ 0 | $ 0 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | ||||
Cash and cash equivalents | $ 4,054,000 | $ 5,861,000 | $ 1,189,000 | $ 3,394,000 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Certain Balance Sheet Account_2
Certain Balance Sheet Accounts - Accounts Receivable, Net (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Balance Sheet Related Disclosures [Abstract] | ||
Trade receivables, net | $ 24,580,000 | $ 22,654,000 |
Sublease and other receivables | 138,000 | 164,000 |
Total accounts receivables, net | 24,718,000 | 22,818,000 |
Charge back | $ 400,000 | $ 439,000 |
Certain Balance Sheet Account_3
Certain Balance Sheet Accounts - Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 43 | $ 83 |
Work-in-process | 392 | 0 |
Finished goods | 301 | 5 |
Inventory | $ 736 | $ 88 |
Certain Balance Sheet Account_4
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 9,101 | $ 8,090 | |
Less accumulated depreciation and amortization | (4,622) | (4,245) | |
Total property and equipment, net | 4,479 | 3,845 | |
Depreciation and amortization | 377 | $ 223 | |
Finance leases | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 4,863 | 4,034 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 2,717 | 2,569 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | 896 | 862 | |
Office equipment and furniture | |||
Property, Plant and Equipment [Line Items] | |||
Total cost | $ 625 | $ 625 |
Certain Balance Sheet Account_5
Certain Balance Sheet Accounts - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Contract research and development | $ 14,460 | $ 12,012 |
Sales rebates, fees and discounts | 8,161 | 8,075 |
Employee compensation | 2,233 | 2,714 |
Consulting and professional fees | 3,344 | 3,669 |
Interest payable | 4,995 | 1,677 |
Clinical trials | 913 | 820 |
Other accruals | 717 | 1,219 |
Total accrued liabilities | $ 34,823 | $ 30,186 |
Notes Payable (Detail)
Notes Payable (Detail) - USD ($) | 1 Months Ended | |||
Nov. 30, 2018 | May 31, 2018 | Apr. 30, 2018 | Oct. 26, 2016 | |
Debt Instrument [Line Items] | ||||
Shares of common stock to purchase by warrant (in shares) | 200,000 | |||
Warrant exercise price (in USD per share) | $ 23 | |||
CRG Loan | ||||
Debt Instrument [Line Items] | ||||
Debt issued | $ 80,000,000 | |||
Remaining borrowing capacity | $ 45,000,000 | |||
Gain (Loss) on Extinguishment of Debt | $ (13,000,000) |
Convertible Senior Notes - Narr
Convertible Senior Notes - Narrative (Details) - Convertible Debt - Convertible Notes - USD ($) | Nov. 15, 2018 | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | |||
Face Amount | $ 210,000,000 | $ 210,000 | $ 210,000 |
Interest Rate | 6.25% | ||
Conversion Price | $ 52.0183 | ||
If-converted Value in Excess of Principal | $ 1,000 | ||
Stock Price Trigger (USD per share) | $ 19.22 |
Convertible Senior Notes - Bala
Convertible Senior Notes - Balance of Convertible Note (Details) - Convertible Debt - Convertible Notes - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 | Nov. 15, 2018 |
Debt Instrument [Line Items] | |||
Face Amount | $ 210,000 | $ 210,000 | $ 210,000,000 |
Unamortized debt discount | (54,130) | (56,156) | |
Unamortized debt issuance costs | (4,688) | (4,863) | |
Net carrying amount of Convertible Notes | $ 151,182 | $ 148,981 |
Lease Liabilities (Details)
Lease Liabilities (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||
Lessee, Operating Lease, Lease Not yet Commenced, Term of Contract | 7 years | |
Lessee, Operating Lease, Term of Contract | 5 years | |
Classification on the Balance Sheet | ||
Operating lease assets | $ 17,514,000 | $ 0 |
Finance lease assets | 3,413,000 | |
Total lease assets | 20,927,000 | |
Operating Leases | 1,415,000 | |
Finance Lease | 1,146,000 | |
Operating | 24,683,000 | |
Finance | 1,895,000 | |
Total lease liabilities | $ 29,139,000 | |
Operating leases | 8 years 7 months 6 days | |
Finance leases | 2 years 10 months 24 days | |
Operating leases (1) | 12.85% | |
Finance leases | 12.31% | |
Operating cash flows from operating leases | $ 1,647,000 | |
Operating cash flows from finance leases | 82,000 | |
Financing cash flows from finance leases | 254,000 | |
Lease cost | ||
Operating lease cost | 1,031,000 | |
Amortization | 290,000 | |
Interest | 82,000 | |
Short-term lease cost | 138,000 | |
Variable lease costs | 486,000 | |
Sublease income | (224,000) | |
Total lease cost | 1,803,000 | |
Lessee, Operating Lease, Lease Not yet Commenced. Amount | $ 100,000 |
Lease Liabilities - Maturities
Lease Liabilities - Maturities (Details) $ in Thousands | Mar. 31, 2019USD ($) |
Operating Leases | |
2019 | $ 3,499 |
2020 | 4,770 |
2021 | 4,880 |
2022 | 4,995 |
2023 | 5,112 |
Thereafter | 20,728 |
Total undiscounted lease payments | 43,984 |
Less interest | (17,886) |
Lease liabilities | 26,098 |
Finance Leases | |
2019 | 1,060 |
2020 | 1,224 |
2021 | 866 |
2022 | 290 |
2023 | 95 |
Thereafter | 0 |
Total undiscounted lease payments | 3,535 |
Less interest | (494) |
Lease liabilities | $ 3,041 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Mar. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Contract termination fees | $ 13.7 |
Shareholders' Equity (Detail)
Shareholders' Equity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Class of Warrant or Right [Line Items] | ||||
Proceeds upon exercise of stock options and warrants | $ 108 | $ 687 | ||
Stock issued from exercise of stock options and warrants (in shares) | 10,744 | |||
Shares of common stock to purchase by warrant (in shares) | 200,000 | |||
Warrant exercise price (in USD per share) | $ 23 | |||
Fair value | $ 1,400 | |||
Warrant term | 5 years | |||
Common stock, Issued shares | 49,022,428 | 49,011,684 | ||
Warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Shares of common stock to purchase by warrant (in shares) | 200,000 |
Shareholders' Equity - Equity (
Shareholders' Equity - Equity (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Class of Stock [Line Items] | ||
Stockholders' Equity Attributable to Parent | $ (100,156,000) | |
Net loss | (24,345,000) | $ (30,054,000) |
Stockholders' Equity Attributable to Parent | (121,019,000) | |
Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Stockholders' Equity Attributable to Parent | 490,000 | 483,000 |
Additional Paid-in Capital [Member] | ||
Class of Stock [Line Items] | ||
Stockholders' Equity Attributable to Parent | 549,479,000 | 520,071 |
Stock Issued During Period, Value, Stock Options Exercised | 108,000 | 687 |
Adjustments to Additional Paid in Capital, Share-based Compensation, Stock Options, Requisite Service Period Recognition | 3,374,000 | 2,966 |
Stockholders' Equity Attributable to Parent | 552,961,000 | 523,724 |
Retained Earnings [Member] | ||
Class of Stock [Line Items] | ||
Stockholders' Equity Attributable to Parent | (650,125,000) | (523,368,000) |
Net loss | (24,345,000) | (30,054,000) |
Stockholders' Equity Attributable to Parent | $ (674,470,000) | $ (553,422,000) |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total | $ 3,374 | $ 2,966 |
Research and development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 1,494 | 1,200 |
Selling, general and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,880 | $ 1,766 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Equity Option - $ / shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated weighted-average fair value (USD per share) | $ 9.47 | $ 9.79 |
Weighted Average | ||
Weighted-average assumptions | ||
Expected volatility | 81.00% | 76.00% |
Expected term, in years | 6 years 1 month 6 days | 6 years 1 month 6 days |
Risk-free interest rate | 2.48% | 2.54% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Detail) | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Options Outstanding | |
Beginning balance (shares) | shares | 10,313,138 |
Granted (shares) | shares | 1,606,500 |
Exercised (shares) | shares | (10,744) |
Forfeited (shares) | shares | (68,373) |
Ending balance (shares) | shares | 11,840,521 |
Vested and expected to vest (shares) | shares | 11,402,367 |
Exercisable (shares) | shares | 7,815,290 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 11.22 |
Granted (USD per share) | $ / shares | 13.49 |
Exercised (USD per share) | $ / shares | 10.01 |
Forfeited (USD per share) | $ / shares | 14.67 |
Ending balance (USD per share) | $ / shares | 11.51 |
Vested and expected to vest (USD per share) | $ / shares | 11.41 |
Exercisable (USD per share) | $ / shares | $ 10.31 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 6 years 7 months 13 days |
Vested and expected to vest (in years) | 6 years 6 months 12 days |
Exercisable (in years) | 5 years 4 months 6 days |
Aggregate Intrinsic Value | |
Balance | $ | $ 71,857 |
Vested and expected to vest | $ | 70,182 |
Exercisable | $ | $ 56,232 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($)shares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Unvested options outstanding (shares) | 4,025,231 |
Period for recognition | 9 years 1 month 6 days |
Shares available for future grants (shares) | 554,083 |
Unrecognized compensation expense | $ | $ 15.6 |