Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 20, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | LA JOLLA PHARMACEUTICAL CO | ||
Entity Central Index Key | 920,465 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Shell Company | false | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 603.7 | ||
Entity Common Stock, Shares Outstanding | 27,076,171 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 172,604 | $ 90,915 |
Accounts receivable, net | 1,381 | 0 |
Inventory, net | 2,020 | 0 |
Prepaid expenses and other current assets | 5,111 | 3,147 |
Total current assets | 181,116 | 94,062 |
Property and equipment, net | 22,267 | 24,568 |
Restricted cash | 909 | 909 |
Total assets | 204,292 | 119,539 |
Current liabilities: | ||
Accounts payable | 8,572 | 11,484 |
Accrued expenses | 12,988 | 703 |
Accrued payroll and related expenses | 7,509 | 4,995 |
Deferred rent, current portion | 1,370 | 1,370 |
Total current liabilities | 30,439 | 18,552 |
Deferred rent, less current portion | 13,609 | 12,785 |
Deferred royalty obligation, net | 124,323 | 0 |
Total liabilities | 168,371 | 31,337 |
Commitments and contingencies (Note 11) | ||
Shareholders’ equity: | ||
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 26,259,254 and 22,167,529 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 3 | 2 |
Additional paid-in capital | 950,258 | 803,071 |
Accumulated deficit | (920,983) | (721,514) |
Total shareholders’ equity | 35,921 | 88,202 |
Total liabilities and shareholders’ equity | 204,292 | 119,539 |
Series C-1 Convertible Preferred Stock [Member] | ||
Shareholders’ equity: | ||
Convertible preferred stock, value | 3,906 | 3,906 |
Series F Convertible Preferred Stock [Member] | ||
Shareholders’ equity: | ||
Convertible preferred stock, value | $ 2,737 | $ 2,737 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 26,259,254 | 22,167,529 |
Common stock, shares outstanding (in shares) | 26,259,254 | 22,167,529 |
Preferred stock, par value (usd per share) | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 8,000,000 | |
Series C-1 Convertible Preferred Stock [Member] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 11,000 | 11,000 |
Preferred stock, shares issued (in shares) | 3,906 | 3,906 |
Preferred stock, shares outstanding (in shares) | 3,906 | 3,906 |
Liquidation preference | $ 3,906 | $ 3,906 |
Series F Convertible Preferred Stock [Member] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000 | 10,000 |
Preferred stock, shares issued (in shares) | 2,737 | 2,737 |
Preferred stock, shares outstanding (in shares) | 2,737 | 2,737 |
Liquidation preference | $ 2,737 | $ 2,737 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue | |||
Net product sales | $ 10,056,000 | $ 0 | $ 0 |
Contract revenue - related party | 0 | 0 | 616,000 |
Total revenue | 10,056,000 | 0 | 616,000 |
Operating expenses | |||
Cost of product sales | 1,643,000 | 0 | 0 |
Research and development | 117,302,000 | 84,575,000 | 62,288,000 |
Selling, general and administrative | 85,162,000 | 30,852,000 | 16,700,000 |
Total operating expenses | 204,107,000 | 115,427,000 | 78,988,000 |
Loss from operations | (194,051,000) | (115,427,000) | (78,372,000) |
Interest expense | (7,303,000) | 0 | 0 |
Interest income | 1,885,000 | 624,000 | 187,000 |
Interest income | (5,418,000) | 624,000 | 187,000 |
Net loss | $ (199,469,000) | $ (114,803,000) | $ (78,185,000) |
Basic and diluted net loss per share (usd per share) | $ (7.85) | $ (5.41) | $ (4.54) |
Weighted-average common shares outstanding - basic and diluted (in shares) | 25,422 | 21,215 | 17,228 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock [Member]Series C-1 Convertible Preferred Stock [Member] | Preferred Stock [Member]Series F Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] |
Beginning Balance (in shares) at Dec. 31, 2015 | 4,000 | 3,000 | 18,244,000 | |||
Beginning Balance at Dec. 31, 2015 | $ 124,527 | $ 3,906 | $ 2,737 | $ 2 | $ 646,408 | $ (528,526) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation expense | 14,349 | 14,349 | ||||
Third party share-based compensation expense | $ 197 | 197 | ||||
Exercise of stock options for common stock (in shares) | 17,548 | 17,000 | ||||
Exercise of stock options for common stock | $ 149 | 149 | ||||
Net loss | (78,185) | (78,185) | ||||
Ending Balance (in shares) at Dec. 31, 2016 | 4,000 | 3,000 | 18,261,000 | |||
Ending Balance at Dec. 31, 2016 | 61,037 | $ 3,906 | $ 2,737 | $ 2 | 661,103 | (606,711) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock issued during period (in shares) | 3,731,000 | |||||
Stock issued during period, value | 117,480 | 117,480 | ||||
Share-based compensation expense | 20,776 | 20,776 | ||||
Third party share-based compensation expense | $ 1,019 | 1,019 | ||||
Exercise of stock options for common stock (in shares) | 174,628 | 175,000 | ||||
Exercise of stock options for common stock | $ 2,693 | 2,693 | ||||
Net loss | (114,803) | (114,803) | ||||
Ending Balance (in shares) at Dec. 31, 2017 | 4,000 | 3,000 | 22,167,000 | |||
Ending Balance at Dec. 31, 2017 | 88,202 | $ 3,906 | $ 2,737 | $ 2 | 803,071 | (721,514) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock issued during period (in shares) | 3,910,000 | |||||
Stock issued during period, value | 109,809 | $ 1 | 109,808 | |||
Share-based compensation expense | 34,748 | 34,748 | ||||
Third party share-based compensation expense | $ 332 | 332 | ||||
Exercise of stock options for common stock (in shares) | 106,370 | 150,000 | ||||
Exercise of stock options for common stock | $ 1,908 | 1,908 | ||||
Issuance of common stock under ESPP (in shares) | 32,000 | |||||
Issuance of common stock under ESPP | 391 | 391 | ||||
Net loss | (199,469) | (199,469) | ||||
Ending Balance (in shares) at Dec. 31, 2018 | 4,000 | 3,000 | 26,259,000 | |||
Ending Balance at Dec. 31, 2018 | $ 35,921 | $ 3,906 | $ 2,737 | $ 3 | $ 950,258 | $ (920,983) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (199,469) | $ (114,803) | $ (78,185) |
Adjustments to reconcile net loss to net cash used for operating activities: | |||
Share-based compensation expense | 35,151 | 21,795 | 14,546 |
Depreciation expense | 4,405 | 1,268 | 730 |
Loss on disposal of equipment | 236 | 199 | 75 |
Non-cash interest expense | 6,797 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (1,381) | 0 | 0 |
Inventory | (2,020) | 0 | 0 |
Prepaid expenses and other current assets | (1,964) | (1,642) | (664) |
Other assets | 0 | 219 | (149) |
Accounts payable | (2,912) | 4,832 | 3,600 |
Accrued expenses | 5,451 | (202) | 227 |
Accrued payroll and related expenses | 2,514 | 2,918 | 987 |
Deferred rent | 824 | 335 | 124 |
Net cash used for operating activities | (152,368) | (85,081) | (58,709) |
Investing activities | |||
Purchase of property and equipment | (2,340) | (9,194) | (2,218) |
Net cash used for investing activities | (2,340) | (9,194) | (2,218) |
Financing activities | |||
Net proceeds from royalty financing | 124,289 | 0 | 0 |
Net proceeds from the issuance of common stock | 109,809 | 117,480 | 0 |
Net proceeds from the exercise of stock options for common stock | 1,908 | 2,693 | 149 |
Proceeds from issuance of common stock under ESPP | 391 | 0 | 0 |
Net cash provided by financing activities | 236,397 | 120,173 | 149 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 81,689 | 25,898 | (60,778) |
Cash, cash equivalents and restricted cash at beginning of period | 91,824 | 65,926 | 126,704 |
Cash, cash equivalents and restricted cash at end of period | 173,513 | 91,824 | 65,926 |
Supplemental disclosure of cash flow information | |||
Interest paid | 506 | 0 | 0 |
Capitalized landlord funded tenant improvements | 0 | 13,696 | 0 |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets | |||
Total cash, cash equivalents and restricted cash | $ 91,824 | $ 65,926 | $ 126,704 |
Business
Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | Business La Jolla Pharmaceutical Company (collectively with its wholly-owned subsidiaries, the Company) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. GIAPREZA TM (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. LJPC-0118, a clinical-stage investigational product, is being developed for the potential treatment of severe malaria, a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito, which feeds on humans. LJPC-401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease, myelodysplastic syndrome and polycythemia vera. The Company was incorporated in 1989 as a Delaware corporation and reincorporated in California in 2012. As of December 31, 2018 , the Company had $172.6 million in cash and cash equivalents, compared to $90.9 million in cash and cash equivalents at December 31, 2017 . Based on the Company’s current operating plans and projections, the Company expects that its cash and cash equivalents as of December 31, 2018 will be sufficient to fund operations for at least one year from the date this Annual Report on Form 10-K is filed with the SEC. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The Company’s consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in its consolidated financial statements and the accompanying notes. Actual results may differ materially from these estimates. Certain amounts previously reported in the financial statements have been reclassified to conform to the current year presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows. Summary of Significant Accounting Policies Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less when purchased as cash equivalents. The Company maintains its cash in checking and savings accounts. Income generated from cash held in savings accounts is recorded as interest income. The carrying value of the Company’s money market savings accounts is included in cash equivalents and approximates the fair value. Cash is classified as restricted cash when certain funds are reserved for a specific purpose and are not available for immediate or general business use. Accounts Receivable, Net Accounts receivable are recorded net of customers’ allowances for prompt-pay discounts, chargebacks and doubtful accounts. Allowances for prompt-pay discounts and chargebacks are based on contractual terms. The Company estimates the allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of its customers and individual customer circumstances. As of December 31, 2018 , the Company did not have any allowances for doubtful accounts. Inventory, Net Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out (FIFO) basis. The Company periodically analyzes inventory levels and writes down inventory as cost of product sales when: inventory has become obsolete; inventory has a cost basis in excess of its estimated net realizable value; or inventory quantities are in excess of expected product sales. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash. The Company maintains its cash in checking and money market savings accounts at federally insured financial institutions in excess of federally insured limits. The Company’s products are distributed in the U.S. through distributors and select wholesalers (collectively, customers) that resell its products to hospitals, the end users. The following table includes the percentage of net product sales and accounts receivable balances for the Company’s three major customers, each of which comprised 10% or more of its net product sales: Net Product Sales Accounts Receivable Year Ended December 31, 2018 As of December 31, 2018 Customer A 37 % 44 % Customer B 31 % 28 % Customer C 30 % 26 % Total 98 % 98 % Property and Equipment, Net Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which range from two to seven years. Amortization of leasehold improvements is computed using the straight-line method over the shorter of the lease term or the estimated useful life of the related assets. Maintenance and repairs are charged to operating expense as incurred. When assets are sold, or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts, and any gain or loss is included in operating expense. Revenue Recognition The Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 606 – Revenue from Contracts with Customers (ASC 606) at the time of its first commercial shipment of GIAPREZA in the first quarter of 2018. The Company had no revenue from product sales prior to the first quarter of 2018. Under ASC 606, the Company recognizes revenue when its customers obtain control of the Company’s product, which typically occurs on delivery. Revenue is recognized in an amount that reflects the consideration that the Company expects to receive in exchange for those goods. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following 5 steps: (i) identify the contract(s) 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) the entity satisfies a performance obligation. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns and Group Purchasing Organization (GPO) discounts, rebates and administrative fees. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items include: • Chargebacks - Chargebacks are discounts the Company provides to distributors in the event that the sales prices to end users are below the distributors’ acquisition price. Chargebacks are estimated based on known chargeback rates and recorded as a reduction of revenue on delivery to the Company’s customers. • Discounts - The Company offers customers various forms of incentives and consideration, including prompt-pay discounts, service fees and other contract fees. The Company estimates discounts and fees primarily based on contractual terms. These discounts and fees are recorded as a reduction of revenue on delivery to the Company’s customers. • Returns - The Company offers customers a limited right of return, generally for damaged or expired product. The Company estimates returns based on an internal analysis, which includes actual experience and a review of comparable companies. The estimates for returns are recorded as a reduction of revenue on delivery to the Company’s customers. • GPO Discounts and Rebates - The Company offers cash discounts to GPO members. These discounts are taken when the GPO members purchase GIAPREZA from the Company’s customers, who then charge the discount amount back to the Company. Additionally, the Company offers volume and contract-tier rebates to GPO members. Rebates are based on actual purchase levels during the quarterly rebate purchase period. • GPO Administrative Fees - The Company pays administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPO members. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly. Shipping and Handling Expense Shipping and handling expense is included in cost of product sales. Research and Development Expense Research and development expense includes salaries and benefits, facilities and other overhead costs, research-related manufacturing costs, contract service and clinical and preclinical-related service costs performed by clinical research organizations, research institutions and other outside service providers. Research and development expense is expensed as incurred when these expenditures relate to the Company’s research and development efforts and have no alternative future uses. In accordance with certain research and development agreements, the Company is obligated to make certain upfront payments upon execution of the agreement. Advance payments, including nonrefundable amounts, for materials or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or the related services are performed. Acquisition or milestone payments that the Company makes in connection with in-licensed technology are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology. The Company considers the future economic benefits from the licensed technology to be uncertain until such licensed technology is incorporated into products that are approved for marketing by the FDA or when other significant risk factors are abated. For accounting purposes, management has viewed future economic benefits for all of the Company’s licensed technology to be uncertain. Patent Costs Legal costs in connection with approved patents and patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are recorded in selling, general and administrative expense in the consolidated statements of operations. Share-based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation - Stock Compensation and ASC 505-50, Equity - Equity Based Payments to Non-Employees , which requires the recognition of compensation expense, using a fair-value based method, for all costs related to share-based payments, including stock options and restricted stock awards. These standards require companies to estimate the fair value of share-based payment awards on the date of the grant using an option-pricing model. The Company has elected to account for forfeitures as they occur. Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rate is recognized in income in the period that includes the enactment date. A valuation allowance is applied against any deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet a “more likely than not” threshold, the Company recognizes the benefit of uncertain tax positions in the consolidated financial statements. The Company’s practice is to recognize interest and penalties, if any, related to uncertain tax positions in income tax expense in the consolidated statements of operations. Interest Expense Interest expense and the amortization of issuance costs related to the deferred royalty obligation (see Note 8) are recognized over the expected repayment term of the deferred royalty obligation using the effective interest method. The assumptions used in determining the expected repayment term of the deferred royalty obligation require the Company to make estimates that could impact the effective interest rate. Each reporting period, the Company estimates the expected repayment term of the deferred royalty obligation based on forecasted net product sales of GIAPREZA. Changes in interest expense resulting from changes in the effective interest rate, if any, are recorded on a prospective basis. Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period, excluding unvested restricted stock awards. Diluted net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding plus potential common shares. Convertible preferred stock, stock options, warrants and unvested restricted stock awards are considered potential common shares and are included in the calculation of diluted net loss per share using the treasury stock method when their effect is dilutive. Potential common shares are excluded from the calculation of diluted net loss per share when their effect is anti-dilutive. As of December 31, 2018 , 2017 and 2016 , there were 14.0 million shares, 13.6 million shares and 10.7 million shares, respectively, of potential common shares, which were excluded from the calculation of diluted net loss per share because their effect was anti-dilutive. Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. There have been no items qualifying as other comprehensive loss, and, therefore, comprehensive loss for the periods reported was comprised solely of the Company’s net loss. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Fair Value Measurements The Company follows the provisions of ASC 820-10, Fair Value Measurements and Disclosures (ASC 820-10), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1) observable inputs such as quoted prices in active markets; Level 2) inputs other than the quoted prices in active markets that are observable either directly or indirectly; and Level 3) unobservable inputs, in which there is little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Cash equivalents consist of money market accounts with maturities of 90 days or less. Due to the high ratings and short-term nature of these funds, the Company considers the inputs to the value of all cash and cash equivalents as Level 1. The Company’s financial instruments include cash and cash equivalents, accounts receivable, inventory, prepaid expenses and other current assets, accounts payable and accrued expenses. The carrying amounts reported in the balance sheets for these financial instruments approximate fair value because of their short-term nature. Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In the first quarter of 2018, the Company adopted Accounting Standard Update (ASU) 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The standard clarifies the presentation of restricted cash and cash equivalents and requires companies to include restricted cash and cash equivalents in the beginning and ending balances of cash and cash equivalents on the statement of cash flows. The standard also requires additional disclosures to describe the amount and detail of the restriction by balance sheet line item. Accordingly, restricted cash is included as a component of cash, cash equivalents and restricted cash in the consolidated statements of cash flows for all periods presented, and the Company has disclosed the amount and detail of the restriction by balance sheet line item. In the first quarter of 2018, the Company adopted ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, there have been issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations and principal versus agent considerations. Refer to the revenue recognition disclosure above. Not Yet Adopted Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting. The standard expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods and services. The provisions of this standard are effective for annual periods beginning after December 15, 2018, and for interim periods within those years. Early adoption is permitted. The Company will adopt the standard in the first quarter of 2019 and expect the standard will have no material impact on its financial position or results of operations. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The standard requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet for most leases and provide enhanced disclosures. The provisions of this standard are effective for annual periods beginning after December 15, 2018, and for interim periods within those years. Early adoption is permitted. In July 2018, the FASB issued additional guidance for companies to elect transition using either: (i) a modified retrospective approach for leases that exist on adoption and in the comparative periods presented; or (ii) an optional approach to initially apply the new lease guidance on the adoption date, without adjusting the comparative periods presented. The Company plans to elect the optional approach and will adopt the standard beginning in the first quarter of 2019. The Company has completed its assessment of the standard and expects to record a right-of use asset of approximately $16.8 million with a corresponding lease liability of $31.8 million as of January 1, 2019 for its 10-year operating lease agreement for its corporate headquarters, which commenced October 30, 2017. |
Balance Sheet Account Details
Balance Sheet Account Details | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Details | Balance Sheet Details Inventory, Net Inventory, net consisted of the following (in thousands): December 31, 2018 2017 Work in process $ 1,907 $ — Finished goods 113 — Total inventory, net $ 2,020 $ — As of December 31, 2018, total inventory is recorded net of $0.8 million of inventory reserves. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): December 31, 2018 2017 Lab equipment $ 9,047 $ 7,812 Furniture and fixtures 2,573 2,282 Computer hardware 1,296 1,238 Software 733 619 Leasehold improvements 14,504 14,852 Total property and equipment, gross 28,153 26,803 Accumulated depreciation and amortization (5,886 ) (2,235 ) Total property and equipment, net $ 22,267 $ 24,568 Accrued Expenses Accrued expenses consisted of the following (in thousands): December 31, 2018 2017 Accrued interest expense $ 6,763 $ — Accrued clinical trials 2,430 577 Accrued manufacturing costs 1,823 — Accrued other 1,972 126 Total accrued expenses $ 12,988 $ 703 |
Restructuring (Notes)
Restructuring (Notes) | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | On October 18, 2018, the Company effected a Company-wide realignment to increase its efficiency and focus on achieving its corporate goals. For the year ended December 31, 2018, total expenses related to the Company-wide realignment were $4.0 million , with $1.6 million included in research and development expense and $2.4 million included in general and administrative expense. Total expenses were comprised of $7.7 million for severance costs, offset by a $3.7 million reversal of non-cash, stock-based compensation expense related to forfeited, unvested equity awards. The Company expects to make the final payment resulting from the Company-wide realignment in the first quarter of 2019. As of December 31, 2018, the Company has paid $5.4 million of the $7.7 million cash charges, and the remaining $2.3 million of the cash charges were included in accrued payroll and related expenses. |
Licensed Technology
Licensed Technology | 12 Months Ended |
Dec. 31, 2018 | |
Research and Development [Abstract] | |
Licensed Technology | Licensed Technology The George Washington University In December 2014, the Company entered into a patent license agreement with the George Washington University (GW), which the parties amended and restated on March 1, 2016. Pursuant to this license agreement, GW exclusively licensed to the Company certain intellectual property rights relating to GIAPREZA, including the exclusive rights to certain issued patents and patent applications covering GIAPREZA. Under this license agreement, the Company is obligated to use commercially reasonable efforts to develop, commercialize, market and sell GIAPREZA. The Company has paid a one -time license initiation fee, annual maintenance fees, an amendment fee and additional payments following the achievement of certain development and regulatory milestones including FDA approval. The Company may be obligated to make additional milestone payments of up to $0.5 million in the aggregate. Following the commencement of commercial sales of GIAPREZA, the Company is obligated to pay tiered royalties in the low- to mid- single digits on products covered by the licensed rights. The patents and patent applications covered by the GW license agreement expire between 2029 and 2038, and the obligation to pay royalties under this agreement extend through the last-to-expire patent covering GIAPREZA. Inserm Transfert SA In February 2014, the Company entered into a license agreement with Inserm Transfert SA (Inserm). Pursuant to this license agreement, Inserm exclusively licensed to the Company certain intellectual property rights relating to LJPC-401. Under this license agreement, the Company has paid a one-time license initiation fee, annual maintenance fees and additional payments following the achievement of certain development milestones. The Company may be obligated to make additional payments of up to $3.7 million upon the achievement of certain development milestones and regulatory approval on products covered by the licensed patent rights. Following the commencement of commercial sales of a product covered by the licensed intellectual property, the Company will be obligated to pay tiered royalties in the low- to mid- single digits on products covered by the licensed rights. The patents and patent applications covered by the Inserm license agreement expire between 2022 and 2038, and the obligation to pay royalties under this agreement extend through the last-to-expire patent covering a licensed product. Other In-Licensed Technology The Company continues to seek additional technology for potential new development programs and, as a result, has entered into various licensing agreements for intellectual property rights. The Company has incurred licensing and milestone fees of $0.7 million , $1.6 million and $0.5 million recorded in research and development expense in connection with its licensing agreements for the years ended December 31, 2018 , 2017 and 2016 , respectively. See Note 11 for future minimum licensing payment commitments. |
Contract Revenue - Related Part
Contract Revenue - Related Party (Notes) | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Contract Revenue - Related Party | Contract Revenue - Related Party In 2015, the Company entered into a services agreement with a related party. Pursuant to the services agreement, the Company provides certain services to this related party, including, but not limited to, research and development and clinical study design and management for projects undertaken. In exchange for providing such services, the Company receives payments at a negotiated, arms-length rate. As a result, the consideration received by the Company for its services is considered to be no less favorable to the Company than comparable terms that the Company could obtain from an unaffiliated third party in an arms-length transaction. The services agreement may be canceled by either party upon 60 -days’ written notice to the other party. The Company had no contract revenue during the years ended December 31, 2018 and 2017. During the year ended December 31, 2016, the Company recognized approximately $0.6 million of contract revenue for services provided under the services agreement. In addition, the Company has a non-voting profit interest in the related party, which provides the Company with the potential to receive a portion of the future distributions of profits, if any. Investment funds affiliated with the Chairman of the Company’s board of directors have a controlling interest in, and the Company’s Chief Executive Officer (CEO) has a non-voting profit interest in, the related party. |
Shareholders_ Equity
Shareholders’ Equity | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Shareholders’ Equity | Shareholders’ Equity Common Stock 2017 Common Stock Offering In March 2017, the Company offered and sold an aggregate of 3,731,344 shares of common stock in an underwritten public offering at a price of $33.50 per share for gross proceeds of approximately $125.0 million . The Company received proceeds of approximately $117.5 million , net of approximately $7.5 million in underwriting commissions, discounts and other issuance costs. 2018 Common Stock Offering In March 2018, the Company offered and sold an aggregate of 3,910,000 shares of common stock in an underwritten public offering at a price of $29.50 per share for gross proceeds of approximately $115.3 million . The Company received proceeds of approximately $109.8 million , net of approximately $5.5 million in underwriting commissions, discounts and other issuance costs. Preferred Stock As of December 31, 2018 , the Company is authorized to issue 8,000,000 shares of preferred stock, with a par value of $0.0001 per share, in one or more series, of which 11,000 are designated as Series C-1 2 Convertible Preferred Stock (Series C-1 2 Preferred) and 10,000 are designated as Series F Convertible Preferred Stock (Series F Preferred). The Series C-1 2 Preferred is convertible into common stock at a rate of approximately 1,724 shares of common stock for each share of Series C-1 2 Preferred and the Series F Preferred is convertible into common stock at a rate of approximately 286 shares of common stock for each share of Series F Preferred. As of December 31, 2018 and 2017 , there were 3,906 shares of Series C-1 2 Preferred and 2,737 shares of Series F Preferred issued and outstanding. As such, as of December 31, 2018 and 2017 , the issued and outstanding Series C-1 2 Preferred and Series F Preferred were convertible into 6,735,378 and 782,031 shares of common stock, respectively. In January 2019, all of the Series F Preferred was converted into 782,031 shares of common stock by the preferred holder. The holders of preferred stock do not have voting rights, other than for general protective rights required by the California General Corporation Law. The Series C-1 2 Preferred and the Series F Preferred do not have dividends. The Series C-1 2 Preferred and the Series F Preferred have a liquidation preference in an amount equal to $1,000 per share. As of December 31, 2018 and 2017 , the aggregate liquidation preference was approximately $3.9 million and $2.7 million on the Series C-1 2 Preferred and Series F Preferred, respectively. Share-based Compensation Expense Stock Options 2013 Equity Incentive Plan In September 2013, the Company adopted an equity compensation plan entitled the 2013 Equity Incentive Plan (2013 Equity Plan). The 2013 Equity Plan is an omnibus equity compensation plan that permits the issuance of various types of equity-based compensation awards, including stock options, restricted stock awards, stock appreciation rights and restricted stock units, as well as cash awards, to employees, directors and eligible consultants. The 2013 Equity Plan has a 10 -year term and permits the issuance of incentive stock options under Section 422 of the Internal Revenue Code of 1986, as amended (IRC). The administrator under the plan has broad discretion to establish the terms of awards, including the size, term, exercise price and vesting conditions. Generally, grants to employees vest over four years, with 25% vesting on the one -year anniversary and the remainder vesting either quarterly or monthly thereafter; grants to non-employee directors generally vest over one year on the one -year anniversary. At the 2016 and 2017 Annual Meetings of Shareholders, the Company’s shareholders approved and adopted an amendment to the 2013 Equity Plan to increase the number of shares of common stock authorized for issuance up to a total of 4,600,000 and 8,100,000 shares, respectively. As of December 31, 2018 , there were 1,340,450 shares of common stock available for future grants under the 2013 Equity Plan. Stock Option Activity The Company’s stock option activity under its option plans was comprised of the following: Outstanding Stock Options and 2013 Equity Plan Shares Underlying Stock Options Weighted- average Exercise Price per Share Weighted- average Remaining Contractual Term Aggregate Outstanding at December 31, 2015 2,318,685 $ 22.01 Granted 483,200 $ 17.83 Exercised (17,548 ) $ 8.52 Forfeited (156,875 ) $ 26.35 Outstanding at December 31, 2016 2,627,462 $ 21.07 Granted 3,704,725 $ 25.94 Exercised (174,628 ) $ 15.42 Forfeited (120,257 ) $ 22.82 Outstanding at December 31, 2017 6,037,302 $ 24.19 Granted 1,978,219 $ 23.66 Exercised (106,370 ) $ 17.95 Forfeited (1,442,937 ) $ 28.07 Outstanding at December 31, 2018 6,466,214 $ 23.26 7.65 years $ 200,279 Vested and expected to vest at December 31, 2018 6,466,214 $ 23.26 7.65 years $ 200,279 Exercisable at December 31, 2018 3,118,365 $ 22.61 6.33 years $ 200,279 The weighted-average grant date fair values of the stock options granted was $20.52 , $23.80 and $15.33 per underlying share for the years ended December 31, 2018 , 2017 and 2016 , respectively. As of December 31, 2018 , $64.5 million of total unrecognized share-based compensation expense related to unvested stock options remains and is expected to be recognized over a weighted-average period of approximately 2.8 years . During the years ended December 31, 2018, 2017 and 2016 stock options to purchase 106,370 , 174,628 and 17,548 shares of common stock were exercised with an intrinsic value of $1.4 million , $3.3 million and $0.1 million , respectively. The total fair value of equity awards vested during the years ended December 31, 2018, 2017 and 2016 was $38.0 million , $12.1 million and $14.5 million , respectively. 2018 Employee Stock Purchase Plan In July 2018, the Company’s board of directors approved the adoption of the 2018 Employee Stock Purchase Plan (ESPP), which was subsequently adopted and approved by the Company’s shareholders at the 2018 Annual Meeting of Shareholders, in order to provide a means for eligible employees to accumulate shares of the Company’s common stock over time through regular payroll deductions. Under the ESPP, eligible employees may purchase shares of the Company’s common stock twice per month at a price equal to 85% of the closing price of shares of the Company’s common stock on the date of each purchase. Eligible employees purchasing shares under the ESPP are subject to an annual cap equal to the lesser of $25,000 or 10% of the employee’s annual cash compensation. Shares purchased under the ESPP cannot be sold for a period of one year following the purchase date (or such shorter period of time if the participating employee’s employment terminates before this one-year anniversary). A total of 750,000 shares of common stock have been reserved for issuance under the ESPP. As of December 31, 2018, 717,701 shares of common stock remained available for future grants under the ESPP. During the year ended December 31, 2018, the Company recorded $0.2 million of stock-based compensation related to the ESPP. Restricted Stock Award Activity Restricted stock awards (RSAs) are grants that entitle the holder to acquire shares of common stock for no cash consideration or at a fixed price, which is typically nominal. The Company accounts for RSAs as issued and outstanding common stock, even though: (a) shares covered by an RSA cannot be sold, pledged or otherwise disposed of until the award vests; and (b) any unvested shares may be reacquired by the Company for the original purchase price following the awardee’s termination of service. The valuation of RSAs is based on the fair market value of the underlying shares on the grant date. In September 2013, the Company issued RSAs consisting of 1,327,048 shares to its CEO, 79,622 shares to a director and an aggregate of 336,185 shares to three non-officer employees. The RSA grants to the CEO, director and one of the employees were for the replacement of canceled stock options and restricted stock units granted in April 2012, which was done in order to complete the capital restructuring that took place in September 2013. These RSAs were granted outside of the 2013 Equity Plan, but are governed in all respects by the 2013 Equity Plan. These RSAs were granted with a combination of performance-based and time-based vesting components. As of December 31, 2017, all performance-based and time-based vesting conditions had been satisfied. In July 2015, the vesting conditions for 1,042,680 shares of unvested and outstanding RSAs awarded to the CEO were amended to provide that vesting and delivery of the shares were deferred until March 15, 2017, subject to the CEO’s continued service with the Company through such date. In December 2016, vesting and delivery was accelerated for 500,000 shares of the RSAs that had been deferred until March 15, 2017. As of December 31, 2017, the remaining 542,680 shares of the RSAs had vested and been delivered. The Company’s RSA activity was comprised of the following: Number of Shares Weighted- average Grant Date Fair Market Value Unvested at December 31, 2015 1,072,899 $ 13.00 Vested (530,219 ) $ 12.78 Unvested at December 31, 2016 542,680 $ 13.22 Vested (542,680 ) $ 13.22 Unvested at December 31, 2017 — — There was no activity for the year ended December 31, 2018. Stock Option Valuation The fair value of each stock option award is estimated on the grant date using a Black-Scholes option pricing model (Black-Scholes model), which uses the assumptions noted in the following table. Expected volatility is based on historical volatility of the Company’s common stock. In determining the expected life of employee stock options, the Company uses the “simplified” method. The expected life assumptions for non-employees’ options are based upon the contractual term of the stock options. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the stock options in effect at the time of the grants. The dividend yield assumption is based on the expectation of no future dividend payments by the Company. The Company estimates the fair value of each stock option grant on the grant date using the Black-Scholes model with the following weighted-average assumptions: Year Ended December 31, 2018 2017 2016 Volatility 114 % 139 % 143 % Expected life (years) 6.07 6.12 5.80 Risk-free interest rate 2.8 % 2.1 % 1.4 % Dividend yield — — — Share-based Compensation Expense Total share-based compensation expense related to all share-based awards was comprised of the following (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 21,113 $ 11,980 $ 5,657 Selling, general and administrative 14,038 9,815 8,889 Total share-based compensation expense $ 35,151 $ 21,795 $ 14,546 Share-based compensation expense recognized for the years ended December 31, 2018 , 2017 and 2016 is reduced by actual forfeitures in the period that the forfeiture occurs. Third Party Share-based Compensation Expense The Company initially estimates the fair value of stock options and warrants issued to non-employees, other than non-employee directors, on the grant date using the Black-Scholes model. Thereafter, the Company re-measures the fair value using the Black-Scholes model as of each balance sheet date as the stock options and warrants vest. In December 2014, the Company granted warrants to purchase 51,000 shares of common stock to two outside third parties at an exercise price equal to the fair market value of the stock on the grant dates. One grant vests 25% on each anniversary date over four years . The other grant vested 100% on the one-year anniversary of the grant. In January 2016, the Company granted a warrant to purchase 17,000 shares of common stock to an outside third party at an exercise price equal to the fair market value of the stock on the date of each grant. The grant vested 100% on the one-year anniversary of the grant. In January 2017, the Company granted a warrant to purchase 25,013 shares of common stock to an outside third party at an exercise price equal to the fair market value of the stock on the date of each grant. The grant vests 100% on the one-year anniversary of the grant. In March 2018, the Company issued 43,056 shares of common stock in a cashless exercise of 83,013 warrants to a third-party warrant holder. As of December 31, 2018, the Company had outstanding warrants to purchase 10,000 shares of common stock. For the year ended December 31, 2018, the Company did not recognize stock-based compensation expense for these warrant grants. For the years ended December 31, 2017 and 2016, the Company recognized compensation expense for these warrant grants of approximately $0.6 million and $0.2 million , respectively. In August and November 2015, the Company granted stock options to purchase 50,000 shares of common stock to two consultants at exercise prices equal to the fair market value of the Company’s common stock on the grant dates. These grants were made from the 2013 Equity Plan. The vesting of these stock options was contingent on the achievement of a performance milestone by the end of 2016, at which time any unvested shares underlying the options would be canceled. The milestone was achieved in the fourth quarter of 2016 at a 75% achievement level, with 25% of the options canceling. For the years ended December 31, 2018 and 2017, the Company did not recognize stock-based compensation expense for these stock option grants. For the year ended December 31, 2016, the Company recognized stock-based compensation benefit for these stock option grants of approximately $0.1 million . In September 2016, the Company granted a stock option to purchase 35,000 shares of common stock to a consultant at an exercise price equal to the fair market value of the Company’s common stock on the grant date. This grant was made from the 2013 Equity Plan. The stock option will vest with respect to 25% of the underlying shares on the one -year anniversary of the grant, with the remainder to vest monthly over the next three years , subject to continued service during that time. In January 2017, this consultant became an employee of the Company. In February 2017, the Company granted stock options to purchase 42,000 shares of common stock to three consultants at exercise prices equal to the fair market value of the Company’s common stock on the grant dates. These grants were made from the 2013 Equity Plan. Two of the stock options will vest with respect to 25% of the underlying shares on the one -year anniversary of the grant, with the remainder to vest monthly over the next three years , subject to continued service during that time. The other stock option will vest with respect to 25% of the underlying shares on the one -year anniversary of the grant, with the remainder to vest monthly over the next two years , subject to continued service during that time. In addition, an employee converted to a consultant during April 2017. Two of his options were modified and are continuing to vest over the next two years . The Company recognized third-party compensation expense for these stock option grants of approximately $0.3 million and $0.4 million for the years ended December 31, 2018 and 2017, respectively. |
Deferred Royalty Obligation
Deferred Royalty Obligation | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Deferred Royalty Obligation | Deferred Royalty Obligation On May 10, 2018, the Company closed a $125.0 million royalty financing agreement (the Royalty Agreement) with HealthCare Royalty Partners (HCR). Under the terms of the Royalty Agreement, the Company received $125.0 million in exchange for tiered royalty payments on worldwide net product sales of GIAPREZA. HCR is entitled to receive quarterly royalties on worldwide net product sales of GIAPREZA beginning April 1, 2018. Quarterly payments to HCR under the Royalty Agreement start at a maximum royalty rate, with step-downs based on the achievement of annual net product sales thresholds. Through December 31, 2021, the royalty rate will be a maximum of 10% . Starting January 1, 2022, the maximum royalty rate may increase by 4% if an agreed-upon, cumulative sales threshold has not been met, and, starting January 1, 2024, the maximum royalty rate may increase by an additional 4% if a different agreed-upon, cumulative sales threshold has not been met. The Royalty Agreement is subject to maximum aggregate royalty payments to HCR of 180% of the $125.0 million to be received by the Company, at which time the payment obligations under the Royalty Agreement would expire. The Royalty Agreement was entered into by the Company’s wholly-owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the Royalty Agreement against La Jolla Pharmaceutical Company or any assets other than GIAPREZA. On receipt of the $125.0 million payment from HCR, the Company recorded a deferred royalty obligation of $125.0 million , net of issuance costs of $0.7 million . During the year ended December 31, 2018 , the Company recognized interest expense, including amortization of the obligation discount, of $7.3 million . The carrying value of the deferred royalty obligation as of December 31, 2018 was $124.3 million , net of an unamortized obligation discount of $0.7 million , and was classified as non-current. Accrued interest expense of $6.8 million is included in accrued expenses in the consolidated balance sheet as of December 31, 2018 . For the year ended December 31, 2018 , the Company made royalty payments to HCR of $0.5 million , and, as of December 31, 2018, the Company recorded royalty obligations payable of $0.4 million in accrued expenses. In the event of certain material breaches of the Royalty Agreement, HCR would have the right to terminate the Royalty Agreement and demand payment of an amount equal to either $125.0 million , minus aggregate royalties paid to HCR, or $225.0 million , minus aggregate royalties paid to HCR, depending on the type of breach. The Company concluded that certain of these contract provisions that could result in an acceleration of amounts due under the Royalty Agreement are embedded derivatives that require bifurcation from the deferred royalty obligation and fair value recognition. The Company determined the fair value of each derivative by assessing the probability of each event occurring, as well as the potential repayment amounts and timing of such repayments that would result under various scenarios. As a result of this assessment, the Company determined that the fair value of the embedded derivatives is immaterial as of December 31, 2018 . Each reporting period, the Company estimates the fair value of the embedded derivatives until the features lapse and/or the termination of the Royalty Agreement. Any change in the fair value of the embedded derivatives will be recorded as either a gain or loss on the consolidated statements of operations. |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution Plan The Company has a defined contribution plan (401(k) Plan) covering substantially all of the Company’s employees. The 401(k) Plan is a tax-qualified retirement saving plan, pursuant to which all employees are able to contribute the lesser of 50% of their annual compensation (as defined) or the limit prescribed by the Internal Revenue Service to the 401(k) Plan on a before-tax basis. The Company matches employee contributions to the 401(k) Plan based on each participant’s contribution during the plan year, up to 3.5% of each participant’s annual compensation. During the years ended December 31, 2018 , 2017 and 2016 , the Company made matching contributions to the 401(k) Plan of $1.4 million , $0.7 million and $0.4 million , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company did not record a provision for income taxes for the years ended December 2018, 2017 and 2016 due to a full valuation allowance against its deferred tax assets. On December 22, 2017, the Tax Cuts and Jobs Act (2017 Tax Act) was enacted. The 2017 Tax Act included a number of changes to existing U.S. tax laws that impacted the Company, most notably a reduction of the U.S. corporate tax rate from 34% to 21%, for tax years beginning after December 31, 2017. The 2017 Tax Act also provided for the implementation of a territorial tax system, a one-time transition tax on certain foreign earnings, the acceleration of depreciation for certain assets placed into service after September 27, 2017 and other prospective changes beginning in 2018, including repeal of the domestic manufacturing deduction, acceleration of tax revenue recognition, capitalization of research and development expenditures, additional limitations on executive compensation and limitations on the deductibility of interest. Pursuant to the SEC Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act, the Company had not finalized its accounting for the income tax effects of the 2017 Act for the year ended December 31, 2017, but included a provisional amount related to the re-measurement of deferred tax assets based on the rates at which they were expected to reverse in the future, which is generally 21% plus the applicable state tax rate, with a corresponding change to the valuation allowance as of December 31, 2017. The Company finalized its accounting for the income tax effects of the 2017 Act during the year ended December 31, 2018 and, as such, the Company’s financial results reflect the income tax effects of the 2017 Tax Act. Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2018 2017 Deferred tax assets: Deferred royalty obligation $ 31,937 $ — Stock-based compensation 11,904 6,744 Depreciation and amortization 1,033 511 Other 1,004 124 Total gross deferred tax assets 45,878 7,379 Valuation allowance (45,878 ) (7,379 ) Net deferred tax assets $ — $ — The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): Year Ended December 31, 2018 2017 2016 Federal statutory rate $ (41,888 ) $ (39,033 ) $ (26,583 ) State tax benefit (14,449 ) — — Research and development credits (5,164 ) (2,691 ) (1,240 ) Foreign rate differential (58 ) 1,249 — Change in valuation allowance 55,167 (35,246 ) 25,091 Stock-based compensation 4,041 2,253 — Expired tax attributes 1,936 2,228 (5 ) Impact of the 2017 Tax Act — 71,199 — Other permanent differences 415 41 2,737 Provision for income taxes $ — $ — $ — As of December 31, 2018 and 2017, the Company established a full valuation allowance against its federal and state deferred tax assets due to the uncertainty surrounding the realization of such assets. Pursuant to Section 382 and 383 of the IRC, utilization of the Company’s federal net operating loss carryforwards and research and development credit carryforwards may be subject to annual limitations in the event of any significant future changes in its ownership structure. These annual limitations may result in the expiration of net operating loss and research and development credit carryforwards prior to utilization. The Company has not completed an IRC Section 382 and 383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. As of December 31, 2018, the Company has estimated federal and state net operating loss carryforwards of approximately $560.2 million and $341.0 million , respectively. The difference between the federal and state tax net operating loss carryforwards is primarily attributable to the capitalization of research and development expenses for California income tax purposes. In addition, the Company has estimated federal and California research and development tax credit carryforwards of approximately $24.6 million and $15.4 million , respectively. The federal net operating loss carryforwards, federal research tax credit carryforwards and state net operating loss carryforwards will begin to expire in 2019, if not utilized. California research and development credit carryforwards will carry forward indefinitely until utilized. The Company believes that it experienced ownership changes in May 2010 and February 2009 at times when its enterprise value was minimal. As a result of the ownership changes and low enterprise values at such times, the Company’s federal and California net operating loss carryforwards and federal research and development credit carryforwards as of December 31, 2017 will likely be subject to annual limitations under IRC Section 382 and 383 and, more likely than not, will expire unused. There were no unrecognized tax benefits as of the December 31, 2018 and 2017. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months. The Company had no accrual for interest or penalties on the Company’s consolidated balance sheets as of December 31, 2018 or December 31, 2017, and has not recognized interest and/or penalties in the consolidated statements of operations for the years ended December 31, 2018, 2017 and 2016. The Company is subject to taxation in the U.S. and various state jurisdictions. The Company’s tax returns since inception are subject to examination by the U.S. and various state tax authorities. The Company is not currently undergoing a tax audit in any federal or state jurisdiction. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases On December 29, 2016, the Company entered into an agreement with BMR-Axiom LP to lease office and laboratory space as its new corporate headquarters located at 4550 Towne Centre Court, San Diego, California (Lease) for a period of 10 years commencing on October 30, 2017. The Lease provides an option to extend the Lease for an additional 5.0 years at the end of the initial term. The Company provided a standby letter of credit for $0.9 million in lieu of a security deposit. This amount will decrease to $0.6 million after year two of the lease and decrease to $0.3 million after year 5 of the lease term. As of December 31, 2018, $0.9 million was pledged as collateral for such letter of credit and recorded as restricted cash. The Lease provided an allowance for tenant improvements of $13.7 million , which was classified as deferred rent on the Company’s consolidated balance sheet and is being amortized as an offset to rent expense with a corresponding charge to depreciation expense on a straight-line basis over the term of the lease. The annual rent under the Lease is subject to escalation during the term. In addition to rent, the Lease requires the Company to pay certain taxes, insurance and operating costs relating to the leased premises. The Lease contains customary default provisions, representations, warranties and covenants. Annual future minimum payments under operating leases as of December 31, 2018 are as follows (in thousands): 2019 $ 3,951 2020 4,070 2021 4,192 2022 4,318 2023 4,447 Thereafter 18,308 Total future minimum lease payments $ 39,286 Rent expense was $2.8 million , $1.7 million and $1.1 million for the years ended December 31, 2018 , 2017 and 2016 , respectively. Licensing Agreements In the normal course of business, the Company enters into licensing agreements under which the Company commits to certain annual maintenance payments. Annual future minimum licensing payments under the Company’s agreements as of December 31, 2018 are as follows (in thousands): 2019 $ 120 2020 120 2021 120 2022 120 2023 120 Total future minimum license payments $ 600 Supply Agreements In the normal course of business, the Company enters into agreements for the manufacturing and supply of its clinical and commercial products. In 2017, the Company entered into agreements arranging for the manufacture and supply of GIAPREZA through 2022. During this time, the Company is obligated to make certain minimum purchases. Annual future minimum payments for manufacturing and supply agreements as of December 31, 2018 are as follows (in thousands): 2019 $ 2,759 2020 2,759 2021 2,759 Total future minimum manufacturing and supply agreement payments $ 8,277 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation and Use of Estimates The Company’s consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include the accounts of the Company and its wholly-owned subsidiaries. |
Principles of Consolidation | All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates | The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in its consolidated financial statements and the accompanying notes. Actual results may differ materially from these estimates. |
Reclassification | Certain amounts previously reported in the financial statements have been reclassified to conform to the current year presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows. |
Cash and Cash Equivalents | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less when purchased as cash equivalents. The Company maintains its cash in checking and savings accounts. Income generated from cash held in savings accounts is recorded as interest income. The carrying value of the Company’s money market savings accounts is included in cash equivalents and approximates the fair value. Cash is classified as restricted cash when certain funds are reserved for a specific purpose and are not available for immediate or general business use. |
Accounts Receivables | Accounts Receivable, Net Accounts receivable are recorded net of customers’ allowances for prompt-pay discounts, chargebacks and doubtful accounts. Allowances for prompt-pay discounts and chargebacks are based on contractual terms. The Company estimates the allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of its customers and individual customer circumstances. As of December 31, 2018 , the Company did not have any allowances for doubtful accounts. |
Inventory | Inventory, Net Inventory is stated at the lower of cost or estimated net realizable value on a first-in, first-out (FIFO) basis. The Company periodically analyzes inventory levels and writes down inventory as cost of product sales when: inventory has become obsolete; inventory has a cost basis in excess of its estimated net realizable value; or inventory quantities are in excess of expected product sales. |
Concentration of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash. The Company maintains its cash in checking and money market savings accounts at federally insured financial institutions in excess of federally insured limits. The Company’s products are distributed in the U.S. through distributors and select wholesalers (collectively, customers) that resell its products to hospitals, the end users. |
Property and Equipment | Property and Equipment, Net Property and equipment is stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which range from two to seven years. Amortization of leasehold improvements is computed using the straight-line method over the shorter of the lease term or the estimated useful life of the related assets. Maintenance and repairs are charged to operating expense as incurred. When assets are sold, or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts, and any gain or loss is included in operating expense. |
Revenue Recognition | Revenue Recognition The Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 606 – Revenue from Contracts with Customers (ASC 606) at the time of its first commercial shipment of GIAPREZA in the first quarter of 2018. The Company had no revenue from product sales prior to the first quarter of 2018. Under ASC 606, the Company recognizes revenue when its customers obtain control of the Company’s product, which typically occurs on delivery. Revenue is recognized in an amount that reflects the consideration that the Company expects to receive in exchange for those goods. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following 5 steps: (i) identify the contract(s) 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) the entity satisfies a performance obligation. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, discounts, returns and Group Purchasing Organization (GPO) discounts, rebates and administrative fees. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items include: • Chargebacks - Chargebacks are discounts the Company provides to distributors in the event that the sales prices to end users are below the distributors’ acquisition price. Chargebacks are estimated based on known chargeback rates and recorded as a reduction of revenue on delivery to the Company’s customers. • Discounts - The Company offers customers various forms of incentives and consideration, including prompt-pay discounts, service fees and other contract fees. The Company estimates discounts and fees primarily based on contractual terms. These discounts and fees are recorded as a reduction of revenue on delivery to the Company’s customers. • Returns - The Company offers customers a limited right of return, generally for damaged or expired product. The Company estimates returns based on an internal analysis, which includes actual experience and a review of comparable companies. The estimates for returns are recorded as a reduction of revenue on delivery to the Company’s customers. • GPO Discounts and Rebates - The Company offers cash discounts to GPO members. These discounts are taken when the GPO members purchase GIAPREZA from the Company’s customers, who then charge the discount amount back to the Company. Additionally, the Company offers volume and contract-tier rebates to GPO members. Rebates are based on actual purchase levels during the quarterly rebate purchase period. • GPO Administrative Fees - The Company pays administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPO members. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly. |
Research and Development Expenses | Research and Development Expense Research and development expense includes salaries and benefits, facilities and other overhead costs, research-related manufacturing costs, contract service and clinical and preclinical-related service costs performed by clinical research organizations, research institutions and other outside service providers. Research and development expense is expensed as incurred when these expenditures relate to the Company’s research and development efforts and have no alternative future uses. In accordance with certain research and development agreements, the Company is obligated to make certain upfront payments upon execution of the agreement. Advance payments, including nonrefundable amounts, for materials or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the related goods are delivered or the related services are performed. Acquisition or milestone payments that the Company makes in connection with in-licensed technology are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology. The Company considers the future economic benefits from the licensed technology to be uncertain until such licensed technology is incorporated into products that are approved for marketing by the FDA or when other significant risk factors are abated. For accounting purposes, management has viewed future economic benefits for all of the Company’s licensed technology to be uncertain. |
Patent Costs | Patent Costs Legal costs in connection with approved patents and patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are recorded in selling, general and administrative expense in the consolidated statements of operations. |
Share-based Compensation | Share-based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation - Stock Compensation and ASC 505-50, Equity - Equity Based Payments to Non-Employees , which requires the recognition of compensation expense, using a fair-value based method, for all costs related to share-based payments, including stock options and restricted stock awards. These standards require companies to estimate the fair value of share-based payment awards on the date of the grant using an option-pricing model. The Company has elected to account for forfeitures as they occur. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rate is recognized in income in the period that includes the enactment date. A valuation allowance is applied against any deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet a “more likely than not” threshold, the Company recognizes the benefit of uncertain tax positions in the consolidated financial statements. The Company’s practice is to recognize interest and penalties, if any, related to uncertain tax positions in income tax expense in the consolidated statements of operations. |
Interest Expense | Interest Expense Interest expense and the amortization of issuance costs related to the deferred royalty obligation (see Note 8) are recognized over the expected repayment term of the deferred royalty obligation using the effective interest method. The assumptions used in determining the expected repayment term of the deferred royalty obligation require the Company to make estimates that could impact the effective interest rate. Each reporting period, the Company estimates the expected repayment term of the deferred royalty obligation based on forecasted net product sales of GIAPREZA. Changes in interest expense resulting from changes in the effective interest rate, if any, are recorded on a prospective basis. |
Net Loss Per Share | Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period, excluding unvested restricted stock awards. Diluted net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding plus potential common shares. Convertible preferred stock, stock options, warrants and unvested restricted stock awards are considered potential common shares and are included in the calculation of diluted net loss per share using the treasury stock method when their effect is dilutive. Potential common shares are excluded from the calculation of diluted net loss per share when their effect is anti-dilutive. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Fair Value Measurement | Fair Value Measurements The Company follows the provisions of ASC 820-10, Fair Value Measurements and Disclosures (ASC 820-10), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1) observable inputs such as quoted prices in active markets; Level 2) inputs other than the quoted prices in active markets that are observable either directly or indirectly; and Level 3) unobservable inputs, in which there is little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Cash equivalents consist of money market accounts with maturities of 90 days or less. Due to the high ratings and short-term nature of these funds, the Company considers the inputs to the value of all cash and cash equivalents as Level 1. The Company’s financial instruments include cash and cash equivalents, accounts receivable, inventory, prepaid expenses and other current assets, accounts payable and accrued expenses. The carrying amounts reported in the balance sheets for these financial instruments approximate fair value because of their short-term nature. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In the first quarter of 2018, the Company adopted Accounting Standard Update (ASU) 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The standard clarifies the presentation of restricted cash and cash equivalents and requires companies to include restricted cash and cash equivalents in the beginning and ending balances of cash and cash equivalents on the statement of cash flows. The standard also requires additional disclosures to describe the amount and detail of the restriction by balance sheet line item. Accordingly, restricted cash is included as a component of cash, cash equivalents and restricted cash in the consolidated statements of cash flows for all periods presented, and the Company has disclosed the amount and detail of the restriction by balance sheet line item. In the first quarter of 2018, the Company adopted ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, there have been issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations and principal versus agent considerations. Refer to the revenue recognition disclosure above. Not Yet Adopted Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting. The standard expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods and services. The provisions of this standard are effective for annual periods beginning after December 15, 2018, and for interim periods within those years. Early adoption is permitted. The Company will adopt the standard in the first quarter of 2019 and expect the standard will have no material impact on its financial position or results of operations. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The standard requires lessees to recognize right-of-use assets and lease liabilities on the balance sheet for most leases and provide enhanced disclosures. The provisions of this standard are effective for annual periods beginning after December 15, 2018, and for interim periods within those years. Early adoption is permitted. In July 2018, the FASB issued additional guidance for companies to elect transition using either: (i) a modified retrospective approach for leases that exist on adoption and in the comparative periods presented; or (ii) an optional approach to initially apply the new lease guidance on the adoption date, without adjusting the comparative periods presented. The Company plans to elect the optional approach and will adopt the standard beginning in the first quarter of 2019. The Company has completed its assessment of the standard and expects to record a right-of use asset of approximately $16.8 million with a corresponding lease liability of $31.8 million as of January 1, 2019 for its 10-year operating lease agreement for its corporate headquarters, which commenced October 30, 2017. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedules of Concentration of Risk | The following table includes the percentage of net product sales and accounts receivable balances for the Company’s three major customers, each of which comprised 10% or more of its net product sales: Net Product Sales Accounts Receivable Year Ended December 31, 2018 As of December 31, 2018 Customer A 37 % 44 % Customer B 31 % 28 % Customer C 30 % 26 % Total 98 % 98 % |
Balance Sheet Account Details (
Balance Sheet Account Details (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory, net consisted of the following (in thousands): December 31, 2018 2017 Work in process $ 1,907 $ — Finished goods 113 — Total inventory, net $ 2,020 $ — |
Property and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, 2018 2017 Lab equipment $ 9,047 $ 7,812 Furniture and fixtures 2,573 2,282 Computer hardware 1,296 1,238 Software 733 619 Leasehold improvements 14,504 14,852 Total property and equipment, gross 28,153 26,803 Accumulated depreciation and amortization (5,886 ) (2,235 ) Total property and equipment, net $ 22,267 $ 24,568 |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): December 31, 2018 2017 Accrued interest expense $ 6,763 $ — Accrued clinical trials 2,430 577 Accrued manufacturing costs 1,823 — Accrued other 1,972 126 Total accrued expenses $ 12,988 $ 703 |
Shareholders_ Equity (Tables)
Shareholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity and Related Data | The Company’s stock option activity under its option plans was comprised of the following: Outstanding Stock Options and 2013 Equity Plan Shares Underlying Stock Options Weighted- average Exercise Price per Share Weighted- average Remaining Contractual Term Aggregate Outstanding at December 31, 2015 2,318,685 $ 22.01 Granted 483,200 $ 17.83 Exercised (17,548 ) $ 8.52 Forfeited (156,875 ) $ 26.35 Outstanding at December 31, 2016 2,627,462 $ 21.07 Granted 3,704,725 $ 25.94 Exercised (174,628 ) $ 15.42 Forfeited (120,257 ) $ 22.82 Outstanding at December 31, 2017 6,037,302 $ 24.19 Granted 1,978,219 $ 23.66 Exercised (106,370 ) $ 17.95 Forfeited (1,442,937 ) $ 28.07 Outstanding at December 31, 2018 6,466,214 $ 23.26 7.65 years $ 200,279 Vested and expected to vest at December 31, 2018 6,466,214 $ 23.26 7.65 years $ 200,279 Exercisable at December 31, 2018 3,118,365 $ 22.61 6.33 years $ 200,279 |
Summary of restricted stock activity | The Company’s RSA activity was comprised of the following: Number of Shares Weighted- average Grant Date Fair Market Value Unvested at December 31, 2015 1,072,899 $ 13.00 Vested (530,219 ) $ 12.78 Unvested at December 31, 2016 542,680 $ 13.22 Vested (542,680 ) $ 13.22 Unvested at December 31, 2017 — — |
Stock Options, Valuation Assumptions | estimates the fair value of each stock option grant on the grant date using the Black-Scholes model with the following weighted-average assumptions: Year Ended December 31, 2018 2017 2016 Volatility 114 % 139 % 143 % Expected life (years) 6.07 6.12 5.80 Risk-free interest rate 2.8 % 2.1 % 1.4 % Dividend yield — — — |
Summary of Share-based Compensation Expense | Total share-based compensation expense related to all share-based awards was comprised of the following (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 21,113 $ 11,980 $ 5,657 Selling, general and administrative 14,038 9,815 8,889 Total share-based compensation expense $ 35,151 $ 21,795 $ 14,546 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Significant components deferred tax assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2018 2017 Deferred tax assets: Deferred royalty obligation $ 31,937 $ — Stock-based compensation 11,904 6,744 Depreciation and amortization 1,033 511 Other 1,004 124 Total gross deferred tax assets 45,878 7,379 Valuation allowance (45,878 ) (7,379 ) Net deferred tax assets $ — $ — |
Provision for income taxes | The difference between the provision for income taxes and income taxes computed using the effective U.S. federal statutory rate is as follows (in thousands): Year Ended December 31, 2018 2017 2016 Federal statutory rate $ (41,888 ) $ (39,033 ) $ (26,583 ) State tax benefit (14,449 ) — — Research and development credits (5,164 ) (2,691 ) (1,240 ) Foreign rate differential (58 ) 1,249 — Change in valuation allowance 55,167 (35,246 ) 25,091 Stock-based compensation 4,041 2,253 — Expired tax attributes 1,936 2,228 (5 ) Impact of the 2017 Tax Act — 71,199 — Other permanent differences 415 41 2,737 Provision for income taxes $ — $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future minimum annual lease payments under lease agreements | Annual future minimum payments under operating leases as of December 31, 2018 are as follows (in thousands): 2019 $ 3,951 2020 4,070 2021 4,192 2022 4,318 2023 4,447 Thereafter 18,308 Total future minimum lease payments $ 39,286 |
Annual future minimum licensing payments | Annual future minimum licensing payments under the Company’s agreements as of December 31, 2018 are as follows (in thousands): 2019 $ 120 2020 120 2021 120 2022 120 2023 120 Total future minimum license payments $ 600 |
Annual future minimum payments for manufacturing and supply agreements | Annual future minimum payments for manufacturing and supply agreements as of December 31, 2018 are as follows (in thousands): 2019 $ 2,759 2020 2,759 2021 2,759 Total future minimum manufacturing and supply agreement payments $ 8,277 |
Business (Details)
Business (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash and cash equivalents | $ 172,604 | $ 90,915 | $ 65,726 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) shares in Millions, $ in Millions | 12 Months Ended | |||
Dec. 31, 2018segmentshares | Dec. 31, 2017shares | Dec. 31, 2016shares | Jan. 01, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Potentially dilutive common shares related to the outstanding preferred stock, stock options, restricted stock units and warrants | shares | 14 | 13.6 | 10.7 | |
Number of operating segments (segment) | segment | 1 | |||
Minimum [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful lives of the assets | 2 years | |||
Maximum [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful lives of the assets | 7 years | |||
Subsequent Event | Accounting Standards Update 2016-02 | ||||
Property, Plant and Equipment [Line Items] | ||||
Right-of-use asset | $ 16.8 | |||
Operating lease, liability | $ 31.8 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Concentration Risk) (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Net Product Sales | |
Concentration Risk [Line Items] | |
Concentration risk | 98.00% |
As of December 31, 2018 | |
Concentration Risk [Line Items] | |
Concentration risk | 98.00% |
Customer A | Net Product Sales | |
Concentration Risk [Line Items] | |
Concentration risk | 37.00% |
Customer A | As of December 31, 2018 | |
Concentration Risk [Line Items] | |
Concentration risk | 44.00% |
Customer B | Net Product Sales | |
Concentration Risk [Line Items] | |
Concentration risk | 31.00% |
Customer B | As of December 31, 2018 | |
Concentration Risk [Line Items] | |
Concentration risk | 28.00% |
Customer C | Net Product Sales | |
Concentration Risk [Line Items] | |
Concentration risk | 30.00% |
Customer C | As of December 31, 2018 | |
Concentration Risk [Line Items] | |
Concentration risk | 26.00% |
Balance Sheet Account Details_2
Balance Sheet Account Details (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Work in process | $ 1,907 | $ 0 |
Finished goods | 113 | 0 |
Total inventory, net | $ 2,020 | $ 0 |
Balance Sheet Account Details_3
Balance Sheet Account Details (Narrative) (Details) $ in Millions | Dec. 31, 2018USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inventory reserves | $ 0.8 |
Balance Sheet Account Details_4
Balance Sheet Account Details (Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 28,153 | $ 26,803 |
Accumulated depreciation and amortization | (5,886) | (2,235) |
Total property and equipment, net | 22,267 | 24,568 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 9,047 | 7,812 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 2,573 | 2,282 |
Computer hardware | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 1,296 | 1,238 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 733 | 619 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 14,504 | $ 14,852 |
Balance Sheet Account Details_5
Balance Sheet Account Details (Accrued Expenses) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued interest expense | $ 6,763 | $ 0 |
Accrued clinical trials | 2,430 | 577 |
Accrued manufacturing costs | 1,823 | 0 |
Accrued other | 1,972 | 126 |
Total accrued expenses | $ 12,988 | $ 703 |
Restructuring (Details)
Restructuring (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring charges | $ 4 |
Reversal of non-cash-stock-based compensation expense | 3.7 |
Payments for restructuring | 5.4 |
Restructuring costs | 7.7 |
Research and development [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring charges | 1.6 |
Selling, General and Administrative Expenses [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring charges | 2.4 |
Employee Severance | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring charges | 7.7 |
Accrued Payroll | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring charges | $ 2.3 |
Licensed Technology (Narrative)
Licensed Technology (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and Development Expense (Excluding Acquired in Process Cost) | $ 0.7 | $ 1.6 | $ 0.5 |
GeorgeWashington [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and Development Expense (Excluding Acquired in Process Cost) | 0.5 | ||
Inserm [Member] [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and Development Expense (Excluding Acquired in Process Cost) | $ 3.7 |
Contract Revenue - Related Pa_2
Contract Revenue - Related Party (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |||
Term of written notice for termination of agreement | 60 days | ||
Contract revenue - related party | $ 0 | $ 0 | $ 616,000 |
Shareholders_ Equity (Narrative
Shareholders’ Equity (Narrative) (Details) | 1 Months Ended | 3 Months Ended | 4 Months Ended | 12 Months Ended | ||||||||||||||
Jul. 31, 2018USD ($)shares | Mar. 31, 2018USD ($)$ / sharesshares | Aug. 31, 2017shares | Mar. 31, 2017USD ($)$ / sharesshares | Feb. 28, 2017consultantshares | Jan. 31, 2017shares | Dec. 31, 2016shares | Sep. 30, 2016shares | Jan. 31, 2016shares | Dec. 31, 2014partyshares | Sep. 30, 2013employeeshares | Dec. 31, 2016shares | Nov. 30, 2015consultantshares | Dec. 31, 2018USD ($)series$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Jan. 31, 2019shares | Jul. 31, 2015shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized (in shares) | 8,000,000 | |||||||||||||||||
Preferred stock, par value (usd per share) | $ / shares | $ 0.0001 | |||||||||||||||||
Weighted-average grant date fair values of stock options granted (in dollars per share) | $ / shares | $ 20.52 | $ 23.80 | $ 15.33 | |||||||||||||||
Unamortized share-based compensation expense | $ | $ 64,500,000 | |||||||||||||||||
Recognized weighted average period | 2 years 8 months 50 days | |||||||||||||||||
Stock options exercised (in shares) | 106,370 | 174,628 | 17,548 | |||||||||||||||
Intrinsic value of stock options exercised | $ | $ 1,400,000 | $ 3,300,000 | $ 100,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ | 38,000,000 | 12,100,000 | 14,500,000 | |||||||||||||||
Warrants granted to purchase common stock (in shares) | 51,000 | |||||||||||||||||
Warrants issued, number of third party recipients (party) | party | 2 | |||||||||||||||||
Third party share-based compensation expense | $ | 600,000 | 200,000 | ||||||||||||||||
Share-based compensation expense | $ | $ 35,151,000 | $ 21,795,000 | $ 14,546,000 | |||||||||||||||
Restricted Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares of unvested stock awards (in shares) | 1,072,899 | 1,072,899 | 0 | 542,680 | 1,072,899 | |||||||||||||
Vested awards (in shares) | 542,680 | 530,219 | ||||||||||||||||
Grant One [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Warrant vesting period | 4 years | |||||||||||||||||
Chief Executive Officer [Member] | Restricted Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares of unvested stock awards (in shares) | 1,042,680 | |||||||||||||||||
Accelerated shares (in shares) | 500,000 | |||||||||||||||||
Vested awards (in shares) | 542,680 | |||||||||||||||||
One-year Anniversary Date of Grant [Member] | Grant One [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Warrant vesting rights percentage | 25.00% | |||||||||||||||||
One-year Anniversary Date of Grant [Member] | Grant Two [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Warrant vesting rights percentage | 100.00% | 100.00% | 100.00% | |||||||||||||||
2013 Equity Plan [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Equity plan, term | 10 years | |||||||||||||||||
Period of share-based payment awards | 4 years | |||||||||||||||||
Shares of common stock authorized for issuance (in shares) | 4,600,000 | 4,600,000 | 8,100,000 | 4,600,000 | ||||||||||||||
Shares available for grant (in shares) | 1,340,450 | |||||||||||||||||
2013 Equity Plan [Member] | Director [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 1 year | |||||||||||||||||
2013 Equity Plan [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 2 years | 1 year | ||||||||||||||||
Award vesting rights, percentage | 25.00% | |||||||||||||||||
Stock options granted (in shares) | 42,000 | |||||||||||||||||
Share-based compensation expense | $ | $ 300,000 | $ 400,000 | ||||||||||||||||
Number of award recipients (consultant/employee) | consultant | 3 | |||||||||||||||||
Number of stock options (option) | 2 | |||||||||||||||||
Number of modified stock options (option) | 2 | |||||||||||||||||
2013 Equity Plan [Member] | Consultant [Member] | Performance Shares [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Stock options granted (in shares) | 50,000 | |||||||||||||||||
Share-based compensation expense | $ | $ (100,000) | |||||||||||||||||
Number of award recipients (consultant/employee) | consultant | 2 | |||||||||||||||||
Performance achievement percent | 75.00% | |||||||||||||||||
Percentage of options canceled | 25.00% | |||||||||||||||||
2013 Equity Plan [Member] | One-year Anniversary Date of Grant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Award vesting rights, percentage | 25.00% | |||||||||||||||||
2013 Equity Plan [Member] | Share-based Compensation Award, Tranche One [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 3 years | |||||||||||||||||
2013 Equity Plan [Member] | Share-based Compensation Award, Tranche Two [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 2 years | |||||||||||||||||
2018 Employee Stock Purchase Plan [Member] | Employee Stock Option [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares available for grant (in shares) | 750,000 | 717,701 | ||||||||||||||||
Maximum number of shares per employee | $ | $ 25,000 | |||||||||||||||||
Percent of employee's annual cash compensation | 10.00% | |||||||||||||||||
Purchase price of common stock, percent | 85.00% | |||||||||||||||||
Share-based compensation expense | $ | $ 200,000 | |||||||||||||||||
Common Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares of common stock issued (in shares) | 43,056 | 3,910,000 | 3,731,000 | |||||||||||||||
Class Of Warrant Or Right, Exercised During The Period | 83,013 | |||||||||||||||||
Class of Warrant or Right, Outstanding | 10,000 | |||||||||||||||||
Stock options exercised (in shares) | 150,000 | 175,000 | 17,000 | |||||||||||||||
Common Stock [Member] | Director [Member] | Restricted Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares of common stock issued (in shares) | 79,622 | |||||||||||||||||
Common Stock [Member] | Chief Executive Officer [Member] | Restricted Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares of common stock issued (in shares) | 1,327,048 | |||||||||||||||||
Common Stock [Member] | Employees [Member] | Restricted Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares of common stock issued (in shares) | 336,185 | |||||||||||||||||
Number of award recipients (consultant/employee) | employee | 3 | |||||||||||||||||
Series C-1 Convertible Preferred Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized (in shares) | 11,000 | 11,000 | ||||||||||||||||
Preferred stock, par value (usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||
Shares issued upon conversion, per share (in shares) | 1,724 | |||||||||||||||||
Preferred stock, shares issued (in shares) | 3,906 | 3,906 | ||||||||||||||||
Preferred stock, shares outstanding (in shares) | 3,906 | 3,906 | ||||||||||||||||
Shares reserved for future issuance (in shares) | 6,735,378 | 6,735,378 | ||||||||||||||||
Liquidation preference per share (in dollars per share) | $ / shares | $ 1,000 | |||||||||||||||||
Liquidation preference | $ | $ 3,906,000 | $ 3,906,000 | ||||||||||||||||
Series F Preferred Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized (in shares) | 10,000 | 10,000 | ||||||||||||||||
Preferred stock, par value (usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||
Shares issued upon conversion, per share (in shares) | 286 | |||||||||||||||||
Preferred stock, shares issued (in shares) | 2,737 | 2,737 | ||||||||||||||||
Preferred stock, shares outstanding (in shares) | 2,737 | 2,737 | ||||||||||||||||
Shares reserved for future issuance (in shares) | 782,031 | 782,032 | ||||||||||||||||
Liquidation preference per share (in dollars per share) | $ / shares | $ 1,000 | |||||||||||||||||
Liquidation preference | $ | $ 2,737,000 | $ 2,737,000 | ||||||||||||||||
Common Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Warrant granted to purchase common stock (in shares) | 25,013 | 17,000 | ||||||||||||||||
Common Stock [Member] | 2013 Equity Plan [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Award vesting rights, percentage | 25.00% | |||||||||||||||||
Stock options granted (in shares) | 35,000 | |||||||||||||||||
Common Stock [Member] | 2013 Equity Plan [Member] | Share-based Compensation Award, Tranche One [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 1 year | |||||||||||||||||
Common Stock [Member] | 2013 Equity Plan [Member] | Share-based Compensation Award, Tranche Two [Member] | Consultant [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Period of share-based payment awards | 3 years | |||||||||||||||||
Minimum [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of series (series) | series | 1 | |||||||||||||||||
Underwriting Agreement [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares of common stock to be issued and sold in underwriting agreement (in shares) | 3,910,000 | 3,731,344 | ||||||||||||||||
Price per share of shares sold (usd per share) | $ / shares | $ 29.50 | $ 33.50 | ||||||||||||||||
Proceeds from the underwriting agreement, including additional shares sold, gross | $ | $ 115,300,000 | $ 125,000,000 | ||||||||||||||||
Proceeds from the underwriting agreement, including additional shares sold, net of cost | $ | 109,800,000 | 117,500,000 | ||||||||||||||||
Issuance costs | $ | $ 5,500,000 | $ 7,500,000 | ||||||||||||||||
Subsequent Event | Common Stock [Member] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Shares issued upon conversion, per share (in shares) | 782,031 |
Shareholders_ Equity (Stock Opt
Shareholders’ Equity (Stock Option and Restricted Stock Award Activity) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares Underlying Stock Options | |||
Outstanding beginning balance, Shares underlying stock options and restricted stock awards (in shares) | 6,037,302 | 2,627,462 | 2,318,685 |
Granted, Shares underlying stock options and restricted stock awards (in shares) | 1,978,219 | 3,704,725 | 483,200 |
Exercised, Shares underlying stock options and restricted stock awards (in shares) | (106,370) | (174,628) | (17,548) |
Forfeited, Shares underlying stock options and restricted stock awards (in shares) | (1,442,937) | (120,257) | (156,875) |
Outstanding ending balance, Shares underlying stock options and restricted stock awards (in shares) | 6,466,214 | 6,037,302 | 2,627,462 |
Vested and expected to vest ending balance, Shares underlying stock options (in shares) | 6,466,214 | ||
Exercisable ending balance, Shares underlying stock options (in shares) | 3,118,365 | ||
Weighted- average Exercise Price per Share | |||
Outstanding beginning balance, Weighted - average exercise price (in dollars per share) | $ 24.19 | $ 21.07 | $ 22.01 |
Granted, Weighted - average exercise price (in dollars per share) | 23.66 | 25.94 | 17.83 |
Exercised, Weighted - average exercise price (in dollars per share) | 17.95 | 15.42 | 8.52 |
Forfeited, Weighted - average exercise price (in dollars per share) | 28.07 | 22.82 | 26.35 |
Outstanding ending balance, Weighted - average exercise price (in dollars per share) | 23.26 | $ 24.19 | $ 21.07 |
Vested and expected to vest ending balance, Weighted - average exercise price (in dollars per share) | 23.26 | ||
Exercisable ending balance, Weighted - average exercise price (in dollars per share) | $ 22.61 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Outstanding ending balance, Weighted - average remaining contractual term (yrs) | 7 years 7 months 25 days | ||
Outstanding ending balance, Aggregate intrinsic value | $ 200,279 | ||
Vested and expected to vest ending balance, Weighted - average remaining contractual term (yrs) | 7 years 7 months 25 days | ||
Vested and expected to vest ending balance, Aggregate intrinsic value | $ 200,279 | ||
Exercisable ending balance, Weighted - average remaining contractual term (yrs) | 6 years 4 months | ||
Exercisable ending balance, Aggregate intrinsic value | $ 200,279 |
Shareholders_ Equity (Summary o
Shareholders’ Equity (Summary of Restricted Stock Awards) (Details) - Restricted Stock [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Beginning balance (in shares) | 542,680 | 1,072,899 |
Vested (in shares) | (542,680) | (530,219) |
Ending balance in shares (in shares) | 0 | 542,680 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Beginning balance (in usd per share) | $ 13.22 | $ 13 |
Vested (in usd per share) | 13.22 | 12.78 |
Ending balance (in usd per share) | $ 0 | $ 13.22 |
Shareholders_ Equity (Stock O_2
Shareholders’ Equity (Stock Options, Valuation Assumptions) (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Volatility | 114.00% | 139.00% | 143.00% |
Expected life (years) | 6 years 25 days | 6 years 1 month 15 days | 5 years 9 months 18 days |
Risk-free interest rate | 2.80% | 2.10% | 1.40% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Shareholders_ Equity (Share-bas
Shareholders’ Equity (Share-based Compensation Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 35,151 | $ 21,795 | $ 14,546 |
General and administrative [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 14,038 | 9,815 | 8,889 |
Warrant [Member] | Research and development [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 21,113 | $ 11,980 | $ 5,657 |
Deferred Royalty Obligation (De
Deferred Royalty Obligation (Details) - USD ($) | May 10, 2018 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Royalty obligation payable | $ 400,000 | |
HealthCare Royalty Partners | ||
Debt Instrument [Line Items] | ||
Proceeds from royalty agreement | $ 125,000,000 | |
Maximum potential royalty payout | 180.00% | |
Required payment for breach of agreement, payment one | $ 125,000,000 | |
Required payment for breach of agreement, payment two | 225,000,000 | |
HealthCare Royalty Partners | Loans Payable | Royalty Financing Agreement | ||
Debt Instrument [Line Items] | ||
Deferred royalty obligation, net | 125,000,000 | 124,300,000 |
Debt issuance costs | $ 700,000 | |
Interest expense | 7,300,000 | |
Unamortized debt discount | 700,000 | |
Accrued interest expense | 6,800,000 | |
Royalty payments | $ 500,000 | |
HealthCare Royalty Partners | Period One | ||
Debt Instrument [Line Items] | ||
Maximum potential royalty payout | 10.00% | |
HealthCare Royalty Partners | Period Two | ||
Debt Instrument [Line Items] | ||
Increase in maximum potential payout percent | 4.00% | |
HealthCare Royalty Partners | Payout Period | ||
Debt Instrument [Line Items] | ||
Increase in maximum potential payout percent | 4.00% |
Defined Contribution Plan (Narr
Defined Contribution Plan (Narrative) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | |||
Matching contributions made | $ 1.4 | $ 0.7 | $ 0.4 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Deferred royalty obligation | $ 31,937 | $ 0 |
Stock-based compensation | 11,904 | 6,744 |
Depreciation and amortization | 1,033 | 511 |
Other | 1,004 | 124 |
Deferred Tax Assets, Gross | 45,878 | 7,379 |
Valuation allowance | (45,878) | (7,379) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Provision for Inc
Income Taxes (Provision for Income Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory rate | $ (41,888) | $ (39,033) | $ (26,583) |
State tax benefit | (14,449) | 0 | 0 |
Research and development credits | (5,164) | (2,691) | (1,240) |
Foreign rate differential | (58) | 1,249 | 0 |
Change in valuation allowance | 55,167 | (35,246) | 25,091 |
Stock-based compensation | 4,041 | 2,253 | 0 |
Expired tax attributes | 1,936 | 2,228 | (5) |
Impact of the 2017 Tax Act | 0 | 71,199 | 0 |
Other permanent differences | 415 | 41 | 2,737 |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Line Items] | |||
Unrecognized tax benefits | $ 0 | $ 0 | |
Accrual for interest or penalties | 0 | 0 | |
Recognized interest and penalties | $ 0 | 0 | $ 0 |
Domestic Tax Authority [Member] | |||
Income Tax Disclosure [Line Items] | |||
Income tax net operating loss carryforwards | 560,200,000 | ||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||
Income Tax Disclosure [Line Items] | |||
California research and development tax credit carryforwards | 24,600,000 | ||
State and Local Jurisdiction [Member] | |||
Income Tax Disclosure [Line Items] | |||
Income tax net operating loss carryforwards | 341,000,000 | ||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||
Income Tax Disclosure [Line Items] | |||
California research and development tax credit carryforwards | $ 15,400,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Narrative) (Details) - USD ($) | 12 Months Ended | 24 Months Ended | 60 Months Ended | |||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2021 | Oct. 30, 2021 | Oct. 30, 2019 | Dec. 29, 2016 | |
Property Subject to or Available for Operating Lease [Line Items] | ||||||||
Asset pledged as collateral | $ 900,000 | $ 900,000 | ||||||
Deferred rent | $ 13,700,000 | |||||||
Rent expense | 2,800,000 | $ 1,700,000 | $ 1,100,000 | |||||
4550 Towne Centre Court, San Diego, California [Member] | ||||||||
Property Subject to or Available for Operating Lease [Line Items] | ||||||||
Term of lease agreement | 10 years | |||||||
Term for option to extend lease agreement | 5 years | |||||||
4550 Towne Centre Court, San Diego, California [Member] | Letter of Credit [Member] | ||||||||
Property Subject to or Available for Operating Lease [Line Items] | ||||||||
Past term of contract | 2 years | |||||||
4550 Towne Centre Court, San Diego, California [Member] | Letter of Credit [Member] | Scenario, Forecast [Member] | ||||||||
Property Subject to or Available for Operating Lease [Line Items] | ||||||||
Security deposit | $ 303,000 | $ 606,000 | ||||||
Past term of contract | 5 years | |||||||
Financial Standby Letter of Credit [Member] | 4550 Towne Centre Court, San Diego, California [Member] | Letter of Credit [Member] | ||||||||
Property Subject to or Available for Operating Lease [Line Items] | ||||||||
Stand by letter of credit | $ 900,000 | $ 900,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Annual Future Minimum Payments Under Operating Leases) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 3,951 |
2,020 | 4,070 |
2,021 | 4,192 |
2,022 | 4,318 |
2,023 | 4,447 |
Thereafter | 18,308 |
Total future minimum lease payments | $ 39,286 |
Commitments and Contingencies_4
Commitments and Contingencies (Annual Future Minimum Licensing Payments) (Details) - Licensing Agreements [Member] $ in Thousands | Dec. 31, 2018USD ($) |
Unrecorded Unconditional Purchase Obligation [Line Items] | |
2,019 | $ 120 |
2,020 | 120 |
2,021 | 120 |
2,022 | 120 |
2,023 | 120 |
Total future minimum license payments | $ 600 |
Commitments and Contingencies_5
Commitments and Contingencies (Annual Future Minimum Payments for Manufacturing and Supply Agreements) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 2,759 |
2,020 | 2,759 |
2,021 | 2,759 |
Total future minimum manufacturing and supply agreement payments | $ 8,277 |
Uncategorized Items - ljpc-2018
Label | Element | Value |
Restricted Cash, Noncurrent | us-gaap_RestrictedCashNoncurrent | $ 0 |
Restricted Cash, Noncurrent | us-gaap_RestrictedCashNoncurrent | 909,000 |
Restricted Cash, Noncurrent | us-gaap_RestrictedCashNoncurrent | 909,000 |
Restricted Cash, Current | us-gaap_RestrictedCashCurrent | 200,000 |
Restricted Cash, Current | us-gaap_RestrictedCashCurrent | 0 |
Restricted Cash, Current | us-gaap_RestrictedCashCurrent | $ 0 |