Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 12, 2020 | Jun. 30, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Transition Report | false | ||
Entity File Number | 000-50679 | ||
Entity Registrant Name | CORCEPT THERAPEUTICS INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 77-0487658 | ||
Entity Address, Address Line One | 149 Commonwealth Drive | ||
Entity Address, City or Town | Menlo Park | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94025 | ||
City Area Code | 650 | ||
Local Phone Number | 327-3270 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,071,264,355 | ||
Entity Common Stock, Shares Outstanding | 114,594,745 | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive proxy statement for its 2020 Annual Meeting of Stockholders are incorporated by reference in Items 10, 11, 12, 13 and 14 of Part III. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CORT | ||
Entity Central Index Key | 0001088856 | ||
Current Fiscal Year End Date | --12-31 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 31,269 | $ 41,625 |
Short-term marketable securities | 244,693 | 165,135 |
Trade receivables, net of allowances | 19,928 | 17,588 |
Inventory | 5,424 | 4,732 |
Prepaid expenses and other current assets | 6,044 | 7,740 |
Total current assets | 307,358 | 236,820 |
Strategic inventory | 11,981 | 11,510 |
Operating lease right-of-use asset | 3,446 | |
Property and equipment, net of accumulated depreciation | 1,050 | 655 |
Long-term marketable securities | 39,352 | 0 |
Other assets | 3,448 | 50 |
Deferred tax assets, net | 45,677 | 62,659 |
Total assets | 412,312 | 311,694 |
Current liabilities: | ||
Accounts payable | 7,537 | 8,266 |
Accrued clinical expenses | 6,477 | 3,521 |
Accrued and other liabilities | 23,269 | 23,786 |
Short-term operating lease liability | 1,558 | |
Total current liabilities | 38,841 | 35,573 |
Long-term operating lease liability | 1,903 | |
Long-term accrued income taxes | 386 | 239 |
Total liabilities | 41,130 | 35,812 |
Commitments and contingencies (Note 10) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.001 per share, 10,000 shares authorized and no shares outstanding at December 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, par value $0.001 per share, 280,000 shares authorized and 119,767 issued and 114,549 outstanding at December 31, 2019 and 116,838 shares issued and 115,031 outstanding at December 31, 2018 | 120 | 117 |
Treasury stock; at cost; 5,218 shares of common stock at December 31, 2019 and 1,807 shares of common stock at December 31, 2018 | (62,704) | (23,657) |
Additional paid-in capital | 457,060 | 417,228 |
Accumulated other comprehensive gain (loss) | 261 | (70) |
Accumulated deficit | (23,555) | (117,736) |
Total stockholders’ equity | 371,182 | 275,882 |
Total liabilities and stockholders’ equity | $ 412,312 | $ 311,694 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 280,000,000 | 280,000,000 |
Common stock, shares issued (in shares) | 119,767,000 | 116,838,000 |
Common stock, shares outstanding (in shares) | 114,549,000 | 115,031,000 |
Treasury stock, shares (in shares) | 5,218,000 | 1,807,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | |||
Product revenue, net | $ 306,486 | $ 251,247 | $ 159,201 |
Operating expenses: | |||
Cost of sales | 5,504 | 5,215 | 3,554 |
Research and development | 89,017 | 75,247 | 40,376 |
Selling, general and administrative | 100,359 | 81,289 | 62,416 |
Total operating expenses | 194,880 | 161,751 | 106,346 |
Income from operations | 111,606 | 89,496 | 52,855 |
Interest and other income (expense), net | 5,070 | 2,657 | (49) |
Income before income taxes | 116,676 | 92,153 | 52,806 |
Income tax expense (benefit) | 22,495 | 16,743 | (76,316) |
Net income | 94,181 | 75,410 | 129,122 |
Other comprehensive income (loss): | |||
Net unrealized gain (loss) on available-for-sale investments, net of tax impact of $(104), $22 and $0, respectively | 327 | 5 | (75) |
Foreign currency translation gain, net of tax | 4 | ||
Total comprehensive income | $ 94,512 | $ 75,415 | $ 129,047 |
Basic net income per share (in dollars per share) | $ 0.82 | $ 0.65 | $ 1.14 |
Diluted net income per share (in dollars per share) | $ 0.77 | $ 0.60 | $ 1.04 |
Weighted average shares outstanding used in computing net income per share | |||
Basic (in shares) | 114,349 | 115,343 | 113,527 |
Diluted (in shares) | 122,566 | 126,688 | 124,515 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | |||
Net unrealized gain (loss) on available-for-sale investments, tax | $ (104) | $ 22 | $ 0 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net income | $ 94,181,000 | $ 75,410,000 | $ 129,122,000 |
Adjustments to reconcile net income to net cash provided by operations: | |||
Stock-based compensation | 29,313,000 | 23,747,000 | 13,361,000 |
Accretion of interest (income) expense | (1,738,000) | (1,721,000) | 456,000 |
Depreciation and amortization of property and equipment | 0 | 0 | 14,000 |
Amortization of debt financing costs | 16,877,000 | 14,067,000 | (76,703,000) |
Deferred income taxes | 0 | 0 | 293,000 |
Excess tax benefits from stock option activity | 703,000 | 236,000 | 106,000 |
Amortization of right-of-use asset | 1,468,000 | ||
Changes in operating assets and liabilities: | |||
Trade receivables | (2,340,000) | (2,288,000) | (5,440,000) |
Other receivable | 0 | 12,896,000 | (12,896,000) |
Inventory | (1,044,000) | (7,779,000) | (2,262,000) |
Prepaid expenses and other current assets | 1,696,000 | (5,071,000) | (705,000) |
Other assets | (3,398,000) | 0 | (26,000) |
Accounts payable | (735,000) | (389,000) | 6,289,000 |
Accrued clinical expenses | 2,956,000 | 1,274,000 | 780,000 |
Accrued and other liabilities | (517,000) | 5,044,000 | 8,546,000 |
Long-term accrued income taxes | 147,000 | 239,000 | 0 |
Operating lease liability | (1,452,000) | 0 | 0 |
Net cash provided by operating activities | 136,117,000 | 115,665,000 | 60,935,000 |
Cash flows from investing activities: | |||
Purchases of property and equipment | (1,088,000) | (298,000) | (419,000) |
Proceeds from maturities of marketable securities | 182,295,000 | 142,655,000 | 29,950,000 |
Purchases of marketable securities | (299,035,000) | (233,124,000) | (102,987,000) |
Net cash used in investing activities | (117,828,000) | (90,767,000) | (73,456,000) |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options, net of issuance costs | 8,419,000 | 9,322,000 | 7,181,000 |
Repurchase of common stock | (30,975,000) | (23,657,000) | 0 |
Payments related to debt obligation | 0 | 0 | (15,134,000) |
Cash paid to satisfy statutory withholding requirement for the net settlement of cashless option exercise | (6,089,000) | ||
Net cash used in financing activities | (28,645,000) | (14,335,000) | (7,953,000) |
Net increase (decrease) in cash and cash equivalents | (10,356,000) | 10,563,000 | (20,474,000) |
Cash and cash equivalents, at beginning of period | 41,625,000 | 31,062,000 | 51,536,000 |
Cash and cash equivalents, at end of period | 31,269,000 | 41,625,000 | 31,062,000 |
Supplemental disclosure: | |||
Income taxes paid | 6,744,000 | 1,351,000 | 377,000 |
Cost of shares repurchased for net settlement of cashless option exercise | 1,983,000 | $ 0 | $ 0 |
Recognition of right-of-use asset and lease liability | $ 4,913,000 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Employees and Directors | Non-employee | Common Stock | Additional Paid-in Capital | Additional Paid-in CapitalEmployees and Directors | Additional Paid-in CapitalNon-employee | Treasury Stock | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2016 | 112,710 | |||||||||
Beginning balance at Dec. 31, 2016 | $ 41,379 | $ 113 | $ 363,534 | $ 0 | $ 0 | $ (322,268) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Issuance of common stock upon exercise of options (in shares) | 2,007 | 2,007 | ||||||||
Issuance of common stock upon exercise of options | $ 7,181 | $ 2 | 7,179 | |||||||
Stock-based compensation related to employee and director options | $ 13,330 | $ 31 | $ 13,330 | $ 31 | ||||||
Other comprehensive loss, net of tax | (75) | (75) | ||||||||
Net income | 129,122 | 129,122 | ||||||||
Ending balance at Dec. 31, 2017 | $ 190,968 | $ 115 | 384,074 | 0 | (75) | (193,146) | ||||
Ending balance (in shares) at Dec. 31, 2017 | 114,717 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Issuance of common stock upon exercise of options (in shares) | 2,121 | 2,121 | ||||||||
Issuance of common stock upon exercise of options | $ 9,322 | $ 2 | 9,320 | |||||||
Stock-based compensation related to employee and director options | 23,834 | 23,834 | ||||||||
Other comprehensive loss, net of tax | 5 | 5 | ||||||||
Purchases of treasury stock (in shares) | (1,807) | |||||||||
Purchase of treasury stock | (23,657) | (23,657) | ||||||||
Net income | 75,410 | 75,410 | ||||||||
Ending balance at Dec. 31, 2018 | $ 275,882 | $ 117 | 417,228 | (23,657) | (70) | (117,736) | ||||
Ending balance (in shares) at Dec. 31, 2018 | 115,031 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Issuance of common stock upon exercise of options (in shares) | 2,929 | 2,929 | ||||||||
Issuance of common stock upon exercise of options | $ 10,402 | $ 3 | 10,399 | |||||||
Shares tendered to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises (in shares) | (631) | |||||||||
Shares tendered to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (8,072) | (8,072) | ||||||||
Stock-based compensation related to employee and director options | $ 29,201 | $ 232 | $ 29,201 | $ 232 | ||||||
Other comprehensive loss, net of tax | 331 | 331 | ||||||||
Purchases of treasury stock (in shares) | (2,780) | |||||||||
Purchase of treasury stock | (30,975) | (30,975) | ||||||||
Net income | 94,181 | 94,181 | ||||||||
Ending balance at Dec. 31, 2019 | $ 371,182 | $ 120 | $ 457,060 | $ (62,704) | $ 261 | $ (23,555) | ||||
Ending balance (in shares) at Dec. 31, 2019 | 114,549 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Description of Business and Basis of Presentation Corcept Therapeutics Incorporated is a commercial-stage pharmaceutical company engaged in the discovery and development of medications that treat severe metabolic, oncologic and psychiatric disorders by modulating the effect of the hormone cortisol. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Korlym ® (“mifepristone”) 300 mg tablets, as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. We have discovered and patented four structurally distinct series of selective cortisol modulators, consisting of more than 500 compounds. We are developing compounds from these series as potential treatments for a broad range of serious disorders. We were incorporated in the State of Delaware in May 1998 . Our headquarters are located in Menlo Park, California. Basis of Presentation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Principles of Consolidation Our consolidated financial statements include the financial position and results of operations of Corcept Therapeutics UK Limited, our wholly owned subsidiary, which we incorporated in the United Kingdom in March 2017. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. We reevaluate our estimates and assumptions each quarter, including those related to revenue recognition, recognition and measurement of income tax assets and liabilities, inventory, allowances for doubtful accounts and other accrued liabilities, including our bonus accrual, clinical trial accruals and stock-based compensation. Fair Value Measurements We value financial instruments using assumptions we believe third-party market participants would use. When choosing which assumptions to make when determining the value of a financial instrument, we look first for quoted prices in active markets for identical instruments (“Level 1 inputs”). If no Level 1 inputs are available, we consider (i) quoted prices in non-active markets for identical instruments; (ii) active markets for similar instruments; (iii) inputs other than quoted prices for the instrument; and (iv) inputs that are not directly observable, but that can be corroborated by observable data (“Level 2 inputs”). In the absence of Level 2 inputs, we rely on unobservable inputs, such as our estimates of the assumptions market participants would use in pricing the instrument (“Level 3 inputs”). Cash and Cash Equivalents and Marketable Securities We consider highly liquid investments that will mature in three months or less from the time we purchase them to be cash equivalents. Cash equivalents are valued using Level 1 inputs, which approximate our cost. We invest the majority of our funds in marketable securities, primarily corporate notes, U.S. Treasury securities, asset-backed securities, commercial paper and repurchase agreements. We classify our marketable securities as available-for-sale securities and report them at fair value as “cash equivalents” or “marketable securities” on our consolidated balance sheet, with related unrealized gains and losses included in stockholders' equity. Realized gains and losses and permanent declines in value are included in “interest and other income (expense)” on our consolidated statement of comprehensive income. Credit and Concentration Risks Our cash, cash equivalents and marketable securities are held in one financial institution. We are subject to credit risk from our cash equivalents and marketable securities. We limit our investments to U.S. Treasury obligations and high-grade corporate debt, asset-backed securities and repurchase agreements with less than a 36-month maturity at the time of purchase. These investments are diversified and do not expose us to concentrations of credit risk. We have never experienced a loss in, or lack of access to, our operating or investment accounts. We have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym - Produits Chimiques Auxiliaires et de Synthèse SA (PCAS). If PCAS is unable or unwilling to manufacture API in the amounts and time frames required, we may not be able to manufacture Korlym in a timely manner. In order to mitigate this risk, we have purchased and hold in inventory a reserve quantity of mifepristone API. We have a concentration of risk in regard to the distribution of our product. A single specialty pharmacy, Optime Care, Inc. (“Optime”), dispenses Korlym to patients for us. Optime is an independent third party. Its unwillingness or inability to dispense Korlym to patients in a timely manner would harm our business. We sell the Korlym that Optime dispenses directly to patients, with title to the medicine passing directly from us to the patient upon the patient’s receipt of the drug. Our receivables risk is spread among various third-party payers - pharmacy benefit managers, insurance companies, government programs and private charities. We extend credit to third-party payers based on their creditworthiness. We monitor our exposure and record an allowance against uncollectible trade receivables as necessary. To date, we have not incurred any credit losses. Inventory and Cost of Sales Regulatory approval of product candidates is uncertain. Because product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained, we record the cost of manufacturing our product candidates as research and development expenses at the time such costs are incurred. We capitalize to inventory manufacturing costs related to Korlym. We value inventory at the lower of cost or net realizable value and determine the cost of inventory we sell using the specific identification method, which approximates a first-in, first-out basis. We assess our inventory levels at each reporting period and write down inventory that is either expected to be at risk of expiration prior to sale, or has a cost basis in excess of its expected net realizable value, or for which there are inventory quantities in excess of expected requirements. We destroy expired inventory and recognize the related costs as cost of sales in that period’s statement of comprehensive income. Cost of sales also includes the cost of manufacturing Korlym, including materials, third-party manufacturing costs and indirect personnel and other overhead costs, based on the number of Korlym tablets for which we recognize revenue, as well as costs of stability testing, logistics and distribution. We classify inventory we do not expect to sell or use in clinical studies within 12 months of the balance sheet date as strategic inventory, a non-current asset. Net Product Revenue We sell Korlym directly to patients through a single specialty pharmacy. We also sell Korlym to a specialty distributor (“SD”), for which we recognize revenue at the time the SD receives Korlym. SD sales were less than one percent of our net revenue in the years ended December 31, 2019 and December 31, 2018 . To determine our revenue from the sale of Korlym, we (i) identify our contract with each customer; (ii) identify the obligations of Corcept and the customer under the contract; (iii) determine the contracted transaction price; (iv) allocate the transaction price to the contract’s performance obligations, which in our case consists of delivering Korlym to the customer; and (v) recognize revenue once Korlym has been delivered, provided we deem it probable that we will collect the payment due to us. Confirmation of coverage by private or government insurance or by a third-party charity is a prerequisite for selling Korlym to a patient. To determine net product revenue, we deduct from sales the cost of our patient co-pay assistance program and our estimates of (a) government chargebacks and rebates, (b) discounts provided to our SD for prompt payment and (c) reserves for expected Korlym returns. We record these estimates at the time we recognize revenue and update them as new information becomes available. Our estimates take into account our understanding of the range of possible outcomes. If results differ from our estimates, we adjust our estimates, causing a change to our net product revenue and earnings. We report any changes in the period they become known, even if they concern transactions occurring in prior periods. Government Rebates: Korlym is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other government programs that are eligible for rebates on the price they pay for Korlym. To determine the appropriate amount to reserve against these rebates, we identify Korlym sold to patients covered by government-funded programs, apply the applicable government discount to these sales, then estimate the portion of total rebates we expect will be claimed. Chargebacks . Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. As it makes such sales, SD recovers the full amount of any related discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym purchased by the SD in prior periods. We deduct from our revenue in each period chargebacks claimed by the SD for Korlym it purchased in that period. We also create each period a reserve for chargebacks we estimate the SD will claim in future periods against Korlym it has not yet resold. We determine the amount of this reserve based on our experience with SD chargebacks and our understanding of the SD’s customer base and business practices. We then deduct this reserve from revenue and include in accrued expenses on our consolidated balance sheet a current liability of equal amount. Patient Assistance Program and Charitable Support: It is our policy that no patient be denied Korlym due to inability to pay. We provide financial assistance to eligible patients whose insurance policies have high deductibles or co-payments and deduct the amount of such assistance from gross revenue. We determine the assistance we provide each patient by applying our program guidelines to that patient’s financial position and their insurance policy’s co-payment and deductible requirements for the purchase of Korlym. We donate cash to charities that help patients with financial need pay for the treatment of Cushing’s syndrome. We do not include payments from these charities in revenue. We provide Korlym at no cost to uninsured patients who do not qualify for charitable support. Sales Returns : Federal law prohibits the return of Korlym sold to patients. Sales to our SD are subject to return. We deduct the amount of Korlym we estimate the SD will return from each period’s gross revenue. We base our estimates on quantitative and qualitative information including, but not limited to, historical return rates, the amount of Korlym held by the SD and projected demand. If we cannot reasonably estimate returns with respect to a particular sale, we defer recognition of revenue until we can make a reasonable estimate. To date, returns have not been significant. The following table summarizes activity in each of the product revenue allowance and reserve categories for the year ended December 31, 2019: Chargebacks Government Rebates Total (in thousands) Balance at December 31, 2016: $ 468 $ 3,427 $ 3,895 Provision recorded during the period 2,637 18,097 20,734 Credit or payments made during the period (2,178 ) (13,563 ) (15,741 ) Balance at December 31, 2017: 927 7,961 8,888 Provision related to current period sales 2,687 28,628 31,315 Provision related to prior period sales — 532 532 Credit or payments made during the period (3,268 ) (25,988 ) (29,256 ) Balance at December 31, 2018: 346 11,133 11,479 Provision related to current period sales 783 24,374 25,157 Provision related to prior period sales — (95 ) (95 ) Credit or payments made during the period (852 ) (27,203 ) (28,055 ) Balance at December 31, 2019: $ 277 $ 8,209 $ 8,486 Leases We adopted ASC Topic 842, effective January 1, 2019, using the modified retrospective method. The reported results for fiscal year 2019 reflect the application of ASC Topic 842, while the reported results for prior fiscal years are not adjusted and continue to be reported under ASC Topic 840. Refer to Recently Adopted Accounting Pronouncements regarding the adoption impact of ASC Topic 842 in the year ended December 31, 2019. We determine whether an arrangement contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. To determine whether a contract is or contains a lease, we consider all relevant facts and circumstances to assess whether the customer has the right to both (i) obtain substantially all of the economic benefits from use of the identified asset and (ii) direct the use of the identified asset. We recognize right-of-use assets and lease liabilities at lease commencement. We measure lease liabilities based on the present value of lease payments over the lease term discounted using the rate equal to the rate we would pay on a loan with monthly payments and a term equal to the monthly payments and remaining term of our lease. We estimate our incremental borrowing rate based on non-tender bank quotes and an analysis of public companies with debt and credit carrying terms similar to our lease term. We do not include in the lease term options to extend or terminate the lease unless it is reasonably certain at commencement that we will exercise any such options. We account for the lease components separately from non-lease components for our operating leases. We measure right-of-use assets based on the corresponding lease liabilities adjusted for (i) prepayments made to the lessor at or before the commencement date, (ii) initial direct costs we incur, and (iii) tenant incentives under the lease. We evaluate the recoverability of our right-of-use assets for possible impairment in accordance with our long-lived assets policy. We do not recognize right-of-use assets or lease liabilities for leases with a term of twelve months or less; rather, we recognize the associated lease payments in the consolidated statements of comprehensive income on a straight-line basis over the lease term. Operating leases are reflected on our consolidated balance sheets as operating lease right-of-use assets, short-term operating lease liabilities and long-term operating lease liabilities. We begin recognizing operating lease expense when the lessor makes the underlying asset available to us. We recognize operating lease expense under our operating leases on a straight-line basis. Variable lease payments are expensed as incurred. Research and Development Research and development expenses include the direct cost of discovering and screening new compounds, pre-clinical studies, clinical trials, manufacturing development, submissions to regulatory agencies and related overhead costs. We expense nonrefundable payments and the cost of technologies and materials used in research and development as we incur them. We base our accruals for discovery research, preclinical studies and clinical trials on our estimates of work completed, milestones achieved, patient enrollment and past experience with similar activities. Our estimates include assessments of information from contract research organizations and the status of our own research, development and administrative activities. Segment Reporting We determine our operating segments based on the way we organize our business, make decisions and assess performance. We have only one operating segment, which is the discovery, development and commercialization of pharmaceutical products. Stock-Based Compensation We account for stock-based compensation under the fair value method, based on the value of the award at the grant date. To date, our stock-based compensation has consisted entirely of option grants, which we value using the Black-Scholes model. We recognize stock-based compensation expense over the applicable vesting period, net of estimated forfeitures. If actual forfeitures differ from our estimates, we adjust stock-based compensation expense accordingly. We recognize the expense of options granted to non-employees based on their fair value at the time of vesting. Income Taxes We account for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”), which requires recognition of deferred tax assets and liabilities for the expected tax consequences of our future financial and operating activities. Under ASC 740, we determine deferred tax assets and liabilities based on the temporary difference between the financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which we expect such differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income to realize the value of some or all of our deferred tax assets (net of our deferred tax liabilities), we establish a valuation allowance offsetting the amount we do not expect to realize. We perform this analysis each reporting period and reduce our measurement of deferred taxes, if the likelihood we will realize them becomes uncertain. The deferred tax assets we record each period depend primarily on our ability to generate future taxable income in the United States. Each period, we evaluate the need for a valuation allowance against our deferred tax assets and, if necessary, adjust the valuation allowance so that net deferred tax assets are recorded only to the extent we conclude it is more likely than not that these deferred tax assets will be realized. If our outlook for future taxable income changes significantly, our assessment of the need for, and the amount of, a valuation allowance may also change. We are also required to evaluate and quantify other sources of taxable income, such as the possible reversal of future deferred tax liabilities, should any arise, and the implementation of tax planning strategies. Evaluating and quantifying these amounts is difficult and involves significant judgment, based on all of the available evidence and assumptions about our future activities. We account for uncertain tax positions in accordance with ASC 740, which requires us to adjust our consolidated financial statements to reflect only those tax positions that are more-likely-than-not to be sustained upon review by federal or state examiners. We recognize in the consolidated financial statements the largest expected tax benefit that has a greater than 50 percent likelihood of being sustained on examination by the taxing authorities. We report interest and penalties related to unrecognized tax benefits as income tax expenses. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which requires lease transactions with terms longer than 12 months to be recognized on the balance sheet as a liability (“lease liabilities”), offset by an asset of equal amount (“right-of-use assets”). ASU No. 2016-02 supersedes the lease accounting requirements of ASC Topic 840, “Leases” and creates Topic 842, “Leases.” We adopted this standard on January 1, 2019, using the modified retrospective approach, which did not cause adjustments to prior comparative periods. We have reviewed all of our contracts that may contain leases and have determined that the only impact is to the accounting for our leased office space. We have applied the practical expedients in Topic 842 that allow us not to reassess lease classification for expired or existing lease contracts. On the date of adoption, we increased our “operating right-of-use assets" and “operating lease liability” by approximately $1.9 million , an amount equal to the present value of our expected payments over the remaining term of the lease. There was no change to our retained earnings. See Note 5 for more information regarding our leased office space and additional operating right-of-use assets capitalized after the date of adoption. In February 2018, the FASB issued ASU No. 2018-02, “Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income.” This standard allows companies to reclassify to retained earnings tax effects related to items that have been stranded in “accumulated other comprehensive income” as a result of the Tax Cuts and Jobs Act (the “Act”). A company that elects to reclassify these amounts must reclassify stranded tax effects related to the Act’s change in US federal tax rate for all items accounted for in “other comprehensive income.” These entities can also elect to reclassify other stranded effects that relate to the Act but do not directly relate to the change in the federal rate. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. We adopted this standard on January 1, 2019. It had no impact on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting,” which expands the scope of ASC 718 to include all share-based payment arrangements related to the acquisition of goods and services from nonemployees. This standard is effective for fiscal years and interim periods within those years beginning after December 15, 2018. We adopted this standard on January 1, 2019. It had no impact on our consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments,” which changes the methodology for measuring credit losses on financial instruments and when such losses are recorded. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurements (Topic 820),” which eliminates or modifies certain disclosure requirements for fair value measurements and requires disclosure of new information. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In August 2018, the FASB issued ASU No. 2018-15, “Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract,” which requires a customer that is a party to a cloud computing service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to recognize as deferred assets. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In December 2019, the FASB issued ASU 2019-12 (ASC Topic 740), “Simplifying the Accounting for Income Taxes”. This standard simplifies accounting for income taxes by removing certain exceptions to the general principles and amending existing guidance to improve consistent application. This standard will be effective for fiscal years, and interim periods within those years, beginning after December 15, 2021. Early adoption is permitted. We are in the process of assessing the impact of this standard on our consolidated financial statements. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Significant Agreements | Significant Agreements Commercial Agreements In August 2017, we entered into a distribution services agreement with an independent third party, Optime, to provide exclusive specialty pharmacy and patient services programs for Korlym beginning August 10, 2017. Under the terms of this agreement, Optime acts as the exclusive specialty pharmacy distributor of Korlym in the United States, subject to certain exceptions. Optime provides services related to pharmacy operations; patient intake, access and reimbursement; patient support; claims management and accounts receivable; and data and reporting. We provide Korlym to Optime, which it dispenses to patients. Optime does not purchase Korlym from us and it does not take title to the product. Title passes directly from us to the patient at the time the patient receives the medicine. The initial term of our agreement with Optime is five years , unless terminated earlier by us upon 90 days’ notice. The agreement contains additional customary termination provisions, representations, warranties and covenants. Subject to certain limitations, we have agreed to indemnify Optime for certain third-party claims related to the product, and we have each agreed to indemnify the other for certain breaches of representations, warranties, covenants and other specified matters. Manufacturing Agreements Related to Korlym We purchase all of our API for Korlym from PCAS. On July 25, 2018, we amended our agreement with PCAS to add a second manufacturing site and extend its term to December 31, 2021, with two one-year automatic renewals, unless either party provides 12 months advance written notice of its intent not to renew. The amendment provides exclusivity between PCAS and Corcept. In the event PCAS cannot meet our requirements, we may purchase API from another supplier. As of December 31, 2019, we had non-cancelable commitments to purchase $0.6 million worth of API from PCAS over the next 12 months. We have agreements with two third-party manufacturers to produce and bottle Korlym tablets. Research and Development Agreements Our clinical trials are conducted through the use of clinical research organizations (“CROs”). Our Phase 3 GRACE trial of relacorilant for the treatment of patients with Cushing’s syndrome is being conducted under an agreement with ICON plc (“ICON”). IQVIA (formerly, "Novella Clinical LLC") is helping us conduct our Phase 2 trial of relacorilant to treat patients with metastatic ovarian cancer and our Phase 1/2 trial of exicorilant to treat patients with CRPC. Medpace, Inc. ("Medpace") is helping us conduct our Phase 2 trial testing miricorilant's activity in reversing recent antipsychotic-induced weight gain. Our agreements with ICON and IQVIA may be terminated by us on 60 days’ written notice or sooner if the parties mutually agree. Our agreement with Medpace may be terminated by us without cause at any time. In July 2019, we entered into clinical study agreements with Quotient Sciences for clinical research on CORT113176, miricorilant and exicorilant, with initial terms of less than one year, with no extensions. We may terminate any of these agreements early should the study data justify or require termination. As of December 31, 2019, we had non-cancelable purchase commitments of approximately $0.4 million from Quotient over the next 12 months. Lease Agreement See discussion below in Note 5, Leases |
Available-for-Sale Securities a
Available-for-Sale Securities and Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Available-for-sale securities and fair value measurements | Available for Sale Securities and Fair Value Measurements The available-for-sale securities in our Consolidated Balance Sheets are as follows: Year Ended December 31, 2019 2018 (in thousands) Cash equivalents $ 18,461 $ 27,075 Short-term marketable securities 244,693 165,135 Long-term marketable securities 39,352 — Total marketable securities $ 302,506 $ 192,210 The following table presents our available-for-sale securities grouped by asset type: Fair Value Hierarchy Level December 31, 2019 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value (in thousands) Corporate bonds Level 2 $ 109,780 $ 136 $ (6 ) $ 109,910 $ 54,513 $ 2 $ (46 ) $ 54,469 Commercial paper Level 2 41,237 — — 41,237 67,906 — — 67,906 Asset-backed securities Level 2 57,195 63 (5 ) 57,253 10,970 — (5 ) 10,965 Repurchase agreements Level 2 18,000 — — 18,000 15,000 — — 15,000 U.S. treasury securities Level 1 75,574 71 — 75,645 39,308 — (21 ) 39,287 Money market funds Level 1 461 — — 461 4,583 — — 4,583 Total Marketable securities $ 302,247 $ 270 $ (11 ) $ 302,506 $ 192,280 $ 2 $ (72 ) $ 192,210 We estimate the fair value of marketable securities classified as Level 1 using quoted market prices for these or similar investments obtained from a commercial pricing service. We estimate the fair value of marketable securities classified as Level 2 using inputs that may include benchmark yields, reported trades, broker/dealer quotes and issuer spreads. We do not intend to sell the investments that are currently in an unrealized loss position, and it is highly unlikely that we will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. As of December 31, 2019, all our marketable securities had original maturities of less than two years . The weighted-average maturity of our holdings was six months . As of December 31, 2019, our long-term marketable securities had remaining maturities ranging from 12 to 17 months . None of our marketable securities changed from one fair value hierarchy to another during the year ended December 31, 2019. |
Composition of Certain Balance
Composition of Certain Balance Sheet Items | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Certain Balance Sheet Items | Composition of Certain Balance Sheet Items Inventory Year Ended December 31, 2019 2018 (in thousands) Raw materials $ 1,389 $ 4,195 Work in progress 10,086 5,624 Finished goods 5,930 6,423 Total inventory 17,405 16,242 Less strategic inventory classified as non-current (11,981 ) (11,510 ) Total inventory classified as current $ 5,424 $ 4,732 Because we rely on a single manufacturer for the active pharmaceutical ingredient (“API”) for Korlym, we have purchased and hold significant quantities of API. We classify inventory we do not expect to sell within 12 months of the balance sheet date as “Strategic Inventory,” a long-term asset. Property and Equipment Year Ended December 31, 2019 2018 (in thousands) Furniture and equipment $ 304 $ 361 Software 1,541 884 Leasehold improvements 533 35 2,378 1,280 Less accumulated depreciation (1,328 ) (625 ) $ 1,050 $ 655 Accrued and other liabilities Year Ended December 31, 2019 2018 (in thousands) Government rebates $ 8,209 $ 11,132 Accrued compensation 12,331 7,879 Legal fees 1,087 314 Income taxes payable 472 1,542 Accrued selling and marketing costs 491 261 Professional fees 367 240 Accrued manufacturing costs 33 2,032 Other 279 386 Total accrued and other liabilities $ 23,269 $ 23,786 Other assets Other assets includes $3.3 million |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases We lease our office facilities in Menlo Park, California. On January 1, 2019, we recognized a right-of-use asset and a corresponding lease liability of $1.9 million . Effective October 1, 2019, we amended the lease to extend its term from March 31, 2020 through March 31, 2022 and to additional space beginning April 1, 2020. As a result of this amendment, we recognized an additional right-of-use asset and corresponding lease liability of $3.0 million . The right-of-use asset and lease liability recognized equals the present value of remaining payments due under our amended lease. As our operating lease does not provide an implicit interest rate, we calculated the present value of remaining lease payments using a discount rate equal to the interest rate we would pay on a loan with monthly payments and a term equal to the monthly payments and remaining term of our lease. We recognize operating lease payments as expenses using the straight-line method over the term of the lease. Operating lease expense for the year ended December 31, 2019 was approximately $1.5 million . Rent expense for the years ended December 31, 2018 and 2017 was $1.3 million and $1.1 million , respectively. For any future operating lease transactions, we will recognize operating lease right-of-use assets and liabilities equal to the present value of the expected lease payments at the lease commencement date. Our right-of-use assets and related lease liabilities were as follows: Year Ended December 31, 2019 (in thousands) Cash paid for operating lease liabilities $ 1,551 Right-of-use assets obtained in connection with operating lease obligations $ 4,913 Remaining lease term (years) 27 months Discount rate 5.0 % As of December 31, 2019, future minimum lease payments under non-cancelable operating leases were as follows: 2020 $ 1,997 2021 2,130 2022 535 4,662 Less imputed interest (1,201 ) Total lease liability $ 3,461 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions There were no related party transactions during the year ended December 31, 2019 . See discussion below in Note 7, Preferred Stock and Stockholders’ Equity , under the caption Common Stock |
Preferred Stock and Stockholder
Preferred Stock and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Preferred Stock and Stockholders' Equity | Preferred Stock and Stockholders’ Equity Preferred Stock Our Board of Directors is authorized, subject to any limitations prescribed by law, without stockholder approval, to issue up to an aggregate of 10,000,000 shares of preferred stock at $0.001 par value in one or more series and to fix the rights, preferences, privileges and restrictions granted to or imposed upon the preferred stock, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences. The rights of the holders of common stock will be subject to the rights of holders of any preferred stock that may be issued in the future. As of December 31, 2019 and 2018 , we had no outstanding shares of preferred stock. Common Stock Significant stock transactions On August 9, 2018, we announced a program to repurchase up to $100 million of our common stock (the “Stock Repurchase Program”). The terms of this program did not require us to acquire any shares and allowed for repurchases by a variety of methods, including in the open market, in block trades, through privately negotiated transactions, accelerated share repurchase transactions or any combination of such methods. The Stock Repurchase Program expired on June 30, 2019. During the year ended December 31, 2019, we repurchased 2.8 million shares of common stock under the Stock Repurchase Program in open market transactions at a cost of $31.0 million (average price of $11.14 per share). In total, we repurchased 4.6 million shares under the Stock Repurchase Program at a cost of $54.6 million (an average price of $11.91 per share). We recorded repurchased shares as treasury stock on our consolidated balance sheet, at cost. We have not decided whether repurchased shares will be retired or sold. During the year ended December 31, 2019, we issued 1.2 million shares as part of net-share settlements of cashless option exercises, of which 0.6 million shares were tendered to satisfy the related cost and statutory withholding requirements. We had no such transactions during the years ended December 31, 2018 and 2017 . We have never declared or paid any dividends. Shares of common stock reserved for future issuance as of December 31, 2019 are as follows: Common stock: (in thousands) Exercise of outstanding options 23,600 Shares available for grant under stock option plans 8,624 32,224 On February 7, 2020, our Board of Directors authorized an additional increase of 4.6 million shares in the number of shares available under the 2012 Equity Incentive Plan (the 2012 Plan), which was equivalent to 4% of the shares of our common stock outstanding at December 31, 2019. Stock Option Plans We have two active stock option plans at December 31, 2019 – the 2004 Equity Incentive Plan (the 2004 Plan) and the 2012 Plan. In 2004, our board of directors and stockholders approved the 2004 Plan, which became effective upon the completion of our initial public offering (IPO). Under the 2004 Plan, options, stock purchase and stock appreciation rights and restricted stock awards can be issued to our employees, officers, directors and consultants. The 2004 Plan provided that the exercise price for incentive stock options will be no less than 100% of the fair value of the Company’s common stock, as of the date of grant. Options granted under the 2004 Plan vest over periods ranging from one year to five years . The vesting period of the options is generally equivalent to the requisite service period. In 2012, our board of directors and stockholders approved the 2012 Plan. As of the effective date of the 2012 Plan, 5.3 million shares that remained available for issuance of new grants under the 2004 Plan were transferred to the 2012 Plan. After that date, no additional options were or will be issued under the 2004 Plan. Vested options under the 2004 Plan that are not exercised within the remaining contractual life and any options under the 2004 Plan that do not vest because of terminations after the effective date of the 2012 Plan will be added to the pool of shares available for future grants under the 2012 Plan. Under the 2012 Plan, we can issue options, stock purchase and stock appreciation rights and restricted stock awards to our employees, officers, directors and consultants. The 2012 Plan provides that the exercise price for incentive stock options will be no less than 100 percent of the fair value of our common stock as of the date of grant. Options granted under the 2012 Plan are expected to vest over periods ranging from one to four years . We assume the vesting period of the options that we grant under the 2012 Plan to be equal to the option grantee’s period of service. Upon exercise of options, new shares are issued. Option activity during 2017 , 2018 and 2019 The following table summarizes all activity under the 2004 Plan and the 2012 Plan: Outstanding Options Shares Available For Future Grant Options Shares Subject to Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life Aggregate Intrinsic Value (in thousands) (in thousands) (in years) (in thousands) Balance at December 31, 2016 7,920 17,663 $ 3.63 Increase in shares authorized for grant 4,508 — Shares granted (5,282 ) 5,282 $ 9.90 Shares exercised — (2,007 ) $ 3.60 Shares canceled and forfeited 484 (484 ) $ 5.04 Balance at December 31, 2017 7,630 20,454 $ 5.22 Increase in shares authorized for grant 4,589 — Shares granted (5,599 ) 5,599 $ 16.27 Shares exercised — (2,121 ) $ 4.40 Shares canceled and forfeited 1,106 (1,106 ) $ 11.08 Balance at December 31, 2018 7,726 22,826 $ 7.72 Increase in shares authorized for grant 4,601 Shares granted (4,976 ) 4,976 $ 11.52 Shares exercised — (2,929 ) $ 3.57 Shares canceled and forfeited 1,273 (1,273 ) $ 12.68 Balance at December 31, 2019 8,624 23,600 $ 8.77 6.51 $ 100,062 Options exercisable at December 31, 2019 15,398 $ 6.80 5.45 $ 91,283 Options fully vested and expected to vest 22,847 $ 8.63 6.44 $ 99,582 The total intrinsic value of options exercised during the years ended December 31, 2019, 2018 and 2017 was $26.6 million , $26.6 million and $22.4 million , respectively, based on the difference between the closing price of our common stock on the date of exercise of the options and the exercise price. The total grant date fair value of options to employees and directors that vested during the years ended December 31, 2019, 2018 and 2017 was $30.2 million , $22.6 million and $12.3 million , respectively. The following is a summary of options outstanding and options exercisable at December 31, 2019. Options Outstanding Options Exercisable Exercise Prices of Options Number of Shares Weighted- Average Remaining Contractual Life Weighted- Average Exercise Price Aggregate Intrinsic Value Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value (in thousands) (in years) (in thousands) (in thousands) (in thousands) $ 1.48 — $ 4.00 6,950 4.2 $ 3.02 $ 63,079 6,874 $ 3.11 $ 62,446 $ 4.01 — $ 7.00 3,233 4.3 $ 5.32 21,974 2,949 $ 5.22 20,296 $ 7.01 — $ 15.00 9,353 8.3 $ 10.73 15,009 3,714 $ 9.99 8,541 $ 15.01 — $ 24.29 4,064 8.1 $ 16.85 — 1,861 $ 16.89 — 23,600 6.5 $ 8.77 $ 100,062 15,398 $ 6.80 $ 91,283 The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value that option holders would have received had all option holders exercised their options on December 31, 2019. The aggregate intrinsic value is the difference between our closing stock price on December 31, 2019 and the exercise price, multiplied by the number of options with exercise prices less than the closing stock price on that date. Stock-Based Compensation related to Employee and Director Options Assumptions used in determining fair value-based measurements for options to employees and directors The following table summarizes the weighted-average assumptions and resultant fair value-based measurements for options granted to employees and directors. Year Ended December 31, 2019 2018 2017 Weighted-average assumptions for stock options granted: Risk-free interest rate 2.34% 2.68% 1.99% Expected term 6.0 years 5.9 years 6.1 years Expected volatility of stock price 67.4% 67.9% 68.1% Dividend rate 0% 0% 0% Weighted-average grant date fair value-based measurement $7.09 $10.11 $6.14 The expected term of options reflected in the table above has been based on a formula that considers the expected service period and expected post-vesting termination behavior depending on whether the option holder is an employee, officer or director. The expected volatility of our stock used in determining the fair value-based measurement of option grants to employees, officers and directors is based on the volatility of our stock price. The volatility is based on historical data of the price for our common stock for periods of time equal to the expected term of these grants. We calculate employee stock-based compensation expense using the number of options we expect to vest, based on our estimate of the option grantees’ average length of employment, and reduced by our estimate of option forfeitures. ASC 718 requires us to estimate forfeitures at the time of option grant and revise this estimate in subsequent periods if actual forfeitures differ from our estimates. Summary of compensation expense related to options to employees and directors We recognized compensation expense of $29.2 million , $23.8 million and $13.4 million related to options to employees and directors during the years ended December 31, 2019, 2018 and 2017 , respectively. As of December 31, 2019, we had $55.0 million of unrecognized compensation expense for employee and director options outstanding as of that date, which had a weighted-average remaining vesting period of 2.48 years . Stock Options to Non-Employees We expense stock-based compensation related to service-based option grants to non-employees on a straight-line basis over the vesting period of the options, which approximates the period over which the related services are rendered, based on the options’ value as calculated by the Black-Scholes option pricing model. In performing this calculation we use the same assumptions as when determining the value of options granted to employees and directors, except that we use the remaining contractual term of the non-employee’s service as the options’ expected term and we recalculate the options’ value each quarter, based on the then current price of our common stock. We recorded charges to expense for non-employee stock options of $0.2 million , zero and approximately zero for the years ended December 31, 2019, 2018 and 2017 , respectively. As of December 31, 2019, there were no awards outstanding to non-employees. Summary of Stock-based Compensation Expense The following table presents a summary of non-cash stock-based compensation by financial statement classification. Year Ended December 31, 2019 2018 2017 (in thousands) Stock-based compensation capitalized in inventory $ 120 $ 87 $ — Cost of sales 144 259 — Research and development 9,541 7,012 3,743 Selling, general and administrative 19,628 16,476 9,618 Total stock-based compensation $ 29,433 $ 23,834 $ 13,361 |
Net Income Per Share
Net Income Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | Net Income Per Share We compute basic and diluted net income per share by dividing our net income by the weighted-average number of common shares outstanding during the period. We used the treasury stock method to determine the number of dilutive shares of common stock resulting from the potential exercise of stock options. The statements of consolidated comprehensive income show the computation of net income per share for each period, including the number of weighted-average shares outstanding. The following table shows the computation of net income per share for each period: Year Ended December 31, 2019 2018 2017 (in thousands, except per share data) Numerator: Net income $ 94,181 $ 75,410 $ 129,122 Denominator: Weighted-average shares used to compute basic net income per share 114,349 115,343 113,527 Dilutive effect of employee stock options 8,217 11,345 10,988 Weighted-average shares used to compute diluted net income per share 122,566 126,688 124,515 Net income per share Basic $ 0.82 $ 0.65 $ 1.14 Diluted $ 0.77 $ 0.60 $ 1.04 As of December 31, 2019, 2018 , and 2017 we had 23.6 million , 22.8 million , and 20.5 million stock options outstanding, respectively. Because including them would have reduced dilution, we excluded from the computation of diluted net income per share, on a weighted-average basis 9.9 million , 5.0 million and 1.1 million stock options outstanding during the years ended December 31, 2019, 2018 and 2017 , respectively, |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The domestic and foreign components of income before income taxes were as follows (in thousands): Year Ended December 31, 2019 2018 2017 (in thousands) Domestic $ 116,676 $ 92,153 $ 52,806 Foreign — — — Income before income taxes $ 116,676 $ 92,153 $ 52,806 The income tax expense (benefit) for the year ended December 31, 2019, 2018 and 2017 consisted of the following: Year Ended December 31, 2019 2018 2017 (in thousands) U.S. federal taxes: Current $ 1,716 $ — $ — Deferred 15,944 14,243 (71,839 ) Total U.S. federal taxes 17,660 14,243 (71,839 ) State taxes: Current 3,900 2,676 388 Deferred 935 (176 ) (4,865 ) Total state taxes 4,835 2,500 (4,477 ) Total $ 22,495 $ 16,743 $ (76,316 ) The income tax benefit for the year ended December 31, 2017 resulted primarily from the partial release of our valuation allowance. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows: Year Ended December 31, 2019 2018 Deferred tax assets: (in thousands) Federal and state net operating losses $ 7,391 $ 23,551 Capitalized research and patent costs 7,317 10,260 Research credits 26,164 24,771 Stock-based compensation costs 12,026 9,124 Operating lease liability 857 — Other 4,186 6,137 Total deferred tax assets 57,941 73,843 Valuation allowance (11,410 ) (11,184 ) Deferred tax liabilities Operating lease right-of-use asset (854 ) — Total deferred tax liabilities (854 ) — Net deferred tax assets $ 45,677 $ 62,659 Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Each quarter, we assess our ability to use our deferred tax assets to offset our expected federal and state taxable income based on the weight of all available evidence, including such factors as the history of recent earnings and expected future taxable income on a jurisdiction by jurisdiction basis. In the fourth quarter of 2017, we determined that it was more likely than not that we would generate sufficient taxable income to utilize our federal and state deferred tax assets in every state except California. We therefore included in our balance sheet the net value of all our deferred tax assets except those applicable to California. We maintain a full valuation allowance in relation to California deferred tax assets as of December 31, 2019 because of the uncertainty regarding the realizability of these deferred tax assets. All tax years from Corcept’s inception remain open to examination by the Internal Revenue Service, the California Franchise Tax Board and other state taxing authorities. The valuation allowance increased by $0.2 million for the year ended December 31, 2019, and decreased by $1.3 million and $116.9 million for the years ended December 31, 2018 and 2017 , respectively. The significant decrease in the valuation allowance during 2017 was the result of our release of the entire valuation allowance previously established on our federal and non-California state deferred tax assets. At December 31, 2019, we had net operating loss carryforwards available to offset any future taxable income that we may generate for federal income tax purposes of $7.7 million , which will begin to expire in the year 2033 , California net operating loss carryforwards of $75.2 million , which will begin to expire in the year 2029 , and net operating loss carryforwards from other states of $9.7 million , which will begin to expire in the year 2023 if not utilized. At December 31, 2019, we also had federal research and development tax credits of $10.4 million and orphan drug tax credits of $14.6 million , respectively and California research and development credits of $7.5 million . The federal tax credits will begin to expire in the years 2030 through 2039 and the California research credits have no expiration date. Utilization of our net operating losses and tax credit carryforwards may be subject to substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code and similar state provisions. Such limitations could result in the expiration of the net operating losses and tax credit carryforwards before utilization. The following table presents a reconciliation from the statutory federal income tax rate to the effective rate. Year Ended December 31, 2019 2018 2017 (in thousands) U.S. federal taxes at statutory rate $ 24,502 $ 19,354 $ 17,954 Changes in valuation allowance — — (119,765 ) Federal tax rate change impact to change in valuation allowance — — 33,233 R&D and other credits (4,504 ) (2,178 ) (1,199 ) State income taxes 3,819 1,975 (2,955 ) Non-deductible compensation 657 394 33 Stock-based compensation (2,107 ) (3,165 ) (3,826 ) Other 128 363 209 Total $ 22,495 $ 16,743 $ (76,316 ) We maintain liabilities for uncertain tax positions. The measurement of these liabilities involves considerable judgment and estimation and are continuously monitored by management based on the best information available, including changes in tax regulations, the outcome of relevant court cases, and other pertinent information. The aggregate annual changes in the balance of gross unrecognized tax benefits are as follows (in thousands): Year Ended December 31, 2019 2018 2017 Beginning Balance $ 4,756 $ 4,139 $ 3,527 Increase in tax positions for prior years 261 — 150 Decrease in tax positions for prior years — (135 ) — Increase in tax positions for current year 1,012 752 462 Decrease in tax positions for current year — — — Ending Balance $ 6,029 $ 4,756 $ 4,139 As of December 31, 2019, 2018 and 2017 , the total amount of unrecognized tax benefits was approximately $6.0 million , $4.8 million and $4.1 million , respectively. A valuation allowance is maintained on the tax benefits related to California deferred tax assets and if these tax benefits were recognized it would not impact the effective tax rate. We had no or immaterial amounts of accrued interest and no accrued penalties related to unrecognized tax benefits as of December 31, 2019, 2018 and 2017 . We do not expect our unrecognized tax benefits to change materially over the next 12 months. While we believe we have adequately provided for all tax positions, amounts asserted by tax authorities could be greater or less than the recorded position. Accordingly, our provisions on federal and state tax-related matters to be recorded in the future may change as revised estimates are made or the underlying matters are settled or otherwise resolved. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies We have entered into a number of agreements to purchase API for the manufacturing of relacorilant, miricorilant and exicorilant. We have also entered into a number of agreements to perform clinical studies on miricorilant and CORT113176. See the discussion in Note 2, Significant Agreements , for further discussion regarding the commitments under these agreements. In the ordinary course of business, we may be subject to legal claims and regulatory actions that could have a material adverse effect on our business or financial position. We assess our potential liability in such situations by analyzing the possible outcomes of various litigation, regulatory and settlement strategies. If we determine a loss is probable and its amount can be reasonably estimated, we accrue an amount equal to the estimated loss. In August 2017, we terminated our pharmaceutical services agreement with our exclusive specialty pharmacy, Dohmen Life Science Services ("Dohmen") for material breach. In August 2017, Dohmen filed a complaint in the Court of Chancery of the State of Delaware against us alleging unlawful termination and breach of contract and requesting declaratory relief and damages. We filed a complaint against Dohmen in the Superior Court of the State of Delaware and a motion to dismiss the Dohmen complaint against us. In November 2017, we answered Dohmen’s complaint in the Court of Chancery of the State of Delaware and asserted counterclaims against Dohmen. Dohmen refused to transfer to us the cash it collected from $12.9 million in Korlym ® receivables, despite its obligation to do so. As of December 31, 2017 , the total amount of these receivables had been included in “Other receivable” on our consolidated balance sheet. In January 2018, we entered into a settlement agreement with Dohmen and mutual release of any and all claims that may have existed between the parties as of that date, pursuant to which Dohmen agreed to deliver to us the cash it had collected from the sale of Korlym on our behalf. The total amount delivered by Dohmen under the settlement agreement was the $12.9 million of Korlym ® receivables described above. No losses and no provision for a loss contingency have been recorded to date. |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | Quarterly Financial Data (Unaudited) The following table is in thousands, except per share amounts: Quarter Ended March 31 June 30 September 30 December 31 2019 Product revenue, net $ 64,829 $ 72,257 $ 81,505 $ 87,895 Gross profit on product revenue 63,589 70,880 80,054 86,459 Net income 18,274 20,186 26,340 29,381 Basic net income per share $ 0.16 $ 0.18 $ 0.23 $ 0.26 Diluted net income per share $ 0.15 $ 0.17 $ 0.22 $ 0.24 2018 Product revenue, net $ 57,659 $ 62,312 $ 64,445 $ 66,831 Gross profit on product revenue 56,485 61,158 63,137 65,252 Net income 17,459 18,196 17,747 22,008 Basic net income per share $ 0.15 $ 0.16 $ 0.15 $ 0.19 Diluted net income per share $ 0.14 $ 0.14 $ 0.14 $ 0.18 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). |
Principles of Consolidation | Principles of Consolidation Our consolidated financial statements include the financial position and results of operations of Corcept Therapeutics UK Limited, our wholly owned subsidiary, which we incorporated in the United Kingdom in March 2017. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. We reevaluate our estimates and assumptions each quarter, including those related to revenue recognition, recognition and measurement of income tax assets and liabilities, inventory, allowances for doubtful accounts and other accrued liabilities, including our bonus accrual, clinical trial accruals and stock-based compensation. |
Fair Value Measurements | Fair Value Measurements We value financial instruments using assumptions we believe third-party market participants would use. When choosing which assumptions to make when determining the value of a financial instrument, we look first for quoted prices in active markets for identical instruments (“Level 1 inputs”). If no Level 1 inputs are available, we consider (i) quoted prices in non-active markets for identical instruments; (ii) active markets for similar instruments; (iii) inputs other than quoted prices for the instrument; and (iv) inputs that are not directly observable, but that can be corroborated by observable data (“Level 2 inputs”). In the absence of Level 2 inputs, we rely on unobservable inputs, such as our estimates of the assumptions market participants would use in pricing the instrument (“Level 3 inputs”). |
Cash and Cash Equivalents and Marketable Securities | Cash and Cash Equivalents and Marketable Securities We consider highly liquid investments that will mature in three months or less from the time we purchase them to be cash equivalents. Cash equivalents are valued using Level 1 inputs, which approximate our cost. We invest the majority of our funds in marketable securities, primarily corporate notes, U.S. Treasury securities, asset-backed securities, commercial paper and repurchase agreements. We classify our marketable securities as available-for-sale securities and report them at fair value as “cash equivalents” or “marketable securities” on our consolidated balance sheet, with related unrealized gains and losses included in stockholders' equity. Realized gains and losses and permanent declines in value are included in “interest and other income (expense)” on our consolidated statement of comprehensive income. |
Credit and Concentration Risks | Credit and Concentration Risks Our cash, cash equivalents and marketable securities are held in one financial institution. We are subject to credit risk from our cash equivalents and marketable securities. We limit our investments to U.S. Treasury obligations and high-grade corporate debt, asset-backed securities and repurchase agreements with less than a 36-month maturity at the time of purchase. These investments are diversified and do not expose us to concentrations of credit risk. We have never experienced a loss in, or lack of access to, our operating or investment accounts. We have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym - Produits Chimiques Auxiliaires et de Synthèse SA (PCAS). If PCAS is unable or unwilling to manufacture API in the amounts and time frames required, we may not be able to manufacture Korlym in a timely manner. In order to mitigate this risk, we have purchased and hold in inventory a reserve quantity of mifepristone API. We have a concentration of risk in regard to the distribution of our product. A single specialty pharmacy, Optime Care, Inc. (“Optime”), dispenses Korlym to patients for us. Optime is an independent third party. Its unwillingness or inability to dispense Korlym to patients in a timely manner would harm our business. We sell the Korlym that Optime dispenses directly to patients, with title to the medicine passing directly from us to the patient upon the patient’s receipt of the drug. Our receivables risk is spread among various third-party payers - pharmacy benefit managers, insurance companies, government programs and private charities. We extend credit to third-party payers based on their creditworthiness. We monitor our exposure and record an allowance against uncollectible trade receivables as necessary. To date, we have not incurred any credit losses. |
Inventory and Cost of Sales | Inventory and Cost of Sales Regulatory approval of product candidates is uncertain. Because product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained, we record the cost of manufacturing our product candidates as research and development expenses at the time such costs are incurred. We capitalize to inventory manufacturing costs related to Korlym. We value inventory at the lower of cost or net realizable value and determine the cost of inventory we sell using the specific identification method, which approximates a first-in, first-out basis. We assess our inventory levels at each reporting period and write down inventory that is either expected to be at risk of expiration prior to sale, or has a cost basis in excess of its expected net realizable value, or for which there are inventory quantities in excess of expected requirements. We destroy expired inventory and recognize the related costs as cost of sales in that period’s statement of comprehensive income. Cost of sales also includes the cost of manufacturing Korlym, including materials, third-party manufacturing costs and indirect personnel and other overhead costs, based on the number of Korlym tablets for which we recognize revenue, as well as costs of stability testing, logistics and distribution. We classify inventory we do not expect to sell or use in clinical studies within 12 months of the balance sheet date as strategic inventory, a non-current asset. |
Net Product Revenue | Net Product Revenue We sell Korlym directly to patients through a single specialty pharmacy. We also sell Korlym to a specialty distributor (“SD”), for which we recognize revenue at the time the SD receives Korlym. SD sales were less than one percent of our net revenue in the years ended December 31, 2019 and December 31, 2018 . To determine our revenue from the sale of Korlym, we (i) identify our contract with each customer; (ii) identify the obligations of Corcept and the customer under the contract; (iii) determine the contracted transaction price; (iv) allocate the transaction price to the contract’s performance obligations, which in our case consists of delivering Korlym to the customer; and (v) recognize revenue once Korlym has been delivered, provided we deem it probable that we will collect the payment due to us. Confirmation of coverage by private or government insurance or by a third-party charity is a prerequisite for selling Korlym to a patient. To determine net product revenue, we deduct from sales the cost of our patient co-pay assistance program and our estimates of (a) government chargebacks and rebates, (b) discounts provided to our SD for prompt payment and (c) reserves for expected Korlym returns. We record these estimates at the time we recognize revenue and update them as new information becomes available. Our estimates take into account our understanding of the range of possible outcomes. If results differ from our estimates, we adjust our estimates, causing a change to our net product revenue and earnings. We report any changes in the period they become known, even if they concern transactions occurring in prior periods. Government Rebates: Korlym is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other government programs that are eligible for rebates on the price they pay for Korlym. To determine the appropriate amount to reserve against these rebates, we identify Korlym sold to patients covered by government-funded programs, apply the applicable government discount to these sales, then estimate the portion of total rebates we expect will be claimed. Chargebacks . Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. As it makes such sales, SD recovers the full amount of any related discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym purchased by the SD in prior periods. We deduct from our revenue in each period chargebacks claimed by the SD for Korlym it purchased in that period. We also create each period a reserve for chargebacks we estimate the SD will claim in future periods against Korlym it has not yet resold. We determine the amount of this reserve based on our experience with SD chargebacks and our understanding of the SD’s customer base and business practices. We then deduct this reserve from revenue and include in accrued expenses on our consolidated balance sheet a current liability of equal amount. Patient Assistance Program and Charitable Support: It is our policy that no patient be denied Korlym due to inability to pay. We provide financial assistance to eligible patients whose insurance policies have high deductibles or co-payments and deduct the amount of such assistance from gross revenue. We determine the assistance we provide each patient by applying our program guidelines to that patient’s financial position and their insurance policy’s co-payment and deductible requirements for the purchase of Korlym. We donate cash to charities that help patients with financial need pay for the treatment of Cushing’s syndrome. We do not include payments from these charities in revenue. We provide Korlym at no cost to uninsured patients who do not qualify for charitable support. Sales Returns : Federal law prohibits the return of Korlym sold to patients. Sales to our SD are subject to return. We deduct the amount of Korlym we estimate the SD will return from each period’s gross revenue. We base our estimates on quantitative and qualitative information including, but not limited to, historical return rates, the amount of Korlym held by the SD and projected demand. If we cannot reasonably estimate returns with respect to a particular sale, we defer recognition of revenue until we can make a reasonable estimate. To date, returns have not been significant. |
Leases | Leases We adopted ASC Topic 842, effective January 1, 2019, using the modified retrospective method. The reported results for fiscal year 2019 reflect the application of ASC Topic 842, while the reported results for prior fiscal years are not adjusted and continue to be reported under ASC Topic 840. Refer to Recently Adopted Accounting Pronouncements regarding the adoption impact of ASC Topic 842 in the year ended December 31, 2019. We determine whether an arrangement contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. To determine whether a contract is or contains a lease, we consider all relevant facts and circumstances to assess whether the customer has the right to both (i) obtain substantially all of the economic benefits from use of the identified asset and (ii) direct the use of the identified asset. We recognize right-of-use assets and lease liabilities at lease commencement. We measure lease liabilities based on the present value of lease payments over the lease term discounted using the rate equal to the rate we would pay on a loan with monthly payments and a term equal to the monthly payments and remaining term of our lease. We estimate our incremental borrowing rate based on non-tender bank quotes and an analysis of public companies with debt and credit carrying terms similar to our lease term. We do not include in the lease term options to extend or terminate the lease unless it is reasonably certain at commencement that we will exercise any such options. We account for the lease components separately from non-lease components for our operating leases. We measure right-of-use assets based on the corresponding lease liabilities adjusted for (i) prepayments made to the lessor at or before the commencement date, (ii) initial direct costs we incur, and (iii) tenant incentives under the lease. We evaluate the recoverability of our right-of-use assets for possible impairment in accordance with our long-lived assets policy. We do not recognize right-of-use assets or lease liabilities for leases with a term of twelve months or less; rather, we recognize the associated lease payments in the consolidated statements of comprehensive income on a straight-line basis over the lease term. Operating leases are reflected on our consolidated balance sheets as operating lease right-of-use assets, short-term operating lease liabilities and long-term operating lease liabilities. We begin recognizing operating lease expense when the lessor makes the underlying asset available to us. We recognize operating lease expense under our operating leases on a straight-line basis. Variable lease payments are expensed as incurred. |
Research and Development | Research and Development Research and development expenses include the direct cost of discovering and screening new compounds, pre-clinical studies, clinical trials, manufacturing development, submissions to regulatory agencies and related overhead costs. We expense nonrefundable payments and the cost of technologies and materials used in research and development as we incur them. |
Segment Reporting | Segment Reporting We determine our operating segments based on the way we organize our business, make decisions and assess performance. We have only one operating segment, which is the discovery, development and commercialization of pharmaceutical products. |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation under the fair value method, based on the value of the award at the grant date. To date, our stock-based compensation has consisted entirely of option grants, which we value using the Black-Scholes model. We recognize stock-based compensation expense over the applicable vesting period, net of estimated forfeitures. If actual forfeitures differ from our estimates, we adjust stock-based compensation expense accordingly. We recognize the expense of options granted to non-employees based on their fair value at the time of vesting. |
Income Taxes | Income Taxes We account for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”), which requires recognition of deferred tax assets and liabilities for the expected tax consequences of our future financial and operating activities. Under ASC 740, we determine deferred tax assets and liabilities based on the temporary difference between the financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which we expect such differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income to realize the value of some or all of our deferred tax assets (net of our deferred tax liabilities), we establish a valuation allowance offsetting the amount we do not expect to realize. We perform this analysis each reporting period and reduce our measurement of deferred taxes, if the likelihood we will realize them becomes uncertain. The deferred tax assets we record each period depend primarily on our ability to generate future taxable income in the United States. Each period, we evaluate the need for a valuation allowance against our deferred tax assets and, if necessary, adjust the valuation allowance so that net deferred tax assets are recorded only to the extent we conclude it is more likely than not that these deferred tax assets will be realized. If our outlook for future taxable income changes significantly, our assessment of the need for, and the amount of, a valuation allowance may also change. We are also required to evaluate and quantify other sources of taxable income, such as the possible reversal of future deferred tax liabilities, should any arise, and the implementation of tax planning strategies. Evaluating and quantifying these amounts is difficult and involves significant judgment, based on all of the available evidence and assumptions about our future activities. We account for uncertain tax positions in accordance with ASC 740, which requires us to adjust our consolidated financial statements to reflect only those tax positions that are more-likely-than-not to be sustained upon review by federal or state examiners. We recognize in the consolidated financial statements the largest expected tax benefit that has a greater than 50 percent likelihood of being sustained on examination by the taxing authorities. We report interest and penalties related to unrecognized tax benefits as income tax expenses. |
Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which requires lease transactions with terms longer than 12 months to be recognized on the balance sheet as a liability (“lease liabilities”), offset by an asset of equal amount (“right-of-use assets”). ASU No. 2016-02 supersedes the lease accounting requirements of ASC Topic 840, “Leases” and creates Topic 842, “Leases.” We adopted this standard on January 1, 2019, using the modified retrospective approach, which did not cause adjustments to prior comparative periods. We have reviewed all of our contracts that may contain leases and have determined that the only impact is to the accounting for our leased office space. We have applied the practical expedients in Topic 842 that allow us not to reassess lease classification for expired or existing lease contracts. On the date of adoption, we increased our “operating right-of-use assets" and “operating lease liability” by approximately $1.9 million , an amount equal to the present value of our expected payments over the remaining term of the lease. There was no change to our retained earnings. See Note 5 for more information regarding our leased office space and additional operating right-of-use assets capitalized after the date of adoption. In February 2018, the FASB issued ASU No. 2018-02, “Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income.” This standard allows companies to reclassify to retained earnings tax effects related to items that have been stranded in “accumulated other comprehensive income” as a result of the Tax Cuts and Jobs Act (the “Act”). A company that elects to reclassify these amounts must reclassify stranded tax effects related to the Act’s change in US federal tax rate for all items accounted for in “other comprehensive income.” These entities can also elect to reclassify other stranded effects that relate to the Act but do not directly relate to the change in the federal rate. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. We adopted this standard on January 1, 2019. It had no impact on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting,” which expands the scope of ASC 718 to include all share-based payment arrangements related to the acquisition of goods and services from nonemployees. This standard is effective for fiscal years and interim periods within those years beginning after December 15, 2018. We adopted this standard on January 1, 2019. It had no impact on our consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments,” which changes the methodology for measuring credit losses on financial instruments and when such losses are recorded. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurements (Topic 820),” which eliminates or modifies certain disclosure requirements for fair value measurements and requires disclosure of new information. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In August 2018, the FASB issued ASU No. 2018-15, “Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract,” which requires a customer that is a party to a cloud computing service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to recognize as deferred assets. This standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We will adopt this standard on January 1, 2020 using the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. The effect on our consolidated financial statements and related disclosures is not expected to be material. In December 2019, the FASB issued ASU 2019-12 (ASC Topic 740), “Simplifying the Accounting for Income Taxes”. This standard simplifies accounting for income taxes by removing certain exceptions to the general principles and amending existing guidance to improve consistent application. This standard will be effective for fiscal years, and interim periods within those years, beginning after December 15, 2021. Early adoption is permitted. We are in the process of assessing the impact of this standard on our consolidated financial statements. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Allowance Activity Included in Trade Receivables Includes Allowance for Doubtful Accounts, Prompt Pay Cash Discounts and Chargebacks | The following table summarizes activity in each of the product revenue allowance and reserve categories for the year ended December 31, 2019: Chargebacks Government Rebates Total (in thousands) Balance at December 31, 2016: $ 468 $ 3,427 $ 3,895 Provision recorded during the period 2,637 18,097 20,734 Credit or payments made during the period (2,178 ) (13,563 ) (15,741 ) Balance at December 31, 2017: 927 7,961 8,888 Provision related to current period sales 2,687 28,628 31,315 Provision related to prior period sales — 532 532 Credit or payments made during the period (3,268 ) (25,988 ) (29,256 ) Balance at December 31, 2018: 346 11,133 11,479 Provision related to current period sales 783 24,374 25,157 Provision related to prior period sales — (95 ) (95 ) Credit or payments made during the period (852 ) (27,203 ) (28,055 ) Balance at December 31, 2019: $ 277 $ 8,209 $ 8,486 |
Available-for-Sale Securities_2
Available-for-Sale Securities and Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Summary of the classification of available-for-sale securities in condensed consolidated balance sheets | The available-for-sale securities in our Consolidated Balance Sheets are as follows: Year Ended December 31, 2019 2018 (in thousands) Cash equivalents $ 18,461 $ 27,075 Short-term marketable securities 244,693 165,135 Long-term marketable securities 39,352 — Total marketable securities $ 302,506 $ 192,210 |
Schedule of available-for-sale securities | The following table presents our available-for-sale securities grouped by asset type: Fair Value Hierarchy Level December 31, 2019 December 31, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value (in thousands) Corporate bonds Level 2 $ 109,780 $ 136 $ (6 ) $ 109,910 $ 54,513 $ 2 $ (46 ) $ 54,469 Commercial paper Level 2 41,237 — — 41,237 67,906 — — 67,906 Asset-backed securities Level 2 57,195 63 (5 ) 57,253 10,970 — (5 ) 10,965 Repurchase agreements Level 2 18,000 — — 18,000 15,000 — — 15,000 U.S. treasury securities Level 1 75,574 71 — 75,645 39,308 — (21 ) 39,287 Money market funds Level 1 461 — — 461 4,583 — — 4,583 Total Marketable securities $ 302,247 $ 270 $ (11 ) $ 302,506 $ 192,280 $ 2 $ (72 ) $ 192,210 |
Composition of Certain Balanc_2
Composition of Certain Balance Sheet Items (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Composition of Inventory | Inventory Year Ended December 31, 2019 2018 (in thousands) Raw materials $ 1,389 $ 4,195 Work in progress 10,086 5,624 Finished goods 5,930 6,423 Total inventory 17,405 16,242 Less strategic inventory classified as non-current (11,981 ) (11,510 ) Total inventory classified as current $ 5,424 $ 4,732 |
Property, Plant and Equipment [Table Text Block] | Property and Equipment Year Ended December 31, 2019 2018 (in thousands) Furniture and equipment $ 304 $ 361 Software 1,541 884 Leasehold improvements 533 35 2,378 1,280 Less accumulated depreciation (1,328 ) (625 ) $ 1,050 $ 655 |
Schedule of Other Accrued Liabilities | Accrued and other liabilities Year Ended December 31, 2019 2018 (in thousands) Government rebates $ 8,209 $ 11,132 Accrued compensation 12,331 7,879 Legal fees 1,087 314 Income taxes payable 472 1,542 Accrued selling and marketing costs 491 261 Professional fees 367 240 Accrued manufacturing costs 33 2,032 Other 279 386 Total accrued and other liabilities $ 23,269 $ 23,786 Other assets Other assets includes $3.3 million |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of information of leases asset and liabilities | Our right-of-use assets and related lease liabilities were as follows: Year Ended December 31, 2019 (in thousands) Cash paid for operating lease liabilities $ 1,551 Right-of-use assets obtained in connection with operating lease obligations $ 4,913 Remaining lease term (years) 27 months Discount rate 5.0 % |
Schedule of Future Minimum Lease Payments under Non-Cancelable Operating Leases | As of December 31, 2019, future minimum lease payments under non-cancelable operating leases were as follows: 2020 $ 1,997 2021 2,130 2022 535 4,662 Less imputed interest (1,201 ) Total lease liability $ 3,461 |
Preferred Stock and Stockhold_2
Preferred Stock and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance as of December 31, 2019 are as follows: Common stock: (in thousands) Exercise of outstanding options 23,600 Shares available for grant under stock option plans 8,624 32,224 |
Summary of Stock Plan Activity | The following table summarizes all activity under the 2004 Plan and the 2012 Plan: Outstanding Options Shares Available For Future Grant Options Shares Subject to Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life Aggregate Intrinsic Value (in thousands) (in thousands) (in years) (in thousands) Balance at December 31, 2016 7,920 17,663 $ 3.63 Increase in shares authorized for grant 4,508 — Shares granted (5,282 ) 5,282 $ 9.90 Shares exercised — (2,007 ) $ 3.60 Shares canceled and forfeited 484 (484 ) $ 5.04 Balance at December 31, 2017 7,630 20,454 $ 5.22 Increase in shares authorized for grant 4,589 — Shares granted (5,599 ) 5,599 $ 16.27 Shares exercised — (2,121 ) $ 4.40 Shares canceled and forfeited 1,106 (1,106 ) $ 11.08 Balance at December 31, 2018 7,726 22,826 $ 7.72 Increase in shares authorized for grant 4,601 Shares granted (4,976 ) 4,976 $ 11.52 Shares exercised — (2,929 ) $ 3.57 Shares canceled and forfeited 1,273 (1,273 ) $ 12.68 Balance at December 31, 2019 8,624 23,600 $ 8.77 6.51 $ 100,062 Options exercisable at December 31, 2019 15,398 $ 6.80 5.45 $ 91,283 Options fully vested and expected to vest 22,847 $ 8.63 6.44 $ 99,582 |
Summary of Options Outstanding and Exercisable | The following is a summary of options outstanding and options exercisable at December 31, 2019. Options Outstanding Options Exercisable Exercise Prices of Options Number of Shares Weighted- Average Remaining Contractual Life Weighted- Average Exercise Price Aggregate Intrinsic Value Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value (in thousands) (in years) (in thousands) (in thousands) (in thousands) $ 1.48 — $ 4.00 6,950 4.2 $ 3.02 $ 63,079 6,874 $ 3.11 $ 62,446 $ 4.01 — $ 7.00 3,233 4.3 $ 5.32 21,974 2,949 $ 5.22 20,296 $ 7.01 — $ 15.00 9,353 8.3 $ 10.73 15,009 3,714 $ 9.99 8,541 $ 15.01 — $ 24.29 4,064 8.1 $ 16.85 — 1,861 $ 16.89 — 23,600 6.5 $ 8.77 $ 100,062 15,398 $ 6.80 $ 91,283 |
Summary of Weighted-Average Assumptions and Resultant Fair Value-Based Measurements for Options Granted to Employees and Directors | The following table summarizes the weighted-average assumptions and resultant fair value-based measurements for options granted to employees and directors. Year Ended December 31, 2019 2018 2017 Weighted-average assumptions for stock options granted: Risk-free interest rate 2.34% 2.68% 1.99% Expected term 6.0 years 5.9 years 6.1 years Expected volatility of stock price 67.4% 67.9% 68.1% Dividend rate 0% 0% 0% Weighted-average grant date fair value-based measurement $7.09 $10.11 $6.14 |
Summary of Stock-Based Compensation | The following table presents a summary of non-cash stock-based compensation by financial statement classification. Year Ended December 31, 2019 2018 2017 (in thousands) Stock-based compensation capitalized in inventory $ 120 $ 87 $ — Cost of sales 144 259 — Research and development 9,541 7,012 3,743 Selling, general and administrative 19,628 16,476 9,618 Total stock-based compensation $ 29,433 $ 23,834 $ 13,361 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Net Income Per Share | Year Ended December 31, 2019 2018 2017 (in thousands, except per share data) Numerator: Net income $ 94,181 $ 75,410 $ 129,122 Denominator: Weighted-average shares used to compute basic net income per share 114,349 115,343 113,527 Dilutive effect of employee stock options 8,217 11,345 10,988 Weighted-average shares used to compute diluted net income per share 122,566 126,688 124,515 Net income per share Basic $ 0.82 $ 0.65 $ 1.14 Diluted $ 0.77 $ 0.60 $ 1.04 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | The domestic and foreign components of income before income taxes were as follows (in thousands): Year Ended December 31, 2019 2018 2017 (in thousands) Domestic $ 116,676 $ 92,153 $ 52,806 Foreign — — — Income before income taxes $ 116,676 $ 92,153 $ 52,806 |
Schedule of Components of Income Tax (Benefit) | The income tax expense (benefit) for the year ended December 31, 2019, 2018 and 2017 consisted of the following: Year Ended December 31, 2019 2018 2017 (in thousands) U.S. federal taxes: Current $ 1,716 $ — $ — Deferred 15,944 14,243 (71,839 ) Total U.S. federal taxes 17,660 14,243 (71,839 ) State taxes: Current 3,900 2,676 388 Deferred 935 (176 ) (4,865 ) Total state taxes 4,835 2,500 (4,477 ) Total $ 22,495 $ 16,743 $ (76,316 ) |
Schedule of Significant Components of Deferred Tax Assets | Year Ended December 31, 2019 2018 Deferred tax assets: (in thousands) Federal and state net operating losses $ 7,391 $ 23,551 Capitalized research and patent costs 7,317 10,260 Research credits 26,164 24,771 Stock-based compensation costs 12,026 9,124 Operating lease liability 857 — Other 4,186 6,137 Total deferred tax assets 57,941 73,843 Valuation allowance (11,410 ) (11,184 ) Deferred tax liabilities Operating lease right-of-use asset (854 ) — Total deferred tax liabilities (854 ) — Net deferred tax assets $ 45,677 $ 62,659 |
Schedule of Reconciliation of Statutory Federal Income Tax Rate to Effective Rate | The following table presents a reconciliation from the statutory federal income tax rate to the effective rate. Year Ended December 31, 2019 2018 2017 (in thousands) U.S. federal taxes at statutory rate $ 24,502 $ 19,354 $ 17,954 Changes in valuation allowance — — (119,765 ) Federal tax rate change impact to change in valuation allowance — — 33,233 R&D and other credits (4,504 ) (2,178 ) (1,199 ) State income taxes 3,819 1,975 (2,955 ) Non-deductible compensation 657 394 33 Stock-based compensation (2,107 ) (3,165 ) (3,826 ) Other 128 363 209 Total $ 22,495 $ 16,743 $ (76,316 ) |
Schedule of Changes in Balance of Gross Unrecognized Tax Benefits | The aggregate annual changes in the balance of gross unrecognized tax benefits are as follows (in thousands): Year Ended December 31, 2019 2018 2017 Beginning Balance $ 4,756 $ 4,139 $ 3,527 Increase in tax positions for prior years 261 — 150 Decrease in tax positions for prior years — (135 ) — Increase in tax positions for current year 1,012 752 462 Decrease in tax positions for current year — — — Ending Balance $ 6,029 $ 4,756 $ 4,139 |
Quarterly Financial Data (Una_2
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Financial Data | The following table is in thousands, except per share amounts: Quarter Ended March 31 June 30 September 30 December 31 2019 Product revenue, net $ 64,829 $ 72,257 $ 81,505 $ 87,895 Gross profit on product revenue 63,589 70,880 80,054 86,459 Net income 18,274 20,186 26,340 29,381 Basic net income per share $ 0.16 $ 0.18 $ 0.23 $ 0.26 Diluted net income per share $ 0.15 $ 0.17 $ 0.22 $ 0.24 2018 Product revenue, net $ 57,659 $ 62,312 $ 64,445 $ 66,831 Gross profit on product revenue 56,485 61,158 63,137 65,252 Net income 17,459 18,196 17,747 22,008 Basic net income per share $ 0.15 $ 0.16 $ 0.15 $ 0.19 Diluted net income per share $ 0.14 $ 0.14 $ 0.14 $ 0.18 |
Significant Agreements (Narrati
Significant Agreements (Narrative) (Details) $ in Millions | Jul. 25, 2018renewal_option | Aug. 31, 2017 | Dec. 31, 2019USD ($) |
Optime Care, Inc. | |||
Debt And Credit Agreements [Line Items] | |||
Initial agreement period | 5 years | ||
Active Pharmaceutical Ingredient | |||
Debt And Credit Agreements [Line Items] | |||
Number of renewal options | renewal_option | 2 | ||
Renewal option period | 1 year | ||
Purchase obligation, due in next twelve months | $ 0.6 | ||
Quotient Sciences agreement | |||
Debt And Credit Agreements [Line Items] | |||
Purchase obligation, due in next twelve months | $ 0.4 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Narrative) (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019USD ($)seriescompoundsegment | Dec. 31, 2017 | Oct. 01, 2019USD ($) | Jan. 01, 2019USD ($) | |
Accounting Policies [Line Items] | ||||
Number of series of selective cortisol modulators | series | 4 | |||
Number of compounds (more than) | compound | 500 | |||
Number of operating segments | segment | 1 | |||
Operating lease right-of-use asset | $ 3,446 | |||
Total lease liability | $ 3,461 | |||
Sales Revenue, Net | Customer Concentration Risk | ||||
Accounting Policies [Line Items] | ||||
Percentage of sales to one specialty distributor, less than | 1.00% | 1.00% | ||
Accounting Standards Update 2016-02 | ||||
Accounting Policies [Line Items] | ||||
Operating lease right-of-use asset | $ 1,900 | |||
Total lease liability | $ 3,000 | 1,900 | ||
Minimum | Accounting Standards Update 2016-02 | ||||
Accounting Policies [Line Items] | ||||
Operating lease right-of-use asset | 1,900 | |||
Total lease liability | 1,500 | |||
Maximum | Accounting Standards Update 2016-02 | ||||
Accounting Policies [Line Items] | ||||
Total lease liability | $ 2,500 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies (Summary of Allowance Activity Included in Trade Receivables Includes Allowance for Doubtful Accounts, Prompt Pay Cash Discounts and Chargebacks) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Allowance for Doubtful Accounts Receivable [Roll Forward} | |||
Balance at beginning of period | $ 11,479 | $ 8,888 | $ 3,895 |
Provision related to current period sales | 20,734 | ||
Credit or payments made during the period | (28,055) | (29,256) | (15,741) |
Provision related to current period sales | 25,157 | 31,315 | |
Provision related to prior period sales | (95) | (532) | |
Balance at end of period | 8,486 | 11,479 | 8,888 |
Chargebacks | |||
Allowance for Doubtful Accounts Receivable [Roll Forward} | |||
Balance at beginning of period | 346 | 927 | 468 |
Provision related to current period sales | 2,637 | ||
Credit or payments made during the period | (852) | (3,268) | (2,178) |
Provision related to current period sales | 783 | 2,687 | |
Provision related to prior period sales | 0 | 0 | |
Balance at end of period | 277 | 346 | 927 |
Government Rebates | |||
Allowance for Doubtful Accounts Receivable [Roll Forward} | |||
Balance at beginning of period | 11,133 | 7,961 | 3,427 |
Provision related to current period sales | 18,097 | ||
Credit or payments made during the period | (27,203) | (25,988) | (13,563) |
Provision related to current period sales | 24,374 | 28,628 | |
Provision related to prior period sales | (95) | (532) | |
Balance at end of period | $ 8,209 | $ 11,133 | $ 7,961 |
Available-for-Sale Securities_3
Available-for-Sale Securities and Fair Value Measurements - Summary of the classification of available-for-sale securities in condensed consolidated balance sheets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | $ 302,506 | $ 192,210 |
Cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | 18,461 | 27,075 |
Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | 244,693 | 165,135 |
Long-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | $ 39,352 | $ 0 |
Available-for-Sale Securities_4
Available-for-Sale Securities and Fair Value Measurements - Schedule of Available-for-Sale Securities (Details) - Estimate of fair value measurement - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 302,247 | $ 192,280 |
Gross Unrealized Gains | 270 | 2 |
Gross Unrealized Losses | (11) | (72) |
Estimated Fair Value | 302,506 | 192,210 |
Corporate bonds | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 109,780 | 54,513 |
Gross Unrealized Gains | 136 | 2 |
Gross Unrealized Losses | (6) | (46) |
Estimated Fair Value | 109,910 | 54,469 |
Commercial paper | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 41,237 | 67,906 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 41,237 | 67,906 |
Asset-backed securities | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 57,195 | 10,970 |
Gross Unrealized Gains | 63 | 0 |
Gross Unrealized Losses | (5) | (5) |
Estimated Fair Value | 57,253 | 10,965 |
Repurchase agreements | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 18,000 | 15,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 18,000 | 15,000 |
U.S. treasury securities | Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 75,574 | 39,308 |
Gross Unrealized Gains | 71 | 0 |
Gross Unrealized Losses | 0 | (21) |
Estimated Fair Value | 75,645 | 39,287 |
Money market funds | Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 461 | 4,583 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | $ 461 | $ 4,583 |
Available-for-Sale Securities_5
Available-for-Sale Securities and Fair Value Measurements - Narrative (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Maximum maturity period | 2 years |
Weighted average maturity period | 6 months |
Minimum | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Long term marketable securities, remaining maturity | 12 months |
Maximum | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Long term marketable securities, remaining maturity | 17 months |
Composition of Certain Balanc_3
Composition of Certain Balance Sheet Items (Composition of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,389 | $ 4,195 |
Work in progress | 10,086 | 5,624 |
Finished goods | 5,930 | 6,423 |
Total inventory | 17,405 | 16,242 |
Less strategic inventory classified as non-current | (11,981) | (11,510) |
Total inventory classified as current | $ 5,424 | $ 4,732 |
Composition of Certain Balanc_4
Composition of Certain Balance Sheet Items (Other Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Condensed Balance Sheet Statements, Captions [Line Items] | ||
Government rebates | $ 8,209 | $ 11,132 |
Accrued compensation | 12,331 | 7,879 |
Legal fees | 1,087 | 314 |
Income taxes payable | 472 | 1,542 |
Accrued selling and marketing costs | 491 | 261 |
Professional fees | 367 | 240 |
Accrued manufacturing costs | 33 | 2,032 |
Other | 279 | 386 |
Total accrued and other liabilities | 23,269 | $ 23,786 |
Deposits for clinical trials | ||
Condensed Balance Sheet Statements, Captions [Line Items] | ||
Other | $ 3,300 |
Composition of Certain Balanc_5
Composition of Certain Balance Sheet Items - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | $ 1,280 | |
Proper and equipment and finance lease right-of-use asset, before accumulated depreciation and amortization | $ 2,378 | |
Less accumulated depreciation | (1,328) | |
Less accumulated depreciation | 625 | |
Property and Equipment, Net | 1,050 | |
Property and Equipment, Net | 1,050 | 655 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | 304 | |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | 1,541 | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | $ 533 | |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | 361 | |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | 884 | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment | $ 35 |
Leases - (Details)
Leases - (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 01, 2019 | Jan. 01, 2019 | |
Lessee, Lease, Description [Line Items] | |||||
Operating lease right-of-use asset | $ 3,446 | ||||
Operating lease expense | 1,500 | ||||
Cash paid for operating lease liabilities | 1,551 | ||||
Right-of-use assets obtained in connection with new operating lease obligations | $ 4,913 | ||||
Remaining lease term (years) | 27 months | ||||
Discount rate | 5.00% | ||||
Incremental minimum lease payments 2020 | $ 1,997 | ||||
Incremental minimum lease payments 2021 | 2,130 | ||||
Incremental minimum lease payments 2022 | 535 | ||||
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |||||
2020 | 1,997 | ||||
2021 | 2,130 | ||||
2022 | 535 | ||||
Payments due | 4,662 | ||||
Less imputed interest | 1,201 | ||||
Total lease liability | $ 3,461 | ||||
Operating Leases, Rent Expense | $ 1,300 | $ 1,100 | |||
Accounting Standards Update 2016-02 | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease right-of-use asset | $ 1,900 | ||||
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |||||
Total lease liability | $ 3,000 | $ 1,900 |
Preferred Stock and Stockhold_3
Preferred Stock and Stockholders' Equity (Narrative) (Details) | Feb. 07, 2020shares | Dec. 31, 2019USD ($)stock_option_plan$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2019USD ($)$ / sharesshares | Aug. 09, 2018USD ($) | Dec. 31, 2016shares | Dec. 31, 2012shares |
Shareholders Equity [Line Items] | ||||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |||||
Preferred stock, par value (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||
Increase in shares authorized for grant (in shares) | 4,601,000 | 4,589,000 | 4,508,000 | |||||
Number of stock option plans | stock_option_plan | 2 | |||||||
Shares available for future grants (in shares) | 8,624,000 | 7,726,000 | 7,630,000 | 8,624,000 | 7,920,000 | |||
Total intrinsic value of options exercised | $ | $ 26,600,000 | $ 26,600,000 | $ 22,400,000 | |||||
Fair value of options vested | $ | $ 30,200,000 | $ 22,600,000 | $ 12,300,000 | |||||
Stock options outstanding (in shares) | 23,600,000 | 22,826,000 | 20,454,000 | 23,600,000 | 17,663,000 | |||
Aggregate purchase price | $ | $ 30,975,000 | $ 23,657,000 | ||||||
Shares issued in net-share settlement of cashless option exercises (in shares) | 1,200,000 | 0 | 0 | |||||
Employee and Director Stock Option | ||||||||
Shareholders Equity [Line Items] | ||||||||
Non-cash stock-based compensation expense | $ | $ 29,200,000 | $ 23,800,000 | $ 13,400,000 | |||||
Unrecognized compensation expense | $ | $ 55,000,000 | $ 55,000,000 | ||||||
Unrecognized compensation expense, weighted-average vesting period | 2 years 5 months 23 days | |||||||
Non-employee | ||||||||
Shareholders Equity [Line Items] | ||||||||
Stock options outstanding (in shares) | 0 | 0 | ||||||
2012 Equity Incentive Award Plan | ||||||||
Shareholders Equity [Line Items] | ||||||||
Increase in shares available for issuance based on percentage of common stock outstanding | 4.00% | 4.00% | ||||||
Exercise price as percentage of fair value of common stock, no less than | 100.00% | |||||||
Shares available for future grants (in shares) | 5,300,000 | |||||||
2012 Equity Incentive Award Plan | Minimum | ||||||||
Shareholders Equity [Line Items] | ||||||||
Stock options, vesting period | 1 year | |||||||
2012 Equity Incentive Award Plan | Maximum | ||||||||
Shareholders Equity [Line Items] | ||||||||
Stock options, vesting period | 4 years | |||||||
2004 Equity Incentive Plan | ||||||||
Shareholders Equity [Line Items] | ||||||||
Exercise price as percentage of fair value of common stock, no less than | 100.00% | |||||||
Shares available for future grants (in shares) | 0 | |||||||
2004 Equity Incentive Plan | Minimum | ||||||||
Shareholders Equity [Line Items] | ||||||||
Stock options, vesting period | 1 year | |||||||
2004 Equity Incentive Plan | Maximum | ||||||||
Shareholders Equity [Line Items] | ||||||||
Stock options, vesting period | 5 years | |||||||
Common Stock | Stock Repurchase Program | ||||||||
Shareholders Equity [Line Items] | ||||||||
Authorized amount | $ | $ 100,000,000 | |||||||
Shares repurchased (in shares) | 2,800,000 | 4,600,000 | ||||||
Aggregate purchase price | $ | $ 31,000,000 | $ 54,600,000 | ||||||
Cost per share (in dollars per share) | $ / shares | $ 11.14 | $ 11.91 | ||||||
Non-employee | ||||||||
Shareholders Equity [Line Items] | ||||||||
Non-cash stock-based compensation expense | $ | $ 200,000 | $ 0 | $ 0 | |||||
Common Stock | ||||||||
Shareholders Equity [Line Items] | ||||||||
Shares repurchased (in shares) | 2,780,000 | 1,807,000 | ||||||
Shares tendered to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises (in shares) | 631,000 | |||||||
Subsequent event | 2012 Equity Incentive Award Plan | ||||||||
Shareholders Equity [Line Items] | ||||||||
Increase in shares authorized for grant (in shares) | 4,600,000 |
Preferred Stock and Stockhold_4
Preferred Stock and Stockholders' Equity (Shares of Common Stock Reserved for Future Issuance) (Details) shares in Thousands | Dec. 31, 2019shares |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 32,224 |
Stock Options Outstanding | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 23,600 |
Shares Available For Grant Under Stock Option Plans | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance (in shares) | 8,624 |
Preferred Stock and Stockhold_5
Preferred Stock and Stockholders' Equity (Summary of Stock Plan Activity) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Shares Available For Future Grant | |||
Beginning balance (in shares) | 7,726 | 7,630 | 7,920 |
Increase in shares authorized for grant (in shares) | 4,601 | 4,589 | 4,508 |
Shares granted (in shares) | (4,976) | (5,599) | (5,282) |
Shares canceled and forfeited (in shares) | 1,273 | 1,106 | 484 |
Ending balance (in shares) | 8,624 | 7,726 | 7,630 |
Shares Subject to Options Outstanding | |||
Beginning balance (in shares) | 22,826 | 20,454 | 17,663 |
Shares granted (in shares) | 4,976 | 5,599 | 5,282 |
Shares exercised (in shares) | (2,929) | (2,121) | (2,007) |
Shares canceled and forfeited (in shares) | (1,273) | (1,106) | (484) |
Ending balance (in shares) | 23,600 | 22,826 | 20,454 |
Options exercisable (in shares) | 15,398 | ||
Options fully vested and expected to vest (in shares) | 22,847 | ||
Outstanding Options, Weighted- Average Exercise Price | |||
Beginning balance (in dollars per share) | $ 7.72 | $ 5.22 | $ 3.63 |
Shares granted (in dollars per share) | 11.52 | 16.27 | 9.90 |
Shares exercised (in dollars per share) | 3.57 | 4.40 | 3.60 |
Shares canceled and forfeited (in dollars per share) | 12.68 | 11.08 | 5.04 |
Ending balance (in dollars per share) | 8.77 | $ 7.72 | $ 5.22 |
Options exercisable (in dollars per share) | 6.80 | ||
Options fully vested and expected to vest (in dollars per share) | $ 8.63 | ||
Outstanding Options, Weighted Average Remaining Contractual Life | |||
Weighted average remaining contractual life | 6 years 6 months | ||
Weighted average remaining contractual life, Options exercisable | 5 years 5 months 12 days | ||
Weighted average remaining contractual life, Options fully vested and expected to vest | 6 years 5 months 8 days | ||
Outstanding Options, Aggregate Intrinsic Value | |||
Aggregate Intrinsic Value | $ 100,062 | ||
Options exercisable | 91,283 | ||
Options fully vested and expected to vest | $ 99,582 |
Preferred Stock and Stockhold_6
Preferred Stock and Stockholders' Equity (Summary of Options Outstanding and Exercisable) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Stock options outstanding (in shares) | 23,600 | 22,826 | 20,454 | 17,663 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 6 years 6 months | |||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 8.77 | $ 7.72 | $ 5.22 | $ 3.63 |
Options Outstanding, Aggregate Intrinsic Value | $ 100,062 | |||
Options Exercisable, Number of Shares (in shares) | 15,398 | |||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 6.80 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 91,283 | |||
$0.96 - $ 4.00 | ||||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum (in dollars per share) | $ 1.48 | |||
Exercise Price Of Options, maximum (in dollars per share) | $ 4 | |||
Stock options outstanding (in shares) | 6,950 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 4 years 2 months 12 days | |||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 3.02 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 63,079 | |||
Options Exercisable, Number of Shares (in shares) | 6,874 | |||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 3.11 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 62,446 | |||
$4.01 - $ 9.00 | ||||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum (in dollars per share) | $ 4.01 | |||
Exercise Price Of Options, maximum (in dollars per share) | $ 7 | |||
Stock options outstanding (in shares) | 3,233 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 4 years 3 months 18 days | |||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 5.32 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 21,974 | |||
Options Exercisable, Number of Shares (in shares) | 2,949 | |||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 5.22 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 20,296 | |||
$9.01 - $ 17.00 | ||||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum (in dollars per share) | $ 7.01 | |||
Exercise Price Of Options, maximum (in dollars per share) | $ 15 | |||
Stock options outstanding (in shares) | 9,353 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 8 years 3 months 18 days | |||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 10.73 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 15,009 | |||
Options Exercisable, Number of Shares (in shares) | 3,714 | |||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 9.99 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 8,541 | |||
$17.01 - $ 24.29 | ||||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum (in dollars per share) | $ 15.01 | |||
Exercise Price Of Options, maximum (in dollars per share) | $ 24.29 | |||
Stock options outstanding (in shares) | 4,064 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 8 years 1 month 6 days | |||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 16.85 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 0 | |||
Options Exercisable, Number of Shares (in shares) | 1,861 | |||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 16.89 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 0 |
Preferred Stock and Stockhold_7
Preferred Stock and Stockholders' Equity (Summary of Weighted-Average Assumptions and Resultant Fair Value-Based Measurements for Options Granted to Employees and Directors) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted-average assumptions for stock options granted: | |||
Risk-free interest rate | 2.34% | 2.68% | 1.99% |
Expected term | 6 years | 5 years 10 months 24 days | 6 years 1 month 6 days |
Expected volatility of stock price | 67.40% | 67.90% | 68.10% |
Dividend rate | 0.00% | 0.00% | 0.00% |
Weighted-average grant date fair value-based measurement (in dollars per share) | $ 7.09 | $ 10.11 | $ 6.14 |
Preferred Stock and Stockhold_8
Preferred Stock and Stockholders' Equity (Summary of Stock-Based Compensation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation capitalized in inventory | $ 120 | $ 87 | $ 0 |
Total stock-based compensation | 29,433 | 23,834 | 13,361 |
Cost of sales | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 144 | 259 | 0 |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 9,541 | 7,012 | 3,743 |
Selling, general and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 19,628 | $ 16,476 | $ 9,618 |
Net Income Per Share (Schedule
Net Income Per Share (Schedule of Computation of Net Income) (Loss) Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Numerator: | |||||||||||
Net income | $ 29,381 | $ 26,340 | $ 20,186 | $ 18,274 | $ 22,008 | $ 17,747 | $ 18,196 | $ 17,459 | $ 94,181 | $ 75,410 | $ 129,122 |
Denominator: | |||||||||||
Weighted-average shares used to compute basic net income per share (in shares) | 114,349 | 115,343 | 113,527 | ||||||||
Dilutive effect of employee stock options (in shares) | 8,217 | 11,345 | 10,988 | ||||||||
Weighted-average shares used to compute diluted net income per share (in shares) | 122,566 | 126,688 | 124,515 | ||||||||
Net income per share | |||||||||||
Basic (in dollars per share) | $ 0.26 | $ 0.23 | $ 0.18 | $ 0.16 | $ 0.19 | $ 0.15 | $ 0.16 | $ 0.15 | $ 0.82 | $ 0.65 | $ 1.14 |
Diluted (in dollars per share) | $ 0.24 | $ 0.22 | $ 0.17 | $ 0.15 | $ 0.18 | $ 0.14 | $ 0.14 | $ 0.14 | $ 0.77 | $ 0.60 | $ 1.04 |
Net Income Per Share (Details)
Net Income Per Share (Details) - shares shares in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options outstanding (in shares) | 23,600 | 22,826 | 20,454 | 17,663 |
Stock Options to Purchase Common Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average options excluded from the computation of diluted net income per share (in shares) | 9,900 | 5,000 | 1,100 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of income Tax (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ 116,676 | $ 92,153 | $ 52,806 |
Foreign | 0 | 0 | 0 |
Income before income taxes | $ 116,676 | $ 92,153 | $ 52,806 |
Income Taxes (Components of Inc
Income Taxes (Components of Income Tax (Benefit)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
U.S. federal taxes: | |||
Current | $ 1,716 | $ 0 | $ 0 |
Deferred | 15,944 | 14,243 | (71,839) |
Total U.S. federal taxes | 17,660 | 14,243 | (71,839) |
State taxes: | |||
Current | 3,900 | 2,676 | 388 |
Deferred | 935 | (176) | (4,865) |
Total state taxes | 4,835 | 2,500 | (4,477) |
Total | $ 22,495 | $ 16,743 | $ (76,316) |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | ||||
Income tax expense (benefit) | $ 22,495,000 | $ 16,743,000 | $ (76,316,000) | |
Decrease in valuation allowance | (200,000) | 1,300,000 | 116,900,000 | |
Unrecognized tax benefits | 6,029,000 | 4,756,000 | 4,139,000 | $ 3,527,000 |
Unrecognized tax benefits, accrued interest | 0 | 0 | 0 | |
Unrecognized tax benefits, accrued penalties | $ 0 | $ 0 | $ 0 | |
Document Period End Date | Dec. 31, 2019 | |||
Federal | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 7,700,000 | |||
California State | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | 75,200,000 | |||
Research and development tax credits | 7,500,000 | |||
Other States | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | 9,700,000 | |||
Research and development tax credit | Federal | ||||
Income Taxes [Line Items] | ||||
Research and development tax credits | 10,400,000 | |||
Orphan drug tax credit | Federal | ||||
Income Taxes [Line Items] | ||||
Research and development tax credits | $ 14,600,000 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Federal and state net operating losses | $ 7,391 | $ 23,551 |
Capitalized research and patent costs | 7,317 | 10,260 |
Research credits | 26,164 | 24,771 |
Stock-based compensation costs | 12,026 | 9,124 |
Operating lease liability | 857 | 0 |
Other | 4,186 | 6,137 |
Total deferred tax assets | 57,941 | 73,843 |
Operating lease right-of-use asset | (11,410) | (11,184) |
Deferred tax liabilities | ||
Operating lease right-of-use asset | (854) | 0 |
Total deferred tax liabilities | (854) | 0 |
Net deferred tax assets | $ 45,677 | $ 62,659 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Statutory Federal Income Tax Rate to Effective Rate) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal taxes at statutory rate | $ 24,502 | $ 19,354 | $ 17,954 |
Changes in valuation allowance | 0 | 0 | (119,765) |
Federal tax rate change impact to change in valuation allowance | 0 | 0 | 33,233 |
R&D and other credits | (4,504) | (2,178) | (1,199) |
State income taxes | 3,819 | 1,975 | (2,955) |
Non-deductible compensation | 657 | 394 | 33 |
Stock-based compensation | (2,107) | (3,165) | (3,826) |
Other | 128 | 363 | 209 |
Total | $ 22,495 | $ 16,743 | $ (76,316) |
Income Taxes (Changes in Balanc
Income Taxes (Changes in Balance of Gross Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning Balance | $ 4,756 | $ 4,139 | $ 3,527 |
Increase in tax positions for prior years | 261 | 0 | 150 |
Decrease in tax positions for prior years | 0 | (135) | 0 |
Increase in tax positions for current year | 1,012 | 752 | 462 |
Decrease in tax positions for current year | 0 | 0 | 0 |
Ending Balance | $ 6,029 | $ 4,756 | $ 4,139 |
Commitments and contingencies (
Commitments and contingencies (Narratives) (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Jan. 31, 2018 | Dec. 31, 2019 | |
Commitment And Contingencies [Line Items] | ||
Losses for contingent liability | $ 0 | |
Provision for a loss contingency | 0 | |
Dohmen Life Science Services | ||
Commitment And Contingencies [Line Items] | ||
Amount received under settlement agreement | $ 12,900,000 | |
Dohmen Life Science Services | Other Receivable | ||
Commitment And Contingencies [Line Items] | ||
Net receivables outstanding | $ 12,900,000 |
Quarterly Financial Data (Una_3
Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Product revenue, net | $ 87,895 | $ 81,505 | $ 72,257 | $ 64,829 | $ 66,831 | $ 64,445 | $ 62,312 | $ 57,659 | $ 306,486 | $ 251,247 | $ 159,201 |
Gross profit on product revenue | 86,459 | 80,054 | 70,880 | 63,589 | 65,252 | 63,137 | 61,158 | 56,485 | |||
Net income | $ 29,381 | $ 26,340 | $ 20,186 | $ 18,274 | $ 22,008 | $ 17,747 | $ 18,196 | $ 17,459 | $ 94,181 | $ 75,410 | $ 129,122 |
Basic net income per share (in dollars per share) | $ 0.26 | $ 0.23 | $ 0.18 | $ 0.16 | $ 0.19 | $ 0.15 | $ 0.16 | $ 0.15 | $ 0.82 | $ 0.65 | $ 1.14 |
Diluted net income per share (in dollars per share) | $ 0.24 | $ 0.22 | $ 0.17 | $ 0.15 | $ 0.18 | $ 0.14 | $ 0.14 | $ 0.14 | $ 0.77 | $ 0.60 | $ 1.04 |