Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 03, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | CORT | |
Entity Registrant Name | CORCEPT THERAPEUTICS INC | |
Entity Central Index Key | 1,088,856 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 116,051,242 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 31,165 | $ 31,062 |
Short-term marketable securities | 128,780 | 57,682 |
Trade receivables, net of allowances | 28,704 | 15,300 |
Other receivable | 0 | 12,896 |
Inventory | 4,947 | 4,576 |
Prepaid expenses and other current assets | 3,579 | 2,669 |
Total current assets | 197,175 | 124,185 |
Strategic inventory | 5,500 | 3,800 |
Property and equipment, net of accumulated depreciation | 552 | 518 |
Long-term marketable securities | 0 | 15,281 |
Other assets | 53 | 50 |
Deferred tax assets, net | 71,102 | 76,703 |
Total assets | 274,382 | 220,537 |
Current liabilities: | ||
Accounts payable | 6,365 | 8,579 |
Accrued clinical expenses | 5,397 | 2,247 |
Other accrued liabilities | 19,111 | 18,743 |
Total current liabilities | 30,873 | 29,569 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock | ||
Common stock | 116 | 115 |
Additional paid-in capital | 401,011 | 384,074 |
Accumulated other comprehensive loss | (127) | (75) |
Accumulated deficit | (157,491) | (193,146) |
Total stockholders’ equity | 243,509 | 190,968 |
Total liabilities and stockholders’ equity | $ 274,382 | $ 220,537 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Product revenue, net | $ 62,312 | $ 35,559 | $ 119,971 | $ 63,158 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | ||||
Cost of sales | $ 1,154 | $ 775 | $ 2,328 | $ 1,421 |
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 20,543 | $ 7,876 | $ 37,593 | $ 15,052 |
Selling, general and administrative | 19,981 | 14,113 | 38,421 | 29,150 |
Total operating expenses | 41,678 | 22,764 | 78,342 | 45,623 |
Income from operations | 20,634 | 12,795 | 41,629 | 17,535 |
Interest and other income (expense) | 562 | (98) | 856 | (323) |
Income before income taxes | 21,196 | 12,697 | 42,485 | 17,212 |
Income tax expense | (3,000) | (50) | (6,830) | (177) |
Net income | 18,196 | 12,647 | 35,655 | 17,035 |
Other comprehensive loss: | ||||
Net unrealized income (loss) on available-for-sale investments, net of tax impact of $(7), $0, $41 and $0, respectively | 25 | (5) | (127) | (17) |
Total comprehensive income | $ 18,221 | $ 12,642 | $ 35,528 | $ 17,018 |
Basic net income per share | $ 0.16 | $ 0.11 | $ 0.31 | $ 0.15 |
Diluted net income per share | $ 0.14 | $ 0.10 | $ 0.28 | $ 0.14 |
Weighted-average shares outstanding used in computing net income per share | ||||
Basic | 115,492 | 113,249 | 115,189 | 113,059 |
Diluted | 127,515 | 123,011 | 127,610 | 122,171 |
CONDENSED CONSOLIDATED STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | |||||
Net unrealized income (loss) on available-for-sale investments, tax impact | $ (7,000) | $ 0 | $ 41,000 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net income | $ 35,655 | $ 17,035 |
Adjustments to reconcile net income to net cash generated from operations: | ||
Stock-based compensation | 10,971 | 5,906 |
Deferred income taxes | 5,642 | 0 |
Accretion of interest (income) expense | (546) | 419 |
Amortization of debt financing costs | 0 | 11 |
Depreciation and amortization of property and equipment | 105 | 22 |
Changes in operating assets and liabilities: | ||
Trade receivables | (13,404) | 356 |
Other receivable | 12,896 | 0 |
Inventory | (2,071) | (1,135) |
Prepaid expenses and other current assets | (910) | (563) |
Other assets | (3) | (25) |
Accounts payable | (2,214) | (216) |
Accrued clinical expenses | 3,150 | 44 |
Other accrued liabilities | 370 | 3,273 |
Net cash provided by operating activities | 49,641 | 25,127 |
Cash flows from investing activities: | ||
Purchases of property and equipment | (140) | (308) |
Proceeds from maturities of marketable securities | 40,300 | 1,800 |
Purchases of marketable securities | (95,664) | (35,853) |
Cash used in investing activities | (55,504) | (34,361) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock upon exercise of options, net of issuance costs | 5,966 | 1,842 |
Payments related to debt obligation | 0 | (10,521) |
Net cash provided by (used in) financing activities | 5,966 | (8,679) |
Net increase (decrease) in cash and cash equivalents | 103 | (17,913) |
Cash and cash equivalents, at beginning of period | 31,062 | 51,536 |
Cash and cash equivalents, at end of period | $ 31,165 | $ 33,623 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 1. Basis of Presentation and Summary of Significant Accounting Policies Description of Business and Basis of Presentation Corcept Therapeutics Incorporated was incorporated in the State of Delaware in May 1998, and our headquarters are located in Menlo Park, California. We are a pharmaceutical company engaged in the discovery, development and commercialization of medications that treat severe metabolic, oncologic and psychiatric disorders by modulating the effect of the stress hormone cortisol. In 2012, the United States Food and Drug Administration (“FDA”) approved our first product, Korlym ® . Basis of Presentation We have prepared the June 30, 2018 balance sheet and statements of comprehensive income and cash flows for the three and six months ended June 30, 2018 and 2017 in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. They do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2018 are not necessarily indicative of the results to expect for the remainder of 2018 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2017 included in our Annual Report on Form 10-K. The December 31, 2017 balance sheet was derived from audited financial statements at that date. Principles of Consolidation Our 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. This entity has entered into no material financial transactions and has no assets or liabilities. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. 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 rely upon 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 are 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 purchased with original maturities of three months or less from the date of purchase to be cash equivalents. Cash equivalents are valued using Level 1 inputs, which approximate our cost. We invest a portion of our funds in marketable securities, primarily U.S. Treasury securities, commercial paper, corporate notes, asset-backed securities 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 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 statement of comprehensive income. Concentration of Credit Risk 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. 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 write down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value. Any expired inventory is destroyed and the related costs are recognized as cost of sales in the statement of comprehensive income in that period. Cost of sales 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 consume within 12 months of the balance sheet date as strategic inventory, a noncurrent asset. Debt Obligation Under our Financing Agreement with Biopharma, we made payments each quarter equal to 20 percent of our Korlym sales in the quarter. Accounting for the Financing Agreement required us to estimate the amount of each future quarterly payment and the accretion of interest expense. We extinguished our obligations under the Financing Agreement in July 2017. No further payments are due. 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 each of the three and six months ended June 30, 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 . 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 patients without insurance who do not qualify for charitable support. 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, based on our experience, 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 such 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, based on our experience, the portion of total rebates we expect will be claimed. We then (i) deduct this reserve from revenue in the period to which the rebates relate and (ii) include in accrued expenses on our consolidated balance sheet a current liability of equal amount . Chargebacks . Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. The SD recovers such discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym sold to SD in prior periods. We deduct from our revenue in each period chargebacks claimed by the SD for Korlym we sold to the SD that period. We also create a reserve for chargebacks we estimate the SD will claim in future periods against Korlym it purchased in the current period but 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 (i) deduct this reserve from revenue and (ii) include in accrued expenses on our consolidated balance sheet a current liability of equal amount. Patient Assistance Program: 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 . 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 been insignificant. The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2018. Chargebacks Government Rebates Total (in thousands) Balance at December 31, 2017: $ 927 $ 7,961 $ 8,888 Provision related to current period sales 1,421 14,280 15,701 Provision related to prior period sales — 181 181 Credit or payments made during the period (1,691 ) (10,987 ) (12,678 ) Balance at June 30, 2018: $ 657 $ 11,435 $ 12,092 Research and Development Research and development expenses include the direct cost of discovery research, 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 research, preclinical activities and clinical trials on our estimates of work completed, milestones achieved, patient enrollment and past experience with similar contracts. Our estimates include assessments of information from third-party contract research organizations and the status of our own clinical trials and other 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 requisite 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 . Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers,” which changes the way companies recognize revenue. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition and creates a new Topic 606, “Revenue from Contracts with Customers.” We conducted our analysis using the “portfolio of contracts” approach, which permits us to analyze as a group all contracts with similar characteristics. We have two customer groups: patients covered by insurance and the SD. We evaluated the contracts with customers governing our sales and reviewed the related disclosures, policies and controls, which we updated as necessary. Because some of our customer contracts are subject to rebates, chargebacks, discounts, co-pay assistance or other deductions (known as “variable consideration”) that affect the price of each transaction We estimated the amount of variable consideration using either the most likely amount or expected value method, as applicable. Topic 606 requires us to estimate the net price of each Korlym sale, including any variable consideration, and recognize the estimated amount as revenue at the time we deliver Korlym to the customer. On January 1, 2018, we adopted Topic 606 using the modified retrospective approach. Adoption of this standard had no impact on our financial statements. In January 2016, the FASB issued Accounting Standards Update No. 2016-01 “Financial Instruments: Recognition and Measurement of Financial Assets and Financial Liabilities.” This update changes accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it clarifies guidance regarding recognition of deferred tax assets that result from unrealized losses on available-for-sale debt securities. We adopted this standard on January 1, 2018. It had no impact on our financial statements. In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments,” which is intended to reduce the existing diversity in practice in how certain cash receipts and cash payments are classified in the statement of cash flows. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows, Restricted Cash (Topic 230) . In May 2017, the FASB issued ASU No. 2017-09, Stock Compensation (Topic 718): “Scope of Modification Accounting,” which changes the accounting for modifications to the terms and conditions of share-based payment awards. We adopted this standard on January 1, 2018. It did not have a material impact on our financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted 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 “lease liabilities” and “right-of-use assets.” We plan to adopt this new standard using the modified retrospective approach on January 1, 2019. While we are continuing to assess the potential impact of the standard, we believe the most significant impact will relate to our accounting for lease agreements for our leased office spaces. We expect that adoption will increase our “lease liabilities” and “right-of-use assets” equally . In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments—Credit Losses (Topic 326), 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.” The 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”). An entity 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 plan to adopt this standard on January 1, 2019. Although we have not concluded our evaluation, we do not expect the adoption of this standard to have a material 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 plan to adopt this new standard on January 1, 2019. Although we have not concluded our evaluation, we do not expect its adoption to have a material impact on our consolidated financial statements. |
Composition of Certain Balance
Composition of Certain Balance Sheet Items | 6 Months Ended |
Jun. 30, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Certain Balance Sheet Items | 2. Composition of Certain Balance Sheet Items Inventory The composition of inventory was as follows: June 30, December 31, 2018 2017 (in thousands) Raw materials $ 4,402 $ 4,287 Work in progress 132 64 Finished goods 5,913 4,025 Total inventory 10,447 8,376 Less strategic inventory classified as non-current (5,500 ) (3,800 ) Total inventory classified as current $ 4,947 $ 4,576 In order to be prepared for potential demand for Korlym and because we rely on single-source manufacturers of both the active pharmaceutical ingredient (“API”) for Korlym and Korlym tablets, we have purchased significant inventory quantities of these materials. We classify inventory we do not expect to sell within 12 months of the balance sheet date as “Strategic Inventory,” a long-term asset. Other Accrued Liabilities Other accrued liabilities consisted of the following: June 30, December 31, 2018 2017 (in thousands) Government rebates $ 11,435 $ 7,961 Accrued compensation 5,270 8,574 Income taxes payable 687 66 Legal fees 387 276 Professional fees 390 207 Accrued selling and marketing costs 301 208 Accrued manufacturing costs 69 955 Other 572 496 Total other accrued liabilities $ 19,111 $ 18,743 |
Available-for-Sale Securities a
Available-for-Sale Securities and Fair Value Measurements | 6 Months Ended |
Jun. 30, 2018 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Available-for-Sale Securities and Fair Value Measurements | 3. Available-for-Sale Securities and Fair Value Measurements Our available-for-sale securities included: Fair Value Estimated Fair Value Hierarchy June 30, December 31, Level 2018 2017 (in thousands) Corporate bonds Level 2 $ 37,309 $ 26,116 Commercial paper Level 2 66,811 32,637 Asset-backed securities Level 2 11,320 — Repurchase agreements Level 2 10,000 — U.S. treasury securities Level 1 24,809 14,210 Money market funds Level 1 1,097 14,979 Total Marketable securities $ 151,346 $ 87,942 Classified as: Cash equivalents $ 22,566 $ 14,979 Short-term marketable securities 128,780 57,682 Long-term marketable securities — 15,281 Total marketable securities $ 151,346 $ 87,942 The estimated fair value of marketable securities is based on quoted market prices for these or similar investments obtained from a commercial pricing service. The fair value of marketable securities classified within Level 2 is based upon inputs that may include benchmark yields, reported trades, broker/dealer quotes and issuer spreads. Our accumulated other comprehensive loss on our balance sheets consisted of net unrealized losses on available-for-sale investments of As of June 30, 2018, all our marketable securities had original maturities of less than two years. The weighted-average maturity of our holdings was four months. None of our marketable securities changed from one fair value hierarchy to another during the three and six months ended June 30, 2018. |
Debt Obligation
Debt Obligation | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Debt Obligation | 4. Debt Obligation As discussed in Note 1, Basis of Presentation and Summary of Significant Accounting Policies, Debt Obligation under the Financing Agreement with Biopharma we made quarterly payments to Biopharma equal to 20 percent of Korlym sales in that quarter. To secure our obligation, we granted Biopharma a security interest in our patents, trademarks, trade names, domain names, copyrights, know-how, books, records and regulatory approvals related to Korlym and certain other assets and any proceeds from them. Biopharma’s right to receive payments expired once our payments reached a total of $45.0 million, which occurred in July 2017. Our obligations under the Financing Agreement are now fully extinguished We recorded no interest expense for the three and six months ended June 30, 2018, compared to $0.1 million and $0.4 million for the three and six months ended June 30, 2017, respectively. Total accreted interest for the full term of the Financing Agreement was $15.0 million. We capitalized $0.1 million of issuance costs related to the Financing Agreement, which we amortized over the term of the obligation. At June 30, 2018 and December 31, 2017, there were no unamortized issuance costs. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Leases In February 2016, we extended the lease for our office space through 2019 and added more space. Effective May 1, 2016, we terminated our lease early and replaced it with a new one effective through March 31, 2019. On March 12, 2018, we amended that lease to add more space. Rent expense for each of the three months ended June 30, 2018 and 2017 was $0.3 million. Rent expense for the six months ended June 30, 2018 and 2017 was $0.6 million and $0.5 million, respectively. As of June 30, 2018, future minimum lease payments under non-cancelable operating leases were as follows: Lease Payments 2018 (remainder) $ 691 2019 342 Thereafter — Total $ 1,033 Contingencies 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 potential outcomes, assuming 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. No losses and no provision for a loss contingency have been recorded to date. |
Stock Option Plans
Stock Option Plans | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Plans | 6. Stock Option Plans We have two stock option plans – the 2004 Equity Incentive Plan (the “2004 Plan”) and the 2012 Incentive Award Plan (the “2012 Plan”). On February 7, 2018, our Board of Directors authorized a 4.6 million increase in the shares available for grant under the 2012 Plan pursuant to the annual increase provisions of the 2012 Plan. During the six months ended June 30, 2018, we issued 1,300,000 shares of our common stock upon the exercise of stock options. The following table summarizes our stock-based compensation: Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 (in thousands) (in thousands) Research and development $ 1,963 $ 850 $ 3,427 $ 1,503 Selling, general and administrative 4,054 2,355 7,544 4,403 Total stock-based compensation $ 6,017 $ 3,205 $ 10,971 $ 5,906 |
Net Income Per Share
Net Income Per Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | 7. 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 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: Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 (in thousands) (in thousands) Numerator: Net income $ 18,196 $ 12,647 $ 35,655 $ 17,035 Denominator: Weighted-average shares used to compute basic net income per share 115,492 113,249 115,189 113,059 Dilutive effect of employee stock options 12,023 9,762 12,421 9,112 Weighted-average shares used to compute diluted net income per share 127,515 123,011 127,610 122,171 Net income per share attributable to common stockholders Basic $ 0.16 $ 0.11 $ 0.31 $ 0.15 Diluted $ 0.14 $ 0.10 $ 0.28 $ 0.14 On a weighted-average basis, 5.0 million and 3.9 million stock options outstanding during the three and six months ended June 30, 2018, respectively, compared to 4.1 million and 4.2 million stock options outstanding during the three and six months ended June 30, 2017 were excluded from the computation of diluted net income per share because including them would have reduced dilution. The following table presents information on securities outstanding as of the end of each period that could potentially dilute the per share data: June 30, 2018 2017 (in thousands) Stock options outstanding 22,983 21,306 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income taxes We recorded an income tax expense of $3.0 million and $6.8 million for the three and six months ended June 30, 2018, respectively, compared to $0.1 million and $0.2 million for the three and six months ended June 30, 2017. Income tax expense for the three and six months ended June 30, 2018, was primarily attributed to the reduction of deferred Our effective tax rate differed from the federal statutory rate due to state income taxes and non-deductible stock-based compensation, which increased our tax expense, offset by research and development tax credits and the reduction in taxable income arising from the exercise of employee stock options during the reporting period . Each quarter, we assess our ability to use our deferred tax assets to offset our expected federal and state taxable income. In our deferred tax assets except those applicable to California. 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 Tax Cuts and Jobs Act of 2017 (“Tax Act”), which became law on December 22, 2017, significantly changed the federal income tax law. Among other things, effective January 1, 2018, the new law reduced the corporate income tax rate from 35 percent to 21 percent, repealed the corporate alternative minimum tax, limited some business deductions, modified the maximum deduction of future net operating losses generated with no carryback but an indefinite carryforward provision and extended the compensation deduction limit applicable to certain highly-compensated executives of publicly traded companies to cover additional executive roles. Accounting Standards Codification (ASC) 740, Income Taxes, requires companies to recognize the effect of tax law changes, such as those enacted by the Tax Act, in the period such changes take effect. We have adjusted our deferred taxes based on the reduction of the U.S. federal corporate tax rate from 35 percent to 21 percent and assessed the realizability of our deferred tax assets based on our current understanding of the new law. As permitted by SEC Staff Accounting Bulletin 118, at December 31, 2017 our accounting for the impacts of the Tax Act was provisional. At June 30, 2018, there have been no changes in our accounting for provisional amounts. We will continue to assess the Tax Act’s impact for the rest of 2018, including its interpretation by regulatory authorities and the courts, and will adjust our disclosures and financial presentation as necessary. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events On August |
Basis of Presentation and Sum15
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation We have prepared the June 30, 2018 balance sheet and statements of comprehensive income and cash flows for the three and six months ended June 30, 2018 and 2017 in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. They do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2018 are not necessarily indicative of the results to expect for the remainder of 2018 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2017 included in our Annual Report on Form 10-K. The December 31, 2017 balance sheet was derived from audited financial statements at that date. |
Principles of Consolidation | Principles of Consolidation Our 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. This entity has entered into no material financial transactions and has no assets or liabilities. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. 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 rely upon 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 are 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 purchased with original maturities of three months or less from the date of purchase to be cash equivalents. Cash equivalents are valued using Level 1 inputs, which approximate our cost. We invest a portion of our funds in marketable securities, primarily U.S. Treasury securities, commercial paper, corporate notes, asset-backed securities 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 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 statement of comprehensive income. |
Concentration of Credit Risk | Concentration of Credit Risk 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. |
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 write down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value. Any expired inventory is destroyed and the related costs are recognized as cost of sales in the statement of comprehensive income in that period. Cost of sales 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 consume within 12 months of the balance sheet date as strategic inventory, a noncurrent asset. |
Debt Obligation | Debt Obligation Under our Financing Agreement with Biopharma, we made payments each quarter equal to 20 percent of our Korlym sales in the quarter. Accounting for the Financing Agreement required us to estimate the amount of each future quarterly payment and the accretion of interest expense. We extinguished our obligations under the Financing Agreement in July 2017. No further payments are due. |
Revenue | 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 each of the three and six months ended June 30, 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 . 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 patients without insurance who do not qualify for charitable support. 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, based on our experience, 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 such 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, based on our experience, the portion of total rebates we expect will be claimed. We then (i) deduct this reserve from revenue in the period to which the rebates relate and (ii) include in accrued expenses on our consolidated balance sheet a current liability of equal amount . Chargebacks . Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. The SD recovers such discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym sold to SD in prior periods. We deduct from our revenue in each period chargebacks claimed by the SD for Korlym we sold to the SD that period. We also create a reserve for chargebacks we estimate the SD will claim in future periods against Korlym it purchased in the current period but 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 (i) deduct this reserve from revenue and (ii) include in accrued expenses on our consolidated balance sheet a current liability of equal amount. Patient Assistance Program: 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 . 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 been insignificant. The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2018. Chargebacks Government Rebates Total (in thousands) Balance at December 31, 2017: $ 927 $ 7,961 $ 8,888 Provision related to current period sales 1,421 14,280 15,701 Provision related to prior period sales — 181 181 Credit or payments made during the period (1,691 ) (10,987 ) (12,678 ) Balance at June 30, 2018: $ 657 $ 11,435 $ 12,092 |
Research and Development | Research and Development Research and development expenses include the direct cost of discovery research, 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 research, preclinical activities and clinical trials on our estimates of work completed, milestones achieved, patient enrollment and past experience with similar contracts. Our estimates include assessments of information from third-party contract research organizations and the status of our own clinical trials and other development and administrative activities . |
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 requisite 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 . |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers,” which changes the way companies recognize revenue. This ASU supersedes the revenue recognition requirements in ASC Topic 605, Revenue Recognition and creates a new Topic 606, “Revenue from Contracts with Customers.” We conducted our analysis using the “portfolio of contracts” approach, which permits us to analyze as a group all contracts with similar characteristics. We have two customer groups: patients covered by insurance and the SD. We evaluated the contracts with customers governing our sales and reviewed the related disclosures, policies and controls, which we updated as necessary. Because some of our customer contracts are subject to rebates, chargebacks, discounts, co-pay assistance or other deductions (known as “variable consideration”) that affect the price of each transaction We estimated the amount of variable consideration using either the most likely amount or expected value method, as applicable. Topic 606 requires us to estimate the net price of each Korlym sale, including any variable consideration, and recognize the estimated amount as revenue at the time we deliver Korlym to the customer. On January 1, 2018, we adopted Topic 606 using the modified retrospective approach. Adoption of this standard had no impact on our financial statements. In January 2016, the FASB issued Accounting Standards Update No. 2016-01 “Financial Instruments: Recognition and Measurement of Financial Assets and Financial Liabilities.” This update changes accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it clarifies guidance regarding recognition of deferred tax assets that result from unrealized losses on available-for-sale debt securities. We adopted this standard on January 1, 2018. It had no impact on our financial statements. In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments,” which is intended to reduce the existing diversity in practice in how certain cash receipts and cash payments are classified in the statement of cash flows. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows, Restricted Cash (Topic 230) . In May 2017, the FASB issued ASU No. 2017-09, Stock Compensation (Topic 718): “Scope of Modification Accounting,” which changes the accounting for modifications to the terms and conditions of share-based payment awards. We adopted this standard on January 1, 2018. It did not have a material impact on our financial statements. |
Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Issued Accounting Pronouncements Not Yet Adopted 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 “lease liabilities” and “right-of-use assets.” We plan to adopt this new standard using the modified retrospective approach on January 1, 2019. While we are continuing to assess the potential impact of the standard, we believe the most significant impact will relate to our accounting for lease agreements for our leased office spaces. We expect that adoption will increase our “lease liabilities” and “right-of-use assets” equally . In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments—Credit Losses (Topic 326), 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.” The 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”). An entity 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 plan to adopt this standard on January 1, 2019. Although we have not concluded our evaluation, we do not expect the adoption of this standard to have a material 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 plan to adopt this new standard on January 1, 2019. Although we have not concluded our evaluation, we do not expect its adoption to have a material impact on our consolidated financial statements. |
Income Taxes | Accounting Standards Codification (ASC) 740, Income Taxes, requires companies to recognize the effect of tax law changes, such as those enacted by the Tax Act, in the period such changes take effect. We have adjusted our deferred taxes based on the reduction of the U.S. federal corporate tax rate from 35 percent to 21 percent and assessed the realizability of our deferred tax assets based on our current understanding of the new law. As permitted by SEC Staff Accounting Bulletin 118, at December 31, 2017 our accounting for the impacts of the Tax Act was provisional. At June 30, 2018, there have been no changes in our accounting for provisional amounts. We will continue to assess the Tax Act’s impact for the rest of 2018, including its interpretation by regulatory authorities and the courts, and will adjust our disclosures and financial presentation as necessary. |
Basis of Presentation and Sum16
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Product Revenue Allowance and Reserve Categories | The following table summarizes activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2018. Chargebacks Government Rebates Total (in thousands) Balance at December 31, 2017: $ 927 $ 7,961 $ 8,888 Provision related to current period sales 1,421 14,280 15,701 Provision related to prior period sales — 181 181 Credit or payments made during the period (1,691 ) (10,987 ) (12,678 ) Balance at June 30, 2018: $ 657 $ 11,435 $ 12,092 |
Composition of Certain Balanc17
Composition of Certain Balance Sheet Items (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Inventory | June 30, December 31, 2018 2017 (in thousands) Raw materials $ 4,402 $ 4,287 Work in progress 132 64 Finished goods 5,913 4,025 Total inventory 10,447 8,376 Less strategic inventory classified as non-current (5,500 ) (3,800 ) Total inventory classified as current $ 4,947 $ 4,576 |
Other Accrued Liabilities | June 30, December 31, 2018 2017 (in thousands) Government rebates $ 11,435 $ 7,961 Accrued compensation 5,270 8,574 Income taxes payable 687 66 Legal fees 387 276 Professional fees 390 207 Accrued selling and marketing costs 301 208 Accrued manufacturing costs 69 955 Other 572 496 Total other accrued liabilities $ 19,111 $ 18,743 |
Available-for-Sale Securities18
Available-for-Sale Securities and Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Schedule of Available-for-Sale Securities | Our available-for-sale securities included: Fair Value Estimated Fair Value Hierarchy June 30, December 31, Level 2018 2017 (in thousands) Corporate bonds Level 2 $ 37,309 $ 26,116 Commercial paper Level 2 66,811 32,637 Asset-backed securities Level 2 11,320 — Repurchase agreements Level 2 10,000 — U.S. treasury securities Level 1 24,809 14,210 Money market funds Level 1 1,097 14,979 Total Marketable securities $ 151,346 $ 87,942 Classified as: Cash equivalents $ 22,566 $ 14,979 Short-term marketable securities 128,780 57,682 Long-term marketable securities — 15,281 Total marketable securities $ 151,346 $ 87,942 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments under Non-Cancelable Operating Leases | As of June 30, 2018, future minimum lease payments under non-cancelable operating leases were as follows: Lease Payments 2018 (remainder) $ 691 2019 342 Thereafter — Total $ 1,033 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-Based Compensation | Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 (in thousands) (in thousands) Research and development $ 1,963 $ 850 $ 3,427 $ 1,503 Selling, general and administrative 4,054 2,355 7,544 4,403 Total stock-based compensation $ 6,017 $ 3,205 $ 10,971 $ 5,906 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Net Income Per Share | The following table shows the computation of net income per share for each period: Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 (in thousands) (in thousands) Numerator: Net income $ 18,196 $ 12,647 $ 35,655 $ 17,035 Denominator: Weighted-average shares used to compute basic net income per share 115,492 113,249 115,189 113,059 Dilutive effect of employee stock options 12,023 9,762 12,421 9,112 Weighted-average shares used to compute diluted net income per share 127,515 123,011 127,610 122,171 Net income per share attributable to common stockholders Basic $ 0.16 $ 0.11 $ 0.31 $ 0.15 Diluted $ 0.14 $ 0.10 $ 0.28 $ 0.14 |
Securities Outstanding that could Potentially Dilute Per Share Data | The following table presents information on securities outstanding as of the end of each period that could potentially dilute the per share data: June 30, 2018 2017 (in thousands) Stock options outstanding 22,983 21,306 |
Basis of Presentation and Sum22
Basis of Presentation and Summary of Significant Accounting Policies (Narrative) (Details) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018SegmentGroup | |
Accounting Policies [Line Items] | ||
Date of incorporation | May 1, 1998 | |
Entity incorporated, State | Delaware | |
Number of operating segments | Segment | 1 | |
Number of customer groups | Group | 2 | |
Financing Agreement with Biopharma | ||
Accounting Policies [Line Items] | ||
Payments as equivalent percentage of sales | 20.00% | |
Debt obligation, periodic payment | quarterly | |
Maximum | ||
Accounting Policies [Line Items] | ||
Investments maturity at time of purchase | 36 months | |
Maximum | Sales Revenue, Net | Customer Concentration Risk | ||
Accounting Policies [Line Items] | ||
Percentage of sales to one specialty distributor | 1.00% | 1.00% |
Basis of Presentation and Sum23
Basis of Presentation and Summary of Significant Accounting Policies (Summary of Product Revenue Allowance and Reserve Categories) (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2017: | $ 8,888 |
Provision related to current period sales | 15,701 |
Provision related to prior period sales | 181 |
Credit or payments made during the period | (12,678) |
Balance at June 30, 2018: | 12,092 |
Chargebacks | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2017: | 927 |
Provision related to current period sales | 1,421 |
Provision related to prior period sales | 0 |
Credit or payments made during the period | (1,691) |
Balance at June 30, 2018: | 657 |
Government Rebates | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2017: | 7,961 |
Provision related to current period sales | 14,280 |
Provision related to prior period sales | 181 |
Credit or payments made during the period | (10,987) |
Balance at June 30, 2018: | $ 11,435 |
Composition of Certain Balanc24
Composition of Certain Balance Sheet Items (Composition of Inventory) (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 4,402 | $ 4,287 |
Work in progress | 132 | 64 |
Finished goods | 5,913 | 4,025 |
Total inventory | 10,447 | 8,376 |
Less strategic inventory classified as non-current | (5,500) | (3,800) |
Total inventory classified as current | $ 4,947 | $ 4,576 |
Composition of Certain Balanc25
Composition of Certain Balance Sheet Items (Other Accrued Liabilities) (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Balance Sheet Related Disclosures [Abstract] | ||
Government rebates | $ 11,435 | $ 7,961 |
Accrued compensation | 5,270 | 8,574 |
Income taxes payable | 687 | 66 |
Legal fees | 387 | 276 |
Professional fees | 390 | 207 |
Accrued selling and marketing costs | 301 | 208 |
Accrued manufacturing costs | 69 | 955 |
Other | 572 | 496 |
Total other accrued liabilities | $ 19,111 | $ 18,743 |
Available-for-Sale Securities26
Available-for-Sale Securities and Fair Value Measurements (Schedule of Available-for-Sale Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Schedule Of Available For Sale Securities [Line Items] | ||
Short-term marketable securities | $ 128,780 | $ 57,682 |
Long-term marketable securities | 0 | 15,281 |
Estimated Fair Value | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 151,346 | 87,942 |
Cash equivalents | 22,566 | 14,979 |
Short-term marketable securities | 128,780 | 57,682 |
Long-term marketable securities | 0 | 15,281 |
Corporate Bonds | Estimated Fair Value | Level 2 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 37,309 | 26,116 |
Commercial Paper | Estimated Fair Value | Level 2 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 66,811 | 32,637 |
Asset Backed Securities | Estimated Fair Value | Level 2 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 11,320 | 0 |
Repurchase Agreements | Estimated Fair Value | Level 2 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 10,000 | 0 |
U.S. Treasury Securities | Estimated Fair Value | Level 1 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | 24,809 | 14,210 |
Money Market Funds | Estimated Fair Value | Level 1 | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities | $ 1,097 | $ 14,979 |
Available-for-Sale Securities27
Available-for-Sale Securities and Fair Value Measurements (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |||||
Net unrealized losses on available-for-sale investments | $ 25,000 | $ (5,000) | $ (127,000) | $ (17,000) | $ (100,000) |
Net unrealized losses on available-for-sale investments, tax impact | (7,000) | $ 0 | $ 41,000 | $ 0 | $ 0 |
Maximum maturity period | 2 years | ||||
Weighted average maturity period | 4 months | ||||
Fair value, assets, Level 1 to Level 2 transfers, amount | 0 | $ 0 | |||
Fair value, assets, Level 2 to Level 1 transfers, amount | $ 0 | $ 0 |
Debt Obligation (Narrative) (De
Debt Obligation (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Contractual Obligation [Line Items] | |||||
Accretion of interest expense | $ 0 | $ 100,000 | $ 0 | $ 400,000 | |
Issuance costs capitalized | 100,000 | 100,000 | |||
Unamortized issuance cost | 0 | $ 0 | $ 0 | ||
Financing Agreement with Biopharma | |||||
Contractual Obligation [Line Items] | |||||
Payments as equivalent percentage of sales | 20.00% | ||||
Debt obligation, periodic payment | quarterly | ||||
Cumulative payments to be made under financing agreement | $ 45,000,000 | $ 45,000,000 | |||
Accretion of interest expense | $ 15,000,000 |
Commitments and Contingencies29
Commitments and Contingencies (Narratives) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | ||||
Lease expiration date | Mar. 31, 2019 | |||
Rent expenses | $ 300,000 | $ 300,000 | $ 600,000 | $ 500,000 |
Losses for contingent liability | $ 0 | 0 | ||
Provision for a loss contingency | $ 0 |
Commitments and Contingencies30
Commitments and Contingencies (Schedule of Future Minimum Lease Payments under Non-Cancelable Operating Leases) (Details) $ in Thousands | Jun. 30, 2018USD ($) |
Operating Leases Future Minimum Payments Due [Abstract] | |
2018 (remainder) | $ 691 |
2,019 | 342 |
Thereafter | 0 |
Total | $ 1,033 |
Stock Option Plans (Narrative)
Stock Option Plans (Narrative) (Details) | Feb. 07, 2018shares | Jun. 30, 2018itemshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of stock option plans | item | 2 | |
Common shares issued upon exercise of options | 1,300,000 | |
2012 Equity Incentive Award Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Increase in shares authorized for grant | 4,600,000 |
Stock Option Plans (Summary of
Stock Option Plans (Summary of Stock-Based Compensation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 6,017 | $ 3,205 | $ 10,971 | $ 5,906 |
Research And Development Expense | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 1,963 | 850 | 3,427 | 1,503 |
Selling, General And Administrative Expense | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 4,054 | $ 2,355 | $ 7,544 | $ 4,403 |
Schedule of Computation of Net
Schedule of Computation of Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Numerator: | ||||
Net income | $ 18,196 | $ 12,647 | $ 35,655 | $ 17,035 |
Denominator: | ||||
Weighted-average shares used to compute basic net income per share | 115,492 | 113,249 | 115,189 | 113,059 |
Dilutive effect of employee stock options | 12,023 | 9,762 | 12,421 | 9,112 |
Weighted-average shares used to compute diluted net income per share | 127,515 | 123,011 | 127,610 | 122,171 |
Net income per share attributable to common stockholders | ||||
Basic | $ 0.16 | $ 0.11 | $ 0.31 | $ 0.15 |
Diluted | $ 0.14 | $ 0.10 | $ 0.28 | $ 0.14 |
Net Income Per Share (Details)
Net Income Per Share (Details) - shares shares in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Stock Options to Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average options excluded from the computation of diluted net income per share | 5 | 4.1 | 3.9 | 4.2 |
Net Income Per Share (Securitie
Net Income Per Share (Securities Outstanding that could Potentially Dilute Per Share Data) (Details) - shares shares in Thousands | Jun. 30, 2018 | Jun. 30, 2017 |
Earnings Per Share [Abstract] | ||
Securities outstanding that could potentially dilute per share data | 22,983 | 21,306 |
Income Taxes - (Narrative) (Det
Income Taxes - (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||||
Income tax expense | $ 3,000,000 | $ 50,000 | $ 6,830,000 | $ 177,000 | |
Reduction of deferred tax assets | 2,500,000 | 5,600,000 | |||
State income tax expense | 500,000 | 1,200,000 | |||
Net operating loss carryforwards | $ 0 | $ 0 | $ 0 | $ 0 | |
Corporate income tax rate | 21.00% | 35.00% |
Subsequent Events - (Narrative)
Subsequent Events - (Narrative) (Details) - Stock Repurchase Program - Common Stock - Subsequent Event | Aug. 09, 2018USD ($) |
Subsequent Event [Line Items] | |
Stock repurchase amount | $ 100,000,000 |
Stock repurchase program expiration date | Jun. 30, 2019 |